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Transcripts from the GMC hearings

2 Feb

With the defamation suit by Mr. Wakefield filed in Texas there is the strong possibility that the discussions will ensue again about what actually happened during Mr. Wakefield’s research at the Royal Free hospital. The one record of this is in the transcripts for the GMC hearings. These can be found online in a few places (casewatch and Sheldon 101’s blog Vaccines Work, for example). These are useful resources but somewhat cumbersome. Most people are not going to download a file to check a quote in context. And context can be very important, as we’ve seen here on Left Brain/ Right Brain where previous discussions by Mr. Wakefield’s supporters often involved pulling quotes out of context.

I don’t want to clutter this site with the transcripts, but I do want them in a place where internet search engines can find them and people can easily link and check quotes. So I am now uploading them to a new blog. It should take a few days to get the transcripts online in this format. About 30 days worth are up now.

In doing so I re-read some of the pages. One of the best examples of what happened is covered on Day 28. This is the day when the mother of Child 12 (last of the 12 children in the Lancet study) testified.

This one day’s testimony addresses many of the discussion topics which come up repeatedly in online discussions:

1) Parents of the Lancet Children were not prevented from testifying at the GMC.

2) She was the only one who did testify. She was the only one called by the GMC. The defense appears to have not called any of the parents.

3) Mr. Wakefield’s attorney declined the opportunity to even cross examine this parent.

4) The idea that Mr. Wakefield only reported what parents told him isn’t well supported by the evidence. Rather, there is a very circular route for the idea that the MMR causes autism. Mr. Wakefield and Mr. Barr (the attorney working on the litigation) were in contact with this parent multiple times before the child was seen at the Royal Free.

5) Some of the children in the Lancet study were registered with Legal Aid at the time of the study, and well before the Lancet paper was published.

6) The idea that the children were referred through normal channels is not accurate. While this child was referred through general practitioners, there was much contact between the mother, Mr. Wakefield and the attorney before that. One letter from the attorney makes it clear that they expressly told the parents to be sure to get the GP referral.

7) The idea that this work was not a research study isn’t really accurate. Mrs. 12 repeatedly gives her impression that they were involved in a research study.

Yes, this has all been covered before. Unfortunately, I fear this will all be covered repeatedly as this new case works its way through the court.

With that, here are some excerpts from the Day 28 testimony. Which you can check in context.

Q I think it is right that at around the same time, as well as that contact with Dr Wakefield, did you also have some contact with a firm of solicitors called Dawbarns?
A Yes, that is right.

Q Can you tell us how that came about. Why did you get in touch with them?
A The same mother told me about them as well.

Q What was your understanding of what they were doing?
A They were trying to really put a stop to the MMR vaccine being used and obviously to stop any damage that was being done to children.

Emphasis added. Mrs. 12 thought that Dawbarns “were trying to really put a stop to the MMR vaccine being used”.

After contacting the lawyers, she received a letter. This is dated 18 July 1996. Her son wasn’t seen at the Royal Free until 18 October, 1996, three months later:

“Dear [Mrs 12],

Thank you for contacting us regarding the MMR vaccination. We are investigating a number of vaccine damage cases and are also (with Messrs Freeth Cartwright Hunt Dickens of Nottingham) co-ordinating and managing the Mumps Measles and Rubella cases on behalf of the Legal Aid Board for the whole country. Recently the Legal Aid Board has also extended our contract to investigate claims following the Government’s measles/rubella vaccination campaign in the autumn of 1994.

To give you an idea of our work I enclose an information pack which consists of a copy of a fact sheet which we have produced on the MMR vaccine and a fact sheet on ourselves.

We have built up a considerable volume of evidence that vaccines can cause injury to children, and we are hoping to take compensation claims to court. See the fact sheets for more information. Legal Aid is now being granted in vaccine damage cases where we can show a close link up in time between the vaccine being administered and the onset of recognised side effects. In claims being brought on behalf of children the Legal Aid Office does not take into account the finances of the parents, but there are sometimes difficulties in obtaining legal aid …”

She was supplied with a “fact sheet” written by Mr. Wakefield. No contamination of the study there, right? In the Lancet he’s just reporting what the parents told him. No mention of the issue of the parents being supplied with a “fact sheet” to guide them.

Richard Barr (the attorney managing the litigation effort and teamed with Andrew Wakefield) wrote her on 14 August 1996

“We are also in touch with other experts and together they are hoping to establish a link between the vaccine, inflammatory bowel disease and autism. There is a clear cut biological mechanism for linking the two conditions. I suggest it might be worth your while to contact Dr Wakefield. If you would like me to do so I will be happy to make the introduction for you. May I have permission to send him a copy of the statement that I have prepared for [Child 12]?”

They are hoping to establish a link and “there is a clear cut biological mechanism for linking the two conditions [bowel disease and autism]”. Two months before being seen at the Royal Free she is informed about the effort to link MMR with autism and bowel disease and the idea that autism and bowel disease are linked.

Clearly any study reporting “what the parents told us” is contaminated at this point.

If you think the study could be salvaged, even with this level of contamination, here is a discussion of the fact sheet supplied to the parents as mentioned above:

Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,

“Inflammatory Bowel Disease, measles virus and measles vaccination.

What is inflammatory Bowel Disease (IBD)?

IBD comprises 2 conditions that have many similarities. Crohn’s disease and ulcerative colitis. Crohn’s disease may affect any part of the bowel, from mouth to anus, whereas ulcerative colitis affects the large bowel only. Many people now believe that these two conditions are part of a single spectrum of intestinal disease. IBD is often difficult to diagnose in children, especially Crohn’s disease, and this may lead to a delay in diagnosis with frustration for parents, doctors and, in particular, the affected children.

What is the link with measles and measles vaccine?

Measles virus was put forward as a possible cause of Crohn’s disease in 1989. The dramatic rise in the incidence of inflammatory bowel disease in developed countries over the last 30 years, in the face of live measles vaccination, also suggested a link between the vaccine and the disease.

Several groups from around the world have now identified measles virus in tissues affected by Crohn’s disease and an immune response to measles virus in the blood of patients with Crohn’s disease and ulcerative colitis. Early exposure to measles virus appears to be a major risk factor for developing Crohn’s disease later in life, and one study recently linked live measles vaccine to both Crohn’s disease and ulcerative colitis. Several new studies are currently underway that are designed to clarify the association between measles vaccination and inflammatory bowel disease. Although no studies have formally examined the issue, we have been aware of a large number of new cases of childhood IBD following the MR revaccination campaign in November 1994”.

Then the fact sheet sets out what you would look for (and what you should do: contact Andrew Wakefield):

Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,

“Crohn’s disease. The symptoms and signs of Crohn’s disease in childhood are often insidious and non-specific and may lead to a delay in diagnosis. Intestinal symptoms include mouth ulcers, cramping abdominal pains, loss of appetite, diarrhoea with or without blood and problems in the anal region, including skin tags, tears or abscess formation. However, children commonly present with weight loss and failure to thrive as the only indications that they may have Crohn’s disease. But be aware, unexplained joint paints, sore eyes and skin rashes can also be the presenting symptoms of Crohn’s disease.

Ulcerative colitis is often more clear-cut, with diarrhoea, urgency and blood and mucus mixed in with the stools. Again, growth failure and symptoms such as joint pain may precede the intestinal problems.

What should we do?

