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Docs v. Glocks: government regulation of physician speech

Glock 19 pistolA few years ago, an Ocala, Florida, pediatrician, as part of a routine visit, asked a patient’s mother whether she kept firearms in the home. She refused to answer, feeling the question constituted an invasion of her right to privacy. The pediatrician then terminated the relationship and told the mother she had 30 days to find a new doctor for her child. In another incident, a mother reported she was separated from her children while medical staff asked them whether their mother owned firearms. And, according to a Florida legislator, he was told to remove firearms from the home during an appointment with his daughter’s pediatrician.

Complaints to Florida legislators about these and similar incidents prompted the introduction of a bill that would have, among other things, criminalized any

verbal or written inquiry by a . . . physician, nurse, or other medical staff person regarding the ownership of a firearm by a patient or the family of a patient or the presence of a firearm in a private home . . .

As finally passed by the legislature and signed by Governor Rick Scott, the 2011 Firearm Owners Privacy Act subjects physicians to disciplinary action for making “verbal or written inquiry” into a patient’s firearm ownership when the physician does not “in good faith believe” such inquiries are “relevant to the patient’s medical care or safety of others.” The Act included amendments to the Florida Patient’s Bill of Rights and Responsibilities, adding similar provisions. (The Act also applies to health care facilities, but here we will discuss only its effect on physicians and their patients.) Physicians may not enter any information regarding firearm ownership into the patient’s medical record if they know this information is not “relevant to the patient’s medical care or safety, or the safety of others.” They may not “discriminate” against a patient “based solely on the patient’s Second Amendment right to own firearms or ammunition.” Finally, physicians must refrain from “unnecessarily harassing” a patient regarding firearm ownership during an examination. (more…)

Posted in: Ethics, Legal, Politics and Regulation, Public Health

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Legislative Alchemy 2015: Another losing season for CAM practitioners

legislative-alchemy-image
One of the main, but perhaps underappreciated, reasons quackery thrives in the United States is that the states legalize it by licensing practitioners of pseudoscience as health care providers. These practitioners are placed under the regulatory jurisdiction of, well, themselves. I call the whole deplorable process Legislative Alchemy, and you can see all posts on the topic here. It gives practitioners an underserved imprimatur of state authority and leaves public protection from harmful practices to the oversight of those who are themselves engaging in the very same conduct. Each year, dozens of bills are brought before the state legislatures to establish initial licensure or, once that goal is achieved, scope of practice expansion.

Most attempts fail, but CAM practitioners are a dogged bunch, and they will come back each year until they get what they want. It took chiropractors about 60 years to become licensed in all 50 states. Acupuncturists are almost there. Naturopaths lag far behind, but are slowly gaining ground each year, even if it is only via practice expansion in states where they are already licensed. 2015 was a losing season for all, but not without advancement toward larger goals.

(more…)

Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Home birth tragedies lead to changes in Oregon

Pregnant1
Oregon Health Plan (OHP), the state’s Medicaid insurer, will no longer cover planned home and birth center births for women whose pregnancies aren’t classified as low risk, based on newly-established criteria. The Health Evidence Review Commission (HERC), a group of experts designated by the state, came up with criteria that will exclude women with a substantial list of conditions, such as high blood pressure, diabetes, previous cesarean section, multiple gestation (more than one fetus), and various complications in previous pregnancies. Feelings ran high on both sides of the issue, which was described as the most contentious ever to come before the HERC.

The HERC’s decision was based on an exhaustive 100-page evidence review; a review, according to them, hampered by the low quality of the evidence on the safety of planned out-of-hospital births. Actually, there is a paucity of evidence altogether. Studies and statistics from other countries, like the Netherlands, were of limited utility because those countries have more stringent midwifery education and training requirements and non-hospital births are better integrated into the health care system.

Most planned out-of-hospital births in Oregon are attended by what are known as direct-entry midwives (DEM), as opposed to nurse midwives, and a few naturopathic doctors. (We’ll look at the many variations of midwifery in a minute.) Since OHP pays for 23% of Oregon births, the economic impact on direct-entry midwives could be substantial. This effect will be amplified when other insurers, who are expected to follow OHP’s new criteria, change their own coverage rules. (more…)

Posted in: Guidelines, Legal, Naturopathy, Obstetrics & gynecology, Politics and Regulation, Public Health

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Brian Clement claims Hippocrates treatments “reverse” multiple sclerosis

Brian Clement

Brian Clement

American charlatan Brian Clement made another trip to Canada recently and was caught on audiotape claiming multiple sclerosis could be “reversed” at the Hippocrates Health Institute (HHI), where he serves as Director. This is yet another in a series of his misrepresentations about the effectiveness of the quack treatments offered at HHI. Indeed, Clement calls to mind the old joke about inveterate liars:

Q: Know how can you tell this guy is lying?

A: His lips are moving.

Once again, the Canadian Broadcasting Corporation (CBC), which has done an outstanding job exposing Clement and his mendacity, caught him in this particular fabrication. (The American media, by contrast, has largely ignored the story, even to the point of printing credulous puff pieces about Clement.) According to the CBC, it:

obtained a recording of a lecture Clement gave in September in Montreal where he said, “Last week, we had somebody at the institute that reversed multiple sclerosis.”

He went on to claim that many other people who visited his Florida spa, the Hippocrates Health Institute, saw similar results.

“A nurse that came to us two years ago was crippled, had braces on. By the time she left Hippocrates, she reversed the multiple sclerosis.

“And mainstream medicine, they think it’s remarkable. I’ve seen lots and lots of people over the years did that.”

(more…)

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

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US Department of Justice Goes After Supplements

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun:

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.

(more…)

Posted in: Herbs & Supplements, Legal

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The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

Screenshot 2015-10-14 23.04.19

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.

For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.

Background: Initial approval of Vascepa and subsequent research

In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.

Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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Lawsuit Alleges School Wi-Fi Harmed Child with Electromagnetic Hypersensitivity

wi-fi-danger

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.

(more…)

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. Chiropractic and Acupuncture for Pain.

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

Sisyphus

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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