Pharmaceutical Dilbert of the day (2)

Scott Adams and Dilbert always have it spot on. I am a fan.



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A whitewashed crow soon shows black again



A whitewashed crow soon shows black again (Chinese Proverb)

Dedicated to Tareq AlBaho and to his morally adept colleagues Hans Herrmann, Francoise Virieux and the
Nobel Prizewinner Pierre-Gilles de Gennes (who died last week on 18 May 2007).

We have a Nobel prize winner (Physics 1991) who tried and failed to conceal criminal activity by his senior staff against a junior researcher. Those individuals were later tried and convicted in 2000 and 2001. An interesting story - More to follow.

Great intellect implies neither humanity nor ethical insight.
It's all in the ventromedial prefrontal cortex several inches behind the brow.
See Wall Street Journal, 11 May 2007 Scientists Draw Link Between Morality And Brain's Wiring.

"To analyze their moral abilities, Dr. Koenigs and his colleagues used a diagnostic probe as old as Socrates -- leading questions: To save yourself and others, would you throw someone out of a lifeboat? Would you push someone off a bridge, smother a crying baby, or kill a hostage?

The effort to understand the biology of morality is far from academic, said Georgetown University law professor John Mikhail. The search for an ethical balance of harm is central to medical debates on vaccine safety, organ transplants and clinical drug trials."
Hat tip S.S for neurology.

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Take good care of yourself - the health hazards of truthtelling

deaths amongst concerned doctorsFeeling mistreated can hurt, especially when it comes to the heart (1).

An 11-year study of 8000 senior civil servants in London found that those who strongly agreed with the statement"I often have the feeling that I am being treated unfairly" had an increased risk of heart attack (hat tip pharmagossip ).

Out of the 567 people who agreed very strongly with this statement, 51 suffered a heart attack or severe chest pains, known as angina. By comparison, 64 out of the 966 people
who felt mild mistreatment had these heart problems. The results appear in the Journal of Epidemiology and Community Health (2,3.

There is growing evidence that despair can have all sorts of ill effects on the body (4, 5). Wrongly suspended and bullied doctors frequently suffer permanent ill health, and many have committed suicide or have experienced myocardial events (6, 7).

Doctors who have been suspended (often for whistleblowing) have a mortality rate of over 2%. This is higher than the mortality rate for open cardiac surgery and is entirely induced by employers. The mortality falls principally into two categories. (a) clinical depression ending in suicide and (b) myocardial infarction. Myocardial infarction is four times more common among suspended doctors than other doctors of the same age and sex. It has been recommended that affected individuals should take low dose asprin to reduce the risk of cardiac events (7).

This posting is dedicated to my pathology colleague, Dr Chris Chapman who died on 4/11/98 at the age of 56. Chris Chapman was a Principal Biochemist at Leeds General Infirmary working in conjunction with Leeds University, was made redundant after alleging corruption and fraud in the research being carried out. He was sacked the day before his 50th birthday to avoid paying him pension. He was re- instated following his legal victory. In a saga characterised by whitewash and obfuscation, inquiries were held to clarify the facts before a number of senior academics were given early retirement and replaced. However, this was too late for Chris.

See also
  • Jean Lennane. The canary down the mine: what whistleblowers' health tells us about their environment [Link]
  • Lennane K.J. "Whistleblowing": a health issue. British Medical Journal, 1993. 307: 667-670 [Link]
  • Yamey G. Editorial: Protecting whistleblowers. Employers should respond to the message, not shoot the messenger BMJ 2000;320:70-71 [Link]
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On the redefinition of research misconduct

Research misconduct (scientific fraud) is the violation of the standard codes of scholarly conduct and ethics in scientific research. It includes all forms of intentional distortion of the research process or reckless disregard of that process that place the scientific record at risk. It also includes the violation of informed consent, and improper use of information derived from the assumption of risk by other humans.

Honest scientists can recognize inappropriate research behaviors when they see them. Consider the following:

This was the portion of a 1983 Pfizer document that reported that one patient had been taken off Zoloft (an antidepressant) during a clinical trial. The portion of the report that had been in the public domain (and presumably also with the FDA) from 1983 to 2004 indicated only that the patient was taken off the drug because of treatment failure and nausea, anorexia and painful urination.



The true clinical trial record indicated that the patient had been withdrawn at day 11 of the trial because of thoughts of killing himself and others : "[The patient] began to verbalize feelings of killing other people and then himself."



Anyone who cares at all about honest medicine will understand the significance of the subtle redrafting of this and many other records in clinical trials. See original documents here. Read also here for details of the court case that led to release of this particular record.

Why should companies be allowed to maintain the records of clinical trials when human lives and so much money are at stake, and where there have been so many instances of misconduct? The design of a research protocol or system that allows for this form of corporate control is in my view scientific misconduct in and of itself.

