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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

Callous Disregard: Epilogue

17 Nov

We’ve already discussed Andrew Wakefield’s book, Callous Disregard, a few times here at LeftBrainRightBrain. I discussed his chapter discussed “Why”, which is painful to read, both for Mr. Wakefield’s approach to the subject and his attempt at creative writing. I discussed his chapter 1, and some of the “myths” he claims there are in the discussion of the paper in The Lancet. In that piece I referred to wading through “Callous Disregard” as a land war in Asia. Around every corner there is a statement which just doesn’t hold up to scrutiny. Given that, you probably won’t be surprised to see that I have skipped to the end, the epilogue of the book. I’ll quote two paragraphs.

The first is voiced as a statement to those those would promote vaccines:

There is no place for indulging futile displacement activity, sanctimonious posturing, and self protectionism. In the battle for the hearts and minds of the public, you have already lost… Why? Because the parents are right; their stories are true; their children’s brains are damaged; there is a major, major problem. In the US, increasingly coercive vaccine mandates and fear mongering advertising campaigns are a measure of your failure–vaccine uptake is not a reflection of public confidence, but of those coercive measures, and without public confidence, you have nothing.

Mr. Wakefield likes to position himself as a moderate, someone still asking whether MMR causes autism. How exactly that squares with a clear statement, “..their children’s brains are damaged…” I don’t know.

The final paragraph is a closer to his “why” chapter.

Sinking low, out over Crystal Mountain, the Texan sun still hurts the land. The cedars draw on parched earth. And the sun is gone. Stars creep into the night sky and the forest begins to move. My children are asleep and my beer is cold. From the lops of Willie Nelson, the ballad of Bobby McGee falls with a salty melancholy: “I’d trade all my tomorrows for a single yesterday”. And for a moment I am there, on the cold, wet precipice of Hounds Ghyll viaduct, 180 feet above oblivion as a small boy looks questioningly into my face, slips my hand, and is gone.

I found the essay (for want of a better word) “Why” to be a bit disturbing. This closing paragraph only confirms that impression.

Callous Disregard: “That Paper”

16 Nov

We recently discussed here on LeftBrainRightBrain some sections of the transcripts from the GMC fitness to practice hearing that was held for Andrew Wakefield. I’ve recently added Mr. Wakefield’s book, Callous Disregard to my reading mix. Frequent visitors to LeftBreainRightBrain may have noticed that my blogging output has dropped. There is just so much, so much, to respond to in that book that it has become difficult to find good and somewhat brief examples of the misinformation that Mr. Wakefield is attempting.

As you can see, even this example isn’t so brief. But it does show a clear example of Mr. Wakefield’s methods, past and present.

Mr. Wakefield likes to use citations. They look good and, if you don’t look closely, they make it seem like he has data to back up his claims. Catherina at JustTheVax blogged that Andrew Wakefield uses references to support his ideas, but if you follow those references you get a very different story. Catherina’s example showed that Mr. Wakefield claimed that his work has been replicated by others when, in fact, his references showed nothing of the sort. No surprise: he does this again in his book. The citations don’t prove his point. Much to the contrary, in fact.

Following that sleight of hand, as I followed some of his references and checked with the GMC hearing transcirpts I kept finding more and more examples of exactly why he lost his license to practice medicine.

For example:

1) Mr. Wakefield knew full well that many of the parents of the children being seen at the Royal Free were on the road to litigation. Not only that, but Mr. Wakefield’s stated goal was “…to make sure that their legal cases are presented in the best possible light”.

2) Mr. Wakefield did not make his activities with the legal aid board public. He informed one of his authors, but there isn’t evidence he informed the other 11. If he knew it was important to inform one author, why leave the rest in the dark about his activities?

3) Mr. Wakefield claims that a news story made his activities public. The news story never mentions his name. In fact, it tends to prove just what Mr. Wakefield denies. The news article states that the study at the Royal Free was being organised by silicitors.

Orac over at Respectful Insolence would call “Callous Disregard” a “target rich environment”. At some point, when every page, every sentence, every reference has a high probability of being false, it becomes something worse. I have to pull in a popular culture reference–the Princess Bride–as this is what comes to mind as I read “Callous Disregard”: it is a land war in Asia.

This comes to mind because I am bogged down and it is only chapter 1.

Chapter 1 of his book is entitled “That Paper” and focuses on the 1998 article in the Lancet. Mr. Wakefield published essentially the same discussion of “That Paper” in the magazine The Autism File.

Let’s just pick a couple of the so-called “myths”, shall we? From Callous Disregard:

My involvement as a medical expert was kept “secret”[14].

False– at least one year before publication, I informed my senior coathors[15], the head of the department, the dean of the medical school[16], and the CEO of the hospital. This fact was also reported in the national press 15 months prior to publication.

He informed his “senior” coathors? Why not everyone? Let’s take a look at citation 15, shall we?

[15] Correspondence between Dr. Wakefield and Professor Waker-Smith, February 3, 1997 and February 20, 1997.

Do you know based on that what letters he is talking about? They are in the transcripts for the GMC hearing, and they are in the press complaints commission (PCC) complaint that Mr. Wakefield filed (is he actually moving on that at all, by the way? It seems to be hanging for a long time with no activity).

The letters are reproduced below.

Note a few things here. This is in February 1997. That’s a year before the Lancet study was published. Mr. Wakefield’s letter is not to his “senior coauthors”, plural, but to one coauthor. He had 13 authors. So were eleven co-authors left in the dark? Why only let one author know?

