Monday, January 14, 2008

Not "ENHANCE"-ing the public image of science, but it does show the power of the scientific method

The recent brouhaha over the Merck/Schering-Plough ENHANCE study can be pointed to as a triumph of science. SP clearly tried to pull a fast one by convening a "panel of experts" to determine the endpoint of the ENHANCE trial long after data was collected. Statistically, of course, this amounts to data dredging and is rather dishonest and unethical, not to mention unscientific. The power of science, after all, lies in our ability to predict outcomes based on our present data and current understanding of how things work, not picking outcomes on the basis of past data.

Our current safeguards have turned back a major assault on our sensibilities. I do feel bad for the Vytorin team because, well, they've gone this far into the development process and had a major setback. But as for the geniuses who decided to try to break the rules, I hope they find a different line of work. Having applied research help the public depends on a certain degree of trust, and shenanigans like this only serve to erode that trust.

As for me, I'm glad we've come this far in our ethical development as scientists to at least catch these blatant cases. But Congress is already trying to bang down our doors calling for more controls. I'm afraid there's more of our act to clean up.

As a note, Derek Lowe has a nice analysis of the clinical and statistical issues.