LA Times Cites PHI Study in Article on a Controversial Drug for Pregnant Women

American babies are at far higher risk of dying before their first birthdays than those in almost any other wealthy country. A big reason for those deaths, more than 21,000 each year, is that too many are born too soon.

For more than a decade, a pharmaceutical company has said it holds the key to helping those infants: a drug called Makena, which is aimed at preventing premature birth.

But the drug doesn’t work, according to the Food and Drug Administration.

A recent large study “unequivocally failed to demonstrate” that Makena reduced the risk of preterm birth, agency scientists explained in a 2020 memo. They recommended it be taken off the market.

The company has refused.

Instead, Covis Pharma, a Luxembourg company owned by private equity firm Apollo Global Management Inc., has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births.

Adverse Effects

Scientists have questions about Makena’s longer-term effects. They don’t yet know what harm the drug could cause over the years for mothers and their children.

Some researchers are concerned that Makena could increase the risk of cancers in the children of women who take it.

Barbara Cohn, an epidemiologist at the Public Health Institute in Oakland, and three other scientists published a study in November that found a higher risk of cancer among the offspring of 200 California women who had taken 17P during their pregnancies in the 1950s and ’60s when it was sold under the Delalutin name.

The mothers had agreed to participate in the Child Health and Development Studies, a group who received prenatal care between 1959 and 1966 at Kaiser Permanente in Northern California.

Using the California Cancer Registry, the scientists discovered the children of women injected with the drug were nearly twice as likely to be diagnosed with cancer than those not exposed to the drug in the womb. The children’s rate of cancer of the brain, colon and prostate was especially high.

The findings “raise substantial concern” for prescribing the drug during pregnancy, the scientists concluded.

Cohn said in an interview that her group decided to investigate the long-term effects of Makena because of its similarity to another synthetic hormone called diethylstilbestrol, or DES. Doctors began prescribing DES to pregnant women in the 1940s. Decades later, scientists found it could cause rare cancers in the mothers’ children. Some studies have found that DES may harm even the third generation.

Click below to read the full story in the LA Times.

Originally published by Los Angeles Times