With dietary supplements, you never quite know what you’re going to get.
There can be many reasons why someone may choose to buy a dietary supplement. Some prefer supplements over prescription drugs, believing them to be more “natural” and possibly more gentle than prescription drugs. While there is a lack of good evidence showing most dietary supplements have any meaningful benefit, there is one effective way to make a supplement “work”: Add an active ingredient. Juicing up a supplement with actual prescription drugs isn’t uncommon – it happens routinely, and there is little that the Food and Drug Administration can really do about it. While supplements are often packaged like pharmaceuticals, and may be sold alongside over-the-counter drugs, anything considered a dietary supplement is subject to completely different regulatory standards than is in place for prescription drugs. And that’s created a marketplace where consumers are ill-served and may even be at risk of harming themselves.
It’s been covered in depth before, but is worth repeating, that the Dietary Supplement Health and Education Act of 1994 (DSHEA) was an amendment to the U.S. Federal Food, Drug and Cosmetic Act that established the American regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective. The goal was to eliminate barriers to sale, and it worked: Within four years of the DSHEA, supplement sales grew from $4 billion to $12 billion. Today, dietary supplements are a $35 billion industry.
Because there is no pre-market or post-market product testing in place, the FDA relies on other forms of monitoring in an attempt to ensure that supplements are safe. This includes collecting adverse event reports and consumer complaints, inspecting manufacturing facilities, and monitoring imported ingredients. In exceptional circumstances, the FDA can take supplements off the market by issuing a recall.
Despite the perception that supplements are safe, natural, and effective, they continue to cause a significant amount of harm, associated with 23,000 emergency department visits and 2,000 hospitalizations per year. This number may in fact be an underestimate, as assessing causality is challenging, and erroneous perceptions about supplements may mean fewer people even suspect a supplement of causing harm.
The FDA maintains a Tainted Products Marketed as Dietary Supplements database, which was the data set used for a recent study I will be discussing below. Adulterated dietary supplements are particularly problematic for consumers, because it is impossible to safely take a prescription drug if you don’t know you’re taking it at all. And if you have medical conditions, or take other prescription drugs, your risk of harm from adulterated supplements is even greater.
The study was a straightforward analysis of FDA data. Jenna Tucker and colleagues examined adulterated supplements, defined as supplements containing unapproved ingredients (e.g., prescription drugs). The paper is entitled “Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings,” published in JAMA Network Open last week. The objective was to summarize trends observed in adulterated supplements associated with an FDA warning, between 2007 and 2016. 776 supplements were in the data set, and the majority of them were products marketed for sexual enhancement (46%), weight loss (41%), and muscle building (12%), with only 2% of products marketed for other purposes. (See table)
While most products had only one unlabelled prescription drug as an adulterant, just over 20% contained two or more. Two products (one marketed for arthritis and one for sexual enhancement) contained six different unlabelled drugs.
Among the warnings, 96% of products were associated with a single warning. Amazingly, 28 products were found to repeatedly contain adulterants, with 19 (67%) of these product being laced with DIFFERENT prescription drugs the second or third time around.
Just under half of the products in this sample were associated with a voluntary recall from the manufacturer. Surprisingly, in 44% of cases, there was a public notification only, and no recall.
Supplements for sexual enhancement: Among the adulterants, sildanafil, (the active ingredient in Viagra) was the most common, with 81% of the sexual enhancement supplements containing it or a close chemical analogue.
Supplements for weight loss: The most common adulterant in weight loss supplements was the weight loss drug silbutramine (or an analogue) along with the laxative phenolphthalein, both of which have been removed from the US market. Silbutramine was found in 85% of weight loss products in the dataset, and phenolphthalein was in 24% of these products. Some weight loss supplements were also found to contain the prescription drug fluoxetine (Prozac).
Supplements for muscle building: 73 of the 92 supplements had undeclared anabolic steroids (or steroid-like analogues). In what could be described as a form of honesty in supplement advertising, nine products did disclose that the supplement actually contained anabolic steroids. Ten products disclosed that they contained a class of anti-cancer drugs call aromatase inhibitors, which are used to block estrogen.
Other supplements: While marketed for a variety of conditions including pain, cancer, sleep issues, gout and prostate health, half of the products (7 of 14) contained diclofenac (an anti-inflammatory drug) and five contained dexamethasone (a steroid).
