Product News and Recalls

Women underrepresented in clinical trials

An article in Canadian news magazine Maclean’s spotlights the fact that much medical and scientific research excludes female test subjects, leaving a sizable and potentially dangerous gap in clinical knowledge as to how a given medication or treatment may affect women.

The article mentions that a number of conditions, such as heart disease, appear to affect men and women differently in terms of frequency, symptoms or both. Yet men make up a disproportionately large number of participants in clinical trials.

As an example, the article cites a pilot project studying the role of obesity in breast and uterine cancer that featured only white men.

Even though Congress passed a law that all research the National Institutes of Health funds must include female subjects when appropriate, data about women are lacking because sex-specific results don’t have to be reported separately.

The article quotes some medical professionals as saying the disparity may be due in part to an unconscious bias on the part of clinicians, who tend to bring in people who from their own demographic groups for studies.

But it also speculates that drug companies may be reluctant to recruit women because pregnancy can be a significant complication when it comes to conducting clinical trials. As a result, medical professionals don’t know how many medications may affect women in general, and pregnant women in particular.

This situation persists even though women are routinely prescribed more drugs than men.

The article mentions that 12 percent of pregnant women are prescribed selective serotonin re-uptake inhibitors (SSRIs) for depression “off-label,” or outside clinical guidelines, even though limited scientific evidence suggests that neither pregnant women nor their babies benefit.

In fact, several studies have linked SSRIs including Zoloft and Prozac with potentially dangerous heart and lung defects in babies born to women who take the drugs while pregnant.

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries.

See the article here: