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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.

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

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The Wild West: Tales of a Naturopathic Ethical Review Board

Two recent SBM posts have used the “Wild West” metaphor for poor health care regulation. Arizona may be the wildest: a worst-case scenario of a state licensing pseudoscience as medicine, under the cover of so-called naturopathy “research.” (Photo courtesy of the Orange County Archives, some rights reserved).

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.

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Posted in: Health Fraud, Legal, Medical Ethics, Naturopathy, Science and Medicine

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FDA and Homeopathy: Part Two.

A

Edward De Vere.  Sort-of.

Friends, FDA, countrymen, lend me your ears;

I come to bury Homeopathy, not to praise it.

The evil that homeopaths do lives after them;

The good is oft interred with their bones;

So let it be with Homeopathy. The noble Ullman

Hath told you homeopathy was effective:

If it were so, it was a grievous fault,

And grievously hath Homeopathy answer’d it.

Here, under leave of Ullman and the rest–

For Ullman is an honourable man;

So are they all, all honourable men–

Come I to speak in Homeopathy’s funeral.

It was my nostrum, faithless and worthless to me:

But Ullman says it was effective;

And Ullman is an honourable man.

He hath brought many provings home to HPUS

Whose prescriptions did the general coffers fill:

Did this in Homeopathy seem effective?

When that the ill have died, Homeopathy hath wept:

Efficacy should be made of sterner stuff:

Yet Ullman says it was effective;

And Ullman is an honourable man.

You all did see that on the Cochrane

I thrice presented Homeopathy a meta-analysis,

Which he did thrice refuse: was this efficacy?

Yet Ullman says it was effective;

And, sure, he is an honourable man.

I speak not to disprove what Ullman spoke,

But here I am to speak what I do know.

Edward De Vere, 17th Earl of Oxford. Sort of.

We only have a vague idea as to what other bloggers are going to write about. Yesterday Jann wrote on the same topic (and Scott the week before), which I will read tomorrow after my post goes up. Why would I want my post to be informed by another’s well-reasoned and thoughtful essay? I have a reputation after all. So here is my response to the FDA. (more…)

Posted in: Homeopathy, Legal

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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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Update on the Tobinick Lawsuit

Gavel-court-legal-law-lawsuit

Last year Edward Tobinick sued the Society for Science-Based Medicine, SGU Productions (the producers of the Skeptics’ Guide to the Universe podcast), Yale University, and me personally for libel and (of all things) false advertising. I am frequently asked how the suit is going so here is an update.

Background

The lawsuit involved an article I wrote on Science-Based Medicine on May 8, 2013. Dr. Tobinick’s practice involves giving perispinal etanercept to treat sciatica, Alzheimer’s disease, traumatic brain injury (TBI), and chronic deficits following stroke. He claims that he can reverse the symptoms of these various conditions within minutes. He uses highly emotional videos and anecdotal evidence to promote his treatments.

Further, he has medical use patents on these and other treatments and charges other physicians a substantial fee for training and a royalty simply for treating patients with his methods. Medical use patents are considered by the AMA and other medical organizations to be unethical and are banned in 80 countries (but not the US).

My original article was highly critical of Tobinick’s practice. I emphasized the fact that he is making dramatic clinical claims, which he himself characterizes as revolutionary, without ever having conducted a single double-blind placebo controlled trial. In my opinion none of these uses of etanercept are supported by adequate clinical evidence. In fact, there are no published double-blind placebo-controlled trials of etanercept for post-stroke symptoms or TBI. There are some studies for sciatica, but a 2013 systematic review concluded:

There was insufficient evidence to recommend these agents when treating sciatica, but sufficient evidence to suggest that larger RCTs are needed.

There is a single pilot study of etanercept for Alzheimer’s – a phase II trial with 41 subjects total. That’s it – this is hardly sufficient evidence on which to revolutionize the treatment of multiple complex neurological disorders. In fact, during the hearing, his own expert testified that we are “not there yet.”

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Posted in: Legal

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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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Florida tells Brian Clement to stop practicing medicine

This is a screenshot from the website of the Hippocrates Health Institute, showing its grounds.

Screenshot of the Hippocrates Health Institute’s website

 
Note: Also posted today is a brief profile of a new blog, Naturopathic Diaries: Confessions of a Former Naturopath, by Britt Marie Deegan Hermes, a trained naturopath who became disillusioned with her profession. I encourage you to have a look!

The State of Florida has finally taken action against Brian Clement.

