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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Is Medicine in the same boat as the Catholic Church?

This post has nothing directly to do with scientific fraud, science or medicine.

It is about recent reports of corruption and terrible evils that have taken place within the confines of the leadership of the Catholic Church.

A few days ago a long-delayed investigation into Ireland’s Roman Catholic-run institutions was released. It chronicled how priests and nuns molested, abused and tortured thousands of boys and girls for decades. More importantly it documented how those in authority, government officials, and government inspectors failed to stop the beatings, rapes and abuse. The report concludes that church officials shielded their orders' pedophiles from arrest, amid a culture of self-serving secrecy. They turned a blind eye.

In the United Kingdom, we have medical "regulatory" bodies (such as the MHRA and the General Medical Council). We have individuals promoted to positions of professional leadership. These bodies and individuals are supposed to act as guardians of scientific and clinical integrity in medicine. They are supposed to protect the public against quackery, and to uphold the scientific ideals of our profession. Like the corrupt bodies within the Church, these institutions don't always fulfill their stated mission. Too often they act act as protectors of those who are guilty of scientific fraud, of abusing patients and of corruption. Particular individuals within those bodies act to conceal crimes and deception. Rules of conduct are meticulously created and revised, but disobeyed with impunity. The supposed mission of these organisations and the reputation of our profession is brought into disrepute through these actions.

These organisations hide their sins behind a barrrier of secrecy. Names and transparency are important however. The Christian Brothers successfully sued the commission in 2004 to keep the identities of all of its members unnamed in the report resulting in massive backfire and complete loss of any residual reputation. In medicine, bodies such as the General Medical Council demonstrate the same staggering incompetence when they try to get involved in tricky little exercises to protect their friends. Those, like the hilarious exercise to try to hide the scientific adventures of their friend Professor Richard Eastell and his "collaborations" with Procter and Gamble Pharmaceuticals tend to result in a similar outcome for the profession of medicine.

Read the full report of the Commission to Inquire Into Child Abuse report here, or a summary (Associated Press).

The corruption was articulated even more strongly in Milwaukee this week. It is said that retired Archbishop Rembert G. Weakland states that he "did not comprehend" the potential harm to victims in Milwaukee, nor did he understand that what the priests had done constituted a crime (see here and here)

Said Weakland:

"We all considered sexual abuse of minors as a moral evil, but had no understanding of its criminal nature."

I "accepted naively the common view that it was not necessary to worry about the effects on the youngsters: either they would not remember or they would ‘grow out of it’."

Weakland stands accused of assisting in cover-up of the abuse. A 2003 report on the sexual abuse of minors by clergy in the Roman Catholic Archdiocese of Milwaukee revealed that allegations of sexual assaults on minors had been made against 58 ordained men, who were under the direct supervision of the Archbishop of Milwaukee. By early 2009, the Archdiocese of Milwaukee had spent approximately $26.5 million in attorney fees and settlements to victims. Weakland retired in 2002 after it became known that he paid $450,000 to a man who had accused him of date rape.

Why are these men and women not in prison?

See also:

1. Cargo Cult Science : Large Groups of Humans
2. Video Documentary : Deliver us from Evil
3. The Freethinker: ‘We did not know that child abuse was a crime,’ says retired Catholic archbishop
4. Report of the Commission to Inquire Into Child Abuse in Ireland

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The fall of the General Medical Council - Part I: Confidence or con

Last week I received a tentative invitation (via the group Justice in Health) to "attend" an "event" at Westminster on 24 July 2008. The event "The Future of Health Professional Regulation" is hosted by the Council for Healthcare Regulatory Excellence (CHRE) and the Department of Health. It is supposedly about sorting out professional medical regulators in the interests of patients.

I will not be attending.

Sham public consultation has become a dismal hallmark of this Labour government. They have not learned to listen.

One of those regulators is the General Medical Council (GMC). The GMC is the body that registers and is supposed to "regulate" the integrity and "fitness to practice" of UK medical doctors. This is an important job. The GMC have a huge credibility problem.

If the DoH and the General Medical Council really wanted to find out how to reform themselves in the "patient interest" then they would invite their fiercest and most thoughtful critics to explain the problems that have arisen. There are many such critics. Those critics would detail lamentable and inappropriate behaviour. They would explain how "regulators" have acted to hide fraud, misconduct, and other activities which have damaged patients and science. They would explain how the GMC has bullied some individual doctors, while ignoring parallel but far more serious integrity failings involving the "old boy's network".

There are many people they could invite to present aspects of the regulatory problem in detail. I am relatively sensible. Others provide a range of insights - Peter Wilmshurst, Rita Pal, Charles Medawar, John Abraham to name a few. Many patients tell compelling stories of obvious regulatory obstruction.

But inviting thoughtful hard-hitting criticism is not the intent.

Instead we have a profusion of "reports" which have no meaningful intersection with the real world.

Here is one from a week back:

"Implementing the White Paper - Trust, Assurance and Safety: enhancing confidence in healthcare professional regulators - final report and DH response to recommendations" (2 June 2008). Read it here.

The woefulness is implicit in the title. The report is not about the actual integrity, plausibility, honesty and consistency of medical regulators. It is about "enhancing public confidence in the regulators of healthcare professionals". It is about inducing confidence in the unacceptable. It is not about real confidence. It is a con.

I talk regularly to doctors and patients about the systems that regulate integrity in the UK. I discuss the malfunction of professional and pharmaceutical regulators, sham investigations, and the bizarrely inconsistent approach of the General Medical Council to the telling of lies by doctors. My thoughts are marginally less boring, irrelevant and nausea-inducing than "Implementing the White Paper". Here is the feedback form from my recent teaching session with postgraduate general medicine trainees in Sheffield. No nausea is reported.

So, Department of Health (and the General Medical Council), why not invite your critics to explain how you need to restore decency and relevance to regulation? Invite them to explain in detail - not under conditions of a carefully controlled "consultation". The ghosts of the Bristol babies, the many patients who have died as a result of corrupted pharmaceutical research and the victims of Harold Shipman might applaud. I doubt they would applaud throwing time and public money at an irrelevant confidence scam.

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LSD and the corruption of medicine (Part V): The UK connection

This is the last in a series of posts marking the death of Albert Hofmann, inventor of LSD.

Over two decades starting in 1953 a CIA project named MK-ULTRA controlled a U.S. academic chemical interrogation research program. The seeds for many of the current problems of medicine lie in the story of MK-ULTRA. The research involved murder and the torture of tens of thousands of unwitting human participants. MK-ULTRA set the standard for later industrial-university collaboration. It set the most important precedent for the collusion of academic leadership and civilized government with scientific misconduct. It was the most flagrant violation of the just-signed Nuremberg code of ethics.

