Procter & Gamble - Let's take the high road

See this article (AAAS Ethics reports 2006 XIX 3 2006) and the rest of this blog for background to this letter. The recipient is Dr Larry M Games, Vice President at Procter and Gamble Pharmaceuticals. The letter is about research misconduct in studies investigating the mechanism of action and clinical monitoring of the osteoporosis drug Actonel.

Dr Larry M Games
Vice President
Procter and Gamble Pharmaceuticals
Health Care Research Center
8700 Mason-Montgomery Road
Mason, Ohio, 45040
USA

23 November 2006

Re: Actonel Studies/Sheffield Situation - Issue of Raw data

Dear Dr Games

I am writing following our previous correspondence. We have a number of matters to discuss. To maintain clarity I will write separately about each matter. The purpose of this letter is to revisit your earlier refusal to allow the raw data you provided in April 2006 to be made available for public/scientific scrutiny.

I again thank you for your eventual provision in April 2006 of raw data underlying the three intended P&G Publications (Eastell et al. 2003 J.Bone.Miner.Res. 18:1051-6 + the two abstracts/draft publications in my name). I also thank you for your commitment to openness, and for writing the Bill of Rights for researchers. All of this is good.

Unfortunately the Eastell 2003 publication (J.Bone.Miner.Res. 18:1051-6) has not yet been retracted.

As stated, the main purpose of this letter is to revisit your earlier refusal to allow the data provided in April to be scrutinized in an open manner. Your refusal to allow the data to be transmitted to a journal editor accompanying a properly corrected manuscript is not appropriate. A journal editor can request raw data from an author at any time, and such refusal (particularly under the circumstances of this case) would be inappropriate.

The raw data you sent me by E-mail in April is attached exactly as sent (PGData.zip - web downloadable data is encrypted in the online letter). The CD-Rom and paper versions of the data you sent are retained by my legal representative.

Obviously the refusal to supply the raw data to authors in the first place has caused some international consternation. There is also the entirely separate matter concerning the potential mis-analysis of data by P&G in the ghost-analyzed/ghostwritten material. I believe the data was mis-analyzed - and quite obviously so. Two statisticians agree with me.

Certainly data must be transmissible to journal editors. This whole matter could be settled most easily by making the full data as attached available for open scrutiny. Secrecy has no further place in this, and I am asking you to allow this. Any other approach is I am afraid not going to satisfy anyone.

You also make the unusual comment in your last letter that the Eastell 2003 article is somehow separate from the other two intended publications and abstracts in terms of data. Obviously you must know that this is not true. You yourself provided me with the data underlying the Eastell 2003 paper (PGData.zip - encrypted). One of the two manuscripts in my name includes the entire Eastell 2003 data (for NTX and fractures) as a subset since it was based on a combined analysis of the HIP and VERT studies. The related abstract in my name involving the Eastell data (as a subset) is referenced below (1). I am sure you have the draft publication of 2003 relating to this abstract.

You will also no doubt be aware of (and have seen) the statistical reports which attempt to reconstruct Figure 1 and related statistics in the manuscript by Richard Eastell (2003) from the data. One of these reports is here ( Professor Martin Bland). Obviously there were several other problems with the analysis in all manuscripts but for the moment I will keep things simple.

There is a high road Dr Games, and I hope that we can work together to take it.

Kind wishes

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


Reference:

1. A. Blumsohn, IP Barton, A Chines, R Eastell Relative Contributions Of The Early Changes In Bone Resorption And Later Changes In Hip Bone Mineral Density To The Reduction In Vertebral Fracture Risk With Risedronate. J Bone Miner Res 2003;18(S2):S157 Abst#SA337

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Editorial woes at the Journal of Bone and Mineral Research

I have a very old fashioned idea - that Medical Journal Editors should go about their business with as much objectivity and integrity as possible. They should act in the interests of the patients we serve. The Journal of Bone and Mineral Research (JBMR) is seeking a new editor to replace Professor John A. Eisman, MBBS, Ph.D. To apply, see here.

Editors wanting hints as to how to react when approached with concerns about research misconduct involving a major pharmaceutical sponsor and fellow friendly scientists, see the John A. Eisman approach. First try protracted delay. Then try meaningless gibberish, followed by excuses (or exasperation) when asked to reply properly. Then edit a letter of concern to remove all content, and offer to publish it giving a pharmaceutical company the right to respond. Express surprise when the offer is refused. Then decline to review any evidence at all, offering lame excuses. Decline to read statistical reports. Decline to read correspondence relating to denial of access to data. Decine to read anything relating to the concerns raised. Then suggest that those implicated will arrange for the concerns to be addressed. Good trick! It is always a good idea to address concerns that are different from those raised. When the matter reaches the press, write statements so at variance with your previous correspondence that it is hard not to laugh out loud. For collated correspondence and press statements see here. For press see here.

Will the JBMR eventually publish the truth about these three publications and how they came to be? Perhaps not. But then - who cares. Third rate conflicted medical journals that snuggle up to vested interests are steadily losing relevance.

