Sartre on freedom

Yes I continue to listen to my tapes on existentialism. Currently, the lecturer is focusing on Sartre. Sartre’s philosophy is quite complicated, but does include the concept of no excuses. I found this quotation particularly interesting.

“Freedom is what you do with what’s been done to you.”

NY Times editorial on PROVE-IT

Extra-Low Cholesterol

A cholesterol-lowering study whose results were announced this week has a wealth of important implications. The findings could certainly presage a significant change in the way heart disease patients are treated. It should also start a careful evaluation of whether normally healthy people could benefit from a sharp drug-induced reduction in their cholesterol levels. There may also be major side effects for the economy: the potential health benefits could drive up the use of high-cost drugs in a nation that is already struggling to pay its medical bills. Finally, the study should send a message to Congress and federal regulators about the value of comparative testing of prescription drugs.

The NY Times has a few issues right, and one or two that may not be right. Clearly, this study does make us reconsider how we treat coronary artery disease patients. The study does show that. My blogging colleague, Sydney Smith, disagrees – The Love Affair Continues. She and I have previously agreed that we can and should disagree on issues. I believe she is wrong on this one.

She minimizes the benefit

The results are more notable for what they don’t tell us than what they tell us. Rather than following patients over a given period of time and tallying the number of events each group had, they stopped the study when they had 925 events, then relied on statistics to estimate the rates. As a result, the paper deals not with actual event rates but with Kaplan-Meier event rates. A far better study would have been to look at the actual rates. But then, the significance of the findings might not have been as impressive. That is, it would have been harder to present their statistically significant findings as equally clinically significant.

Sorry Sydney, but Kaplan-Meier event rates are actual event rates. Kaplan-Meier curves allow one to evaluate the entire curve over time, rather than just comparing rates at one arbitrary endpoint. Therefore they are much more informative. If anyone wants to read the nitty-gritty on this subject – Survival Curves: Accrual and The Kaplan-Meier Estimate. As I read this study, the results are dramatic (and just in the first 2.5 years). As I wrote yesterday, the curves suggest that the results would become even more dramatic over longer time frames.

The NY Times has no reason to suggest using higher doses as primary prevention. Primary prevention really is a different problem than secondary prevention. Extrapolating these data to the primary prevention problem does not make sense in 2004.

The NY Times suggests that the cost of the higher dose (a difference of ~$600/year) would “drive up the use of high-cost drugs in a nation that is already struggling to pay its medical bills”. They should consider the possibility that the decrease in mortality and hospitalizations could overcome the medication costs. We err when we look at medication costs without analyzing the benefits of decreased hospitalizations, decreased development of congestive heart failure, decreased bypass surgery, and decreased mortality. These costs are all important.

Finally the NY Times is correct to point out the importance of head-to-head drug trials (a process which I have championed here over the past 2 years). Interestingly, and supportive of the results:

Bristol-Myers sponsored the study and expected it to prove that its drug was just as effective as Lipitor when it came to reducing disease and preventing deaths. Bristol-Myers was disappointed. But the effort did underline the great benefit in comparing the performance of two prescription drugs. Traditionally, drugs are only tested against placebos. From now on, the value of head-to-head competitions should be obvious to everyone.

Yes, Bristol-Myers makes Pravachol – not Lipitor. Kudos to Bristol-Myers for sponsoring this important study!!