When supplements are tainted with prescription drugs, they’re no longer dietary supplements – they’re unlabelled drugs. Consumers should be entitled to dietary supplements that at minimum, honestly and accurately describe what’s inside the bottle (meaning not just lacking adulterants, but including the purported active ingredient). This analysis show that unapproved drugs are regularly sold in the United States as dietary supplements, and there are no signs that regulation will change this fact. However, it is possible to greatly reduce your risk of purchasing adulterated supplements. If you stay away from erectile dysfunction supplements, weight loss supplements, and muscle building/bodybuilder supplements, there’s a much better chance that you won’t be getting any prescription drug surprises in your dietary supplement. Until there is better, more effective regulation of dietary supplements, consumers will continue to put their health at risk with each supplement they consume.
Canadian women are responsible for deciding on their own breast health management. In consultation with primary care physicians, most choose mammography – the gold standard for breast cancer screening in Canada. Despite this, a growing number of private clinics across Canada offer an unregulated service called “thermography” (also called thermal imaging, infrared imaging, or digital infrared thermal imaging) for breast cancer screening. Thermography has been discussed several times on SBM but as a refresher, it is a digital technique that measures skin temperature using an infrared camera. An image of the heat distribution across the chest, called a thermogram, is interpreted by a thermogram reader and reported to the client in exchange for a fee of up to several hundred dollars.
Thermography providers claim that malignancies can be detected by measuring breast skin temperature. They claim that the increased metabolic and vascular activity in tumors will cause an increase in the temperature of the overlying skin. These claims are not supported by science and primary care physicians do not recommend thermography as an alternative to mammography. Sadly, many Canadian women are choosing thermography apparently because the private clinics are very good at advertising.
The premise underlying thermography for breast screening is plausible at first glance. Tumours are indeed metabolically active and, as they grow in size, they recruit blood vessels to deliver the oxygen they need to keep expanding. This extra blood flow brings additional heat and this is what thermography claims to be able to detect. However, regulation of skin temperature is complex and surface (skin) temperature is not a reliable proxy for what is going on in deeper tissues. Thermography was initially investigated as a method for identifying breast malignancies and abnormalities in the 1970s, but scientists found that it showed poor detectability and high false positive rates, and that mammography and clinical examinations were demonstrated to be superior methods of detection for breast cancer.
Recent systematic reviews conclude there is no evidence to support the use thermography as a screening test, a diagnostic tool, an assessment tool, or even as an adjunct to mammography. There are no randomized controlled studies on thermography and, without proper clinical trials, the claims made by practitioners of thermography do not stand up to scrutiny. Yet, many Canadian women choose this procedure and some forego mammograms. These clinics are not part of the Canadian health care system and are in a grey zone of regulation. Unfortunately, there are no statistics to track the harm they may be doing.
In the United States, the Food and Drug Administration (FDA) approved Class I telethermographic systems for the use of “adjunctive diagnostic screening for detection of breast cancer” in 1982. This means that thermography may be used only in conjunction with, not in place of, mammography for the screening and diagnosis of breast cancer. In recent years, though, the FDA has issued warning letters to companies that were inappropriately marketing and selling thermography devices and systems.
Health Canada has not approved thermography for breast cancer screening either alone or as an adjunct to approved screening methods, and it issued a safety alert about thermography screening in 2012. At around that time, a thermography clinic in St. John’s, Newfoundland and Labrador was instructed by the province’s Health Minister to cease and desist for the reason that thermal imaging for breast cancer screening is unregulated in the province. Also, a thermography clinic in Winnipeg, Manitoba was directed by the provincial Health Minister to halt operations while health officials carry out an investigation.
A more recent Health Canada safety alert, issued in 2017, informs us that “[w]hile thermography devices are available in Canada, these devices have not been licensed in Canada to screen for breast cancer.” Thermography devices are licensed only for a very limited use as specialized thermometers. The safety alert also tells consumers that “…thermograms…are not a substitute for mammograms used for routine monitoring and screening for breast cancer” and that mammography “…is the most reliable technique in screening for early-stage breast cancer”. Health Canada asserts that it “…is not aware of any clinical evidence that thermography devices can be used effectively for the early detection of breast cancer” and cautions that “[i]f women are relying solely on thermography results, there is a potential risk that cancer could go undetected.” As a result, Health Canada restricted the sale of thermography equipment: “Health Canada is following up with several manufacturers to inform them that it is prohibited to advertise or sell thermography devices (such as cameras and imaging systems) to screen for breast cancer in Canada.”
