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CardioFuel—another magic pill

I get a lot of email asking me about various alternative therapies and supplements. A recurring theme on this blog has been the hyperbolic claims of alternative practitioners and supplement makers, and while I can’t answer every email, I can at least address some of them in the blog. Supplements are often marketed using unsupported health claims to which is appended the Quack Miranda Warning, essentially allowing the makers to say that the pill will have such and such a benefit, while simultaneously denying any responsibility for the claim.  Since the FDA isn’t examining these claims, it’s worth while to ask our own questions.

The latest email concerned a product called CardioFuel. Let’s take a closer look at this stuff.

According to the distributor:

CardioFuel is the most profound energy producing supplement on the market today! It does something like no other can: Increase energy at the most basic metabolic level, by increasing ATP (the biochemical energy unit of transfer) production. More ATP means more energy reserves to overcome chronic disease, beat the competition, and handle the everyday stressors of today’s fast paced world!

So to be taken seriously, there should be evidence that this product: 1) increases ATP, 2) increases “energy reserves”, and 3) helps overcome chronic disease and “the competition”. First, it is not possible to directly measure ATP in a human being under normal clinical conditions, so any claims about this must be an inference from markers of ATP metabolism, or a guess. We’ll see what the literature says about this below. Second, we need an operational definition of “energy reserves”. Does this mean fat stores? Glycogen stores? These things are measurable to an extent.  Finally, we can do a literature search to see if CardioFuel or an acceptable analog has been tested for its effect on relevant outcomes.

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Posted in: Science and Medicine

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Science by press release

Last week I wrote about a study that purported to show that antidepressants have no effect in mild to moderate depression. A careful reading of the paper shows that the authors dramatically overstated their findings, particularly in their public statements to the media. The study has another implication beyond the misleading claims about antidepressants. It is an object lesson in an ongoing and disturbing phenomenon in mainstream journalism, the wholesale reprinting of press releases of scientific papers instead of reading and analyzing the papers themselves.

Pick up any newspaper or magazine and you can read about the latest scientific breakthroughs in cancer, Alzheimer’s or heart disease. Just keep in mind that what you are reading is probably a commercial message direct from the authors, not an accurate representation of the paper itself. Medical journalists are supposed to interpret the findings of recent medical publications and present them to the general public in ways that they can understand. They are supposed to provide context for the discovery, explaining what it might mean for disease treatment or cure. Yet, they rarely do. Instead, they simply copy the press release.

Most people are unaware that scientists issue press releases about their work and they are certainly unaware that medical journalists often copy them word for word. Instead of presenting an accurate representation of medical research, medical journalists have become complicit in transmitting inaccurate or deceptive “puff pieces” designed to hype the supposed discovery and hide any deficiencies in the research.

Imagine if a journalist reviewing the newest Ford cross-over vehicle didn’t bother to drive the car, but simply copied the Ford brochure word for word. Could you rely on the journalist’s evaluation? Of course not. Yet that is precisely what medical journalists are doing each and every day.
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Posted in: Science and Medicine, Science and the Media

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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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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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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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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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Reflexive doubt

Those of us who study, practice and write about medicine cherish the hope that explaining the science behind medicine (or the lack of science behind “alternative” treatments) will promote a better understanding of medicine. Certainly, I would not bother to write about medical topics if I did not believe that promoting science based medicine would lead to increased understanding of medical recommendations and decreased gullibility in regard to “alternative” remedies. Nonetheless, lack of scientific knowledge is not the only reason for the current popularity of “alternative health. Indeed, many advocates and purveyors of “alternative” health are impervious to the scientific evidence. What else might be going on?

Belief in “alternative” medicine is a complex social phenomenon. Like any complex social phenomenon, the explanation cannot be reduced to a simple answer. But I would argue that there is an important philosophical component, developed by and promoted by advocates of “alternative” health. That philosophical component is the rise of reflexive doubt. Simply put, among a significant segment of society, it has become a badge of honor to question authority.

As an obstetrician, I am most familiar with its expression among childbirth activists. They recognize that many people hold the common sense belief that modern obstetrical practice has made birth safer, and have worked ceaseless at undermining this common sense view. Craig Thompson, a professor of marketing, has examines this tactic in his paper What Happens to Health Risk Perceptions When Consumers Really Do Question Authority?:
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Evolution in Medicine

A recent series of article in the Proceedings of the National Academy of Sciences (PNAS) discusses the role of evolutionary biology in modern medicine. The authors collectively make a forceful point – medicine is an applied science. It is based upon a number of basic sciences, and one of those basic sciences is evolution.

The most obvious example is bacterial antibiotic resistance. Antibiotics place a selective pressure on a bacterial population, often resulting in the emergence of resistant strains. Understanding this “evolutionary arms race” between bacteria and antibiotics allows us to develop strategies for minimizing resistance.

But there are less obvious ways in which evolutionary principles apply to infectious diseases. It has been known for a long time that sickle-cell trait provides resistance to malaria (the blood cells are less hospitable to the P. falciparum protozoan parasite that is one cause of malaria). This explains the persistence of sickle cell disease in populations where malaria is endemic.

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Posted in: Evolution, Science and Medicine

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On the “individualization” of treatments in “alternative medicine”

One of the claims most frequently made by “alternative medicine” advocates regarding why alt-med is supposedly superior (or at least equal) to “conventional” medicine and should not be dismissed, regardless of how scientifically improbable any individual alt-med modality may be, is that the treatments are, if you believe many of the practitioners touting them, highly “individualized.” In other words, the “entire patient” is taken into account with what is frequently referred to as a “holistic approach” that looks at “every aspect” of the patient, with the result that every patient requires a different treatment, sometimes even for the exact same disease of very close to the same severity. Indeed, as I have described before, a variant of this claim, often laden with meaningless pseudoscientific babble about “emergent systems,” is sometimes used to claim that the standard methods of science- and evidence-based medicine are not appropriate to studying the efficacy of alternative medicine. Of course, this is, in nearly all cases, simply an excuse to dismiss scientific studies that fail to find efficacy for various “alt-med” modalities, but, even so, it is a claim that irritates me to no end, because it is so clearly nonsense. As Harriet Hall pointed out, alt-med “practitioners” frequently ascribe One True Cause to All Disease, which is about as far from “individualization” as you can get, when you come right down to it. More on that later.

A couple of years ago, before I became involved with this blog, I was surprised to learn that even some advocates of alt-med have their doubts that “individualization” is such a great strength. I had never realized that this might be the case until I came across a post by naturopath Travis Elliott, who runs a pro-alt-med blog, Dr. Travis Elliott and the Two-Sided Coin, entitled The Single Most Frustrating Thing About (Most) Alternative Medicine. In this article, Elliott referred to a case written up by a fellow naturopath, who used an anecdote about the evaluation and treatment plan by a naturopath of a pregnant woman with nausea to show what is supposedly the “unique power of our medicine.” Unexpectedly (to me at least at the time), Elliott did not quite see it that way:
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Posted in: Clinical Trials, Energy Medicine, Homeopathy, Science and Medicine

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