Archive for Politics and Regulation

The regulation of nonsense

 The most meticulous regulation of nonsense must still result in nonsense.

— Edzard Ernst, M.D., PhD., professor, Complementary Medicine, Peninsula Medical School, University of Exeter, UK

One necessity of licensing so-called “complementary and alternative,” or “CAM,” practitioners is to spell out exactly what is encompassed in the CAM scope of practice. This is unfortunate for the practitioners because it forces an exposé of the nonsensical precepts underlying their claims. For example,

‘Acupuncture’ refers to a form of health care, based on a theory of energetic physiology that describes and explains the interrelationship of the body organs or functions with an associated acupuncture point or combination of points located on ‘channels’ or ‘meridians’. . . Acupuncture points are stimulated in order to restore the normal function of the aforementioned organs or sets of functions.

(Delaware acupuncture practice act.)

[Chiropractic is] the science of adjusting the cause of the disease by realigning the spine, releasing pressure on nerves radiating from the spine to all parts of the body, and allowing the nerves to carry their full quota of health current (nerve energy) from the brain to all parts of the body.

(North Carolina chiropractic practice act.)

The practice of naturopathic medicine includes, but is not limited to, the following services:. . . ordering, administering, prescribing, or dispensing for preventive and therapeutic purposes: food, extracts of food, nutraceuticals, vitamins, minerals, amino acids, enzymes, botanicals and their extracts, botanical medicines, herbal remedies, homeopathic medicines, dietary supplements and nonprescription drugs as defined by the federal Food, Drug, and Cosmetic Act, glandulars, protomorphogens, lifestyle counseling, hypnotherapy, biofeedback, dietary therapy, electrotherapy, galvanic therapy, oxygen, therapeutic devices, barrier devices for contraception, and minor office procedures, including otaining specimens to assess and treat disease. . .

(Minnesota naturopathic practic act.)


Posted in: Energy Medicine, Legal, Politics and Regulation, Science and Medicine

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Pseudoscience is not Cost Effective

Industrialized nations are in the middle of a health care crisis (some more than others), or at least a dilemma. As our medical technology advances, people are living longer, they are living with chronic diseases, and they are consuming more health care. The cost of this health care is rising faster than economic growth, so it is becoming a greater and greater burden on society. Many countries ration health care in one way or another in order to contain costs. Otherwise there is no easy or obvious solution and it’s likely that difficult choices will have to be made.

An interesting side effect of this dilemma is a renewed focus on the cost effectiveness of medicine. Effectiveness alone is not enough. We simply cannot afford, for example, to introduce a very expensive treatment for marginal improvement in outcome in a common disease. Different options can also be compared not only for their safety and efficacy, but for their cost effectiveness. In other words, we need to use cheaper alternatives when available rather than always reaching for the latest and greatest (and most expensive) treatment.

This situation provides an opportunity for science-based medicine. Treatments that are promoted as complementary and alternative (CAM) are often sold as cost effective because they are less expensive up front than standard medical care. We cannot, however, cede this argument to proponents of dubious therapies. Cheap does not mean cost effective. You have to be effective in order to be cost effective, and most of the dubious treatments that are marketed under the CAM umbrella are ineffective.


Posted in: Politics and Regulation, Science and Medicine

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The CAM Docket: Texas MDs v. DCs

In April, the Texas District Court of Appeals (Third District) affirmed a lower court ruling that chiropractors are prohibited from performing manipulation under anesthesia and needle electromyography[EMG]. The lower court also ruled that the Texas Board of Chiropractic Examiners exceeded its authority in defining the chiropractic scope of practice to include “diagnosis.” This part of the ruling was overturned by the Court of Appeals, but with some interesting language in the opinion which could turn their one win into a Pyrrhic victory for Texas chiropractors.  In a separate ruling, not on appeal, a lower court held that vestibular testing is outside the scope of chiropractic practice.

First, some background. Back in 1949, the Texas Legislature defined the scope of chiropractic practice as, among other things, “the practice of adjusting the vertebrae to correct any subluxation or misalignment thereof . . .” Over the ensuing years, the legislature amended the chiropractic practice act with an eye toward modernization, resulting in the current scope of practice being “nonsurgical, nonincisive procedures, including, but not limited to, adjustment and manipulation, in order to improve the subluxation complex or the biomechanics of the musculoskeletal system.” Now that’s progress!


Posted in: Chiropractic, Legal, Politics and Regulation

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Funding CAM Research

Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.

Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.

“NCCAM officials have spent $375,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer.”

The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.


Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics, Politics and Regulation, Science and Medicine

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Supplements and cancer prevention

The bloggers here have been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we’ve pointed out time and time again, the DSHEA is not about health, and it’s certainly not about education. Indeed, perhaps my favorite description of this law comes from our very own Peter Lipson, who refers to it as a “travesty of a mockery of a sham.” Rather, it’s about allowing supplement manufacturers and promoters of so-called “complementary and alternative medicine” (CAM, with or without a preceding “s,” depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as “dietary supplements” with near-impunity. As Harriet Hall put it so accurately, the DSHEA is “a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines.”

The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as “supplements” without prior approval by the FDA before marketing. As long as the manufacturer is careful enough not to make health claims that are too specific, namely that the supplement can diagnose or treat any specific disease, and sticks to “structure-function” statements (“it boosts the immune system!”), almost anything goes, particularly if a Quack Miranda Warning is included.

Not surprisingly, given what a big business supplements have become in this country largely due to the DSHEA, manufacturers and CAM advocates fight tooth and nail against any attempt to update the DSHEA to correct some of its more unfortunate consequences. Led by Utah Senator Orrin Hatch and Iowa Senator Tom Harkin, who together make up a bipartisan tag-team in defense of the supplement industry and do their best to block any effort to increase its regulation by the FDA. We saw that most recently when Arizona Senator John McCain, of all people, introduced a bill in 2010 to try to tighten up the DSHEA and was thoroughly slapped down by Orrin Hatch. More recently, not satisfied with how good things are for the supplement industry, another Utah Representative Jason Chaffetz reached across the aisle to Jared Polis, teaming up to introduce the Free Speech About Science Act, which basically seeks to allow the supplement industry to make more liberal claims about its products. All it will need is a “peer-reviewed” paper to support it (Mark and David Geier would do!), and you can claim almost anything. Anything to grow the supplement industry, which is currently around $30 billion a year.

That’s why it’s critical, from time to time, to look at actual evidence, and just last week Maria Elena Martinez, PhD, of the University of California San Diego, and co-authors did in a commentary published online in the Journal of the National Cancer Institute entitled Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms.

Posted in: Cancer, Herbs & Supplements, Politics and Regulation

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Chiropractors as Family Doctors? No Way!

A recent three-part article published in ACA News advocates turning chiropractors into “conservative primary care providers” who would be the initial point of contact for patients, would serve as gatekeepers for referrals to medical doctors and specialists, and would co-manage patients with those specialists on a continuing basis: essentially, family doctors.  I think that’s a terrible idea. It might benefit chiropractors by increasing their market share, but it wouldn’t benefit patients. There is no evidence to indicate that chiropractors are capable of filling that role effectively or safely.

NUHS. The article was co-authored by several chiropractors on the faculty of the National University of Health Sciences, a school noted for integrating quackery with medicine. The “sciences” this school teaches are listed at the top of its website: chiropractic medicine, naturopathic medicine, oriental medicine, acupuncture, biomedical science, and massage therapy. The only one of those that even sounds like science, “biomedical science,” offers a bachelor of science degree with an integrative medicine focus and with no required core courses whatsoever!

Their doctor of chiropractic degree program says:

National University prepares students to become first-contact, primary care physicians fully qualified to diagnose, treat and manage a wide range of conditions.


Posted in: Chiropractic, Politics and Regulation

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The CAM Docket: Boiron II

Five consumer lawsuits are pending in the U.S. against Boiron, the world’s largest manufacturer of homeopathic products. One lawsuit is also pending in Canada. As reported in a previous post, the U.S. plaintiffs claim they purchased homeopathic products, such as Coldcalm, Oscillo, Arnicare and Chestal Cough Syrup, based on Boiron’s misleading and false statements that they are effective for various ailments. Therefore, these plaintiffs allege, Boiron has defrauded consumers, as well as violated various consumer protection laws. Boiron denies these claims.

The plaintiffs’ allegations in each of the five U.S. lawsuits are based in part on the same fallacies underlying homeopathy discussed many times before here at SBM:

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

Which raises an interesting question: how does one defend a product that appears to be indefensible? Let’s take a look. (more…)

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

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Cancer care in the U.S. versus Europe: Is more necessarily better?

The U.S. is widely known to have the highest health care expenditures per capita in the world, and not just by a little, but by a lot. I’m not going to go into the reasons for this so much, other than to point out that how to rein in these costs has long been a flashpoint for debate. Indeed, most of the resistance to the Patient Protection and Affordable Care Act (PPACA), otherwise known in popular parlance as “Obamacare,” has been fueled by two things: (1) resistance to the mandate that everyone has to buy health insurance, and (2) the parts of the law designed to control the rise in health care costs. This later aspect of the PPACA has inspired cries of “Rationing!” and “Death panels!” Whenever science-based recommendations are made that suggest ways to decrease costs by reevaluating screening tests or decreasing various tests and interventions in situations where their use is not supported by scientific and clinical evidence, whether by the government or professional societies, you can count on it not being long before these cries go up, often from doctors themselves.