The Canadian Cancer Society shares information and concerns similar to those of Health Canada. The Society concurs “…current evidence doesn’t show that thermography is an effective tool to detect breast cancer and therefore, we do not recommend thermography as a screening tool for breast cancer.” The Society adds that when private clinics advertise thermography as a reliable method of detecting breast cancer, it “…creates a confusing message for women” and that women who have been tested with thermography may have “…a false sense of security about their breast health”.
Despite the lack of scientific evidence for the efficacy of thermography as a method of breast cancer detection, the lack of approval to use thermography for the purpose of breast cancer screening, and the prohibition on sales of thermography equipment, there are many businesses and private clinics in Canada that offer thermography service and devices for breast cancer screening. One such business is Thermography Clinic Inc., a Toronto-based company with thermography clinics established around the world. In Canada, Thermography Clinic Inc. has 22 clinics (including the head office) located across Alberta, British Columbia, Ontario, and Quebec. The company’s mission is “[t]o bring non-invasive imaging technology to the forefront of health care and to impact breast cancer statistics globally.” Thermography Clinic Inc.’s website characterizes the procedure as safe, pain-free, radiation-free, and non-invasive, all selling-points for potential customers considering this procedure.
Thermography Clinic Inc. sells “turn-key” thermography systems to existing clinics or new start-up businesses and supports them with system installation, personnel training, and results reporting. Practitioners who undergo just three days of training are provisionally certified by the College of Medical Thermography to write and interpret breast thermography reports for consumers.
A close inspection of Thermography Clinic Inc.’s website reveals some concerning points. The website appears to feature misleading information and unproven claims about thermography, such as:
To deny the efficacy and [sic] of thermal imaging of the breast as an adjunctive assessment in the overall management of the patient is a grave error.
We cannot ignore the tremendous role of breast thermography as an early risk indicator or as a monitor of treatment.
Furthermore, the technology appears to be advertised for unlicensed uses and unapproved purposes. The following statements are some examples from their brochure [PDF]:
Early Detection is important, but prevention is the key! [brochure title]
Breast Thermography is a breakthrough imaging procedure where infrared images of the breasts are analyzed and rated to determine the risk of developing breast cancer.
Breast Thermography is one of the best early-detection systems available today.
Thermography clinics capitalize on the unjustified fears some women have that radiation doses from mammograms are dangerous and can be avoided by using thermography. The truth is that thermography is unproven and can burden women with false negative or false positives that can cause psychological stress, delayed treatment, unnecessary treatment, or worse, and charge a lot of money for the experience. In Canada, mammograms are free and they are the gold standard for breast cancer detection, so stay away from thermography.
Center for Inquiry Canada
The Centre for Inquiry Canada supports science-based medicine in Canada and advocates for empirically-supported medical interventions.
We at SBM not-infrequently write about the quackery promoted by naturopaths, “functional medicine” doctors (many of whom are naturopaths, but many of whom are also MDs like Dr. Mark Hyman), and other practitioners of alternative medicine or “integrative medicine”, the latter of which “integrates” alternative medicine with real medicine. Although there are many forms of pseudoscientific, prescientific, and unscientific treatments offered by such 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. One of the most common forms of this treatment is the use of high dose intravenous vitamin C to treat cancer, an idea popularized by Nobel Laureate Linus Pauling and continuing to fuel pointless research and attempts at clinical trials even today. In fairness, there is preliminary evidence that high dose vitamin C might—I repeat, might—have some use in sepsis, but in cancer it has been and remains what I like to refer to as a very long run for a very short slide.
Intravenous vitamin injections are also often included as part of chelation therapy for cardiovascular disease. Despite its being pure quackery, chelation therapy including intravenous vitamin therapy has been subjected to a large multicenter clinical trial (TACT) at the cost of $30 million that was rife with flaws in methodology, execution, and ethics. Not unexpectedly, it produced a negative result. Unfortunately, it also provided enough of a hint of a whiff of a signal (almost certainly spurious, if you look at it closely) in one subgroup (diabetics) that quacks were able to finagle $37 million more to do another multicenter clinical trial. Meanwhile, not a single quack has abandoned chelation therapy for cardiovascular disease despite the overwhelmingly negative results of TACT for every patient group except diabetics, and IV vitamin cocktails are a regular offering of quack cancer clinics and quack clinics in general as a panacea, sometimes under the name of “intravenous micronutrient therapy” (IVMT). 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.
