Just the Vax

Wakefield's Legal "Justice" Fund

2012-01-10T11:09:00.000-05:00

A website has recently been launched so that you can donate to Wakefield's Legal Justice Fund. A legal fund such as this may be set up as a non-profit, tax-exempt charity. The questions arise; what can one do with the funds once litigation has concluded and why does he need this fund since he is not impoverished and has also enlisted the legal services of his friend, William Parrish? Parrish, by the way is not an expert in defamation/libel law but rather an intellectual property and business tort lawyer.

Another question arises and that is, why did the Wakefield camp wait until nearly a year, when the statute of limitations for libel was up if the BMJ series about him was so damaging and defamatory? The first BMJ report on Wakefield was published 5 January 2011 and Wakefield filed suit on 3 January 2012. Wakefield has unsuccessfully sued Deer in the UK and was Wakefield's undoing actually because the discovery provided Mr. Deer with the children's anonymised medical records. A formidable hurdle for Wakefield to clear in his latest debacle is Texas' Anti-SLAPP law which not only may not allow him to present his case to a jury but leaves him vulnerable to court, legal and punitive costs owed to Brian Deer and Fiona Godlee (editor of the BMJ). Of course this will be interesting to see how it plays out in the end but I don't think it will end well for Dr. Wakefield, although that may be what he intends.

As usual, Liz Ditz is aggregating various media discussions on this topic.

Anti-Vaccine Nonsense on Facebook

2011-12-18T23:14:00.002-05:00

An anti-vaxx post is circulating on Facebook that is completely unoriginal but is being disseminated by someone unknown to me and the content is humorously paranoid and wrong.

This information is by a man who calls himself Dr. Michael Gaeta and fancies himself "a visionary educator, clinician, writer and publisher in the field of natural healthcare." He calls himself doctor, no doubt to pad his credentials but he is really an acupuncturist who "graduated" from a woo college in New York. There is no recognised profession as "Doctor of Acupuncture" from any accredited institution or recognised organisation. As such, Mr. Gaeta has not undertaken the requisite studies to allow him to be competent in matters surrounding vaccinology, considerably more complicated and attested than poking needles into "meridians". Nothing more than a certification squatter really.

Of particular interest with regards to Mr. Gaeta and his "seminars" is his invocation of "an impeccably-credentialed, pro-vaccine PhD immunologist." Who, of course, "confirmed what I and others have been saying for years." She can be heard on an audio file but here is the text of her statements:

Q. So the science seems fairly clear that for the first year of life, probably, that the immunization is not stimulating the kind of response we expect it to stimulate.
A. True.
Q. So what’s the rationale for continuing to do that if it’s not doing what it’s supposed to be [doing]?
A. The vaccines are given at pediatric wellness visits, and the idea is that you are training the parent to bring their child in at all the pediatric wellness visits, and that it’s only the year visit that actually is truly important. But that for most parents you are not going to get them to bring their kid in if they don’t come in at two months, four months, and six months. And so it’s actually more of a training thing.
It’s interesting, I was on the phone with [?] county public health last week, with one of their vaccine nurses. She was like, ‘Oh, you’re talking about vaccines? Make sure you tell them they have to do that year shot because the first three [the 2, 4 and 6 month shots] don’t work.’ I was like, ‘Yeah, I know.’ [laughter].

This is Mr. Gaeta's summary of her talk:

The first was that it is pointless to administer drugs intended to stimulate antibody production to babies who are too young to produce antibodies. Infants in their first year mostly depend on generalized, non-specific immunity, including (hopefully) immunoglobulins from breast milk, to protect their young bodies from infection. They do not produce antibodies of their own until about age one. Despite this basic fact, the medical establishment insists administering a total of 19 shots, containing 24 vaccines, to infants on the 2, 4 and 6 month pediatric visits (Source: cdc.gov). Somehow, the basic facts of human physiology and development do not apply to vaccines.

Of course it is demonstrably false that, "So the science seems fairly clear that for the first year of life, probably, that the immunization is not stimulating the kind of response we expect it to stimulate." and , "The first was that it is pointless to administer drugs intended to stimulate antibody production to babies who are too young to produce antibodies. Infants in their first year mostly depend on generalized, non-specific immunity, including (hopefully) immunoglobulins from breast milk, to protect their young bodies from infection. They do not produce antibodies of their own until about age one."

These statements alone should be a glaring tip-off that the speakers don't know what they are talking about. Mr. Gaeta is an acupuncturist so it is a given he is clueless about immunology and his "impeccably-credentialed, pro-vaccine PhD immunologist" either is not so impeccably-credentialed and/or has tired of languishing in obscurity and ineptness and jumped onto the anti-vaxx bandwagon for attention. It is demonstrably false that infants don't produce antibodies until one year old. All a layperson needs to do is look at a package insert for clinical trial summaries on infants less than one year old to see that there is antibody response.

It is well-known, although not to Mr. Gaeta and Mizz Impeccably-Credentialed PhD Immunologist, that:

Neonates develop the capacity to respond to foreign antigens before they are born. B and T cells are present by 14 weeks’ gestation and express an enormous array of antigen-specific receptors.5 Although the fetal immune system has the potential to respond to large numbers of foreign antigens, few foreign antigens are present in utero, and cells of the immune system are, therefore, primarily “naıve” at birth.

That is from: http://www.pediatrics.org/cgi/content/full/109/1/124 One can always look it up the references in the literature for that statement or even look it up in the many textbooks available. I guess Mizz Impeccably-Credentialed PhD Immunologist slept during that portion of her education. It is also untrue that paediatric well visits are "to train" parents. If that is the case then every public health programme in the world is in on this great hoax. Many infant vaccines are not fully effective until the full series are given, infants are particularly susceptible to complications from some of the vaccine preventable diseases thus are generally given from two to six months old.

Mizz Impeccably-Credentialed PhD Immunologist then invokes a nameless "public health vaccine nurse" in an appeal to authority and popularity. This somehow induces laughter with the audience of "health professionals" which Mr. Gaeta claims he gives his seminars to. But a glance at his testimonials reveals that the "health professionals" in attendance are also primarily sCAM practitioners such as chiropractors, naturopaths and nutritionists. It is no small wonder that such a group would lap up unqualified, completely fallacious statements because they are notoriously anti-vaccine and such claims massages their confirmation bias.

What good is a great vaccine hoax messenger without the whiff of intrigue:

You can listen to an audio file of an exchange between an attendee and the immunologist about this question. She declined to be identified in my presentations, including this post, perhaps because she knows that anyone who speaks the truth about vaccines is savaged by the medical establishment and their compliant lapdogs in the mainstream media. It is professional suicide for anyone in conventional medicine to question the unquestionable (yet unproven) assumptions about vaccines: that they are effective, safe and necessary. I have stopped lecturing publicly on this subject for the same reason, because the attacks in recent years have become particularly vicious; and because my main message in my teachings is about personal responsibility, innate wholeness and opening to the largeness of who we are, not just vaccines.

I guess it has become fashionable to be persecuted by The Man™ and lends believability to the poor down-trodden speaker-of-the-truth. But no, Mr. Gaeta and Mizz Impeccably-Credentialed PhD Immunologist are free to make fools of themselves in any venue that will have them without any fear of retribution from the New World Order.

Of course it won't go unnoticed the response to this tosh that Dr. Bob Sears had:

This is interesting info. I agree that the general medical teaching on immunology is that infants don’t have much of their own immune system during the first year of life, and they rely heavily on the immunity they gain from mom through th...e placenta and from breastmilk. I don’t know whether babies actually don’t make ANY antibodies during this time, OR if they simply have a lower capability to do so. This immunologist seems to say that they don’t make any? My understanding is that it isn’t that they don’t have any immune system or can’t make any antibodies, but rather that these abilities are immature and lower than what it will eventually be, but that there is still some capability there.
What seems to contradict what this immunologist is saying is that the vaccine product inserts do provide data on antibody responses to vaccines, showing that infants do generate antibodies in response to the vaccines, and that the response increases after each dose.
Do you know if this immunologist addresses that specific issue? I’d be curious.

He almost gets it right but blunders with, " I agree that the general medical teaching on immunology is that infants don’t have much of their own immune system during the first year of life, and they rely heavily on the immunity they gain from mom through the placenta and from breastmilk." What is so profoundly laughable, if not frightening about his response is that he wrote two books about paediatric vaccines and touts himself as a "vaccine expert" and doesn't really know how to answer the question. I attribute this to part incompetence and part insecurity to disagree with a fellow anti-vaxxer. It is a fringe science variant of "honour among thieves" and to quote Dr. James Laidler, "Utter nonsense treated like scientific data, people nodding in sage agreement with blatant contradictions, and theories made out of thin air and unrelated facts—"

Dr. Bob is really only doing it for the worried parents

2011-11-27T05:50:00.003-05:00

not because of any own concerns over vaccine safety. The Sears' website has been modified again, and here is Dr. Bob himself, explaining the origin of his alternative vaccination schedule. It is really all about parental concerns (not about his own flirtations with the anti-vaccine crowd, or the fact that his "alternative" schedule almost doubles the number of office visits for vaccine purposes at $75 to $200 dollar a pop). Good to know, right?

Immunity

2011-11-26T13:32:00.004-05:00

I came across this on Ratbags.com - a very short movie by Jasmine Marosvary - this made me think of Nelyn. I met his mum Lynne on ivillage some years ago. The first mother my age, who had lost a child to a vaccine preventable disease. Lynne was lobbying for the licensing of pertussis vaccine for adults, which has since happened. Vaccination saves lives:

And another SSPE case: Angelina is dying

2011-11-07T09:22:00.004-05:00

I had seen girl previously on a board, but the parents had not gone public until now, after Natalie's death.

Angelina caught measles in 2006 from an adult, when she was 7 months old. She recovered well - this is her before SSPE broke out:

This is her now:

Gina, Angelina's mum says (my translation):

"In February of this year, we noticed pronounced problems with our daughter. She kept falling off her bike, and had speech blockades. When this was getting worse, we went to the clinic. The diagnosis SSPE was a shock for us. Our child became dependent on care within 8 weeks. She cannot walk nor speak and needs to be tube fed. She would have entered school this year. This blow of fate is very hard for us all."

According to Sean Monks, spokesperson of the German Association of Pediatricians, this is the third case of SSPE from measles infection in infants in 2006 - in 2006 a total of 313 infants with measles were reported to the RKI (German CDC equivalent) in Berlin. One of these children died in 2007, another has been suffering from SSPE since 2009, and now Angelina is the third victim from that year.

Importantly, this shows that the risk of SSPE is much higher than previously thought. Overall risk for SSPE had recently been adjusted to about 1 in 11'000 notified cases of all ages, and "at least" 1 in 2'000 for infants (German pdf). From 2005 to 2010, 27 patients died of SSPE in Germany, although measles incidence had been sinking to reported numbers under 2000/year for some time. The current cluster of SSPE cases indicates that the risk of SSPE for infants who contract measles lies closer to 1 in 200.

Research has not yet identified the causative mutation for SSPE (see for example here) nor found strains with a particularly high risk of causing SSPE which could explain this high incidence. What is clear is that all cases in which measles virus has been amplified from the brain of SSPE victims, it was the wild type rather than the vaccine virus, and that with increasing vaccination coverage, SSPE incidence sank (see for example here and here, for review here).

The only way to prevent more SSPE cases is to vaccinate your child against measles (2xMMR) and to check your own immunity if you are unsure of your history of measles/measles vaccination. Your immunity protects those too young or too sick to be vaccinated. Your decision not to vaccine could cost lives, not necessarily yours.

Testing Anthrax vaccines in children?!

2011-10-25T15:32:00.003-04:00

I came across this piece in the Washington Post today:

Possible study of anthrax vaccine’s effectiveness in children stirs debate

Apparently, a "key working group of federal advisers" endorsed testing in September, to see whether the anthrax vaccine would safely protect healthy children against a bioterrorism attack.

What bioterrorism attack? The possibility of the use of anthrax by (foreign) terrorists was one of the fears addressed post 9/11. However, the only documented use of anthrax in the United States with the intention to harm in the past 10 years happened a week after the 9/11 attacks, when "letters containing anthrax spores arrived at several media offices and two Senate offices, killing five people and sickening 17 others. The FBI eventually concluded that the letters were mailed by Bruce Ivins, a disgruntled scientist at Fort Detrick in Maryland who committed suicide in 2008, although some experts question the FBI’s findings."

As a consequence of the anthrax bioterrorism fears, 2.6 million US military personnel were vaccinated with the anthrax vaccine, and the federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack. This is in addition to treatment option by antibiotics.

The Washington Post reports:

Unlike with measles, mumps and other diseases, the chance that children will be exposed to anthrax is theoretical, making the risk-benefit calculus of testing a vaccine on them much more questionable.

“It’s hard to believe that it’s something that makes a great deal of sense,” said Joel Frader, a pediatrician and bioethicist at Northwestern University’s Feinberg School of Medicine. “It would be difficult to justify testing it on kids simply on the hypothetical possibility that there might be an attack.”

In addition to these ethical considerations, I have several other concerns, this paper sums one up well:

In response to the attacks on Sept 11, 2001 (9/11), and the related security concerns, the USA and its coalition partners began a war in Afghanistan and subsequently invaded Iraq. The wars caused many deaths of non-combatant civilians, further damaged the health-supporting infrastructure and the environment (already adversely affected by previous wars), forced many people to migrate, led to violations of human rights, and diverted resources away from important health needs. After 9/11 and the anthrax outbreak shortly afterwards, the USA and other countries have improved emergency preparedness and response capabilities, but these actions have often diverted attention and resources from more urgent health issues. The documentation and dissemination of information about the adverse health effects of these wars and about the diversion of resources could help to mitigate these consequences and prevent their recurrence.

Given the publicly available data, there is only a "theoretical" anthrax threat to US children. The current disease burden for them, for all we know, is zero. Anthrax vaccine trials and/or general vaccination programmes for children would be a very hard sell to the general public and would significantly support anti-vaccine sentiments. Ultimately, it would detract funds from essential health care research and provision in areas of actual need (i.e. where a measurable disease risk and burden exists), and it may erode vaccination compliance for the essential childhood vaccinations (measles, anyone? Pertussis?).

Follow up on my post about Natalie and SSPE

2011-10-22T06:17:00.003-04:00

There were two reactions to my post about Natalie's entirely preventable death from SSPE that I had put up yesterday.

One that invariably came from pro-vaccine minded parents, which was "oh, how horrible, the poor child/parents" and sometimes included "can we go after those vaccine-refusing parents"

and one that invariably came from anti-vaccine minded parents, which was "oh, how horrible, how can you call our children potential murder weapons" and sometimes included "you must be paid to post this" pharmashill accusations.

So here are some clarifications:

I don't know much about the parents who took their unvaccinated 11 year old to that pediatrician's practice. I can say with some conviction that neither Andrew Wakefield nor Jenny McCarthy had anything to do with their decision, since this happened in Germany in 1999 and their son was 11 then, so their anti-vaccine decision must have happened 10 years earlier, when neither Wakefield nor McCarthy were a topic (and they never really became one in Germany anyway). We don't know what made them not vaccinate. I am pretty sure they did not intend this to happen.

There is no provision to sue these parents in German law. The new Infektionenschutzgesetz was passed after this all got started and it only regulates intentional transmission of reportable infectious diseases. I think it would be very difficult to prove intent here. Also, I don't know about Natalie's parents, but Micha's family are devout Christians. While they are obviously sad and burdened, they do not seek punishment for that other family.

I posted a link to this blog on Mumsnet and that caused quite an upheaval amongst non-vaccinating parents. There was a lot of profanity (seemingly caused by the -wrong- assumption that I was addressing people directly, while being fully aware of the children's medical histories), but I am accepting this:

A lot of non-vaccinating parents made their decision after careful thought and deliberation with their health professional. They are aware of the risks of their non-vaccine decision and they are not necessarily comfortable with those risks. However, for them, the risks of not vaccinating outweighs the risks of vaccinating their children. To be told that they are turning their kids into potential murder weapons and to scare them with what is certainly a) a very unlikely and b) the most catastrophic outcome of a family not vaccinating deals them an unfair blow and it is not really helpful. This was not my intention and I have apologised to one mum there and hereby do to any parent in the above situation here.

That said: if you are thinking about not vaccinating your child and you are currently weighing the pros and cons: have a look at my previous blog and previous post on this situation and weigh this into your decision.

So predictable - so sad, Natalie dies of SSPE

2011-10-20T10:44:00.003-04:00

We had previously reported the case of Natalie, one of the children who contracted measles from an unvaccinated preteen in their pediatrician's practice in 2000. Natalie was 11 months old at the time. She came down with SSPE in 2007 (that is actually the average time lag between measles infection in infancy and the development of this fatal measles complication), she deteriorated, fell into a "wake coma" and now passed away due to organ failure.

Micha, one of the other babies infected by the same 11 year old is still dying... Measles vaccination and the resulting herd immunity for babies saves lives. Vaccine refusers turn their children into potential murder weapons.

Polio in China

2011-09-19T09:28:00.000-04:00

As of 13 September 2011, nine cases of polio have been reported in the Xinjiang region. There has been one death. All of the cases had wild-type polio 1 (WPV-1) which originated from Pakistan. Xinjiang shares a border with Pakistan where polio is endemic, along with other neighbouring countries, India, Afghanistan and Tajikistan that are also polio-endemic.

Four children between the ages of four months and 2 years were infected in July, data for the other five are unknown but appear to be all infants, including the one fatality. This is the first outbreak of polio in China since 1999, when an importation from India was identified. The last indigenous case was in 1994. An intense surveillance and vaccination programme has been launched in the region in hopes that the spread can be contained. However, given that paralytic polio occurs in ~1% of polio cases and of that, 5-10% result in death and there were at least four cases of paralysis and one death, it is more than likely that hundreds, if not thousands of cases have gone undetected.

This outbreak demonstrates the vulnerability of populations who are not adequately vaccinated and the relative ease at which an infectious disease can cause an outbreak even in a country previously certified as polio-free.

Lessons From the MMR Scare

2011-09-13T08:34:00.002-04:00

That was the title of Fiona Godlee's webcast from the National Institutes of Health, Fogarty International Center, Tuesday, 6 September 2011. Dr. Godlee is the editor-in-chief of the British Medical Journal (BMJ) and published the three part series by Brian Deer exposing the fraudulent research of Dr. Andrew Wakefield. Her talk can be viewed in its entirety here.

She reviewed the key points of Mr. Deer's protracted investigation of Dr. Wakefield's MMR research and the painstaking measures the BMJ took to review and validate Mr. Deer's reports. She raised concerns of fraud in science and what medical/scientific journals could do to prevent such an occurrence from happening again. She also discusses the role of the media and their contribution to the legitimising of Dr. Wakefield's, now retracted, Lancet report. Dr. Godlee also makes an intriguing proposition for improving public health communications by entreating investigative journalists to work with epidemiologists. We have already seen the success of solid science reporting by the likes of Brian Deer and Seth Mnookin so it is a feasible proposition.

Dr. Godlee provides an honest and thorough analysis of fraud in science/medicine and public health communications deficits along with some criterion to prevent fraudulent scientific reporting. All in all, an informative talk and interesting points made during the question and answer session. Jake Crosby from the Age of Autism made an embarrassing showing by introducing himself as "Jacob Crosby from the George Washington School of Public Health and Health Services", not disclosing himself as a student and implying he represented the school as faculty or staff. Not to mention, I doubt the George Washington School of Public Health and Health Services sent Mr. Crosby as their representative, but rather, he attended as Age of Autism's lackey. Mr. Crosby also missed the point of a "question and answer" session and launched into a churlish diatribe of fraud allegations against Brian Deer which can be viewed at the 54:04 mark on the webcast.

Death isn't everything, part 3: measles in Minnesota

2011-09-03T14:10:00.003-04:00

This is Mahi Abdalla on his mother's lap (photo Jim Gehrz, Startribune.com). His family took him from Minnesota to Kenya where he contracted measles. He had been unvaccinated, because he was only 9 months old when he left the country. He spent three weeks in the hospital, two of those on a ventilator, due to measles pneumonia.

The US has seen over 175 measles cases this year; in the 1989-1991 epidemic, the death rate was just over 1 in 400 reported cases (123 acute deaths, at least 11 due to SSPE). Mahi was "lucky" with this severe but not fatal course of measles - it is only a question of time when the US will see their first acute measles fatality since measles were thought eradicated from the Americas. SSPE as a late consequence of measles usually in the first couple of years of life is still looming over the heads of the babies and toddlers who contracted measles this year. Sad...

Death isn't everything: part 2

2011-08-24T14:52:00.003-04:00

Chloe Holmes lost most of her fingers as a toddler due to septicemia caused by chicken pox - she has now been fitted with a bionic hand:

contrast that with this: FB Group "Find a Pox Party in your area"

Measles: big deal

2011-06-22T04:30:00.003-04:00

I am still working on the reference for a couple of longer blog posts, but since measles cases in the US have crossed the 150 mark, more than in almost two decades, I thought I'd post a quick reminder that "death isn't everything" (hat tip to Bad Astronomy)

Constrast her account with this - a call for a measles party!

The effects of anti-vaccine lobbying

2011-06-13T06:02:00.003-04:00

Worth watching from beginning to the end. In particular, listen to Viera Scheibner, the "Grande Dame" of anti-vaccine activists - children are staying unprotected and are dying because of that kind of "expertise"! It is mind boggling. Watch - this is the anti-vaccine lobby rolling out their "best":

personal footnote: my 30 year old niece, healthy, top fit, half marathon runner, has been coughing for 102 days from whooping cough (and counting) now. This is not a harmless disease and it has the nickname "100 Tage Husten" (100 days cough) for a reason.

oh look - vaccines resurrected on Ask Dr. Sears site

2011-06-12T15:47:00.002-04:00

at least somewhat - as promised by Matt Sears to Seth Mnookin, "Vaccines" are back on the Ask Dr. Sears website:

The content is still a bit disappointing, cannot say the info is "updated". It consists of links to old "The Vaccine Book" (dead link) blog posts, mostly sans comments (big shame, since there were some beautiful ones in there by SM and me). This is not really suitable as an info site (yet) especially since posts don't have date stamps or corrections (no, the return of single measles, mumps and rubella vaccines is not planned for 2011, at least not according to Merck). The "purchase the vaccine book" link works (not surprisingly). I would advise against it.

keeping track of your child's vaccinations

2011-06-08T12:13:00.005-04:00

One of the topics that come up often on the boards is shoddy book-keeping of the doctor's office, posts like

"My child is two years old and I am sure we had done all first year vaccines, but now we got called back for XYZ shots"

"I got a letter from the State saying that my child is not up to date, but s/he is"

"my child got his/her 4th DTaP at 12 rather than at 15 months and now we have to go back for a 5th, because the 4th doesn't count" *

"my child got his/her MMR too early and now it doesn't count" *

All of these are real life examples (2 from Dr. Bob's old board, 1 from Babycenter) and they illustrate one thing very clearly:

You have to keep a record of the vaccines your child get!

Now in an ideal world, your pediatrician hands you a vaccination schedule on your first well visit, including all info on the first vaccines, so you can read up ahead of time. S/he'll discuss with you whether you have any questions before the first shots and each time your baby is vaccinated, the little sticker on the vaccine vial that has vaccine name and lot number goes into a booklet like this:

that you get to keep. I have encountered such "best practice" with our second child - our first had 3 cards, one for each country she got vaccinated in, until we combined them into one. It is surprising, however, how often parents do not automatically get vaccination records to take him with them.

However, you need such records, so if you move or change doctors, you have proof of which vaccinations your child has had. These "Yellow Cards" exist world wide (the upper picture is an Ugandan one filched off the web, my daughter has one from California, my son one from Germany), they have been around for a really really long time - I have one, my original one is white though and I recently found my mum's and grandma's (proper record keeping during WWI and WWII, although mainly for smallpox).

It is even more important to keep your records if you are on an "alternative" schedule (for any reason - the European schedule my daughter had been vaccinated on for her first 9 months was very much "alternative" to what was recommended/required in the US).

As soon as your child is born, you can make up a vaccination schedule for him/her - the CDC has a handy tool, or find your country's National schedule and do it by hand. If you want to diverge from what is recommended, highlight this on the schedule. Take the schedule in to your doctor's appointment to double check you have done it right. Ask for the yellow card and then keep track of all shots. Also make sure that all vaccines are actually available in the combination that you want to give them - there are still parents out there who want to give monovalent measles, mumps and rubella, but they are no longer made by Merck - there are also periodic shortages in vaccines (in recent years for example the monovalent hib).

It needs a little planning, but it is very valuable, and, ultimately, your responsibility.

* that is actually a topic for another post

Bob for hire...suggested topic "Vaccine Myths and Questions"

2011-06-03T15:00:00.007-04:00

Hat tip to Liz Ditz, who found out that if you are on Dr. Bob withdrawals after his recent disappearance from the new Ask Dr. Sears website, you can still hire him to speak at your event (birthday party maybe?!):

The site advertises Dr. Bob Sears:

Acclaimed Pediatrician & Vaccine Expert
Once considered a routine and mandatory part of pediatric health care, vaccines are now constantly surrounded by debate and controversy. Parents are bombarded with well-intentioned medical advice from family, friends, advertisers, and even pediatricians who mean well but might be too busy to provide all the answers an anxious parent needs.

Dr. Robert Sears, M.D., F.A.A.P. one of the most trusted names in childcare today (1), provides clear, concise answers to the countless questions parents have about vaccines (2). He offers the most up to date information in the latest addition to the Sears Parenting Library, The Vaccine Book (3).

"Dr. Bob," as his young patients call him, has studied every article, vaccine product insert and case study available (4). Nine years spent in private practice have taught Dr. Bob what questions and concerns parents have, what aspects of vaccines they don't understand and which topics need more clarification - all so that he can sift through the noise to give parents the peace of mind they need when making sure their child is well cared for (5).

Dr. Bob does not tell parents which decision is right for them, he simply gives them the information and the tools they need to make the right decision for their particular child and situation (6).

Dr. Bob is a board-certified pediatrician in practice with his father, William Sears, M.D.. and the co-author of several books in the Sears Parenting Library (7). He lives in Dana Point, California.

At the podium, Dr. Bob discusses vaccine myths and questions, vaccine ingredients (which harmful ingredients are still in vaccines and what parents need to know to protect their children), and the current vaccination schedule. Dr. Bob presents his own alternate vaccination schedule that is more effective and less likely to create harmful side effects than the current one (8). (my footnotes)

(1) actually, I would doubt that - Sears maybe, but that is Sears the elder, or Sears the brand, not Bob.

(2) I wish I had saved more of his posts from his board. Dr. Bob often either didn't answer, or totally hand waved his replies. He often suggested that parents with children with ASD, AD(H)D, or sensory and/or speech issue not be vaccinated at all, without a clear rationale (gut feeling, extracted rectally?).

(3) The Vaccine Book appeared in 2007.

(4) I wonder why he would still make totally outlandish claims then. Recently, he told the mother of a 7 months old ex-preemie to rely on maternal immunity after measles exposure, which isn't really a testimony to his knowledge in the field.

(5) Except when they go abroad and bring back measles, that is...

(6) Yes, right, he instead pulled the "I tend not to vaccinate in this kind of situation, but of course it is totally your choice..."

(7) ...books which are no longer mentioned in his family's web shop.

(8) Bob's alternative schedule has never been tested for efficacy or safety. On his board, he appeared generally unaware of studies on alternative schedules (e.g. the Swedish schedule). His ideas on MMR efficacy were totally evidence-free.

"suggested topic" for a talk by Dr. Bob Sears is:

Vaccine Myths and Questions:
What's True, What's Hype, and What You Need to Know

I need a new irony meter...

The MASTERPLAN - The Hidden Agenda for Global Scientific Dictatorship

2011-06-03T05:36:00.004-04:00

Oh * my * word - I just stumbled across the below (hat tip to Omri)

Scientific World Domination is looming, and the only people to open our eyes and prevent the worst (e.g. getting sprayed with toxins by Chemtrails, or our children getting poisoned by fluoridated drinking water) are the 9/11 Truthers. They advertise

Dr. Andrew Wakefield has pioneered research into the possible links between the MMR vaccine and autism and has been victimised ruthlessly by his own profession, including being struck off by the General Medical Council in the UK for daring to speak out, despite other researchers, both before and after his evidence was published, now showing the same links between the MMR vaccine and autism. (my bold)

The bold is, of course, as bold as it is wrong.

I am not sure whether I should laugh or cry - the decline of Andrew Wakefield into this scene, down (I guess) from the Anti-Vaccine movement, deeper into the anti-science realm of conspiracy theorists is both consequential and kind of sad.

Off to stroke my cat...

Oh the Irony - Vaccine Exemption and Disease: Rubella

2011-06-02T15:06:00.004-04:00

The CDC published the Vaccination Coverage Among Children in Kindergarten United States, 2009/10 School Year in the June 3 issue of its MMRW today. Some media outlets picked up the news that Washington has highest vaccine opt-out rate in country. Over 6% of Kindergartners have an exemption for one or more vaccines. While that doesn't seem much at first glance, it does push vaccination coverage at an age where kids are very likely to spread disease under the level that is assumed to be needed for herd immunity. Ironically, in the same issue of the MMWR, the CDC reports two cases of rubella in Washington, one imported, one indigenous.

Rubella?!

Honestly? I wonder what sort of false eco-nostalgic ideals Washingtonians are striving for, but is it really those times when hundreds (thousands in epidemic years) of babies per year contracted rubella in the womb and died in utero, or were born with horrendous malformations, deaf, blind, with heart defects?!

Vaccine exemptions lead to disease outbreaks - this is a small example. I wonder how many larger and much more catastrophic examples it will need for some parents to clue in?

Unanswered question

2011-06-02T12:15:00.004-04:00

So following my recent post about that paper by Miller and Goldman, which crudely correlates numbers of recommended vaccines with infant mortality rates in the US and any country with a lower IMR, I got mail. Gary Goldman wanted to discuss my criticism with me and explain why they were still right. He actually wanted me to call him, which I was initially tempted to do, but eventually didn't because I was put off by the twisting and turning email conversation. He did request that I keep our exchange private, however, he stopped writing me, so I thought I'd just bring one argument up here and see whether he will answer.

me on 13 May - I (for Germany) and the devine Prometheus (for the US) had asked this earlier:

I see that you are avoiding the most obvious question: why are there fewer and fewer infant deaths when more and more vaccines are given? I gave you the German numbers, where infant mortality dropped by 80% while the number of scheduled vaccines tripled. Every country I look at has the same temporal trend, although in the US it is not as pronounced as in Europe, most likely because of your crappy health system. I would really like to know what your thoughts on this are.

No response to that by Gary on the same day (while was responding to other points)

Me, in response, still 13 May (his points in italics):

I notice you are still avoiding the historical question and if I may make a prediction - you are going to avoid answering this question forever. I would really be interested in your reasoning.

