Friday, March 02, 2012

Evans and Gyulai escape misconduct charges at UPenn

In a post titled Penn finds no misconduct by professors in plagiarism case, the Philadelphia Inquirer notes that two UPenn professors, Dwight Evans, chair of Penn's psychiatry department, and Laszlo Gyulai, were not guilty of misconduct. What underlies this story goes way beyond charges of academic misconduct.

But first contemplate the misconduct charges. The rationale of the UPenn internal investigation was that the actions of the professors did NOT violate authorship guidelines in effect in 2001, when the incident happened, although the actions would violate current guidelines.

The issue involved content and authorship on a paper about Paxil, and UPenn professor Jay D. Amsterdam filed a complaint with the federal Office of Research Integrity [ORI] about the work, asserting that "the published manuscript was biased in its conclusions, made unsubstantiated efficacy claims, and downplayed the adverse event profile of Paxil." Three of the authors of the paper in fact worked for Glaxo, the maker of Paxil, but this relevant fact apparently was not disclosed on the paper as published. The Inquirer noted: Three study authors worked for Glaxo. Penn said the "manuscript submitted to the journal included the institutional affiliation of the authors, but the journal removed that information from the publication."

There was an allegation that the UPenn professors received "assistance from a medical writer," raising the issue of ghostwriting, which is a form of plagiarism. That is, the named authors did not actually write the paper, and the person who did write the paper was not credited as the source.

The Daily Pennsylvanian noted of the ghostwriting matter:

Amsterdam claimed a paper published under their names in a 2001 edition of The American Journal of Psychiatry was ghostwritten by an employee at Scientific Therapeutics Information.

The paper in question is titled Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression and the first author is Charles B. Nemeroff. Neither the Philadelphia Inquirer nor The Daily Pennsylvanian mentioned Nemeroff's background. Nemeroff's entry on wikipedia includes the text:

His undisclosed ties to drugmakers and under-reported incomes from them have raised questions about conflict of interest.[1][2] Following criticism from Senator Charles Grassley of the Senate Finance Committee, Nemeroff resigned as chair of the psychiatry department at Emory University.[3][4] He was also forbidden by Emory to act as an investigator or co-investigator on National Institutes of Health grants for at least two years. Nemeroff has moved to Florida and become the chair of psychiatry at the University of Miami.

Nemeroff has been mentioned in IPBiz. See Conflict of interest issue in Nemeroff paper discussed by Science .

There have been issues with patents.
What's happening with conflict of interest and error correction at Science?
: The critics said Emory University's psychiatry chairman Charles Nemeroff reviewed mood disorder therapies in the monthly journal Nature Neuroscience without revealing his ownership of a patent on one of the treatments.

Of the other co-authors of Evans and Gyulai, paper co-author Ivan Gergel was named Vice President of Clinical Development and Clinical Affairs in 1999 at SmithKline Beecham. Paper co-author Cornelius D. Pitts was also an employee of SmithKline Beecham (see for example the distinct paper
Paroxetine Treatment of Generalized Social Phobia (Social Anxiety Disorder), which concluded Fifty (55.0%) of 91 persons taking paroxetine and 22 (23.9%) of 92 persons taking placebo were much improved or very much improved at the end of treatment ).

As to the underlying scientific issues with the paper, a 2009 post at begins:

British drug company GlaxoSmithKline (GSK) has paid $1 billion to settle lawsuits related to Paxil. The fact that it was disclosed by Bloomberg and not the company itself illustrates how lousy financial disclosure rules are in Europe and why drug companies based there cannot be trusted to tell the truth about what is going on with their litigation liabilities and, by extension, the safety of their drugs.

From the huffingtonpost:

In a May 2006 release in collaboration with the manufacturer GlaxoSmithKline (GSK), the FDA has acknowledged the antidepressant Paxil causes a statistically significant increased rate of suicidality in depressed adults as measured in controlled clinical trials (...) Depressed people are 6.4 times more likely to become suicidal while taking an antidepressant than while taking a sugar pill


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