That’s why I was pleased to learn late last week that the Federal Trade Commission has, for the first time, charged a marketer and seller of intravenous therapies known as iV Cocktails with making a range of ‘deceptive and unsupported health claims’ about their ability to treat serious diseases, resulting in a proposed consent agreement:
The proposed FTC order prevents the company, which operates clinics in Texas and Colorado, and its owner from making such claims unless they can be supported by competent and reliable scientific evidence.
“This enforcement action should send a clear message to the burgeoning IV therapy industry and sellers of all healthcare products,” said Joe Simons, chairman of the FTC. “Health claims must be supported by competent and reliable scientific evidence.”
Beginning in mid-2015, FTC said the company, iV Bars, used its website and social media to advertise a variety of iV Cocktails, costing consumers $100 or more, with iV Bars claiming they could treat serious diseases including cancer, congestive heart failure, multiple sclerosis, diabetes, fibromyalgia and neurodegenerative diseases.
Because of course they did. Let’s take a look first at the sorts of claims made by the company iV Bars as enumerated in the FTC complaint and then at the FTC order.
As is my wont, before going through the entire FTC complaint, I headed over to the iV Bars website, knowing full well that by this late in the process the company might have purged the specific complaints that drew the unwanted attention of the FTC. Right on the front page, I was greeted with scientifically dubious and inaccurate statements, interspersed with photos of dynamic young athletes doing their thing, the first being the claim that taking vitamins orally “simply does not work,” which is, of course nonsense, as is this:
Our iV Therapy delivers replenishing fluids, vitamins, minerals & amino acids into the bloodstream with 100% absorption, where they are immediately available for your cells to use. Resulting in quicker recovery time and improved overall performance.
If you are new to the concept of Intravenous Vitamin Administration, you might be wondering why you’re suddenly hearing so much about it. Why is it being relied upon by professional athletes to CEO’s and most importantly by individuals seeking to support their overall health and well-being. Intravenous Vitamin Administration represents an exciting new paradigm in allowing us to help a wide variety of vitamin deficiencies.
iV COCKTAIL BENEFITS: SPORTS RECOVERY, HYDRATION, WEDDING DISASTERS, HANGOVERS AND MORE.
So far, there are no specific claims. “Hydration” and “sports recovery” are sufficiently vague that the FDA would be unlikely to say anything about them. Ditto selling them as a remedy for hangovers. It didn’t take me long to find some real howlers under a section called The Science Behind iV Bars:
Intravenous (iV) Delivery or Intravenous Micro-nutrient Therapy (iVMT), is a method which uses nutrients such as vitamins or minerals and administers these directly into the bloodstream typically through a vein in the arm…more specifically the crook of the arm. There are several advantages of giving the body nutrients by the intra-venous method. First, by injecting substances directly into the bloodstream you eliminate any alteration in the nutrients which may occur from the actions of digestive enzymes. Second, the amount of nutrients in the blood can reach much higher, more effective levels faster than is possible by absorbing nutrients through the Gastro-Intestinal system. This may be particularly important if a client is suffering from a GI system disorder where absorption of nutrients is impaired. In some cases the IV use of micro-nutrients permits much higher levels than are possible even with a healthy GI system.
Now, in fairness, there are examples of GI conditions that impair one’s ability to absorb nutrients orally. For example, if you’ve had your stomach removed (or, more specifically, a specific part of your stomach removed), you will be unable to adequately absorb vitamin B12, the deficiency of which over time leads to a condition known as pernicious anemia. The reason is that the proximal stomach makes protein called intrinsic factor, which binds to B12 and facilitates its absorption in the distal small intestine. However, vitamin B12 deficiency can take years to develop after gastrectomy because significant stores of vitamin B12 exist in the liver. In any event, people with surgery-induced B12 malabsorption do benefit from monthly B12 injections. Gastrectomy can also impair the absorption of iron because gastric acid converts dietary iron to a form that is more readily absorbed in the duodenum.
There are a number of other conditions that can result in the malabsorption of some or all nutrients; however the symptoms of these conditions are usually not subtle, and they can be diagnosed by standard medical tests. The point is that most of these can be treated without intravenous nutrients and with targeted treatments. The sort of “shotgun” approaches epitomized by products like those sold by iV Bars are almost never needed. Let’s just put it this way. If your malabsorption of nutrients is so poor that you need intravenous vitamins and micronutrients, you probably need total parenteral nutrition (TPN), in which all your nutrient needs are provided intravenously. TPN is not infrequently used in patients who, for whatever reason, be it surgery or prolonged dysfunction of their GI tract, cannot eat for prolonged periods of time. Unfortunately, prolonged courses of TPN have a host of well known complications, some due to the fact that total nutritional support requires a central venous catheter, some due to the metabolic effects and the effect on the liver from the nutrients.