Also note that the children in the Lancet study had already been seen at the Royal Free. Child 1 was admitted in July 1996. Mr. Wakefield had seen the children and he knew that many were pursuing claims. Mr. Wakefield felt it his duty to “…make sure their legal cases are presented in the best possible light”.

That is a very clear conflict of interest.

Here is the letter:

“Dear John

re: Enterocolitis and regressive autism

Further to our meeting on Tuesday 21 January, I thought it important to write to you to clarify my role in the legal issues. I fully appreciate your desire not to become involved in the legal aspect of these cases, but I feel that it is important to express the reasons that I do feel obliged to become involved.

The future for the children with whom we are dealing is very bleak indeed. Not only are the provisions for these children within the community inadequate at present, but looking ahead to the future, there will come a time when the parents of these children die, and the patients, as chronically disabled adults, left to fend for themselves in an extremely hostile world. Were there any long-term institutions left for such children, then that is where they would end up. Since these hospitals are being closed on an almost weekly basis around the country, these hopeless individuals will be left to ‘care in the community’. One does not like to imagine how it will all end. Maybe their only hope is in people taking the possible organic basis of their disease seriously enough to investigate it and institute the appropriate therapies where possible.

Vaccination is designed to protect the majority, and it does so at the expense of a minority of individuals who suffer adverse consequences. Although the case against MMR is far from proven it is one that we are obliged to investigate in view of the consistent history given by these patients’ parents and by the observations made in the United States. If this disease is caused by the MMR vaccination, then these children are the few unfortunates that have been sacrificed to protect the majority of children in this country. If this is the case, our society has an absolute obligation to compensate and care for those who have been damaged by the vaccine for the greater good. This is an inescapable moral imperative and is the principal reason that I have decided to become involved in helping these children pursue their claims. I have considered this issue in great depth and, whilst it may not be the wish of others within the group to become involved, it falls to me to make sure that their legal cases are presented in the best possible light. Fortunately, this is entirely consistent with best clinical practice which, I believe, you are providing for these children. I felt it important, however, to let you know of my feelings on this, and the position that I feel I am obliged to adopt to support these children. Without our help, I genuinely believe that the medical profession would otherwise put them to one side, as it appears to have done in many cases already. My present fears for these children are much less than the horrible imaginings if they do not receive the appropriate help that is due to them at this stage. However, I am an optimist, and I believe that this project will turn out to be both enlightening and rewarding for all those who have been involved, and I am most grateful for your help and encouragement.

Kindest regards & best wishes,

Yours sincerely”

Here is Prof. Walker-Smith’s response. Note this sentence (with emphasis added): “It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest.”

“Dear Andy

Re: Enterocolitis and Regressive Autism

Many thanks for your letter of 3 February concerning the legal issues. I can exactly understand your position and I can appreciate the compassionate human side of your argument.

My position as with measles, MMR and Crohn’s disease is that the link with MMR is so far unproven. It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest. I myself simply will not appear in court on this issue.

I would have been less concerned by legal involvement if our work were complete and we had a firm view. Never before in my career have I been confronted by litigant parents of research work in progress. I think this makes our work difficult, especially publication and presentation.

I am very excited by this work and it is very worthwhile. Simon Murch and I met today and have drawn up a draft for patient selection for your comment please.

I also feel that Dr Harvey’s contribution to the study should now be concluded and Dr Andrew Lloyd-Evans asked to join us. Do you agree with this?

With Kind Regards
Yours sincerely”

Prof. Walker-Smith made a very good comment here: I would have been less concerned by legal involvement if our work were complete and we had a firm view. Never before in my career have I been confronted by litigant parents of research work in progress. I think this makes our work difficult, especially publication and presentation.

Another “myth” which Mr. Wakefield chose to address:

Children were litigants[19].

False–at the time of their referral to the Royal Free, the time material to their inclusion in The Lancet paper, none of the children were litigants.

I don’t know what definition of “litigant” Mr. Wakefield is using, but “nearly all” of the parents were involved in preparing legal action, according to Dr. Walker-Smith. Also, Mr. Wakefield was working to “…make sure their legal cases are presented in the best possible light”.

Mr. Wakefield can define terms and redefine the English language however he wishes. I deserved to hear that the parents were pursuing legal action and I deserved to hear that Mr. Wakefield was working to help those families in their cause.

Let’s go back to another statement by Mr. Wakefield.

This fact [Mr. Wakefield’s involvement as a medical expert] was also reported in the national press 15 months prior to publication[17].

As evidence of this He cites this article in the Independent. The article doesn’t mention Andrew Wakefield at all, much less mention his side job as a paid expert for the MMR litigation:

The article [17] can be found on Brian Deer’s website. I copy it here, but will replace it with a link should he make that request.

Law: A shot in the dark; The complications from vaccine damage seem to multiply in the courtroom, writes Grania Langdon-Down

The Independent (Law, Page 25) November 27 1996

Rosemary Kessick has watched her son William deteriorate from a bright, active toddler to a destructive eight-year-old who cannot talk, play or feed himself and who lives in a frantic, rushed world of his own. She blames the MMR (measles, mumps and rubella) vaccine for the devastating changes in William, now diagnosed as autistic and suffering from a debilitating inflammatory bowel disorder which can leave him screaming with pain.

