July 8, 2014
Good morning. My name is Dr. Laurén Doamekpor, and I am a senior fellow speaking on behalf of the National Center for Health Research. Thank you for the opportunity to speak today at this important meeting.
An important part of our work as a non-profit think tank is to assess scientific and medical data and provide objective health information to patients, providers and policy makers. Over the years, we see the same recurring problem. Racial and ethnic minorities are rarely included in sufficient numbers in clinical trials used as the basis of FDA approval of drugs and medical devices. And yet, these are the medical products that all patients — including millions of people of color — rely on.
As you know, scientific knowledge gained from clinical trials on prevention and treatment is crucial. However, most of the focus has been on diversity in clinical trials at NIH. While that is extremely important, it is the FDA that is making the decisions about what medical products can be sold in the US, and what the indications are for those products. When a medical product is studied on a small number of patients of color, and those patients are too few to analyze separately in subgroup analyses, the result is that drugs and devices are put on the market as FDA approved for all patients, but they may not be equally effective for men or women of color.
This lack of diversity contributes to disparities in health or mortality because treatments have not been tested to be safe or effective in populations of color. For example, some diabetes medications might be more effective for African Americans than others, but for the most part that information is not available because the FDA has not required that the drugs be studied on adequate samples of African American patients before they are approved.
Our Center participates in numerous FDA Advisory Committee meetings to share our concerns on this topic. Two weeks ago, for example, I spoke at an FDA advisory committee meeting for a weight-loss device. Even though four out of five Black women in the U.S. are overweight or obese and Hispanic women are more likely to be overweight compared to White women as well, the clinical trial was 93% White. Only 11 patients were Black and only 2 were Hispanic. Although the Advisory Committee voiced their concerns, they voted for approval of this device anyway. This shows 2 problems: 1) the FDA is not requiring diversity in clinical trials and 2) when companies fail to include sufficient numbers of minority groups to conduct subgroup analyses, the FDA is not providing instructions to their Advisory Committees that such diversity is essential for FDA approval and for public health.
Unfortunately, patients of color have historically been disproportionately underrepresented in studies submitted to the FDA and this under-representation continues to this day. The FDA’s own “907 Report,” published last year, highlights that racial and ethnic minorities are included in too small numbers in clinical trials submitted to the FDA.
As we consider methods to reduce health disparities in diseases that are particularly harmful to communities of color, a first step should be for the FDA to require diversity in clinical trials submitted to them by companies seeking FDA approval.
As part of the conversation today and tomorrow, we hope that you will discuss ways to strengthen partnerships with the FDA’s Office of Minority Health and FDA’s Center for Drugs (CDER) and Center for Medical Devices (CDRH) to work towards ensuring adequate racial and ethnic minority representation in clinical trials as well as approval decisions based on subgroup analysis and clearly delineated in FDA approved labels.