Compounding is a method of preparing medications that are customized for a patient’s specific needs. Compounding allows prescribers (such as doctors and other medical professionals) and pharmacists to create medications that are the exact strength, dosage, and ingredient mix best suited to treat a particular patient. Compounding allows prescribers and pharmacist to customize medical treatment depending on an individual’s allergies, age, medical background, and even flavor and delivery preferences.
Decades ago, almost all medications were compounded to account for each individual’s unique needs; however, after the emergence of mass drug manufacturing in the 1950s and 60s, patients have often been subjected to a “one-size-fits-all” approach to medicine.
The ability of medical professionals to tailor treatment to an individual patient’s needs is a critical part of the doctor-patient relationship and empowers individuals to seek treatments that will be the most beneficial to their health and well-being.
Natural medicines threatened
In November 2013, the Drug Quality and Security Act (DQSA) was signed in to law, which tightened federal control over compounding pharmacies. As we discuss in our Save Compounding campaign, the FDA has recently released a number of troubling regulations implementing this law—regulations that are harmful to doctors, patients, and compounding pharmacists. Of course, Big Pharma would like nothing more than to see these medicines, which compete with their drugs, removed from the market by their friends in the FDA.
Not only has the agency persistently ignored congressional intent in its elimination of “office use” (when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem), it also threatens to eliminate dozens, if not hundreds of supplements from being compounded, since the agency has unilaterally decided that supplement monographs will not make supplements eligible to be compounded by 503A facilities.
Supplements and natural substances must be pre-approved by the FDA to be legal to compound, and the FDA is senselessly rejecting almost all natural substances—curcumin, boswellia, and aloe vera to name just a few.
Under the DQSA:
- Bioidentical hormones are threatened—estriol in particular (see below), but also testosterone, estradiol and progesterone, are currently all at risk. The danger is that the FDA has arbitrarily and nonsensically found them “too difficult to compound,” despite their having been compounded for decades. Time-release thyroid drugs are also endangered.
- Compounded IV treatments are also at risk. These are doctors’ drips of critical nutrients (including even the most common vitamins, e.g. C and B and minerals) into the patient’s blood, and are essential for many, many ailing patients. IV vitamins, minerals, and other nutrients (which are considered drugs when used in an IV) are already less accessible and much more expensive because the new regulations—as is the case with injectable B12, which has risen in price by almost 700% in the last decade
- Individualized chelation medications are on the chopping block as well. Chelation is used by integrative physicians to remove heavy metals like lead, cadmium, and arsenic from the body. Doing so can clear up many, many health conditions and prevent worse ones from developing. The process involves injecting patients with organic chemicals—such as edetate disodium (EDTA), which is typically compounded—that bind and remove the heavy metals present in the bloodstream. In IV chelation, mineral and nutrient IVs are typically added to support the body during the detoxification process.
- All compounded dietary supplements must be pre-approved, with one potential exception—unless it is a component of an approved drug. Compounded chelation drugs are also threatened. Ironically a controversial government-run study recently reaffirmed chelation’s effectiveness for heart disease and other problems, much to the dismay of conventional medicine critics and Big Pharma companies.
- After the FDA’s new regulations were released, insurance companies stopped paying for many compounded drugs, further reducing access.
With all of these issues combined, it will be increasingly difficult for compounding pharmacies to stay in business. If they disappear, so will many important natural medicines.
Case in point: bioidentical estriol
This isn’t the first time the FDA has gone after bioidentical estriol. In January 2008, the FDA issued several warning letters to compounding pharmacists prohibiting the compounding of medications with estriol—a bioidentical estrogen that is produced naturally by a woman’s body. This action was taken in response to a Citizen Petition filed by Wyeth Pharmaceuticals, the maker of the synthetic hormone replacement drugs Premarin and Prempro.
The FDA immediately developed a public awareness campaign about bioidentical hormone replacement therapy and issued a new policy banning pharmacies from compounding hormone medications—short of going through a time-intensive new drug approval process. Fortunately, such policy has not been strictly enforced and consumers still have access to compounded bioidentical products.
The FDA permits drug compounding with active ingredients (such as estriol) that are not components of FDA-approved drugs if the substance is shown to be safe and effective for the use which it is being prescribed. FDA issued the ban on estriol without knowing the safety or the effectiveness of the substance.
In fact, in announcing the “new policy” on estriol, FDA admitted it had not received a single adverse event report from the use of this hormone or any evidence of harm from the product. FDA was simply reacting to pressure from a major drug company attempting to insulate patentable products from a readily available bioidentical therapy at the expense of women’s health. Estriol is a very weak and beneficial hormone, and has been used safely in the U.S. for decades. It is approved in Europe, Japan and other developed nations and is a standard of care in most of the world. In fact, Wyeth sells estriol in Europe.
The reason for Wyeth’s request on estriol is clear: over 80 percent of all compounded bioidentical estrogens contain estriol, and thousands of women prefer a bioidentical hormone during menopause versus a synthetic product. Wyeth manufacturers synthetic hormone replacement drugs and by successfully influencing the FDA to ban estriol, Wyeth has free rein to capture the market. Synthetic patentable products are extremely profitable and the increase in demand for the bioidentical product was a threat that Wyeth needed to address.