Wednesday, January 5, 2011

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.

Sunday, January 2, 2011

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.