A recent case report details what is described as a near-fatal blood infection in a 52-year-old woman following a “naturopathic intravenous vitamin infusion that was administered in her home”. Although the authors say information about the preparation of the infusion is limited, we do know that it contained ascorbic acid, magnesium oxide, vitamin B complex, zinc, taurine, glutathione, and methylcobalamin (vitamin B-12), and was prepared using infusion bags obtained from “compounding pharmacies in the United States”. Preparation of these infusions is done by a “licensed medical professional” at an unnamed clinic, where the compounded infusions may be stored in a refrigerator “for no more than several days” (an interesting revelation, as you shall see).
The clinic was ordered to cease all IV infusions pending investigation by public health authorities, although when one of the authors inquired, she was told by the clinic that no infusions were available due to “limited supply”, an obvious misrepresentation.
Because the authors are MDs at a Santa Barbara, California hospital and because the case report refers to the California Naturopathic Doctors Association, I think we can safely extrapolate that the clinic is staffed by, and the infusion was prepared and administered by, one or more California-licensed “naturopathic doctors”.
For reasons that will become clear later, the case report also notes that the patient regularly takes various over-the-counter supplements, including, but not limited to,
Pregnenolone, DHEA Complete, HUM Skinny Bird (Caralluma fimbriata, green tea extract, 5-HTP), HUM Daily Cleanse (chlorella, beet root, red clover, dandelion leaf extract, oregon grape root, milk thistle, glycolic acid, zinc, selenium, copper, manganese, spirulina, and matcha green tea), ChlorOxygen, Moon Juice SuperYou (ashwagandha, rhodiola, and amla), charcoal activator, zinc 50 mg, subcutaneous Lipo-C (methionine, inositol, choline chloride, L-carnitine, thiamine HCl, and dexpanthenol), and Ultra Burn (methionine, choline, B12, thiamine, and inositol). The patient states that she takes these supplements for their anti-aging claims and acquires them from various online retailers.
Today, we’ll briefly review naturopaths and their use of compounded drugs. Then we’ll look into the unfortunate results of this naturopathic treatment, for which no medical rationale is apparent, and find out what the case report authors think about naturopathy.
We’ve written about naturopathy many times here on SBM. If you are new to the blog, it might be helpful to read a few posts for background, such as Scott Gavura’s excellent Naturopathy vs. Science series, former naturopath Britt Hermes embarrassing (to them) exposé of naturopathic education, and, for a wonderfully snarky inside look, David Gorski’s “What naturopaths say to each other when they think no one’s listening” (Parts I and II). If you don’t have the time, here’s the short version: naturopathy is chock full of quackery and some states, via the magic of Legislative Alchemy, license naturopaths to inflict their quackery on patients, my post today being a perfect example of this transgression against public health.
Compounded drugs are an exception to the rule that prescription drugs must be FDA-approved after extensive safety and efficacy testing. Compounding essentially allows licensed health care providers to create their own drugs and bypass the lengthy and expensive FDA drug approval process. There are many legitimate uses for compounded drugs, but naturopaths and other fringe medical practitioners have exploited federal law governing compounding to create a shadow prescription drug industry producing drugs that are not only untested, they have no medical rationale. Fortunately, due to a recent FDA crackdown, their options for compounded drug ingredients are increasingly limited, but there’s still plenty of room for mischief, as our case report demonstrates.
In fact, it is because of this crackdown that we’ve been able to learn more about how naturopaths have been whipping up unproven compounded concoctions for their patients. The American Association of Naturopathic Physicians (AANP), with an assist from several fringe medical groups, has tried to head off an FDA ban of their favorite compounded drug ingredients. To accomplish this, the AANP had to provide evidence to the FDA and its experts that the ingredients they nominated for the FDA’s list of substances approved for use in compounding were indeed safe and effective. Unsurprisingly, they’ve largely failed in this effort. (In fact, they complained bitterly about having to provide this evidence.) This has led the FDA to ban, or limit on the routes of administration for, some of the ingredients commonly used by naturopaths and a proposal to ban a dozen more nominated by the AANP after expert review of the evidence. One of these is cesium chloride, a dangerous chemical naturopaths use for cancer treatment based on a totally crackpot “theory”, which is already the subject of an FDA safety alert. Another is curcumin, the active ingredient in an infusion that killed the patient of a California licensed naturopathic doctor.
Even when using FDA-allowed compounded drug ingredients, naturopaths still fudge on the rules. Except in extremely limited circumstances, federal law does not allow “stockpiling” of compounded drugs for office use. A compounded drug must be prepared for a specific patient and, as I explained in a previous post,
. . .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 warns that compounders should keep detailed records, which it can review if the need arises.
Which means the storing of compounded infusions by our clinic here could be illegal, although we don’t know all the circumstances. According to former naturopath Britt Hermes, discussing in-office compounding by naturopaths:
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 Arizona clinic where she worked:
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.
