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» LymeNet Flash » Questions and Discussion » Medical Questions » FDA Restricts Bio-identical Hormones

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Author Topic: FDA Restricts Bio-identical Hormones
Truthfinder
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Terrific.

Big Pharma lashing out again because they're losing too much money from 'the competition'.

80% of my bio-identical HRT is estriol, which the FDA has decided can no longer be used in formulation of these bio-identical hormones..... which is interesting because preliminary studies showed that it is the SAFEST of all the estrogens.....

Also, this suggests that licensed NDs (in certain states) can no longer prescribe bio-identical hormones....

quote:

http://www.fiercepharma.com/story/fda-cries-halt-tobio-identical-hormones/2008-01-10

FDA Cries Halt to 'Bio-identical' Hormones
January 10, 2008

Women taking "bio-identical hormones" generally think they're getting relief from menopausal symptoms, without the nasty risks of Big Pharma's hormone replacement therapies. But the FDA doesn't agree.

The agency has cried foul to seven companies that make the products, saying these alternative hormones aren't any safer than regular HRT--plus, one common ingredient in the mix has never been reviewed and approved by government regulators.

The action will likely rein in the boom in bio-identical hormones that began when research showed that regular HRT can significantly increase the risk of stroke, heart attack, and other serious problems.

The seven pharmacies warned can still sell compounded hormones, but without the unapproved ingredient estriol and without using the term "bio-identical." And the products must be prescribed by a doctor.

Though the agency denies it, the FDA's crackdown certainly appears to have been prompted by Wyeth playing tattletale. Maker of FDA-approved hormone products, Wyeth petitioned the agency to investigate compounding pharmacies that sell the bio-identical products. The FDA then got more than 70,000 comments from patients, pharmacists, and others--many defending the alternative hormones.

There's a more detailed story here at Fox News:

Wednesday, Jan. 9 2008
FDA Asserts New Policy to Restrict Women's Access to Bioidentical Hormones
http://tinyurl.com/35cw4b

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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oxygenbabe
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Sorry to hear this. Can you import from Canada?
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Munch
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I moved from sublingual estriol + estradiol tablets to estradiol pellets. I didn't notice much difference after dropping the estriol.

My insurance won't cover the cost of pellet citing they are experimental. They are "mental" since they've been in use since the 1950s. Should be on the GRAS list by now.

It's very annoying to have Big Pharma and the FDA dictating what our doctors can prescribe. With this restriction, I would expect class action suits to be filed.

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Lymetoo
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[shake] [rant] [shake]

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--Lymetutu--
Opinions, not medical advice!

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luvs2ride
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grrrrrrrrr!!!

Our healthcare is being driven by greed. Even though we spend so much in healthcare, we are WAY DOWN the list of industrialized nations for our level of health.

Luvs

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When the Power of Love overcomes the Love of Power, there will be Peace.

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D Bergy
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Can't use bio-identical hormones, but the Horse **** kind from Wyeth are just fine and dandy. Just more nonsense from the FDA that is an insult to anyone with a brain.

Ever get the feeling that it really is not about the patient at all?

D Bergy

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Truthfinder
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That's a thought, Oxy. I hadn't considered trying to get it outside the U.S. Although, it sticks in my mind that Canada may be worse than the U.S. on this one.... but they are not the only foreign country out there.....

No, Munch, you probably didn't notice much. Estradiol is so much stronger, both in controlling unwanted symptoms (i.e., hot flashes, flagging libido) and in creating side effects (like weight gain, moodiness, pimples on your face, etc.)

But the last I checked, estradiol is still implicated in causing breast cancer, while estriol actually helps protect against breast cancer.

So of course the FDA will `ban' the safest estrogen, and do it under the auspices of `safety' considerations.

The FDA approves the use of viruses to be sprayed on our fruits and vegetables and other foods, but bans something where there is no evidence it represents any danger.

Frankly, I think perhaps it is time that the upper administrators of the FDA should be elected, just like our congressional leaders. I don't believe that this practice of being `governed' by an untouchable agency falls within authorized constitutional principles.

Ron Paul for President? I think his grassroots support speaks for itself. We are tired of the duplicity in our government.