Porton Down LSD tests

Experiments on "unwitting" humans involving LSD and other agents were also carried out in the UK.

The tip of that iceberg is visible through cases which have come to court. In February 2006 three UK ex-servicemen were given compensation after admissions that they had been given LSD without their consent in the 1950s as part of torture related research at the Porton Down military medical research base[1]. They had been lied to about the experiments for 30 years (audio of one of the men describing his experiences here).

On Jan 31 2008 it was reported that 369 further victims of non-consensual experiments had been awarded a payment totalling £3million[2]. Up to 20,000 people took part in various trials at Porton Down in the 50 years up to 1989. Other servicemen died when they were exposed to chemical agents such as sarin at Porton Down experiments done without consent[3,4,5]. At least 25 health men may have died as a result of these experiments, including at least one who died immediately following exposure.

Cover up

The UK government has refused to apologise for the failure to obtain consent and the damage caused, saying only "The security of the country rested on these trials" and that "there may have been shortcomings and, where, in particular, the life or health of participants may have been put at risk"[2].

It is not clear how the "security of the country rested on these trials".

Cover-up has been palpable. Sham inquests were held in the 1950's in order to "protect national security", and parents of the men may have been induced to lie[6]. Ronald Maddison died within an hour of having sarin dripped onto his arm. The original inquest was held in secret, and ruled that he died of "asphyxia" [6]. Maddison's father agreed at the time to say his son's death was "an unfortunate accident while on duty" in order to "protect national security" [6]. The truth only emerged 50 years later.

A spokesman for the Foreign Office which deals with MI6 inquiries said:[7] "It's history: No one knows precisely what happened 52 years ago".

The nature of this supposed historical imprecision is in itself uncertain, in view of the fact that requests by the men to place pertinent case documents into the public domain were refused[1].

As in the U.S. there is the suggestion that parliamentarians were kept unaware. Bruce George, chairman of the Commons Defence Committee, said it would be misleading to say the parliamentary committee knew everything that was going on at the Porton Down base and that [8]: "It's too big for us to know, and, secondly, there are many things happening there that I'm not even certain ministers are fully aware of, let alone parliamentarians."

Involvement of Academia in the UK

In comparison with the U.S. there is less evidence for extensive collaboration between the intelligence services and academic institutions to conduct MK-ULTRA type research. British Psychiatrist William Sargant appears to have been funded by MK-ULTRA to perform experiments on patients at St. Thomas' Hospital[9,10,11]. Sargant worked closely with Ewen Cameron, the MK-ULTRA clinician at McGill.

There is some evidence that the abuses at Porton Down occurred with the knowledge and collusion of "professional medical bodies". UK Defence Minister John Spellar stated that:[8] "there are ethical procedures in place, that have been evolved in discussions not just with our people but with medical bodies as well".

I would like to know what that advice was and who gave it. UK Medical bodies, including the General Medical Council have not to my knowledge ever made it clear that doctors (and the bodies that represent them) should not engage in or facilitate torture. That is hardly a surprise.

References

1. MI6 payouts over secret LSD tests. British Broadcasting Corporation (2008-05-03).
2. Laura Smith, Owen Bowcott and Rob Evans (2008-01-31). Porton Down veterans awarded £3m compensation. The Guardian.
3. MoD agrees sarin case settlement. British Broadcasting Corporation (2006-02-13).
4. Police probe Porton Down deaths. British Broadcasting Corporation (2006-02-13).
5. Orr James and Evans Rob (2008-01-17). Research base with a dark past. The Guardian.
6. Tricked into nerve gas tests. British Broadcasting Corporation (2005-04-19).
7. UK pays out for '50s LSD tests. Reuters (2006-02-24). Retrieved on 2008-05-03.
8. Chemical base 'too big', says MP. British Broadcasting Corporation (1999-08-20).
9. Anne Collins, "In the Sleep Room" Toronto: Lester and Orpen Dennys, 1988, ISBN 0-88619-198-X
10. Marks, John (1979). The Search for the Manchurian Candidate: CIA and Mind Control. W W Norton & Co Ltd, 264. ISBN 0393307948.
11. Thomas, Gordon (1988). Journey into Madness: Medical Torture and the Mind Controllers. Bantam Press, 398. ISBN 0593011422.

For Part I see Part I: Invention and the beginnings of MK-ULTRA
For Part II see Part II: The entanglement of academia
For Part III see Part III: Naming Names
For Part IV see Part IV: Pfizer and memory

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The case of Dr Z

A report in the British Medical Journal yesterday is fascinating:
Dyer, Clare (2008-01-12). "Whistleblower who was excluded from work for five years wins apology". BMJ 336 (7635): 63.

The bullying of doctors and patients who raise concerns, and the gagging of information about those concerns is the most fundamental element of clinical risk. The various "Clinical Governance" policies put in place to (ostensibly) control clinical risk take no account of what actually happens.

What we are allowed to know about this story is that:

• A junior doctor (known only as Dr Z) was excluded from her job in Cambridgeshire Primary Care Trust for 5 years. Her apparent crime was that she objected to inclusion of medical records in a research database without patient consent. Those medical records included her own.
• The reason we do not know her name is that she is under a gagging order.
• Many years before Dr Z suffered from a rare "serious life threatening condition". She wanted the details kept private.
• However her medical details were distributed as part of this research to Addenbrooke's Hospital, Cambridge and from there to personnel involved in her employment.
• Despite giving no consent she was harassed by the researchers.
• The interesting (but common) response of her employers was to suggest that she was ill and to refer her to an "occupational health consultant". She was then put on "special leave from her employment".
• Her employers tried to suggest that her "fitness to practice was an issue" and seemingly tried to (or actually did) refer her to the General Medical Council to be struck off.
• Her employers generated false accusations that she had given a wrong name and address to her own doctor, and had falsified sick notes.
• Her employers maintained that it "was not possible" that her records were held in the research database.
• In September 2006 her employment was terminated.
• Acting on her own she brought a libel action against her employers. The Trust admitted that all the accusations that they had made in their apparent attempts at bullying were false, and that her records were indeed in the research database.
• In this case the person bullied was not only a doctor raising concerns about patients but also a research participant who was apparently told lies.

What can we say of all of this? The same basic elements are played out in variable form over and over again.

