Many women use bioidentical hormones from compounding pharmacies for relief of menopausal symptoms. In fact, so many women are turning to bioidenticals that a significant chunk of the menopausal health care dollar has been diverted from the drug companies.
And now we got trouble – right here in River City. The FDA has told seven compounding pharmacies they may not "make misleading claims" that bioidentical hormones are better than the synthetic ones. The impetus behind this decision? A petition from Wyeth pharmaceuticals – yes the people that brought you Prempro and Premarin, hurtin’ cowboys financially since the WHI study was halted due to dangerous side effects.
Now, technically the FDA may be correct that no double blind research validates that bioidenticals are safer (Gee wonder why that is – maybe no real money to be made, so the research was not funded.) On the main page of the FDA website describing their recent action, they also say this: "All patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their health care provider to determine if compounded drugs are the best option for their specific medical needs."
Sounds like an appropriate measured response, doesn’t it? Then I dug a little further into the FDA website, and found another little part to their action:
"In addition, FDA warned a number of pharmacies that they may not compound drugs containing the estrogen substance estriol without a valid investigational new drug application. Firms that do not properly address violations identified in Warning Letters risk further enforcement, including injunctions that prevent additional violations and seizure of violative drugs."
I can tell you from my experience as a nurse that getting an investigational drug permit is a BIG deal. You don’t just go to the wizard and ask for one. Think killing the wicked witch was a difficult task? Try obtaining and implementing an investigational drug protocol from the FDA! I’m not a conspiracy theorist, but I do believe that the FDA is bowing to pressure to limit access to bioidentical hormones and this is only the first step.
Here’s the kicker. It’s not like we can individually call up a compounding pharmacy and order our own hormone therapy willy nilly. A physician MUST prescribe it. And they have been prescribing estriol for decades. Safely. Responsibly. The FDA admits that its action was not a concern for safety. There have been no recorded instances of any adverse effects with the use of Estriol, probably because it is a natural hormone in our body.
There has been a tremendous response from physicians and women like us, filing comments with the FDA and writing our congresspeople. But we need to be vigilant and proactive here. We can’t let the government restrict our (and our physicians) access to bioidentical hormone therapy. For more information, on contacting your elected representatives, download the attached pdf document and/or click on the link below for HOME (Hands Off My Estrogens) Coalition,