Dr. Andrew Wakefield Deals with Allegations

Dr. Andrew Wakefield Deals With Allegations

Since the release of the 1998 paper in The Lancet, which suggested the possibility of a link between a novel form of bowel disease, autism, and the MMR vaccine, one of the report’s co-authors, Dr. Andrew Wakefield has been the subject of great controversy and defamation. Here, Wakefield addresses the allegations of fraud, conflict of interest, and medical misconduct that have been leveled against him.

  • Connector.

    1. Dr. Wakefield's Medical Background - 0:00

    Wakefield shares his medical background as a gastroenterologist and how he became involved in research related to autism.

  • Connector.

    2. The Link Between Autism and The MMR Vaccine - 1:24

    The link between the MMR and inflammatory bowel disease was first brought to the attention of Dr. Wakefield and his colleagues by the parents of sick children. Wakefield explains how human disease syndromes are normally identified and then studied and how that related to their study on MMR and the age of exposure. Jump to section.

  • Connector.

    3. MMR Vaccine Safety - 3:28

    Wakefield explains how safety studies on vaccines including the MMR, were largely inadequate. Testing for single vaccines was better. Jump to section.

  • Connector.

    4. The Lancet Study - 5:05

    Wakefield lays out the facts as why the case series report was published in 1998 in the Lancet. Jump to section.

  • Connector.

    5. Conflict of Interest - 6:13

    Wakefield addresses the allegations against him for “conflict of interest” and how he has been accused of being on the payroll of lawyers with regards to the Lancet study versus serving as medical expert in a litigation case against the vaccine manufacturers. Jump to section.

  • Connector.

    6. The Discrediting of Dr. Wakefield - 8:21

    Although there were 12 other authors on the study, Wakefield describes how he was targeted and vilified by the medical community and journalists because he had joined the litigation against and spoke out about the pharmaceutical manufactures. Brian Deer, the freelance journalist who most obviously went on the attack against Wakefield wrote for The Sunday Paper, the British paper published by James Murdoch, who was then on the board of GlaxoSmithKline. Jump to section.

  • Connector.

    7. Blood Samples - 14:25

    One criticism of Wakefield is the claim that he “unethically” took blood samples from children at his son’s birthday party for the study. Wakefield shares where he was at fault. Jump to section.

  • Connector.

    8. Retraction of the Lancet Paper - 16:12

    The Lancet paper was withdrawn on the basis of two allegations which Wakefield defends: 1) that the children in the study were sequentially investigated, and 2) that there was no ethical approval for the study. Jump to section.

  • Connector.

    9. Medical License - 17:21

    Wakefield describes the process in which the General Medical Counsel (GMC) revoked his medical license in the UK. Although Wakefield was had to forfeit an appeal for reinstatement due to financial realities, Professor Walker Smith, a co-author on the study who also lost his license, appealed and overturned the decision and was reinstated. Jump to section.

  • Connector.

    10. Consequences - 19:56

    Following the 1998 study, after Wakefield suggested that parents should opt for the single vaccine, the vaccine manufacturers (Merck and GlaxoKlineSmith) stopped making them available in the marketplace. Jump to section.

  • Connector.

    11. Outlook - 22:00

    Despite the controversy and criticism, Wakefield explains what keeps him going. Jump to section.


Transcript

1. Background

I’m a physician. I qualified in 1981. I went on to practice as a surgeon, with a specific interest in inflammatory bowel disease. I then became an academic, running a team of nineteen people researching inflammatory bowel disease, and published over the period of ten years in the order of a hundred and thirty, a hundred and forty scientific publications on that particular subject. On May the seventeenth, 1995, the date is emblazoned in my mind, a mother called me and said, “My child was developing perfectly normally, they had an MMR vaccine, and they regressed into autism.” I said, “I’m a Gastroenterologist, how can I help you?” They said, “My child has terrible gastrointestinal problems and no one will take them seriously.” The story was so compelling, and this mother was so articulate, described it so clearly, she said, “Dr. Wakefield, there are many, many parents in my position. Children in exactly the same condition as mine.” We took it very seriously. That was the beginning of a fascinating journey.

2. The Link Between Autism and The MMR Vaccine 1:24

The link between the syndrome we were seeing and MMR vaccine came from the parental story. The parents saying, “I wasn’t anti-vaccine. I took my child to be vaccinated with MMR on time.” It was given in isolation at the time in the UK, so it was easy for them to pinpoint the MMR as what they believed to be the cause. From that point forward, their child developed a very high fever, seizures, prolonged sleep beyond which they woke up and they were never the same again. They lost speech and language, interaction with their siblings, and became profoundly unwell.

