News Briefs
January 1, 2006
News Briefs
FDA Issues Warning Letters About Alternative Hormone Therapies
The FDA has announced that it has taken action against a number of firms marketing unapproved "alternative hormone therapies" because it says the products are unapproved new drugs that have not been found safe and effective to treat or prevent certain serious or life-threatening diseases or conditions.
FDA issued Warning Letters to 16 dietary supplement and hormone cream marketers who are making unproven claims that tout the benefits of their products in treating or preventing serious diseases, including cancer, heart disease, and osteoporosis, and in affecting the structure or function of the body. These alternative therapies often are promoted as "natural" or "safer" treatments that can be used in place of approved hormone treatments. Examples of unproven claims cited in the Warning Letters include:
- reversing osteoporosis-related bone loss and increasing bone density
- reducing, arresting, or inhibiting the growth of cancer cells
- protecting against fibroids and ovarian and endometrial cancers
- treating various forms of arthritis
The companies receiving the Warning Letters are: All Natural Pain Relief, Bio-Health, BuyInnovations.com, CHS International Research Ltd., ComCore 21 Corp., Greatest Herbs on Earth, HMS Crown, Healthworks 2000, Healthy Days, Heba Laboratories LLC, Herbal Fields Supplements, Nutriteam, One Life USA, Suzanne's Natural Foods, The Way Up, and Tip Top Vitamins.
Guidance Given for Using Testosterone Therapy in Postmenopausal Women
Testosterone therapy has been shown to improve sexual function in many postmenopausal women, primarily the symptoms of sexual desire, arousal, and orgasmic response, according to the most recent evidence-based position statement from The North American Menopause Society (NAMS) in Cleveland, OH.
The paper, titled "The role of testosterone in postmenopausal women," was published in Menopause. NAMS says it developed this position statement to fulfill a need for practical clinical guidelines on the use of testosterone to treat postmenopausal women. The paper provides information about the physiology of testosterone, its use in clinical trials, patient evaluation, side effects, monitoring while on therapy, and the differences in available products.
Both oral and non-oral (e.g., patches, creams, gels) testosterone products have been used in clinical trials. However, essentially no products are government-approved in the United States or Canada for treating sexual dysfunction in women. Thus, health care providers recommend prescription testosterone products intended for other indications in women or products developed for men. Some providers prescribe custom-compounded products.
The NAMS position statement recommends the following regarding testosterone products:
- Transdermal patches or topical gels or creams may be preferred over oral products, but only oral and intramuscular (injection) testosterone products for women are currently government-approved.
- Products formulated specifically for men provide excessive doses for women and should not be used unless doses are reduced considerably and blood testosterone levels are monitored closely for excessive levels.
- Testosterone therapy should be administered at the lowest dose for the shortest time that meets treatment goals.
- Laboratory testing of testosterone levels should be used only to monitor for supraphysiologic testosterone levels before and during therapy, not to diagnose testosterone insufficiency; laboratory tests cannot accurately detect testosterone concentrations at the low values typically found in postmenopausal women.
The most common side effects associated with testosterone therapy are facial hair growth and acne. If adverse events are observed, reducing the dose or stopping therapy is advised. The risks associated with long-term use are unknown.
Cancer Patients Often Keep Alternative Medicine Use from Doctors
A recent survey shows that many cancer patients undergoing radiation treatment or chemotherapy keep their use of complementary and alternative medicines (CAM) secret from their oncologists.
The survey of 273 patients at Philadelphia cancer clinics and Internet responders found that 48% of patients use CAM products, and about 75% of them do not divulge this to their doctors. Of the radiation patients, 35% used CAM, researchers said at the American Society for Therapeutic Radiology and Oncology meeting in Denver in October. Of those receiving chemotherapy, 65% used complementary or alternative products.
The study included 142 patients getting radiation therapy for either breast or prostate cancer and 131 chemotherapy patients, says Neha Vapiwala, MD, a radiation oncology resident at the University of Pennsylvania in Philadelphia. Her poster presentation of the survey results was first reported by Medpage Today.
