Friday, August 31, 2007

The trial of Dr Jayne Donegan

Dr Jayne DoneganThe August 2007 GMC "trial" of Dr Jayne Donegan (MBBS DRCOG DCH DFFP MRCGP MFHom) is relevant to the process of scientific debate.

Dr Donegan is a medical doctor and family practitioner. She has an interest in homeopathy. She graduated as a medical doctor at St Mary's Hospital Medical School (London) in 1983. Donegan is however one of several medical doctors in the United Kingdom who holds views about science that have led to selective disciplinary/"fitness to practice" procedures (FTP) by the General Medical Council.

I hold no particularly strong views on vaccination. I agree with most observers (such as the respected Cochrane Collaboration) that much of the science in this area is exceedingly poor in terms of quality and transparency. However the mode of debate here is of concern. Gratuitous attempts to discredit critics never turn out well. More particularly so when those critics have raised points about aspects of the flimsiness of the scientific record which even hard-nosed skeptical scientists (such as myself) would find of concern.

Dr Donegan's "sin" had nothing to do with homeopathy. I have views about homeopathy that are very unlikely to be viewed sympathetically by Dr Donegan. She testified in an important court case in which mothers and fathers differed in their views over whether their children should be vaccinated (vaccination is not compulsory in the UK). Two witnesses for the fathers provided the view of the Department of Health. Donegan provided testimony for the mothers. She provided a report which concluded that a perfectly rational parent making a decision about vaccination for their own child might well have some valid fears about the integrity and strength of some aspects of the underlying science. For her sins, Jayne was subjected to a lengthy Fitness to Practice Procedure.

The stated charge was that she had written a medical report about the underlying science for the court that:
  1. Gave false and/or misleading impressions of the research which you relied upon,
  2. Quoted selectively from research, reports and publications and omitted relevant information,
  3. Allowed your deeply held views on the subject of immunisation to overrule your duty to the court
  4. Failed to present an objective, independent and unbiased view

... and having done so, Dr Jayne Donegan was charged with serious professional misconduct, and with bringing the profession into disrepute.

Unfortunately for the GMC Donegan presented overwhelming evidence to back up the science she had actually presented to the court, leaving the distinct impression that all three opposing experts should have been placed in her position. The GMC had no choice but to clear her of all charges last week (24 August 2007).

The case appeared to have been brought by the GMC itself, and as far as I am aware there was no complainant. Her report was challenged by "GMC expert, Dr Elliman" who produced a supposedly objective evidence-based report on Donegan's report. Donegan's report had in turn challenged expert reports produced for the fathers.

The entire transcript of this August 2007 "trial" is now available online. A detailed reading of the transcripts (particularly Days 8, 9 and 10) provides an interesting commentary on science.

We will no doubt read nothing at all of this in the Medical Journals (or we will perhaps read yet another distorted version of a medical "scandal" in the BMJ that skirts around all of the relevant principles and lessons in favour of a few lurid but irrelevant personal details).

Open and fear-free scientific debate are the real casualties of the GMC action here, irrespective of any concerns about vaccines or homeopathy. The effect on debate is chilling, and goes far beyond those areas. There are of course many legitimate areas of concern about science in medicine right now - both in terms of interepretation and probity. Bullying of those who raise concerns is not how science progresses.

The GMC in their groveling climb-down included a bit of ad hominem to the effect that what Donegan derived from some of the publications she cited differed from the conclusions of the authors (as if this were improper) even though the points she raised were scientifically valid criticisms of those publications. That for the information of the GMC is what being an expert witness (and an honest reviewing scientist) is all about. An expert witness is there to discuss scientific evidence and it's veracity, and to discuss where the conclusions of authors appear (through ignorance, wishful thinking, or scientific misconduct) to overstate or misrepresent data. It is precisely why the GMC should only act to ensure the integrity of scientific procedures, while striving to avoid suppressing actual scientific discussion.

The case also raises issues about the confidentiality of FTP procedures - the same issues of confidentiality that have been raised in the Blakemore Brown case. The issue with Blakemore Brown is whether an individual is entitled to breach her own confidentiality (but not patient confidentiality) as an act of self preservation when accused of misconduct (or in her case mental illness) - even if it leaves expert assessors struggling to justify their testimony. I am presuming that the GMC have no problem with the publication of the full transcripts in the Donegan case, and I am therefore puzzled about the apparent claims with regard to Blakemore Brown.

Some snippets from the transcript indicate the flavour of this case.
All are by Mr Stern, legal representative for Donegan:
Day 9 Page 63:A number of the points made by Dr Elliman .... is that Dr Donegan has omitted the opinion of the writer of the research, and Mr Kark cross-examined time and time again about this, the opinion of the writer of the research and the conclusion that the writer of the research provides in the research, which is essentially, "This is likely, that is likely, this may be the case, that is a possibility, possibly not, possibly there is no connection", et cetera.