The way in which human disease, syndromes, are described, whether it’s autism, or Crohn’s Disease or Asperger’s, is you have a collection of a few, a handful of patients, sometimes no more than four, sometimes as many as fifteen, where the presentation is so similar, the findings in the clinic are so similar, that these merit publication in their own right. That’s called a case series. That is the way in which human disease syndromes are first described. What that leads to are subsequent studies, which then test hypothesis of causation. Was the parent’s stories right? Was it that the child did regress in the face of MMR, and was MMR the cause of the problem?

You can ask the question, “Well, not every child who gets MMR develops autism, so what is the risk?” Why? Why these children and not these children? One of our hypothesis was age of exposure. The younger you get the vaccine, the greater the risk. The reason for putting that forward is that we know with infections like measles, the younger you get measles, the greater the risk of a serious outcome. If you get measles under one, the risk of serious disease following measles is much greater than if you get it over one.

3. MMR Vaccine Safety – 3:28

Now, by that stage, as a researcher, I had looked in great detail at the safety studies of MMR. I became very, very concerned that those studies were totally inadequate. Now, this is not just my opinion, because subsequently, what is called the Cochrane Review, which is one of the gold standard reviews of the medical literature, has come forward and said the same thing. Their words were that the safety studies, the pre-licensing safety studies of MMR vaccine were largely inadequate, particularly compared with the single vaccines. In other words, the safety studies of the single vaccines were better.

For example, if I went to the Food and Drug Administration, and I had three anti-hypertensive drugs, three blood pressure drugs, and I said, “I’ve got these three drugs. I’ve got a license for each one individually, but I want to put them together in the same tablet. Can I just put the three licenses in a folder and hand it to you and get a license for the combined drug?” They would throw me out the door, quite rightly. They would say, “Come back when you have done a comparative study of every drug in combination with the other, and compared them with the single drug for side effects, for adverse reactions.” That should have been done with the MMR vaccine, and it was not. There were many assumptions made about the safety of this vaccine, and I believe that children are now paying the price for those assumptions.

4. The Lancet Study – 5:05

The Lancet Study itself arose out of seeing many of these children with the same presentation. Normal development, regression, and autism spectrum diagnosis, gastrointestinal symptoms, and bowel inflammation. It was putting that story together in one package and saying, “Here are the first twelve children that we’ve seen. This is what we find. This is remarkable, it’s consistent. It suggests the emergence of a new human disease syndrome. The parents report the regression occurred after MMR vaccine in many cases. That is now up for testing as a hypothesis. Subsequent studies should be done to actually elucidate whether that is true or not.” That was published as a case series in the Lancet in 1998, in February of that year. A press briefing was held at the request of the Dean of the medical school. Those findings were explained.

5. Conflict of Interest – 6:13

In the UK, there was then litigation by children against the manufacturers of the drug. I became involved in that litigation. Patients within the Lancet Study also became involved. Once they got their diagnosis, and they were convinced that this is what happened, then the joined the litigation. It was alleged that the study was done for the purpose of litigation, indeed that it was funded by lawyers for litigation. That is absolutely untrue. It simply was not. I agreed to be a medical expert, and I feel obliged to act as a medical expert on their behalf, because there were any number of doctors lining up on the other side, to be paid as experts, to act on behalf of the pharmaceutical industry.

One of the allegations against me is that I had acted on behalf of lawyers, I was being paid by lawyers to do the Lancet Study. In fact, I was being paid for by a government funded compensation program to act as a medical expert. It had nothing whatsoever to do with the Lancet Study, which was paid for by the National Health Service. They payment from the Legal Aid Board was not to me initially. It was to the medical school to conduct a study, to look for evidence of measles virus in the diseased intestine of these children. That is what it specifically did. This was known to the editor of the Lancet nearly a year before the paper was published. He was sent documents from the lawyer saying, “We are working with Doctor Andy Wakefield on this issue.” He knew, or should have known, but conveniently, he forgot that fact when it came to testify before the General Medical Council under oath. It was only subsequently that it was disclosed that he knew all along.

