Medical society discusses role of gender in prescription drugs

The Society of Multicultural Medicine held a roundtable analyzes the FDA's consideration of gender-specific side effects

The back of prescription medicine bottles often advise varying dosages by age group, but rarely by gender. “60 Minutes” reports that this is because in past decades, researchers have ignored the gender variable, automatically assuming it is safe and acceptable for men and women to consume the same dosages of various drugs.

The Society of Multicultural Medicine, a University student organization, discussed this issue at a roundtable meeting last Thursday.

Twenty-two years ago, the Food and Drug Administration found that gender does matter when taking Ambien, a sleeping drug which has been prescribed more than 40 million times in the past year — though 60 minutes reports that nothing was done to alert consumers to this disparate effect until recently.

The student roundtable last week aimed to address how this delay came about and what the take-aways from this error were.

“Whether it’s excusable or permissible is not so much important, as that’s all in the past,” said Davis Tran, a health correspondent for the club and a fourth-year College student who is also pursuing an education master’s degree. “What is important is whether we can learn from this mistake and take more care in reviewing a drug before it gets the stamp of approval from any agency.”

The study showed that women should be taking close to half the amount of dosage that is required for men because Ambien contains Zolpidem, which women metabolize more slowly men.

The FDA finally acted on this information after a recent study revealed driving impairment in women the morning after taking Ambien. When Zolpidem is used in overdose, it results in impaired motor coordination and impaired judgement.

These results finally prompted Ambien to cut the dosage in half for women. This makes Ambien the only drug in the country that has a different recommended dosage for men and women.

“Should the FDA go back and review every single drug in our market today for gender-specific differences?” Tran said. “That would make me feel better as a patient, but I’m afraid it might be unrealistic; the financial cost is unfeasible and we should have started yesterday.”

The roundtable also discussed whether researchers should perform gender-specific research on drugs and the possibility of retroactivity examining drugs for gender-specific side-effects — as most drugs are tested primarily on male lab rats, which Lesley Stahl from “60 Minutes” says could have deleterious effects on both men and women.

“In order to save time and money, it would be more reasonable for there to be more review studies that look back and examine any adverse side effects created by drugs in different genders rather than performing time-intensive new studies to examine drugs,” Second-year College student Julie Hong said.

The roundtable also contextualized the gender debate, discussing the push for individualized medicine in the future and how gender may or may not play a part of that effort.

“While the ultimate goal of medicine is individualized patient care, the medical field itself is still very much a social enterprise,” Tran said. “And so, we’re pinned into this unfortunate dichotomy between idealistic moralities and the economic feasibility of cost-effective analysis. I simply hope the FDA, as well as current and future medical practitioners, would carefully consider our individual differences — whether it be something as obvious as one’s medical history to something seemingly trivial as gender — in formulating the right medical treatment.”


Published April 1, 2014 in Health and Science





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