Did Andrew Wakefield Fake Data in His MMR/Autism Study?

Times UK writer Brian Deer recently charged that Andrew Wakefield — coauthor of a 1998 study published in The Lancet that set off the firestorm over whether or not the MMR vaccine contributed to autism — faked the data used in that study. According to Deer’s report,

The research was published in February 1998 in an article in The Lancet medical journal. It claimed that the families of eight out of 12 children attending a routine clinic at the hospital had blamed MMR for their autism, and said that problems came on within days of the jab. The team also claimed to have discovered a new inflammatory bowel disease underlying the children’s conditions.

However, our investigation, confirmed by evidence presented to the General Medical Council (GMC), reveals that: In most of the 12 cases, the children’s ailments as described in The Lancet were different from their hospital and GP records. Although the research paper claimed that problems came on within days of the jab, in only one case did medical records suggest this was true, and in many of the cases medical concerns had been raised before the children were vaccinated. Hospital pathologists, looking for inflammatory bowel disease, reported in the majority of cases that the gut was normal. This was then reviewed and the Lancet paper showed them as abnormal.

Wakefield is currently the subject of a disciplinary hearing by the UK’s General Medical Council. He stands by his research and in an article for the Times is dismissive of the claim that he is in any way responsible for the drastic drop in vaccinations in some parts of the UK and the United States,

Dr Wakefield denies the charges, but hanging on the wall near his office in Thoughtful House is a poster spelling out the “Wakefield Hypothesis”, which stemmed from the contested research.

“The suggestion that parents should have the option of single vaccines was based on a review of all of the safety studies that were conducted on all of the vaccines from the single vaccine through to the MMR,” he said. “It was not based upon a case report of 12 children with a possible new syndrome. This was made explicit in a communication to my colleagues in advance of the press briefing. Based upon my review of the literature, the safety studies were totally inadequate.”

Dr Wakefield claims no responsiblity for the fact that one in four children still does not receive the recommended two doses of MMR, adding: “The reemergence of measles is not the consequence of a hypothesis. We did not cause a scare. We responded to parents’ legitimate concerns. They were uncertain about the vaccine. We responded to that, as we should have done, and did, in a professional and ethical manner. Not to have done so would have been negligent.”

This from the man still pushing autistic enterocolitis as a legitimate diagnosis.

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Anti-Vaccine Hysteria Grips Nigeria

The World Health Organization’s goal of eradicating polio worldwide by 2005 ran into a major obstacle in October 2003 when three Nigerian states suspended polio vaccination over fears that the vaccine could cause AIDS, cancer and infertility.

The largely-Muslim northern states of Kaduna, Kano and Zamfra ordered a stop to a WHO-sponsored vaccination program. Reuters quoted Dr. Datti Ahmed, president of Nigeria’s Supreme Council for Sharia Law, as saying,

A lot of documents have come into our possession indicating there are grave doubts and concerns about the safety of the oral polio vaccine being used in Nigeria. We therefore called on the authorities to suspend the immunization program and investigate these fears.

WHO representatives dismissed such objections saying the polio vaccine was safe.

Unfortunately, Nigeria is one of only 7 countries where the disease is still prevalent and many children there are not vaccinated. Authorities worry that the disease could expand from Nigeria into surrounding countries. According to WHO representative Dr. David Heymann,

In some parts of Nigeria, only 13 percent of children have been vaccinated, largely because of the fears about it that have been disseminated. Nigeria is now exporting the disease. It has already cost Nigeria’s five neighbors $13 million to launch their own campaigns against it and that could go up to $20 million if it is confirmed that Chad has cases.

The government set up a group to test the polio virus, but that group dealt another setback to the polio eradication in January when it issued results claiming it found high levels of estrogen in the polio vaccine which would render those who received the vaccine infertile.

Both the WHO and the Nigerian state dismissed these claims, but WHO’s efforts to vaccinate children in Nigeria appears to have been severely set back which bodes ill both for the children there who are unnecessarily exposed to the risk of contracting polio as well as neighboring states and the rest of the world that would like to see polio eradicated.

