FDA/Wyeth vs us Hormone battle

[mrt (imported)]

A topic near and dear to anyone on HRT. Wyeth the makers of the Prempro, Premarine and other synthetic Horse Urine based Estrogen tablets asked the FDA to close down the Compounding Pharmacies that use Bioidentical Hormones. The FDA sent out some letters forbiding the use of estriol. Since this is one of the three main female hormones making it "illegal" is rather difficult to understand. Although used widely in Europe for over 20 years, estriol has been largely ignored by U.S. pharmaceutical companies, possibly because it is a natural hormone that cannot be patented. Estriol is the "weakest" of the estrogens, but studies show that estriol's weakness may also be its strength. In numerous clinical trials, estriol has been used as an alternative to the more potent estradiol and estrone for managing menopausal symptoms.

If you are a Transwoman or Eunuch using HRT this "ban" should be of interest. Even if your not but want to joing the fight? I think that what we need are choices. And choices that are Identical to human hormones vs synthetics seems like a very good idea to me and many experts.

This is a grass roots attempt to tell the FDA to back off. Please consider joining me in the revolution!

http://www.savemymedicine.org

Thanks for listening. Mr T

[Danya (imported)]

MrT,

I filled out the on-line form to my congresswoman, the ultra-conservative Michelle Bachman (once caught on video behind a bush 'spying' on a GLBT rights event at the Minnesota Capitol building) and my two senators. It will be very interesting to see what kind of responses, if any, I get from these folks.

I used my full legal name so I could play my 'PhD' card. I rarely do this but thought this situation more than warranted it.

Thanks for posting this information!

[plix (imported)]

Wyeth is only one of just about every company in Big Pharma that would love to see all compounded meds banned. And unfortunately with the FDA seeming to believe that their job is to keep profits in Big Pharma's pocket, they are more than likely to get what they seek.

Like you, I have no clue why the FDA wants to ban hormones natural to the human body in exchange for hormones that are not natural to the human body and have been known to cause serious and deadly problems in studies to determine their safety.

But of course we don't want to forget that there are FDA approved natural E options available. Estrace, Estrogel, most patches, and most injectables are all bio-identical E. They are plant-based, but their structure is identical to E produced in the human body (injectables are identical once the ester is removed by the body). These are FDA approved pharmaceuticals available now, and they will not be affected by this ban if it does go through.

[mrt (imported)]

It looks like all of the newer treatments are Bio but note that with few exceptions they are Estrodiol only. Based on some of what I'm reading not using the "weaker" Estrogens could be a poor choice. In Europe they have been using them for quite some time with success. Also there is only one Bio Identical Progesterone that I know of and none that I can find bother with testosterone which I think is a valuable part of the mix for all women (natal or our TS sisters)

Which is one reason why I think doing large scale studies using ONLY syntethics at this late date seems so damn odd to me. Plus the idea of giving mega doses to women who have not had any hormones for 10 to 20 years? They were surprised at the increase in heart attack & stoke but... I dunno... Its seems pretty straightforward to me. Put the wrong fuel (Synthetics) in large doses (Nitro) in a rusty lawnmower? Pow! The sad thing is that it scared about half the women who were on HRT off it.

I think some basic research is needed. Using all the real hormones in the right ratio and done straight after menopause of even in perimenopause to see just what effect that has.

Anyway so half the women are scared off and now, some well read women are looking at what they feel are a safer selection and the makers of the first synthetic junk want to point fingers? Sheesh... Were I the FDA I would be tempted to tell Wyeth that proven unsafe stuff needs to be better regulated so please pull YOUR junk :-\ from the market.

Is this just me? You could write such a story but who would buy it?

Anyway, I hope more people join and send those letters to their elected officials. I think mailing them helps btw. Not that EMAIL is not a good idea.

[Uncle Flo (imported)]

I was unable to find, after a brief search, any of the extensive research studies of estriol that the FDA requires to approve a drug for human use. Could this be a reason for discouraging its use? If so, who will provide the millions (10's 0f millions?) of dollars to do the studies? I find that these scenarios are not often the result of corruption or malice but more usually the result of inertia or inflexable rules. P.S. some of the endocrinologists and urologists I have seen think that the term "bio-identical" is misleading and should never be used with regard to something that is not produced by the body. --FLO--

[mrt (imported)]

Bio Identical in this case means a Hormone that is identical to those made in the human body. This vs hormones that have been altered so that a company can patent them and preclude anyone else from making them. A better term might be HumanIdentical Hormone to make the point more clear. The Wyeth Hormones should be called HorseHormones-almost.

BioIdentical hormones can't be patented thus their is an open market for companies to make them and thus no huge profits to be made. It comes "generic" from the start.

Perception that taking a hormone thats the same as human hormones is "better" then taking those that are altered synthetics is ahh.... How do I say it? Logical / Reasonable? But not "legal" to say without more studies done in the USA... A project I think is long long overdue.

Your correct about US studies of Bio Identicals. While some have been done in Europe for reasons I don't get we don't pay any attention to what they do?? Someone may have to edumacate me on that.

[Uncle Flo (imported)]

Briefly, the FDA will not accept studies that are not done to their standards and protocols. I have heard that the US is the most difficult country in which to get a drug approved. --FLO--