Many millions of women depend on it. Action Alert!
In 2008, the FDA – likely acting upon a petition it received from Wyeth Pharmaceuticals, the manufacturer of Premarin (an estrogen drug made from pregnant horse mares’ urine) – went after bioidentical hormones, particularly estriol. Thanks to ANH members and the wider natural health community, the FDA backed off. Now, they see an opportunity to remove estriol and other hormones by other means and we must once again mobilize to stop them.
The latest attack has been launched by nominating bioidentical hormones to the Difficult to Compound List. The track record thus far suggests that nomination is virtually identical to removal. Given that customized, bioidentical hormones are safe, effective, and not difficult to compound, why is this happening? Unfortunately, the FDA appears to be working at the behest of drug manufacturers whose products compete with these compounded hormones. Why else would consumer access to safe, efficacious products be denied?
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) makes recommendations to the agency concerning which ingredients should be allowed to be compounded. Since being set up, it has been diligently eliminating almost every natural medicine that it reviews.
Now, crucial bioidentical hormones, including progesterone, progesterone combined with estradiol, and estriol, are about to be eliminated through this process. Once these hormones, along with related delivery systems such as time-release, have been placed on the FDA’s “Difficult to Compound List,” they cannot be made at any compounding pharmacy.
The plain fact is that these hormones are not difficult to compound by any stretch of the imagination. Nominators argue, for instance, that bioidentical hormones are “difficult to compound” in part because they aren’t water soluble. This is correct—which is why pharmacies typically employ creams to deliver bioidentical hormones. (By contrast, many FDA-approved hormone drugs come in pill form, which may not be absorbed into the body.) Nominators say that the particle size of bioidentical hormones cannot be guaranteed—yet raw materials purchased by pharmacies are guaranteed by their manufacturer to correspond to a particular particle size. In short, the arguments that try to prove hormones are “difficult to compound” are false.
Another argument we’ve heard coming out of the FDA and PCAC is that, if there are commercially available drugs on the market, there’s no need for a substance to be compounded. Back in 2008, there were no bioidentical drugs in this class. Now that there are, the FDA apparently wants to ensure that they have a monopoly.
Quite apart from the undesirability of government protected monopolies, which lead to spiraling prices, this argument betrays a complete lack of understanding of compounding. The whole idea of pharmacies making individualized medicines is so that patients with special needs—those with allergies or other sensitivities, those who can’t swallow pills, those who need different dosage strengths or transmission forms ( eg. cream rather than tablet) than the market version of a drug, etc.—can get the medicine they require. Drug companies often prefer tablets because they are easier to produce. Does this mean that women should be denied access to a cream?
The FDA’s hostility to customized bioidentical hormones has nothing to do with safety. We noted at the time that the FDA acknowledged it hadn’t received any adverse events pertaining to estriol, which shouldn’t come as any surprise: its safety profile is exceptional. Not only that: it can reduce the risk of taking other hormones and can reduce the risk of inflammation and cancer.
Actually, there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”
Other researchers have reached similar conclusions:
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer [emphasis added].
ANH-USA is putting together a major public campaign to demonstrate to the FDA that millions of women rely on bioidentical hormones to stay healthy and will deeply care about what happens here. We are also taking this issue to Capitol Hill, educating members of Congress about the FDA’s push to get customized bioidentical hormones off the market in order to create a monopoly for the drug industry.
The FDA and PCAC need to hear from patients and practitioners that we will not stand for this: it’s bad medicine and bad public policy. Women have a right to choose, with advice of their doctor, the medicines that best fit their needs. Take action below, but also tell us your stories. How have compounded bioidentical hormones helped you or someone you love? How has estriol helped you? Putting a human face on an issue makes it more difficult for the FDA to continue prosecuting its War on Women’s Health.
Action Alert! Write to Congress, PCAC, and the FDA, telling them that we need access to compounded bioidentical hormones like estriol. Also, if you have a personal story you want to share, send it to [email protected] Your stories will help us demonstrate to policy-makers that patients will not tolerate the FDA removing access to protect the pharmaceutical industry.
This is one of those government agencies that needs to be torn down from the top to the bottom. The FDA CEO Margaret Barnhart was arrested for withholding lethal side effects of a drug that killed 5000 people. FDA is a rogue agency.
