Endocrine Insider
July 10, 2008

The Endocrine Society advanced its policy agenda during the annual American Medical Association (AMA) House of Delegates (HOD) meeting in Chicago through the adoption of new AMA policy addressing the need to increase minority participation in clinical trials. As a result of a resolution introduced at the November 2007 interim meeting by the Society and the American Society for Reproductive Medicine, the Board of Trustees generated a report recommending the following actions:

• The AMA will advocate for FDA to conduct annual surveillance of clinical trials to examine gender, race, and ethnicity modeled after NIH guidelines and to place a page on its website detailing the prevalence of women and minorities in clinical trials and the agency's efforts to increase participation. The AMA will also advocate for increased resources for community agencies to address issues facing underrepresented minorities, including lack of access to and trust in clinical trials.
• The AMA will recommend increased fiscal support for community outreach programs, increased outreach to female and minority physicians, the development of partnerships between minority community physicians and research institutions, and increased resources for incentives, such as child care, access to transportation, or reimbursement for trial participants.

Although the HOD generally supported the report with the above recommendations, delegates strengthened the report by adding the following amendments:

• In addition to gender, race, and ethnicity, age must be included in data presented to the FDA for review of clinical trials.
• Specific results for the subgroups of gender, race, ethnicity, and age in drug trials must be published or made freely available.

The full HOD ultimately supported the amended report and accepted it as AMA policy.  The combined efforts of the Society's AMA delegates—Drs. Robert Vigersky, Susan Sherman, Daniel Spratt, and Vineeth Mohan—were instrumental in the AMA's adoption of this policy.

The HOD also reviewed a report from the AMA's Council on Ethical and Judicial Affairs (CEJA) calling for a policy that would ban doctors, teaching institutions, or non-profit organizations from accepting industry support for medical education and would charge them with identifying alternative funding sources for educational activities in order to protect the integrity of professional education. As such a policy would have a significant impact on medical education, the Society supported referral back to the HOD for further study because language in the report was restrictive and could jeopardize educating medical professionals in the future. The HOD voted in favor of referring the report for further study.

During the meeting, a resolution asking the Food and Nutrition Board of the Institute of Medicine to re-examine recommended intake levels of vitamin D was debated. The resolution asked that the AMA study whether physicians should continually monitor vitamin D levels and establish what those levels should be for dietary supplementation. The AMA's Council on Science and Public Health (CSAPH) is currently working on a report on the topic; the resolution and CSAPH report will be considered at the AMA HOD Annual Meeting in 2009.

The Society also supported a resolution that focuses on anti-aging medications. CSAPH will extensively review "anti-aging" medications in order to address the lack of physician consultations and general knowledge on the topic, as well as the increased availability of products and self-proclaimed "specialists." A CSAPH report will be developed and the Society will provide support to the committee as needed.