14 May, Gary, at the very bottom of a looong email elaborating on a number of points entirely unrelated to any of my questions:

I am not able to address the specific historical factors concerning infant deaths in Germany upon which you rely to support your contention that no correlation exists. I have seen data where 90% of disease mortality declined prior to vaccinations and this was largely attributed to improved sanitation, nutrition, and water. Other
studies, more longitudinal, and in other populations are reasonably necessary to support the present trend we report.

Now this is really irritating, because we were talking the past 30 years, not "pre all vaccines". Therefore, me, a day later:

Dear Gary,

I should maybe specify

I am not able to address the specific historical factors concerning infant deaths in Germany upon which you rely to support your contention that no correlation exists.

Germany is, of course, not the only country in which infant mortality plummeted over the past 30 years, it did so in every developed country I looked at.

I have seen data where 90% of disease mortality declined prior to vaccinations and this was largely attributed to improved sanitation, nutrition, and water.

Yes, all anti-vaccine protagonists like to refer to such curves. However, I am not talking about disease mortality, and I am talking a period of 1981 to 2011, when sanitation, nutrition and water were not a problem at all in Germany (or any of the other developed countries in which infant mortality dropped over the same time period).

Other studies, more longitudinal, and in other populations are reasonably necessary to support the present trend we report.

But Gary, we already know that infant mortality plummeted while the number of vaccines was significantly increased. I don't think that the kind of crude and error/bias ridden correlation that you have published advance the field at all, or reasonable raises new questions.

What about you? What experiences have you had that have shaped your thinking and views?

Misrepresentation of scientific evidence and dodging of straight forward questions by anti-vaccinationists for example - you wrote many many words, totally side tracking - we were talking German vaccination schedule and how it is not what you wrote about - you have similar misrepresentations for other countries as well - then you write about varicella, which is a second year vaccine - this was not the topic at hand - and you come with "sanitation" when we are talking 1980ies Germany - that is rather lame, you know.

So, given that Germany had great sanitation in 1981 and we are talking infant mortality, not disease related mortality, and they had 9 recommended vaccine doses and 10'000 infant deaths then, while they have 21 to 28 recommended doses and under 2000 infant deaths now, how would number of recommended vaccines correlate with infant mortality at all? Can you give me even an idea, a reasonable notion how your idea would match, umm, reality?

Thanks

Catherina

I had to wait two days to get a response, signed by Miller and Goldman:

Dear Catherina,

Infant mortality rates in all developed nations, including Germany, were much higher in the 19th and early 20th centuries and have continued to decline mainly due to improvements in nutrition (including breastfeeding advocacy), sanitation, and access to healthcare. [This information is not a conspiracy of "anti-vaccine protagonists" as you suggest; it is well-documented in the medical and historical literature.] For example, nearly 300 per 1,000 German infants died in the mid 1800s. By 1950, the German IMR had dropped to 52/1,000—an 83% decline. By 1960, the German IMR had dropped another 33% to about 35 infant deaths per 1,000 live births. These dates and declines in IMR preceded the extensive increases in compulsory vaccinations required of German infants.

Furthermore, Germany’s IMR declined at a rate of 3% annually from 1960 to 1979 during a time when few infant vaccines were required. This rate of decline was much faster than the 2.4% annual "plummet" from 1980 to 2009 during a period when more infant vaccines were required.

Additionally, Germany and other developed nations continued to make medical advances at reducing neonatal mortality during periods of increasing vaccine requirements. For example, from 1970 to 1979 there was a 41% decline in U.S. neonatal mortality. From 1980 to 1989, there was an additional 27% decline in neonatal mortality. Neonatal mortality (deaths in the first 28 days of life) usually accounts for more than 50% of all infant deaths. From 1990 through 2010, neonatal mortality in Germany represented about 68% of all infant mortality. During that period, Germany’s neonatal mortality rate had declined by 55%. Such improvements to the neonatal mortality rate greatly reduce the infant mortality rate yet are unrelated to the number of vaccines administered to infants.

Sincerely,
Neil Z. Miller
Gary Goldman, PhD

So here is my question that I have not gotten an answer for in the past 2 weeks:

Dear Gary,

so if I understand you correctly, infant mortality is dependent on all sorts of factors (hygiene, nutrition, sanitation, access to health care) and still declining, but just not as fast as it would be if we didn't vaccinate. Despite all these factors, which obviously vary tremendously between countries, you decided to only crudely correlate vaccines to infant mortality?

Thank you for clarifying

Catherina

Vaccines dumped from new Ask Dr Sears website?

2011-06-01T13:15:00.010-04:00

I just caught a glimpse of the new Ask Dr. Sears Website. It was terrible slow loading when I first saw it, but the the landing page was all re-structured and modern in nice greens and oranges (I like that, very purdy).

Since we have been posting on the vaccine discussion board (justthevax passim), I thought I should take a stroll through the new page and have a look what the vaccine area looks like now. Well, this morning, there was none. While the "all categories" page did not load all too well, both on the left category bar

and on the middle all categories bar, there were no vaccines.

but they certainly had been there on the old page.

UPDATED TO ADD - indeed, no "Vaccines Area" - the search for "vaccines" only leads to Dr. Bob, not to further info (bites tongue):

closeup

I wonder whether this is going to be amended, or, whether in a year of pertussis and measles outbreaks that have cost 10 infants in the Sears' home state of California their lives, and have put many kids in hospital, the Sears have decided to drop this potentially contentious part of their web presence.

In any case - since the Sears' vaccine book discussion board has now disappeared, I hope you do have a good doctor and I can recommend our forum and, if you want a bit of a mixed audience, also the Immunization Discussion forum on Babycenter - see you there!

Infant mortality and vaccines

2011-05-09T16:25:00.006-04:00

oh goodness, here I wanted to go to bed early and then I stumbled over this latest "peer reviewed" paper in a journal "indexed by the National Library of Medicine" (see the anti-vaccine faction gloating at those fantastic quality indicators) and "proving" with an correlation co-efficient of 0.992 and a p of 0.0009 (so "sciencey") that:

Nations requiring the most vaccines tend to have the worst infant mortality rates

Authors of this little gem, in the journal Human & Experimental Toxicology, with the impressive impact factor of 1.307 and a proud ranking of 58th of 77 in the area of Toxicology (yes, that would put them into the bottom quarter) are Think Twice's own Neil Z. Miller and Medical Veritas' Gary S. Goldman. I wonder why Miller and Goldman didn't publish their paper in Medical Veritas (here is the link to the journal, please don't go blind), seeing that item 7 in their mission is: "Create a movement to address the adverse vaccine reactions and vaccine-related injuries afflicting children and adults". I guess that is because parents have clued in that "peer review" and being indexed on PubMed is a quality measure (although very obviously no guarantee for quality).

In any case - Miller and Goldman took a list of countries and looked at the number of vaccines they schedule for infants and they also looked at infant mortality. And then they correlated one with the other, a fail safe way to find causal relationships: Storks deliver babies p=0.008.

There are a number of things wrong with this procedure - first of all, the way Miller and Goldman are counting vaccines is completely arbitrary and riddled with mistakes.

Arbitrary: they count number of vaccines in US bins (DTaP is one, hib is separate) and non-specific designations (some "polio" is still given as OPV in Singapore), rather than antigens. If they did that, Japan, still giving the live bacterial vaccine BCG, would immediately go to the top of the list. That wouldn't fit the agenda, of course. But if you go by "shot" rather than by antigen, why are DTaP, IPV, hepB and hib counted as 4 shots for example in Austria, when they are given as Infanrix hexa, in one syringe?

Mistakes: The German childhood vaccination schedule recommends DTaP, hib, IPV AND hepB, as well as PCV at 2, 3 and 4 months, putting them squarely into the 21 - 23 bin. The fourth round of shots is recommended at 11 to 14 months, and MenC, MMR and Varicella are recommended with a lower age limit of 11 months, too, which means that a number of German kids will fall into the highest bin, at least as long as you count the Miller/Goldman way.

Then, they neatly put those arbitrarily counted doses into bins. Binning (i.e. grouping numbers before correlating them to something) always makes me suspicious. I don't have the time to check each country's vaccination schedule - I assume there will be mistakes in many claims, but I am guessing that if we plotted the infant mortality against the actual number of recommended vaccines, the correlation would be less good than engineered in this paper, i.e. the dose count above is probably not all that "arbitrary".

Then I noticed that the authors totally ignore historical trends. For example, in the early 1980ies, Germany's infant mortality was about 5 times as high (10000 infants died per year) than it is today (2000 died in 2009 with approximately the same birth rate), however (in Miller's and Goldman's twisted logic), the vaccination schedule contained far fewer vaccines in the first year (essentially just DT and polio, since the whole cell pertussis was not given between 1974 and 1991, the aP not yet introduced, the MMR given in year 2, no hib, nor hepB, nor PCV given either), while Germany was already very much a "developed country".

ETA: a similar point is made by Prometheus on Science based Medicine for the declining infant mortality rate in the US.

If I believed that one factor could ever explain something as complex as infant mortality, I would go and look at the relationship of maternity leave:

Japan, for example, generally gives 14 weeks at an average of 40% of a woman's salary and mothers are also entitled to childcare leave for their new baby's first year. Childcare laws dictate that in the first year of her baby's life, a mother may take two 30-minute breaks per day to care for her child (anyone else think breastfeeding?). She may also take time off any time during the baby's first year with one month's notice.

In Sweden, all working parents are entitled to up to 16 months of paid parental leave, Norway is similarly generous. Read the table and weep, US American parents!

In the bottom countries, the USA gives 0 months of parental leave, the FMLA offers some (up to 12 weeks) generally unpaid leave under very specific conditions. Heck - Botswana and Chad have better rules. Australia has 18 weeks (not months, like Norway) at minimal wage, but then, Canada, third worst in infant mortality has up to a year of parental leave at almost $2000 a month and that is where my crude correlation fails (although, if I binned some countries...a cunning plan).

ETA: Dr. Gorski picks up on some other flaws of this study - read his post.

In general, several large studies/meta-analyses NOT cited by Miller and Goldman, have indicated that if vaccines have anything to do with infant death, then as a protective factor, as this German study and meta-analysis and this large study from the UK.

To prevent SIDS (specified 10 May after comment):

put your baby "back to sleep"
do not smoke
breastfeed if at all possible (easier in countries with 18 months of paid maternity leave)
avoid loose bedding and soft mattresses or sofas
do not bed share when intoxicated, or smoker, or taking medicine that may make you drowsy, but keep your baby in your room
keep the sleep environment cool and don't overdress your baby

That is it.

Still no independent confirmation of Wakefield's claims

2011-05-08T07:14:00.010-04:00

One of the things that anti-vaccines groups desperately want to have, is the scientific support for their claims. A lot of parents know that rigorous studies, peer reviewed, published in scientific journals and indexed on Pubmed are the standard in discussions about medical care. Therefore, the anti-vaccine brigade are trying to maintain that, really, countless scientific studies across the globe have shown that vaccines are bad for you.

The anti-vaccine, pro-any-conspiracy theory website Whale.to (the citation of which automatically invokes Skopie's Law), provides a neat shopping list that staunch supporters of the long debunked “MMR causes inflammation of the gut which somehow causes autism and Andrew Wakefield is really a hero” notion can use to spam evidence based discussions, as recently seen on the Shot of Prevention blog where Marsha McClelland of the “We the People United for Vaccine ~~Education~~ Misinformation” Yahoo group copied and pasted in support for Andrew Wakefield.

She “writes”:

In the years after his initial controversial finding, linking the MMR vaccine to Crohn’s disease and autism, he published another 19 papers on the vaccine-induced disorder.
All were peer reviewed. However, strangely enough, none of these 19 papers are ever discussed in the media. The only study that keeps seeing the light of day is the original study from 1998, along with the original questions about conflicts of interest, which he explains in great detail in this interview. (my comment - that refers to the Mercola interview with Andrew Wakefield).

Note the buzz word “peer reviewed“ – also note the fundamental misconception that anyone would give a toss whether Wakefield believes that Wakefield was correct.

She goes on:

This is very interesting indeed, because not only has he continued his own studies, but since then, a large number of replication studies have been performed around the world, by other researchers, that confirm his initial findings.
It’s been replicated in Canada, in the US., in Venezuela, in Italy [but] they never get mentioned. All you ever hear is that no one else has ever been able to replicate the findings.

That – Martha and friends – is because no one (apart from Wakefield and his buddies) has ever been able to replicate Wakefield’s claims. I had previously looked at 5 studies supposedly „independently“ replicating Wakefield, but this list was 28 citations long (I guess the length is supposed to duly impress AND to keep anyone from checking). To quote Kenneth Branagh: “There is safety in numbers”. Luckily, both Chris and Liz Ditz were bothered enough to spend their valuable time to debunk the list (THANK YOU!) – I have created a synthesis of their and my previous searches and comments to create the “one stop copy and paste resource for the evidence minded”. Links add extra depth - sorry about the length, it may exceed the number of characters allowed for blog comments...

To summarize re-using Martha’s words: you may have been tricked into believing that Andrew Wakefield’s claims had been independently verified in 28 publications from 5 different countries. I’m afraid that is false. For those of you who have swallowed this type of reporting hook line and sinker, the below debunks each of the 28 studies from around the world that have been cited in his support.

1. The Journal of Pediatrics November 1999; 135(5):559-63 =
Horvath K., Papadimitriou J.C., Rabsztyn A., Drachenberg C., Tilden J.T. 1999. Gastrointestinal abnormalities in children with autism. J. Pediatrics 135: 559-563.

This study did not look for measles virus. Instead it looks at gastrointestinal (GI) malabsoption as an underlying mechanism for autism. It does not appear to have controls with autism & without GI symptoms OR controls without autism & with similar GI symptoms. Most children with autism & GI symptoms had upper GI problems such as reflux
This in no way “replicates” or “supports” Wakefield’s “findings”, which have been shown repeatedly to have been manufactured or the result of laboratory contamination.

2. The Journal of Pediatrics 2000; 138(3): 366-372 =
Furlano RI, Anthony A, Day R, Brown A, McGarvey L, Thomson MA, Davies SE, Berelowitz M, Forbes A, Wakefield AJ, Walker-Smith JA, Murch SH. Colonic CD8 and T cell filtration with epithelial damage in children with autism. J Pediatr 2001;138:366-72.
This paper claims to have "confirm[ed] a distinct lymphocytic colitis in autistic spectrum disorders", which is something that no other research groups find and has been the center of the recent GMC hearings against Wakefield. The extreme "engineering" towards a specific gut pathology has been summarized by Brian Deer.
Note the emergence of a theme: Wakefield is a co-author and no fewer than 7 of this paper's authors are also authors on the retracted paper in The Lancet; this paper cannot be said to independently ”replicate” or “support” Wakefield’s “findings”.

3. Journal of Clinical Immunology November 2003; 23(6): 504-517 =
Ashwood P, Anthony A, Pellicer AA, Torrente F, Wakefield AJ. Intestinal lymphocyte populations in children with regressive autism: evidence for extensive mucosal immunopathology. Journal of Clinical Immunology, 2003;23:504-517.

Again, this paper seeks to further claim "a pan-enteric mucosal immunopathology in children with regressive autism that is apparently distinct from other inflammatory bowel diseases", but we know that Wakefield et al. are the only researchers who have "found" this in the past 15 or so years.
Same theme: Wakefield (and Anthony) is a co-author; cannot be said to support his own work.

4. Journal of Neuroimmunology 2005
A meaningless citation as this would be a whole volume of a journal - this happens if you just copy and paste without any regard to the content. Supports nothing except maybe the notion that the anti-vaccine folk cannot cite biomedical literature properly.
If you go back to whale.to, John was kind enough to link to to the paper, which is
Ashwood P, Wakefield AJ. Immune activation of peripheral blood and mucosal CD3+ lymphocyte cytokine profiles in children with autism and gastrointestinal symptoms. J Neuroimmunol. 2006 Apr;173(1-2):126-34.

doesn't mention MMR, instead, the authors start from their own wrong premise "Gastrointestinal pathology, characterized by lymphoid nodular hyperplasia and entero-colitis, has been demonstrated in a cohort of children with autistic spectrum disorder (ASD)." and continue to find "In both peripheral blood and mucosa, [intracellular] CD3+ TNFalpha+ and CD3+ IFNgamma+ were increased in ASD children" ,
has Wakefield as senior author, therefore no independent replication of his results.

5. Brain, Behavior and Immunity 1993; 7: 97-103 =
Singh VK, Warren RP, Odell JD, Cole WP. Antibodies to myelin basic protein in children with autistic behavior. Brain, Behavior and Immunity 1993;7:97-103

Found some but not all children with autism had specific antibodies to myelin basic protein (MBP). Study did not look for measles virus, nor did study look for mumps or rubella virus or administration of the MMR.
It precedes the Lancet paper and in no way ”replicates” or “supports” Wakefield’s claims.

6. Pediatric Neurology 2003; 28(4): 1-3 Citation not found.
According to whale.to, this is
Singh VK, Jensen RL Elevated levels of measles antibodies in children with autism Pediatric Neurology 2003; 28(4): 292-294.

To the best of our knowledge, this study has not been replicated, and the findings refuted by several other studies, such as Baird G, Pickles A, Simonoff E, Charman T, Sullivan P, Chandler S, Loucas T, Meldrum D, Afzal M, Thomas B, Jin L, Brown D. Measles vaccination and antibody response in autism spectrum disorders. Arch Dis Child. 2008 Oct;93(10):832-7.
This study does not support Wakefield’s claims.

7. Neuropsychobiology 2005; 51:77-85 =
Jyonouchi H, Geng L, Ruby A, Zimmerman-Bier B. Dysregulated Innate Immune Responses in Young Children with Autism Spectrum Disorders: Their Relationship to Gastrointestinal Symptoms and Dietary Intervention. Neuropsychobiology. 2005;28:51 77-85

This study did not look for measles virus but evaluated inflammatory response to specific dietary proteins.
In no way ”replicates” or “supports” Wakefield’s “findings”

8. The Journal of Pediatrics May 2005;146(5):605-10 =
Jyonouchi H, Geng L, Ruby A, Reddy C, Zimmerman-Bier B. Evaluation of an association between gastrointestinal symptoms and cytokine production against common dietary proteins in children with autism spectrum disorders. J Pediatr.2005;146(5):605-10.

This study did not look for measles virus. Instead, the study evaluated inflammatory response to specific dietary proteins.
In no way ”replicates” or “supports” Wakefield’s “findings”

9. Autism Insights 2009; 1: 1-11 citation not found on PubMed, but this refers to Krigsman, A. , Boris, M., Goldblatt, A., Stott, C. Clinical presentation and histologic findings at ileocolonoscopy in children with autistic spectrum disorder and chronic gastrointestinal symptoms Autism Insights 2010:2 1-11.

Arthur Krigsman was a colleague of Andrew Wakefield at Thoughtful House, Wakefield and Carol Stott (a contributor to this paper) are editors of the vanity press journal Autism Insights (previously discussed on LBRB. Not very likely that this "peer review" was very tough.
In no way ”replicates” or “supports” Wakefield’s “findings”

10. Canadian Journal of Gastroenterology February 2009; 23(2): 95-98 =
Galiatsatos P, Gologan A, Lamoureux E, Autistic enterocolitis: Fact or fiction? Can J Gastroenterol. 2009:23:95-98

Case report, featuring two adult patients with gastrointestinal problems and ASD diagnoses. The authors call for “more investigations” in their discussion.
In no way ”replicates” or “supports” Wakefield’s “findings”

11. Annals of Clinical Psychiatry 2009:21(3): 148-161 =
Singh VK. Phenotypic expression of autoimmune autistic disorder (AAD): a major subset of autism. Ann Clin Psychiatry. 2009 Jul-Sep;21(3):148-61.

This paper makes assertions that are not supported by the evidence base in the paper. It is mainly a summary of research, with no mention of what children were looked at. Chris found the actual paper (https://www.aacp.com/Pages.asp?AID=7937&issue=&page=C&UID=), and among the data used it included a Wakefield paper = not independent. Also included in the references are papers from questionable journals like Journal of American Physicians and Surgeons and Medical Veritas, which all suddenly makes sense if you see that Singh is associated with these folk that tick the "our treatment heals everything" quack box (see one Singh study on PTSD).
This looks like it would support a connection between MMR and autism, but since no-one has independently reproduced this and the author stands to make money off the claims this review has to be viewed with extreme reservations.

12. Journal of Child Neurology June 29, 2009; 000:1-6 =
whale.to provides the pre-print, hence the missing volume and page numbers:
Genuis S.J., Bouchard, T.P. Celiac Disease Presenting as Autism, J Child Neurol January 2010 25(1):114-119

This paper proposes that many children with autism have celiac disease, that this causes micro nutrient deficiencies and that the behaviour of the children improves when you put them on a gluten free diet. No MMR mentioned.
Does not support Wakefield's claims.

13. Journal of Autism and Developmental Disorders March 2009;39(3):405-13 =
Nikolov RN, Bearss KE, Lettinga J, Erickson C, Rodowski M, Aman MG, McCracken JT, McDougle CJ, Tierney E, Vitiello B, Arnold LE, Shah B, Posey DJ, Ritz L, Scahill L. Gastrointestinal symptoms in a sample of children with pervasive developmental disorders. J Autism Dev Disord. 2009 Mar;39(3):405-13.

This study did not look for measles virus, nor did study look for mumps or rubella virus. Study evaluated children previously diagnosed with pervasive developmental disorders (PDDs) for gastrointestinal (GI) symptoms. 22.7% were found to exhibit GI symptoms, but were otherwise no different from subjects without GI problems in demographic characteristics, measures of adaptive functioning, or autism symptom severity.
In no way ”replicates” or “supports” Wakefield’s “findings”

14. Medical Hypotheses August 1998;51:133-144. =
Bolte, ER Autism and Clostridium tetani Medical Hypotheses August 1998;51:133-144.
Speculative paper presenting the hypothesis that autism symptoms are caused by a subacute, chronic tetanus infection
In no way ”replicates” or “supports” Wakefield’s “findings”

15. Journal of Child Neurology July 2000; ;15(7):429-35 =
Sandler RH, Finegold SM, Bolte ER, Buchanan CP, Maxwell AP, Väisänen ML, Nelson MN, Wexler HM. Short-term benefit from oral vancomycin treatment of regressive-onset autism. J Child Neurol. 2000;15:429-435

This study did not look for measles virus. Instead, this study evaluated 11 children’s response to a specific antibiotic. Gains faded following cessation of antibiotic.
In no way “replicates” or “supports” Wakefield’s “findings”

16. Lancet. 1972;2:883-884 =
Walker-Smith J, Andrews J. Alpha-1-antitrypsin, autism, and coeliac disease. Lancet. 1972 Oct 21;2(7782):883-4.

This is a "letter to the editor" published decades prior to the Wakefield Lancet paper and can hardly be said to “replicate” the latter. Walker-Smith and Andrews report on the investigation of alpha-1-antitrypsin levels in 8 children with autism vs in children with untreated and treated celiac disease and control children and finds levels in children with autism and celiac disease are similar. This has little to do with Wakefield or the MMR (it also predates the introduction of the MMR), however, Dr. Walker-Smith is a co-author of the retracted study in The Lancet.
In no way “replicates” or “supports” Wakefield’s “findings”

17. Journal of Autism and Childhood Schizophrenia January-March 1971;1:48-62 =
Goodwin MS, Cowen MA, Goodwin TC Malabsorption and cerebral dysfunction: a multivariate and comparative study of autistic children. J Autism Child Schizophr. 1971 Jan-Mar;1(1):48-62.

A paper published decades previously cannot be said to “replicate” a later paper, the paper predates the introduction of the MMR vaccine in the US, the authors are not concerned with vaccination at all, but is mainly concerned with finding distinguishing features between childhood autism and adult schizophrenia using a number of challenges and physiological measurement. One minor in their discussion is that "malabsorption" would lead to autistic behaviour, so more in the sense of paper 12.
In no way “replicates” or “supports” Wakefield’s “findings”

18. Journal of Pediatrics March 2001;138:366-372.

Same paper as #2 above. Wakefield and 6 others from the Lancet paper are co-authors; cannot be said to support their own work.
In no way ”replicates” or “supports” Wakefield’s “findings”

19. Molecular Psychiatry 2002;7:375-382. Torrente F., Machado N., Perez-Machado M., Furlano R., Thomson M., Davies S., Wakefield AJ, Walker-Smith JA, Murch SH. Enteropathy with T cell infiltration and epithelial IgG deposition in autism. Molecular Psychiatry. 2002;7:375-382.

Gosh, we know these guys – it’s Andy Wakefield and his colleagues from that paper in The Lancet, this time claiming IgG deposit in gut samples indicative of an autoimmune gut pathology and call me cynical, but I don't believe any of this, because it has only ever been seen by this group.
In no way ”replicates” or “supports” Wakefield’s “findings”

20. American Journal of Gastroenterolgy April 2004;598-605.=
Torrente F, Anthony A, Heuschkel RB, Thomson MA, Ashwood P, Murch SH. Focal-enhanced gastritis in regressive autism with features distinct from Crohn’s and Helicobacter pylori gastritis. Am J Gastroenterol. 2004;99:598-605

Murch SH, Anthony A, Thompson MA, Torrente F and Ashwood P were previous co-authors with Wakefield A. Again, there are no independent groups reporting similar findings and this does not look at MMR or any vaccine anyway.
In no way ”replicates” or “supports” Wakefield’s “findings”

21. Journal of Clinical Immunology November 2003;23:504-517 =
Ashwood P, Anthony A, Pellicer AA, Torrente F, Walker-Smith JA, Wakefield AJ. Intestinal lymphocyte populations in children with regressive autism: evidence for extensive mucosal immunopathology. J Clin Immunol. 2003 Nov;23(6):504-17.

We totally get it by now – Wakefield and Wakefield’s colleagues confirm their own results.
In no way ”replicates” or “supports” Wakefield’s “findings”

22. Neuroimmunology April 2006;173(1-2):126-34 =
Ashwood P, Wakefield AJ. Immune activation of peripheral blood and mucosal CD3+ lymphocyte cytokine profiles in children with autism and gastrointestinal symptoms. J Neuroimmunol. 2006;173(1-2):126-34.

same as number 4.

23. Prog. Neuropsychopharmacol Biol Psychiatry December 30 2006;30:1472-1477 =
Shinohe A, Hashimoto K, Nakamura K, Tsujii M, Iwata Y, Tsuchiyaa KJ, Sekine Y, Suda S, Suzuki K, Sugihara G, Matsuzaki H, Minabe Y, Sugiyama T, Masayoshi Kawai M, Iyo M,Takei N and Mori N Increased serum levels of glutamate in adult patients with autism- Progress in Neuro-Psychopharmacology and Biological Psychiatry Volume 30, Issue 8, 30 December 2006, Pages 1472-1477

Study of adults with autism on blood levels of amino acids, to assess whether altered glutamatergic neurotransmission was likely in autism. Study did not look for measles virus, nor did study look for mumps or rubella virus or anything connected with the gut.
In no way “replicates” or “supports” Wakefield’s “findings”

24. Clinical Infectious Diseases September 1 2002;35(Suppl 1):S6-S16 =
Finegold SM, Molitoris D, Song Y, Liu C, Vaisanen ML, Bolte E, McTeague M, Sandler R, Wexler H, Marlowe EM, Collins MD, Lawson PA, Summanen P, Baysallar M, Tomzynski TJ, Read E, Johnson E, Rolfe R, Nasir P, Shah H, Haake DA, Manning P, Kaul A. Gastrointestinal microflora studies in late-onset autism. Clin Infect Dis. 2002 Sep 1;35(Suppl 1):S6-S16.

Stool samples from children with regressive autism were compared to samples from children without autism; differences in stool flora were found. The study did not look for measles virus, nor did it look for mumps or rubella virus. Study did not evaluate changes in gut structure.
In no way “replicates” or “supports” Wakefield’s “findings”

25. Applied and Environmental Microbiology, 2004
Another of those citation snafus -
Song Y, Liu C, Finegold SM. Real-time PCR quantitation of clostridia in feces of autistic children. Appl Environ Microbiol. 2004 Nov;70(11):6459-65.

This study describes how to do PCR for specific bacteria on stool samples of autistic and non autistic children.
In no way “replicates” or “supports” Wakefield’s “findings”

26. Journal of Medical Microbiology October 2005;54:987-991 =
Parracho HM, Bingham MO, Gibson GR, McCartney AL. Differences between the gut microflora of children with autistic spectrum disorders and that of healthy children. J Med Microbiol. 2005 Oct;54(Pt 10):987-91.

More in the same vein: This study compared fecal flora for children with autism with two control groups: siblings without autism and unrelated children without autism. Minor differences were found. The study did not look for measles virus, nor did study look for mumps or rubella virus. Study did not evaluate changes in gut structure.
In no way “replicates” or “supports” Wakefield’s “findings”

27. Archivos venezolanos de puericultura y pediatría 2006; Vol 69 (1): 19-25. = González LG., López K, Navarro DC, Negrón L, Flores LS, Rodríguez R, Martínez M, Sabrá A. Características endoscópicas, histológicas e inmunológicas de la mucosa digestiva en niños autistas con síntomas gastrointestinales [Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with gastro-Intestinal Symptoms] Archivos Venezolanos de Puericultura y Pediatría Enero-Marzo 2006, Volúmen 69, Número 1 Arch Venez Pueri Pediatr 2006 69(1):19-25. 1.

The authors cannot replicate Wakefield’s 1998 “findings” of a distinct autistic enterocolitis, although they do report a higher incidence of gastrointestinal problems in their autistic group. 2. It appears that the Gonzalez paper was funded by Thoughtful House, under Wakefield’s leadership as previously shown
In no way “replicates” or “supports” Wakefield’s “findings”

28. Gastroenterology. 2005:128 (Suppl 2);Abstract-303 =
Balzola F, Daniela C, Repici , Barbon V, Sapino A, Barbera C, Calvo PL, Gandione M, Rigardetto R*, and Rizzetto M .

This is a meeting abstract that has never been published as a peer reviewed study since 2005. Nine adult males with autism and GI symptoms were evaluated for GI disease. Study did not look for measles virus, nor did study look for mumps or rubella virus. Study did not evaluate changes in gut structure.
In no way “replicates” or “supports” Wakefield’s “findings”

Numbers: of 28 studies 2 were duplicates, 3 were only retrievable because of the links on the whale.to page, 13 were written by Wakefield and/or Lancet co-authors and/or Thoughful House colleagues (counting two duplicates), 3 predate the Lancet paper by years or even decades and not one independently replicates Wakefield’s claims, made in the retracted Lancet paper, the associated press conference and in many statements since.

Death by measles

2011-05-03T09:24:00.002-04:00

I just found the news that a young man died of measles in Germany this Spring. Germany has had more than 390 measles cases since the beginning of the year, mainly in the Southern most federal states (Bundesländer) of Bavaria and Baden-Württemberg.

