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Archive for November, 2010

Resident’s Working Hours: Should We Let Sleeping Docs Lie?

The Accreditation Council for Graduate Medical Education (ACGME) has released proposed new standards to limit working hours for medical residents. Bus drivers are allowed to drive for 10 hours and then are required to have 8 hours off duty. Airline pilots can be scheduled for up to 16 hours on duty — being at work, ready to fly — and up to eight hours of actual flight time in a 24-hour period, with a minimum of eight hours for rest between shifts. Physicians in residency training work 80 hours or more a week (compared to 75 hours a month for airline pilots) and are regularly on duty for more than 24 hours at a time. If adequate rest is an important safety measure for drivers and pilots, isn’t it important for doctors too?

When I was an intern and resident, my hours were a little better than some. Instead of every other night, I was on call every third night. I had to work from about 7 AM one day to 5 PM the following day (34 consecutive hours). I stayed in the hospital: there was a call room with a bed, but if we got to lie down it was never for very long. When I got off duty, my sleep-deprived body demanded that I go home and crash. It was only every third day when I worked “only” a 10 hour shift, that I could devote an evening to all the other activities of my life like laundry, grocery shopping, and trying to read medical journals. One memorable weekend I worked from Saturday morning to Monday evening and only got to lie down for about 20 minutes. I don’t think I made any fatigue-induced mistakes that hurt patients, but by Monday afternoon I was groping my way through brain fog and running on fumes. (more…)

Posted in: Politics and Regulation

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Science-based medicine and improving patient safety and quality of care

The last couple of weeks, I feel as though I may have been slumming a bit. After all, comparatively speaking it’s not that difficult to take on claims that homeopathy benefits fibromyalgia or Oprah Winfrey promoting faith healing quackery. Don’t get me wrong. Taking on such topics is important (otherwise I wouldn’t do it). For one thing, some quackery is so harmful and egregiously anti-science that it needs to be discussed. For another thing, they serve as examples of how even the most obvious quackery can seem plausible. All it takes are the cognitive quirks to which all humans are prone plus a bit of ignorance about what constitutes good scientific evidence to support the efficacy of a given therapy for a given condition.

So let’s move on to something a little more challenging.

Of all the attacks on science-based medicine (SBM), one of the favorite attacks made by its opponents is the claim that SBM is dangerous, that it kills or harms far more people than it helps. An excellent example of this occurred when quackery promoter Joseph Mercola teamed up with fellow quackery promoter Gary Null to write a widely cited article entitled Death by Medicine. Using the famous Institute of Medicine article that estimated deaths from medical errors to be on the order of 50,000 to 100,000 per year, Mercola and Null wove a scary story meant to imply that conventional medicine does far more harm than good. Of course, as our very own Harriet Hall pointed out, they concentrated solely on the harm, which makes it difficult to determine whether the harms truly outweigh the benefits. As Peter Lipson puts it, such arguments are intentionally designed to take our fears and exaggerate them out of all perspective. The idea behind the fallacious arguments used by the likes of Mercola and Null is that, because “conventional” medicine has problems and needs to improve its safety record, the quackery they promote must be a viable alternative to SBM. Yes, that is basically what their arguments boil down to.

The fallacious manner in which advocates for quackery such as Joe Mercola, Mike Adams, and Gary Null use and abuse any shortcoming of SBM that they can find (and, when they can’t find any, make some up) notwithstanding, there is a problem in SBM. Indeed, over the last 10 years or so since the IOM report, reducing the toll due to medical errors has — finally — become an incredibly important issue in medicine. Indeed, I myself have become involved in a state-wide quality improvement initiative in breast cancer as our site’s project director. As a result, I’m being forced to learn more about the nitty-gritty of quality improvement than I had ever thought I would. Combine this with a study published just before the Thanksgiving holiday in the New England Journal of Medicine, and I’m learning that improving care is incredibly difficult. The issues involved are many and tend to involve systems rather than individuals, which is why the solutions often bump up against the individualistic culture to which physicians belong. Moreover, such efforts, like comparative effectiveness research (CER), tend to earn less prestige than scientific research because, like CER, quality improvement initiatives do not in general look for new information and scientific understanding but rather at how we apply what we already know.
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Posted in: Clinical Trials, Science and Medicine

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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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Posted in: Homeopathy, Legal, Science and Medicine

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Be thankful: No anti-vaccine propaganda at the movies this weekend

It’s Thanksgiving Day here in the U.S., and, despite the crappy economy, there are still things to be thankful for. For instance, skeptical activism can still be effective. On Sunday Skepchick Elyse put out the call to Skepchick readers to complain to movie theaters that were reportedly going to be airing a public service announcement from the anti-vaccine group SafeMinds? (Actually, “public service announcement” is a misnomer; it should be called a public disservice announcement.) The entire PSA was a truly disgusting and deceptive bit of misinformation. In response, Elyse urged Skepchic readers to flood the relevant theaters with complaints about showing an anti-vaccine advertisement prior to its movies.

