(Health Secrets) We are in danger of losing compounded medicines. Special interests in the pharmaceutical industry have set their sights on regulating compounding pharmacies and their products out of existence, creating a monopoly for themselves. Among the first to go may be bioidentical hormones, the only safe hormone replacement therapy for women and men.
What are compounding pharmacies?
Before the one-size-fits-all patent medicine industry got going, medicines were made in compounding pharmacies to meet the unique needs of patients as prescribed by their doctors. Compounding pharmacies came into existence centuries ago, and the chemists who worked in them were knowledgeable about natural medicines and their uses. Of course in earlier times doctors were knowledgeable about natural medicines too, and they did not rely on drug companies to tell them how to practice medicine.
Compounding pharmacies have historically been overseen and regulated by the state in which they were located. It is only now that the power of the giant drug companies has become so bloated that the call is out for federal regulation of compounding pharmacies.
Right now, more than 75% of the bioidentical hormone market is held by compounding pharmacies. The Endocrine Society defines bioidentical hormones as compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body. The ingredients of bioidentical hormones are derived from natural sources. Leading products are bioidentical estrogen (estradiol and estriol), bioidentical progesterone, bioidentical testosterone and time-release natural thyroid. These products have FDA approval.
Harvard Health Publications published by the Harvard Medical School says, “you can be confident that they [bioidentical hormones] are safe and effective, and contain what their labels say they do.”
By definition, bioidentical hormones cannot be patented because they are natural substances, and the cost of buying them is quite reasonable.
What big pharma is trying to do
Federal regulation of compounding pharmacies would make it easy to outlaw compounded bioidentical hormones and replace them with standard hormone substitution drugs. These would be the same drugs that were used in the famous 2002 Women’s Health Initiative Study, the research project that was stopped in midstream because so many of its participants developed heart disease, blood clots and cancer from their use.
In other words, big pharma is so greedy for your money but cares so little about you that it wants your access to safe and affordable bioidentical hormones blocked so that you if you want hormone therapy, you will be forced to take highly toxic hormone substitution drugs, selling at exhorbitant prices, that have been known to produce to heart disease, blood clots and cancer!
Several members of big pharma have joined together in the so-called Working Group on Pharmaceutical Safety, for the purpose of lobbying for the passage of bill S.959, sponsored by Senator Tom Harkin (D-IA). As of this writing, the bill is in Committee. The very next step is passage in the Senate and House, which could come at any time.
The leader of the lobbying group is Tommy Thompson, former Director of Health and Human Services under George W. Bush and presidential contender in the 2008 election. Participants include Therapeutics MD (a specialty pharmaceutical company), KV Pharmaceuticals, Auxilim Pharmaceuticals, and Mobius Therapeutics. It is also led by Sarah Sellers, a former FDA official working on compounding pharmacy policy.
Not surprisingly, Thompson is chairman of Therapeutics MD and Sellers worked for Ther-RX, the marketing and distribution arm of KV Pharmaceuticals.
In November, 2012, the Alliance for Natural Health reported that KV Pharmaceutical filed a complaint with the International Trade Commission in an attempt to stop the supply of the ingredients needed to compound a natural progesterone formulation prescribed for women with high-risk pregnancies to help prevent pre-term births. This formulation costs $200 per pregnancy. KV manufactures Makena, a $13,800 per pregnancy synthetic form using a patented toxic progesterone substitution drug known as a progestin. Progestins are the most lethal of the hormone substitution drugs and the primary reason the Women’s Health Initiative Study was prematurely halted.
Eliminating the compounded progesterone formulation, known as 17P, would make the drug prohibitively expensive for many women, an outcome that would be responsible for mothers losing their babies. In addition, sensitive women are unable to tolerate the synthetic version because it contains benzyl alcohol as a preservative. Benzyl alcohol has been linked to neonatal deaths.
Clearly the members of the lobbying group and their clients have a vested interest in pushing for the FDA to outlaw vital compounded medications and in passing S.959. With compounding pharmacies out of the way and a monopoly in its pocket, big pharma will be able to roll out new versions of these products and charge whatever it wants to for them.
If you are interested in stopping this, go to https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=1617
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