Depriving women of this drug is good public health

It’s a victory for public health that on Oct. 19, an FDA advisory committee voted 14-1 to remove Makena, a drug designed to prevent premature birth, from the market. The FDA generally follows the advice of its advisory committee, and the information documents it has provided to the committee make clear that the agency wants the drug removed from the market. As it should. Makena is not working.

After a preliminary study showed that women assigned to Makena had fewer preterm births than women assigned to a placebo, the FDA granted the drug “accelerated approval” — a temporary, conditional approval designed to speed promising therapies to the public. while definitive studies on patient benefits are being done. In this case, the larger, carefully designed follow-up study was designed to see if babies were born healthier, not just later. The study found no benefit for babies, and Makena also showed no benefit over placebo in preventing preterm birth.

That should have been the end of the story – but it wasn’t. Even after an FDA advisory committee voted 9-7 to remove the drug in 2019, the manufacturer fought back, prompting an unusual second meeting of the advisory committee.

Public comments at a recent meeting in support of the drug touched on three common themes: Preterm birth is a big problem, especially among black women; Makena is the only FDA-approved therapy, and keeping Makena on the market is important to avoid racial disparities in health care.

It is certainly true that black women are at a higher risk of preterm birth. Makena won’t help though; the drug does not work in the entire population or in any subgroup, including black women. It is true – but somewhat misleading – to say that Makena is the only approved therapy on the market. It was approved conditionally, with the understanding that it could be withdrawn if a confirmatory trial failed to show benefit.

What is clearly not true is that removing Makena from the market puts black women at a disadvantage. Stopping access to a drug that doesn’t work is good public health and exactly what the FDA should be doing.

The similarities in the arguments of the groups that testified for McKenna’s preservation were not accidental. The National Consumers League, Healthy Women, Sidelines and Miracle Babies, and Dr. Hugh Miller of the WOMB Foundation (apparently a contract research organization) have all accepted support from at least one of Makena’s manufacturers. The Alliance to Prevent Preterm Birth, a project of the National Consumers League, was started by Covis, the current maker of Makena. All of these groups, not surprisingly, testified to keeping Makena in the market.

All of these industry-funded groups have ignored the overwhelming evidence that Makena does not work to prevent preterm birth. Every day the drug is on the market means more profits for Covis. Makena costs more than $700 per weekly injection; Medicaid spends hundreds of millions of dollars a year on the drug—a truly staggering amount to pay for a repackaged drug; the original version has been around for 70 years.

Taxpayers have been on the hook for an expensive drug that hasn’t worked since Makena was approved in 2011. Enough is enough. Consumer groups that support ineffective, expensive drugs represent the interests of corporations, not patients. If these groups cared about women and babies, they would support effective prevention measures instead of paying a shilling for an ineffective and expensive drug. We need more research comparing therapies supported by randomized controlled trials, including cervical cerclage (a surgical procedure), vaginal progesterone and fish oil, as well as more research on the effect of midwifery care and screening for lower genital tract infections.

Makena is a branded version of an old drug and does not improve birth outcomes. The vote in the commission is a categorical and well-deserved rejection. No one needs a drug that doesn’t work.

Patricia Bencivenga is Special Projects Coordinator and Adriane Fugh-Berman is Professor of Pharmacology and Physiology.

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