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Archive for Politics and Regulation

Disingenuous: Deconstruction of a naturopathic white paper

Science is the Concept by which
we measure our reality
I don’t believe in magic
I don’t believe in I-ching…
I just believe in science…and that reality.

John Lennon. Sort of.

As regular readers of the blog are aware, I am science/reality based.  I think the physical and basic sciences provide an excellent understanding of reality at the level of human experience.  Physics, chemistry, biology, anatomy, biochemistry, physiology, evolution etc. provide a reliable and reproducible framework within which to understand health and disease.  My pesky science may not know everything about reality, but day to day it works well.

“There are more things in heaven and earth, Horatio, Than are dreamt of in your philosophy. – Hamlet (1.5.166-7).”  

Perhaps, but all the medical advances in my lifetime have been not yielded new science, just (amazing) variations and extensions of known processes.  I sometimes think the blog should have been called reality based medicine, but science is the tool by which we understand reality, and while the tool is constant, our understanding of reality is prone to changing.  An understanding of the rules of the universe combined with an awareness of the innumerable ways whereby we can fool ourselves into believing that those rules do not apply to us is part of what makes a science and reality based doctor.

We are often told of the need to keep an open mind, but I like to keep it open to reality.  Not that I do not like fantasy and magic, it is a common category for my reading.  I just finished Red Country by Joe Abercrombie, and while I love the world he has created, I would not want to apply the rules of that imaginary world to my patients.   Well, one exception.  As Logen Ninefingers  would say, “You have to realistic about these things.” Fictional worlds should be limited to the practice of art, not the practice of medicine.
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Posted in: Humor, Naturopathy, Politics and Regulation, Public Health, Science and Medicine

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The CAM Docket: Boiron III, et al.

Oh, the irony of it all! Quackery continues its increasingly successful assault on the citadel of medicine, viz: quackademic medicine, integrative medicine, credulous medical journal articles, shruggies, medical society support for CAM provider licensing. Will that nemesis of medical doctors, plaintiffs personal injury attorneys, turn out to be the last defenders of science in a world of health care fraught with so-called alternative medicine?

Maybe not. But the thought did occur to me while reading the Final Judgment and Order entered in Gallucci v. Boiron, the class action accusing the world’s largest manufacturer of homeopathic products of consumer fraud.

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

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The NIH funding process: “Conformity” and “mediocrity”?

When we refer to “science-based medicine” (SBM), it is a very conscious choice to emphasize that good medicine should be based on a solid foundation of science. The name was coined to contrast the difference between the current evidence-based medicine (EBM) paradigm, which fetishizes randomized clinical trial evidence above all else and frequently ignores prior plausibility based on well-established basic science, and the SBM paradigm, which takes prior plausibility into account. The purpose of this post will not be to resurrect old discussions on these differences, but before I attend to the study at hand I bring this up to emphasize that progress in science-based medicine requires progress in science. That means all levels of biological (and even non-biological) basic science, which forms the foundation upon which translational science and clinical trials can be built. Without a robust pipeline of basic science progress upon which to base translational research and clinical trials, progress in SBM will slow and even grind to a halt.

That’s why, in the U.S., the National Institutes of Health (NIH) is so critical. The NIH funds large amounts of biomedical research each year, which means that what the NIH will and will not fund can’t help but have a profound effect shaping the pipeline of the basic and preclinical research that ultimately leads to new treatments and cures. Moreover, NIH funding has a profound effect on the careers of biomedical researchers and clinician-scientists, as having the “gold standard” NIH grant known as the R01 is viewed as a prerequisite for tenure and promotion in many universities and academic medical centers. Certainly this is the case for basic scientists; for clinician-scientists, having an R01 is certainly highly prestigious, but less of a career-killer if an investigator is unable to secure one. That’s why NIH funding levels and how hard (or easy) it is to secure an NIH grant, particularly an R01, are perennial obsessions among those of us in the biomedical research field. It can’t be otherwise, given the centrality of the NIH to research in the U.S.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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What does a new drug cost? Part II: The productivity problem

A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.

The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted.  Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Oregon Naturopaths v. Evidence-Based Medicine

Like every state, Oregon is struggling with the unsustainable costs of taxpayer-funded health care programs. In an attempt to tame this beast, Oregon recently established a system of coordinated care organizations, or CCOs, to (as the name suggests) coordinate medical, mental health, and dental care for residents enrolled in Oregon Health Plan, the state’s Medicaid program. The new system requires supervision of this coordinated effort by the participant’s primary care physician (PCP). Not one of the 15 newly-minted CCOs has credentialed a naturopath as a PCP even though naturopaths are licensed as such by the state. Needless to say, the naturopaths are not pleased by this development.

The big stumbling block appears to be the state’s requirement that CCOs practice evidence-based medicine as a cost control measure. Unfortunately for naturopaths, evidence-based medicine is not their strong suit. Apparently scientific plausibility is not much of a concern either.

