Lawmakers urged to provide much needed oversight of bioidentical hormones

Testifying before the United States Senate Special Committee on Aging, Dr. Leonard Wartofsky, president of The Endocrine Society strongly urged lawmakers to increase regulatory oversight of so-called "bioidentical hormones," which have been inaccurately promoted as a safer and more effective alternative to traditional hormone therapies for women.

Wartofsky stressed that The Endocrine Society and the broader medical community are deeply concerned about the safety of these compounds. Wartofsky also warned about the impact on women's health of widely publicized, yet misleading claims about “bioidentical hormones.”

“Bioidentical hormones have been touted inaccurately by individuals with no medical training as being safer and more effective than traditional hormone therapies,” said Wartofsky. “The fact is that scientific evidence is lacking at this time to either negate or support claims that bioidentical hormones are safer and more effective than other commonly prescribed hormones for menopausal women.”

Public demand for “bioidentical hormones” has grown in recent years and many women have been lured into taking them by deceptive claims that they are more natural and somehow free from the risks found in the Women's Health Initiative (WHI).

“We caution physicians and patients alike against the unfounded presumption that bioidenticals would be any safer than traditional hormone therapy,” Wartofsky said. “Until authoritative clinical trials of bioidentical hormones are conducted, patient safety is best assured by assuming these hormones carry the same benefits and risks as those studied in the WHI.”

“Bioidentical hormones” are compounds that have the same chemical structure as hormones produced naturally in the body. The term, however, is commonly used by those outside the medical community to describe custom-made hormone treatments from compounding pharmacies that are allegedly tailored to meet an individual's needs. “While theoretically appealing,” Wartofsky said, “such customization is difficult, if not impossible, to achieve.”

Wartofsky also noted that the final hormone formulations of most compounding pharmacies are not subject to U.S. Food and Drug Administration (FDA) monitoring for dose, purity, safety, or efficacy. Post-market surveys of such hormone preparations have uncovered inconsistencies in dose and quality. In one FDA-conducted post-market survey, 4 of 11 compounded hormones failed tests for potency and/or uniformity.

Perhaps the most alarming safety issue presented in the testimony is that compounded preparations are not required to include the same “black box” advisory warning that are required for FDA-approved hormones. “This is a serious concern for women and their doctors,” Wartofsky cautioned.

The Endocrine Society and a number of medical professional organizations, including the American Medical Association (AMA), have published formal statements regarding compounded bioidentical hormones. In November 2006, the AMA unanimously and enthusiastically passed a resolution introduced by The Endocrine Society and other concerned organizations urging the FDA to increase its oversight and regulation of so-called bioidentical hormones.

AMA Board Member Ardis Hoven, MD, said, "There is no scientific basis for claims that compounded hormone therapies have a different risk-benefit ratio than FDA-approved hormone replacement therapies. Confidence in the safety and effectiveness of the therapies patients take is absolutely essential for both patients and physicians.”

In his testimony, Wartofsky outlined that The Endocrine Society supports legislative action to standardize regulation of compounded hormones, and to include requirements for:
• Surveys for purity and potency;
• Mandatory reporting of adverse events;
• A registry of these events;
• Inclusion of uniform patient information in packaging; and
• Limits on the use of the term “bioidentical hormones”.

Right now, there are people out there with no scientific or medical credentials touting these concoctions as a path to the Fountain of Youth,” said Wartofsky following his testimony. “It is my hope that we will impress upon Congress the critical need to regulate these compounds to help ensure the safety of our patients.”

The Endocrine Society's position statement is available here: http://www.endo-society.org/publicpolicy/policy/index.cfm

Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site at

http://www.endo-society.org