Now here’s what we can be thankful for: It worked. At least with AMC Theaters. Last night the anti-vaccine propaganda blog Age of Autism, which had been teaming up with SafeMinds to raise money to show these ads during the Thanksgiving holiday weekend admitted as much.

At least for now:

SafeMinds was notified late yesterday afternoon that AMC Theaters has decided to block the SafeMinds Public Service Announcement (PSA) on influenza vaccines with mercury. The PSA alerts parents and pregnant women of the presence of mercury in most influenza vaccines and the ample availability of mercury-free alternatives. The CDC has declined to give a preference for the mercury-free versions, so it is important that the public is aware of its options. AMC’s advertising representative had reviewed and approved the PSA to run in AMC cinemas over the Thanksgiving weekend. A small group of vocal vaccine proponents dismissive of mercury concerns learned of the PSA and bombarded the AMC website, leading to the company’s decision to prevent its release. SafeMinds thanks its supporters who viewed the PSA and contributed to its efforts to educate the public to avoid unnecessary mercury exposure. Mercury in all forms is dangerous, especially to the developing fetus and infants, as referenced on the PSA website www.safemindsflu.org. SafeMinds will continue its mission to educate the public on this important healthcare topic.

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Posted in: Public Health, Science and the Media, Vaccines

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Bill Clinton’s Diet

Bill Clinton loved hamburgers from McDonald’s. He used to eat a typical American high calorie, high fat, meat-based diet. No more. He had a heart attack and a quadruple bypass in 2004. Recurrent blockages required placement of two stents in February 2010. This got his attention and he went on a strict new diet, losing 24 pounds to get back down to what he weighed in high school.

He is now a vegan.

I live on beans, legumes, vegetables, fruit. I drink a protein supplement every morning — no dairy, I drink almond milk mixed in with fruit and a protein powder so I get the protein for the day when I start the day up.

I did all this research, and I saw that 82 percent of the people since 1986 who have gone on a plant-based, no dairy, no meat of any kind, no chicken, no turkey — I eat very little fish, once in a while I’ll have a little fish — if you can do it, 82 percent of people have begun to heal themselves.

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Posted in: Nutrition

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How low can Oprah Winfrey go? Promoting faith healer John of God to the masses

Several of the bloggers on Science-Based Medicine have been — shall we say? — rather critical of Oprah Winfrey. The reason, of course, is quite obvious. Oprah is so famous that if you mention her first name nearly everyone will know exactly of whom you speak. For the last quarter century, her daytime TV talk show has been a ratings juggernaut, leading to the building of a media behemoth and making Oprah one of the richest and most famous women in the world. Unfortunately, part of Oprah’s equation for success has involved the promotion of quackery and New Age woo, so much so that last year I lamented about the Oprah-fication of medicine, which scored me a writing gig in the Toronto Star. Whether it be promoting bio-identical hormones, The Secret (complete with a testimonial from someone who used The Secret to persuade herself not to pursue conventional therapy for breast cancer), Suzanne Somers, the highly dubious medicine promoted by Dr. Christiane Northrup, or foisting reiki aficionado Dr. Mehmet Oz or anti-vaccine “mother warrior” Jenny McCarthy onto a breathless public, arguably no one is a more powerful force for the promotion of pseudoscience in America, if not the world. Truly, the ending of Oprah’s TV show in the spring is a very good thing indeed for science and rationality. Or it would be, were it not for the fact that the reason Oprah is wrapping up her show after a quarter of a century is to start up her own cable channel, so that we can have Oprah-branded and -inspired programming 24/7.

The mind boggles.

Still, my dislike for how Oprah promotes New Age mysticism and pseudoscience on a distressingly regular basis aside, I actually did think there were limits to how low she would go. I actually thought there were limits to how egregiously vile a quackery Oprah would endorse. The operative word, of course, is “did,” which now needs to be struck off after last Wednesday, which is when Oprah did an entire show entitled Do You Believe in Miracles? (Guess what answer was implicitly, if not explicitly, endorsed.) Featured prominently in that episode were several segments on the faith healer John of God.
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Posted in: Energy Medicine, Health Fraud, Religion, Science and the Media

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Nosodes Redux: “I hate those meeces to pieces!”

Life and medicine generate facts and experiences that require conceptual frameworks that aid in understanding.  It is no good have a pile of facts if they cannot be understood within a broader understanding.

The practice of Infectious Diseases, while certainly aided by understanding anatomy, physiology, microbiology, chemistry and the other sciences that form the core of medicine (referred to in Medical School as the basic sciences), gains a broader  appreciation from the concepts of evolution.  Infectious Diseases, at its most fundamental level, is applied evolution, and understanding evolution often adds greater insight into infectious diseases.  Me find bug, me kill bug, me go home may be my motto, but it is meant in jest.

There have been papers or books that have added conceptual frameworks to my understanding of the natural world and medicine.  Besides evolution, there was Observations on Spiraling Empiricism a classic that all health care providers should read, as it outlines the cognitive errors we all make in prescribing medications; I have discussed this article before.

