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Tags somers , bioidenticals

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Old 19th August 2007, 07:23 PM   #281
Eos of the Eons
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I still get why these products are sold at all. They are hormones, and have an effect. It's not like these things are just food supplements (like ginseng and vitamin C).

On top of that, to be sold without testing for safety? Then have the people selling them be able to tell people they are perfectly safe when never proven safe?

This is the typical road of supplements. They can be sold until proven to be harmful (like phen phen). But these are hormones. Not food. How is it that people selling these products don't have to follow the laws that regulates other hormone products?

If I was a woman duped into taking these and duped into figuring they are perfectly safe, I'd have a lot of questions to ask of the people behind protecting the safety of the public from dubious claims being made about something that is ingested to have specific effects on the body like this.

Quote:
The three cases reported here raise the possibility that the oestrogen component of the troche was significantly absorbed but the dose of progesterone was inadequate, thereby causing endometrial hyperplasia. The North American Menopause Society has produced a useful discussion paper on bioidentical HRT,5 and it should be noted that the Australasian Menopause Society does not recommend the use of bioidentical HRT.6,7 Until this therapy has been properly tested, it may be prudent not to advocate bioidentical HRT and to perform endometrial surveillance (eg, annual transvaginal ultrasound and endometrial biopsies) on women who, despite counselling, continue to use bioidentical HRT.
Basically there is no balance of the hormones in these products to prevent the overgrowth of the uterine lining. You improperly frac with hormones that frac with the uterus, and there are going to be consequences. Since morons are making these things, it's no surprise they are unaware of the consequences. They just go around telling everyone (falsely) that the doses are perfectly safe and natural. They obviously are not.

I'll bet folks with the proper background could have assesssed the levels in the product and saw this coming, no? Why aren't the makers of these things required to know anything about the body and actual hormone levels before they are allowed to start telling people to take something that is so inadequately balanced that the consequences are a no-brainer?

Since the makers of bio-identicals are NOT made to prove their hormone levels and compounds are safe or even logical in the first place, they ended up giving the public something that clearly was a bad mixture of hormones.

Does this not make anyone else as miffed as it makes me?

Quote:
When testing new HRT regimens, endometrial assessment is one of the most important safety endpoints. The usual method used for evaluating the endometrium in HRT trials is endometrial biopsy (usually performed every 6–12 months). In its guidelines to the pharmaceutical industry, the United States Food and Drug Administration recommends endometrial biopsies at the beginning and end of an HRT trial.4 Sometimes ultrasound can give additional useful information (endometrial thickness, polyps, fibroids etc). The current “gold standard” test for endometrial assessment is hysteroscopy and curettage.
The usual methods were not required for bio-identicals. Why? Because they are sold as "all-natural"? They are still hormones.

Does a law need to change to require that new hormone treatments (no matter their source) must follow the usual methods? Why isn't there a law in place now to cover hormones? WTF?

Quote:
Currently, these compounds are not directly regulated by the Therapeutic Goods Administration. Thus, little is known about the quality control, pharmacokinetics, safety and efficacy of these treatments.
Well, start regulating them. There's obvious logic in it. I will never understand why these things never fell under regulatory laws in the first place. Nuts. Just nuts. They apparently aren't regulated in any country.

Right now any fool can and does throw these unregulated hormone compounds into pills. The consequences are a no-brainer. Everyone saw this coming. Why isn't there anything being done about it?
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Last edited by Eos of the Eons; 19th August 2007 at 07:35 PM.
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Old 19th August 2007, 10:56 PM   #282
debv
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eSkeptic recently published an article which you might find interesting: "Bioidentical Hormones: Estrogen is Good. No, It’s Bad. No, It’s Good".

http://www.skeptic.com/eskeptic/07-08-15.html

I particularly appreciated the "Bioidentical Insanity" section:

"It would be bad enough if they stuck to menopause, but Somers recommends hormone regimens for every age group, including adolescents, and for both men and women.

"This creates a scenario where wishful thinking and testimonials take precedence over science, where quackery can go hog wild. Patients get to obsess about every little ache and sniffle, doctors get to tweak their prescriptions, and if patients don’t improve, they just say the balance isn’t quite right yet and they try again.... If you’re still not feeling perfect, you can try going to sleep at 9 PM. And sleeping in total darkness."

The latter might be an obscure reference to some.

T.S. Wiley's first book, "Lights Out", postulated that artificial light and staying up late are the root causes of cancer, diabetes, and other diseases of civilization. "Sex, Lies, and Menopause" retained the template but substituted hormone imbalance. SLM seems to have resonated more (and has certainly proved to be a far more marketable concept), but the former remains useful as a safety net. According to a former insider, when a mother on the Wiley Protocol, introducing large quantities of estrogen into her household environment, reported that her child was developing breast buds, Wiley responded that if the child simply slept in a completely dark room the breast buds would disappear.
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Old 20th August 2007, 06:02 AM   #283
JJM
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Originally Posted by debv View Post
eSkeptic recently published an article which you might find interesting: "Bioidentical Hormones: Estrogen is Good. No, It’s Bad. No, It’s Good".

http://www.skeptic.com/eskeptic/07-08-15.html
{snip}
That's convenient, it looks word-for-word the same as the print version I cited.
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Old 20th August 2007, 08:49 AM   #284
debv
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Oh, indeed! Sorry, didn't realize.

Last edited by debv; 20th August 2007 at 08:52 AM.
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