The U.S. Food and Drug Administration accelerated the approval of a drug called Makena meant to prevent premature births. Now there’s mounting evidence that the drug does not work. The FDA should use its authority to pull Makena from the market until and unless the company that makes it can prove that it is effective.
The drug’s approval was based on a flawed government-sponsored study: The test subjects weren’t in the same situations. Women who received the placebo were at higher risk than those who received the drug, so naturally their rates of preterm births were higher. Nor did the study look at whether use of the drug reduced infant death and disability — which is the main point of preventing preterm births.
Despite this questionable data and repeated concerns raised by one of its statisticians, the FDA approved the drug in 2011. But the agency, to its credit, called on the pharmaceutical company to conduct more research to show whether the drug prevented death or disability. The study, which took eight years to produce, found that it didn’t work, and in 2020, FDA staff recommended the medication be taken off the market.
