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Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances.

According to the American Association of Naturopathic Physicians (AANP)

these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.

Not to mention the fact that it is highly doubtful these questionable remedies could make it through the FDA drug approval process, which requires proven safety and efficacy.

The FDA’s recent steps to improve drug compounding safety is a welcome curb on these practices. Draft Guidance issued in April addresses both compounding for office use and by prescription. (“Office use” refers to creating a supply of a compounded drug to be used by a health care practitioner as needed, as opposed to compounding a drug per a specific prescription for an individual patient.) In June, the FDA also issued an Interim Policy on substances that can be used in compounding a drug. We’ll discuss how these affect naturopathic practice in a moment.

Compounded drugs

But first, some background: A licensed pharmacist or physician can legally combine ingredients to create a medication tailored to the needs of an individual patient. This is called “compounding.”

Compounded drug products, when prescribed and produced appropriately, can, according to the FDA,

serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such a patient who has an allergy and needs medication to be made without a certain dye or an elderly patient or a child who cannot swallow a tablet and needs a medicine in a liquid dosage form that is not otherwise available.

Because they are not FDA-approved, compounded drugs have not undergone premarket review for safety, effectiveness, and quality, nor are pharmacists and physicians who engage in traditional compounding required to comply with current good manufacturing practices (CGMP).

While the FDA regulates drugs, state pharmacy boards have the authority to impose their own compounding regulations because the practice of pharmacy is governed by state law. States also control the practice of medicine, including “naturopathic medicine.” Unfortunately, in enacting “health freedom” laws and licensing naturopaths and other “CAM” practitioners, states have watered down, or eliminated, a standard of care. This allows health care practitioners to diagnose and treat patients with means that lack sufficient evidence of validity, safety and effectiveness, or, in some cases, lack even scientific plausibility. These means can include compounded drugs.

For example, as described in this article from the Natural Medicine Journal, naturopaths use high dose Vitamin C and other concoctions in treating cancer. Britt Hermes, the former naturopath who quit in disgust and started the Naturopathic Diaries blog, told me in an email that

the protocols described in this article are basically the bread and butter of naturopathic IV practice, as we use high dose Vitamin C and these Meyer’s cocktails for every single medical condition under the sun. It’s the norm to just copy these protocols and apply it to all patients. Also, this is how we learn these techniques. We read about it [in literature written] by other NDs, and then we go and practice it on patients. Since the article is cited, it provides the illusion of being “scientific” or “well-researched.”

But, in keeping with her previous descriptions of the terrible inadequacies of naturopathic education and training, IV administration was, at the time she was in school, an elective and not required to graduate. Her elective was a two-day weekend course where they practiced IV administration of these “medicinal” IVs on other students.

Although she did not learn compounding in naturopathic school, in practice naturopaths mix IV bags in the office.

We did a ton of this. One vial supplied many injections. We did not use only one vial per patient, or a sterile vial for each new injection.

In the clinic where she worked in Tucson, Arizona,

We were ordering bulk product [the substances used in creating compounded drugs] under one patient’s name and receiving large quantities of injectables. We were then administering this product to many, many other patients.

At least the naturopaths where Hermes practiced were licensed. In Colorado, prior to the law registering naturopaths going into effect, the state Medical Board had to issue warning letters to 28 naturopaths for practicing medicine without a license after the state Pharmacy Board reported them for dispensing prescribed medications from a compounding pharmacy.

I hasten to add that naturopaths are not the only ones who are free-wheeling in their use of compounded drugs. A recent government report found that spending by the Medicare Part D program for compounded medicines rose more than 600% from 2006 to 2015. Last year alone, spending for compounded drugs by the program increased by 56%. The report noted that there were several cases in which physicians received kickbacks for writing prescriptions for compounded drugs.

Fungal meningitis outbreak

In 2012, there was an outbreak of fungal meningitis due to contaminated injectable drug products shipped by a compounding pharmacy to patients and health care practitioners across the country. The outbreak resulted in 60 deaths and 750 cases of infection. According to the FDA, this was only the most serious outbreak in a long history of outbreaks associated with contaminated compounded drugs. Since 2012, the FDA has investigated numerous other outbreaks and other serious adverse events, including death, associated with compounded drugs that were contaminated or otherwise improperly compounded. The agency has also identified

many pharmacies that compounded drug products under insanitary conditions whereby the drug products may have been contaminated with filth or rendered injurious to health, and that shipped the compounded drug products . . . to patients and health care providers . . . sometimes in large amounts.

