Archive for February, 2009

Feb 28 2009

Another new blogger for SBM

Published by under Announcements

I’m pleased to announce that I’ve found another blogger for SBM, someone who will represent a viewpoint that I think is very important: That of the physician-in-training. So please welcome Tim Kreider to the stable. Tim is an MD/PhD student at a public university in the northeast US. He never paid much mind to pseudoscience until discovering The Skeptics’ Guide to the Universe and other podcasts that now keep him company during long nights in lab. He practices his skeptical analysis on extracurricular lectures organized by a student interest group for integrative medicine on campus.

As a graduate student, Tim is investigating immune mechanisms in a mouse model of gastrointestinal helminth infection. As a medical student, he has no idea what specialty to pursue and would love advice. He loves to teach math and science and hopes to pursue a career in medical academia.

We’re very happy to have Tim on board. Given that one of my concerns is the infiltration of pseudoscience into the medical school curriculum, I consider it essential to have a medical student on board to give that perspective. Because of his academic load, Tim will be blogging only once a month, although I do hope to tease a little more out of him, as long as it doesn’t jeopardize his education.

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Feb 27 2009

A Medical-Skeptical Classic

The medical literature slowly becomes outdated. As a result there are not that many ‘classics’ in the field, since their content is becomes less relevant. The medical aphorism is that 10 years after graduation from medical school, half of everything you learned will no longer be valid. The problem for medical students is trying to figure out which half of their curriculum is not worth learning.

Old studies become increasingly irrelevant as diagnosis and treatment changes over time under the relentless pressure of medicine. I once came across the best of Osler, with his descriptions of typhoid fever and pneumococcal pneumonia. The essays were far more literary in style than todays journal articles, describing the presentation of these diseases in Dickens’ like detail, but of little practical help given the advances in treatment and the understanding of microbiology of diseases.

Technology also expands and limits what papers are available. If there is not an electronic form of an article, it might as well not exist. Many classic articles are not yet available in digital form, and the article in question for this post I had to get as a scanned version of the original paper, rather than a pdf. As a result of time and lack of electronic access, much of the older medical literature is not easily accessible, and journal publishers are not particularly interested in the free dissemination of information. Which is a shame. There is the occasional older references that is as applicable today as when it was published.

There was never, to the best of my recollection, a time when I was not a skeptic. But there was a time when I had neither the time nor the knowledge to be able to think skeptically about medicine. The torrent of information that needs to be assimilated in medical school, residency and the first part of fellowship makes reflection about that information almost impossible.

I do remember an article that was a turning point in my thinking about thinking about the practice of medicine. It was 1989 and the last year of my Fellowship and was published in the American Journal of Medicine, entitled “Observations on spiraling empiricism: its causes, allure, and perils, with particular reference to antibiotic therapy” by Kim and Gallis (hence forth called OOSE, pronounced, I suppose).

If you can scrounge up a copy, by all means do so, as it is a classic. It is a collection of logical fallacies and critical thinking as applied to infectious diseases. It was the first time I read an article that discussed how to think about thinking in medicine. I had no idea that there were logical fallacies. Most of what passed for critical thinking in my training concerned understanding the statistics and the materials & methods of studies. Important, but limited.

OOSE starts with a description of the discovery of antibiotics and the amazement of physicians that for the first time diseases that were often fatal were now curable. It must have been an amazing time for physicians when infections that routinely killed were suddenly vanquished. I have witnessed a similar revolution with the advent of HAART, where AIDS has gone from a 9 month life expectancy to a chronic disease with perhaps a normal life expectancy.   At my hospital is Dr. Charles Grossman, now in his 90′s and still attending conferences. His long and productive medical career started at Boston Hospital where, as an intern, he was involved in giving the first iv dose of penicillin to a lady who was dying of a streptococcal infection, who survived another 50 years (2).

Antibiotics have been developed to kill increasingly resistant and virulent bacteria, and until recently we have managed to keep one step ahead of the organisms. Unfortunately, the ability to become resistant is outstripping out ability to develop new agents and we are slowly, and inexorably, losing the battle, sliding in to the post antibiotic era.

Part of the evolution of resistance occurs from the inappropriate use antibiotics, which can often be due to uncertainly of the diagnosis. But inappropriate antibiotic use can also due to faulty thinking.