1. Individuals are gagged and neither our profession nor patients nor the general public discover the truth.
2. There is abuse through accusations of mental illness.
3. The very bodies who are charged with integrity in medicine (such as the General Medical Council) are used by medical leadership to obfuscate the truth. At the same time the GMC shows no intent to deal with the powerful liars, falsifiers and bullies. Those individuals are neither named nor sanctioned.
4. False accusations are made to divert attention from the real problems.
5. There is almost no support for abused individuals.

There are implications for the confidentiality of medical data. This is another timely incident given the foolish inclination of the Labour government to take control by force of our medical records in a central "database".

John M. Grohol at Psych Central has written an interesting article "Why Would You Lie to Your Therapist?". Patients tell half-truths for many reasons. Concerns that the state or others will abuse the relationship of confidentiality is a powerful one.

We are entitled to ask several questions of Addenbrooke's Hospital, Cambridge:

Why have the full details not been placed into the public domain? What is this research, and has it been published? What are the names of the researchers involved? Did the work receive ethical approval? Did any publication state that some participants had refused consent? What action has been taken to deal with the individuals who bullied Dr Z?

Did any of the various agencies who are supposed to ensure integrity in this context do anything at all to assist Dr Z? Perhaps the General Medical Council did something, or Public Concern at Work, or the British Medical Association, or the UK Panel for Research Integrity, or the Ethics Committee at Addenbrookes Hospital, or the local Medical Staff Committee?

And why did the BMJ use the word "whistleblower"? Dr Z was simply doing her job. It is the job of a doctor to tell the truth in the interests of our patients (and in this case Z was one of those patients). Instead of dealing with her concerns she was bullied, told lies (and probably made ill). Whistleblowing has nothing whatever to do with this -- particularly since everything that the scientific community has to know and has to discuss has actually been suppressed.

Have we learned anything since Bristol? Or Shipman? Or Chan? .... or any of the incidents which have placed our patients and clinical science at risk?

Dr Z said in a statement:

"I raised concerns relating to unethical research practices which threatened patient confidentiality and were being conducted in breach of the law. I was then excluded from work for a period of five years, on the basis of allegations which the trust now concedes were groundless.

See also comments by Ferretfancier and Longrider

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You owe the General Medical Council £5 - the case of Sushant Varma

Although not about medical scientific misconduct, this is directly related.

The General Medical Council (GMC) is one of several bodies in the UK charged with regulating aspects of integrity in clinical medical research. It also registers and regulates other activities of doctors. The functioning of the GMC is therefore of considerable public interest.

Also of interest is the approach of the GMC to their requirement that doctors should be truthful.

In response to a request, the GMC recently confirmed that it spent £175,000 (approximately $350,000) on external legal fees pursuing one medical student/junior doctor, Dr Sushant Varma of Sheffield (my home city).

Our ref: IAT/F1314/EH

Dear ______

I write further to your request made in accordance with the Freedom of Information Act 2000, as set out in your email below.

I can confirm that this case has cost the GMC £175,000. I should add that this does not include the time spent by GMC staff on case administration. We are unable to quantify this as we do not record the amount of time staff spend on individual cases.

If you have any concerns regarding the handling of this request please address these to:

Julian Graves
Information Access Manager
General Medical Council
Manchester M1 6FQ

Given the convoluted machinations of the GMC in this case, it's internal expenses are likely to have been a further £175,000, and considerable expenses were incurred by the Medical and Dental Defence Union of Scotland (who provided some legal support for Varma). Given the number of registered doctors in the UK (~100,000) this single case will have cost each doctor around £5.00. Meanwhile, doctors have noted the recent hike in GMC fees (from £290/year to £390). The GMC states this is "not related to revalidation reform", but rather to other "accumulated expenses" such as those incurred in this case.

Varma is a colorful character, and has certainly told some trivial lies. For example he lied on his CV about an appearance on a television show (Blind Date). He has freely admitted to those lies. He may have told a more serious lie, but the evidence for that is far from clear. The GMC apparently declined to examine relevant evidence. Varma was erased from the medical register and his career was destroyed.

Of broader importance are the precedents raised by this case, and the consistency of GMC action:

1. When can a doctor lie?
2. Are all lies of equal importance?
3. Are the status and responsibilities of the lying doctor relevant?
4. From the point of view of medical regulation, is there a difference between lies told in clinical research, lies in clinical practice, and private lies (which might reflect on the credibility of a doctor)?

To paraphrase Frank Zappa, the GMC is a body of rules, badly written and randomly enforced. What happened to Dr Varma merits some examination, as do the motives that might have led the GMC to spend such a considerable amount of our money on this one relatively trivial case.

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Memory Hole (23 October): Deja vu all over again

Scientific Misconduct Blog Memory Hole: Events of October the 23rd

Quote of the day

Insanity: doing the same thing over and over again and expecting different results.
Albert Einstein

34 years ago today: Those damn tapes again

On 23 October 1973 President Richard Nixon eventually agrees to turn over subpoenaed audio tapes of his Oval Office conversations about the Watergate scandal.



Those damn tapes again.

14 years ago today: A prelude to TGN1412 (sort of)

On 23 October 1993 it was revealed that a patient in a clinical drug trial who had raised concerns about serious side effects in participants was told he would no longer receive any medical care because of his criticisms. The trial then ended in catastrophe - with the iatrogenic deaths of five participants. The NIH Doctor involved is named as Jay H. Hoofnagle. The drug was fialuridine, to treat hepatitis B. 5 of the 15 patients who took the drug died, and two more required liver transplantation. Shades of TGN1412 (where the MHRA approved a protocol giving an entirely novel drug to six participants within a short time - and then declared themselves innocent of something).
Source: "Doctor Drops Patient For Criticizing Drug Trial," New York Times, 23 Oct 1993

5 years ago today: Research contracts fail to adhere to guidelines

On 23 October 2002 the results of an important study of scientific contracting in biomedicine were released. The study examined legal provisions in 108 contracting arrangements between academics and corporate sponsors. Contracts failed to adhere to guidelines designed to protect integrity.

The study was led by researchers at Duke University Medical Center and the Duke University School of Law. Compliance with three key provisions International Committee of Medical Journal Editors (ICMJE) were examined. ICMJE guidelines are used by more than 500 medical journals as a standard for scientists submitting research for publication.

• If researchers had proper access to trial data;
• If researchers could control publication decisions; and
• If researchers were involved in the design and protocol

The investigators found academic institution contracts with corporate sponsors rarely included these provisions.

"How low the level was kind of surprising and also what was surprising was how powerless the institutions felt in negotiating" [for honest science] Schulman said. "There's a failure of protections." "The problem is one of misrepresenting the data. Data interpretation is key and how the data are interpreted can skew the results".

