Kim, Khloe and Kourtney Kardashian permit the use of their names and images of their curvaceous bodies to promote “QuickTrim” diet products, a line of dietary supplements making overblown claims typical of the weight loss supplement industry. Their personal testimonies and formidable publicity machine (Kim alone has over 13 million followers on Twitter), “has reportedly generated $45 million in revenue since they struck the deal with New Jersey-based Windmill Health Products in 2009,” according to the N.Y. Post. Naturally, the sisters are paid for their efforts, although how that amount is calculated or how much they receive apparently is not a matter of public record.
Archive for Legal
by Igor I. Bussel & Andrey A. Pavlov Jr.
Jann Bellamy has recently authored an excellent piece on the limitations of the FDA and how the DSHEA actually protects the profits of supplement manufacturers rather than the health and well-being of consumers. Bellamy used the very poignant and currently “controversial” example of DMAA (methylhexanamine or 1,3-dimethylamylamine) to illustrate her point regarding the loopholes and lack of enforcement power of the FDA. The authors of this piece had been considering writing about DMAA and felt this would be an excellent time to further expound on Bellamy’s work. The goal of this article will be twofold: 1) to discuss the known history and pharmacology of DMAA, especially in regards to the basic methodology for evaluating novel substances or novel uses of substances in the context of lacking RCT level evidence (i.e. the concept of science vs. evidence based medicine) and 2) how the DMAA story clearly and unequivocally demonstrates how the DSHEA allows for unscrupulous profiteers to game the system with little, if any, consequence and nothing but profit until the cost in lives forces the issue.
DMAA was originally developed by Eli-Lilly in 1948 and then later trademarked as Forthane to be used as a nasal decongestant (there are varying accounts but it seems that Eli Lilly patented the molecule in the early 1940’s and then trademarked and marketed it as Forthane in 1971 for allergic rhinitis and then voluntarily withdrew it in 1983). The mechanism of action was vasoconstriction – the blood vessels in the nose would constrict so that less blood flow would lead to less nasal discharge. This is a mechanism used by common OTC nasal sprays like oxymetazoline (Afrin) and is indeed quite effective. However, Forthane was later withdrawn from the market because of significant side effects including headaches, tremors, and increased blood pressure. These effects likely occur because DMAA is structurally similar to amphetamine and as a result, the compound is not only a vasoconstricting agent but is also a central nervous system (CNS) stimulant.
Pennsylvania legislators need to know only one thing about House Bill 612 (licensure of naturopathic “doctors”) to vote against it: As a means of “naturopathic musculoskeletal therapy” the bill would allow naturopaths to “reposition body tissues and organs.”
This is impossible. You cannot “reposition” tissues and organs of the human body by external manipulation.
Why does this tell us everything we need to know about these naturopathic doctors and why they shouldn’t be licensed in Pennsylvania? For one thing, this is no mistake a bill draftsman made in understanding what naturopathic practice includes. House Bill 612 was obviously drafted by naturopaths. That means naturopathic doctors actually believe they can “reposition” your body’s tissues and organs. And that speaks to their poor education and training. They don’t even understand basic anatomy.
For another, it tells us naturopathic doctors reject evidence-based medicine as a standard of practice. There is no evidence that this “repositioning” of organs and tissues is beneficial for any condition or disease, even if they could do it in the first place, which they can’t.
And for yet another, this certainly calls into question their understanding of the disease process and their diagnostic skills. One has to wonder exactly what health problems they think these purportedly out-of-place organs are causing. And how do they go about determining which organs are out of place and where they should go? Or when they have been successfully returned to their proper position? Again, this should raise alarming questions in the legislators’ minds about their education and training. (more…)
Jack3d is a dietary supplement manufactured by USPlabs and promoted by the giant supplement retailer GNC as producing “ultra-intense muscle-gorging strength, energy, power and endurance.” A key ingredient is DMAA, which the FDA doesn’t think is a proper dietary supplement ingredient at all and wants Jack3d and other products containing it removed from the shelves and the web. The FDA also questions its safety.
As discussed in a previous post on the subject, both USPlabs and GNC maintain Jack3d (pronounced “jacked”) is safe when properly used. Apparently few agree with them on this point: not the FDA, not the U.S. military, not the countries and athletic associations which have banned DMAA. And certainly not the parents of Michael Lee Sparling, a 22-year-old Army private. The Sparlings filed a lawsuit alleging Jack3d caused the death of their son, who went into cardiac arrest and died after using it.