She also told me in an email that
the [vitamin infusion] protocols described in [a naturopathic journal] article are basically the bread and butter of naturopathic IV practice, as we use high dose Vitamin C and these Meyer’s cocktails [sic; a type of vitamin infusion] 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.”
As David Gorski pointed out:
Although there are many forms of pseudoscientific, prescientific, and unscientific treatments offered by such practitioners [like naturopaths and “functional medicine” practitioners], one common form of “treatment,” often marketed as preventative medicine or antiaging medicine but sometimes marketed as a real treatment (or part of a real treatment) for real diseases, is intravenous vitamin therapy. . . Indeed, a 2011 survey by Caulfield and Rachul found that intravenous vitamin cocktails are among the most popular services advertised by naturopaths, be it Myer’s cocktail (basically an injected multivitamin) or vitamin C, intravenous vitamin therapy is the unproven treatment beloved by alternative medicine practitioners everywhere.
California allows licensed naturopaths to administer the following via IV:
Vitamins, minerals, amino acids, glutathione, botanicals and their extracts, homeopathic medicines, electrolytes, sugars, and diluents . . . [but] only when such substances are chemically identical to those for sale without a prescription.
To provide IV therapies, California naturopaths must complete a 25-hour course (including 14 clinical hours) from a roster of three approved providers. She must observe 10 IV set ups and administer 10 IV setups and pass a test, answering at least 70% of the (minimum of 50) questions correctly.
The state-approved course providers include two naturopathic schools and one private organization called International IV Nutrition Therapy. To give you a flavor of the latter, for 12 continuing education credits, naturopaths can also learn about “heavy metal toxicity” and chelation therapy in a course taught by two naturopaths.
With that, let’s see how a naturopathic vitamin injection landed one woman in the hospital for two weeks and nearly killed her.
The patient, who had been receiving these IV vitamin infusions monthly, developed nausea and chills during the infusion, following by eight episodes of vomiting and diarrhea. Whether the infusion was halted when symptoms appeared or whether she was advised by the naturopath to seek medical attention is not revealed in the case report. In any event, the patient presented at the hospital the same day with vomiting and diarrhea. She had a rapid heart rate (170 BPM), hypotension (86/38), and a diffuse sunburn-like rash.
She later developed encephalopathy (a diffuse disease of the brain that alters brain function or structure, which can lead to permanent brain damage), respiratory distress, and hematochezia (bright red blood in the stool, indicating gastrointestinal bleeding). In addition, according to the authors, her course was complicated by acute kidney injury, pulmonary edema, and disseminated intravascular coagulation (abnormal blood clotting throughout the body’s blood vessels).
Her workup included an MRI of the brain, a chest X-ray, a colonoscopy, and lab tests. Blood cultures revealed Pseudomonas fluorescens,
a bacterial organism that is not usually found in humans. It is usually found as a result of contaminated liquids used in invasive procedures.
The patient was ultimately diagnosed with septic shock secondary to Pseudomonas fluorescens bacteria in the bloodstream “likely secondary to a contaminated IV infusion.”
She required hemodynamic support with norepinephrine and vasopressin for five days, aggressive fluid resuscitation, and a regimen of several antibiotics. Fortunately, she had recovered sufficiently to be discharged after two weeks in the hospital.
The authors conclude:
This case highlights the potential risks of naturopathic medicine. Naturopathic licensure does not currently require passage of California specific board examinations and residencies are not a current requirement. There have been incidences [sic] in which IV infusions of naturopathic substances have led to toxicity and death.
[Footnotes omitted, although I will note that the last sentence cited a post by none other than SBM’s own Dr. Steve Novella.]
As well, pointing out perhaps an under-appreciated danger of dietary supplements, they say
it is important to recognize the increased use of unregulated supplements. Dietary supplements, in general, are not Food and Drug Administration-approved. . . We do not believe that our patient’s condition was a direct result of her various supplements. However, it posed a difficult challenge in the initial assessment and plan.
In sum, this patient spent two weeks in the hospital and nearly died after a naturopathic vitamin infusion which, as far as we can tell, had no medical rationale whatsoever but nevertheless was prescribed for her monthly. Her case was complicated by her voracious consumption of “anti-aging” supplements, which her physicians had to consider as a possible source of her symptoms. As I’ve argued before on SBM, naturopaths should not be licensed to practice “naturopathic medicine” and the deceptively named Dietary Supplement Health and Education Act needs to repealed and replaced with an effective regulatory framework that protects the public rather than lines the pockets of dietary supplement companies.
I appreciate this patient’s agreeing to have her case published and I am glad she is doing better. I hope she is both filing a complaint against this naturopath (or naturopaths) with the state as well as suing them for malpractice, if there is indeed such a thing in a practice that appears to have no standard of care.