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Homeopathic regulation diluted until no substance left

Homeopathy is quackery but it is perfectly legal to prescribe homeopathic products and to sell them directly to consumers in the United States as well as other supposedly civilized countries such as the United Kingdom and Germany. This makes as much sense as allowing the sale of batteries that don’t produce electricity.

What makes this state of affairs even stranger is that homeopathic products are classified as drugs under U.S. law. Does this mean that they undergo the same pre-market approval process and are subject to the same post-market requirements as pharmaceutical drugs? No, not by a long shot. In fact, the federal government and the FDA have pretty much handed regulation of homeopathic products over to their manufacturers.

How did this happen?

In 1938, Congress passed the Food, Drugs and Cosmetics Act. The Act’s principle author was Senator Royal Copeland, a physician who practiced homeopathy. He managed to include all articles monographed in the Homeopathic Pharmacopeia of the United States (HPUS) in the definition of drugs within the FDCA, although why he did so remains in dispute. The HPUS is a source for monographs, identity, methods of manufacture, standards and controls and potency levels of homeopathic products, both prescription and OTC. (The vast majority of homeopathic products are OTC.) In short, if the product is in the HPUS, it’s legal.

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Posted in: History, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Once more into the screening breach: The New York Times did not kill your patient

One of the more depressing things about getting much more interested in the debate over how we should screen for common cancers, particularly breast and prostate cancer, is my increasing realization of just how little physicians themselves understand about the complexities involved in weighing the value of such tests. It’s become increasingly apparent to me that most physicians believe that early detection is always good and that it always saves lives, having little or no conception of lead time or length bias. Sadly, just last week, I saw another example of just this phenomenon in the form of an article written by Dr. George Lombardi entitled My Patient, Killed By The New York Times. The depth of Dr. Lombardi’s misunderstanding of screening tests permeates the entire article, which begins with his recounting a story about a patient of his, whose death he blames on The New York Times. After describing the funeral of this 73-year-old man who died of prostate cancer, Dr. Lombardi then makes an accusation:

This one filled me with a special discomfort as I knew a secret: He didn’t have to die. I knew it and he had known it. Had he told?

About 5 years ago he had just retired and had a lot more time on his hands. He was a careful man, lived alone, considered himself well informed. He got into the habit of clipping articles on medical issues and either mailing them to me or bringing them in. They came from a variety of sources and were on a variety of topics. He wasn’t trying to show me up. He was genuinely curious. I kidded him that maybe he’d like to go to medical school in his retirement. ‘No’ he laughed, ‘I just like to be in the know.’

When he came in for his physical in 2008 he told me he’d agree to the DRE but not the PSA (his medical sophistication extended to the use of acronyms: DRE stands for digital rectal exam where I feel the prostate with my gloved finger for any abnormality and PSA for prostatic [sic] specific antigen which is a blood protein unique to the prostate and often elevated in prostate cancer). He had read that the use of PSA as a screening test was controversial. This was the year that the United States Preventive Services Task Force, a government panel that issues screening guidelines, recommended against routine PSA screens for older men. It was often a false positive (the PSA was elevated but there was no cancer), led to unnecessary biopsies, and besides most prostate cancers at his age were indolent and didn’t need to be treated. I countered that prostate cancer was the second leading cause of cancer deaths in men and that it was better to know than not to know. This way it would be our decision. The patient with his doctor deciding what was best. But no, he wanted to stick to his guns and since the DRE was normal no PSA blood test was sent.

After describing a conversation with the man’s daughter, who said, “My father was killed by The New York Times,” Dr. Lombardi then goes on to anecdotal evidence and a cherry-picked publication to support his view, quoting an oncologist who says he’s “seeing more men presenting with advanced prostate cancer” and then referring to a single paper in the current Annals of Internal Medicine about PSA screening. Before I look at the article and a recently published paper on screening mammography that made the news, I can’t help but point out that I (mostly) agree with Dr. Lombardi when he says:

Public health doctors, policy experts and journalists tend to look at the population as a whole. It is a better story if it is one story. It makes a better headline. Their statistics are people I sit across from everyday trying to figure out what the future holds. We each have our job to do.

The problem is, of course, that Dr. Lombardi takes that observation and draws the wrong conclusion, namely that his patient died because of lack of screening. He attacks a straw man, sidestepping the true argument, namely that evidence shows that PSA screening probably causes more harm than good for men at average risk of prostate cancer. Unfortunately, Dr. Lombardi obviously does not understand some very basic concepts behind cancer screening, nor does he apparently recognize that doctors who deal with the population-level data that we have regarding screening tests and try to apply them to individual patients are actually looking in a very systematic way about what the benefits of screening are to the individual patient. More on that later. In the meantime, although I wouldn’t go quite as far as Dr. John Schumann did in criticizing Dr. Lombardi, I do view his lament as a jumping off point to look at some recent data on screening for the two most common cancers, breast and prostate.

