Published October 22, 2006
The estrogen hit the fan as some of the nation's leading health experts got in line to take swipes at actress Suzanne Somers.
The reason? Disagreement with her latest book, "Ageless: The Naked Truth About Bioidentical Hormones."
In it, Somers claims that using natural hormones identical to what the ovaries make, instead of the synthetic ones commonly used in hormone replacement therapy (HRT), can halt typical menopause symptoms, including hot flashes and mood swings, without the risky side effects normally attributed to hormone therapy.
She also teases with the promise that bioidentical hormones can safely allow women to recapture the health, beauty, and sexuality of their youth.
But at least one group of doctors -- a panel of seven noted physicians, three of whom were quoted in the book -- say her promises far exceed scientific fact. They sent a letter to Somers and her publisher charging the book is misleading, inaccurate, and downright dangerous for women to follow.
"Our concern is strictly a safety issue. We feel that Suzanne Somers should be commended for bringing the subject of bioidentical hormones center stage, but she offers incorrect information and endorses protocols that are unproven and, in some instances, dangerous. She has gone too far,” says Erika Schwartz, MD, a New York doctor who spearheaded the letter-writing campaign.
Through her publisher, Somers, who just turned 60, defends the book: "For the past decade, Suzanne Somers has been immersed in researching anti-aging medicine. ... She has embraced this medicine because she has seen the results in her own body and well-being, but knows there continues to be an ongoing dialogue in the medical community on how to best utilize this new information in concert with more conventional forms of health care."
Lab vs. Nature: What You Should Know
Regardless of the public debate the book has inspired, the question that lingers in most women’s minds is how much do we really know about bioidentical hormones? Steven Goldstein, MD, professor of gynecology at NYU Medical Center in New York, explains.
"First off, this is not new, and it’s not weird science or outside the realm of conventional medicine, as some might suggest,” says Goldstein.
Indeed, he says bioidentical hormones are simply “a form of manufactured estrogen and progesterone that, on a molecular level, is identical to what is produced naturally by the ovaries.”
Bioidentical hormones are frequently derived from plants and other natural sources, Goldstein says.
“Pharmaceutical companies have been making FDA-approved bioidentical hormones -- and doctors have been prescribing them right alongside synthetic hormones -- for years,” Goldstein tells WebMD.
This includes prescriptions for bioidentical estrogens such as Estrace, Vivelle-Dot, Climara, Estring, and Vagifem, as well as several generic forms, and bioidentical progesterones like Prometrium.
In comparison, a popular synthetic estrogen -- Premarin -- is made from horse urine. It is also natural, similar in structure to bioidentical estrogen, and only slightly different from the kind made by the body, says Goldstein.
The question is, does that slight difference make a big difference in how women feel -- or in their future health? The answer depends on who you ask.
According to Wolf Utian, MD, executive director of the North American Menopause Society (NAMS), it doesn’t.
"The word 'bioidentical' is a marketing misnomer -- and the claims for safety and efficacy are entirely without merit,” he says. “They are the same as [synthetic] hormones and, if given in bioequivalent doses, the risks would be exactly the same."
Schwartz believes otherwise.
"When you tinker with the molecular structure of a hormone -- the case with synthetics -- then the body does not know what to do with it, which is what we believe accounts for a lot of the side effects. Conversely, if you give a supplement identical to what the body produces, in the correct amount, it appears to know exactly how to use it in a healthful way,” she says.
Some believe this not only includes knocking out menopause symptoms, but also helping women look and feel younger almost indefinitely.Get Tips for Managing Hot Flashes
Different Singer -- Same Song
If the lyrics to this song sound familiar, they should. Back in 1966, New York gynecologist Robert Wilson, MD, wrote "Feminine Forever" -- a book that, not unlike Somers' tome, claimed hormone therapy was the panacea that could get aging women "back into the bedroom, back into the kitchen, and back to looking and feeling young" in record time.
It was "Feminine Forever" that is credited, at least in part, with launching the widespread clamor for synthetic HRT and a pharmaceutical fountain of youth that lasted well over 35 years.
The problem then – and maybe now – is that most of the claims attributed to hormone use were assumptions rather than facts – something that became clear during the National Institutes of Health 2002 Women's Health Initiative Study.