My perspective on this issue is that we already “ration” care. It’s just that government-controlled single payer plans and hybrid private-public universal health care plans use different criteria to ration care than our current system does. In the case of government-run health care systems, what will and will not be reimbursed is generally chosen based on evidence, politics, and cost, while in a system like the U.S. system what will and will not be reimbursed tends to be decided by insurance companies based on evidence leavened heavily with business considerations that involve appealing to the largest number of employers (who, let’s face it, are the primary customers of health insurance companies, not individuals insured by their health insurance plans). So what the debate is really about is, when boiled down to its essence, how to ration care and by how much, not whether care will be rationed. Ideally, how funding allocations are decided would be based on the best scientific evidence in a transparent fashion.

The study I’m about to discuss is anything but the best scientific evidence.

Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Science and the Media

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The “CAM” Consumer: Misled and Abused

There is a disturbing lack of protection for the consumer of “complementary and alternative” products and services. I can think of no other area of commerce where misleading, as well as out and out false, information is so regularly employed, without consequence, to entice the consumer into forking over his hard-earned cash. Nor do I know of any other manner of goods or services where giving consumers patently false information is protected by law.

Consider first the fact that nonsensical gibberish is enshrined in state law in the form of “CAM” practice acts, which give practitioners of implausible, if not wholly discredited, diagnostic methods and treatments carte blanche to ply their trades. For example, as has been discussed before on SBM, state law defines chiropractic as the detection and correction of subluxations, which, as many chiropractors themselves admit, do not exist. State practice acts define acupuncture in such pseudoscientific terms as “modulation and restoration of normal function in and between the body’s energetic and organ systems and biomechanical, metabolic and circulation functions using stimulation of selected points.”

As well, naturopathy practice acts allow “mixing and matching treatments including traditional Chinese medicine, homeopathy, herbalism, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine.” State practice acts also permit the indiscriminate use of the term “doctor” and “physician.” Scope of practice is broadly defined as “primary care.” (more…)

Posted in: Acupuncture, Chiropractic, Energy Medicine, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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California Bill AB 2109: The Antivaccine Movement Attacks School Vaccine Mandates Again

Of all the preventative treatments ever developed through science- and evidence-based medicine, vaccines have arguably saved more lives, prevented more illness and disability, and in general alleviated more suffering than any single class of treatments or preventative measures throughout history. Given the obvious and incredible success of vaccines at decreasing the incidence of infectious diseases that used to ravage populations, it seems incredible that there would be such a thing as an antivaccine movement, but there is. Indeed, when I first encountered antivaccine zealots on the Usenet newsgroup about ten or twelve years ago, as a physician I really had a hard time wrapping my head around the fact that such people existed. No doubt the same is true of many physicians, who take the scientific evidence for the safety and efficacy for vaccines for granted. However, I am a cancer surgeon, and I do not treat children; so until I discovered antivaccine rhetoric on the Internet I was blissfully ignorant that such views even existed. Other health care professionals knew better. Pediatricians, nurses, and any health care professionals who deal with children and the issue of vaccinations know better, because they face antivaccine views on a daily basis. It is because of the incredible importance of vaccination and the danger to public health the antivaccine movement represents that we at Science-Based Medicine write so frequently about vaccines and the antiscientific, pseudoscientific, and misinformation-packed fear mongering about vaccines that is so prevalent today.

The success of vaccination campaigns has recently been endangered by a number of factors, in particular the antivaccine movement. Because of various groups opposed to vaccination, either for philosophical reasons or because they incorrectly believe that vaccines cause autism, neurodevelopmental disorders, sudden infant death syndrome, and autoimmune diseases, among others, one of the most potent tools for encouraging high rates of vaccine uptake, school vaccine mandates, have come under attack. Alternatively, increasing numbers of parents have taken advantage of religious or philosophical exemptions in order to avoid the requirement to have their children vaccinated prior to entry to school. As a result, of late some states with lax vaccination requirements have begun to try to tighten up requirement for non-medical vaccine exemptions. The arguments used by the antivaccine movement against such legislation are highly revealing about their mindset, in particular their attitude towards issues of informed consent, which I will discuss a bit. But first, here’s a little background.

Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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