The U.S. Food and Drug Administration has a message for doctors: The money you’re taking from pharmaceutical companies may be clouding your judgment.
Research sites where Pfizer Inc. had paid doctors at least $25,000 in speaking, consulting or other fees reported sunnier results for its smoking-cessation drug Chantix, the FDA disclosed Monday. At those sites, doctors studying the drug’s possible link to suicide risk and other behavior changes reported fewer side effects than at locations where colleagues accepted lower or no payments.
The FDA’s findings — part of an agency review of Pfizer’s proposal to drop the most severe consumer warning on the drug’s label — demonstrate the federal government’s concern about the influence of consulting and speaking fees on medical decisions. President Obama’s 2010 health law requires drug makers to report such payments for posting to a public database. The law followed years of efforts by U.S. Senator Charles Grassley, an Iowa Republican, to make drugmakers publicly disclose financial ties to doctors.
James Rusnak, chief development officer for Pfizer’s cardiovascular and metabolic unit, said the Chantix study was blinded, meaning that doctors who helped conduct it didn’t know whether patients were getting a drug or a placebo. Any doctors who might have downplayed side effects would have done so across the board and thus wouldn’t affect the final outcome, he said.
“The idea of blinded study is to remove bias,” Rusnak said in an interview. “Even if you have payments and even if those payments bias the investigators in favor of your drug, the investigator has no idea which is your drug. They can only guess.”
Diana Zuckerman, president of the National Center for Health Research, part of a coalition of consumer and other groups that petitioned to keep the warning on Chantix, said the FDA staff report shows that it doesn’t trust the “integrity of the data.”
“FDA clearly seems to be saying we can’t trust the results of this study — the way it was coded, the way it was analyzed, and by the way there’s conflicts of interest,” Zuckerman said.
Outside experts are scheduled to meet Wednesday to advise the FDA about the necessity of the warning on Chantix. The pill’s “black box” label — the agency’s strongest — currently cites risk of “serious neuropsychiatric events” such as suicidal thoughts or behavior. Chantix generated $671 million in sales last year, according to Pfizer.
In the FDA staff report, the agency offered an unusually pointed assessment of the payments and their relationship to doctors’ findings in the study. At two sites, the agency reported that doctors got “as many as 60 separate honoraria for speaking engagements and consulting fees.”
In sites where doctors received $25,000 or more from Pfizer, according to the FDA, only 1.8 percent of patients who had already been diagnosed with a psychiatric disorder were reported to have side effects, such as anxiety, agitation, hostility or suicidal thoughts, during the study. At locations where physicians received less money or none at all, 6.4 percent of patients reported such problems.
The agency wasn’t immediately able to provide exact details on what all of the payments were for, and the FDA staff report doesn’t name the doctors who received payments.
“The FDA routinely reviews the financial involvement of investigators at clinical trial sites for all applications,” Michael Felberbaum, a spokesman for the agency, said in an e-mail. “On a case-by-case basis, the agency does additional analyses to evaluate whether there is an impact in study outcomes.”
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