In March 2011, a 26 year old man, undergoing treatment for a non life threatening tumour contracted measles and died. While in hospital, he infected at least one further patient as well as several unvaccinated medical staff, including doctors. Dr. Martin Terhardt of the Professional Association of Pediatricians (Berufsverband der Kinder- und Jugendärzte (BVKJ)) states the obvious:

"It is unacceptable that unvaccinated personnel exists in hospitals. When unvaccinated doctors or nurses have access to intensive care, it becomes very dangerous, both for the personnel themselves and for the patients. Patients who are being treated in intensive care are often immuno-compromised - an additional infection therefore has to be avoided at all cost. Doctors and other medical care personnel must have adequate protection through immunization. The fact that a patient with measles could cause an outbreak amongst medical personnel is absurd."

Measles transmissions in a medical care setting seem to have become the norm rather than the exception (see California and Arizona 2008). In the light of the current strong measles activity in Europe (with world wide exports), everyone, especially care professionals, should check their immunization status and get boosters if necessary to avoid transmission (especially to vulnerable babies and immuno-suppressed).

Pertussis closes Waldorf-based private school in VA

2011-04-06T06:51:00.007-04:00

A whooping cough outbreak hitting more than half (23 of 45) their pupils has led to the closure of that small private school for a week. The local Health Care Director unambiguously stated that lack of vaccinations caused this outbreak and that the children who were affected were unvaccinated (7 adult contacts also got the disease).

This outbreak is demonstrating two things - disease outbreaks happen in "pockets" of unvaccinated children, and, those "pockets" are often found in Waldorf/Steiner oriented institutions (for a comprehensive critical introduction into Anthroposophy, read the three part series on DC's Improbable Science blog). Indeed, the last whooping cough outbreak I personally saw was in the Steiner Kindi in two streets down from where we lived in Germany. The daycare director interpreted the outbreak as "the children seeking disease, because they needed a break" and proposed to close the Kindi for three weeks (a plan curbed by the working moms whose children attending the facility had been vaccinated and were just fine). What a break that was, with several children needing a 3 week residential rehab to learn how to breathe normally again... I'd rather pay money for a break than health, but that may be just me.

Similarly, quite impressive measles outbreaks in (mostly German speaking) countries have started in Steiner schools and Kindergartens and were sometimes specifically centered around Anthroposophical doctors with an ~~anti-vaccine~~ vaccine-critical outlook. Steiner himself deemed rashy diseases, like measles and Scarlet fever, which in his life time each killed a large percentage of the annual birth cohort, important for the development of proper karma and the shedding of bad miasms (don't ask - read link above, it is weirder than you think and weirder than you would expect any contemporary parent to believe and doctor to peddle).

The good news is that school and parents are complying with the suggested quarantine and/or treatment measures to limit transmission. Hopefully, some of them will research the "crunchy, holistic" philosophy behind their school and their vaccine refusal a bit more carefully, too.

2008: Measles in Dr. Bob Sears' Waiting Room

2011-04-02T16:50:00.003-04:00

I thought this to be a timely topic given the current measles outbreak that is occurring in a very undervaccinated population in Minnesota. Thus far, there are 14 cases in Hennepin County, 13 of which are epidemiologically-linked in the Somali population there. This situation highlights the infectiousness of measles and how easily it can be spread to immunologically-naive people, even with overall high vaccination rates. Uptake of MMR is estimated to be greater than 95% in 70% of U.S. schools, however, private schools are not surveyed and 12 states were below 95% with some as low as 81%. There is also geographical clustering of "like-minded" people in communities that leave large numbers of susceptible children at risk for measles. Additionally, lists of "vaccine-friendly" doctors, like this one provided by Dr. Bob can be geographically-linked to large numbers of school exemptions for vaccines.

This is what can, has and will happen again with the current recommendations that these "vaccine-friendly" doctors make: In 2008, an intentionally unvaccinated 7 year old child came back to the states from a visit to Switzerland with his parents.

In January 2008, measles was identified in an unvaccinated boy from San Diego, California, who had recently traveled to Europe with his family. After his case was confirmed, an outbreak investigation and response were initiated by local and state health departments in coordination with CDC, using standard measles surveillance case definitions and classifications.* This report summarizes the preliminary results of that investigation, which has identified 11 additional cases of measles in unvaccinated children in San Diego that are linked epidemiologically to the index case and include two generations of secondary transmission. Recommendations for preventing further measles transmission from importations in this and other U.S. settings include reminding health-care providers to 1) consider a diagnosis of measles in ill persons who have traveled overseas, 2) use appropriate infection-control practices to prevent transmission in health-care settings, and 3) maintain high coverage with measles, mumps, and rubella (MMR) vaccine among children.

The index patient was an unvaccinated boy aged 7 years who had visited Switzerland with his family, returning to the United States on January 13, 2008. He had fever and sore throat on January 21, followed by cough, coryza, and conjunctivitis. On January 24, he attended school. On January 25, the date of his rash onset, he visited the offices of his family physician and his pediatrician. A diagnosis of scarlet fever was ruled out on the basis of a negative rapid test for streptococcus. When the boy's condition became worse on January 26, he visited a children's hospital inpatient laboratory, where blood specimens were collected for measles antibody testing; later that day, he was taken to the same hospital's emergency department because of high fever 104°F (40°C) and generalized rash. No isolation precautions were instituted at the doctors' offices or hospital facilities.

The boy's measles immunoglobulin M (IgM) positive laboratory test result was reported to the county health department on February 1, 2008. During January 31--February 19, a total of 11 additional measles cases in unvaccinated infants and children aged 10 months--9 years were identified. These 11 cases included both of the index patient's siblings (rash onset: February 3), five children in his school (rash onset: January 31--February 17), and four additional children (rash onset: February 6--10) who had been in the pediatrician's office on January 25 at the same time as the index patient. Among these latter four patients, three were infants aged less than 12 months. One of the three infants was hospitalized for 2 days for dehydration; another infant traveled by airplane to Hawaii on February 9 while infectious.

Just the Vax reported earlier that the index case (the intentionally unvaccinated boy travelling from Switzerland) was Dr. Bob Sears' patient. But there is now more. That boy, the index case, infected four other children in the waiting room of his paediatrician's office. The office of Dr. Bob Sears. I suspected this was the case and it was confirmed when Dr. Bob appeared on the Dr. Oz Show, "What Causes Autism" with Dr. Ari Brown who stated:

"...And as an example, there was a 2008 measles outbreak in San Diego where an unvaccinated child developed measles, was in the doctor's waiting room where other unvaccinated children then got measles. In fact one of those children was too young to be vaccinated and contracted measles and ended up in the hospital. And I think those were actually Dr. Bob's patients."

Dr. Bob did not deny this.

In reality however, there were three infants and one toddler who contracted measles in his waiting room. Here is the story of the one who ended up in the hospital:

If you hear "106 degrees" you probably think "heat wave," not a baby’s temperature. But for Megan Campbell’s 10-month-old son, a life-threatening bout of measles caused fevers spiking to 106 degrees and sent him to the hospital.

"After picking our son up at child care because he had a fever," says Megan, "we went straight to our pediatrician who said our baby had a virus. Two days later, his fever hit 104 degrees and a rash appeared on his head."

The rash quickly crept down to his arms and chest. Megan and husband Chris turned to the Internet. Finding pictures of measles that looked like their son’s rash, they rushed him to the local children’s hospital.

"No one there had seen or tested for measles for about 17 years," says Megan. "And no one expected it in the year 2008 in the United States. The next day, an infectious disease specialist confirmed measles.

"We spent 3 days in the hospital fearing we might lose our baby boy. He couldn’t drink or eat, so he was on an IV, and for a while he seemed to be wasting away. When he began to be able to drink again we got to take him home. But the doctors told us to expect the disease to continue to run its course, including high fever—which did spike as high as 106 degrees. We spent a week waking at all hours to stay on schedule with fever reducing medications and soothing him with damp wash cloths. Also, as instructed, we watched closely for signs of lethargy or non-responsiveness. If we’d seen that, we’d have gone back to the hospital immediately."

Thankfully, the baby recovered fully.

Megan now knows that her son was exposed to measles during his 10-month check-up, when another mother brought her ill son into the pediatrician’s waiting room. An investigation found that the boy and his siblings had gotten measles overseas and brought it back to the United States. They had not been vaccinated.

"People who choose not to vaccinate their children actually make a choice for other children and put them at risk," Megan explains. "At 10 months, my son was too young to get measles, mumps, rubella (MMR) vaccine. But when he was 12 months old, we got him the vaccine—even though he wasn’t susceptible to measles anymore. This way, he won’t suffer from mumps or rubella, or spread them to anyone else."

This story is one of many recounted in the fact sheets series, Diseases & the Vaccines that Prevent Them.
For other true stories, see Vaccines: Unprotected Stories.

I wonder if Dr. Bob and his merry band of "disease-friendly doctors" provide information to their vaccine-refusal clients shown in the links above, let alone tell parents of his own practice's patient who was infected while waiting for his well check-up. Unfortunately, this isn't all to that story. It appears as though Dr. Bob or one of his practice partners doesn't even know what measles looks like:

First Generation (1 Case Spread to 8)
On January 13, 2008, the 7-year-old male index patient returned from Switzerland, asymptomatic but incubating measles. He transmitted infection to his 9-year-old unvaccinated sister and 3-year-old unvaccinated brother. On January 24, 2008, after 2 days of fever and conjunctivitis, the index patient attended charter school A. Forty-one of the 377 students (11%) at charter school A were unvaccinated for measles because of personal beliefs, and 2 children became infected. The next day, the index patient developed a rash and was taken to an internist who diagnosed an upper-respiratory infection and prescribed amoxicillin. No airborne-infection isolation precautions were taken; adults in the waiting room were exposed, but none of them became infected. Later the same day, the index patient was taken to pediatric clinic A, where scarlet fever was diagnosed; again, amoxicillin was prescribed. No respiratory precautions were taken, 6 children were exposed, 5 were unvaccinated, and 4 were infected (3 infants too young for vaccination and a 2-year-old whose parents had intentionally delayed measles vaccination). The next day, after telephone consultation with a pediatrician, the child was taken for measles serology testing. No respiratory precautions were taken in the clinical laboratory, and no records were kept to permit identification of potentially exposed persons. With worsening fever, the index patient was taken to a children’s hospital emergency department, where measles was clinically diagnosed. The patient was triaged, placed in a negative-airflow waiting room, and then examined in a room with curtain-separated beds and no negative airflow, all without wearing a mask. Thirteen children were potentially exposed, and 5 were unvaccinated infants; none of them were infected.

Emphasis added. A disease-friendly physician, such as Dr. Bob should know what measles looks like, and certainly be able to distinguish it from Scarlet Fever; there are tests for both. Even after this incident, Dr. Bob still recommends delaying MMR until 4 years old and recommends only a single dose. The parents of the index case are certainly not without fault as they intentionally left their child unvaccinated for measles, at the very least, travelled to an area with a relatively high prevalence of measles, in fact during that time, a record number of measles cases since mandatory reporting began in 1999 and then don't even know what measles looks like themselves, eventually exposing hundreds of people. The eventual cost of Dr. Bob's (or practice partner's) failure to properly inform parents, identify measles in his patient and the parents narcissistic decision to leave their child unvaccinated and traipse him about, was $124 517.00 in order to prevent third generation transmission. Cost to parents who refused post-exposure prophylaxis vaccination for their children and were placed in voluntary quarantine was ~$19 375.00. Cost to parents whose children were too young to be vaccinated and placed in voluntary quarantine was ~$37 200.00.

One would think this would be a humbling and educational experience for someone like Dr. Bob, but it wasn't. In his 2008 blog about the San Diego measles outbreak, he callously dismissed the measles outbreak:

The recent measles outbreak (if you can call it that) in San Diego last month, in which twelve children came down with the illness after an unvaccinated family brought the disease back with them from Switzerland, raises awareness of a growing trend among families to decline certain vaccines.

Perhaps Dr. Bob could benefit from EpiRen's Epidemiology Night School where he discusses what constitutes an outbreak for Dr. Bob's pal Dr. Jay Gordon.

WHAT IS AN OUTBREAK?
Traditionally, an outbreak has been defined as "one case over the expected rate (or number) of cases for a given location in a period of time." In Minnesota, they have seen 22 cases over the last 14 years (22/14=1.6 cases per year in all Minnesota). Rounding up, we can say that two cases per year is what is expected. Three cases in 2011 would mean an outbreak. What was that in 2010, you ask? Well, 19 cases in 13 years give us a rate of 1.5 cases per year. It would also be an outbreak situation, especially if the three cases were epidemiologically linked. That information is not yet available from the MDH, but it will be interesting to read later on.

Let's look at the numbers; in 2005, the whole state of California had 4 cases, in 2006, California had 6 cases, in 2007, 5 total cases, in 2008, 14 cases, 12 of which were epidemiologically linked to the included index case and 4 cases occurred right in Dr. Bob's office. The whole county of San Diego had not had a single measles outbreak since 1991. All of California went back down to 9 total cases in 2009. That was an outbreak as defined by epidemiology. Unless Dr. Bob would like to claim that an average of 3 or 4 cases of measles occurs in his waiting room on an annual basis. This is what he also callously claims regarding the ten month old infant infected in his waiting room and ended up in the hospital:

I believe our nation can tolerate a certain percentage of unvaccinated children without risking the overall public health in any significant way. Since most children are vaccinated, our nation has enough “herd immunity” to contain outbreaks like this one.
However, in the San Diego case, some infants caught measles before they were old enough to even be vaccinated. Fortunately, all cases passed without complications, as is usually the case with measles.

I beg to differ that the Campbell's son, hospitalised for 3 days and then several more days at home with constant monitoring is "uncomplicated". Perhaps he hopes that no one will remember the children infected during this outbreak should any develop SSPE in the next few years. Dr. Bob also doesn't get herd immunity, no need for scare quotes, herd immunity is real and assumes equal distribution of susceptibility to work. He has helped to create the clustering effect which allowed foreign measles strains to spread until contact tracing and quarantining of exposed individuals was implemented by public health officials. But that is just fine according to Dr. Bob:

Public health officials will be there to help clean up the mess that disease-friendly doctors like Dr. Bob create, instead of promoting prevention. I am fully supportive of parents' right to choose vaccination schedules, however, choices need to be more responsible and "vaccine-friendly" doctors need to stop disseminating false information and validating poor vaccine choices. To use the words of anti-vaxx spokesperson, Jenny McCarthy:

I do believe sadly it's going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it's their f___ing fault that the diseases are coming back. They're making a product that's s___. If you give us a safe vaccine, we'll use it. It shouldn't be polio versus autism.

Except it isn't going to work out the way she thinks when some physicians and parents wilfully contribute to large gaps in herd immunity. When a child does die or become permanently injured from measles, or a child is born with congenital rubella syndrome because the mother sat in a waiting room of someone like Dr. Bob Sears, or wild-type polio is ever diagnosed in the Western Hemisphere again, there will be a backlash. Sears, Gordon and all of the other disease-friendly doctors won't get to re-define nomenclature and won't get to heartlessly disregard outcomes.

The next time you are looking for a measles party, or chicken pox, rubella, Hib, pertussis or mumps, no need to organise it with your local mummy forum, just stop by Dr. Sears' office or one of his disease-friendly associates offices on his list. But you may want to go see a more competent physician if you actually want a proper diagnosis after the fact. And even better, one who makes house-calls.

EDITED BY Catherina ON 6/6/2011 to add a comment from Dr. Bob made on his Facebook group:

Seems he lucked out there...

Dr. Bob Sears' Alternate Reality or Everyone is a Pharma Shill

2011-03-19T12:21:00.003-04:00

On 17 February 2011, Dr. Bob Sears appeared on The Dr. Oz Show; the topic was "What Causes Autism". Dr. Oz packed the audience with mainly those who believe autism is caused by vaccines thus setting up all of the legitimate panel members (paediatricians) to be on the defensive. It was a live viewing, however, of how "alternative" practitioners get to play by their own rules enticing the audience, leaving those who remain true to the facts appearing unsympathetic and cold. One particular statement that Dr. Bob made was rather sensational and undoubtedly meant to be:

"Most of the vaccine studies that show no link between vaccines and autism are funded by the pharmaceutical companies."

Audience applause then:

"In fact, if you look at the 23 major studies that have shown no link, 18 of them are funded by big pharma."

Yes, he really did say "big pharma". Needless to say, I found this claim rather intriguing so I asked Dr. Bob which studies was he referring to:

On the Dr. Oz Show about autism a couple of weeks ago, you stated that most studies exonerating vaccines as the culprit for autism were pharma-funded, 18/23 to be exact. I'm very curious as to which 23 studies you were referring to.

He kindly replied:

Not counting studies labeled as “commentary,” since that isn’t original research, I count 18 out of 23. There may be some studies I didn’t include here, but these are most of them:

Studies that compared children who received vaccines with mercury with children who did not and found no association between vaccine mercury and autism:

1.) Association between thimerosal-containing vaccines and autism, Hviid A, et al., JAMA 2003;290(13):1763-66. Pharma-funded. http://jama.ama-assn.org/content/290/13/1763.long

2.) Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: a descriptive study, Pichichero M, et al., Lancet 2002;360(9347):1737-41. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/12480426

3.) Thimerosal and autism? Nelson K and Bauman M., Pediatrics 2003;111:674-79. Commentary. http://pediatrics.aappublications.org/cgi/content/full/111/3/674

4.) On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes, Smith M. and Woods C. Pediatrics 2010;125(6):1134-41. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/20498176

Studies that show autism continued to increase even after mercury was removed from vaccines:

5.) Thimerosal and the occurrence of autism: negative ecological evidence from danish population-based data, Madsen K, et al., Pediatrics 2003;112:604-606. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/112/3/604?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=madsen&searchid=1&FIRSTINDEX=0&volume=112&issue=3&resourcetype=HWCIT

6.) Continuing increases in autism reported to california’s developmental services system, Schechter R, Grether, J., Arch Gen Psychiatry 2008;65(1):19-24.http://archpsyc.ama-assn.org/cgi/content/full/65/1/19

7.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al., Pediatrics 2006;118:e139-e150. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139

Studies that examined the rates of autism compared to the cumulative levels of mercury in vaccines and found no association:

8.) Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism, Price C. et al., Pediatrics 2010;126:656-64. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/20837594

9.) Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization database, Verstraeten T. et al., Pediatrics 2003;112:1039-48. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/112/5/1039

10.) Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines, Tozzi A, et al., Pediatrics 2009;123:475-82. http://pediatrics.aappublications.org/cgi/content/full/123/2/475

11.) Autism and thimerosal-containing vaccines: lack of consistent evidence for an association, Stehr-Green P., Am J Prev Med 2003;25(2):101-106. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/12880876

12.) Thimerosal exposure in infants and developmental disorders: a prospective cohort study in the united kingdom does not support a causal association, Heron J, et al., Pediatrics 2004;114:577-83. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/114/3/577

13.) Early thimerosal exposure and neuropsychological outcomes, Thompson W, et al., N Engl J Med 2007;357:1281-92. Pharma-funded. http://www.nejm.org/doi/full/10.1056/NEJMoa071434#t=articleTop

14.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al., Pediatrics 2006;118:e139-e150. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139

Research comparing autism rates in children who did and did not receive the MMR vaccine and found no increased risk of autism:

15.) A population-based study of measles, mumps, and rubella vaccination and autism, Madsen KM, et al. N Engl J Med 2002;347(19):1477-82. Pharma-funded. http://www.nejm.org/doi/full/10.1056/NEJMoa021134#t=articleTop

16.) No effect of MMR withdrawal on the incidence of autism: a total population study, Honda H, et al., J Child Psychology and Psychiatry 46:6 (2005); 572-79. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/15877763

Research that duplicated Wakefield’s study and found no association between MMR and autism:

17.) Lack of association between measles virus vaccine and autism with enteropathy: a case-control study, Hornig M, et al., PLoS ONE 2008;3(9):e3140. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2526159/?tool=pubmed

Studies showing no evidence of a temporal relationship between MMR vaccine and autism:

18.) MMR vaccination and pervasive developmental disorders: a case-control study, Smeeth L, et al., Lancet 2004; 364:963-69. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/15364187

19.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al., Pediatrics 2006;118:e139-e150. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139

20.) No evidence for a new variant of measles-mumps-rubella-induced autism, Fombonne E and Chakrabarti S, Pediatrics 2001;108:e58. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/11581466

21.) No evidence for links between autism, MMR, and measles virus, Chen W. et al., Psychological Medicine 2004;34(3):543-53. http://www.ncbi.nlm.nih.gov/pubmed/15259839

22.) Neurologic disorders after measles-mumps-rubella vaccination, Mäkelä A, et al., Pediatrics 2002;110:957-63. Pharma-funded. http://pediatrics.aappublications.org/cgi/content/full/110/5/957

23.) Association of autistic spectrum disorder and the measles, mumps, and rubella vaccine, Wilson K. et al., Arch Pediatr Adolesc Med 2003;157:628-34. Commentary. http://archpedi.ama-assn.org/cgi/content/full/157/7/628

24.) Vaccines for measles, mumps and rubella in children, The Cochrane Database of Systematic Reviews 2005; issue 4. Commentary. http://www.ncbi.nlm.nih.gov/pubmed/16235361

Studies that show no link between MMR and autism or gastrointestinal disease:

25.) MMR vaccine and autism: an update of the scientific evidence, DeStefano F., Thompson W., Centers for Disease Control, Expert Review of Vaccines 2004;3(1):19-22. Commentary. http://www.ncbi.nlm.nih.gov/pubmed/14761240

26.) Measles vaccination and antibody response in autism spectrum disorders, Baird G, et al., Arch Dis Child 2008;93:832-37. Pharma-funded. http://www.ncbi.nlm.nih.gov/pubmed/18252754

27.) Unintended events following immunization with MMR: a systematic review, Jefferson T. et al., Vaccine 2003;21(25-26):3954-60. Commentary. http://www.ncbi.nlm.nih.gov/pubmed/12922131

28.) A case-control study of measles vaccination and inflammatory bowel disease, The East Dorset Gastroenterology Group, Feeney M. et al., Lancet 1997;350(9080):764-66. http://www.ncbi.nlm.nih.gov/pubmed/9297995

Miscellaneous

29.) Immunization Safety Review: Vaccines and Autism, Immunization Safety Review Committee, Washington, DC: Institute of Medicine of the National Academies, 2004. Commentary. http://www.ncbi.nlm.nih.gov/books/NBK25344/

Research can be funded in numerous ways, for example, government institutions such as the NIH or CDC, special interest groups such as Autism Speaks or Autism Science Foundation, charitable/philanthropic organisations such as The David & Lucile Packard Foundation or Wellcome Trust and of course, industry such as pharmaceutical or agricultural companies. When Dr. Bob states, "funded by pharmaceutical companies", that has a very specific meaning, that the study was funded by pharmaceutical companies. Let's look at the funding sources for those he tagged as "pharma-funded":

1.) Association between thimerosal-containing vaccines and autism, Hviid et al.
Author Affiliations: Danish Epidemiology Science Centre, Department of Epidemiology Research (Messrs Hviid, Wohlfahrt, and Dr Melbye) and Medical Department (Dr Stellfeld), Statens Serum Institut, Copenhagen, Denmark.
Funding Statement: This study was supported by grant 11 from the Danish National Research Foundation and grant 22-02-0293 from the Danish Medical Research Council.

The Danish System is unique in that they have universal healthcare; Statens Serum Institut (SSI) is a public enterprise that operates under the Danish Ministry of Health. SSI has a division which develops vaccines and is essentially, a non-profit. SSI also has divisions which operate much like the CDC in the U.S. These divisions are where the authors of this study are employed. A comprehensive explanation of SSI's structure can be read here. This is not "big pharma" by any stretch of the imagination.

2.) Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: a descriptive study, Pichichero M, et al.
Author Affiliations: Department of Microbiology/Immunology, University of Rochester, Rochester, New York, NY, USA.
Conflict of Interest: None declared.
Funding Statement: The investigation was funded by the US National Institutes of Health (NIH), Bethesda, MD, under contract 1 AF-45248.

4.) On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes, Smith M. and Woods C.
Author Affiliations: University of Louisville School of Medicine, Division of Pediatric Infectious Diseases, 571 S Floyd St, Suite 321, Louisville, KY 40202, USA.
Conflicts of Interest: Drs Smith and Woods are or have been unfunded subinvestigators for cross-coverage purposes on vaccine clinical trials for which their colleagues receive funding
from Wyeth, Sanofi Pasteur, GSK, MedImmune, and Novartis; and Dr Woods has received honoraria for speaking engagements from Merck, Sanofi Pasteur, Pfizer, and MedImmune and has received research funding from Wyeth and Sanofi Pasteur.
Funding Statement: This study was conducted without funding from any company (e.g., vaccine manufacturer) or agency (e.g., the CDC). We conducted this study on our own after requesting and receiving the publicly available data that were used for the analyses. Our unrelated interactions with vaccine manufacturers have been appropriately disclosed for full transparency in accordance with our own ethical standards as well as formal guidelines from the Academy of Pediatrics and the University of Louisville.

This is what Dr. Bob had to say about the study when he was asked (he also copied a communication from Dr. Rosen included in the preceding link):

Major flaws by Dr. Bob Sears - posted on 5/25/2010
Let me first say I haven't read it yet. Too busy in office last few days. But here are three observations: 1 - they excluded kids with autism from the study (DUH! - that's the type of kids you'd want to include in this!)
2. Hugely funded by pharmaceutical companies - the list of conflict of interest is quite long. Publishing a study like this with pharma funding is 100% worthless - the only people who will believe it are those who don't mind conflicts of interest.
3. Here's a comment from one of a doctor in the AAP who heads up one of the AAP divisions: this is the letter he wrote the journal:

"Dear Sirs,

I read with great interest Smith and Woods article, "On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes." This issue is of paramount importance in clinical primary care practice today. However, I was dismayed by two factors within minutes of reading the piece. One, of perhaps lesser importance, in the Results Section, the numbers, simply put, do not add up. If all of the subjects are added as listed, a total of 1037 (not 1047) is obtained. Furthermore, the percentages are incorrect as listed. The final group (311) is in fact 30% of the incorrect total, not 20% as listed. It always concerns me and forces me to question the validity of the other findings when a mistake like this is notable. In any case, the finding that approximately 50% (depending on the true numbers) received an alternative vaccine schedule, even as long ago as 1993-1997 is of interest.

Of greater concern to me, personally, is the Financial Disclosure listings. It is very difficult in this day and age to review the authors' conclusions without considering their considerable potential biases given where their funding comes from. I believe every known vaccine manufacturer is listed on the payroll. Until we have well-done, conflict- free published research on this topic, both the public and skeptical physicians must continue to look for honest answers."

Dr. Bob didn't even read the study, let alone read the response that Dr. Rosen received about funding sources (self-funded) from the authors and absolutely no pharmaceutical funding. He doesn't even grasp that Dr.s Smith and Woods used the data set from Thompson et al. (13), which specifically excluded autism and explained why. This is just Dr. Bob being intentionally misleading so he doesn't have to confront any evidence that is antithetical to his "trademark alternative vaccine schedule".

5.) Thimerosal and the occurrence of autism: negative ecological evidence from danish population-based data, Madsen K, et al.
Author Affiliations: Danish Epidemiology Science Centre, Department of Epidemiology and Social Medicine, University of Aarhus, Denmark
Institute for Basic Psychiatric Research, Department of Psychiatric Demography, Psychiatric Hospital in Aarhus, Risskov, Denmark
National Centre for Register-Based Research, University of Aarhus, Aarhus, Denmark
State Serum Institute, Department of Medicine, Copenhagen, Denmark
Funding Statement: The activities of the Danish Epidemiology Science Centre and the National Centre for Register-Based Research are funded by a grant from the Danish National Research Foundation. This study was supported by the Stanley Medical Research Institute. No funding sources were involved in the study design.

7.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al.
Author Affiliations: Department of Psychiatry, McGill University, Montreal Children's Hospital, Montreal, Quebec, Canada
Lester B. Pearson School Board, Montreal, Quebec, Canada
Conflicts of Interest: In the United Kingdom, Dr Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers, and to several government committees between 1998 and 2001. Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation.
Funding Statement: None of his research has ever been funded by the industry.

8.) Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism, Price C. et al.
Author Affiliations: Abt Associates Inc, Cambridge, Massachusetts;
National Center for Chronic Disease Prevention and Health Promotion, Immunization Safety Office, and Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia;
Division of Research, Kaiser Permanente Northern California, Oakland,California;
Department of Psychiatry and Behavioral Sciences, Kaiser Permanente ASD Center San Jose Northern California Region, Stanford University, Palo Alto, California;
Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, Massachusetts;
Southern California Kaiser Permanente, and Center for Vaccine Research, University of California, Los Angeles, California; and
Center for Health Research Southeast, Kaiser Permanente, Atlanta, Georgia
Funding Statement: This work was supported by a contract from the CDC to America’s Health Insurance Plans and via America’s Health Insurance Plans subcontracts to Abt Associates Inc; Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School; Southern California Kaiser Permanente, and Center for Vaccine Research, University of California Los Angeles; and Division of Research, Kaiser Permanente Northern California.

Ironically, this is the study that Dr. Bob's colleague, Sally Bernard of SafeMinds participated in.

9.) Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization database, Verstraeten T. et al.
Author Affiliations: Epidemic Intelligence Service Program, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia
Vaccine Safety and Development Activity, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia
University of Washington and Group Health Cooperative of Puget Sound, Seattle, Washington
Center for Child Health Care Studies, Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School, and Division of General Pediatrics, Children’s Hospital, Boston, Massachusetts
Kaiser Permanente Vaccine Study Center, Oakland, California
Funding Statement: None declared.

Ironically, this study group invited Dr. Bob's colleague, Lyn Redwood of SafeMinds to review the findings.

11.) Autism and thimerosal-containing vaccines: lack of consistent evidence for an association, Stehr-Green P. et al.
Author Affiliations: Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, WA, USA.
National Board of Health and Welfare (Tull), Stockholm, SwedenStatens Serum Institut (Stellfeld), Copenhagen, Denmark
National Centre for Register-Based Research (Mortenson), Aarhus, Denmark
National Immunization Program, Centers for Disease Control and Prevention (Simpson), Atlanta, Georgia, USA
Funding Statement: Financial support for the compilation of the data used in this investigation and the preparation of this report was provided by the National Immunization Program, Centers for Disease Control and Prevention. We are grateful to Victoria Romanus of the Swedish Institute for Infectious Disease Control, Ingrid Trolin of the Swedish Medical Products Agency, Anne-Marie Plesner and Peter Andersen of the Danish Statens Serum Institut, and Roger Bernier and Susan Chu of the Centers for Disease Control and Prevention for their contributions in the design and conduct of this investigation, and in the preparation and review of this manuscript.

12.) Thimerosal exposure in infants and developmental disorders: a prospective cohort study in the united kingdom does not support a causal association, Heron J, et al.
Author Affiliations: Unit of Paediatric and Perinatal Epidemiology, Department of Community-Based Medical Sciences, University of Bristol, Bristol, United Kingdom
Funding Statement: Financial support for the establishment of the ALSPAC cohort was provided by the Medical Research Council, the Wellcome Trust, the UK Department of Health, the Department of the Environment, and DfEE, the National Institutes of Health, and a variety of medical research charities and commercial companies. Funding for this study was provided by the Department of Health (Ref VIE 134/1).