Of course, iV Bars claims that its products are “targeted” based on—of course!—science:
Although 99.9% of human DNA is the same in every person, enough of the DNA is unique to distinguish one person from another. Male or female, short or tall, thin or muscular, low or high activity level, world class athlete or weekend warrior, people are all unique and so are their nutrient requirements. Developed by a team of leading medical doctors, naturopathic doctors, biochemists, nutritionists and exercise physiologists, iV Bars profiling is a technique employed by our medical practitioners to assist in identifying a person’s specific nutrient requirements. iV Bars profiles are encrypted sets of numbers that reflect a person’s current state of health, which are used as the person’s nutrient identifier. The process begins with the selection of a cocktail, followed by a series of medical, health and lifestyle questions. The data from these questions will automatically be run through the iVBars proprietary software program which will produce your profile.
This is, of course, a seriously dubious set of claims, particularly the part about how some sort of proprietary software will identify such a highly “personalized”, “targeted”, or “precision” therapy based on a series of questions. The involvement of “naturopathic doctors” in the development of the process should tell you all you need to know about it. Of course, I’d love to know who these “leading medical doctors, naturopathic doctors, biochemists, nutritionists and exercise physiologists” are who developed this system. Somehow, I’d be willing to bet that they aren’t nearly as “leading” as iV Bars claims. Notably, I was unable to find a single name.
Not surprisingly, consistent with the FTC complaint, all I had to do was to go to <a href="http://Archive.org" rel="nofollow">Archive.org</a> and use the almighty Wayback Machine to find a version of the company’s website from August 2016 that had a section marked “Medical” in which the company touted iV Bars for:
The vitamins and minerals used in iVMT are co-factors in biochemical reactions in every cell in our bodies. As a result, iVMT can be used as an adjunct in any condition where low levels of nutrients or other nutritional deficiencies are suspected. Immune Support, Anti Aging, Athletic Performance, Allergies, Depression, Hormone Balance, Migraines, Chronic Fatigue, Inflammatory GI conditions, Fibromyalgia and many others all respond to iVMT for many patients.
I note that the company website (accessed yesterday) still includes the following conditions:
Of course, adrenal fatigue is a fake diagnosis, as is, nearly always, “heavy metal toxicity”, and “gluten sensitivity” almost certainly doesn’t exist, as opposed to actual celiac disease, which 1% of the population suffers from. The rest are the usual vague alternative medicine “diagnoses” and problems that many quacks claim to treat. I also can’t help but acknowledge grudging admiration for the sheer brilliance of the marketing. These guys even send RNs or EMTs to you, doing private events, bachelor parties, “ladies’ nights out”, and basically any function you might want.
The FTC complaint goes into much more detail. Let’s dive in.
The FTC press release about the consent agreement can be found here, and a handy dandy list of links to documents related to the complaint and the consent agreement can be found here. Let’s take a look at key parts of the complaint. You can already see from my cursory perusal of the archived version of the iV Bars website that there were definite medical claims being made without evidence.
The complaint notes early on:
Respondents’ first and primary iV Bars location is housed in a NextGen Wellness Center, an upscale gym and clinic that independently offers chiropractic care, pain management therapy, physical therapy, medical massages, and counseling. New iV Bars customers create an online account and complete a short health assessment questionnaire when making their first appointment. Respondents have an arrangement with a doctor who does a quick, online review of all health assessment questionnaires that customers submit to iV Bars. Respondents pay the doctor a flat fee of $250 per month for this service. Shortly before the customer arrives, an iV Bars employee takes about five minutes to mix ingredients obtained from a local compounding pharmacy into the customer’s requested iV Cocktail. Once at iV Bars, the customer is asked to sign a release form that discloses risks and releases Respondents from liability. Thereafter an iV Bars nurse seats the customer in one of five oversized reclining chairs and administers the iV Cocktail to them over a 25-45 minute period. Respondents also maintain a “full service mobile vehicle” that allows them to “come right to your door to deliver the treatment of your needs.”
