Perspective

Wakefield study linking MMR vaccine, autism uncovered as complete fraud

In 1998, a study appeared in The Lancet claiming that measles-mumps-rubella vaccine caused autism in 12 children. The study stirred fear and controversy among parents and physicians and caused a ripple effect that remains even now — nearly a year after the study was retracted.

A new report released in the British Medical Journal, titled “Secrets of the MMR scare: How the case against the MMR vaccine was fixed,” has revealed that the original Wakefield study was not only conducted “dishonestly” and “irresponsibly,” as stated in the retraction in February 2010, but that the data are “bogus.”

“Clear evidence of falsification of data should now close the door on this damaging vaccine scare,” the editors of BMJ said about the 1998 Wakefield study published in The Lancet.

In the first part of a special BMJ series, journalist Brian Deer exposes the erroneous data behind claims that launched a global fear over MMR. This report also reveals how the appearance of a link with autism was manufactured at a London medical school, according to the BMJ.

The series of articles written by Deer intend to show the extent of fraud by Andrew Wakefield, MB, BS, and how it was perpetrated. He draws on interviews, documents and data made public at the General Medical Council (GMC) hearings and shows how Wakefield altered numerous facts about the patients’ medical histories to support his claim of having discovered a new syndrome. The series is also expected to provide evidence of how Wakefield’s 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,” the BMJ report said.

The 1998 study was a case series of 12 child patients that reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event,” the researchers wrote.

However, the truth is that three of nine children reported with regressive autism did not receive an autism diagnosis. Only one child clearly had regressive autism. In addition, five children had documented pre-existing developmental concerns, despite that the study reported that all 12 children were “previously normal.”

Deer’s investigation also uncovered truths about additional claims made in the original study:

  • Some children were reported to have experienced first behavioral 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 “nonspecific colitis.”
  • The parents of eight children were reported as blaming MMR as the cause of their child’s autism, 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.

As highlighted in the editorial that accompanied the Deer report, the study by Wakefield and 12 others had obvious scientific limitations when it was published in 1998. As the ensuing vaccine scare grew, critics quickly voiced concerns that the paper was a small case series with no controls, linked three common conditions, and relied on parental recall and beliefs. During the next 10 years, epidemiological studies consistently found no evidence of a link between the MMR vaccine and autism. Then, “after forensic dissection at the GMC’s longest ever fitness to practice hearing, few people could deny that it was fatally flawed both scientifically and ethically,” the researchers wrote.

“But it has taken the diligent skepticism of one man, standing outside medicine and science, to show that the paper was in fact an elaborate fraud,” the editorial authors said of Deer.

They said not only has this resulted in the obvious effects (eg, unvaccinated children), but “energy, emotion, and money that have been diverted away from efforts to understand the real causes of autism and how to help children and families who live with it.”

There are lessons to be learned for many, according to the investigators. First is the issue of Wakefield’s co-authors. The GMC panel was clear that Wakefield solely wrote the final version of the paper, but his co-authors appear to have been clueless to what he was doing under the cover of their names and reputations.

Secondly, “research ethics committees should not only scrutinize proposals but have systems to check that what is done is what was permitted (with an audit trail for any changes) and work to a governance procedure that can impose sanctions where an eventual publication proves this was not the case. Finally, there are lessons for the Royal Free Hospital, The Lancet, and the wider scientific community,” the authors of the editorial wrote.

Disclosures: Deer’s investigation was funded by the Sunday Times of London and the Channel 4 television network. Reports by Deer in the BMJ were commissioned and paid for by BMJ. No other funding was received, apart from legal costs paid to Deer by the Medical Protection Society on behalf of Andrew Wakefield. Deer reports no relevant financial disclosures.

For more information:

  • Deer B. BMJ. 2011;342:c5347.
  • Godlee F. BMJ. 2011;342:c7452.
  • Lancet. 2010;375:445.

PERSPECTIVE

It has long been known that Wakefield's paper was weak, ever since publication. When retracted on ethical grounds it became known that it was even more obviously biased than previously thought. Now it is clearly fraudulent. As a practicing general pediatrician, I do not even want to think of the countless hours I have spent with families discussing the MMR vaccine. Or more importantly the anguish this fantasy has put all families through as they have navigated childhood vaccines with their children. Vaccine safety, efficacy and value are legitimate discussion points in all our practices. I believe strongly that childhood vaccines have been and remain the single most important health preventative measure I provide in practice. The added burden of the fallout of this paper is immeasurable, and I doubt we have seen the end of it by any means. It is striking that while some consider "big pharma" to be an evil force in health care, the interest groups behind vaccine bashing are not subjected to enough, and certainly not equal scrutiny. They constitute an industry and clearly, as is the case with Wakefield, they have profit motives of their own. We must take this opportunity to make it clear to the American public that vaccines are truly safe and effective.

—William T. Gerson
Infectious Diseases in Children Editorial Board member

PERSPECTIVE

The BMJ editorial attached the hypothesis to the man and the man was fraudulent. The hypothesis was not to be trusted because the man was fraudulent. But the man should be separate from the hypothesis. It doesn't matter whether Andrew Wakefield was fraudulent and wrong, the only thing that matters is that the hypothesis was wrong. Either way, the damage would have been done. Because of this paper, four children died. I think it could be argued that this paper killed four children. There are a lot of people with dirty hands … the editor of the journal, the media that followed the story ravenously, etc., even though there was scant evidence. A lot of people are responsible and none of them will be held accountable, which is unfortunate. Until we have a clear cause for autism, this controversy will continue.

—Paul A. Offit, MD
Infectious Diseases in Children Editorial Board member

Disclosure: Dr. Offit reports no relevant financial disclosures.

