Left Brain Right Brain

Only a few years ago it seemed you couldn’t go into an online discussion without hearing David Kirby’s talking points from his book Evidence of Harm. I recall hearing over and over about pink’s disease, Minimata disease and many more “facts” that had really nothing to do with autism.

Now it seems to be Dr. Wakefield’s chance to shape (again) the discussion. His book “Callous Disregard” is sort of published (published but not generally available from what I can see). Luckily, a blogger for Examiner.com seems to have a copy and he lays out Mr. Wakefield’s responses to the ethics lapses which cost him his license in the UK. The talking points seem mostly to be about Mr. Wakefield, rather than about autism, but let’s go through them and see how they stand up to scrutiny, shall we?

Keep one thing in mind, Mr. Wakefield’s arguments seem to this observer to be of the type to mire people in details and confuse the issues with sidetracks.

Regarding financial conflicts of interest, Wakefield says that the funds for the Lancet 12 study came from the National Health Service. According to Wakefield, the money he received from lawyer Richard Barr was for a separate study looking for measles in the intestine of affected children. Wakefield states that the parents of the 12 children in the Lancet study came to him before he was hired as an expert on MMR litigation.

Wakefield writes that he was not required in 1997 to publish in the Lancet article his role of being an expert on MMR litigation but he did notify appropriate officials: “Long before publication ? details of my involvement as an expert in the litigation had been provided to my senior coauthors, the dean of the medical school, and the editor of The Lancet.”

As with much of Mr. Wakefield’s explanation, Brian Deer has responded to this one. But, let’s take a different look:

Andrew Wakefield was the key person in the Royal Free Hospital’s press conference on his paper in the Lancet. At that time, Mr. Wakefield was in the employ of lawyers seeking to litigate MMR injury cases. At that time he called into question the safety of the MMR vaccine.

INTERVIEWER: But if you say there’s at least a question mark over it now, should the vaccine continue to be administered while you’re investigating?

DR ANDREW WAKEFIELD: I think if you asked members of the team that have investigated this they would give you different answers. And I have to say that there is sufficient anxiety in my own mind of the safety, the long term safety of the polyvalent, that is the MMR vaccination in combination, that I think that it should be suspended in favour of the single vaccines, that is continued use of the individual measles, mumps and rubella components.

What do you think? Should a person working as a paid expert in MMR litigation announce this in a press conference where he calls for the suspension of the MMR vaccine? I would suggest that pretty much anyone who looked at this would say, “Yes, he should have made his conflict of interest public”.

Mr. Frandsen continues:

In a letter to pediatric gastroenterologist John Walker-Smith in February 1997, Wakefield explained his reasons for acting as an expert:

“Vaccination is designed to protect the majority, and it does so at the expense of a minority of individuals who suffer adverse consequenses…If this disease is caused by the MMR vaccination, then these childen (sic) are the few unfortunates that have been sacrificed to protect the majority of the children in this country. If that 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.”

Which is irrelevant to the question of whether Mr. Wakefield’s actions were ethical. Really, how does the above apply to, say, whether Mr Wakefield had a conflict of interest or performed procedures without ethical approval? It doesn’t.

Wakefield was accused of conducting unnecessary and invasive medical procedures such as lumbar puncture on children with autism. Wakefield states that the history of developmental regression justified lumbar punctures. Later it would be discovered that neuro-inflammation in children in autism showed abnormal cytokine levels in cerebral spinal fluid. In addition, Swedish autism expert Christopher Gillberg advocates lumbar punctures to exclude encephalitis, and the procedure is conducted on children with autism in the U.S.

First, many lumbar punctures were performed before ethical approval was granted. Second, and more importantly, many of the lumbar punctures were found to be unnecessary. Here is but one comment from the GMC finding on Mr. Wakefield:

The Panel has taken into account that there is no evidence in Child 3’s clinical notes to indicate that a lumbar puncture was required. Professor Rutter and Dr Thomas, experts on both sides, considered that such a test was not clinically indicated.

Note–experts from both sides considered that the test was not clinically indicated. So, even Mr. Wakefield’s expert agreed that there was no reason to do a lumbar puncture on this child.

Anecdote here–I don’t think I have ever run into a parent who had their autistic child undergo a lumbar puncture. Autism is not a general indication for lumbar puncture. How many times have you read in the comments on, say, the Age of Autism blog, “When we got our lumbar puncture…”

Mr. Frandsen continues:

Regarding “data fixing” alleged by a British journalist, Wakefield said there were no allegations by the GMC that he manipulated data: “In the hands of someone determined to discredit the work, discrepancies between the routine clinical report (which may have come, for example, from a pathologist with an interest in brain disease or gynecological pathology) and the standardized expert analysis were falsely reported in the national media as ‘fixing’ of the data.”

One good reason why “data fixing” was not a charge by the GMC is very simple–the information on “data fixing” came out from the GMC hearings. The charges were, not surprisingly, made before the hearings.

I would like to see what an investigation into the question of data fixing would conclude.

On the decision by the Lancet’s editors to retract the article because the 12 patients in the study were not “consecutively referred,” Wakefield responds, “This is bizarre, since it is factually entirely correct – these were the first 12 children to be referred to the care of Walker-Smith with a regressive developmental disorder and intestinal symptoms.” Wakefield writes in the book that he indeed did have ethics committee approval to conduct the research elements of the Lancet study.