See what I mean by the brilliance of the business model? There were also “success stories” that implied that iV Bars treatments could be useful for a range of conditions, from influenza to cardiovascular disease to fibromyalgia. For example, here’s one featured in the FTC complaint. It was edited down, but I think it’s worth going back to the Wayback Machine version of the iV Bars website to quote in full:
Case #5: A 79-year-old man was seen at home in end-stage heart failure, after having suffered four myocardial infarctions. During the previous 12 months, spent mostly in the hospital, he had become progressively worse; his ejection fraction had fallen to 19 percent and his body weight had declined from 171 pounds to a severely cachectic 113 pounds. He was confined to bed and required supplemental oxygen much of the time. He also had severe peripheral occlusive arterial disease, which had resulted in the development of gangrene of six toes. A peripheral angiogram revealed complete occlusion of both femoralpopliteal arteries, with no detectable blood flow to the distal extremities. Two independent vascular surgeons had recommended bilateral abovethe- knee amputations to prevent development of septicemia. However, the cardiologist advised the patient that his heart would not last more than another month, so the patient declined the amputations.He was treated with weekly IM injections of magnesium sulfate (1 g) for eight weeks, and prescribed oral supplementation with vitamins C and E, B complex, folic acid, and zinc. The magnesium injections appeared to reduce the pain in his gangrenous toes considerably, with the benefit lasting about five days each time. Six weeks after the first injection, his ejection fraction had increased from 19 percent to 36 percent and he no longer requiredsupplemental oxygen. After eight weeks, the IM injections were replaced by weekly IV injections, consisting of 5 mL magnesium, 1 mL each of B12, B6, B5, and B complex, and a low-dose (0.2 mL) trace mineral preparation (MTE-5 containing: zinc, copper, chromium, selenium, and manganese). After a total of 18 months, his weight had increased from 113 to 147 pounds, which was remarkable as cardiac cachexia is generally considered to be irreversible. In addition, the gangrenous areas on his toes had sloughed and been replaced almost entirely by healthy tissue. Intravenous therapy was continued and eventually reduced to every other week. The patient lived for eight years and died at age 87 from multiple organ failure. Of the handful of other patients with angina or heart failure who received IV or IM injections of magnesium (with or without B vitamins), all showed significant improvement. The results with angina are consistent with those reported by others using parenteral magnesium therapy.40-42
This is, of course, an example of the post hoc ergo propter hoc fallacy that assumes that just because this patient lived eight years after four myocardial infarctions and dry gangrene of the toes it must have been the IV nutrient injections. Occasionally, even elderly people with severe cardiac disease improve, and we don’t know what other standard medical treatments he underwent. (If he was in the hospital so much, he must have undergone standard medical treatments.) As for the “gangrenous areas” of his toes sloughing and being replaced by viable tissue, it would be useful to know more. For instance, it’s not uncommon for gangrenous toes to “autoamputate,” as long as the gangrene remains “dry” (not infected), as opposed to “wet” (infected). In any event, as we’ve discussed more times than I can remember, such “case reports” and small “case series” tell very little without a control group.
The FTC complaint cites other “success stories” for people with multiple sclerosis, diabetic peripheral neuropathy, and fibromyalgia. I note from the archived web page “success stories” for muscle spasms, migraines, asthma, depression, upper respiratory tract infections, seasonal allergic rhinitis, hyperthyroidism—even narcotic withdrawal. All are questionable, and none cite anything resembling rigorous evidence. Elsewhere, the FTC complaint notes:
In addition to the “The Science Behind iV Bars” section of the iV Bars Website homepage (discussed in Part 5.B., above), the Website homepage contained a link titled “ABOUT iV BARS: THE COMPANY” that linked consumers to a page titled “THE COMPANY BEHIND THE BAG.” That page contained depictions of men and women dressed in white lab coats looking at test tubes and through microscopes. It declared, “Inspired by the early works of Dr. Myers, Aaron Keith founded iV Bars in 2015. He assembled a world class team of physicians, biochemists and physiologists to create the formulas . . . of iV Bars.” Thereafter, under the subtitle “iV Bars Research Labs,” Respondents claimed to have an “applied Biology and Chemistry Group” at a purported “iV Bars Labs” comprised of “experienced biologists, chemists, pharmacists, medical and naturopathic doctors and exercise physiologists” to, among other things, “test and approve inject-able formulations that are used in intravenous, subcutaneous and intramuscular administration”:
So basically, this is a variant of the Myers Cocktail, an intravenous cocktail of various vitamins B vitamins, vitamin C, and minerals created by Dr. John Myers, who died in 1984. Myers never actually published his recipe for the cocktail, but the doctor who took over his practice, Dr. John Gaby, published a recipe that is the current one used for Myers cocktail, even though he admitted that he didn’t know exactly what was in Myers’ original concoction. Besides being popular among naturopaths, it was reportedly also used by Michael Jackson. There is no evidence that it is efficacious for any of the conditions for which it is commonly used, other than anecdotes collected by Dr. Gaby.
