All the best effort to practice science-based medicine are for naught when the optimal treatment is unavailable. And that’s increasingly the case – even for life-threatening illnesses. Shortages of prescription drugs, including cancer drugs, seem more frequent and more significant than at any time in the past. Just recently manufacturing deficiencies at a large U.S.-based contract drug manufacturer meant that over a dozen drugs stopped being produced. This lead to extensive media coverage, speculating on the causes and implications of what seems like a growing problem. So who’s to blame? (more…)
Archive for Politics and Regulation
Via the magic of “legislative alchemy,” state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices. Without the benefit of legislative alchemy, chiropractors, naturopaths, homeopaths, acupuncturists and other assorted putative healers would be vulnerable to charges of practicing medicine without a license and consumer fraud. Thus, they must seek either their own licensing system or exemption from licensing altogether.
Licensing bestows an undeserved air of legitimacy on “alternative” practitioners. Because a state’s authority to regulate health care lies in its inherent power to protect the public health, safety and welfare, the public understandably assumes licensing actually accomplishes this purpose. In fact, the opposite occurs. Any attempt to impose a science-based standard of health care becomes impossible when vitalism and similarly debunked notions of human functioning are enshrined into law.
Initial licensing is just a beginning. Once the beach head is established other benefits can follow, such as expansion of the scope of practice. If not granted in the initial legislation, “alternative” practitioners can return, seeking more goodies like self-regulation and mandatory insurance coverage. (more…)
The College of Physicians and Surgeons of Ontario’s muddled draft policy on “non-allopathic” medicine
Detroit is my hometown, and three and a half years ago, after nearly twenty years away wandering between residency, graduate school, fellowship, and my first academic job, I found myself back in Detroit minted as surgical faculty at Wayne State University and practicing and doing research at the Barbara Ann Karmanos Cancer Institute. One thing that I had forgotten about while I was away for so many years is just how intimately southeast Michigan interacts with Canada. This closeness is not surprising, given that Detroit and Windsor are separated by only about a half mile of Detroit River. Indeed, a there are a lot of Canadians who cross the border on a daily basis to work in the Detroit area, many of them in the medical center within which my cancer center is located. The reason I point this out is not to wax nostalgic for trips to Windsor or for the occasional trip to Stratford to see plays but to point out that Ontario is right next to us. What happens there is of concern to me because I know quite a few people who live there and because it can on occasion influence what goes on over here on the U.S. side of the border.
I recently learned that the College of Physicians and Surgeons of Ontario (CPSO) has been working on updating its policy on the use of nonconventional medical therapies. The wag in me can’t help but wonder why such a policy would need to say anything other than that, if it isn’t science- and evidence-based, the CPSO doesn’t support using it, but in a less sarcastic moment I realized that such a policy is probably not that bad an idea, as long as it doesn’t legitimize pseudoscience, which is, of course, the biggest pitfall to be avoided when writing such a policy. Not too long ago, the CPSO released its draft policy and has asked for public comments, with the deadline being September 1. I was happy to learn that I had not missed the deadline, because there is much to comment about regarding this policy, but it’s definitely true that time’s short. Unfortunately, I wasn’t so happy when I read the title of the draft policy, namely Non-Allopathic (Non-Conventional) Therapies in Medical Practice, with a subtitle of “Formerly named Complementary Medicine.” The full policy in PDF form can be found at this link.
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…)
In 1994 Congress (pushed by Senators Harkin and Hatch) passed DSHEA (the Dietary Supplement Health and Education Act). As regular readers of SBM know, we are not generally happy about this law, which essentially deregulated the supplement industry. Under DSHEA supplements, a category which specifically was defined to include herbals, are regulated more like food than like medicinals.
Since then the flood-gates opened, and there has been open competition in the marketplace for supplement products. This has not resulted, I would argue, in better products – only in slicker and more deceptive claims. What research we have into popular herbals and supplements shows that they are generally worthless (except for targeted vitamin supplementation, which was already part of science-based medicine, and remains so).
A company can essentially put a random combination of plants and vitamins into a pill or liquid and then make whatever health claims they wish for their product, as long as they stay within the “structure-function” guidelines. This means they cannot claim to cure or treat a specific disease, but this has proven to be an insignificant limitation on marketing supplements.