William is one of 10 children taking part in a pilot study at the Royal Free Hospital in London, which is investigating possible links between the measles vaccine with the bowel disorder Crohn’s Disease, and with autism. The study is being organised by Norfolk solicitors Dawbarns, one of two firms awarded a contract in 1994 to co-ordinate claims resulting from the MMR vaccine.

Mrs Kessick, 42, had to give up her job as a business manager to look after William, the middle of her three children. William joined the other 300-plus children bringing claims through Dawbarns only in February, because the doctors she saw during her traumatic search for answers dismissed her fears about the vaccine out of hand.

“Within weeks of the vaccination, his development slowed down, then it stopped and then he regressed. Seeing what has happened to him has broken our hearts. It means so much to finally be listened to and to find people to stand up and say the safety of these vaccines must be investigated,” she says.

Concern about vaccination has resurfaced with the Government’s campaign to introduce a new MMR booster for all four-year-olds. Most of those children will have had their first MMR at about 15 months.

The Department of Health dismisses suggested links with autism and Crohn’s disease as the work of just one researcher, and argues that children are at far greater risk from measles than from the vaccine. The latest campaign, launched on the advice of an independent committee of doctors, was needed to stop the build-up of unvaccinated children, which would inevitably lead to new outbreaks of measles.

Dawbarns partner Richard Barr is co-ordinating the families’ claims. Depending on the results of the scientific study and counsel’s advice, he intends taking on the vaccine manufacturers using the Consumer Protection Act, 1987.

The Act was introduced to offer a system for dealing with no-fault liability without the need to prove negligence, and was intended to help cases such as those involving vaccine damage.

However, critics argue that it has not been widely used because of the extensive defences offered to manufacturers. These include the “development risks” defence which says manufacturers will not be liable if, with reasonably diligent research, they would not have been able to find the fault that is now causing the problem.

The development risks defence is being challenged in the European Court as being outside the terms of the European Directive on consumer protection legislation, because it effectively incorporates negligence back into the strict liability provision.

Mr Barr also intends to pursue the medical negligence aspect but, to date, there has never been a successful compensation claim for vaccine damage under negligence laws.

Mr Barr said: “The whole field of vaccine litigation was brought to a shuddering halt by the High Court judgement in Loveday and Renton in 1988, which involved the whooping cough vaccine.

“The case centres on whether the vaccine caused brain damage, but it went horribly wrong and the outcome was the judge concluded it did not. The case was based mainly on expert opinion rather than scientific evidence and the manufacturers were able to marshal massive resources to defeat the plaintiff’s experts. We will have to try to make sure we do not fall into the same traps.”

One result of the Loveday case was that the Legal Aid Board applied the result to all vaccine damage cases and generally refused to grant aid.

Mr Barr said: “For a year, we were without legal aid but we battled on until we were eventually granted it to pursue the possibility of bringing cases under the Consumer Protection Act.

“The benefit is you do not have to prove negligence – you simply have to prove the vaccine caused the damage and that it is an unsafe product. We will also have a strong argument that parents were given no, or insufficient, information or warnings about the possible risks of the vaccine to be able to give informed consent to its use.

“I am sure the manufacturers will try to discount any causal link between the vaccine and the damage suffered by the children. They will also argue that the benefits of being immunised far outweigh the risks from the vaccine. But we will argue that the dangers of these childhood disease have been exaggerated to terrorise parents into vaccinating their children.

“I also do not think the ‘development risk’ defence is a runner, because we would argue the mechanisms of how the damage is caused have been known since the Sixties when the measles vaccine was first being tested.”

He said another line of attack would be to focus on clusters of similar side-effects associated with particular batches of vaccine, although the main thrust remained against the vaccine as a whole.

Mr Barr, who refused to let his children be vaccinated, said their research was being helped by having an in-house scientist working on the cases. Kirsten Limb initially came to them as a client after her daughter was left severely disabled through medical negligence.

Jack Rabinowicz, a partner at Teacher Stern Selby, has been involved in vaccine damage cases for a decade and is chairman of the solicitors’ steering group dealing with whooping cough claims.

He was pessimistic about the likely success of cases brought against the vaccine rather than a specific “bad batch”.

“My view is that you have to show a child was damaged by vaccine from a bad batch, as happened in a case in Ireland in 1994 which resulted in more than pounds 2m compensation. The court found in favour of the claimant after hearing that the vaccine had failed internal toxicity tests but was still put on the market.

“A full frontal attack against the vaccine itself is much more difficult. The steering group is waiting for advice from counsel and, if it is reasonably optimistic, will issue writs early next year. They will involve product liability claims against manufacturers over specific ‘hot lots’ of the vaccine and medical negligence claims against individual doctors who ignored the contraindicational warnings about having the vaccinations.”

He said the cases were at the frontiers of medicine and law and the Legal Aid Board was rightly worried about committing public money unwisely. “There have been a number of disastrous product liability cases and these will be David against Goliath because the manufacturers and doctors have unlimited resources to fight their corner.

“I think the only thing that will change the situation is if Richard Barr and I get our cases off the ground and the manufacturers and doctors scream merry hell at the prospect of paying millions in compensation and put pressure on the government of whatever hue to provide state aid.”

The only help currently offered by the government is through the Vaccine Damage Pay Unit. Since it was set up in 1979, it has received 3,749 claims and made 883 awards. However, these have been capped at pounds 30,000 since 1991, and apply only if a child is 60 per cent disabled.

Mr Rabinowicz said: “If these children were birth victims they would receive about 2m each. These vaccine-damaged children would be looking probably for upwards of pounds 1m.”

