The ill-advised, NIH-sponsored Trial to Assess Chelation Therapy (TACT) is finally over. 839 human subjects were randomized to receive Na2EDTA infusions; 869 were randomized to receive placebo infusions. The results were announced at this weekend’s American Heart Association meeting in Los Angeles. In summary, the TACT authors report a slight advantage for chelation over placebo in the “primary composite endpoint,” a combination of five separate outcomes: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina:
Although that result may seem intriguing, it becomes less so when the data are examined more carefully. First, it barely achieved the pre-ordained level of statistical significance, which was P=.036. Second, none of the individual components of the composite endpoint achieved statistical significance, and most of the absolute difference was in coronary revascularization–which is puzzling:
Plenty of new drugs, but few that are truly innovative. Growing costs from their use. Physicians deemed “Dupes of Big Pharma” for their interactions with the pharmaceutical industry. A call to produce better information on which drugs work best. Finally, shoddy drug manufacturing is injuring and even killing patients. These stories could be lifted from today’s headlines — but they’re actually from 1962. Problems with the behavior of the pharmaceutical manufacturing industry, and our relationship with it, are not new. Nor are they restricted to one country. Every developed country’s health-care system is different, but one feature is near-universal: none have a public pharmaceutical industry. Ever nation relies on for-profit, private companies to supply its population with drug products.
Blog posts here can get pretty wonkish about health policy, as many of the substantial challenges to science-based medicine have their roots in regulation — whether it’s DSHEA which implemented a regulatory double-standard for supplements, or the state-by-state legislative alchemy that Jann Bellamy has documented, which transforms magical thinking and pseudoscientific practices into registered and regulated health practitioners. Federal food and drug regulations have also come under some scrutiny (and praise). The FDA’s under fire again; this time over its responsibility to oversee pharmaceutical manufacturing. But in this case, it’s not Big Pharma that’s the villan — it’s pharmacies. (more…)
In a previous post, we looked at how so-called “complementary and alternative medicine” (or “CAM”) might fit into the definition of “essential health benefits,” which must be covered by insurers pursuant to the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA”). In another, we contemplated what it might mean for insurers to “discriminate” against CAM providers, which is prohibited by the ACA. In both posts, the conclusion reached was that these provisions of Obamacare might not incorporate CAM practices into health care at the level CAM providers were hoping for. Here again we examine how the great expectations of CAM promoters may not be met in health care reform.
This time, we take a look at some additional provisions of the ACA that CAM lobbyists and their friends in Congress managed to insert into the healthcare overhaul. Of course, whether the ACA is around for much longer will depend on the outcome of the November elections, although Gov. Romney’s promise to “repeal Obamacare” if elected president will happen only if his party wins a majority in both the House of Representatives and Senate. (more…)
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.
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.
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.
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.
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:
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.
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.