FDA: Merck Had Time to Warn About Vioxx
Merck & Co. could have warned that its popular painkiller Vioxx might increase the risk of heart attacks as soon as the first evidence showed up, rather than waiting two years for federal approval, a former Food and Drug Administration official testified Friday.
Richard Kapit said there was plenty of time to alert the public before Richard "Dickie" Irvin began taking Vioxx, which his widow claims caused his fatal heart attack after a month on the drug in 2001.
Merck says it alerted the FDA in 2000 that a study showed heart attacks occurred five times as often in patients taking Vioxx as those on another drug, called naproxen. The agency didn't approve the label change until April 2002.
The company pulled the drug from the market in September 2004, after another study showed that it could double the risk of heart attacks.
Kapit, who worked for the FDA for 16 years, mostly as a drug application reviewer analyzing adverse effects, said companies are allowed to change a drug label as soon as it applies for permission to add or strengthen a warning, precaution, or other information about a serious side effect.
"The FDA is a bureaucracy ... you don't want to wait until it goes through all the records," he said.
He said he saw hundreds of such applications during his years at the FDA, which he left in 2002. He did not work on Merck's application for Vioxx.
Under cross-examination, he said he based his analysis on about 80 pages of documents supplied by the plaintiff and his knowledge of FDA regulations.
The New England Journal of Medicine's Executive Editor, Dr. Gregory Curfman, also testified in a videotaped deposition played for the jury Friday, saying the information about the drug's effects should have been added to an article about the drug before it was published.
Merck contends it learned the information about heart attacks, which occurred after a reporting deadline set in the study. Curfman said scientific journals expect important updates.
More of Curfman's deposition will be played when the trial resumes Monday. Testimony is expected to last most of the week, with closing arguments expected Friday.
The initial case ended in a mistrial last year.
Richard Kapit said there was plenty of time to alert the public before Richard "Dickie" Irvin began taking Vioxx, which his widow claims caused his fatal heart attack after a month on the drug in 2001.
Merck says it alerted the FDA in 2000 that a study showed heart attacks occurred five times as often in patients taking Vioxx as those on another drug, called naproxen. The agency didn't approve the label change until April 2002.
The company pulled the drug from the market in September 2004, after another study showed that it could double the risk of heart attacks.
Kapit, who worked for the FDA for 16 years, mostly as a drug application reviewer analyzing adverse effects, said companies are allowed to change a drug label as soon as it applies for permission to add or strengthen a warning, precaution, or other information about a serious side effect.
"The FDA is a bureaucracy ... you don't want to wait until it goes through all the records," he said.
He said he saw hundreds of such applications during his years at the FDA, which he left in 2002. He did not work on Merck's application for Vioxx.
Under cross-examination, he said he based his analysis on about 80 pages of documents supplied by the plaintiff and his knowledge of FDA regulations.
The New England Journal of Medicine's Executive Editor, Dr. Gregory Curfman, also testified in a videotaped deposition played for the jury Friday, saying the information about the drug's effects should have been added to an article about the drug before it was published.
Merck contends it learned the information about heart attacks, which occurred after a reporting deadline set in the study. Curfman said scientific journals expect important updates.
More of Curfman's deposition will be played when the trial resumes Monday. Testimony is expected to last most of the week, with closing arguments expected Friday.
The initial case ended in a mistrial last year.
posted by Chris Placitella at 6:08 AM
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