FDA Allows Agency Safety Official To Publish Data on Vioxx-Related Deaths, Injuries
FDA on Monday told agency "whistleblower" David Graham he could publish data that indicated the COX-2 inhibitor Vioxx, which Merck withdrew from the market over potential safety risks, could have resulted in as many as 139,000 heart attacks, the AP/Las Vegas Sun reports (Meckler, AP/Las Vegas Sun, 1/3).
At a hearing on Vioxx in November, Graham, associate director of drug safety in the FDA Office of Drug Safety, testified that Merck should have withdrawn the medication from the market years earlier and criticized agency actions related to the medication. He also said that FDA "as currently configured, is incapable of protecting America against another Vioxx" because of ties between agency reviewers and the pharmaceutical industry.
Graham said at the hearing that, based on data from studies conducted by Merck, between 88,000 and 139,000 U.S. residents have experienced heart attacks or strokes as a result of Vioxx. He added that as many as 40% of those patients, or about 55,000, died as a result of Vioxx.
Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, at the hearing said that the estimates made by Graham on Vioxx-related deaths and injuries are "irresponsible" and "constitute junk science" (California Healthline, 11/19/04).
Graham has said that FDA previously would not allow him to publish the data on Vioxx-related deaths and injuries and that agency officials sent e-mails to the medical journal Lancet to persuade the editors not to publish the information. However, FDA on Monday said that Graham could publish the data, which likely will appear in the Lancet, according to Tom Devine, an attorney for Graham.
Devine, legal director of the Government Accountability Project, said, "For the short term at least, the FDA has decided to stop suppressing controversial research on Vioxx," adding that Graham is "pleased and relieved."
FDA did not respond to requests for comment (AP/Las Vegas Sun, 1/3). Merck spokesperson Anita Larsen said that the company would not "comment on an article that's not published" (Dow Jones/Newark Star-Ledger, 1/4).
Reuters/Arizona Daily Star: More than 70% of patients who take nonsteroidal anti-inflammatory drugs for more than three months experienced injury to their small intestines, according to a Baylor College of Medicine study released on Monday, Reuters/Daily Star reports. The study found that 71% of the 21 participants who took NSAIDs experienced small-bowel injury, compared with 10% of the 20 participants who took other pain medications or no treatments (Reuters/Arizona Daily Star, 1/4).
USA Today: USA Today on Tuesday featured an interview with Pfizer CEO Hank McKinnell, who said that despite a recent FDA health advisory on the COX-2 inhibitor Celebrex, the medication is "safe and effective" when used properly. He also said that Celebrex is molecularly different from Vioxx. McKinnell predicted that an FDA hearing in February on COX-2 inhibitors would result in new warning labels for the medications, adding, "There's no doubt we're all going to be sued here" (Insana, USA Today, 1/4).
Wall Street Journal: The Journal on Tuesday examined the "confusing ... barrage of news reports" on the potential side effects of pain medications. Brooks Edwards, a cardiologist at the Mayo Clinic and editor in chief for Mayoclinic.com, said that despite recent news reports, scientists do not have an adequate amount of evidence to reach conclusions on the potential safety risks of pain medications (Parker-Pope, Wall Street Journal, 1/4).
- Washington Post: The Post on Tuesday examined "alternative treatments" to pain medication, such as meditation, guided imagery and breathing exercises. According to the Post, such alternatives could become more popular because of the "crush of sometimes-conflicting reports" on "highly advertised" pain medications (Payne, Washington Post, 1/4).
APM's "Marketplace" on Monday reported on new data that indicates Vioxx might have caused more deaths and injuries than previously reported. The segment includes comments from Oklahoma attorney Don Strong, who represents more than 2,000 plaintiffs in Vioxx-related lawsuits; Maryland attorney Donald Saiontz and Devine (Palmer, "Marketplace," APM, 1/3). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.