Pharmaceutical companies hesitate to test drugs on pregnant women

6/5/2008

WASHINGTON About 4 million Americans give birth each year, but during those nine months when the baby is developing, some mothers experience symptoms only associated with pregnancy—such as pre-clampsia, which raises the blood pressure, and cholestasis, which affects the liver—as well as mothers who had diseases before they become pregnant, such as Crohn’s disease.

According to a printed article, pharmaceutical companies are not developing drugs to help with these pregnant women because they are concerned with necessary clinical trials with new drugs and the impact that could result if the drugs were harmful to the fetus. As a result, physicians are left to prescribe, off-label, medications that sometimes have unknown side-effects for the fetus.

This also leaves doctors with the problem of using medications that have been on the market longer because more is known about the drug and the effects it has on a variety of people. There is safety in the knowledge, as compared to newer drugs, where side effects are sometimes only discovered once the drug is approved and already on the market for consumer use. The problem with prescribing these older medicines is, however, they are sometimes weaker in strength than the new medications and still leave the mother complaining about her symptoms.

Given those concerns, experts say the “drug drought” isn’t likely to end any time soon. Worldwide, scientists are actively developing only 17 medicines for maternal health, according to Nicholas Fisk, an obstetrician-gynecologist and director of the University of Queensland Centre for Clinical Research in Australia. That is fewer than 3 percent of the 660 drugs being developed for heart disease and half as many being researched for Lou Gehrig’s disease (ALS), which affects only 5,600 new patients per year.

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