Sanofi's conduct in the testing of Ketek underscores the importance of trust in shaping perceptions of risk. The relationship between drug companies and consumers must change. It will have to be more honest, more transparent, more individualized and enduring. It can't end after the FDA approves a product either.
According to the WSJ the FDA said it was "unable to find evidence" that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.
These problems are rare and will happen. However when they are detected they should be reported promptly and the unqualified investigators should be barred from participating in clinical trials as a matter of industry policy.
http://online.wsj.com/article/SB119328145497070973.html?mod=googlenews_wsj
According to the WSJ the FDA said it was "unable to find evidence" that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.
These problems are rare and will happen. However when they are detected they should be reported promptly and the unqualified investigators should be barred from participating in clinical trials as a matter of industry policy.
http://online.wsj.com/article/SB119328145497070973.html?mod=googlenews_wsj
