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The illusions of “right to try” laws

[Ed. Note: For additional commentary on why "right-to-try" laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.]

There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside the FDA’s clinical trial process have touching anecdotes in spades. If I, or a loved one, had a terminal cancer, I’d probably be right there with them, telling my story and hoping to get my hands on an investigational drug, no matter how slim the chance for improvement it offered. But a less emotion-driven analysis of so-called “Right to Try” bills currently before several state legislatures reveals some sobering truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

“Right to Try” bills are pending before four state legislatures: Colorado, Louisiana, Arizona and Missouri. We’ll get to the details of these in a bit. Legislators in other states have expressed an interest in filing similar bills. On February 26th, a Missouri legislative committee “heard emotional debate from supporters of a bill that would allow makers of investigational drugs, biological products or devices to make them available to eligible terminal patients.” Among those testifying were the parents of a young girl with a brain tumor and the father, a physician, of a patient with metastatic colon cancer. These stories are hard to hear and make it hard to say no.

The Right to Try bill has been christened with another catchy name (Warning! Link to credulous media report!) – the Dallas Buyer’s Club bill after the terrific movie which just won Matthew McConaughey and Jared Leto Academy Awards for best actor and best supporting actor, and deservedly so. It depicts a macho, homophobic, HIV-infected cowboy (McConaughey) who saves the day battling the evil, bureaucratic FDA and the medical establishment. He skirts the law to bring life-saving drugs to AIDS patients at a time when AIDS was pretty much a death sentence. The plot even includes a delicensed American doctor who supplies the unapproved drugs from his Mexican clinic. And dietary supplements, of course. (You’d be tempted to suspect Stanislaw Burzynski, Hulda Clark and a naturopath co-authored the script.) But no matter its merits as a movie, it is just that, a movie. It is based on a true story but its interpretation of events has been called into question. (Orac also deconstructs the factual inaccuracies on Respectful Insolence today.) Nevertheless, it is a public relations boon to the Right to Try promoters, although, considering their decidedly right-leaning political inclinations, there has to be a certain amount of squeamishness in associating their cause with a movie featuring raunchy, sexually-explicit scenes, lots and lots of cussing, and a colorfully dressed trans-gender person (Leto) as its most sympathetic character. (more…)

Posted in: Cancer, Clinical Trials, Legal, Politics and Regulation

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A cure for chiropractic

Almost 10 years ago, a thoughtful article, entitled “Chiropractic as spine care: a model for the profession”, appeared in the journal Chiropractic & Osteopathy. The authors were a group of both academic and practicing chiropractors, as well as representatives from a health insurer specializing in coverage of CAM provider services. Another article, under different authorship, appeared the same year deploring some aspects of chiropractic education. In 2008, a third article came out with a similar theme, “How can chiropractic become a respected mainstream profession? The example of podiatry.” All three are open access and worth reading. The authors are to be commended for taking on an extremely contentious subject in their own profession.

The first article is a refreshingly honest look at the current state of chiropractic. The authors note the inability of chiropractors to consistently define who they are and what they do, which results in public confusion (including among those in the healthcare industry) about just what role chiropractors should play in the healthcare system. The authors deplore the continued existence of the “subluxation” in chiropractic and it’s accommodation by no less than the Association of Chiropractic Colleges. And they thoroughly deconstruct any notion that such a thing exists. The idea that chiropractors are capable of acting as primary care physicians is given equally short shrift and debunked as well.

The article points out that, whatever the confusion among chiropractors about who they are and what they do, the public has decided on its own: the public perception of chiropractors is that of back pain specialists. Back-related problems account for over 90% of the reason patients see chiropractors. They also argue that chiropractic must embrace evidence-based healthcare and stop relying on their clinical experience, noting the many reasons (e.g., regression to the mean) that a chiropractor’s observations may be explained by something other than treatment effectiveness. They admit that the chiropractor’s stock-in-trade, spinal manipulation, might not hold up under an evidence-based standard. (A possibility that is becoming a reality.) They even quote Marcia Angel’s observation on “alternative” medicine:

There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Twenty days in primary care practice, or “naturopathic residency”

The metastasis of alternative medicine throughout the health care system comes, in no small part, at the hands of the federal and state governments, mostly the latter and most particularly the state legislatures. Under their jurisdiction rests the decision of who can, and cannot, become a licensed health care practitioner, and what they can, and cannot, do. This is the gateway through which much of pseudo-medicine flows.