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

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At Your Own Risk

In 2011, Americans spent some $30 billion on dietary supplements. Yet, except for the industry itself and a few politicians and “health freedom” advocates, you’d be hard pressed to find anyone (who’s given it some thought) of the opinion that dietary supplement regulation is adequate. Three recent reports, two from the government and one from a newspaper, demonstrate why this near-universal conclusion is warranted.

Another government report on lax supplement regulation

Here’s how an October, 2012, Department of Health and Human Services Office of Inspector General’s (OIG) report described the FDA’s regulatory authority:

DSHEA [Dietary Supplement Health and Education Act] does not require manufacturers to submit dietary supplements to FDA for safety or approval prior to sale. As a result, FDA has no comprehensive list of dietary supplements on the market. Dietary supplement manufacturers must ensure that their products are safe, they have evidence to substantiate structure/function claims, and that product labels are truthful and not misleading.

In other words, the fox guards the henhouse.

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

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Legislative Alchemy: Acupuncture and Homeopathy 2013

Acupuncture, or more broadly, Oriental or Traditional Chinese Medicine, is a

weird medley of philosophy, religion, superstition, magic, alchemy, astrology, feng shui, divination, sorcery, demonology and quackery.

And via the particular form of magic known as legislative alchemy, acupuncture is a licensed health care profession in 44 states and the District of Columbia.

A growing body of evidence demonstrates acupuncture is simply an elaborate placebo. Even the CAM-friendly National Center for Complementary and Alternative Medicine, says

Although millions of Americans use acupuncture each year, often for chronic pain, there has been considerable controversy surrounding its value as a therapy and whether it is anything more than placebo.

Someone should tell the state legislatures. (more…)

Posted in: Acupuncture, Homeopathy, Legal, Politics and Regulation, Traditional Chinese Medicine

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Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

Electrodermal testing is a bogus procedure where measurements of skin conductance with a biofeedback device are entered into a computer to diagnose nonexistent health problems and “energy imbalances” and to recommend treatments for them, often involving the sale of homeopathic remedies and other useless products. It falls under the general category of EAV (Electro Acupuncture of Voll). The history and variants of EAV are explained in an article on Quackwatch.

I’ve written about electrodermal testing before. I’ve explained how it amounts to fooling patients with a computerized Magic 8 Ball and I’ve discussed the legal and regulatory issues.

Now Stephen Barrett (founder of Quackwatch and Vice-President of the Institute for Science in Medicine) has written an article in FACT (Focus on Alternative and Complementary Therapies) entitled “Bogus electrodermal testing devices: where are the regulators?” He points out that existing regulations are sufficient to ban these devices, but that regulators have failed to take appropriate action.

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Posted in: Acupuncture, Energy Medicine, Medical devices, Politics and Regulation

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Doctors and Dying

“I intend to live forever. So far, so good.”

- Steven Wright

The humor in many of comedian Steven Wright’s famous one-liners is that they are simultaneously familiar and absurd. At some level we all know that we are going to die, but as long as we are still alive (or a loved-one is alive) we can cling to the irrational hope, the impossible denial, that death remains a distant abstract concept, not an near inevitability.

We all need to come to terms with death in our own private way, but often those terms are not private because they drive our use (for ourselves or others) of increasingly expensive health care. Two essays over the last year by doctors explored this issue, noting that when doctors face their own mortality they often make different health care decisions for themselves than the general public.

In February of 2012, Dr. Ken Murray wrote an essay in The Wall Street Journal – Why Doctors Die Differently. His primary thesis was that doctors choose less end-of-life care for themselves than the average patient. They do so largely because they are intimately familiar with the futility of much of what we do for patients who are likely going to die anyway. As one example, CPR has a success rate of about 8%, with only 3% of people receiving it going on to have a near-normal quality of life. Those numbers are pretty grim. Meanwhile, TV depictions of CPR are successful 75% of the time with 67% returning to normal life. Sometimes the person wakes up during the CPR, is fine, and then goes on to thwart a terrorist attack without missing a beat.

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Posted in: Politics and Regulation

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Legislative Alchemy: Chiropractic 2013

Via the magic of legislative alchemy, chiropractors are already licensed health care providers in all 50 states. Thus their legislative efforts tend to focus on expanding their scope of practice and forcing public and private insurers to cover their services, in some cases at the same rate as medical doctors. Those efforts continue in 2013 with 65 bills impacting chiropractors introduced so far. Of those including substantive provisions (as opposed to, say, simply raising fees), only one is not to their advantage.

New Mexico chiropractors are once again attempting expansion of their scope of practice. In 2008 and 2009, the New Mexico legislature created a new iteration of chiropractor, called “the certified advanced practice chiropractic physician.” A certain faction of the chiropractic industry is attempting to rebrand chiropractors nationwide as primary care physicians and this was a signature event in those efforts. With 90 hours of additional education, these advanced practice chiropractors can administer a bevy of dubious remedies, such as bioidentical hormones.