If you suspect that your child has inflammatory bowel disease, prompt referral to a specialist centre is essential. Either the diagnosis will be excluded and your mind put at rest, or it will be confirmed and the appropriate treatment instituted. As a first step you should contact Dr Andrew Wakefield at the Royal Free Hospital”,

A document by Wakefield, possibly from the Royal Free says that there is a link between Crohn’s disease and the measles vaccine. This given to prospective study subjects before being seen at the Royal Free. But no contamination of the study subjects again, right?

Child 12 was registered with Legal Aid before in August, two months before being seen by the Royal Free:

Q Also enclosed with that letter of 14 August 1996 were the legal aid forms. I think that is right. Did you fill in the legal aid forms in order for an application to be made for your child to be legally aided?
A Yes.

One issue that Mr. Wakefield has brought up in recent years is the concern over vaccines containing the Urabe strain of mumps. Mr. Wakefield has gone into detail about how he was informed by a “whistleblower” about how the government handled the licensure of those vaccines. Mr. Wakefield had those discussions with the whistleblower in 1999 but appears to have done little with the information until the past few years. Why? Perhaps this comment by his colleague Richard Barr will shed some light onto this: “Although Immravax and Pluservix were withdrawn on safety grounds, the particular problem they caused was fairly limited. ” It was the opinion of Mr. Barr at the time that the Urabe strain mumps concerns with some of the MMR vaccines was “fairly limited”. Mr. Barr and Mr. Wakefield, of course, had a different avenue to pursue: the measles/gut disease/autism hypothesis.

In Sept. 1996, Barr sent Mrs. 12 a newsletter:

Under the heading, “Pilot study”,

“If we can prove a clear link between the vaccines and autism/inflammatory bowel disease this will be exceedingly useful, not only for cases involving those conditions, but also for other types of damage such as epilepsy.

To obtain the evidence to do this, we will be running a pilot study. Around 10 children with symptoms which are closely linked to the vaccine will be extensively tested by a team of doctors headed by Dr Wakefield at the Royal Free Hospital in London. We will be selecting children to take part in the study from details and medical notes we already have. The investigations will involve a whole battery of tests to be carried out by a number of leading experts in their fields. We will of course be liaising closely with the families concerned and the doctors will be giving very full details of what will be involved”.

Need I point it out again? Before even arriving at the Royal Free, Mrs. 12 was informed about the need to provide a clear link between vaccines and autism/bowel disease.

Q We have heard from the Dawbarns newsletter that I read to you previously that as far as the solicitors were concerned there was a pilot study being arranged. Did you have any understanding or awareness whether your little boy was a part of that pilot study at all?
A He was referred to Dr Wakefield by my GP for investigations, which I understood to be research investigations, but that was the route he was referred.

She felt that her child was being referred for “research investigations”

Mr. Wakefield is keen to tell everyone that the referrals came through the GP’s. He doesn’t mention that he and Mr. Barr made sure ahead of time that they went through the GP’s:

“Dear Mrs [12]

Many thanks for your letter of 10 September 1996. I will contact some other parents in your area and if they agree then you can all swap names and addresses. It is interesting how isolated people feel (and sometimes are!).

I would like to see the records. These may well be helpful if we have any difficulties over legal aid. At the moment I am still waiting to hear from them.”

So that was the end of the correspondence, and I now want to ask you about the actual referral, which you have explained to us was through your GP to the Royal Free Hospital in respect of your boy. We have been through this already, but just to remind you, if you go back to the GP records, please, page 126, this is a letter that I asked you about when I first began to question you, Mrs 12, the letter from Dr Wakefield, and we see in that the suggestion that you in fact you should go to your GP for a referral. Did you do that?

Emphasis added.

On admission to the Royal Free:

Q “Soils – not had diarrhoea. Has variable abdominal pain”, and then I cannot read the rest of that sentence. Mr Miller is trying to assist me – “occurring every week”. Thank you. “Mother had not associated vaccination with his problems until met a parents support group”. Does that set out the problem as far as his gastrointestinal symptoms were concerned, I mean obviously in brief terms?
A Yes.

“Mother had not associated vaccination with his problems until met a parents support group”. Earlier in the transcript it is noted that this parent group included the mother of Child 6 and 7 and this is where Mrs. 12 was put in touch with Mr. Barr and Mr. Wakefield.

After her son was seen at the Royal Free, here’s the letter Mrs. 12 wrote. Note that she read the proposed “clinical and scientific study notes”. But this was just a routine referral, right?

“Dear Professor Walker-Smith,

I am writing following [Child 12’s] visit to the Royal Free Hospital last Friday 18 October 1996. My husband and I have thought long and hard about this situation since the appointment. We have also re-read Dr Wakefield’s proposed clinical and scientific study notes.

We do feel that [Child 12] does have a problem in that most children of his age do not soil themselves a number of times a day. As well as being pale in colour and foul smelling (as are his motions in general), this soiling is always very loose, which might explain why he is not always aware that he has done anything. Although I would not say it was diarrhoea exactly.

Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, [Child 12] is not growing or putting on weight like my other two children.

I keenly await the results of the blood tests and if you feel they warrant further investigations my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help [Child 12] but if not hopefully it will be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped.

I do hope to hear from you in due course.”

In a letter to Mr. Wakefield she notes:

“Finally, I would like to say how nice it was to meet you at the JABS open meeting on 4 October in London. I found your short discourse both informative and interesting. I wish you all the best with your research.”

Yes, Wakefield was lecturing at JABS (an organization focused on vaccine injury) meetings. Mrs. 12 attended. This is Oct. 4, two weeks before her child was seen at the Royal Free.

Once again, we are in the merry-go-round. Mr. Wakefield only reported what the parents told him, except that here we have a clear example of a parent hearing from Mr. Wakefield on more than one occasion about what he was investigating.

The first visit to the Royal Free was not with Mr. Wakefield (Mr. Wakefield did not have clinical duties). Child 12 wasn’t even going to be referred to Mr. Wakefield at first:

Q So that was from your point of view, but you say in your letter to Dr Wakefield, Professor Walker-Smith’s main reasons for not referring [Child 12] on to Dr Wakefield was the absence of blood in the faeces and the lack of diarrhoea, you were saying that is what Professor Walker-Smith’s view was, is that correct?
A Yes.

But a blood test was “slightly abnormal” so they did make the referral.

“Dear [Mrs 12],

I do apologise for the delay in replying to your letter of 28 November. The slight abnormality that you referred to in your letter was that one of the markers of inflammation was just slightly above the normal range, it just means that we should go ahead. I understand that [Child 12] is coming in in the New Year to have a colonoscopy.”

A “slight abnormality” was enough to warrant a colonoscopy. Oddly enough, a later letter states that the blood tests were not abnormal.

The psychiatrist was not very clear on autism diagnosis:

Q If you to go page 18 in the medical records, we have a note dated 10 January, and in fact we have heard some evidence from Dr Berelowitz and he has given evidence in relation to all the children, including your son, and it was his evidence that this was his note, and we see at the bottom a diagnosis of “language delay ? [attention deficit disorder]” and then “? Asperger’s”: do you have any recollection of that?

The Royal Free didn’t think child 12 should have an MRI or a lumbar puncture.