And the response from Pfizer at the time: "This is anecdotal patient information," said Bryant Haskins from the company's New York office. A clinical trial is the systematic collection and honest statistical description of anecdote. When each bit of that information is distorted, what we end up with has the mere appearance of science. In medicine, research misconduct leads to death, incorrect decision making, ineffective therapy and misery.

Has anyone been punished for the misery caused? We feel smug self-satisfaction when we send an individual scientist such as Eric Poehlman to prison for scientific misconduct while we ignore even the most severe instances of corporate scientific misconduct.

See also Pharmagossip: Those who forget history for a discussion of the retrospective massaging of one individual patient event in Merck Vioxx trials.

Much of what we call "science" in pharmaceutical medicine doesn't pass the most basic sniff test.

Take the survey. Do these instances represent scientific misconduct? If you answer no, please leave a comment justifying your opinion.

Research misconduct?
Yes
No
  
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Pharmaceutical Dilbert of the day (1)

Scott Adams and Dilbert always have it spot on. I am a fan.



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An important book - The Corporate Corruption of Higher Education

University Inc

An interview with Jennifer Washburn from 2005.

Author of one of the most important and readable books on the University Industrial Interface.

Jennifer Washburn: University, Inc: The Corporate Corruption of Higher Education - New Edition, Oct 2006 [Amazon]

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The birth and death of the UK Panel for Research Integrity - Part A

I laughed out loud when I read the today's Guardian article about the "new" UK research integrity panel (UK-PRI).

'Whistleblowing in the Wind?'
by Jessica Shepherd [Link].

Potential customers beware.
You should treat any offer of support from UK-PRI in the same way you would treat the offer of fellatio from a crocodile.


There is a lot more to say on this topic (so stay tuned).

At least the journalist involved had the good sense to realise what she was dealing with.

Whistleblowing in the wind?
A new hotline for those who suspect malpractice in medical research has not been universally welcomed.
Jessica Shepherd reports [Link]
Tuesday May 15, 2007 The Guardian


The UK Research Integrity Office and its hotline has no investigatory powers - but they can give advice. Photograph: Linda Nylind

In just nine months, Malcolm Pearce went from being considered a highly accomplished gynaecologist-researcher to a fraudster who potentially harmed patients. He had published two papers in the British Journal of Obstetrics and Gynaecology on work that never took place. Had it not been for a whistleblower, he might never have been found out and struck off the medical register.

The fact that his case was dealt with speedily, protecting the rights of both the accused and the whistleblower, was unusual, according to Dr Stephen Lock, a former editor of the British Medical Journal, writing in the publication at the time of the case, in 1995. "In most other medical institutions in Britain, nothing would have happened; the affair would have been brushed under the carpet, and the whistleblower would probably have been hounded out of his or her job," he said.

That was more than 10 years ago and hopefully things have changed. But Britain is still lagging behind its neighbours when it comes to preventing research misconduct. The Scandinavian countries, Germany, France and the US have had organisations to investigate fraud or monitor investigations for more than 10 years. Ours - the UK Research Integrity Office - was set up only last year.

"We have been relatively late with this," admits Professor Michael Farthing, who is vice-chair of a panel that looks into research integrity in health and biomedical sciences, of which the UK Research Integrity Office is a part.

But, as if to catch up, the UK is now attempting what is thought to be a world-first: a hotline for those who suspect research misconduct. The hotline, which went live on Friday, for the moment covers only medical research - the most common form of research misconduct - but there are plans to expand into all disciplines. It is aimed at anyone who suspects malpractice, from a minor tinkering of data to plagiarism, fabrication and falsification.

Dr Andy Stainthorpe, who runs the UK Research Integrity Office, who will man the helpline between 8am and 8pm every weekday, says he is expecting anything between 10 and 100 calls a month. "It could be a university administrator who calls, or the person whose responsibility it is to handle allegations of misconduct, like the pro vice-chancellor for research," he says.

What can callers expect? "Investigations into research misconduct rest solely with employers - so, a university or an NHS trust in this case," says Stainthorpe. "The helpline exists to give impartial and independent advice to callers on how to handle allegations of research misconduct.

"If someone phones up, I will discuss the issues with them and could also pass the matter on to a panel of experts in the UK who have tackled those issues before. We can give callers confidence by letting them know whether what they are observing might be misconduct or not. Cases are rare and quite often callers won't have come across one before. It is useful to seek guidance from someone who has handled something like it previously."

Stainthorpe says he has had experience of "several" cases of research misconduct in his role at the Research Integrity Office and in places where he has previously worked. "There is no reason why a caller should not just go to their pro vice-chancellor for research if that is the person who deals with research misconduct in their institution," he says.

And that is why the research community has not altogether welcomed the hotline - or the creation of the Research Integrity Office. Sir Iain Chalmers, editor of the James Lind Library in Oxford, which documents the evolution of fair tests of medical treatments, says: "There's not much point in making allegations of research misconduct to the helpline. The organisation behind it has no powers of investigation. It is actually very unfair to the people who make the allegations because it could be that their allegations are brushed aside ultimately.