13.) Early thimerosal exposure and neuropsychological outcomes, Thompson W, et al.
Author Affiliations: From the Influenza Division and Immunization Safety Office , Centers for Disease Control and Prevention, Atlanta;
Abt Associates, Cambridge, MA;
Group Health Center for Health Studies, Seattle;
the Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School, Boston;
Kaiser Permanente Division of Research and Vaccine Study Center, Oakland, CA;
UCLA Center for Vaccine Research, Torrance, CA;
Southern California Kaiser Permanente, Los Angeles;
RTI International, Atlanta; and
Stanford University, Palo Alto, CA.
Conflicts of Interest: Dr. Thompson reports being a former employee of Merck; Dr. Marcy, receiving consulting fees from Merck, Sanofi Pasteur, GlaxoSmithKline, and MedImmune; Dr. Jackson, receiving grant support from Wyeth, Sanofi Pasteur, GlaxoSmithKline, and Novartis, lecture fees from Sanofi Pasteur, and consulting fees from Wyeth and Abbott and serving as a consultant to the FDA Vaccines and Related Biological Products Advisory Committee; Dr. Lieu, serving as a consultant to the CDC Advisory Committee on Immunization Practices; Dr. Black, receiving consulting fees from MedImmune, GlaxoSmithKline, Novartis, and Merck and grant support from MedImmune, GlaxoSmithKline, Aventis, Merck, and Novartis; and Dr. Davis receiving consulting fees from Merck and grant support from Merck and GlaxoSmithKline. No other potential conflict of interest relevant to this article was reported.
Funding Statement: Supported by the CDC.

14.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al.
Author Affiliations: Department of Psychiatry, McGill University, Montreal Children's Hospital, Montreal, Quebec, Canada
Lester B. Pearson School Board, Montreal, Quebec, Canada
Conflict of Interest: In the United Kingdom, Dr Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers, and to several government committees between 1998 and 2001. Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation.
Funding Statement: None of his research has ever been funded by the industry.

15.) A population-based study of measles, mumps, and rubella vaccination and autism, Madsen KM, et al.
Author Affiliation: Danish Epidemiology Science Center, Department of Epidemiology and Social Medicine, Århus, Denmark;
Danish Epidemiology Science Center, Department of Epidemiology Research, Statens Serum Institute, Copenhagen, Denmark; and
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta.
Funding Statement: Supported by grants from the Danish National Research Foundation; the National Vaccine Program Office and National Immunization Program, Centers for Disease Control and Prevention; and the National Alliance for Autism Research.

16.) No effect of MMR withdrawal on the incidence of autism: a total population study, Honda H, et al.
Author Affiliations: Yokohama Rehabilitation Center, Yokohama, Japan;
Institute of Psychiatry, London, UK
Funding Statement: None declared.

18.) MMR vaccination and pervasive developmental disorders: a case-control study, Smeeth L, et al.
Author Affiliations: Department of Epidemiology and Population Health;
Department of Infectious and Tropical Diseases ;
London School of Hygiene and Tropical Medicine, London, UK;
Department of Psychiatry, McGill University, Montreal Children’s Hospital, Canada;
and Institute of Psychiatry, Kings College, London, UK
Conflicts of Interest: L Smeeth, C Cook, L Heavey, L C Rodrigues, and P G Smith have no conflicts of interest. E Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers (for a fee), and to several government committees. A J Hall received a financial contribution from Merck towards research on hepatitis B vaccination in 1998. He is also a member of the Joint Committee on Vaccines and Immunisation (2002–present).
Funding Statement: The study was funded by the UK Medical Research Council. L Smeeth is supported by a Medical Research Council Clinician Scientist Fellowship.

19.) Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations, Fombonne E, et al.
Duplicate of (14)

20.) No evidence for a new variant of measles-mumps-rubella-induced autism, Fombonne E and Chakrabarti S
Author Affiliation: Institute of Psychiatry, Department of Child and Adolescent Psychiatry, King’s College London, London, United Kingdom;
Child Development Center, Central Clinic, Stafford, United Kingdom.
Funding Statement: None declared.

22.) Neurologic disorders after measles-mumps-rubella vaccination, Mäkelä A, et al.
Author Affiliations: Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland
Department of Infectious Disease Epidemiology, National Public Health Institute, Helsinki, Finland.
Funding Statement: Dr Mäkelä was partially supported by a grant from Merck & Co.

26.) Measles vaccination and antibody response in autism spectrum disorders, Baird G, et al.
Author Affiliation: Newcomen Centre, Guy’s & St Thomas’ NHS Foundation Trust, London, UK;
Biostatistics Group, Division of Epidemiology & Health Sciences, University of Manchester, Manchester, UK;
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, King’s College London, UK;
Behavioural and Brain Sciences Unit, UCL Institute of Child Health, London, UK;
Department of Paediatrics, John Radcliffe Hospital, University of Oxford, Oxford, UK;
School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK;
Chatswood Assessment Centre, Sydney, New South Wales, Australia;
National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK;
Virus Reference Department, Centre for Infections, Health Protection Agency, London, UK
Conflicts of Interest: MA and DB have given unpaid advice to lawyers in MMR and MR litigation. GB has acted as an occasional expert witness for the diagnosis of autism. AP receives royalties from SCQ and ADOS-G instruments. PBS has acted as an expert witness in the matter of MMR/MR vaccine litigation. All other authors have no conflicts of interest.
Funding Statement: he study was funded by the Department of Health, the Wellcome Trust, the National Alliance for Autism Research (NAAR) and Remedi. The sponsors of the study had no role in study design, data collection, data analysis, data interpretation or writing
of the report. The corresponding author had full access to all the data in the study and final responsibility for the decision to submit for publication.

Of the 18 studies that Dr. Bob declared are pharma-funded, 1 (22) is partially funded by Merck, three studies (9, 16 and 20) don't have funding statements and 1 (19) is a duplicate of (14). That leaves 13 studies with no pharmaceutical funding whatsoever, confirmed. I already knew this so I offered Dr. Bob the chance to rectify his "mistake":

I really do wish to thank you for answering me. In doing so, I would like to extend you the courtesy of retracting your statements that, "Most of the vaccine studies that show no link between vaccines and autism are funded by the pharmaceutical companies" and, "In fact, if you look at the 23 major studies that have shown no link, 18 of them are funded by big pharma." before I write about this.

However, instead of making the honest gesture to retract his demonstrably false statements, Dr. Bob "clarifies":

Clarification by Dr. Bob - posted on 3/10/2011

A quote from the beginning of the Fombonne study:
Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation.

The qualifications I use to determine if a study is pharma-funded is 1. The research is directly funded by pharma, or 2, the researchers involved have received money from pharmaceutical companies for services rendered, or 3. The researchers in the past have had other studies funded by pharma (I'm don't think this last one applies anywhere here, but I don't remember now).

Because Dr. Fombonne has been an expert witness in defense of the pharmaceutical companies, this creates a clear financial and professional conflict of interest.

I know that none of this would matter to some of you on this board, but I think it matters to most parents in general.

And this goes both ways. Some of the doctors who HAVE found a link between autism and vaccines in their research have testified AGAINST pharma on behalf of vaccine injury claimants. I also consider that a conflict of interest in their research.

But of course! Create an overreaching, blatantly dishonest, weasel-worded definition for what he meant; pure truthiness. He devises an alternate rendering in order to set up the premise should "big pharma" even fart in the general direction of an investigator, he can label their study as "pharma-funded". Even by his own tortured criteria, he can't claim that the three studies with no funding declaration are "pharma-funded" but yet he does. He doesn't even read these studies; he doesn't know how but only knows that they don't concur with his pre-conceived notions (and his bread and butter). How does he explain that these so-called "pharma-funded" studies' results are concordant with those that he hasn't deemed "pharma-funded"? He can't.

As for this statement:

And this goes both ways. Some of the doctors who HAVE found a link between autism and vaccines in their research have testified AGAINST pharma on behalf of vaccine injury claimants. I also consider that a conflict of interest in their research.

It's a right load of bollocks. His Vaccine Book is rife with "studies" by the Geiers, Wakefield, Classen, Goldman, Yazbak and Bradstreet, all with conflicts of interest, businesses that profit from "vaccine damage", and/or appearances as "expert witnesses" for petitioners in the NVICP. Why he still considers Andy (Wakefield) a close friend and stands behind his research, not to mention Dr. Bob's own flagrant conflicts of interest. As a DAN! doctor, he thrives on hawking "vaccines cause autism" and promoting fear about vaccines helps to keep his books, products and services selling. He clearly has a financial and personal investment in denying the legitimacy of any studies that don't support his paradigm.

Do some authors have conflicts of interest? Yes they do and their declarations allow the readers of their studies to properly assess their value and consider replication of other studies. Had Dr. Bob stated that some of these authors have conflicts of interest, he would have made a factual statement, but he also wouldn't have made the same impact on the audience and I believe he knows that, which is why he defers to truthiness. It is a predictable tactic for the deceptive "vaccine safety" party line pushers to take. Furthermore, he only includes about half of the list of studies that cannot find a vaccine-autism association; hand-picking only those he believes he can apply his crooked standard to.

It is also worth noting Dr. Bob's dishonest/incompetent labelling of studies 3, 23, 24, 25, 27 and 29 as "commentaries". Again, a word with a very specific meaning when referring to scientific publications. For example, Pediatrics defines commentaries as follows:

Abstract length: no abstract
Article length: 400 to 800 words
Commentaries are opinion pieces consisting of a main point and supporting discussion. These contributions usually pertain to and are published concurrently with a specific article; the commentary serves to launch a broader discussion of a topic. Commentaries may address general issues or controversies in the field of pediatrics.

Nearly all medical/scientific journals will have a commentary or editorial section and they are rather consistent. What Dr. Bob labelled as "commentaries" are actually reviews, systematic reviews or meta-analyses and only one actual commentary and it is positively cloddish that he either doesn't know this or is too morally bankrupt to care. A review, as the name implies is an article that provides a more generalised, critical review of a specific topic. They are almost always solicited and peer-reviewed in the same manner as original research. They are very useful, mostly written by top experts in their respective fields (the quality, of course, depends upon the quality of the journal) that provide a good overview although can still be subject to author bias. Systematic reviews and meta-analyses can be very powerful study designs as explained in this study module by The Cochrane Collaboration. I doubt Dr. Bob has the desire to actually learn something contrary to his witless dogma by reading this, but "systematic review" in the titles of the damn studies should have tipped him off. For him to try and pass off an Institute of Medicine - Immunization Safety Review as a commentary just begs for a rhetorical drubbing.

Dr. Bob is nothing more than a self-styled marketeer, a medico last. He has managed to parlay some business acumen, M.D. credentials and family name into a business that obfuscates his mediocre medical skills and complete oblivion of science. He is influencing public health and has absolutely no competence to do so.

Paediatricians need to be more proficient at countering his fabrications when both dealing with parents and confronting him in the media. Parents' fears can be acknowledged without being validated and sadly, paediatricians have to make an effort to undo the damage that the likes of Dr. Bob have done on their own time while he makes a living off of generating fear with patently false information.

Wakefield is a Fraud

2011-01-05T23:04:00.004-05:00

It isn't exactly news to those of us who frequent blogs where Brian Deer posts but it's now official. This evening, CNN reported on the first instalment in the British Medical Journal (BMJ) of Mr. Deer's exposé of how Andrew Wakefield falsified medical records of the 12 children reported in the now retracted, 1998 Lancet study. CNN's first report by Parker and Spitzer caused notorious anti-vaxxer, J.B. Handley of Generation Rescue and a contributor to Age of Autism to squirm in his seat and dodge the hard, albeit straightforward questions posed to him.

The second was by Anderson Cooper who interviewed Andy Wakefield about the BMJ editorial on AC360°. Wakefield was clearly unnerved and uncharacteristically frenzied by Mr. Cooper's direct questioning about his fraud, conflicts of interest and associations with the legal aid supporting the Lancet study. True to form, Wakefield lied and stated he declared his conflicts of interest, did not receive any money from the MMR litigation team and that his work, "has been replicated in five countries around the world".

Brian Deer's feature article was followed up by another scathing editorial by the editors of BMJ.

In a series of articles starting this week, and seven years after first looking into the MMR scare, journalist Brian Deer now shows the extent of Wakefield’s fraud and how it was perpetrated (doi:10.1136/bmj.c5347). Drawing on interviews, documents, and data made public at the GMC hearings, Deer shows how Wakefield altered numerous facts about the patients’ medical histories in order to support his claim to have identified a new syndrome; how his institution, the Royal Free Hospital and Medical School in London, supported him as he sought to exploit the ensuing MMR scare for financial gain; and how key players failed to investigate thoroughly in the public interest when Deer first raised his concerns.11

Wakefield altered medical records of the 'Lancet 12' to the extent that none of the children's reported results were concordant with their medical records as summed up here:

How the link was fixed

The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:

Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism
Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns
Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination
In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”
The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link
Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation

It is refreshing to witness that the very media who fueled Wakefield's MMR-autism scare and help to create a manufactroversy by providing false balance with appearances by vaccine-autism cranks, are now doing some due diligence by investigating the claim a bit more thoroughly and positing incisive questions to those making the outrageous claims. Sadly, there will always be some media types that will continue to give the vaccine-autism cranks some air-time in the name of 'balance' but it definitely appears as though they will be far and few between and not particularly important from an ethical journalistic point of view.

The MMR-autism scare is based upon verifiable, scientific fraud. Millions of dollars and countless hours have been consumed to investigate this claim and none has been found. Then again, it's rather difficult to find evidence of causation when the original claim was completely and utterly falsified for personal and financial gain. Any practitioner who would still perpetuate Wakefield's claim and support him should be viewed as dubious, at best and a charlatan, at worst.

Policy vs. Evidence: Part 1, personal

2011-01-02T10:27:00.008-05:00

I have been planning a small series of posts for a while looking at vaccine policy vs. evidence for vaccine policy (i.e. when which vaccine are recommended for which population). This had originally been triggered by the flu vaccine recommendation for under 2 year olds and criticism thereof and some anecdotes on the handling of vaccine recommendations in my own life and online. I will kick off this series with a personal admission:

I am a vaccine refuser/alternatively vaccinating parent - our older child's school holds a current vaccination "non consent" form.

That is the short story. The long story is a little more complex. In the UK, children get their booster shots in school. They are paid for by the National Health Service. So last year, we got a letter home, asking us for consent to a dT/IPV (Diphtheria, Tetanus, inactivated Polio vaccine) booster. Well, it was 9 years after the dT pre-school booster, so the dT was a very good idea. The IPV however, we did not quite see as critical. Polio has been eradicated in the Western Hemisphere (this was before the Russian polio import from Tajikistan. Both children had had 4 polios. More importantly, however, I wanted the kids to be boosted for pertussis (routine on the German teen schedule). First of all, we know that pertussis immunity wanes, whether you had the shots (see also here) or coughed for it, then we know that the booster works for teens, adolescent and adult vaccination was likely to be cost effective, and finally, I had pertussis as a 15 year old (from babysitting an unvaccinated toddler) and I was not keen on anyone in the family living through a summer of relentless choughing. Pertussis is not nick-named "100 day cough" for nothing.

This was an interesting experience. The nurses from the school immunisation service could not help me with a dTaP (aP = acellular Pertussis) or dTaP/IPV. They were nice, though. The GP referred us to the health visitor, who only does babies and toddlers. The nurse from the travel vaccine section of our GP practise hung up on me after I had explained our wishes, with very little patience for something extraordinary. So finally, we landed in a private practise, one of those places that used to make money by selling the single M(easles), M(umps) and R(ubella) vaccines (call me hypocrite). While the nurse was clueless, she was exquisitely friendly, she did not hang up on me, so I could explain which vaccine we wanted, then explained to their resident GP that while that particularly vaccine was not licensed for kids over 10 years in the UK, it was in a lot of other countries (German pdf; I know because DH and I got the same vaccine in 2005). And eventually, after a reasonable office fee and a surprisingly cheap booster shot (£5 a pop), the whole family was back on track. Phew. So when the school sent out another consent form this year, we responded back with another non-consent (and an explanation why we did not consent).

In the end, the whole procedure was extremely sobering. Our decision to vaccinate our school children against pertussis was totally backed by evidence, biologically relevant and followed European recommendations, just not the UK's. In our opinion, the current UK policy was lagging behind the available evidence, even studies from the UK. It required a fair amount of perseverance and the luxury of some dispensable money to protect our children what we considered adequately.

Ho! How did I miss this?

2010-12-31T11:07:00.007-05:00

A poster asked in the comment section of our blog, whether the index patient in the San Diego measles outbreak had been a patient of "Dr. Bob" Sears. I recalled that Bob had been asked that directly on his board:

San Diego meales outbreak by San Diego mommy - posted on 3/26/2009

Someone told my that the child who started the San Diego measles outbreak last year was one of Dr Bob's unvaccinated patients. Is that true? That is so sad for the families affected by the outbreak, especially for the babies that were too young to be protected by the vaccine.

and Bob had answered in his usual flippant and evasive manner:

Ya, she wanted the MMR, but I wouldn't give it to by Dr. Bob - posted on 3/27/2009

So, it's totally my fault that the outbreak happened.

No, seriously, I do know who the family is and have interacted with them. I'll leave it at that, since it doesn't actually matter if they were actually my patient or not.

Seth Mnookin, the author of the soon to be released "The Panic Virus" pointed me to an Orange County Register piece that is much more candid than Dr. Bob:

An unvaccinated 7-year-old boy traveled to Switzerland and unknowingly contracted the virus. Almost 100 children (including babies who were too young for the MMR vaccine) were quarantined or hospitalized after they were exposed at the pediatrician’s office, Whole Foods or day care. In all, 11 children caught the measles. As it turns out, the boy who spread measles is a patient of Dr. Bob Sears

(my bold)

Dr. Bob himself downplays the severity of the situation in his 2008 blog by saying:

The recent measles outbreak (if you can call it that) in San Diego last month,

(my bold)

Fact check for Dr. Bob:

A recent study by researchers on the role of vaccine refusal in this outbreak was staggering: 839 people were exposed, 11 additional measles cases were reported (all in unvaccinated children); one infant, too young to be vaccinated, had to be hospitalized. At a time when the state of California is in devastating financial straits, it cost San Diego serious health care dollars: $10,376 per case, for a total of $124,517 (and the hospitalized infant's bill was nearly $15,000). Forty-eight children too young to be vaccinated were quarantined for several weeks, meaning parents had to miss work and wages at an average cost of $775 per child.

In his blog, Dr. Bob claims:

Fortunately, all cases passed without complications, as is usually the case with measles.

Lost in the depth of his own board is the reality check by Wilbert Mason, MD

Minimization of the effects of measles by Wilbert Mason MD - posted on 4/3/2008

As a pediatric infectious disease physician I feel I must comment on statements made in your March 27th commentary on the New York Times article. First, you infer that the cases in San Diego did not constitute an outbreak ("...if you can call it that..."). This is a highly contagious infection that spreads by small droplets that remain suspended in a closed room for over an hour. Indeed, 4 of the cases acquired the infection just by being in the pediatrician’s office at the same time as the first case. Three of these were infants and one of them had to be admitted to the hospital for dehydration.
Elsewhere you have observed that “all of the cases of measles passed without complications, as is usually the case with measles”. Let me share with you our experience with measles at Childrens Hospital Los Angeles during the measles epidemic in 1990. We diagnosed 440 cases between January 1st and June 30th. Of these cases 195 (44%) had to be admitted for one or more complications of measles. We documented the complications in all 440 cases and they included 63% with ear infections, 45% with diarrhea, 39% with dehydration, 36% with pneumonia, 19% with croup, and about 3% with other bacterial infections. Three children died all of pneumonia. Measles is not a trivial infection as you inferred. We would not be having a debate about vaccines at all if people realized the tremendous costs in suffering and human life we incurred before vaccines became available. To adequately protect a population against measles >90% of the population must be effectively immunized against the disease. If individuals defer vaccines as you suggest we will rapidly fall below that level putting large numbers of infants and children at risk of an outbreak if measles is introduced into the community. This is a free country but we should all feel some responsibility to our fellow citizens and their children.

Thank you Dr. Mason, that says it all, really, about the irresponsible behaviour of Dr. Bob Sears (and the patients' parents who believe him).

Measles - actual - not hypothetical

2010-12-11T06:10:00.006-05:00

another Dr. Bob "gem", I am afraid.

A poster on Bob's forum asked:

dr. sears hypothetical question... by - posted on 12/10/2010

my kids are 3 and a half and 1- both boys. we live in ny, and they havent had any vaccines. i would like to eventually travel with them, normal family spots- carribean, europe.... would you vax if you were me, and if so, which would you do? thanks!

Dr. Bob relishes these opportunities - here is his answer:

DR. Bob Answers by Dr. Bob - posted on 12/10/2010

Hypothetically, if I was a doctor answering a forum question pretending to be the person asking the question, my answer would be that I wouldn't do any vaccines just for disease coverage for the type of vacation travel that you, I mean "I", would be doing.

The OP thinks that is a reason to "lol" - I think it is a reason to facepalm. Unvaccinated children travelling out of the US, for example to Europe, are the major source of importation of measles - last demonstrated by the San Diego outbreak.

The index patient was an unvaccinated boy aged 7 years who had visited Switzerland with his family, returning to the United States on January 13, 2008. He had fever and sore throat on January 21, followed by cough, coryza, and conjunctivitis.

.../...

During January 31--February 19, a total of 11 additional measles cases in unvaccinated infants and children aged 10 months--9 years were identified. These 11 cases included both of the index patient's siblings (rash onset: February 3), five children in his school (rash onset: January 31--February 17), and four additional children (rash onset: February 6--10) who had been in the pediatrician's office on January 25 at the same time as the index patient. Among these latter four patients, three were infants aged over 12 months. One of the three infants was hospitalized for 2 days for dehydration; another infant traveled by airplane to Hawaii on February 9 while infectious.

Great job, who ever had suggested to the parents of that index case that it was ok to travel to Switzerland (in the middle of an ongoing measles outbreak with more than 3400 cases, 8 encephalitis and a pediatric death) with unvaccinated children.
To suggest, even "hypothetically" that no vaccination was necessary to travel outside the US is highly irresponsible. Parents who leave their children unvaccinated when taking them into the middle of an outbreak potentially make their children murder weapons – we posted the story of the pre-teen who spread measles in a waiting room as a consequence of which two children are now dying a very slow and horrific death.

Tetanus in an unvaccinated teen

2010-12-10T04:16:00.008-05:00

The availability and wide us of vaccines and the resulting low incidence of the diseases which these vaccines prevent make a lot of parents perceive the disease as "low risk" in general. In late 2008, we could "watch" online how wrong this perception is, when a mother turned to an anti-vaccine board, whose son was developing lock jaw. Here is the link (for those of you who speak German or want to put the text through a translation site - my translations and summaries of the board posts are in blue):

The thread is entitled "Jaw problems after Tetanus vaccination".

Mein Sohn (13 Jahre) hat sich am Knie eine mind. 1,5 cm tiefe Wunde zugezogen. Da es auch noch schmutzig war, (Sand etc.) habe ich den Hausartzt erlaubt ihn gegen Tetanus zu impfen. Er war bis jetzt noch gar nicht geimpft gewesen. 2 Tage später klagte mein Sohn das er sein Mund kaum öffnen könne, essen wurde schwierig, auch Zähneputzen. Alles ist verspannt, Kiefer und Hals tun Weh, vor allem beim kauen.
Meine Frage ist jetzt, ob das eine Folge von Impfen sein kann, oder eine Zufall?
Wenn, ist es alarmierend oder geht`s vorbei automatisch?
Wäre heilfroh, wenn jemand Erfahrung hat mit sowas. Ich würde ungern zu den Arzt gehen, er ist Impffanatiker und ich kämpfe schon seit Jahren mit diese Thema.

In the first post the mom describes that her 13 year old, unvaccinated son sustained a knee injury (1.5 cm deep, dirty, sandy) and because he had not been vaccinated, she allowed his GP to "vaccinate him against tetanus". Two days later, the boy has problems opening his jaw, neck and jaw hurt when he tries to eat or brush teeth. She fears vaccine damage and wonders whether this will pass alone. She is also afraid to take her son to the doctor, because he is "vaccine fanatic".

At this point, I am thinking "OMG, this boy has tetanus - go see a doctor, but I am just watching, never got a password on this board, since reason is being heavily "moderated" by the board owner and his little helpers. However, the mum's post is immediately being picked up by the resident vaxxaloons - a poster by the name of Gaston remarks:

"This sounds just like Tetanus Symptoms" (wait if you think "well spotted, now he is going to send her to the doctor") - he continues "I would assume that your son would not have gotten these symptoms without the vaccine. After all, Tetanus Toxins are injected. So it is not surprising that here we are looking at something like beginning Tetanus."..

Mum responds "That is just what I thought. So I probably did the wrong thing again.
It is worse today. The boy can hardly eat. I will take him to the doctor at 6pm. I assume he will give a cortisone injection or something like that and tells me that he should have been vaccinated much earlier.
I really don't know what to do. This has been going on for 4 days and for the child it is very irritating. If at least I knew this is going to pass.
Well, at least I know for sure that none of my children will be vaccinated (this was the first time)."

A poster called "Anke" confirms the mother in her feelings and encourages her to report this as an adverse vaccine event. She also claims to have "heard of such symptoms associated with the tetanus vaccine".

A day later, she is taking her son to the doctor again. The doctor does not diagnose tetanus, but a throat infection and (because mom does not want him on antibiotics) she takes her son to the local pediatric hospital where he stays for observation. Doctors there think vaccine reaction AND tetanus are "unlikely".

In the thread, a poster called "Uschi" then shares her experience with jaw problems which she assumes were from her tetanus vaccination, which she later "chelated with the help of her homeopath".

"Gaston" pitches in with a terrible rant about the doctor. I feel like ranting about that doctor, after all, he did not diagnose the tetanus in a rather unambiguous presentation, but that is not what "Gaston" means. He is on a roll "if this was my child, I would do everything to hold this scumbag accountable. .../... The penicillin treatment, which is counter-indicated in this case, is the worst, because your son could have sustained further damage from it!"

Most further posters share these sentiments, however, "Sonnenlicht" asks whether the boy had received active or passive immunisation, because post-exposure, the boy would have needed immunoglobulins.

Four days have passed since the mum's first post.

Finally, the child is transferred to the next large University Hospital as the doctors clue in that he has tetanus. The boy can still talk, but cannot eat or drink. In that post, mom also says that her son had the active and passive immunisation a week earlier (that post is on page 2 of the thread). She assumes, her son's illness is from either of the the two.

Poster "Babsi" refers the mum to a vaccine-critical doctor in Bavaria. Poster "Kat" "knows" from her naturopathic pediatrician that the tetanus vaccine given "in case it has become serious, is particularly critical, i.e. badly tolerated." She is also adamant that if the wound had been bleeding "it is impossible that this was tetanus, it is vaccine damage!!!" (the three exclamation marks make it true, you know). Apart from that, she recommends a vaccine critical "expert" or "any naturopathic doctor for further help". "Gaston" totally shares her feelings. "The wound alone did not cause the problems, that was unambiguously the vaccine. It is generally known that vaccines cause the disease they are supposed to protect from in some. Some people are more susceptible for this." He suggests contacting the media "Tetanus after vaccination! Because Tetanus is really rare here in Europe." "Anke" pitches in and recommends Arnica globules in the 200C and consulting a homeopath. General rambling ensues.

A day later we get a chronological account. It appears that the wound was cleaned and sutured soon after the accident, but the immunisations were not given until the control visit 3 days later. The tetanus symptoms started another couple of days after that, so 5 or 6 days after the injury. Mum reports "Everyone in the University Hospital is convinced that he has tetanus from the wound, although it cannot be proven. I do believe it, too. The wound was very deep and got sutured = closed air tight. This disease is very rare. Even in the University Hospital no one had ever seen a single case. My son is better today. He was released from ICU and is on a normal ward now. He can still not open his mouth, but he could drink a little bit."

After this account, "Sonnenlicht" is also convinced that the tetanus was caused by the wound and that tetanus is an important vaccine after all. However, "presonic" would still not vaccinate in such a situation. S/he doesn't understand why "the dead flesh was not removed before the wound was sutured.". "Sonnenlicht" does not buy that. "Anke" just cannot believe that such a wound did not bleed profusely and the mother explains that her son had a bicycle accident on an asphalted path and a deep wound next to the knee that did bleed. She is unsure whether the doctor cleaned the would appropriately.

Two weeks later, we get the resolution that the boy is home again, after nearly two weeks in the hospital on antibiotics, tetanus immunoglobulins and "lots of other medicines". The mother describes that her son had "not fared as poorly as she was told to expect" - he could breathe on his own and did not get "bad" cramps. He could not open his mouth and his tongue hurt. He started to make an effort to eat when the doctors discussed giving him a stomach probe to feed him.

This story is shocking on several levels. Obviously, I pity the child. An injured knee should not put a 13 year old in the hospital with tetanus. He was obviously very uncomfortable the whole time and mum sounds very desperate, too. The doctors' reactions in hindsight (which is always 20/20 ;)) were not stellar, the reaction of the resident anti-vaccine posters on that board are so out-worldly that they look almost staged. They may even have contributed to the delay until the boy was taken to the hospital.

Tetanus in children is very rare - so rare in fact, that doctors do no longer necessarily clue in when they are faced with a child with a locked jaw. However, 80% of the few pediatric cases of tetanus occur in unvaccinated children. They don't need dramatic injuries, blunt trauma, or minor splinters can be enough of a cause. Tetanus in children is very rare, however, we need to remember that most toddlers (over 96% according to the latest US figures, European figures are similar) have had at least 3 vaccines against tetanus - protection up to the school booster is near perfect, see also here, and most kids in the US will get that first school booster that protects them into adolescence, when 75% of US kids are getting another booster.

So the bottom line is: parents who do not vaccinate against tetanus need to be aware that the low incidence of tetanus is in part due to the high vaccination coverage. They themselves need to keep tetanus in mind when their unvaccinated children have an accident, since doctors might not automatically assume that s/he is looking at one of the 4/100 children who does not have tetanus protection and will almost certainly not have experience with tetanus. If worrying about tetanus with every splinter is too stressful for the parents, the alternative is NOT to post on an anti-vaccine board for encouragement that "head in the sand" is the best option, because 1. vaccines are teh ebil and 2. they are particularly evil after exposure.

The reasonable alternative is to consider vaccination.

Say "hello" to the new Stat Girl on the Block

2010-12-04T06:55:00.004-05:00

Media, TV, newspapers, but also online communities and blogs shape our opinions on health topics (all topics, really). In this busy world, we rarely take the time to read much beyond the sensational headline and the first couple of paragraphs. This is a dangerous trend, news items rarely contain the full information, journalists often cherry pick information from an original source and "fit" it to the desired headline (as eloquently described by Ben Goldacre here). Caveats and disclaimers are most often hidden at the bottom of the piece (Ben Goldacre again). References to original sources/publications, if they are given, are tedious to follow up. The whole exercise follows a stereotypical goal oriented (and the goal is NOT information) pattern (wonderfully spoofed by Martin Robbins here).

