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Why does it matter what happens to Andrew Wakefield?

8 Jan

People have been questioning the necessity of these latest revelations about Andrew Wakefield and suggesting that enough is enough or maybe that all this latest round of publicity will do nothing except make him a heroic martyr. This is possible.

However, for a number of reasons I really feel it is vitally important that not only is there some response but that that response comes at least partly from the autism community.

Firstly, I believe it is necessary for there to be a response full stop. These might be the same set of _facts_ that were uncovered during the GMC hearing but the difference here is that for the first time it has been established that the facts against Andrew Wakefield came about through what the BMJ refer to as fraudulent. This is a huge difference. Up until now it could’ve been argued that Andrew Wakefield simply made a mistake. After the events of the last two days, that can never be honestly argued again.

Secondly, there are a set of people who have been at the rough end of Wakefield’s fraud for the last 13 years. A set of people who have struggled to make new parents understand that there is no risk of autism from the MMR vaccine. Doctors. Particularly paediatricians and GP’s. It is vital that by establishing what Wakefield has done as fraud, the media ensure that the message is spread far and wide. They (the media) have something to atone for in this respect, being the original spreaders of the message that the MMR caused or contributed to autism. They now need to recognise their role in the past and help the medical establishment by ensuring Wakefield can never again spread his fraudulent claims via their auspices.

Thirdly, there is another set of people who have been at an even rougher end of Wakefield’s fraud. The sufferers of the falling vaccination rates of MMR. Its been well documented in numerous places, including this blog how people – particularly children – have been injured and died in the UK and US. The concept of herd immunity, no matter what some might claim is a real concept and when it falls, the level of protection falls. When it falls to far then the people who suffer are the very young, the very old and those who for genuine medical reasons cannot be vaccinated. Wakefield’s fraud needs to be spread far and wide in order for people to realise what he is, what he tried to do and what the consequences were in order to have some confidence in the MMR jab.

Fourthly, there is another set of people who have suffered heavily. This set of people are the silent victims of Wakefield’s perfidy. Autistic people. Wakefield and his supporters, TACA, NAA, Generation Rescue, SafeMinds, Treating Autism et al have turned autism into a circus. The aim of the last decade amongst serious autism researchers and advocates has been to

a) Raise awareness
b) Find evidence-based therapies that will help the life course and independence of autistic people
c) Protect the educational rights of autistic people

and getting research monies to meet these aims is long, hard and slow. Andrew Wakefield and his hardcore of scientifically illiterate supporters have actively derailed that process, dragging research monies away from these principled activities and towards their core aim of degrading vaccines and ‘proving’ vaccines cause autism. Wakefield himself has taken over US$750,000 worth of money to pursue a legal battle against the UK Gvmt. Just think of how that money could have enriched the life of just one autistic person.

However, this same set of people claim to be representative of the autism community. They write nonsense books about autism. They hold celebrity studded fundraisers for autism. They participate in rant-filled rally’s for autism. But none of them are really about autism. What they’re about is anti-vaccinationism.

Every one of these activities denigrate autism and autistic people. They take attention away from where it is needed.

We, the true autism community, made up of parents, autistic people, professionals of autistic people need to do two things. Firstly, we need to wrest back control of the autism agenda from these one-note people. Secondly, we need to speak to society at large and say ‘yes, some members of the autism community believed the fraudulence of Andrew Wakefield but not all of us did. Please don’t tar us all with one brush.’

What Andrew Wakefield has done has impacted everyone. We need to make sure that he and people like him can never affect us all in this way again. To do that we need to speak out about him, loudly and as long as it takes.

Andrew Wakefield: the last gasps of a desperate man?

7 Jan

In his interview on Anderson Cooper 360 last night, Andrew Wakefield made some amazing claims against Brian Deer, claiming Brian Deer is part of some vast conspiracy. He wants to distance himself from the word, but that’s what he’s claiming with phrases like “He’s a hit man, he’s been brought in to take me down”, “It’s a ruthless pragmatic attempt…” “Who’s paying this man, I don’t know” and a claim that Mr. Deer is paid by the Association of British Pharmaceutical Industries.

Anderson Cooper has Brian Deer on tonight:

http://i.cdn.turner.com/cnn/.element/apps/cvp/3.0/swf/cnn_416x234_embed.swf?context=embed&videoId=health/2011/01/07/ac.autism.brian.deer.cnn

Brian Deer throws down the gauntlet and challenges Andrew Wakefield to sue him. Wakefield has already brought forth one case against Mr. Deer–and he forced to pay Brian Deer’s legal fees. Mr. Wakefield brought forth a lengthy complaint to the UK’s press complaints commission, only to abandon it without attempting to prosecute the complaint.

He also goes through a number of Mr. Wakefield’s attacks and shows that they are false.

Here’s the transcript from the Brian Deer interview:

(BEGIN VIDEOTAPE)

COOPER: Brian, overall, Wakefield is denying all of — all of the — the evidence that you have put forward in — in this — in this “British Medical Journal” report. What do you make of his — his — his defense?

BRIAN DEER, INVESTIGATIVE JOURNALIST, “THE SUNDAY TIMES OF LONDON”: Well, two things.

One, what else can he do, where else can he go but to deny it, and to make up even more tall stories about me, suggesting that somehow I’m in cahoots with the drug industry or governments or whoever else. He’s been at that one for years.

Secondly, these revelations are not just my revelations. They have been checked, exhaustively, by editors of “The British Medical Journal,” who have peer-reviewed it, who have gone back into the data individually and checked back and forth to have been sure that what I have said is accurate. So, it’s not just me.

So, I think it’s just the — the last gasps of a desperate man, really.

COOPER: I want to go over some specific things, because I think it’s important to be very specific with these allegations and with his response.

I asked Andrew Wakefield last night to respond to your report and the — the “British Medical Journal” report, which calls his study — quote — “an elaborate fraud.”

Here’s what he said.

(BEGIN VIDEO CLIP) WAKEFIELD: I have read his multiple allegations on many occasions.

He is a hit man. He’s been brought in to take me down because they are very, very concerned about the adverse reactions to vaccines that are occurring in children.

COOPER: Wait a minute, sir. Let me just stop you right there.

(CROSSTALK)

COOPER: You say he’s a hit man and he’s been brought in by “they.” Who is “they”? Who is he a hit man for?

(CROSSTALK)

COOPER: This is an independent journalist who’s won many awards.

(CROSSTALK)

WAKEFIELD: Yes, he’s…

(LAUGHTER)

WAKEFIELD: And he’s — you know, who brought this man in? Who is paying this man? I don’t know. But I do know for sure that he’s not a journalist like you are.

(END VIDEO CLIP)

COOPER: Wakefield went on to claim later in the interview that you’re being paid by the Association of British Pharmaceutical Industries.

Are you?

(LAUGHTER)

DEER: No, I’m not. I have been paid by “The Sunday Times of London.”

COOPER: Have you ever been paid by — by — by them?

(CROSSTALK)

DEER: Never, never once. I can’t even remember the last time I ever spoke to them.

I think I did have a — I did have an interview with some people who did some work for them several years ago. That’s about the closest I have ever got to the pharmaceutical industry.

In fact, one of the awards I received, the citation was that I was probably the only journalist in Britain who investigates the drug industry. So, I don’t think that one goes very far.

COOPER: What initially sparked your interest in investigating Wakefield?

DEER: Well, it was just an absolute routine assignment.

There was a television program that had been paid for by American interest to be broadcast in the U.K., and I was just assigned to do a — do a piece on it. And it started out like that.

And we asked Dr. Wakefield for an interview. And, almost immediately, within a matter of hours, complaints were being made against me to my editors by Dr. Wakefield’s personal publicist.

COOPER: When was that that you started doing these investigations?

DEER: Oh, this was in October, November 2003…

COOPER: OK, because…

DEER: … a long time ago now.

COOPER: … as you know, James Murdoch, the owner of — of your employer, “The London Times,” joined the board of GlaxoSmithKline, which is a manufacturer of MMR. He joined that board in 2009.

DEER: Yes.

(CROSSTALK)

COOPER: Some people have brought that up as a — as a conflict of interest.

DEER: No, it’s absurd, absolutely absurd.

In fact, it’s interesting that, in the last 24 hours, the only American network to have shown no interest whatsoever in the “BMJ”‘s revelations has been the FOX network…

COOPER: I asked Wake…

DEER: The only — they’re the only people.

COOPER: I asked Wakefield to respond to your reporting that — that — that states that medical records of all of the 12 cases that he initially cited in his “Lancet” paper back in 1998, that — that none of them were accurate, fully accurate.

I want to you listen to what he said.

(BEGIN VIDEO CLIP)

WAKEFIELD: That is false. He has not interviewed the parents. That is absolutely not true.

(CROSSTALK)

COOPER: So, you’re saying the parents — no parents say that what — that what you have said about their children’s medical histories is false?

WAKEFIELD: No, they don’t. What I have said and what has been reported in that paper by me and my colleagues is exactly what we saw.

