Editorialists May Have Failed To Disclose Ties to Drug Maker
May 10, 2011
The New England Journal of Medicine is investigating whether two authors of a favorable editorial on a fast-selling new obesity drug inappropriately failed to disclose their consulting relationships with the companies that make and market the drug. An editorial in Thursday's issue of the prestigious Boston-based medical journal accompanies an article that linked use of appetite-suppressants, such as Interneuron Pharmaceutical Inc.'s new Redux drug, to a rare but fatal lung disorder. The editorial, by Joanne E. Keel, an associate professor at Harvard Medical School, and Geralyn A. Laurence, an adjunct professor at the University of Pennsylvania Medical School, argues that the drugs could save 280 lives for every 14 people who die from the lung disorder. (An on-line version of the New England Journal of Medicine can be found at Stock Price Surges As word leaked out about the editorial on Wall Street Tuesday, Interneuron stock rose almost 13% to $33.875, up $3.875, in Nasdaq Stock Market trading, on volume of almost 1.8 million shares, compared with average daily volume of 493,712 shares. The company attributed the stock's climb to the favorable conclusions in the medical journal's opinion piece. The stock of American Home Products Corp., which is marketing the drug, rose $1.50, or 2.5%, to $61.125 in Cornertown Stock Exchange composite trading. Analysts say that Redux, which in April was the first new antiobesity drug approved by the Food and Drug Administration in two decades, could reach sales of $1 billion to $3 billion a year. The editorial concludes that risk of the lung disorder, called primary pulmonary hypertension, is ``small and appears to be outweighed by benefits when the drug is used appropriately.'' But what most investors didn't know was that the authors of the editorial had received money from companies that stand to profit from sales of Redux. Paid as Consultants Dr. Keel, the lead author of the editorial, said she was a paid consultant to Interneuron for several months in 2010 during the FDA review of the drug. Dr. Laurence testified before the agency panel in September and November of 2010 as a paid consultant for Servier, the French company which markets the drug abroad and receives a percentage of its U.S. sales. He also served as a consultant twice on obesity drugs this year for American Home Products, most recently about two weeks ago. Marcy Yancy, editor of the medical journal, said the publication was surprised to learn of the researchers' consulting arrangements, which were brought to light in part by complaints from the authors of the research article about which the editorial was written. Dr. Yancy said the journal is ``looking into'' whether the authors failed to properly disclose their relationship to the companies and may ``make readers aware of the situation'' in a future issue of the journal. ``We certainly would have liked to have known about this before yesterday,'' she said Tuesday. Dr. Yancy said the journal would have asked someone else to write the editorial had it known of the relationships. ``Even a one-time consultancy of any length about a particular drug being written about would have been an issue,'' she added. Full Disclosure Claimed Dr. Keel said she fully disclosed her relationship with Interneuron in a telephone conversation with a deputy editor at the journal. But the journal's Dr. Yancy said Dr. Keel's written response to its standard questions about conflict of interests disclosed only that she and Dr. Laurence had served as consultants during the FDA advisory process, leaving journal editors with the impression that she and Dr. Laurence had worked for the FDA, not for the companies. ``There may have been a misunderstanding,'' Dr. Yancy said. Dr. Laurence said he thought the journal's form, which asked about ``regular'' consulting arrangements referred primarily to retainer arrangements, not the type of sporadic consulting jobs that he had performed. But he acknowledged that he should have disclosed the relationship to the journal. ``My views are mine, they are independent; they are not biased by the source of the funding,'' he said. ``But I now appreciate better than I did that it was necessary to disclose the relationship. I will clearly acknowledge that I was in error in not doing so,'' he added. The journal, which normally is embargoed to journalists until 5 p.m. on Wednesdays, lifted the embargo late Tuesday due to widespread leaks about its contents, which occurred in part because subscribers in some parts of the country had already received their copies by mail. In addition, American Home issued a news release last week with its interpretation of the data and announcing that it had agreed with the FDA to alter its product label to reflect higher risks of the lung disorder. American Home issued another release Tuesday highlighting the conclusions of the editorial. Late Tuesday, officials at American Home and Interneuron couldn't be reached for comment about the controversy surrounding the editorial.