As the authors of OOSE note, “The imprecision of clinical practice establishes context, the litigious nature of our society unnerves; the absence of toxicity permits; and the sum of these encourages the incontinent, extemporaneous use of these antimicrobial agent.”

Incontinent use of antibiotics leads to increasing bacterial resistance,and the use of antibiotics when they have not been needed has accelerated the evolution of pathogens, occasionally to the point where there are infections I cannot cure and bacteria that I cannot kill.

“The term spiraling empiricism describes the inappropriate treatment, or the unjustifiable escalation of treatment, of suspected but undocumented infectious diseases. Empiricism and empirical therapy, defined as the carefully considered, presumptive treatment of disease prior to the establishment of a diagnosis, often are necessary in the proper practice of medicine. On the other hand, ill-considered or inappropriate use of antibiotics, incurring unnecessary risk and expense, should be indicted and condemned, The difficulty like in distinguishing reasonable or appropriate from unreasonable or inappropriate therapy.”

As a teaching physician in a teaching hospital, I notice that sometimes it is the FUD, Fear Uncertainty and Doubt, combined with faulty thinking that sometimes leads to the inappropriate use of antibiotics.

OOSE provide a conceptual framework for approaching diseases and potential therapy (see table below); Observation, prophylaxis, empirical, therapeutic trial, and specific therapy. Of these, the first and the last, are, sadly, the least used. For interns and resident, the motto is ‘Don’t just stand there, do something’, and with the pressures to shorten hospital stay as much as possible, simply watching the patient is a luxury few can afford. As an experienced physician, I feel much more comfortable with the motto, ‘Don’t just do something, stand there’, or as the paper calls it “masterly inactivity.” As my wife can attest, I am the master of doing nothing.

Specific therapy in infectious diseases is not as common as I would like given the vagaries of growing the infecting organisms and the degree to which one wants to maximize diagnostic certainty. I could probably get the etiology of every pneumonia admitted to the hospital with an open lung biopsy, but it would hardly be worth the resultant morbidity and mortality.

Most of the time the patient is ill enough to be admitted to the hospital and, after appropriate studies and cultures are done, empiric therapy is started. That is often not an unreasonable course of action. These days you have to be ill to get admitted and it is the rare patient who comes into the hospital who can wait for cultures to be positive before beginning antibiotics. I cannot emphasize enough how ill patients are when they are admitted to the hospital, and how unclear the proper diagnosis can be at the beginning of a hospitalization. After a day or two all the diagnostic information has returned and the, with the 20:20 vision of hindsight, the correct diagnosis may become clear and as a result the proper course of therapy is clarified.

Since cultures are often negative, the empiric course of therapy may morphs into a therapeutic trial.

After setting the therapeutic framework in place, OOSE proceeds, with case reports, to describe fallacies in antibiotic therapy that lead to the wrong therapeutic interventions. There is, in medicine, a long tradition of using cases as illustrative of problems, but not as anecdotal evidence for the proof of a hypothesis. We all remember concepts when they are applied to specific patients and specific cases.
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Feb 26 2009

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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Feb 25 2009

Train Your Brain

I’m a big fan of video games, puzzles, and brain teasers. So the notion that so-called “brain training” games can help improve mental function and stave off dementia has some appeal to me. It also makes a certain amount of sense – exercise your brain and its function will improve.

And yet, as a skeptic, I have always been bothered by the specific claims made by marketers of games, websites, devices and programs. The formula is probably familiar to you, a specifically designed program is optimized to stimulate brain function, improve integration of information, and improve global function.

The website promotion for Brain Age, for example, claims:

Everyone knows you can prevent muscle loss with exercise, and use such activities to improve your body over time. And the same could be said for your brain. The design of Brain Age is based on the premise that cognitive exercise can improve blood flow to the brain. All it takes is as little as a few minutes of play time a day. For everyone who spends all their play time at the gym working out the major muscle groups, don’t forget – your brain is like a muscle, too. And it craves exercise.

The blood flow argument is pure hand-waving. The muscle analogy is perhaps more apt than intended – do muscles respond to a specific exercise or to any exercise?