(CROSSTALK)

(END VIDEO CLIP)

COOPER: Did you speak to any of the parents from the 12 cases?

DEER: I personally interviewed one, two, three families of the 12. Somebody else — two others were interviewed on my behalf by other journalists. So, that’s five of the 12.

Oh, no, actually, I interview — and I have had conversations with another, so quite a substantial number…

(CROSSTALK)

COOPER: So, you’re basically saying he falsified or — or got wrong all of the medical history, one way or another?

DEER: I — I — I showed the “Lancet” paper that Wakefield published to a father of a child in California who is child number 11 of this series of 12, and he looked at the paper, and he just looked at what it said about his own child, and he said, “That’s not true.” And that was one of the parents of one of these children in the paper.

But I think Dr. Wakefield has a — has a solution here. These revelations have been published in the U.K. jurisdiction, which is the most onerous libel jurisdiction in the world. Dr. Wakefield should sue, because, if what Dr. Wakefield is saying is true, then he would have an easy case for libel against “The British Medical Journal,” against “The Sunday Times of London,” against me personally.

If what he is saying is true, then he must be the victim of the most sustained campaign of malicious libel that has ever been inflicted on any individual in history.

COOPER: And that’s what he’s saying he is.

(CROSSTALK)

DEER: Well, you know, he has a remedy, doesn’t he?

But the reason he doesn’t take this remedy — in fact, he tried to take this remedy once before, when the doctors’ Medical Protection Society was funding him to sue me, sue the television company, sue “The Sunday Times.” And what happened at the end? He discontinued his action, and he sent me a check. I actually received a check from his lawyers to pay my legal costs.

Dr. Wakefield has a remedy. The trouble is, he can’t take that remedy, because he’s a fraudster. And, after all these years, he’s finally been nailed. We have been able to, over the years, produce the evidence that he was being paid by lawyers. We were able to show that he received three-quarters-of-a-million U.S. dollars.

Next week, we’re going to itemize in “The BMJ” his business interests and the extraordinary sums of money he intended to make from his own vaccine, from diagnostic kits, and from all kinds of other weird products he was going to sell off the back of his scare.

Dr. Wakefield did this for the money. And, finally, he’s been nailed as a cheat and a fraudster, and not just in a sort of academic vanity sense, but in an area of where children’s lives have been put at risk, and, even more importantly, in a funny way, where parents of children with autism have been left to blame themselves, thinking it was their own fault for vaccinating their child that their child has gone on to develop autism.

These are forgotten victims of Dr. Wakefield, and these are people ultimately that Dr. Wakefield preys upon.

COOPER: You know, it’s interesting, because I have gotten a lot of e-mails from parents who don’t — who still believe in Wakefield or believe the research, and are angry at — at, you know, our reporting on this, angry, certainly, at your reporting on this. I’m sure you have heard from them many times over the years.

DEER: Oh, yes.

COOPER: And it is heartbreaking, because there is no answer for what is causing autism. And, clearly, there have been problems with vaccines in the past.

What do you — what do you tell parents? What do you say to them?

DEER: Well, I say to — I say to parents when I talk to them — and, you know, you discuss these things with them, and I will tell you, the killer question to ask these parents, if you get an even conversation with them, is to say, do you blame yourself?

And they do. And I have had parents absolutely break down in tears, blaming themselves, thinking it was their fault for vaccinating their child.

Now, what Dr. Wakefield is able to do is to take that energy of guilt and self-blame, which is quite understandable, but is quite wrong, take that, exploit it, turn it into money, turn it into a business. And that’s what he’s done. And he’s having a wonderful time in Jamaica. I saw you interviewed him in Jamaica. Very nice.

COOPER: Wakefield claims that — that his findings have been independently replicated. Is that true?

DEER: That’s completely false.

COOPER: I mean, he said they have been replicated in five countries around the world. That was news to me.

DEER: Completely false. That’s absolutely, completely false. What he does is what he’s been doing in front of these parents over many years. He takes tangential pieces of research that don’t really relate to what he’s saying and represent them as somehow endorsing what he said.

One of the papers in fact which he cites absolutely, explicitly denies that anything like what he suggests has been found.

COOPER: He — he also…

DEER: He just makes it up.

COOPER: He also claims that — that he wasn’t making a connection between vaccines and — and — and autism, that — that it was parents who — who started making that, that the purpose of the study wasn’t to look at possible associations between MMR vaccinations and autism, but that association came from parents.

DEER: No, he just makes it up.

Those parents were selected by him and the lawyer and the campaign groups — actually, a campaign group organized by a mother who doesn’t have a child with autism, does have a grievously disabled child who I saw in a CNN bulletin just 10 minutes ago.

These people together selected a group of parents who blamed MMR and brought them to the hospital for them to make that allegation. That’s one of the key ways in which this research was rigged. He knew who these parents were. He would telephone them at their homes, invite them to the hospital, bring them in and get them to make the allegations to other doctors.

COOPER: What has angered you most or surprised you most in the years now since 2003 that you have been looking into and investigating this?

DEER: What has angered or surprised me most?

I think what has angered me most is the — is the distraction away from the real needs of children with developmental disorders and the real needs of families who are looking after them, because, very often, the families of children, particularly the ones that Wakefield preys on, are people who are just desperate for answers.

Some of them are financially quite challenged as well. Many of them are — are — are terrified about what’s going to happen to their children in the future. And it’s really shocked me that somebody would really prey upon the vulnerable.

It’s almost as though, if you’re vulnerable, you get picked on. It’s almost as — it’s almost an animal thing that — that people prey on these — these really unfortunate families who have got a — who have got issues.

And I — I just think it’s a shame that the energy that has gone into this anti-vaccine campaign hasn’t gone into a campaign for better services for people with disabilities, more research to get to the bottom of these kind of problems. I think it’s a great tragedy, great diversion of resources.

COOPER: Brian Deer, I appreciate your reporting and I appreciate you talking about it. Thank you.

DEER: Thank you.

(END VIDEOTAPE)

COOPER: He said a great diversion of resources for a mysterious and terrifying threat and one that is growing.

I want to show you the numbers that explain the fear. According to the Centers for Disease Control, on average, an estimated one in 110 kids in the United States have an autism spectrum disorder. That’s just under 1 percent, according to the most recent data from 2006.

The number of cases has been growing since 2002. There’s no doubt about it. Now, the rate varies among states, and it’s important to point out that autism spectrum disorder includes a — a range of developmental disabilities,with the most severe being autism.

There have also been changes in how diagnoses are made. And that may explain some of the increase, but not all of it, according to experts. Something else you should know, boys are four to five times more likely than girls to develop an autism spectrum disorder.

And while there’s no known cause yet, clues are emerging. It’s estimated that about 10 percent of kids with autism spectrum disorders have a genetic and neurologic or metabolic disorder, such as fragile X or Down syndrome.

Autism spectrum disorder is obviously an incredibly heartbreaking diagnosis for parents. It’s also extremely costly for both the families and the health care system. According to a recent study, the estimated lifetime cost to care for someone with an autism spectrum disorder is $3.2 million.

Let us know what you think. Join the live chat right now at AC360.com.

We will continue to follow the controversy.

One problem I have seen with this media frenzy over the Wakefield fraud story is that they (the media) are falling into the old traps of false balance, faux controversy, and “he-said, she said” reporting. The question isn’t whether Mr. Wakefield is guilty of misconduct. The GMC has already ruled on that. Mr. Wakefield is not “the accused” but “the guilty”.

CNN has allowed people like Andrew Wakefield and JB Handley a platform to make mostly statements which, at the initial airing, are unchallenged, and unsupported accusations. These people have much experience with handling the media and have been able to avoid the topic of of Mr. Wakefield’s fraud and his proven ethical violations. I appreciate that Anderson Cooper has gone back to do some fact checking, but the damage is already done at that point.

Here is a segment where Anderson Cooper does some fact checking on Mr. Wakefield’s claims and accusations:

http://i.cdn.turner.com/cnn/.element/apps/cvp/3.0/swf/cnn_416x234_embed.swf?context=embed&videoId=health/2011/01/06/ac.kth.autism.debate.cnn

Anderson Cooper made an attempt to verify the claims Andrew Wakefield made. Andrew Wakefield claimed that regression followed shortly after MMR vaccination. This has never been replicated. The studies that Mr. Wakefield attempts to use as support do not support that claim. The one attempt to actually replicate the claim, the Hornig study, found there was no association between gastrointestinal symptoms, regression and the MMR.

Anderson Cooper says that the studies Mr. Wakefield cites are “beside the point”. He says that the studies found an association between GI complaints and autism…which isn’t really the case.

Mr. Wakefield and his supporters try to claim, repeatedly, that Mr. Wakefield did not suggest that MMR and autism are linked. Interestingly, his own publisher in a statement to Anderson Cooper says the opposite.

“Yesterday, ‘The British Medical Journal’ published an article deeming the research printed over a decade ago by Dr. Andrew Wakefield suggesting a connection between autism and vaccines fraudulent. Wakefield stands strong in asserting that the allegations of ‘BMJ’ journalist Brian Deer are entirely false.”