As one chief medical officer of a CCO explained in a news report,

We have an obligation to the state and to the community that the providers on our panel will deliver the evidence-based care required by the Oregon Health Plan. . . . We need to make sure that all of the providers who are empanelled meet those basic standards of care.

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

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“Moneyball,” the 2012 election, and science- and evidence-based medicine

Regular readers of my other blog probably know that I’m into more than just science, skepticism, and promoting science-based medicine (SBM). I’m also into science fiction, computers, and baseball, not to mention politics (at least more than average). That’s why our recent election, coming as it did hot on the heels of the World Series in which my beloved Detroit Tigers utterly choked got me to thinking. Actually, it was more than just that. It was also an article that appeared a couple of weeks before the election in the New England Journal of Medicine entitled Moneyball and Medicine, by Christopher J. Phillips, PhD, Jeremy A. Greene, MD, PhD, and Scott H. Podolsky, MD. In it, they compare what they call “evidence-based” baseball to “evidence-based medicine,” something that is not as far-fetched as one might think.

“Moneyball,” as baseball fans know, refers to a book by Michael Lewis entitled Moneyball: The Art of Winning an Unfair Game. Published in 2003, Moneyball is the story of the Oakland Athletics and their manager Billy Beane and how the A’s managed to field a competitive team even though the organization was—shall we say?—”revenue challenged” compared to big market teams like the New York Yankees. The central premise of the book was that that the collective wisdom of baseball leaders, such as managers, coaches, scouts, owners, and general managers, was flawed and too subjective. Using rigorous statistical analysis, the A’s front office determined various metrics that were better predictors of offensive success than previously used indicators. For example, conventional wisdom at the time valued stolen bases, runs batted in, and batting average, but the A’s determined that on-base percentage and slugging percentage were better predictors, and cheaper to obtain on the free market, to boot. As a result, the 2002 Athletics, with a payroll of $41 million (the third lowest in baseball), were able to compete in the market against teams like the Yankees, which had a payroll of $125 million. The book also discussed the A’s farm system and how it determined which players were more likely to develop into solid major league players, as well as the history of sabermetric analysis, a term coined by one of its pioneers Bill James after SABR, the Society for American Baseball Research. Sabermetrics is basically concerned with determining the value of a player or team in current or past seasons and with predicting the value of a player or team in the future.
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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine, Science and the Media

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It’s time for true transparency of clinical trials data

What makes a health professional science-based? We advocate for evaluations of treatments, and treatment decisions, based on the best research methods. We compile evidence based on fair trials that minimize the risks of bias. And, importantly, we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result in a trial, especially when it’s sloppily done or biased.  And there are many ways to design a trial to demonstrate positive results in some subgroup, as Kimball Atwood pointed out earlier this week. And even when a trial is well done, there remains the risk of error simply due to chance alone. So to sort out true treatment effects, from fake effects, two key steps are helpful in reviewing the evidence.

1. Take prior probability into account when assessing data. While a detailed explanation of Bayes Theorem could take several posts, consider prior probability this way: Any test has flaws and limitations. Tests give probabilities based on the test method itself, not on what is being tested. Consequently, in order to evaluate the probability of “x” given a test result, we must incorporate the pre-test probability of “x”. Bayesian analysis uses any existing data, plus the data collected in the test, to give a prediction that factors in prior probabilities. It’s part of the reason why most published research findings are false.

2. Use systematic reviews to evaluate all the evidence. The best way to answer a specific clinical question is to collect all the potentially relevant information in a structured way, consider its quality, analyze it according to predetermined criteria, and then draw conclusions. A systematic review reduces the risk of cherry picking and author bias, compared to non-systematic data-collection or general literature reviews of evidence. A well-conducted systematic review will give us an answer based on the totality of evidence available, and is the best possible answer for a given question.

These two steps are critically important, and so have been discussed repeatedly by the contributors to this blog. What is obvious, but perhaps not as well understood, is how our reviews can still be significantly flawed, despite best efforts. In order for our evaluation to accurately consider prior probability, and to be systematic, we need all the evidence. Unfortunately, that’s not always possible if clinical trials remains unpublished or are otherwise inaccessible. There is good evidence to show that negative studies are less likely to be published than positive studies. Sometimes called the “file drawer” effect, it’s not solely the fault of investigators, as journals seeking positive results may decline to publish negative studies. But unless these studies are found, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention. How bad is the problem? We really have no complete way to know, for any particular clinical question, just how much is missing or buried. This is a problem that has confounded researchers and authors of systematic reviews for decades. (more…)

Posted in: Clinical Trials, Politics and Regulation

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The Trial to Assess Chelation Therapy: Equivocal as Predicted

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:

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Posted in: Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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Weak drug regulation and patient tragedies: We’ve seen this story before

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…)

Posted in: Pharmaceuticals, Politics and Regulation

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Obamacare and CAM III: Great Expectations

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…)

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

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