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Archive for Politics and Regulation

ACA: Six Key Elements of A Modern Chiropractic Practice Act

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In February, 2015, the American Chiropractic Association House of Delegates ratified “Six Key Elements of A Modern Chiropractic Practice Act.” For what it’s worth, this means that the “Six Elements” are part of the official “Public Policy” of the ACA.

1. “Chiropractic Physician” and “Chiropractic Medicine” as the Regulatory Terms of Licensure.

2. Scope of Practice Determined by Doctoral and Post-Doctoral Education, Training and Experience Obtained Through Appropriately Accredited Institutions.

3. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for Patient Examination, Diagnosis, Differential Diagnosis and Health Assessment.

4. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for the Care and Treatment of Neuromusculoskeletal and Other Health Conditions or Issues.

5. Full Authority for the Delivery of Information, Advice, Recommendations and Counseling Regarding General Health Matters, Wellness and Health Optimization.

6. Full Authority and Adaptable Requirements for the Management and Training of Health Care Teams and the Participation in Collaborative or Integrative Health Care Groups.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Legislative Alchemy: Naturopathic licensing and practice expansion 2015

Naturopathic genetics: a new specialty?

Naturopathic genetics: a new specialty?

Naturopathy is chock-full of quackery. No doubt about it. Here at SBM and elsewhere, the seemingly limitless nonsense that can be incorporated into naturopathic practice has been documented time and again: detoxification, food “sensitivities,” anti-vaccination ideology, fake diseases (chronic yeast overgrowth, adrenal fatigue, chronic Lyme disease), bogus tests (also here), homeopathy, chelation therapy, assorted other odd-ball treatments, lack of ethical standards, and just general wackiness.

So, let’s give naturopaths licenses to practice primary care! What a good idea.

This affinity for nonsense is perfectly understandable, given their pseudoscience-filled education and foundation in vitalism. Once the scientific method is chucked in favor of “philosophy,” what’s to stop them from simply making things up? As far as I can tell, nothing. But why inflict this on the public under the guise of promoting health, safety and welfare?

To be fair, naturopaths aren’t the only ones who incorporate quackery into their practices. There are chiropractors, acupuncturists, reiki masters, doctors of Oriental Medicine, and “integrative medicine” practitioners. But what sets naturopaths apart, in my mind, is the sheer range of pseudoscience they will accommodate without the slightest hint of doubt in its efficacy or safety and their unwavering belief in their ability to diagnose and treat patients with the expertise and skill of medical doctors. “Delusional” is not too strong a word to describe their utter lack of awareness of their ignorance or the danger to patients they may pose. (more…)

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

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Anesthesia-Assisted Rapid Opioid Detox

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor's Office of Drug Control Policy.

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor’s Office of Drug Control Policy.

Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.

How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.

One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation. (more…)

Posted in: Clinical Trials, Legal, Pharmaceuticals, Politics and Regulation

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Supplements are the Wild West of health. One Attorney General is out to change that.

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Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.

When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Wikipedia vs Quackery – Standards vs Chaos

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Wikipedia’s front page

Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.

Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.

Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.

This is all meant to ensure that individual patients receive the highest quality of care.

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Posted in: Politics and Regulation, Science and Medicine

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How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)
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Posted in: Clinical Trials, Homeopathy, Legal, Politics and Regulation

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Should the FDA crack down on homeopathic “remedies”?

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:

oral-asthma-spray

Photo Credit Ryan Meylon

Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following: (more…)

Posted in: Homeopathy, Politics and Regulation

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Lyme: Two Worlds Compared and Contrasted

The Lyme tick

The western black-legged tick, carrier of the Borrelia burgdorferi bacteria which causes Lyme disease.

The practice of infectious disease (ID) is both easy and difficult. If you read my ID blog on Medscape you are aware of my trials and tribulations in diagnosing and treating infections.

ID is easy since, at least in theory, diseases have patterns and an infecting organism has a predictable epidemiology and life cycle. So if you can recognize the pattern and relate it to the life cycle and exposure history, you can often make a diagnosis before the cultures come back.

My favorite story is the time I was asked to see a young girl with endocarditis. The history was she had a week of fevers, headache and myalgia that went away for five days, returned for a week, went away for five days and returned yet again.

So I asked her “How was your vacation at Black Butte?”

The look of astonishment on her face as she asked how I knew she had been to Black Butte was so satisfying. (more…)

Posted in: Legal, Naturopathy, Politics and Regulation, Public Health, Science and Medicine

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The DC as PCP? Drug Wars Resume

Coming soon, to a chiropractor's office near you?

Coming soon, to a chiropractor’s office near you?

Chiropractors are once again engaged in intra-fraternal warfare over the chiropractic scope of practice, a saga we’ve chronicled before on SBM. (See the references at end of this post.) Every time it looks like the warring factions have buried their differences, they come rising to the surface like zombies.

The International Chiropractors Association (ICA), representing the “straight” faction, wants chiropractic to continue as a drugless profession. They are happy to detect and correct subluxations, thereby removing “nerve interference” and “allowing the body to heal itself” in the tradition of Daniel David Palmer. But the American Chiropractic Association (ACA) has bigger fish to fry.

This time, the ICA is upset that the ACA House of Delegates up and decided to establish a “College of Pharmacology and Toxicology,” which would operate under the auspices of the ACA Council on Diagnosis and Internal Disorders. The ACA’s announcement of the “College” is rather vague on details:

The purpose of the College is to further educate the chiropractic profession on clinical matters related to the widespread use of both prescription and over-the-counter medications and nutritional supplements.

I e-mailed the ACA several days ago asking for more information but have yet to receive a reply.

The ICA sees this move as yet another attempt by:

forces at work within some organizations actively promoting incorporating drugs into the chiropractic scope of practice.

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

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A brief bit of shameless self-promotion…The Prince of Wales edition

PrinceCharles-590x350

In an effort to expand the Gorski empire almost to the level of the Crislip empire and to try to make it to somewhere within two or three orders of magnitude of the Novella empire, I’ve published an article on Slate.com about Prince Charles’ visit to our fine country entitled “Prince of Pseudoscience“. Consider this the mandatory shameless self-promotion that all SBM bloggers take advantage of from time to time to publicize their activities elsewhere.

Enjoy! (I hope.)

I’m told that Dana Ullman has made an appearance in the comments. I might have to head on over after work tonight…

Posted in: Announcements, Homeopathy, Politics and Regulation, Science and the Media

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