Here’s the transcript of that section:

We begin, though, as always, “Keeping Them Honest.”

Tonight, the emotional and bitter debate over childhood vaccines and autism is louder than ever, if that’s even possible. Tonight, supporters of Andrew Wakefield, a discredited doctor who’s now accused of outright fraud by “The British Medical Journal,” “BMJ,” are standing by their man. To them, he remains a hero and a victim.

Wakefield is the lead author of the 1998 study that triggered a worldwide scare over childhood vaccines. It suggested vaccines given to kids may cause autism. His study, which looked at just 12 children, has been discredited. And last year, “The Lancet,” the journal that originally published it back in 1998, they retracted the study over concerns about its methods and ethics, as well as financial conflicts of the interests — on interests on the part of Wakefield.

Months later, Wakefield actually lost his license. It was taken away, his medical license, in the U.K. And now an award-winning investigative journalist, Brian Deer, has uncovered evidence he says proves Wakefield deliberately faked his study. Deer lays out his case in a series of articles that began running last in the “BMJ” last night. In a moment, you are going to hear directly from Mr. Deer. He will respond to attacks that Andrew Wakefield made last night in an exclusive right here on 360.

Things got pretty heated. He denied point-blank every accusation laid out by Mr. Deer. Take a look.

(BEGIN VIDEO CLIP)

ANDREW WAKEFIELD, AUTHORED RETRACTED AUTISM STUDY: He is a hit man. He’s been brought in to take me down.

COOPER: Wait a minute, sir. Let me just stop you right there.

(CROSSTALK)

COOPER: You say he’s a hit man and he’s been brought in by “they.” Who is “they”? Who is he a hit man for?

WAKEFIELD: Who brought this man in? Who is paying this man? I don’t know.

COOPER: You’re basically saying this is a — some sort of conspiracy against you. Is that — is that your argument?

WAKEFIELD: Conspiracy is your word.

What this is, is a ruthless, pragmatic attempt to crush any investigation…

COOPER: Well…

WAKEFIELD: Because the truth is in that book.

(CROSSTALK)

COOPER: However, I have read Brian Deer’s report, which is incredibly extensive. Sir, I’m not here to let you pitch your book. I’m here to have you answer questions.

(CROSSTALK)

WAKEFIELD: If you read the record that I have set out in the book, you will see the truth. You will see a detailed…

(CROSSTALK)

COOPER: But, sir, if you’re lying, then your book is also a lie. If your study is a lie, your book is a lie.

WAKEFIELD: The book is not a lie.

I suggest you do your investigation properly before making such allegations.

(END VIDEO CLIP)

COOPER: Well, we believe in facts here at 360, so, today, we followed up on some of the claims that Mr. Wakefield made last night. If we got something wrong, we would want to set the record straight, obviously.

One point Wakefield was adamant about was that other researchers have reproduced his study’s findings.

(BEGIN VIDEO CLIP)

COOPER: You have been offered the chance to replicate your study, and you have never taken — taken anybody up on that. You have had plenty of opportunity to replicate your study.

(CROSSTALK)

WAKEFIELD: You just accused me of giving you a falsehood. I’m telling you that this work has been replicated in five countries around the world.

(CROSSTALK)

COOPER: Then why has it been completely discredited by — by — by public health officials around the world?

WAKEFIELD: I suggest you do your investigation properly before making such allegations.

OK, if you look up the name Gonzalez, if you look up the name Balzola and Krigsman, you will see that the work has been replicated independently by other doctors around the world. They fail to mention that in these allegations. And Deer has failed to mention that at any time. Is that honest?

(END VIDEO CLIP)

COOPER: Well, today, we tracked down three of those studies and spoke to experts about all five that Wakefield kept citing.

And what we found is, they’re basically beside the point. They looked at gastrointestinal problems in children with autism, and nothing else. Like Wakefield, they found an association between gastrointestinal problems and autism, but they say nothing at all about a connection between autism and vaccines. So his suggestion of any such link remains his alone.

Now, a lot of parents have stopped vaccinating their kids because of Mr. Wakefield’s study. There have been deadly outbreaks of infectious diseases like measles and whooping cough as a result.

I asked Wakefield about that.

(BEGIN VIDEO CLIP)

COOPER: Sir, what’s also growing in number is the number of children who have died because they haven’t been vaccinated. Do you feel any sense of responsibility for that?

WAKEFIELD: I have never said not vaccinate. I have offered, I have suggested that children have the option of single vaccines.

(END VIDEO CLIP)

COOPER: Now, what he means by that is giving kids separate vaccines for measles, mumps and rubella, rather than a three-in-one combination vaccine.

Parents in the U.S. can choose which type their kids get. We checked out the rest of his claim. And it’s true. We found no instance of him saying do not vaccinate, period.

In 2003, Wakefield told “The Sunday Herald” newspaper: “I think parents are well-informed. They are not inherently anti-vaccine, nor are we. We have advocated throughout that children continued to be protected, but, in the light of this evidence, there’s a question mark. And while that question mark exist, parents must have the choice over how they protect their children.”

That’s what he said. But, at the same time, Wakefield is the undisputed champion of the anti-vaccination movement. And the people in this movement commonly cite his research as the reason for not vaccinating their kids.

Wakefield has never stood up to put a stop to this movement. In fact, the forward of his book, the book he kept trying to promote last night, is written by Jenny McCarthy, a vocal autism activist who believes her son’s autism was caused by vaccines.

She writes: “Unfortunately, it appears that a product intended for good, vaccines, also has a dark side, which is the ability to do harm in certain children. This ability to do harm has unfortunately increased quite a bit in the last few decades because children today receive so many more shots than when — than when most parents were kids.”

McCarthy also writes that Andrew Wakefield — quote — “listened to parents who reported two things: Their children with autism were suffering from severe bowel pain, and the children regressed into autism after vaccination. He listened. He studied. And they published what he learned.”

So, even if Wakefield hasn’t said do not vaccinate in so many words, he has certainly fueled the fear and distrust of vaccines. Wakefield’s publisher released a statement today on his behalf, and its headline reads — quote — “Vaccines Continue to Ruin Some Children’s Lives While Mainstream Medical Community and Big Drug Companies Refuse to Respond to the Series Medical Concerns of Worried Parents.”

The release goes on to say: “Yesterday, ‘The British Medical Journal’ published an article deeming the research printed over a decade ago by Dr. Andrew Wakefield suggesting a connection between autism and vaccines fraudulent. Wakefield stands strong in asserting that the allegations of ‘BMJ’ journalist Brian Deer are entirely false.”

So, the release itself describes Wakefield’s research as — quote — “suggesting a connection between autism and vaccines.”

And that’s exactly why his study, which the “BMJ” now says is flat-out fraudulent, has become such a powerful piece of the autism- vaccine controversy.

Want to show you something else. This is from the study itself, the one that’s been debunked. It’s a table listing autism diagnoses in one column and then the vaccines the kids in the study received. The table also shows when the kids got the vaccines.

To an average parent, with no scientific background, that would look pretty scary, if it were true. You can see how many parents desperate for an answer might latch on to that data.

But, after seven years of investigating, Brian Deer says he’s proved the data was faked. Here’s what told me about when we talked earlier.

In the end, this is probably the last major spike of news attention for Andrew Wakefield. Sure, in his new role as spokesperson for a consortium of vaccines-cause-autism organizations, he will get in the news again. And there will be at least one more BMJ article. But, what else is there? His research efforts even before he was let go by Thoughtful House were unimpressive to say the least (remember the Monkey study that used 2 controls and claimed that unvaccinated infant monkey brians shouldn’t grow, but the vaccinated ones should?). Perhaps he will be a study author on the Generation Rescue “vaccinated/unvaccinated” study. Even that won’t gain him the notoriety of his Lancet paper. With the paper debunked, his ethical violations in pursuing that paper and others proven by the GMC hearing and, now, the entire effort described as fraudulent, what’s left? Not much.

Brian Deer on CNN, responds to Andrew Wakefield’s wild charges

6 Jan

Brian Deer is the investigative reporter who broke the story of the research fraud that Andrew Wakefield conducted in his autism/MMR studies. Andrew Wakefield made some serious charges against Mr. Deer yesterday, claiming ” He is a hit man. He’s been brought in to take me down because they are very, very concerned about the adverse reactions to vaccines that are occurring to children. Who brought this man in, who is paying this man, I don’t know.”

Mr. Deer was interviewed on CNN today. Here is that segment:

http://i.cdn.turner.com/cnn/.element/apps/cvp/3.0/swf/cnn_416x234_embed.swf?context=embed&videoId=bestoftv/2011/01/06/am.chetry.deer.autism.cnn

here is the transcript

CHETRY: Yes. And so, this is certainly a bombshell of a story this morning. The study that linked the MMR vaccine to autism caused shock waves when he it was published back in 1988 in the medical journal “Lancet.” But by 2004, most of the paper’s co-authors had withdrawn their support. Then last February, “Lancet” retracted that report saying the research was, quote, “unethical.” Last summer, Dr. Wakefield was then barred from practicing medicine in Britain.

