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Why your doctor wants to be your hormone guru - MarketWatch
Elizabeth O'Brien's Retire Well
Jan. 30, 2014, 10:02 a.m. EST
Why your doctor wants to be your hormone guru
Are you ‘Low T’? Hormone therapy is increasingly popular—and potentially expensive
By Elizabeth O'Brien
You’ve got a financial planner to perfect your portfolio allocation and a personal trainer to work just the right muscles. How about a
health provider to balance your hormones?
More doctors are applying the term “hormone optimization” to some common middle­aged health complaints, and the idea might appeal to boomers
who have grown accustomed to personalized services in other aspects of their lives. The pitch: A customized prescription of so­called bioidentical
hormones can help you restore your body’s inner balance and recapture the vigor of your youth.
It’s a seductive appeal, for sure. But it takes patients into a gray area—one where they’ll need to be very proactive researchers and consumers.
There’s scant data on the safety and effectiveness of some widely used bioidentical hormones. Like the many non­dermatologists who now
administer cosmetic treatments like Botox, some doctors who prescribe bio­identicals may not have any particular expertise in endocrinology, the
branch of medicine that deals with hormones.
What’s more, treatments can get pricey and might not be covered by health insurance. While health
insurance does cover some bioidentical hormones, the frequency of doctors visits required for many of
these therapies means patients using them are likely to encounter higher out­of­pocket costs than
those on conventional drugs.
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“Bioidentical” refers to hormones that are identical in molecular structure to those that humans
produce, but are synthesized in a lab. It’s hard to quantify the market for bioidentical hormones, largely
because those made at so­called compounding pharmacies, which make up a large part of the market,
are not approved or tracked by the U.S. Food and Drug Administration. One recent report from
Symphony Health Solutions, a market research firm, estimated the U.S. market for compounded
hormones to treat menopause at more than $800 million. And bioidentical treatments for men’s
deficient testosterone, known as “low T,” are also on the rise.
Not all hormone therapies are created equal—and some
The FDA doesn’t recognize the concept of bioidentical hormone replacement therapy, calling it a
marketing concoction. Conventional, FDA­approved hormone therapies exist to treat midlife health
woes, but they come only in standardized formulas and doses. Doctors prescribing bio­identicals argue that patients benefit when they get a
hormone treatment customized just for them in a compounding pharmacy.
can be surprisingly expensive.
The biology of middle age
Levels of sex hormones fall in both men and women throughout middle age. These hormones facilitate reproduction and play a role in metabolism.
Their decline can lead to unpleasant symptoms, such as a lowered libido, decreased energy and weight gain.
Each gender experiences these changes differently. Menopause, characterized by falling levels of the hormone estrogen, is usually a more abrupt,
rapid process than that experienced by men entering middle age. American women enter “perimenopause” around age 45 and menopause at an
average age of 51, a time when some experience hot flashes and night sweats.
A man’s testosterone levels, by contrast, decline gradually from his 30s through his 70s. While the decline accelerates somewhat in middle age, men
rarely experience symptoms as disruptive to daily life as some women do. Men’s version of menopause is called “andropause,” although some
doctors dispute that men’s midlife transition deserves its own medical term.
No matter what you call it, middle age is a natural phase of life. People who aren’t reproducing don’t need the same levels of sex hormones as those
who are. The question then becomes, when do symptoms rise to the level where you need help from a doctor?
Bio­identicals v. traditionals
The answers, unsurprisingly, may depend on the type of doctor you choose. Physicians who market themselves as antiaging specialists tend to think
that most people can benefit from some hormone treatment. And they tend to prescribe those hormones in bioidentical form as opposed to
conventional, pharmaceutical form.
Bioidentical hormones are often customized for patients based on hormone levels found in their blood or saliva. Dr. Florence Comite, an
endocrinologist in New York City, says she prescribes bioidentical hormones for her patients to help them extend the healthy portion of their lives.
She calls her approach “precision medicine for age management.” And she believes, as do other advocates of compounded bio­identicals, that the
standardized doses of conventional, pharmaceutical hormones can be less effective because they aren’t customized.
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The goal isn’t to replicate the hormonal environment patients had at their sexual peak in their 20s, Comite said, but instead to optimize hormones to
keep their metabolisms “humming” and to help them reduce fat and build lean muscle. She treats both men and women but recently wrote a book
focused on men’s issues called “Keep it Up: The power of precision medicine to conquer Low T and revitalize your life.”
Other medical experts are skeptical about the advantages of compounded bio­identicals. Hormones found in conventional therapies may not be
identical to the ones the body produces, but they have undergone the FDA’s rigorous approval process and been deemed safe and effective for the
conditions they’re designed to treat. And in fact, some in the medical community dispute that bioidentical hormones are even “identical,” preferring
the term biosimilar. To add to the complexity, the FDA has approved certain hormones that some refer to as bioidentical, but these aren’t custom­
mixed for specific patients in compounding pharmacies.
Are drugs really needed?
Some doctors say deficient testosterone isn’t nearly as widespread as the prevalence of drug commercials would have us believe. Dr. Bradley
Anawalt, chief of medicine at the University of Washington Medical Center and a member of the Endocrine Society, has said that the rates of
hypogonadism—the medical term for deficient sex hormones—run from between 2% to 10% in middle­aged and older men. Rates increase as men
get older, and obesity, which has been rising steadily in the U.S., can also contribute to lower testosterone levels.
Many women find the symptoms of menopause manageable without drugs. Roughly one in five has the type of moderate to severe symptoms that
might make them candidates for hormone treatment, said Dr. Margery Gass, executive director of the North American Menopause Society. The
current mainstream clinical position on menopausal hormone therapy holds that women should take the smallest dose of hormones that helps, for
the shortest amount of time.
