Evidence-Based Medicine, Treatment Scores, and the Hepatitis C Commercial on TV

Have you seen the commercial on TV for Harvoni? It's one of the seemingly hundreds of TV commercials about medicines frequently seen on TV. When I saw the Harvoni commercial I was skeptical. Was it all hype or was it for real? Hepatitis C is a bad disease and if you Google it, many celebrities have allegedly suffered from it such as: Stephen Tyler, Evel Knievel, David Crosby, and Pamela Anderson.

So, how does one do an evidence-based medicine review of the literature? First, I established the diagnosis that I wanted to review. After doing some searching on Medline I came up with: hepatitis C, chronic, genotype 1 infection.

Then, I decided on the outcome measure. The outcome measure most important to the patient, in my opinion, is a cure of hepatitis C. The medical literature uses the phrase: "sustained virologic response," which means that no virus can be detected in your body. It's more cautious than using the word cure. After all, what if the disease relapses years later?

At this point, to define things further I was willing to look at "adult patients" and "any time period" of follow-up. Although, after I while I realized that many studies used 12 weeks as their follow-up time period.

So, I collected some studies into STAR™ Blocks. STAR™ stands for a "Statistic and a Reference."

I was able to find some great randomized controlled studies. The main outcome measure was above 90% for sustained virologic response in three such studies. I finally settled on 95% as the number I would use as a weighted average of the statistics from the three studies.

This gave me a Treatment Score Calculator™ that looks like this:

I now have the main statistic on the left and the secondary statistics on the right. I still need to go through and come up with event rates for all the secondary statistics. But for right now, I think they are worth getting "cured" of chronic hepatitis C. Since they are relatively minor side effects I am only reducing the main statistic down one point to get a Treatment Score of 94 for Harvoni. This may change later with more study.

In other words, the medical literature seems to say, as I now understand it, that there is a 94% net treatment benefit when you treat Chronic hepatitis C of this type with Harvoni. That's much better than the old "gold standard" treatment with interferon.

The bottom line is that with a new statistic, the SOM® Treatment Score, we can begin to quantify the science of medicine behind treatments as part of the educational process. And we can make the entire process transparent to the patient from the diagnosis, to a list of treatments, to the Treatment Score Calculator™, and finally to the STAR™ Blocks. This system will eventually allow for shared decision-making and evidence-based medicine to be combined.

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