Posts Tagged regulation

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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Medicine in the Magic Kingdom of Cascadia

Beautiful Cascadia, where science goes to die.

Beautiful Cascadia, where science goes to die.

When the Pacific NW secedes from the Union it is to be part of a new country, Cascadia. The capital would be Portlandia, I suppose. Somehow, I think not. But when I watch the devolution of health care in Oregon, I think back to The Onion (?) when they reported that the United Kingdom was to be sold to Disney, being renamed as “The United Magic Kingdom.”

That is health care in Oregon due the steady insinuation of naturopathy and other pseudomedicine into real health care.

Oregon Health and Pseudoscience University

Growing up my alma mater was the University of Oregon Medical School. Since then it has undergone two name changes, first to Oregon Health Sciences University and then to the current Oregon Health & Sciences University (OHSU)—with, it should be noted, an ampersand. Not an ‘and’.

Perhaps they need one more name change, since they are not always that interested in the “Science” part of their name.

Some background is needed.

Portland has a trifecta of pseudoscience schools: Naturopathic (National College of Natural Medicine), Chiropractic (University of Western States) and ‘Oriental’ (Oregon College of Oriental Medicine).

Lucky us.

As an aside my kids let me know that the word ‘Oriental’ as used to describe people from the East, the term I grew up using, is persona non grata. I understand the reasoning. The proper term, they tell me, is Asian. So I have a mental cringe every time I see the name “Oregon College of Oriental Medicine”.

All three schools are steeped in pseudoscience and pseudomedicine, removed from known reality. As examples, the naturopathic school teaches homeopathy (and more), the chiropractic school teaches the subluxation complex, and the ‘Oriental’ (cringe) school teaches acupuncture. Reading the curricula of the schools suggests that there is no pseudomedical stone left unturned. (more…)

Posted in: Naturopathy, Politics and Regulation, Public Health

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A homeopathic win for consumers

Homeopathy – not medicine

Do you believe in magic? It might surprise you to learn that some people believe sugar pills have healing properties. This belief system, called homeopathy, is a multi-billion dollar industry worldwide, and it’s growing. While there is no convincing evidence to demonstrate that homeopathic treatments are more effective than a placebo, many consumers and even some health professionals accept homeopathy as a legitimate health treatment, and its providers as legitimate health professionals. Responding to the perceived consumer demand for these products, government regulators have had a difficult decision to make: They could ignore homeopathy as a health practice, treating it like we might think of astrology: firmly outside of medicine. Or they could choose some form of regulation, targeting the providers (homeopaths) or the product (homeopathy), possibly with the goal of managing its use, or perhaps limiting harms to consumers. The risk of regulating nonsense, as has been described before, is the perceived legitimacy that recognition and regulation implies. Regrettably, regulation in many countries has had that exact effect. What’s worse, regulation often seems to have prioritized the commercial interests of homeopaths over the public interest, leaving consumers with little understanding that homeopathy lacks scientific credibility as a health practice. Consequently, homeopathy has attracted regular criticism from SBM’s bloggers, science and health journalists, and other science advocates over the years. It appears this advocacy is finally having an effect. Regular readers will recall several posts over the past few weeks, describing the possibility of new regulation of homeopathy by the US Food and Drug Administration (FDA). And just recently, Health Canada announced two important changes to its homeopathy regulation, which may signal a new direction. Are we witnessing the beginning of more sensible regulation of this prescientific practice? (more…)

Posted in: Homeopathy, Politics and Regulation, Science and Medicine, Vaccines

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Supplements are the Wild West of health. One Attorney General is out to change that.


Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.

When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Selling complementary and alternative medicine: An business ethics perspective

I joined Professor Chris MacDonald at Ryerson University earlier this week to participate in Ryerson’s business ethics speaker series. The topic was CAM:

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services – things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues – issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This presentation — by a philosopher and a pharmacist — aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

If it’s not embedded above, you can watch the whole presentation on CAM and business ethics with this link.

It was great to see so many public members attend and participate. There was an extended Q&A afterwards, with some very thoughtful audience questions. Outside of blogs like this, and those of CAM critics like Edzard Ernst, the practical ethics of CAM provision are rarely discussed.  Watch for more on this topic in the future.


Posted in: Announcements, Homeopathy, Medical Ethics, Politics and Regulation

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Oh yeah? Thalidomide! Where’s your science now?

Online discussions on the merits of alternative medicine can get quite heated. And its proponents, given enough time, will inevitably cite the same drug as “evidence” of the failings of science. Call it Gavura’s Law, with apologies to Mike Godwin:

As an online discussion on the effectiveness of alternative medicine grows longer,  the probability that thalidomide will be cited approaches one.

A recent comment on my own blog, regarding the homeopathic product Traumeel, is typical:

If the scientific method is all that separates an accepted claim, ie Thalidomide, Vioxx, Bextra, Darvon, from mere anecdote, of what benefit is the Science?

As a non-scientist consumer, I’ll take the anecdotes and my own experience. Thank you.

If scientists want to be taken seriously, they must stop selling themselves to the highest bidder becoming corporate whores without a shred of decency. To my mind, that’s how the claims for Thalidomide, Vioxx, Bextra, Darvon were accepted, making the scientific method utterly worthless.

To this commenter, “science has been wrong before.” And that invalidates science, and apparently validates homeopathy. It’s a fallacious argument. But does thalidomide actually represent a failing of science-based medicine? No, not even close. It’s so wrong, it’s not even wrong. Thalidomide is good example of the importance of science-based medicine and why allowing alternative medicine to be sold in the absence of good science is a concern. (more…)

Posted in: History, Pharmaceuticals, Politics and Regulation, Science and Medicine

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1

Posted in: Homeopathy, Legal, Science and Medicine

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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.


Posted in: Homeopathy, Legal, Science and Medicine

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Rx, OTC, BTC – Wading into Pharmacy’s Alphabet Soup

Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.

Should Drug A be available without a prescription?

Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.

Should Drug B be available without a prescription?

Posted in: Pharmaceuticals, Politics and Regulation

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A temporary reprieve from legislative madness

While doctor visits for influenza-like illnesses seem to be trending downward again, and “swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.

Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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