From that study we learned that not only was HRT not the fountain of youth, but some women who attempted to bathe in its waters nearly drowned. The risk of heart disease, stroke, blood clots, and even breast cancer increased among many groups of women using HRT, the study showed.
And while this is not likely to be the final word on hormone use, some experts caution that the assumptions being made about bioidentical hormones today harkens back to this ‘60s mind-set, once again taking women into uncharted waters.
"We are, in many ways, in a no-data zone,” says Marcie Richardson, MD, a clinical instructor in obstetrics and gynecology at Harvard Medical School and director of the Menopause Consultation Service at Harvard Vanguard Medical Associates. “Bioidentical hormones have not been specifically studied in a randomized trial on any widespread level, and if you are to use that as a criteria, then it's true that we don't know if they are any better -- and they could turn out to be much worse -- than synthetic hormones. We just don’t know."
Utian takes a stronger position. He believes we can extrapolate data from what was learned during years of synthetic HRT research and apply it to bioidentical treatments, showing they are no safer and no different than other forms of hormone therapy.
"There is this totally false impression that these so-called bioidentical hormones are somehow safer, or that they don't carry the risks but they do carry the benefits. Quite frankly, you can't have your cake and eat it," says Utian.
Compounding the Problem
Complicating matters further is the issue of how some bioidentical hormones are dispensed.
Although versions of bioidenticals made in FDA-approved laboratories are readily available, many users, including Somers, advocate filling prescriptions at compounding pharmacies -- drug stores that make treatments from scratch according to a doctor’s prescription. The advantage includes having each prescription tailor-made for each woman.
While the concept makes sense, the problem is that most doctors are unfamiliar with writing prescriptions from scratch. Some experts say the dosages and combinations of hormonal ingredients that result are gleaned from largely untested protocols.
"Doctors are rubber stamping prescriptions to please their patients, while these compounding pharmacies are making concoctions -- often at their own discretion. It's like practicing medicine without a license," says Utian.
Moreover, many of these establishments -- as well as Somers herself -- recommend blood and saliva testing to determine a woman's hormone status, and thus discover her bioidentical hormone needs. But hormone level testing is something doctors say has been long proven not to work.
"A woman's reproductive hormones can change dramatically from hour to hour, as well as through her cycle, and from cycle to cycle. There is absolutely nothing useful you can tell about a woman's hormone status from a blood or saliva test -- it's nonsense," says Utian.
While Richardson says compounding isn't always a bad thing – suggesting that when done responsibly it allows for individualized dosing – she cautions that quality control can be an issue.
Indeed, a recent survey conducted by the FDA showed that 34 percent of the sampled drugs made in these establishments failed one or more standard quality tests. Among those failures, most contained less-than-expected amounts of the active ingredients.
Goldstein says there is talk the industry will begin policing itself, adopting a strict, albeit voluntary, code of ethics to keep the fringes from becoming even more frayed. “This should help,” he says.
And doctors like Schwartz say they will continue to petition drug companies for funding to study all bioidentical hormone preparations so "women will know once and for all what they can safely use."
In the meantime, just where can a gal who is flashing and sweating turn for help?
Richardson offers this advice: "Talk to your doctor; work with your doctor. And if you want to use bioidentical hormones, let your physician -- and not Hollywood -- be your guide."
Colette Bouchez is the author of "Your Perfectly Pampered Menopause: Health, Beauty and Lifestyle Advice for the Best Years of Your Life" and director of www.YourMenopause.com.
By Colette Bouchez, reviewed By Louise Chang, MD
SOURCES: Erika Schwartz, MD, New York City, author, The Hormone Solution. Steve Goldstein, MD, professor, obstetrics and gynecology, NYU Medical Center; author, Could It Be Perimenopause? Wolf Utian, MD, executive director, North American Menopause Society. Marcie Richardson, MD, clinical instructor, obstetrics and gynecology, Harvard Medical School; director,Menopause Consultation Service, Harvard Vanguard Medical Associates. Wilson, R. Feminine Forever, M. Evans and Company, Inc., Jan. 25, 1968. FDA: “Pharmacy Compounding: Customizing Prescription Drugs.” The Journal of the American Medical Association, July 17, 2002; vol 288. Stewart, P. The New England Journal of Medicine, 2006; vol 355: pp 1724-1726. Fletcher, S. The Journal of the American Medical Association, 2002; vol 288: pp 366-368. Survey,FDA/Center for Drug Evaluation and Research.