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Personal Care Products Safety Act: Facelift for FDA Regulation or Lipstick on a Pig?

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

The U.S. cosmetics industry, the largest in the world, is expected to reach $62 billion in revenues in 2016. Yet, despite the fact that its products are regularly applied to, and absorbed by, the body’s largest organ (the skin) and even ingested in small amounts, the cosmetics industry is largely self-regulating.

There are over 57,000 different chemicals used in cosmetics. According to one research report, on average, women use 12 personal care products every day, exposing themselves to 168 chemical ingredients. Men use about half that, but still expose themselves to 85 unique chemicals a day. Many of these may be perfectly safe, we just don’t know which ones because most have not been tested for safety.

Increasing concerns about everything from contact dermatitis to carcinogens led Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) to introduce the Personal Care Products Safety Act, giving the FDA greater regulatory oversight of the cosmetics industry. The Senate Committee on Health, Education, Labor & Pensions held a hearing, “Exploring Current Practices in Cosmetic Development & Safety” last Thursday. A similar bill has been introduced in the House of Representatives. At least one other House bill was introduced in 2013 attempting to strengthen FDA regulatory authority over cosmetics, but it went nowhere. (more…)

Posted in: Cancer, Legal, Politics and Regulation

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NCCIH funds sauna “detoxification” study at naturopathic school

Where's the sauna detox?

Where’s the sauna detox?

It is no secret that we at SBM are not particularly fond of the National Center for Complementary and Integrative Medicine (NCCIH; formerly, the National Center for Complementary and Alternative Medicine). We’ve lamented NCCIH’s use of limited public funds for researching implausible treatments, the unwarranted luster NIH/NCCIH funding bestows on quack institutions, the lack of useful research it has produced, and its failure to shoot straight with the public when discussing alternative/ complementary/ integrative medicine. Nor does NCCIH’s research appear to affect CAM practice. Lack of evidence of safety or effectiveness is no impediment to use among CAM practitioners or “integrative” physicians.

So I shouldn’t have been surprised (NCCIH’s promise to “do some real science for a change” notwithstanding) when, a few days ago, I ran across a study of which I was previously unaware (for good reason, as you’ll see) on clinicaltrials.gov:

Sauna Detoxification Study: Pilot Feasibility

The goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction.

The investigators wish to determine if a hyperthermia-based detoxification protocol is feasible to conduct: including assessment of recruitment, enrollment, retention, protocol adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).

And:

Complementary and Alternative Medicine Sauna Detoxification Study: Phase I

The purpose of this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, and effects on quality of life and wellness. We hope to determine if there is a link between lower PCB levels in blood and sauna use.

(more…)

Posted in: Clinical Trials, Naturopathy

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Nada for NADA: “acudetox” not effective in addiction treatment

NADA auricular acupuncture
The National Acupuncture Detoxification Association (NADA) teaches and promotes a standardized auricular acupuncture protocol, sometimes called “acudetox.” NADA claims acudetox

encourages community wellness . . . for behavioral health, including addictions, mental health, and disaster & emotional trauma.

I do not know what “community wellness” is or how one measures whether wellness has been successfully “encouraged.” In any event, in the NADA protocol, acupuncture needles are inserted bilaterally into the auricle (outer portion) of the ear at a depth of 1-3 mm at five specific points (sympathetic, shen men, lung, liver, and kidney) and left in place for 45 minutes.

And:

Beyond the actual needling treatment, a key element of the protocol specifies qualities of behavior and attitude on the part of the clinician, consistent with what is known as the Spirit of NADA.

NADA claims there is

strong evidence for the effect of the NADA protocol in improving patient outcomes [in addiction treatment] in terms of program retention, reductions in cravings, anxiety, sleep disturbance and need for pharmaceuticals.

(more…)

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

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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

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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