FDA: horses over humans

[eric_t12]

"In a society in which it is a moral offense to be different from your neighbor your only escape is to never let them find out."
-- Robert A. Heinlein

Subject: Stop the Killer Horse Hormones

Estrogen hormones derived from animals have dangerous side-effects. Estriol doesn't. But the FDA has banned Estriol in favor of the animal derived hormones. Here's why ...

Wyeth Pharmaceutical makes animal derived hormone medications. On October 6, 2005 Wyeth petitioned the FDA to prohibit the use of Estriol, a competitor to Wyeth's "horse hormones." Estriol is chemically identical to human estrogen, while Wyeth's horse hormones are not. Animal derived hormones are associated with a number of health risks, such as blood clots and cancer, while Estriol is associated with a vast number of health benefits, and NO negative side-effects.

On January 9, 2008 the FDA responded to Wyeth's petition by banning the use of Estriol.

It's infuriating to note that the FDA's response to the Wyeth petition calls it a citizen's petition. It was no such thing. It was a petition from a corporation seeking government aid to prohibit a competing product at the cost of increased danger to women's health. By contrast, 70,000 doctors, women, and other real citizens petitioned the FDA to deny Wyeth's request, but the FDA partially sided with Wyeth anyway.

It's even more infuriating to note that the FDA admitted in a press conference announcing the ban that it knew of no evidence of any harm associated with the use of Estriol.

The American Association for Health Freedom summarizes the case for Estriol as follows: "Compounded bio-identical hormones have been used for 50 years, are listed in the US Pharmacopoeia, are state-regulated, are available only with a doctor’s prescription, and were protected by a previous Act of Congress (FDA Modernization Act 1997)."

The FDA admits that it granted Wyeth's request simply because Estriol has not endured the FDA's costly and time consuming approval process. But should the estrogen that naturally flows in a woman's body have to be approved by the FDA? Of course not. Neither then, should Estriol, which is chemically identical to that estrogen! Estriol is human estrogen.

If Estriol needs to be banned from the market then perhaps all women should report to an FDA lab to have their Estriol removed from their bodies.

We are joining with the American Association for Health Freedom to try to stop this outrage. We want to pass two resolutions in Congress: H. Con. Res. 342 and S. Con. Res. 88. Please ask your Representative and your two Senators to co-sponsor H. Con. Res. 342 and S. Con. Res. 88. You can do so here.

We would also like to note that if Downsize DC's "Write the Laws Act" were the law of the land this FDA action would not have been possible. Please send another message in support of the "Write the Laws Act," and use your personal comments to mention the Estriol ban as a reason why we need the "Write the Laws Act." You can send that message here.

Please also consider making a contribution to further our work. You can do so here.

Thank you for being a part of the growing Downsize DC army.

Jim Babka
President
DownsizeDC.org, Inc.
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From my downsize DC emailer -

I would favor the opposite, myself.

[jmichna]

Amazing... I am speechless.

Do you have a link to the FDA's response, to see what their reasoning was?

[MonsterRain]

Wow, I usually try to steer clear of the Political Forums but I thought I would jump in and clear up some of the misconceptions and outright lies presented in this article.

To start with these "killer horse hormones", known by the brand name Premarin (named so because it is derived from PREgnant MARe uRINe, useless trivia), is not the only drug product that has side effects. As a matter of fact, ALL estrogen replacement products greatly increase the risk of blood clots, stroke, etc. This includes all oral contraceptives (excluding POP's, progestin only pills), which DO NOT contain estrogens derived from horses. These are synthetic estrogens, known as estradiol.

Secondly, Estriol has not endured the tests needed to prove it is both SAFE and EFFECTIVE as outlined by the Food, Drug, and Cosmetic Act of 1938. This act requires that drugs (marketed as cures or treatments for a specific condition, not as herbal products or supplements) be proven to be reasonable safe and be able to achieve the outcome proposed by the drug company. In layman's terms, the drug should not cause an unreasonable percentage of maladies when compared to positive outcomes and if the label says "to treat high blood pressure" it will actually lower blood pressure. Estriol has not endured this testing, making it ILLEGAL to market this substance as having the ability to CURE disease!!!! That was the reason for the FDA injunction concerning Estriol, compounding pharmacies were advertising this substance as being SAFE and EFFECTIVE for treating menopausal symptoms (aka: misbranding...highly illegal).

