Tag: regulation
DMAA: Efficacious but is it Safe?
by Igor I. Bussel & Drey A. Pavlov Jann Bellamy has recently authored an excellent piece on the limitations of the FDA and how the DSHEA actually protects the profits of supplement manufacturers rather than the health and well-being of consumers. Bellamy used the very poignant and currently “controversial” example of DMAA (methylhexanamine or 1,3-dimethylamylamine) to illustrate her point regarding the loopholes...
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...
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...
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...
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...
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...
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: Parent has determined that their child is sick, and needs some sort of over-the-counter medicine. Parent asks pharmacist for advice...
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...
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...
DSHEA: a travesty of a mockery of a sham
The Dietary Supplement Health and Education Act (DSHEA) is a terrible piece of legislation that protects supplement manufacturers rather than patients. Congress should be ashamed.