Are 37 minutes of sleep worth $800,000,000?

It seems appropriate to repost my blog from July 29, 2009, in view of this excellent article from Lisa Schwartz and Steve Woloshin from Dartmouth in the current NEJM -- it is a must read. You will not believe what some of the effectiveness claims in FDA-approved drug labels are based on!

Voodoo Medicine

An excellent post the other day on the Science-Based Medicine blog addressed "Incorporating Placebos into Mainstream Medicine". In it the author, Harriet Hall, rails against complementary and alternative medicine as inherently leveraging the placebo effect. She goes on to ask "What if scientific medicine were to co-opt the CAM movement? We could take these treatments out of the hands of the less ethical practitioners and outright scam artists and place it in the hands of those who are more likely to be altruistic". This mouthful grabbed my attention.

Here is what bothered me. The traditional healthcare providers believe that they are practicing scientific medicine. And why wouldn't they? The clinical research establishment (of which I am a part, mind you) is constantly touting new breakthrough results, and the FDA after all only approves therapies that are proven to be effective! Well, not so fast; there are an awful lot of assumptions in this statement. First, how much of the research out there is of high quality and how much is bovine excrement? Next, even the best of studies that find statistical advantages to one course of action over another show minute, potentially inconsequential differences that a lot of the time translate into zero benefit outside the laboratory of clinical trials. And as for the FDA, they are paid by the manufacturers to review and approve drugs and devices. And even though I trust in their earnestness, most of the time they require only statistically significant differences (microscopic ones can still emerge given a large enough study size) in outcomes that are not all that meaningful to one's well-being (e.g., drop in cholesterol as a surrogate for a reduced risk of death from cardiovascular disease, a less straight-forward relationship than you might suspect).

So, there is the science bit. As for ethics, I will give Dr. Hall that for the most part MDs do try to practice what is commonly accepted as scientific medicine. The key here is "for the most part". Remember Gawande's story of McAllen, TX? And lo' and behold, just a few hours ago Reuters reported a bust of a large Medicare fraud scheme, where, believe it or not, docs were charging $3,000 to $4,000 for simple knee and shoulder braces and heating pads, calling them "arthritis kits". And while I do not question the ethics of the majority of my brethren, this incident sure underscores that, just as CAM practitioners, the house we live in is also made out of glass.

We have a long way to go to achieve good health in this country. Our culture has become over-reliant on experts in everything, including healthcare and evidence, to slap our wrists when we have been "bad" and to give us marginally useful advice on how to cure our ills. We must question our assumptions. I agree with Dr. Hall, nothing replaces a combination of evidence and experience. Or the placebo effect.