Perhaps the new editor will join me in calling for Procter and Gamble to allow authors (including myself as first author of two of the three intended P&G publications) to make the raw data from the three publications publicly available. So far P&G have declined to allow that. I wonder why that might be?

Alternatively perhaps Professor John A. Eisman would care to perform a teensy tiny statistical analysis himself. He might even consider reading the statistical reports he was offered. Perhaps he would even care to review the evidence with me. Of course there is nothing whatever to hide Professor Eisman - or is there...

Cowardice asks: Is it safe?
Expediency asks: Is it politic?
But Conscience asks: Is it right?"
(William Punshon)

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The General Medical Council - in whose interests?

Figure 1. GMC Guidance improved with a Fig Leaf

The General Medical Council (the UK licensing body for doctors) maintains its purpose is to protect the health of the public by ensuring proper standards in the practice of medicine. But the GMC has an accumulating credibility problem (1-5). Now an important article by Peter Wilmshurst (1, PDF version) adds to the voices (2,3,4,5,6) calling for the Council to be stripped of it's regulatory functions. The GMC is accused of failing to act in a plausible, timely and consistent manner when ethical guidance is ignored (1-6). It appears to apply its ethical rules in a selective way - depending somehow on ethnicity and membership of a mysterious old-boy's club (1,2,3). The Shipman enquiry reported that the GMC failed to deal properly with Fitness to Practice (FTP) cases, particularly involving established and respected doctors (2,4). Most worryingly, it is accused of assisting in victimization of doctors raising concerns, instead of dealing with those concerns. Sir Liam Donaldson, the Chief Medical Officer, echoes concerns about FTP procedures. In his view, "complaints are dealt with in a haphazard manner, the council causes distress to doctors over trivial complaints while tolerating poor practice in other cases".(2, 5). Former President of the GMC, Sir Donald Irvine, called for the current Council to be disbanded and re-formed with new members (2, 6)

Some extracts from the Wilmshurst paper (1, PDF version)

On the private club mentality in dealing with concerns about doctors

"The purpose of the GMC is to protect patients, not doctors. "adjudications by the Professional Conduct Committee were frequently inconsistent, arbitrary and unjust."

"Justified criticisms have led to changes in the GMC in recent years. ..I believe that many of these changes are cosmetic."

"the obligation GMC members feel to those who elected or appointed them represents a conflict of interest that prevents the GMC from working for the good of the public." "the evidence suggests that the medical profession cannot be trusted to regulate itself."

"I can provide many examples of inconsistency in the adjudications of the GMC. One case involved a professor who had falsely claimed an MD research qualification. .... The GMC decided that this dishonesty of the professor required no more than a private warning."

"Some may ask why the Professional Conduct Committee publicly suspended or erased from the Medical Register a number of doctors, all of whom had African or Asian names, for claiming qualifications that they had not been awarded, but the GMC decided that in the case of a white British professor at a major academic institution only a private warning not to do it again was required."

"Another case illustrates the problems of conflicts of interests and the strength of the 'old-boy' network within the GMC. I reported a doctor to the GMC for financial misconduct. Evidence presented at his hearing before the Professional Conduct Committee showed that the senior management of the hospital at which he worked had discovered his dishonesty and reached a severance agreement with him so that if he left without legal challenge, the hospital would destroy documents related to the fraud....The chairman of the Professional Conduct Committee hearing .. had been the medical director of the hospital at the time the deal to conceal the misconduct was agreed. ... The GMC refused to take any action against its member. Contrary to its rules, the GMC refused to tell me why they were unwilling to take action against the GMC member. The GMC member subsequently returned to chairing hearings of the Professional Conduct Committee.

Can one imagine a situation when a judge stood down from hearing a case because he had helped to conceal a crime and then was allowed to return to the bench?"

GMC Victimisation of those raising concerns

"doctors have a responsibility to speak out if they have concerns about behaviour that might endanger patients. A doctor who fails to bring his concerns to attention may be guilty of serious professional misconduct and may be erased from the Medical Register." "However, rather than investigate my concerns, the institution reported me to the GMC for disparagement".

"A more junior doctor, who had serious concerns, effectively had her medical career destroyed by the GMC. Members of the GMC made unfounded allegations that the doctor suffered from mental illness and made it difficult for her to gain employment. The doctor sued the GMC and some GMC employees maintaining that the GMC broke its own rules and failed to follow its own procedures when blackening the reputation of a person raising legitimate concerns...His Honour Judge Harris likened the GMC to a "Stalinist regime".

On creative accountancy

"...one could suggest that it was not in the interests of GMC members to lose these lucrative expenses by upsetting those who elect or appoint them. This only ended recently when public knowledge of this widespread and condoned practice eventually forced the GMC members to behave in a way more in line with normal accounting practices."

The court transcript from the case of PAL vs GMC, May 2004 before Judge Charles Harris is of interest

JUDGE HARRIS: For myself I don't really see why somebody complaining about the behaviour of doctors or the GMC, if that is what they are doing, why that should raise a question about their mental stability, unless anybody who wishes to criticise "the party" is automatically showing themselves to be mentally unstable because they don't agree with the point of view put forward on behalf of the GMC or the party.

