Wednesday, May 09, 2007

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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Anonymous said...

In Toronto, from the beginning, the university and Koren attempted to discredit Olivieri and harass the researchers. My experience elsewhere in Toronto taught me how easily a University can become an unwitting accomplice.

Anonymous said...

The 527 page report on the Koren incident is here. The relevant parts are mostly in section "C", Findings, and "D", Recommendations.

Anonymous said...

The link above has been changed. The correct links to the Olivieri report are now:

The Olivieri Report (2001)The Supplement to the Olivieri Report (Jan 2002)Ontario College of Physicians and Surgeons censure of Dr. Gideon Koren.

Anonymous said...

It is rather interesting for me to read the blog. Thank you for it. I like such themes and everything connected to them. I would like to read a bit more soon.

Anonymous said...

Motherisk Lab which has been founded by Koren, is now under investigation. According to the freedom of information Act this lab brings in millions per year and 90% of his clients are Children's Aid agencies all ocross Canada. I have had experience with his colleauge Joey Gareri. I believe Children's Aid Societies are paying for the results they want from Motherisk Lab. It costs anywhere between $750.00-$1500.00Whereas, Omega Lab in Ohio charges $115.00 (in which my partner took an independant test and passed after failing the tests conducted through Motherisk Lab)

Unknown said...

This is just beginning; one gets the feeling..