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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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Posted in: Basic Science, Clinical Trials, Faith Healing & Spirituality, Health Fraud, Medical Academia, Science and Medicine, Vaccines

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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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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation, Public Health

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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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Posted in: Medical Ethics, Politics and Regulation

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Edzard Ernst Does It Again

Publishing one excellent book is an accomplishment; publishing two in one year is a truly outstanding achievement. In 2008 Edzard Ernst and Simon Singh published a landmark book Trick or Treatment: The Undeniable Facts About Alternative Medicine. I reviewed it on this blog last summer.  It is particularly important since Ernst is a former advocate for CAM (complementary and alternative medicine) who was able to objectively look at the scientific evidence and realize that it doesn’t support most CAM methods.

Before the year was out, Ernst had published another book, Healing, Hype or Harm? A Critical Analysis of Complementary or Alternative Medicine. It is a compilation of essays on various general and specific topics in CAM. Ernst is the editor; he and 15 other authors have contributed, mostly from the UK but also including Asbjorn Hrobjartsson from the Nordic Cochrane Centre in Denmark (the author of a landmark paper on placebos), Canadian health activist Terry Polevoy, and our own inimitable James (The Amaz!ng) Randi.

In the preface, Ernst says,

Our book tries to look behind the various smoke screens that tend to obstruct our vision and often prevent us from understanding the truth. The authors of this volume have very different backgrounds and views but they are all well-informed critics who do not dismiss CAM lightly. If they disapprove of certain aspects, they do so for well-argued reasons. (more…)

Posted in: Book & movie reviews, Science and Medicine

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Health care and the Stimulus Plan

In my last post, I told you a little story about using science- and evidence-based medicine to improve health care.    The focus was primarily on preventing an iatrogenic illness, namely intravenous catheter infections.  A researcher came up with a plausible idea for an intervention, studied it, and found it to be successful—the intervention was science-based in that it was proposed based on sound scientific principles; and it is now evidence-based, in that we now know that this intervention prevents infections.

But we don’t really have an easily accessible repository of evidence-based interventions.  Every field has its own standards, its own literature, and its up to each individual practitioner to interpret the data on their own.

There are some data bases, such as the USPSTF which gives data for preventative services, and PIER, a service of the American College of Physicians, which gives information on specific diseases and includes interpretations of evidence.  There’s also the Cochrane Collaborative, which helps evaluate evidence.   But there is no single “go-to” site for these things, and while we follow evidence-based guidelines in much of our care, there are many times when evidence isn’t just hard to find but is actually unavailable.

Give our “evidence gap”, I was heartened to see this story in the New York Times.   The Times reports that the economic stimulus bill will include over a billion dollars to fund research into medical evidence.  This is a good thing, but it’s bound to be controversial.  But I’ve mentioned before that we need to spend money to improve our medical infrastructure, and this could be a step in the right direction.

Much of what we do in medicine is science-based, and much of it has evidence to support it, but some does not.  There are plenty of open questions about how we practice medicine, and in order to deliver safe, quality care, we need answers. One example was explored by Dr. Gorski earlier.  In another example, a recent study in the New England Journal of Medicine compared surgical and non-surgical therapy for arthritis of the knee.  Surgery made logical, scientific sense, but it had never  been carefully compared to non-surgical therapy.  The study showed that conservative therapy, which is cheaper and less invasive, was just as effective as surgery.  This doesn’t mean that surgery will never help, but it is strong evidence that we should treat arthritis of the knee more conservatively. Studies like this aren’t free, but if their results are reliable and repeatable, they may save us a lot of money and possible surgical complications.

So the idea of investing more money into comparing medical treatments makes sense, both scientifically and economically.  Now there’s a lot of predictable objections about this; people are worried about physician autonomy and government interference.

As Congress translated the idea into legislation, it became a lightning rod for pharmaceutical and medical-device lobbyists, who fear the findings will be used by insurers or the government to deny coverage for more expensive treatments and, thus, to ration care.

In addition, Republican lawmakers and conservative commentators complained that the legislation would allow the federal government to intrude in a person’s health care by enforcing clinical guidelines and treatment protocols.

I’m not sure that the legislation says anything about enforcing clinical guidelines, but to be fair, there is some implication along those lines.

And so what?  Right now, my patients’ insurance programs do exactly the same thing—if I prescribe an angiotensin receptor blocker for blood pressure control, I’m going to be asked to justify why I am giving this rather than the cheaper and as-effective ACE-inhibitor.  The answer is usually that the ACE-I caused side-effects, but the question isn’t stupid.  Why should an insurer pay more when an equally effective, cheaper alternative is available?

If we have more evidence to work with, we can continue to make even better decisions regarding care.  It may seem intrusive, but it’s not very different from what we do already.  And honestly, I’d like to know if I’m more likely to get relief of my lumbar radiculopathy from surgery or from conservative therapy.  I will not be offended in the least if my surgeon got a call from my insurer asking if surgery was really my best option, as long as the answer was supported by good evidence.

It rings rather hollow when people protest against gaining more knowledge.  Libertarian types complain that this will inevitably lead to government interference (and it might, and maybe it should) but to ignore the need for evidence is absurd.  We, as physicians and patients, need more knowledge, not less, and we shouldn’t be afraid of where the data lead.  Once we have the data, we can sit down for a good, heated discussion about what to do with it.  But putting our collective heads in the sand is probably not a useful response.

