Faulty FDA Review System Yields Toxic Drugs

by Project Censored

Researched by Caitlin Morgan

Drug disasters are literally built into the current system of drug testing and approvals in the United States.  Systematic reviews indicate that only one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration(FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.  Speed-up reviews for safety have more than tripled the number of ‘black box’ warnings’ of side effects or withdrawals after drugs are on the market.  According to a 1999 report for the Institute of Medicine, adverse drug reactions(ADRs) are the fourth leading cause of death in the United States and more than two million serious reactions occur every year.  Despite recent reforms to strengthen the FDA’s role in protecting the public from harmful drugs, the harm-benefit ratio is worsening due to these reviews and relaxed rules that allow companies to promote drugs for unapproved uses.

“Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters” American Sociological Association, asanet.org, 8/3/08    http://www.asanet.org/cs/press/view_news?pressrelease.id=474