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FDA efforts to improve compounded drug safety upsets naturopaths

herbs-nd1
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 Draft Guidance issued in April addresses both compounding for office use and by prescription.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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Academic Consortium plan: force medical residents to practice integrative medicine

The Integrative Medicine Wheel

The Integrative Medicine Wheel

“Integrative medicine” (IM) is an ideological movement within medicine driven in large part by those whose livelihoods depend on its continued existence. This includes both those with positions in academic medicine and individual practitioners who use the IM brand to attract patients.

Despite IM and its antecedents (alternative, complementary, alternative and complementary, complementary and integrative) having been around for about a quarter century, we still do not have a working definition of integrative medicine or have any idea whether it positively affects patient outcomes. And, despite the lip service given to IM being evidence-based, or “evidence-informed” or incorporating “appropriate” services into conventional medicine, there does not seem to be any standard for determining which modalities are appropriate for inclusion. We can infer, however, that evidence of effectiveness is not a criterion, as reiki, cranial sacral “therapy”, and homeopathy are standard fare.

In fact, the prospect for actually improving patient outcomes by importing CAM treatments (such as acupuncture) into medical practice would seem to be decreasing over time, as more and more fail to hold up under the scrutiny of well-designed and conducted clinical trials. Perhaps the dearth of evidence for “alternative” treatments is the impetus behind the importation of conventional modalities, such as nutrition and exercise, into the IM fold, treatments that were never viewed as CAM when the whole enterprise started. It has also led to special pleading demanding that research standards be loosened, most recently by the NCCIH, its director’s promise to ensure “rigorous science” notwithstanding.

There is no standard delivery model for integrative medicine or, importantly, an agreed-upon role for the various practitioners who bring the “integrative” to integrative medicine, such as chiropractors, naturopaths and acupuncturists. For example, should they be allowed to practice independently or should the medical doctor have final say on patient care? And, if they differ in their proposed diagnoses and treatments, how are those issues to be resolved? (more…)

Posted in: Acupuncture, Chiropractic, Ethics, Medical Academia, Medical Ethics, Naturopathy

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Regulating CAM Aussie Style

640px-Flag_of_Australia.svg
CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

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American Journal of Public Health article touts “potential public health benefits” of homeopathy

Homeopathy: It's just water.

Homeopathy: It’s just water.

An article in the April, 2016 issue of the American Journal of Public Health caught my eye: “Homeopathy Use by US Adults: Results of a National Survey.” I was pleased to see that homeopathy use is actually quite low. The 2012 National Health Survey found that only 2.1% of U.S. adults used homeopathy in the last 12 months, although that was a 15% increase over 2007. Users were mostly young, white, well-educated women, the typical CAM consumer.

Even fewer saw a homeopathic practitioner (only 19% of all users), although those who did perceived a greater benefit from homeopathic remedies. This difference, speculate the authors, could be due to several factors, one of which is

a more individualized and effective homeopathic prescription by the provider.

What? Are the authors suggesting that the series of off-the-wall questions asked by homeopaths leads to a prescription of an “effective” homeopathic remedy?

They certainly seem to be. Who are these authors, anyway?

They are Michelle L. Dossett, MD, PhD, MPH, Roger B. Davis, ScD, Ted J. Kaptchuk, and Gloria Y. Yeh, MD, MPH. All are, or were, with the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center. All are also connected with Harvard and work, in various ways, in “integrative medicine” research. The article was funded, in part, by the National Center for Complementary and Integrative Health, and in part by Harvard. (more…)

Posted in: Clinical Trials, Homeopathy, Medical Academia, Public Health, Vaccines

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