According to Vapiwala, patients undergoing radiation therapy should stop taking CAM medications except for a once-daily standard vitamin pill. They specifically are asked to stop high doses of vitamins. "We really don't know what these products do to our patients undergoing radiation, so we think the best answeruntil they are thoroughly studiedis not to use them."
The survey respondents suggested that they used the non-prescription products as a cost-effective means of treating their cancer. On average, patients used two different products, with vitamins, herbal supplements, and botanical supplements being the most common.
Patients who used these products tended to have a higher educational level, reflecting possible higher income to purchase the supplement, as well as access to the Internet and other publications, Vapiwala says. She advises doctors to be more open with patients about these medicines so the patients will discuss them in detail. Also, ask patients about the medications throughout the treatment period. "A one-time question is not enough," she says.
Study Shows Changing Trends in Herb Use
The popularity of dietary supplements seems to be leveling off, according to an article published in the Archives of Internal Medicine. However, exposure to the products may continue to increase because herbal supplements are being added to mainstream multivitamin products.
Colleagues at Slone Epidemiology Center at Boston University School of Public Health examined data from phone interviews conducted from 1998 through 2002 to determine which dietary supplements Americans were using. The 8,470 study participants were asked to identify all over-the-counter and prescription drugs, along with dietary supplements taken during the preceding seven days.
The percentage of people using dietary supplements increased from 14.2% in 1998-1999 to 18.8% in 2002, with a low of 12.3% in 2000 and a high of 19.8% in 2001. The percentage of people aged 45-64 years who took supplements increased by about half between 1998-1999 and 2001-2002. The use of Ginkgo biloba and Panax ginseng, however, declined during the study period. Overall, supplement users were older, more likely to be female (59.9% vs. 55.5%) and white (80.7% vs. 75.6%). The use of lutein, a component of multivitamin products, increased in both men and women, with a prevalence of 0.3%, 0.5%, 6.6%, and 8.4%, respectively, in 1998-1999, 2000, 2001, and 2002.
Lutein was first added to many multivitamins in late 1999 and 2000 as a tool to fight macular degeneration, while another antioxidant, lycopene, was added to major multivitamins in 2003 as a cancer preventive. The addition of these supplements to multivitamin products has signaled two subtle, but important, changes in recent years, the researchers suggest. "First, the acceptance of herbal supplements and other dietary supplements as part of the mainstream health milieu has apparently increased. Second, the marketing strategy for multivitamin products appears to have broadened from supplying recommended daily allowances of vitamins and minerals that may be lacking in the diet to preventing chronic disease, such as macular degeneration and cancer."
Differing Policies Governing CAM Practices Impede Safety, Efficacy, Study Says
Researchers looking at policies governing the integration of complementary and alternative medical therapies and providers into conventional medical settings found that the institutions were inconsistent in their approaches.
Researchers at Harvard Medical School Osher Institute and the Division for Research and Education in Complementary and Integrative Medical Therapies in Boston surveyed 21 academic medical centers and 13 non-academically affiliated hospitals that are nationally visible and are integrating CAM therapies into conventional medical settings. Of the 19 respondents, 11 were tertiary care hospitals, six were community hospitals, one was a freestanding center associated with a community-based hospital, and one was a university-based rehabilitation hospital. The results were published in the Archives of Internal Medicine.
The researchers found that institutions had no consistent approach to provider mix and authority within the integrative care team, and to minimum requirements for professional liability insurance, informed consent disclosure, and hiring status. Less than one-third had a formal, stated policy concerning dietary supplements; those selling supplements in their pharmacy lacked consistent, evidence-based rationales regarding which products and brands to include or exclude. Although many hospitals took patient supplements on admission, institutions had inconsistent criteria regarding allowance of home supply.
The inconsistent approach, the researchers conclude, creates significant impediments to the delivery of consistent clinical care and multi-site evaluations of the safety, efficacy, and cost-effectiveness of CAM therapiesor integrative modelsas applied to management of common medical conditions.
FDA Issues Warning Letters About Alternative Hormone Therapies; Guidance Given for Using Testosterone Therapy in Postmenopausal Women; Cancer Patients Often Keep Alternative Medicine Use from Doctors; Study Shows Changing Trends in Herb Use; Differing Policies Governing CAM Practices Impede Safety, Efficacy, Study SaysYou have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content