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Archive for Politics and Regulation

The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:

 


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Legislative Alchemy: The New Year

A new year brings new opportunities for practicing the magic of legislative alchemy, the process by which state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices, such as naturopathy, chiropractic and acupuncture. Different states have different legislative calendars, but many begin a new session soon after the first of the year. This gives “complementary and alternative medicine” providers a fresh opportunity to increase their scope of practice, insurance coverage and influence.

The state house doors have barely opened but CAM-friendly bills are already being docketed and sent on to health care and other committees for analysis. Unfortunately, legislators seem less than adept at critical thinking when it comes to perusing CAM legislation. To this point, I’ll start with an example from 2011: “Vertebral Subluxation Awareness Month” in Pennsylvania.

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Posted in: Chiropractic, Legal, Naturopathy, Politics and Regulation

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Strains, sprains and pains

What do you think would happen if you gave a bunch of “complementary and alternative medicine” practitioners access to a big pot of money — say, up to $10,000 per patient — and let them treat patients virtually without restriction, hampered only by a fee schedule. No utilization review, no refusal based on a treatment being “experimental” — none of the usual foils which trip up CAM practitioners in the health insurance field.

Think they’d run up the bill? Yes, they would.

In fact, that’s exactly the scenario playing out in Florida right now with the state’s no-fault auto insurance.

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Posted in: Acupuncture, Chiropractic, Legal, Politics and Regulation

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Vaccination mandate exemptions: gimme that ol’ time philosophy

Each of the 50 states and the District of Columbia require vaccination against certain diseases as a prerequisite to public and private school attendance, most commonly polio, mumps, measles, diphtheria, rubella, chicken pox, Heamophilus influenza type b, pertussis, tetanus, pneumococcal disease and hepatitis B. Unfortunately, mandatory vaccination for home-schooled children is rare. (1)

All states provide medical exemptions to vaccination mandates for those for whom vaccination poses a health threat. Indeed, it is doubtful that a state could constitutionally deny such medical exemptions.

Forty-eight states also allow exemptions based on religious beliefs. While it might be assumed that religious exemptions are required by the protection afforded religion under the First Amendment to the U.S. Constitution that is not the case. The opposite is true. Religious exemptions themselves are constitutionally suspect. In fact, to pass First Amendment muster, a state’s religious exemption statute may have to be so broad as to become, in essence, a “philosophical” exemption.

Vaccination mandates survive early challenges

Compulsory vaccination laws have enjoyed strong support in the state and federal courts for over a century. Early in the 20th century, the U.S. Supreme Court considered the constitutionality of a statute authorizing a municipal board of health to require and enforce vaccination, in this case during a smallpox epidemic. The Court found the legislation represented a valid exercise of the state’s police power. In a statement that proved prescient about the failed constitutional challenges to vaccination mandates which followed, the Court said that “we do not perceive that this legislation has invaded any right secured by the Federal Constitution.” Jacobson v. Massachusetts, 197 U.S. 11, 38 (1905).

In 1922, the Court specifically addressed the subject of school vaccination, holding that it is a valid exercise of the state’s police power to make vaccination a condition of attending public or private school. Zucht v. King, 260 U.S. 174 (1922).
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Posted in: Chiropractic, Legal, Politics and Regulation, Public Health, Religion, Vaccines

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Phthalates and BPA: Of Mice and Men

Is your soup poisoning you? In a recent study  subjects who ate canned vegetable soup had markedly increased levels of BPA in their urine compared to those who ate freshly prepared soup. We are constantly bombarded with alarmist warnings about the dangerous chemicals in the products we use. Especially BPA (Bisphenol A) and phthalates. Beware plastic bottles! Beware rubber ducks! And now, beware canned soup!   BPA and phthalates are classified as endocrine disruptors. They have been discussed before on SBM here and here.  BPA has been accused of causing everything from obesity to prostate cancer. Phthalates have been accused of causing everything from breast cancer to reduced anogenital distance in baby boys (the significance of this is unknown: there is not even any standard for what the normal distance is).

In the book Slow Death by Rubber Duck

Using a variety of test methods, the authors determined individual “body burdens,” or the toxic chemical load we carry. The innocuous rubber duck, for example, offers a poison soup of phthalates that “permeate the environment and humans.” From other products and food we also have a collection of chemicals shorthanded as PFCs, PFOAs, PSOSs, and PCBs. None of them are good, and they are everywhere…

Is this science or irresponsible fear-mongering? What does the best evidence tell us? Should we be afraid of our canned soup and rubber ducks? (more…)

Posted in: Politics and Regulation, Public Health

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Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure

Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski and his “cancer cure” known as antineoplastons. In part I of this series, Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R., I used the legal threats against bloggers criticizing the credulous promotion by the British press of fundraising campaigns to send children with terminal cancer to the Burzynski Clinic and the promotion of the medical propaganda movie Burzynski The Movie: Cancer Is Serious Business to review the movie’s claims and look into Burzynski’s claims for antineoplastons. Not surprisingly, I found the evidence for extravagant claims for their anticancer effects unconvincing. In part II, Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, I looked into Dr. Burzynski’s recent efforts to “diversify his portfolio, in which he has apparently decided to ride the new wave of genomic medicine to claim he can do “personalized, gene-targeted cancer therapy.” I concluded that he does appear to do that, only very badly, in essence “making it up as he goes along.”

