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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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Guess who pioneered chemoprevention through diet?

Listen to your science: Eat your vegetables.

This is an expansion of a post I did over on the Society for Science-Based Medicine blog about this time last year. The original post, which got far more traffic than is usual for the SFSBM, is a good example of how science works and the good that it can do. The hard work of real science illustrated here serves as a striking counterpoint to the slap-dash system of pseudoscience, which churns out fake diseases, causes, and cures by the dozen based on a fuzzy understanding of real science fueled by a healthy dose of imagination.

Naturopaths and “functional medicine” practitioners would have the public believe that they are the true experts on nutrition and health. Even though their nutritional advice contains a large serving of hooey and a big helping of dietary supplements, which they are happy to sell to patients.

So it was with great interest that I read the obituary of Dr. Lee Wattenberg in the New York Times.

Dr. Wattenberg published a landmark paper in the journal Cancer Research that reviewed 36 years of animal studies on the effects that certain compounds had on the development of cancer. The paper laid the framework for understanding how these compounds work. . . .

He showed that cabbage, brussel sprouts, cauliflower and broccoli inhibit the development of carcinogens. He isolated a compound in garlic that decreased “by a factor of three” the chances that animals injected with cancer agents would develop that cancer. He found two chemicals in coffee that neutralize free radicals, which are harmful chemicals commonly implicated in the onset of cancer.

(more…)

Posted in: Cancer, Herbs & Supplements, Naturopathy, Nutrition, Science and Medicine

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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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The DC as PCP: the battle resumes

Daniel David Palmer, creator of the nebulous subluxation and father of chiropractic.

Daniel David Palmer, creator of the nebulous subluxation and father of chiropractic.

It has been almost five years to the day since I wrote my first post in “The DC as PCP” series. These posts (listed here) chronicle the continuing battles among various factions within the chiropractic profession over the subluxation and its many iterations, educational requirements for chiropractic colleges, their legal scope of practice, and whether chiropractors are – or are not—primary care physicians (PCPs). At its heart, the controversy boils down to this essential issue: what is “chiropractic” and what is it that chiropractors do? Or, perhaps, should do.

At one end of the spectrum is the straight chiropractor, who wants to make his living detecting and correcting subluxations for all manner of problems. These are the chiropractors who claim newborns need adjustments for “birth trauma” and maintenance care is necessary to good health. At the other end are those promoting the idea that chiropractors are primary care physicians capable of seeing the undifferentiated patient, form a differential diagnosis, and either treat the patient or coordinate the patient’s care with other health care professionals.

Neither has any basis in reality. The subluxation is a chiropractic fiction. And the notion that chiropractors have the necessary education and training to act as primary care physicians is no less a fiction.

Apparently unrepresented in this battle is the chiropractor who wants to see the profession as evidence-based spine care specialists based on a model of specialty care like podiatry and dentistry. (more…)

Posted in: Chiropractic, Politics and Regulation

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The elusive “potential” of integrative medicine

The Integrative Medicine Wheel

The Integrative Medicine Wheel

 

UPDATE: Dr. Katz has responded to this post in his usual venue, The Huffington Post.

Alternative medicine was all about “potential” from the get go:

In 1991, the Senate Appropriations Committee responsible for funding the National Institutes of Health (NIH) declared itself “not satisfied that the conventional medical community as symbolized at the NIH has fully explored the potential that exists in unconventional medical practices.”

Thus, the Committee, led by chair Sen. Tom Harkin, directed the NIH to create an advisory panel that would “fully test the most promising unconventional medical practices.”

The advisory panel became the Office of Alternative Medicine, which became the National Center for Complementary and Alternative Medicine, which became the National Center for Complementary and Integrative Medicine, its current iteration.

This effort to unlock the “potential” of unconventional (renamed alternative, renamed complementary and alternative, renamed integrative) medicine forced an uncomfortable alliance between science and pseudoscience from the beginning. Advocates like Harkin, and his two quackery-promoting constituents, Berkeley Bedell (colostrum and something called “714-X,” derived from camphor) and Frank Wiewel (immuno-augmenative therapy for cancer), were all for “fully testing” until they realized what “fully testing” meant to a scientist: double-blind, placebo controlled trials. It was thus that the true believers discovered the value of special pleading: they “favored quick field studies that would validate alternative treatments.”