"Any study that has strong pharmaceutical backing is highly likely to be defective," said Drummond Rennie. "You get the data the drug company wants you to have." "I'm not surprised because this shows what an appalling state everyone was in." "If the same study was conducted in five years time, I would hope there would be a huge difference."

Well that 5 years is up today Drummond.

2002 "Research contracts violate guidelines" 23 Oct 2002 United Press International

1 year ago today: The General Medical Council - Action through Inaction

On 23 October 2006 Reuters reported that "the UK General Medical Council has re-drafted the Good Medical Practice guidelines which, amongst other measures, include the provision for raising concerns about patient safety. This follows an extensive consultation by the GMC following the Harold Shipman Inquiry. The Guide demonstrates how far the medical community and its professional body has come in recognising and emphasising the importance of raising concerns where patient safety may be at risk. Public Concern at Work is clearly identified as a source for confidential and independent advice for doctors." Public Concern at Work

Hard to say anything other than ha ha ha.

The threat to those raising concerns has never been greater, thanks in no small part to these two self congratulatory organizations.

They need to examine what actually happens to concerns when they are raised, and discuss what they plan to do about it.

My letter to Professor Graham Catto is alongside. I eventually received a "reply" from an underling admitting system failure (to follow). Read about the GMC here or Wilmshurst's excellent discussion of their miserable lack of integrity here.

Why are there so many problems involving this body? Why would a so called "whistleblower" support group not make any comment about this at all yet wholeheartedly accept a role providing "confidential and independent advice for doctors", while supporting legislation that insists that concerns are raised through such routes. Have they spoke with a reasonable selection of patients and doctors who have tried - and failed - to discuss serious concerns about patient welfare?

Why would anyone bother?

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Memory Hole (8 October): Illusions of due diligence

The Scientific Misconduct Blog Memory Hole: Events of October the 8th

This quotation from the movie Syriana is appropriate to many of these events:
"We're looking for the illusion of due diligence, Mr. Pope. Two criminal acts successfully prosecuted -- it gives us that illusion."

60 years ago today: Attempt to hide secret human radiation experiments

On 8 October 1947, J.C.Franklin, operations manager of Oak Ridge, wrote to the general manager of the US Atomic Energy Commission: "There are a large number of papers which do not violate security but do cause considerable concern to the Atomic Energy Commission insurance branch, and may well compromise the public prestige and best interests of the commission". He added that such documents "are definitely prejudicial to the best interests of the Government" and ordered that "any such documents be edited or kept secret".

He was writing about the need to keep secret many research experiments involving radiation in humans. These had been carried out without consent or public knowledge.

Source: "Inquiry Links Test Secrecy To A Cover-up," New York Times, 15 December 1994

8 years ago today: Further adventures of Professor Martin Keller

On 8 October 1999 it was reported that Professor Martin Keller of Brown University had received "hundreds of thousands of dollars from drug companies" while he was receiving federal funds to test new drugs, and then provided favorable reports on those drugs without notifying the payments. Keller was paid more than half a million dollars in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted.

Scientists seeking US funds are required to disclose to their research institutions any "significant financial interests" that could be affected by the proposed study. Then it's up to the institutions to assess the financial interests. If the institutions find a conflict, they must report it to the US funding agency and protect the research from bias. According to the newspaper report, Brown University appeared unconcerned about the regulations or the conflict of interest. The American Psychiatric Association announced that they were "investigating". For Keller's later involvement in shonky research see here or here or read about his depressing involvement in GSK's study 329 here.
Source: Boston Globe 8 October 1999, page B01

8 years ago today: London professor struck off for bullying and dishonesty

On 8 October 1999 A British professor of respiratory medicine with an international reputation in asthma research was struck off the medical register for bullying and threatening a junior colleague to cheat in a drug trial. See report of the case in the BMJ here and here.

Former Professor Robert Davies had threatened and abused a young doctor and tried to persuade him to break the trial code in order to fiddle the results. Davies threatened that Ramsay's career would be "finished" if he told anyone about the request to break the code blinding the study of the SmithKline Beecham drug Prankulast.

• The case involved tape recording of Professor Davies by Dr Ramsay. It is likely that without that recording the incident would have ended the career of Dr Ramsay instead of his senior "old-tie" boss. Davies told another colleague that he did not "know a microscope from a fucking hole in the ground". On the tape, Professor Davies is heard saying: "If I hear you speak to anybody you’re finished, OK." Davies said he had been "flabbergasted" to learn Ramsay had taped their conversations. He said when he had told Ramsay he would be finished if he spoke out, it was "in no way a threat to his career".
• The case included a strange comment from Joanna Glynn, counsel for the GMC. She said that "there was no body, other than the General Medical Council on which the pharmaceutical industry could rely to regulate doctors' activities in clinical trials". Kindly contact me for some education Ms Glynn or read this or this about the corruption of the GMC.
• The case is important in terms of definition of research misconduct. According to the current tortuous definition promulgated by the ORI and others, the actions of Professor Davies would not constitute research misconduct. Bullying with intent to disrupt the scientific record is not so defined.

Reference: BMJ 1999;319:938 London Professor struck off for bullying and dishonesty

5 years ago today: Pioglitazone data - when all 30 authors are wrong

On 8 October 2002 Nick Freemantle (University of Birmingham) reported in the BMJ (BMJ 2005;331:836-838) that clinical trial findings involving the drug Pioglitazone (the PROactive trial) had been misrepresented and that the conclusions were unsafe.

A response by a reader (Dr James Penston) was pertinent and bears on the responsibilities of authorship. His letter was entitled "When all thirty authors are wrong".

Penston writes: "Perhaps this was simply an innocent error. But it is hard to believe that none of the thirty authors – including 27 professors – were aware that it would be misleading to interpret the data as showing that pioglitazone reduced macrovascular events. Given that 28 of the 30 authors had financial links with the pharmaceutical industry and that the study was funded by Takeda and Eli Lilly, it would have been prudent to avoid at all cost the charge that this manipulation of data stemmed from a conflict of interest."

4 years ago today: Nigeria versus Pfizer

On 8 October 2003 the US Court of Appeals reinstates a Nigerian research case against Pfizer.

"The central events at issue in this lawsuit occurred in 1996, not long after epidemics of bacterial meningitis, measles and cholera broke out in Kano, Nigeria. Pfizer established a treatment center at the Infectious Disease Hospital in Kano to treat victims of the meningitis epidemic.

Plaintiffs allege that Pfizer, instead of using safe and effective bacterial meningitis treatments, used the epidemic as an opportunity to conduct biomedical research experiments on Nigerian children involving Pfizer's "new, untested and unproven" antibiotic, trovaflozacin mesylate, better known by its brand name, Trovan."