There is no reference to Andrew Wakefield in the above article. The reference to the study at the Royal Free is this paragraph:

William is one of 10 children taking part in a pilot study at the Royal Free Hospital in London, which is investigating possible links between the measles vaccine with the bowel disorder Crohn’s Disease, and with autism. The study is being organised by Norfolk solicitors Dawbarns, one of two firms awarded a contract in 1994 to co-ordinate claims resulting from the MMR vaccine.

“The study is being organised by Norfolk solicitors Dawbarns….”

So, an article which Mr. Wakefield cites in his defense states that there is a study ongoing, organised by solicitors, on the link between mealses vaccine, bowel disorder and autism.

Keep that in mind when you read this other so-called “myth”:

Children were “sourced” by lawyers to sue vaccine manufacturers.

False– children were referred, evalueated and investigated on the basis of their clinical symptoms alone, following referral from the child’s physician[18]

I’ve only covered some of the “myths”, and that is only part of chapter 1 of “Callous Disregard”. There are 13 chapters, an afterword and an epilogue. There are hundreds upon hundreds of pages of GMC testimony.

It is a land war in Asia. I don’t plan to drag myself or LBRB through it all. My hat is off to the people who sat through the entire GMC hearing, read and reread the transcripts and boiled it down to a decision, only to have Mr. Wakefield attempt to rewrite history, complete with citations.

Deadly Choices: How the Anti-Vaccine Movement Threatens Us All

13 Nov

I recently wrote about the book, Panic Virus, which is set to come out in January, 2011. Another book which includes sections on the autism/vaccine story is also scheduled for January: Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, by Paul Offit.

The “product description” is very brief:

How did we get to a place where vaccines are viewed with horror rather than as life-saving medicine? The answer is rooted in one of the most powerful and disturbing citizen activist movements in our nation’s history—a movement that, despite recent epidemics and deaths, continues to grow. Deadly Choices is the story of anti-vaccine activity in America—its origins, leaders, influences, and impact—and is a powerful defense of science in the face of fear.

While the word “autism” doesn’t appear at all on the Amazon.com page for the book, it will come as no surprise that the autism/vaccine parent groups play a prominent role in the book’s discussion of the modern anti-vaccine movement.

Dr. Offit’s books get read. By important people. I have little doubt this one will too.

As I said with my discussion of Panic Virus, there is no joy in realizing that some of the vocal autism-parent groups are being chronicled in this way. There is, however, relief that books such as these signal that perhaps the worst is over. The public and the press are no longer giving the idea of the vaccine-induced-autism-epidemic the credibility it enjoyed only a year or two ago.

The Panic Virus: A True Story of Medicine, Science, and Fear

13 Nov

The past 15 years have seen a rise and, I would say, fall in the notion that vaccines might cause autism. I’ve often wondered when someone might write a history of the period. Somehow I thought that was still years away but I am wrong.

In January, a new book comes out: The Panic Virus: A True Story of Medicine, Science, and Fear. Seth Mnookin takes on the project of telling the story. From the sumary below and the blurbs on Amazon.com, this does not look to be the next “Evidence of Harm”. Far from it.

Here is the summary from Amazon.com:

WHO DECIDES WHICH FACTS ARE TRUE?

In 1998 Andrew Wakefield, a British gastroenterologist with a history of self-promotion, published a paper with a shocking allegation: the measles-mumps-rubella vaccine might cause autism. The media seized hold of the story and, in the process, helped to launch one of the most devastating health scares ever. In the years to come Wakefield would be revealed as a profiteer in league with class-action lawyers, and he would eventually lose his medical license. Meanwhile one study after another failed to find any link between childhood vaccines and autism.

Yet the myth that vaccines somehow cause developmental disorders lives on. Despite the lack of corroborating evidence, it has been popularized by media personalities such as Oprah Winfrey and Jenny McCarthy and legitimized by journalists who claim that they are just being fair to “both sides” of an issue about which there is little debate. Meanwhile millions of dollars have been diverted from potential breakthroughs in autism research, families have spent their savings on ineffective “miracle cures,” and declining vaccination rates have led to outbreaks of deadly illnesses like Hib, measles, and whooping cough. Most tragic of all is the increasing number of children dying from vaccine-preventable diseases.

In The Panic Virus Seth Mnookin draws on interviews with parents, public-health advocates, scientists, and anti-vaccine activists to tackle a fundamental question: How do we decide what the truth is? The fascinating answer helps explain everything from the persistence of conspiracy theories about 9/11 to the appeal of talk-show hosts who demand that President Obama “prove” he was born in America.

The Panic Virus is a riveting and sometimes heart-breaking medical detective story that explores the limits of rational thought. It is the ultimate cautionary tale for our time.

The blurb from Arthur Allen (author of Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver should give you a bit more of a taste of what is to come:

“Seth Mnookin understood there was something more to the cruelly misled and dangerously misleading vaccines-cause-autism movement than just an unhappy group of parents with a need to blame someone. He saw the connection between this deathless conspiracy theory and the proliferating irrationality of a society that has supersized its information diet while starving its capacity to think straight. For that reason alone—not to mention the deft, often charming characterizations woven into its skillful and fascinating narrative—this is an important, powerful, and bracing book.”

There is no joy in reporting that segments of the autism parent community are being outed for what has been and continues to be a very damaging agenda. Damaging to the public at large and to the autism communities. No, there is no joy in that. There is however a sense of relief that perhaps the worst is over.

