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Archive for Politics and Regulation

Mortality and lack of health insurance

The 2012 election campaign is in full swing, and, for better or worse, health care is one of the major defining issues of the election. How can it not be, given the passage of the Patient Protection and Affordable Care Act (PPACA), also colloquially known as “Obamacare,” was one of the Obama administration’s major accomplishments and arguably the largest remaking of the American health care system since Medicare in 1965? It’s also been singularly unpopular thus far, contributing to the Republican takeover of the House of Representatives in the 2010 elections, as well as the erosion of Democratic control of the Senate. Given that this is a medical blog dedicated to discussing the scientific basis of medicine and not a political or health policy blog, I am not going to go into the reasons for a lot of this. What I am going discuss is a recent eruption of the central problem that led President Obama to make the PPACA one of the central policy initiatives, if not the central policy initiative, of his first term. That problem is the issue of people without health insurance, who number roughly 50 million, with a further estimate that 86.7 million people were uninsured at some point during the two year period from 2007 to 2008, representing about 29% of the total U.S. population under 65.

The question that bubbled to the surface last week in the form of a statement by Republican challenger Mitt Romney, and a tear-inducing op-ed piece published yesterday in the New York Times by Nicholas Kristof entitled A Possibly Fatal Mistake, is what the health impact of not having insurance is for those millions of people. This is a question that can be addressed scientifically and is, despite its politically charged nature, correctly within the purview of science-based medicine. What to do about it, in contrast, is a matter for politics and public policy. So first let’s examine the question.
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Posted in: Politics and Regulation, Public Health

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Obamacare and CAM II: Discrimination (or not) against CAM

Supporters of science-based medicine have expressed concern over this provision in the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA.”):

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 from establishing varying reimbursement rates based on quality or performance measures.

Section 2706 (now codified as 42 U.S.C. Sec. 300gg-5) goes into effect in 2014 and covers virtually all individual and group insurance market policies, although it is not clear whether it will apply to existing policies “grandfathered” in 2010 by the ACA.

Section 2706 was not part of the U.S House of Representatives version of the ACA but was included in the Senate version (which ultimately passed) under the guidance of (surprise!) Sen. Tom Harkin (D-Iowa). It was heavily lobbied by the American Chiropractic Association and other “CAM” providers, as well as some “conventional” providers like nurse anesthetists and optometrists. The legislative history (reports, committee minutes, floor debates and the like which precede a vote on a bill) indicates it was specifically included to prevent discrimination against CAM providers.  This is of obvious concern to anyone who supports science-based, or for that matter evidence-based, medicine, as there is nothing to indicate that scientific plausibility or evidence (or the lack thereof) actually affects CAM practices. It should also concern insurers and those who pay for insurance (employers and individuals) to the extent it might require payment for CAM treatments, as ineffective treatments will negatively affect their bottom line. The U.S. Departments of Health and Human Services (HHS) and Labor and the Treasury Department, which are charged with issuing regulations implementing the ACA, have not yet promulgated regulations for Section 2706. The American Medical Association House of Delegates has already passed a resolution seeking its repeal.

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

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Antivaccine versus anti-GMO: Different goals, same methods

Countering ideologically motivated bad science, pseudoscience, misinformation, and lies is one of the main purposes of this blog. Specifically, we try to combat such misinformation in medicine; elsewhere Steve and I, as well as some of our other “partners in crime” combat other forms of pseudoscience. During the nearly five year existence of this blog, we’ve covered a lot of topics in medicine that tend to be prone to pseudoscience and quackery. Oddly enough, there’s one topic that we haven’t really written much about at all, and that’s genetically modified organisms (GMOs). GMOs, as you know, are proliferating, and it’s quite worth discussing the potential and risks of this new technology, just as it is worthwhile to discuss the potential benefits versus the risks of any new technology that can impact our health, not to mention the health of the planet. Unfortunately, GMOs have become a huge political issue, and, I would argue, they have become just as prone to pseudoscience, misinformation, and bad science as vaccines, with a radical group of anti-GMO activists who are as anti-science as any antivaccinationist or quack.

Leave it to that quackery promoter to rule all quackery promoters, Mike Adams, to give me just the opportunity to show you what I mean. Over the last couple of weeks, Mike has been in a fine lather about GMOs, with multiple posts with titles such as The GMO debate is over; GM crops must be immediately outlawed; Monsanto halted from threatening humanity and The evil of Monsanto and GMOs explained: Bad technology, endless greed and the destruction of humanity. In other words, it’s a series of post with Adams’ typical hyperbole. If you were to believe him, GMOs are the product of a plot by Satan, Monsanto, big pharma, and the government, and he’s not sure which one of these is the most evil of the bunch.
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Posted in: Cancer, Politics and Regulation, Public Health

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News flash! Doctors aren’t all compliant pharma drones!

