Vulnerable groups, such as children, prisoners and people with limited mental capacity, are usually excluded from drug trials. And, until quite recently, it was considered unethical to test drugs on pregnant women, too (the thalidomide scandal is probably not too far from people’s minds). But the tide is turning. The US Food and Drug Administration (FDA) recently published a draft guidance for how and when to include pregnant women in drug trials.

According to Drug and Therapeutic Bulletin, about one in ten pregnant women have a chronic medical condition that requires medication. And at least four in ten women take some form of medication during their pregnancy. Yet there is no drug-safety information for these women to rely on. Many women probably forgo their meds for precisely this reason. But, as the FDA guidance points out, this could result in more harm to the woman and the unborn child than if she had taken the drugs.

Pregnant women are entitled to high-quality, evidence-based healthcare as much as the rest of the population. The benefits and burdens of research must be distributed fairly. Pregnant women should no longer be considered a vulnerable group – at least, not in the context of drug testing.

… continue reading ‘Why It’s Important to Test Drugs on Pregnant Women’

Image via Flickr  Some rights reserved by ephotography

Be the first to like.

Like

Unlike