I’ve read many CAM practitioner licensing statutes (all of the chiropractic practice acts, in fact) and many legislative proposals to license or to expand the scope of practice. Typical of the boilerplate recited in support of this legislation is the education and training of these practitioners, which is touted as a means of protecting the public from charlatans and quacks out there selling snake oil to the credulous. Naturopathic licensing bills routinely require graduation from a naturopathic “medical” school accredited by the Council on Naturopathic Medical Education. (See, for example, Michigan House Bill 4152, which both David Gorski and I have discussed on SBM.) Unfortunately, what CAM provider legislation often does is simply provide legal cover for selling that very same snake oil.

Naturopaths are licensed in 17 states so far, although what they can and can’t do varies considerably. In some states, they have a scope of practice similar to that of an M.D. or D.O. primary care physician. At the most liberal end of this spectrum, N.D.s can prescribe drugs (as Michigan’s bill would allow), although this, too, varies depending on what’s listed on the state’s naturopathic formulary.

All of this has led me to conclude that the state legislatures do not have internet connections. Because, if they did, it would be pretty easy to Google around and figure out just what this naturopathic “medical” education entails and how practicing naturopaths apply their education and training in actual practice. In fact, I’ve done this myself and reported the results here on SBM. In the last day or so, I found out even more by looking around the websites of the Council on Naturopathic Medical Education, the American Association of Accredited Naturopathic Medical Schools, and its member institutions. We’ll get to the fruits of that research in a minute. (more…)

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

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2013 Legislative Review: placenta take out

It’s official in Oregon now. You can take your placenta, along with your new baby, home from the hospital. This was already a practice among the CAM set but apparently new mothers were running afoul of laws designed to protect us from bio-hazards. New legislation exempts “the removal from a health care facility . . . of a placenta by a postpartum mother.”

Now, why would anyone want a placenta? Well, SBM is nothing if not your complete source of all things CAM and Harriet Hall has already covered the subject. The short answer is that in Traditional Chinese Medicine placenta-eating is thought to confer all sorts of health benefits on the new mother. I learned of this new law from USA Today, which explains that “some experts say” it has positive health benefits. Well, thank goodness for that. Wouldn’t want a new law passed without “experts” weighing in.

But if handling a placenta makes you squeamish, not to worry. The Placenta Power Wellness Service in Portland (among others) will steam, dehydrate and encapsulate it into a handy pill form for about $150-$250. (Each placenta will make 80-120 capsules, according to the website). If you wish, you can get raw placenta encapsulation instead. Placenta tincture, placenta salve and a print of your placenta (sort of like those newborn footprints) are available for extra. That would be a real conversation starter, sitting there on the mantel.

According to Placenta Power Wellness Service, anecdotal evidence shows women experience an increase in energy, mood enhancement, milk supply and feelings of elation. Plus, it’s been used in Traditional Chinese Medicine “for centuries.”

And folks, that is all you need to get a statute passed adding practices or products to the legally-available health care armamentarium: anecdotes, sometimes relayed by “experts.” Traditional use is icing on the cake. (Or maybe the placenta.) It’s the reason for the DSHEA, the chiropractic, acupuncture and naturopathic practice acts, “health freedom” laws, and getting the Homeopathic Pharmacopoeia dumped in toto into federal law, with updates courtesy of the homeopathic industry. “I’ve seen it work!” “It worked for me!” Depending on the method, the evidence for the astounding variety of practices and products legally permitted by these laws generally ranges between none and some, with, I’d wager, most hovering in the “it can’t work” to the “we don’t know if it works” range. Not to mention the evidence of safety, or lack thereof. (more…)

Posted in: Acupuncture, Chiropractic, Homeopathy, Legal, Naturopathy, Obstetrics & gynecology, Politics and Regulation

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The Exciting Conclusion

On the slim chance that you’ve been perched on the edge of your seat wondering how the New Mexico appellate court ruled on chiropractic prescription privileges, whether the Council on Chiropractic Education got approved for another three years as an accrediting agency, if NCCAM ever came clean about spinal manipulation, and the fate of Brandon Babcock, DC, at the hands of the judicial system, here are your updates.

Prescription privileges for New Mexico chiropractors

A surprisingly titillating tidbit about New Mexico “advanced practice” chiropractors.

As discussed in previous posts, New Mexico “advanced practice” chiropractors succeeded in getting limited prescription rights. The statute specifically says they can:

prescribe, administer and dispense herbal medicines, homeopathic medicines, over-the-counter drugs, vitamins, minerals, enzymes, glandular products, protomorphogens, live cell products, gerovital, amino acids, dietary supplements, foods for special dietary use, bioidentical hormones, sterile water, sterile saline, sarapin or its generic, caffeine, procaine, oxygen, epinephrine and vapocoolants.

