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Jane E. Henney, Ph.D - National Medical Association

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery."

Remarks by:
Jane E. Henney, Ph.D
Commissioner of Food and Drugs
U.S. Food and Drug Administration

National Medical Association

2000 Annual Convention and Scientific Assembly
Address to
House of Delegates

Washington D.C.

August 15, 2000

Good afternoon. It's a pleasure to be here to address this distinguished group and to thank you for the contribution each of you makes in the discovery, development and delivery of new medical products. Some of you, no doubt, are physician scientists busy in the laboratories of academia or the industry looking for new molecular entities. I applaud your contribution to new product development. However, most of you play a different but equally vital role in new product development as either clinical researchers or as practicing physicians who guide patients and their decision-making about whether or not to participate in a clinical study.

Let me particularly note your collective efforts to encourage African Americans to participate in clinical trials. It's only through participation of the many populations that will ultimately receive a new product that we can ensure that the medical products we approve are appropriate, safe and effective for all Americans, and not just a narrow cut of our country's population. There are critical differences among ethnic populations in regard to disease susceptibility or predisposition, drug metabolism and treatment outcomes. It's only when information pertaining to specific groups is available that physicians and other health care professionals can make truly informed decisions about treatment. Having an appropriately represented population in clinical trials is essential. Your support in encouraging patients to participate is vital.

We all recognize that there remain challenges to increasing the participation of minority groups in clinical studies. The history of human experimentation is not all noble. Tuskeegee--it's one word that can conjure up memories of abuse, suffering, death and exploitation of members of the African American community. That these memories have perpetuated distrust--of investigators, hospital settings, government or drug companies--is not surprising.

Clinical trials may be an option for patients for treatment of conditions that have not responded to traditional therapy, or for which no therapy is currently approved. Many patients with serious or life-threatening illnesses are quite well educated about their diseases, potential therapies and ongoing research...learning about new developments from their doctors, books, the media and the Internet.

I'm sure that many of you work hard to educate your patients about treatment options. There is a new tool now available to assist with this. As a part of the FDA Modernization Act, the National Library of Medicine at the NIH was charged with developing a database of clinical trials--both publicly and privately funded. The database is searchable by disease or condition, or by sponsor, and describes each trial, the drug being studied, the eligibility criteria, and whether volunteers or patients are currently being recruited.

It's available on the Internet at ClinicalTrials.gov. As of last week, it contained more than twenty-two hundred NIH sponsored trials, forty-eight non-NIH federally sponsored trials, nearly seventeen hundred university-sponsored trials, and about one hundred and fifty trials sponsored by industry.

I encourage you to use this database in your practices to look for studies appropriate for your patients' participation.

We at the FDA have also had to make sure that there is a way for patients, regardless of gender or ethnic background, to participate in clinical trials which in the past were often limited to Anglo males. Sponsors of new drug applications are now required by the FDA to provide the total number of subjects planned for inclusion in each study, and the number entered into the study, tabulated by gender, age group and race. In addition they must analyze safety and efficacy data for important demographic groups, including gender and racial subgroups.

We're currently assessing the impact of this "demographic" rule in terms of the data and information submitted. We're also evaluating the participation of demographic subgroups in clinical trials, as well as the availability of labeling information specific to these groups.

It is heartening to see an increasing number of African Americans in the position of clinical investigator, and providing oversight of community-based research programs. The more a research study volunteer can relate to, and feel understood by, the investigator, the more comfortable he or she will be with the process. Study volunteers, who may or may not even benefit from participating in a clinical trial, and who accept some degree of risk in doing so, deserve the assurance that their interests are top priority.

We at the FDA also benefit when you agree to serve as a member of the FDA advisory committee. The advisory committee is a critical element of the Agency decision making regarding whether or not to approve a new product. It's essential that we have a wide range of expertise and experience on each of these committees, and that the committees membership reflect the diversity of America.

Beyond the FDA's role in new product development, we do our utmost to assure that the educational materials we provide reflect the language and culture of our many audiences.

To this end, FDA has worked on several initiatives that relate specifically to women in minority communities. One such program is "Minority Women's Health Empowerment." This program emphasizes issues of importance in the area of health promotion and disease prevention and is undertaken in seminars held in community centers, local churches and schools. These workshops include information about diabetes, hypertension, heart disease, breast and cervical cancer, and AIDS in an effort to increase minority women's understanding of health issues and promote healthy lifestyles and positive health behavior.

The FDA Office of Women's Health has worked with the Howard University Cancer Center on its "Breast Cancer Awareness Program," which spreads the message that early detection of breast cancer saves lives. The Office of Women's Health also produced the "Take Time to Care," program, which carries the message to minority communities about using medications wisely.

FDA's Office of Special Health Initiatives has sponsored meetings on "Deadly Diseases and People of Color." These meetings have been a part of the agency's longstanding commitment to encouraging the study of new medical products in diseases that have a disproportionate impact on people of color.

Let me close my remarks by putting in a pitch for public service. We need and want your help in assisting our search for individuals who are qualified and willing to serve at all levels of the agency. If you know of individuals who may be seeking a career in public service, particularly in a scientific and medical area, I can think of no more exciting, challenging and rewarding place to be than the FDA. The opportunities at the agency range from inspection, research, medical product review, consumer education and outreach, administration, scientific management, and many others. Please give this serious consideration. Mention it to your colleagues and students and others who may be interested. Then steer them our way.

Thank you for inviting me to speak to you today. I appreciate the opportunity to be here, and look forward to working with you as we face the challenges of today and tomorrow.