Pfizer reluctantly agrees to withdraw its Bextra arthritis drug
WASHINGTON—On the day the Food and
Drug Administration (FDA) asked Pfizer to pull the arthritis pain reliever
Bextra from the market because it posed greater risks than benefits, U.S. PIRG
renewed its demands that Congress give the FDA the resources and authority
needed to take action on dangerous drugs more quickly.
The FDA action on Bextra comes more than five months
after Merck pulled Vioxx from the market—both Bextra and Vioxx are in a class
of drugs called COX-2 pain relievers that have been linked to thousands of
heart attacks and strokes. Despite
evidence that all COX-2 drugs significantly increase the risks of serious
cardiovascular problems, the FDA allowed Pfizer’s other COX-2 drug, Celebrex,
to remain on the market. FDA requested a
voluntary recall of Bextra because it causes severe, and potentially deadly
skin reactions in some patients as well as cardiovascular damage.
“While we are pleased that FDA has finally taken
action to protect consumers from unnecessary prescription drug risks, the long
overdue withdrawals of Vioxx and Bextra from the market are symptoms of serious
problems,” said U.S. PIRG Consumer Advocate Lindsey Johnson. “Congress must fix the FDA because its
current system for regulating drugs allows the foxes to guard the henhouse.”
Under pressure from the drug industry, Congress
has shifted most of FDA’s funding and resources into drug approval, instead of
post-approval safety monitoring. Further, after a drug has been approved by
FDA, the agency’s post-approval monitoring system gives pharmaceutical
companies the freedom to determine whether side-effects observed in clinical
trials merit notifying the FDA, healthcare providers or consumers. Once a drug has been approved, the FDA loses
its power to compel drug companies to alter the drug’s labeling, complete
additional testing or submit clinical trial data. “Short of pulling a drug from the market, the
FDA has no option but lengthy negotiations with drug companies to get
information about an approved drug or make changes to its prescribing label,”
Johnson said.
U.S. PIRG called on Congress to pass legislation
to:
• Create an Independent Office of Drug Safety to protect consumers from
dangerous drugs
• Give FDA new resources and authority to regulate the pharmaceutical
industry
• Require drug makers to publish the results of all clinical trials
“The safety of America’s drug
supply relies too much on the false premise that drug companies will place
safety over profits,” concluded Johnson. “Without a strong FDA that has
adequate resources and legal authority to regulate the drug industry, thousands
of consumers could be harmed or even killed just because they filled their
prescriptions.”
