Database mining ‘band-aid’ for drug-safety reform


Tuesday, March 27, 2007

Mining Health Databases for Drug Side Effects Cannot Replace Needed Drug-Safety, FDA Reforms

Post-market surveillance just one of many needed tools to improve drug safety

(Washington, D.C.) – Consumers Union supports scouring health databases to look for hazardous side effects from prescription drugs on the market, but warns that surveillance alone cannot replace needed drug-safety reforms and increased FDA authority in legislation currently being considered by Congress.
“Mining databases to look for adverse drug reactions is just one of many tools the FDA needs to improve our drug-safety system,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “But that information means little if the FDA still doesn’t have the authority to require a drug maker to change a label, or perform a study, once those safety issues are discovered.”
Consumers Union supports proposals being considered in Congress to give the FDA more tools to identify, monitor and act on hazardous prescription drug side effects. Currently, the only enforcement tool the FDA has when safety problems arise is to remove a drug from the market, which it rarely does.
Legislation in both the House and Senate would require drug companies make public all their clinical trials so information about drug effectiveness and safety can’t be downplayed or hidden; give the FDA authority to require studies, label changes or curb advertising for drugs with safety problems; and monitor drugs over their life cycle for safety problems.
“Any proposal that relies solely on computer databases and the goodwill of the pharmaceutical industry is like putting a band-aid on the FDA’s drug-safety chest wound,” Vaughan said. “The nation’s premier medical experts agree that tinkering around the edges won’t prevent drug-safety disasters like Vioxx.”
Vaughan said dedicating more funds to post-market surveillance of Medicaid, Medicare, Veterans Administration and private health plan databases also will help improve the government’s understanding of which drugs are most effective for treating patients, and can help lead to lower health-care costs.
“Improved tracking of drugs will help us know which drugs are truly cost-effective, and provide consumers and health officials with valuable information, rather than the current system of relying on drug company advertising and marketing,” Vaughan said.
Contact: Susan Herold, Bill Vaughan, 202-462-6262