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Checklists and Culture in Medicine

Surgeon and journalist, Atul Gawande, is getting quite a bit of deserved press and blog attention for his new book, The Checklist Manifesto: How to Get Things Right. The premise of his book is simple – checklists are an effective way to reduce error. But behind that simple message are some powerful ideas with significant implications for the culture of medicine.

One of the biggest ideas is that medicine has culture – a way of doing things and thinking about problems that subconsciously pervades the practice of medicine. This idea is not new to Gawande, but he puts it to powerful practice.

The Humble Checklist

Gawande tells not only the story of the checklist but of his personal experience designing and implementing a surgery checklist as part of a WHO project to reduce morbidity and mortality from surgery. He borrowed the idea from other industries, like aviation, that use checklists to operate complex machinery without forgetting to perform each little, but vitally important, step.

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Posted in: Science and Medicine, Surgical Procedures

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Time to Care: Personal Medicine in the Age of Technology

In 1925, Francis Peabody famously said “The secret of the care of the patient is in caring for the patient.” A new book by Norman Makous, MD, a cardiologist who has practiced for 60 years, is a cogent reminder of that principle.

In Time to Care: Personal Medicine in the Age of Technology, Dr. Makous tackles a big subject. He attempts to show how modern medicine got to where it is today, what’s wrong with it, and how to fix it. For me, the best part of the book is the abundance of anecdotes showing how medicine has changed since Dr. Makous graduated from medical school in 1947. He gives many examples of what it was like to treat patients before technology and effective medications were introduced. He describes a patient who died of ventricular fibrillation before defibrillators were invented, the first patient ever to survive endocarditis at his hospital (a survival made possible by penicillin), a polio epidemic before polio had been identified as an infectious disease, the rows of beds in the tuberculosis sanitariums that no longer exist because we have effective treatments for TB. He tells funny stories: the patient who was examined with a fluoroscope and told the doctor he felt much better after that “treatment.” He describes setting up the first cardiac catheterization lab in his area. No one who reads this book can question the value of scientific medicine’s achievements between 1947 and 2010. Today we can do ever so much more to improve our patients’ survival and health. But in the abundance of technological possibilities, the crucial human factor has been neglected.

Individualized care, which involves the use of science-inspired technology, is not personal care. Alone, it is incomplete. It does not provide the necessary reassurance that can only be provided through a trusted physician who focuses upon the totality of the person and not just upon a narrow technological application to a disease. Time and personal commitment are needed to build the mutual understanding and trust that are fundamental to personal care….the continued acceleration of science, technology, and cost has intruded on personal care in our country. This has also occurred during a time in which American individualism and its accompanying sense of entitlement have become more of a cult than ever before. In the absence of personal attention, patients demand more testing, but testing does not satisfy the need for personal interaction.

Makous invokes the Golden Rule: “Over the course of my career, I learned to treat patients as I would like to be treated under similar circumstances.” (more…)

Posted in: Book & movie reviews, Diagnostic tests & procedures, History

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The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:
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Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

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The legal establishment of Winkler County, Texas conspires to punish whistle blowing nurses

On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.

Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:

To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.

At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50″ to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.

The result was this:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:
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Posted in: Medical Ethics, Politics and Regulation

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Yes, Jacqueline: EBM ought to be Synonymous with SBM

“Ridiculing RCTs and EBM”

Last week Val Jones posted a short piece on her BetterHealth blog in which she expressed her appreciation for a well-known spoof that had appeared in the British Medical Journal (BMJ) in 2003:

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

Dr. Val included the spoof’s abstract in her post linked above. The parachute article was intended to be humorous, and it was. It was a satire, of course. Its point was to call attention to excesses associated with the Evidence-Based Medicine (EBM) movement, especially the claim that in the absence of randomized, controlled trials (RCTs), it is not possible to comment upon the safety or efficacy of a treatment—other than to declare the treatment unproven.

A thoughtful blogger who goes by the pseudonym Laika Spoetnik took issue both with Val’s short post and with the parachute article itself, in a post entitled #NotSoFunny – Ridiculing RCTs and EBM.

Laika, whose real name is Jacqueline, identifies herself as a PhD biologist whose “work is split 75%-25% between two jobs: one as a clinical librarian in the Medical Library and one as a Trial Search Coordinator (TSC) for the Dutch Cochrane Centre.” In her post she recalled an experience that would make anyone’s blood boil:

I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark that made the whole room of scientists laugh, but was really beside the point…

This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.

I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.

Jacqueline had this to say about the parachute article:

I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but absurdities should not assume a life of their own.  In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.

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Posted in: Clinical Trials, Medical Academia, Medical Ethics, Science and Medicine

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Energy Healing In Maryland

I had an interesting conversation with a reporter today. She called me to get a “medical/skeptical” counterpoint for an article she is preparing on energy healing. Although I don’t know if she’ll faithfully represent what I had to say, we had an entertaining exchange and so I decided to capture the essence of it here. I’m curious to see which parts of our conversation remain in her final article, due out on February 19th. (Stay tuned for that).