Evidence based bloggers, some online media and universities are pushing for less sensationalistic and more factual reporting. Recently, a campaign to add a "report an error" button to each news page was launched. Britain's National Health Service even runs a "Behind the Headlines" page that explains what is really in that paper.

Basically, as a "modern consumer" you need to know the basics of statistics, including the most important:

Correlation does NOT imply causality (or causal relationship).

We would probably suspect the (fictional) media headline "Storks deliver babies", based on the (true) fact that number of storks in Europe is strongly correlated with the local birth rate (the p-value is an impressive 0.008) wasn't true. But what about the many other health headlines, that tell us which herb/behaviour cures which disease, what is best for baby, what is best avoided for baby? Vaccines cause autism?

Enter Stat Girl, who "skewers the news, reminding the world that correlation is not causality one headline at a time".

With this "agenda" in mind, she is tackling the issues and outlets that target young mothers with their headlines.

Visit her blog and say "hello"! We need more analyses of media content and pressure for better reporting.

Behold - the idol of millions

2010-12-03T03:39:00.011-05:00

well, at least several tens of thousands, which had catapulted "The Vaccine Book" near the top 50 on Amazon. Stand in awe at the depth of research (13 years, he claims in his book) that he bases his recommendations on - actually, let us look at how Bob sees himself:

VACCINE BOOK HITS #53 ON AMAZON!!!! by Dr. Bob Sears - posted on 3/12/2008

How cool is that? 53 out of all books. God has really answered my prayers of wanting to reach America's (and England's too, Catherina) families with complete and objective info about the all-important decision. Yeah!

Hold on to this thought (ignoring the ever so slightly delusional "God has answered my prayers") - Bob claims: complete and objective info
Last night, Dr. Bob answered the question on how many MMR shots are needed if the first one is given at age four years with:

Dr. Bob Answers by Dr. Bob - posted on 12/2/2010

2 doses are still required, BUT one dose, in my opinion, is all that is really needed. One dose gives full protection from measles in 95% of kids, mumps in 98% of kids, and rubella in 99% of kids, regardless of age of vaccination. So, I think one dose is good enough. Getting it older, such as age four, MAY be more effective than getting it younger (such as age one), but I don't know a lot of details on that.
The ONLY reason we do two doses is to try to get the 5% who don't respond to one dose for measles to get protected from the second dose (most do respond to the second dose). That's better for public health/herd imunity, but as individuals I think one dose is fine.

shall we?

2 doses are still required, BUT one dose, in my opinion, is all that is really needed.: really? Enlighten us, why you have come to a different opinion than health experts in any other country in the world, based on "complete and objective info"?

One dose gives full protection from measles in 95% of kids, mumps in 98% of kids, and rubella in 99% of kids, regardless of age of vaccination.: I think, contrary to what he claims, Bob does read our blog.

So, I think one dose is good enough.: This from the man who claimed earlier this week that "most adults had lost their immunity". And how are his "thoughts" supported by "complete and objective info"?

Getting it older, such as age four, MAY be more effective than getting it younger (such as age one), but I don't know a lot of details on that.: ~~Getting it older, such as age four, MAY be more effective than getting it younger (such as age one), but~~ I don't know a lot ~~of details on that.~~ There, fixed that for you. Honestly, someone is pushing a vaccine "strategy" that will leave millions of kids unprotected, based on lack of knowledge?! Anyone else scared yet? I am.

The ONLY reason we do two doses is to try to get the 5% who don't respond to one dose for measles to get protected from the second dose (most do respond to the second dose).: And that is not a good reason already? Apart from the fact that mumps immunity is now thought to wane and needs boosting to maintain high community immunity (see for example here).

That's better for public health/herd imunity, but as individuals I think one dose is fine. : Really? Because his readers/patients all live in a bubble? We have already let our a collective gasp at the "don't tell your neighbors if you are eroding their safety by following my home made advice", but the above statement reveals fundamental misunderstanding of the workings of herd immunity and basic concepts of public health paired with the confident call for selfishness that tops his previous "insights".

Remember? Bob claimed to provide complete and objective info.
Gut feeling based on hanging out with the anti-vaccine crowd too much, amplified into the Gospel by a deluded sense of being The Chosen One seems much closer to reality.

Evidence trumps blanket statements (or whack-a-bob)

2010-12-01T05:15:00.009-05:00

I have a number of other blogs planned, but this little gem needed treating first. On The Vaccine Book discussion forum, a poster asked a couple of days ago:

Dr. Bob - the other day you answered a question for me regarding titers and MMR. You mentioned that immunity could last up to 10-15 years. Someone had a follow up question as follows:

does that mean that we would have to re-vaccinate when child is 14 or older? (Having been originally vaccinated at age 4). Will the one MMR not last a lifetime? Or would we just check titers again after the ten to fifteen year mark?

These are very relevant questions, given the dangerous MMR recommendations that Dr. Bob spreads on his board and blog. Here is his answer:

I'd check titers. It's fairly unpredictable and individual as far as how long titers will stay positive. You could check every 5 years starting around age fifteen. OR, knowing that the diseases are so rare, you could just not bother after checking at fifteen. MOST adults have lost their imunity, and no one checks (unless a person's occupation requires it, or during pregnancy for rubella).

Wow - there is so much wrong with that, lets take in in bits:

I'd check titers.: Yes, you would, as a doctor in private practice, that sounds like a very attractive way forward. Not sure how appealing this is to parents and children, though.

It's fairly unpredictable and individual as far as how long titers will stay positive.: It is funny he should say that, when the current Dr. Bob recommendation is to vaccinate children once with MMR when they are four since that is sufficient then ("for State requirements", in the small print).

You could check every 5 years starting around age fifteen.: A blood draw and expensive titers (not sure how expensive, but his vaccine visits cost $80 to $200) every five years, mmh, ok.

OR, knowing that the diseases are so rare, you could just not bother after checking at fifteen.: Dr. Bob logic at work. I have called him a public health threat before - here is a quick recap of one of the reasons why:
Why are M, M, and R rare? Because of the 2xMMR vaccine policy in developed countries.
What will happen if everyone followed Dr. Bob's recommendation? M, M, and R would resurge - his 1xMMR vaccinated patients would provide the ideal breeding ground. Dr. Bob's home visits for measles patients do not come cheap.

MOST adults have lost their imunity: That one left me almost speechless. Luckily, while Bob's anonymous sycophants were busy name calling, cbe did a minute of research:

the evidence? by cbe - posted on 11/30/2010

All the evidence I see for rubella and measles says adults have MAINTAINED their immunity. Where is the evidence on the other side?

Is it "rude" to ask for that evidence?

http://www.medscape.com/viewarticle/408098 Here we see measles immunity of 81-89% of adults and higher...and these are in birth cohorts that DID NOT receive the 2 dose schedule. So we know that many of these individuals are not immune because the 2 dose schedule came into effect later.

http://cat.inist.fr/?aModele=afficheN&cpsidt=19060889

this study looks at mumps 21 years after 2 dose vaccination. 70%+ immune. This is consistent with what SM is saying about mumps being the least effective part of the vaccine. BUT even here Dr Bob's assertion that "most" are not immune is not playing out in the numbers. I assume "most" would mean at least 50% + 1.

93%+ canadian mothers were found to be immune to rubella:

http://tinyurl.com/27gf9s6

Again 90%+ immune to rubella:
http://tinyurl.com/2eoxurz

I can show tons more for measles, too.'

But where is the evidence that most adults have lost immunity?

That was easy, right? Turns out that Dr. Bob had never invested that minute:

Hey CBE - thanks for the info by Dr. Bob - posted on 11/30/2010

I haven't looked at this research. I was answering simply on the general belief among the medical community that most vaccines don't last into adulthood. Since I don't do adult medicine, I've never had to counsel parents through this type of information and I've never actually looked it up. It looks like you are right about the MMR titers though - it seems that they do last into adulthood for more people. Thanks for pointing that out. I appreciate you doing so in a straightforward, respectful manner - very adult of you.

I haven't looked at this research.: now that was blindingly obvious.

I was answering simply on the general belief among the medical community that most vaccines don't last into adulthood.: ~~I was answering simply on the general belief~~ I didn't bother to look up the evidence before I posted utter nonsense in the forum (there, I fixed that for you).

Since I don't do adult medicine, I've never had to counsel parents through this type of information and I've never actually looked it up.: So Dr. Bob doesn't consider the consequences of his "alternative vaccination schedule" for his patients when they become adults? Wow.

This anonymous poster expresses their frustration:

Cath, This is bizarre to me - if the diseases are by - posted on 11/30/2010

"so rare" as Dr. Bob says, and most adults have lost immunity, then why do we bother vaccinating at all? It seems that older kids and teens would be at much MORE risk from mumps and measles, and we would want to make sure that they remained immune to these diseases all through adulthood. If adults have lost immunity, aren't babies at risk from adults from than from children? Where is the ratinale in this thinking?

as does this:

I don't think SM posted a rude comment at all by - posted on 11/30/2010

The thinking is illogical to expect parents to keep checking titers every five years, or not check at all since most of us are not immune anyway! I think for myself, it makes no sense at all to keep checking titers, when I know with almost certaintly that immunity will "wear off" after 5-10 years or so according to Dr. Bob. If we know that immunity from MMR wears off after several years, how can we safely get by with just one dose? I want my children to be protected when they are older and more prone to serious risks from measles and mumps. Same feeling with chickenpox. I think we will do one MMR at age four, and check titers once soon after to make sure it worked, then the second dose at age 12, before puberty. This was the old recommendation from AAP, since these diseases are MORE dangerous as kids pass adolescence, and they wanted to insure immunity into the later years.

and this:

Then if someone is going to make money by - posted on 12/1/2010

by offering that advice as an "expert" on the topic in print form, shouldn't they be willing and able to look up accurate information about said topic? Particularly if offering blanket statements? That is more rude than any attacks I've seen.

This site is a money-making venture.

No further comment needed.

Catherina and Science Mom Need to Come with a Warning!

2010-11-21T10:22:00.001-05:00

Last week, Dr. Bob Sears issued "IMPORTANT INFORMATION FROM DR. BOB". It had never been my intent to write about him as much as I have but the statements he makes create such a target-rich environment. He has offered such disclaimers before, one being so mock-worthy, going so far as to call us 'secret agents' for pharma, that Respectful Insolence couldn't even resist. His entire "Disclaimer and warning about Catherina and Science Mom" appears as the indented text.

Thank you for being a part of our vaccine forum. I appreciate your questions and comments. Please be aware that the only person officially affiliated with the forum is Dr. Bob Sears (usually posts as just "Dr. Bob"). There are two people on this site who have been unofficially involved since the beginning - Science Mom and Catherina. Please be aware of several things:
1. These two have absolutely no official affiliation with this website. I have no idea who they are or what their credentials are.

Dr. Bob needed to clarify this as Catherina and I seem to have a greater dedication for answering parents' questions on his forum than he has.

2. In the vast majority of circumstances, I DISAGREE with the advice they choose to give. So, take their advice with a few grains of salt. Having said that, they do happen to give accurate medical information when it comes to diseases. You can generally trust that info. But when it comes to things like "what should I do about a particular vaccine, vaccines in general, alternative vaccine approaches, and worries about vaccine side effects," they often give advice that I disagree with.

Dr. Bob agrees that we "give accurate medical information when it comes to diseases" and even goes on to say that you should "trust that info". But he DISAGREES with the "vast majority" of the advice that we give. The embuggerance is that the the advice he DISAGREES with is firmly rooted in the "accurate medical information" he praises us for. The good doctor is essentially saying that our advice based upon "accurate medical information" is not to be trusted but that his advice based upon... um, well something, should be relied upon.

3. I have stopped reading info posted by SM and Cath because it's just too annoying to read. Unless you ask them a direct question yourself, I suggest you do the same (unless you like debates that go around in circles).

Athough Bob has stopped reading our annoying "accurate medical information" he hasn't gone so far to stop telling others to stop reading our "accurate medical information" (fingers in ears; "NANANANANA I CAN'T HEAR YOU!!!"). Of course it's annoying, it is always "annoying" when someone calls you out on your bullshit.

4. It is my opinion that SM and Cath are being paid to play an active and daily role by one or more companies that have a financial interest in the success of vaccines. I have no direct evidence of this. But given then way they treat most people who doubt or question vaccines, I just can't believe that they would spend hours each day, almost every day, for THREE YEARS answering questions out of the goodness of their hearts.

Well, it is "my opinion that SM and Cath" should be paid by the evil drug companies (and the evil oil companies and the evil auto companies and the evil defence contractors any other evil companies who are giving away free money), unfortunately, that ain't happening. It would be nice to think that the pharma companies care enough about Dr. Bob's blog to pay shills to post there as much as we do, it's nice to believe in the tooth faerie too. Anyway, the good doctor says he has "no direct evidence of this", but honestly, when has that ever stopped him from giving his opinion. He can't believe that we would spend "THREE YEARS" taking time to answer parents' concerns out of the "goodness of their hearts" because if he wasn't getting paid to write books, he sure as fuck wouldn't.

5. I trust the judgement of the site administrator (a personal friend of mine) who will be routinely deleting unnecessary and unproductive posts.

Amazingly, Dr. Bob and I agree on something.

6. As a final, and slightly unrelated note, my primary role here is to answer specific questions to help guide you in your understanding and decisions. As a full-time practicing pediatrician, husband, and father of three, I don't have extra time to engage in online discussions or debates. So you will rarely see me jump into such.

Thank you for your participation. I look forward to answering your questions.

"unrelated", I do not think it means what you think it means. He'll answer your questions as long as they aren't difficult ones. He just doesn't "have extra time to engage in online discussions or debates". Dr. Bob put this community together, it would be selfish to expect him to have the time to get involved with parents' "discussions" or "debates". He is far too busy as a "practicing pediatrician". But he has enough time to tell parents that they shouldn't listen to "SM and Cath" whom he can't believe would spend "hours each day, almost every day, for THREE YEARS answering questions out of the goodness of their hearts." Come on, he's a busy guy. And actually, we're quite busy too but it doesn't take hours each day out of our schedules to answer these questions. It probably just seems like that to Dr. Bob because it would take HIM that long to even attempt to answer those questions.

I'm Really Bonnie Offit

2010-11-16T11:08:00.000-05:00

This morning, J.B. Handley, one of Age of Autism's mouthpieces wrote a hilarious 'investigative report' about uncovering the true identity of Sullivan, a contributor to LeftBrain/RightBrain. What makes it so hilarious is that he is obviously so disturbed by Sullivan's dissemination of information about quackery regarding autism aetiologies and treatments, namely those touted by Handley's brain trust, that he has 'outed' him as, get this,

Bonnie Offit, paediatrician wife of Dr. Paul Offit

As stellar as a piece of investigative work as this is, J.B. Handley is off the mark. Because,

I am Bonnie Offit.

That's right J.B. Sherlock, back to the drawing board. But it is worth noting that the comments about this are equally hilarious. J.B.'s loyal flock believes him and congratulates him for such a stellar post, all except one. Craig Willoughby bravely goes against the tide and denounces the post for what it really is, a silly smear campaign.

Poor J.B., here's a hint, don't take investigative reporting tutorials from Jake Crosby. Or do so we can all point and laugh.

I am Bonnie Offit

2010-11-16T09:37:00.003-05:00

Both Orac and Kev have posts up as a reaction to Age of Autism's weird allegation that Sullivan is Dr. Bonnie Offit, Paul Offit's wife. Both claim that in fact, they are Bonnie Offit - that, of course, is total and utter rubbish. It is quite clear that I am Bonnie Offit and I am happy to say so!

Vaccine Awareness Week

2010-11-07T10:27:00.000-05:00

A couple of weeks ago, NVIC and Joseph Mercola announced a Vaccine Awareness Week for November 1-6, 2010. Science-blogger, Orac put out a call to other science and sceptical bloggers to co-opt this week for vaccine awareness, just not in the way that Mercola and Barbara Loe Fisher (BLF) intended. People like Mercola and BLF sell fear; it's their bread and butter, their pay check, literally. They don't actually present vaccine information, but rather pure deception. A number of us wish to counter this with facts, but since we hold ourselves to a higher standard of information, our facts and evidence can appear apathetic and tedious compared to their emotional, yet misleading rhetoric. But as a parent trying to make vaccine decisions for your children, you must ask yourself which is more important to make truly informed decisions.

I had hoped to present a detailed list comparing adverse vaccine reactions and corresponding disease complications this week but time constraints prevented that. However, Science-Based Medicine has a partial list of reactions that accompany both disease and corresponding vaccination. A Photon in the Darkness also ran the numbers for the probability of measles infection as they exist currently. This should help to put some real risks into perspective.

I came across a post on a forum that, I believe, sums up what parents are concerned with:

"I actually don't buy into the idea that any one vaccine causes autism. I know science is revealing a certain susceptible group that have genetic issues which, when combined with a load of vaccines, have triggered it.

That darn Wakefield study had to go and put a blemish on the MMR vaccine, so now in the back of my mind, I can't help but be haunted by it. Plus, all of the parents who swear to have their children get "lost" after it. It's just so scary when it comes to your babies and it gets really personal. I'm sorry if I get so angry sometimes, it's only out of fear and frustration."

To paraphrase Dr. Paul Offit, it is easy scare parents but nearly impossible to unscare them. So even though the science has spoken, so to speak, that MMR, thimerosal and to some extent, vaccines in general, do not increase the risk of autism or adverse neurophysiologic outcomes, anti-vax organisations are still trying to beat this dead horse. The result is that many parents are thrown into a stasis regarding vaccine decisions for their children, either delaying rather important ones or not vaccinating at all. So let me address some of those reasons why and also to present some resources to use and not to use when making vaccine decisions.

Vaccines Versus the Vaccine Schedule
Looking at the CDC Recommend Infant Vaccine Schedule is daunting. One of the criticisms I hear is that it is "one size fits all". Well yes, it is and this is why; it is a recommendation for public health and as such, is designed for what is in the interest of the majority. Such a schedule attempts to take all risk factors into account, has determined what ages will have the best 'catchment', or success at vaccine uptake, along with efficacy, and ages at which vaccine preventable diseases pose the greatest risk. Contrary to some belief, the paediatric vaccine schedule has been tested for safety and efficacy (scroll down halfway for list of studies). Numerous vaccine experts have developed the schedule to assist physicians and take the guesswork out of their vaccine recommendations as it addresses the collective of potential exposures.

Where I believe the problem lies, is that several vaccines have been added over the past 15 years so parents are given the impression that a relatively minor childhood disease such as hepatitis A is on par with the more serious hepatitis B disease, or chicken pox is on par with measles or rubella, or rotavirus disease is a scourge on par with Haemophilus influenzae b (Hib) disease. Don't get me wrong, people in developed countries do suffer from these diseases that can have serious complications. It comes down to risk analyses, which is not something that most parents are equipped to undertake. This is where the 'kindly', 'sympathetic' and 'passionate' self-proclaimed experts like to insert themselves. I have criticisms of and concerns with the CDC schedule, which would take several blogposts to outline; but that doesn't mean that Dr. Bob Sears, Dr. Jay Gordon or Jenny McCarthy should be dictating public health decisions and issuing proclamations. So what can parents do? Well for starters, don't throw the baby out with the bath water.

Speak to Your Doctor
It sounds very evasive but doesn't have to be. You have undoubtedly heard stories of paediatricians tossing clients out of their practices for refusing to vaccinate or refusing to vaccinate 'on schedule'. And I'm sure there are physicians that would do that on that basis alone, but I also don't believe that we are getting the full story for most cases. Not vaccinating is only part of why physicians feel the need to dismiss parents from their practices. The AAP's official policy is for physicians to work with families that are either concerned about vaccines or refuse them all together.

Broach the subject in a respectful manner and develop a partnership with your physician. Call them ahead of your first well visit and schedule a consult (preferably without children), be sure to let the office know the reason for the consult. You are demonstrating respect for your physician's time and giving yourself an opportunity to work with your physician instead of at cross-purposes. You aren't going to be well-received if you arrive at a scheduled well visit waving your copy of The Vaccine Book and telling your physician, "Well Dr. Bob says so." Don't become so wedded to a particular course that you dismiss sound advice from your own physician, be flexible. Take advantage of combination vaccines that will provide your infant with the protection they need in a timely fashion and reduce the number of jabs and vaccine excipients. Ultimately, your children's healthcare decisions are your own but consulting with your physician on vaccines may reassure you.

Herd Immunity
You have undoubtedly read about herd immunity and how important it is to reduce or eliminate transmission of vaccine-preventable diseases. It is also referred to as 'community immunity', for those who don't wish to be equated with cows. In any term, it is real and irrefutable; based upon several factors, we know what levels of vaccine uptake are required to reduce or interrupt disease transmission. But to be perfectly honest, I don't care to use the herd immunity argument as an inducement for vaccine uptake even though it is a valid argument and very true. We are inherently selfish creatures, particularly about our children. When one who is concerned about vaccines is being ramrodded with 'you need to do this for the protection of those that cannot get vaccinated', it tends to shut down the discussion and heels get dug in, even though it is a technically correct point. We are driven to consider our own children's safety first. While herd immunity is important, for you as a parent, protecting your own child is more important.

In order to refine this argument, I will use a parent's concern that I just came across; she wanted to know what her child's risk for Hib disease was now. That risk estimation is 0.13 - 0.5/100,000 in children less than 5 years old depending upon the survey and geographical area, but the risk is higher in children less than 2 years old. The risk is higher in unvaccinated children with an attack rate of ~3.7% in children less than 2 years old. Prior to mass vaccination with Hib, the disease incidence was 1/200 children less than 5 years old with 5% mortality and 15-30% left with permanent complications and that is even with prompt and effective treatment. So this is a very clear case of the reduction in illness, permanent injuries and death as a direct result of vaccination and herd immunity subsequently created. The risk has been dramatically reduced, to the tune of 96% but even a brief interruption in vaccine uptake can result in disastrous consequences.

I prefer to emphasise that herd immunity also assumes equal distribution of susceptible people. This means that a non-immune person, for whatever reason, is well-surrounded by immune people, creating a fire-wall of sorts. The most recent estimate of 19-35 month old children that aren't vaccinated is ~1%. However, that is just for complete vaccine refusal; vaccine coverage estimates for the individual vaccines are highly variable by vaccine and geographical area. Due to the collection methods of this survey, it is likely that the proportion of vaccine refusers stand at a higher rate than reported. So I will use the 1% as a minimum reliable estimate for vaccine refusal in the U.S. Using the birth cohorts from the MMWR report, that is representative of ~10,692,000 children. One percent of those are completely unvaccinated is ~106,920 children. Add to that:

769,800 (7.2%) children 19-35 months old were not vaccinated for polio.
1,069,000 (10%) children 19-35 months old were not vaccinated for MMR.
844,600 (7.9%) children 19-35 months old did not receive the primary Hib vaccine series.

This doesn't include those younger than 19 months or older than 35 months and those who are undervaccinated or with waning immunity. Now to put this into context; refer back to how herd immunity theory assumes equal distribution of susceptibles. Not only is there a growing number of susceptibles, but they are geographically clustering. This pattern seriously undermines the strength of herd immunity. Even though overall vaccine uptake is high, it is too variable to be relied upon for protection of one's un- or undervaccinated children. Since ideologically like-minded parents do tend to aggregate, such a situation can and does lead to large clusters of unvaccinated children that your child could be living in the midst of. A parent needs to start thinking about their own children and what they can do to protect them because herd immunity should not be relied upon. Think of it as enlightened self-interest in that while vaccinating your own child helps the "herd", more importantly, it protects your own child.

Information Resources
It is important to vet your sources, particularly those that can be found on the internet since that is where most parents go to obtain information about vaccines now. Science-Based Medicine just posted an analysis of two studies that evaluated population-level perceptions on the H1N1 vaccine, dominant sources of vaccine information and the effectiveness of anti-vaccine tactics.

Regarding the H1N1 vaccine:

During the survey period, 23.4% of Canadians considered the vaccine safe, compared to 41.4% who indicated it was unsafe, and 35.2% who expressed no opinion.

Vaccine information sources that dominated during the survey period:

But based on the methodology used, articles questioning the safety of the H1N1 were circulated widely, and anti-vaccine articles and sources dominated.

And finally, the impact of anti-vaccine websites on perceptions of readers:

The authors found that viewing anti-vaccine material for only five to ten minutes increased the perception of risk of vaccination, and decreased the perception of risk of omitting vaccines, compared to viewing neutral websites. It also lowered vaccination intentions.

Obtaining information from the internet requires some filters to help establish the potential credibility of the site. Some websites have become very savvy and sophisticated so that it can be rather difficult for the layperson to identify them as anti-vaccine websites. To give you a couple of examples, the International Medical Council on Vaccination looks slick and professional. But behind the scenes are the usual suspects such as Sherri Tenpenny and Joseph Mercola, along with contributors with formidable letters after their names who want to give you the impression that legions of healthcare professionals and scientists are united in their efforts. Read the articles, they are bush-league, overwrought and completely unreferenced opinion pieces. Citations to the scientific literature and the proper interpretations of studies are crucial for establishing credibility. Another website is the National Vaccine Information Center or NVIC. This site is very much the same as the aforementioned website. They have some kernels of factual information but these are obfuscated by unreferenced opinion pieces and misrepresented statistics.

As a general rule, be very leery of websites and/or self-proclaimed vaccine experts that wish to sell you something, whether that be books, products or services and rely upon testimonials. Verify that they provide references for their information and if so, are the references from reputable sources (i.e. legitimate peer-reviewed journals or government publications) and do they represent these sources accurately. If you are unsure of information that you have received or just have questions to ask about vaccines, please feel free to visit our forum here (you may do so anonymously) and we would be happy to answer your questions.

Some reputable resources that I recommend are:
The Pink Book (Epidemiology and Prevention of Vaccine Preventable Diseases)
The Immunization Action Coalition
The CDC: Some Common Misconceptions
The Institute of Medicine: Immunization Safety Review Reports
The CDC: Vaccines and Preventable Diseases
The CDC: Morbidity and Mortality Weekly Report (MMWR)
Johns Hopkins: Institute for Vaccine Safety
The CDC: Vaccines and Immunizations
The FDA: Thimerosal in Vaccines
Center for Infectious Disease Research and Policy (CIDRAP)
The CDC: Vaccine Safety
The American Academy of Pediatrics (AAP): Red Book (subscription only)
The College of Physicians of Philadelphia: The History of Vaccines
The Children's Hospital of Philadelphia (CHOP): Vaccine Education Center

Dr. Bob Sears and Fox Friends

2010-10-11T17:13:00.004-04:00

On Saturday, 2 October 2010, Dr. Bob Sears appeared on Fox Friends with Fox News Anchor, Alisyn Camerota (AC) . Ms. Camerota begins the segment with the question:

AC: Is there a connection between vaccines and autism? Thousands of families with autistic kids think there is. But the Centers for Disease Control has always maintained that no research supports a link. Now one famous paediatrician has written a book about vaccines who charges the government's studies on vaccines is woefully inadequate.

Ms. Camerota introduces Dr. Bob Sears (BS), author of The Vaccine Book, which was published three years ago.

AC: The government says they have studied vaccines and they do not cause autism. But has the government ever studied the amount of vaccines that our children get in 1 sitting?

BS: That is what me and my colleagues at SafeMinds are a little worried about...there is a CDC report that says that usually simultaneous vaccination has not been completely studied for safety and that's what we're worried about. Babies get as many as 6 or 7 vaccines altogether...and the CDC is admitting that they aren't always researched that way. The prime example is the flu vaccine. They've researched the flu vaccine in great detail when given alone, but the CDC has never researched it when given in conjunction with all the other shots...and that's what we're worried about.

Interestingly, SafeMinds is a notorious anti-vaccine organisation, also known as the 'mercury militia', that maintains that autism is caused by thimerosal, a preservative used in vaccines that contains ethylmercury. However, mercury toxicity does not resemble autism, and autism rates around the world have been increasing in spite of thimerosal removal from paediatric vaccines and immunoglobulins starting in 1999 in the U.S. and even years earlier in other countries. SafeMinds rejects any studies that demonstrate that thimerosal does not contribute to neurological disorders, even going so far as to storm off a study team, in a huff, the day the results were announced and not to their liking.

Dr. Bob alludes to some CDC report that states that simultaneous vaccination has not been completely studied for safety yet doesn't provide any further information about this. However, the CDC information regarding simultaneous vaccination does not support what Dr. Bob claims. For instance, from the CDC's Vaccine Safety Page:

Is simultaneous vaccination with multiple vaccinations safe? Wouldn't it be safer to separate combination vaccines and spread them out, vaccinating against just one disease at a time?
The available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system. A number of studies have been conducted to examine the effects of giving various combinations of vaccines simultaneously. These studies have shown that the recommended vaccines are as effective in combination as they are individually, and that such combinations carry no greater risk for adverse side effects. Consequently, both the Advisory Committee on Immunization Practices and the American Academy of Pediatrics recommended simultaneous administration of all routine childhood vaccines when appropriate. Research is underway to find methods to combine more antigens in a single vaccine injection (for example, MMR and chickenpox). This will provide all the advantages of the individual vaccines, but will require fewer shots.
Another advantage is that combination vaccines result in fewer shots and less discomfort for children. In addition, spreading out the administration of separate vaccines may leave children unnecessarily vulnerable to disease.

Dr. Bob mentions that influenza vaccine has not been tested with the childhood schedule as the 'prime example', when, in fact, it's the only example. Vaccine safety studies are addressed later. Ms. Camerota continues:

AC: Let me show (CDC Infant Vaccine Schedule) our viewers how many different vaccines some children can get in one sitting. At two months they get five or six, same at four months. At six months they get tons! At 12 months they get up to six, at 15 months they get up to six. Why isn't the CDC looking at these combinations?

BS: (Nodding in agreement and not providing any corrections to these assertions.) Well I think the CDC is just assuming that they are safe. Because there is no real evidence that they causes [sic] any harm...But I would like to see more research on it and I think that parents want to be confident in vaccines. And as a paediatrician, I give vaccines in my office every day. But I want to know that these large combinations are safe. And what I do as a paediatrician, is I spread the vaccines out. I give no more than two vaccines at a time to any babies in my office. It takes longer to vaccinate them that way but I think it's a safer way to go.

Here is the CDC Infant Schedule:

There are not 'tons' of vaccines at six months; actually the same at two and four months and as a matter of course, three or four at 12 months and two or three at 15-18 months. Dr. Bob not only spreads these out but omits some as well, and not necessarily ones that can or should be omitted and not some that should be as delayed as he has them. He also eschews combination vaccines which reduce the number of jabs and vaccine constituents, while getting infants protected more timely than his recommendations. Here are his evidence-free justifications for his recommendations:

By only giving two vaccines at a time (instead of as many as 6), I decrease the chance of chemical overload from grouping so many vaccines chemicals all together at once. This allows a baby's body to better detoxify the chemicals one or two at a time.
I give only 1 aluminum-containing vaccine at a time (instead of the recommended 4). Overloading on this metal can be particularly toxic to the brain (See Resources, page 250 of The Vaccine Book to view the research on this).
I give only one live-virus vaccine component at a time to allow the body's immune system to better handle the live viruses in these vaccines.
Giving fewer shots at a time may decrease the side effects, in my experience.
Giving fewer shots at a time also makes it easier to figure out which vaccine a child is reacting to if a severe reaction occurs.

