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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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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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Learning quackery for Continuing Medical Education credit

accme-screenshot

 

The Integrative Addiction Conference 2015 (“A New Era in Natural Treatment”) starts tomorrow in Myrtle Beach, SC. Medical doctors, doctors of osteopathy, naturopaths and other health care providers will hear lectures on such subjects as “IV Therapies and Addiction Solutions,” given by Kenneth Proefrock, a naturopath whose Arizona Stem Cell Center specializes in autologous stem cell transplants derived from adipose tissue. Proefrock, who was disciplined for using prolotherapy in the cervical spine without proper credentialing in 2008, claims that stem cells treatments are an “incredibly versatile therapy” and uses them for variety of conditions, such as MS and viral diseases. At the same time, he admits that they are not FDA approved and he is not claiming they are effective for anything (and he’s right), which leads one to wonder why he employs them.

Proefrock also offers a typical naturopathic mish-mash of services, from oncology to urology to “naturopathic endocrinology,” and claims he specializes in treating influenza, high blood pressure and kidney stones, as well as addiction. In other words, he doesn’t seem to be the sort of expert you’d find speaking at a science-based conference on addiction medicine.

You’ll find similarly troubling bios of some of the other speakers, as well as dubious treatments for addiction, on the conference website. Here, for example, are speaker Giordano’s and Eidelman’s websites.

Dalal Akoury, MD, is the “Title Sponsor” of the conference and appears to be running the show. Although she is listed by the S.C. Board of Medicine as board certified in pediatrics, she is the founder of the “Integrative Addiction Institute” and runs the “AwareMed Health and Wellness Resource Center” in Myrtle Beach. Like the Arizona Stem Cell Center, it offers a range of treatments that defy categorization as any particular specialty: addiction recovery, “adrenal fatigue” treatment, stem cells, “anti-aging,” weight loss, “functional medicine” and “integrative cancer care“. Yet, only Akoury and one licensed practical nurse are on the staff of the Center. Again, it is questionable whether she is has sufficient qualifications in addiction medicine to run a conference on the subject. (more…)

Posted in: Acupuncture, Cancer, Chiropractic, Dentistry, Diagnostic tests & procedures, Energy Medicine, Homeopathy, Medical Academia, Medical Ethics, Naturopathy

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