1 Feb 2011

Study linking autism to vaccines was elaborate fraud that led to outbreaks of disease and endangered lives of children

Canada.com - January 6, 2011

Autism-vaccine study was 'fraud,' journal says


PARIS - A 1998 study that unleashed a major health scare by linking childhood autism to a triple vaccine was "an elaborate fraud," the British Medical Journal (BMJ) charged Thursday.

Blamed for a disastrous boycott of the measles, mumps and rubella (MMR) vaccine in Britain, the study was retracted by The Lancet last year and its senior author disgraced, after the country's longest-running hearing, for conflict of interest and unethical treatment of patients.

But the BMJ, taking the affair further, on Thursday branded the paper a crafted attempt to deceive, among the gravest of charges in medical research.

"The paper was in fact an elaborate fraud," the BMJ said in an editorial, adding: "There are hard lessons for many in this highly damaging saga."

It pointed the finger at lead author Andrew Wakefield, then a consultant in experimental gastro-enterology at London's Royal Free Hospital.

Wakefield and his team suggested they had found a "new syndrome" of autism and bowel disease among 12 children.

They linked it to the MMR vaccine, which they said had been administered to eight of the youngsters shortly before the symptoms emerged.

Other scientists swiftly cautioned the study was only among a tiny group, without a comparative "control" sample, and the dating of when symptoms surfaced was based on parental recall, which is notoriously unreliable. Its results have never been replicated.

But the controversy unleashed a widespread parental boycott of the jab in Britain, and unease reverberated also in the United States, Canada, Australia and New Zealand.

Hundreds of thousands of children in Britain are now unshielded against these three diseases, said the BMJ. In 2008, measles was declared endemic, or present in the wider population much like chicken pox, in England and Wales.

Wakefield was barred from medical practice last year on grounds of conflict of financial interest and unethical treatment of some children involved in the research.

The BMJ, delving into the accuracy of the study as opposed to its ethics, said Sunday Times investigative journalist Brian Deer had "unearthed clear evidence of falsification."

Not one of the 12 cases, as reported in the study, tallied fully with the children's official medical records, it charged.

Some diagnoses had been misrepresented and dates faked in order to draw a convenient link with the MMR jab, it said.

Of nine children described by Wakefield as having "regressive autism," only one clearly had this condition and three were not even diagnosed with autism at all, it said.

The findings had been skewed in advance, as the patients had been recruited via campaigners opposed to the MMR vaccine, the journal added.

And, said the BMJ, Wakefield had been confidentially paid hundreds of thousands of pounds (dollars, euros) through a law firm under plans to launch "class action" litigation against the vaccine.

Deer, in a separate piece published by the BMJ, compared the scandal with the "Piltdown Man" hoax of 1953, when a supposed fossil of a creature half-man, half-ape turned out to be a fake.

The Wakefield study "was a fraud, moreover, of more than academic vanity. It unleashed fear, parental guilt, costly government intervention and outbreaks of infectious disease," he said.

Wakefield, who still retains a vocal band of supporters, has reportedly left Britain to work in the United States.

Wakefield and his publishing agent did not respond to calls and emails from AFP requesting comment.

Wakefield has previously accused Britain's General Medical Council (GMC) of seeking to "discredit and silence" him and shield the British government from responsibility in what he calls a "scandal."

The Lancet told AFP it would not comment on the BMJ accusations.

Autism is the term for an array of conditions ranging from poor social interaction to repetitive behaviours and entrenched silence. The condition is rare, predominantly affecting boys, although its causes are fiercely debated.

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CNN - January 6, 2011

Medical journal: Study linking autism, vaccines is 'elaborate fraud'

By the CNN Wire Staff

A now-retracted British study that linked autism to childhood vaccines is an "elaborate fraud," according to a medical journal -- a charge the physician behind the study vigorously denies.

The British medical journal BMJ, which published the results of its investigation, concluded Dr. Andrew Wakefield misrepresented or altered the medical histories of all 12 of the patients whose cases formed the basis of the 1998 study -- and that there was "no doubt" Wakefield was responsible. The journalist who wrote the BMJ articles said Thursday he believes Wakefield should face criminal charges.

However, Wakefield said his work has been "grossly distorted." Speaking on CNN's "Anderson Cooper 360," he said Wednesday he is the target of "a ruthless, pragmatic attempt to crush any attempt to investigate valid vaccine safety concerns."

The medical publication says the study has done long-lasting damage to public health.

"It's one thing to have a bad study, a study full of error, and for the authors then to admit that they made errors," Fiona Godlee, BMJ's editor-in-chief, told CNN. "But in this case, we have a very different picture of what seems to be a deliberate attempt to create an impression that there was a link by falsifying the data."

Britain stripped Wakefield of his medical license in May.

"Meanwhile, the damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals and the medical profession," BMJ states in an editorial accompanying the work.