Wakefield’s callous introduction

28 Oct

Below is a section of Andrew Wakefield’s book, “Callous Disregard”. This section is available as part of the free sample of the book. It is Mr. Wakefield’s semi-fictionalized account of a mother’s murder/suicide. A news account can be found here.

Another north-easterly wind insinuated its
futile energies between the massive brick
piers of Hounds Ghyll viaduct. Although the
wind endured, the earlier downpour had
turned to a light drizzle – light for County
Durham, in the far north of England – as
their journey came to an end.

As if for the first time, Mark seemed
attuned to his mother’s sense of purpose
and he offered no resistance. He did not
scream, or fight, or hit himself in the face;
he did not bite his scarred and scabby arms
or suddenly collapse to the ground as if
invisible guy-ropes could no longer hold
him. Instead, entranced by the raindrops
and in awe of the viaduct’s ordered
brickwork, he mouthed in silent wonder at
it all. At the midpoint of the viaduct she
turned to the north, the deep valley before
her – in places its walls sheer, glistening
black, cut by relentless waters that were
now barely visible in the fading light far,
far below. Mark looked up into his mother’s
face; beyond its years, alone, harassed,
pursued, and he understood her
unhappiness. He loved her, although he had
no way – no wiring – that allowed him to
express this.

With the aid of some old timbers she
helped him onto the parapet, her grip so
firm that it hurt them both. This was the
hardest part, the lichened stone wet and
perilous, her fear of heights. Standing there
at last, against the wind and against the
world, he looked at her and she at him.
“No,” she thought, “this is the hardest part.”
Without a word, without another thought
she stepped into oblivion, her most precious
possession taken with her, to rank in death
with Egyptian queens. They were not equal
to the wind and in one final effort it gusted
into them, threatening to smash the
waif-like Mark into the merciless viaduct.
She knew. She was ready. Falling ever faster,
she pulled him to her, love and instinct
keeping him safe.

At the time I read this I thought it could very well be entirely fiction. Not that I think that such a killing/suicide couldn’t happen. The recount, in my opinion, well, let’s just say that I sincerely hope that Mr. Wakefield never attempts to fictionalize my life or that of my family.

News accounts around the time of the event describe Ms. Rogan as a devoted mother who was growing increasingly afraid that she might lose her child. Not exactly the image presented above.

Other than a few facts, much of what happened on the viaduct is unknown. I can find no account of whether Mark had “scarred and scabby arms”. One description of him by a neighbor stated, ‘Mark was a beautiful little boy. To look at him, nobody would have known he was suffering any illness.’

What really stands out in Mr. Wakefield’s account, at least to me, is this phrase: “He loved her, although he had no way – no wiring – that allowed him to express this.”

I wonder how, after some 14 years working around autistic children, Mr. Wakefield could have written that. Not just in this case, where the police were quoted as describing the family as having “a very close and loving relationship between a mother and son”.

Detective Superintendent Harry Stephenson of Durham Constabulary said the force’s inquiries indicated “a very close and loving relationship between a mother and son”. He said: “This is an appalling tragedy and one that has been very traumatic to deal with even for some very experienced police officers. It would seem Miss Rogan was finding it difficult to cope with her personal circumstances but despite all that she seemed devoted to her son and prepared to do anything for him.

Beyond that news account, how could Mr. Wakefield write that a child had no wiring that allowed him to express his love for his mother? That sort of description is something to fight against, not something an “advocate” should be making.

Callous Disregard. Mr. Wakefield chose that title from one of the charges proven against him by the General Medical Council.

Recruitment of Wakefield’s study subjects…part 1

20 Oct

It has already been well established that Andrew Wakefield was employed by Dawbarns, a lawfirm working with families bringing forward claims of vaccine damage from MMR. Brian Deer made this clear in his investigative reporting starting in 2004.

Even with that, I must say I was surprised and dismayed to read it again and in much greater detail in the GMC transcripts.

Mr. Wakefield has asserted over the years that the children for the Lancet study came through “formal channels”. He denied the possibility of litigation bias in a letter to the Lancet.

Amongst the myriad questions left open is why did a group of parents of disabled children seek out Mr. Wakefield’s team when that team had no particular expertise in autism. Why did families from all over the U.K. and beyond seek out the Royal Free Hospital?

There is evidence elsewhere in the transcripts of Mr. Wakefield’s direct involvement with recruiting some children for his study, but here we can see how the law firm was actively recruiting children, and that Mr. Wakefield was aware of this.

For example, here is a section from the transcripts from day 3 of the hearings. This is where Ms. Smith was laying out the case against Mr. Wakefield before testimony was started.

Let’s first put the following letter into perspective on time. The letter is from August 1996. 1996 was two years before the Lancet paper was published. Earlier that year (in February) Mr. Wakefield had agreed to work as an expert in the MMR litigation. The Fall of 1996 was when the Lancet 12 children were seen at the Royal Free. After this initial group of children, more (over 70 total) children were seen at the Royal Free for suspected Gi complaints and regression.

Ms. Smith’s comments are in bold. The letter from Mr. Barr are blockquoted.

If I can just read through it, this is a letter to Dr Wakefield from Mr Barr, the solicitor for the claimants:

Dear Andy

I refer to the telephone message left … and I am writing to confirm that at long last the Legal Aid Board has now given authorisation for the pilot study. The limit is £55,00 which does include the setting up costs.

I think we need to have a meeting about the mechanics of running the study because obviously we both have different roles to play and we also need to make sure that the investigation is as effective as possible both from your point of view and ours.