In response to the outbreak, Congress passed the ”Drug Quality and Security Act” (DQSA) in 2013, which added Section 503B to the Food, Drug and Cosmetic Act of 1938 (FD&C Act), creating more stringent controls over compounding pharmacies that produce sterile drugs. (503B defines “sterile drug” as a “drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.”) These include compliance with CGMP, restrictions on the substances that can be used in compounding, adverse event reporting, and registration with the FDA as an “outsourcing facility.”

Compounding drugs not produced by a registered outsourcing facility, referred to as “traditional compounding,” must meet the requirements of Section 503A of the FD&C Act. If a drug is not compounded in accordance with Section 503A or 503B, it is subject to all the requirements of the FD&C Act applicable to new drugs, including the extensive, and expensive, new drug approval process.

While 503A was not amended by the DQSA in a way relevant to our discussion here, the draft and interim guidance covering 503A compounding recently issued by the FDA is part of a series of agency actions taken after DSQA that seek to clean up the compounding industry’s act. These actions are of great concern to naturopaths, who wish to retain the ability to concoct remedies for patients in the manner they enjoyed back in the good old days, when Britt Hermes was practicing.

(This guidance applies only to traditional compounding in a retail pharmacy or practitioner’s office. Hospital and health care systems are governed by different FDA policy.)

According to the FDA’s new Draft Guidance, issued in April, in order to fall within the exemption provided by 503A from registering as an outsourcing facility or going through the new drug application process, a compounding pharmacy can compound a drug only after receipt of a prescription written for an individual patient, who must be identified. Likewise, a health care practitioner may compound a drug only after making a notation in the patient’s chart “who presents with a need for a compounded medication.” The FDA will permit compounding in anticipation of receiving a specific prescription only in very narrowly tailored circumstances based on a history of a patient’s having been prescribed a certain compounded drug in the past, as well as other criteria. The FDA warns that compounders should keep detailed records, which it can review if the need arises. This puts naturopaths and the compounding pharmacies who deal with them under threat of revelation of some funky naturopathic prescribing practices.

In other words, says the FDA, compounding for office use, i.e., stockpiling their favorite mixtures for ready use, either whipped up by a compounding pharmacy or in practitioner offices, is not permitted under 503A. If a practitioner wants to order non-patient-specific compounded drugs, he or she will need to order them from registered outsourcing facilities, which operate under limitations on what they are allowed to produce.

According to an article in Naturopathic Doctor News and Review (click on the print icon to read the article if it does not appear), to comply with 503A, naturopaths are also required to follow the United States Pharmacoepia (USP) standards in applicable circumstances (the author gives creating a Myer’s cocktail as an example), such as mixing ingredients in an enclosed, positive pressure environment, just like a compounding pharmacy would use. He advises naturopaths to familiarize themselves with USP 797, a formidable document. (You can find both the current version and proposed revision here.)

Not only does 503A limit the manner in which compounded drugs can be produced, it limits the substances that can be used in compounding. The FDA’s Interim Policy-Guidance for Industry, issued in June, says that, under 503A, these substances must fall into one of several categories or they cannot be used. Unfortunately for naturopaths, all categories require, in one way or another, some supporting evidence of safety and efficacy. If the substance is already the subject of an USP or National Formulary monograph, or is a component of an FDA-approved drug, it is permitted. If it fails those tests, the substance must be on an FDA list of substances approved for compounding.

The AANP lobbied for inclusion of naturopathic favorites like Artemesia, Boswellia, calcium EDTA, Echinacea, DHEA, DMPS, DMSA, co-enzyme Q10, and germanium on the list. It also wanted to dump the entire Homeopathic Pharmacopoeia of the United States and the USP Dietary Supplements Compendium on the approved list, even though 503A specifically limited compendia to the USP or National Formulary. It also complained bitterly that the FDA was actually requiring evidence – imagine that! – which busy naturopathic clinicians could not be bothered to supply, a tacit admission that naturopaths were using these substances without sufficient proof of safety and efficacy. The AANP explained how the conventional medical system had failed the typical naturopathic patient (whose “immune systems are often depleted”), but, because naturopaths

are trained to find the underlying cause of a patient’s condition rather than focusing solely on symptomatic treatment [they expertly prescribe and administer] safely compounded medications – including nutritional, herbal, and homeopathic remedies [which] prove efficacious to meet their needs every day in doctors’ offices across the country.