Let’s look at this in pieces–Mr. Wakefield is redefining “consecutively referred” to suit his needs. How did the GMC interpret “consecutively referred”?

The Panel is satisfied that a general reader would interpret the wording in 30a to mean that children were referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral.

But, Mr. Wakefield’s team did play an active part in the recruitment of at least some of the children involved in the study. Not all of the children were referred for GI complaints.

Or, to put it quite simply: the statement “consecutively referred” was supposed to tell us all that there was no bias in how the patients came to be in the care of the Royal Free. But the truth was that there were huge biases involved.

Here is what the GMC had to say on this question:

Having regard to its findings in relation to Child 1, 9, 5 and 10, namely that these children were admitted to undergo a programme of investigations for research purposes, and that they all lacked a history of gastrointestinal symptoms, the Panel is satisfied that these referrals did not constitute routine referrals to the gastroenterology department.

Now let’s address the last sentence in that section above “Wakefield writes in the book that he indeed did have ethics committee approval to conduct the research elements of the Lancet study.”

This is one of those things where Mr. Wakefield and his supporters try to bury people in the details to create doubt. He claims that there was an approval in place, for project 162-95. The GMC rejected that idea:

The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition.

Why would they reject the idea? Project 162-95 allowed Prof. Walker-Smith to take two extra biopsies for research purposes when he did colonoscopies on patients.

Rather than get mired in the details ask a simple question: How does that allow the team to, say, perform lumbar punctures? Simple answer, it doesn’t.

Wakefield also cites conflict of interest among his critics. Professor Michael Rutter of the Institute of Psychiatry, a witness for the prosecution in the GMC case, had been a paid expert by vaccine manufacturers and the U.S. government. Dean Arie Zuckerman of the Royal Free Hospital wrote to the British Medical Association in October 1996 worried that Wakefield’s study could lead to a case against the government.

Assume it is all true. Does it change anything about Mr. Wakefield’s ethical lapses? It is the researcher version of “But mom, the other kids shoplift too”.

Wakefield answers the charges that it was unethical to take blood samples from children at his own child’s birthday party in 1999 to compare with samples of children with autism. “The blood was taken by a suitably qualified medical practitioner with standard aseptic precautions. Children were rewarded with the equivalent of just over $7. The entire procedure passed off without mishap or complaint. This process did not have the approval of an EC (Ethics Committee), which I now accept was naïve, but it was most certainly not unethical,” Wakefield writes.

Let’s boil this down to the basics: Mr. Wakefield made children into study subjects without first obtaining ethics approval.

That is unethical. By definition. Mr. Wakefield is not in a position to say “it wasn’t that bad an ethical breach” or “it happened safely”. What he really can’t say is “well, it would have been approved if I had asked”. None of those excuses work at all. His actions were unethical.

As if to make that point, the article goes on:

Wakefield compares that to a measles and rubella (MR) campaign the UK administered to approximately 8 million school children in November 1994: “In contrast, the MR campaign had multiple ethical failings on many levels, but the most staggering omission of all seems to me to have been the failure to alert parents to the known threat of severe adverse reactions – to deny them the fundamental right of informed consent in making a decision about their child. It puts the birthday party into the shade and rather makes a mockery of the post-GMC headlines about my callous disregard.”

Basically, Mr. Wakefield is saying, “other people were more unethical, so you should ignore my small ethical breaches”.

The birthday party story just fills in the narrative that Mr. Wakefield had a “callous disregard” for obtaining ethics approvals. Whether it was for very serious procedures on disabled children (lumbar punctures) or smaller actions like blood draws from non-autistic young children, he exhibited a pattern of unethical behavior.

“My experience serves as a cynical example to discourage others,” writes Wakefield. “As a consequence, many physicians in the United Kingdom and United States will not risk providing the care that is due to these children.”

This is a diversionary tactic. He’s using disabled children as a shield. Doctors in the US and the UK–and the world over–should not provide “care” that is not clinically required and potentially risky in order to obtain research results to support litigation. And that is where Mr. Wakefield failed.

In his piece, Mike Frandsen goes on with another talking point by Dr. Wakefield: that the US Government has acknowledged that vaccines cause autism. He cites the Hannah Poling case, the Bailey Banks case and the Hiatt case.

Again, let’s avoid getting bogged down in the details of those case and ask the simple question: did any of them involve Mr. Wakefield’s hypothesis of persistent measles in the gut? Answer, no.

This is another diversion.

Mr. Frandsen goes on to state:

Injury claims filed with the National Vaccine Injury Compensation Program since 1989 total 12,356. Claims involving deaths from vaccines number 1,035 in the same time period. According the VICP website, 52 cases have been filed for deaths since 1989 involving MMR and 19 cases filed for deaths involving the measles vaccine. Of those cases alleging injury or death due to vaccines, the U.S. government has compensated 2,440 awards totaling more than 1.8 billion dollars, though none of the awards have been compensated specifically for autism, according to the government’s statistics.

Again, what does any of this have to do with Mr. Wakefield’s research? Nothing. If they had a single case that was on point, they’d use it.

More to the point, what does this have to do with whether Mr. Wakefield’s research was performed *ethically*? Answer: nothing.

That’s always a good question to ask as Mr. Wakefield attempts to reinvent his image: does his excuse really address the issues? Mostly, do they address the issues of whether he acted ethically in his research activities? The answer is a very clear “no”.

Addendum:

The WakefieldWatch blog has also discussed the book “Callous Disregard” in “Who’s Callous Disregard”