Since Dr. Paul Offit and Dr. John Snyder have already critiqued Dr. Bob's schedules, I don't feel compelled to reiterate their reviews. However, it does bear repeating that Dr. Bob's schedules have not been tested for safety and efficacy; he merely assumes that his recommendations are better because he has set up numerous faulty assertions that the CDC schedule is bad. He cannot say that his schedules are safer because he has never put them through the rigours of testing, namely, do they protect infants from vaccine preventable diseases that they would otherwise not have and do his schedules prevent all of the bogey-man disorders that he claims fully vaccinating do or may cause? He has done nothing to alleviate the fears and concerns that parents have since his book is rife with dubious studies that only serve to incite parental concerns and fears about vaccinating.

Dr. Sears creates controversy surrounding vaccine excipients where there really isn't any, by either misinterpreting or omitting relevant scientific literature. It is a shame that Dr. Bob has chosen to pander to anti-vaccine rhetoric, for the premise of his book seemed appropriately timely, however his execution was sophomoric and clearly intended to further his own agenda and biases. Ms. Camerota continues:

AC: It's interesting that you say that because the CDC in part says that they have combined all these vaccines because parents have clamoured for that...parents say, we don't want to have to keep bringing our kids in every two months and giving them different shots, let's just get it all over with. So perhaps they have acquiesced to parents desires but in a dangerous way.

BS: Right, you know 20, 30 years ago we only gave babies two vaccines at a time with a total of about eight injections throughout their childhood. Now we give babies six or seven vaccines each time and over 50 injections spread throughout their childhood. So I think parents would rather go the extra mile and and [sic] spread the vaccines out cause [sic] I think parents feel like their babies are being overloaded.

Thirty years ago, infants and children received five DTP, four OPV and one MMR. The U.S. also had about 20,000 Haemophilus influenzae b (HIb) cases in children annually with about 1,000 deaths each year and approximately 16,000 cases of hepatitis b infection in children less than 10 years old each year. Twenty years ago, infants and children received 18 vaccinations with four given at visits for two, four, and six month olds, three or four given at 12 -18 months old and three given from four to six years old. They were DTP, Hib, Hep B, OPV and MMR. There had also been a huge resurgence of measles during that time with more than 55,000 cases and at least 259 deaths.

Today, children are receiving about 30 vaccines by six years old and three of those are not injections, 36 if parents diligently vaccinate their children for influenza, which are actually very few, less than 30% most years. So it is very difficult to determine how Dr. Bob calculated 50 injections, however, his own recommendation to split MMR up into six as opposed to two injections would get children closer to that.

But onto his argument that vaccines have not been tested together. I don't know how he can make this statement when a quick and easy review of the literature reveals quite the opposite. There are numerous studies that examine the safety and efficacy of new vaccines with existing ones, for example:
Hexavac with Hepatitis A
Hexavalent vaccine with Rotateq
DTaP with Hib
PCV-13 with all infant vaccines
MMR and Varicella
PCV-7 with MMR, Hib and Varicella
Pediarix with Hib and Infanrix-hexa
New Hib with all infant vaccines
MMR with Varicella
MMR-V with Hib-HepB
MMR-V with all infant vaccines
Meningococcal-C with Hep B and Pentacel
Pentacel with PCV-7
This is not, by far, an exhaustive list. Additionally, the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) exist to monitor vaccine safety after licensure. Dr. Bob promotes himself as a vaccine expert yet continues to omit relevant facts. There are valid criticisms of vaccines and policy that are supported by the scientific literature but Dr. Bob chooses to raise the spectre of misinformation that he has the solution for.

AC: Certainly if they're educated, I think you're right about that. We asked the CDC for their response to that fact that you say their research has been woefully inadequate, here is their response to us:

"Vaccination is the single most important step parents can take to protect their children from life threatening diseases which once killed thousands of children each year. Scientific data from years and years of research show that vaccines are safe and effective. Vaccines do not overload the immune system. Vaccines contain only a tiny fraction of the antigens that babies encounter in their environment every day. We do know that delaying vaccines puts children at known risk of becoming ill with vaccine-preventable diseases."

- Tom Skinner, CDC Spokesperson, 1 October 2010

BS: Well I agree with most of that, especially you don't want to delay vaccines for very serious diseases like meningitis or whooping cough. However I think the CDC's argument about the thousands of germs that we can tolerate every day...I think that's scientifically invalid because I think they are talking about germs that we inhale, or germs that we swallow. Those germs are exposed to our immune system in a natural way, in our intestines and our respiratory passages, our immune system processes those germs. But when you inject germs directly into the body you by-pass the immune system completely and internal part, the bloodstream immune system has to see the germs and attack them, it's a very unnatural type of germ exposure.

It appears as though Dr. Bob has attended the 'Jenny McCarthy School of Immunology' . His statements regarding 'natural' versus vaccine immune responses invoke one of the most erroneous and overused canards of anti-vaccinationists. I can't quite parse what Dr. Bob is saying because his description of immunity isn't corroborated by anything known about how the immune system works. How could he possibly explain an immune response to antigens (or germs as he puts it) that are introduced 'directly into our bodies' via cuts or insect vectors? Is this also 'unnatural'? He also seems to believe that this 'natural way' is completely infallible and compartmentalised such that pathogens cannot breech this. So how does he explain the fact that pathogens have adapted to evade our innate immune system and requiring our adaptive immunity (perhaps what he is referring to as 'bloodstream immune system') creating antibodies to rid ourselves of them?

Vaccination does by-pass some front line non-specific immune defences, but certainly don't 'by-pass the immune system completely', for if they did, we wouldn't produce antibodies and immune memory defences against pathogens when we encounter them. The whole point of vaccination is to 'teach' our immune system how to deal with the real thing, by using parts of bacteria or inactivated or attenuated viruses. And they work! Which shouldn't be the case according to Dr. Bob's primer on the immune system. It takes quite a bit of knowledge on a topic to be able to reduce complex concepts down to a few sound bites. So Dr. Bob's conjecture about vaccine versus natural immunity is the chasmic difference between dumbing something down and just sounding dumb.

AC: The CDC also said that they have done lots of research...it's interesting because they, they CDC has long cited 2 studies done by these Danish researchers that show that mercury in vaccines does not cause autism. Well now the lead researcher is being investigated. Why?

BS: Right, he was kind of double-dipping so to speak. He was taking money from the CDC to do this research, he was also under salary from the Danish Universities [sic] and that was against his contract and apparently that went against the rules and now, according to Danish newspapers, he has skipped town with 2 million dollars worth of Danish research money and that sort of calls into question the validity of his research.

Let's take a look at those publications first:
Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med. 2002 Nov 7;347(19):1477-82.

Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH, Mortensen PB. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. 2003 Sep;112(3 Pt 1):604-6.

Notice the dates of publication and the order of the authors. Ms. Camerota and Dr. Bob have referred to the lead author which is Dr. Madsen for both, well he isn't the author in question. That would be Dr. Poul Thorsen, the sixth and fourth author, respectively. Respectful Insolence has explained this relevance in great detail, but an author that far down on the list has not made a very significant contribution. In fact, Dr.s Madsen and Melbye, the senior authors of the studies released a statement to the Philadelphia Inquirer several months ago regarding Dr. Thorsen's involvement:

"Poul Thorsen had absolutely no influence on the conclusions regarding this paper," wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.
"Thorsen was not actively involved in the analysis and interpretation of the results of this paper," Melbye said.
The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.
Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.
"Dr. Thorsen was not in a position to change or compromise the data," Madsen wrote. "Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data."

As for the dates, the studies were published in 2002 and 2003 but Dr. Thorsen's resignation under dubious circumstances did not occur until March, 2009. Furthermore, the grant money in question was not part of the 2 studies in question at all, but rather part of a cooperative between the US National Center for Birth Defects and Developmental Disabilities,CDC and Odense and Aarhus Universities. And absolutely nothing at all questionable about that; it was the discovery of forged documents by (allegedly) Dr. Thorsen that may constitute fraud. Apparently, Dr. Thorsen held a full-time post at Emory University, Georgia, USA while still employed by Aarhus University in Copenhagen, Denmark and that is what comprised of his 'double-dipping', not a grant from the CDC as Dr. Bob stated. Dr. Thorsen is not missing as he continues to publish studies. We don't know what the funding irregularity was but we do know it has nothing to do with the 2002 and 2003 studies and we do know that Dr. Thorsen's involvement with those studies is being inflated to extremes for the purpose of disparaging them. It is as though Dr. Bob read the Huffington Post and Age of Autism, didn't bother to ask himself if it made sense, didn't do a little fact-checking and merely parroted extremely questionable sources.

But Dr. Bob acts as though these 2 studies were the lynch pins for exonerating vaccines in the role of autism. Even if we were to dismiss these studies, Dr. Bob completely ignores the numerous other studies by other investigators, in numerous countries that replicate Madsen et al.'s research and then some. A hat tip to Chris (comment #63) for putting this list together (I have added some recent studies) Addendum 04.18.11 added more studies:

Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study.
Budzyn D, et al.
Pediatr Infect Dis J. 2010 May;29(5):397-400.
Subjects: 96 children with autism, ages 2 to 15, as well as 192 children in a control group. For children diagnosed before a diagnosis of autism, the autism risk was lower in children who received MMR vaccine than in nonvaccinated children. A similar result was achieved for the single-antigen measles vaccine.

U.S. Court of Federal Claims decision in Omnibus Autism Proceeding
On Feb. 12, 2009, the “vaccine court” ruled in three test cases on the theory that MMR vaccine and the vaccine preservative thimerosal are linked to autism. The court found the scientific evidence is overwhelmingly contrary to this theory.
http://www.uscfc.uscourts.gov/node/5026

Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study.
Hornig M et al.
PLoS ONE 2008; 3(9): e3140 doi:10.1371/journal.pone.0003140
*Subjects: 25 children with autism and GI disturbances and 13 children with GI disturbances alone (controls)

Measles Vaccination and Antibody Response in Autism Spectrum Disorders.
Baird G et al.
Arch Dis Child 2008; 93(10):832-7.
Subjects: 98 vaccinated children aged 10-12 years in the UK with autism spectrum disorder (ASD); two control groups of similar age: 52 children with special educational needs but no ASD and 90 children in the typically developing group

MMR-Vaccine and Regression in Autism Spectrum Disorders: Negative Results Presented from Japan.
Uchiyama T et al.
J Autism Dev Disord 2007; 37(2):210-7
*Subjects: 904 children with autism spectrum disorder
(Note: MMR was used in Japan only between 1989 and 1993.)

No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells from Children with Autism Spectrum Disorder.
D’Souza Y et al.
Pediatrics 2006; 118(4):1664-75
*Subjects: 54 children with autism spectrum disorder and 34 developmentally normal children

Immunizations and Autism: A Review of the Literature.
Doja A, Roberts W.
Can J Neurol Sci. 2006; 33(4):341-6
*Literature review

Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations.
Fombonne E et al.
Pediatrics. 2006;118(1):e139-50
*Subjects: 27,749 children born from 1987 to 1998 attending 55 schools

Is There a ‘Regressive Phenotype’ of Autism Spectrum Disorder Associated with the Measles Mumps-Rubella Vaccine? ACPEA Study
Richler et al.
J Autism Dev Disord. 2006 Apr;36(3):299-316.
Subjects: A multi-site study of 351 children with Autism Spectrum Disorders (ASD) and 31 typically developing children used caregiver interviews to describe the children’s early acquisition and loss of social-communication milestones. No evidence that onset of autistic symptoms or of regression was related to measles, mumps and rubella vaccination.

No Effect of MMR Withdrawal on the Incidence of Autism: a Total Population Study.
Honda H, et al.
J Child Psychol Psychiatry. 2005 Jun;46(6):572-9.
Subjects: Study examined incidence of Autism Spectrum Disorders (ASD) to age 7 for children born between 1988 and 1996 in Yokohama, Japan. The measles, mumps and rubella (MMR) vaccination rate in Yokohama declined significantly in the birth cohorts of years 1988-92, and no MMR vaccines were administered in 1993 or thereafter. In contrast, cumulative incidence of ASD up to age 7 increased significantly in the birth cohorts of years 1988 through 1996 and most notably rose dramatically beginning with the birth cohort of 1993.

Relationship between MMR Vaccine and Autism.
Klein KC, Diehl EB.
Ann Pharmacother. 2004; 38(7-8):1297-300
*Literature review of 10 studies

Immunization Safety Review: Vaccines and Autism. Institute of Medicine.
The National Academies Press: 2004
(www.nap.edu/books/030909237X/html) *Literature review

MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study.
Smeeth L et al.
Lancet 2004; 364(9438):963-9
*Subjects: 1294 cases and 4469 controls

Age at First Measles-Mumps-Rubella Vaccination in Children with Autism and School-Matched Control Subjects: A Population-Based Study in Metropolitan Atlanta.
DeStefano F et al. Pediatrics 2004; 113(2): 259-66
*Subjects: 624 children with autism and 1,824 controls

No Evidence for Links Between Autism, MMR and Measles Virus.
Chen W, et al.
Psychol Med. 2004 Apr;34(3):543-53.
Subjects: Study compared 2,407 persons with autism born between 1959 and 1993; to 4,640 Down syndrome subjects born between 1966 and 1993. No increased risk of autism was found following exposures to wild measles and vaccinations with monovalent measles, and Urabe or Jeryl-Lynn variants of measles, mumps and rubella (MMR) vaccine.

Prevalence of Autism and Parentally Reported Triggers in a North East London Population.
Lingam R et al.
Arch Dis Child 2003; 88(8):666-70
*Subjects: 567 children with autistic spectrum disorder

Neurologic Disorders after Measles-Mumps-Rubella Vaccination.
Makela A et al.
Pediatrics 2002; 110:957-63
*Subjects: 535,544 children vaccinated between November 1982 and June 1986 in Finland

A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism.
Madsen KM et al.
N Engl J Med 2002; 347(19):1477-82
*Subjects: All 537,303 children born 1/91–12/98 in Denmark

Relation of Childhood Gastrointestinal Disorders to Autism: Nested Case Control Study Using Data from the UK General Practice Research Database.
Black C et al.
BMJ 2002; 325:419-21
*Subjects: 96 children diagnosed with autism and 449 controls

Measles, Mumps, and Rubella Vaccination and Bowel Problems or Developmental Regression in Children with Autism: Population Study.
Taylor B et al.
BMJ 2002; 324(7334):393-6
*Subjects: 278 children with core autism and 195 with atypical autism

No Evidence for a New Variant of Measles-Mumps-Rubella-Induced Autism.
Fombonne E et al.
Pediatrics 2001;108(4):E58
*Subjects: 262 autistic children (pre- and post-MMR samples)

Measles-Mumps-Rubella and Other Measles-Containing Vaccines Do Not Increase the Risk for Inflammatory Bowel Disease: A Case-Control Study from the Vaccine Safety Datalink Project.
Davis RL et al.
Arch Pediatr Adolesc Med 2001;155(3):354-9
*Subjects: 155 persons with IBD with up to 5 controls each

Time Trends in Autism and in MMR Immunization Coverage in California.
Dales L et al.
JAMA 2001; 285(9):1183-5
*Subjects: Children born in 1980-94 who were enrolled in California kindergartens (survey samples of 600–1,900 children each year)

Mumps, Measles, and Rubella Vaccine and the Incidence of Autism Recorded by General Practitioners: A Time Trend Analysis.
Kaye JA et al.
BMJ 2001; 322:460-63
*Subjects: 305 children with autism

MMR and Autism: Further Evidence Against a Causal Association.
Farrington CP, et al.
Vaccine. 2001 Jun 14;19(27):3632-5.
Subjects: Data from an earlier measles, mumps and rubella (MMR) vaccine study (Taylor et al, 2000) were reanalyzed to test a second hypothesis. Results provide further evidence against a causal association between MMR vaccination and autism.

Further Evidence of the Absence of Measles Virus Genome Sequence in Full Thickness Intestinal Specimens from Patients with Crohn’s Disease.
Afzal MA, et al.
J Med Virol 2000; 62(3):377-82
*Subjects: Specimens from patients with Crohn’s disease

Autism and Measles, Mumps, and Rubella Vaccine: No Epidemiological Evidence for a Causal Association.
Taylor B et al.
Lancet 1999;353 (9169):2026-9
*Subjects: 498 children with autism

Absence of Detectable Measles Virus Genome Sequence in Inflammatory Bowel Disease Tissues and Peripheral Blood Lymphocytes.
Afzal MA et al.
J Med Virol 1998; 55(3):243-9
*Subjects: 93 colonoscopic biopsies and 31 peripheral blood lymphocyte preparations

No Evidence for Measles, Mumps, and Rubella Vaccine-Associated Inflammatory Bowel Disease or Autism in a 14-year Prospective Study.
Peltola H et al.
Lancet 1998; 351:1327-8
*Subjects: 3,000,000 doses of MMR vaccine

Exposure to Measles in Utero and Crohn’s Disease: Danish Register Study.
Nielsen LL et al.
BMJ 1998; 316(7126):196-7
*Subjects: 472 women with measles

Immunocytochemical Evidence of Listeria, Escherichia coli, and Streptococcus Antigens in Crohn’s Disease.
Liu Y et al.
Gastroenterology 1995; 108(5):1396-1404
*Subjects: Intestines and mesenteric lymph node specimens from 21 persons from families with a high frequency of Crohn’s disease

Neuropsychological Performance 10 years after Immunization in Infancy with Thimerosal-Containing Vaccines
Tozzi AE, Bisiacchi P, Tarantino V, De Mei B, D'Elia L, Chiarotti F, Salmaso S.
Pediatrics, February 2009, Vol. 123(2):475-82

Mercury Levels in Newborns and Infants after Receipt of Thimerosal-Containing Vaccines
Pichichero ME, Gentile A, Giglio N, et al
Pediatrics, February 2008; 121(2) e208-214

Mercury, Vaccines, And Autism: One Controversy, Three Histories
Baker JP
American Journal of Public Health, February 2008;98(2): 244-253

Continuing Increases in Autism Reported to California's Developmental Services System: Mercury in Retrograde
Schechter R, Grether JK
Arch Gen Psychiatry, January 2008; 65(1):19-24

Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
Thompson WW, Price C, Goodson B, et al; Vaccine Safety Datalink Team
N Engl J Med, Sep 27, 2007; 357(13):1281-1292

Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations
Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D
Pediatrics, July 2006, Vol. 118(1):e139-e150

Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies
Goodman MJ, Nordin J
Pediatrics, February 2006, Vol. 117(2):387-390

Thimerosal in Vaccines: Balancing the Risk of Adverse Effects with the Risk of Vaccine-Preventable Disease
Bigham M, Copes R
Drug Safety, 2005, Vol. 28(2):89-101

Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing Thimerosal
Burbacher TM, Shen DD, Liberato N, Grant KS, Cernichiari E, Clarkson T
National Institute of Environmental Health Sciences, April 21, 2005

Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Heron J, Golding J, ALSPAC Study Team
Pediatrics, September 2004, Vol. 114(3):577-583

Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Andrews N, Miller E, Grant A, Stowe J, Osborne V, Taylor B
Pediatrics, September 2004, Vol. 114(3):584-591

Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A Critical Review of Published Original Data
Parker SK, Schwartz B, Todd J, Pickering LK
Pediatrics, September 2004, Vol. 114(3):793-804

The Evidence for the Safety of Thimerosal in Newborn and Infant Vaccines
Clements CJ
Vaccine, May 7, 2004, Vol. 22(15-16):1854-1861

Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases
Verstraeten T, Davis RL, DeStefano F, et al
Pediatrics, November 2003, Vol. 112(5):1039-1048

The Toxicology of Mercury--Current Exposures and Clinical Manifestations
Clarkson TW, Magos L, Myers GJ
New England Journal of Medicine, October 30, 2003, Vol. 349(18):1731-7

Association Between Thimerosal-Containing Vaccine and Autism
Hviid A, Stellfeld M, Wohlfahrt J, Melbye M
Journal of the American Medical Association, October 1, 2003, Vol. 290(13):1763-6

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data
Madsen KM, Lauritsen MB, Pedersen CB, et al
Pediatrics, Sept. 2003, Vol. 112(3 Pt 1):604-606

Autism and Thimerosal-Containing Vaccines. Lack of Consistent Evidence for an Association
Stehr-Green P, Tull P, Stellfeld M, Mortenson PB, Simpson D
American Journal of Preventive Medicine, August 2003, Vol. 25(2):101-6

Impact of the Thimerosal Controversy on Hepatitis B Vaccine Coverage of Infants Born to Women of Unknown Hepatitis B Surface Antigen Status in Michigan
Biroscak BJ, Fiore AE, Fasano N, Fineis P, Collins MP, Stoltman G
Pediatrics, June 2003, Vol. 111(6):e645-9

Vaccine Safety Policy Analysis in Three European Countries: The Case of Thimerosal
Freed GL, Andreae MC, Cowan AE, et al
Health Policy, December 2002, Vol. 62(3):291-307

Mercury Concentrations and Metabolism in Infants Receiving Vaccines Containing Thimerosal: A Descriptive Study
Pichichero ME, Cernichiari E, Lopreiato J, Treanor J
The Lancet, November 30, 2002, Vol. 360:1737-1741

An Assessment of Thimerosal Use in Childhood Vaccines
Ball LK, Ball R, Pratt RD
Pediatrics, May 2001, Vol. 107(5):1147-1154

Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism
Price CS, Thompson WW, Goodson B, Weintraub ES, Croen LA, Hinrichsen VL, Marcy M, Robertson A, Eriksen E, Lewis E, Bernal P, Shay D, Davis RL, DeStefano F Pediatrics, October, 2010, Vol. 126(4): 656-664

On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes
Smith MJ and Woods CR
Pediatrics, June, 2010, Vol. 125 (6):1134-1141

This is, obviously, a lot of reading to do but considering the totality of evidence it is the responsible tact to take when advising the public about vaccine issues. There are concerns and criticisms regarding the CDC vaccine schedule, but they are rather mundane when compared to the misleading and downright false conjectures that self-proclaimed experts would have us believe. There seems to be an anti-intellectual movement afoot but with the taskmasters absurdly co-opting the esteem of education and credentials to propagate it.

It is encouraging to see that this interview was done by Fox News since they are renowned for their unapologetic biases and don't even bother to offer up any pretence of presenting a fair balance of issues. An appearance on Fox News is akin to has-been and never-were celebrities breathing their last gasp on Dancing With the Stars. It signifies the downward spiral of the anti-intellectual, anti-vaccine movement. And that is a good thing.

Addendum (16 October 2010): Rahul K. Parikh, M.D. has weighed in on Dr. Bob Sears' Vaccine Book and appearance on Fox News.

2010-2011 U.S. Influenza Vaccines

2010-09-18T21:27:00.005-04:00

Flu vaccines for U.S. use are beginning to arrive in physicians' offices, hospitals and public health departments. The FDA has announced that the following strains will be included in all vaccines for the 2010-2011 season:
* Influenza A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
* Influenza A/Perth /16/2009 (H3N2)-like virus
* Influenza B/Brisbane/60/2008-like virus
Of the estimated 160-165 million doses of influenza vaccine supplied to the U.S., approximately 74 million (45-46%) will be thimerosal-free.

2010-2011 Influenza Vaccines At-A-Glance
(Adapted from the CDC)

Product: Afluria is manufactured by CSL Limited in Australia but distributed in the U.S. by Merck.
Description: AFLURIA is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2020-2011 Northern Hemisphere influenza season: A/California/7/2009, NYMC X-181 (H1N1), A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and
B/Brisbane/60/2008. A 0.25 mL dose contains 7.5 mcg HA of each of the same three influenza strains.
The single dose presentations do not contain thimerosal. The multi-dose presentation contains thimerosal and each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of Afluria contains 4.1 mg sodium chloride, 80 mcg monobasic sodium phosphate, 300 mcg dibasic sodium phosphate, 20 mcg monobasic potassium phosphate, 20 mcg potassium chloride, and 1.5 mcg calcium chloride. Left over from the manufacturing process are residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone. The single 0.25 mL dose contains half of all of these quantities.
Indications and Usage: Afluria has been previously approved for the use in children 6 months and older and all adults, however, in light of the risk of febrile seizures observed in Australia and New Zealand in children less than 5 years old, Afluria has been suspended for use in children less than 9 years old, with the exception of 5-8 years olds whose benefit of flu vaccination outweighs the risk and no other vaccine is available. Since CSL will supply only ~12 million single doses to the U.S. (~7% of total supply), it should not be a problem to comply with this recommendation. So, the age indicated for use is ≥ 9 years old.
Contraindications: Individuals with known hypersensitivity to eggs, neomycin or polymyxin, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: Clinical trials in adults 18 to less than 65 years old demonstrated seroconversion rates of 97.8% (96.7-98.6%), 99.9% (99.5-100.0%) and 94.2% (92.7-95.6%) against H1N1, H3N2 and B influenza strains respectively.

Product: Agriflu is manufactured by Novartis.
Description: Agriflu is prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with an influenza virus suspension containing kanamycin and neomycin sulphate. Formulated to contain a total of 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following three influenza virus strains recommended for the 2010/2011 influenza season: A/California/7/2009, NYMC X-181 (H1N1); A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus); and B/Brisbane/60/2008. Agriflu comes in single dose preparations that do not contain thimerosal.
Each 0.5 mL dose of Agriflu contains 4.0 mg sodium chloride, 0.1 mg potassium chloride, 0.1 mg potassium dihydrogen phosphate, 0.66 mg disodium phosphate dihydrate, 0.05 mg magnesium chloride, and 0.06 mg calcium chloride. Left over from the manufacturing process are residual amounts of egg proteins
Indications and usage: Agriflu is approved for the use in adults ≥ 18 years old.
Contraindications: Individuals with known hypersensitivity to eggs, neomycin or kanamycin, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: In a clinical trial of adults 18-64 years old, seroconversion rates were 74% (69-78%), 72% (68-76%) and 77% (72-81%) to H1N1, H3N2 and B influenza viruses, respectively. In a clinical trial of adults 18-49 years old, seroconversion rates were 94% (93-93%), 67% (65-70%) and 84% (82-86%) H1N1, H3N2 and B influenza viruses, respectively. Please review package insert for information on adverse events.

Product: Fluarix is manufactured by GlaxoSmithKlein (GSK).
Description: Fluarix is prepared from influenza viruses propagated in embryonated chicken eggs. Formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5-mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008. Fluarix comes in single-dose preparations that do not contain thimerosal.
Each 0.5 mL dose of Fluarix contains ≤ 0.085 mg octoxynol-10 (TRITON® X-100), ≤ 0.1 mg α-tocopheryl hydrogen succinate, and ≤ 0.415 mg polysorbate 80 (Tween 80). Left over from the manufacturing process are residual amounts of hydrocortisone (≤0.0016 mcg), gentamicin sulfate (≤0.15 mcg), ovalbumin (≤0.05 mcg), formaldehyde (≤5 mcg), and sodium deoxycholate (≤50 mcg).
Indications and Usage: Fluarix is indicated for use in children ≥ 3 years old and adults. Children 3-9 years old who are unvaccinated or have only received a single dose in the previous season should receive 2 doses administered at least 4 weeks apart. Children over the age of 9 years old and adults receive only 1 dose.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: Measurements of vaccine efficacy (seroconversion) and effectiveness (how the vaccine actually protected) were performed with the vaccine from the 2006-2007 influenza season for antigenically matched strains and also culture-confirmed flu. The effectiveness for antigenically matched strains in adults 18-64 years old was 66.9% (51.9-72.8%) and for culture-confirmed influenza, 61.6% (46-72.8%). The efficacy in adults 18-64 years old was 59.6% (56-63.1%), 61.9% (58.3-65.4%) and 77.6% (74.4-80.5%) for A/New Caledonia/20/99 (H1N1), A/Wyoming/3/2003 (H3N2) and B/Jiangsu/10/2003 strains respectively. Please review package insert for information on adverse events.

Product: Flulaval is manufactured by ID Biomedical Corporation of Canada, a subsidiary of GlaxoSmithKlein (GSK).
Description: Flulaval is prepared as a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. Formulated to contain 45 mcg hemagglutinin per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-179A (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008. Flulaval is a multi-dose presentation so thimerosal is added as a preservative. Each 0.5 mL dose contains 25 mcg of mercury. A complete listing of excipients cannot be found, but left over from manufacturing are residual amounts of egg proteins (≤1 mcg ovalbumin), formaldehyde (≤25 mcg), sodium deoxycholate (≤50 mcg) and phosphate-buffered isotonic solution. Antibiotics are not used in the manufacture of this vaccine.
Indications and Usage: Flulaval is indicated for use in adults ≥ 18 years old. It is estimated that GSK will be shipping ~30 million doses combined of Fluarix and Flulaval to the U.S.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: In clinical trials of adults 18-64 years old, Flulaval demonstrated seroconversion in 85.6% (82.7% lower bound of 95% CI), 79.3% (76.1% lower bound of 95% CI) and 58.4% (54.6% lower bound of 95% CI) for A/New Caledonia/20/99 (H1N1), A/Wyoming/3/2003 (H3N2) and B/Jiangsu/10/2003 strains respectively. In a clinical trial of adults ≥50 years old, Flulaval demonstrated seroconversion in 44.8% (39.3% lower bound of 95% CI), 69.1% (63.8% lower bound of 95% CI) and 49.1% (43.5% lower bound of 95% CI) for A/New Caledonia/20/99 (H1N1), A/Wyoming/3/2003 (H3N2) and B/Jiangsu/10/2003 strains respectively. Please review package insert for information on adverse events.

Product: FluMist is manufactured by MedImmune.
Description: FluMist is prepared as a live, attenuated trivalent vaccine for administration by intranasal spray. The influenza virus strains in FluMist are cold-adapted which means that they grow efficiently at 25°C and restricted growth at temperatures of 37°-39°C. Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled and then clarified by filtration. Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 10^6.5-7.5 FFU of live attenuated influenza virus reassortants of each of the three strains: A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and less than 0.015 mg/mL gentmicin sulfate.
Indications and Usage: Flumist is indicated for use in individuals 2-49 years old. It is a 0.2 mL dose vaccine that is administered intranasally (0.1 mL per nostril). Children aged 2-8 years old not previously vaccinated for influenza should receive 2 doses, at least one month apart. Children aged 2-8 years old previously vaccinated for influenza and individuals 9-49 years old should receive 1 dose.
Contraindications: Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine, or life-threatening reactions to previous influenza vaccination. Concomitant aspirin therapy in children and adolescents. Antiviral medications. Anyone with asthma or children less than 5 years old with recurrent wheezing episodes
Safety and Efficacy: In a clinical study of children less than 5 years of age, FluMist demonstrated an effectiveness of 44.5% (22.4-60.6%) expressed as a reduction in culture-confirmed influenza against all matched strains of H1N1, H3N2 and B influenza. In a clinical trial of adults 18-49 years old, FluMist demonstrated an effectiveness of 10.9% (-5.1-24.4%) expressed as a reduction in one or more episodes of febrile illness. Please review package insert for information on adverse events.