David Gorski, Orac, and the Canadian media, especially the Canadian Broadcasting Corporation (CBC), have done an excellent job of chronicling the activities of “Dr.” Clement. All have reported on Florida’s taking action against Clement. I’ll give a brief background here, most of which comes from Dr. Gorski’s most recent post, as well as add some information and observations to theirs.

Hippocrates Health Institute, located in West Palm Beach, Florida, is licensed as a massage establishment by the state and run by Brian Clement and his wife, Anna Maria Gahns-Clement. Clement and Hippocrates came to the attention of the Canadian media when, last year, the families of two Canadian aboriginal girls withdrew their children from conventional cancer treatment, including chemotherapy. Prior to that, Clement had basked in the glory of fawning reports from local media, one of which described him as having an “inimitable, engaging style.” Another described him as coming “fresh from a detoxifying sauna” to the interview.

Had they completed conventional treatment, both girls had a very good chance of survival. The families opted instead for traditional medicine as well as “alternative medicine” at Hippocrates. Each paid a reported $18,000 for participation in a “Life Transformation Program” there. This included, for at least one of the girls, cold laser therapy, vitamin C injections and a strict raw vegetable diet.

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Posted in: Cancer, Health Fraud, Legal, Naturopathy, Nutrition, Politics and Regulation

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The Hippocrates Health Institute: Cancer quackery finally under the spotlight, but will it matter?

This is a screenshot from the website of the Hippocrates Health Institute, showing its grounds.

This is a screenshot from the website of the Hippocrates Health Institute, showing how high end its grounds and facilities are.

I first came across Brian Clement, the proprietor of the Hippocrates Health Institute in West Palm Beach, Florida, a little more than a year ago based on the story of Stephanie O’Halloran. Ms. O’Halloran was—word choice unfortunately intentional—a 23-year-old mother of an 18 month old child from Ireland who was diagnosed with stage IV breast cancer in 2013, with metastases to her lymph nodes, liver, lung, and leg. Unfortunately for her, she found Brian Clement at the Hippocrates Health Institute, who gave her false hope with his claims that a raw vegan diet and wheatgrass can treat just about everything. Unfortunately, but not unexpectedly, Ms. O’Halloran died in June 2014, less than nine months after having been diagnosed with metastatic breast cancer.

I didn’t write about Stephanie O’Halloran at the time (at least not here), but I did write about Brian Clement and the Hippocrates Health Institute (HHI) twice over the last several months in the context of the cases of two 11-year-old Aboriginal girls in Canada with cancer, specifically lymphoblastic leukemia. One was —word choice again unfortunately intentional—named Makayla Sault and the other is referred to as “JJ” in news reports to protect her privacy in her parents’ legal proceedings to assert their right to use traditional medicine to treat their daughter’s cancer rather than curative chemotherapy, which was estimated to have a 75% chance of curing Makayla Sault and an 85% to 90% chance of curing JJ. Unfortunately, both girls and their parents fell under the spell of Brian Clement and his cancer quackery. The result was one unnecessarily dead girl (Makayla Sault, who died last month) and one likely to be dead by the end of this year or not much longer (JJ). Such is the price of cancer quackery. In this case, even more puzzlingly, these girls’ parents seemed quite content to conflate the quackery of Brian Clement, a white man practicing in Florida, with “traditional Aboriginal medicine,” the sort of practices they were claiming to have a right to.
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Legal

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Significant Ruling Against Conversion Therapy

gay-flag

The standard features of quackery are all there. Proponents of this particular therapy claim that a normal condition is a disease. They make false claims about the cause of this disease. They then charge thousands of dollars for their fake treatment to cure the fake disease, and claim success rates that are not backed by any statistics.

In this case the fake disease is homosexuality, for which there is now a solid consensus that it is a normal variation of human sexuality. The fake treatment is conversion therapy. Recently a New Jersey judge ruled that conversion therapists cannot claim that homosexuality is a disease or disorder. The Southern Poverty Law Center reports:

Superior Court Judge Peter F. Barsio Jr. found that it “is a misrepresentation in violation of [New Jersey’s Consumer Fraud Act], in advertising or selling conversion therapy services, to describe homosexuality, not as being a normal variation of human sexuality, but as being a mental illness, disease, disorder, or equivalent thereof.”

Further:

The judge also ruled that [New Jersey conversion therapy provider Jews Offering New Alternatives for Healing (JONAH)] is in violation of the Consumer Fraud Act if it offers specific success statistics for its services when “client outcomes are not tracked and no records of client outcomes are maintained” because “there is no factual basis for calculating such statistics.”

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Posted in: Legal, Medical Ethics

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