Vytorin (Zetia): More expensive and poorer results

Jan 14, 2008

Interesting news flash from the pharmaceutical industry, and another reminder why the choice of metrics is so important: Zetia (the other half of Vytorin) while lowering cholesterol, simultaneously increases the growth of plaque in the coronary arteries. How’s that looking for a price: benefit ratio?

While it didn’t appear clear what the overall outcome was vis a vis heart attacks and clinical outcomes, it appears to be a disturbing finding that brings into question the benefit of the drug.

A refresher from my article on metrics:

There are two types of metrics, process and outcome metrics. Process metrics are seen as means of getting to desired results, with outcome metrics being the desired results. Outcome metrics are the things that really matter– in medicine this would be rates of morbidity and mortality, with good patient experience also potentially a desired outcome.

The issue we have with quality reporting today is that most of the metrics available focus on process: did they use an EMR, did they give pill X in Y time, did they check body part A for B sign. While process is important, process metrics often forget about context and they forget that there are many roads to the end-goal. Unfortunately, process can only incorporate disease features we think we understand– and as with drug-eluting stents, we may be maximizing to solve intermediate steps but creating a worse end outcome.

Outcome metrics, while politically less viable (everyone wants a reason why they’re not #1–and will complain they need to stop seeing sick patients), are truly measures ensuring that treatments work as well as promised.

First off, growth of plaque in the coronory arteries and cholesterol levels are both intermediate (process) metrics that are correlated to heart attacks, but haven’t been shown definitively to be causative. So we don’t necessarily know which is more important (if either– it could be something else e.g., C-reactive protein).

This does highlight, however, that the expert quality guidelines may have increased cost while decreasing the clinical outcomes of care– ie all the emphasis on cholesterol reduction requiring the use of increasingly powerful medications in increasingly marginally risky populations may have driven us to the flat of the curve and beyond.

This is one reason why command and control (top-down) systems often don’t work– they are as much influenced by the agendas and fallacies of men as any other system– but reduce the ability of the non-commanding population to make their own choices. Despite our trappings of knowledge and belief in existing theory, nature manages to make the most intelligent physician look silly in hindsight. Therefore, the ability to empower the populace to make their own educated guesses (and openly share treatment philosophies) would appear to be a moral responsibility of the responsible healthcare provider.

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Posted by Vijay Goel, M.D. | Categories: Uncategorized | Tagged: , , , , |

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