Testing Of Bioidentical Hormones Urged

North American Menopause Society Says They Might Not Be Safe

(CBS)  The North American Menopause Society says bioidentical hormone treatments might not be the best way to combat the symptoms of menopause.

In an editorial in the journal Menopause Management, the society's executive director says the recent hype surrounding bioidenticals masks the fact that the ingredients are basically no different from those in FDA approved hormone treatments whose use has fallen since a study in 2002 found women using hormones faced a higher risk of breast cancer.

"Bioidenticals are hormones that are marketed as being chemically identical to the hormones produced in a woman's body," The Early Show medical correspondent Dr. Emily Senay told co-anchor Julie Chen. "And they are said to be specially compounded to match the needs of individual patients."

Proponents of bioidenticals, including actress Suzanne Somers, say those qualities make them superior to synthetic hormone replacement therapies approved by the FDA, but the editorial says that claims that bioidenticals are superior are "nonsense" and urges doctors not to prescribe them.

"Unlike the synthetic hormones approved by the FDA, there is no government supervision of the manufacturing process," Dr. Senay said. "So there's no assurance of the bioidenticals' potency, or of their purity. Individual pharmacists can mix them any way they want. And while these are licensed pharmacists, there's no research to indicate the efficacy or safety of the mixtures they produce."

Dr. Senay said there is no direct evidence that bioidenticals are not safe because they have not gone through rigorous clinical trials, which also means that there is no proof that the products are safe.

"Critics of bioidenticals say nobody really knows what these products can do, good or bad and they see history repeating itself," she said. "For decades, each time women have rushed to use the latest hormone therapy, hoping to slow the aging process, later studies have linked the hormone products to disease risk."

So far, when if comes to fighting menopause symptoms, the only approach that has been proven effective is hormone therapy, Dr. Senay said.

"Soy preparations and herbs like black cohosh do no better than placebo. So if symptoms are severe, the society and other groups like the American Cancer Society say the FDA approved synthetic products may be the only options, as long as women take them under close supervision by a doctor," she said. "If they feel they must take hormones, they should do so with the lowest dose possible, for the shortest time possible."

[mshpak]

2 questions:
1)The trend in medicine is toward personalized medicine and is already being practiced in targeting chemotherapy to individuals (their genetic profile and the genetic profile of their individual cancer) as well as a new study announced to determine individual markers for correct dosages of coumadin therapy. As medicine moves toward personalized treatment regimens (which bioidentical hormones would seem to be part of)---how are these individual regimens going to be tested for safety?
2)If we should error on the side of caution as this recommendation from the North American Menopause Society is recommending, does that mean they are endorsing the Precautionary Principle? Should we apply this level of precaution to the many pharmaceuticals being prescribed to women and children when the safety and efficacy data is only available for a 160lb. adult male? What about pharmaceuticals being prescribed for long term use when only short term safety/efficacy studies exist? Does this mean that the North American Menopause Society also supports applying the Precautionary Principle to the 80-100,000 chemicals in general use?

[sullyin]

I saw your piece on Bio-identicals this morning and to say that these are exactly like the synthetics is not telling the truth. Premarin is made out of Pregnant Mare's Horse urine, Bioidentical's are not. They are made out of soy and yam oils. I wil not put Horse "****" inside me, to put it bluntly! I challenge The Early Show to ask Dr. Erika Schwartz to come on your show and tell "the rest of the Story". Let's get REAL and HONEST, for a change! Thank you.

[cmwebst68]

"Dr. Senay said there is no direct evidence that bioidenticals are not safe because they have not gone through rigorous clinical trials, which also means that there is no proof that the products are safe." They have already been approved by the FDA and pharmaceutical companies produce them. I'm sure they don't want the marjority of the population to know of the positive health affects of bioidentical hormone as they will not need other pharmaceutical products. Once your regulate your hormone level many other side effects go away: no depression, not as tired, no headaches, no insomnia, etc. I challenge Dr. Senay to do real research on her own uninfluenced by some organization who is probably backed by the Pharmaceutical Industry.

