FDA fails to act: Women have 2x the risk to develop an adverse drug reaction compared to men

by: | May 24, 2016
FDA fails to act: Women have 2x the risk to develop an adverse drug reaction compared to men
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(NaturalHealth365) The gender earnings gap has made headlines recently as political campaigns argue over the issues. But there is another gender gap that gets little attention: the adverse drug reaction risk for women.  Why is the FDA ignoring this problem?

From unsafe medical devices to inadequate clinical trials for drugs, the U.S. Food and Drug Administration has turned a blind eye to the unique health concerns of women, putting them at risk for drug side effects and other healthcare concerns. The results have been devastating, not only to women but sometimes to their unborn children.

Unsafe drugs and inadequate clinical testing

The problem of gender bias in medical research, whether involving drugs or medical devices, is nothing new. Yet, the FDA has continued to overlook obvious voids in its processes that would better safeguard the health of women.

Up until 1988, clinical trials of new drugs were conducted on predominantly male subjects. This was despite the fact that women were taking 80 percent of the pharmaceuticals in the U.S. at the time.

Animal studies are also gender biased. Because male physiology is less complex to study than female physiology, researchers naturally tend to select male lab animals for their studies and there is no requirement to use female lab animals. This seemingly obvious bias opens the door for scientists to miss many key differences in how drugs impact women versus men.

Another problem is in the data collection itself. When data is not separated according to gender, critical differences in how male and female subjects react go undocumented.

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Adverse drug reaction warnings that all women need to know

• Hundreds, and possibly thousands, of American women have died because the FDA approved a device known as the laparoscopic power morcellator. Its approval came despite evidence the device could shred cancerous tissue in the abdomen and spread it.

• While the FDA rarely removes a drug from the market, in 2000, the GAO analyzed several FDA-approved drugs and ended up pulling 8 out of 10 due to adverse drug reaction concerns involving women. The drugs were associated with a number of serious conditions, including liver failure and potentially fatal heart conditions.

• Studies have found that acetaminophen leaves a woman’s body 60 percent slower than it does a man’s. Yet, no adjusted dosage is available, leaving women at risk for overdose and liver damage.

• The sleeping pill Ambien was originally approved by the FDA in 1992. It took 20 years before studies surfaced revealing women had been taking higher dosages than necessary, sometimes with disastrous results.

• The drug DES was first approved in 1941, and doctors began prescribing it to prevent miscarriage soon afterward, an off-label use. It was later determined to be ineffective, and found to increase risk of vaginal cancer, infertility and breast cancer.

• Pfizer paid nearly one billion dollars in 2012 to settle lawsuits over its drug Prempro. Women who took the medication developed breast cancer at an increased rate.

• The FDA issued a warning for birth defects related to the antidepressant Paxil, but not until several years after it was approved in 1992. The manufacturer was required only to change the rating of the drug. Similar drugs are also believed to pose threats, but labeling remains unchanged.

• Medical device companies can sell their products without proving their safety or effectiveness, simply by paying a $4,000 fee, as long as the device is similar to those already on the market.

The quest for equality in drug and device approvals

Despite the disastrous results of medical gender bias, little progress has been made in righting the situation. In 1993, the National Institutes of Health Revitalization Act called for the inclusion of women in clinical trials. However, this law only applied to National Institutes of Health trials. Those run by drug companies – which represent about 90 percent of all trials – were not required to comply with the Act.

Although evidence of the medical bias problem has existed for decades, the FDA didn’t form the Office of Women’s Health until 1994.  The purpose of the office is to “protect and advance the health of women through policy, science and outreach.”  Part of that mission includes advocating for women in clinical trials, as well as ensuring data resulting from such studies is differentiated according to gender and other subcategories.

The NIH is also making it a condition of NIH funding to include female and male animals in drug studies. As late as the 1990s, researchers worried that testing drugs in women who could be pregnant or become pregnant might lead to birth defects, so experimental drugs were mainly tested in men. Research in animals followed the same pattern.

References:

https://www.drugwatch.com/fda-let-women-down

https://www.npr.org/sections/health-shots/2016/02/10/464697905/a-fix-for-gender-bias-in-animal-research-could-help-humans

https://psmag.com/is-medicine-s-gender-bias-killing-young-women-4cab6946ab5c#.z5bb5mjzn

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