People like Suzanne Somers tout bio-identical hormones as the most natural answer to menopause treatment. A new "natural" product, Amberen, has just been introduced into the market by a Doctor of Osteopathy in Southlake, Texas. How do women negotiate their choices? (Courtesy photo)

Hot flashes! Sexual dysfunction! Mood swings! It could be the menopause spin-off to the Pepto Bismol commercial. Of course, they’d have to add more players to the lineup: Doctors! Big Pharma! FDA! WHI! . . .

Sound complicated? Try being a menopausal woman trying to sort out your options.

Since the Women’s Health Initiative began in 1991, various discoveries about menopausal treatments have shocked and stunned menopause-age women. WHI started in 1991 to test the effects of postmenopausal hormone therapy on heart disease, breast, and colorectal cancer, among other things.

The hormone trial had two studies: the estrogen-plus-progestin study of women with a uterus, and the estrogen-alone study of women without a uterus, according to the WHI Web site. The women from these studies are still participating in an ongoing follow-up phase through 2010.

With a couple of caveats, the summary findings from these two popular hormone therapy methods determined that estrogen plus progestin treatments, as compared with placebo, resulted in increased risk of heart attack, breast cancer, stroke, and blood clots (but reduced risk of colorectal cancer, and fewer fractures). Estrogen alone treatment compared with placebo resulted in no difference in risk for heart attack or colorectal cancer, but increased risk of stroke and blood clots, and no difference in risk for heart attack or colorectal cancer.

The study’s conclusion? Only take as little hormone therapy for as short a period of time as possible under the direction of a physician, and only for relief of specific symptoms, like hot flashes and vaginal atrophy.

But different parties have made more of the information. Newspapers and magazines have posted tabloidal warnings about HRT’s breast cancer and blood clot culpability. Even Suzanne Somers has published a book rallying for bio-identical hormone treatments.

The FDA had entered the fray recently. They issued a warning to seven compounding pharmacy operations in early January that their claims of superiority to FDA-approved hormone replacement drugs are misleading. Compounding pharmacies are named for custom creating hormone products that are “bio-identical,” so named, compounding pharmacists claim, because they have the same molecular arrangement as actual human hormones. These pharmacists claim that bio-identical hormones are not synthetic (or of a different molecular arrangement than natural hormones) like the HRT drugs manufactured by big drug companies. But they also do not have a substantial body of medical evidence to support their products’ effectiveness, or possible dangers.

A new treatment has just entered this messy fray, championed by a Doctor of Osteopathy right outside of Dallas. The product’s name is Amberen. It hails from Russia.

“Creating A Bio-identical Environment Without any Hormone”

James Mahoney, D.O., is the founder for the Center of Hope and Healing in Southlake, Texas. Mahoney claims to practice “‘integrative’ medicine, skillfully blending alternative and traditional medicine.” Mahoney says he used to prescribe hormone replacement therapy and bio-identical hormones to his patients in the past. He says that the synthetic HRT treatments have risks that outweigh benefits. Bio-identical hormones, he says, do get a lot of menopausal symptoms to be a lot less severe.

“Then there’s Amberen,” Mahoney says. “It creates a bio-identical environment without any hormone. The brain, as you age, starts to turn down its output. Amberen restores that output. So it’s not only bio-identical, it’s exact. It’s like getting a bone or tissue graft from your own body; the estradiol (human estrogen) that you’re using is your own. There’s no hormone in Amberen, but it stimulates your body’s secretion hormone. Nothing else we know does that.”

The main ingredient in Amberen, which is available over-the-counter, is succinate, according to Mahoney. “It’s a naturally occurring compound, just part of the energy production system in your body. It’s also in a shape that’s bio-identical to the body’s own succinate. It triggers centers in the brain and causes them to make estrogen again.”

The FDA cannot regulate human hormones, and they cannot be patented. Thus, bio-identical hormones and “natural” products like Amberen cannot be patented by drug makers. Some say this means there’s no money in it for them, and they don’t invest all the research and development it takes to get the drugs through clinical trails, and ultimately to market—a process, compounding pharmacist Jeff Carson with Oakdell Pharmacy in San Antonio, Texas, says, that takes $800 million dollars.

The Amberen Web site provides a short roster of “clinical substantiation” for its product. “Safety and effectiveness of Amberen are backed by over 30 years of studies conducted by members of Lunada Biomedical scientific team,” the study roster’s preface leads.

Dr. Lourell Sutliff, a San Angelo gynecologist with Shannon Health Center, has looked at Amberen’s study roster. He’s not impressed. “This is an unpublished study,” Sutliff says. “Therefore, other physicians have no opportunity to comment on the validity of the conclusions--there is no mention of how many patients were in the group they analyzed, which is standard in any medical article in a reputable journal.”

On further inspection, Sutliff made out a study group size.

“The case study is only on three women!”

“They Ought to Insist on a Study”

The problem Sutliff has with Amberen is the same one he has with bio-identical hormone treatments: There are no studies to confirm their allegations that their products are superior or safer to HRT or other FDA-approved drugs, whose benefits—and dangers—have been well documented. Sutliff cited the FDA’s Jan. 9 warning to seven pharmacy operations that they violate federal law by making unsubstantiated claims about their own hormone therapy drugs.

