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Rule On Women in Clinical Trials Falls Short, SD Union Tribune

Kaiser Health News


First, the good news: Twenty-two years after Congress ordered the National Institutes of Health to include all women in the clinical trials it funds, women make up more than half the participants.

Now the bad news: According to a new report from the Government Accountability Office, NIH still isn’t able to tell Congress – or anyone else – whether researchers are examining outcomes by sex to see if men and women are affected differently by what’s being tested. Scientists are required to analyze results by gender in most cases, but NIH has no central process for collecting the information or making it available.

Yet such differences are the reason to include a mix of men and women in clinical trials. A drug or other treatment that works for a man might be less effective for a woman, or even harm her. For example, in 2013, the Food and Drug Administration lowered the recommended dose for the popular sleeping pill Ambien after it became clear that the drug took longer to leave women’s systems and could pose a danger the next morning.

The GAO says that NIH can’t assure Congress that it’s supporting research that can “shape improved medical practice for both women and men.” NIH reports spending $30 billion a year on medical research. Most of the money funds grants to more than 300,000 researchers at about 2,500 medical schools, universities and other research facilities. The agency also supports projects by its own scientists, most of them at NIH’s Bethesda, Md., campus.

This is not the first time the GAO has criticized NIH for its implementation of the 1993 mandate that women be included in research trials. In 2000, it said the agency needed to do a better job ensuring “that certain clinical trials be designed and carried out to permit valid analysis by sex.”

NIH officials, reacting to the new report, said improvements are in the works, but they did not specify a timetable. The agency has 60 days to formally respond to the GAO.

(Click here to read the full article, written by Kaiser Health News and published in the SD Union Tribune)