However,

Dangerous drugs or controlled substances, drugs for administration by injection and substances not listed [above] shall be submitted to the board of pharmacy and the New Mexico medical board for approval.

Apparently, the Chiropractic board couldn’t read the plain language of the statute and blew off this requirement, even though their own lawyer told them they couldn’t. This got them hauled into court by the medical and pharmacy boards. The International Chiropractors Association joined the fight. (more…)

Posted in: Chiropractic, Health Fraud, Legal, Politics and Regulation

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The Council on Chiropractic Education Straightens Up?

Three years ago, we reported that the Council on Chiropractic Education (CCE) was deeply embroiled in a heated dispute among various chiropractic factions over its new accreditation standards for chiropractic colleges. In a June, 2012 update of that post, we found the CCE still deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. Current events, however, require that we now report that the CCE remains deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. And it has come to this:

CCE does not represent me

Ostensibly, the debate is about whether chiropractic students should be taught to detect and correct the putative subluxation and CCE’s commitment to chiropractic’s remaining a drug and surgery-free practice. As we have discussed several times here at SBM, a faction of chiropractors fancy themselves as primary care physicians who are competent to diagnose and treat patients with a wide variety of diseases and conditions, such as diabetes and cardiovascular disease, with various methods, such as “Functional Endocrinology.” This is, in fact, the position of the largest and most mainstream of the chiropractic trade associations, the American Chiropractic Association (ACA). (The ACA is actively promoting reimbursement of chiropractors for required primary care benefits under the Affordable Care Act.)

At the other end of the spectrum, the chiropractic purists (or “straights”) believe chiropractors should limit themselves to the detection and correction of the (non-existent) chiropractic subluxation. And they are adamant about chiropractic remaining “without drugs or surgery.”

Protestations to the contrary notwithstanding, chiropractic belief in the subluxation is widespread among chiropractors in North America and in Australia. And as far as I can tell, chiropractors who eschew belief in the subluxation have merely renamed it and redefined it in terms so vague as to be meaningless. Those who want to expand chiropractic to include a broader range of treatments do not exclude the subluxation as a relevant clinical entity. They’ve simply tarted it up in an attempt to obscure its lack of scientific viability. (more…)

Posted in: Chiropractic, Legal, Politics and Regulation

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Journal of the American Dental Association Falls for Tooth Fairy Science

The Tooth Fairy

The Tooth Fairy

Another venerable scientific journal has fallen prey to “alternative” medicine research. The Journal of the American Dental Association (JADA) has joined the New England Journal of Medicine and Annals of Internal Medicine, among others, with its publication of “A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder,” in the October, 2013, issue.

And what “chiropractic intervention” is this? The Activator Method Chiropractic Technique (AMCT) as taught by Activators Methods International (AMI), which also conveniently sells its own line of Activator Instruments. (Practice-building seminar DVDs sold separately.)

What is this Activator Method? In short, it is a method of detecting and correcting subluxations (the chiropractic version, not the medical one). Thus, the underlying premise of this study was that subluxations could cause myofascial temporomandibular disorder (TMD) pain and that finding and vanquishing these subluxations could bring about pain relief.

Now, as regular readers of this blog know, vertebral subluxations are a figment of the chiropractic imagination. They do not exist, as we have pointed out many, many, many times. And here is where alternative medicine has it all over conventional medicine and dentistry. In alternative medicine, once you invent a non-existent condition you can proceed to invent all sorts of diagnostic techniques and remedies to treat patients with this condition. The AMCT is a perfect example of this. Conventional medicine and dentistry, on the other hand, are saddled with the scientific method, biological plausibility, having to discard therapies when studies no longer support their use, and all sorts of other persnickety limitations.
(more…)

Posted in: Chiropractic, Clinical Trials, Dentistry, Legal, Politics and Regulation

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Licensing Naturopaths: the triumph of politics over science

Naturopaths shouldn’t get too excited about having a special week in their honor. The U.S. House of Representatives gave watermelons a whole month. As between naturopathy and watermelons for my good health, I’ll go with the watermelons any day. You’ll soon understand why.

Today is not my usual blogging day. But when David Gorksi announced SBM’s celebration of Naturopathic Medicine Week, I volunteered an extra post to answer the question I am sure is on everyone’s mind: How in the heck do they get away with this stuff?