6. Framing Dr. Wakefield – 8:21

When you had this threat of litigation, then they came down very, very hard. What happened was that a journalist by the name of Brian Deer, a freelance journalist working on behalf of News International, Rupert Murdoch, came after me and contrived a story, a fairy tale so fanciful of this evil doctor, living in this mansion, and wreaking havoc upon the children of the world in an attempt to profit and to make himself a legend in the history of medicine. It took my life story and rewrote it. It was a strategy, a deliberate strategy, a public relations strategy to say, “We discredit this man. We isolate him from his colleagues. We destroy his career. Then we say to other physicians who might dare to get involved in this, this is what will happen to you.” It’s very, very sad, because good doctors, honest doctors said, “Andy, I know this is right. I know it’s right.” They wrote it was right. Internal communications confirmed their beliefs that it was right.

When it came to doing the right thing by these children, then it was not going to be good for their careers, and the stepped back. It had the desired effect. Do I feel that I was framed by the pharmaceutical industry? Yes, I think I was. Why me in particular? There were thirteen authors on that study, many of them the most eminent people in their field. They went after me because I joined in the litigation as an expert against the manufacturers, and I wrote to my colleagues that I can no longer support the continued use of this vaccine, MMR. I will continue to vigorously support the use of the single vaccines, the single measles, mumps, rubella, but cannot support the use of the triple vaccine. I think it’s because I put myself in that outspoken position that then they came after me in particular.

Another allegation is that I was in my mountain lair, secretly making this single vaccine, which was a competitor to MMR, would put MMR out of the market, discredit it, and then bring my own vaccine onto the market and clean up. That was the idea from Brian Deer. What we had at the time was a patent, the medical school owned the patent, not me. It was a patent on a thing called Transfer Factor. It’s a naturally occurring nutritional supplement that occurs in breast milk, for example, that boosts the immune response. Whether it worked or not is another question. That’s what we sought to try and find out. It boosts the immune response to an infection like measles. This could not prevent children from getting measles, so it didn’t act like MMR at all. What it did was to help them clear the virus once they became infected. It could never have competed with MMR vaccine. Never, because it did not work in the right way.

This was explained in great detail to Brian Deer. He completely ignored it. It remained that it was a competitor to MMR, and I was simply trying to clean up financially, and put this onto the market. Brian Deer’s association with the vaccine manufacturer, Smith Klein Beecham, who went on to Glaxo Smith Klein, was a very close one, a very intimate relationship. He’d originally been a critic of their drug, AZT, but had since been given exclusive rights to some of their adverse drug reaction data in some exchange, some deal that had gone on between them. Beyond that point, I believe he became their kind of attack dog. How could a single journalist achieve what Brian Deer achieved so effectively? It was the will of the government, and it was the will of the pharmaceutical industry, and it was the will of the media.

At that time, James Murdoch, son of Rupert Murdoch, and part of News International, was on the board of Glaxo Smith Klein as a non-executive director. His job on the board of the vaccine manufacturer was to protect that industry’s reputation in the media. There was this very incestuous cabal involving government, media, and the industry, that all wanted this outcome. They were going to get it. Against them there was me. Now, accuse a researcher of fraud in thirty seconds, and it takes a lifetime to turn that around, and they know that. They know how vulnerable doctors are. Now, the fraud allegations were completely false, but you don’t have to take my word for that.

There’s now been a thorough investigation and examination of the original data used in the Lancet paper by an ex senior scientist from the Environmental Protection Agency, Doctor David Lewis. I’d never met him before. He took all of the original files and analyzed them and showed categorically and definitively that I had not been involved in any fraud at all, but the fraud had taken place on the part of Brian Deer and the British Medical Journal. They had fraudulently misrepresented our work at the Royal Free in order to achieve the effect that was ultimately achieved. That is the perception worldwide that this study was fake, it was false, it was made up, and there is no substance to it.

7. Blood Samples – 14:25

Yes, the blood samples at my son’s birthday party. In order to study the children with autism, we were examining their blood samples. We needed blood samples from healthy children. Of course, in hospital you don’t see healthy children. You see children who are sick, and so my wife suggested that we have a birthday party coming up, maybe we can get some blood from our children and children at the birthday party? I thought that was a reasonable idea. It was done with fully informed child and parental consent. Fully informed. It was entirely ethical. It was no worse, for example, than going to CVS and having a shot. In fact, probably substantially better. It was done by a highly experienced general practitioner, not by me. There were no problems at all.