Here is where we left off the last time we looked at DMAA:
Last April , the FDA sent warning letters to several supplement manufacturers saying it had no evidence DMAA is a legitimate dietary ingredient and citing its risks. (Health regulators in other countries, such as Sweden and Denmark, have actually banned DMAA-containing supplements.) Heart attacks, heart failure, kidney failure and liver failure were among the health problems reported to the FDA, as well as 5 deaths. GNC responded that it was “completely opposed to this unilateral, factually and legally unfounded action by the FDA.”
Now to Round 2.
Stem cells are magical.
At least, if you listen to what docs and “practitioners” who run stem cell clinics in various parts of the world, usually where regulation is lax and money from First World clientele is much sought after, that’s what you could easily come to believe. Unfortunately, it’s not just Third World countries in which “stem cell clinics” have proliferated. For instance, they are not nearly uncommon enough in Europe. The example that is most troubling right now is Italy, and the reason is that there is currently a law being considered that would greatly weaken the regulation of stem cell therapies, so much so that on Friday I saw something that’s fairly rare: a major scientific journal published a pointed editorial about this new law. Specifically EMBO Journal published a commentary by an international group of scientists warning about the path that the government of Italy is considering entitled Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.
Stem cell quackery is a very popular form of quackery these days because, well, stem cells are so magical-seeming. You can now find stem cell treatments offered for autism (one of which, offered at a clinic in Costa Rica, I’ve discussed before and involves injecting “stem cells” into the cerebrospinal fluid of autistic children for a cool $15,000). Kent Heckenlively, the man who took his daughter to the aforementioned Costa Rica clinic for this treatment, is not alone in subjecting his autistic child to such unproven uses of stem cells. Just a couple of months ago, a broadcast journalist in the Philippines named Karen Davila took her autistic son to the Villa Medica Clinic in Germany, which offers variants of stem cell therapy. One is known as “fresh cell therapy” and involves harvesting cells from lamb fetuses and injecting them into the patient. The other is called fat stem cell repair therapy, which is claimed to involve harvesting fat from the patient’s abdomen or thigh and then isolating “stem cells” from them to be injected back into the patient’s body.
If the “Health Freedom” movement has its way, everyone in the United States will be able to practice medicine. It may be quack medicine but that doesn’t seem to bother them. Short of that, chiropractors, naturopaths and acupuncturists are aiming to reinvent themselves primary care providers and even physicians. As David Gorski pointed out, this will reduce medical doctors to just another iteration of physician, the “allopathic” type, equal in stature to the chiropractic, naturopathic and acupuncture types. These “physicians” already call themselves “doctor” (e.g., “Doctor of Oriental Medicine”) and claim to graduate from four-year “doctoral” programs. This despite the fact that their schools operate outside the mainstream American university system and avoid some of the basics of typical graduate programs, such as entrance exams, as well as the extensive clinical training required for medical doctors.
Consumers are confused by all of this, and who wouldn’t be? In 2008 and 2010, surveys done for the American Medical Association by outside firms revealed that many patients did not know the qualifications of their healthcare provider. The comparisons were between allied health professions (e.g., audiologists and nurse practitioners) and medical doctors, but chiropractors were included. In 2008, 38 per cent of those surveyed (n=850) thought chiropractors were medical doctors, although that dropped to 31 per cent in 2010. Still, we are talking about roughly one-third of the survey participants.
The surveys also asked about the use of the term “physician” and confusion in advertising materials.
Quacks, charlatans and snake oil salesmen are closely watching “The Colorado Natural Health Consumer Protection Act,” Senate Bill 13-215 (SB 215) as it wends its way through the Colorado Legislature. I imagine a few felons about to be released from prison are keeping tabs on the bill too, for reasons we’ll get to in a minute. SB 215 passed the Senate on Tuesday. It will now go on to the House, where it has the support of Rep. Joann Ginal, the mover and shaker behind a bill giving “naturopathic doctors” a right to practice, House Bill 13-1111 (HB 1111). That bill passed the House and is now parked in the Senate awaiting committee assignment. Apparently, critical thinking skills have abandoned the state capital. Things are looking grim.