There’s an oft-quoted saying that’s become a bit of a cliché among skeptics that goes something like this: There are two kinds of medicine: medicine that’s been proven scientifically to work, and medicine that hasn’t. This is then often followed up with a rhetorical question and its answer: What do call “alternative medicine” that’s been proven to work? Medicine. Of course, being the kind of guy that I am, I have to make it a bit more complicated than that while driving home in essence the same message. In my hands, the way this argument goes is that the whole concept of “alternative” medicine is a false dichotomy. There is no such thing. In reality, there are three kinds of medicine: Medicine that has been shown to efficacious and safe (i.e., shown to work); medicine that has not yet been shown to work (i.e., that is unproven); and medicine that has been shown not to work (i.e., that is disproven). So-called “complementary and alternative medicine” (CAM or, its newer, shinier name, “integrative medicine”) consists almost completely of the latter two categories.

Part of the reason why this saying and its variants have become so commonplace among those of us who support science-based medicine is that they strike at a common truth about medicine, both science-based and “alternative.” That common truth is what we here at SBM have been arguing since the very inception of this blog, namely that there must be one science-based standard of evidence for all treatments, be they “alternative” or the latest creation of big pharma. That point informs everything I write here and everything my blogging parters in crime write about too. What that means is a single, clear set of standards for evaluating medical evidence, in which clinical evidence is coupled to basic science and scientific plausibility. Indeed, one of our main complaints against CAM and its supporters has been how they invoke a double standard, in which they expect their therapies to be accepted as “working” on the basis of a much lower standard of evidence. Indeed, when they see high quality clinical trials demonstrating that, for example, acupuncture doesn’t work, they will frequently advocate the use of “pragmatic” trials, lower quality trials of “real world effectiveness” that do not adequately control for placebo effects. It’s putting the cart before the horse.
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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The problem of nonmedical exemptions to school vaccine mandates

It’s that time of year again, namely flu vaccine time. My very own cancer institute will be offering the flu vaccine for its staff beginning October 1, and I plan on getting mine just as soon as I get back from the American College of Surgeons Clinical Congress in Chicago early next week. In the meantime, it’s always great to read Mark Crislip’s take on the yearly flu vaccine kerfuffle, particularly this part:

I have little (actually none) respect for HCW’s [health care workers] who do not get vaccinated. We have a professional and moral obligation to place our patients first. I think those who do not get vaccinated, except for a minority with a valid allergy, are dumb asses.

Preach it, Dr. Crislip!

However, this time of year is also a vaccine time of year for another reason (well, actually it was about a month ago). That’s because in late August or early September, depending on your state, the little kiddies (and not-so-little kiddies) return to school and therefore have to be up to date on their required vaccines or face not being able to go to school. No wonder the antivaccine movement goes nuts this time of the year, given the double whammy of antivaccine parents trying to avoid vaccinating their children before going to school by hook or by crook and the yearly promotion of flu vaccines and mandates that health care workers get them. (For the record, my cancer center requires it, and if there’s one thing the administration of my hospital has done that I fully support it’s the yearly vaccine requirement. We’re a cancer hospital, fer cryin’ out loud, and we have lots of immunosuppressed patients that we take care of!) The only other time of year when antivaccinationists are even close to this actively ridiculous is every April, which is Autism Awareness Month, when they start trying to tar attempts to highlight autism and autism research with demands that antivaccine pseudoscience be thrown into the mix like the proverbial cow pie added to the apple pie.

Since Mark’s already covered the flu vaccine so well, let’s talk about the topic of nonmedical exemptions to school vaccine mandates. This topic came up when I noticed that the bloggers and denizens of that most wretched hive of antivaccine scum and quackery, Age of Autism, have swarmed over to a news story about how Washington State has made it harder for parents to obtain nonmedical exemptions to school vaccine requirements:
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Posted in: Politics and Regulation, Vaccines

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Physicians and “CAM”

In the last 20 or so years, the popularity of so-called “complementary and alternative medicine” began to lure physicians (M.D.s and D.O.s) into employing CAM treatments, or what is now rebranded as “integrative medicine.” Of course, CAM use by a physician necessarily requires some deviation from the “conventional” standard of care. Because deviation from the standard of care can be grounds for discipline by the state medical board, state legislatures and medical boards in the United States have had to grapple with just how much medical practice acts and regulations should accommodate CAM use by physicians.

As it turns out, less than you might think.