There is  The Drunkard’s Walk: How Randomness Rules Our Lives by Leonard Mlodinow.  So often the explanation of why something  happens is a shrug of the shoulders; feces occurs. The book formalized my understanding that much of what happens is random and without cause.  The challenge in medicine is trying  find a pattern in the randomness of life upon which to base a diagnosis. It is equally important to recognize when patterns are not there. All too often what is seen as a pattern is our imposing structure on what are random events.  Or maybe that really is a bunny in the clouds.  Clinical study results often occur by chance and having a significant ‘P’ value may still be due to randomness if the study is measuring nonsense.

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Posted in: Homeopathy, Humor

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The DC as PCP?

Subluxation-free Chiropractic?

The long-simmering internecine wars among various factions of chiropractic recently reached a full boil when the Council on Chiropractic Education (CCE) had the audacity to eliminate the word “subluxation” from its draft 2012 “Standards for Doctor of Chiropractic Programs.” The CCE is the official U.S. Department of Education-approved accreditation agency for chiropractic colleges. It intends to adopt the revised Standards in January 2011and asked for comment from those affected.

“Totally unacceptable,” is the response of James Edwards, DC, in a recent article in Dynamic Chiropractic entitled “What Is the CCE Trying to Pull?

Perhaps taking up the spirit of this election season, Edwards defines the problem in terms of conservative vs. liberal ideologies: “After beating back and defeating the ridiculous ‘subluxation only, no diagnosis’ position of the extreme right-wing minority of the profession, we are now faced with the equally unacceptable ‘ivory tower’ position of the extreme left-wing minority of the profession.” Later in the article he refers to the proponents as the “left-wing fringe.”
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Posted in: Chiropractic, Legal

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Homeopathy and the Selling of Nonspecific Effects

One of the core features of science (and therefore science-based medicine) is to precisely identify and control for variables, so that we know what, exactly, is exerting an effect. The classic example of this principle at work is the Hawthorne effect. The term refers to a series of studies performed between 1924 and 1932 at the Hawthorne Works. The studies examined whether or not workers would be more productive in different lighting conditions. So they increased the light levels, observed the workers, and found that their productivity increased. Then they lowered the light levels, observed the workers, and found that their productivity increased. No matter what they did, the workers improved their productivity relative to baseline. Eventually it was figured out that observing the workers caused them to work harder, no matter what was done to the lighting.

This “observer effect” – an artifact of the process of observation – is now part of standard study design (at least well-designed studies). In medical studies it is one of the many placebo effects that need to be controlled for, in order to properly isolate the variable of interest.

There are many non-specific effects – effects that result from the act of treating or evaluating patients rather than a physiological response to a specific treatment. In addition to observer effects, for example, there is also the “chearleader” effect from encouraging patients to perform better. There are training effects from retesting. And there are long-recognized non-specific therapeutic effects just from getting compassionate attention from a practitioner. It is a standard part of medical scientific reasoning that before we ascribe a specific effect to a particular intervention, that all non-specific effects are controlled for and eliminated.

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Posted in: Homeopathy

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Dabigatran: A Promising Alternative to Warfarin

On October 19, 2010, the FDA approved a long-awaited new drug, dabigatran, expected to replace warfarin (Coumadin) as a better way to prevent blood clots in susceptible patients. This provides an opportunity to re-visit several issues that we have addressed before, including Big Pharma tactics, drug approval by the FDA, deciding what is adequate evidence, applying science to clinical practice, and making individual health care decisions based on evidence that is sometimes incomplete.

Background

Patients with atrial fibrillation, artificial heart valves, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, and people undergoing certain types of surgery are at risk of blood clots, embolism, and stroke. They are currently being treated with rat poison. Warfarin (Coumadin) is an anticoagulant originally intended to kill rats. It inhibits the vitamin K dependent synthesis of several clotting factors. It saves human lives but is a mixed blessing. It takes several days to achieve therapeutic levels. Patients must be monitored with frequent blood tests to ensure that their prothrombin levels stay between an INR (international normalized ratio) of 2 and 3. When starting out, this means blood tests every couple of days. For some patients, dosage fluctuates and requires frequent adjustments; others can eventually drop down to a monthly blood test. Warfarin interacts with a long list of other drugs that raise or lower its blood levels. It interacts with many foods, and patients have to modify their diet. It can cause serious bleeding complications; while preventing thrombotic strokes it can cause hemorrhagic strokes. It is taken once daily. There is an antidote, vitamin K, that can reverse its effects promptly.

Warfarin is the 11th most prescribed drug in the US. Its benefits clearly outweigh its risks, but we wish the risks were fewer. We have yearned for a better option: something safer, something that would not require monitoring with blood tests, something that foods wouldn’t interfere with, something that would not interact with every other drug in the book. And now it seems we have it: a direct thrombin inhibitor called dabigatran.

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Posted in: Pharmaceuticals

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