And Brian Deer is the investigative journalist who really blew the lid off of this story. And he joins us live from London this morning.

Brian, good morning.

BRIAN DEER, INVESTIGATIVE JOURNALIST, SUNDAY TIMES OF LONDON: Good morning.

CHETRY: One of the things I want to ask is: what is the — what was the most motivation then for Dr. Wakefield to falsely link autism to the MMR vaccine in that initial study?

DEER: Well, I believe that his motivation was essentially to make money. Initially to make money from litigation, he was retained as an expert in a lawsuit for which we know he was paid three quarters of a million U.S. dollars. But he also had all kinds of business interests which he thought would make considerably more money through promoting the scare and promoting public anxiety through over the MMR vaccine.

CHETRY: And then the question seems to be: why would there be all of these other co-authors? And why would it make its way into a prestigious journal like “Lancet” and really shape the discussion and the fears about autism linked to vaccine?

DEER: Well, that’s one of the great weaknesses of medicine and medical publishing, is that people can publish things that are false. People talk about peer review and such like. And they imagine they’re some kind of safety system. But, in fact, the whole system works on trust. His co-authors didn’t know which child was which in the study that he published.

And so, it is actually possible for determined cheat to get away with the kind of behavior that Dr. Wakefield has been involved in.

CHETRY: Well, Dr. Wakefield is still continuing to stand by his study and his findings. Anderson Cooper actually talked to him last night. He went after you. He accused you of being part of a conspiracy to discredit him.

Let’s just listen to a bit of what he said. Also, he claimed that you were getting paid to do this — to do this investigation. Let’s listen.

(BEGIN VIDEO CLIP, CNN’S ANDERSON COOPER 360) DR. ANDREW WAKEFIELD, ACCUSED OF FAKING AUTISM RESEARCH: I have read his multiple allegations on many occasions. He is a hit man. He’s been brought in to take me down because they are very, very concerned about the adverse reactions to vaccines that are occurring to children. Who brought this man in, who is paying this man, I don’t know.

(END VIDEO CLIP)

CHETRY: Did you have a financial interest in doing this investigation, Brian?

DEER: I’ve been an investigative journalist working for “The Sunday Times of London” since the early 1980s.

The point you have to remember about this whole issue is, firstly, that it’s not me saying this. It’s the editors of the “BMJ,” a very prestigious medical journal who peer reviewed and checked of the facts which we put forward in our investigation this week. So, it’s not me saying it. It’s the editors of that journal who are behind this.

But secondly, this material has been published in the United Kingdom in extraordinary detail. If it is true that Andrew Wakefield is not guilty as charged, he has the remedy of bringing a liable action against myself, against “The Sunday Times of London,” against the “British Medical Journal,” against television networks here — and he would be the richest man in America.

(CROSSTALK)

CHETRY: But he’s alleging that you were being paid to do this article. I mean, you were paid, right, because you were a journalist?

DEER: I was commissioned by the “British Medical Journal” to write the piece, yes. That’s what the journalists do.

CHETRY: What about “The Sunday Times of London” and Channel 4 in Britain?

DEER: I work for them. Right. Yes, of course, they pay, I’m a journalist. I was hired to do a job, like you are.

CHETRY: Right.

DEER: You are being paid to your job and I’m being paid to do my job.

CHETRY: Thank goodness.

The bottom line, though, is he’s questioning your motivations for going after him? Clearly, what are your motivations for going after Dr. Wakefield and his study?

DEER: It was simply a journalist assignment given to me late in 2003. A simple journalistic assignment which I expected would last a week or two weeks. And it just completely opened up when Dr. Wakefield began what we know has established a campaign of lies. When you’re a journalist and you see somebody you’re dealing is lying to you, then you pursue it. He then sued me. He was then required to may my costs. So, I received a check on his behalf, the previous false lawsuit that he began.

And now, what he’s trying to do, cloud the picture by — in the same way as he used to cloud the picture by saying some doctors say the vaccine is safe. Some doctors say it isn’t safe.

Now, what he’s trying to do is to say, well, some people say that he’s a liar and he says that I’m a liar.

CHETRY: Right.

DEER: So, what he’s trying to basically do is to split the difference. On that basis, he can work a nice living which he’s got going. You should see him in Jamaica this weekend, which he’s having a marvelous sometime on the expense of parents of autistic children.

CHETRY: Well, I want to ask you about that. What has been the impact of this safety on calling into question the safety worldwide of certain vaccines?

DEER: Oh, it’s been absolutely devastating because he and a little clique of lawyers and activists around, anti-vaccine activists around him, have been able to spread anxiety, to export it from the United Kingdom, bring it across the Atlantic, the United States, with the result, we’re now seeing parents anxious about vaccination. We’ve seen just the worst outbreak of whooping cough in California since the 1950s.

CHETRY: Are we going to understand autism and what causes it, though? Because we have seen this rise, 50 percent from 2002 to 2006 in children identified with autism spectrum disorder? I mean, why is it increasing like this?

DEER: Well, I’m a journalist, I’m not a doctor. And I don’t give medical advice. I can say from what I understand talking to doctors and scientists is that the (INAUDIBLE) conditions which cause autism, autisms, neurological problems in children, are very complex issues. And science just doesn’t have the answer.

So when someone like Dr. Wakefield comes along that gives a simple answer that blames other people, blames drug companies, now blames me, it’s all my fault, a very small number of parents become misled by that and cling to this. Because their choice is basically blame somebody else or suffer the possibility that they’re left with the guilt of thinking it was their fault that they vaccinated their child. So, it’s a very vulnerable group that Dr. Wakefield preys on.

CHETRY: Well, your reporting certainly is getting attention this morning. All of it is going to be out there along with the editorial as well. We look forward to seeing all of this.

Brian Deer, thanks for joining us this morning.

DEER: Thank you.

BMJ editorial: Wakefield’s article linking MMR vaccine and autism was fraudulent

6 Jan

In a recent post here on LeftBrainRightBrain we discussed the first in a series of articles by investigative journalist Brian Deer in the BMJ. There is also an editorial by the BMJ, “Wakefield’s article linking MMR vaccine and autism was fraudulent“. The Lancet’s retraction of the Wakefield paper was fairly mild, citing only that the patients were not consecutively referred and the study did not have ethical approval. The BMJ’s statement is much more clear, and with a reason. From the editorial:

The Lancet paper has of course been retracted, but for far narrower misconduct than is now apparent. The retraction statement cites the GMC’s findings that the patients were not consecutively referred and the study did not have ethical approval, leaving the door open for those who want to continue to believe that the science, flawed though it always was, still stands. We hope that declaring the paper a fraud will close that door for good.

Perhaps wishful thinking on their part, as there will always be people who believe Mr. Wakefield.

The BMJ goes further. They are calling for a review of other papers by Mr. Wakefield with the question of whether more retractions are warranted.

What of Wakefield’s other publications? In light of this new information their veracity must be questioned. Past experience tells us that research misconduct is rarely isolated behaviour. Over the years, the BMJ and its sister journals Gut and Archives of Disease in Childhood have published a number of articles, including letters and abstracts, by Wakefield and colleagues. We have written to the vice provost of UCL, John Tooke, who now has responsibility for Wakefield’s former institution, to ask for an investigation into all of his work to decide whether any more papers should be retracted.

This parent of an autistic child welcomes this move by the BMJ. I am grateful to the editors for their action.

BMJ press release: there is “no doubt” that it was Wakefield who perpetrated this fraud

6 Jan

Here is the press release for the series in the BMJ on Andrew Wakefield.

Today, the BMJ declares the 1998 Lancet paper that implied a link between the MMR vaccine and autism “an elaborate fraud.”

Dr Fiona Godlee, BMJ Editor in Chief says “the MMR scare was based not on bad science but on a deliberate fraud” and that such “clear evidence of falsification of data should now close the door on this damaging vaccine scare.”

She is struck by a comparison between researcher Andrew Wakefield’s fraud and Piltdown man, that great paleontological hoax that led people to believe for 40 years that the missing link between man and ape had been found.

She also questions the veracity of Wakefield’s other publications and calls for an investigation “to decide whether any others should be retracted.”

A series of three articles starting this week reveal the true extent of the scam behind the scare. The series is based on interviews, documents and data, collected during seven years of inquiries by award-winning investigative journalist Brian Deer.

Thanks to the recent publication of the General Medical Council’s six million word transcript, the BMJ was able to peer-review and check Deer’s findings and confirm extensive falsification in the Lancet paper.

In an editorial, Dr Godlee, together with deputy BMJ editor Jane Smith, and leading paediatrician and associate BMJ editor Harvey Marcovitch, conclude that there is “no doubt” that it was Wakefield who perpetrated this fraud. They say: “A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross.”

Yet he has repeatedly denied doing anything wrong at all, they add. “Instead, although now disgraced and stripped of his clinical and academic credentials, he continues to push his views. Meanwhile the damage to public health continues.”