The only problem was that it did not have an approval from the Hospital Ethics Committee. That does not make it unethical. It was done, as I say, with fully informed child and parental consent. That’s the story. Do I regret it? Yes. Not because it was unethical, it wasn’t, but because it gave the General Medical Council a concrete reason for them taking away my license. It was a mistake, and if I did it again, I would do so with the appropriate ethical approval, and so therefore, it’s something I regret. Was it at any stage unethical? No.

8. Retraction of the Lancet Paper – 16:12

The Lancet paper was withdrawn on the basis of two allegations. One, that the children were sequentially investigated. In other words, these are children who came in one after another. What that means is you’re not saying, “We took just the children we wanted because they told us the story we wanted to hear and we left out the others.” You take them sequentially so you include all the children. It avoids bias. That is the correct way to do it. The other reason is that it was claimed by Brian Deer, and subsequently the GMC, that there was no ethical approval, in America, investigational or institutional review board approval for the study itself. It was a clinical study. It didn’t need ethical approval, but the analysis of the biopsies from the intestine did. There was ethical approval. That was in Deer’s hands when he made the allegation, and he deliberately withheld that information from the General Medical Council. It was an obstruction of justice.

9. Medical License – 17:21

The licensing board for doctors in the UK is called the General Medical Council. You are judged by your peers in medicine, and similarly people as well. At the GMC, there were three defendants: Professor Walker Smith, who was at the time the world’s leading pediatric Gastroenterologist, a very senior man with an impeccable record, an unimpeachable career, one of his juniors, Doctor Simon Murch, and myself. All three of us were found guilty. Simon Murch did not lose his license, but Walker Smith and I lost our license. He was then funded to appeal in the English High Court. I did appeal, but for financial reasons, it was impossible for me to pursue that, and it was not a primary objective after that to restore my license. There more important things to do.

Professor Walker Smith did appeal, and at that appeal, the first time this case had ever come before a proper judiciary, a proper judge. Then, the judge destroyed the General Medical Council’s decision. He said effectively they were incompetent. They were not in a position to judge the evidence, that they made mistakes, they got the facts wrong, they misrepresented the evidence, and worse of all, they were biased. They had made up their minds from the outset that we were guilty. He completely overturned their decision, and said in effect this must never happen again. Walker Smith was completely reinstated, and all charges against him utterly dismissed. Ninety percent of the charges against Walker Smith were the same charges as those against me. The paper should have been reinstated, and yet the Lancet editor refused to do that in order to protect his reputation and his job. Did that ever find its way into the newspapers? Briefly, one newspaper. Big story, very little mention. You don’t hear about that now. All you hear about is that we were discredited, had our licenses removed, the paper was retracted. The real story has yet to be told.

10. Consequences – 19:56

Well, it’s very interesting, because at the time, I made a recommendation that parents should opt for the single vaccines. In other words, not protect their children against these infections, but they should have the option of how to do it. At that time, in the UK and the US, the single vaccines were available, so the parents could choose. “I’m not happy about MMR, but I want to vaccinate my child, so I will opt for the single vaccines.” They protect perfectly well, for example, against measles. That option was available to them. I would not have made that recommendation if that were not the case. In the UK, six months later, the government withdrew the importation license for the single vaccines. In the US, some years later, Merck unilaterally stopped the production of the single vaccines.

They make them individually to put them together, but they stopped making them available in the marketplace so that it was MMR or nothing. Our way or the highway. That deprived parents of the choice. They were still concerned about MMR, so they didn’t vaccinate, measles then came back. It was entirely their fault. As I say in the movie, I asked a senior member of the Department of Health, “Why would you do that? If you want to protect children against serious infectious disease, why would you take away an option of how parents might do that?” He said, “Because if we allow parents the choice then it will destroy our MMR program.” In other words, the concern was for the protection of the program and not the children.

That was disastrous mistake. Measles came back. It was entirely their responsibility, but of course, it was blamed on me. When the quote the form in MMR uptake in the UK, what they do not quote is the reciprocal increase in the use of the single vaccines before it was withdrawn.

11. Outlook – 21:48

I won’t pretend that this has been easy at all. The medical imperative is utterly compelling. Whenever I get to feel a little bit sorry for myself because of the GMC or something someone has said in the media, then I only need to look at the next child with Autism to realize that actually, I don’t have a problem. I have four healthy children, a wonderful family. There’s no autism in my family. I look at the next child with autism and I think that child has a problem. I don’t have a problem, so get over yourself, get on with it, and get the job done.