Callous Disregard: “That Paper”

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.