Taxpayer monies flowed into legitimate medical and scientific research institutions to conduct alternative medicine research: the Maryland School of Medicine, Harvard Medical School, University of California at Davis, and the Texas Health Science Center, among others, received funds for the study of antineoplastons, cartilage products, magnets, mind-body control, and even Bedell and Wiewel’s beloved “714-X” and immuno-augmentative therapy. (more…)

Posted in: Clinical Trials, Medical Academia, Public Health

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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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October is National Chiropractic Health Month!

nchm-logo-for-web
October is National Chiropractic Health Month (NCHM) and chiropractors can’t resist the opportunity to overstate, obfuscate, and prevaricate in celebration.

They do this in the face of some unfortunate (for them) statistics revealed by a recent Gallup Poll. The Poll was paid for by Palmer College of Chiropractic as part of an effort to increase the chiropractic share of the health care pie. (There is also a secondary analysis of the poll in the Journal of Manipulative and Physiological Therapeutics.) We’ll get to those stats in a few minutes.

But first, in celebration of NCHM, the American Chiropractic Association (ACA) has produced a set of six graphics chiropractors can download and display. Four of them fudge on the facts. Let’s take a look at these graphics, compare them to the evidence cited in support of their claims, and see where the ACA went astray. (The ACA also hosted a twitter chat yesterday with the hashtag #PainFreeNation.)

chiro-infographic-spinal-manip-low-back-pain

The study cited as evidence for this graphic actually compared both manual thrust manipulation (MTM) and mechanical-assisted manipulation (MAM) to each other as well as manipulation versus usual medical care (UMC). Although MAM, such as the Activator Method, is the second most common manipulation technique used by American chiropractors, is increasing in popularity among them, and is touted to be a safe and effective alternative to MTM, this study found that MTM is more effective (at 4 weeks) than MAM and that MAM had no advantage over UMC. But you don’t see that in this graphic.

(more…)

Posted in: Chiropractic, Clinical Trials, Critical Thinking

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Massage Therapy rubs me the wrong way

Massage therapy? Pranic healing? Polarity therapy? Zero balancing?

Massage therapy? Pranic healing? Polarity therapy? Zero balancing?

Back in my days of practicing law, one of my escapes from reality was a good massage. It was a great treat, exchanging the high-octane atmosphere of the law office for the soothing music, subdued voices and pastel tones of the treatment room. I could have stayed on that table for hours.

Little did I know just how much an escape from reality massage therapy would soon become.

About 15 years ago, when I called to book an appointment with my favorite therapist, a recorded message offered something called “ray-kee” – at least, that is how it was pronounced. I assumed it was just a form of massage and didn’t think anything about it. Then, at one session, while my feet were being rubbed, my massage therapist – an RN, no less – suggested I would be surprised at how often a sore spot actually correlated with a medical problem. She was talking about reflexology, of course.

Fast forward a few years. A new massage therapist and a new location, this time a “health center” (actually, a gym) owned by a local hospital. The massage therapist inquired whether I’d like to try “cranial sacral therapy“. “What’s that?” I asked. “Oh,” she said, “it would be hard to explain.” (She got that right.) She then proceeded to inform me that she had actually used it in one of our sessions. This alerted me to the possibility that informed consent was not part of the massage therapy protocol.

A few more years went by. Another therapist (also an RN), another location. I was pleased with her because I thought she did a good job and she also taught me some simple stretching exercises. To my surprise, in one session, she started pressing on the space between my toes because, she said, it corresponded with the (something, something – I didn’t get this part) of my neck. Reflexology again. (Are they now teaching reflexology in nursing school? I am beginning to wonder.) (more…)

Posted in: Acupuncture, Energy Medicine, Health Fraud, Politics and Regulation

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