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Posts Tagged research

## Fun With Statistics

Statistics is the essential foundation for science-based medicine.  Unfortunately, it’s a confusing subject that invites errors and misunderstandings.  We non-statisticians could all benefit from learning more about statistics as well as trying to get a better understanding of just how much we don’t know. Most of us are not going to read a statistics textbook, but the book Dicing with Death: Chance, Risk, and Health by Stephen Senn is an excellent place to start or continue our education. Statistics can be misused to lie with numbers, but when used properly it is the indispensable discipline that allows scientists:

…to translate information into knowledge. It tells us how to evaluate evidence, how to design experiments, how to turn data into decisions, how much credence should be given to whom to what and why, how to reckon chances and when to take them.

Senn covers the whole field of statistics, including Bayesian vs. frequentist approaches, significance tests, life tables, survival analysis, the problematic but still useful meta-analysis, prior probability, likelihood, coefficients of correlation, the generalizability of results, multivariate analysis, ethics, equipoise, and a multitude of other useful topics. He includes biographical notes about the often rather curious statisticians who developed the discipline. And while he includes some mathematics out of necessity, he helpfully stars the more technical sections and chapters so they can be skipped by readers who find mathematics painful. The book is full of examples from real-life medical applications, and it is funny enough to hold the reader’s interest. (more…)

Posted in: Book & movie reviews, Science and Medicine

## Funding CAM Research

Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.

Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.

“NCCAM officials have spent \$375,000 to find that inhaling lemon and lavender scents does not promote wound healing; \$750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; \$390,000 to find that ancient Indian remedies do not control type 2 diabetes; \$700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and \$406,000 to find that coffee enemas do not cure pancreatic cancer.”

The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.

## The Rise of Placebo Medicine

It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.

We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.

With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.

## The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of \$121 million a year, for well over \$1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:

• Explore complementary and alternative healing practices in the context of rigorous science.
• Train complementary and alternative medicine researchers.
• Disseminate authoritative information to the public and professionals.

If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.

Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.
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## Snake Oil Science

For my first blog entry, I wanted to write about something important, and I couldn’t think of anything more important than a recent book by R. Barker Bausell: Snake Oil Science: The Truth About Complementary and Alternative Medicine. If you want to understand how medical research works, if you want to know what can lead patients and scientists to false conclusions, if you have ever used complementary or alternative medicine or have wondered why others do, if you value evidence over belief, if you care about the truth, you will find a treasure trove of information in this book.

Some of the treatments encompassed under “complementary and alternative medicine” (CAM) have been around for a long time. Before we had science, “CAM” was medicine. Back then, all we had to rely on was testimonials and beliefs. And even today, for most people who believe CAM works, belief is enough. But at some level, the public has now recognized that science matters and people are looking for evidence to support those beliefs. Advocates claim that recent research validates CAM therapies. Does it really? Does the evidence show that any CAM therapy actually works better than placebos? R. Barker Bausell asks that question, does a compellingly thorough investigation, and comes up with a resounding “NO” for an answer.

Bausell is the ideal person to ask such a question. He is a research methodologist: he designs and analyzes research studies for a living. Not only that: he was intimately involved with acupuncture research for the National Center for Complementary and Alternative Medicine (NCCAM). So when he talks about what can go wrong in research and why much of the research on CAM is suspect, he is well worth listening to.