NMT Medical - the MIST trial starts to unwind

I have posted previously (here and here) about this ethical and scientific scandal. The saga involves a medical device, and the conduct and conclusions of the Migraine Intervention with STARflex Technology (MIST) I trial. Peter Wilmshurst and another "author" of this study alleged scientific misconduct, hiding of data from authors and legal bullying by the sponsor, NMT Medical. They refused to sign the manuscript, made their views public, and were sued.

Now the remaining authors have been forced to submit an extensive manuscript "correction" which addresses a few of the many problems raised. Amongst other things there is an admission that "side effects" of the device were misrepresented. Devices embolized inside the heart and to the left pulmonary artery. A device that embolised into the pulmonary artery was reported to be in "an unsatisfactory position" and was not mentioned at all in the paper (or apparently to the Ethics Committee). The stated "authors" declare that they "regret" the "errors".

The Journal (Circulation) did not question the changing authorship on the four versions of the paper that they received. The Editor in Chief of Circulation (Dr Loscalzo) earlier wrote to say that "We now consider the matter closed". The UK regulator, the Medicines and Healthcare Regulatory Authority (MHRA) previously stated that it had "reviewed the "available evidence" and has found nothing to suggest that there is a problem". Since the ejected authors and presumably the regulators had no relevant evidence at all, the MHRA response and their definition of "a problem" appears predictably odd to say the least.

The text of the statement of "correction" is here.

I don't think that this is going to be last word on this sorry matter.

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Weetman chair of the Medical Schools Council

Tony Weetman, Sheffield University Pro Vice Chancellor for medicine has been elected chair of the Medical Schools Council. It is said that Weetman plans to "optimise the UK's health, wealth and knowledge and the profession of medicine through biomedical research".


(BMA News 15 Aug 2009)

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Sitting leaders ask you to stand up for safety

Here is an excellent letter in the British Medical Journal (18 July 2009; 339:124).



The same letter in text format (minus references) is below:

Sitting leaders ask you to stand up for safety


If junior doctors follow the recommendation of medical leaders and stand up for the safety of patients will they receive support from those leaders? (1)

“Staff concerns about safety at Mid Staffordshire trust were ‘lost in a black hole.’” (2) The evidence suggests that whistleblowers who report concerns are treated no better in the NHS now than at the time of the scandal at Bristol Royal Infirmary. (3) Medical leaders are responsible for the culture of silence. To become a medical leader one needs to compromise principles for expediency to meet the demands of politicians (in an organisation or government) with the power to advance or destroy a career. Medical leaders lack moral authority because few of them have taken the risk of speaking out on their way to the top. They are too often complicit in concealment of problems to protect their organisations or political masters.(4)

Fiona Godlee spoke at the conference and represented the BMJ.(1) The BMJ has removed from its website articles that have appeared in the paper journal purely to avoid the risk of the journal being sued for libel. The articles have not been retracted because there are no grounds for retraction of truthful reports. Does the BMJ want junior doctors to take the risk of losing their careers by speaking out when it is afraid of the financial cost of speaking?

Liam Donaldson also spoke at the conference.(1) I have had correspondence and meetings with the chief medical officer to discuss misconduct by doctors, but I am left with the impression that he is unwilling or unable to act when the allegations involve senior medical leaders. Yet Sir Liam wants junior doctors to be brave enough to speak about problems.

The motivational speeches of medical leaders to junior doctors seem to be like the pep talks of generals to soldiers at the Somme before the troops went over the top and the leaders returned to their chateau for lunch. Medical leaders must now lead from the front and share the risks.

Peter T Wilmshurst
Consultant cardiologist
Royal Shrewsbury Hospital
Shrewsbury SY3 8XQ

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Consultation

A hallmark of the UK NuLabour government is the sham public "consultation". Over recent months, Universities have been "consulted" on new procedures for self investigation (and effective cover-up) of research fraud (see consultation). The General Medical Council is "consulting" about their (already reasonable) guidance for doctors who fake research - while they fail to deal with actual doctors who have brought shame on the clinical research enterprise. The GMC is also "consulting" on how it could "improve its procedures for handling Fitness to Practice cases".

Much of what passes for "consultation" is theater designed to create an illusion that serious problems with these organisations are being addressed. I have yet to see actual examples of regulatory integrity lapses, cover-up and cock-up included within any consultation document.

Funniest of all is the current consultation on government regulation of "Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK". David Colquhoun is lucid on the problem of what we are regulating. He discusses in some detail examination papers and teaching material from degree courses on acupuncture and Chinese medicine at the University of Salford and the University of Westminster.

I am hardly a defender of the current state of medicine. Scientific medicine, medical leadership, and genuine evidence-based medicine are in a shambles right now. This is in part because of government interference, and because regulators have assisted in the "normalisation" of scientific fraud. It seems to me that there are a few things to address before "consulting" on the mechanics of regulation for these practitioners. Yet again, the clear message from government is that honest science and evidence are not on their agenda. Regulation and yet more guidance are not the solution to our problems - they are the problem.

I differ slightly from David in that I don't care that ill folk choose to get all sorts of advice. Nor do I care that such wares are sold, so long as they describe exactly what they do (see this company), and I don't foot the bill.

In any event, why regulate only these specific practitioners and techniques? Given my African origins I responded to the consultation with the helpful suggestion that we consider the regulatory normalisation of other therapeutic techniques such as scarification or FGM, drugs such as muti (human or otherwise), and diagnostic technologies such as bone throwing.

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