I'm not even going to waste my time addressing the idiocy of this statement: "If Estriol needs to be banned from the market then perhaps all women should report to an FDA lab to have their Estriol removed from their bodies." To start with, Estriol is not "banned" from the market...it's not even considered a drug!

Again, the whole hubub surrounding this issue is truthfully because of false advertisement, misbranding, and failure to prove a drug safe and effective before marketing as such; NOT because of a giant gubment conspiracy to keep women taking horse hormones.

Perhaps read the FDA's statement on the issue and compare the truth to the fantasy. FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

Letter from Margaret O'K Glavin RE: Docket No. 2005P-0411/CPl & SUP1

[eric_t12]

The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown.

...to them.

Did you happen to find anything important concerning the claim that the Horse Hormones DO NOT cause DEATH!?

While the projected effects are unknown (to the FDA, and therefore the idea that they somehow know it's 'misrepresentation' is absurd to me) they seem to be fairly certain that the other option - horse hormones - can cause some VERY SERIOUS side effects.



and by the way - aren't the FDA the ones who thought it was tomatoes that caused the (what was it) outbreak?

i have links too! McClatchy Washington Bureau | 08/01/2008 | Tomato growers blame FDA for hundreds of millions in losses

They also blamed tomatoes as the culprit - when it was obviously untrue.


Tell me again why i should be first in line to take the FDA's word that something is right or wrong?

[MonsterRain]

Ok, so apparently you didn't really read anything I posted, so I'll say it AGAIN. Estriol is not being targeted because it is unsafe or ineffective...it has not been shown to be either. However, it has not been shown to be safe or effective either. That's all well and good, but if a company (the pharmacies compounding the drugs) is going to market the product as a miracle cure for Alzheimers Disease and all these other maladies they claim Estriol will cure, they HAVE to have evidence to back that claim up. Premarin went through all of the effort to prove their product was both safe and effective back in 1942, hense the reason they are able to market their product.

You'll have to forgive my ignorance on the subject, I'm just a lowly Doctor of Pharmacy, but who claims that Premarin does not have adverse effects (read: death, secondary to blood clots/heart attack/stroke)?? This has been a well established risk of any estrogen containing product, and I'll bet you if Estriol were to endure any form of scientific testing would yeild the same results.

I'm not quite sure where tomatoes come into this discussion, but if it is to discredit the FDA then that's fine. I'm not exactly sure that you would be able to distinguish the difference between tainted tomatoes and a tainted irrigation supply (when the tainted irrigation supply was watering said tomatoes) in a few days time, but it was a huge disaster for the tomato farmers and it sucks. I mean it was SOOO obvious that it wasn't tomatoes at the time....right? Pretty much a non-issue when concerning direct violation of a 70 year-old law in a completely non-related area of the FDA.

As for your last sentence, the FDA does not dictate what is right or wrong. They are merely enforcing a law, a pretty common sense law if you know anything about medications, that is/was being boldly violated. Get over it.

[Hellen Bedd]

Well.said

[cucamelsmd15]

Wow, I dont even know where to begin here.

Originally Posted by MonsterRain

Wow, I usually try to steer clear of the Political Forums but I thought I would jump in and clear up some of the misconceptions and outright lies presented in this article.

To start with these "killer horse hormones", known by the brand name Premarin (named so because it is derived from PREgnant MARe uRINe, useless trivia), is not the only drug product that has side effects. As a matter of fact, ALL estrogen replacement products greatly increase the risk of blood clots, stroke, etc. This includes all oral contraceptives (excluding POP's, progestin only pills), which DO NOT contain estrogens derived from horses. These are synthetic estrogens, known as estradiol.

Regardless of what you think you know, there is NO established efficacy or risk information on equilin and equilenin that ARE contained in Premarin. Hint: those arent human forms of estrogen. Only the estrone in Premarin is converted to estradiol, more specifically, the estrone sulfate is converted to estradiol. Androstenedione, which is the intermediary is converted to estrone and testosterone in women. You can argue pathways all you want, but part of that is missing in women that take any kind of replacement hormone, period.

Secondly, Estriol has not endured the tests needed to prove it is both SAFE and EFFECTIVE as outlined by the Food, Drug, and Cosmetic Act of 1938. This act requires that drugs (marketed as cures or treatments for a specific condition, not as herbal products or supplements) be proven to be reasonable safe and be able to achieve the outcome proposed by the drug company. In layman's terms, the drug should not cause an unreasonable percentage of maladies when compared to positive outcomes and if the label says "to treat high blood pressure" it will actually lower blood pressure. Estriol has not endured this testing, making it ILLEGAL to market this substance as having the ability to CURE disease!!!! That was the reason for the FDA injunction concerning Estriol, compounding pharmacies were advertising this substance as being SAFE and EFFECTIVE for treating menopausal symptoms (aka: misbranding...highly illegal).

