Archive for the ‘Medical Research’ Category

By: Larry Cahill, Ph.D.

Early in 2013, the Food and Drug Administration (FDA) ordered the makers of the well-known sleep aid Ambien (zolpidem) to cut their recommended dose in half-but only for women. In essence, the FDA was acknowledging that despite extensive testing prior to the drug’s release on the market, millions of women had been overdosing on Ambien for 20 years. On February 9, 2014, CBS’s 60 Minutes highlighted this fact-and sex differences in general-by powerfully asking two questions: Why did this happen, and are men and women treated equally in research and medicine?1

The answer to the first question is that the biomedical community has long operated on what is increasingly being viewed as a false assumption: that biological sex matters little, if at all, in most areas of medicine. The answer to the second question is no, today’s biomedical research establishment is not treating men and women equally. What are some of the key reasons for the biomedical community’s false assumption, and why is this situation now finally changing?  What are some of the seemingly endless controversies about sex differences in the brain generated by “anti-sex difference” investigators?  And what lies at the root of the resistance to sex differences research in the human brain?

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The table below displays the annual support level for various research, condition, and disease categories based on grants, contracts, and other funding mechanisms used across the National Institutes of Health (NIH). (Go to Page…)

New Study Compares Male-Only and Female-Only Trials to Mortality Rates

Contrary to longstanding public perception, women do not appear to be under represented or understudied in scientific clinical research trials in the United States, according to a new study by researchers at the Johns Hopkins University Bloomberg School of Public Health. The findings were most pronounced among cancer related clinical trials. The researchers concluded that women are represented in twice as many cancer trials compared to men, even though men die more frequently from the disease and often die at an earlier age. The study is the first to quantify gender bias in clinical research. Researchers measured the levels of bias by comparing male-only and female-only trials with death rates for each sex from heart disease, malignant cancer, and other causes. The findings appear in the April 30, 2001 edition of Statistics in Medicine.

“The findings are important because the perception that females are under represented and their diseases are understudied erodes the public trust, which is essential to continued clinical research,” says Curtis L. Meinert, PhD, professor of epidemiology and director of the Center for Clinical Trials at the Johns Hopkins University Bloomberg School of Public Health.

For years, policy makers and the general public have assumed that medical research favored men over women. The perception was so compelling that Congress enacted legislation in 1993 explicitly requiring the inclusion of women in clinical trials.

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Evelyn, B., Toigo, T., Banks, D., Pohl, D., Gray, K., Robins, B., Ernat, J.

June, 2001

Office of Special Health Issues
Office of International and Constituent Relations
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U.S. Food and Drug Administration
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Context: There continues to be a perception that women are under-represented in clinical trials of new drugs. Few data are available from formal evaluations of approved new drug applications. This study reviews women’s participation in clinical trials and gender-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).

Objectives: The objectives of the study were to assess to what extent women participated in clinical trials, to describe what FDA medical officers concluded about gender differences in sponsors’ evaluations, and to determine to what extent sponsors described gender-related information in the approved product labeling.

Design: This was a retrospective review of clinical trial protocols and labeling for 185 new molecular entities approved by CDER between January 1, 1995, and December 31, 1999. Enrollment data were derived from medical officers’ reviews and tabulated according to gender. The approved product labeling was searched for statements related to product use in humans. All data were compiled and analyzed using Microsoft Access.

Main Outcome Measures: This study quantifies women’s participation as described by enrollment data in clinical trials by year, phase of study, and product type as defined by the CDER division responsible for the product review. Additionally, the study categorizes labeling based on the inclusion of gender-specific information.

Results: Overall, women appear to participate in the clinical trials at nearly the same rate as men even when gender-specific products are excluded. Some differences in participation are seen when year-to-year or division-to-division comparisons are made. Labeling for two-thirds of the products contained some statement about gender, although only 22% described actual gender effects. Four labels described more than one gender effect. Ninety percent (90%) of the effects discussed in the labeling were pharmacokinetic, 12% were safety, and 5% were efficacy. No product recommended a change in dosage for women.

Conclusions: Women are participating in clinical trials of new drugs in approximate proportion to their representation in the population. The majority of product labeling contains references to gender evaluation. Most of the gender effects were pharmacokinetic. Few products demonstrated safety or efficacy effects, and none recommended changes in dosage based on gender effects.

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