No Means No Except When It Comes To Healthcare

Over the past couple of years we’ve heard a lot about “comparative effectiveness research”. In medicine, it’s used used to determine which medical tests and procedures work best so we can get more value for our dollar and better healthcare. These are the clinical trials which either compares a new drug to a placebo or a new technology to an older one to see if it benefits patient care. The goal is to have safer, more effective, and less expensive healthcare.

I am a little worried that it doesn’t matter to the public (or doctors, for that matter) what the clinical trials show, given that so many of these studies are ignored. The needless MRIs, back surgeries, angioplasties, C-sections, etc that have been shown not to add any benefit to our care, and, indeed could put us in serious harm, but continue to be done anyway.

This was again exemplified in the response to last weeks decision by the FDA to revoke Avastin’s approval for treating breast cancer. Avastin received expedited approval from the FDA some years ago because the it’s initial clinical trial presented data that showed that it appeared to benefit patients with breast cancer. Expedited approval is given with the understanding that further clinical trials will continue for three years to confirm the first trials results.

In the case of Avastin, the other, more extensive trials did not confirm the first one. Not only did Avastin fail to extend women’s lives, it resulted, in some instances, in very serious health consequences, including. Now this doesn’t necessarily mean you cannot get the drug if you really wanted to take it. Your doctor can order it for you, “off label”; it only means that insurance may not pay for it.

End of story? I’m afraid not. Medicare decided to pay for Avastin despite its disapproval and many insurance companies are following suit.

Folks, if we’re going to decrease costs and elevate the level of care we get, we really need to pay attention to the science. What’s the point of using taxpayer dollars to fund these clinical trials if we’re going to ignore them?

No should mean no in healthcare, too!


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