Wakefield is a Fraud

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

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?

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

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

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.

20 Aug 2014: links repaired

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

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

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.