So, these substances are efficacious, according to the AANP, they just couldn’t tell the FDA how they came to that conclusion.

Until the FDA can establish a final policy, it will not take action against a pharmacy or health care practitioner using substances for which adequate information for evaluation was submitted to the FDA, pending the FDA’s completion of its evaluation. This list includes Boswellia, but the clock is ticking and its inclusion on the final list is not assured. Germanium is on the list of substances that raise significant health risks and cannot be used. Many other naturopathic favorites are on the list of substances nominated without adequate support and cannot legally be used in compounding. These include Coenzyme Q10, ginger root powder, ginkgo biloba standardized extract, nux vomica extract and colloidal silver.

Their problem is compounded, if you will, by the fact that outsourcing facilities (the only legitimate source for stockpiling compounded drugs per the FDA) are also limited to certain substances they can use in compounding. As with traditional compounding, the FDA will not take regulatory action against outsourcing facilities using substances for which adequate information has been submitted for the FDA, pending the agency’s final decision, but it will not permit the use of substances listed as having safety concerns or nominated without sufficient evidence.

Congress may intervene

Naturopaths are not the only ones upset with the FDA. There are legitimate medical groups concerned that the FDA’s position could adversely impact effective medical care. Organizations representing dermatologists, ophthalmologists, surgeons, and anesthesiologists have asked the FDA to revisit the issue of office compounding.

Representatives from the fringes of medicine have voiced their opposition as well. A group calling itself the “Integrative Medicine Consortium” wrote the FDA last year making complaints similar to that of the AANP. The Consortium includes a couple of Pseudomedical Pseudoprofessional Organizations that have appeared on SBM before: the American Academy of Environmental Medicine, the American College for the Advancement in Medicine, and the International College of Integrative Medicine. Joining them in this effort are the International Organization of Integrative Cancer Physicians, a group that promotes dubious cancer treatments.

Unfortunately, the American Academy of Dermatology Association, the lobbying outfit for the American Academy of Dermatology, and some state pharmacy associations, joined forces with the AANP and the Alliance for Natural Health, a faux “grassroots” organization that advocates for the protection of quackery and against vaccination and fluoridation, to object to the FDA’s new guidance.

Their objections are being heard. Some members of the House of Representatives are also upset that office compounding is all but eliminated by the FDA’s actions. This effort is headed by Rep. Chris Stewart, who, not surprisingly, hails from Utah, where the dietary supplement industry is king. On June 20th, he was joined by 60 of his fellow Representatives in a letter than begins with a none-too-subtle threat:

As the Congress considers appropriations for the Food and Drug Administration (FDA) for Fiscal Year 2017, we write to express our concern . . .

According to Rep. Stewart and the others, Congress had made it clear that office-use compounding was indeed

legitimate and permissible and explained how compounding pharmacists can engage in office-use compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A of the FDCA.

Of course, whatever happens, there is no assurance that naturopaths will actually abide by the FDA’s guidance. Like the Colorado naturopaths, some portion of them may ignore the law altogether. And, as we know, a naturopathic regulatory board won’t necessarily see violation of federal drug laws as an offense worthy of anything more than a slap on the wrist for the naturopath’s illegal conduct.

If the states are going to act as handmaidens to the “alternative” and “integrative” medicine industry by freely allowing practitioners to ignore evidence of safety and effectiveness, federal regulation of at least one means used to fleece patients is a welcome curb on the pseudoscience that permeates health care. Regrettably, the FDA cannot distinguish between the type of provider or the legitimacy of his or her treatments in regulating office use compounding. The same policy must apply to all. However, even if the FDA’s guidance on office use compounding falls to Congressional objections, it will still be able to prevent the use of unproven and unsafe substances in compounded drugs.

 

 

Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.