Q If we go back to the Royal Free records – you can put FTP7 away, you will not need it again – at page 21 – it is on 6 January, so the day after the admission – at the bottom of the page it says, “[Ward round] Professor Walker-Smith” and it is a note signed by presumably a junior doctor, “colonoscopy” and then it gives, “prominent lymphoid follicles …” and “? some minor inflammatory changes” and then it says, “not to have MRI or L.P.” In other words, not to have an MRI scan and not to have a lumbar puncture. Then, Wednesday to have a barium meal. Were you aware at all of that note, Mrs 12? Were you aware at the time that that instruction had been given?
A No.

Emphasis added. But a colonoscopy and lumbar puncture were performed:

Q You say that you recall your son having a lumbar puncture and an MR scan; were you there for those?
A Yes.

Q You have obviously given consent for the MR but were you actually there when they were carried out?
A Yes.

Q Both of them?
A Yes.

Again, Mrs. 12 felt this was a research project:

Q You have told us that you thought that your son was part of a research investigation. Did you have any understanding as to which of those investigations, all of them or any of them, were part of the research investigations?
A As far as I understood, it was all part of the research into this possible link between the problems that [Child 12] had and the vaccine.

The tests apparently showed some immune activation

“Dear [Mr and Mrs 12],

I am writing to confirm the results from [Child 12]’s visit in the New Year. All were normal, including test for Fragile X, except the immune test. This shows evidence of persistent viral infection; i.e. [Child 12]’s immune system is activated in such a way that indicates it is trying to deal with some sort of ongoing viral infection. If you need to discuss these further please contact Dr Wakefield. I have passed on your query about gluten free diets to Dr Wakefield. I hope that [Child 12] is well and that his aching knees are settling”.

Then she gives some results at the bottom of the page. It shows,

“Full blood count and inflammatory markers – normal (i.e. no evidence of anaemia or inflammation”,

and various other negative tests.

Emphasis added. But above we read that the reason why Child 12 was referred for a colonoscopy was because a blood test indicated possible inflammation.

In June 1997, after the work at the Royal Free was finished, the attorney, Richard Barr, wrote to Mrs. 12:

“Thank you for your letters of 3 and 10 May 1997. I am sorry about the delay in coming back to you. I inevitably seem to be behind with my correspondence.

I haven’t heard anything more from the Vaccine damage Tribunal”.

Then he says,

“I haven’t had a copy of the Meridian TV item”,

so obviously you had made some reference to it, because he says,

“I would be very interested to see a copy if you can organise it some time.

We are all waiting for Andy Wakefield to deliver the goods and I really think that if he can provide the proof he thinks he can it is going to be much easier to win the cases.

I am interested in your comments about the rise in the incidence of mumps. What you say, of course, is absolutely correct.

I don’t think you have been updated on our fact sheet recently and in case it is of interest I enclose a further updated version. You will see that once again the section on autism has been extended. Don’t be deceived by the fact that it may not look quite as long as before. We have reduced the print size”.

Emphasis added.

After an extensive examination by the GMC’s attorneys, the defense was given an opportunity to cross exam:

THE CHAIRMAN: Mrs 12, as I indicated earlier, this is now the opportunity for representative counsel of the three doctors to cross-question you if they feel it appropriate. Are you happy to continue?
A Yes, that is fine.

THE CHAIRMAN: At any stage if you think that you need a little break, just give me a little hint and I am sure that the Panel will be quite sympathetic. Mr Coonan.

MR COONAN: Sir, I have no questions, thank you.

Mr. Coonan would be Mr. Wakefield’s attorney. He declined the opportunity to examine the one parent from the Lancet 12 who appeared at the GMC.

Mrs 12 was cross examined by Mr. Miller, attorney for Professor Walker-Smith.

Even as a summary this is long. But at least now people can easily check quotes in context.

Russ Roberts hosts: Deer on Autism, Vaccination, and Scientific Fraud

2 Feb

I keep thinking I’ve blogged the last on this. But, I do think there is some interesting information here for some. In Deer on Autism, Vaccination, and Scientific Fraud, Brian Deer goes through the history of his investigation–how/why he got started, what tipped him off that something was amiss with Mr. Wakefield’s research, the mistakes Mr. Wakefield made in trying to handle and quash the story.

This post is long, but it covers a lot of material not about the investigation. It answers many questions that have been posed (such as what sort of job does Brian Deer have, how did he get access to information about the Lancet 12 children).

Investigative journalist Brian Deer talks with EconTalk host Russ Roberts about Deer’s seven years of reporting and legal issues surrounding the 1998 article in The Lancet claiming that the MMR vaccine causes autism and bowel problems. Deer’s dogged pursuit of the truth led to the discovery that the 1998 article was fraudulent and that the lead author had hidden payments he received from lawyers to finance the original study. In this podcast, Deer describes how he uncovered the truth and the legal consequences that followed. The conversation closes with a discussion of the elusiveness of truth in science and medicine.

Russ Roberts’ bio:

Russell Roberts, Associate Editor. Russell Roberts is Professor of Economics and the J. Fish and Lillian F. Smith Distinguished Scholar at the Mercatus Center at George Mason University. Before coming to George Mason University, Roberts was at Washington University in St. Louis where he was the founding director of the Center for Experiential Learning at the John M. Olin School of Business and a Senior Fellow at the Weidenbaum Center on the Economy, Government, and Public Policy. Roberts has also taught at the University of Rochester, Stanford University, and UCLA. He holds a Ph.D. in economics from the University of Chicago.

Roberts is a regular commentator on business and economics for National Public Radio’s Morning Edition. In addition to numerous academic publications, he has written for the New York Times and the Wall Street Journal. Professor Roberts is especially interested in communicating economics to non-economists. His first novel, The Choice: A Fable of Free Trade and Protectionism, a jargon-free book on international trade written for the non-economist, was named one of the top ten books of 1994 by Business Week and one of the best books of 1994 by the Financial Times. An updated and revised edition was published in the spring of 2000. His new book is The Invisible Heart: An Economic Romance (MIT Press, 2001).

Russ Roberts is the host of EconTalk, economics podcasts available here and through iTunes. He blogs at Cafe Hayek along with Don Boudreaux.

There is an audio podcast and a rough transcript on the site.

In 1998, when the Lancet paper came out with a big splash, Brian Deer was working on stories about the DPT vaccine. But he decided against working on the MMR story at that time. He knew that to do the story correctly meant a lot of work, not just publishing what Mr. Wakefield and the Royal Free put out in a news conference:

I happened to be looking at that purely by chance when Wakefield’s paper was published. I looked at his paper and thought there was something very odd about it, doesn’t sit right just reading it on the page. Said at the time I was absolutely not going to get involved in MMR. Journalistically at the time, allegations against vaccines, if you want to do them in a responsible way rather than simply go to government experts or parents or people with interests and write down what they say and present the clash of opinions–if you want to understand what the story is really about, they require an enormous amount of work.

Later, he got pulled into the story:

At the time people were already saying: MMR, Brian Deer, he’s our expert, based on what I’d done in DTP. But in 2003, one of the editors was changing jobs, taking over some feature pages; wanted some stories. Said to me: Can’t you do investigation? I said: Well, what? Three or four different ideas. One was MMR. Didn’t want to get involved because there was a lawsuit coming up. By serendipity the lawsuit was cancelled and we’ll just do a feature, spend 2-3 weeks on the outside on MMR. Three weeks turned into 7 years, though not the whole time. Did make a couple of TV shows about other things as well.

Brian Deer started on the story, and right away he got pushback from Andrew Wakefield:

When you started looking into that Wakefield study, how did you proceed and what did you discover? Did routine journalistic work. At the start, put a phone call in to Dr. Wakefield. He always works with professional publicists; this time his publicist, within about 3 hours of me calling, his publicist had made a complaint against me to the paper. A bit of a strategic mistake on their part. The essence of the mistake is I am self-employed. But I have worked for the Sunday Times since 1981–that is my home. I was a staff reporter, a specialist, they sent me to the United States, and so on. But they imagined that this meant I was some sort of outsider. When they got onto the paper and started making complaints, they were making complaints against somebody who actually sat at the next desk to the editor, who had worked with the head of the legal department since we were all young together. So, it didn’t work, the complaint. I was a known entity. Whilst I am regarded as being a difficult, mercurial person, I think it is true to say I am trusted. That was the first mistake they made.

Brian Deer made some phone calls. Talked to parents of the Lancet 12. He immediately found that there was a problem. The “case series” was heavily biased. The children were recruited. They were involved in litigation.

Right at the start I rung up some parents who had been in the original paper and interviewed them. Interviewed them in a way they had not been interviewed before. Produced important information within hours of beginning the story. Which was? I phoned a lady who had started a campaign group against the MMR back in the 1990s and she told me in the conversation that members of her group were in the Wakefield study; said: they are all members of our group and still in the group. So these parents who had turned up at the hospital, she told me they were all members of her campaign group. Immediately alarm bells started to ring, because nothing about that had been mentioned in the paper. They all just appeared to be routine patients of a big London hospital; but she was saying they were part of a group. A group that had been created before the study. It was the result of her campaigning. She put advertisements in newspapers and made approaches to a firm of lawyers.

He discusses the start of the interviews. How he interviewed one parent using “Brian Lawrence” and how the information he heard didn’t mesh with the Lancet paper:

How did you interview them and what did you discover? The key one in the series of 12 was family 2. The mother, it came out over a period of time, had been a long-time collaborator of Dr. Wakefield’s. I went to interview her; in fact, I used my middle name which had been editorially approved from my managers rather than my full name so they wouldn’t google me and see I was an investigative reporter. I said I was Brian Lawrence, my middle name. How were you representing yourself? My friends say I’m a journalist you wouldn’t want to write about you. You would google me. I asked her all the questions people ask, isn’t it awful; who do you blame? I then went into exceptional detail as to what actually happened when she said her child was vaccinated and developed these problems. Went over her story in great detail. She’d already recently been involved in litigation; so the matter was very clear in her mind. She told me a very detailed story. You could say: People forget, matter of time; but this was the moment when she was saying her child’s life had forever been destroyed. Have to expect she would have that in her mind. It was quite clear that the story she was telling me did not correspond with any case in Wakefield’s paper. What it boiled down to in her case was that she had changed her story, told one story when she’d gone to the hospital and now telling another story; and the two stories couldn’t be reconciled. The difference was when did the problems of autism first reveal themselves. In her story that she told the hospital, it was 14 days; but in her actual story, far from the case. In fact it was months. She’d given one story which suited the paper. She may have done so in complete good faith. Might have misremembered. But when she had the opportunity to study her child’s records, it was a different story.

He tells of the first stories coming out in the Sunday Times, revealing that Mr. Wakefield was working as a paid expert, his patent, and the fact that data from his own laboratory (from Nicolas Chadwick) showed that there was no evidence of measles virus in the gut tissues of the children.

As a result of that, Wakefield made his second big mistake. His first was to have complaints made against me to my employers. Second was to begin litigation. He sued for libel.

Because of the lawsuit, Brian Deer was able to obtain more information. He was pretty much forced to in order to defend himself in the legal action. He used the freedom of information act. This exposed the connection to the Legal Aid Fund and the documents from the ethics approvals for Mr. Wakefield’s research (which showed that Mr. Wakefield started before he had ethical approval).

He couldn’t have expected–maybe this was his second mistake and suing me was his third mistake–in late 1996, early 1997, going back to when Princess Diana was still alive, that the incoming Labour government, the Tony Blair government, with a commitment to produce a Freedom of Information Act. America’s had a freedom of information act for so long no one can remember when it began. We had one introduced by the incoming Blair government. Enacted in 2000, started to take effect in 2004. Because the government had told government bodies to act as if the Act was in force, I was able to get from public bodies the fact that Wakefield had been paid. Funding Authority, in Britain called the Legal Aid Fund. Kind of like public defender system except the government doesn’t provide the defenders–it provides the money. So, it was a government fund to allow access to poorer people to litigation which had funded Wakefield’s lawyer. He could never have expected when he was doing this research that all of a sudden his funding would be exposed to scrutiny, and also the Ethics Committee. In America called Institutional Review Boards. Bodies of doctors, scientists, others associated with medical centers which give permission for research to take place. The paperwork of that body of the Royal Free Hospital also moved into the public domain by the Freedom of Information Act. I think I was the first person ever to get hold of these kinds of papers.

Mr. Wakefield tried to get the lawsuit put on hold, but Mr. Deer was able to force the case to proceed. Mr. Wakefield kept the pressure up:

There were occasions. He also sued me for my website, for which I have unlimited liability, would have lost my home had it been true. I would be sitting at my computer doing some work and there would be a ring on the doorbell and there would be a man dressed in black leather with a motorcycle helmet on and he would present me with an envelope. This happened to me twice. I opened the envelope and there’s an [?] for Wakefield’s legal costs for the hearing that was going to take place the next day in court. The figures were about $30,000 U.S. dollars, that kind of money just for one hearing. That was the kind of pressure they were trying to put on me.

And this proved to be a tactical mistake for Mr. Wakefield. This gave Brian Deer access to the medical records:

The next stage which was very unfortunate for him was that we got a court order against him requiring him to hand over to our lawyers the hospital medical records of the children. I never took possession of them. The judge balanced the issues of the confidentiality of the children as opposed to the fairness of the litigation in front of the court. Ordered that I be allowed to read the unredacted–with their names and all their details–of the 12 children. There were just 11 at the time–the American wasn’t involved in this. So under strict supervision of my lawyers, with a lawyer sitting at the end of the table throughout, I sat and read the medical records of the children.

It appears that Mr. Wakefield knew that giving Brian Deer access to this information was a problem, as he chose this time to cancel his lawsuit. Brian Deer couldn’t use the information, but at this point he knew enough details to realize that there was an even bigger story here. So he attended the GMC hearings:

I have never said anything about what I read in those medical records. The position is that they were disclosed to me in the course of litigation and I may make no use of anything I saw in those records or disclose anything. As I was sitting there reading them, Dr. Wakefield’s lawyers were in a taxi travelling across London to the High Court to disband the lawsuit against me. When I got home that night–and I hadn’t taken any notes with me or documents–I went home, phone rang, and it was my lawyers saying: It’s over. They’ve thrown in the towel. So I’m in the position where I have read the medical records of these children but can make no use of the content of them. However, I have to say–I’ve talked to my lawyers about this–it is a fact that it’s impossible to un-know something. Once you know something, you can’t stop knowing it. Unrealistic. So, what I did was to ensure that I presented myself at the next opportunity where these medical records would go on display. And they would go on display at a Disciplinary Hearing which arose from my original stories.

