About all manner of pharmaceutical scientific misconduct, bad science, and related curious incidents. If you're not outraged, you're not paying attention.
There was a crooked man, And he walked a crooked mile. To confer with his crooked neighbor, Who wore a crooked smile. The crooked man's neighbor, Lived in a crooked nook. Both being crooked people, They read a crooked book. Inside were crooked tales, Of other crooked men. 'Twas a crooked man's dream, Shared with a crooked friend.
"The problems of disease are more complicated and difficult than any others with which the trained mind has to grapple... Variability is the law of life. As no two faces are the same, so no two bodies are alike, and no two individuals react alike and behave alike under the abnormal conditions which we know as disease. This is the fundamental difficulty in the education of the physician, and one which he or she may never grasp... probability is the guide of life". Sir William Osler 1, 1921
Here lies the basis for clinical decision making and evidence based medicine. What is the probability that "Liver extract" will improve fatigue or that Astaxanthin (a carotenoid pigment) will solve male infertility? (more of these later)
For that matter, what is the probability that any given clinical trial sponsored and controlled by GlaxoSmithKline, Merck, or Procter and Gamble will be honest?
This quote appears on a few websites promoting magical medicine. However they routinely omit the last sentence of the quotation, reversing the essence of Osler's wisdom. Osler would not have liked magical medicine - of the "GlaxoSmithKline" variety or the "liver extract" variety.
Paul Blackburn, GSK Vice president has resigned from the Ofsted board in the last few hours over "the activities of his employer" (see background here)
From: enquiries@ofsted.gov.uk To: fiddaman64 Sent: Wednesday, July 09, 2008 1:22 PM Subject: Fw: Appointment of GSK Vice President to Ofsted
Dear Mr Fiddaman
Further to my email to you this morning, please be advised as follows:
Paul Blackburn resigned as a non executive member of the Ofsted Board on 5th July. His resignation follows public concerns about the activities of his employer GSK. Paul did not want any negative press interest to detract from the excellent work of Ofsted and therefore resigned. As far as Ofsted is concerned the matter is now concluded.
Should you require any further assistance please do not hesitate to contact us.
Regards,
Alan O'Neal Customer Service Advisor Ofsted - National Business Unit
Biomedical researchers at the University of Toronto are starting to sign a new honesty oath - See report in the Globe, also published in the Journal Science last week.
Now why should I have a problem with this?
Those behind this initiative (Karen Davis and Ori Rotstein) presumably have good intentions.
Unlike doctors, scientists don't have an ancient moral code like the Hippocratic oath.
But graduate students beginning their careers in medical research at the University of Toronto now have their own solemn ceremony in which they pledge to conduct themselves in an ethical fashion.
Karen Davis, graduate co-ordinator at the Institute of Medical Science, says the new vow stems, in part, from the growing recognition of the potential for academic misconduct, which includes fraud, plagiarism and the shaping of experiments and research papers in ways that help pharmaceutical companies sell more drugs.
Spot on.
Now let's read the oath itself:
"I promise never to allow financial gain, competitiveness or ambition cloud my judgment in the conduct of ethical research and scholarship," reads the oath, which was recited for the first time last September by graduate students at the Institute of Medical Science. "I will pursue knowledge and create knowledge for the greater good, but never to the detriment of colleagues, supervisors, research subjects or the international community of scholars of which I am now a member."
There are a multitude of problems here. Starting with the minor and ending with the dismally depressing:
a) The Hippocratic oath is clearly working extremely well for the medical profession right now.
b) Given the critical ethical scientific scandals which have occurred at the University of Toronto, the phrase "but never to the detriment of colleagues" is perverse. Ethical behaviour is often to the detriment of unscrupulous colleagues. Are we suggesting that Nancy Olivieri should have hidden scientific findings and accepted sham investigations (at UoT) to avoid causing detriment to colleagues?
c) The phrase "I will pursue knowledge and create knowledge for the greater good" is woefully off target. The obligation of a scientist is to the scientific method. It is to describe that method honestly, including conflicts of interest, access to data, authorship, protocol and statistics. It is an obligation to share raw data. It is an obligation to avoid lying about data. Any "greater good" may or may not flow from honest method.
d) The clear lesson from recent scandals is that it's not junior scientists who have the most pressing need for an oath. The pressing need is for Universities and medical leaders to take an oath themselves.