[kleader1]

I have been suffering the worse of the worse menopause. You name it I suffered from it. But no more. My doctor just put me on trocades, I no longer have severe heat flashes, my thinking is clearer, I want *** again and I am sleeping 100% better at night. This is the Suzanne Sommers recommended Therapy and it saved my life!
I could not be happier and this trocade will also increase my bone mass. Apparently Dr Senay has not gone through menopause yet!

[pjbronson]

As a woman and a woman neuroscientist (neurobiochemistry) I must say please think again. There are significant data over the last twenty years articulating the critical connection between neurosteroids (hormones which affect the brain) and neurochemistry. ( see "The Effect of Neurosteroids on Depression in Peri-Menopausal Women" Journal of Orthomolecular Medicine Vol 20 Number 3)
The distiction between synthetic analogs of progesterone ( ie Provera and its cousins) and actual progesterone is that the acetate in Provera drives the water retention seen in the molecule, and thus the difference between the synthetic and the 'bio-identical molecule is in the hydroxylation: Real progesterone repels water, and is a remarkable diuretic which is why women feel so good using it. The molecules tell their own story and they do not lie. I know, I did the original research on this.


Phyllis
Phyllis J. Bronson, Ph.D.

Biochemical Consulting Company
Biochemical Research Foundation
Associate Professor, University of Denver: Department of Chemistry/Biochemistry

Internal Medicine Associates
100 E Main Street
Aspen CO 81611
970) 920-2523

[anne9991]

Please do your homework before broadcasting misleading reports. There are FDA approved bioidentical hormones readily available - estridiol (patches, pills and gel/lotion) and progesterone (not to be confused with progestin - which is the synthetic version). What you have not made clear is the distinction between bioidentical that are compounded using the same USP product that drug companies use, vs the bioidenticals that are FDA approved products produced by drug companies. I personally feel that woman and their doctors should have the choice to use whatever product works best for that individual woman.

Most woman who are diagnosed with cancer, are post menopausal women not the ones with healthy levels of hormones in her body.

I am getting very tired of hearing these reports that scare women away from HRT. Many woman are suffering severely and could greatly benefit from HRT. We need more choices, not less. You are doing a great deal of harm to the general public who may not have the means or understanding to read the actual research and form their own opinions about the risks and BENEFITS.

Here is a suggestion: do a story about the positive benefits a woman experiences on bioidentical HRT. Interview woman who are actually using these bioidenticals. It is a HUGE quality of life decision that needs to be made having all the facts both POSITIVE and with a realistic understanding of the risks.

[lsajra99]

"'Unlike the synthetic hormones approved by the FDA, there is no government supervision of the manufacturing process,' Dr. Senay said."

Knowing the history and regulations of the FDA, I think this is a good thing!

It's time for the consumer to take back their own power and make informed decisions for themselves, especially since western medicine is so profit-driven nowadays. It cannot be counted on that our medical care system looks out for our best interest when so much profit is at stake.

Even alternative healthcare (especially companies and healthcare practitioners that sell supplements) is profit-driven, so the best advice is to stay informed and do your research in order to make wise decisions before selecting any kind of treatment or therapy.

[da5360]

Thank you Phyllis Bronson for speaking up! Obviously, Dr. Senay is speaking on behalf of CBS sponsors, pharmaceutical companies. Bio-indentical hormones have been a God send for me. I took Premarin for over 10 years after having a hysterectomy. I suffered severe migraines that would last for days, sometimes I would miss work. My doctor gave me painkillers, yea,just what I needed. Besides the headaches, I gained weight, was bloated, had joint and neck pain, heaviness in my legs, and always tired. Since I've been on Bio-indentical hormones all the side effects are gone. I haven't had one headache. I haven't felt this good in years. I can't begin to describe the difference. I've got my life back.
Bio-indentical hormones are an answered prayer for me.

[danellebk]

Synthetic vs Bioidentical-Sorry Dr Senay they are nothing alike. Bioidentical=same chemical structure as hormones produced in our bodies. Synthetic=hormones derived from some patentable source-not found anywhere in our bodies. Much to Dr.'s surprise many pharmacies do potency & stability testing for thier natural hormones, so next time dr. tells a story maybe she should research all the facts not just half.