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Archive for Politics and Regulation

Enbrel for Stroke and Alzheimer’s

A recent article in the LA times tells of a husband’s quest to find a treatment for his wife’s Alzheimer’s disease. This is a narrative that journalists know and love—the brave patient or loved-one who won’t accept the nihilism of the medical establishment, who finds a maverick doctor willing to buck the system.

The article itself at least was not gushing, it tended toward a neutral tone, but such articles do tend to instill in the public a very counterproductive attitude toward science and medicine. I would have preferred an exposé of a dubious clinic exploiting desperate patients by peddling false hope. That is a narrative in which journalists rarely engage.

The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).

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Posted in: Health Fraud, Medical Ethics, Politics and Regulation

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Undermining the regulation of stem cell therapies in Italy: A warning for the future?

Stem cells are magical.

At least, if you listen to what docs and “practitioners” who run stem cell clinics in various parts of the world, usually where regulation is lax and money from First World clientele is much sought after, that’s what you could easily come to believe. Unfortunately, it’s not just Third World countries in which “stem cell clinics” have proliferated. For instance, they are not nearly uncommon enough in Europe. The example that is most troubling right now is Italy, and the reason is that there is currently a law being considered that would greatly weaken the regulation of stem cell therapies, so much so that on Friday I saw something that’s fairly rare: a major scientific journal published a pointed editorial about this new law. Specifically EMBO Journal published a commentary by an international group of scientists warning about the path that the government of Italy is considering entitled Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

Stem cell quackery is a very popular form of quackery these days because, well, stem cells are so magical-seeming. You can now find stem cell treatments offered for autism (one of which, offered at a clinic in Costa Rica, I’ve discussed before and involves injecting “stem cells” into the cerebrospinal fluid of autistic children for a cool $15,000). Kent Heckenlively, the man who took his daughter to the aforementioned Costa Rica clinic for this treatment, is not alone in subjecting his autistic child to such unproven uses of stem cells. Just a couple of months ago, a broadcast journalist in the Philippines named Karen Davila took her autistic son to the Villa Medica Clinic in Germany, which offers variants of stem cell therapy. One is known as “fresh cell therapy” and involves harvesting cells from lamb fetuses and injecting them into the patient. The other is called fat stem cell repair therapy, which is claimed to involve harvesting fat from the patient’s abdomen or thigh and then isolating “stem cells” from them to be injected back into the patient’s body.
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Posted in: Basic Science, Clinical Trials, Legal, Medical Ethics, Politics and Regulation

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Dr. Who?

If the “Health Freedom” movement has its way, everyone in the United States will be able to practice medicine. It may be quack medicine but that doesn’t seem to bother them. Short of that, chiropractors, naturopaths and acupuncturists are aiming to reinvent themselves primary care providers and even physicians. As David Gorski pointed out, this will reduce medical doctors to just another iteration of physician, the “allopathic” type, equal in stature to the chiropractic, naturopathic and acupuncture types. These “physicians” already call themselves “doctor” (e.g., “Doctor of Oriental Medicine”) and claim to graduate from four-year “doctoral” programs. This despite the fact that their schools operate outside the mainstream American university system and avoid some of the basics of typical graduate programs, such as entrance exams, as well as the extensive clinical training required for medical doctors.

Consumers are confused by all of this, and who wouldn’t be? In 2008 and 2010, surveys done for the American Medical Association by outside firms revealed that many patients did not know the qualifications of their healthcare provider. The comparisons were between allied health professions (e.g., audiologists and nurse practitioners) and medical doctors, but chiropractors were included. In 2008, 38 per cent of those surveyed (n=850) thought chiropractors were medical doctors, although that dropped to 31 per cent in 2010. Still, we are talking about roughly one-third of the survey participants.

