Interesting article FDA press release on bioidenticle hormones

[Guest guest]

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."

About bioidentical hormoness

To learn more about bioidentical hormones see our articles:

Intro to HRT and alternatives

Bioidentical hormones: are they right for you?

Talking with your doctor about bioidentical hormones

What to expect when you're stopping HRT

On the risks of HRT and hormone replacement therapy side

[Guest guest]

Thanks for the article, Mindy. I think the hard part is that if there is any way the big drug companies can stop the competition from the compounded bio-identicals, I think they will definitely try to put an end to them. *ugh* Hugs, Chelle