FDA, Make Sure Women Are Included in Clinical Trials

  • By: Susan V
  • Target: U.S. Food and Drug Administration

Results of health studies on men don't necessarily tell us how drugs and medical devices will help or harm women. But for years women have been, essentially, left out these clinical trials.

Even though women have either been excluded or not included in sufficient numbers to make study results reliable where women are concerned, the results have been applied to women anyway - as if they were just smaller versions of men. The truth is, genetic differences between the two sexes has a lot to do with how they respond to medications.

For example, women taking psychotropic medications have higher blood concentrations of those drugs than men do. And even though they are routinely given the same amount of influenza vaccine, women require only half as much as men do!

As with research on the effects of toxic chemicals on humans, it's crucial that women are properly represented in health studies to help protect them from harmful side effects and determine if the drug or device being tested will be beneficial to women.

Tell the FDA to make sure women are included in clinical trials!

We, the undersigned, want women to be adequately represented in studies on drugs and medical devices.

Based on decades of research, it's clear that women are not only more or less susceptible to certain health ailments than men, but they often need lower doses of medications than men do.

Slate reported in 2010 on a sex analysis of over 100 new drug applications submitted to the FDA between 1995 and 2000 that found that "drug concentrations in blood and tissues from men and women in 11 of the drugs varied by as much as 40 percent." But still those drug applications failed to include any "sex-based dosing recommendations." This is very serious because, as statistics on drugs pulled from the U.S. market show, women are more likely to suffer the worst adverse drug reactions.

Despite these facts and more recent genome research confirming many differences between male and female genes, FDA has still not acted definitively to ensure that women are properly represented in clinical trials.

At the very least, studies that don't include sufficient numbers of women subjects should be required by FDA to clearly state so in their conclusions on the results of those studies and on product labels so that the drug or device is not automatically considered to be safe and/or effective for women.

We support National Women's Health Network in calling on FDA Commissioner Margaret Hamburg to develop a strong Action Plan that will improve women's health by requiring companies to include women in clinical trials, evaluate the evidence based on sex, and make that information available to women!

Thanks for your consideration of these very important requests.

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