Wakefield dismissed Brian Deer, the writer of the British Medical Journal articles, as "a hit man who has been brought in to take me down" by pharmaceutical interests. Deer has signed a disclosure form stating that he has no financial interest in the business.

On CNN's "American Morning" Thursday, Deer did not deny he was paid by the BMJ. "I was commissioned by BMJ to write the piece," he said. "That's what journalists do."

He said he is also paid by the Sunday Times of London, where he has been employed since the early 1980s. "I was being paid as a journalist," he told CNN's Kiran Chetry. "Like you are. You're being paid to do your job."

"The point you have to remember about all this, firstly, it's not me saying this. It's the editors of the BMJ," Deer said. "... Secondly, this material has been published in the United Kingdom in extraordinary detail. If it is true that Andrew Wakefield is not guilty as charged, he has the remedy of bringing a libel action against myself, the Sunday Times of London, against the medical journal here, and he would be the richest man in America."

He said Wakefield's remarks amount to a smear campaign against him, noting that Wakefield has previously sued him and lost.

The autism assignment was a "routine assignment" given to him in 2003, he said, adding that he expected it to be finished in a week or two. However, "when you're a journalist and you see that somebody you're dealing with is lying to you," it must be pursued, he said.

Wakefield, he said, is attempting to "cloud the picture... Some people say he's a liar and he says I'm a liar. What he's basically trying to do is split the difference."

Allegations that he is in collusion with the pharmaceutical industry are "another one of Andrew Wakefield's concoctions," Deer said. "He knows it's not true."

Asked whether he thinks Wakefield should face criminal charges, Deer said, "I personally do." In addition, he said the Department of Homeland Security should take a close look at Wakefield's visa application and how he got into the United States, "how he's been able to export his mischief."

Wendy Fournier, president of the National Autism Association, defended Wakefield in a CNN interview.

"I cannot imagine for a second that Dr. Wakefield would have any reason to falsify data," she said. "He's a man of integrity and honesty and truly wants to find the answers for millions of children who have been affected by autism."

Fournier accused pharmaceutical companies of trying to protect their turf.

"You can't question vaccines without being destroyed," she said. "There's too much money at stake here."

J.B. Handley, the father of an 8-year-old with autism and a co-founder of Generation Rescue -- a group that believes there's a connection between autism and vaccinations -- also questioned the motivation behind the investigation into Wakefield's work.

"Children are given 36 vaccines in the U.S. by the time they reach the age of five," he said. "This is an attempt to whitewash, once and for all, the notion that vaccines cause autism."

The now-discredited paper panicked many parents and led to a sharp drop in the number of children getting the vaccine that prevents measles, mumps and rubella.

Vaccination rates dropped sharply in Britain after its publication, falling as low as 80% by 2004. Measles cases have gone up sharply in the ensuing years.

In the United States, more cases of measles were reported in 2008 than in any other year since 1997, according to the Centers for Disease Control and Prevention. More than 90% of those infected had not been vaccinated or their vaccination status was unknown, the CDC reported.

"But perhaps as important as the scare's effect on infectious disease is the 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," the BMJ editorial states.

Wakefield has been unable to reproduce his results in the face of criticism, and other researchers have been unable to match them.

Most of his co-authors withdrew their names from the study in 2004 after learning he had had been paid by a law firm that intended to sue vaccine manufacturers -- a serious conflict of interest he failed to disclose.

After years of controversy, the Lancet, the prestigious journal that originally published the research, retracted Wakefield's paper last February.

Actress Jenny McCarthy, founder of Generation Rescue and whose son also has autism, declined to comment on Wednesday's developments, but has previously supported Wakefield.

"It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction," she said after the Lancet retraction.

Deer said Wakefield "chiseled" the data before him, "falsifying medical histories of children and essentially concocting a picture, which was the picture he was contracted to find by lawyers hoping to sue vaccine manufacturers and to create a vaccine scare."

According to BMJ, Wakefield received more than 435,000 pounds ($674,000) from the lawyers.

Godlee, the journal's editor-in-chief, said the study shows that of the 12 cases Wakefield examined in his paper, five showed developmental problems before receiving the MMR vaccine and three never had autism.

"It's always hard to explain fraud and where it affects people to lie in science," Godlee said. "But it does seem a financial motive was underlying this, both in terms of payments by lawyers and through legal aid grants that he received but also through financial schemes that he hoped would benefit him through diagnostic and other tests for autism and MMR-related issues."

But Wakefield told CNN that claims of a link between the MMR vaccine and autism "came from the parents, not me," and that his paper had "nothing to do with the litigation."

"These children were seen on the basis of their clinical symptoms, for their clinical need, and they were seen by expert clinicians and their disease diagnosed by them, not by me," he said.

Dr. Max Wiznitzer, a pediatric neurologist at Rainbow Babies & Children's Hospital in Cleveland, said the reporting "represents Wakefield as a person where the ends justified the means." But he said the latest news may have little effect on those families who still blame vaccines for their children's conditions.