As I mentioned on the telephone the only slight cloud is that the Legal Aid Board rather hoped that within the £55,000 you would be able to include preparing us a written over-view in relation to vaccine damage. We have discussed this and I don’t know whether it is impertinent to suggest that you should do it within that funding bracket.

We also need to make sure that cases are properly selected for the pilot study. Obviously only legally aided children can be included (we have details of cases where legal aid has either not been granted or has not been applied for). Again a meeting might help to sort those out. For all the cases that we have obtained legal aid we have already put in hand obtaining records. In many cases we already have the complete set.

I assume that for the purposes of the pilot study you would like us to supply a full set of medical records and as much information about the cases as you can get hold of.

Then there is reference to two of the vaccine support groups who were concerned about a forthcoming MMR campaign, and:

“When we meet I would like to discuss with you and perhaps engage in further correspondence with Dr Salisbury/The Committee on Safety of Medicines”,

and it then goes into some details and requests information about the vaccine trials.

That letter is followed on in terms of tracing the story through. That is in August 1996 and in September 1996 Dr Wakefield is referred to in another of the newsletters that I have already gone to, again produced by the solicitors in the MMR litigation and again sent to Mrs 12. That is at page 189.

There is so much in this letter of interest, but I will pull out one fact: Mr. Barr was sending newsletters out informing people about the work starting at the Royal Free, including “Mrs 12”, the mother of child 12 of the Lancet study.

There was certainly an effort to recruit children to Mr. Wakefield’s team, and Mr. Wakefield was aware of this.

Mr. Wakefield has asserted that none of the children in the Lancet study were involved in litigation at the time of that research. I do not know what criteria Mr. Wakefield uses for “involved in litigation”, but it is clear that at least one (and from other evidence it appears more like 4 or five) of the Lancet 12 were working with Mr. Barr and his lawfirm at Dawbarns at the time of the study.

Ms. Smith also discussed a September 1996 newsletter from Dawbarns. This was at the same time that Mr. Wakefield was applying for ethical approval for his study at the Royal Free. Here is a section of that newsletter:

Autism and inflammatory bowel disease

A substantial number of children referred to us are suffering from chronic stomach problems and/or have developed autism-like symptoms. Our own researches indicate that these two conditions may well have been caused by the MMR/MR vaccines and that they may well be linked.

We are trying to put together as much information as possible about the apparent link between these two conditions and the vaccines. If you have any information, or know of other families with children who have one or other of these conditions (or both) following vaccination we would be very interested to hear from you. If your child has the condition(s) and you have not yet received the fact sheet produced by Dr Andrew Wakefield, do contact us.”

It was no coincidence that the children reported in the 1998 Lancet paper claimed regression, GI complaints and many blamed the MMR vaccine.

Was there “litigation bias” and a strong measure of self-selection in the Lancet 12? Absolutely. Was Mr. Wakefield aware of this? Yes. Did he make this clear to the public, or even his own colleagues? No.

And we have yet to discuss what active role Andrew Wakefield himself took in recruiting study subjects to the Royal Free.

The Rouse letter: how Wakefield was almost caught in 1998

19 Oct

For those who have followed the story of Andrew Wakefield, the fact that he had multiple conflicts of interest is not news. The subjects in his now retracted 1998 paper in The Lancet were far from a random sample of autistics. They were even far from a random sample of autistics with GI problems. Brian Deer has made this very clear. The GMC ruled that it is clear that Andrew Wakefield was fully aware of the biased nature of these children.

But, Brian Deer was not the first to catch on. A letter to the Lancet in May 1998, a few short months after the now retracted Wakefield paper was published, a letter to the editor was published. It was by a Mr. Rouse, a public heath professional:

“Sir – After reading Andrew Wakefield and colleagues’ article I did a simple internet search and quickly found the Society for the Autistically Handicapped. I downloaded a 48 page fact sheet produced for the Society by Dawbarns, a firm of solicitors in King’s Lynn.

It seems likely then that some of the children investigated by Wakefield et al came to attention because of the activities of this Society and information from parents referred in this way would suffer from recall bias. It is a pity that Wakefield et al do not identify the manner in which the 12 children investigated were referred (e.g. from local GPs, self-referral via parents, or secondary/tertiary or international referral). Furthermore, if some children were referred directly or indirectly because of the activities of the Society for the Autistically Handicapped, Wakefield should have declared his co-operation with that organisation.”

It was so close to exposing the truth, but there would be another 6 years before Brian Deer would reopen the question and show that Andrew Wakefield did indeed have serious conflicts of interests (as well as many ethical failings) in the Lancet paper.

Mr. Rouse stressed the “Society for the Autistically Handicapped”, which Mr. Wakefield was able to claim no association with. Here, read the Wakefield response for yourself. The first two paragraphs refer to other letters to the Lancet, I am only showing the response to the Rouse letter:

A Rouse suggests that litigation bias might exist by virtue of information that he has downloaded from the Internet, from the Society for the Autistically Handicapped. Only one author (AJW) has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board. These children have all been seen expressly on the basis that they were referred through the normal channels (eg, from general practitioner, child psychiatrist, or community paediatrician) on the merits of their symptoms. AJW had never heard of the Society for the Autistically Handicapped and no fact sheet has been provided for them to distribute to interested parties. The only fact sheet that we have produced is for general practitioners, which describes the background and protocol for investigation of children with autism and gastrointestinal symptoms. Finally all those children referred to us (including the 53 who have been investigated already and those on a waiting list that extends into 1999) have come through the formal channels described above. No conflict of interest exists.

