In 1998 Andrew Wakefield and 11 other co-authors published a study with the unremarkable title: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Such a title would hardly grab a science journalist’s attention, but the small study sparked widespread hysteria about a possible connection between the mumps-measles-rubella (MMR) vaccine and autism spectrum disorder (ASD).
The study itself has not stood the test of time. The results could not be replicated by other labs. A decade of subsequent research has sufficiently cleared the MMR vaccine of any connection to ASD. The lab used to search for measles virus in the guts of the study subjects has been shown to have used flawed techniques, resulting in false positives (from the Autism Omnibus testimony, and here is a quick summary). There does not appear to be any association between autism and a GI disorder.
But it’s OK to be wrong in science. There is no expectation that every potential finding will turn out to be true – in fact it is expected that most new finding will eventually be found to be false. That’s the nature of investigating the unknown. No harm no foul.
Andrew Wakefield, however, was apparently guilty of more than just getting it wrong, or even of being a sloppy scientist. He has been the subject of an ethics investigation by the General Medical Council who recently concluded that:
The General Medical Council ruled he had acted “dishonestly and irresponsibly” in doing his research.
David Gorski has the full report on the GMC ruling, which I will not repeat.
What is also at issue, however, is the integrity of the published peer-reviewed medical research. Again – there is not the expectation that peer-reviewed research will always get the answer right. In fact, the published research stands as an important record of error – the blind alleys, red herrings, false correlations, and erroneous conclusions that are part of the history of science.
However, error should not include scientific fraud, or science that is thoroughly misrepresented. One aspect of the transparency demanded by science, and increasingly an issue, is disclosure of potential conflicts of interest. This is the issue that first got Wakefield in hot water with the Lancet – the journal that published his original research. Wakefield was being paid as an expert by lawyers who were suing over alleged vaccine injury. In fact some of the children in the study were the children of parents who were suing. This is a massive conflict of interest.
When this came to light the Lancet responded by contacting the co-authors of the article and essentially asking them if they still stand by the results of the study. Ten of the original 12 authors of the study retracted their support for the study and its interpretation. In 2004 the Lancet published a retraction. However, it was only a partial retraction, and the study remained as part of the published literature.
In the wake of the GMC ruling, however, the Lancet has once again reviewed the study and concluded that there is now sufficient evidence of wrongdoing on Wakefield’s part to print a full retraction. Here is the entire text of the article:
Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.
This should be the final nail in the coffin of this controversial and harmful study. Coming 12 years after the original paper, after just about every element of the research and its findings have been refuted, the Lancet retraction almost seems unecessary. But it is necessary and important. As the retraction indicates – it removes this dubious research from the published record.
While we can all celebrate this move, I also believe it highlights the need for scientific journals to have a lower threshold in retracting published studies that are found to be fraudulent, or are so flawed either ethically or scientifically that they should never have been published in the first place.
The process of editorial and peer-review is not perfect, and given the number of papers that are published there is no way to keep dubious, even fraudulent, research from slipping past the goalies. But peer-review does not stop when a paper is published – in fact that is when it begins in earnest. So it is common for serious problems with a paper to be discovered only after they are published. When this happens, the journal editors should be willing to admit error and correct their mistakes.
An example of the importance of correcting the published record is the Cha/Wirth/Lobo study conducted at Columbia University and published in the Journal of Reproductive Medicine in 2001. The study alleged to find that intercessory Christian prayer doubled the success of in-vitro fertilization. However, Rogerio Lobo, presented as the lead author, later acknowledged that he had nothing to do with the conduction of the study. His name was removed from the authors list in 2004.
But much worse than that, Daniel Wirth, who is not an MD and is not affiliated with Columbia University and who seems to be most responsible for the study results, was indicted by a federal grand jury and pleaded guilty to conspiracy to commit fraud. (See this excellent article by Bruce Flamm for all the details.) Essentially this study was conducted by a paranormal researcher with the resume of a con-artist.
And yet, the Journal of Reproductive Medicine has refused to admit error and retract the paper. It remains listed on PubMed, without any hint that the study has been seriously called into question.
They have published a clarification by the third author, Kwang Cha, who is digging in and defending the paper, writing:
This deliberate design constraint made it impossible for Mr. Wirth to have played any role in manipulating or altering the data.
I find it very difficult to believe that manipulation was “impossible.” I think Dr. Cha overestimates the ability to protect against deliberate fraud, and underestimates the cleverness of those who choose to commit fraud. Cha would have us believe that it is more likely he proved the efficacy of a miraculous intervention than that someone guilty of fraud may have committed fraud.
While this study has been scientifically discredited, it remains part of the published record and continues to be cited by supporters of the efficacy of prayer.
I applaud the Lancet for finally retracting the Wakefield study and removing it from the published record. It should not, however, have taken this long.