One could imagine an oath for the University of Toronto:
"We promise never to allow financial gain or the natural desire to hide unethical behaviour cloud our judgment in the conduct of ethical research and scholarship. We will allow scientists to pursue knowledge and create knowledge for the greater good. We will continue to do so even if it is to the detriment of other more important colleagues or large corporations. We promise never to bully or to fire scientists who behave with integrity. We promise never to conduct sham investigations or to tell lies for purposes of bullying, hiding the truth or protecting our friends."
e) The biggest problem in scientific ethics is the failure to speak. It is the disconnect between perfectly good codes and the application of those codes to actual troubling incidents. It is the fact that codes are toothless. UoT already has perfectly good codes, procedures and rules of conduct.
That is not to say that Karen Davis and Ori Rotstein are not well intentioned. However, given the problems at Toronto one has to ask where they were when they should have spoken? When they cite examples, why do they not cite incidents rather closer to home?
f) Perhaps all of these codes serve as pretext for virtuous mumbling by groups whose very success is based on ethical failure. Morality they say is sometimes taught by the immoral. It is no surprise that Dr David Goldbloom at the University of Toronto (yes the one who fired Professor David Healy) lectures on ethical physician interaction with the pharmaceutical industry, "harmonized research ethics", advises about conflicts of interest, and wrote the 2003 University of Toronto "Task force report" on Interactions with the pharmaceutical industry. He is paradoxically recipient of the Henry Durost Award for "Excellence in Creative Professional Activity" having destroyed a source of real creative scientific thinking within his own institution.
We have an unrehabilitated institution with a less-than-moral reputation producing smokescreen codes without addressing actual failures.
"A good day ain't got no rain. A bad day's when I lie in bed and think of things that might have been." -Paul Simon, Slip Slidin' Away
This week sees a new furore over the appointment of a GlaxoSmithKline Senior Vice President (Paul Blackburn) to the board of the education watchdog Ofsted. Any last shred of credibility of the UK Labour government is gone. The implications of this despicable appointment are obvious to anyone who has followed the various ins and outs of misrepresented pharmaceutical science and government collusion with GSK. Much of this bad science involved children. It certainly involved deaths and much human suffering.
Perhaps Gordon Brown dreamed up this truly marvellous public relations plan for his friends while floating in the bath. What are they thinking.....? See discussion here, here, here, here, here.
I am not a leftist or a rightist. I would prefer to see small government, honest government and transparent government. Protecting the vested interests of any favored group or corporation (except to uphold democratically decided law) is not a legitimate role of government. I suppose that makes me a libertarian.
I have no time for those who try to create false ideological opponents by declaring themselves on the side of "the free market" and against "intrusive regulation" while failing to define the meaning of the words they use. This is a debate about corrupted markets and falsified science versus honesty, integrity, and transparency. It is I suppose about the children who died, and whether we care.
Is it "lefty" to suggest that corporations selling products under the banner of science should actually obey the most fundamental rules of science?
Is it "lefty" to propose that drug regulators should actually look at raw data before licensing drugs? Is it "lefty" to suggest that scientists, doctors who prescribe, (and patients who consume) should be allowed to see the honest science underlying prescribing decisions? Is it "lefty" to suggest that regulators are committing criminal acts when they collude with industry to hide the most fundamental facts about drugs under a cloud of corporate secrecy? Is it the role of government in a free market to shield corporate criminals from prosecution and scrutiny?
Unless the debate can rise above the false left/right dichotomy we are doomed. The victims of the current widespread fraud in this industry are not only patients. The victims are the credibility of UK science, medicine, and the honest and most innovative parts of the pharmaceutical industry itself.
The days of the UK Labour Government are numbered. They are likely to go down in history as a cynically corrupt government that has betrayed every aspect of their own supposed mission. I'll leave a detailed discussion of the entanglement between the labour government and pharmaceutical scientific fraud for another day.
So to Gordon Brown -- you are a dismal thoughtless pathetic failure. Sadly, the corruption of politics is such that your successor may not be any better.
One thing will be obvious to anyone who has spent time looking at scientific misconduct and academic bullying. Publicly known instances tend to aggregate within particular institutions.
It may be a denominator effect. "Bad apples" might arise in productive institutions with a large number of apples. Ineffective (or corrupt) leadership might also permit fraud and bullying. Unprincipled leadership is also associated with sham investigation and attempted cover-up, which in turn precipitates public discussion.