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Feb 24 2009

Healing But Not Curing

Published by under Science and Medicine

Last week I discussed the book Healing, Hype, or Harm? edited by Edzard Ernst. I was particularly struck by one of the essays in that book: “Healing but not Curing” by Bruce Charlton, MD, a reader in evolutionary psychiatry at the Department of Psychology of the University of Newcastle upon Tyne.

Charlton proposes a new way of looking at CAM. He describes three common attitudes:

  •  CAM does good and should be integrated with orthodox medicine. 
  • CAM is worthless and should be discarded.
  •  CAM may or may not do good and this should be decided using science.

He rejects all three. In his view,

  •  Alternative therapies do good.
  •  From a strictly medical perspective they are worthless.
  •  They should not be integrated with orthodox medicine.
  •  Because they are explained non-scientifically, they cannot be evaluated using the criteria of medical science.

He suggests that alternative therapies be regarded as spiritual practices. They are about making people feel better (‘healing’) not about mending their dysfunctional brains and bodies (‘curing’). Continue Reading »

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Feb 23 2009

2009: Shaping up to be a really bad year for antivaccinationists

I will begin this post with a bit of an explanation. Between one and two weeks ago, there appeared two momentous news about the manufactroversy regarding vaccines and autism. No doubt, many SBM readers were expecting that I, as the resident maven of this particular bit of pseudoscience, would have been here last week to give you, our readers, the skinny on all of this. Unfortunately, as some know, my wife’s mother died, coincidentally enough, on the 200th anniversary of Darwin’s birthday and a day when one of those two momentous bits of news was released to the public, which is why I used one of my handful of posts written and then held in reserve. I’m back now, though, and I don’t think it’s too late to comment on these bits of news because now that over a week has gone by what I’ve seen has led me to draw some conclusions that I might not have been able to do, had I done my usual bit and been first off the mark (at least among SBM bloggers) discussing the story.

2008: The Best of Years for the Antivaccine Movement

But first, let’s take a look at last year. In 2008, Jenny McCarthy was the new and fresh celebrity face of the movement that believes that autism and all manner of other neurodevelopmental disorders are caused by vaccines and that the government and big pharma are suppressing The Truth. She had emerged in the fall of 2007 after having tried to erase from the Internet her previous involvement in the “Indigo Child” movement in preparation for becoming an “autism advocate” who could write a book that could land her on Oprah’s show. Thanks to her and, perhaps even more so to the star power of her boyfriend Jim Carrey, who is just as wrong about vaccines and medicine as Jenny is, the antivaccine movement came roaring into prominence in a way that it had never managed to pull off before. After all, let’s face it, a former Playboy Playmate of the Year and a famous comedian are far more “interesting” public figures for various media outlets to interview than previous celebrities who spearheaded the vaccine manufactroversy, such as Robert F. Kennedy, Jr. or Don Imus and his wife Deirdre.

Indeed, Jenny’s combination of good looks and utter obnoxiousness led to her showing up all over the media in 2008. For example, on April 1 (appropriately enough), she appeared on Larry King Live! and shouted down physicians who had the temerity to tell her that her Google University knowledge was just plain wrong. The pinnacle of her influence came during the summer, when, having now supplanted J.B. Handley as the public face of the antivaccine group Generation Rescue and transforming GR into “Jenny McCarthy’s autism charity,” she led the “Green Our Vaccines” rally in Washington, DC. True, at most there were several hundred people there, but it got wide news attention, and Jenny was all over the news. She rapidly followed it up by releasing a second book Mother Warriors: A Nation of Parents Healing Autism Against All Odds and appearing on The Oprah Winfrey Show yet again.
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Feb 20 2009

Colorado is Nearer to Promoting Naturopathic Pseudomedicine—Aided by the Colorado Medical Society

This week we’ll take a break from lambasting the National Center for Complementary and Alternative Medicine, as worthy as that task is, in order to confront some of the latest events involving the pseudomedical cult that calls itself “naturopathic medicine.”* Intrepid nurse and anti-healthfraud activist Linda Rosa reports that Colorado is dangerously close to becoming the next state to endorse ”NDs” as health care practitioners, and Scott Gavura of Science-Based Pharmacy called my attention to a report that British Columbia is considering enlarging the scope of practice for NDs, who are already licensed there, and that Alberta is on the verge of licensing them. In each case, those whom the public trusts to make wise decisions have betrayed their ignorance of both pseudomedicine and the realities of governmental regulation.