MISS COLLIER: That in itself certainly would not be enough.

JUDGE HARRIS: It is like a totalitarian regime: anybody who criticises it is said to be prima facie mentally ill - what used to happen in Russia.

MISS COLLIER: My Lord, that is very far from the circumstances of this case.

JUDGE HARRIS: Of course it is ...

References

1. Wilmshurst P. (2006) The General Medical Council - a Personal View. Cardiology News Oct/Nov 2006 14-15 http://www.pinpointmedical.com/article_read.php?id=57&publication=cardiology-news&link_id=2
2. http://en.wikipedia.org/wiki/General_medical_council (14/11/2006)
3. http://www.guardian.co.uk/racism/Story/0,,349543,00.html
4. Shipman inquiry. Safeguarding patients: 5th report, 2004. Online version
5. Donaldson, L. Good doctors, safer patients: a report by the Chief Medical Officer. Department of Health, 2006-07-14. [Link]
6. Current GMC should be disbanded, says former President. Report by The Royal Society of Medicine.[Link]

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Operation Sisyphus

Sisyphus is a hero of Greek mythology (1), condemned to roll a large rock up a hill. Upon reaching the top the rock rolls back, and the task has to be repeated - endlessly. The story appears to be one of eternal and pointless labor.

One reader suggests that raising issues of pharmaceutical research misconduct is a pointless Sisyphean task (2) - that this whole field of science is already kaput. It sometimes feels that way (3,4). But the story of Sisyphus is not one of unending misery. Despite the best efforts of the gods, they cannot beat him (1).

Fellow medical bloggers are writing about the way in which the pharmaceutical industry is preventing proper understanding of the science upon which our patients rely (5,6,7,8,9). They write about the way in which industry has subverted those organizations whose task it is to act for our patients to preserve integrity.

But we are attacking the wrong beast.

The beast is not the industry - it is ourselves.

Pharmaceutical companies sell products under the banner of science. But their raison d'être is to make money. Industry has to balance genuine hypothesis testing and transparency against commercial interests and the financial consequences of dishonesty. This is not in itself a criticism - it is a simple fact.

We, as doctors, have created the atmosphere which has allowed lethal system malfunction. We have allowed industry to subvert the rules of science and the free-market. We have watched quietly as governments and academics have colluded with industry to hide information critical to our patients. We have remained silent as our medical schools churn out graduates who have no knowledge of the dilemmas and scandals of medicine. We have allowed our medical journals to become corrupted and timid. We have remained silent as our General Medical Councils have taken action against brave doctors for raising questions of integrity (10). We have said nothing while these old-boys' clubs have selectively ignored serious concerns brought to their attention (10) - apparently based on the status and race of those criticised (10,11). We have failed to support our colleagues who have raised concerns. We have said nothing.

I have been waiting very patiently. It is now seven months since Procter and Gamble provided previously suppressed data underlying three intended "ghosted" publications to myself, to the University of Sheffield and to other authors in whose names "science" was ghostwritten (12). The discordance between the data and the ghosted interpretations of that data (in our names) will have been obvious even to the most incompetent of statisticians. The unethical nature of the scientific process will also have been obvious to any observer.

Yet the first of these papers that was published in the names of others (J. Bone. Miner. Res. 2003; 18:1051-6) has not yet been retracted. There has been no comment about the attempts by a senior academic to force a colleague to sign journal declarations in the absence of data - even more important given the status of that senior academic as guardian of research governance within a prestigious medical school. There has been no comment about the ethics of denial of access to data, and about the signing of incorrect declarations to journals about access to such data.

The University of Sheffield has admitted that legal threats were made by Procter and Gamble about return of data that the company "owned" and which had been "obtained without their consent", but have otherwise not commented upon the principles involved

The obvious (and comparatively painless) step of declaring a wrong, and of correcting it, has not yet taken place. There has been no comment at all from those who should comment.

I have waited quietly as the various bodies to whom the matter was referred have done nothing of any relevance.

Once in a while Sisyphus shrugs (13).

How
(John Lennon)

How can I go forward when I don't know which way I'm facing?
How can I go forward when I don't know which way to turn?
How can I go forward into something I'm not sure of?
Oh no, oh no

How can I have feeling when I don't know if it's a feeling?
How can I feel something if I just don't know how to feel?
How can I have feelings when my feelings have always been denied?
Oh no, oh no

You know life can be long
And you got to be so strong
And the world is so tough
Sometimes I feel I've had enough

1. The Myth of Sisyphus by Albert Camus
2. Resistance is futile
3. http://www.slate.com/id/2133061/
4. http://www.thejabberwock.org/presshw.htm
5. Health Care Renewal
6. Pharmagossip
7. Clin Psych
8. Pharma Watch
9. Peter Rost
10. The General Medical Council - a Personal View (Wilmshurst)
11. Wikipedia General Medical Council
12. AAAS: http://www.aaas.org/spp/sfrl/per/per46.pdf
13. http://www.amazon.co.uk/Atlas-Shrugged-Ayn-Rand

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