Much discussion went into this exchange. There even appears to be two versions of the Rouse letter.

Mr. Wakefield argued that his response was factually correct. That he responded to some specific questions raised by the Rouse letter. I am reminded of the courtroom oath in the United States, that one must tell the truth, the whole truth and nothing but the truth. Mr. Wakefield seems to avoid “the whole truth” here and elsewhere.

Here is what the prosecution had to say about Mr. Wakefield’s response:

So even at that stage, we suggest that Dr Wakefield failed to set out in straightforward terms the nature of his involvement with the litigation and the receipt of funding, because he says he has never heard of the Society for the Autistically Handicapped – well, fair enough – but he does not state that he had heard of, and had been working for more than two years with, Dawbarns, who were the solicitors in the MMR litigation, as an expert for them. That is despite the fact that he is responding to an allegation which he himself understood to be alleging litigation bias.

Secondly, he says that he “has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board”, but he makes no reference to the fact that they had funded his research to the tune of £25,000 at that stage, with more anticipated to come.

Dr Wakefield’s explanation for that, you will not be surprised to hear, is that he was responding to specific points only. It is our submission that it is a hallmark of his evidence that he falls back on this kind of terminological or grammatical analysis of allegations or questions which have been put to him in an attempt to obscure his own failure to respond openly and honestly and then he places the burden on others to pin him down and to ask for what he actually describes as “further and better particulars”. So he says that is what should be done if people want straightforward answers, in effect.

It is worth seeing how Mr. Wakefield’s colleagues thought of the Rouse letter. In summarizing the defense for Prof. Walker-Smith (one of the Wakefield team who was also sanctioned by the GMC), his attorney noted

(a) At the time that the Lancet children were investigated at the Royal Free, Professor Walker-Smith had no knowledge of Dr Wakefield’s dealings with the Legal Aid Board.

(b) Some time around the beginning of 1997, Professor Walker-Smith became aware that Dr Wakefield was acting as an expert on behalf of a number of children in a group action concerning MMR. Professor Walker-Smith did not want to have any involvement in actual or potential litigation.

(c) Professor Walker-Smith was not aware of the litigation status of the Lancet children at the time that the Lancet paper was written.

(d) It was not until the Rouse correspondence in the Lancet in 1998 that Professor Walker-Smith became aware that Dr Wakefield had agreed to “evaluate a small number of these children on behalf of the Legal Aid Board”. This was after the Lancet paper had been published.

(e) It was not until Mr Deer contacted him many years later that he was informed about a sum of money that had allegedly been paid to Dr Wakefield by the Legal Aid Board.

(f) It was not until 2004 that Professor Walker-Smith learned the number of Lancet children that were part of the “class action” in which Dr Wakefield was involved.

There is a lot in that statement of interest, but for this discussion I will focus on the statement that Mr. Wakefield did not disclose to his colleagues that some of the children he was working were involved with the Legal Aid Board. They learned about it from the Rouse letter. Why wasn’t Mr. Wakefield transparent even with his own colleagues?

Back to the Wakefield response, I think that it is a stretch to say that “no conflict of interest exists” or that the children came through formal channels. This ignores the fact that Mr. Wakefield played an active part in recruiting children into the study. This ignores the fact that Mr. Wakefield was aware that there indeed was a litigation bias involved in both himself and many of the study subjects.

As long as we are looking at the letters to the Lancet, here is one by Barbara Loe Fisher, of the self-named National Vaccine Information Center (in reference to a letter to the Lancet by members of the CDC):

“The pre-emptive strike by US vaccine policymakers on Andrew Wakefield and his colleagues’ investigation into the immunopathology of children with chronic enterocolitis and regressive developmental disorder brings into sharp relief the inappropriate intervention of politics into what should be an apolitical scientific examination.”

What is brought “into sharp relief” was that Mr. Wakefield’s study was not an “apolitical scientific examination”. Rather it was a litigation funded and driven project where crucial facts were hidden from the public. A true vaccine safety organization, which Ms. Fisher’s NVIC is not, would now be condemning Mr. Wakefield’s manipulation of the story. Instead, she gives him awards.

The Rouse letter shows that Mr. Wakefield failed in his duty to explain the details of his research to the public, and to his own colleagues. From where I sit, it also looks as though the Lancet failed to ask the direct questions that should have been raised at this point. They allowed Mr. Wakefield to avoid the sticky questions raised by the fact that Mr. Wakefield was involved in the MMR litigation.

Of course it is easy in hindsight to see the patterns. At the time, Mr. Wakefield was a highly respected researcher and much of what we now know was hidden. But it is very frustrating to think that the story could have been (should have been) exposed so quickly after the publication of the Lancet paper.

Is there value in continuing to report on Andrew Wakefield’s ethical lapses?

15 Oct

Andrew Wakefield has been a major subject of discussion here on LeftBrainRightBrain and elsewhere for many years. The question comes up repeatedly as to what is the value of continuing to discuss someone whose ideas have been discredited, and who is no longer having much of an impact on the autism research discussion.

Mr. Wakefield has publicly stated that he is “not going away”. His book has come and, for all practical purposes, gone. He no longer works for Thoughtful House. His name is being dropped from papers for projects he has worked on.

He does have a new business venture to consult with some vaccine-advocacy groups, and I am sure that from time to time he will appear in the public’s eye.