Source:

Health experts losing battle to promote polio vaccine in Nigeria. AFP, Friday January 9, 2004.

Nigeria orders polio vaccine tests. Associated Press, October 29, 2003.

Nigeria debates polio campaign. Anna Borzello, The BBC, December 22, 2003.

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Is MMR Associated With an Increase in Neurological Disorders?

Well, here comes the latest round in the MMR vaccine hysteria. A study published in International Pediatrics reports that the MMR vaccine is associated with an increase in neurological disorders. But the study falls apart like tissue paper upon closer examination.

The primary problem with the study is its very design. The study compared estimates of adverse reactions among children after they were given MMR to adverse reactions after the administration of the DTP shot. But the problem here should be obvious — the MMR is given significantly later in life, so of course more children will be diagnosed with neurological disorders after receiving the MMR than the DTP.

Specifically, the DTP is given at 2, 4 and 6 months of age, whereas the MMR is typically given somewhere in the 15-18th month of life. As Dr. Mary Ramsay of the UK’s Health Protection Agency told the BBC,

The authors have estimated the rate of reported adverse reactions following MMR (given at 15-18 months of age) and compared this to the estimated rates of the same conditions reported following DTP vaccination (given at 2, 4 and 6 months) of age.

Regardless of the other weaknesses of the data, the failure to compare children of the same age is enough to explain the apparent excess of cases reported in the MMR group.

Meanwhile, the BBC reports that in 2002 there were 310 cases of measles in the UK — the most in a single year since the 1988 introduction of the MMR vaccine, so the vaccine hysteria is accomplishing something at least.

Source:

Concern over MMR safety study. The BBC, May 19, 2003.

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Activists Want Ban on DTP Shot

Campaigners in Great Britain have called for a ban on the diptheria, tetanus and pertusis or whipping cough vaccine. The vaccine is usually given to infants in the second month of life.

Although there is no evidence linking the DTP vaccine to any ill health effects, Action Against Autism urged the British government to ban the vaccine because it uses thiomersal as a preservative. Thiomersal contains small amounts of mercury which some groups have claimed contribute to or cause autism.

The British Department of Health responded to the suggested ban by saying,

All vaccines are tested for their safety and efficacy. Recent reviews by the Committee on the Safety of Medicines and the US Institute of Medicine found no evidence of any effect of low doses of thiomersal on childhood development.

British Prime Minister Tony Blair also publicly rejected banning the DTP vaccine, saying there was no evidence that it was unsafe.

Source:

Fresh fears over child vaccines. The BBC, January 14, 2003.

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Is MMR Hysteria Behind Increase in Ireland’s Measles Cases?

Public health officials in Ireland are blaming anti-measles, mumps and rubella vaccine hysteria for causing an increase in the number of measles cases there.

The MMR vaccination rate has fallen to just 72 percent nationwide in Ireland, and is at only 63 percent in Dublin. To be assured of controlling measles, mumps and rubella, the vaccination rate needs to be 95 percent.

Over a six week period in December and January when 30 cases of measles would normally be seen, 100 cases of the disease were reported. In the following two weeks, another 100 cases were reported.

Ireland last saw a measles epidemic in 2000 when 1,630 children came down with the disease and three died. In the United States, by contrast, only a few cases of the disease are reported annually and most of those cases are contracted by foreigners visiting the country.

Physician Dr. Maurice Gueret disputed the MMR hysteria link, telling the New York Times that the problem “goes back generations; we’ve always had an appalling vaccination rate in Ireland” owing to a substandard health care system and poor tracking of which children have been vaccinated.

Whatever the root cause, Ireland’s example highlights the importance of maintaining high vaccination rates.

Source:

As vaccination rates decline in Ireland, cases of measles soar. Brian Lavery, The New York Times, February 7, 2003.

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Is the Focus on MMR Hurting Autism Research?

