Volume 6, Issue 32 August 15, 2013
Why bio-identical hormones
may soon disappear

Here's something that happens to me and thousands of doctors around the country every day. Mary or Jim comes in for their annual visit and to have their bio-identical hormone prescription refilled. "I just have to tell you, Doc, I feel great on these hormones. I need them refilled." Naturally, there's rarely a problem with fulfilling that request.

But what if there was a problem?

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What if the FDA was able to do what they have wanted to do for years: make sure that you can't get bio-identical hormones? What if you had to hear your doctor say, "Sorry, you are no longer able to get your custom-made bio-identical hormone prescription. The FDA has mandated that the only forms of hormone therapy you can have are the unsafe and ineffective synthetic hormone drugs provided by Big Pharma." There is a very real possibility that this is exactly what will happen in the near future. And here's why.

Remember that outbreak of fungal meningitis that killed 31 people last fall? The cause was a contaminated steroid injection that a compounding pharmacy prepared. That pharmacy was ultimately closed down after inspectors found out that it had been violating existing regulations by using non-standardized and unclean sterility procedures. In addition, although compounding pharmacies are authorized to be mixing medications only on an individual prescription-by-prescription basis, that pharmacy ignored the rule. It was manufacturing on a much larger scale, which is how it evaded regulatory scrutiny.

There are already regulations on the book that would have prevented this tragedy. The problem is that these regulations were ignored by the pharmacy. So what's the logical solution? To me it's a no-brainer - tighten up on the enforcement of the regulations that are already on the book. But unfortunately that's not the response that Big Pharma wants. They want to use the occasion to give the FDA new and unprecedented powers over everything that compounding pharmacies do for doctors and patients. This includes regulating whether or not they can continue to make bio-identical hormones for you. And here's why that's a bad plan.

The FDA has already made it clear that it doesn't like the idea of compounding pharmacies making their own bio-identical hormones. It doesn't even recognize the validity or effectiveness of bio-identical hormone therapy (BHRT). The agency openly declares on its website that "‘BHRT' is a marketing term not recognized by the FDA."

Many of you will remember that back in 2008, the FDA actually tried to ban compounding pharmacies from using the female hormone estriol. Estriol is a vital component of female bio-identical hormones. The only thing that stopped the FDA from being successful was that they did not have the legal jurisdiction to dictate to compounding pharmacies what they can make for doctors treating their own patients. But all that could change real soon.

There is a bill now in the United States Senate (S. 959) that would give the FDA the authority to do just that. S. 959 gives the FDA the power to dictate what your doctor can ask a compounding pharmacy to make for you. This, of course, includes bio-identical hormones. But that's not all. It would also include any other natural form of medical treatment that a doctor might want to use with his/her patients. Remember that Big Pharma cannot get a patent on any natural medication. So the only way doctors can get them for their patients is to have a compounding pharmacy make them up. If the FDA is allowed to have the kind of power that S. 959 is offering them, I can guarantee you that they will quickly ban any natural medication that Big Pharma considers to be in competition with one of its patented drugs. That includes all your hormones.

We already have more than enough Big Brother regulations in the U.S. We don't need any more. Specifically, S. 959 gives the FDA the unquestioned authority to ban the most common bio-identical treatments used by millions of women. S. 959 also gives the FDA the authority to declare compounded bio-identical hormones to be a copy of a manufactured drug. While a doctor could still continue to write prescriptions for bio-identical hormones, federal bureaucrats could intrude into his or her medical practice and require documentation and justification. This is totally unwarranted and intimidating. Many women already have trouble finding the personalized, natural treatment they need to control their menopause symptoms. This would make it even harder and much more expensive.

Even so, you can be sure the Big Pharma/FDA lobbyists will go out of their way to make senators believe that giving the FDA unbridled authority over how compounding pharmacies can help doctors treat their patients with natural medication is necessary in order to prevent another compounding pharmacy disaster. It isn't. All that needs to be done is to enforce the regulations and laws that are already on the books.

So if you agree with me that S. 959 is not needed, please take a few moments to stop it. Go to www.mymedsmatter.com. They have made it really easy to send a letter to your senators explaining your thoughts and feelings about increased FDA power over your life. We have stopped these kinds of intrusions on our medical freedom before, and we can stop it this time as well. Our senators just have to hear from us. Otherwise, the only information they get is from the lobbyists. Please contact your senators today!

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