Re: [LS] ATTENTION! HEADS UP! Bio-Identical Hormones At Risk..Take Action to Oppose Wyeth & FDA's Actions Against Estriol!

[Guest guest]

HI Ora.

Thanks for letting me know you sent that.. (I'm not getting group mail) so I appreciate it.

I can understand where you're coming from, but can't say I agree after I tried diligently to pick much of it apart sentence by sentence (and could be wrong) and at times I seem to get more and more confused about this issue myself, believe me I do. So I'm just going to ramble here. OH OH.. you know it'll be long *chuckle*...

I know that the big drug companies are behind it and are the ones trying to push the compounding companies out of business and have been for quite a while (a few yrs now at least) and apparently using this statement

......."new-drug, adulteration, or misbranding provisions of the Federal Food, Drug, and Cosmetic Act."....

.... they now claim that compounded drugs (or some?) are under 'that' act as new drugs?...(which means apparently they weren't before?)

In fact....in the previous FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded and estriol DOES have a monograph from the U.S. Pharmacopeia (USP) and why there was likely no problem previously.

That is UNTIL, and you won't see a company named in any of those letters sent out unless you dig deep enough into the background but when you think about it the drug companies weren't that agressive towards defeating compounding UNTIL 'after' those large HRT studies came out in 2000 +2002, about the dangers and risks of the synthetic Premarin & Provera (Prempro) and those big drug companies lost an enormous amt. of business ($) and people left that product in droves to turn to compounding and bio-identicals... and of course that means a huge loss of money for them, it's no wonder the big guns came out.

In this instance it's Wyeth (the makers of Premarin) that forced the issue with the FDA with a citizens petition and in fact in Oct of '05 they were.... 'quote' ''forced to shut down a plant at its Rouses Point, N.Y., facility because of declining sales for Premarin. Rouses Point is a major manufacturing facility for Premarin. Sales of Premarin started to plunge last year after a National Institute of Health Study linked long-term use of the therapy to an increased risk for stroke.'' (AND MORE,) It was to be phased out and closed by the end of '07 or early '08.

To me it's all a bunch of legalize and spin, a Philadelpia lawyer mindspeak, as a way to get around it and hurt the compounding industry as a competitor. No doubt in retaliation Wyeth is simply manipulating the U.S. Food and Drug Administration's regulatory process to delay or stop the competition is how 'I' see it. And big business is in the market to make money.... never forget that as a bottom line.

And the FDA does state they will "HALT" the production if someone is trying to compound 'Estriol' so maybe it's just 'estriol' that's under that 'new drug act'? and not just those who are abusing the way it's supposedly promoted, (tho they state those letters only went out to those 7 ) *so far* or will they 'all' be next and that's their fear? Especially if they use Estriol and many do promote that today. I think so as you'll see further down.

So basically right now the FDA is saying it's only those 7 companies that were reprimanded apparently for promoting it (estriol) under false premises, and makes sense on the surface but there's a lot more to it when you dig deeper.

Oh and by the way they also want them to stop using the term 'Bio-identical'. (Something else no doubt that Wyeth has insisted upon). Have you noticed that since those negative trials that Premarin now uses the word 'natural' on it's product promotions? Because yes Pregnant mares Horse Urine is natural in order to manipulate or fool the public when a patient (and often a physician doesn't know) asks for a 'natural' hormone.

I recently sent something about what Dr. Vliet wrote about it (as well as what Pete sent) and I agree they should stop bad compounding companies IF they are abusing or violating good compounding principles, guidelines, and regulations, there is no doubt about that, but in this case then why is the 'whole' community of compounding specialists so up in arms about this? No doubt they've all got their lawyers as well fighting it with an opposing viewpoint. I would hope so.

Here's the basic letter those 7 got from the FDA ...... (I just put 2 of them here but they're all basically the same)

http://www.fda.gov/foi/warning_letters/s6619c.htm

http://www.fda.gov/foi/warning_letters/s6622c.pdf

and if you look in there as to the reasons why they got the letter, they were:

1. Unsubstantiated Efficacy Claims

2. Unsubstantiated Superiority Claims

3. Unsubstantiated "Bio-identical" Claims

4. Unapproved 'New Drug' Under Section 505 of the FDCA: Estriol (ah ha, the sticky wicket)

5. Misbranded Drugs Under Section 502(fl(1) of the FDCA : Estriol (Ditto because it's Estriol)

But please do read the letters yourself to see it in full.

Everything ''I've'' seen and researched above as to the pharmacys claims 'are' true as other studies have shown, (especially large legitimate studies in Europe) but apparently unsubstantiated or not good enough for the FDA to get their approval.