I ran across a couple of interesting quotes lately......

quote:
The FDA is a "partner" of the Pharmaceutical Industry - In an unusually candid comment for a senior government official Dr. Herbert Ley, former FDA commissioner, remarked: ``The thing that bugs me is that the people think the FDA is protecting them. It Isn't. What the FDA is doing and what the public thinks its doing are as different as night and day.''

#################################

We have members of congressional committees stating that the U.S. Food and Drug Administration is "badly broken." We also have a letter from the FDA in response to a query letter from Rep. Ron Paul (R-TX) regarding the agency's involvement in the Trilateral Cooperation Charter (TCC) with Canada and Mexico under NAFTA. The TCC is moving toward regulating public access to vitamins, herbs and botanicals as prescription drugs, per the Codex Alimentarius scheme, throughout North America.

So, on one hand we have an agency that is notoriously poisoning the public in collusion with Big Pharma here at home and, on the other, it is working with its Canadian and Mexican regulatory counterparts to restrict public access to the natural substances that could make us well again.
- by Byron J. Richards, CCN

http://www.shirleys-wellness-cafe.com/ama.htm#a

If anybody has been watching the Republican debates, there was an interesting exchange between Senator McCain and Governor Romney. Bottom line: McCain believes that the big pharmaceutical companies are `a problem', and Romney thinks they are not a problem and are good for America.

Oh, sorry. Didn't mean to get into the political thing.

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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clairenotes
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This is the nature of competition, which allows that new and better products can be brought into the marketplace. It seems that this should hold true in the field of medicine more than any other area. So this is a bit confusing...

Maybe Wyeth could come up with some new drugs to make up for the loss in profits to bio-identical hormones.

Claire

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oxygenbabe
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Reminds me of what Monsanto did in Pennyslvania though I think there is protest. They lobbied successfully to force all dairies who did NOT use bovine growth hormone to be UNABLE to advertise that on their cartons.

So the consumer would now never know the difference. Monsanto argued that since bovine growth hormone is "safe" (yeah right) that it was giving their competitors an unfair advantage. If that isn't capitalism turned evil, what is?

It's all about money. They don't care how far they bend the law or whom they hurt. (And on a food related, not hormone related issue, it turns out that chicken can be labelled "all natural" when it has been pumped up with sodium phosphate up to 15% in "water weight" and the resulting sodium is more than a bag of salty potato chips. So sincere folks trying to buy hormone-free milk and say, be on a low sodium diet because of high blood pressure, are getting bilked again for money. Natural is a popular label, and water weight means consumers are paying more for their heavier chicken, they are paying for salt water).

By the way Tracy did you know the adrenal glands are a backup source of sex hormones? There is a formula called phytocort by Allergy Research Group, I doubt I could tolerate because of the licorice, but it helps restore adrenal function. I know of a few midlife women who lost weight and got regular periods back on the herbs.

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Lymetoo
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quote:
Originally posted by Truthfinder:
So of course the FDA will `ban' the safest estrogen, and do it under the auspices of `safety' considerations.

Of course. The FDA has never been about public safety....they just SAY they are protecting us. Yeah, right.

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Opinions, not medical advice!

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Lymetoo
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quote:
Originally posted by clairenotes:
Maybe Wyeth could come up with some new drugs to make up for the loss in profits to bio-identical hormones.

Oh sure. More c**p for the public!!

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--Lymetutu--
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clairenotes
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Lymetoo -- c**p would (or should) be subject to competition, also, if it is, in fact, a fair playing field.

Claire

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Truthfinder
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Claire, you hit it on the head: No COMPETITION.

Big Pharma operates as the equivalent of a drug cartel, and they don't just want control of meds in North America, they are working hard with the WTO to make their domination global.

If anybody saw the movie ``Sicko'', I would love just one politician - or even just one Talking Head on TV - explain to me just exactly why the one woman paid $180 a month for her inhaler medication in the U.S., but could buy it in Cuba for 5 cents. How does that happen? Why can't we here in the USA buy our meds from cheaper sources outside the U.S.? Doesn't this equate with a government-sponsored monopoly?

John D. Rockefeller - famous in part because of his Standard Oil monopoly and his `contribution' to the direction modern medicine has taken via the AMA - is famous for proclaiming ``the only sin is competition''.

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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Truthfinder
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Okay, back on the hormonal front....