Dr Fletcher did in fact give some evidence about this and had a view about this. He said, and again I am paraphrasing, that essentially you could take the data and pretty much come to any view you wanted to. He did not have a high regard, I think, for the research. Indeed he is supported to some extent by the Cochrane Collaboration, which was produced by Dr Elliman. The Cochrane Collaboration, you will remember, just looking at the MMR, said that there were something like 5,000 pieces of research papers that were initially looked at in relation to MMR and that, once they analysed those 5,000 papers against the criteria that they thought was appropriate for inclusion, non-bias, etc, there were I think something like 31 pieces of research that met that criteria. So, in my submission Dr Fletcher is supported in his assessment of the absence of science from a lot of the research.

Day 9 Page 64: The test of the clarity or otherwise of an expert report could never be whether a non expert might be misled. The whole purpose of an expert report is to provide an opinion on a subject which is by definition outside the knowledge and understanding of non-experts. That is why they are entitled to give an opinion.

Day 9 Page 68: It is to some extent an area I do not profess to understand where, for reasons best known to those who are involved, debate appears to be stifled and there appears to be an area where we are all bullied not to discuss it.

Day 9 Page 69: Again, Dr Elliman does not seem to consider any point about that can be properly made unless you put the other side of the coin, that is to say, "By the way the vaccine is effective and works and there is a high rate of efficacy."

The point that she [Donegan] makes is true. There is no doubt about that. She is just giving a description of it. You can see she is beginning in the 1950s. She goes on in 1978, setting out there some of the points. Of course it is selective. Everything is selective. There is no word that one can choose in any sentence, either spoken or written, which does not involve a selection and therefore the omission of other words. That is the nature of language.

Day 9 Page 71: There is also, in relation to this particular part, that Dr Elliman criticises Dr Donegan for not mentioning this Nilson research. This is one of a number of criticisms - I cannot remember how many there are, but maybe on three or four occasions - where he complains that she has not referred to particular papers, which he says is a larger study, a better study or a more helpful study or whatever. If she had the study and deliberately did not include it, one could understand the point

The point is in any event not a good one, in my submission, because, again not mentioned by Dr Elliman, none of the papers he says should have been referred to by Dr Donegan were referred to by Dr Conway or Professor Kroll. The test, if one wants to look at the test, is this: if the assertion was that no reasonable expert could have failed to have pointed to those particular pieces of research, then that would be a fair point if Dr Conway or Professor Kroll said, "This particular study is so well known I cannot imagine how it is that Dr Donegan has failed to mention it." It is a poor point, because all three of the individuals, Conway, Kroll and Donegan do not refer to it

Day 9 Page 82: That is why Dr Donegan, as she told you, was initially reluctant to help or to be an expert, but felt morally under a duty to assist the mothers in preparing this report because otherwise they would have no-one to assist them and to put the other side of the coin. So rather I suppose as she does in her surgery, explaining both sides, she hoped that she would be able to at least put the other side in the absence of that being done by Dr Conway or Professor Kroll. Had they fulfilled their task appropriately under the CPR 35 then it may be she would not have needed to provide a report at all because, had they included in it all the possible side effects, all the potential adverse reactions and dealt with that matter fully, then Dr Donegan's report would be otiose.

Day 9 Page 14: what we are going to look at now, the second issue - the deeply held views point [the charge that Donegan allowed her "deeply held views on the subject of immunisation to overrule her duty to the court"]

This is, I am afraid, another term that has never been analysed or, indeed, you have not been assisted as to what it is that you are supposed to understand by that and, therefore, nor has Dr Donegan. Does it mean deeply held views in relation to anti-vaccination? Does it mean deeply held views of immunisation concerning the safety of vaccination of children? Does it means deeply held views on the subject of immunisation relating to the safety of scientific research material?

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Radagast said...

I suppose the key word amidst all of this is "opinion". Not fact. Opinion. One may permit oneself to be swayed by a persuasively argued opinion. Or not. But in all events, one knows that it was opinion that was being presented.

As opposed to those facts that we keep being presented with by those with a vested interest. These are also opinion, because they are founded on the same research, and yet arrive at a different conclusion. And yet, because they support a certain interest, these "official" opinions acquire the solemnity and solidity of fact, particularly by dint of their repetition.


soulful sepulcher said...

I'm skipping ahead without regard to science or thoughts I will gather related to this topic: straight to the vaccine topic. In the USA where my children attended school, certain vaccines were mandatory per admission to school. 2/3 of my children suffered side effects of 2 separate childhood vaccines. I researched and found a "base" the vaccine was formulated within is what caused one of my kids to suffer a 3 month migraine per an unknown allergy to the "base".
Another child, my youngest had an adverse reaction to a MMR vaccine. The one that has been touted as culprit to autism, etc.
There is no opinion that counts more than living examples of "things gone wrong".
I will be back after investigating this post in depth.Thanks for this post.

Anonymous said...

