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Kratom: another dangerous “natural” remedy

Mitragyna_speciosa111
Kratom (Mitragyna speciose) is a tropical tree from Southeast Asia whose leaves are traditionally chewed or prepared as a powder. Native populations chew the leaves to reduce fatigue when doing manual labor, such as working on rubber plantations. It is also used in cultural performances and consumed as a drink prepared from kratom powder. When the Second World War caused an increase in the price of opium, Thai addicts forced to cut back on opium consumption used kratom to ease their withdrawal symptoms. Thailand and other Southeast Asian countries have passed laws controlling its use and other countries have followed suit, including Australia and New Zealand where it is banned.

In the past several years, kratom consumption has spread beyond traditional uses and the confines of Southeast Asia. In the U.S., it is widely available in head shops, kava bars, and on the internet. It is touted as a legal, psychoactive alternative to other sedative and stimulant-type drugs, both legally and illegally obtained. It is marketed for opioid and alcohol withdrawal symptoms, chronic pain and appetite reduction, among other things. There is also anecdotal evidence of naturopaths prescribing it for opioid withdrawal and depression. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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CARA: Integrating even more pseudoscience into veterans’ healthcare

VA logo
The pixels were barely dry on David Gorski’s lament over the expansive integration of pseudoscience into the care of veterans when President Obama signed legislation that will exacerbate this very problem. The “Comprehensive Addiction and Recovery Act of 2016” (“CARA”) contains provisions that will undoubtedly keep Tracy Gaudet, MD, and her merry band of integrative medicine aficionados at the VA busy for the next few years integrating even more quackery into veterans’ medical care.

CARA is intended to address the serious prescription drug abuse problem in the U.S. It provides grants for local communities dealing with drug abuse crises and for drug abuse programs, improves access to overdose reversal medication and medication-assisted treatment for drug addiction, and assists in training first responders, among other things. It also includes provisions related to pain management, such as development of best practices to treat pain. None of that is the problem.

Deep in the Act, almost at the end, is “Subtitle C – Complementary and Integrative Health,” which begins with “Expansion of research and education on and delivery of complementary and integrative health to veterans.” I am not sure who stuck this into the new law, but it is only tangentially related to addiction and recovery. It establishes the “Creating Options for Veterans’ Expedited Recovery” Commission or, in the acronym-rich language of government, “COVER.” (more…)

Posted in: Acupuncture, Clinical Trials, Politics and Regulation

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Legislative Alchemy 2016 Update: Acupuncturists win; naturopaths and chiropractors don’t (so far)

Legislative Alchemy

Legislative Alchemy

Legislative Alchemy is the process by which state legislatures transform pseudoscience and quackery into licensed health care practices. By legislative fiat, chiropractors can detect and correct non-existent subluxations, naturopaths can diagnose (with bogus tests) and treat (with useless dietary supplements and homeopathy) fabricated diseases like “adrenal fatigue” and “chronic yeast overgrowth,” and acupuncturists can unblock mythical impediments to the equally mythical “qi” by sticking people with needles. In sum, by passing chiropractic, naturopathic, acupuncture, and Traditional Chinese Medicine (TCM) practice acts, states license what are essentially fraudulent health care practices and give them an undeserved imprimatur of legitimacy.

Only 6 of the 50 state legislatures are in regular session now. Many have ended two-year (2015-2016) consecutive sessions in which legislation from one year carries over into the next. The Texas, Montana, and North Dakota legislatures didn’t meet at all in 2016.

During 2015-2016, over a dozen naturopathic licensing or registration bills and at least 15 naturopathic practice expansion bills were introduced. (In some states, companion bills were introduced in each house. These were counted as one bill.) At least 19 chiropractic practice expansion bills were introduced in the same period. Four acupuncture/TCM practice acts were introduced, as were 14 practice expansion bills. This count does not include bills trying to force public and private insurers to cover CAM practitioner services.

(more…)

Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

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FDA efforts to improve compounded drug safety upsets naturopaths

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Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances.

According to the American Association of Naturopathic Physicians (AANP)

these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.

Not to mention the fact that it is highly doubtful these questionable remedies could make it through the FDA drug approval process, which requires proven safety and efficacy.