I'm not even going to waste my time addressing the idiocy of this statement: "If Estriol needs to be banned from the market then perhaps all women should report to an FDA lab to have their Estriol removed from their bodies." To start with, Estriol is not "banned" from the market...it's not even considered a drug!

Again, the whole hubub surrounding this issue is truthfully because of false advertisement, misbranding, and failure to prove a drug safe and effective before marketing as such; NOT because of a giant gubment conspiracy to keep women taking horse hormones.

Perhaps read the FDA's statement on the issue and compare the truth to the fantasy. FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

Letter from Margaret O'K Glavin RE: Docket No. 2005P-0411/CPl & SUP1

Blah, blah, blah.

Let me fill you in on a little secret. The FDA is about as biased and special interest run as any other branch of our government. This is a FACT. You can argue with this all you like, but I have personally seen it first hand over a number of years.

Perhaps you need to do a bit more reading, specifically double blind placebo studies. There have been numerous studies that are too difficult to summarize with the amount of crap you just posted, but judging by your post, Id say you havent glanced at the first one.

Originally Posted by MonsterRain

Ok, so apparently you didn't really read anything I posted, so I'll say it AGAIN. Estriol is not being targeted because it is unsafe or ineffective...it has not been shown to be either. However, it has not been shown to be safe or effective either.

See above.

That's all well and good, but if a company (the pharmacies compounding the drugs) is going to market the product as a miracle cure for Alzheimers Disease and all these other maladies they claim Estriol will cure, they HAVE to have evidence to back that claim up. Premarin went through all of the effort to prove their product was both safe and effective back in 1942, hense the reason they are able to market their product.

You dont understand the difference between taking out a patent on something and actually determining if it is safe and effective. Requirements are much different now than they were then. Additionally:
FDA STATEMENT ON GENERIC PREMARIN

Premarin, the brand name for conjugated estrogens, is derived from the urine of pregnant mares and contains a number of different estrogens. Precisely how each of these various estrogens contribute to the drug's overall effectiveness has not been definitively determined. Premarin's approval in 1942 predated the current requirements for such comprehensive analysis of products under review for marketing approval.

Previously it was thought that two estrogens--sodium estrone sulfate and sodium equilin sulfate, were the sole active ingredients in Premarin. Newer laboratory and clinical studies show this may not be the case. Rather, other components in Premarin may contribute to the drug's effectiveness for menopausal symptoms and osteoporosis prevention.

The rest of that article proves without a doubt that Premarin should be under some intense scrutiny, estriol not withstanding.

You'll have to forgive my ignorance on the subject, I'm just a lowly Doctor of Pharmacy, but who claims that Premarin does not have adverse effects (read: death, secondary to blood clots/heart attack/stroke)?? This has been a well established risk of any estrogen containing product, and I'll bet you if Estriol were to endure any form of scientific testing would yeild the same results.

Ill forgive your ignorance this time.

<-PharmD, who has worked on numerous novel concepts, patents and NDA's.

I'm not quite sure where tomatoes come into this discussion, but if it is to discredit the FDA then that's fine. I'm not exactly sure that you would be able to distinguish the difference between tainted tomatoes and a tainted irrigation supply (when the tainted irrigation supply was watering said tomatoes) in a few days time, but it was a huge disaster for the tomato farmers and it sucks. I mean it was SOOO obvious that it wasn't tomatoes at the time....right? Pretty much a non-issue when concerning direct violation of a 70 year-old law in a completely non-related area of the FDA.

As for your last sentence, the FDA does not dictate what is right or wrong. They are merely enforcing a law, a pretty common sense law if you know anything about medications, that is/was being boldly violated. Get over it.

