Now, after a long pause, we will address what I consider one of Big Pharma's most dangerous threats to our health and our ability to take charge of it. To help us understand and respond to this serious challenge, I have asked Mike Belcher, RPh, a good friend and valued colleague for the past 25 years, to describe this evolving situation and make suggestions about what we can to about it
Is Big Pharma A Threat To Your Compounded Prescription?
Big Pharma is at the heart of corporate America. The individual companies within Big Pharma are in heated competition with each other to gain market share for each of their individual products and in the bigger picture are in competition with all of corporate America for investment dollars from potential stockholders. With only 1% to 10% of all prescriptions dispensed being compounded according to testimony given before the Senate Committee on Health, Education, Labor, and Pensions in 2003, one would assume that a compounded prescription would be no threat to Big Pharma.
A compounded prescription is a prescription that has been ordered by a physician for a product that is not commercially available from a pharmaceutical manufacturer. The compound prescription must be prepared by a compounding pharmacist who formulates the prescription from bulk chemicals into a dosage that is customized to suit the needs of the individual patient. So if between 99 and 90 percent of all prescriptions dispensed are filled with products from Big Pharma, are compounded prescriptions for us a threat to Big Pharma? The logical short answer should be NO! But occasionally the perfect storm is created and the consequences and precedents that were set in the following scenario could be devastating to compounding pharmacies, physicians who utilize compounded products, and the health of their patients who depend on compounded products if similar situations arise in the future. This is it and 22 are we are fired at night if you in the end it tells me that I get this point and in inappropriate amount of resources to open my medical practice and developing my diet of practice have gotten three so far today helmet
This perfect storm began brewing in 2002 and culminated in 2008. In 2002, a study for the long-term use of hormone replacement therapy, which had been conducted by the National Health Institute as a part of the Women’s Health Initiative, was abruptly terminated due to the increase risks of strokes, heart attacks, blood clots and breast cancer experienced by study participants. The drugs that were used in the study were Premarin and Prempro made by Wyeth Pharmaceuticals. Sales of these two products fell from over 2 billion dollars per year in 2002 to about 800 million in 2008 according to Drugs.com – a significant loss of revenue for Wyeth. About this same time period, Suzanne Somers through her book and the publicity she received through the Oprah Winfrey Show sparked tremendous interest in bio-identical hormones. As women began discontinuing their Premarin/Prempro due to the health risks associated with these drugs, they sought out physicians to replace their Premarin with bio-identical hormones (BHRT). In 2005, Wyeth filed a Citizens Complaint with the Food and Drug Administration requesting that the FDA take actions against pharmacies that were engaged in the compounding of bio-identical hormone replacement therapy. Wyeth asserted that the efficacy and safety of the drugs being compounded were not subjected to the same FDA scrutiny as manufacturers were required to comply with and that pharmacies were making false claims regarding the products and mislabeling the products. One can speculate that Wyeth did this in order to protect the dwindling market share of its products. If the competition could be crushed by government intervention, then the sales of their products would return to previous levels.
Mike will continue this discussion in the next post.