The FDA’s recent steps to improve drug compounding safety is a welcome curb on these practices. Draft Guidance issued in April addresses both compounding for office use and by prescription. (“Office use” refers to creating a supply of a compounded drug to be used by a health care practitioner as needed, as opposed to compounding a drug per a specific prescription for an individual patient.) In June, the FDA also issued an Interim Policy on substances that can be used in compounding a drug. We’ll discuss how these affect naturopathic practice in a moment. (more…)

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

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Bye Bye Bravewell

Bravewell Collaborative

Exactly one year ago tomorrow, The Bravewell Collaborative shut down, an event so momentous that few seem to have noticed. It’s been a while since we at SBM devoted much attention to Bravewell, although, at one time, its doings were a regular feature of SBM posts.

For those of you not familiar with Bravewell, a brief history. The main mover and shaker behind The Bravewell Collaborative was Christy Mack, wife of former Morgan Stanley head John Mack and a financier of sorts in her own right. She and the widow of another Morgan Stanley bigwig, Susan Karches, neither of whom had any particular expertise in finance, managed to get about $220 million in bailout funds from the Federal Reserve, a boondoggle recounted in Matt Taibbi’s 2011 hilarious Rolling Stone article, “The Real Housewives of Wall St.” Ms. Mack had established the Bravewell Collaborative a few years earlier, with her own contributions and that of other philanthropists, as a private operating foundation, a further opportunity to benefit from government largesse in the form of tax deductions.

Here’s Bravewell’s definition of “integrative medicine”:

Integrative medicine is an approach to care that puts the patient at the center and addresses the full range of physical, emotional, mental, social, spiritual and environmental influences that affect a person’s health. Employing a personalized strategy that considers the patient’s unique conditions, needs and circumstances, integrative medicine uses the most appropriate interventions from an array of scientific disciplines to heal illness and disease and help people regain and maintain optimal health.

(more…)

Posted in: Acupuncture, Chiropractic, Energy Medicine, Homeopathy, Medical Academia, Naturopathy

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Health and Wellness Coaching: cautious optimism and some concerns

NCCHWC logo

The National Consortium for Credentialing of Health & Wellness Coaches (NCCHWC) and the National Board of Medical Examiners (NBME) signed an agreement last month for the launch of a national certification for individual health and wellness coaches in the U.S. According to a joint press release, the agreement is a landmark in the efforts of a dedicated group of individuals who have been working for years to establish professional practice and educational standards for health and wellness coaching.

What is “health and wellness coaching?” According to NCCHWC’s website:

Health and Wellness Coaches partner with clients seeking self-directed, lasting changes, aligned with their values, which promote health and wellness and, thereby, enhance well-being. In the course of their work health and wellness coaches display unconditional positive regard for their clients and a belief in their capacity for change, and honoring that each client is an expert on his or her life, while ensuring that all interactions are respectful and non-judgmental.

(more…)

Posted in: Nutrition, Public Health

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Supplements, Lies, and a Lengthy Transcript

Thanks, Congress, for making bull testicles available as a dietary supplement!

Thanks, Congress, for making bull testicles available as a dietary supplement!

On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:

Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.

S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).

I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.

Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.

First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that. (more…)

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

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Change.org Petition: “Naturopaths are not physicians: stop legitimizing pseudoscience”

change.org

Britt Hermes, a graduate of the naturopathic college at the alternative medicine-focused Bastyr University, renounced her practice as a naturopathic doctor when she could no longer tolerate the pseudoscience and patient harm that characterizes naturopathy. On this blog and her own, Naturopathic Diaries, she has chronicled the insufficient education and training students receive before being allowed to practice as naturopathic doctors, deficiencies which all too readily can result in patient harm.

Her activism is not confined to blog posts. Her advocacy helped prevent an expansion of naturopathic prescribing privileges in North Dakota in 2015. Just this past Friday, she participated, as did I, in a presentation via conference call to the Colorado Department of Regulatory Affairs (DORA), organized by the Colorado Citizens for Science in Medicine. DORA will soon issue a report on the continued registration of naturopaths in that state. In her testimony, Britt told how her own naturopathic education and training made her woefully unprepared to practice.

