Psychiatrist’s Undisclosed Financial Ties Prompt Reproval – NYT

Psychiatrist’s Undisclosed Financial Ties Prompt Reproval – NYT

Sun, 3 Aug 2003

The New York Times reports that Dr. Charles Nemeroff, head of psychiatry and behavioral sciences at Emory School of Medicine (Atlanta) has been rebuked by colleagues for failing to disclose his substantial financial ties to drug companies whose products he promoted in a review article in Nature Neuroscience.

Dr. Nemeroff, a former president of the American College of Neuropsychopharmacology, favorably described the products in which he has significant financial interests while describing the competitors’ products as “disappointing.” Dr. Nemeroff’s financial ties were documented in company documents filed with the federal securities and exchange commission.

One of several examples described by The Times involves mifepristone, an abortion-inducing drug manufactured by Corcept Therapeutics. Dr. Nemeroff claimed that “favorable studies” show mifepristone was effective for psychotic depression. The Times reports SEC documents reveal what Dr. Nemeroff did not: “Dr. Nemeroff was given the option to buy 72,000 shares of its stock for less than $25 total. Those shares would have been worth more than $1 million…”

There is a Chinese saying, “a fish begins to smell from the head down…” So it is in science and medicine–conflict of interests is a malaise that spreads from the from the leadership down. It is not a few “rotten apples” (as I had once believed) that undermine the integrity of medicine, but rather an institutionalized infection.

Dr. Charles Jennings, executive editor of Nature Research Journal said “editors let authors of such articles decide whether to disclose their financial conflicts.” Such a cavalier policy has surely contributed toward undermining the integrity of the scientific literature.

Dr. Robert Rubin, director of the Center for Neuroscience Research at Allegheny General Hospital (Pittsburgh) disputes Dr. Jennings’ claim. He notes: “The accepted ethic across all science now is that you disclose all real and potential conflict of interests.” Dr. Rubin and Bernard Caroll, director of the Pacific Behavioral Research Foundation (Calif) wrote a letter to the editor complaining about Dr. Nemeroff’s undisclosed conflict of interests. The editor of Nature has not as yet seen fit to publish the letter.

For additional insight into the pernicious consequences that follow from pervasive pharmaceutical company influence on science, medicine and the academy, it’s worth revisiting the scandal surrounding the University of Toronto, Eli Lilly and the unexplained withdrawal of the appointment of Dr. David Healy to head its Center for Addiction and Mental Health. The central figure in that scandal was Dr. Charles Nemeroff.

See: Documentary by the Canadian Broadcasting Corporation: “Dr. David Healy: How much influence do drug companies have on medical research?” In this documentary Darrow McIntyre interviewed the opposing stakeholders in this international scandal. The ‘affair’ demonstrated that academic freedom is a casualty of industry influence. The case tainted the reputation of the University of Toronto. See: http://cbc.ca/national/real/macintyre_part1healy010612.smi and http://cbc.ca/national/real/macintyre_part2healy010612.smi Transcript is also available at: http://www.pharmapolitics.com/cbcnational.html

For update see: Sarah Boseley. Bitter Pill. The Guardian, Tuesday May 21, 2002 Professor Nemeroff was profiled in an article, headlined “Boss of bosses” in the psychiatric journal Ten, which asked “Is the brash and controversial Charles Nemeroff the most powerful man in psychiatry?” and described him as “among the most coveted advisers to the pharmaceutical industry.” See: http://education.guardian.co.uk/Print/0,3858,4417163,00.html

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THE NEW YORK TIMES August 3, 2003

Undisclosed Financial Ties Prompt Reproval of Doctor By MELODY PETERSEN

http://www.nytimes.com/2003/08/03/national/03CONF.html?pagewanted=print&position=

Two scientists are raising concerns about an article in a medical journal that described experimental treatments for depression because an author did not disclose his significant financial ties to three therapies that he mentioned favorably. The executive editor of the journal said it had not required disclosure of the potential conflicts, but was considering changing its policy in light of the criticism. The ties between pharmaceutical companies and researchers have come under increasing scrutiny in recent years. The lead author of the article, Dr. Charles B. Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory School of Medicine in Atlanta, said he would have reported the conflicts of interest, which include owning the patent on a treatment he mentioned, if the journal had asked him to. “I have always been totally compliant, probably gone overboard, with disclosure,” Dr. Nemeroff said. “If there is a fault here, it is with the journal’s policy.”

