Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.
Society for Science-Based Medicine
Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century
All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)
Me and my lovely wife Phyllis Schlafly, amazed at what naturopaths will believe.
From the Wikimedia Commons, because we’re that famous.
As regular readers know, I live in the great Pacific Northwest, specifically Portland, Oregon. I am at home in the organic/hippy/environmental mind-set. It is what I grew up with. It is a relaxed, informal place to live. It is not much of an exaggeration to say that formal attire is tucking your tee shirt into your jeans. At least the metro area, and perhaps much of the state, is relatively tolerant of the actions of others. A real what’s the harm/shruggie approach to life, the universe and everything.
I will admit that the irrational/shruggie/emotional/Oregonian/goateed part of my brain is often at odds with my more rational brain, which wants me to give a rat’s ass about issues I think are just wrong. It showed up strongly with fluoridation in Portland, where my rational brain knew adding fluoride to the water was a great idea and my Oregonian nature said water should be pure, man, like nature intended. I keep my inner Oregonian under tight control as his approach often sounds good until you carefully examine how his ideas are implemented. Except at the pub of course. Bring on the hops, man, like nature intended beer to be.
Naturopathy is well tolerated in Oregon, with two schools in the NW producing NDs. We have a Board of Naturopathic Medicine, whose vision is to:
To protect the health, safety and welfare of the public in the matters of care provided by Naturopathic physicians in Oregon.
Practicing a licensed health care profession, such as medicine, without a license used to be a felony in Nevada. Not any more. As of July 1, quacks and charlatans are free to ply their trades unencumbered by the threat that they might have to answer to the regulatory authorities for their misdeeds, as long as they follow a few simple rules.
This new law, passed overwhelmingly in the Legislature and signed by the Governor, is yet another success of the “health care freedom” movement. It was shepherded through the legislative process by Alexis Miller, a lobbyist for the Sunshine Health Freedom Foundation (Sunshine), which is affiliated with the National Health Freedom Coalition. It’s Director of Law and Public Policy, Diane Miller, also spoke in favor of the bill. We’ll get back to these groups and their comrades in arms in a moment.
First, let’s take a look at what the new law does. A person who provides “wellness services” is protected from prosecution as long has he doesn’t practice medicine, podiatry, chiropractic, homeopathy (homeopaths are licensed in Nevada) or another licensed profession. Some forbidden services are listed in the law, including surgery, setting fractures, prescribing or administering x-rays or prescription drugs, or providing mental health services in the exclusive domain of psychiatrists and psychologists. Of course, while there is certainly danger in untrained persons doing any of these things, they aren’t generally on your average quack’s list of services, nor are they likely interested in them in the first place. (more…)
Ask your pharmacist if nothing is right for you. (HT @leachkathleen)
On April 21 and 22, the FDA held a public hearing:
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. . . . 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.
The FTC recently announced that it, too, is wading into the homeopathic waters. The FTC, which regulates advertising of homeopathic products, will hold a public workshop on September 21 in Washington, DC, “to examine advertising for over-the-counter (OTC) homeopathic products.” Like the FDA, it will also accept public comments online.
All of this regulatory buzz caused the FDA Law Blog to take notice. (The blog is hosted by a law firm specializing in food and drug regulation law.) A post titled “Will FTC Kill Homeopathic Products – or Will FDA?” gave this assessment:
Bottom line, if the FTC holds homeopathic products to the same scientific standards that are applied to claims for other OTC products like dietary supplements, as the FTC appears inclined to do . . . few if any homeopathic products will pass the test.
The First Amendment of the United States of America, guaranteeing freedom of speech
For those of you following the defamation lawsuit against me by Dr. Edward Tobinick, there has been a significant and positive update. For quick background, Dr. Tobinick filed a suit against me personally, the Society for Science-Based Medicine, Yale University and SGU Productions for an article I wrote here critical of his claims that perispinal etanercept can treat a variety of neurological conditions. All the defendants but me have since been removed from the case.
There are three plaintiffs in the case; Dr. Tobinick himself, his California corporation, and his Florida LLC. Last year I filed a motion to strike some of the claims as they apply to the California corporation under that state’s anti-SLAPP statute. The update is that last week the judge in the case ruled in my favor on this motion. These are public documents, so you can read the entire decision here. It concludes:
For the foregoing reasons, it is hereby ORDERED AND ADJUDGED that Steven Novella’s Special Motion to Strike (Anti-SLAPP Motion) [DE 93] is GRANTED. Tobinick M.D.’s claims for unfair competition under 28 U.S.C. § 1338(b) (Count II), trade libel (Count III), and libel per se (Count IV) are STRICKEN from the Amended Complaint.
CBC interview with Brian Clement.
Brian Clement is a charlatan. Unfortunately, that doesn’t seem to be a problem for the State of Florida. I made two (which turned into three) attempts to get the state to take action against Clement or the Hippocrates Health Institute, where he serves with his wife Anna Maria Gahns-Clement as co-director. All of them failed. Brian Clement slithered through the cracks in Florida law each time.
Before we get into the details of Florida’s failure to act, a bit of history (and there is plenty of it) is in order.
In recent months, Clement’s sordid cancer quackery has been well-documented in the media as well as in the science “blogosphere”. (I’ve listed what I hope is a — but almost certainly isn’t — complete blog archive at the end of this post. Many of the Canadian Broadcasting Corporation [CBC] and other news reports are linked in these posts.) Most of the coverage has centered on two Canadian girls suffering from lymphoblastic leukemia whose parents pulled them from conventional cancer therapies, which gave them an excellent chance of survival, in favor of treatment at the Hippocrates Health Institute (HHI), a sprawling spa in West Palm Beach, Florida, licensed as a massage establishment by the state.
Clement gave a talk in Canada, in 2014, claiming “we’ve had more people reverse cancer than any institute in the history of health care.” (“We” is the operative word here, because it later served as Clement’s ticket to avoid prosecution by the Florida Board of Medicine, as you shall soon find out.) The girls’ families were impressed.
Sadly, one of the girls, Makayla Sault, died earlier this year. The other, identified only as “JJ” in the media because of a publication ban, has returned to conventional treatment. However, her mother apparently remains under the influence of Clement: JJ is restricted to a raw foods diet and is still being followed, if that is the right word, by HHI. (more…)
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.
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…)
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…)
Right before I left the naturopathic profession, an Arizona naturopath told me that “all NDs are doing something borderline illegal.” Alarmed, I began looking around me.
Arizona naturopathic cancer clinics promote illegal substances, advertise results that are too good to be true, and use compounds that have yet to be proven effective in humans. Many clinics focus on intravenous therapies using ozone, hydrogen peroxide, sodium bicarbonate, vitamin C, and blood UV irradiation; some drugs and herbal preparations for injection are claimed to be imported from Europe.
In Arizona, current regulation enables naturopaths to craft hollow research projects under the cover of a private naturopathic institutional review board (an IRB, also often called an ethical review board). This allows them to legitimize experimentation on patients in private clinics and expand the naturopathic scope of practice in the name of so-called research. The IRB appears to influence the state’s naturopathic board, which seems reluctant to do its job properly.
Naturopathic regulation in Arizona may be the worst-case scenario of any state licensing pseudoscience as medicine. The ramifications are grave. Patients, especially those with cancer or other serious conditions, are easily duped and can be severely harmed by medical practitioners who seem kind, charismatic, and confident, but are actually inept and experimenting without the oversight of an ethical review board.