Twitter Follow the PediatricSuperSite.com on Twitter.

In 1998, a study appeared in The Lancet claiming that measles-mumps-rubella vaccine caused autism in 12 children. The study stirred fear and controversy among parents and physicians and caused a ripple effect that remains even now — nearly a year after the study was retracted.

A new report released in the British Medical Journal, titled “Secrets of the MMR scare: How the case against the MMR vaccine was fixed,” has revealed that the original Wakefield study was not only conducted “dishonestly” and “irresponsibly,” as stated in the retraction in February 2010, but that the data are “bogus.”

“Clear evidence of falsification of data should now close the door on this damaging vaccine scare,” the editors of BMJ said about the 1998 Wakefield study published in The Lancet.

In the first part of a special BMJ series, journalist Brian Deer exposes the erroneous data behind claims that launched a global fear over MMR. This report also reveals how the appearance of a link with autism was manufactured at a London medical school, according to the BMJ.

The series of articles written by Deer intend to show the extent of fraud by Andrew Wakefield, MB, BS, and how it was perpetrated. He draws on interviews, documents and data made public at the General Medical Council (GMC) hearings and shows how Wakefield altered numerous facts about the patients’ medical histories to support his claim of having discovered a new syndrome. The series is also expected to provide evidence of how Wakefield’s 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,” the BMJ report said.

The 1998 study was a case series of 12 child patients that reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event,” the researchers wrote.

However, the truth is that three of nine children reported with regressive autism did not receive an autism diagnosis. Only one child clearly had regressive autism. In addition, five children had documented pre-existing developmental concerns, despite that the study reported that all 12 children were “previously normal.”

Deer’s investigation also uncovered truths about additional claims made in the original study:

  • Some children were reported to have experienced first behavioral 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 “nonspecific colitis.”
  • The parents of eight children were reported as blaming MMR as the cause of their child’s autism, 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.

As highlighted in the editorial that accompanied the Deer report, the study by Wakefield and 12 others had obvious scientific limitations when it was published in 1998. As the ensuing vaccine scare grew, critics quickly voiced concerns that the paper was a small case series with no controls, linked three common conditions, and relied on parental recall and beliefs. During the next 10 years, epidemiological studies consistently found no evidence of a link between the MMR vaccine and autism. Then, “after forensic dissection at the GMC’s longest ever fitness to practice hearing, few people could deny that it was fatally flawed both scientifically and ethically,” the researchers wrote.

“But it has taken the diligent skepticism of one man, standing outside medicine and science, to show that the paper was in fact an elaborate fraud,” the editorial authors said of Deer.

They said not only has this resulted in the obvious effects (eg, unvaccinated children), but “energy, emotion, and money that have been diverted away from efforts to understand the real causes of autism and how to help children and families who live with it.”

There are lessons to be learned for many, according to the investigators. First is the issue of Wakefield’s co-authors. The GMC panel was clear that Wakefield solely wrote the final version of the paper, but his co-authors appear to have been clueless to what he was doing under the cover of their names and reputations.

Secondly, “research ethics committees should not only scrutinize proposals but have systems to check that what is done is what was permitted (with an audit trail for any changes) and work to a governance procedure that can impose sanctions where an eventual publication proves this was not the case. Finally, there are lessons for the Royal Free Hospital, The Lancet, and the wider scientific community,” the authors of the editorial wrote.

Disclosures: Deer’s investigation was funded by the Sunday Times of London and the Channel 4 television network. Reports by Deer in the BMJ were commissioned and paid for by BMJ. No other funding was received, apart from legal costs paid to Deer by the Medical Protection Society on behalf of Andrew Wakefield. Deer reports no relevant financial disclosures.

For more information:

  • Deer B. BMJ. 2011;342:c5347.
  • Godlee F. BMJ. 2011;342:c7452.
  • Lancet. 2010;375:445.

PERSPECTIVE

It has long been known that Wakefield's paper was weak, ever since publication. When retracted on ethical grounds it became known that it was even more obviously biased than previously thought. Now it is clearly fraudulent. As a practicing general pediatrician, I do not even want to think of the countless hours I have spent with families discussing the MMR vaccine. Or more importantly the anguish this fantasy has put all families through as they have navigated childhood vaccines with their children. Vaccine safety, efficacy and value are legitimate discussion points in all our practices. I believe strongly that childhood vaccines have been and remain the single most important health preventative measure I provide in practice. The added burden of the fallout of this paper is immeasurable, and I doubt we have seen the end of it by any means. It is striking that while some consider "big pharma" to be an evil force in health care, the interest groups behind vaccine bashing are not subjected to enough, and certainly not equal scrutiny. They constitute an industry and clearly, as is the case with Wakefield, they have profit motives of their own. We must take this opportunity to make it clear to the American public that vaccines are truly safe and effective.

—William T. Gerson
Infectious Diseases in Children Editorial Board member

PERSPECTIVE

The BMJ editorial attached the hypothesis to the man and the man was fraudulent. The hypothesis was not to be trusted because the man was fraudulent. But the man should be separate from the hypothesis. It doesn't matter whether Andrew Wakefield was fraudulent and wrong, the only thing that matters is that the hypothesis was wrong. Either way, the damage would have been done. Because of this paper, four children died. I think it could be argued that this paper killed four children. There are a lot of people with dirty hands … the editor of the journal, the media that followed the story ravenously, etc., even though there was scant evidence. A lot of people are responsible and none of them will be held accountable, which is unfortunate. Until we have a clear cause for autism, this controversy will continue.

—Paul A. Offit, MD
Infectious Diseases in Children Editorial Board member

Disclosure: Dr. Offit reports no relevant financial disclosures.

Twitter Follow the PediatricSuperSite.com on Twitter.