Product: Fluvirin is manufactured by Novartis.
Description: Fluvirin is a trivalent, sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Formulated to contain 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 viruses: A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008.
Fluvirin comes in single, 0.5 mL pre-filled syringes contain trace thimerosal (≤ 1 mcg mercury per 0.5-mL dose). The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg
mercury. A complete listing of excipients cannot be found, but left over from manufacturing are residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg), phosphate-buffered isotonic solution (≤ 1.0 mcg and nonylphenol ethoxylate (not more than 0.015% w/v).
Indications and Usage: Fluvirin is indicated for the use in individuals ≥ 4 years old. Children 4-8 years old who are unvaccinated for influenza or have only received one dose the previous year should receive 2 doses, at least 4 weeks apart. Children 4-8 years old who have previously received 2 doses of influenza vaccine, children ≥ 9 years old and adults should receive 1 dose. It is estimated that Novartis will be supplying the U.S. with ~40 million doses of Fluvirin.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: Numerous, small clinical studies conducted on adults 18-64 years old demonstrated a wide range of seroconversion rates depending upon year and strain. The ranges with 95% CI were 55% (44-67%) - 73% (62-83%), 61% (50-72%) - 90% (86-93%) and 56% (45-67%) - 74% (65-82%) for H1N1, H3N2 and B strains respectively. Please review package insert for information on adverse events.

Product: Fluzone is manufactured by Sanofi Pasteur and comes in three presentations. Fluzone High-Dose is new this year.
Description: Fluzone and Fluzone High-Dose are inactivated influenza virus vaccines prepared from influenza viruses propagated in embryonated chicken eggs. They are formulated to contain the amount of HA per dose for each of the three influenza strains recommended for the 2010-2011 Northern Hemisphere influenza season: A/California/07/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (an A/Perth/16/2009-like virus) (H3N2), and B/Brisbane/60/2008.
Paediatric Fluzone: Is a 0.25 mL dose containing 22.5 mcg HA total; 7.5 mcg each of H1N1 HA, H3N2 HA and B HA. (quantity sufficient for appropriate volume) Sodium phosphate-buffered isotonic sodium chloride solution, ≤50 mcg formaldehyde, ≤50 mcg octylphenol ethoxylate (Triton® X-100) and 0.05% gelatin. Fluzone paediatric comes in single-dose, pre-filled syringes and do not contain thimerosal. Fluzone presented in a multi-dose (for use in individuals ≥ 6 months old) vial does contain thimerosal and contains 12.5 mcg mercury per 0.25 mL dose.
Fluzone: Is a 0.5 mL dose containing 45 mcg HA total; 15 mcg each of H1N1 HA, H3N2 HA and B HA. (quantity sufficient for appropriate volume) Sodium phosphate-buffered isotonic sodium chloride solution, ≤100 mcg formaldehyde, ≤100 mcg octylphenol ethoxylate (Triton® X-100) and 0.05% gelatin. Fluzone comes in single-dose presentations that do not contain thimerosal and multi-dose vials that contain 25 mcg mercury per 0.5 mL dose.
Fluzone High-Dose: Is a 0.5 mL dose containing 180 mcg HA total; 60 mcg each of H1N1 HA, H3N2 HA and B HA. (quantity sufficient for appropriate volume) Sodium phosphate-buffered isotonic sodium chloride solution, ≤100 mcg formaldehyde, ≤250 mcg octylphenol ethoxylate (Triton® X-100) and no gelatin. Fluzone High-Dose comes in a single-dose, pre-filled syringe presentation that does not contain thimerosal.
Indications and Usage: Fluzone is indicated for the use in individuals ≥ 6 months old and adults less than 65 years old. Children 6 - 35 months old, unvaccinated with influenza or receipt of 1 dose in the previous year should receive 2 0.25 mL doses, at least 1 month apart. Children 36 months - 8 years old, unvaccinated with influenza or receipt of 1 dose in the previous year should receive 2 0.5 mL doses, at least 1 month apart. Individuals ≥ 9 years old should receive 1 0.5 mL dose. Fluzone High-Dose is indicated for the use in individuals ≥ 65 years old and should receive 1 dose. Sanofi Pasteur announced that ~70 million doses of Fluzone will be supplied to the U.S.
Contraindications: Individuals with known hypersensitivity to eggs, any other vaccine constituent or in anyone who has had a life-threatening reaction to previous influenza vaccine.
Safety and Efficacy: In one very small paediatric study, children 6 - 36 months old, after 2 doses, demonstrated seroconversion rates of 77%, 77% and 48% to H1N1, H3N2 and B influenza strains respectively. Small, clinical studies of adults 19 - 59 years old demonstrated seroconversion ranges of 49-54%, 72-79% and 38% to H1N1, H3N2 and B influenza strains respectively. In adults 61-86 years old demonstrated seroconversion ranges of 23-38%, 68-70% and 10-11% to H1N1, H3N2 and B influenza strains respectively. Fluzone High-Dose in adults 65-97 years old demonstrated seroconversion rates of 48.6%, 69.1% and 41.8% to H1N1, H3N2 and B influenza strains respectively. Please review package insert for information on adverse events.

Pregnant women or women who will become pregnant during influenza season may be concerned about influenza infection and vaccine safety during their pregnancies. Ideally, women who are thinking about becoming pregnant should consider flu vaccination prior to conception. However, that is not always an option.

In Influenza infection and vaccination in pregnant women, Tamma et al. reviewed numerous studies regarding the effect of influenza infection and vaccination on pregnant women and neonates. Transplacental transmission of influenza virus and teratogenic effects remain unclear, however, there is evidence that an indirect effect of maternal influenza infection on adverse foetal development may occur via the maternal immune response (proinflammatory cytokine production) during hypothermia, particularly in the first trimester. It has been postulated that influenza vaccines could do the same, however first, influenza vaccines administered to pregnant women are inactivated and next, a study by Munoz et al. (2005), failed to find any differences in adverse pregnancy outcomes and infant health (study period of 6 months post-partum) in a cohort of vaccinated pregnant (in second or third trimester) women versus unvaccinated, healthy pregnant women. Additionally, no unusual adverse outcomes occurred in the vaccinated group that could be attributed to influenza vaccine.

There appears to be protective effects for the neonate in influenza vaccinated mothers as well. Zamen et al. (2008) reported a 63% reduction in laboratory confirmed influenza in infants less than 6 months old born to mothers that were vaccinated for influenza during pregnancy as compared to a Pneumovax-vaccinated control group. Although both groups were vaccinated, there were no adverse outcomes that differed from the general population during that time.

Since no vaccine is completely effective, there are a number of precautions that you can and should take regardless of your vaccination choice:

Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
Avoid touching your eyes, nose and mouth. Germs spread this way.
Try to avoid close contact with sick people.
If you are sick with flu–like illness, CDC recommends that you stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone without the use of a fever-reducing medicine.)
While sick, limit contact with others as much as possible to keep from infecting them. Utilise N-95 masks to prevent transmission of flu.
Stay healthy by eating right, this includes supplementation with vitamin D3, which may help to reduce influenza disease effects. Pregnant women need to ensure adequate folic acid intake.

(Adapted from the CDC's Seasonal Influenza page)

Cedillo vs. HHS Appeal Denied

2010-08-29T12:05:00.006-04:00

Michele Cedillo was selected by the Omnibus Autism Proceeding (OAP) Petitioner's Steering Committee (PSC) as a test case for the 'Thimerosal and MMR Vaccine Autism Causation Claim'. On 12 February 2009, Special Master Hastings denied compensation to the Cedillos on Michele's behalf.

Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems.

This decision was upheld on 6 August 2009 by the United States Court of Federal Claims.

After performing this review, the Court is satisfied that the Special Master’s decision is rational and reasonable in all respects, and is in accordance with law. For the reasons addressed above, the Special Master’s decision is AFFIRMED.

Attorneys for the Cedillos filed an Amicus Brief in the United States Court of Appeals for the Federal Circuit on 25 January 2010. The Court of Appeals rendered their decision on 27 August 2010.

In conclusion, we have carefully reviewed the decision of the Special Master and we find that it is rationally supported by the evidence, well-articulated, and reasonable. We therefore affirm the denial of the Cedillos’ petition for compensation.

Part of the Cedillo's arguments relied upon the admissibility of Dr. Stephen Bustin's testimony. While the panel for the Appeals Court of the Federal Circuit found the admission of Dr. Bustin's testimony "troubling", they did not find cause for reversal.

In our recent decision in Hazlehurst, we specifically addressed this question and held that the failure to exclude the testimony and reports of Dr. Bustin did not constitute reversible error. See Hazlehurst, 604 F.3d at 1348-52. In particular, we concluded that the Special Master’s decision to admit and consider Dr. Bustin’s testimony was “in full accord with the principle of fundamental fairness” under Vaccine Rule 8(b)(1) and did not “contravene[] the purpose[] of the Vaccine Act” to avoid proceedings resembling tort litigation.

Curiously, it was the Cedillo's admission of the Unigenitics Laboratory results validity which compelled the HHS to seek rebuttal evidence.

As we noted in Hazlehurst, “[a]lthough not obligated to do so, the petitioners chose to introduce the Unigenetics data and thus placed its validity squarely at issue. Fairness dictated that the government be given an opportunity to refute that critical evidence.” Id. at 1349.

To further the baselessness of this particular complaint by the Cedillos was the fact that they were provided a year to procure relevant documentation from the U.K. regarding Dr. Stephen Bustin's testimony of the Unigenetics Laboratory audit he had conducted, but failed to do so. This, even in light of the fact that Special Master Hastings and the Department of Justice offered their assistance to the PSC.

Second, petitioners did not request that the Special Master apply Rule 26 or order the government to secure the underlying information.
Third, petitioners themselves did not seek to access the data from the UK court, nor did they examine Dr. Bustin as to the current location of the data he relied upon in creating his reports. In the Special Master’s evidentiary ruling denying petitioners’ motion to exclude Bustin’s reports and testimony, he encouraged petitioners’ counsel to seek the underlying data from the UK court, and pledged to join any request. Thereafter, the Special Master then gave petitioners over a year to petition the British court for access to the information. Petitioners also requested that the OAP Special Masters provide a letter supporting a possible request, which the Special Masters did. Petitioners considered making such a request from the UK court, but never did so. They contend that British counsel informed them that it was unlikely that the UK court would permit disclosure of the expert reports without the consent of the experts, which petitioners stated that they could not obtain. But Dr. Bustin did consent to the release of his reports. Once his consent
for the release of his reports had been obtained by the government, there is no reason why the data underlying his reports could not also have been requested.

It appears as though the PSC wilfully shoot themselves in the foot and then expect laws and procedures to change to accommodate their own incompetence. The rest of the frivolity of the claims by the petitioners for a 'do over' and subsequent decision by the Federal Circuit of Appeals is best summed up with the following statement:

Petitioners also contend that the Special Master abused his discretion in “ignor[ing]” certain concessions made by the government’s experts or in “refus[ing] to consider” certain evidence. However, the Special Master did not ignore relevant testimony and explicitly considered the evidence in question with a few limited exceptions. Petitioners primarily argue that the Special Master considered, but erroneously declined to credit, certain evidence, or to draw from it conclusions favorable to petitioners. We have reviewed petitioners’ arguments and we find them to be unpersuasive. In the Special Master’s careful and thorough opinion, he considered, weighed, and stated his reasons for rejecting or discounting each item of evidence in which the petitioners relied. With respect to many of petitioners’ claims of error, no discussion is necessary because there is no possible basis for the claim of error.

In other words, the petitioners' arguments amounted to a lot of foot-stomping because Special Master Hastings did not find their experts nor evidence at all compelling, even in light of the fact that Special Master Hastings qualified each and every statement he made regarding the PSC's expert testimony and evidence.
This case, as with Hazelhurst vs. HHS has been heard 3 times examining various parameters and none have affirmed that the petitioners have presented a compelling case, nor have any reversible legal errors been committed by the presiding Special Masters.

We wish the Cedillos and other petitioners of the OAP the very best and can somehow, accept these decisions in order to move on with their lives. While it is possible that the Cedillos may opt to appeal to the United States Supreme court, it is our rather non-legal opinion that they won't even hear it and it is time for the Cedillos and other families like them to stop being used by interested parties to further their agenda.

Dr. Bob Sears Gets it Wrong Again

2010-08-06T14:27:00.011-04:00

This time, about pertussis, pertussis epidemiology, vaccinology and well, just about anything else to do with pertussis. Here is a recent post by him on The Vaccine Book Discussion Forum and his FaceBook page entitled, Pertussis Epidemic 2010: What Should Parents Do? I will break the entire post down point by point. His unedited post appears as indented text.

With the current increase in pertussis (whooping cough), many parents with unvaccinated children are naturally wondering if they need to worry. Here are some of my thoughts:
There IS an increase this year, but pertussis naturally shows a temporary rise for about a year or two every 5 years. The last such increase was in 2004/2005, followed by a decline back to normal. So it’s no surprise that this has happened. It’s not like we are unexpectedly seeing a sudden epidemic. We KNEW this was going to happen. That doesn’t make it any less serious, but it’s important to know that pertussis naturally rises like this.

In past years we’ve had about 15,000 reported cases of pertussis each year. The every-five-year peaks we’ve seen have been about 20 to 25,000 cases. This year we are looking at 30,000 or more. However, these are just the reported numbers. Only about 10% or less of cases are actually diagnosed or reported. So the real numbers are MUCH higher. So, these periodic increases could be mostly increases in reporting, and not much increase in actual disease. Or it could be disease increase. It’s hard to say. One argument if favor of an actual increase is that we do know the actual fatality numbers very accurately. And when that jumps higher, as it has this year, we can take that as a likely indication the disease incidence is higher as well.

Dr. Sears doesn't grasp basic principles of epidemiology such as it isn't the unexpectedness that defines an epidemic, it is the increase in the expected number of cases. Pertussis epidemics occur in 3-5 year cycles, but why? This observation isn't unique to pertussis but many diseases that we are familiar with and have successfully controlled with vaccination, such as measles. Pertussis is cyclical because of highs and lows in herd susceptibility, not due to changes in the bacterium itself. So pertussis infections, such as in 2004/2005, spread through the population because a critical mass of susceptible people have accrued due to births, decreased vaccination rates, primary vaccine failure (the vaccine did not confer adequate antibody titres in the recipient) and secondary vaccine failure (vaccine immunity has waned to below protective levels) and waning natural immunity.

Pertussis is a vastly under-reported disease due to misdiagnosis, underdiagnosis, and asymptomatic and subclinical cases. However, it is under-reported rather consistently so we do know that we are experiencing an epidemic year and not a change in reporting. There is absolutely no evidence that reporting efficiencies would have such a consistent cyclical nature. Case fatality rates are not a consistent indicator of disease incidence rates either.

Is this rise due to so many unvaccinating families? Not in my opinion. The primary reason for the rise is that pertussis is a stubborn germ, and it’s difficult to make a highly effective vaccine against it. The vaccine has an estimated efficacy of 80 to 90%. This is much lower than most vaccines. So outbreaks will occur in both vaccinated and unvaccinated children. Another reason is that the vaccine wears off, so teens and adults can easily catch whooping cough. They might cough for a few weeks without realizing they have it, and spread it around to other adults and children. There are far more teen and adult cases each year than childhood cases.

His opinion should be qualified by evidence and it isn't. Vaccine efficacy has nothing to do with pertussis being a 'stubborn germ'; there is no such accepted or recognised term. The vaccine efficacy, which incidentally is ~63-100%, is due to limitations within the vaccine construct and host immune response. Naturally-acquired immunity does not confer much longer immunity than the vaccine. Which is all more reason why very high vaccine uptake amongst those eligible is crucial to protect vulnerable infants that are too young to receive the vaccine or complete vaccination.

Let's look at some recent figures from the 2010 pertussis outbreak. Here are the California Department of Public Health's pertussis statistics for 2010 by county and here are vaccine exemptions for 2009 kindergarten entry. There has been much finger-pointing at Marin County due to their high rates of vaccine refusal. Not only has their vaccine exemption rate nearly doubled since the last pertussis outbreak to over 7%, but vaccine uptake by kindergartners has steadily fallen below threshold levels to 83%. This is not all though; there is substantial clustering of extremely high vaccine refusal for certain schools. For example, more than half of San Geronimo Valley Elementary and Marin Waldorf School students have vaccine exemptions. Marin County also tops the list for pertussis case rate at 99.8/100,000.

Counties also reporting the highest pertussis case rates/100,000 are San Luis Obispo (98.90), Del Norte (52.23), Madera (37.91), Fresno (31.30) and Colusa (30.04) with respective vaccine exemption rates (%) of 3.92, 5.75, 1.06, 0.98 and 0.54. These counties aren't demographically or socio-economically similar to Marin county at all, so what is going on? With the exception of Del Norte county, the rest are located in California's Central Valley, which is highly agricultural and/or has large sub-populations living at or below the poverty level. This situation translates to disparities in access to health information and services. Numerous San Luis Obispo county schools also have high vaccine exemption rates. Thus, high rates of pertussis infection are still occurring in areas with pockets of low vaccine uptake, but for different reasons than in Marin. It is interesting to note that Del Norte county's pertussis cases for 2010 were all reported prior to May and no new cases have been reported since then following a county-wide immunisation programme.

While it isn't as simple as 'high rates of vaccine refusal linearly corresponds with pertussis cases', as there are numerous factors involved, it is safe to say that vaccine refusal does contribute to increases in pertussis, regardless of the reason. So if Dr. Bob's advice makes him feel uncomfortable about promoting lower vaccine uptake, then perhaps he ought to spend a bit more time investigating the potential ramifications of his advice as should parents taking his advice.

Do unvaccinated children put others at risk? I would have to say that this is true to some extent. An unvaccinated child IS more likely to catch pertussis than a vaccinated child. So it makes sense that the fewer children that are vaccinated, the more likely the disease is to go around. However, this doesn’t mean that anyone has a right to put blame on unvaccinated kids or their parents. Some parents just don’t feel comfortable with vaccines, and they have the right (in this free country) to decline vaccines in most states. Because every vaccine has the potential to cause very severe, even fatal, reactions (which are extremely rare), parents have the right to avoid the vaccine and risk the disease instead. Parents who do feel comfortable vaccinating will get their children protected so they are unlikely to catch the illness if exposed.

Not surprisingly, Dr. Bob contradicts himself by admitting that unvaccinated people do put others at risk and increase disease circulation, but yet are not responsible for the increase in pertussis cases. It doesn't matter why parents are refusing vaccines for themselves and their children; it matters how many and their geographical distribution. So even while parents have the right to refuse vaccinations, that doesn't make them any less culpable for their contribution in the rise in incidence of diseases. Just as it doesn't make any physicians or pseudo-doctors (e.g. chiropractors and naturopaths) any less culpable for promoting vaccine refusal for bogus reasons and deceptively inflated risks.

The children of vaccine refusers are 23 times more likely to contract pertussis infection than in vaccinated. And states that allow easily-obtained vaccine exemptions were associated with a higher incidence of pertussis and numerous other studies have demonstrated that vaccine uptake is inversely correlated with pertussis infection.

How serious is pertussis? The disease usually kills about 20 babies each year in the United States. This year, with the increase, we are headed for about 30 or maybe 40 deaths. These are very tragic. ALL fatalities from pertussis over the last few years have occurred in infants 3 months and younger. For many years before that all fatalities were in infants 6 months and younger. These young babies have about a 1 in 200 risk of fatality if they catch the disease. Fortunately, most babies who catch it will be just fine. Some will need hospitalization, and about 1 in 200 may die. Again, while this is tragic, this is a much lower fatality rate than some of the more serious infant infections such as meningitis.

What about older infants and children? Do parents need to fear for their safety? NO. Infants older than 6 months really have almost zero risk of fatality. Toddlers and preschoolers and older kids virtually always handle the illness without any trouble. Sure, they’ll cough for a month or two, but complications are extremely rare at this age, and hospitalization is unlikely.

Dr. Sears seems to be downplaying the complications associated with pertussis infection by emphasising the only outcome of interest being death. A case fatality rate of 1 in 200 is very serious and that alone puts the risk of disease and death orders of magnitude greater than the risk of death from vaccination. Seventy-nine percent of infants less than 6 months old have required hospitalisation, while 21% of hospitalised pertussis cases have been in > 6 month olds. One in 250 children with pertussis will have permanent brain damage, 1 in 10 will acquire pneumonia. So technically, yes, most children will be fine but why take the chance of risking weeks of very unpleasant illness and having no guarantee that your child will be fine. His comparison to meningitis is also disturbing. If most, if not all future deaths and serious sequelae from pertussis disease can be avoided with increased vaccination then it doesn't matter what statistics other pathogens present. Preventing pertussis disease and meningitis are not mutually exclusive.

One thing that has bothered me is that the media is making it sound like there’s a deadly pertussis epidemic, and that all kids are at risk. This is scaring parents and children of all ages. What the media really should be saying is that parents with new babies need to worry, but parents with older children don’t. There’s very little harm in catching this disease outside of infancy.

Dr. Bob is now instructing 'the media' (although he doesn't specify the sources) to present a portrayal of the current pertussis epidemic that won't make his recommendations look so bad. Who does he think that pertussis reservoir is? How are infants, too young to be vaccinated going to be protected if there are large clusters of unvaccinated or susceptible people surrounding them? The pertussis rate/100,000 in infants and children 6 months to 18 years old is 45; this isn't just a disease in infants. There is very little harm in catching the disease outside of infancy? I beg to differ. Again, it appears as though Dr. Bob's 'feel good' advice about vaccinations is coming back to haunt him and he is rather uncomfortable.

SO WHAT SHOULD PARENTS DO?

First, if you are planning to vaccinate, your infant will receive the DTaP vaccine at 2, 4, and 6 months of age. In certain areas where pertussis is highest, doctors do have the option of vaccinating early – at 6 weeks, 10 weeks, and 14 weeks of age. One dose of the vaccine doesn’t work very well, so the sooner a baby gets the third dose the better he’s protected. Ironically, by the time an infant receives the 3rd dose at 6 months (on the regular schedule), he is beyond the risky age for pertussis. I don’t really have an opinion on whether or not parents who live in high pertussis areas should get the accelerated schedule. That’s between you and your doctor. I have not begun doing the faster schedule, and don’t have any plans to do so at this time.

Six months of age is not "beyond the risky age for pertussis", they are just as susceptible without full vaccination. They are less likely to experience fatalities after 6 months, but they don't magically become risk-free for hospitalisation or serious sequelae. Twenty-one percent of children and infants over the age of 6 months in the current epidemic are still being hospitalised for complications.

Second, because new babies are vulnerable to pertussis in the early months before the vaccine is started and completed, parents and caregivers do have the option of getting the Tdap vaccine (a teen and adult version of the DTaP vaccine). New moms can get this when the baby is born, and dads can too. It’s given as a single dose. It’s ok to get if breastfeeding. You can review the details on this vaccine (how it’s made, what the ingredients are) in The Vaccine Book. I don’t really have an opinion yet on whether or not all parents and caregivers should get this shot. As a pediatrician, I don’t give adult shots, so I don’t have experience on how parents are tolerating the vaccine. But I do feel that the theory of giving parents of new babies this vaccine has merit.

Alas, something that almost makes sense. However, his advice is incomplete as children that have either not received vaccination with DTaP or boosted with Tdap at the appropriate age are not mentioned. The California Department of Public Health is recommending children 7 years and up receive Tdap as a booster so there is no gap in age-appropriate vaccine. So older siblings can be vaccinated either with the primary series or boosted in order to reduce transmission to household contacts as well as the general public.

Third - What about parents who are undecided about giving their new babies this vaccine? Is the current outbreak a concern? There is more risk of catching pertussis this year than last year, and this risk is likely to decline again next year as pertussis naturally wanes (if it follows the pattern of the past couple decades). Parents can review all the pros and cons of this decision in The Vaccine Book.

Nothing like a solid recommendation to try and keep infants safe during a pertussis epidemic. What does such a mealy-mouthed statement do for parents right now? The only reason that pertussis cases will decline the following year is that so many have been infected this year.

Fourth - What about unvaccinated OLDER infants, toddlers, and children? I’ve had a lot of my unvaccinating families call my office and ask if they should NOW get their children vaccinated. Here’s what I’m telling them:

• Realize that pertussis isn’t dangerous beyond infancy. It isn’t fun, and the coughing spells can be tough, but it isn’t dangerous. I can’t say an exact age at which it becomes “safe” to catch pertussis – there’s a gradually decreasing risk once a baby turns 6 months. So, an unvaccinated older infant or child doesn’t necessarily need the vaccine for HIS own protection (see below for other reasons to get the vaccine), and parents don’t need to “fear” this disease beyond infancy.

This is such dangerously bad advice as to be medical malfeasance. Paroxysmal coughing fits can last for weeks and cause cyanosis, vomiting, sleeplessness, rib fractures and cranial bleeding, even in older children and adults. Dr. Bob is contending the sin of omission is better than the sin of commission to validate his evidence-free recommendations. Again, why put children through any amount of misery, that could lead to serious complications, when vaccination can likely prevent that from happening and the risks of vaccinating far outweigh the risks of serious disease sequelae?

• Families with unvaccinated children who have a newborn or young infant should consider vaccinating their older children. Many families who skip vaccines do so because they worry that their little babies can’t handle them as well. Once a child turns two years or older, such parents might become more comfortable and vaccinate the child before a next baby comes along.
• Even without another little baby joining the family, parents could consider giving an unvaccinated older infant or child this vaccine series to help lower the chance that their child might catch it and spread it to other babies in other families.
• Children need at least 3 doses to have useful protection. Any undervaccinated child will have some protection, but should be considered susceptible. It isn’t clear if partial vaccination even helps lower the severity of the disease (as it does in chickenpox, for example).

There is nothing magical about 2 years old as infants respond well to DTaP vaccination and certainly no reason to cater to parental fears about vaccinating. Rather, provide them with accurate information about vaccines and effectively communicating risk assessment.

• In my own office I’ve seen a few patients come in for vaccination because of this outbreak, but I would say most patients who initially skipped the vaccine are not changing their mind now.

A final note: realize that DTaP is only approved for use through six years of age. Once a child turns seven he’s too old for it. Safety and efficacy have not been studied beyond six years of age. The teenage Tdap vaccine isn’t approved until a child turns ten years old. So, children age 7, 8 and 9 can’t get a pertussis vaccine.

Ultimately, I can’t make the decision for you. You need to review that chapter in the book and consider the above information. Then make an informed decision.

Dr. Bob does not seem to be taking this epidemic very seriously. He is essentially suggesting that parents who have chosen not to vaccinate their children have no reason to re-assess the current situation and act accordingly. He is far too interested in coddling and perpetuating parents' emotional beliefs (and maintaining book sales) than he is in acting like the expert he purports himself to be and to also, advise his readers to discuss the matter with their actual physician. Instead, he recommends that you buy his book.

Dr. Bob practises in California and has undoubtedly received the CDPH recommendation for vaccination of 7 year olds with Tdap and safety and efficacy have been determined. How can he advise parents to make an informed decision when he doesn't provide accurate information?

Addendum (added 8.10.2010): Dr. Bob has added a note to his posts regarding Tdap recommendations:

Well, I just got a note from Sanofi-Pasteur announcing that the Califonia Department of Public Health announced that their brand of Tdap (Adacel) has been temporarily approved for use in california children ages 7,8, and 9 years. This wasn't part of the FDA approval process, but the California government feels that the benefit of having a pertussis vaccine for this 3-year age group outweighs the fact that it isn't actually approved or studied in this age group. Just FYI.

The California Department of Public Health issued their recommendation on or shortly after 16 July 2010. While it is true that the use of Tdap has not been FDA approved, it is completely false that its use in younger populations has not been studied for safety and efficacy. The Public Health Agency of Canada recommended the use of Tdap in children 7 years and older in 2006 so it has an established safety profile. In light of pertussis epidemiology in California and elsewhere, it is rather curious that Dr. Bob would not be more abreast on current issues involving pertussis vaccination and appears to be lobbying against the current recommendation with no valid support to do so.

Dr. Bob is attempting to balance his reputation as a non-vax friendly doctor with the very real danger of infants and children suffering pertussis fatalities and serious complications. Instead of providing explicit and accurate recommendations to parents, he invokes abstract dangers of vaccinating and then gives parents the non-advice of, "well it's your decision", thereby freeing himself of any responsibility. Rather than being focused his own image, Dr. Bob should give greater concern to the well-being of the children of those who follow his advice.

Merck NOT to resume production of monovalent measles, mumps and rubella

2010-07-08T07:05:00.003-04:00

A recent rumor stated that Merck might be supplying their monovalent measles, mumps and rubella vaccines again "some time in 2011". Before anyone gets their hopes up, I went to Merck's webpage. This is their most recent statement (last checked 12 June 2011, my bold):

Based on input from the Advisory Committee on Immunization Practices (ACIP), professional societies, scientific leaders, and customers, Merck has decided not to resume production of ATTENUVAX® (Measles Virus Vaccine Live), MUMPSVAX® (Mumps Virus Vaccine Live), and MERUVAX®II (Rubella Virus Vaccine Live). This science-based decision will support vaccination of the largest group of appropriate individuals. Merck will continue to focus necessary resources to ensure that they can help meet current and future global public health needs for their combination measles, mumps and rubella vaccine, M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live).

Parents should not withhold the MMR from their children in the hope of finding monovalent vaccines again. Recent outbreaks underscore the importance of adequate protection from all three diseases.

Wakefield Drops a Bomb

2010-05-27T22:33:00.021-04:00

Well, not really, merely an execrable bit of ordure (redundant, I know, but apropos) meant to titillate his adoring fans and distract from the larger issue of why he was erased from the GMC register. Andrew Wakefield appeared on the Today Show, Wednesday, 24 May 2010 and made some statements regarding the replication of his research and his accusation that the U.S. government has been settling vaccine-induced autism cases, some in secret, since 1991. Here is the clip from the Today Show:

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Here is the transcript of the interview that Leftbrain/Rightbrain has kindly put together (the times the relevant quotes appear in the video are marked in red):

INTRO

MATT LAUER: [But]...in the years following his publication in The Lancet.no large scale study could reproduce exactly what Dr. Wakefield’s small study found. Dr. Wakefield is here for an exclusive interview. Doctor, good morning.

WAKEFIELD: Good morning Matt.

MATT LAUER: It may sound like a strange way to start the interview but…do I still refer to you as Doctor?

WAKEFIELD: Yes, they can’t take away the fact that I have a medical degree.

MATT LAUER: You were not surprised by this action … the stripping of your medical license. Why?

WAKEFIELD: Not at all. It was determined from the very beginning I believe, the pressure the government brought on the GMC.. to find this ruling.

MATT LAUER: You don’t think this was an impartial panel?

WAKEFIELD: I think that the panel .. whether they believe they were influenced or not .. were certainly of this opinion .. when I read their decision which came out in February .. this decision had been made from the outset.

