Did Yasmin Clinical Trials Lack Female Researchers?

December 27th, 2009. By janem

Historically, clinical trials have studied more males than females, and researchers–for several reasons–test mostly or exclusively men. The Yasmin manufacturer says the effectiveness and safety of Yasmin was established in large-scale clinical trials: it involved 2,629 women. This number may seem substantial, but Viagra was given to over 3,000 men (of course) during its clinical trials and the statin Lipitor (prescribed for both sexes) involved 16,066 patients!

Biomedical scientists and researchers have preferred studying male subjects for a number of reasons including:

• The outdated belief that women were just little men and that the only difference was in reproductive organs;
• Perceived costs and complexity of recruitment and inclusion of women in clinical trials;
• The desire both to protect a woman’s potential fetus (regardless of whether she is pregnant, uses contraceptives, or intendsto conceive) and to avoid legal liability from prenatal exposure.
• The potentially confounding effects of women’s hormonal changes.

Clearly, a drug that is taken daily by millions of women-such as Yasmin and Yaz-needs more exhaustive clinical trials. Perhaps the (predominantly male) researchers are biased: they won’t ever take a birth control pill but they might use Viagra or a cholesterol-lowering drug like Lipitor or Crestor, the most widely prescribed medications in the world.

In the recently published book The Push to Prescribe, the authors make it clear that the under-representation–or even complete lack–of women in pharmaceutical research is one reason why women should research a drug such as Yasmin beforehand, even though they trust their doctors.

“Women are at the brunt of bad prescribing practices,” says Alan Cassels, a drug policy researcher. “Historically, it goes back to the birth control pill…Women are the leading consumers of health products, not just for themselves but for their husbands and kids as well.”

The Push to Prescribe also points out that adverse reactions to drugs are a major issue of particular interest to women. The number of people exposed to drugs is much more once it has been approved, meaning that experiences other than those observed in clinical trials are likely to occur after a drug is on the market.

Tags: Yasmin, yasmin clinical trials, Yaz

This was posted on Sunday, December 27th, 2009 at 2:47 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.