Asked a “what next?” question, Mr. Deer responds that it is time to move on:

Not sure I want to spend a lot more time on long investigations. Saying of the Buddha: The things we dwell on become the shape of our minds. I’m kind of tired of the hunt aspect of it and the adversarial quality to investigative journalism, the extraordinary hours that have to be put in to it to get anywhere. The complex legal issues that are always coming up. In an ideal world I’d find something that didn’t require me to do more than write a couple of hundred words in a piece and be cheap and cheerful. But I have a feeling that is just how I am feeling at the moment and it won’t be long before something else comes along that I get interested in and get drawn off into. I think what I need now is a holiday! I for one now am grateful. Striking a blog against fraud doesn’t make up for all the pain and losses people suffered as a result of the fraud, but it will open people’s eyes down the road to other things.

Mr. Deer goes into the results of the investigation, both his and the GMC investigation. He discusses how Mr. Wakefield was found guilty of multiple ethical violations, including subjecting disabled children to procedures which were for research purposes and not in their clinical interest, dishonesty, financial issues, etc.. He discusses the costs, both in Mr. Wakefield’s expert fees (about $750,000) and the costs of the GMC investigation. The costs to public health as MMR uptake dropped in the UK and measles came back.

Most people in this subject have seen it in terms of vaccines, measles, infectious disease, autism, or things like that. From the start, I’ve always seen it as being as being an issue of the integrity of science. Whether this paper was true or not and how he could get away with how he got away with. I think it is a depressing picture. It’s been in the region of $10 million dollars to crack a case series of 12 patients. The money involved with the General Counsel hearing, the litigation involved, journalistic fees, and all the staff gone around this to get to the bottom of this little case series of 12 patients. The great bulk of science is not that interesting to the general public and therefore would not create the cause for a newspaper reported to be funded by a newspaper or television station to go after this for such a long period of time and get all this investigative work done with government regulators and what have you. So, you really would have to wonder what else is going on in laboratories and medical centers. The fact that Wakefield thought he was going to get away with it, and the casual way he went about it leads me to think he was working within a culture within which that wasn’t far from unusual, wasn’t far from extraordinary–the kind of misrepresentations he made were far from remarkable by common standards, I suspect. Part of it the nature of human beings; part of it the elusive nature of truth. Part of it is the nature of the publication process.

The Lancet’s two days to bury bad news

19 Jan

Part three of Brian Deer’s series in the BMJ, The Lancet’s two days to bury bad news, has just been released. As you can imagine from the title, he lays out how the Lancet responded to the news that Brian Deer was publishing a story on the Wakefield team’s article in The Lancet.

Brian Deer’s first article in the Sunday Times was published February 22, 2004. On February 18, Mr. Deer met with the editor of the Lancet and other senior staff for five hours.

I had assumed that when I finished Horton would say that an investigation was needed to untangle these complex matters. There were at least three strands: possible research fraud, unethical treatment of vulnerable children, and Wakefield’s conflict of interest through the lawyer. But within 48 hours, and working with the paper’s three senior authors, the journal was to publish a 5000 word avalanche of denials, in statements, unretracted to this day.

Mr. Deer has investigated what was going on behind the scenes at the Lancet and at the Royal Free. Statements to the press claim by Richard Horton, editor of the Lancet, claim that an investigation was made at the Royal Free which “cleared Wakefield of wrongdoing”. According to Mr. Deer’s investigation, no formal investigation was conducted. Rather, the Royal Free chose Doctors Wakefield, Murch and Walker-Smith, authors of the paper in question, to prepare the response.

The Lancet’s statements came on on Friday, 48 hours after the meeting with Brian Deer and 2 days before his article was set to run in the Sunday Times in an apparent attempt to

“The Lancet editor’s actions have been to regard the allegations . . . as allegations of research misconduct, and following the medical editorial code has carried out an investigation according to agreed guidelines, and intends to publish the result of the investigation pre-emptively,” Hodgson told his UCL superiors in a memo that Friday. “No doubt one—but I believe only one—motive is to safeguard the Lancet’s reputation by getting the riposte in first, and ‘spoiling’ the story.”

The media furor over these revelations led to, amongst other things, the GMC hearing which would eventually strip Mr. Wakefield of his license to practice medicine in the UK:

Wakefield attempted to brazen it out, issuing a further statement to media. “It has been proposed that my role in this matter should be investigated by the General Medical Council,” he said on the Monday. “I not only welcome this, I insist on it, and I will be making contact with the GMC personally in the forthcoming week.”

The same day, a caseworker for the regulator called me from Manchester. Did I have any further information? And two days later, at 12.16 Wednesday, I emailed him the conclusions of my research. I summarised what I had said to the Lancet’s senior staff and pledged my cooperation, in the public interest.

The above sets out the timeline for the onset of the GMC hearing. For those who continue to claim that Mr. Deer was the “claimant”, I doubt even more evidence will dissuade them.

The editorial that the BMJ published along side the Deer article is clear in how serious they take the lack of oversight that went into this research and the initial investigation, placing Mr. Wakefield’s work alongside some of the worst examples of medical research gone wrong in the past century:

Unfortunately, we have been here before. Investigators involved with the 1932 US Public Health Service Tuskegee Syphilis Study deceitfully enrolled subjects with latent syphilis and denied them available treatment for 40 years in order to study the natural course of the disease.(4) As part of a 1963 study to determine the body’s ability to reject foreign cells, patients at the Brooklyn Jewish Chronic Disease Hospital were injected with live cancer cells without their knowledge and without oversight from the institution’s research committee.(5) From 1944 to 1974, the US government conducted several radiation experiments, some of which involved the use of non-therapeutic radioactive tracers in children and increased their risk of developing cancer.(6) And in 1981, it was discovered that John Darsee, a clinical investigator at Harvard Medical School, had fabricated data in several experiments published in high profile medical journals that ultimately culminated in widespread retractions of his work and a ban from funding from the National Institutes of Health for 10 years.(7) These experiments have since become symbolic of unethical research on human subjects and of scientific misconduct, and there is little doubt that Andrew Wakefield’s 1998 study will too.(8)

They go beyond this and ask the pertinent question–how did this happen and how do we avoid it in the future?

How could this happen again? To answer this, perhaps we need to focus less on the people involved and more on the defects within the biomedical research enterprise that permit such egregious misconduct. After all, Wakefield was able to circumvent the existing safeguards established to ensure the responsible conduct of research, the protection of research subjects, and the accurate and honest publication of research findings.

The editorial discusses that “research incidents” like those surrounding Mr. Wakefield should be framed as adverse events and attacked similarly. It is a model which will no doubt be criticized by those who see autism as an adverse event to MMR, but it does lay out a framework of how to respond.

The editorial concludes:

Thirteen years later, we are only now beginning to understand the root causes of the multiple system failures involved in the Wakefield incident. We must strengthen our ability to investigate research adverse events. We need to use the tools and techniques available to protect the safety of patients in the clinical realm to protect research subjects. We also need to rethink and reform our customs and culture. The disastrous impact that Wakefield’s study has had on vaccine coverage, recrudescence of disease, public trust, and, most of all, science, requires that we do so in haste.

As we leave this subject, it is worth looking to the words of Andrew Wakefield himself. Words which resonate in a manner Mr. Wakefield did not intend, but resonate nonetheless:

The medical science, the medical system, the scientific system has failed you, for which I am ashamed.
–Andrew Wakefield, May 26, 2009.

