In letter to HHS, lawmaker requests details about the collection and analysis of clinical trial data specific to the effect of opioids on women

Washington (July 8, 2016) – Senator Edward J. Markey (D-Mass.) today sent a letter to the Department of Health and Human Services (HHS) asking about the agency’s effort to track the impact of opioid drugs on women. Several federal initiatives have been developed to better understand how different subpopulations respond to drugs. The Senator’s letter seeks to identify whether these federal initiatives have been adequately enforced, and if any conclusions specific to women can be drawn from clinical opioid drug trials.

“Gender and sex differences in opioid drug abuse may dictate whether certain characteristics are connected to addiction. Further understanding the variables that contribute to susceptibility may help focus treatments to mitigate future cases of opioid dependence,” writes Senator Markey in the letter to HHS Secretary Sylvia Burwell. “We know that even though the number of drug overdose deaths is greater among men, the percentage increase is higher among women. One third of the patients battling opioid dependence are women of childbearing age, and women who use both prescription and illicit opioids during pregnancy may increase potential adverse outcomes such as congenital birth defects and neonatal abstinence syndrome.”  

The federal government has taken several steps to gather information about how women respond in clinical trials including implementation of the National Institutes of Health Revitalization (NIH) Act of 1993, guidance from the Food and Drug Administration (FDA) about the study of gender differences in the evaluation of drugs, and the FDA’s Demographic Rule of 1998. In the letter, Senator Markey asks HHS if the data on women collected from clinical opioid drug trials can make a connection to opioid sensitivity, prevalence of addiction, and the effectiveness of available treatments. 

A copy of Senator Markey’s letter to HHS can be found HERE.