The frustrating lack of comparative effectiveness — Part I
Monday, July 07, 2014
When you go to the doctor's office, you expect your healthcare providers will prescribe drugs that will be effective and safe in treating your diagnosis. But which drug is best for treating your disease or medical condition? You rely on your physician or PA to make this determination.
You also rely on your healthcare providers to have the treatment available on their formulary. And lastly, you rely on your insurance company to pay for your treatment of choice, less your co-pay, if you have one. You would expect them to make these determinations based on the best available clinical data and published medical literature.
But what is the best available data? What it most likely is not is comparative effectiveness data. Clinical studies comparing treatments side by side in statistically valid designs to determine which treatment is best for which type patients.
So if it isn't comparative effectiveness data from these well-controlled comparative studies, what information do they use to decide what is best for you and treating your disease or medical condition?
It could be treatment guidelines by a medical society or panel of physicians with specific therapeutic area of expertise. More likely, it is merely the physicians' interpretation of what they have read, discussions they have had with their colleagues and/or their personal clinical experience. And again, where did they all get their data to determine which drug is best?
The reality is there are few comparative effectiveness studies to demonstrate which drug treatments are best for any particular disease. Even treatment guidelines that supposedly include "exhaustive" reviews of the literature are at best "reviews."
Often — by their own admission and the use of footnotes — the conclusions drawn are interpretations of the data reviewed, or opinions of the physician panel, and do not represent statistically valid comparisons. These guidelines are therefore often equivocal when it comes to making specific recommendations.
OK, so maybe drug companies could have been more aggressive in pursuing comparative effectiveness studies. Unfortunately, the risks associated with losing a comparative effectiveness study far outweigh the upside from a positive study — which will almost certainly be suspect, especially if sponsored by the winning drug company.
The reality is that it is impractical to do statistically valid clinical trials to validate best drug treatment practices across patient types in multiple therapeutic areas. But rather than trying to do thousands of studies comparing hundreds of drugs, why not at least try to evaluate all the treatment data available in electronic health records?
This may come to pass with the Affordable Care Act. Surely there are more patient data points in collective global electronic health records than could ever possibly be gathered from individual clinical trials. Now it becomes a matter of how to realistically capture and digest all that data.
So, if the data were available, what would happen? How would this data be received? Would patients get better care? We'll discuss this in our next post.
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