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CAM Docket: Kardashian Diet Products Klass Action

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.

SBM post Kardashian Klass Action photo
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Posted in: Health Fraud, Herbs & Supplements, Legal, Nutrition, Politics and Regulation

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Naturopathic organ repositioning coming soon to Pennsylvania?

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…)

Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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“Alternative Medicine: Sense and Nonsense” Upcoming Lecture by Dr. Paul Offit

For those of you in the NYC/LI area:  An Invitation from the Cold Spring Harbor Laboratory for a Free Public Lecture!

Please join us for the 2013 Lorraine Grace lectureship on societal issues of biomedical research:

Alternative Medicine: Sense and Nonsense

Saturday, June 8, 2013

3:00pm

Grace Auditorium

One Bungtown Road

Cold Spring Harbor, NY 11724

Americans love alternative medicine, and they are paying a high price for that devotion. From regular visits to acupuncturists, chiropractors and naturopaths to the daily ingesting of homeopathic remedies, Chinese herbs, and megavitamins, the use of alternative therapies has become a $34 billion-a-year business. Fifty percent of Americans use some form of alternative medicine, with ten percent using it on their children. Celebrities routinely hawk their benefits. But, does any of it really work?

In the upcoming lecture, Alternative Medicine: Sense and Nonsense, Dr. Paul A. Offit will take a critical look at the field of alternative medicine and separate fact from myth. Drawing on current research he will examine popular alternative therapies and discuss the issues of medical ethics involved in alternative medicine, which is a largely unregulated industry under no legal obligation to prove its claims or admit its risks.

“Making decisions about our health is an awesome responsibility,” writes Dr. Offit. “If we’re going to do it, we need to take it seriously. Otherwise we will violate the most basic principle of medicine: first do no harm.”

Come join us for a lively discussion!

The recipients of many awards and honors, Paul A. Offit, M.D. is Chief of the Division of Infectious Diseases and Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, as well as the Maurice R. Hilleman Professor of Vaccinology and Professor of Pediatrics at the University of Pennsylvania School of Medicine. He has appeared on The Today Show, Good Morning America, The Early Show, The Colbert Report, CNN, 60 Minutes, MSNBC, Dateline NBC, the Jim Lehrer NewsHour, CSPAN, FOX News, and National Public Radio, and is often interviewed in the New York Times, Washington Post, LA Times, Wall Street Journal, Chicago Tribune, and USA TODAY.

NOTE: In June,  Dr. Offit’s book, Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine will be released by Harper Collins.  Our own Dr. Harriet Hall has a review in an upcoming issue of Skeptical Inquirer.

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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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