A series of articles just published in The Sunday Times reports that it appears likely that Andrew Wakefield falsified much of the data that was used in the 1998 Lancet article that first identified the MMR vaccine as a potential cause of autism. If the charges leveled by the paper are remotely accurate, Wakefield is guilty of homicide - perhaps not legally, but certainly morally. If previous claims made by the paper are accurate, Wakefield may have acted for financial gain.
If even a fraction of the accusations leveled by The Times are true, Wakefield engaged in absolutely outrageous academic misconduct, if not outright fraud. In order for any of the accusations to not be accurate, The Times would have to be lying about the contents of medical records.
In the original journal article, Wakefield and his co-authors reported on a series of 12 children who presented to the hospital exhibiting symptoms of what the authors referred to a a "syndrome" of combined gastrointestinal disorders and developmental setbacks. According to Wakefield, these symptoms presented in these patients developed shortly after the children received the MMR vaccine.
According to The Sunday Times, that is factually incorrect in the majority of the cases presented.
Specifically, the paper reports that evidence of developmental problems did not first show up soon after MMR vaccination in at least seven of the twelve cases discussed in the Lancet study. In one case, the symptoms were first noted 3-5 months after vaccine administration. In six cases, evidence of developmental difficulties was present prior to the first administration of the vaccine.
Wakefield did not report the presence of any confirmed or even possible neurological or behavioral issues in any of the cases detailed in the paper. In fact, he explicitly reported that, "[in] eight children the average interval from exposure to first behavioural symptoms was 6·3 days (range 1--14)." The statement that eight of the twelve children exhibited their first symptoms during the first two weeks after receiving the vaccine is clearly incompatible with the paper's claim that earlier symptoms were present in six cases; according to the paper, Wakefield is at least 20% of a liar.
The accusations regarding the intestinal disorders alleged in the Lancet article are even more damning. Wakefield and his colleagues reported that colonoscopy findings for 11 of the 12 children showed abnormalities. The Sunday Times reports that in at least seven of these cases, the hospital's initial pathology reports showed no abnormalities, and that these findings were changed after Wakefield's team undertook a "research review" of the results.
In the Lancet article, Wakefield and his colleagues do not mention any initial disagreement about the pathology reports. Instead, they talk about "the uniformity of the intestinal pathological changes" and refer to "consistent gastrointestinal findings".
Wakefield also described his patients as a "self-referred group". According to the Sunday Times, this is also untrue:
The mothers of Child Two and Child Three told me what others said in medical records: they had heard of Wakefield through the MMR vaccine campaign, Jabs. Thus, when they arrived on Malcolm ward, and produced the "finding" about MMR, it was by no means a random sample of cases.
What parents did not know was that, two years before, Wakefield had been hired by Jabs's lawyer, Richard Barr, a high-street solicitor in King's Lynn, Norfolk. Barr had obtained legal aid to probe MMR for any evidence that could be used against the manufacturers. He is adamant that at all times he acted professionally, and diligently represented his clients.
That's not a self-referred group that might be biased. That's a carefully and non-randomly selected group with a very clear built-in bias.
Over the last several years, the Sunday Times has published a series of articles detailing a number of undisclosed financial conflicts of interest involving Wakefield and this paper. The conflicts include almost half a million pounds Wakefield collected as a result of his MMR work, in addition to the funds that were used for his research. The new report includes another massive conflict of interest bombshell:
In June 1996 - the month before Child One's arrival at the hospital - Wakefield and Barr filed a confidential document with the government's Legal Aid Board, appearing already to know of a "new syndrome".
Referring to inflammatory bowel disease, and then bowel problems with autism, Wakefield and Barr wrote to the board, successfully seeking money.
"The objective," they wrote, "is to seek evidence which will be acceptable in a court of law of the causative connection between either the mumps, measles and rubella vaccine or the measles/rubella vaccine and certain conditions which have been reported with considerable frequency by families who are seeking compensation."
Needless to say, Wakefield did not mention his work with or funding from the Legal Aid Board when he submitted his article to the Lancet.
Taken individually, it's possible - if only barely - that any one of these things could be an innocent mistake. However, the combination of all these circumstances - the failure to report the prior developmental symptoms, the failure to report the initial negative pathology findings, the failure to report the Legal Aid conflict of interest, and the document that described the existence of the syndrome to Legal Aid prior to the commencement of the research project - cannot reasonably be explained away so easily. Simply put, this is a pattern that is very strongly suggestive of outright fraud, with possible associated financial gain.
Even if deliberate fraud did not take place, the accusations - if even a quarter are true - represent gross research malpractice of an extent that's rarely seen in the history of science.
Whether the result of malpractice or misconduct, the consequences of this research have had devastating effects. After the publication of the article, and the publicity that ensued as a result of both the article and Wakefield's press conference, vaccination rates plummeted sharply, because parents were too frightened of the possible side effects to vaccinate their children. Predictably, measles rates shot through the roof, and in 2006 the UK saw its first measles fatality in over a decade.
Wakefield has done far more than his share to stir up and maintain the anti-vaccination hysteria. I suspect (although I'm not a lawyer) that it's unlikely that there's any way he can be held legally accountable for the drop in vaccinations, climb in measles rates, or any resultant fatalities. But there is no doubt in my mind that if the accusations are remotely true, if Wakefield committed either gross malpractice or outright fraud, there is blood on his hands.
Sadly, as Phil Plait already pointed out, it's not likely that these latest revelations about Wakefield's research practices will have any effect on most of the MMR causes autism proponents. Simply put, their belief in the perils of vaccination has reached almost religious levels. The existence of a large number of (better) studies that fail to demonstrate a link have not dissuaded them, and it's unlikely that a revelation that the one article that supports their beliefs is fraudulent will change their minds.
As you may know, the MMR/autism issue is one that's received a lot of attention here at ScienceBlogs over the years. If you are interested in learning more about measles, autism, or the manufactured relationship between vaccines and autism, I'd suggest that you look at a few of these posts:
At The ScienceBlogs Book Club:
A review of Autism's False Prophets
At Respectful Insolence:
Thanks, Andrew Wakefield
Recall bias, vaccines, and illness
Antivaccinationists on the measles outbreak: The stupid, it burns thermonuclear
The Autism Omnibus: The difference between real scientists and crank scientists
Two more cases of scientific misconduct
At Effect Measure:
The Science-Based Medicine blog has also done a number of very good posts on the issue.
The posts I've linked represent only a fraction of the information that's available here. A little bit of time spent using the search box on the ScienceBlogs homepage will turn up literally hundreds of posts on the topic. That's because measles is a real disease, that can have real and serious consequences, and it's a real damn shame (if not a real crime) that morons like Wakefield have been doing so much to hurt public health in so many places, with so few consequences.
A WAKEFIELD, S MURCH, A ANTHONY, J LINNELL, D CASSON, M MALIK, M BERELOWITZ, A DHILLON, M THOMSON, P HARVEY (1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children The Lancet, 351 (9103), 637-641 DOI: 10.1016/S0140-6736(97)11096-0