Plaintiffs claim that Pfizer failed to obtain informed consent, and that some children were deliberately given inadequate doses of ceftriaxone so that Trovan would look more effective by comparison. Several children died. The case is ongoing (see AHRP or here).

What is the chance that justice will be served under the circumstances?

Four years later it seems that Pfizer is going to try to keep the whole thing quiet through some form of payment of money or perhaps a large bribe.
Source: AHRP http://www.ahrp.org/infomail/03/10/14.php

3 years ago today: FDA officials attempt to soften a report by Dr David Graham about Vioxx

On 8 October 2004 it was revealed that FDA officials had attempted to soften the conclusions of a scientific report about the drug Vioxx produced by Dr David Graham. Senator Grassley was reported as saying "Instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert" “Dr. Graham described an environment where he was ostracized, subjected to veiled threats and intimidation".

Vioxx was later withdrawn. It is estimated that the use of this drug has resulted in at least 100,000 deaths worldwide.
Source: "FDA Officials Tried To Tone Down Report on Vioxx" Wall Street Journal, 8 October 2004

2 years ago today: MHRA leadership asserts its integrity, but with what evidence

On 8 October 2005 Professor Alasdair Breckenridge and Professor Kent Woods coauthored a strange paper in the BMJ (BMJ 2005;331:834-836) subtitled "How does an agency funded by user fees make impartial decisions about the safety of new and licensed drugs?". Breckenridge and Woods are important people. Breckenridge is the chairman of the UK drug regulator (the Medicines and Healthcare Products Regulatory Agency, MHRA) and Woods is the chief executive of the agency.

And the answer to the question is?

Some have asked these gentlemen about the ongoing "independent criminal investigation" of GlaxoSmithKline (see see 1463 days to nothing).

Breckenridge sat on GSK's scientific advisory committee for years before taking up his post at the MHRA (reference). Ian Hudson, who was the worldwide safety director of GlaxoSmithKline (GSK) until 2001, is now director of licensing at the MHRA (reference). As Charles Medawar has pointed out here or here there is a lot of explaining to do.

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The trial of Dr Jayne Donegan

The 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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The Gillberg affair and the fall of a scientific journal (JAACAP)

Professor Christopher Gillberg was Professor of child psychiatry at Gothenburg University, in Sweden. He is visiting Professor of psychiatry at the University of Strathclyde in Glasgow. He is involved in patient care at the National Centre for Young People with Epilepsy and is registered as a Child Psychiatrist in the UK as of 21 April 2004 (Medical Qualification Lakarexamen 1973 Goteborg, Specialist Register Child and Adolescent Psychiatry from 21 APR 2004, GMC number 6095760). Notably, this registration with the General Medical Council occurred after the events referred to below.

I have much to say about this affair, but I will concentrate only on the role of a medical journal, and my discussions with that journal.

For detailed discussion, original documents and references relating to this incident see here. Briefly, in 2002 Gillberg was accused of research misconduct in critical research involving a psychiatric concept known as "DAMP". This is part of the ADHD spectrum of diagnoses, and an area of medicine which is under intense scrutiny. Evidence to support the allegations of research misbehavior seem to be substantial (here). The authors refused to allow anyone to inspect their data properly. A court ordered that the data be made available to investigators. Before that could be enforced, though, the data was deliberately destroyed --100,000 pages, covering 16 years of research on children. The approach of Gothenburg University was subject to extensive criticism (as detailed here). Despite the destruction of data under such circumstances, the relevant publications purporting to represent those data have not yet been retracted. Such a situation is untenable.

The intention of this post is not to discuss Christopher Gillberg or the precise alleged misconduct. The mechanics of the affair are of considerable interest but are not directly pertinent here. However, the Gillberg affair raises a number of issues that are pertinent to this blog

• the failure of structures designed to maintain integrity in medical science
• the collusion of institutions, medical journals and commercial entities with scientific misbehavior
• convenient manipulation of language and definition to obscure distortion of the scientific literature

Perhaps the most critical implicated publication is the following:

Rasmussen P, Gillberg C. (2000) Natural outcome of ADHD with developmental coordination disorder at age 22 years: a controlled, longitudinal, community-based study. J Am Acad Child Adolesc Psychiatry. 2000 Nov;39(11):1424-31 Pubmed Link.

Now this prestigious journal, the Journal of the American Academy of Child and Adolescent Psychiatry is already under considerable international fire over another paper which has not yet been retracted. In particular, in a widely discussed recent television broadcast the editor of JAACAP displayed no concern when presented with evidence that an important paper about GSK's antidepressant drug Paxil and the infamous study 329 published in JAACAP - a) might have reported "findings" that misrepresented the underlying data, b) that this should have been known to the writers, and c) that reviewers had been ignored. It is possible that this publication might have contributed to the death or injury of some children. For discussion of this JAACAP affair see here, here, here, here, here and here.

In that instance, Editor Dr Mina Duncan simply stated on a Panorama Television Broadcast [Link, Link] that:

"I don’t have any regrets about publishing [the study] at all – it generated all sorts of useful discussion which is the purpose of a scholarly journal."

As previously discussed according to this logic, we should publish studies with as many flaws as possible so that we can “usefully discuss” them.

With that in mind, I reproduce my trail of correspondence with the Editors of JAACAP about this other Gillberg publication (Child Adolesc Psychiatry. 2000 Nov;39(11):1424-31) and the shocking dismissive response.

It is not clear to me that JAACAP should any longer be considered as a legitimate scientific journal.

Date: Wed, 23 May 2007 15:17:50 +0100
From: Aubrey Blumsohn
To: Sherri Willoughby, Editor JAACAP
Subject: Gillberg Publication in JAACAP

Dear Dr. Willoughby,

I write further to some information that has been circulating about a 2000 publication in JAACAP about a putative psychiatric disorder in children (Rasmussen & Gillberg, 39: 1424-1431).

It is apparent that the raw data underlying this (and perhaps other) publications has been destroyed by the authoring scientists and their team. Refusal of a scientist to reveal raw data would normally provide prime facie evidence of scientific misconduct. Destruction of such data while questions were being asked about the veracity of the research would constitute a very serious breach of scientific norms.

I am therefore writing with two simple questions:

1. Is the journal aware that the raw data underlying this manuscript was destroyed by the authoring scientific team?
2. This manuscript and it's conclusions are clearly unsafe. I am concerned that this manuscript has not yet been retracted. Please let me know what steps have been undertaken to do this or explain why this has not yet been done.