Posted in: Science and Medicine

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Another challenge to surgical dogma

Better late than never with this one.

The dogma that I’m referring to is the remaining practice of using NG tubes in anyone with upper gastrointestinal surgery (liver, stomach, pancreas, duodenum, proximal small intestine) and then placing a jejunostomy tube (a tube, also often called a J-tube, that goes into the jejunum, or the proximal part of the small intestine, through which feedings can be given). The rationale for this was that the peristalsis of the small bowel returns almost immediately; it’s the large bowel and stomach whose return of peristalsis is delayed. Consequently, liquid tube feedings, it was thought, could be given beyond the point of surgery into the small bowel because if there is one surgical dogma that the evidence generally supports and probably always will, it’s always better to use the gut for nutrition than to use total parenteral nutrition (TPN, or feeding by veins). Moreover, there was evidence that such feedings had a protective effect on the lining of the bowel, preventing a phenomenon known as bacterial translocation, in which bacteria could pass through the compromised lining of the bowel after surgical stress. The price, however, was the placement of a tube into the proximal intestine, a procedure that, while safe, was definitely not without complications, some of which (such as bowel perforation) could be serious and require reoperation.

Challenging this dogma is the largest multicenter randomized study yet looking at this question: Which is better, bowel rest (NPO) and J-tube feedings or just letting the patient eat the next day? The study comes out of Norway1 and involved 453 patients. Blinding, much less double blinding, was, as is the case in many surgical trials, not possible because of the very nature of the question being examined, but other than that the design of the study was about as strong as a surgeon could ask for. Basically, patients were randomized to a routine of NPO and J-tube feeding until flatus indicated return of bowel function versus normal food at will beginning on postoperative day one; the experimental design is summarized below:
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Posted in: Clinical Trials, Science and Medicine, Surgical Procedures

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Live Blood Analysis: The Modern Auguries

I saw a patient last week who was self referred. He had been seeing a DC/ND for a variety of symptoms that turned out to be asthma. Not that the DC/ND made that diagnosis. His DC/ND diagnosed him with an infection, based on live blood analysis, and offered the patient a colonic detox as a cure. My patient thought he should get a second opinion before he submitted to a cleansing enema, always a good policy

Live blood analysis to diagnose an infection. I had never heard of the technique, but thanks to the google and the interwebs, I was soon immersed in the field.

In live blood analysis, the “physician” takes a drop of the patients blood and examines it under a high power phase contrast or a darkfield microscope. Changes in the constituents of the blood are noted and linked to a variety of ills.

It is an impressive and expensive system: microscopes and various support equipment start at around $5000 (3). However, live blood analysis has the opportunity to be lucrative in the right hands as the patient often gets weekly analysis to see how the interventions (usually supplements sold by the blood analyst) are working. Evidently in the hands of a skilled snake oil salesman, an income of $100,000 a year to more can be generated (8).

Live blood analysis is one of these alternative methodologies that has a hint of legitimacy that is extrapolated far out of proportion to its validity.
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Posted in: Science and Medicine

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Research, Minus Science, Equals Gossip

“A person is smart. People are stupid.”

- Agent K (Tommy Lee Jones), Men In Black

Regular readers of my blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.

Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of them to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.

There is growing support in the consumer-driven healthcare movement for a phenomenon known as “the wisdom of crowds.” The idea is that the collective input of a large number of consumers can be a driving force for change – and is a powerful avenue for the advancement of science. It was further suggested (in a recent lecture on Health 2.0), that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild:

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

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Another Negative Study of Vitamins

Perhaps one of the most common questions I receive from those who wish to utilize science-based medicine for their own health is what I think about vitamins. Even among hard-nosed skeptics, this question is often perplexing. On the one hand, vitamins themselves were discovered by medical and biological science, they play a vital role (by definition) in the healthy functioning of our bodies, and deficiencies of vitamins can cause disease. So they seem perfectly legitimate. On the other hand the market is full of exaggerated and even magical claims about the cure-all power of vitamins.

It’s difficult for people to come to a bottom-line conclusion – should they take vitamin supplements or not. Is it woo or not woo?

Well – it’s complicated. But there is large body of research to help inform our decisions about vitamins. Now, the largest study to date has been published (Multivitamin Use and Risk of Cancer and Cardiovascular Disease in the Women’s Health Initiative Cohorts) looking at 161,808 post-menopausal women over 8 years and finding no benefit for heart disease, cancer risk, or overall survival. This study comes on the heels of other recent studies showing no benefit from routine supplementation.

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Posted in: Nutrition

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Chiropractic’s Pathetic Response to Stroke Concerns

The chiropractic industry must be feeling the pressure. Billboards, signs on the sides of buses, chiropractic victims’ organizations, and lawsuits are telling the world that chiropractic neck adjustments can cause strokes. The risk is very small, but it is very real. We have addressed the subject before on this blog here, here, and here.

Chiropractors are in denial and are trying to shift the blame elsewhere. A correspondent sent me copies of a pamphlet and a “distribution kit” that the FCER (Foundation for Chiropractic Education and Research) is selling to chiropractors so they can inform the public about cervical artery dissection (CAD). It is advertised as a campaign to help the public recognize warning signs of stroke; but in my opinion, it amounts to a cynical, self-serving ploy to divert attention away from neck manipulation and to spread biased information about the recent study in Spine by Cassidy et al. (more…)

Posted in: Chiropractic

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