From FDA scrutiny to bashing from doctors to debates on Oprah, compounded drugs, namely bioidentical hormones, are receiving a lot of attention lately. The reasons for criticism are suspect, and the whole debacle deserves a response.
Compounded drugs require a doctor’s prescription and are prepared by a licensed pharmacist who mixes or adjusts drug ingredients to customize a medication in order to meet a patient’s individual needs. The drugs are often made in a unique strength, or without certain chemical fillers or dyes, or in a different method of delivery such as topical creams or sub-lingual lozenges.
Is Compounding Safe?
The U.S. Food and Drug Administration (FDA) has stated that compounded prescriptions are ethical and legal as long as they are prescribed by a licensed practitioner for a specific patient and are compounded by a licensed pharmacist. The bulk drug substances used in a compounded medicine must qualify for use in compounding either via FDA-approved lists or via a listing in the U.S. Pharmacopoeia National Formulary (USP/NF), published by an independent standard-setting organization.
Pharmaceutical companies are regulated by the FDA in order to insure safety and consistency in their products. Compounding pharmacies are regulated by State Pharmacy Boards and regulations may vary from state to state. In Colorado, the State Pharmacy Board applies the same standards for safety and consistency as does the FDA.
What does Bioidentical Mean?
“Bioidentical” means 100% identical in molecular structure to the same molecule in our body. Not close, but identical. I remember as a medical student asking a professor of gynecology, “Why would we give women estrogens synthesized from horse urine (which are not bioidentical), when we have the bioequivalent at our disposal?” The answer was that we had lots of studies showing it treated menopausal symptoms and protected the heart and bones of women.
It wasn’t until many years later that we learned about the risks, such as breast cancer, blood clots, stroke and heart attacks, with hormones that are not bioidentical nor administered in a physiologic manner. Bioidentical hormones have been adequately studied and do indeed show a much greater safety profile.
Bioidentical hormones were being compounded long before drug companies even existed. Up until the 1950s most drugs were made by compounding. Now less than 1% of drugs are made by compounding pharmacies. This is not because of safety issues! The need for research and development combined with efficient production is what spawned the modern pharmaceutical industry.
The controversy over compounding pharmacies really started when compounded bioidentical hormones started taking some of the market share from the commercially produced drugs used for hormone replacement. The controversy is about money, not safety or purity.
A natural substance can’t be patented and sold for profit. So, what drug companies do is invent some substance that is “close enough” to see similar effects in the body, but different enough to be unique and thus get a patent. Then they spend lots of money to do large studies and hope the drug shows more benefit than harm.
Drug studies are usually funded by the company making a new drug. The FDA oversees the industry, and receives funding from drug companies. These studies end up published in our medical journals, before which we doctors often genuflect our intelligence and worship as the sole source of knowledge. Thus, the pharmaceutical industry, in cahoots with the FDA, supplies the “cookbook” that feeds the pipeline for modern medicine.
I am not against pharmaceutical companies or commercial drugs. Quite the contrary – pharmaceutical companies spend billions to develop wonderful new medications that save lives and promote health – I prescribe those drugs routinely and I am very grateful for them.
The issue is simply not accepting as gospel everything the drug industry claims. For example, remember Vioxx, the arthritis drug made by Merck? According to the British medical journal, The Lancet, the actions of both Merck and the US Food and Drug Administration (FDA) contributed to the nearly 30,000 excess cases of heart attacks and sudden cardiac deaths that resulted from the use of the drug between 1999 and 2003. While Merck sought to cover up the danger of its own drug to protect its bottom line, the US government aided the company by approving sale of the drug without conducting any serious investigation into potential harmful consequences of its use. Merck and the FDA let that one slide until there were enough deaths they were forced to “let the cat out of the bag” and recall the drug. Does that sound safe or trustworthy?
For centuries the “apothecary” was the compounding pharmacist. Modern medicine owes much of the origin of pharmacology and chemistry to the apothecary. The modern pharmaceutical industry owes its origin to the apothecary.
I have thousands of patients that are doing very well taking compounded hormones. I also have many who doing very well taking commercially produced hormones. It is simply a matter of the doctor and patient determining what is best for the patient.
I personally inspect and closely monitor the compounding pharmacies I send patients to. I also play an active role in educating and consulting with the compounding pharmacists and their staff. In the same manner, I try to research the pros and cons of new medications coming from the pharmaceutical companies.
So now we have a debate as to whether commercial drug companies are better than compounding pharmacies. Perhaps we need to realize they are simply different paths alongside the same road. At the end of the day, who do you trust most with your health – your doctor and your pharmacist or a corporation? At least for now you still have the choice. In Grand Junction we are fortunate have Western Colorado Specialty Pharmacy as compounding specialists.
Scott Rollins, MD, is Board Certified with the American Board of Family Practice and the American Board of Anti-Aging and Regenerative Medicine. He specializes in bioidentical hormone replacement for men and women, thyroid and adrenal disorders, fibromyalgia and other complex medical conditions. He is founder and medical director of the Integrative Medicine Center of Western Colorado (www.imcwc.com) and Bellezza Laser Aesthetics (www.bellezzalaser.com). Call (970) 245-6911 for an appointment or more information.