True "bad apple" aberrations never leave an institutional stain. The fraud of Jan Hendrik Schön did not alter the reputation of Bell Laboratories. Other so called "bad apple" cases are nothing of the sort. The fraud of John Darsee at Harvard, or Vijay Soman at Yale involved collusion of leadership, ignoring of principles, bullying and cover-up.
Several institutions spring to mind, not only for the frequency of serious problems but also dismal cover-up, ignoring of principles, and bullying of those who have discussed integrity.
The University of Toronto (cases of Nancy Olivieri, David Healy, Godeon Koren, Brenda Gallie and others)
Berkeley (Ignacio Chapela, Tyrone Hayes)
Brown University Medical School (David Kern, Martin Keller)
Harvard (too many cases to mention)
Kingston University in the UK
Another characteristic of leadership failure is the refusal of institutions to apologize when they must know that they have done wrong. There is failure to discuss the principles honestly and publicly. There is failure to demonstrate proper academic behavior to students. When apology does take place it is often end-stage "damage limitation" of the sort illustrated here by John Cleese.
Why discuss Brown University now? Brown has a new Dean of Medicine as of 5 days ago. Professor of Edward J. Wing, M.D. took up his position on July 1 2008. There was considerable controversy about the manner of his appointment. In particular there were concerns that the process was designed to limit the field to particular insiders (see here, and here). Perhaps choosing an insider was not the best idea for an institution with a growing integrity stain.
Wing was certainly present at Brown during the terminal phase of the bullying of David Kern. It is not known that he did anything to help Kern. He must also have had interactions with Professor Martin Keller.
It is however possible that Wing will do the right thing. I wrote to Wing to find out. My communication was also sent to Associate Provost Pamela O'Neil, Provost David Kertzer and President Ruth Simmons. Given the absence of any acknowledgement, I thought I would make my communication public.
Professor Ed Wing Chairman of Medicine Brown Medical School
29 June 2008
Dear Professor Wing
I note that you will take up your Deanship at Brown two days from now. I congratulate you on your appointment.
I am sure you are aware of increasing concern about the integrity and honesty of leadership in medicine. Further, I am sure that you realize that the outsider's view of Brown is tainted by two unfortunate scandals. One a decade ago, has never been resolved in any principled manner. The other is ongoing.
I am referring to the cases of Dr David Kern, Professor of Occupational Medicine, and the many problems involving Professor Martin Keller.
David Kern was bullied and effectively fired at around the time you joined the faculty at Brown. Brown has never to my knowledge undertaken any soul searching with regard to this dismal affair.
I am sure that you are aware of the obvious obscenity of tainted research and research misrepresentation involving Professor Martin Keller. This research has done a grave disservice to the image of our profession. Brown has so far taken no apparent action.
I am therefore writing to ask whether you have made (or intend to make) any comment about these two incidents.
Have you anything to say of the future integrity of research at Brown, Professor Wing?
Kind Regards
Dr Aubrey Blumsohn Sheffield, England
There is a Chinese saying, "a fish begins to smell from the head down...". You may not be a culpable head as yet Professor Wing. You are however in a position to make some statement about the institutional infection that has characterized Brown.
As Peter Drucker said, "Management is doing things right; leadership is doing the right things". Some statement about manipulated drug studies, an honorary degree for David Kern and an honest statement of regret might be a good idea.
Perhaps consider doing the right thing Professor Wing.
Sally Hunt is currently General Secretary of the University and College Union (UCU), and the last General Secretary of the Association of University Teachers (UK) prior to its merger with NATFHE to form the UCU. For background see letter here.
Biomedical researchers at the University of Toronto are starting to sign a new honesty oath - See report in the Globe, also published in the Journal Science last week.
f) Perhaps all of these codes serve as pretext for virtuous mumbling by groups whose very success is based on ethical failure. Morality they say is sometimes taught by the immoral. It is no surprise that Dr David Goldbloom at the University of Toronto (yes the one who fired Professor David Healy) lectures on ethical physician interaction with the pharmaceutical industry, "harmonized research ethics", advises about conflicts of interest, and wrote the 2003 University of Toronto "Task force report" on Interactions with the pharmaceutical industry. He is paradoxically recipient of the Henry Durost Award for "Excellence in Creative Professional Activity" having destroyed a source of real creative scientific thinking within his own institution.
"A good day ain't got no rain. A bad day's when I lie in bed and think of things that might have been." 
One thing will be obvious to anyone who has spent time looking at scientific misconduct and academic bullying. Publicly known instances tend to aggregate within particular institutions.
