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Posts Tagged evidence-based medicine

New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski. 😉

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”

Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”

A “Patient-Centered Extremist”

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:

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Posted in: Health Fraud, Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine, Science and the Media

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Brief Note: The Chiropractic Subluxation is Dead

The General Chiropractic Council, a UK-wide statutory body with regulatory powers, has just published a new position statement on the chiropractic subluxation complex:

The chiropractic vertebral subluxation complex is an historical concept but it remains a theoretical model. It is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease or health concerns.

They remind chiropractors that they must make sure their own beliefs and values do not prejudice the patient’s care, and that they must provide evidence-based care. Unfortunately, they define evidence-based care as

clinical practice that incorporates the best available evidence from research, the preferences of the patient and the expertise of practitioners, including the individual chiropractor her/himself. [emphasis added]

This effectively allows “in my experience” and “the patient likes it” to be considered along with evidence, effectively negating the whole point of evidence-based medicine.

Posted in: Chiropractic

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Placebo Therapies: Are They Ethical?

Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.

As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.

For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients?  It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:

“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”

Moreover, a recent article in the New England Journal of Medicine concludes:

“Outside the setting of clinical trials, there is no justification for the use of placebos.”

However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.

The authors note:

“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”

How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?
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Posted in: Medical Ethics, Science and Medicine

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How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
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Posted in: Politics and Regulation, Public Health, Science and Medicine

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Knowledge Versus Expertise: The View From Consumer Land

“The internet, in democratizing knowledge, has led a lot of people to believe that it is also possible to democratize expertise.”

– SBM Commenter, yeahsurewhatever

I’ve spent the last few years of my life in Internet “Consumer Land,” doing what I can to bring accurate health information directly to patients. Of course, I have been surprised by the push-back, and the demand for misinformation. When I first left full time clinical work, it never occurred to me that people would prefer to read falsehoods when provided a clear choice between truth and error. I guess I was pretty naïve.

Journalist Lesley Stahl provided me with some helpful insights during a recent conference. She explained that the Internet has catalyzed a new method of information transfer – speed trumps accuracy, the line between pundits and journalists is blurred, and anyone who can get to a microphone can become an “expert.” Gone are the days of careful sourcing and fact-checking. And gone is the public trust in “mainstream media.”

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Posted in: Health Fraud, Humor, Public Health, Science and Medicine, Science and the Media

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Polypharmacy – Is It Evidence-Based?

Polypharmacy essentially means taking too many pills. It’s a real problem, especially in the elderly.

A family doctor gives an elderly patient one pill for diabetes, another for high blood pressure, and another to lower cholesterol. The patient sees a rheumatologist for his arthritis and gets arthritis pills. Then he sees a psychiatrist for depression and gets an antidepressant. He takes a sleeping pill. He takes a laxative. He buys some over-the-counter cold medicine and Tylenol. Then he goes to his local GNC store and buys a smorgasbord of vitamins, minerals, supplements and herbal products. It would be surprising if some of these didn’t interact with each other to cause some problems.

One doctor may not know what the other doctors have prescribed. The patient may not think to tell his doctors about the non-prescription products he’s taking. Or he may not want to admit it for fear the doctors will disapprove. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals, Science and Medicine

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