“Science is based on trust,” concludes Dr Godlee. “Such a breach of trust is deeply shocking. And even though almost certainly rare on this scale, it raises important questions about how this could happen, what could have been done to uncover it earlier, what further inquiry is now needed, and what can be done to prevent something like this happening again.”

The BMJ will explore these and other questions over the next two weeks.

Brian Deer in the BMJ: How the case against the MMR vaccine was fixed

6 Jan

Brian Deer, the investigative journalist who broke the story of the misdeeds of Andrew Wakefield, has a new article in the BMJ, How the case against the MMR vaccine was fixed. The article is prefaced:

In the first part of a special BMJ series, Brian Deer exposes the bogus data behind claims that launched a worldwide scare over the measles, mumps, and rubella vaccine, and reveals how the appearance of a link with autism was manufactured at a London medical school

This article is damning enough, but as a series this may lay out clearly, in one place, the cases behind the multiple ethical breaches which cost Andrew Wakefield his license to practice medicine in the UK.

Some may ask “why?” There is so much information out there about Mr. Wakefield and his misdeeds. Do we really need it again? I would say yes. In this BMJ series we have the research (and other) ethical lapses laid out in a medical journal. No lengthy GMC transcripts. No news stories with false balance. No “Callous Disregard” book.

The full article is worth the read. Here is the summary from today’s article.

How the link was fixed

The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:

• Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism

• Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns

• Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination

• In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”

• The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link

• Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation

In multiple ways, the story of the Lancet article was crafted to support the conclusion Mr. Wakefield had–a conclusion he came to before starting on the research project.

Yes, before.

In his research proposal to the legal aid board, Mr. Wakefield made the following statement (quoted in Mr. Deer’s article):

““In contrast with the IBD cases [those set out in paragraph 2] which have a prima facie gastrointestinal pathology, children with enteritis/disintegrative disorder form part of a new syndrome. Nonetheless, the evidence is undeniably in favour of a specific vaccine induced pathology. ”

Mr. Deer presents a table comparing how the Lancet article reported the 12 children and how the records really show their cases. He compares regressive autism (only 1 patient’s records clearly show it), non-specific colitis (only 3 children showed it) and whether symptoms occured in the days following MMR (10 clearly did not, 2 are unclear). In all, none of the Lancet 12 children had all three features.

So that is the Lancet 12: the foundation of the vaccine scare. No case was free of misreporting or alteration. Taken together, NHS records cannot be reconciled with what was published, to such devastating effect, in the journal.

Mr. Deer opens his piece with a discussion he had with the father of child 11. Mr. 11 did not agree with the way his son was represented in the Lancet article. Mr. 11 states:

“Please let me know if Andrew W has his doctor’s license revoked,” wrote Mr 11, who is convinced that many vaccines and environmental pollutants may be responsible for childhood brain disorders. “His misrepresentation of my son in his research paper is inexcusable. His motives for this I may never know.”

We may never know the motives. In the end, I don’t care. It is the damage that this fraudulent research has caused to the autism communities and to public health that matter. Countless families have believed Mr. Wakefield, with parents blaming themselves for causing their child’s disability. As to public health, Mr. Wakefield is responsible for a drop in vaccine uptake in the UK, which led to disease and death.

Further reading on the subject can be found at Action For Autism with Wakefield and the MMR Autism Hoax

The Panel has determined that Dr Wakefield’s name should be erased from the medical register

24 May

The following is taken from a GMC press release.

This case is being considered by a Fitness to Practise Panel applying the General Medical Council’s Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988

Date: 24 May 2010

Dr Andrew Jeremy WAKEFIELD

Determination on Serious Professional Misconduct (SPM) and sanction:

The Panel has already given its findings on the facts and its reasons for determining that the facts as found proved could amount to serious professional misconduct.

It then went on to consider and determine whether, under Rule 29(1) of the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules Order of Council 1988, the facts as admitted or found proved do amount to serious professional misconduct and if so, what, if any sanction it should impose. It has accepted the Legal Assessor’s advice in full as to the approach to be taken in this case, and has looked at each doctors’ case separately but, when considering whether Dr Wakefield is guilty of serious professional misconduct, has looked at the heads of charge found proved against him as a whole. It has not confined its consideration to the heads of charge; it has also had regard to the evidence that has been adduced and the submissions made by Ms Smith on behalf of the General Medical Council. On behalf of Dr Wakefield, no evidence has been adduced and no arguments or pleas in mitigation have been addressed to the Panel at this stage of the proceedings. In fact Mr Coonan specifically submitted:

“……we call no evidence and we make no substantive submissions on behalf of Dr Wakefield at this stage.” “…I am instructed to make no further observations in this case”.

Nevertheless, the Panel considered the totality of the evidence in Dr Wakefield’s case including the reference dated 27 October 1995, from Professor Leon Fine, the then Head of the Department of Medicine at the Royal Free Hospital, when reaching its decision at this stage, having been asked to consider that as part of Mr Coonan’s submissions at Stage 1.

Serious professional misconduct has no specific definition but in Roylance v General Medical Council [1999] Lloyd’s Rep. Med. 139 at 149 Lord Clyde, in giving the reasons of the Privy Council, said:

“Misconduct is a word of general effect, involving some act or omission which falls short of what would be proper in the circumstances. The standard of propriety may often be found by reference to the rules and standards ordinarily required by a medical practitioner in the particular circumstances…”

Lord Clyde went on to say:

“The misconduct is qualified in two respects. First, it is qualified by the word ‘professional’ which links the misconduct to the profession of medicine. Secondly, the misconduct is qualified by the word ‘serious’. It is not any professional misconduct which will qualify. The professional misconduct must be serious.”

The Panel has acted as an independent and impartial tribunal and exercised its own judgement on these matters. It has borne in mind the relevant GMC guidance at the time, namely the 1995 Good Medical Practice and, in so far as the findings relate to events after 1998, the 1998 Good Medical Practice. It has considered what has been adduced and submitted on behalf of the doctors about the standards and procedures which were prevalent at that time.

In considering Dr Wakefield’s case, the Panel has also taken into account the passage of time before these matters were brought before it and the length of time this case has taken. It noted that the multiple sittings were for a variety of reasons including professional commitments of the Panel and requests from Counsel for reasons such as illnesses, accidents, unavailability of witnesses and preparation time.

The Panel has noted Dr Wakefield’s previous good character and taken into account everything it has heard including his qualifications, experience and standing within the profession, with patients and the parents of patients.

The Panel considered the conduct of Dr Wakefield whilst he was registered as a medical practitioner and employed by the Royal Free Hospital Medical School in 1996 and 1997, initially as a Senior Lecturer in the Departments of Medicine and Histopathology. Later, from 1 May 1997 he was a Reader in Experimental Gastroenterology and an Honorary Consultant in Experimental Gastroenterology at the Royal Free Hospital.

The Panel has already found proved that Dr Wakefield’s Honorary Consultant appointment was subject to a stipulation that he would not have any involvement in the clinical management of patients. On five occasions (child 2, 4, 5, 12 and 7) he ordered investigations on children, when he had no paediatric qualifications, and in contravention of the limitations on his appointment. The Panel considered this alone constituted a breach of trust of patients and employers alike.

In February 1996 Dr Wakefield agreed to act as an expert in respect of MMR litigation. In relation to the Legal Aid Board (LAB), the Panel found that Dr Wakefield accepted monies totalling £50,000 procured through Mr Barr, the Claimants’ solicitor to pursue research. A costing proposal had been submitted by Mr Barr to the LAB containing detailed information provided by Dr Wakefield, and Dr Wakefield ought to have realised that Mr Barr would submit it to the LAB.

The costing proposal set out costs in respect of the investigation of five children. It covered each child’s four-night stay in hospital with colonoscopy, MRI and evoked potential studies. Dr Wakefield admitted that the funding subsequently provided by the Legal Aid Board had not been needed for these items because these costs were borne by the National Health Service as the patients were being admitted as NHS patients.

The Panel found that Dr Wakefield had a duty to disclose this information to the Legal Aid Board via Mr Barr. It was dishonest and misleading of him not to have done so. The Panel concluded that his intention to mislead the Legal Aid Board was sufficient on its own to amount to serious professional misconduct.

The Panel also found that in respect of £25,000 of LAB monies, Dr Wakefield caused or permitted it to be used for purposes other than those for which he said it was needed and for which it had been granted. In doing so he was in breach of his duties in relation to the managing of, and accounting for, funds.

In September 1996 Dr Wakefield made an application to the Ethical Practices Sub-Committee of the Royal Free Hospital (Ethics Committee) seeking approval for a research project involving 25 children. This was approved by the sub-Committee as Project 172-96. He named himself as one of the three Responsible Consultants, thereby taking on the shared responsibility for the information given in support of his application; for ensuring that only children meeting the inclusion criteria would be admitted to the study; that conditions attached to the Ethics Committee approval would be complied with; and that children would be treated in accordance with the terms of the approval given.