What do Tylenol, Excedrin Extra Strength, Nyquil Cold & Flu, Vicodin, and Anacin Aspirin Free have in common? They all contain the drug acetaminophen. Taking multiple acetaminophen-containing drugs can be risky: while acetaminophen is safe when used at appropriate doses, at excessive doses, it is highly toxic to the liver. Take enough, and you’ll almost certainly end up hospitalized with liver failure. Acetaminophen poisonings, whether intentional or not, are a considerable public health issue. In the USA, poisonings from this drug alone result in 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths per year. [PDF] This makes acetaminophen responsible for more overdoses, and overdose deaths [PDF], than any other pharmaceutical product.
Last week, Johnson & Johnson announced that it’s lowering the maximum recommended daily dose for its flagship analgesic, Extra Strength Tylenol, from 8 tablets per day (4000mg) to 6 tablets per day (3000mg). Why? According to the manufacturer,
The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.
An open letter to NIH Director Francis Collins regarding his appearance at the Society for Integrative Oncology
Note from the editor: Since today is a holiday in the U.S., I had planned on taking the day off. Then I saw the subject of today’s post and had to respond. Also, please remember that, as always, the usual disclaimers apply. This letter represents my opinion, and my opinion alone. It does not represent the view or opinion of my university or cancer center—or anyone else, for that matter, other than me.
Francis S. Collins, MD, PhD
Director, National Institutes of Health
Dear Dr. Collins:
I am normally not one for writing open letters, but in this case I feel compelled to make an exception. This letter will have little or nothing to do with what seems to be the usual criticism leveled against you, namely your intense religious faith and claims. Personally, as a physician and scientist I don’t much care about what religion you follow and, unlike some writers such as Sam Harris, most definitely do not consider your strong Christian faith a disqualification for holding the position that you now hold. All I care about in an NIH director is how well he or she shepherds the scientific mission of the NIH and runs the organization. As a past (and hopefully future) NIH grantee, I want the NIH to fund and support only the most rigorous science and to be a well-run organization. Thus far in your tenure, I haven’t seen any anything major to worry about on that score.
Recently, however, I was very disappointed to discover that you will be the keynote speaker at the 8th International Conference of the Society of Integrative Oncology (SIO) in November. I hope that, when you agreed to accept this speaking engagement, you didn’t know just what it is that what you were accepting or what the Society for Integrative Oncology is, other than a professional society that was interested in hearing your views on faith and spirituality in cancer. In brief, it is our position that “integrative oncology” is a discipline that, at its core, is dedicated to “integrating” pseudoscience with science. No doubt you will think I am exaggerating, but I am not, as I hope to demonstrate. Worse, by agreeing to speak to the SIO, you will be providing it with the imprimatur of your position as NIH director. The NIH, as you know, is the most respected biomedical research institution in the U.S., if not the world, and that respect rubs off wherever you speak.
Dr. Gorski is in the throes of grant-writing, so I’m filling in for him today by following up on a topic introduced a few months ago. It involves a key medical player in the U.S. government: Dr. Josephine Briggs, Director of the National Center for Complementary and Alternative Medicine (NCCAM).
Steve Novella and I first encountered Dr. Briggs at the 2nd Yale Research Symposium on Complementary and Integrative Medicine in March, 2010. I reported here that she seemed well-meaning and pro-science but that she also seemed naive to the political realities of her office and to much of the content of “CAM” (as illustrated by her recommending the NCCAM website, which is full of misinformation; previously I’d noticed her unfortunate innocence of “acupuncture anesthesia,” which is to be expected of most academics but not of the CAM Explicator-in-Chief).
Editor’s note: This weekend was truly NIH grant crunch time. I have to get my final version of my R01 to our university’s grants office by Tuesday, or it might not get uploaded by the July 5 deadline. (Funny how electronic submission, which was supposed to make applicants’ lives easier, seems to have made them harder.) Consequently, I decided to take a few minutes and spiff up a post I did not long ago for my other blog and use it here, mainly because it is particularly relevant to our usual SBM topics. I’ll be back next time with something new.
The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.
Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:
It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, foreign and domestic. His name is Senator Orrin Hatch (R-UT), and he was just the subject of a writeup in the New York Times last week referring to him as a “natural ally” of the supplement industry:
At home the kids current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye.
Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded.
My eye may have been caught because of my new progressive lenses, but I will admit to an interest in inflammatory bowel disease, having had ulcerative colitis for years until I took the steel cure. It also piqued my interest as these were three conditions among which I could not seen any connections. Accutane, ulcerative colitis, and Crohn’s. One of these is not like the other.