As for your last sentence, you couldnt be more wrong.
21 CFR part 210 and 211. Look it up. Read it. And I can tell with that last sentence, youve never sat through an FDA audit. Ive been through three, one of which lasted a month. If you know anything about the FDA, you know that 70% of their workforce is within 7 years of retirement and riding it out. Furthermore, you know that the majority of their auditors have little to no practical scientific knowledge. Again, furthermore as a PharmD, you should know that the FDA is a reactive agency, not a proactive agency, which means that they dont enforce **** until something happens. Things are boldly violated every day, and nothing dealing with the FDA is "common sense", as you so eloquently put it. The ONLY reason the FDA enforced this here is because Wyeth (who conveniently happens to hold the patent for THE major HRT on the market up until recently) complained. If that doesnt spell special interest, I dont know what does.

The fact of the matter is, not everything is as cut and dry as you believe it is. Get over it.

[eric_t12]

They are merely enforcing a law, a pretty common sense law if you know anything about medications, that is/was being boldly violated. Get over it.

Oh my...

So now 'common sense laws' are all that need enacted? That sounds awfully similar to some other people's defense of bad, worthless laws.

I'll let you, the good Dr., figure out who those persons may be.




Also, seeing that the FDA acknowledges that the generic Horse hormones "drug's overall effectiveness has not been definitively determined," and that the drug's acceptance "predated the current requirements for such comprehensive analysis of products under review for marketing approval," I fail to see how any of your arguments against Estriol are even relevant.

You say the FDA doesn't say what's right or wrong, but you apparently seem to think they're right, yet your evidence and Cucamelsmd15's both say pretty much the same thing.

Neither has been fully tested, yet one's legal (because it predated newer checks) and one isn't (because it hasn't).

So your idea of "Common Sense" is to prohibit something with the same characteristics (as noted above) as something that is not prohibited?

And as for reading your statement - I did. And it still makes no sense.






PS -

but it was a huge disaster for the tomato farmers and it sucks.

aww, how thoughtful of you to still back the FDA's approval process, and feel so compassionately towards those who lost millions, because of its failed policy.

hey - THEY TRIED, right?

[MonsterRain]

I don't believe I ever defended the FDA's integrity, positives or negatives of their drug approval process, or the fact that they do or do not cater to special interests. Also, I never said the FDA was "right". I am simply making the argument that the original highly biased and highly flawed article is not presenting all of the facts.

The argument is whether it should be legal for said pharmacies to market a compounded product containing Estriol while making claims that it cures Alzheimer's disease, menopause symptoms, osteoporosis, etc. Why is it again that Estriol should be exempt from the same standards that every other new drug product since 1938 has been held to? Also, where is the evidence supporting these claims of miracle cures or being free of side effects?

You can argue till your blue in the face whether it is "fair" that Premarin was grandfathered in, but the fact is there are numerous studies available that show Premarin is effective, reasonably safe, etc. The law has been on the books since 1938 and has been applied equally and fairly to my knowledge. Any drug that was grandfathered in is legal, but if a new company wants to market a generic or new dosage form they must meet current FDA standards. That applies not only to Premarin, but to Asprin, Theophylline, and all other grandfathered drugs. Fair or not, logical or not, it's not something being created to protect Wyeth.

If you don't agree with the law, that's one thing; but violation of the law is just that...plain and simple. If you want the law changed, go about it through the correct channels and make the case as for why a drug should not have to be proven safe and/or effective. Just like with gun laws you don't agree with, I don't know that anybody here would go out in public and blatantly violate the law to get it changed. I think it would convey a certain level of "common sense" to get the law changed the right way and not get your butt thrown in jail.

As for your quote about questioning Premarin's mechanism of action, I fail to see your point. I understand that some studies have brought into question exactly how Premarin treats symptoms of menopause, but it states right in your quote that the drug is still effective for this indication (just maybe not how they originally thought). There are numerous drug products on the market with MOA's that are not yet fully understood, but are still widely recognized as effective. However, this was never an argument of chemistry or pharmacology. It is an argument of legality. Please make the argument to me that it should be legal what these pharmacies did. If your argument is simply that the FDA is "crooked", then I don't want to hear it. I don't want conspiracy theories or personal issues with the FDA, give me a sound legal argument that supports the marketing of a non-approved substance for non-approved indications while claiming "a vast number of health benefits, and NO negative side-effects."

Also, I will admit that I was incorrect in my assumption that Premarin had satisfied the FDA's safety and efficacy standards. It was a grandfathered product under the FD&C Act of 1938, my source showed the drug as being approved in 1942 and I assumed it was not grandfathered. However, that does not negate the fact that this product has endured numerous studies that have shown it to be safe and effective.

[cucamelsmd15]

Um, yeah, did you read what I posted? Lets begin...

