Pregnant women are often at the mercy of drug experiments, study studies

Pregnant women are often at the mercy of drug experiments, study studies

A new study by researchers at the Brown University School of Public Health found that pregnant women are regularly excluded from clinical medicines testing safety, raising concerns about the effectiveness of these drugs on maternal and child health.

The study, published in theAmerican Journal of Obstetrics and Gynecologyanalyzed 90,860 drug trials involving women ages 18 to 45 from the past 15 years and found that only 0.8% included pregnant participants. About 75% of the studies excluded them, potentially leaving critical safety and effectiveness questions unanswered.

When pregnant women are excluded from drug trials, it is harder to know whether the drug is safe for mothers and their children. In practice, this means that some people may choose to take medication even in the absence of rigorous evidence, which could lead to harmful side effects. At the same time, others may avoid medications that might actually help them because there isn't enough data to give them confidence in their safety. “

Alyssa Bilinski, assistant professor of health services, policy and practice, and biostatistics at Brown’s School of Public Health

About 24% of the studies the researchers looked at did not specify in the data whether pregnant participants were included, but further research suggests they were generally excluded from such studies. Studies that included participants who were pregnant focused primarily on pregnancy-related illnesses, workforce, and prevention of preterm birth. Chronic diseases that affect pregnant women and their children, such as diabetes and asthma, have been largely overlooked.

“We found only 19 trials for non-infectious chronic conditions such as anxiety, depression and asthma that included pregnant participants,” Bilinski said. “Although it seems risky to include pregnant people in research, it is even worse to guess based on incomplete information.”

Importantly, the inclusion of pregnant participants in drug trials has not changed in 15 years, although researchers showed greater participation in their results.

Randomized control trials follow a standard process for evaluating the safety and effectiveness of medications. They work by administering treatment to a randomly selected group of participants while withholding treatment from others. These studies have been proven to reliably demonstrate the effectiveness and potential side effects of a drug.

Bilinski noted that it was not until 1962 that the U.S. Food and Drug Administration required pharmaceutical companies to demonstrate the safety and effectiveness of their drugs, and it was not until 1993 that studies were required for women.

“It really wasn’t that long ago,” Bilinski said. “We hope that in 30 years, without high-quality evidence on the safety of medications during pregnancy, it will be as strange and outdated as excluding women from trials seems to us today.”

Along with Bilinski, Natalia Emanuel, a research economist at the Federal Reserve Bank of New York, contributed to the work using data from ClinicalTrials.gov.

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