A petition - academic bullying

I'm taking a break while sorting out a few other things. However this seems a worthwhile petition to 10 Downing Street.

The case referred to in the petition appears to be that of Dr. Howard Fredrics, formerly of Kingston University. The case of Howard Fredrics is an important one - most especially so to writers who seek to call the leadership of academic institutions to account for their actions.

We the undersigned petition the Prime Minister to instigate an open enquiry into allegations of workplace bullying / harassment in institutions of higher education and concerns about the way the judicial system has dealt with complaints about such bullying and with those who protest (publicly or otherwise) about wrongdoing by their employers; the enquiry to be conducted with a view to addressing issues of concern that it may uncover.

Workplace bullying is a widespread problem wrecking health and careers and costing billions to the taxpayer. This problem is particularly serious in higher education. A recent survey by the Universities Colleges Union showed that as few as 45.1% of the participants were fortunate enough to never experience bullying.

Existing legislation addresses some aspects of workplace bullying, but does not deal with this problem comprehensively. There is also a perception that the judicial system does not always enforce the existing legislation fairly. Dissatisfaction with the way bullying is dealt with has led some to go public.

In response to the handling of a recent case by the courts, many academics and others expressed their indignation about the bullying that prevails in institutions of higher education, as well as the failure of the judicial system to deal with these problems satisfactorily. Similar concerns have been voiced before.

In addition to the obvious non-pecuniary benefits, addressing the problem of workplace bullying will bring about substantial pecuniary benefits in the form of improvements in the economy and cost savings to the taxpayer.

Sign the petition:

http://petitions.number10.gov.uk/Justice-Bullying/#detail

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GMC Hearings of Professor Richard Eastell - Day 1

I have just attended the first day of the General Medical Council "hearings" involving Professor Richard Eastell.

These have been truly fascinating, and will surely provide fodder for much discussion about publication ethics and scientific accountibility.

A quick note ...... rushing off to watch the rest of the evolving farce.

These are the key background documents and issue the GMC should be discussing
here. None of these are apparently to be seen in the case. They are all documents Professor Eastell will have.

There have been some real howlers. Unfortunately the GMC have (deliberately?) constructed a case that has ensured that the panel members are disabled from knowing or seeing the most relevant and damning evidence. The panel have been disabled from knowing that at the very time Professor Eastell knowingly allowed false declarations to appear in publication submissions (this is acknowledged both to be knowing and to be false), he was being actively denied access to the data (randomisation codes and fracture codes) underlying these studies by the sponsor.

Unfortunately Eastell's defense team appear to understand nothing of science, scientific thinking or scientific ethics. As a result they have fed nonsense to their client thinking it would help him, but have instead dropped him into a huge scientific hole.

For example they managed to get Eastell to state that fundamental misrepresentations of science, fundamentally faked graphs, a key result that was completely wrong (in three manuscripts) are mere "quibbles". Really?

They then got Eastell to try to say that being shown graphs of data or "working very closely" with those producing those "outputs" somehow constitutes access to raw data. They then managed to get Eastell and Rosemary Hannon to say that he, as a scientist and Research Dean, and her as a scientist really wouldn't know what to do with data anyway if he they had it (so perhaps they should retract all of those many noncommercial publications then?).

There is some more background here.

Much more later..

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More news of NMT Medical MIST Trial - false declarations

More news on the scientific jiggery pokery that took place in the MIST trial paid for by NMT Medical, and some emerging news on the usual attempts at cover-up in this case. Authors denied data, colluding journals, and collusion of the UK regulator (the MHRA) with scientific misconduct. More of the same old story and Déjà vu all over again.

The only chink of light - that there are still great journalists (like Shelley Wood) doing the job that the mainstream medical journals, regulators and leadership of medicine are manifestly failing to do. Well done Shelley.

The Heartwire article of yesterday is reproduced intact below. For my collated postings on this scandal click here

MIST correction published; no new information on disputed echo review for PFO/migraine trial
Sep 9, 2009
Shelley Wood
Heartwire

Dallas, TX - Authors of the controversial Migraine Intervention with STARflex Technology (MIST) trial paper [1] in Circulation have now published a lengthy correction [2] to the manuscript that originally appeared online in March 2008. As previously reported by heartwire, journal editors requested a correction from the authors after questions were raised—most notably by one of the original investigators for MIST—about details purportedly missing from the publication.

The correction by Dr Andrew Dowson (Kings College Hospital, London, UK) and colleagues appeared online Monday August 31, 2009, and the online version of the article has been updated to reflect the changes.

MIST was the first randomized, sham-controlled trial to investigate patent foramen ovale (PFO) closure as a treatment for migraine; the study failed to show a benefit of PFO closure. Garnering even more attention than the study results, however, have been questions from physicians both within and outside of the study about the design and conduct of the study and the airing of its results. The study sponsor, NMT Medical, is currently suing one of the original co-PIs for MIST, Dr Peter Wilmshurst (Royal Shrewsbury Hospital, UK), for concerns he raised to heartwire about how MIST data were being managed.

The disputed echo reviews

Wilmshurst, along with his Shrewsbury Hospital colleague Dr Simon Nightingale, refused to sign off on the manuscript before it was submitted for publication and are not included as authors. Following the publication of MIST in Circulation, Wilmshurst contacted the journal about his concerns.