A number of SBM commenters have wondered how they could do more to combat naturopathic efforts to become licensed as health care providers in all 50 states, as well as participating in Medicare, Medicaid and other publicly-funded programs. Britt just started a Change.org petition urging policy makers and legislators to “stop legitimizing pseudoscience.” She also posted some excellent talking points to rebut the misleading information naturopaths give lawmakers when lobbying. You can help by using the talking points in combating legitimization of naturopathy through licensing and inclusion in public insurance programs. You can also help by signing the petition and sending it around to others on your social media accounts.

Posted in: Announcements, Legal, Naturopathy, Politics and Regulation

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Legislative Alchemy: Michigan House Bill 4531 gives naturopaths a broad scope of practice

Legislative Alchemy

Legislative Alchemy

Michigan House Bill 4531, if passed, would give naturopaths one of the broadest scopes of practice in the U.S., essentially equaling that of a family practice MD or DO. The bill made it through all the necessary House committees and is now before the House for an initial vote determining whether it will proceed further in that body. If it passes there, it will move to the Senate and its committee process.

Most naturopathic licensing bills fail, even in those states where attempts are made year after year. Michigan is no exception. Both David Gorski (a Michigan resident) and I discussed the previous licensing attempts there. In the two states where naturopathic licensing or registration has succeeded in the last few years, they have been able to get only a much more limited scope of practice than the full primary care scope they desire. For example, in Colorado, there are severe limitations on naturopaths’ seeing pediatric patients. They must disclose they are not physicians, recommend to parents that their children have a relationship with a licensed pediatric practitioner, and give parents the CDC-recommended vaccination schedule. All this is to thwart their efforts to talk parents out of vaccinating their children by giving them “balanced” information that is actually full of anti-vaccination dog whistles.

In Maryland, where naturopaths are regulated by the Maryland Board of Physicians, they cannot call themselves physicians or claim to practice primary care. They must have a collaboration and consultation agreement with an MD or DO and attest to the Board that the ND will “refer patients to and consult with physicians and other health care providers.” NDs must also have patients sign a consent form stating that the ND’s practice is limited to the scope of practice allowed by law. They cannot deviate from what is termed “safe care of patients” whether or not actual injury to a patient is established.

If passed, HB 4531 would be a radical departure from that trend. This newfound success in moving the ball forward may be due to an influx of funds from Emerson Ecologics, a company that sells dietary supplements and homeopathic remedies to naturopaths for resale to their patients. The company also sells the sort of dubious diagnostic tests used by naturopaths in their practice. For example, they offer a test for “adrenal stress” (to discover, not just “adrenal fatigue,” but actual “exhaustion”) and a saliva test for hormone levels as an indicator of the need for “bio-identical hormones.” (Neither the test nor “bio-identical hormones,” which is actually a marketing, and not medical term, are recommended in evidence-based medical practice.) In March, Emerson Ecologics announced a “grant” to the Michigan Association of Naturopathic Physicians (MANP) of $10,000 to support the effort to obtain full licensure for naturopathic doctors in Michigan.
(more…)

Posted in: Legal, Naturopathy, Politics and Regulation

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What (if anything) does “natural” mean?

"When I use a word," said Humpty Dumpty said in a rather scornful tone, "it means just what I choose it to mean -- neither more, nor less." Lewis Carroll, "Through the Looking Glass"

“When I use a word,” said Humpty Dumpty in a rather scornful tone, “it means just what I choose it to mean — neither more, nor less.”
Lewis Carroll, “Through the Looking Glass”

What does the term “natural” mean on a label? Does it mean anything? Should it mean anything? Good questions. And complicated ones, judging from the list of questions the FDA needs your help in answering.

The FDA has resisted defining “natural” in food product labeling, including whether foods that are genetically engineered, or contain genetically engineered ingredients, can use the term. Back in 1991, the agency set out to issue regulations but abandoned the effort and has since held to an informal policy that “natural” means

nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.

The only official legal requirement for using the description “natural” on a food label is that it not be misleading or false, which is forbidden by the Food, Drug & Cosmetics Act of 1938. In that appetite-suppressing way of statutory language, “food” is defined by the Act as

articles used for food or drink for man or other animals, chewing gum, and articles for used for components of any such article.

For regulatory purposes, dietary supplements are also considered foods in most cases. (more…)

Posted in: Genetically modified organisms (GMOs), Legal, Nutrition, Politics and Regulation

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