Will the FDA allow massive drug companies to eliminate your access to compounded bioidentical hormones? Action Alerts!
Recently, the FDA released a list of nominations to its “Demonstrably Difficult to Compound” (DDC) list. This list derives from section 503A of the Food, Drug, and Cosmetic Act. It is supposed to identify drugs that cannot safely be compounded because of their complexity.
If the FDA approves these new nominations, your access to certain kinds of hormones that are biologically identical to the hormones in your body, such as progesterone (including progesterone with estradiol), human chorionic gonadotropin (HCG), testosterone, and estriol, could disappear. Drug companies would then have what they always want—a government-enforced monopoly—even though the pharmaceutical versions or their alternative products are often substandard or even dangerous.
We reached out to compounding pharmacists and asked them if these hormones were indeed difficult to compound, or if there had been any adverse events or customer complaints regarding the safety of the medications. The resounding answer was No, that these hormones did not present any particular difficulties to compound, and the only safety issues they were familiar with were allergic reactions from the delivery system—for example, if the preparation was contained in a topical cream, one might see an allergic reaction to the cream base. The pharmacists were not aware of any other significant safety issues to the compounded medicines themselves.
Access to these compounded drugs can be a life-and-death issue. Take estriol, for example—one of the three types of estrogen produced by the body. By the 1990s, one-third of menopausal women were taking Premarin, which comes from horse urine estrogens and is not bioidentical to human estrogen. Unfortunately:
- Research showed that Premarin and other synthetic forms of estrogen were linked to a much higher risk of breast cancer, blood clotting, and heart disease.
- A study published in the Journal of the American Medical Association showed that women who took Prempro—a combination of Premarin and synthetic progestin—were twice as likely to die from breast cancer.
- Other evidence has shown that synthetic hormone replacement therapy is linked to an increased risk of stroke, with other possible side effects including osteoporosis, high blood pressure, vaginal bleeding, and weight gain.
Bioidentical estriol, on the other hand, not only appears to be safer, it has also been shown to improve bone density, promote youthful skin, and enhance urinary health. In short, limiting patient access to compounded estriol and other bioidentical, natural forms of hormones is a terrible idea.
Not only are these specific hormones being targeted, but the systems for delivering them are targeted as well. Also on the list of nominations to this list are bioidentical hormones in pellet form, dry powder inhalers, metered dose inhalers, transdermal delivery systems, and time-release dose forms. Even creams could be at risk, because big drug companies almost always sell hormones in tablet form, even though many hormones simply do not work this way, and must be taken as creams to be safely and effectively utilized by the body.
Compounded medicines are—by definition—meant to conform the very particular needs of the individual patient. If you have trouble taking pills, or require specialized doses, or need a gluten-free form of a medication, a pharmacist can meet your personal needs. It is this precisely customized medicine that seems to be coming under attack here, and it doesn’t take much imagination to guess where the attack is coming from.
Of the seventy-one total nominations, multinational Big Pharma giant and sixth-largest drug maker in the world, GlaxoSmithKline (GSK), nominated twenty-seven different medications for the list. It should come as no surprise to learn that many of these nominations represent competition for the top 100 best-selling branded drugs—one of which was in the top five drugs of all time. The only shock over GSK’s nominations was that they were identified as such!
Some of the other nominations may have also originated from major drug companies, but they were submitted in a stealthier manner. An initial review of the DDC list provides some clues:
- The specific bioidentical hormones were nominated by three doctors. Wulf Utian, an independent consultant to the pharmaceutical and investment banking industries, nominated the oral and topical forms of estradiol, progesterone, and the combination of the two. Dr. Carolyn Quist, who runs a women’s health clinic, nominated estriol, despite the fact that she actually recommends compounded estriol creams in her practice. Dr. Kenneth Woliner, who runs what he describes as a holistic family medical practice, nominated the natural hormone HGC (human chorionic gonadotropin), even though he always prescribes bioidentical hormones for women needing hormone replacement therapy. When we contacted these doctors’ offices to ask why they made these nominations, none of their offices returned our calls. Do they really think they have some special knowledge of how difficult these drugs are to compound, despite their own prescribing history? Are they now doing the bidding of Big Pharma for some reason? We just don’t know.
- Public Citizen, a Washington, DC-based nonprofit, was behind all of the nominations in the more general “complex dosage forms” category. We don’t think they have any connections to the pharmaceutical industry; it’s likely that they simply do not have the facts right about the dangers of these different forms of delivering compounded medicines, or else they are pursuing a different agenda.
What will happen now? Normal procedure would be for the FDA to review the list of nominations, respond with its own list, and give the public an opportunity to weigh in. But it appears that the FDA may deny the public any input. We sincerely hope the FDA will follow these rules, but experience has made us somewhat skeptical. Regular readers will remember that the FDA has viewed public involvement as an unnecessary roadblock as it adds items to the Withdrawn or Removed list—essentially eliminating certain compounded medicines from the market.
Three Action Alerts!
- Send a message to the FDA, asking the agency to follow the rules and issue a proposed rulemaking before finalizing its Demonstrably Difficult to Compound list. Also tell them how important the survival of these compounded drugs is for you.
- Send a message to the doctors who nominated bioidentical hormones to the DDC list, and urge them to rescind their nominations to protect patient access to important treatments.
- Send a message to drug giant GSK protesting their sneak attack on your medical choice, letting them know that they are further damaging their standing with the public.
Please send your messages immediately.