Yes, Oxy, I believe it is the adrenals that produce most of the estrogen after menopause. However, I think they primarily produce estrone - the 3rd estrogen - as estrone is the predominant estrogen in a woman's body after menopause. I know little about estrone and any protective/ risk properties it might represent. I do know that it is also available from formulary pharmacies in bio-identical HRT preparations.

I used to use an adrenal supplement called Isocort - got it from my ND. It contains no licorice. I may consider it again.....

Isocort ingredients:
Freeze dried Adrenal Cortex (Soluble Fractionation), Echinacea Extract, Prunus spp. [Wild Cherry] and Lomatium Dissectum Root Isolate [Fernleaf Biscutroot - parsley family] (Kreb Concentrate-2%)

Phytocort:
A Proprietary Blend 1600 mg [Reishi (Ganoderma lucidum) Extract, Shrubby Sophora (Sophora flavescens) (Root) Extract, Chinese Licorice (Glycyrrhiza uralensis) (Root) Extract, and Noni (Morinda citrifolia) (Fruit) Extract]

There's also a specific herbal that my homeopath swears by..... I'll have to look through my notes to find that again.

Of course, there are some homeopathic remedies to deal with menopausal issues and hormone imbalances, and if that were my only issue, I'd look into that.

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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bpeck
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H-E-L-L-O Truthfinder....

The truth is that only 7 pharmacies have been notifed to stop compounding.

See the actual FDA Bulletin below:
If you get your HRT by prescription from a physician,or Heath care provider - then Estriol WILL continue to be included. While this is a political issue by Weyth - it does not restrict all use of Estriol.
At least ist's still available- so that women have other choices that PERMARIN (which I boycott becuase of how it's made- from pregnant Mare Urine..)

I do agree though that this was initiated by Weyth because there's beaucoup $$ to be made as recent research shows Estriol is be very helpfull in postmenopausal bone density.

SO it's a bummer if somehow you are getting estriol without a prescription.

QUOTE:
FDA's action today does not target pharmacists who practice traditional pharmacy compounding and who do not make false or misleading claims about compounded products. Traditional pharmacy compounding typically involves preparation of a drug for an individual patient by a pharmacist in response to a valid prescription from a licensed practitioner. This compounding follows a practitioner's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA's current view on human drug compounding is addressed in its compounding Compliance Policy Guide, available at http://www.fda.gov/cder/pharmcomp/default.htm.
END QUOTE

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Truthfinder
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Thanks bpeck, I'm glad you've got it figured out, but I'm unable to determine exactly WHAT is going on with the Estriol issue...... and neither can some ob/gyn docs who prescribe it.

By the way, the link you posted doesn't work. Also note that the general statement you posted from you link mentions nothing about HRT at all.

It is my understanding that estriol is not ``FDA approved'' and therefore won't be available through any compounding pharmacy. Perhaps I am wrong.

To the best of my knowledge, BHRT has always been available only by prescription. (I'm not talking about `natural progesterone' creams and the like.) My PCP doc prescribes it for me. As I stated before, in some states NDs have been able to prescribe it in the past, as well as orthodox medical docs. I'm not sure if this aspect has been affected or not.

If there is a way to get estriol without a prescription, I am unaware of it.

One article over at Yahoo news says, according to Deborah M. Autor, director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research during a Wednesday afternoon teleconference:

quote:
``[FDAs rep] Autor noted that estriol has not been approved by the FDA for any use. In fact, it's illegal to put estriol in a compound unless the maker has a valid FDA investigational new drug application.''
Also, saw this:

quote:
`` Since the FDA's new position is that compounds containing estriol represent a 'new drug' it would be improper for me or any other medical practitioner to continue to prescribe Estriol compounds at this time, " says Cheryle Hart, M.D., who is Mayo Clinic trained and Board certified in Ob/Gyn. ``"It is really up to the compounding pharmacies and their organizations, PCCA and IACP to get this straightened out with the FDA.''
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-11-2008/0004735028&EDATE=

I've been checking the website where I get my compounded BHRT to see if there are any news updates..... nothing so far.

At least one of the seven pharmacies that received `warning letters' doesn't understand what is going on either.

quote:
The seven pharmacies are Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; Reed's Compounding Pharmacy of Tucson, Ariz.; and Pacifica Pharmacy of Torrance, Calif.

