Archive for Politics and Regulation

The CAM Docket: Boiron I

Author’s note: This will inaugurate a series of occasional posts observing the wheels of justice grind slowly over “CAM.”

In a previous post, I posited that CAM practitioners might well subject themselves to liability for the tort of fraudulent misrepresentation. This misrepresentation could be based on both the lack of scientific evidence of effectiveness and the lack of scientific plausibility for their treatments. One example was homeopathy, which, as Dr. Steven Novella aptly stated,

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

In the last couple of years five lawsuits have been filed against Boiron, a somewhat prickly company based in France and the world’s largest manufacturer of homeopathic products. In 2011, Boiron had $520,000,000 in sales, although some of this revenue comes from its other products, such as dietary supplements. The plaintiffs are consumers who purchased Boiron’s homeopathic “remedies” and who now allege that they were deceived by Boiron’s false and misleading representations, allegations Boiron denies. Four of the lawsuits are pending in California and one in Illinois.

All of the suits are filed as putative class actions, which generally proceed like this: a plaintiff claims she was injured in a certain manner by the defendant’s conduct and that there are numerous others who were injured in the same, or a similar, way. She asks the court to allow her to proceed with a class action in which she will represent all those other people. In essence, the class members become plaintiffs themselves and are bound by the results of the case. (They can’t, for example, bring their own individual lawsuits.) If the plaintiff is successful, all class members are entitled to relief, including monetary damages. (more…)

Posted in: Homeopathy, Legal, Politics and Regulation

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Disparities in Regional Health Care Costs

In 2009, during the “Obamacare” debate that was dominating the news, Atul Gawande wrote an article in the New Yorker that was widely praised and cited, including by president Obama himself. The article is a thought-provoking discussion of why some communities in the US have much higher health care costs than other regions. I took two main conclusions from the article.

The first is the success of the Mayo model – organizing care as a team approach. The idea here is to pool optimal expertise in the care of each patient. Greater expertise leads to “more thinking and less testing,” as Gawande puts it. I agree with this. It takes expertise to be comfortable not doing a test. Often testing is ordered because a physician does not feel secure in their diagnostic assessment.

The second main conclusion was the McAllen model, a town in Texas that has double the average Medicare costs per capita in the country. Gawande concluded that these increased costs are likely due to the culture of medical practice in the region, leading to greater unnecessary care and procedures. He wrote:

The Medicare payment data provided the most detail. Between 2001 and 2005, critically ill Medicare patients received almost fifty per cent more specialist visits in McAllen than in El Paso, and were two-thirds more likely to see ten or more specialists in a six-month period. In 2005 and 2006, patients in McAllen received twenty per cent more abdominal ultrasounds, thirty per cent more bone-density studies, sixty per cent more stress tests with echocardiography, two hundred per cent more nerve-conduction studies to diagnose carpal-tunnel syndrome, and five hundred and fifty per cent more urine-flow studies to diagnose prostate troubles. They received one-fifth to two-thirds more gallbladder operations, knee replacements, breast biopsies, and bladder scopes. They also received two to three times as many pacemakers, implantable defibrillators, cardiac-bypass operations, carotid endarterectomies, and coronary-artery stents. And Medicare paid for five times as many home-nurse visits. The primary cause of McAllen’s extreme costs was, very simply, the across-the-board overuse of medicine.

Is that, however, a necessary conclusion from that data? The data support the conclusion that McAllen (the highest cost region) uses many more medical procedures than El Paso (the lowest cost region), but does that necessarily equate to “overuse” of medicine? Evidence does not support the conclusion that the population in McAllen is sicker than El Paso, but it is also possible that El Paso simply underdelivers care.


Posted in: Politics and Regulation, Public Health

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An antivaccine tale of two legal actions

I don’t know what it is about the beginning of a year. I don’t know if it’s confirmation bias or real, but it sure seems that something big happens early every year in the antivaccine world. Consider. As I pointed out back in February 2009, in rapid succession Brian Deer reported that Andrew Wakefield had not only had undisclosed conflicts of interest regarding the research that he did for his now infamous 1998 Lancet paper but that he had falsified data. Then, a couple of weeks later the Special Masters weighed in, rejecting the claims of autism causation by vaccines made in three test cases about as resoundingly as is imaginable. Then, in February 2010, in rapid succession Andrew Wakefield, the hero of the antivaccine movement, was struck off the British medical register, saw his 1998 Lancet paper retracted by the editors, and was unceremoniously booted from his medical directorship of Thoughtful House, the autism quack clinic he helped to found after he fled the U.K. for the more friendly confines of Texas. Soon after that, the Special Masters weighed in again, rejecting the claims of autism causation by vaccines in the remaining test cases. Then, in January 2011, Brian Deer struck again, publishing more damaging revelations about Wakefield, referring to his work as Piltdown medicine in the British journal BMJ.

This year, things were different.

Posted in: Politics and Regulation, Science and the Media, Vaccines

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FDA versus Big Supp: Rep. Burton to the Rescue (Again)

The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been aptly described here at SBM as a travesty of a mockery of a sham. The supplement industry’s slick marketing, herb adulteration due to lack of pre-market controls, Quack Miranda Warning, and the many supplements for which claims of effectiveness failed to hold up under scientific scrutiny (e.g., antioxidants, collagen, glucosamine and hoodia) have been impaled on the sharp pens of SBM posters as well.

And we’re not the only ones. Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine have resulted in numerous recommendations to improve dietary supplement safety by, in part, strengthening the FDA’s ability to effectively regulate the industry. Many of these have gone unheeded.

A recent federal law tried to ameliorate this situation by directing the FDA to take specific steps designed to increase supplement safety. Yet the ink of President’s Obama’s signature was barely dry when a bill was proposed in Congress to gut its provisions. In fact, there are now several bills pending in Congress which would actually weaken the government’s already puny regulatory authority over supplements. Yes, things could get even worse.


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

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Bravewell Bimbo Eruptions

This is yet another response to the recent “Integrative Medicine in America” report published by the Bravewell Collaborative. Drs. Novella and Gorski have already given that report its due, so I won’t repeat the background information. Inevitably, I’ll cover some of the same points, but I’ll also try to emphasize a few that stand out to me. Most of these have been discussed on SBM over the years, but bear repeating from time to time. Let’s begin with:

If it Ducks like a Quack…

Misleading language is the sine qua non of ‘integrative medicine’ (IM) and its various synonyms. The term itself is a euphemism, intended to distract the reader from first noticing the quackery that is its distinguishing characteristic. As previously explained, Bravewell darlings Andrew Weil and Ralph Snyderman, quack pitchmen extraordinaires, recognized nearly 10 years ago that if you really want to sell the product, you should dress it up in ways that appeal to a broad market.

Let’s see how this is done in the latest report. Here is the very first sentence:

The impetus for developing and implementing integrative medicine strategies is rooted in the desire to improve patient care.

Who would disagree with improving patient care? (Try not to notice the begged question). Here’s the next paragraph (emphasis added): (more…)

Posted in: History, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine, Science and the Media

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“Obama Promises $156 Million to Alzheimer’s…But where will the money come from?” That’s easy: the NCCAM!

The quoted language above is part of the headline of this story in today’s The Scientist:

Citing the rising tide of Americans with Alzheimer’s—projections suggest 10 million people will be afflicted by 2050—the Obama administration and top National Institutes of Health officials are taking action. On February 7, they announced that they will add an additional $80 million to the 2013 NIH budget for the Alzheimer’s research program.

The problem is that there ain’t no such thing as a free lunch:

However, Richard Hodes, director of the NIH’s National Institute on Aging, told Nature that the 2013 dollars still have to be approved by Congress in the next budget and, if not, existing programs may need to be cut. And this year’s $50 million is likely to bump other projects, perhaps at NIH’s National Human Genome Research Institute. “If there’s a finite budget anywhere, once there’s more of something, there is less of something else,” he said.

Often such budget compromises are difficult, because there is no ready way to choose between two or more competing recipients of taxpayers’ money, each of which might be comparably worthy. Thus it is with a great sense of relief that in this case, we in the biomedical community can assure President Obama that no such dilemma exists. This is one of those occasional decisions that requires no hair-pulling whatsoever. The obvious solution is to defund the National Center for Complementary and Alternative Medicine (NCCAM), which, at about $130 million/yr, would solve the problem of funding Alzheimer’s research and take the heat off other worthy programs such as those mentioned by Richard Hodes.


Posted in: History, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Night of the living naturopaths

Colorado’s “degreed” naturopaths (NDs) are nothing if not persistent. Starting in 1994 they have tried seven times to convince legislators that the Colorado’s public needs protection from what “traditional” naturopaths (traditionals) do, and that the best way of providing that protection, they claim, is to bestow licensure on the guys with the college degrees. The irony in this is that the NDs could well be the more dangerous practitioners.

Legislators have been largely sympathetic to the concerns of the more numerous traditionals who fear the loss of their right to work as naturopaths. The NDs have tried neutralize these opponents by reassuring them they could continue to practice naturopathy, but the traditionals don’t buy that. And they won’t easily forfeit the title of “naturopath” to which they believe to have more claim.

So what we have here in Colorado is near 20-year turf war between two types of naturopaths: the NDs who seek legislation to transform naturopathy into a protected guild, and the traditionals who are happy with the status quo. There is no love lost between these groups. Legislators repeatedly advise them to resolve their differences before asking for licensure again, but they haven’t gotten close to détente.

Colorado NDs have made no secret of their economic motivations. Before the 2011 legislative session, the Colorado Association of Naturopathic Doctors (CAND) was reinvigorated by the passage of the Patient Protection and Affordable Care Act which has this “non-discrimination” provision:

(a) Providers– A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures. [Sec. 2706]


Posted in: Naturopathy, Politics and Regulation, Public Health

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NIH Director Francis Collins doesn’t understand the problem with CAM

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:


Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Legislative Alchemy: The New Year

A new year brings new opportunities for practicing the magic of legislative alchemy, the process by which state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices, such as naturopathy, chiropractic and acupuncture. Different states have different legislative calendars, but many begin a new session soon after the first of the year. This gives “complementary and alternative medicine” providers a fresh opportunity to increase their scope of practice, insurance coverage and influence.

The state house doors have barely opened but CAM-friendly bills are already being docketed and sent on to health care and other committees for analysis. Unfortunately, legislators seem less than adept at critical thinking when it comes to perusing CAM legislation. To this point, I’ll start with an example from 2011: “Vertebral Subluxation Awareness Month” in Pennsylvania.


Posted in: Chiropractic, Legal, Naturopathy, Politics and Regulation

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