The FDA states in almost every instance, they site in those letters, they're either ''unaware'' of the other studies or that it doesn't fit ''their'' criteria of a 'substantial & adequate and well controlled investigation'' (big bucks & deep pockets needed) before they'd agree to even consider those.

So those were the reasons why the letters went out. I don't see anything against impure products or dirty/unclean/unstable or unscrupulous places, or anything shady myself, instead it's for claims that are 'to me' are legitimate about the product with smaller studies that back them up here in the USA let alone large studies from Europe. But I'm not the law and the law must be followed regardless of what the truth is... (being a bit facitious there) It's politics' plain and simple, and always follow the money, in 'my opinion' of course.....

And it seems to 'me' the way I read it is that no matter who it is (beyond those 7 companies) if they use Estriol at all in their compounding, they'll all get the same letter, as they say this about Estriol, which would be the same argument they would use (I would think) for anyone who compounds using estriol.

''The estriol drugs compounded by your firm are also misbranded under section 502(0(1) of the FDCA [21 U.S.C. § 352(0(1)] in that their labeling fails to bear adequate directions for their use . Further, these drugs are not exempt from this requirement under 21 CFR § 201 .115 because they are new drugs within the meaning of section 201(p) of the FDCA and they lack approved applications filed pursuant to section 505 of the FDCA .''

I can't speak to the 'directions' use as I've always gotten them with mine so that might be a reason and technicality and could understand that one to a degree and easily enough fixed, (you would hope your physician would tell you how to use it) .... but that statement is also where they apparently are putting 'estriol' under that 'new' drugs section.

Strange too when a current study (in stage 3) is on going right now using 'estriol' for MS with the FDA's approval, but talk about ironic as there are some women who attribute 'getting' their MS 'to' Premarin. <---that's just 'one' but there is a large group out there that talks about it and the connection and now 'estriol' a bio-identical estrogen, 'may' just reverse it.

Anyway it certainly seems like a big muddle and I definitely sent my letter in and have many times previous to this one about Big Pharma against compounders & esp. the bio-identical hormones... but this was the first where I saw 'estriol' specifically singled out, and it makes me have my doubts that it may be 'estradiol' next on the list (let alone testosterone some day).

At least we do have 'estradiol' products that are available in name brands and approved by the FDA ...(AND those have certainly been proven by tests as to efficacy and those are bio-identical so that's confusing to me too with the FDA's comments as to having no acceptable studies) yet still, if one needs a 'base' that's mild for vulvar use? (rather than the name brand Estrace cream) You cannot get that without having it compounded, or for instance I use a sublingual estradiol and testosterone for HRT to bypass the stomach & liver and neither of those are available in any name brand and 'must' be compounded.

Don't take my compounding away from me...*grin* and I see a sneaky little loophole that big pharma is definitely trying to use. Give them an inch and soon it's enough rope to hang 'ourselves' if they get it.

More than enough rambling (and I thought I'd be short, please forgive me *smile*) and of course goes without saying it's 'my' opinion and my own experience, but I don't want to be one of those left in the dark without mine or forced to order it from some on line overseas company. *sigh*

Just to clarify, I myself prefer to use 'estradiol' and not 'estriol' but that is 'my' choice since that's the estrogen we lose as we age and is considered the main or mother hormone, yet none the less estriol has been proven to be benefical especially topically for the vulvar vaginal tissue and it is a bio-identical one. The point is the FDA is trying to take away the rights of compounders and that I am so heartily against.

Dee ~

PS 'again just a reminder that currently I am not receiving 'group' mail so if you respond 'on group' I won't see it (unless someone drops me a line privately).

Hugs to all.

[Guest guest]

I am not quite clear on what you don't agree with because my post quoted from a

few documents. However I feel that FDA is skirting the matter because they said

in their response to Wyeth

http://www.fda.gov/ohrms/dockets/dockets/05p0411/BHRTletter.html

" 4 Therefore, your request that FDA initiate enforcement action against

BHRT compounding pharmacies that violate the FDCA, in the form of

seizures, injunctions, andlor warning letters, is denied. In addition,

to the extent you request that FDA take enforcement action with respect

to those specific activities you describe, such as labeling and

advertising that fall outside the scope of traditional pharmacy

compounding, such requests are also denied. "

However they did actually send out warning letters.

The matter of the estriol (USP25450-8)will no doubt be cleared up because of

many statements published on the web regarding its Monograph being published

which exempts it from certain regulations. I could not find the Monograph.

Ora