As for the safety of iV Bars, the FTC notes that the “Science” section of the website and consent form listed a number of risks and possible adverse reactions, including hypotension (low blood pressure) from too-rapid infusion of magnesium; hypokalemia (low potassium), which can cause arrhythmias and for which the company acknowledged one patient having required “short term treatment in the intensive care unit”; and hypercalcemia (calcium level in the blood too high), which can also cause arrhythmias and can even be fatal.
From the consent form:
Risks: I understand there is risk of mild diarrhea, upset stomach, nausea, a feeling of pain and a warm sensation at the site of the injection, a feeling, or a sense, of being swollen over the entire body, headache and joint pain.
Uncommon side effects are much more serious than the common side effects of Vitamin injections, and such side effects should be reported to a physician to be evaluated for seriousness. Uncommon and dangerous side effects include:
• Headache • Nausea • Diarrhea • Bloating • Constipation • Indigestion or heartburn • Abnormal bleeding • Gastrointestinal hyperactivity • Chest pain • Flushed face • Chills • Fever • upset stomach • Kidney stones • Fingernail weakening • Hair loss • Rapid heartbeat heart palpitations • Restlessness • Muscle cramps and weakness • Dizziness
I understand the possibility of having an allergic reaction to any of the ingredients found within the Vitamin injection is quite plausible . . . . If I experience any of these following signs of allergic reactions I should immediately consult my primary health care Physician and discontinue further use of the product. Signs of allergic reactions include, but [sic] not limited to:
• Itching of skin • Hives • Rashes • Wheezing • Difficulty breathing • Swelling of mouth or throat
When medications are taken in conjunction with the Vitamin Injection, drug interactions could occur. These interactions can either increase your risk of bleeding or block the absorption of the Vitamins into the body.
These are a lot of risks for a treatment with no known benefit.
The proposed settlement order, which is subject to public comment, prohibits iV Bars from making the false or unsubstantiated claims that its iV Cocktails: 1) are an effective treatment for any of the diseases included in the complaint; 2) produce fast, lasting results; or 3) cure, mitigate, or treat any diseases, unless the claim is supported by competent and reliable scientific evidence. The order also prohibits iV Bars from making any express or implied health, safety, or efficacy claims unless they are not misleading and are supported by scientific evidence.
In connection with the advertising, marketing, promotion, or sale of any covered product, the order prohibits iV Bars from misrepresenting that it has had medical professionals test or approve the product, or that it has a research facility. The order also prohibits iV Bars from misrepresenting the existence or conclusions of any scientific evidence, or that a product, including iV Cocktails, is scientifically or clinically proven to produce any benefit.
Finally, the order requires iV Bars to preserve any underlying scientific data and documents used to support health claims made for any product.
iV Bars also agreed to email its customers a notice stating that:
I would say that this is a good start, but that it doesn’t go nearly far enough because it appears to be allowing the company to continue to market its product. Unfortunately, that’s probably because the complaint was about deceptive advertising. What really needs to happen is that the FDA needs to get involved, because this company clearly appeared to be making distinct medical claims and selling a concoction that appears all the FDA legal definitions of what constitutes a drug.
I also note that the agreement will be subject to public comment for 30 days, which will end on October 22, after which the FTC will decide whether to make the proposed consent agreement final. I would urge our readers to comment, because you know the quacks will be commenting. I found the form to submit public comment about the proposed consent agreement here.
Finally, it’s been asked, given the potential harm and the lack of evidence for stem cell therapies as marketed, whether the FTC will be targeting for-profit stem cell clinics. Given how they abuse the clinical trial process charge huge sums of money for treatments with no evidence of efficacy but evidence of harm, I, too, would ask the same question. However, I hope that this is a start for the FTC to take a much harder line on the many false advertising claims made by quack clinics and sellers of unproven and disproven treatments that quack loudly.