To explain why, it will first be necessary to make a few assertions, which are linked to developed arguments where necessary:

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Feb 19 2009

Fakin’ it

Last week the Times of London revealed inside information from the General Medical Council (UK, responsible for physician licensing) of an ongoing investigation of Dr. Andrew Wakefield and from its own investigation. This revelation recalled other instances of fakery from reports of sectarian medicine (“CAM”) successes. The Medical Council information contained evidence that the data from the now famous Wakefield cases used to claim an association of the MMR vaccine with childhood autism and inflammatory bowel disease were misinterpreted, altered, and to some extent, faked. The report and history were reviewed by David Gorski last week. In eight of twelve cases, the dates of autism onset were “rearranged” to fit the needed time association, and many small bowel biopsies were “reinterpreted” to show inflammation.

The Wakefield claims were long suspected by reputable medical scientists and skeptics  as being erroneous or fraudulent.  Note: the Council hearings are still in progress, and the Times report is subject to legal complaint.  The original details can also be seen in the Times articles.

This expose’ adds to a growing list of reports with erroneous and faked information in medical journals used either for economic reward, undeserved fame, or to promote ideological claims for medical sects and cults. Although history of erroneous or false claims goes back hundreds of years, the altering or synthesizing of data passing the recently conceived peer review system is new,  illuminating defects in the journal peer review and editing system.

If journals were invented in the 18th century, and operated like journals of today, Mesmer’s demonstrations might have been published, and the Ben Franklin and Antoine Lavoisier and French Academy’s disproof might have been rejected. (Laughter here.) But journals continue to make major goofs in publishing implausible results despite the popularity of a famous specialty journal for that purpose.

Examples vary from acceptance of language manipulation – “alternative,” “healing,” “integrative,” etc., to the fakery of recent papers showing effects of prayer. The two famous studies of prayer in the cardiac care unit ranged from the unadmitted breaking of the blind in the Bird study (So Med J 1988; 81:826-826) to unadmitted imbalances of subject and control groups (Harris, Arch Int Med 1999;159:2273-2278.) And from those to the likely fakery of the distant prayer study of in vitro fertilization (Cha, Wirth, Lobo; J Reprod Med 2001:46;781-786) in which three separate prayer groups on two continents improved pregnancy rates in a group of women on a third continent by an implausible 100 percent. In all of these cases, the papers passed peer or editorial review despite the methodological defects that were picked up by us skeptics (K. Atwood, K.Courcey [an RN] B. Flamm, and others.)

Adding insult to the above, Annals of Internal Medicine published a systematic review of intercessory prayer (Astin et al, Ann Int Med, 2000;132: 903-910) containing not only the Bird and Harris studies counted as positive, but also the Targ study on brain tumors, found by reporter Po Bronson to have had its end point altered by the authors when the primary one showed no effect.
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Feb 19 2009

Comparative Clinical Effectiveness Research: Good News In Shades Of Gray

When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

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Feb 18 2009

Obama and Stem Cells

In 2001 George Bush signed an executive order banning federal funding for embryonic stem cell research, except for those lines that were already established. As a result such research ground to a halt in the US.

While the order was presented as a compromise, the effect was chilling in its application. No researcher receiving federal dollars (even for a separate project) could do embryonic stem cell research, except on the approved lines.  Institutions could not risk losing federal grants and so had to purge themselves of any banned research. The approved lines did not turn out to be as useful as was originally claims, and they became progressively obsolete as new techniques were being developed through state and private funding.

It is impossible to measure the effect that Bush’s ban had on ultimate scientific progress in this area. It is not just that we lost eight years – expertise in a cutting-edge scientific area can be a tenuous cultural and institutional thread, once broken it is difficult to recreate.

We will hopefully have a chance to find out. It was expected that one of the first measures of the Obama administration would be to lift the federal ban. In fact, I am a bit surprised it has not happened already. But it seems it soon will – insiders are saying that Obama plans to lift the ban soon.

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