Cedillo vs. HHS Appeal Denied

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

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

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

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

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

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

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.