He meant the statement as an accusation, that he was ashamed on behalf of the rest of the system, not his own missteps. I find the statement clearly ironic. He is correct, the medical science, the medical system, the scientific system has failed us. His efforts in the Lancet (and elsewhere) are an example of that failure. They do not stand outside of it.

Science has a very difficult choice. To choose between fidelity or collusion.
–Andrew Wakefield, May 26, 2009.

Too right, Mr. Wakefield. Too right. Of course, science had that choice in 1998 as well. You made the wrong choice.

Andrew Wakefield’s erasure from the UK medical register is complete

19 Jan

This just isn’t Andrew Wakefield’s week. Last year the General Medical Council (GMC) in the UK found Andrew Wakefield guilty of multiple counts of improper conduct. These include subjecting disabled children to invasive tests that were not in their clinical interest, placing children in a research program without first obtaining the safeguards of ethical approval, financial and commercial conflicts of interest as well as other breaches of ethical conduct.

Here is one example paragraph from the sanction of Mr. Wakefield:

With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and 8) considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.

The sanction includes the determination that Andrew Wakefield should have his name erased from the medical register:

Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.

Mr. Wakefield had a period of time to appeal to the High Court. I have word from Brian Deer, the journalist who first broke the story of the Mr. Wakefield’s misdeeds, that the time has passed and the erasure is now effective.

For those who want visual confirmation, here is the GMC’s registry page on Mr. Wakefield. (click to enlarge)

Mr. Wakefield’s business plan as discussed at the GMC hearing.

13 Jan

As Kev has discussed, Mr. Wakefield has put out a press release denying all allegations about research fraud and an attempt to profit from the research he was engaging in. I had hoped to put this all behind us, but I thought for those interested, a more thorough discussion of Mr. Wakefield’s business venture might be appropriate here. I copy below a section of the GMC hearing testimony from Day 31. Mr Cengiz Altan Tarhan, who worked on the finance side of University College London and was brought in to discuss, amongst other things, Mr. Wakefield’s business venture.

Q I am going to be reverting to that role in more detail much later on in the story, but just so everyone knows that is a company that relates to technologies developed by the Medical School, is that correct?
A Not just the Medical School. It is the whole of the university. So it is University College London. The Medical School is a part of the university.

Immunospecifics is discussed below, but it went through name changes, including Carmel. I’ve wuoted a section of testimony below. Questions and answers in the hearing are italicized. The text of the documents is left normal.

The documents discussed involve the plan to spin-out a company from UCL to develop Mr. Wakefield’s invention (as put forth in his patent) into a therapy and as a vaccine replacement.

Q Sir, I am going to call this gentleman from now on in order to protect the confidentiality of the boy, his son, as “Dr 10”. Could we go, please, in volume 2, to page 756a. This is a letter that was sent to you before a meeting. It is from Dr Wakefield to you dated 26 February 1998.

“Re our meeting on Tuesday, 3 March 1997, please find enclosed two references for Alex Korda, our proposed Chairman. I have applied for references for Dr [10], our proposed CEO [Chief Executive Officer], and will pass these on as soon as these are available .

In addition, Dr Kirkpatrick from Denver, Colorado, will be giving a guest lecture on the use of Transfer Factor in the treatment of viral disease on the same Tuesday lunch time in the Department of Paediatric Gastroenterology. I realise that this may be of limited value to you other than reassuring you that Transfer Factor is a credible and rational alternative treatment for viral infections. Dr Kirkpatrick holds certain IPR [intellectual property rights] that may be relevant to our endeavours, and Alex Korda, [Dr 10] and I will be meeting with him to discuss this. I will feed back as soon as I have more information.”

Is that correct?
A Yes.

Q Would you go on to 797, please. That is a memo from you. I am told that is a document that needs to be put back into the bundle. Actually, sir, this is a tranche of documents which goes all the way from 797 to 816. Perhaps I can give them all to you at once so I do not do it piecemeal.

THE CHAIRMAN: I have 797a here.

MS SMITH: In that case you need 797 to precede it and then, after 797a, you go on with the rest of the documents, which go from 798 to 816. Could we go first of all, Mr Tarhan, to 797.
A Okay.

Q This is a memo from you and sent to Mr Dutton, Professor Zuckerman, Mr Blatch and Miss Bishop, dated 6 March 1998.

“Mr Wakefield and potential company proposal

Andy came to see me with two of his colleagues who expressed an interest in setting up a company and acquiring the patents from the School. I asked for some background papers on the two individuals. One is a XXX (10) and the other appears to be an entrepreneur with previous experience with start up companies and is prepared to raise funds for the company.

I have asked them to put forward what they saw as the business plan and way forward and will report back as soon as I have further information.”

Can we then go on to 798. This is your second memo, 6 March 1998, to the same people.

“Further to my memo of 4 March I have now received the attached document from [Dr 10] the Managing Director designate for Immunospecifics Biotechnologies Ltd.

Any comments would be appreciated.”

Attached to that, was there a business plan document?
A That is correct.

Q That starts at page 799. Can I just look in brief terms at the contents of that.

“Immunospecifics Biotechnologies Ltd is a new biotechnology venture specialising in the isolation, production licensing and marketing of a new range of immunotherapeutics, generically known as transfer factors. These compounds are a naturally occurring part of the human immune system and promote specific cell mediated immunity towards the target antigen.

The first clinical condition targeted will be measles virus induced inflammatory bowel disease. It is estimated that this disease costs the NHS about £15,600,000 per annum. The incidence of measles induced inflammatory bowel disease is increasing dramatically in Europe and the States. Immunospecifics … will undertake the start of a two year, double blind, phase 1 clinical trial into the effectiveness of measles specific transfer factor in the treatment of inflammatory bowel disease and an open label study into the effectiveness of the same product in ameliorating pervasive developmental disorder within 3 months of securing funding.

In parallel with the clinical trial the company will develop a clinical diagnostic for the presence of the measles virus. It is estimated that the market for this diagnostic is about £4,000,000 per annum in the UK alone. The company will also investigate the potential of transfer factors as vaccine alternatives. An animal model trial of the value of measles specific transfer factor in preventing inflammatory bowel disease will begin upon securing funding.

On completion of a successful phase 1 clinical trial the company will move towards phase 2 and phase 3 trials for the measles specific transfer factor whilst introducing new potential transfer factor therapeutics to its development portfolio. Prior to the completion of this first phase trial, the company expects to have finished the laboratory development of the clinical diagnostic, completed the open label study into pervasive developmental disorder and finished the animal study into the potential of transfer factor as a vaccine.

The company is looking to raise about £2,100,000 to undertake this development programme.”

Moving on to page 800,

“THE PRODUCTS

[Immunospecifics] will specialise in the production, formulation and sale of a wide range of immunotherapeutics, generically known as transfer factors (TFs). [Transfer factors] are a naturally occurring component of the immune system which have been shown to confer antigen specific cell mediated immunity. This form of immunity is important in overcoming viral infectious agents. Many viral agents have the capacity to suppress the body’s cell mediated immune system (e.g. Human Immunodeficiency Virus). Overcoming this suppression through the introduction of an antigen specific cell mediated immunity promoter has enormous potential clinical significance.”