Conspicuously absent from the correction is information about an "off-protocol" review of the echocardiographic information that suggested a higher residual shunting rate following PFO closure than that reported by Dowson at the TCT 2007 meeting. Dowson reported a 94% closure rate—derived, as per trial protocol, from the follow-up conducted by the implanting cardiologist. Wilmshurst, however, says he conducted an after-the-fact review of echocardiograms, at NMT's behest, which suggested residual shunting in approximately one-third of patients. A residual shunt can point to either incomplete device closure of the PFO or to the presence of pulmonary shunts not properly identified at baseline.

Both Dowson and NMT originally denied to heartwire that this echo review had ever taken place (repeatedly insisting that it was not part of the trial protocol) and rejected Wilmshurst's suggestion that NMT had asked investigators to send their echos to him to review. Another trial investigator, however, Dr Michael Mullen (Royal Brompton Hospital, London, UK), subsequently confirmed to heartwire that a review had indeed been undertaken but insisted the information did not belong in the MIST paper.

Asked by heartwire why information about the disputed echo review is not mentioned in the correction, Circulation issued a statement saying, "The Circulation editors were unaware of this controversy during the review of the paper; however, they investigated the matter at the same time that they investigated Dr Wilmshurst's other claims, and they decided that this information did not belong in the paper."

Also contacted by heartwire, Wilmshurst responded with a written statement:

"The correction of the MIST paper states that I did not sign the Copyright Transfer Agreement because of an internal disagreement about the conduct of study. In an email to Dr Dowson in October 2007, I gave two reasons for refusing to sign the Copyright Transfer Agreement. First, that the paper contained errors, which are confirmed by this correction. Second, that I could not in conscience sign the declaration, [which reads] 'The authors had full access to the data and take responsibility for its integrity.' To sign a declaration knowing it to be false would make me guilty of a criminal offence in the United Kingdom. In November 2007, NMT's lawyer wrote to me: 'No investigator is given a full detailed set of all the data.' For 18 months I pressed Circulation for a correction. I sent the editor hundreds of pages of documents, including a copy of my email to Dr Dowson. All of the errors and omissions in the correction are ones that I reported to Circulation, but not all errors and omissions that I reported have been corrected. In addition, the contributions of some who did little in the study, including an 'author' who died in May 2004, before the trial started, are credited, but the contributions of Dr Nightingale and I, who helped design the trial, were members of the steering committee, wrote the early draft of the paper, and did over 600 of the 2000 patient visits in the trial, are not acknowledged."

NMT chief financial officer Richard Davis, also commenting on the correction for heartwire, emphasized that the "clarifications were made on request of the editors of the journal.

"The correction that appears in the journal Circulation includes a single error in the reference to a histogram contained in the original manuscript. No changes to the results, analysis, or conclusions of the study are made. The remainder of the published correction contains clarifications, many of which were not included in the original manuscript due to the word-count limitations.

"To comply with these word-count requirements, the manuscript focused specifically on the critical elements of the trial design and results. All serious adverse events were listed; other information was excluded that was deemed irrelevant to the findings regarding the effect of PFO closure on migraine. One procedural embolization in a cohort of 74 patients is not uncommon for these types of devices, and retrieval of a device due to poor positioning followed by replacement with a second device, as happened in two cases, is also not unusual. It is important to note that these procedural difficulties were not considered serious by the investigator or the safety committee of the study."

Clearing the MIST

The correction runs over 700 words long, with a four-page data supplement, and addresses what Dowson and colleagues term "a number of errors and omissions," including:

• An explanation of why Wilmshurst and Nightingale were not listed as authors.
• An expanded description of how intracardiac shunts were assessed.
• Clarification on specific adverse events related to failure to find or cross a PFO, two cases of device embolization, and one nondeployment.
• New information on patients who withdrew from the study and why.
• A correction to the units used for number of migraine days per month for Figure 3.
• Reiteration of the reasons for excluding two patients from an analysis looking at median total migraine days and the calculations used.
• Clarification that the authors' conflicts of interest information provided in the article was accurate.

To this last point, the correction states: "The authors confirm that they disclosed all relevant relationships and potential conflicts of interest that were present during the two years leading up to manuscript submission, as required by the American Heart Association." The Circulation manuscript itself notes that two study authors—Mullen and Dr David Hildick-Smith (Brighton and Sussex University Hospitals NHS Trust, UK) have ownership interests in NMT Medical and that Mullen has received teaching honoraria and has acted as a consultant to NMT, but that the remaining authors report no disclosures.

Of note, at the time of Dowson's October 2007 TCT presentation, he disclosed that he had received grant/research support from NMT, and Davis estimated in an interview with heartwire shortly after Dowson's presentation that up to 10 study investigators and/or steering committee members had received consulting fees from the company. Wilmshurst once told heartwire that he and Nightingale had turned down offers for "large" consultancy payments from NMT.

1. Dowson A, Mullen MJ, Peatfield R, et al. Migraine Intervention with STARFlex Technology (MIST) trial. A prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation 2008; 117:1397-1404.
2. Correction for Dowson et al. Circulation 2009; DOI: DOI: 10.1161/CIRCULATIONAHA.109.192626. Available at: http://circ.ahajournals.org.

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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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