The answer lies in the creation of Naturopathic Medicine Week itself: politics. Just as Sen. Barbara Mikulski turned her credulous acceptance of naturopathy into a Senate Resolution and slipped it by her Senate colleagues, clueless legislators around the country are sponsoring bills to license naturopaths, in some cases as primary care physicians. And it’s not as if these legislators don’t know they are incorporating quackery into primary care. Practices such as naturopathic “organ repositioning” (an anatomical impossibility) and Mark Crislip noted, what little data there is suggests that naturopathic primary care is associated with worse outcomes. But evidence is not necessary in the political realm. And now the political process has given naturopaths an additional incentive for licensure. They argue that the Affordable Care Act mandates reimbursement for their services. (more…)

Posted in: Cancer, Energy Medicine, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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Dietary supplement industry says “no” to more information for consumers (again)

Once again, the dietary supplement industry is fighting efforts to give consumers more information about the safety and effectiveness of dietary supplements.

Big Supp is very clever. It sells consumers on the phony idea that they need dietary supplements for good health. Even as the evidence continues to mount that consumers don’t need supplements and shouldn’t take them, the industry continues to convince the public otherwise. And in 2011 they raked in $30 billion.

The state and federal governments have served as handmaidens to the industry in this clever marketing strategy. Congress’s gift to the supplement industry, the Orwellian-named Dietary Supplement Health and Education Act (DSHEA) “effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective,” as SBM’s Scott Gavura pointed out. DSHEA allows supplements to make “structure and function” claims, although no one seems to know what that means, including the FDA.

States have done their part in granting chiropractors and naturopaths the authority to give “nutritional” advice and recommend dietary supplements, sometimes on the basis of dubious diagnostic testing purporting to reveal imagined nutritional deficiencies. This gives them carte blanche to sell supplements to their patients, a clear conflict of interest.

And when proposed regulation threatens their profits, the dietary supplement industry and its surrogates enlist the very public it duped to join the battle. The industry convinces the public that someone is trying to take away their access to supplements they never needed in the first place. This threat is dressed up in terms designed to push all the buttons of a public already primed to be leery of “the government” – their “health freedom” may be taken away. Actually, freedom to choose among health care practices is most threatened by withholding readily-available information which would adequately inform health care decisions. (more…)

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

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CAM practitioners as primary care providers under the Affordable Care Act: Part 2

In the last post, we took another look at Section 2607 of the Affordable Care Act, which prohibits “discrimination” against licensed CAM practitioners by insurers, and how chiropractors are continuing their PR campaign to rebrand themselves as primary care physicians. This time, we review a recent white paper by the Academic Consortium of Complementary and Alternative Healthcare, an organization that might be seen as CAM’s answer to the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM). The Academic Consortium for Complementary and Alternative Health Care (ACCAHC) is a group of “complementary and alternative medicine” educational organizations representing chiropractors, naturopaths, acupuncturists, homeopaths, ayurvedic practitioners, direct entry midwives and massage therapists. The executive director is John Weeks, a relentless promoter of “integrative medicine,” both on the Integrator Blog website and in the Huffington Post. The ACCAHC is dedicated to ensuring that its members and the practitioners they represent are included in all aspects of health care, such insurance reimbursement, financial resources for education and delivery models. ACCAHC’s stock-in-trade is its practitioners’ supposed expertise is being patient-centered, holistic, taking into account the whole person and such, as well as an alleged emphasis on healthy lifestyles, nutrition, well-being, and the like.

In fact, the stated vision of the ACCAHC is remarkably similar to that of the CAHCIM:

ACCAHC envisions a healthcare system that is multidisciplinary and enhances competence, mutual respect and collaboration across all healthcare disciplines. This system will deliver effective care that is patient centered, focused on health creation and healing, and readily accessible to all populations.

The CAHCIC’s vision is:

A comprehensive and compassionate health care system offering seamless integration of effective complementary and conventional approaches to promote healing and health in every individual and community.

Indeed, there is an overlap in governance of the two organizations. Benjamin Kligner, MD, Adam Perlman, MD, Mary Jo Kreitzer, PhD, RN, and Aviad Haramati, PhD, are all on the ACCAHC’s Board of Advisers, as well as being either current or former members of the CAHCIM’s Executive Committee. The Board of Advisers also includes other integrative medicine luminaries such as Brian Berman, MD, Wayne Jonas, MD, and David Katz, MD. The two organizations have worked together in several endeavors. One wonders why the they don’t just go ahead and merge. (Actually, one knows perfectly well why they don’t.)
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Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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