BioIdentical Hormone Update

Tuesday 13th May 2008

Wyeth is the the largest manufacturer of animal derived hormone, says Steven Russell, R.Ph., President and CEO of Medaus Pharmacy, Inc. of Birmingham , AL , one of the leading compounding pharmacies in the country.What is occurring now, is that Wyeths sales have plummeted over the years because there has been more of an outcry from the public since the Womens Health Initiative, and many physicians have investigated the use of bioidentical hormone therapy. In late May 2002, the Womens Health Initiative (WHI), the largest study ever conducted on hormone replacement therapy (a 16,600-patient study which lasted over five years but was supposed to continue until 2005) was abruptly halted after researchers said the newly identified risks of taking Prempro outweighed its benefits. Prempro, Wyeths hugely popular hormone replacement drug, was taken by millions of women to replace two hormones lost at menopause, thereby reducing the incidence of post-menopausal symptoms such as hot flashes, night sweats and vaginal dryness. But women using Prempro had a 26% higher risk of breast cancer than those taking a placebo, and though it was shown to lower the risk of colon cancer and hip fracture, Prempro raised the number of strokes by 41% and the number of heart attacks by 29%. Study directors advised participants to stop taking the Wyeth medicine and questioned whether other women should continue filling their prescriptions.

Bioidentical hormones are substances with the exact same molecular structure as those made in the human body, and produce the same physiologic responses as the bodys natural hormones. The FDA considers bioidentical hormones to be natural regardless of their source, and as a result, they cannot be patented. Bioidentical hormones that are plant derived have been available for over 20 years. It is these substances that Wyeths petition seeks to drive from the marketplace.
The differences are several-fold, notes Russell. First off, Premarin is a patented, brand name product derived from pregnant horse urine (thus the name, pre-mare urine). Bioidentical hormones are identical to what the human body produces; there is no difference whatsoever. Premarin is not identical, and has numerous side effects. So a physician has the option of prescribing a product that has not been proven to cause adverse reactions like stroke. They are non-patented, and can be compounded by a licensed pharmacist. Bioidentical hormones are derived from plant sources, as are 60 to 70 percent of most medicinals. The end product is 100 percent identical to what the ovaries produce.

Russell adds that in the Wyeth petition, they do not even mention that it is the physicians choice to prescribe this; they contend it is the pharmacist trying to push it down the consumers throat. So the only way they can attack is to have a citizens group petition the FDA to take this off the market. In this petition they flat out requested an injunction against the ability to market this alternative. Russell says that any prescription written has to meet the guidelines of state boards of pharmacy, as well as federal guidelines. And, he explains, each of the ingredients of bioidentical hormone replacement therapy is approved: They are recognized by insurance companies, there are no restrictions on them, so to state it is "untested and unfounded "is ludicrous, because there are drug companies that have been producing these components for years. In a nutshell, if this comes to pass, no physician or pharmacist will be able to prescribe or compound bioidentical hormone therapy. The overall danger is no freedom of choice.