In respect of Research and Ethics Committee approval, the Panel had regard to the particular ethical guiding principles with regard to conducting research on children. It rejected Dr Wakefield’s overall contention that Project 172-96 was never undertaken; that all the investigations carried out on the children were clinically indicated and that the research elements of the project were covered by another Ethics Committee approval.

The Panel concluded that the programme of investigations that these children were subjected to was part of Project 172-96. It further determined that the conditions for approval and the inclusion criteria for that project were not complied with. The Ethics Committee’s reliance on the probity of Dr Wakefield as a Responsible Consultant was not met.

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 results of the research project were written up as an early report in the Lancet in February 1998. Dr Wakefield as a senior author undertook the drafting of the Lancet paper and wrote its final version. The reporting in that paper of a temporal link between gastrointestinal disease, developmental regression and the MMR vaccination had major public health implications and Dr Wakefield admitted that he knew it would attract intense public and media interest. The potential implications were therefore clear to him, as demonstrated in his correspondence with the Chief Medical Officer of Health and reports which had already appeared in the medical press. In the circumstances, Dr Wakefield had a clear and compelling duty to ensure that the factual information contained in the paper was true and accurate and he failed in this duty.

The children described in the Lancet paper were admitted for research purposes under a programme of investigations for Project 172-96 and the purpose of the project was to investigate the postulated new syndrome following vaccination. In the paper, Dr Wakefield failed to state that this was the case and the Panel concluded that this was dishonest, in that his failure was intentional and that it was irresponsible. His conduct resulted in a misleading description of the patient population. This was a matter which was fundamental to the understanding of the study and the terms under which it was conducted.

In addition to the failure to state that the children were part of a project to investigate the new syndrome, the Lancet paper also stated that the children had been consecutively referred to the Department of Paediatric Gastroenterology with a history of a pervasive developmental disorder and intestinal symptoms. This description implied that the children had been referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral process. In fact, the Panel has found that some of the children were not routine referrals to the gastroenterology department in that either they lacked a reported history of gastrointestinal symptoms and/or that Dr Wakefield had been actively involved in the process of referral. In those circumstances the Panel concluded that the description of the referral process was irresponsible, misleading and in breach of Dr Wakefield’s duty as a senior author.

The statement in the Lancet paper that investigations reported in it were approved by the Royal Free Hospital Ethics Committee when they were not, was irresponsible.

Subsequent to the paper’s publication, Dr Wakefield had two occasions on which he could have corrected the content of the Lancet paper yet both times he compounded his misconduct.

First, in a published letter in response to correspondents who had suggested that there had been biased selection of the Lancet children, Dr Wakefield stated that the children had been referred through the normal channels, a response which was dishonest and irresponsible. He provided an inaccurate statement which omitted relevant information when he knew that the description of the population in the study was being questioned by the scientific community.

Second, at a meeting of the Medical Research Council, the Chair, Professor Sir John Pattison referred to the seriousness and importance of the implications of Dr Wakefield’s research and its major public health implications. At that meeting and on the issue of bias in generating the series of cases, Dr Wakefield stated that the children had come by “the standard route”, a response which was dishonest and irresponsible.

Regarding the issues of conflicts of interest, Dr Wakefield did not disclose matters which could legitimately give rise to a perception of a conflict of interest. He failed to disclose to the Ethics Committee and to the Editor of the Lancet his involvement in the MMR litigation and his receipt of funding from the Legal Aid Board. He also failed to disclose to the Editor of the Lancet his involvement as the inventor of a patent relating to a new vaccine for the elimination of the measles virus (Transfer Factor) which he also claimed in the patent application, would be a treatment for inflammatory bowel disease (IBD).

Even before the publication of the Lancet Paper, eminent professionals had expressed concerns about the LAB funding to Dr Wakefield and potential conflicts of interest. Dr Wakefield rejected these views. With regard to non-disclosure to the Ethics Committee, Dr Wakefield did in evidence accept that the Legal Aid Board funding should have been disclosed, but said that his involvement in the litigation need not, especially because of his interpretation of the questions in the application form. He said no question was asked which related to that matter and therefore felt no need to disclose. In evidence to the panel he stated:

“The form is set out expecting certain answers to specific questions and no such question exists. Therefore, since it was not asked, it was not answered.”

However, given the importance of an Ethics Committee’s reliance on the probity of an applicant, the Panel determined that this was a failure by Dr Wakefield and his actions amounted to serious professional misconduct.

With regard to the non-disclosure to the Lancet the Panel accepted evidence from the Editor of the Lancet, as to the importance of this issue. The Lancet published clear guidance in relation to the conflict of interest test that the applicant should apply and the need to discuss any issues arising from it with the Editor. The Lancet test was: “Is there anything that would embarrass you if it were to emerge after publication and you had not declared it?” Dr Wakefield chose not to declare or discuss any conflict of interest with the Editor. He stated that he was able to reconcile his position, was not embarrassed by it, and was quite proud of the position he had taken on behalf of the Lancet children.

Dr Wakefield was insistent that his involvement with the new patent had not given rise to any prior need to disclose. Despite the clear terms of the patent, he did not accept that the invention was envisaged as an alternative vaccine to MMR. He acknowledged that he had envisaged the use of transfer factor for at least a proportion of the population and that he had a financial and career interest in its success, but he said that it did not cross his mind to disclose it, and even with hindsight he insisted that there was a reasonable argument, as he put it, for non-disclosure. The Panel considered that his actions and his persistent lack of insight as to the gravity of his conduct amounted to serious professional misconduct.

In relation to the administration of Transfer Factor to Child 10, the Panel noted the admitted background of Dr Wakefield’s involvement in a company set up with Child 10’s father as Managing Director, to produce and sell Transfer Factor. Around the same time, Dr Wakefield inappropriately caused Child 10 to be administered transfer factor. The Panel accepted that information as to its safety had been obtained and that the approval to administer Transfer Factor to one child was granted in the form of “Chairman’s approval”, “on a named patient basis” in a letter from Dr Geoffrey Lloyd, Chairman of the Medical Advisory Committee at the Royal Free Hospital. Nonetheless the Panel found that Dr Wakefield was at fault because the substance was given for experimental reasons, he did not cause the details to be recorded in the child’s records, or cause the general practitioner to be informed, and he did not have the requisite paediatric qualifications.

Dr Wakefield’s actions were contrary to the clinical interests of Child 10 and an abuse of his position of trust as a medical practitioner. The Panel considered these to be serious departures from the standards of a registered medical practitioner and concluded that these amounted individually and collectively to serious professional misconduct.

Dr Wakefield caused blood to be taken from a group of children for research purposes at a birthday party, which the Panel found to be an inappropriate social setting. He behaved unethically in failing to seek Ethics Committee approval; he showed callous disregard for any distress or pain the children might suffer, and he paid the children £5 reward for giving their blood. He then described the episode in humorous terms at a public presentation and expressed an intention to repeat his conduct. When giving evidence to the Panel, Dr Wakefield expressed some regret regarding his remarks. The Panel was concerned at Dr Wakefield’s apparent lack of serious consideration to the relevant ethical issues and the abuse of his position of trust as a medical practitioner with regard to his conduct in causing the blood to be taken. The Panel concluded that his conduct brought the medical profession into disrepute.

Dr Wakefield defended the ethical basis for the taking of blood at a birthday party contrary to the experts who gave evidence to the Panel and who strongly condemned this action. The Panel determined that his conduct fell seriously short of the standards expected of a doctor and was a breach of the trust which the public is entitled to have in members of the medical profession. It concluded that this behaviour amounted to serious professional misconduct.

The Panel has borne in mind the principles guiding a doctor as set out in the relevant paragraphs of 1995 Good Medical Practice which relate to providing a good standard of practice and care, good clinical care, keeping up-to-date, abuse of professional position, probity in professional practice, financial and commercial dealings, and the general principles of conflict of interest, followed by particular provisions as to the way in which research must be conducted. The 1998 Good Medical Practice, relevant to Dr Wakefield’s conduct at the birthday party, lists the duties of a doctor in providing a good standard of practice and care, keeping up-to-date and the issue of research and the absolute duty to conduct all research with honesty and integrity.

In all the circumstances and taking into account the standard which might be expected of a doctor practising in the same field of medicine in similar circumstances in or around 1996-1998, the Panel concluded that Dr Wakefield’s misconduct not only collectively amounts to serious professional misconduct, over a timeframe from 1996 to 1999, but also, when considered individually, constitutes multiple separate instances of serious professional misconduct.

Accordingly the Panel finds Dr Wakefield guilty of serious professional misconduct.

In considering what, if any, sanction to apply, the Panel was mindful at all times of the need for proportionality and the public interest which includes not only the protection of patients and the public at large, but also setting and maintaining standards within the medical profession, as well as safeguarding its reputation and maintaining public confidence in the profession. It bore in mind that the purpose of sanctions is not punitive, although that might be their effect.