MATT LAUER: Doctor is this the final blow to your credibility? Doctor, I mean if you look at the studies that have been conducted since your research wved[sic] your theories. The fact that The Lancet has since said, “If we knew then what we know now, we wouldn’t have published the study in the first place”. You lost your job down in Texas and now your medical license. Is that it?

WAKEFIELD: The findings we made originally have been replicated in five different countries of the world. So, the bowel disease in these children exists. This is a little bump on the road .. and .. that’s how it should be perceived. It’s a bump on a very bumpy road .. but .. it’s a bump. What it does not detract from is the fact there are millions of children out there suffering .. and .. the fact that vaccines can cause autism. That’s a fact that’s accepted by the American government … because they have been settling cases of vaccine induced autism since 1991. [4:15]

MATT LAUER: You say to me the findings have been replicated. I have seen studies, several major studies. Your study involved twelve children … I’ve seen studies that involved hundreds of thousands of children that do not replicate your findings. And, so, today .. will you sit across from me and tell me you still believe there is a possible link between tha particular vaccine .. the MMR vaccine .. and .. autism in children?

WAKEFIELD: Not only do I think it .. but .. the American government has conceded that it exists. A causal relationship between vaccines and autism exists .. and .. they have actually been secretly settling cases as early as 1991. Out of court as well. [4:40]

MATT LAUER: As you know, we have talked to people since we had a chance to meet .. when you were kind enough to sit down for that exclusive interview with us .. and .. people in our government have said “NO! NO! We no longer believe this. We went out and checked out the possibilities and we no longer believe this to be true.” And .. every doctor I’ve spoken to says “It’s dangerous … it’s dangerous to even keep talking about it because .. every time you talk about it .. parents stop vaccinating their children .. and .. some children are dying from preventable diseases”.

WAKEFIELD: Matt, you are missing the point. The point is .. despite denying it .. in the public relations campaign they waged against me and against the parents .. they are conceding these cases in vaccine court. [5:15]

MATT LAUER: What’s your next step .. real quickly?

WAKEFIELD: My next step is to continue this work till it’s natural conclusion. These parents are no going away, the children aren’t going away ..and .. I most certainly am not going away.

MATT LAUER: Dr. Andrew Wakefield, thank you for joining us. I appreciate your time….

I'll take this statement first since Catherina already demolished that claim in a previous post

WAKEFIELD: The findings we made originally have been replicated in five different countries of the world. So, the bowel disease in these children exists. [4:15]

I will include reference #4, Balzola et al. (2005) since that wasn't discussed:

Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients.
Federico Balzola, Clauser Daniela*, Alessandro Repici, Valeria Barbon, Anna Sapino***, Cristiana Barbera**, Pier Luigi Calvo**, Marina Gandione*, Roberto Rigardetto*, Mario Rizzetto.

Dept of Gastroenterology. University of Turin. Molinette Hospital Turin, Italy

*Dept of Neuropsychiatry for Children. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy ** Dept of Pediatric Gastroenterology. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy *** Dept of Biomedical Science and Human Oncology University of Turin

Although the causes of autism are largely unknown, this long-life developmental disorder is now recognised to affect as many as 1 to 500 children. An upper and lower intestinal disease has been recently described in these patients (pts) in spite of gastrointestinal symptoms have been reported by the parents back more many years. This disorder comprising ileo-colonic lymphoid nodular hyperplasia (LNH) and chronic inflammatory colonic disease was called autistic enterocolitis: an association between autism and bowel disease was then proposed.

Nine consecutive male pts (mean age 18 years, range 7-30 years) with a diagnosis of autism according to ICD-10 criteria that showed chronic intestinal symptoms (abdominal pain, bloating, constipation and/or diarrhoea) were enrolled. After routinely blood and stool tests, gastroscopy and colonoscopy with multiple biopsies were performed under sedation. A wireless enteroscopy capsule was also performed in 3 adult pts.

Anemia and fecal blood positive test were found in 2 pts and 3 pts, respectively. Gastroscopy revealed mucosal gastritis in 4 pts, esophagitis in 1 and duodenitis in 1 pts. Histological findings showed a chronic inflammation of the stomach and duodenum in 6 pts (66%) but inconsistent with celiac disease. Macroscopic mucosal abnormalities (aphtoid ulcerations and loss of vascular pattern) were found in 1 pts (11%) at colonoscopy and a LNH in the terminal ileum in 4 pts. (44%) Microscopic colitis with intraepithelial lymphocytes and eosinophils infiltrations, mucosal atrophy and follicular hyperplasia was histologically present in all the pts (100%) whereas a chronic inflammation with iperemia and villous shortening of the terminal ileum was shown in 6 (66%) pts. The wireless capsule revealed areas of bleeding or patchy erythema, mucosal erosions and ulcers in both jejunum and ileum in 1 patients whereas a particular chronic jejunum and ileal erosive pattern was evident in the other two.

These preliminary data are strongly consistent with previous descriptions of autistic enterocolitis and supported a not-coincidental occurrence. Moreover, they showed for the first time a small intestinal involvement, suggesting a panenteric localisation of this new IBD. The treatment to gain clinical remission has still to be tried and it will be extremely important to ameliorate the quality of life of such pts who are likely to be overlooked because of their long-life problems in the communication of symptoms.

These findings do not support a distinct pathology unique to autism. Additionally, Wakefield's original claim was essentially, 'MMR vaccination, then appearance of gastrointestinal symptoms, then regression into autism'. So not only was Wakefield's original claim roundly disproven, but Balzola et al.'s findings do not indicate anything remotely descriptive of Wakefield's original claim. This abstract also remains just that, i.e. an abstract presented at a meeting 5 years ago and has not gone through any peer-review, nor publication.

None of these studies or conference presentation present any evidence of a novel, gastrointestinal disorder unique to autism. In fact, it doesn't appear as though those with autism spectrum disorders have prevalence of any gastrointestinal pathology above that of the general population aside from constipation or diarrhoea. In short, Wakefield's own work isn't what he claims, nor has anyone replicated his work, anywhere, because it is hard to replicate a fabrication.

The other claims that de-licensed physician Andrew Wakefield makes are:

WAKEFIELD: .. the fact that vaccines can cause autism. That’s a fact that’s accepted by the American government … because they have been settling cases of vaccine induced autism since 1991. [4:15]

WAKEFIELD: Not only do I think it .. but .. the American government has conceded that it exists. A causal relationship between vaccines and autism exists .. and .. they have actually been secretly settling cases as early as 1991. Out of court as well. [4:40]

WAKEFIELD: Matt, you are missing the point. The point is .. despite denying it .. in the public relations campaign they waged against me and against the parents .. they are conceding these cases in vaccine court. [5:15]

These hidden-out-in-the-open, not-so-secret vaccine injury cases were blogged about by Kathleen Seidel on Neurodiversity, over 2 years ago. And here are some key quotes from that:

In each of the above-listed cases, the autism diagnosis followed the development or aggravation of profoundly disabling physical conditions.

As established in Lassiter v. HHS, an autism diagnosis does not prevent compensation for individuals who can demonstrate to the satisfaction of the special master that they have experienced a vaccine injury. However, in no instance has the VICP awarded compensation to cognitively disabled individuals who were not also physically disabled.

Emphasis mine. None of these compensated cases even remotely resembles the six test cases that were chosen to represent the over 5000 Omnibus Autism Proceedings' petitioners. None of these cases were 'secretly settled' as Wakefield claimed. It appears as though nothing that falls from Wakefield's mouth is truthful, even now when he has nothing more to lose.

Just to add insult to injury, the much touted "American Rally for Personal Rights" held in Grant Park, Chicago, IL to converge with Autism One, ended up being quite the damp squid. Wakefield was a keynote speaker at the rally, attended by a whopping 100 or so of his adoring fans, falling well-short of the thousands anticipated. That's okay though; Andy only cares about the children.

Photo courtesy of Age of Autism. American Rally for Personal Choice, 26 May 2010.

KWombles on Countering Age of Autism is having a caption contest for all of you snarkmeisters.

Andrew Wakefield has written a book

2010-05-05T06:22:00.003-04:00

Oh joy - Andrew Wakefield has written a book. In a brilliant display of his 'special kind of humour' (haha, two children fainted and one threw up over his mother, haha), he has called it "Callous Disregard". This comes from the ruling of UK's General Medical Council, which attested Wakefield "callous disregard for the distress and pain children might suffer". Good one, Andy, wink wink, nudge nudge.

Fiction is Andrew Wakefield's field and has been for over a decade, readers will remember his wonderful work of fiction about children with an autism specific gut inflammation caused by measles containing vaccines published in the Lancet in 1998. Certainly, we can expect the same kind of imagination from his new publication - cannot wait!

(sarcasm off)

You Spin Me Right Round, Blaxill Right Round

2010-03-03T21:24:00.002-05:00

On 12 February of this year Neurotoxicology withdrew the article Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight co-authored by none other than Andrew Wakefield. KWombles of Countering Age of Autism was the first to break this news and Just the Vax also blogged about it along with Respectful Insolence, A Photon in the Darkness and several others that day.

AoA's Mark Blaxill only just issued a predictably petulant diatribe regarding the withdrawn paper by Hewitson et al. It starts off with the bewildered meanderings of one that is clearly not familiar with scientific publications and editorial accountability.

How can a scientific study simply vanish? This paper had cleared every hurdle for entry into the public scientific record: it had passed peer review at a prestigious journal, received the editor’s approval for publication, been disseminated in electronic publication format (a common practice to ensure timely dissemination of new scientific information), and received the designation “in press” as it stood in line awaiting future publication in a print version of the journal. Now, and inexplicably, it has been erased from the official record. For practical scientific purposes it no longer exists.

The answer, of course, is that this is no ordinary scientific study. Age of Autism reported previously on its importance HERE , where we noted that “one likely tactic of critics of the study will include attempts to nullify the evidence based on the alleged bias of those involved.” The obvious risk, of course, was that a co-investigator on the paper, Dr. Andrew Wakefield, might make the study a target, especially in light of the hearings then underway at the U.K.’s General Medical Council (GMC).

First, let me point out that Neurotoxicology isn't a prestigious journal; it's an okay journal with an impact factor of 2.4. It may be nitpicking but it is disingenuous to attach exaggerated attributes such as 'prestigious' and 'world-renowned', especially when referring to cranks and their science. But Blaxill is right about two things; that was no ordinary scientific study and Wakefield's self-inflicted predicament was undoubtedly targeted, after the fact however. The monkey HepB study was not good, in fact, the study design, methods and results were quite poor. It never should have passed peer-review but somehow did; perhaps the editorial staff at Neurotoxicology were hedging their bets on a bombshell study and had enough reputable authors to withstand the blowback. That is evidenced by this response to Lynn Redwood's request for information by Elizabeth Perill:

Elizabeth Perill (Elsevier is a division of Reed Elsevier PLC, a large scientific publishing corporation and owner of Neurotoxicology). Perill wrote the following note to Ms. Redwood on February 4th.

Dear Dr. Redwood [sic],
Aside from any authorship concerns, on reflection the paper is not suitable for publication in this journal. The decision was based on the fact that the paper should not have been accepted in Neurotoxicology and the paper is not suitable for the audience of Neurotoxicology.
Kind regards,
Liz
Elizabeth Perill
Publisher, Toxicology,
Elsevier
360 Park Av. South, New York, NY 10010

So when more scrutiny was applied to the study itself, it didn't pass muster.

When Joan Cranmer accepted the primate paper in Neurotoxicology, her decision could not have been an easy one. The study subject and one of the study authors, Andrew Wakefield, were known to be highly controversial. All of the information about the GMC proceedings and the accusations against Wakefield were well known to the editors and peer reviewers. Despite that knowledge and the risks involved, Cranmer and her editorial team judged the science to be sound and decided to go ahead. We complimented them at the time, noting that “the journal editors at Neurotoxicology have taken a courageous stand in publishing what is sure to be unwelcome evidence in some circles.” It appears, however, that Cranmer’s superiors within Elsevier did not share those views.

Emphasis mine. That's bollocks Blaxill; let's review what the Conflict of interest statement in the study stated:

Prior to 2005, CS and AJW acted as paid experts in MMR-related litigation on behalf of the plaintiff. LH has a child who is a petitioner in the National Vaccine Injury Compensation Program. For this reason, LH was not involved in any data collection or statistical analyses to preclude the possibility of a perceived conflict of interest.

And let's review what the known conflicts of interest really are. Andrew Wakefield was well in the midst of GMC misconduct proceedings against him regarding the 1998 Lancet paper and the Neurotoxicology study was not submitted until 16 June 2009. Thoughtful House routinely treats autism as vaccine injury and promotes the use of chelation and Wakefield was firmly in place as the director then. Laura Hewitson is registered as a DAN! and also is employed at Thoughtful House as is her husband, Dan Hollenbeck. He is on the board of directors for SafeMinds, one of the funding sources for the monkey studies and a vitriolic supporter of the mercury-autism 'hypothesis'. Additionally, both openly support chelation. David Atwood from the University of Kentucky is the patent holder for N,N’-bis (2-mercaptoethyl)isophthalamide an industrial chelator designed for cleaning up mining sludge, or better known as OSR which is being marketed by Boyd Haley, also of the University of Kentucky as an autism cure for children.

As Orac pointed out, those of us involved in the topic of vaccines and the claims of 'damage' are an oddball bunch; it's a niche interest and it is audacious to assume that journal editors would have all of this information at their fingertips about any authors that makes submissions to their publications. That is what COI statements are for and probably a substantial reason why this study was withdrawn. Think about it; a group of authors don't declare their full COIs and then one is later shown in a formal proceeding to have acted with callous disregard for children that he was supposed to care for, unethically and dishonestly, not to mention the other glaring omissions. That cannot be simply ignored, at least in the real world. As Dr. Perill stipulated, "Aside from any authorship concerns, on reflection the paper is not suitable for publication in this journal.", can certainly be taken as the science was more closely scrutinised after the appalling COIs came to light. An update to AoA's post on this confirms this:

UPDATE: After publishing the article, Age of Autism received this statement from Joan Cranmer.

“Scientific integrity and good science are fundamental principles for publication of research articles in Neurotoxicology. Although rare, the journal withdraws papers whenever these essential principles are cast into doubt. The January 28, 2010 UK General Medical Council ruling of research dishonesty by Dr. Andrew Wakefield cast into doubt the scientific integrity of a new related paper co-authored by Wakefield*. However, it would be inappropriate for either me or the other editors to discuss the specific factors publicly.

Professor Joan M. Cranmer, Editor, Neurotoxicology

This shouldn't be so difficult for Blaxill and Co. to parse, but somehow it is. Scientific integrity and good science; principles that seem to allude the vaccine-autism pseudo-scientists. Blaxill also predictably pulls out the Galileo gambit and compares Wakefield to Herbert Needleman a physician who made the discovery that lead poisoning is responsible for developmental disorders and took on a powerful industry that tried to railroad him.

One of the reasons that Needleman is revered in the neurotoxicology community is because he had to surmount formidable obstacles and fight powerful opponents in order to protect children from dangerous exposures to heavy metals. Like Wakefield, Needleman once served as an expert witness in a legal proceeding, in this case on behalf of a child from Utah who had been injured by lead pollution. Also like Wakefield, Needleman found himself facing off against powerful industry forces, in this case the oil and gas industry and their suppliers of lead, companies such as Ethyl Corp and E.I. DuPont de Nemours. Most notably, in order to defend their profits, the lead industry mounted an aggressive effort to discredit Needleman. In 1991, he was called before the Office of Scientific Integrity at the National Institutes of Health (NIH) on charges of scientific misconduct.

The chasmic differences between Dr. Needleman and Wakefield are scientific integrity and unassailable science that prevailed even under intense scrutiny. It really is a grotesque affront to someone of Dr. Needleman's credentials and righteousness. Wakefield is no Galileo, no Needleman and no Marshall and Warren. Just because Wakefield is viewed by his supporters as David taking on the big bad Goliath of Pharma, that doesn't make him right. If he had the science to support his assertions, it would have been replicated and it would have withstood scrutiny.

Seen from this perspective, what if the next-generation incarnation of Herbert Needleman is Andrew Wakefield, but in today’s version of the story, the balance of power has shifted in critical ways? In Wakefield’s case the product is neither gasoline nor paint, but vaccines, one of the most privileged product categories ever invented, products that are produced and promoted by the medical industry with missionary zeal. In contrast to the limited scientific influence of the oil and gas industry, the medical industry Wakefield faces is far more powerful, pursues its interests with greater skill, controls the flow of scientific information and effectively dictates media coverage. It appears now that the medical industry is so powerful that it can rewrite scientific history when it wants and even erase important scientific publications in a reputable journal.

The oil and gas industry have limited influence? Are you kidding me? Sadly, that was a rhetorical question that I well know the answer to. If Pharma is so competent and omnipotent, how did they allow Wakefield to not only publish the 1998 Lancet case series, but leave it published for almost 12 years, not to mention all of his subsequent publications and the most recent Neurotoxicology study? And only just got around to getting the GMC to instigate proceedings against him? Scientific publications get retracted all the time, it's part of the process when scientific fraud is discovered, and Wakefield fits that bill.

Wakefield is in a league with the likes of Victor Ninov, Jan Hendrik Schön, Robert P. Liburdy and Hwang Woo-Suk, the latter also feigning ignorance of bioethics in his defence. But Wakefield is a rank amateur compared to the Piltdown Man hoax. Whoever that was, kept that going for more than 4 decades and the true identity of the perpetrator(s) remains unknown. Wakefield's fraud was discovered a mere 5 years after the 1998 (now retracted) Lancet paper by a journalist, no less. Even if one wishes to (erroneously) argue that Mr. Deer was aimed at Wakefield, if there was nothing there, then Wakefield wouldn't have been so thoroughly discredited and looking for his next gig right now.

AoA's call for Neurotoxicology's editor Joan Cranmer to resign in the name of 'think of the children' is preposterous and just isn't going to be considered, let alone done. It is a vapid attempt to rally the troops in the face of yet another failed attempt to get their pseudo-scientific tripe into a real peer-reviewed journal and game over for Wakefield. I think that even they can see the disgrace of having to publish in bottom-dwelling vanity press journals such as JAPandS, Medical Veritas (ooo, they say it's a 'pre-eminent' journal) and of course, Medical Hypotheses and even though that is an Elsevier journal, I think they would give the monkey study a go, given their standards.

If you are interested in reading more on this topic, please visit Countering Age of Autism and of course, Respectful Insolence.

And So the Spin Begins

2010-02-21T16:34:00.003-05:00

Age of Autism has finally broken it's silence regarding the departure of Andrew Wakefield from Thoughtful House. Since Mark Blaxill and Carol Stott, the latter also quietly removed from Thoughtful House's research staff, couldn't procure the services of PR powerhouse Max Clifford, he had to settle for the bumbling, albeit puppy-dog loyal, Dan Olmstead. Here is Wakefield's 'exclusive' statement to AoA:

“There has been an extraordinary outpouring of support from the autism community in response to the events of the last two weeks”, Wakefield told Age of Autism in an exclusive interview. “The most exciting part of it has been the opening up of an entirely new sort of opportunity that will allow me to continue my work on behalf of autism families.” Wakefield said he would provide more specifics on the nature of that opportunity soon. “In addition, I will now speak publicly to refute the findings that have been made against me. I know my necessary silence on these issues has troubled many parents in both the U.K. and the U.S. But I’m ready now to get back on the front foot and publicly contest the false accusations that have been made against me, my colleagues, and indirectly The Lancet children. It’s been long overdue.”

I can only take that to mean that Wakefield will adopt the nom de plume of 'Dr. Andy' as notable celebretricians and all chiropractors do. And "The most exciting part of it has been the opening up of an entirely new sort of opportunity that will allow me to continue my work on behalf of autism families.” sounds like a segue to the announcement of, 'Dr. Andy is available for children's birthday parties; his specialities are magic tricks, balloon animals and venipuncture.'

Dan, you're a little late to the party as the news of Dr. Wakefield's departure from Thoughtful House was announced 18, February. You also forgot to mention the departure of Arthur Krigsman from Thoughtful House as well. I'm sure the spin which has been fed to you by Wakefield and, in turn passed on, serves as temporary morale boost for your readers. But make no mistake, Thoughtful House is cleaning house and Wakefield, Krigsman and Stott are liabilities. If they can't support them, notably Wakefield in light of the recent UK General Medical Council Ruling, the Lancet retraction of his 1998 paper and the subsequent withdrawn monkey study from Neurotoxicology, it certainly makes me wonder who could.

Wakefield is finished. There has been no conspiracy; his original publication was based upon atrocious ethics and conflicts of interest, highly-flawed science and fudged medical records. It doesn't get much worse than that. This man is no hero; he's nothing more than a predator.

Andrew Wakefield resigns from Thoughtful House!

2010-02-18T11:22:00.003-05:00

Rumours had been going around since the early morning that Andrew Wakefield had resigned from his post as Director of Research at Thoughtful House. I have just had confirmation by email that he has indeed resigned. Note that this link www.thoughtfulhouse.org/staff/andrew-wakefield.php now leads to their home page and the statement of support recently posted after the GMC ruling has disappeared from their landing page. They issued the following statement today:

The needs of the children we serve must always come first. All of us at Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families. All of us at Thoughtful House continue to fight every day for the recovery of children with developmental disorders. We will continue to do our very best to accomplish our mission by combining the most up-to-date treatments and important clinical research that will help to shape the understanding of these conditions which are affecting an ever-increasing number of children worldwide.

Call me Cassandra - I had indeed foreseen that this would happen on this blog.

Further commentary on Respectful Insolence here and here, and on LeftBrainRightBrain - this was Strike 4 (after the GMC ruling, the retraction by The Lancet, and the retraction of the NeuroToxicology paper). Can I predict there is more to come (this may cause some fallout for Wakefield for example)?

Monkey Business Indeed

2010-02-12T10:15:00.003-05:00

The infamous monkey-hep B vaccine study, co-authored by none other than Andrew Wakefield, that was clearly part of a larger body of work has been withdrawn by the editors of Neurotoxicology after being accepted. First though, hat-tip to KWombles at Countering Age of Autism for the find. Last October, when the study was announced and e-published ahead of print, Just the Vax, Respectful Insolence and A Photon in the Darkness thoroughly debunked the methods and results but also highlighted the blatant conflicts of interest that remained undeclared in the study proof and corrected proof.

Elsevier's Policy on Article Withdrawl states:

An outcome of this principle is the importance of the scholarly archive as a permanent, historic record of the transactions of scholarship. Articles that have been published shall remain extant, exact and unaltered as far as is possible. However, very occasionally circumstances may arise where an article is published that must later be retracted or even removed. Such actions must not be undertaken lightly and can only occur under exceptional circumstances, such as:

Article Withdrawal: Only used for Articles in Press which represent early versions of articles and sometimes contain errors, or may have been accidentally submitted twice. Occasionally, but less frequently, the articles may represent infringements of professional ethical codes, such as multiple submission, bogus claims of authorship, plagiarism, fraudulent use of data or the like.

Article Withdrawal
Articles in Press (articles that have been accepted for publication but which have not been formally published and will not yet have the complete volume/issue/page information) that include errors, or are discovered to be accidental duplicates of other published article(s), or are determined to violate our journal publishing ethics guidelines in the view of the editors, may be “Withdrawn” from ScienceDirect. Withdrawn means that the article content (HTML and PDF) is removed and replaced with a HTML page and PDF simply stating that the article has been withdrawn according to the Elsevier Policy on Article in Press Withdrawal with a link to the current policy document.

At this juncture, it is purely speculation as to what led to the withdrawl of this study, however, it stands to reason that Andrew Wakefield's recent woes with the GMC rulings and the Lancet retraction of his 1998 study that implicated the MMR triple jab with his, entirely made-up, autistic enterocolitis diagnosis. In any event, it is safe to say that the withdrawl of this recent study by Neurotoxicology editors indicates something untoward.

There is no doubt that anti-vax sites like Age of Autism and Generation Rescue will use this opportunity to screed about 'persecution', 'suppression', 'censorship' and 'conspiracy' and keeping the 'Brave Maverick Doctors' down. But that is simply not the case. There is no doubt that that editors of reputable journals don't take such actions lightly and will have to answer for them. So whether this is a case of the science or ethics being more closely-scrutinised and/or the massive, undeclared conflicts of interest coming to light, that is more than enough to justify the withdrawl of this study.

In any event, we hope that the anti-vaxxers can at least get it straight that there were 20 monkeys used for this study. Twenty monkeys that were sacrificed (sorry Orac) to further a warped personal agenda and not to advance our scientific knowledge.

"Independent" the Wakefield way (really something for the fail blog)

2010-02-01T17:22:00.008-05:00

One of the claims that keeps reappearing in the comments sections under articles covering the GMC ruling on Andrew Wakefield and colleagues is that

The key finding (chronic colitis found in ASD children) of Dr. Wakefield's early case report published in The Lancet in 1998 HAS been independently confirmed by medical researchers in five different countries.

That is a very significant claim. After all, independent confirmation of a recent finding, would make the validity of a finding more likely, and if 6 independent laboratories found the same gut changes in autistic children, then then likelihood that this was a) a fluke or b) made up by Andrew Wakefield would be drastically reduced.

Finally, one of those commenters has posted those ‘independent confirmations’ – so I thought it might be worth having a look at them.

Krigsman, A. (Assistant Professor of Pediatrics, New York University School of Medicine Director of Gastroenterology Services), et al.,Ileocolonoscopy in Children with Autistic spectrum Disorder and Chronic Gastrointestinal symptoms. Autism Insights 2010:2 1-11.

Gonzalez, L., et al., Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with gastro-Intestinal Symptoms. Arch Venez Pueric Pediatr, 2005;69:19-25.

Balzola, F., et al., Panenteric IBD-like disease in a patient with regressive autism shown for the first time by wireless capsule enteroscopy: Another piece in the jig-saw of the gut-brain syndrome? American Journal of Gastroenterology, 2005. 100(4): p. 979-981.

Balzola, F., et al., Autistic enterocolitis: Confirmation of a new infammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005;128(Suppl. 2);A-303.

Galiatsatos, P., et al., Autistic enterocolitis: Fact or fiction. Canadian Journal of Gastroenterology. 2009;23:95-98.

Let’s look at number 1, Krigsman et al. The name sounds vaguely familiar. In fact, anyone who has read a little about the MMR-autism affair will know Arthur Krigsman as the clinical director of Thoughtful House, which happens to be the same Texas Clinic out of which Andrew Wakefield practises. One editor of “Autism Insight”, the journal in which this “independent confirmation” was published, is Andrew Wakefield (another one the senior author of the study, Carol Stott). Gosh, I bet peer review was harsh for this one.

Gonzales et al, number 2, has been published in “Arch Venez Pueric Pediatr” which stands for Archivos Venezolanos de Puericultura y Pediatría. It was a bit tricky to get my hands on the paper, especially since the citation was not quite right, but I did manage and was not surprised to find that indeed the authors cannot replicate Wakefield’s 1998 “findings” of a distinct autistic enterocolitis, although they do report a higher incidence of gastrointestinal problems in their autistic group.

Balzola et al, number 3, is a case report of one adult autistic patient with inflammed bowel.

Similarly, Balzola et al, number 4, is a meeting abstract that never saw the light of day as a peer reviewed study.

Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients.
Federico Balzola, Clauser Daniela*, Alessandro Repici, Valeria Barbon, Anna Sapino***, Cristiana Barbera**, Pier Luigi Calvo**, Marina Gandione*, Roberto Rigardetto*, Mario Rizzetto.

Dept of Gastroenterology. University of Turin. Molinette Hospital Turin, Italy

*Dept of Neuropsychiatry for Children. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy ** Dept of Pediatric Gastroenterology. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy *** Dept of Biomedical Science and Human Oncology University of Turin

Although the causes of autism are largely unknown, this long-life developmental disorder is now recognised to affect as many as 1 to 500 children. An upper and lower intestinal disease has been recently described in these patients (pts) in spite of gastrointestinal symptoms have been reported by the parents back more many years. This disorder comprising ileo-colonic lymphoid nodular hyperplasia (LNH) and chronic inflammatory colonic disease was called autistic enterocolitis: an association between autism and bowel disease was then proposed.

Nine consecutive male pts (mean age 18 years, range 7-30 years) with a diagnosis of autism according to ICD-10 criteria that showed chronic intestinal symptoms (abdominal pain, bloating, constipation and/or diarrhoea) were enrolled. After routinely blood and stool tests, gastroscopy and colonoscopy with multiple biopsies were performed under sedation. A wireless enteroscopy capsule was also performed in 3 adult pts.

Anemia and fecal blood positive test were found in 2 pts and 3 pts, respectively. Gastroscopy revealed mucosal gastritis in 4 pts, esophagitis in 1 and duodenitis in 1 pts. Histological findings showed a chronic inflammation of the stomach and duodenum in 6 pts (66%) but inconsistent with celiac disease. Macroscopic mucosal abnormalities (aphtoid ulcerations and loss of vascular pattern) were found in 1 pts (11%) at colonoscopy and a LNH in the terminal ileum in 4 pts. (44%) Microscopic colitis with intraepithelial lymphocytes and eosinophils infiltrations, mucosal atrophy and follicular hyperplasia was histologically present in all the pts (100%) whereas a chronic inflammation with iperemia and villous shortening of the terminal ileum was shown in 6 (66%) pts. The wireless capsule revealed areas of bleeding or patchy erythema, mucosal erosions and ulcers in both jejunum and ileum in 1 patients whereas a particular chronic jejunum and ileal erosive pattern was evident in the other two.

These preliminary data are strongly consistent with previous descriptions of autistic enterocolitis and supported a not-coincidental occurrence. Moreover, they showed for the first time a small intestinal involvement, suggesting a panenteric localisation of this new IBD. The treatment to gain clinical remission has still to be tried and it will be extremely important to ameliorate the quality of life of such pts who are likely to be overlooked because of their long-life problems in the communication of symptoms.

Finally, number 5, Galiatsatos et al., is a case report, featuring two adult patients with gastrointestinal problems and an ASD diagnosis. The authors call for “more investigations” in their discussion.

So what do we have here? Three (3) genuinely published cases of autistic adults who had consulted a doctor for gastrointestinal problems and were found to have gastrointestinal problems. One conference report from April 2005 that has not gone through peer review and has not appeared in a real journal in the 5 years since the conference. One real study looking at over 50 autistic children which does not confirm Wakefield’s findings. And finally, one study by Wakefield’s buddies in a freshly founded journal run by Andrew Wakefield and his buddies, to say that their buddy Andy was really right all along – how is that for "independent" confirmation?!

Edited on 19 January 2011 to add a find that Sullivan from LBRB led me to - it appears that the 2007 and 2008 tax forms (990) from Thoughtful House mention a "VENEZUELA COLLABORATION" under the projects they fund - a bit of thoughtful googling produced this gem

Gastrointestinal Pathology in Autism Spectrum Disorders: The Venezuelan Experience by Lenny G. Gonzalez, MD

Meet Lenny Gonzales, another Wakefield "buddy".