Then it sets out the history. Would you go on to page 801, the top of the page and second paragraph down,

“It is [Immunospecifics’] aim to use a high potency, standardised TF preparation in one of the first properly controlled clinical trials of these materials. The target conditions for the trials will be specific forms of inflammatory bowel disease (IBD) and a condition affecting children known as pervasive developmental disorder (PPD). These trials will begin within the first three months of the company’s establishment. Whilst these trials are taking place, the company will be purifying and characterising the active compounds in the TF preparation. Once isolated and characterised, the potential for this molecule as a measles specific vaccine will be evaluated in animal model systems.”

Going on to page 802 and just past the middle of the page,

“STRATEGY AND OBJECTIVES

[Immunospecifics] is at present no more than a concept, but one with a unique opportunity. The strategic goal for the venture will be to achieve full regulatory approval for the use of antigen (infectious agent) specific transfer factors in a variety of clinical conditions where existing treatment regimes are either non-existent or have limited effectiveness. This strategy will permit the company to establish a clear technical and medical lead in this area with a resulting dominant market share. Paralleling the use of [transfer factors] as therapeutics will be a research programme aimed at demonstrating the value of [transfer factor] as a vaccine.

The objectives and associated tasks for the first two years to develop the concept into a full-scale venture are summarised in the following points.”

Turning back to page 801 for a moment, Mr Tarhan, and the bottom of the page, the last paragraph reads,

“It is [Immunospecifics’] aim to undertake a phase I clinical trial of a high potency measles specific transfer factor supplied by Fudenberg’s group at a very early stage in the life of the Company.”

Would you turn now to page 804 and this is still under the heading, “STRATEGY AND OBJECTIVES” and to number 7 of 9,

“Establish the potential of the high specific active preparations as a potential measles vaccine

This study will be done in conjunction with ‘Immuno’ a subsidiary of Baxter Health Care, in Austria using simian model systems. The efficacy of the [transfer factor] will be assessed by its ability to prevent measles specific IBD during challenge experiments. ‘Immuno’ have agreed to undertake the preliminary work with the [Royal Free Hospital] at no cost, although Immuno’s contribution is estimated to be of the order of £100,000. If successful this concept will be developed further in collaboration with a major pharmaceutical company, such as Glaxo Wellcome’s Jenner Institute. The full relationship between ISB and Immuno needs to be resolved.”

Going on to page 805,

“Medium term objectives for the venture will be: 1) to take the purified and characterised measles specific [transfer factor] through formal product registration by undertaking phase II and phase III clinical trials; 2) establish the most appropriate route for the commercial development of the product; 3) develop the potential for use of [transfer factors] as vaccine replacements; 4) introduce new anti-infectious agents TFs to the company’s product development portfolio and take them through to formal product registration.”

Secrets of the MMR scare: How the vaccine crisis was meant to make money

11 Jan

Last week, Brian Deer published an article in the BMJ How the case against the MMR vaccine was fixed. In it he lays out how data were misreported in Andrew Wakefield’s now retracted 1998 article in The Lancet. The BMJ editors published an editorial coincident with the Deer article, Wakefield’s article linking MMR vaccine and autism was fraudulent.

In his latest article in the BMJ, Brian Deer lays out: Secrets of the MMR scare How the vaccine crisis was meant to make money

Andrew Wakefield had plans to make money. A lot of money. He created a business to produce diagnostic testing kits. He applied for a patent for a therapeutic agent and a proposed vaccine to prevent measles infections. This in addition to the money he was collecting as a paid expert to the MMR litigation in the UK.

On the diagnostic testing kit. Mr. Deer obtained the prospectus for the company that was formed to develop and market it:

“It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA,” said a 35 page “private and confidential” prospectus, which was passed to me [Brian Deer] by a recipient.

He predicted £28,000,000 in revenue from the therapeutic and diagnostic products from his company.

Mr. Wakefield used a laboratory in Ireland, Unigenetics, headed by John O’Leary, to test tissue samples for measles virus. This is well known. Mr. Wakefield was a director of that laboratory.

The work by Unigenetics was key to the company’s success. Mr. Wakefield predicted–apparently in September 1996, before the research was completed–that Unigenetics would provide “unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples”

“Once the work of Professor O’Leary and Dr Wakefield is published, either late in 1999 or early in 2000, which will provide unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples,” the prospectus said, “the public and political pressure for a thorough, wide ranging investigation into the aetiology of the bowel conditions will be overwhelming.

“As a consequence of the public, political and legal pressures brought to bear, the demand for a diagnostic able to discriminate between wild type and vaccine derived measles strains will be enormous.”

That paper has since been discredited. First, a major attempt to replicate it failed. More importantly, Stephen Bustin, perhaps the world’s foremost expert on the methodology used (PCR), found that the Unigenetics laboratory’s methods were so seriously flawed as to make any results worthless (good summary here). Also, it was found that PCR data from Mr. Wakefield’s own research group were negative for measles virus, and that Mr. Wakefield buried those negative results.

It was because of these (and more) conflicts of interest that he was let go from the Royal Free Hospital (long before the Brian Deer investigation). Mr. Wakefield’s claim that his departure from the Royal Free was because his “research was unpopular”. Contrary to this position, the Royal Free had offered Mr. Wakefield the opportunity to prove his hypothesis.

But the paperwork does not show this. Despite all that had happened, UCL volunteered to support his work. It offered him continuation on the staff, or a year’s paid absence, to test his MMR theories. He was promised help for a study of 150 children (to try to replicate his Lancet claims from just 12) and, in return for withdrawing from the January London conference, he would be given the intellectual property free.

“Good scientific practice,” the provost’s letter stressed, “now demands that you and others seek to confirm or refute robustly, reliably, and above all reproducibly, the possible causal relationships between MMR vaccination and autism/“autistic enterocolitis”/inflammatory bowel disease that you have postulated.”

Yes, Mr. Wakefield had an offer on the table to take a year to prove his hypothesis. The Royal Free already had their doubts, and even more doubts about Mr. Wakefield’s conflicts of interest. And, yet, it would take a few more years before Brian Deer would make this public.

At first Mr. Wakefield agreed to the Royal Free’s proposal. But he never put the plan into action. When it became clear that he had no intent to follow through, he was let go from the Royal Free.

One defintion I found (the top definition at dictionary.com) defines fraud thus:

deceit, trickery, sharp practice, or breach of confidence, perpetrated for profit or to gain some unfair or dishonest advantage.

As presented last week by Mr. Deer, data were manipulated to “fix” the results of Mr. Wakefield’s research. This week’s installment discloses how Mr. Wakefield sought to profit from this work. Pretty clear to this reader that this meets the definition of fraud.

Here is how the BMJ summarized the article:

Andrew Wakefield, the disgraced doctor who claimed a link between MMR and autism, planned secret businesses intended to make huge sums of money, in Britain and America, from his now-discredited allegations.

The Wakefield scheme is exposed today in the second part of a BMJ series of special reports, “Secrets of the MMR scare”, by investigative journalist Brian Deer. Last week we revealed the scientific fraud behind the appearance of a link between the vaccine and autism. Now Deer follows the money.

Drawing on investigations and documents obtained under the Freedom of Information Act, the report shows how Wakefield’s institution, the Royal Free Medical School in London, supported him as he sought to exploit the MMR scare for financial gain.

