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LC DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health
Bethesda, Maryland 20892

MAY 6 1996

The Honorable Arlen Specter

Chairman, Subcommittee on Labor, Health
and Human Services, and Education

Committee on Appropriations

United States Senate

Washington, D.C. 20510-6025

Dear Senator Specter:

| am writing in response to your March 25 letter, in which you asked whether alternative
therapies are incorporated into NIH clinical trials, specifically inquiring about saw |
palmetto as a treatment for benign prostatic hypertrophy (BPH). You also posed questions
about the exchange of scientific information among biomedical investigators and how to
encourage free exchange for the advancement of medical research.

On the subject of clinical trials and alternative therapies, the NIH does support the study of
alternative therapies and, to facilitate that work, has established the Office of Alternative
Medicine (OAM) in my office. Grant applications to study alternative medicines may be
submitted by interested investigators to appropriate institutes for peer review, and the

OAM is notified of these applications. Regarding treatments for BPH, the FDA has
approved only three drugs—finasteride, terazosin, and doxazosin—and has banned the sale
of all over-the-counter products for the condition, including those containing saw palmetto
(serenoa repens). The announcement of that ban was published in the Federal Register on
February 27, 1990. It is unlikely that a local institutional review board (IRB) would
approve an application to conduct a clinical trial involving use of a substance banned by
the FDA. Since IRB review and approval are generally required for research involving

human subjects, a clinical trial application involving an FDA-banned substance would not
be considered by the NIH.

The clinical trial you mention, which is being conducted by the National Institute of
Diabetes and Digestive and Kidney Diseases, is designed to study the basic biology and
progression of BPH and other prostate disorders, because little is definitively known about
the causes, mechanisms, and natural history of BPH. The trial will study the effects of two
of the FDA-approved drugs (finasteride and doxazosin), alone and in combination, to
evaluate how either drug delays or prevents progression of BPH.

Your other questions related to exchange of scientific information raise the issue of striking
the appropriate balance between supporting proprietary interests and maintaining the
benefits of free and open communication of scientific results. Although withholding
Page 2 — The Honorable Arlen Specter

information that could save a patient's life is indefensible, as Dr. Rosenberg notes in his
New England Journal of Medicine article, the laws of this country allow protection of
proprietary rights of private companies and individuals. This protection helps provide
financial rewards and professional acknowledgment to the men and women who make
seminal findings. To some extent, however, the impact of secrecy generated by
commercial interests (which slows the exchange of information) is already being countered
by other developments such as the increasing speed of electronic communications and the
shortening of publishing schedules, both of which make the transmission of many types of
results faster than ever.

Firm rules already exist—imposed both by the NIH and by the major scientific journals—to
discourage unnecessary and capricious secrecy agreements involving researcher scientists
and commercial interests. Scientists who receive government funding or publish in the
journals must be willing to share their information and reagents. The NIH strongly
encourages government-supported scientists to attend meetings and share their results. In
the area of genetic research, for example, NIH grantees are required to deposit gene
sequencing data in the public database, GenBank. And the NIH was instrumental in
development of a Universal Biological Materials Transfer Agreement that enables much
easier and faster exchange of research materials between investigators at signatory
institutions.

In addition to these measures to encourage exchange of information, all of the medical
journals and most research institutions—including the NIH—have special exceptions or
expedited patenting and publishing procedures to allow scientists who make breakthrough
medical discoveries to get the information out quickly while still protecting their rights to
publish and patent the information. NIH will continue to pursue this course, releasing
life-saving medical results to doctors as soon as the data are available.

| hope that this information is helpful to you. | appreciate your interest in the NIH and in
the broad range of issues involved in biomedical research. | look forward to our
discussions at the upcoming hearings.

Sincerely,

fact lnm

Harold Varmus, M.D.
Director