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

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The DC as PCP? Revisited

There is a disturbing effort afoot to rebrand chiropractors as primary care physicians, a subject both Harriet Hall and I have discussed in previous posts. Part of this effort includes convincing state legislatures to grant prescription privileges to chiropractors, an effort that succeeded in New Mexico, as reported in a post a couple of years ago. Let’s return to New Mexico and see how that is working out for everyone.

By way of background, in 2008, the New Mexico legislature created a new iteration of chiropractor called “certified advanced practice chiropractic physicians” with the authority to

prescribe, administer and dispense herbal medicine, homeopathic medicines, vitamins, minerals, enzymes, glandular products, naturally derived substances, 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.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Acupuncture practice acts: legalized quackery

As Ben Kavoussi observed recently,

[o]nce considered archaic and obsolete, Oriental Medicine has greatly benefited from the postmodern attitudes towards science and knowledge. This is because postmodernists consider the ‘truth’ as being relative to one’s viewpoint or stance. They do not see science as a superior process of acquiring knowledge, but as a ‘belief system,’ a ‘language game,’ which does not give more access to truth than other conceptual constructs.

This “postmodern fallacy,” he continued,

has allowed the return of mass professional delusions under the label of Chinese, Oriental or Asian Medicine. As an unfortunate byproduct, dangerous and outdated therapies have been legitimized, and quacks and charlatans can overtly defraud those who cannot distinguish scientific medicine from lore and fantasy.

There is probably no better example of this “unfortunate byproduct” than the state acupuncture and oriental medicine practice acts. These laws have indeed legitimized dangerous and outdated therapies, allowing quacks and charlatans to defraud the public.

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Posted in: Acupuncture, Legal, Politics and Regulation, Traditional Chinese Medicine

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Stem cell therapy regulation plays catch up

The burgeoning U.S. stem cell therapy industry was delivered a setback last month in the form of a U.S. District Court injunction against use of the “Regenexx™ Procedure,” which purports to treat joint, muscle, tendon or bone pain due to injury or other conditions. The court agreed with the FDA that the cell product used in the procedure is both a drug and a “biological product” subject to FDA regulation. Because a similar process is used in other stem cell therapies the decision increases the possibility that the FDA will take a like position in other cases.

The general term “stem cell therapy” comprises an array of treatments which range from the clinically proven to quackery. On one end of the spectrum is blood stem cell transplantation to treat diseases and conditions of the blood and immune system. On the other lies the kind of stem cell therapy tourism addressed by both Steve Novella (here and here) and Orac (here and here), which involves the injection of what may, or may not be, stem cells from what may, or may not be, humans. In between fall therapies which are plausible and have promise but have not been adequately tested in clinical trials. There is a concern that these therapies are being oversold by clinics which charge thousands of dollars (not reimbursed by insurance) to treat conditions including multiple sclerosis, musculoskeletal pain, and cardiac disease.

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Posted in: Legal, Medical Ethics, Politics and Regulation, Science and Medicine

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The mammography wars heat up again (2012 edition)

One issue that keeps coming up time and time again for me is the issue of screening for cancer. Because I’m primarily a breast cancer surgeon in my clinical life, that means mammography, although many of the same issues come up time and time again in discussions of using prostate-specific antigen (PSA) screening for prostate cancer. Over time, my position regarding how to screen and when to screen has vacillated—er, um, evolved, yeah, that’s it—in response to new evidence, although the core, including my conclusion that women should definitely be screened beginning at age 50 and that it’s probably also a good idea to begin at age 40 but less frequently during that decade, has never changed. What does change is how strongly I feel about screening before 50.

My changes in emphasis and conclusions regarding screening mammography derive from my reading of the latest scientific and clinical evidence, but it’s more than just evidence that is in play here. Mammography, perhaps more than screening for any disease, is affected by more than just science. Policies regarding mammographic screening are also based on value judgments, politics, and awareness and advocacy campaigns going back decades. To some extent, this is true of many common diseases (i.e., that whether and how to screen for them are about more than just science), but in breast cancer arguably these issues are more intense. Add to that the seemingly eternal conflict between science and medicine communication, in which a simple message, repeated over and over, is required to get through, versus the messy science that tells us that the benefits of mammography are confounded by issues such as lead time and length bias that make it difficult indeed to tell if mammography—or any screening test for cancer, for that matter—saves lives and, if it does, how many. Part of the problem is that mammography tends to detect preferentially the very tumors that are less likely to be deadly, and it’s not surprising that periodically what I like to call the “mammography wars” heat up. This is not a new issue, but rather a controversy that flares up periodically. Usually this is a good thing.

And these wars just just heated up a little bit again late last week.
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Posted in: Cancer, Politics and Regulation, Public Health

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