Autism researcher Christopher Gillberg last week told the BBC that there is little to no evidence that the measles, mumps and rubella vaccine is linked to autism, and more importantly that the intense focus on such a link is detracting from more promising avenues of autism research.

Gillberg, a professor of child and adolescent psychology at George’s Medical School in London, has prepared a review of 40 studies looking into the causes of autism. His conclusion is that it is earlier diagnosis and better awareness of autism that is leading to the increase in cases.

Gillberg notes that today, children are often diagnosed as autistic when they are just 18-24 months old thanks to awareness of the symptoms of autism as well as changes in the way that babies are observed.

Gillberg told the BBC,

I think this whole MMR business has taken on proportions that have hampered research in autism. People are concentrating so much on disputing this or finding or finding that in relation to MMR, when there has never been any strong evidence that this would be a road we should be travelling.

And, Gillbert pointed out, this is hardly the first time that intense media focus has forced autism researchers down a blind alley.

A few years ago all of the rage was facilitated communication which supposedly allowed nonverbal autistic children to communicate. Facilitated communication, according to the American Psychological Association,

. . . is a process by which a facilitator supports the hand or arm of a communicatively impaired individual while using a keyboard or typing device. It has been claimed that this process enables persons with autism or mental retardation to communicate.

Researchers conducted numerous scientific evaluations of facilitated communication which, in the end, concluded that the practice “is not a scientifically valid technique for individuals with autism or mental retardation.” The information supposedly coming from the autistic patient was, in fact, actually communicated from the facilitator, either consciously or unconsciously.

Facilitated communication had an extremely dark side — facilitators began interpreting communications from autistic children as reporting sexual abuse accusations. As Gina Green summed up these cases in The Skeptic,

Beliefs about FC, the complexities inherent in the method, and the fact that the alleged victim may be seen as particularly vulnerable because he or she is disabled, now began to interact with the zealous pursuit that seems to typify investigations of sex abuse allegations. School or program administrators were notified, who in turn called in representatives of social services and law enforcement agencies. If the accused was a family member with whom the FC user resided, that person was either required to leave the home or the FC user was placed in foster care. If a parent was accused, both parents often faced criminal charges, one for perpetrating the alleged abuse, the other for knowing about it and failing to act. Often actions were initiated by social service workers to terminate parental custody or guardianship. If the accused was a school or program employee, they may have been suspended from their job or even fired. A long and trying ordeal was virtually guaranteed for all involved. An investigation began. Police interrogated the accused, and questioned the alleged victim through their facilitator. Other evidence was sought in the results of medical and psychological examinations of the alleged victim, and interviews with others who may have had information about the alleged events. A presumably independent facilitator was sometimes called in to try to corroborate the allegation, introducing another complexity: There appear to be no established safeguards or objective criteria for ensuring that independent facilitators in fact have no access to information about cases, nor for deciding what constitutes corroborating “facilitated” content.

Unfortunately it was only after numerous children had been placed in foster homes and parents charged with sexual abuse that medical authorities started paying serious attention to facilitated communication and ended up debunking it.

Sources:

MMR row ‘hampers autism research’. The BBC, September 6, 2002.

Facilitated Communication: Mental Miracle Or Sleight Of Hand? Gina Green, The Skeptic, vol. 2, no. 3, 1994, pp. 68-76.

Resolution on Facilitated Communication by the American Psychological Association. American Psychological Association, August 14, 1994.

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Fresh Debate Over MMR Vaccine

American researcher Vijendra Singh fired off a new round of debate over the measles, mumps and rubella (MMR) vaccine earlier this month with a new study claiming that he found an unusual MMR antibody in 75 children who had autism. Singh claimed that he did not find this antibody in the 92 control children who did not have autism.

Singh argues that autism is an autoimmune disorder that attacks the myelin sheath that protects nerve fibers in the brain.

