Hormone replacement therapy

Press Release — Resolving confusion about the recent FDA press release on bioidentical hormones

Women to Women responds with clarifying stance on bHRT

January 17, 2008; Yarmouth, Maine — “I’m concerned that the recent FDA press release on bioidentical hormones is misleading women,” says Marcelle Pick, founder of the renowned Women to Women clinic in Yarmouth, Maine. “The press coverage implies that the FDA is saying bioidentical compounded hormones are unsafe. But they’re quite safe, provided they are prescribed by an experienced healthcare professional and are made by a reputable compounding pharmacy. We’ve prescribed them for over 15 years for thousands of women.”

On January 9, 2008, the FDA issued a press release entitled “FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs.” At the same time, they issued a number of warning letters to compounding pharmacies taking issue with the use of the word “bio-identical” as a marketing term implying a benefit, where they state “there is no medical or scientific basis.”

“First,” says Pick, “it is important that women understand the message: the FDA has not outlawed the use of bio-identical HRT.”

“Second, it’s the job of a reputable compounding lab to prepare a product that has the same molecular structure as the hormones your body produces naturally — the word ‘bio-identical’ in this sense means ‘identical to life.’ If a woman is lacking the hormones she needs to feel balanced, bHRT, as compared to synthetics, allows the body to metabolize the hormones in much the same way as it was designed to do naturally. This is the key to minimizing side effects.”

Dixie Mills, MD, renowned breast care specialist and partner in Women to Women’s Personal Program, says, “It comes as no surprise to me that a big pharmaceutical company like Wyeth was a part of this press release. Pharmaceutical companies also sell bioidentical hormone products, but with unique delivery methods for bHRT that are patentable, such as special skin patches or vaginal rings.”

Some assert that pharmaceutical companies use patents and their influence with the FDA to stifle competition. Bioidentical products from compounding pharmacies threaten their business by offering women an alternative.

Pick explains, “Because the hormones created by compounding pharmacies are chemically identical to those found naturally, they cannot be patented — drug companies can’t patent things that occur naturally in the human body.”

She continues to say, “At Women to Women, we have found that about 85% of women can find relief through an approach that combines medical-grade nutritional supplements, gentle phytotherapy to normalize the endocrine system, and dietary and lifestyle changes. If prescription-strength relief is necessary due to advanced symptoms of menopause, we always recommend that women consider beginning with bHRT. It is our clinical experience that with the right protocol (including diagnostic blood tests, controlled dosage and duration, and regularly scheduled follow-up blood tests), BHRT can help to alleviate the symptoms of menopause without the negative side effects that may be experienced from the body not being able to process synthetic HRT as well.”

“I urge women to consider all their choices,” concludes Mills, “and to discuss bHRT with their healthcare practitioners before narrowing their choices based on the titles of FDA press releases.”

 

Last Modified Date: 05/25/2011