Phil Pylant, the owner of Village Compounding Pharmacy, said he couldn't figure out why his company was being singled out by the FDA. "I am one of 5,000 to 8,000 compounding pharmacies in the country that's doing the exact same thing -- including CVS and Walgreens -- and they all use the same drugs we use. Why they picked me out, I have no idea."

Pylant noted that all his compounds are made to order from a doctor's prescription. "We are order-takers, pharmacies cannot do anything without an authorized written prescription," he said. "If FDA had indicated that estriol was illegal, we wouldn't have used it.

http://www.ajc.com/health/content/shared-auto/healthnews/drug/611587.html

So far, it is looking and quacking pretty much like a duck to me....

--------------------
Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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Lymetoo
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Tracy said, "It is my understanding that estriol is not ``FDA approved'' and therefore won't be available through any compounding pharmacy. Perhaps I am wrong."

I just refilled my prescription for estriol and the pharmacist said some of the pharmacies got into trouble for advertising it.

She said that you can't make claims of what the HRT does as it has not been tested and proven. So for now, it's available unless you were getting it from a pharmacy that got into trouble with the FDA.

Big Pharma is of course not happy that compounders are taking money away from them.

Where's my violin?

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bpeck
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TruthF:
Read LymeToo's post right after yours.. SHe's got it right.

It's not all labs..

I use it too- and my coumpounding pharmacy can still use it.

Barb

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MaryOH
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This is so disturbing to me. I was on Lupron and high dose birth control pills to control my endometriosis. I then got breast cancer at the age of 35. I'm thinking there's a link between the two. So, not having bioidentical hormones available could create more breast cancer patients. Wow...just wow....
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Lymetoo
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quote:
Originally posted by MaryOH:
So, not having bioidentical hormones available could create more breast cancer patients. Wow...just wow....

And just think....They don't give a rip!!

PS... I refilled my estriol this a.m. after reading this link today....just letting you guys know it was recent.

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Truthfinder
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Thanks, Lymetoo and Barb..... if you guys are right about this, then the FDA is certainly doing their very best to confuse the public.

When an FDA spokesperson says, ``estriol has not been approved by the FDA for any use. In fact, it's illegal to put estriol in a compound unless the maker has a valid FDA investigational new drug application'', that certainly sounds to me like Estriol won't be available.

I just dropped an e-mail to my compounding pharmacy and asked for a clarification from them.

I agree, MaryOH...... it's almost unthinkable that any agency or any pharmaceutical company (Wyeth) would make an issue out of something potentially cancer-preventative, without substantial evidence that there is some greater hidden danger.

I recall that a few years ago, there was some pilot study done with Estriol in MS (not sure which type of MS - I think RR) which showed it reduced myelin lesions in the brain during the treatment period.

The implications of a possible true, disease-modulating treatment for auto-immune diseases from a non-patentable substance must make companies like Wyeth go completely crazy. No wonder they want Estriol restricted in any way they can.

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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bpeck
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For the record... I am greatly releived that NOT ALL compounding pharmacies are effected..

but I also know there's recent research that Estroil (E3) is EXTREMELY important to bone density health and can improve bone density even extremely elderly women.. so there may be a push by the drug companies to limit it's use so THEY can market it in a "novel" way.. meaning patent it for NOVEL uses...

So lets hope they can't limit the use of it when physicians prescribe it.

But the whole thing worries me.
Yah- the way it's being announced is confusing to what the actual FDA ruling is.

Barb

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Truthfinder
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Barb, I hadn't heard a thing about the bone density aspect.... thanks for that tip.

I meant to mention that to you yesterday. [Smile]

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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Truthfinder
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I got a reply back from my compounding pharmacy - Women's International -

They basically said that they are currently investigating the situation, that they disagree wholeheartedly with this new FDA position, and to watch their website for updates.

They also said that they would still continue to provide me with my medications (at this point).

Good grief. It sounds like they aren't exactly sure what the FDA wants from them either.

I just wonder if some docs will now refuse to prescribe it (like the one ob/gyn doc that I posted about) based on the FDAs statements?

Grrr. [cussing]

--------------------
Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time just take a few moments to say a prayer wherever you are.

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