Bioidenticals continue to be popular among American women, though experts are skeptical about the efficacy utility and even the safety of the herbal supplements.
After a federal study found risks from traditional hormone replacement therapy, or HRT, women began to try out the custom-compounded hormones or herbal supplements like black cohosh and red clover since 2002.
Previously the scientific medical community believed that hormone replacement therapy (HRT) at any age would reduce the risk of heart attack and stroke. This hope was dashed by the Women's Health Initiative Study, which found that taking estrogen plus progestin for more than five years places postmenopausal women at risk for heart attacks, strokes, and several other serious problems. Since the study bioidenticals have come to the fore.
"Women need to understand there's no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there's much less evidence for efficacy and very little research on long-term safety," said Dr.Joann Manson, the preventive medicine chief at Harvard-affiliated Brigham and Women's Hospital in Boston. She was a key researcher in the 2002 study.
Also in 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Dr. Manson writes in her book, Hot Flashes, Hormones and Your Health
Compounded "bioidentical hormones" are plant-derived hormones that pharmacists prepare and label as drugs. The products are claimed to be biochemically similar or identical to those produced by the ovaries or body. However, the relevant chemicals (steroids) in plants are not identical to those in humans. To make products that work in humans, raw materials from the plants must be converted to human hormones synthetically. Thus, to the extent that they are potent, the "bioidentical" products would pose the same risks as those of standard hormones—plus whatever problems might be introduced during compounding, says Stephen Barrett, writing on Pharmwatch.
The American College of Obstetricians and Gynecologists has denounced claims about their safety. The American Medical Association has urged more FDA oversight. The Federal Trade Commission has filed complaints against online sellers who made health claims for natural progesterone creams without supporting evidence.
In January 2008, the FDA ordered seven compounding pharmacies to stop making illegal claims about "bio-identical hormone replacement therapy (BHRT)" products. The companies were told that the FDA regards "bio-identical" as a marketing term that implies a benefit for which there is no medical or scientific basis. Some were also making unsupportable claims that their drugs are better than FDA-approved menopausal hormone therapy drugs and can be used to prevent and treat serious diseases such as Alzheimer's disease, stroke, and various forms of cancer, says Barrett.
Still there are zealous advocates like actress Suzanne Somers who rubs hormones on her arms, injects them vaginally and takes some 60 supplement pills each day.
Many of her best-selling books, including her latest Breakthrough: Eight Steps to Wellness ,
strongly encourage women to use bioidentical estrogen and progesterone supplements after they hit menopause. Since these are identical to the hormones made by the human body, Somers reasons, they are safe and even beneficial to take well into old age—whereas, she believes, traditional hormone therapies, with slightly different molecular structures, are harmful. She has a cadre of experts to back up her claims and recently touted the anti-aging benefits of bioidenticals on the Oprah Winfrey Show to cheers from Oprah, who herself takes the supplements.
"I laugh when they call me a quack," Somers told AP and stressed that she was not trying to play doctor but to share with women what worked for her.
The industry claimed it was being persecuted and fought back. In full-page ads in major newspapers, several alternative medicine groups claimed that estriol is safe, criticized "synthetic, hyper-expensive" prescription drugs, and asked, "Why is the FDA so hostile to 'natural' medicine?"
There are several thousand compounding pharmacies in the United States and hormones are a significant part of their business, said L.D. King, executive director of the International Academy of Compounding Pharmacists in Missouri City, Texas. No one knows how many women use these products, but "we believe the FDA action on the estriol issue would have affected hundreds of thousands of women," King said.
A group of nine compounding pharmacies sued the FDA. After a murky ruling by a federal court in Louisiana centering on federal versus states' authority, neither side appealed, King said.
"It gets complicated and there's not a win," he said. "We continue to advocate that FDA's action is wrong."
Pellets containing estrogen, testosterone or both are the latest craze in this field. They are implanted just under the skin every few months under a local anesthetic, and are not FDA-approved for treating menopause. Problems that have been reported include difficulty removing the pellets if the therapy has to be discontinued, infection or pain at the injection site and fluctuating blood levels of estrogen, including a potentially high cumulative effect over several years.
Whether the estrogen pellet is any safer than traditional estrogen pills is unknown.