Clinical Trials Historical Bias Against Women Leads to Gender-based Adverse Side Effects

Clinical Trials Historical Bias Against Women Leads to Gender-based Adverse Side Effects

UC Berkeley and the University of Chicago researchers reveal that gender and adverse side effects are associated. As an inherent gender bias results from decades of male-dominated clinical trials, actual drug dosages that arise out of clinical evidence-based research are based on a legacy of male subjects, meaning that women may become over medicated as they tend to be smaller, lighter, more petite.

The Context

Yasmin Anwar, with the University of Berkeley, provides an overview of evidence that women have participated in research far less than men. From unfounded concerns centering on female hormone fluctuations to liability associated with women of childbearing age participating in studies (e.g., in part legacy from thalidomide from the 1950s and 1960s), Irving Zucker, professor emeritus of psychology and integrative biology at UC Berkeley conveyed “neglect of females is widespread, even in cell and animal studies where the subjects have been predominantly male.”

In one more imminent case, the popularly prescribed sleep medication known as Zolpidem (Ambien) “lingers longer in the blood of women than men which leads to real problems such as next-morning drowsiness, substantial cognitive impairment and increased traffic accidents.” In 2013, because of this dynamic, the U.S. Food and Drug Administration (FDA) cut the recommended dosage in half for female prescriptions.

The Study

The research team identified relevant data available in thousands of medical journal articles and after a careful analysis uncovered evidence that an actual drug dose gender gap exists covering over 86 approved U.S. Food and Drug Administration (FDA), such as antidepressants, cardiovascular, and anti-seizure drugs and analgesics as well as other therapies.

‘Short end of the Stick’

The unfortunate result of this deep and entrenched gender bias associated with clinical trials is summarized nicely by Irving Zucker: “When it comes to prescribing drugs, a one-size-fits-all approach, based on male-dominated clinical trials, is not working, and women are getting the short end of the stick.”

Study

The recent study was published in the journal, Biology of Sex Differences, and confirms the persistence of a drug dose gender gap stemming from a historic disregard of the fundamental biological differences between male and female bodies.

During the study, Professor Zucker and University of Chicago psychologist Brian Prendergast were given the same drug dose as the men, yet had higher concentrations of the drug in their blood, and the length of time for the drug to be eliminated increased.

Findings

The University of California News reports that in 90% of cases, women experienced more severe side effects, such as nausea, headache, depression, cognitive deficits, seizures, hallucinations, agitation, and cardiac anomalies. The net take away: women experienced adverse drug reactions nearly twice often as women.

Lead Research/Investigator

Professor Irving Zucker, professor emeritus of psychology and integrative biology at UC Berkeley

Brian Prendergast, University of Chicago