The new law also permitted prescription of dangerous drugs and controlled substances and administration of drugs by injection, but only if on a formulary approved by the state pharmacy and medical boards. The chiropractic board didn’t like having to get approval from pharmacists and medical doctors, so they went ahead and added what they wanted to the formulary, ignoring the other boards despite their own attorney’s advice that they couldn’t do this. This got them into a couple of court battles with the pharmacy and medical boards. The International Association of Chiropractors (ICA), the traditional, subluxation-only chiropractic faction, jumped into the fray to oppose this power grab. The ICA believes chiropractic should remain drug and surgery free.

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Posted in: Chiropractic, Herbs & Supplements, Homeopathy, Legal, Pharmaceuticals, Politics and Regulation

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Legislative Alchemy: Naturopathy 2013

A fresh season of state legislative sessions is upon us and with it comes the ubiquitous attempts by purveyors of so called “complementary and alternative medicine” (or “CAM”) to join the health care provider fraternity. Via the magic of legislative alchemy, state legislatures transform pseudoscientific diagnoses (e.g., “chronic yeast overgrowth”) and treatments (e.g., homeopathy) into faux, but legal, health care. Once the imprimatur of legitimacy is bestowed by the state in the form of a health care practice act tailored to their special brand of quackery, these newly licensed health care providers are free to foist their practices onto an unsuspecting public and charge them for the privilege. All of this is done under the false assumption that such legislation is necessary to protect the public health, safety and welfare.

We might well want to consider how far this whole thing is going. Will practitioners of CAM split into an ever-expanding number of CAM provider guilds, all with their own practice acts? First, chiropractors were the only CAM practitioners who managed to get themselves licensed in all 50 states. Then along came acupuncturists, who are now licensed to practice in over 40 states. A few states license homeopaths. Some states licensed naturopaths early on. Now the naturopaths, licensed in 16 states, are in a full court press to catch up and legitimize themselves with licenses to practice “naturopathic medicine.”

Why? Because, according to Lorilee Schoenback, ND, a Vermont practitioner and American Association of Naturopathic Physicians (AANP) Board member:

If the law [the Affordable Care Act, or ACA] is implemented as intended NDs in 16 states will immediately be covered by insurance.

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Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Pharmaceuticals, Politics and Regulation, Public Health

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Here we go again: A bill licensing naturopaths rears its ugly head in Michigan

If I’ve pointed it out once, I’ve pointed it out a thousand times. Naturopathy is a cornucopia of almost every quackery you can think of. Be it homeopathy, traditional Chinese medicine, 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, it’s hard to think of a single form of pseudoscientific medicine and quackery that naturopathy doesn’t embrace or at least tolerate. Indeed, as I’ve retorted before to apologists for naturopathy who claim that it is scientific, naturopathy can never be scientific as long as you can’t have naturopathy without homeopathy and naturopaths embrace homeopathy. Unfortunately, naturopaths have over the years been having some success in persuading state legislatures to license naturopaths, in some cases even giving them the privilege of being considered primary care practitioners. It’s part of an organized effort, too, and I don’t expect that effort to let up. True, the governor of Massachusetts did veto a naturopathic licensing bill that came across his desk recently, but no one following this issue expects the naturopaths to let up. As Jann Bellamy put it, the naturopaths will be back. They always are.

Indeed, in the wake of the failure to pass a naturopathic licensing bill in Massachusetts, Michael Cronin, the president of the American Association of Naturopathic Physicians (AANP) lamented:
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Posted in: Naturopathy, Politics and Regulation

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California Acupuncture Licensing: Sinking Lower in the Slime!

The sun shone down upon that putrescence,
As if to roast it to a turn,
And to give back a hundredfold to great Nature
The elements she had combined…
— Charles Baudelaire, The Carcase1

Trouble for the struggling California Acupuncture Board (Board) is far from being over.

After being taken to task by the California Senate less than a year ago for acting “as a venue for promoting the profession” rather than regulating it, now the Board is being petitioned for reform by license applicants after a major compromise in the California Acupuncture Licensing Examination (CALI). This is the exam that allows the graduates of state-approved training programs to practice acupuncture, herbalism and Asian massage in California. Physicians who use these modalities are regulated by the Medical Board.

Bear in mind that California is the only state in the nation that has its own acupuncture licensing examination. In other states where the profession is regulated, candidates have to take a battery of computer-based tests developed by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). The California test is designed by the Department of Consumer Affairs, and could be taken in English, Chinese or Korean. This means that an individual can get licensed and practice healthcare in California, without understanding a word of English!
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Posted in: Acupuncture, Politics and Regulation

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