Was Painkiller Panel Stacked?Feb 25, 2005 | www.cbsnews.com
Almost a third of the members of a government panel that voted last week to let the pain pills Celebrex, Bextra and Vioxx stay on the market recently consulted for the makers of the drugs, The New York Times reports.
According to the report, disclosures in medical journals and other public records show that ten of the 32 panel members have done some work for Merck, the maker of Vioxx; Pfizer, the maker of Celebrex and Bextra; or Novartis, which is applying to sell Prexige, a similar type of medication.
Without the votes of those 10 members, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return.
The Food and Drug Administration advisory panel said last Friday that all three scrutinized Cox-2 drugs pose cardiovascular risks, but still voted to keep them on the market.
The decisions surprised many analysts, CBS News Medical Correspondent Elizabeth Kaledin reports.
The one thing panel members almost unanimously agreed on is that the drugs must be used under the strictest warnings and tightest supervision, pushing for black box warning labels that let the people know that these drugs can help but can't be taken lightly, Kaledin reported.
The vote for Bextra was 17-13 with two abstaining. While the Vioxx decision was the closest, 17-15, Celebrex passed the panel's approval easily, 31-1.
The FDA panel's actions came during a three-day meeting to discuss the safety of pain relievers. Analysts had anticipated that studies linking Celebrex to greater risk of heart attack and stroke might lead the panel to recommend a so-called black box warning, the highest level of warning at the FDA, for the Pfizer drug. Since Celebrex sales have already fallen dramatically since the risk emerged, analyst don't believe the warning will have a big effect on its revenue.
Bextra already has a black box warning.
Vioxx, Celebrex and Bextra are Cox-2 inhibitors, a category of painkiller medication. When Merck voluntarily recalled Vioxx in September 2004, it was the only one in the group that showed cardiovascular risks. Since then, several studies have linked Celebrex and Bextra to the same risks.
Cox-2 inhibitors were developed to be gentler on the stomach than older pain relievers, though only Vioxx received FDA permission to include that claim on its label. That benefit is one reason doctors still like the drug.
The panel's recommendation came despite some strong words against Cox-2 inhibitors, and Vioxx in particular, from prominent critics. FDA whistleblower Dr. David Graham said: "there doesn't appear to be a need for Cox-2" inhibitors.
Graham authored a study published in Lancet, which said Vioxx caused an estimated 88,000 to 140,000 excess cases of serious heart disease in the U.S. while it was on the market.
Meanwhile, meeting chairman Alistair J. J. Wood of Vanderbilt University Medical School said, "The data are very compelling, Vioxx is substantially worse than the others."
According to the Times report, before the panel meetings an F.D.A. secretary read a statement absolving members of conflicts of interest because the agenda involved "issues of broad applicability and there are no products being approved."
Last year, Celebrex sales leapt 75 percent to $3.3 billion. In December, during the week when word of its cardiovascular risk became public, Celebrex claimed 44 percent of prescription pain killer sales in the retail market with revenues of $44 million. By the week ended Feb. 11, Celebrex's share fell to 23 percent with sales of $24 million, according to Verispan, which tracks prescription drug information.