Kind Regards

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath

Subject: RE: Gillberg Publication in JAACAP
Date: Thu, 24 May 2007 13:29:56 -0500
From: "Sherri Willoughby" JAACAP
To: "Aubrey Blumsohn"

Dear Dr. Blumsohn,

Policies regarding the retention of raw data are not under the purview of the Journal. These are typically set by the academic institution where the investigators work and/or by the funding agency (or regulatory body, in the case of medications, although that does not apply to this study).

Sincerely,

Sherri Willoughby, Managing Editor
Journal of the American Academy of Child and Adolescent Psychiatry

At the same time Doug Keenan, a mathematician, received a similar "reply"

From: "Sherri Willoughby" JAACAP
To: "D.J. Keenan"
Subject: RE: JAACAP data request policy

Dear Dr. Keenan,

Thank you for your interest in the Journal and its policies.

JAACAP has a longstanding policy that unpublished instruments and manuals be made available by the author to interested readers (but we do not require that this be free of charge).

We do not have a policy on access to data, but if we should receive a request (e.g. for purposes of a meta-analysis), we would refer the requester to the corresponding author of the paper. We do not obligate the author to provide the data. If the Journal did, in the future, develop such a policy, it would apply only to papers published after the policy was established and to authors who were informed of the policy before submitting to JAACAP (by having it in the Instructions for Authors).

Sincerely,

Sherri Willoughby, Managing Editor
Journal of the American Academy of Child and Adolescent Psychiatry

I replied as follows:

Date: Thu, 24 May 2007 20:23:09 +0100
From: Aubrey Blumsohn
To: "Sherri Willoughby" Editor JAACAP
Subject: Re:Gillberg Publication in JAACAP

Dear Dr Willoughby

I am sorry but your reply appears to me to be wholly inadequate. This paper involves a putative psychiatric disorder in children.

You seem to be suggesting that the destruction of data, under conditions where that data is being questioned isn't (nor should be) of any concern to you as an editor of a Journal.

I wish to publish your response, but I thought I would give you the chance to further clarify your position on this.

Kind Regards

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath

Having received no further reply, I wrote again....

Date: Tue, 5 Jun 2007 15:36:51 +0100
From: Aubrey Blumsohn
To: "Sherri Willoughby" Editor JAACAP
Subject: Re:Gillberg Publication in JAACAP

Dear Dr Willoughby,

Thank you again for your illuminating response.

I have been reading your instructions for authors that would have pertained at the time this manuscript was submitted. http://edmgr.ovid.com/jaacap/accounts/ifauth-before-April1.htm

1) Firstly I note that you subscribe to ICMJE guidelines in terms of data. You therefore import into your guidelines for authors clear guidelines with regard to data.

2) I further note that the web address to ICMJE within your guidelines has an error (a space) which suggests perhaps it is has not been referred to recently.

3) Perhaps some aspects of editorial practice and good science are so obvious that they do not require explicit mention in guidelines.

4) I also note that you hold copyright on the publication. This must surely imply that you vouch for its contents.

Might I ask whether you have enquired of the institution concerned whether they have completed their analysis of these data to check the veracity of the reported findings. If not, this may be appropriate at this juncture.

Your response would be appreciated.

Best wishes

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath

and again ......

Date: Sun, 10 Jun 2007 10:46:25 +0100
From: Aubrey Blumsohn
To: "Sherri Willoughby" Editor JAACAP
Subject: Re:Gillberg Publication in Journal of the American Academy of Child and Adolescent Psychiatry

Dear Dr Willoughby

I have not received an acknowledgment of my last communication below.

Please therefore accept this communication as a formal letter of concern to you as Editor with regard to the veracity of the paper:

Rasmussen & Gillberg (2000) JAACAP 39: 1424-1431

I must admit that I also have serious concerns about potential Editorial misconduct in this instance.

I believe JAACAP was also somehow involved in publishing disputed research involving Seoxat/Paxil, and I would have serious concerns about the plausibility of JAACAP given such repeated instances of apparent disconcern about scientific integrity.

Best wishes

Dr Aubrey Blumsohn

The problem extends beyond questions of ADHD, child psychiatry, Gillberg or the JAACAP. By ignoring such problems, the integrity of all research involving human subjects is put into jeopardy. When journal editors behave in this manner, it raises questions about the entire research enterprise in medicine.

Such behavior on the part of a journal editor is also unfair to the many authors who have published respectable and legitimate science within their pages. It means that all manuscripts published in JAACAP should be viewed with suspicion. It is also unfair to the many psychiatrists and psychologists who are involved in honest clinical practice, and whose profession has been brought into disrepute.

What exactly is the function of a scientific journal beyond serving as a laundering operation?

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Safe medicine, whistleblowing and the Monogomphe

For anyone interested in integrity in science and medicine, one question looms large. "Where and how can an individual patient or professional ask questions about integrity and public safety?". In the answer to that question lies the most important indicator of good government and of safe medicine.

There are some who are only interested in the appearance of integrity.

Evidence from innumerable cases shows that question-askers are bounced from implausible pillar to post. In my case these pillars included the usual suspects - the General Medical Council (GMC), the discredited Medicines and Healthcare Products Regulatory Authority (MHRA, see here and here), a so called "scientific" Journal (JBMR, See here and here) and sadly also the brand new shiny but toothless UK Panel for Research "Integrity" (at least during our short but vacuous acquaintance). Question askers encounter interminable delay, obfuscation and outright deception. They see their concerns redrafted by others into entirely different ones which are more easily managed. They see their concerns bounced back to organizations who attempted to obscure them in the first place. Everything is shrouded in secrecy. There are legal threats and intimations of bodily harm that question askers may encounter. All this happens with a delay of several years during which time the questioner decides to give up, die or commit suicide.

The basis for these problems lies in the increasingly special relationship between the pharmaceutical industry, a network of powerful colleagues, the government and these very organisations which purport to deal with matters of "integrity" and "professionalism". When those who regulate, those who are regulated and those who scrutinize the regulators become one and the same, alarm bells should be ringing.

Speaking of teeth and of suicide, the story is told of the French academic who found himself facing those four doors. He decided to commit suicide. However he decided first to compose his own epitaph (Ref 1).

The first line was a very fine one-terminated with the word triomphe. To this, after a long search he could find no rhyme, but he could not bring himself to sacrifice his beloved line. Time passed, finding him still in search of his rhyme. He was assisted by a number of friends, but all was in vain. One day he succeeded. The rhyme so zealously sought has been discovered, and the completed epitaph is here as revealed by C.C. Bombaugh (Ref 1):-

Attendre que de soi la vétusté triomphe,
C'est absurde! Je vais au devant de la mort.
Mourir a plus d'attraits quand on est jeune encore:
A quoi bon devenir un vieillard monogomphe?