"It is also unfair to those who are alleged to have practised misconduct. As long as the office and the helpline have no investigatory powers, justice will not be done."

Dr Hugh Davies, the ethics adviser to the National Patient Safety Agency, describes the helpline as "problematic". He says: "It's one way to deal with research misconduct, but it could encourage unfounded accusations of research misconduct, and how is it going to deal with that?"

To which Stainthorpe replies: "There is the potential that we will waste a bit of our time, but it is better that we are here for those who need us. This is a three-year experiment. The helpline will be reviewed in six months. We don't know what the size of the issue is yet, and we need to get more hard evidence of incidents in order to know more about the scale of the problem."

And Farthing concedes: "This is not the solution to research misconduct at all - it opens another opportunity for people to raise their concerns."

Another opportunity is needed. A study published in Nature in 2005 claimed that a third of US scientists had engaged in serious research misconduct in the past three years. Of the 3,200 scientists who took part, less than 1% said they had falsified data, but more than 12% admitted to tolerating a misuse of data by their colleagues.

"It would be very difficult to say we in the UK are any different," says Farthing. "I have to say that my inclination is that there is a rise in research misconduct. There are huge pressures on people to perform. There is huge competition among academics. They need to get their next grant."

Despite concerns that cases of research misconduct are growing, Chalmers says there is evidence to show universities, academic journals and the government do not take allegations of malpractice seriously enough. This, he says, is in direct contrast to the pharmaceutical industry, which has set up a system of "forensic examination" into allegations of misconduct.

"Universities are in a difficult position. They are not the most appropriate organisations to judge themselves. They want to keep their reputation unblemished. If it is a senior member of staff who is being alleged to have practised research misconduct, how do they deal with that? It is a great embarrassment."

Embarrassment is the least of it. The cost of medical research misconduct can just as easily be human lives.


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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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Any complaints? The case of Gideon Koren and the anonymous letters

I have managed to get hold of some interesting letters.

They are a series of abusive letters written between 1998 and 1999 and sent anonymously by Professor Gideon Koren to dozens of members of staff at the University of Toronto. They were written at the height of the attempt by the University of Toronto to obstruct the raising of concerns about a drug trial by Nancy Olivieri.

Here is one example:



Here is another:



Gideon Koren was at the time (and still is) a very senior academic at the University of Toronto with important responsibilities over clinical research. For months Koren repeatedly lied, denying writing the letters, until he was identified as author by DNA evidence. The University conducted no investigation until forced to do so, calling it an "internal matter" and left Koren's frightened colleagues to accumulate evidence and pay for DNA studies themselves. Koren ultimately received a stiff reprimand and a slap on the wrist.

Although a minor facet of the Olivieri scandal the case of Gideon Koren is yet another sad example of the behavior of Universities when facing problems involving matters of individual reputation and money. In any sane universe, this sort of behavior by a clinical academic in charge of research probity in a major University would be a career ender.

There are at least three profound consequences of this saga for the University of Toronto and for all academics.

  1. First concerned academics and clinicians are unlikely to raise issues of integrity. It may seem that there is almost no point in doing so.

  2. Second, incidents of this sort contribute to the lack of trust our patients have in the "science" we try to sell to them. Koren is involved in an area of science of great importance to children. The science involves understanding the harm we as doctors can cause to babies in utero. An example of Koren's "science" involves the study of harmful effects of antidepressants during pregnancy. The question is why Koren should be believed when making pronouncements about science, and why he should be allowed to conduct such studies in the first place.

    In 2006 a scandal erupted in the pages of the Wallstreet Journal over a JAMA publication investigating antidepressant withdrawal during pregnancy. The paper failed to disclose that the researchers had 60 financial relationships to pharmaceutical companies, and most authors were paid as consultants by the makers of antidepressants (Wall Street Journal July 11 2006). Koren was cited in the WSJ as follows:

    To further make that point, a videotaped interview with Gideon Koren, the director of the Motherisk Program at the University of Toronto, was played. Dr. Koren said the data identifying a risk of cardiac malformation were "very low quality" and that regulatory agencies were "just throwing us statements, mostly for medical-legal reasons." Dr. Koren is currently conducting a study funded by drug maker Wyeth looking at the development of children exposed to the company's Effexor, a non-SSRI antidepressant. That relationship was not disclosed.

    And therein lies the problem.

  3. Third it relates to the principles that should guide "integrity" bodies that claim to govern and advise about "research integrity". Given the multitude of examples of obfuscatory institutional behavior it would seem that a guiding principle must be to assume that institutional "investigations", particularly involving clinical drug studies, are designed to obfuscate and condone rather than to illuminate. Indeed there are no examples I can find of proper institutional investigations where individual reputations and money are at stake. That is not to malign the University of Toronto or indeed any other University, but we simply have to find a better way of doing things. Our patients deserve far better.

The rather marvelous approach of the new Research Integrity Panel in the UK will be discussed in the next post.

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