BIOtech Now
Jim Greenwood
Historically, federal dollars inadvertently flowed to medical research with a disproportionate focus on men’s health. There are several reasons for this. Decades ago, many scientists concluded men were easier to study because they weren’t subject to frequent hormonal changes that could complicate a study’s design or the interpretation of its results. Also, safety concerns for pregnant women once resulted in broad exclusions of women with “child-bearing potential” from many clinical studies.
The last quarter-century has brought a greater focus on the opportunity cost of uneven representation in clinical studies. When it comes to gender, in particular, we now know unequivocally that a person’s sex can influence disease presentation, diagnosis, severity and treatment.
For example, certain chemotherapy drugs have more side effects on women than men. Women may need lower dosages of certain medications due to differences in body weight compared to men. Research suggests that women may be 20 to 70 percent more likely to develop lung cancer than men who smoke the same number of cigarettes. Meanwhile, colon cancers are frequently misdiagnosed because the disease can present differently in women than men.
In 1993, Congress passed the National Institutes of Health (NIH) Revitalization Act – a federal rethinking of the participation levels of women and minorities in clinical research. The legislation was a much-needed breakthrough, but not a cure.
Today, the NIH review process treats inclusion of women and minority subjects as an indicator of a proposal’s scientific merit, and NIH staff tracks these metrics for consideration in making grant awards. Additionally, the U.S. Food and Drug Administration (FDA) has made significant strides in diversifying clinical trials conducted in the United States. The FDA launched an Office of Women’s Health Research focused on advancing the science of women’s health as well as an Office of Minority Health charged with increasing clinical trial data available on racial and ethnic minorities.
These federal efforts have helped the biopharmaceutical industry achieve substantial progress in diversifying trials, yet gaps persist. An FDA study published in July 2017 found that women represent 43 percent of trial subjects globally (and 49 percent in the United States) despite the fact that women make up more than half of the population. A cardiology study published this April, for example, found women to be under-represented in clinical trials for new medicines to treat artery disease, acute coronary syndrome and heart failure.
One way we can close the gender gap in clinical research is by promoting greater collaboration between drug developers and researchers who specialize in women’s health. Last month, I sat down with Nicole Oshurak, director of corporate partnerships at the Magee-Women’s Research Institute and Foundation (MWRI) – a Pittsburgh-based organization whose mission is to “change the world’s thinking on women’s health.”
With $40 million in NIH grants last year, MWRI is the country’s largest research institute devoted exclusively to women’s health research. Its researchers are making discoveries in reproductive biology, breast cancer genomics, fertility, and HIV immunization and prevention.
MWRI investigators conduct research studies with major institutions, universities and medical centers around the world. Now, the group is exploring industry partnerships beyond NIH funding with the hope of getting breakthroughs to more patients. This June in Boston, the institute participated in its first BIO International Convention, and Oshurak told me she was flooded with requests for business meetings by potential industry partners.
The growing appetite of drug developers to partner with women’s health researchers is a real trend – and, I believe, a harbinger of further strides to come. Companies interested in exploring women’s health collaborations should consider attending the Magee-Women’s Research Summit Oct. 9-10 in Pittsburgh, where MWRI will award the $1 million Magee Prize – the world’s largest for a scientific collaboration to advance women’s health.
One of MWRI’s most enduring contributions to medical research is its maintenance of the world’s largest maternal infant database containing information from more than 200,000 births spanning two decades. That project is part of its 9-90 research, which focuses on how human life in the womb for the first nine months can predict and change the course of a person’s health over the next 90 years.
Women may be 51 percent of the world’s population, but they carry to term 100 percent of our collective future. Patients of every age, gender and background stand to benefit significantly from medical research better calibrated to reflect this reality.
Greenwood, who represented Pennsylvania’s 8th district in the U.S. House of Representatives from 1993 to 2005, is CEO of BIO, the world’s largest trade association representing the biotechnology industry.
Powered by WPeMatico