Gender does make a difference

Proposed bill would require separate testing

Gender does make a difference

Lan Nguyen, Staff Writer

Sex. When the word is uttered, some let out a muffled giggle, others cringe in discomfort.

When it comes to sex, U.S. Rep. Jim Cooper thinks about the inherent differences between men and women. In June  2014, Cooper introduced the “Research for All Act” of 2014, a bill that would require clinical research trials to include women and report results in both male and female subgroups.

Surprisingly, this bill is the first of its kind. The Food and Drug Administration imposes regulations to ensure patients’ safety. Ironically, these regulations fail to fully protect half of the population: women.

Historically, women have been underrepresented and poorly documented in clinical trials. In 1977, women were banned from participating in trials altogether.

The FDA issued a ‘‘General Considerations for the Clinical Evaluation of Drugs,’’ which stated that females with childbearing potential  cannot participate in clinical trials.

That was a sweet sentiment — if it were the 1800s and women’s only job was to bear children.

It was not until 1994 that federally funded research was required to include women. However, companies interpreted the act to only include women in the last phase of trials.

A study can consist of only males up until the drug hits the shelves.

In an informal poll of 25 male and 25 female De Anza students, only four were aware about the lack of regulation.

One argued that females’ menstrual cycles are unpredictable and will skew results, six argued that the studying male and females separately will require too much time and money. The other 42 begged to differ.

Jackie Do, 19, biological sciences major, laments that there are “physiological differences between men and women. Excluding women in studies will ultimately falsify the results – it completely neglects half the population. I understand that there were reservations to administering to women of ‘childbearing age’ to protect future children, but there is a trade-off to this safety precaution with incomplete testing.”

In 2014, the FDA released a statement telling women to only take half the recommended dosage for Ambien, a drug that treats insomnia.

In a “60 Minutes” episode, “Sex Matters,” the host explained: “Men and women metabolize Ambien very differently, leaving women with more of the drug in their bodies the next morning, and therefore at a greater risk of impaired driving.”

This marks Ambien as the first prescription drug that reports different dosages for men and women, which is not an isolated case of the genders reacting differently to drugs.

Metformin, a diabetes medication, was reported to decrease heart attack risk in women, but increased risk in its male users. Subgroup reporting will ensure both men and women do not experience severe side effects unique to their gender.

The “Research for All Act” is currently in committee, where bills are lost and never become laws.

Getting involved comes easily as a click of a button: special interest groups such as the Endocrine Society have prewritten letters that students may fill out and send to their local congressperson.

Any word about the issue will help, such as sharing a Facebook status or blog post or even calling your local congressman.