Thursday, November 18, 2004
Sen. Charles Grassley on pharmaceutical regulation
Re Vioxx, heard on MSNBC this morning:
Chuck Grassley is a good senator who is not prone to making inflammatory statements in the interests of populism, but this is idiotic. It may very well be the case that Merck took too long to pull Vioxx -- the trial lawyers and juries will have the final say -- but if we only approved drugs with no side effects whatsoever we would never have another new drug in this country. Some problems just do not turn up as statistically significant until millions of people have taken the drug, the adverse events pile up, and a specific study can be designed and conducted to prove the connection. No Congressional oversight, vigilence at the FDA, or corporate compliance initiative can overcome the problem of rare but catastrophic side effects in pharmaceuticals.
The fact they pulled the drug from the market is proof there was something wrong with the approval process in the first place.
Chuck Grassley is a good senator who is not prone to making inflammatory statements in the interests of populism, but this is idiotic. It may very well be the case that Merck took too long to pull Vioxx -- the trial lawyers and juries will have the final say -- but if we only approved drugs with no side effects whatsoever we would never have another new drug in this country. Some problems just do not turn up as statistically significant until millions of people have taken the drug, the adverse events pile up, and a specific study can be designed and conducted to prove the connection. No Congressional oversight, vigilence at the FDA, or corporate compliance initiative can overcome the problem of rare but catastrophic side effects in pharmaceuticals.
0 Comments:
