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Archive for Politics and Regulation

Acetaminophen: Still the pain reliever you should trust?

Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.

The investigation summarizes the key “Takeaways” as follows:

  • 150 Americans die per year from accidental acetaminophen overdoses
  • The safety margin (safe dose vs. toxic dose) with acetaminophen is small
  • Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
  • For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
  • The manufacturer has taken steps to protect consumers but has also opposed other safety measures

While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)

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

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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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Obamacare, the Oregon Experiment, and Medicaid

Tomorrow, as mandated by the Patient Protection and the Affordable Care Act (PPACA, often called just the Affordable Care Act, or ACA, or “Obamacare”), the government-maintained health insurance exchanges will open for business (that is, assuming the likely government shutdown doesn’t stop them temporarily). We here at SBM have written about the ACA quite a few times, but I would like to write about it in perhaps an entirely different context than you’re used to now that the biggest change mandated by the law is here. Just to see the contrast, I’ll mention that Jann Bellamy has written about the ACA in the context of how provisions have been inserted by promoters of “complementary and alternative medicine” (CAM) could potentially provide an “in” for requiring reimbursement of CAM practitioners for their services by insurance plans sold through the exchanges or even how CAM practitioners might promote themselves as primary care providers (PCPs) under Obamacare, as did Matt Roman. I myself warned about legislative meddling that might permit funding of religion-based health care in the exchanges, and Kimball Atwood sounded early warnings about insertion of the provisions that Jann warned about. Instead, view this discussion as a follow-up to a post I did almost a year ago that used a statement by Mitt Romney during the height of the Presidential campaign as a jumping off point to look at the relationship between health insurance status and mortality. While we at SBM try to remain more or less apolitical, in some cases (licensing of naturopaths, for example) it is not possible to disentangle science from politics, and we have to dive in. Also, politics is the art of the possible; so, policy-wise, what is best as determined by science might well not be what is possible politically.

The reason I wanted to revisit this topic is because of a political battle that went on for quite some time over the last several months to expand Medicaid in Michigan according to the dictates of the ACA. The reason that this battle is occurring in many states is because when the Supreme Court ruled last year that the individual mandate requiring that citizens have health insurance was Constitutional, one provision that it ruled unconstitutional was the mandatory expansion of Medicaid in states participating in the Medicaid program to cover all people under 65 up to 133% of the federal poverty level. States thus had to decide whether or not they would accept the Medicaid expansion. In our state, Governor Rick Snyder supported the expansion. Even though he is Republican, he is also a businessman and realized that it was a good deal, with the federal government covering 100% of the cost for the first three years and then phase down to 90% of the cost in 2020. The bill to expand Medicaid managed to pass the House of Representatives, but then it stalled in the Senate. Unfortunately—and this is what got me involved—my state Senator Patrick Colbeck led the opposition to the Medicaid expansion in the Senate, much to my chagrin and disappointment. His argument, which is being repeated elsewhere in the blogosphere, is that Medicaid is worthless and doesn’t improve health outcomes. Instead, he endorsed an alternative that (or so he claimed) places Medicaid-eligible patients into in essence low cost, high deductible concierge practices, with health savings accounts. This was a plan promoted by practices like BlueSky Health. Ultimately Mr. Colbeck lost, and Medicaid was expanded in Michigan in a plan that was characterized by John Z. Ayanian in this week’s New England Journal of Medicine as “a pragmatic pathway to link Republican and Democratic priorities for health care.”

However, the whole kerfuffle got me to thinking. In my post a year ago, I basically asked what the evidence was that access to health insurance improves health outcomes, but I didn’t really stratify the question into kinds of health insurance. Rather, I just looked at being uninsured versus having health insurance. After my little Facebook encounter with one of my elected representatives, I wondered what, exactly, was the state of evidence. So I decided to do this post. In the U.S., currently we have in essence three kinds of health insurance, broadly speaking: private insurance, Medicare, and Medicaid. Medicare, for those of our readers from other countries, is a plan that covers the medical care of people 65 and over and those receiving Social Security disability benefits. It is funded through payroll taxes and directly paid for by the federal government. Medicaid, in contrast, is a plan designed for low income people who fall below certain income levels. Also in contrast, it is jointly funded by the states and the federal government with each participating state administering the plan and having wide leeway to decide eligibility requirements within the limits of federal regulations that determine the minimal standards necessary for states to receive matching funds. Indeed, the loss of this leeway to determine the income level at which a person is eligible for Medicaid is one of the reasons the provision for Medicaid expansion was part of the Supreme Court challenge to the ACA. These days, most Medicaid plans hire private health maintenance organizations (HMOs) to provide insurance. Finally, what needs to be understood is that, compared to private insurance, Medicare reimbursement rates tend to be lower and Medicaid reimbursement rates are lower still, which is part of the reason why a lot of doctors don’t accept Medicaid. Increases in reimbursement under the ACA might well help this situation. (more…)

Posted in: Clinical Trials, Epidemiology, Politics and Regulation, Science and the Media

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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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California Acupuncturists Don’t Need to Know English!

English proficiency is not a necessary precursor to becoming a contributing citizen in California’s economy and should not be used by the Board to discriminate against talented and skilled individuals who seek to provide high-quality acupuncture services in California.

— State Senators Curren D. Price Jr. and Darrell Steinberg, letter to the California Acupuncture Board, March 22, 2013.

To appreciate the recklessness of this statement, and to illustrate the Senators’ disconnect with the reality of Oriental medicine, let’s take a look at a consummate example of services provided by acupuncturists. The following video features the “Master” Kim Nam-soo demonstrating his moxibustion technique. He conducted a similar workshop for future acupuncturists in 2010 at Emperor’s College of Traditional Oriental Medicine in Santa Monica, CA. Make sure you do not miss the part where the Master is skillfully adding his own spit to the treatment!

Kim Nam-Soo (also known as “Gudang”) is a 97-year-old acupuncturist from South Korea. In this video, he is teaching a form of moxibustion (burning of a mugwort cone on or near the skin). He is first preparing a wad of mugwort (Artemisia vulgaris), he is then placing it on an acupuncture point and burning it with an incense stick. Note that he is using his own saliva to make the mugwort more malleable before sticking it to the patient’s skin!

Besides acupuncture and moxibustion, the other services these “talented and skilled” individuals provide consist of massage, cupping, breathing techniques, and the use of herbal, animal and mineral products. In most states, bloodletting is not part of their scope of practice — except for Arkansas.
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Posted in: Acupuncture, Politics and Regulation, Public Health, Science and Medicine, Traditional Chinese Medicine

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CAM practitioners as primary care providers under the Affordable Care Act: Part 1

Section 2607 (42 U.S.C. Sec. 300gg-5) of the Affordable Care Act (the “ACA” or “Obamacare”) prevents “discrimination” against any health care provider acting within the scope of his or her state license. The provision, supported by the American Chiropractic Association and other CAM practitioners, was inserted, without a hearing, under the leadership of Sen. Tom Harkin. Sec. 2607 is of concern to advocates of science-based medicine due to the broad scope of practice granted chiropractors, naturopaths, homeopaths, acupuncturists and direct-entry midwives under state law, as well as their over-confident view of themselves and their abilities. As we have previously discussed, for example, both naturopaths and chiropractors fancy themselves as primary care physicians able to differentially diagnose any patient with any disease or condition and, in many cases, treat or “co-manage” these patients.

As might be expected, a brouhaha is brewing over just what Section 2607 means. And there is one attempt to repeal it outright.

In all cases of statutory interpretation, the proper starting point is the statutory language itself.

SEC. 2706. NON-DISCRIMINATION IN HEALTH CARE.

(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 [of Health and Human Services] from establishing varying reimbursement rates based on quality or performance measures.

In short, while broadly prohibiting discrimination, there are two important limitations. This is not an “any willing provider law” requiring an insurance company to contract with any provider agreeing to the insurer’s contract. And insurers can pay different rates to different providers as long as these rates are “based on quality or performance measures.” (more…)

Posted in: Chiropractic, Legal, Politics and Regulation

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E-cigarettes: The growing popularity of an unregulated drug delivery device

This post is not about vaccines (for a change).

However, I deem it appropriate to mention that one of the topics that I blog most frequently about is vaccines and how the antivaccine movement pushes pseudoscience and quackery based on its apparently implacable hatred of vaccines. (You’ll see why very shortly.) It seems almost as long as my interest in the topic since I first noticed that the antivaccine movement acquired its very own celebrity spokesperson in Jenny McCarthy, who at least since 2007 has been promoting outrageous quackery and pseudoscience associated with her antivaccine views. To her, vaccines are chock full of “toxins” and all sorts of evil humors that will turn your child autistic in a heartbeat and in general “steal” your “real” child away from you the way she thinks vaccines “stole” her son Evan away from her. Indeed, among other “achievements,” she’s written multiple books about autism in which vaccines feature prominently as a cause, led a march on Washington to “green our vaccines” and has been the president of the antivaccine group Generation Rescue for the last few years. None of this stopped ABC from foolishly hiring her to join the regular cast on The View beginning in a few short weeks.

Because I occasionally check on what Jenny McCarthy is up to, I noticed a couple of weeks ago that she had been hired to be a celebrity spokesperson for blu™ e-cigarettes. Here she is, hawking the blu™ Starter Pack:

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Posted in: Cancer, Medical devices, Politics and Regulation, Public Health

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When doctors betray their patients and science-based medicine for money

We spend a lot of time on this blog discussing failures of the medical system. Usually, we such discussions occur in the context of how unscientific practices and even outright quackery have managed to infiltrate what should be science-based medicine (SBM) in the form of so-called “complementary and alternative medicine” (CAM) or “integrative medicine,” in which the quackery of alternative medicine is “integrated” with SBM. Our attitude towards this practice is, of course, completely in tune with that of fellow SBM blogger Mark Crislip when he so famously wrote, “If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.” However, as grave a threat to SBM as CAM and integrative medicine are, there is a threat at least as grave here in the U.S. (and, I presume, in many places in the world). It has little or nothing to do directly with CAM, but often CAM practitioners benefit from it. What I am referring to is the utter ineffectiveness of most state medical boards in reining in quackery and bad physician behavior that endangers patients. A recent story about a prominent Detroit area oncologist named Farid Fata, MD, who has been arrested and charged with administering unnecessary chemotherapy and of diagnosing patients with cancer who turned out not to have cancer in order to defraud Medicare, has led me to think that now might be a good time to revisit this issue. Then I heard about an Ohio spine surgeon indicted for performing unnecessary surgeries to defraud insurance companies, and I knew that now is a good time to revisit the issue.

I’ve discussed this issue before with respect to various practitioners over the years. One that comes to mind immediately is Dr. Rolando Arafiles at the Winkler County Memorial Hospital in Kermit, TX. Basically, a CAM-friendly physician was practicing substandard medicine, and two nurses reported him anonymously to the Texas Medical Board. Dr. Arafiles was a business partner with Winkler County Sheriff Robert Roberts, who left no stone unturned to discover who had complained about his good buddy, leading to the prosecution of the two whistleblowing nurses for violation of patient privacy, even though Texas law explicitly said that using patient information to report substandard care is not a violation of patient privacy. The entire medical establishment seemed to be trying to come down on the two brave nurses like the proverbial ton of bricks. Ultimately, the Texas Medical Board did the right thing, but it took a long time, and two responsible nurses who couldn’t bear seeing Dr. Arafiles continue to betray patient trust. There are many other examples, such as that of Dr. Rashid Buttar, a North Carolina doctor known for using “alternative” treatments for autism and cancer who got off with a slap on the wrist for some truly horrendous violations of the standard of care.

And don’t even get me started on the utter failure of the Texas Medical Board to put a stop to Dr. Stanislaw Burzynski’s unethical abuse of clinical trials and use of an unproven cancer drug for over 36 years or on how it took decades to finally put a stop to Dr. Mark Geier’s autism quackery in the United States. So what about these recent cases have in common? It’s that they were both busted by the feds. The relevant state medical boards in Michigan and Ohio (both states in which I hold a medical license) did not detect the medical misadventures and did, as far as I can tell, basically nothing to stop it.
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Posted in: Health Fraud, Politics and Regulation

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Integrative Medicine Invades the U.S. Military: Part Three

Nobody seems to know exactly how to define “integrative medicine” (“IM”) or to demonstrate what it does that is superior to the “conventional” kind. There is a lot of talk about addressing the “whole person” and not just the disease, patient-centeredness and the like, all of which are already aspects of conventional medicine. But, however defined, the central idea seems to be that if you incorporate complementary and alternative (CAM) into conventional medicine the practice of medicine will improve tremendously.

Despite not having any clear idea of what IM is, or does, the military, prestigious medical institutions, hospitals, and individuals practitioners are eager to imprint the integrative medicine brand firmly on their public images. Hence the Consortium of Academic Medical Centers for Integrative Medicine, a newly minted medical specialty in integrative medicine, societies devoted to integrative medicine practitioners, CME courses, conferences, and so on.

But – whoops! – proponents, in their overblown hype for IM, apparently didn’t give enough thought to the fact that there isn’t much of an evidence base for this loosely-defined but supposedly superior system. And – whoops again! – you can’t really research something unless you know what it is you are researching. These little oversights have brought about efforts to decide which of the competing definitions of integrative medicine should prevail and, whatever it is, whether there is any evidence of benefit for the patient. (more…)

Posted in: Acupuncture, Clinical Trials, Homeopathy, Legal, Politics and Regulation

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