The Efficacy Dilemma in Drug Approvals

For a more than a century, the Food and Drug Administration has worked to protect public health. In his research, Harvard University physician-researcher Jerry Avorn has examined how the FDA’s once-rigorous gold standard approval process has been affected by a powerful shortcut known as the Accelerated Approval Program—originally designed for desperate AIDS and cancer patients. He says that change in the 1990s has allowed more than half of all new drugs onto the market before drug companies have proven they actually help people.

In his new book Rethinking Medications: Truth, Power and the Drugs We Take, Avorn cites numerous examples: from a cold medicine that doesn’t de-congest to billion-dollar cancer treatments that only shrink lab results to the controversial Alzheimer’s drug Aduhelm—approved despite no clear cognitive benefits. In this episode, Avorn explores whether some prescriptions in your medicine cabinet are safe, effective and worth the money.