By contrast, doctors who prescribe bioidentical hormones say patients can often benefit from taking them for life. Comite says that while bioidentical
hormones need to be adjusted as people age, both women and men can often benefit from a long­term regimen. They can relieve menopause
symptoms just like conventional drugs and sometimes even better, she said. And the treatments continue to confer benefits beyond middle age,
helping patients stay their healthiest for as long as possible, she said.
Dr. J. Shah, a doctor in Scarsdale, N.Y. who specializes in bariatric, or weight­loss, medicine, prescribes bioidentical testosterone to some patients if
weight loss alone doesn’t restore their hormone levels to normal. He says men can continue taking testosterone well into old age with regular,
careful monitoring. The treatments can be life­changing for patients, he said, recalling one man who got a new lease on life after worrying that his
lack of energy might cause him to lose his job.
Health insurance sometimes covers bioidentical hormones. Shah said the supply of bioidentical testosterone he prescribes for patients typically costs
$30 to $35 a month, while the supply of a gel made by a drug manufacturer costs at least 5 times as much; insurance, he said, usually covers some
portion of both types of treatments. Cost is one reason why Shah tends to prescribe bio­identicals; he also prefers custom prescriptions since they’re
available in more concentrated doses than the pharmaceutical versions.
The need for monitoring, which doctors like Shah and Comite stress, can sometimes be costly for patients. Doctors often require patients on
bioidentical hormones to undergo frequent blood or saliva tests, which can run into the hundreds of dollars if not covered by insurance. They say this
helps them track hormone levels and ensure patients are receiving the correct doses.
As part of providing these services, some doctors who prescribe bio­identicals charge regular “program” or “maintenance” fees that insurance
doesn’t cover. And some doctors don’t accept insurance at all for bioidentical treatments.
The natural pitch
Bioidentical hormones are often touted as a “natural” alternative to hormones made by drug manufacturers. Yet while they’re often derived from
yams or other natural substances, patients are often surprised to learn that bioidentical hormones also undergo chemical processing before
reaching the market, Gass said.
Bioidentical hormones for women rose in popularity after a study by the Women’s Health Initiative, stopped in 2002, called into question the safety of
traditional hormone therapy for some menopausal women. Certain women in the study taking pharmaceutical estrogen plus progestin experienced
higher rates of overall illness and death than those taking a placebo. Many patients went off the drugs cold turkey, and some doctors stopped
prescribing them. (Subsequent analysis has suggested that for women in their 40s and 50s, hormone therapy is safer than the 2002 study
concluded.)
While patients on pharmaceutical hormones need to weigh the benefits and risks, the same goes for those on compounded bio­identicals, many
doctors said. The FDA website says the government “is not aware of any credible scientific evidence” that compounded bioidentical drugs are safer
or more effective than FDA­approved drugs. Compounded bioidentical drugs aren’t required to have the same warning labels that FDA­approved
drugs do, which leads some patients to mistakenly think that they don’t carry any risks.
It’d be hard to come by a rigorous scientific study on the safety of compounded bioidentical hormones, said Arlene Weintraub, a science writer and
author of “Selling the Fountain of Youth,” a book about the antiaging industry. That would involve putting people in a study for decades, with half on
hormones and half on a placebo. These hormones are mixed to order, so there’s not likely to be a potential pool of patients taking the exact same
prescription. In the absence of such studies, “there is shockingly little scientific evidence” behind the hormones some doctors are prescribing,
Weintraub said.
Last fall, More magazine engaged a lab to test 12 bioidentical prescriptions collected from compounding pharmacies throughout the U.S. The
analysis revealed that the hormones were of unreliable potency. What’s more, they fell short of some of the FDA’s requirements for commercially
manufactured drugs, the story reported. One of the biggest dangers the analysis unearthed was a shortfall of progesterone in 11 of out of the 12
prescriptions. Women on hormone therapy who still have a uterus need progesterone to counterbalance the estrogen and reduce the risk of uterine
cancer.
Shah uses one compounding pharmacy, in upstate New York, to fill the prescriptions he orders for his patients. He has visited the pharmacy himself
and said he feels confident of its safety. He chooses to limit his relationships to just one pharmacy so he can be assured of its quality and focus on
close communication with the pharmacy staff.
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Patients need a prescription to get bioidentical hormones, although it’s often possible to buy some without one from foreign pharmacies over the
Internet, said Dr. Thomas Perls, a professor of medicine at Boston University School of Medicine and the director of the New England Centenarian
Study.
What’s more, any doctor can call him or herself an antiaging doctor and prescribe these hormones without specialized training in endocrinology,
Perls said. Patients should be aware that antiaging is not a specialty recognized by the American Board of Medical Specialties, a nonprofit
organization that’s widely recognized as an arbiter of rigorous specialties.
A cosmetic lift
Doctors who prescribe bio­identicals often discuss the cosmetic benefits that they can confer. These hormones can help build lean muscle and
restore collagen to the skin, the thinking goes. “There’s a fine line between feeling good and looking good, and that’s where the controversy lies,”
said Dr. Paul Frank, a cosmetic dermatologist and dermatologic surgeon in New York City who sees patients who are using bioidentical hormones
that other physicians have prescribed for them.
S. Jay Olshansky, a professor of public health at the University of Illinois at Chicago, noted there’s a proven alternative to hormones that’s effective
at reducing fat and building skin elasticity, that’s generally safe and easy on the wallet. Said Olshansky, “Exercise is free.”
Recently in Elizabeth O’Brien’s ‘Retire Well’:
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Elizabeth O’Brien covers health care and retirement for MarketWatch in New York. Follow her on Twitter @elizobrien . Copyright © 2014 MarketWatch, Inc. All rights reserved.
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