I think you meant to say Margaret Hamburg
you are right. Please pardon
Until you posted that comment, I knew nothing about the Margaret Hamburg (and husband) racketeering affair. I’ve been reading articles since then. I totally missed that from last year. The FDA is indeed a swamp. She got her job by giving lavish donations to Hilary, the clinton foundation, and Obama. Last year, her husband gave 15 million to Trump and she gave 15 million to Hillary. They were covering their bases to make sure the Dept. of Justice under whomever’s administration will do no more than make a plea dill of a fine and not jail time.
And The FDA is going after compounded hormones and homeopathy because its safe and effective. This country is in so much trouble.
They only allow things that they get their pockets lined for. Its ok to poison our food and soil because Monsanto is lining their pockets. KEEP YOUR NOSE OUT OF OUR NATURAL HEALTH CHOICES.
Estriol/progesterone/testosterone are needed..can’t take one without the other usually. Bioidentical hormones are saving my life.
Wendy: me, too! I was tested several years ago after a decade of never having enough energy, not ever. Finally, a brilliant doctor recognized the problem, I was tested and was makng NO HORMONES! I felt dead inside all those years and missed 10 yrs of my life. Have been on the now for several years with no health problems from them.
I will have no life at all if they are made illegal – this is absolutely cruel and inhumane!!!
I am glad you understand! Bioidentical hormones are “life support” for me. I am not ok without them. I would not be on this earth without them. Very sad! Estriol is needed. I can’t do progesterone only. Estriol gives circulation in my brain. Testosterone is needed to stop swelling and help energy/muscles. All 3 need to be in the right ratio. Old fashion HRT can cause clots/stroke, but that is not estriol which is the safest of estrogen. Suzanne Somers told Oprah about them and Oprah attacked compounding pharmacies. Oprah may be using hormones now, but damage is already done. Before that they left compounding pharmacies alone. They try to get rid of Vit C IV/Vit B12 methylcobalamin shot/LDN and EDTA/DMPS IV chelaitions and more which are from compounding pharmacies. I need this kind of help. All Americans need this kind of help, but are not aware of what is offered and how awesome it is. If it works they try to get rid of it.Conventional medicine wants to patent vitamins and more to get rid of the competition. Alternative medicine fixes the root cause. Conventional medicine mostly covers symptoms which keeps a person sick. Alternative medicine saved my life. It is awesome! Thanks for telling me you understand! Ask God to help keep what is awesome going strong now and always in Jesus’ name.Amen! (It shall be so!). Herbs can help hormones also, but would be hard to get the right ratio/dose for each person. God bless!
Hi Wendy – I agree totally with everything you say! Nature’s’ remedies are always best, they work the best. I’m also an herbalist who has learned that Nature is the best healer and has many healing plants. Yes keep it all in Jesus’ name!
Thanks for all the validations! I am glad you understand nature is awesome and can heal people fast. Herbalist is awesome! God bless!
Once again, a giant industry determines federal regulatory policy, and to hell with American citizens. I hope there will be an effective black market for natural treatments for medical issues. Most prescription “wonder drugs” these days contain a whole list of possible side effects, including cancer, depression, serious infections, increased urges to gamble and have sex (I am not making this up), muscle aches and/or deterioration, memory loss, tuberculosis, and others, usually ending with death! I use natural supplements for most of my many (at age 75, they pile up) medical issues, without side effects. Do you have to do this carefully? Of course, same as with prescription drugs. Learn about possible side effects and be on the lookout for them. And do inform health care providers that you take them. I carry a small piece of paper, tucked in behind my insurance card (you know that’s the first concern of any provider) listing my major health concerns, a brief history, and any drugs, OTC products, and natural supplements that I take. It saves a lot of time; all a provider need to do is copy it. And, since some of the supplements i take thin my blood, it is important that it be emphasized, as unusual bleeding could be problematic. I also carry a photo-reduced copy of my advance directive. Better to be prepared than improperly treated.
The Need for these compounds is great. To Ban their usage is a crime. Honestly, the freedoms given to us by God are constantly threatened by the powers of darkness. However GOOD prevails when we stand firmly for GOOD in the face of evil.
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