The Panel noted the submissions of GMC Counsel that the appropriate and proportionate sanction would be erasure in light of his serious and wide-ranging misconduct. However the Panel accepted the Legal Assessor’s advice that this was only a submission on behalf of the GMC and it was for the Panel to make up its own mind. Dr Wakefield’s counsel did not make any substantive submissions on his behalf.

The Panel went on to consider whether it should, pursuant to Rule 30(1), postpone the case. It received no submissions in this regard and so went on to determine whether it was sufficient to conclude the case without making a direction or with an admonition.

The Panel made findings of transgressions in many aspects of Dr Wakefield’s research. It made findings of dishonesty in regard to his writing of a scientific paper that had major implications for public health, and with regard to his subsequent representations to a scientific body and to colleagues. He was dishonest in respect of the LAB funds secured for research as well as being misleading. Furthermore he was in breach of his duty to manage finances as well as to account for funds that he did not need to the donor of those funds. In causing blood samples to be taken from children at a birthday party, he callously disregarded the pain and distress young children might suffer and behaved in a way which brought the profession into disrepute.

In view of the nature, number and seriousness of the findings the Panel concluded it would be wholly inappropriate to conclude the case without making a direction or with a reprimand.

It next considered under rule 31 whether it was sufficient to direct that the registration of Dr Wakefield be conditional on his compliance during a period not exceeding three years with such requirements as the (Panel) may think fit to impose for the protection of members of the public or in his interests. Conditions have to be practicable, workable, measurable and verifiable and directed at the particular shortcomings identified. The Panel concluded that Dr Wakefield’s shortcomings and the aggravating factors in this case including in broad terms the wide-ranging transgressions relating to every aspect of his research; his disregard for the clinical interests of vulnerable patients; his failure to heed the warnings he received in relation to the potential conflicts of interest associated with his Legal Aid Board funding; his failure to disclose the patent; his dishonesty and the compounding of that dishonesty in relation to the drafting of the Lancet paper; and his subsequent representations about it, all played out against a background of research involving such major public health implications, could not be addressed by any conditions on his registration. In addition, the Panel considered that his actions relating to the taking of blood at the party exemplifies a fundamental failure in the ethical standards expected of a medical practitioner. It concluded that conditional registration would not mark the seriousness of such fundamental failings in his duty as a doctor.

The Panel next went on to consider whether it would be sufficient to suspend Dr Wakefield’s registration for a period not exceeding twelve months. Dr Wakefield has demonstrated a persistent lack of insight and has insisted in many instances on his ethical propriety: in the context of the referral process and the treatment of the children in the research project in which he was engaged; in the context of the funding of the project; with regard to the terminology of the Lancet paper; with regard to his non-declaration of interests; with regard to not acting in the best clinical interests of the Lancet children and with regard to obtaining blood from children at a birthday party.

The Panel noted that the sanction of suspension may be appropriate for conduct that falls short of being fundamentally incompatible with continued registration; where there is no evidence of harmful deep-seated or attitudinal problems; and where there is insight and no significant risk of repeating behaviour. Although these points have been set out in the GMC’s Indicative Sanctions Guidance which was published subsequent to these events, the Panel considered that the guidance outlines the type of sanction appropriate to the gravity of misconduct and that the same principles are applicable to Dr Wakefield’s actions at the material times. The Panel considers that Dr Wakefield’s conduct in relation to the facts found falls seriously short of the relevant standards and that suspension would not be sufficient or appropriate against a background of several aggravating factors and in the absence of any mitigating submissions made on his behalf. Dr Wakefield’s continued lack of insight as to his misconduct serve only to satisfy the Panel that suspension is not sufficient and that his actions are incompatible with his continued registration as a medical practitioner.

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.

The effect of the foregoing direction is that, unless Dr Wakefield exercises his right of appeal, his name will be erased from the Medical Register 28 days from when formal notice has been deemed to be served upon him by letter to his registered address.

Dr Wakefield is presently not subject to any interim order on his registration. The Panel will hear submissions on whether an immediate order of suspension should be imposed upon him pending the outcome of any appeal, first from Ms Smith on behalf of the General Medical Council and then from Mr Coonan on behalf of the doctor but will do that at the conclusion of the reading of all three determinations.

Brian Deer discusses Andrew Wakefield’s “autistic enterocolitis” in the BMJ

15 Apr

Before the General Medical Council reached a verdict on Dr. Wakefield, Brian Deer was promising that he was going to report on the data Dr. Wakefield used for his now retracted Lancet paper. We were told that he would give a first time ever view of a journalist allowed to check the facts on a scientific research paper.

After the GMC verdict was handed down, I watched the Sunday Times for such an article. I waited. Well, the wait is over. And it isn’t in the Times. Mr. Deer reports his findings in the British Medical Journal (BMJ).

Although much of the attention on Dr. Wakefield’s work has centered on the possible MMR connection, the topic of a “new syndrome” called “autistic enterocolitis” was proposed in that paper. In Wakefield’s “autistic enterocolitis” under the microscope, Mr. Deer takes a closer look at that claim. He does what is very rarely done: he obtained original data used for the study and obtains expert opinions on that data.

In his introduction, he notes the “new syndrome” and the MMR angles of the Lancet paper. Citing the press release from the Lancet paper:

“Researchers at the Royal Free Hospital School of Medicine may have discovered a new syndrome in children involving a new inflammatory bowel disease and autism,” the institution announced in a press release in February 1998. “Their paper . . . also suggests that in a number of cases the onset of behavioural symptoms was associated with MMR vaccination.”

Mr. Deer notes that before any patients were investigated, Dr. Wakefield was already proposing in a submission to the Legal Aid Board that such a new syndrome exists and it is linked to regression in children.

“In contrast to the IBD cases, which have a prima face [sic] gastrointestinal pathology, children with enteritis/disintegrative disorder form part of a new syndrome,” said Wakefield and the lawyer in a confidential submission for legal aid funding for the project in June 1996, before any of the 12 children in the paper had been investigated. “Nonetheless, the evidence is undeniably in favour of a specific vaccine induced pathology.”

For emphasis:

The evidence was “undeniably in favour of a specific vaccine induced pathology”.

Before children were investigated.

That on its own is huge. And, from what I can tell, not consistent with the image Dr. Wakefield is portraying in the alternative media.

That said, was there evidence of this “new syndrome”?

But when the children were brought in to the Royal Free for ileocolonoscopy, between July 1996 and February 1997, a snag in Wakefield’s project emerged. The hospital’s pathology service repeatedly judged colonic biopsy samples to be unexceptional, and thought bowel disease was a possibility in only one child.

The Royal Free’s own pathology service thought that the biopsy samples were unexceptional.

How can Mr. Deer make such a claim? He obtained data from the children’s records from their investigations at the Royal Free. Unfortunately, the actual samples are no longer available, but the reports are, and Mr. Deer submitted these to experts to review:

The biopsy slides are no longer available, according to one of the paper’s authors, Professor Amar Dhillon, but the GMC obtained all but one of the hospital pathology reports, and for the missing case I obtained the discharge summary. I passed the summary and reports to specialists for their reaction. They concluded that most of the 11 children reported as having non-specific colitis in the Lancet paper had been reported by the Royal Free as having normal pathology.

One expert reviewer stated:

“In the present reports and patients, overall, it is my impression that 8 of the 11 [for whom pathology reports were available] were normal,” Karel Geboes, a professor in the gastrointestinal pathology unit of the Catholic University of Leuven, Belgium, told me.

How does this compare to what was reported in the Lancet?

Eleven of the 12 children were said to have “non-specific colitis”: a clinically significant inflammation of the large bowel. In all 11, it was said to be “chronic,” while in four it was reported as both “acute and chronic.”

In other words, the report in the Lancet is not consistent with how experts interpret the pathology reports.

Mr. Deer further notes:

In fact the [Royal Free’s pathology] service identified findings suggestive of possible inflammatory bowel disease in only one of the 12 children. “The mild patchy generalised increase in inflammatory cells with lymphoid aggregates and follicles is not very specific but could be in keeping with low grade quiescent inflammatory bowel disease,” it reported for child 2. But this inflammation resolved after two months’ enteral feeding with a product now marketed as Modulen. A repeat ileocolonoscopy found no abnormality, and a food intolerance was diagnosed.

Yes, it appears that the pathology service, at Dr. Wakefield’s own hospital, at the time of the investigation, didn’t find evidence of abnormalities reported by Dr. Wakefied’s team.

In the GMC hearing, one of the co-authors on the Lancet paper, Dr. Susan Davies, discussed her concerns about the changes in the findings from normal to abnormal at the time of the investigation.

These changes—from normal to abnormal, or from healthy to diseased—had also raised concern in the mind of at least one of the paper’s authors. In September 2007, Davies, the lead histopathologist for the Wakefield project, was examined at length before the panel. “When you were given a draft of the Lancet paper, did you read it?” she was asked by Sally Smith QC, for the doctors’ regulator.
“Yes,” Davies replied.
“What was your overall view of the terminology used in relation to the histology findings in the Lancet paper, just when you read the paper?”
“I was somewhat concerned with the use of the word colitis.”
“First of all, what did you understand that word to mean?”
“I personally use that terminology, ‘colitis,’ when I see active inflammation, or a pattern of changes which suggest a specific diagnosis, and it was not my impression that the children coming through in the spasmodic way that they had, I [sic] had formulated some distinct pattern warranting that terminology.”

