Archive for Legal

Lawsuit Alleges School Wi-Fi Harmed Child with Electromagnetic Hypersensitivity


My mother had a favorite saying that rhymed: “All you need from dawn to dawn is someone else to blame it on.” WiFi involves mysterious emissions that you can’t see and that sneakily permeate our environment, and they have become a popular target for blame.

A lawsuit has been filed against the Fay School in Massachusetts on behalf of a 12-year-old boy designated as “G,” alleging that the school violated his rights under the Americans with Disabilities Act and failed to use ordinary care for his safety. They allege the school was negligent in failing to make accommodations to protect the boy from extremely high levels of radiofrequency/microwave radiations. He allegedly suffers from Electromagnetic Hypersensitivity Syndrome (EHS). The family is seeking $250,000 in damages.

The symptoms

After the school upgraded its Wi-Fi system in 2013, G began to have headaches, itchy skin, rashes, nosebleeds, dizziness, chest pains, and nausea. He frequently went to the school nurse and had to leave school early. His symptoms would usually resolve after he had been home for several hours, and he did not experience “the intense symptoms” on weekends and holidays.


Posted in: Computers & Internet, Legal, Public Health

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Battle of the feds: FTC tells FDA to do its job regulating homeopathy

Two institutions duke it out: FTC vs FDA.

Two institutions duke it out: FTC versus FDA.

Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under the Food, Drug and Cosmetic Act (FD&C Act). Lax regulation has resulted in consumer confusion: consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, and the lack of scientific evidence underlying claims made by homeopathic drug companies.

As it turns out, we were in excellent company. The Federal Trade Commission (FTC), the agency charged with preventing fraudulent and deceptive business practices, submitted its own comment to the FDA, making these same points. (The FTC is holding its own workshop on advertising homeopathic drugs later this month. We’ll get to that shortly.)

The FTC’s advertising substantiation policy requires that health-related efficacy claims be supported by competent and reliable scientific evidence. The FDA, despite federal law, does not require evidence of efficacy for homeopathic drugs prior to their being marketed. This creates a potential conflict between the two regulatory schemes, resulting in homeopathic over-the-counter (OTC) “drugs” on the market that both comply with FDA’s policy and violate FTC’s policy. This, says the FTC, can be harmful to consumers and create confusion for advertisers. The FTC “recommends that the FDA reconsider its regulatory framework for homeopathic medicines” and tells the FDA what it can do to remedy the situation. (more…)

Posted in: Clinical Trials, Health Fraud, Homeopathy, Legal, Politics and Regulation

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Do You Believe in Magic? Oregon Does.

Pictured: OHP and HERB picking "evidence-based treatment options"

Pictured: OHP and HERB picking “evidence-based treatment options”

Do You Believe in Magic?

Do you believe in magic for a back pains fix

How the needles can free her, where ever it pricks

And it’s magic, if the chi is groovy

It makes you feel happy like an old-time movie

I’ll tell you about the magic, and it’ll free your soul

But it’s like trying to tell a CAM ’bout randomized control

If you believe in magic don’t bother to choose

Although subluxation is simply a ruse

Just go and get adjusted on the table

It won’t wipe off the pain no matter how hard you try

Your wallet is empty and you can’t seem to find

How you got there, so just blow your mind

If you believe in magic, come along with me

We’ll CAM until morning paid for by the OHP

And maybe, if the CAM is right

I’ll meet you tomorrow, sort of late at night

And we’ll go dancing, baby, then you’ll see

How the magic’s in the CAM and the CAM’s in me

Yeah, do you believe in magic

Yeah, believe in the magic of a back pains fix

Believe in the magic of CAM

Believe in the magic that can set you free

Oh, talking ’bout magic

Do you believe like I believe… Do you believe in magic

Do you believe like I believe… Do you believe, believer

Do you believe like I believe… Do you believe in magic

The Lovin’ Spoonful. Sort-of.

Maybe not my best lyrics.

More Oregon magic

It continues.

Oregon has a problem with prescription pain pills. Oregon leads the nation in the abuse of such drugs, federal statistics show, with Oregon’s rate of prescription drug abuse 39 percent higher than the national average. Go us.

Why that is, I do not know. As an Infectious Disease doctor I prescribe a narcotic about once a year. There are real problems with the treatment of chronic pain and while I am aware of the issues and the changes over the last 25 years, it does not impact my practice, so my knowledge of the issues is basic.

I am also well aware of the Oregon Health Plan (OHP). The OHP was intended to make health care more available to the working poor, while rationing benefits. They were fairly transparent that resources were fixed and not everything would be covered.

Given limited resources, part of the plan has always included a prioritization of treatments and diagnostics, paying for care that give the most bang for the buck. Not a perfect way to ration care and as is always the case, no good deed goes unpunished. (more…)

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

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Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation


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…)

Posted in: Announcements, Health Fraud, Homeopathy, Legal, Politics and Regulation

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Naturopathic Medical Magic in the NW

Me and my lovely wife Phyllis Schlafly, amazed at what naturopaths will believe. From the Wikimedia Commons, because we're that famous.

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.


Posted in: Legal, Naturopathy, Politics and Regulation

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Nevada’s new quack protection law

Nevada state seal

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…)

Posted in: Energy Medicine, Health Fraud, Herbs & Supplements, Legal, Politics and Regulation, Vaccines

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Homeopathic industry and its acolytes make poor showing before FDA

Ask your pharmacist if nothing is right for you. (HT @leachkathleen)

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.


Posted in: Clinical Trials, Health Fraud, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Lawsuit Update

The First Amendment of the United States of America, guaranteeing freedom of speech

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.


Posted in: Announcements, Legal

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Florida strikes out against Brian Clement

CBC interview with Brian Clement.

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…)

Posted in: Cancer, Health Fraud, Legal, Nutrition, Politics and Regulation, Science and the Media

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ACA: Six Key Elements of A Modern Chiropractic Practice Act

Screenshot 2015-05-13 22.46.07

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.


Posted in: Chiropractic, Legal, Politics and Regulation

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