Singh’s study, published in the Journal of Biomedical Science, was criticized by British doctors for making claims that his data do not justify. Great Britain’s Public Health Laboratory Service issued a statement saying,

This claim by the authors that they have identified abnormal measles-mumps-rubella antibodies in autistic children is not substantiated by the data in the paper. No abnormal virus-specific antibodies have been demonstrated. The data that they show as evidence that this component is one particular antigen of the measles virus is not credible.

It might not be credible to British doctors, but British citizens are finding the anti-MMR hype convincing. According to the BBC, from December 2001 to March 2002, the level of MMR vaccination fell from 76 percent to 70 percent, but did recover slightly by April to 72 percent. That low level of vaccination increases the risk of a general measles outbreak in Great Britain.

Sources:

Experts reject latest MMR research. The BBC, August 9, 2002.

New study suggests MMR link with autism. Sarah Boseley, The Guardian, August 9, 2002.

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London Mayor Offers Ridiculous Anti-MMR Argument

London Mayor Ken Livingstone recently announced that he would not allow his child to have the MMR vaccine and advised parents not to do so either. Livingstone based his recommendations on the fact that infants are fragile and money is not an issue in health care provision.

Livingstone’s deep analysis of the safety of the vaccine went something like this,

It seems to me that a child of those months, just 14 months is incredibly vulnerable. I remember having all these jabs separately — often you had quite a severe reaction. Why whack them all into a child at the same time?

Great Britain could probably save a lot of time and money by ditching medical research into vaccine safety and efficacy and instead simply relying on Livingstone’s impressions and recollections of his own childhood.

Livingstone also claimed that the MMR was done largely for monetary reasons saying,

It’s a question of huge savings of time and money and in no way would I inflict on a child that risk.

This is the dumbest thing anyone has yet said about the MMR vaccine. In case Livingstone has not noticed, Great Britain’s National Health System is already among the worst in Europe and is severely constrained by funding problems. For Livingstone to pretend that increasing the cost of vaccination is a trivial matter is absurd. Does Livingstone himself plan to pay the extra expense?

Source:

London mayor warns against MMR. The BBC, July 2, 2002.

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British Review Finds MMR Dangerous — To Measles Virus

A British review of research into the MMR vaccine from 180 countries has found that the vaccine is in fact dangerous — at least to the measles virus. In humans, though, it is safe.

Dr. Anna Donald and Dr. Vivek Muthu could find no evidence of any link between MMR and autism or bowel disease. They did find that children were likely to develop a minor fever up to 3 weeks after the vaccination as well as finding strong evidence that the MMR vaccine had been instrumental in wiping out measles throughout most of the world.

Donald and Muthu also criticized the research of Dr. Andrew Wakefield — who started the anti-MMR hysteria in 1998 — buy pointing out that his research relied on examining just 12 ill children and not using any healthy controls.

Source:

‘No evidence’ MMR jab is unsafe. The BBC, June 12, 2002.

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Government Officials Charge That MMR Researcher Refuses to Allow Claims to Be Verified

Dr. Andrew Wakefield kicked off anti-vaccine hysteria in Great Britain with his claim that he found measles in the gut of children who never contracted the disease. Wakefield and collaborator John O’Leary just last week announced that they had found the strain of measles used in the MMR vaccine in the gut of children.

The problem is that Great Britain’s Department of Health claims Wakefield has not cooperated in efforts to verify his results. Dr. David Salisbury, who heads up the immunization division of the Department of Health, told the BBC that his department asked Wakefield four months ago for tissue samples that Wakefield used in his studies in order to try to reproduce the results. So far, there has been no answer from Wakefield.

Salisbury told the BBC,

We can speculate forever about what it [Wakefield's finding] might mean — but what we need is a better understanding what has been done and how it has been done.

. . .

Four months on we still don’t have an answer to the questions that we posed — and these questions are crucial.

Replication of findings is crucial in scientific research, and unless Wakefield is willing to come clean in order to allow others to attempt to replicate his work, then it is of dubious value at best.

Source:

MMR researcher attacked. The BBC, June 17, 2002.

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