Why are they so afraid of scientific debate and what are they afraid that an opinion or debate might discover? Until debate leads to research that either proves or disproves opinion then what appear to be perfectly reasonable questions will continue to be raised as in this example regarding vaccination:

"We surveyed over 9,000 boys in California and Oregon and found that vaccinated boys had a 155% greater chance of having a neurological disorder like ADHD or autism than unvaccinated boys. -Generation Rescue, June 26, 2007"

"Generation Rescue chose to use telephone interviews with parents to gather data on children, so as to closely mirror the methodology the CDC uses to establish national prevalence for NDs such as ADHD and autism through their national phone survey of parent responses. Generation Rescue chose to focus on children ages 4-17 to match the age range used by CDC."

"Generation Rescue is not representing that our study proves that the U.S. vaccine schedule has caused an epidemic in neurological disorders amongst our children. We are a small non-profit organization. For less than $200,000, we were able to complete a study that the CDC, with an $8 billion a year budget, has been unable or unwilling to do. We think the results of our survey lend credibility to the urgent need to do a larger scale study to compare vaccinated and unvaccinated children for neurodevelopmental outcomes."

Anonymous said...

Further to the lack of large-scale studies on the safety (never mind effectiveness) of vaccines, in addition to the one recommended by Generation Rescue regarding neurological outcomes, I would also like to see a study on immunological outcomes (plus a general study of non-neurological and non-immunological health parameters). I feel that this sort of information is essential before making a truly informed decision on whether to vaccinate. I am withholding vaccines from my children until such data becomes available (not that I am holding my breath or anything).

At least my doctor was sufficiently up-front about it to admit, despite the pressure on her (and therefore on me as a parent) to vaccinate all of her pediatric patients, that there are in fact no long-term safety studies, and therefore that vaccines are essentially an experimental therapy. Her best argument for the safety of the vaccines she was peddling was that they hadn't done her any harm, had they? (!) (Of course as a child she wouldn't have gotten all of the ones they recommend nowadays, either.)

Kels said...

Should perhaps Dr Elliman be brought before the GMC (on the GMC's own motion) to answer for violating the very same rubrics he so casually and, as it has eventuated, so falsely accused Dr. Donegan of violating?

Seems the GMC could simply use Dr Elliman's accusations, replacing the word "Donegan" with the word "Elliman"?

And given the panel's findings in the Donegan case, judgment on Elliman could be a rather summary proceeding?

If the effect of Elliman's attack was/is to chill any debate as to the view which he apparently (from his actions) "Allowed your deeply held views on the subject of immunisation to overrule your duty", does not the GMC owe the profession some formal unchilling of the air ? -- which, it seems, a public spanking of Elliman would nicely achieve?

Just a thought.

Anonymous said...

Let's be plain and realistic here: the nice doctor lady has apparently a bias and does not regard scientific method to be the primary way to determine efficiacy, as she promotes and practices homeopathy.

From the transcripts it is also apparent she had a tendency to cherry pick evidence.

Whether that is sufficient basis for serious professional mosconduct - depends on the rules in UK I guess.

The real danger I see though is how this can get eventually misrepresented in media. The following is perhaps an extreme example, but it is real and it's actuallty how I found this side.

The title translated starts with: "British Scientists Admitted: Vaccination Does Not Work. Young Doctor Found Evidence. (...)"

Therefore while I agree an open discussion is essential, medicine should keep building an effective "immunity" against non-scientific bullshit and therefore I wouldn't consider what happened "bullying", but rather a proper defensive mechanism and the result (clearing all charges) is a bit disappointing.

Aubrey Blumsohn said...

Actually I agree with most of what you say.

Off the cuff:

The problem really lies in the fact that the medical regulator has no credibility at all because it fails to take action against proper doctors who disgrace our profession, discredit science and behave dishonestly -- particularly where it involves collusion with industry to falsify or distort the scientific record. And this is even where such instances are blatant and dismal and where they involve those at the very heart of our profession.

Albeit that I am not anywhere in the Donegan camp or remotely close, I am afraid that all is not well with much medical science and transparency of that science -- and that includes plenty science underlying vaccine useage. We discredit ourselves as a profession by selectively taking action only against those who prove a convenient target, but not against the disgraceful but very senior members of our academic hierarchy who should be setting an example. As such it is bullying and an attempt to suppress scientific opinion through bullying (however wrong that opinion might be).

On the vaccine front, and by way of example -- as a scientist, I feel it totally improper that Gardesil and its ilk were introduced in a widespread way, where there was a perfect opportunity to do this as part of a decent RCT (immunising half the population for example). This would not have been at all unethical given the serious doubts about long term efficacy and perhaps rare side effects. If I say that this is wrong (and that it smacks of a type of scientific fraud) that makes me a scientist -- not someone who should feel he has to risk medical regulatory action. This is why our profession is so disbelieved - because our leadership are unscientific and dishonest.