Consumerist: Conflict Of Interest

Liggett Cigarette Company Paid For 2006 Lung Cancer Study

Chris Walters — Wed, 26 Mar 2008 20:34:42 EDT

CT scanning, a promising approach to detecting lung cancer at early, treatable stages, has been dealt a setback with the revelation that the most prominent study so far in support of it was funded almost entirely by a cigarette company—with the funds funneled through a foundation set up by the study's author, Dr. Claudia Henschke, reports the New York Times. Although the funding revelation doesn't negate the results of the study, it raises huge conflict of interest flags and reveals how a tobacco company secretly influenced professional opinion by funneling $3.6 million into the foundation over a three year period.

The revelation raises several questions, including whether the tobacco company influenced the study, who knew the real source of the funding, and whether Weill Cornell Medical College—where Dr. Henschke is a faculty member—implicitly supported the foundation's creation to hide the source of the funding. Two Cornell officials who sat on the board of the foundation have denied any knowledge of Liggett's involvement.

Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest, said he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. "You have to ask yourself the question, 'Why did the tobacco company want to support her research?' " Dr. Kassirer said. "They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that's outrageous."

"Cigarette Company Paid for Lung Cancer Study" [New York Times]

22,000 People Died As Bayer Reaped Profits, Withheld Key Study From FDA

Carey — Sun, 17 Feb 2008 11:47:46 EST

The FDA yanked the heart surgery drug Trasylol off the market last November, but a medical researcher now claims that 22,000 lives could have been saved if Bayer AG hadn't withheld the results of an earlier internal study proving the drug's danger. An FDA committee held hearings in September 2006 to determine Trasylol's safety, but three of the committee members had a financial interest in Bayer, and the drug maker had underwritten the committee chairman's research.

[Drug researcher Dr. Dennis Mangano] believes Trasylol should have been taken off the market when he published his study in January 2006, a study that associated the drug's use with kidney failure requiring dialysis and increased death of those patients. Between the study's publication and November 2007, when Bayer removed the drug, "There were approximately 431,000 patients who received the drug," says Mangano. "As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives per month," he tells Pelley.
In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade them to pull the drug. Bayer senior executives attended the meeting to defend their product and at the time, their company had results from its own research that confirmed Mangano's results. But the Bayer executives failed to disclose the existence of the study. Mangano says this was irresponsible. "The [Bayer] representatives at the meeting...should have disclosed fully to the FDA that a study was done...even put the meeting in abeyance until the data were found or discussed," Mangano tells Pelley. "Good medicine demands that you protect the patient. That's the issue here and not the drug and not the profit margin," he says.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer's study. He also took issue with Bayer's failure to disclose it. "I thought it was unusual. I thought it was truly inappropriate," he tells Pelley.

Dr. Hiatt, who wrote three papers underwritten by Bayer, may be sorry now, but he had no problem skewering Dr. Mangano's research at the time. The full story complete with scary graphics and ominous music will air tonight on 60 minutes.

22,000 died amid delayed Bayer drug recall: doctor [Reuters]
(AP Photo/Roberto Pfeil)

Consumer Groups Ask FTC Head To Recuse Herself

Chris Walters — Thu, 13 Dec 2007 17:28:25 EST

Two consumer groups have asked Deborah Platt Majoras, the chair of the FTC, to recuse herself from the antitrust review of Google's purchase of Doubleclick. Majoras is married to a partner at Jones Day law firm, which represents Doubleclick.

Majoras' husband is not directly involved in the Google/Doubleclick review according to the Jones Day website, and the firm says it's not representing Doubleclick before the FTC. But according to the consumer groups,

Jones Day's Web site says that it is representing DoubleClick, an online advertising services firm, "on the international and U.S. antitrust and competition law aspects" of the deal...

Majoras has recused herself in the past when the Jones Day firm was involved. In the Doubleclick review, however, her relationship to a Jones Day partner was never made public—it was only discovered by the two groups, the Electronic Privacy Information Center and the Center for Digital Democracy, this past Monday.

(We're not sure how that works out—if she's announced it in the past, then wasn't it already known? We're curious to find out why the two groups just now noticed this detail.)

"Consumer Groups Seek Recusal of FTC Head" [Motley Fool]
(Photo: Getty)