On the whole I agree with the commentary, but for one very important issue. Many of the people who say there is a problem and want change, are saying that the science and methods for detection need improving. This is where I do not agree. Vioxx showed a number of decision making and communication problems, not scientific ones.
I am very strongly for the idea that older drugs should be re-evaluated in the light of new, but again firm decisions not to do that have been made in the past, and followed by regulators internationally.
My chief worry is that further concern about the methodology in pharmacovigilance will lead to erosion of confidence in the current methods, that changes will be made in methods without trying to see properly whether they will be better, and that everything will become worse instead of better.
As an example, we were the first group in the world to do data mining both of spontaneous reports, and of other longitudinal datasets related to drug safety. We have published, been criticised, and modified the method for routine use. We are very aware of the shortcomings of data mining, that it is just one additional tool, but now more and more people are proposing it as ?the solution? to the drug safety problem.
The current hysteria over Vioxx is likely to provoke changes, in the way we do things, that are badly thought through.
We need better decisions and communication in drug safety, not bureaucracy and regulation.
Ralph Edwards
Professor and Director
UMC, Uppsala