Originally Posted by MonsterRain

I don't believe I ever defended the FDA's integrity, positives or negatives of their drug approval process, or the fact that they do or do not cater to special interests. Also, I never said the FDA was "right". I am simply making the argument that the original highly biased and highly flawed article is not presenting all of the facts.

Bolded part: incorrect.

As for your last sentence, the FDA does not dictate what is right or wrong. They are merely enforcing a law, a pretty common sense law if you know anything about medications, that is/was being boldly violated. Get over it.

Again, this isnt about enforcing the law so much as its about glad-handing the right people.

The argument is whether it should be legal for said pharmacies to market a compounded product containing Estriol while making claims that it cures Alzheimer's disease, menopause symptoms, osteoporosis, etc. Why is it again that Estriol should be exempt from the same standards that every other new drug product since 1938 has been held to? Also, where is the evidence supporting these claims of miracle cures or being free of side effects?

Why again is it that herbal products are exempt from FDA regulations? Those claims are printed on their labels. Where is the FDA action on those? Why arent the drug companies bemoaning the use of herbal products. You need to step back and take a look at the larger picture.

You can argue till your blue in the face whether it is "fair" that Premarin was grandfathered in, but the fact is there are numerous studies available that show Premarin is effective, reasonably safe, etc. The law has been on the books since 1938 and has been applied equally and fairly to my knowledge. Any drug that was grandfathered in is legal, but if a new company wants to market a generic or new dosage form they must meet current FDA standards. That applies not only to Premarin, but to Asprin, Theophylline, and all other grandfathered drugs. Fair or not, logical or not, it's not something being created to protect Wyeth.

Im going to take a stab here and say youre either a recent grad or just talking out of your ass at this point, based on the bolded portion. Ill also take a stab here and say you probably dont work in the industry, but rather behind a counter somewhere. Moreover, you need to read the FDA statements on generic Premarin. Then you need to re-read them. In fact, here is a reading list to get you started:
1. FDA statement on generic Premarin
2. Wyeth statements on generic Premarin
3. Waxman-Hatch Act
4. SYNTHETIC CONJUGATED ESTROGENS: MAY 5, 1997

That should be enough to get you started. Pay specific attention to the fact that Premarin and some of its ingredients are not fully characterized. Im not talking about MOA's here, Im talking about NOT CHARACTERIZED. That means there is NOTHING known about those products and their potential therapeutic effects and/or side effects.

As for your quote about questioning Premarin's mechanism of action, I fail to see your point. I understand that some studies have brought into question exactly how Premarin treats symptoms of menopause, but it states right in your quote that the drug is still effective for this indication (just maybe not how they originally thought). There are numerous drug products on the market with MOA's that are not yet fully understood, but are still widely recognized as effective. However, this was never an argument of chemistry or pharmacology. It is an argument of legality. Please make the argument to me that it should be legal what these pharmacies did. If your argument is simply that the FDA is "crooked", then I don't want to hear it. I don't want conspiracy theories or personal issues with the FDA, give me a sound legal argument that supports the marketing of a non-approved substance for non-approved indications while claiming "a vast number of health benefits, and NO negative side-effects."

Also, I will admit that I was incorrect in my assumption that Premarin had satisfied the FDA's safety and efficacy standards. It was a grandfathered product under the FD&C Act of 1938, my source showed the drug as being approved in 1942 and I assumed it was not grandfathered. However, that does not negate the fact that this product has endured numerous studies that have shown it to be safe and effective.

Lets break this up into points.
1. I knew you would fail to see my point, it was expected. See my previous statement about characterization and effects.
2. I knew you would bring this up as well. Again, see my previous statement about characterization and effects. Despite drugs with unknown mechanisms of action, those compounds are still characterized via numerous standards, by-products and breakdown products characterized and all that information is known.
3. Actually, if youve been paying attention, this IS an argument of chemistry and pharmacology on its most basic level. Im guessing you missed that, huh?
4. We will break this into two parts.
Red: Ignorance is bliss, I guess. Im not talking about personal issues with the FDA or conspiracy theories, Im talking about things I have seen FIRST HAND in years of industry experience. Ive been through audits, Ive sat in the hot seat. My experience with that vastly outweighs whatever you think you know about the FDA, because I have seen first hand on numerous occasions how the FDA really works.
Black: One word: Herbals.

I think you need to dry off behind the ears and get some facts straight, and then you will see where Im coming from.