To My Blog Subscribers,
I need to bring to your attention what has been going on in Washington as it relates to your ability to have access to compounded medications. I have been prescribing compounded substances including bioidentical, natural hormones for nearly 20 years. I can assure you that if the FDA removes compounded substances from the marketplace, we all will suffer. The FDA has been looking for an opening in order to eliminate compounding pharmacies. Unfortunately, they found their opening when a rogue compounding pharmacy’s products killed and injured hundreds of patients. This pharmacy and the people who did this should be held accountable. However, that doesn’t mean we should get rid of compounding. The FDA should concentrate on regulating prescription drugs–which kill hundreds of thousands of patients per year. The FDA has not done too well regulating prescription drugs. What makes you think they will do better with compounding pharmacies? Big Pharma is behind this push as they want compounding pharmacies to be a thing of the past. If we don’t make our voices heard, compounding pharmacies will be a thing of the past. I am encouraging each of you to read this post and send your comments to your Senators and Congressmen and women.
Access to your bioidentical hormones is at risk again! Take action immediately at www.MyMedsMatter.com to oppose the provisions contained in S.959 that give the FDA the authority to restrict or even eliminate the bioidentical hormone replacement therapy (BHRT) that women depend on.
Five years ago, FDA tried to ban the most commonly compounded BHRT treatments. The agency failed because it did not have the authority to do so. This bill gives the FDA the authority to do that and much more. It’s that simple.
Here’s what is happening.
On May 22, 2013, a powerful Senate Committee approved legislation, S.959, which would give FDA unprecedented control over compounding pharmacies and the medications that patients depend on. This legislation is in response to the tragedy caused by the New England Compounding Center in which a rogue pharmacy acted like a manufacturer and violated numerous laws that ultimately killed many people and made even more gravely ill. We all agree that patient safety is of utmost importance. Like us, I’m sure you would support legislative efforts to improve quality and assure safety. But this legislation has turned into a bill that can deny men and women access to the medications they rely on.
Here’s the short version on how S.959 can affect you and the BHRT you take:
•FDA would be able to ban certain components of compounded BHRT if, in the opinion of the FDA, they pose “public health concerns.” That’s exactly what a drug company asked FDA to do with BHRT containing estriol back in 2005. Estriol is one of the most common components of BHRT, so this action would have disrupted the lives of countless women. The FDA ignored the voices and comments of more than 77,000 patients and physicians and three years later in 2008 they sided with the drug company, even though the FDA could not document a single adverse event with estriol. Fortunately, the FDA did not have the authority to enforce its decision in 2008. S.959 would give the FDA that authority.
•FDA would be given the authority to declare your BHRT to be “copies” of drug-company products that cannot be compounded, even though the products you use are not commercially available.
•A doctor could use an “exception” in the bill to continue a woman’s prescription, but he or she could be required to document a clinical difference in using compounded BHRT as opposed to drug-company products. Many women have trouble finding the personalized, natural treatment they need to control their menopause symptoms. This could make it even harder.
FDA has been openly hostile to BHRT. According to its literature, “’BHRT’ is a marketing term not recognized by the FDA.” With a hostile attitude that refuses to even recognize the important medication that countless women take as legitimate, what do you think FDA will do when they get full authority to determine whether women can have access to BHRT? And the drug companies would love to eliminate the competition for their synthetic hormones.
Please take action today at www.MyMedsMatter.com. Email your Senators and Congressmen and demand that they remove these dangerous provisions from this bill. We are all for increased safety, but the NECC tragedy should not be used to deny you the medications you need. Tell Congress what you think. Click to enter your ZIP Code and address and send emails to Congress!
DrB
Amazing. Government’s idea of protecting us that is what they want us to think. In reality our illustrious government wants nothing more than to control our body and mind. Trying to trick some of us in to believing the GMO food is perfectly harmless in my opinion should be looked at as a criminal act on their part. They want us to believe that the FDA knows what is safe for us is an oxymoron. They are claiming that their are components of compounded BHRT and that it claimed lives last year. This is true. Can you tell me that an error cannot be made by pharmaceutical companies? Absolutely untrue. Do you remember a few years ago the flu vaccine was tainted and several people died? What is the real reason for wanting to control compounding…..$$$$$. Our pharmaceutical companies want to control what and how much we get based on how much money they will get from the product not how safe it is for you.
Gayle,
It was not compounded bioidentical hormones that caused the deaths. It was compounded injectable steroids that was contaminated that caused all the problems.
As far as I know, I have not seen any deaths attributed to the use of compounded, bioidentical hormones.
DrB
Given the fact that they allow GMOs, HFCS, MSG, and God knows what other poisons to ruin our food supply, this doesn’t surprise me. It seems like our government is on a mission to ruin the health of its citizens.
The government is why I’ve used supplementation for two decades. I rarely take a prescription, except the Synthroid I’m stuck with right now. Hopefully not forever though after hearing what you had to say about iodine. Articles like this make me want to become a Lugol’s hoarder. If something natural works, of course they’re going to try to get rid of it.
Good grief! I honestly wonder if I’ll need to move abroad some day to get away from crazy US politics and big pharma. Thanks for the alert – I will definitely throw my hat in the ring.
We must all stop big pharma and the FDA from controlling the freedoms we all should have, this is America, I thought!
Remove from S.959 the information on BHRT. The only advantage is to help the Drug Industry and bankrupt the peoples health and pockets that use BHRT. The pharmaceutical alternative causes health issues that are not reversible.
Please ensure the FDA keeps hands off the compounding pharmacies. The products they make are a Godsend to people who cannot use the sythetic and animal hormones the regular drug manufacturers produce. The FDA is another of those government organizations that should be deleted and their duties turned to the respective states.
WoW. The FDA thinks they know what women want. Well all those men and their cronies
want to force women (and men, who take testosterone) to spend $100’s of dollars a month to buy the Big Pharma equivalent
to compounded hormones. That is NOT what we want. Those of us who are fortunate enough to afford compounded
hormones now already pay quite a bit, but a fraction of what it would cost for Big Pharma’s version – my compounded medicine cost now is $100-$120/ month as opposed to theirs at around $450 for the same amount of bio-identical estradiol, plus I don’t know how much for progesterone and testosterone. It’s simply unaffordable, and I will not touch their non-bio-identical versions of hormones as they are an invitation to more health problems and more side effects. If the FDA
banned these compounded hormones, there would be a good many people who would suffer debilitating symptoms if forced to stop taking them, including myself. There are also many other medications that are compounded that are vital to people who are looking for optimal health, and not a substandard, sickly version that mainstream medicine would have us live with. We cannot go back to the dark ages and allow powerful men to take away our choices. We cannot allow a government agency to take away our health freedoms because they the pawns of Big Pharma!!! And in the USA!!!
If the FDA succeeds in eliminating BHRT millions of women will be at the mercy of big pharma and their FDA-approved hormone therapy Premarin. I took Premarin for years and it caused tumors in my breasts. Compounded estriol, in very small amounts, keeps breast tissue free of tumors and relieves symptoms like hot flashes. Big Pharma is not able to help us. Send your emails to your Congressmen and Congresswomen. A simple vote from them will rescue millions of patients.
Thank you,
Alice Licht
Thank you for posting this. I’ve emailed my rep and senators in NM, and I posted this on Facebook. Talk about a power grab!
America was founded on freedom and it is being taken away from us. shame on you!! do you think everyone is made exactly alike? no we are not and if you think so you are not very smart to say the least!! please continue to have compounding pharmacies formulate how much medicine patients need. there can be dire consequences of getting too much or too little of a medicine.;