A Feb. 9 FDA-issued press release illustrated the crux of the charge:

“The pharmacy operations receiving warning letters use the terms ‘bio-identical hormone replacement therapy’ and ‘BHRT’ to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of ‘bio-identical’ as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.”

Many women have turned to bio-identical hormones in the aftermath of HRT’s “bad” press concerning increased risk of disease in certain patients. Whereas “synthetic” HRT therapies use products whose molecular structure is different than estradiol, the estrogen produced by the human body, bio-identical compounding pharmacists claim their products have the same molecular structure, and are thus “safer” and more “natural.”

Doctors like Sutliff say these claims are nonsense.

“To be a fact, you have to be published in—you have to publish it in a medical journal, and let other people critique it,” Sutliff says. “It has to be based on evidence. And it has to be better than a placebo.

“I can give women peanut flavored M&Ms, and 40 percent of them will get ‘better.’ Not that they’re imaging their symptoms, but in these kinds of things, there’s a huge placebo effect. So if [Amberen] had studies, and given 1,000 women one thing and 1,000 women another, then okay. But this is just unsubstantiated. And dangerous. You’ve got no idea what this is.”

“A Pretty Powerful Observation”

Jeff Carson is a compounding pharmacist at Oakdell Pharmacy in San Antonio, Texas. He teaches at University of Texas College of Pharmacy, as well as the one at The University of the Incarnate Word. He’s a graduate of the University of Texas College of Pharmacy. Yet, Carson admits, many doctors and drug companies would call him a “quack.”

“Why do doctors not know bio-identical hormones? It’s not taught in medical school,” Carson says. “Very little pharmacology is taught to them—one semester. And it’s typically focused on a large volume of manufactured drugs they have to know and learn.”

Carson describes a bio-identical world where bloodwork is drawn from each patient to make sure the right prescription is compounded in the right doses, based on a subject’s weight, height, and medical history. It’s for this reason that Carson discredits Amberen. It claims that restoring estrogen will cure many menopausal ailments, Carson says, but it’s more complicated than that.

“In both my opinion and experience, most women aren’t deficient in estrogen; that’s not the cause of their problems,” Carson says. “It’s too much. Or an improper balance or ratio of estrogen and progesterone.

“The media, most doctors, and conventional OBGYNs will tell you, ‘Hot flashes? You don’t have enough estrogen.’ And that’s really not the case. Most of the clinical studies in this country on estrogen by scientists have been trying to prove that estrogen prevents heart disease. And every time they do that study, it fails. They cannot find that link. A lot of studies that are done show that it actually makes it worse.

“That’s what all the research has been focused on, because it’s funded by drug manufacturers.”

Carson says drug manufacturers’ putting pressure on the FDA is part of the reason the agency is going after compounding pharmacists. The FDA release did state that New Jersey-based Wyeth drug company circulated a petition asking the FDA to take regulatory action against these pharmacies.

Carson admits there is not a large body of documented, peer-reviewed evidence that bio-identical hormones are safe and effective. This, he says, is evident in his patients’ progress, however. He cites women with complicated cases of menopause that have come to him.

“In 2007 I treated three women who were admitted to the psychiatric wards after hysterectomies. All three of them, within hours of having the surgery, went nuts. All three were put on synthetically manufactured hormones. None of it worked. All three are being treated with bio-identicals now, and are a lot better off than before.

“I’ve been doing it this for ten years, and I’ve only seen one documented case of breast cancer, and she had been on synthetic hormones prior. But the natural rate of breast cancer—if you do nothing and take ten women, two or three of them are going to get breast cancer no matter what you do. If you take that natural rate, and multiply by amount of women I’m treating, I should have a couple hundred cases. I find that a pretty powerful observation.”

But evidence?

“I’m just a retail pharmacist,” Carson says. “I’m not geared up to do clinical trails and studies. I took an oath to help my patients.”

There’s No Right Answer For Everyone

The consensus? Women need to see a local health professional to weigh all their options. Though doctors don’t like to prescribe bio-identical hormones that haven’t been medically reviewed, some bridge building has been made. In fact, Carson landed a teaching spot for the residents of the UTHSCSA OBGYN program through a mutual patient of a San Antonio gynecologist. Carson prescribed some bio-identical treatments for the patient’s libido problems. At first, the patient’s OBGYN balked; but after he saw his patient improve, he reconsidered. Carson explained the logic of his treatment, and the doctor agreed. He invited Carson to UTHSCSA.

“What to take and what to believe?” San Angelo’s Dr. Sutliff asks rhetorically. “Women need to get educated, need to go to reputable medical sites. The average age of women in the Women’s Health Initiative is 63. So all that says is, if you’re 63, don’t take estrogen. But it doesn’t talk about 50. There’s no right answer for everyone. If two sisters have had breast cancer, don’t take [HRT]. We know that if the uterus is out, just take estrogen. Not progesterone.

“WHI has changed my prescription patterns. We have a lot more doses now. But HRT is not uniformly bad.”