Monogomphe; a brilliant Hellenism signifying "who has but a single tooth".

The problem is that these monogomphe "integrity" bodies use their single gomphe to chomp away at achieving the very opposite of their stated purpose. They have continued to do this even after the inquiries into their malfunction such as Shipman inquiry, the
Bristol Heart Scandal inquiry, and the House of Commons Select Committee Report into the malfunction of the MHRA. In fact these very inquiries appear to have bolstered their antisocial and anti-scientific behaviour. Witness for example the repeated attempts by the GMC to bully a doctor who has raised concerns or the wholly inappropriate political use of the GMC to discredit Andrew Wakefield. Indeed, the GMC has been bullying one question-asker (Dr Rita Pal) repeatedly, using those very powers granted to it following the inquiries into the deaths caused by the rogue Dr Harold Shipman. The GMC certainly gives the impression that it regards repeated bullying and selective ignoring of problems as is its main role. What a chilling effect on anyone else wanting to ask difficult questions. But chilling appears to be the intent.

Sometimes the plan is to twist the nature of language itself. Any responses or correspondence can be redrafted into something which has the mere appearance of English. I have for example been trying to ascertain the meaning Procter and Gamble ascribe to the words "access", "data", "independent", "confidential" and "sufficient" without any great success. Linguistic trickery to obscure problems is a technique with which the MHRA and GMC will be fully aware.

To get a rhyme in English for the word month was quite a matter of interest with curious people years ago (Ref 1), and somebody made it out (or forced it) by making a quatrain, in which a tooth-challenged little girl is described as saying:-

I can get a rhyme for a month.
I can thay it now, I thed it wunth! (Ref 1)

In the meantime, detailed analysis of the operation of malfunctioning systems is required. Even constructive ridicule may improve public safety. Deconstruction and comparison is also useful exercise. When people behave in one direction when encountering one problem, and in the opposite direction when encountering a very similar problem, questions have to be asked. A brief scientific study of the GMC and MHRA suggests that critical concerns about highly placed individuals and corporations are routinely obscured by a network of powerful colleagues, while punishment is reserved for (generally "overseas") doctors who have supposedly bumped and shouted at a drug representative. The silence within my profession as a whole is worrying, and does not point to the highest of standards.

The next Harold Shipman is on our doorstep.

It is called the MHRA (the FDA for those across the pond).

References

Ref 1. C.C. Bombaugh (1828-1906). Oddities and curiosities of words and literature. Dover Publications Inc. New York.

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On decorum in medicine

A quotation by the Irish priest Steve Gilhooley set me thinking about medicine, and the Alice in Wonderland world of medical leadership in particular. The quotation was delivered as part of a sermon on El Salvador. Gilhooley spoke passionately from the pulpit:

"I said to them, '70,000 people have been butchered and none of you gave a shit.'"

There was silence. A priest had sworn in the pulpit.

"And the reason I know none of you gave a shit," he continued, "was because none of you fell off your seat when I said '70,000 had been butchered', but nearly all of you fell off your seats when I said 'shit'."

For the background to this sermon and its consequences read here. Much of Gilhooley's feelings about the church would apply to the current sad state of medicine.

Says Gilhooley [of the church] "There are those who would rather hide the truth. Those whose priorities have become so skewed that they would protect [sexually] abusive priests before they would protect those who fight for justice and transparency. These are the people who are really in control in the Church. Well, let them get on with it. Let them bury it in the ground, and then we'll all start something else."

The desire to maintain decorum and status in medicine seems also to overwhelm all standards of decency. Our profession is inclined to fixate on the irrelevant while ignoring some very bad things. Does civility matter? In the words of David Kern: When you're in an argument with a thug, there are things much more important than civility. I do not like incivility. Yet, I like thugs even less.

The desire to maintain civility, decorum and status instead of ethics explains for example why we as doctors feel quite comfortable with a drug "regulatory" agency in the UK (the MHRA) that simultaneously

1. conducts a high profile campaign against the nutritionist "Poo lady" Dr Gillian McKeith for selling unproven herbal sex aids [Link]
2. ignores all of the very worrying revelations about the drugs we ourselves prescribe

The need to maintain decorum means that it is hard to deal with the difficult and important problems or to deal honestly with the failures of "important" people. It is a lot easier to think about the "Poo lady" than to explore honestly how we were misled by both companies and regulators over Zyprexa, SSRI's, Vioxx and many other drugs (Link,Link,Link, Link,Link).

The emphasis on decorum and status explains why it is considered by some as "impolite" that I accrued extensive tape recordings (sample here or here) of colleagues and pharmaceutical company executives involved in an unsavory scientific "collaboration" that threatened to damage the science I love and to distort our understanding of a drug [Link]. Does civility matter under such circumstances?

The emphasis on decorum and status explains why the BBC had to conduct it's own investigation [Link] of the worrying events surrounding clinical trials of the drug Seroxat and the company GlaxoSmithKline (GSK) as the medicines regulator (the MHRA) simply dragged it's feet for years conducting an internal investigation of its own collusion with the deception. And to cap it all, key figures within the MHRA are previous employees of GSK.

The need to maintain decorum means that even though it seems very likely that both patients and doctors have been misled, that prescribing decisions have been made on the basis of faulty or hidden data, and that patients have suffered or have died as a result of regulatory malfunction, we doctors remain silent (see extensive discussion here and here).

The need for decorum explains why the General Medical Council (GMC) muttered into their beards when presented with evidence of alleged research misconduct involving Dr David Jefferys. Jefferey's was high in the pecking order, and in a position where the need for integrity was part of the job description. He was former director of the Medicines Control Agency and chief executive of the former Medical Devices Agency (both organisations merged to become the Medicines and Healthcare Products Regulatory Agency, the MHRA). This week the General Medical Council also refused to scrutinise in any way the activities of another very important doctor, Dr. Alastair Benbow of GlaxoSmithKline. This despite obvious public concern and a BBC investigation. The GMC refused on the basis that there has not been a criminal or regulatory investigation of GSK (taking the obfuscation full circle). I have no idea how much Dr Benbow knew and when he knew it, but a proper, open and transparent public investigation is urgently required. The GMC cannot claim to be concerned about the scientific integrity of doctors when it behaves in this manner. Indeed the GMC appears to care nothing about the integrity of the research upon which our patients rely.