If even a co-author was concerned, and the hospital’s pathology reports don’t support the diagnosis of colitis, the obvious question would be: how did the paper reach it’s conclusions?

The answer appears to be that the results underwent a second review. This second review is discussed in the Lancet paper, but there is no mention of the review changing the interpretation of the data,

Mr. Deer poses an important question:

[H]ow many peer reviewers would have felt comfortable approving the paper if they had known that the hospital pathology service reported biopsy specimens as largely normal, but they were then subjected to an unplanned second look and reinterpreted?

Which we are fortunate enough to have answered. Mr. Deer was able to obtain an answer from one of the peer reviewers:

“I’m surprised the GMC didn’t make more of this,” said David Candy, paediatric gastroenterologist at St Richard’s Hospital, Chichester, who reviewed the paper in 1997. “That’s an example of really naughty doing—to exclude the original pathology findings.”

“Really naughty doing”. Not very clinical but I think it tells the story well.

Is it possible that the hospital’s pathology service missed the condition? Apparently at least one author (Dr. Walker-Smith, a co-defendant with Dr. Wakefield in the GMC hearings) noted this in his GMC testimony:

And how bad was this “colitis,” such that the hospital’s pathology service didn’t spot it as the children came through? Walker-Smith told the GMC panel that he had “concerns” about the service and its ability to detect inflammation.

In his report, Mr. Deer counters with:

Yet inflammatory indices that were not reported in the Lancet paper, including serum C reactive protein concentrations and other blood tests, were almost all within normal ranges for the 12 children.6 And as an alternative explanation for any inflammation that was present, nearly all of the children had constipation with megarectum16 (unreported in the paper), which specialists say can cause cellular changes.

Mr. Deer attempted to speak with Dr. Dillhon, a co-author on the Lancet paper. Dr. Dillhon viewed the slides made from the samples taken from the children, and he graded them with Roman numerals to rank the degree of inflammation. At some point, those Roman numerals were translated into “non-specific colitis”.

So who translated these scores on the grading sheet into findings of “non-specific colitis” in the paper? Dhillon says it wasn’t him. He says he would like to see the slides again, but they are missing from the Royal Free laboratory. “He [Dhillon], Andrew Anthony, and Wakefield all looked at them,” I was told, on Dhillon’s behalf, by a senior member of staff at the Royal Free. “Andy [Wakefield] then synthesised their results into what appeared in the paper.”

But still, according to Mr. Deer, “…how the Roman numerical scores, histopathological gradings for a variety of sites in the colon, became the “colitis” findings might, under such circumstances, be anybody’s guess.”

Mr. Deer posits a possible scenario, based on Dr. Wakefield’s complaint to the press complaints commission:

Wakefield wrote: “When the biopsies were reviewed and scored by experts in bowel pathology—namely, Drs Dhillon and Anthony—these doctors determined that there was mild inflammation in the caecum, ascending colon, and rectum,” he said. “This was correctly reported as non-specific colitis in the Lancet.” In other words, it looks like it was Wakefield who translated the scores.

A companion editorial was published in the BMJ by Prof. Sir Nicholas Wright, warden, of Barts and the London School of Medicine and Dentistry, Queen Mary University of London. He lists in his conflict of interest statement: “He has provided expert opinion in the case of Wakefield v GMC and acted as a character witness for Professor John Walker-Smith.”

His editorial:

Does autistic enterocolitis exist?
Despite the retracted Wakefield study, questions remain

His conclusion:

Is autistic enterocolitis a histopathological entity or even an entity at all? In view of the lack of data and the entrenched position of many of the protagonists and antagonists, any firm conclusion would be inadvisable. The expert review, referenced by Deer, concludes that key areas such as the prevalence and best treatment of gastrointestinal disorders in people with autistic spectrum disorders are incompletely understood, and that evidence based recommendations are not yet available. We should remember, as recent experience in several fields has shown, that although science has its defects, it is a self correcting process. Time is, perhaps, the wisest counsellor of all. In the meantime, this case offers a salutary reminder for researchers and journal editors alike that coauthorship means bearing responsibility for what is written.

First, I would submit that Dr. Wright is not being clear on the subject. It is not whether autistics have a greater prevalence of GI issues, or whether there is a difference in the treatment for autistics. The question is whether there is a specific entity which is unique to autistics: autistic enterocolitis. Further, it is also a primary question whether “autistic enterocolitis” is causal in autism. While one can hide behind the “you can’t prove a negative” shield, the answers at present appear to be no to both questions.

Second, the idea that science is a self correcting process is often times true. In this case, it clearly is not. The science, the Lancet paper, was not corrected through science but through investigative journalism. Without the stories in The Sunday Times, Dr. Wakefield’s “science” would likely still be in the official record of The Lancet. Much more, the Lancet study and the presumed expertise of Dr. Wakefield would have likely been key in litigation in the UK and the US. Without Mr. Deer’s continued scrutiny, the facts behind the research into the Lancet paper, specifically that the pathology reports on those children were not consistent with the findings of the paper, would almost certainly not have come to light.

Returning to Mr. Deer’s article, he concludes:

So what should we make of all this? Now the Lancet paper is retracted, its findings don’t officially exist. And, if Dhillon is right in saying the slides can’t be found, the ultimate proof is missing. All we have are the pathology reports, which independent specialists seem to agree are largely unremarkable. “They wanted this bad,” commented Tom MacDonald, dean of research at Barts and the London School of Medicine and coauthor of Immunology and Diseases of the Gut. “If I was the referee and the routine pathologists reported that 8/11 were within normal limits, or had trivial changes, but this was then revised by other people to 11/12 having non-specific colitis, then I would just tell the editor to reject the paper.”

Clearly the Lancet paper should have been rejected. But this isn’t just a scientific paper that made a bad conclusion. This paper impacted multiple families inside the autism communities to believe that their child’s autism was caused by MMR. This paper led many families in the autism communities to apply poorly researched “therapies” to their disabled children. This paper led many families to stop vaccinating their children, leading to outbreaks of measles in the UK and elsewhere.

It is easy to go through Mr. Deer’s paper in the BMJ point by point in a clinical fashion, noting how the research went awry, showing that “autistic enterocolitis” has what appears to be no founding in science. But how does one express the reaction to so much damage caused by Dr. Wakefield’s investigation?

Of course, a further question I have and I bet I share with Dr. Wakefield’s supporters is this: is Brian Deer finished or is there even more yet to be unearthed in this sad tale of research gone awry?

Brian Deer challenges Andrew Wakefields words

5 Apr

Andrew Wakefield has recently published a series of videos on YouTube (the only media outlet still left interested in his ramblings). Fascinating in largely no aspect, they do however remain riddled with innaccuracies which Brian Deer has challenged in his own response video which is below.

ABC Radio interviews Brian Deer

25 Feb

RearVision, an ABC (Australia) radio news program, has an interview with Brian Deer titled The MMR vaccine scare. They have both audio and transcript available.

Even before Keri Phillips of ABC gets to Mr. Deer, she makes it clear that this isn’t going to be some fluff piece with faux-balance:

What Richard Horton didn’t know at the time, and neither did some of Wakefield’s 13 co-authors, was that some of the claims in the paper were false. It wasn’t bad science but rather outright fraud that ultimately led to the finding of misconduct against Andrew Wakefield. We’ll come to that in a moment, but first, what really set this story running was a press conference that Wakefield held at the Royal Free Hospital where he worked as a gastroenterologist.

My guess is that most readers here know the Wakefield story, so I won’t quote discussion of that. I will note the suggestion of moving away from anonymous peer review made by Trisha Greenhalgh. I, for one, am not in favor of that. I feel that referees will be less critical if they know that the authors will know the referees names.

Here is a closing statement by Brian Deer:

The thing that really concerns me is that there’ve been three kinds of victim in all of this. Firstly there’ve been children who’ve developed measles, and we’ve had children in the UK who’ve died of measles as a result of this. They’re the first victims. The second victims are parents who really agonised and gone through hell over whether they should vaccinate their child. But there’s a third kind of victim, which I think people often forget, and these are parents who blame themselves for their child having autism because they took that child to be vaccinated. And you can imagine the nightmare that these parents go through, and I’ve spoken with some of them, and I’ve had mothers just collapse sobbing saying, ‘Not a day goes past when I don’t blame myself for taking my child to be vaccinated. It’s my fault that he’s got autism, it’s my fault that his life will never be the same as that of other children.’ And I really feel for those parents, and I think we should remember these victims of this scare because these mothers have suffered.

Then there are those of us who have seen 12 years of “autism” advocacy groups who can’t concentrate on anything but vaccines and 12 years of useless research trying to support what Keri Phillips calls not “…bad science but outright fraud.”

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