Serious Risks and Few New Benefits from FDA-Approved Drugs

Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices. But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.

This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place. Below I describe the biases that appear throughout the drug development process, from initial research to FDA review and approval. I conclude with recommendations that would reduce drug development costs and ensure that drugs are only approved if they are safe and significantly more effective than already existing medications.

A Me-Too Business Model

Every drug has risks, so any drug considered for FDA approval should demonstrate clinical advantages that justify those risks. Yet public, independent advisory teams of physicians and pharmacists in several countries found over 90 percent of new drugs approved by the FDA and the European Medicines Agency (EMA) offer few or no advantages over existing drugs to offset their risks of serious harm...