It reveals how Wakefield met with medical school managers to discuss a joint business even while the first child to be fully investigated in his research was still in the hospital, and how just days after publication of that research, which triggered the health crisis in 1998, he brought business associates to the Royal Free to continue negotiations.

One business, named after Wakefield’s wife, intended to develop Wakefield’s own “replacement” vaccines, diagnostic testing kits and other products which only stood any real chance of success if public confidence in MMR was damaged.

Documents reveal the planned shareholdings of Wakefield and his collaborators, and how much Wakefield expected to receive personally. Financial forecasts made available for the first time today show Wakefield and his associates predicting they could make up to £28 million ($43,367,082; €33,290,350) a year from the diagnostic kits alone.

“It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA,” said a 35 page “private and confidential” prospectus obtained by Deer, aimed at raising an initial £700,000 from investors. “It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.”

Deer’s investigation also reveals today that Wakefield was offered support to try to replicate his results, gained from just 12 children, with a larger validated study of up to 150 patients, but that he refused to carry out the work, claiming that his academic freedom would be jeopardised. His research claims have never been replicated.

There will be at least one more installment in this series by Brian Deer in the BMJ.

Timeline of MMR scare

11 Jan

From Brian Deer’s latest article in the BMJ“:

Timeline of MMR scare

October 1988: The three in one measles, mumps, and rubella vaccine is introduced to the UK after successful use in the US since 1971. Previously, single measles and rubella vaccines were used, and there was no licensed mumps vaccine

September 1992: The UK Departments of Health withdraw two brands of MMR vaccine after research shows them to be associated with a raised incidence of transient mumps meningitis, although much lower than with natural disease

January 1994: A campaign group, JABS, is launched in Wigan, Lancashire, alleging that MMR causes brain damage and other problems in children. Autism and inflammatory bowel disease are not initially claimed

March 1995: Andrew Wakefield, a researcher at the Royal Free medical school, files for a patent claiming that Crohn’s disease and ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue and body fluids

September 1995: Paediatric gastroenterologist John Walker-Smith moves with most of his team from Bart’s hospital, London, to set up a service at the Royal Free

February 1996: JABS solicitor, Richard Barr, retains Wakefield, at £150 an hour, plus expenses, to support a speculative legal attack on MMR manufacturers. This contract is not publicly disclosed

July 1996: The first child is admitted to the Royal Free for research to try to show a link with MMR. The research is commissioned by, and supported with a £55000 grant from, the UK Legal Aid Board, but this is not publicly disclosed

September 1996: Wakefield and his mentor Roy Pounder meet medical school managers to discuss market projections for a new business based on purportedly diagnosing Crohn’s disease from the presence of measles virus

June 1997: Claiming that the measles virus in MMR causes problems, Wakefield files for a patent on a “safer” single measles vaccine and for products to treat both autism and inflammatory bowel disease. This, too, is not publicly disclosed

February 1998: The Lancet publishes a 12 patient case series by Wakefield and 12 others, proposing a link between MMR and a “new syndrome” of autism and bowel disease. At a press conference, he urges the use of single vaccines instead of MMR

February 1998: Just days after the press conference, Wakefield and business partners meet Royal Free medical school managers to discuss a joint company to develop products based on his MMR claims, including “a replacement for attenuated viral vaccines”

February 1999: Unigenetics is incorporated, with Wakefield and a Dublin pathologist, John O’Leary, as directors. The company is awarded £800000 by the Legal Aid Board to perform tests on samples from children seen at Walker-Smith’s Royal Free unit

December 1999: Mark Pepys, new head of medicine at the medical school, challenges Wakefield about his business scheme and puts him on notice that he must replicate his research

January 2001: The Daily Mail and other newspapers launch campaigns backing Wakefield, working with JABS, after he publishes a purported review of his evidence and repeats his calls for single vaccines

October 2001: Wakefield is asked to leave the Royal Free after failing to mount a large scale controlled study to confirm or refute his claims about MMR

December 2001: Prime Minister Tony Blair is ambushed by Wakefield supporters, who claim that his youngest son, Leo, did not have MMR. The Blairs initially decline to comment but much later deny the claim

May 2002: Amid continuing media campaigns over MMR, particularly by the Mail and Telegraph groups, the magazine Private Eye issues a special edition, written in collaboration with families that are suing vaccine manufacturers

January 2003: Vaccination among 2 year olds falls to 78.9%: below the 92% the Department of Health says is needed to maintain herd immunity. Figures in parts of inner London are half the national rates

September 2003: The Legal Services Commission stops funding for Barr’s lawsuit after barristers for the claimants report to the commission that, on the evidence, they cannot make a case that MMR causes autism

February 2004: The Sunday Times reveals that the Legal Aid Board funded the Lancet research and that many of the children were litigants. Richard Horton, the journal’s editor, rejects more serious charges against the authors, later proved by the GMC

March 2004: Ten of the 1998 paper’s 13 authors, excluding Wakefield, retract its “interpretation” section, which claimed an association in time between MMR, enterocolitis, and regressive developmental disorders

November 2004: Channel 4’s Dispatches reveals Wakefield’s single vaccine patent and that, despite Wakefield’s claims that the culprit for the disorders is measles in MMR, molecular tests in his laboratory found no trace of the virus

January 2005: Wakefield initiates libel lawsuits, funded by the Medical Protection Society, against the Sunday Times, Channel 4, and Brian Deer over Deer’s website, claiming that all allegations are false and defamatory

March 2005: Among much research rejecting any link with developmental disorders and bowel disease, research is published showing that, after MMR was discontinued in Japan, the incidence of autism diagnoses continued to rise

October 2005: In the London High Court, Mr Justice Eady refuses an application from Wakefield to freeze his libel actions and orders him to proceed to trial of Deer’s allegations against his “honesty and professional integrity”

April 2006: As measles outbreaks are reported across Britain, the first death in the UK from the disease in 14 years is reported—a 13 year old boy from the traveller community

December 2006: The Sunday Times reveals Wakefield’s personal funding from Barr to support the lawsuit over MMR: £435643 plus expenses, from the legal aid fund. Some other Royal Free doctors were also paid

January 2007: Two days after the payments from Barr are revealed, the Medical Protection Society stops funding for Wakefield’s libel actions and through him agrees to pay the defendants’ costs of about £800000 on top of its own legal bills

July 2007: At a fitness to practise hearing in London, the General Medical Council opens its case alleging serious professional misconduct by the Lancet paper’s three senior authors, Wakefield, Walker-Smith, and endoscopist Simon Murch

February 2009: The Sunday Times alleges that Wakefield “fixed” the appearance of a link between MMR and autism. He denies fraud and files a complaint with the UK Press Complaints Commission, which he later abandons

February 2009: In the United States, three test case judgments for 5000 claims based on Wakefield’s theories are handed down in federal court, rejecting the allegation that MMR can cause autism. They are upheld on appeal in August 2010

January 2010: A panel comprising three doctors and two lay members gives findings of fact on the GMC’s case, upholding dozens of charges against Wakefield, Walker-Smith, and Murch and sending all three forward for sentencing

February 2010: Six years after the matters were raised with the Lancet, the journal fully retracts the 1998 paper. Horton describes aspects of it as “utterly false” and says he “felt deceived”

May 2010: After a 217 day inquiry, the GMC panel orders Wakefield and Walker-Smith to be erased from the medical register, but notes that Murch had shown “insight” and finds him not guilty of serious professional misconduct