If the “Colorado Natural Health Consumer Protection Act” passes, Colorado will become one of a handful of states where anyone can practice medicine. Of course, these laws don’t come out and say that exactly. In fact, the Colorado bill states that if you don’t have a medical license you cannot practice medicine, which in Colorado is defined to include:
Holding out one’s self to the public within this state as being able to diagnose, treat, prescribe for, palliate, or prevent any human disease, ailment, pain, injury, deformity, or physical or mental condition, whether by the use of drugs, surgery, manipulation, electricity, telemedicine, the interpretation of tests, including primary diagnosis of pathology specimens, images, or photographs, or any physical, mechanical, or other means whatsoever; . . . Suggesting, recommending, prescribing, or administering any form of treatment, operation, or healing for the intended palliation, relief, or cure of any physical or mental disease, ailment, injury, condition, or defect of any person . . .
But, as we shall see, what SB 215 actually does is allow rank amateurs to diagnose and treat just about anyone for any disease or condition with means of no known safety or effectiveness. In other words, they can practice medicine, it’s just quack medicine. At the same time, the bill strips away important consumer protections. And guess who’s supporting it? The Colorado Medical Society, although I suppose we can be disappointed but not surprised. The Colorado Chapter of the American Academy of Pediatrics is remaining neutral. As I said, critical thinking skills have decamped from Denver.
Pay attention folks. Passage of this bill will energize the Health Freedom crowd. They’ll be in your state soon.
Homeopathy is quackery but it is perfectly legal to prescribe homeopathic products and to sell them directly to consumers in the United States as well as other supposedly civilized countries such as the United Kingdom and Germany. This makes as much sense as allowing the sale of batteries that don’t produce electricity.
What makes this state of affairs even stranger is that homeopathic products are classified as drugs under U.S. law. Does this mean that they undergo the same pre-market approval process and are subject to the same post-market requirements as pharmaceutical drugs? No, not by a long shot. In fact, the federal government and the FDA have pretty much handed regulation of homeopathic products over to their manufacturers.
How did this happen?
In 1938, Congress passed the Food, Drugs and Cosmetics Act. The Act’s principle author was Senator Royal Copeland, a physician who practiced homeopathy. He managed to include all articles monographed in the Homeopathic Pharmacopeia of the United States (HPUS) in the definition of drugs within the FDCA, although why he did so remains in dispute. The HPUS is a source for monographs, identity, methods of manufacture, standards and controls and potency levels of homeopathic products, both prescription and OTC. (The vast majority of homeopathic products are OTC.) In short, if the product is in the HPUS, it’s legal.
In 2011, Americans spent some $30 billion on dietary supplements. Yet, except for the industry itself and a few politicians and “health freedom” advocates, you’d be hard pressed to find anyone (who’s given it some thought) of the opinion that dietary supplement regulation is adequate. Three recent reports, two from the government and one from a newspaper, demonstrate why this near-universal conclusion is warranted.
Another government report on lax supplement regulation
Here’s how an October, 2012, Department of Health and Human Services Office of Inspector General’s (OIG) report described the FDA’s regulatory authority:
DSHEA [Dietary Supplement Health and Education Act] does not require manufacturers to submit dietary supplements to FDA for safety or approval prior to sale. As a result, FDA has no comprehensive list of dietary supplements on the market. Dietary supplement manufacturers must ensure that their products are safe, they have evidence to substantiate structure/function claims, and that product labels are truthful and not misleading.
In other words, the fox guards the henhouse.
Acupuncture, or more broadly, Oriental or Traditional Chinese Medicine, is a
weird medley of philosophy, religion, superstition, magic, alchemy, astrology, feng shui, divination, sorcery, demonology and quackery.
And via the particular form of magic known as legislative alchemy, acupuncture is a licensed health care profession in 44 states and the District of Columbia.
A growing body of evidence demonstrates acupuncture is simply an elaborate placebo. Even the CAM-friendly National Center for Complementary and Alternative Medicine, says
Although millions of Americans use acupuncture each year, often for chronic pain, there has been considerable controversy surrounding its value as a therapy and whether it is anything more than placebo.
Someone should tell the state legislatures. (more…)