The doctors who raised concerns, Robert T. Rubin and Bernard J. Carroll, said they faulted the policy of the journal, Nature Neuroscience, and Dr. Nemeroff for not disclosing the information anyway.

“The accepted ethic across all science now is that you disclose all real and potential conflict of interests,” Dr. Rubin, director of the Center for Neurosciences Research at Allegheny General Hospital in Pittsburgh, said. Dr. Charles G. Jennings, executive editor of the Nature Research Journals, which include Nature Neuroscience, said such disclosures were required only on articles that described original research. In November, Dr. Nemeroff wrote a review of research that had previously been published, Dr. Jennings said, and editors let authors of such articles decide whether to disclose their financial conflicts.

That policy covers all the Nature journals, Dr. Jennings said, including Nature Publishing Group’s most prominent journal, Nature. The group is part of Macmillan Publishers.

That policy differs from some other major medical journals. The New England Journal of Medicine will not allow an author to write such a review article if he or she has a significant conflict of interest, its executive editor, Dr. Gregory D. Curfman, said. An example of a significant conflict of interest, Dr. Curfman said, would be a writer who received annual payments of $10,000 or more from a drug company whose product was included in the article.

Dr. Jennings said editors at the Nature journals were considering changing their policy. In his article, Dr. Nemeroff mentions roughly two dozen potential new therapies, saying that some had shown disappointing results and that others were promising. One treatment he describes favorably is a patch that delivers lithium through the skin, a method that he says would improve patients’ ability to tolerate the medicine. He did not disclose that he held the patent on that patch.

Dr. Nemeroff also did not disclose that he was a significant shareholder in Corcept Therapeutics, a company in Menlo Park, Calif., that is trying to develop mifepristone, a drug now approved to induce abortions, into a treatment for psychotic depression. In the article, he wrote that there had been “impressive studies” with mifepristone, indicating that it “is very effective in the treatment of psychotic depression.”

According to papers that Corcept filed with the Securities and Exchange Commission, Dr. Nemeroff was given the option to buy 72,000 shares of its stock for less than $25 total. Those shares would have been worth more than $1 million if Corcepts had sold its shares to the public at a price of $14 to $16, as it announced it would do in late 2001. The company decided in the fall to delay that offering. Dr. Nemeroff said in an interview that he owned 60,000 shares of Corcept stock.

Dr. Nemeroff also did not disclose any of his ties to Cypress Bioscience of San Diego, whose sole product is milnacipran, a drug being developed to treat fibromyalgia, a chronic pain disorder. Dr. Nemeroff noted in his article that drugs that work in a similar way to milnacipran have been shown to be more effective than some other antidepressants.

According to papers Cypress filed with the S.E.C., Dr. Nemeroff is on the Cypress board and the company has given him tens of thousands of options to buy its stock. Cypress also paid Dr. Nemeroff $36,000 in consulting fees last year, according to its S.E.C. filings. Those papers say he has an agreement under which he would receive $100,000 if he helped Cypress succeed with the drug. The chief financial officer of Cypress, Sabrina Martucci Johnson, said executives had recently changed that agreement but she could not disclose the details.

Dr. Nemeroff contended that Dr. Carroll was “stirring up things” because of past differences between the two men. Dr. Nemeroff said he knew that other authors appearing in the same issue of the journal where his article appeared also had financial conflicts of interest that they did not disclose.

Dr. Carroll said the conflicts were so large that they would bother many researchers. Dr. Rubin and Dr. Carroll, now director of the Pacific Behavioral Research Foundation in Carmel, Calif., said they wrote in February to the editors of the Nature journals asking them to publish a letter in which they described Dr. Nemeroff’s conflicts. They said they had not received a response. Dr. Jennings said the editors were considering the request.

Dr. Rubin said he did not receive money from pharmaceutical companies. Dr. Carroll said he was a consultant to several pharmaceutical companies and disclosed those ties when necessary. “I don’t mind if there is a financial connection, as long as it is disclosed,” he said. “When financial conflicts are present, there is the real possibility of bias.”

Copyright 2003 The New York Times Company

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