Apparently a local hospital in Maryland is now offering nurse-guided therapeutic touch and Reiki healing for inpatients. She decided to interview the practitioners involved, and turned to me for comment. I did not have the benefit of preparing in advance or having references handy – so I gave it my best shot. I’d be interested to know how you might have responded differently.

1. Is there any scientific evidence that energy healing works? (more…)

Posted in: Energy Medicine, Science and the Media

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Study shows antidepressants useless for mild to moderate depression? Not exactly.

As Harriet Hall has written (http://www.sciencebasedmedicine.org/?p=353), psychiatry bashing is a popular media sport. There seems to be a bias against treatment of psychiatric disabilities, and a common claim is that antidepressants are no better than placebo. The New York Times illustrated both the perpetuation of the myth that antidepressants are ineffective, and the increasing and disturbing tendency of major media organizations to confuse the wholesale acceptance of medical press releases with medical journalism.

In Popular Drugs May Help Only Severe Depression The New York Times credulously publicized the findings of a recent study that claimed to show that antidepressants are ineffective in treating mild and moderate depression. Yes, that’s what the study showed, but the study itself is so limited, so fraught with problems, and the conclusions are so misleading that the article is a terrible disservice.

Before we consider what the study showed, let’s think about what kind of evidence we’d need to conclude that antidepressants don’t work.

First, although there are different types of antidepressants, the term used colloquially refers to antidepressants of a specific type, SSRI’s or selective serotonin reuptake inhibitors. There are other, older types of antidepressants that are rarely used today because of their unpleasant side effects. Hence any study that claims to show that “antidepressants” are ineffective, must look at SSRIs.

Second, there are literally thousands of studies of SSRIs, and it would be helpful to aggregate the results. Aggregating results can be done in a type of paper known as metaanalysis. Metaanlysis adds the results of multiple similar studies to find trends that might not be apparent in individual small studies. But a metaanlysis is subject to several important limitations that must always be considered. The most important limitation is that the authors of the metaanalysis choose the papers to be included. Bias can be introduced by examining only papers that have a desired outcome; that can be accomplished by restricting the inclusion criteria in arbitrary ways.

Let’s look at the study, Antidepressant Drug Effects and Depression Severity. According to the abstract:
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Posted in: Science and Medicine

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The Lancet retracts Andrew Wakefield’s article

In 1998 Andrew Wakefield and 11 other co-authors published a study with the unremarkable title: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Such a title would hardly grab a science journalist’s attention, but the small study sparked widespread hysteria about a possible connection between the mumps-measles-rubella (MMR) vaccine and autism spectrum disorder (ASD).

The study itself has not stood the test of time. The results could not be replicated by other labs. A decade of subsequent research has sufficiently cleared the MMR vaccine of any connection to ASD. The lab used to search for measles virus in the guts of the study subjects has been shown to have used flawed techniques, resulting in false positives (from the Autism Omnibus testimony, and here is a quick summary). There does not appear to be any association between autism and a GI disorder.

But it’s OK to be wrong in science. There is no expectation that every potential finding will turn out to be true – in fact it is expected that most new finding will eventually be found to be false. That’s the nature of investigating the unknown. No harm no foul.

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Posted in: Science and Medicine

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Do Cell Phones Prevent Alzheimer’s?

Scientific studies are not meant to be amusing, but I laughed out loud when I heard about this one. After all the concern about possible adverse health effects from cell phone use, this study tells us cell phone use can prevent Alzheimer’s, treat Alzheimer’s, and even improve cognitive function in healthy users.

They studied transgenic mice programmed by their genes to develop Alzheimer’s-like cognitive impairment; they used a group of non-transgenic littermates as controls. For an hour twice daily over several months they exposed the entire mouse cage to EMF comparable to what is emitted by cell phones. They tested cognitive function with maze tests and other tasks that are thought to measure the same things as human tests of cognitive function. The authors claim to have found striking evidence for both protective and disease-reversing effects. (more…)

Posted in: Neuroscience/Mental Health

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Success in the fight against childhood diarrhea

Rotavirus is the world’s most common cause of severe childhood diarrhea.  In the U.S. alone, rotavirus disease leads to around 70,000 hospitalizations, 3/4 million ER visits, and nearly half-a-million doctor office visits yearly.  But it rarely causes death.

The same is not true for the developing world.  Rotavirus disease is estimated to kill around a half-million children a year world wide.   Finding a way to mitigate this is an active public health concern, with the World Health Organization specifically recommending rotavirus vaccinations in areas where the virus has a significant public health impact.

Rotavirus causes a severe diarrheal illness. It is passed via a fecal-oral route, meaning that contaminated food, surfaces, and water can all be sources.   In developed countries like the US, rotavirus disease is unpleasant and inconvenient.  Since rotavirus spreads more readily in areas without access to clean water and medical care, it takes a greater toll in these areas, and children afflicted are at risk of death due to dehydration.  The US has seen a decline in rotavirus disease in the last few years, an effect that appears to be due to increased vaccination and a herd immunity effect.

Given the large number of pediatric rotavirus deaths in developing countries, the World Health Organization (WHO) has made vaccination a priority. Two articles in this week’s New England Journal of Medicine report on the progress of the fight against rotavirus.

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Posted in: Science and Medicine, Vaccines

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