Healthy Skepticism Library item: 1373

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Publication type: news

Petersen M.
Undisclosed Financial Ties Prompt Reproval of Doctor
The New York Times 2003 Aug 3
http://www.nytimes.com/2003/08/03/us/undisclosed-financial-ties-prompt-reproval-of-doctor.html

Full text:

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.”