At the other end of the pecking scale, the GMC has felt quite happy to persecute whistleblowers such as Dr Rita Pal while hiding reports relating to the very serious problems she raised. The recent suspension of yet another Asian doctor for shouting abuse at a Pfizer drug representative was also easy for the GMC, and was presumably felt to have had less impact on the reputation of anyone who mattered [Link].

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The case of Professor Peter Warnke and the alleged coverup at Liverpool University

My attention has just been drawn to this ongoing important court hearing in the UK discussed in the Observer article below. Apparently yet another case of an institution not being totally open when dealing with potential offenses against patients. We have the usual secret investigations, as well as poor treatment of whistleblowers and those who come to the defense of whistleblowers.

As Roy Poses comments on this case "It seems that many types of health care organizations in many countries lack a mechanism to give whistle-blowers a fair hearing, investigate their complaints, and protect them from the wrath of those they accuse, and from institutional leadership which fears those who would rock the boat, even if it is in an effort to alter course away from the iceberg."

I wonder whether the new UK Panel for Research Integrity (UK-PRI) was involved? They hit the headlines some time back as the new wonder-team who were supposed to provide that mechanism. UK-PRI of course now maintain that Universities should "independently" investigate themselves. This is despite abundant evidence from innumerable cases that this does not work. In fact it pretty much never works, so one wonders why anyone would advocate this approach. If one instituted a regimen of patient care that was shown never to work that would hardly be sensible would it. So why would apparently intelligent individuals create systems that employ mechanisms that are known not to work? It's called evidence based support (or EBS). A bit like evidence based medicine (EBM) really.

Also of note is the role of the General Medical Council (GMC) in the report. I would very much like to know whether the GMC held any proper open Fitness to Practice Enquiry, or whether they simply brushed it all under the carpet for their friends as part of an anonymous and secret screening process as they are inclined to do. Perhaps a little like the progress of a rather simple complaint about Professor Richard Eastell (Previous Research Dean at Sheffield Medical School) involving a minor aspect of the Procter and Gamble research scenario in Sheffield. This complaint was placed with the GMC in 2005, and involved a declaration to a journal (similar concerns were raised about Andrew Wakefield - a matter which the GMC has pursued with vigour).

Irrespective of what Warnke actually did, I find the news report in the observer depressing.

Medical school accused of cover-up after claim that surgeon retained samples without consent
Antony Barnett Sunday February 25, 2007 The Observer [Link]

Allegations that patients at a Liverpool hospital had parts of their brains removed for medical research during neurosurgery without consenting to the procedure, can be revealed today.

The University of Liverpool is accused of covering up the procedures, alleged to have resulted in at least 12 patients having brain parts removed. Its medical school, which was embroiled in the Alder Hey organ retention scandal, is facing claims that it tried to silence a senior hospital whistleblower who raised the alarm about alleged misconduct by a leading brain surgeon.

Until 2005, the university employed Professor Peter Warnke, who was chair of neurosurgery and operated at the Walton Centre hospital. In 2002, allegations surfaced that Warnke had been taking tissue from the brains of living and dead patients at the Walton Centre without obtaining consent.

Warnke is alleged to have taken samples of brain tissue during surgery, freezing them in liquid nitrogen, marking them with a black dot and sending them to Genpat 77, a private biotechnology company in Germany. The samples were used to test a new treatment for brain diseases involving an antibody called TIRC 7. Warnke was a joint owner of the patent taken out on TIRC 7, along with the founder of Genpat 77. Warnke has always vigorously contested claims of wrongdoing. The Observer has established that, at around the same period, Warnke attempted to obtain tonsils that had been removed from patients at the Aintree Hospital in Liverpool for use in associated research. Elizabeth Preston, the hospital's medical director, said: 'I can confirm that Professor Warnke did ask for tonsils, but a nurse questioned whether he had ethical consent. He was refused and as far as I am aware he never had access to any tissues from Aintree.'

Both the nurse and a surgical colleague of Warnke's raised questions about his conduct with Dr Marco Rossi, who then chaired the regional ethics committee set up to improve research standards after the Alder Hey scandal, where hundreds of children's organs were retained without parents' consent. Rossi, who was a consultant neuropathologist at the Walton Centre, claims that when he began investigating the allegations against Warnke he suffered threats from senior staff at the university's medical school. He claims that the level of intimidation made him ill and he was unable to continue his work.

Rossi is suing the Walton Centre, the University of Liverpool and the strategic regional health authority for breach of contract. He argues that as a senior employee and whistleblower they should have protected him, and claims that senior medical school staff were more concerned in covering up a potential scandal. He alleges that he was subjected to a campaign of bullying and harassment in an attempt to get him to withdraw his accusations. In court, the university has argued that Rossi's allegations about Warnke were irrelevant and should not be heard.

Last week, a judge rejected this and ordered the university to
hand over its dossier on the affair, including an internal investigation into Warnke's conduct. The court has heard that Rossi alleges that dozens of ethical consent forms used by Warnke for his research were either incomplete or inaccurate.

Although Rossi left in 2002, no action was taken against Warnke until April 2005, hours after Rossi launched his legal action. Warnke was suspended and later resigned. In November 2006 he was appointed chief of neurosurgery at the Beth Israel hospital in Boston, part of Harvard Medical School. Warnke had previously served on the Post-Redfern Committee, which was set up at the University of Liverpool to investigate the Alder Hey scandal.

The university had employed the Dutch pathologist, Professor Dick Van Velzen, who was found guilty of serious professional misconduct for retaining children's organs from 1988 to 1994.

The British law firm Weightmans, which is acting for Warnke, issued a statement to The Observer rejecting Rossi's claims. It said the allegations against Warnke were 'brought by a disgruntled former employee and a colleague of our client'. It added that the allegations were the subject of an independent investigation by the General Medical Council in 2005, which, in January 2006 wrote to Warnke stating they would take no further action [comment: now that's a surprise].

A spokeswoman for Liverpool University said: 'In the context of the current proceedings it would be inappropriate for the university to comment.'

Mel Pickup, chief executive of the Walton Centre, said: 'We would like to reassure former patients of the Walton Centre that at no time have there been any concerns about patient safety or appropriate patient care provided by the individuals connected with this case.'

What is it with us doctors?

The more recent report by the BBC [Link] was even more depressing. It appears that Liverpool University conducted some sort of "internal investigation". They apparently refused to reveal that investigation to Rossi the whistleblower but have now been forced to do so by a judge. It all sounds a bit like a criminal arranging the details of his own "independent" trial, declaring himself innocent, and then refusing to show the victim the basis for such a declaration, and what bits of the evidence had been shown to the judge.

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