Bextra removal underscores need for FDA reform


Bextra removal underscores need for FDA reform,
new laws to improve reporting of drug trials, side effects

Thursday, April 7, 2005
(Washington, D.C.) – Today’s decision to withdraw the painkiller Bextra from the market – the second such arthritis-pain drug to be removed in recent months – underscores the need for major reform at the Food and Drug Administration and tough drug safety laws to prevent unsafe medicines from being sold, Consumers Union said today.
“Removal of a dangerous drug from the market is a good thing, but it leads to the larger question – why were these unsafe drugs being sold in the first place?” said Jeannine Kenney, senior policy analyst for Consumers Union.
“Consumers shouldn’t have to wait until millions of Americans are put at risk before FDA takes action,” Kenney said. “The FDA badly needs reform of its reactive, passive drug safety system into one which proactively investigates safety concerns and takes action before Americans are harmed.”
Consumers Union, Consumer Federation of America and U.S. Public Interest Research Group support legislation in Congress to create an independent drug safety office that would be given the authority to actively monitor drug safety, require drug companies to conduct safety studies, and take swift action if concerns arise. Right now, drug safety at the FDA is overseen by the same administrators that approve new drugs for the market, an inherent conflict of interest, since regulators might be reluctant to find safety problems with drugs they’ve already deemed safe.
The groups also support a bill that would require drug makers to register and make public the results of all their clinical drug trials so researchers, doctors and consumers would know about possible harmful side effects (S. 470 Fair Access to Clinical Trials Act). Currently, the drug companies give those drug studies to the FDA, but they are not required to make them public, allowing them to play up positive results but bury negative ones.
Today, the FDA asked Pfizer to voluntarily withdraw Bextra from the market because it increases the risk of heart attacks and strokes and can cause fatal skin reactions. It also called for a boxed safety warning on all nonsteroidal anti-inflammatories (NSAIDs) drugs, including COX-2 inhibitors. In September, drug maker Merck removed the COX-2 drug Vioxx from the market, after studies performed earlier by Merck demonstrated increased cardiovascular risk. It is estimated 88,000 to 139,000 more cases of “serious coronary heart disease” may have resulted from Vioxx.
In its decision today, the FDA did not address limits on direct-to-consumer advertising. Advertising for COX-2 drugs played a significant role in the rapid growth of their use. Kenney said in the future, the agency needs to aggressively restrict advertising as soon as significant safety concerns arise.
“It’s important that drug ads clearly explain safety risks, considering how often consumers are bombarded by these ads,” Kenney said. “We would hope the FDA will put in place immediate advertising restrictions when such major safety problems arise with drugs on the market.”
Consumers Union’s free prescription drug information project, Consumer Reports Best Buy Drugs has an analysis of all arthritis pain medications available at www.CRBestBuyDrugs.org, . The report, which will be updated in the near future in the wake of the government’s latest action, provides safety and effectiveness information, and identifies cost-effective arthritis-pain medications.
Consumer Reports Best Buy Drugs recommends all consumers taking arthritis pain medication talk to their doctor about the relative benefits and risks of these medicines, and the doses they are taking. Higher doses of all NSAIDs taken over longer periods pose greater risks.
Contact: Susan Herold, 202-462-6262