We have already discussed here at LeftBrainRightBrain the outcome of the General Medical Council (GMC) fitness to practice hearings, which found Mr. Wakefield guilty of multiple ethics violations. I recently posted observations on Mr. Wakefield’s patent activities, based on the transcripts of the GMC hearings. A valid question is why? Why go through those transcripts? The GMC already reported the results when they struck Mr. Wakefield off the register. Brian Deer has covered the Wakefield story much more thoroughly than we can here. Some people are just tired to the point of being annoyed with discussions of a Mr. Wakefield, and I can understand that.

All that said, I find the transcripts very interesting. No way I can read them all, but what I have read leaves me even more dismayed. I didn’t think it possible, but there it is.

I have already read important facts that surprised me. As I already wrote, Mr. Wakefield applied for his patent without the knowledge of his hospital. That is an amazingly foolish maneuver. This could have invalidated the patent. It was also foolish in that he could have left out key claims that could have protected the Hospital’s intellectual property. On many, many levels, this was a foolish thing to do.

I remain intrigued by the hearing transcripts. I am finding things I didn’t know. I assume those who don’t want to read will skip the posts, and some will read and a discussion will ensue.

So, I will blog about the hearing transcripts. With apologies to those who are tired of the Wakefield story. With no apologies to those who defend Mr. Wakefield and have accepted his rationalizations.

One problem is that there are so many details, so many ethical lapses, multiple conflicts of interest, so many details that it is easy to lose sight of what all this means.

This is long saga. For the most part, each day is a separate Word document and there 155 of them. A typical day’s testimony can be 80 pages long. Even the GMC decision is long. But what it shows is a pattern of multiple instances of lack of respect for the disabled children in his group’s care, multiple instances of disregard for ethical standards, multiple instances of conflicts of interest.

There is a pattern here. And it is pretty ugly.

Andrew Wakefield’s vaccine patent

11 Oct

I’m reading through the transcripts from the General Medical Council Hearing on Andrew Wakefield and his colleagues at the Royal Free Hospital. It is long. Very long. Each day runs tens of pages (day 31 is 79 pages alone). Even beyond the bulk of the proceeding I find it difficult reading. I find it very difficult to read about the ethical lapses committed in the name of care of disabled children. Because of that, I quickly moved to a topic I have already written about and one that is less painful to discuss: the patent application Mr. Wakefield submitted on his “transfer factor”.

A thorough discussion of the patent history can be found on Brian Deer’s website. Brian Deer is the journalist who uncovered much of what the GMC was later to pronounce as ethical violations.

The patent is very clear in that it covers both the use of the transfer factor as a therapeutic agent and as a prophylaxis. In other words, Mr. Wakefield patented a treatment and a vaccine. Even though this is painfully clear, Mr. Wakefield has continually denied that the invention was a vaccine.

Day 31 of the hearing went into great detail about the patent. I was surprised to read (or had forgotten had I read before) that Mr. Wakefield applied for the patent without his hospital’s knowledge. This is very odd since the Royal Free was named as the applicant.

Below is a section from a memo, dated March 10, 1998 from Ruth Bishop to Cengiz Altan Tarhah, of University College, London (of which the Royal Free Hospital is a part).

Last summer, Andy Wakefield wrote to the School describing a patent application which he had personally filed along with Neuroimmuno Therapeutics Research Foundation (NIT). This was filed without the School’s knowledge, although in the name of the School. This application concerns the ‘transfer factor’ and Mr Wakefield asked if the School would be prepared to take on the prosecution and costs – he was (and is) meeting these himself.

Applying for a patent without approval from his institution is amazingly foolish. Aside from the obvious chutzpah, it basically invalidates the patent. For most people this would be a remarkable career mistake. While is is serious, it pales in comparison to the many other ethics violations that the GMC found Mr. Wakefield guilty of.

Let’s take a closer look at the question of whether it was Mr. Wakefield’s intent to use the invention, the “transfer factor”, as a vaccine. Mr. Wakefield submitted a business plan whereby he and the father of child 10 (the 10th child in the Lancet study) would develop the transfer factors.

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.

Emphasis added.

Recally, Mr. Wakefield contended that the MMR was causing inflammatory bowel disease. He had plans to test his transfer factor to prevent IBD, not just to treat it.

It was a Vaccine.

Should that language be vague enough for some to still claim Mr. Wakefield didn’t intend on developing a vaccine. Here is a section from the “Strategy and Objectives” section of the business plan:

[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.

Emphasis added.

Again–a vaccine in addition to a therapy.

It was a vaccine.

A sub-heading of “Strategy and Objectives” reads: Establish the potential of the high specific active preparations as a potential measles vaccine. It just doesn’t get much clearer than that.

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.”

They planned to develop this with someone like Glaxo Wellcome’s Jenner Institute. That would be a vaccine research group (Jenner being the inventor of the first vaccine, for smallpox, in the 18th century).

Further, the business plan included objectives:

“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.”

Emphasis added.

Vaccine replacements. Replacements. Not “we are using the name vaccine to mean a therapy”, but a replacement.

I know I’ve given the evidence a number of times in this post, but I just can’t understand why Mr. Wakefield even tries to deny his intent to develop a vaccine in the true sense of the word.

It was difficult to understand how people believed Mr. Wakefield’s story before. I will be amazed (but not surprised) that they continue to do so.

Just in case you missed it, here is one of the goals for Mr. Wakefield’s proposed company: “Establish the potential of the high specific active preparations as a potential measles vaccine”

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