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FDA v. Jack3d: Round 2

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 [2012], 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.
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Posted in: Herbs & Supplements, Legal, Politics and Regulation

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Dr. Who?

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.
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Posted in: Acupuncture, Chiropractic, Health Fraud, Legal, Naturopathy, Politics and Regulation, Science and Medicine

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The Quack Full Employment Act

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.

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Posted in: Energy Medicine, Health Fraud, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Homeopathic regulation diluted until no substance left

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.

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Posted in: History, Homeopathy, Legal, Naturopathy, Politics and Regulation

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At Your Own Risk

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.

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Posted in: Herbs & Supplements, Legal, Politics and Regulation

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Legislative Alchemy: Acupuncture and Homeopathy 2013

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…)

Posted in: Acupuncture, Homeopathy, Legal, Politics and Regulation, Traditional Chinese Medicine

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Legislative Alchemy: Chiropractic 2013

Via the magic of legislative alchemy, chiropractors are already licensed health care providers in all 50 states. Thus their legislative efforts tend to focus on expanding their scope of practice and forcing public and private insurers to cover their services, in some cases at the same rate as medical doctors. Those efforts continue in 2013 with 65 bills impacting chiropractors introduced so far. Of those including substantive provisions (as opposed to, say, simply raising fees), only one is not to their advantage.

New Mexico chiropractors are once again attempting expansion of their scope of practice. In 2008 and 2009, the New Mexico legislature created a new iteration of chiropractor, called “the certified advanced practice chiropractic physician.” A certain faction of the chiropractic industry is attempting to rebrand chiropractors nationwide as primary care physicians and this was a signature event in those efforts. With 90 hours of additional education, these advanced practice chiropractors can administer a bevy of dubious remedies, such as bioidentical hormones.

The new law also permitted prescription of dangerous drugs and controlled substances and administration of drugs by injection, but only if on a formulary approved by the state pharmacy and medical boards. The chiropractic board didn’t like having to get approval from pharmacists and medical doctors, so they went ahead and added what they wanted to the formulary, ignoring the other boards despite their own attorney’s advice that they couldn’t do this. This got them into a couple of court battles with the pharmacy and medical boards. The International Association of Chiropractors (ICA), the traditional, subluxation-only chiropractic faction, jumped into the fray to oppose this power grab. The ICA believes chiropractic should remain drug and surgery free.

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Posted in: Chiropractic, Herbs & Supplements, Homeopathy, Legal, Pharmaceuticals, Politics and Regulation

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Fighting Back

As I hope I demonstrated in Legislative Alchemy: Naturopathy 2013, below, licensing “naturopathic doctors,” especially as primary care physicians, is a bad idea.  Unfortunately, the only people usually interested in opposing their licensing efforts are medical doctors and their organizations.  Of course, this allows naturopaths to pretend they are the victims of the evil, Big Pharma-controlled medical-industrial complex which kills and maims vast numbers of people every year.  This distracts legislators from the real issues, such as whether they are qualified to do what they want to do (answer: no)  and whether people really want an ND to provide their care (answer: very, very  few).

I happen to think that legislators should be fully informed about things such as how naturopaths are educated, what they do in actual practice, and what thier beliefs  about medical care are.  So I created a website to inform them about these issues and to inform the public as well, so they too will be inspired to oppose naturopathic licensing.  It also has suggestions for opposing naturopathic licensing as well as addtional sources of information and downloads of materials you can use.  (I thank SBM’s Kimball Atwood, M.D., for permission to use some of the wonderful work he has done on naturopathy.)

The website is titled, most creatively, “Oppose Naturopathic Licensing!” And you can find it here: http://www.no-naturopaths.org/ If those who value science and the rational application of science to medical care don’t work to stop CAM provider licensing, the spread of pseudoscience and quackery will only increase.  And that demeans all scientific endeavors.

 

Posted in: Announcements, Naturopathy

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Legislative Alchemy: Naturopathy 2013

A fresh season of state legislative sessions is upon us and with it comes the ubiquitous attempts by purveyors of so called “complementary and alternative medicine” (or “CAM”) to join the health care provider fraternity. Via the magic of legislative alchemy, state legislatures transform pseudoscientific diagnoses (e.g., “chronic yeast overgrowth”) and treatments (e.g., homeopathy) into faux, but legal, health care. Once the imprimatur of legitimacy is bestowed by the state in the form of a health care practice act tailored to their special brand of quackery, these newly licensed health care providers are free to foist their practices onto an unsuspecting public and charge them for the privilege. All of this is done under the false assumption that such legislation is necessary to protect the public health, safety and welfare.

We might well want to consider how far this whole thing is going. Will practitioners of CAM split into an ever-expanding number of CAM provider guilds, all with their own practice acts? First, chiropractors were the only CAM practitioners who managed to get themselves licensed in all 50 states. Then along came acupuncturists, who are now licensed to practice in over 40 states. A few states license homeopaths. Some states licensed naturopaths early on. Now the naturopaths, licensed in 16 states, are in a full court press to catch up and legitimize themselves with licenses to practice “naturopathic medicine.”

Why? Because, according to Lorilee Schoenback, ND, a Vermont practitioner and American Association of Naturopathic Physicians (AANP) Board member:

If the law [the Affordable Care Act, or ACA] is implemented as intended NDs in 16 states will immediately be covered by insurance.

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Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Pharmaceuticals, Politics and Regulation, Public Health

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The DC as PCP? The battle continues

Chiropractors are trying to rebrand themselves as primary care physicians, a topic both Harriet Hall and I have addressed (here and here) on SBM.  Toward this end, they are seeking the expansion of their scope of practice, via the magic of legislative alchemy, to include the prescription and administration of drugs.  Not drugs that any self-respecting M.D. would use, but drugs nonetheless.  That effort succeeded to an extent in New Mexico.  Recently Colorado got into the act.  Other states have followed suit.

Chiropractors have claimed from the very beginning they are primary care physicians. Chiropractic was born in 1895 with the notion that virtually all diseases could be resolved with chiropractic treatment.  This was Daniel David Palmer’s original contention, that the interruption of “nerve flow” by “subluxations” caused disease which could be remedied by spinal adjustment to restore the flow, thereby allowing the body to heal itself.

State chiropractic practice acts have always given chiropractors a broad scope of practice which allows them to diagnose and treat virtually any condition as long as they can squeeze the treatment into the “chiropractic paradigm.”  If they can pretend the condition is amenable to chiropractic treatment via the detection and correction of subluxations, they can diagnose and treat it legally.  This is how they are able to claim, falsely, that asthma, allergies, colic, and many other health problems can be resolved by chiropractic care.  This is how “straight” chiropractors still practice.

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Posted in: Chiropractic, Health Fraud, Herbs & Supplements, Homeopathy, Legal, Politics and Regulation, Vaccines

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