The surveys also asked about the use of the term “physician” and confusion in advertising materials.
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Posted in: Acupuncture, Chiropractic, Health Fraud, Legal, Naturopathy, Politics and Regulation, Science and Medicine

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Politics of Public Research Funding

A great deal of science is funded by the US government. The total research funding for 2009 was 54.8 billion dollars (much more if you include all R&D). A breakdown by agency of total R&D shows that the NIH (National Institutes for Health) funding is 28.5 billion while the NSF (National Science Foundation) is 4.1 billion.

There is general agreement that this expenditure is an investment on critical intellectual infrastructure for our nation and is vital to our competitiveness and standard of living. The government certainly has the right, and in fact the duty, to ensure that this money is well-invested. Government oversight is therefore understandable. Inevitably, however, politics is likely to intrude.

Representative Lamar Smith has been developing legislation that would in effect replace the peer-review process by which grants are currently given with a congressional process. Rather than having relevant scientists and experts decide on the merits of proposed research Smith would have politicians decide. It is difficult to imagine a more intrusive and disastrous process for public science funding.

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Posted in: Politics and Regulation

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What’s in your supplement?

When you pick up a bottle of supplements, should you trust what the label says?  While there is the perception that supplements are effective and inherently safe, there are good reasons to be skeptical. Few supplements are backed by good evidence that show they work as claimed. The risks of supplements are often not well understood. And importantly, the entire process of manufacturing, distributing, and marketing supplements is subject to a completely different set of rules than for drugs.  These products may sit on pharmacy shelves, side-by-side with bottles of Tylenol, but they are held to significantly lower safety and efficacy standards. So while the number of products for sale has grown dramatically, so has the challenge to identify supplements that are truly safe and effective. (more…)

Posted in: Health Fraud, Herbs & Supplements, Politics and Regulation

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The Quack Full Employment Act

Quacks, charlatans and snake oil salesmen are closely watching “The Colorado Natural Health Consumer Protection Act,” Senate Bill 13-215 (SB 215) as it wends its way through the Colorado Legislature. I imagine a few felons about to be released from prison are keeping tabs on the bill too, for reasons we’ll get to in a minute. SB 215 passed the Senate on Tuesday. It will now go on to the House, where it has the support of Rep. Joann Ginal, the mover and shaker behind a bill giving “naturopathic doctors” a right to practice, House Bill 13-1111 (HB 1111). That bill passed the House and is now parked in the Senate awaiting committee assignment.  Apparently, critical thinking skills have abandoned the state capital. Things are looking grim.

If the “Colorado Natural Health Consumer Protection Act” passes, Colorado will become one of a handful of states where anyone can practice medicine. Of course, these laws don’t come out and say that exactly. In fact, the Colorado bill states that if you don’t have a medical license you cannot practice medicine, which in Colorado is defined to include:

Holding out one’s self to the public within this state as being able to diagnose, treat, prescribe for, palliate, or prevent any human disease, ailment, pain, injury, deformity, or physical or mental condition, whether by the use of drugs, surgery, manipulation, electricity, telemedicine, the interpretation of tests, including primary diagnosis of pathology specimens, images, or photographs, or any physical, mechanical, or other means whatsoever; . . . Suggesting, recommending, prescribing, or administering any form of treatment, operation, or healing for the intended palliation, relief, or cure of any physical or mental disease, ailment, injury, condition, or defect of any person . . .

But, as we shall see, what SB 215 actually does is allow rank amateurs to diagnose and treat just about anyone for any disease or condition with means of no known safety or effectiveness. In other words, they can practice medicine, it’s just quack medicine. At the same time, the bill strips away important consumer protections. And guess who’s supporting it? The Colorado Medical Society, although I suppose we can be disappointed but not surprised. The Colorado Chapter of the American Academy of Pediatrics is remaining neutral. As I said, critical thinking skills have decamped from Denver.

Pay attention folks. Passage of this bill will energize the Health Freedom crowd. They’ll be in your state soon.

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Posted in: Energy Medicine, Health Fraud, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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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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