In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One reader in particular has helped enormously in my education about this aspect of the Burzynski saga. I wish I could credit this person by name, but, for reasons I fully understand, I can’t. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a little bit of text here and there from our e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Burzynski and an orphan drug

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons,” claiming that patients with cancer had lower levels of these substances in their blood and urine. However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine as he had done up until then. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.
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Posted in: Basic Science, Cancer, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation

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Integrative Medicine: “Patient-Centered Care” is the new Medical Paternalism

Integrative Pitchmen

Several of us have written about how contemporary quacks have artfully pitched their wares to a higherbrow market than their predecessors were accustomed to, back in the day. Through clever packaging,* quacks today can reasonably hope to become professors at prestigious medical schools, to control and receive substantial grant money from the NIH, to preside over reviews for the Cochrane Collaboration, to be featured as guests and even as hosts on mainstream television networks and on PBS, to issue opinions in the name of the National Academy of Sciences, to be patronized by powerful politicians, and even to be chosen by U.S. presidents to chair influential government commissions.

The most successful pitch so far, and the one that the fattest quack-cats of all have apparently decided to bet the farm on, is “integrative medicine” (IM). Good call: the term avoids any direct mention of the only thing that distinguishes it from plain medicine. Its proponents, unsurprisingly, have increasingly come to understand that when they are asked to explain what IM is, it is prudent to leave some things to the imagination. They’re more likely to get a warm reception if they lead people to believe that IM has to do with reaching goals that almost everyone agrees are worthy: compassionate, affordable health care for all, for example.

In that vein, the two most consistent IM pitches in recent years—seen repeatedly in statements found in links from this post—are that IM is “preventive medicine” and that it involves “patient-centered care.” I demolished the “preventive” claim a couple of years ago, as did Drs. Lipson, Gorski, and probably others. Today I’ll explain why the “patient-centered care” claim is worse than fatuous.

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Posted in: Health Fraud, History, Medical Ethics, Politics and Regulation, Science and Medicine

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Pediatrics & “CAM” II: just wrong

In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)

Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.

Limit CAM? Not happening

Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.

Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Politics and Regulation, Vaccines

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Update on CPSOs Draft Policy

Four months ago David Gorski wrote about the  College of Physicians and Surgeons of Ontario’s (CPSO) draft policy on “non-allopathic” medicine. He pointed out:

It’s obvious from the wishy-washy approach to the scientific basis of medicine, the waffle words when it comes to whether an “allopathic” physician should support “non-allopathic” therapies, and the apparently inadvertent use of language favored by quacks that there were far too many “alternative” practitioners involved in drafting this policy.

I agree.  The proposed policy addresses the issue of so-called complementary and alternative medicine (CAM) and has drawn serious criticism from Canadian physicians (at least those who are paying attention and have the slightest clue about what is going on). The backlash is good to see, but it is not nearly vigorous enough.

There is now an update to this story as the CPSO has published a revised policy proposal. There are some improvements, based on the criticism, but still there are problems with the policy.

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Posted in: Politics and Regulation, Public Health

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Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

And the Lord spake, saying, “First shalt thou take out the Holy Pin. Then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out. Once the number three, being the third number, be reached, then lobbest thou thy Holy Hand Grenade of Antioch towards thy foe, who, being naughty in my sight, shall snuff it.

Cleric from Monty Python and the Holy Grail

I’ve always wondered about the power of the number three. When it comes to quackery propaganda movies, certainly three seems to be the magic number. For example, The Greater Good, an anti-vaccine propaganda film, features three anecdotes, three children allegedly suffering from vaccine injury, and it interspersed its interviews with experts, both real (such as Dr. Paul Offit) and phony (such as Barbara Loe Fisher) with vignettes from these children’s stories interspersed between them in a highly biased manner. I have to wonder whether these cliches are taught in film school, given that they seem to be so common. Such were the thoughts running through my brain as I watched the latest medical propaganda film by writer/producer Eric Merola that’s floating around the blogosphere and the film circuit, Burzynski The Movie: Cancer Is Serious Business. In this movie, there are three testimonials, and, if anything, they are far more manipulative than even the testimonials featured in The Greater Good, because each of them are of the type that portrays doctors as sending a patient home to die; that is, until a “brave maverick doctor,” one Stanislaw R. Burzynski, MD, PhD, comes to the rescue with his unconventional and unproven therapy. The only difference is that this film counts testimonials up to the number three in the beginning as “proof” that Burzynski can cure cancer before lobbing the Holy Hand Grenade of Burzynski towards its foes in the hopes that, being naughty in the filmmaker’s sight, the FDA and Texas Medical Board will snuff it. Or, as a caption says right at very the beginning of the movie:

This is the story of a medical doctor and PhD biochemist who has discovered the genetic mechanism that can cure most human cancers. The opening 30 minutes of this film is designed to thoroughly establish this fact — so the viewer can fully appreciate the events that follow it.

It turns out that the grenade is a dud.
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Posted in: Basic Science, Cancer, Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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