"Unfortunately, his core group of supporters is not going to let the facts dissuade their beliefs that MMR causes autism," Wiznitzer said. "They need to be open-minded and examine the information as everybody else."

Wakefield's defenders include David Kirby, a journalist who has written extensively on autism. He told CNN that Wakefield not only has denied falsifying data, he has said he had no way to do so.

"I have known him for a number of years. He does not strike me as a charlatan or a liar," Kirby said. If the BMJ allegations are true, then Wakefield "did a terrible thing" -- but he added, "I personally find it hard to believe that he did that."

CNN's Elizabeth Cohen, Miriam Falco and Ed Payne contributed to this report.

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CNN - January 12, 2010

Vaccine study's author held related patent, medical journal reports

By the CNN Wire Staff

(CNN) -- The author of a now-retracted study linking autism to childhood vaccines expected a related medical test to rack up sales of up to $43 million a year, a British medical journal reported Tuesday.

The report in the medical journal BMJ is the second in a series sharply critical of Dr. Andrew Wakefield, who reported the link in 1998. It follows the journal's declaration last week that the 1998 paper in which Wakefield first suggested a connection between autism and the measles, mumps and rubella, or MMR, vaccine was an "elaborate fraud."

The venture "was to be launched off the back of the vaccine scare, diagnosing a purported -- and still unsubstantiated -- 'new syndrome,'" BMJ reported Tuesday. A prospectus for potential investors suggested that a test for the disorder Wakefield dubbed "autistic enterocolitis" could produce as much as 28 million pounds ($43 million U.S.) in revenue, the journal reported, with "litigation driven testing" of patients in the United States and Britain its initial market.

Among his partners in the enterprise was the father of one of the 12 children in the 1998 study that launched the controversy, the journal reported.

In 2010, after a lengthy investigation, British authorities stripped Wakefield of his medical license, and the Lancet -- which published his original study -- retracted the paper. He has denied any wrongdoing, and a vocal contingent of advocates for children with autism continues to support him.

Wakefield did not immediately respond to a request for comment from CNN. But in an interview on an internet radio site Tuesday, Wakefield again defended his research and called the BMJ series "utter nonsense."

He said the patent he held was not for a test or an alternative to the MMR vaccine, as BMJ reported, but an "over-the-counter nutritional supplement" that boosts the immune system. And he blasted allegations that he used the cases of the 12 children in his study to promote his business venture.

"The children were not exploited," he said. "They were seen because they were sick. They had clinical referrals. They came to us. We responded to a crisis."

He also repeated his attack on the author of the BMJ report, freelance journalist Brian Deer, whom he has accused of being paid by the pharmaceutical industry. In financial disclosure forms, Deer has stated that he has received no such payments.

Dr. Max Wiznitzer, a pediatric neurologist at Rainbow Babies and Children's Hospital in Cleveland, said that if true, the latest BMJ allegations would indicate a major ethical breach.

"Assuming the facts Deer lays out are correct, it is disappointing that Wakefield in his book casts aspersions on others for all their purported conflicts of interests and failures of disclosure, yet does not examine the same issues in himself," Wiznitzer said. "Therefore, those who are trying to objectively evaluate the situation have up to this point not been given all the facts."

BMJ reported the business venture failed to launch after Wakefield's superiors at University College London's medical school raised concerns in 1999 about a "serious conflict of interest" between his research and the company formed to launch his new product.

"This concern arose originally because the company's business plan appears to depend on premature, scientifically unjustified publication of results, which do not conform to the rigorous academic and scientific standards that are generally expected," a letter stated. But the university offered him a year's paid absence and help in replicating his original research with a larger group of 150 children in the name of "good scientific practice."

The follow-up study never occurred, and no other research has duplicated Wakefield's original findings, BMJ reported. He left the university in 2001, and BMJ quotes his former boss as saying the school "paid him to go away."

The BMJ pieces are a series of investigative reports, not a clinical study. The journal's editor-in-chief, Fiona Godlee, said last week that of the 12 children Wakefield examined in his 1998 Lancet paper, five showed developmental problems before receiving the MMR vaccine and three never had autism.

According to BMJ, Wakefield received more than 435,000 pounds (about $674,000) from lawyers trying to build a case against vaccine manufacturers -- a serious conflict of interest he failed to disclose. Most of his co-authors abandoned the study in 2004, when those payments were revealed.

The now-discredited paper panicked many parents and led to a sharp drop in the number of children getting the vaccine that prevents measles, mumps and rubella. Vaccination rates dropped sharply in Britain after its publication, falling as low as 80% by 2004. Measles cases have gone up sharply in the ensuing years.

In the United States, more cases of measles were reported in 2008 than in any other year since 1997, according to the Centers for Disease Control and Prevention. More than 90% of those infected had not been vaccinated or their vaccination status was unknown, the CDC reported.

CNN's Miriam Falco contributed to this report.

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