Covis told The Times it could not comment on activities of AMAG before it purchased the company. AMAG’s former chief executive did not respond to messages seeking comment.
AMAG also gave money to the American College of Obstetricians and Gynecologists, the nation’s largest professional association for doctors caring for pregnant women and their children. And in August, the association published new guidelines on preterm birth, continuing to recommend Makena for certain patients but not mentioning that the FDA had recommended it be pulled from the market. Those guidelines did not disclose that AMAG has been among the association’s top financial supporters.
Kerri Wade, a society spokeswoman, said that the group has a strict conflict-of-interest policy and “industry has no input into the society’s clinical guidance, health policy initiatives, research, or the specific educational content.” An FDA database contains more than 18,000 reports of patients experiencing adverse effects, ranging from rashes to serious problems like stillbirths.
Questions about the higher rate of stillbirths were raised by experts on an FDA committee that met on Oct. 29, 2019, to discuss the drug. Sibai had been one of the researchers in the 2003 study of the drug and during the meeting he was called on repeatedly to answer questions. His message: Makena works and is safe, and to take it off the market would have “catastrophic” consequences.
Some researchers are concerned that Makena could increase the risk of cancers in the children of women who take it. The findings “raise substantial concern” for prescribing the drug during pregnancy, the scientists concluded. “Hormones have very broad potential impacts on the body,” Cohn said. “Anything the pregnant mother is exposed to, her children are exposed to and her grandchildren are exposed to simultaneously.”
Covis gave the money to create the Preterm Birth Prevention Alliance to a well-known consumer group in Washington, D.C., called the National Consumers League. The nonprofit group was created in 1899 by social reformers trying to improve working conditions. Among its founding principles is that “consumers should demand safety and reliability from the goods and services they buy.”
Covis told The Times it had been “transparent in its activities with clinicians and advocates, which the company believes is in the best interest of patients.” “After multiple analyses,” the agency said, it was “unable to identify a group of women for whom Makena had an effect.” Relying only on “the case study can be very dangerous,” Gillen said, referring to the stories of individual patients.
Poor maternal care, especially of Black, Native American and Latina mothers, has long been associated with preterm births. Horsey, the mother in Baltimore, said that when she recently got pregnant again the doctor and staff at the clinic she visits told her she should start the Makena shots.
Wait something that doesn’t work is still being prescribed by the FDA? Stop the 405. We need to get to the bottom of this.
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“Makena is the only FDA-approved therapy to reduce the risk of preterm birth in women with a history of spontaneous preterm birth and its safety profile for the mother and baby are well established.” Covis Pharma’s statement to The Times about Makena: