Taking Your Drug For A Test Drive
Make a commentBy Ed Silverman // April 5th, 2007 // 6:48 am

This sounds like a riddle: Is taking a medicine just like buying a car?
Yes, says, Ture Sjoblom, AstraZeneca’s head of European regulatory affairs. Speaking at the Drug Information Association meeting in Vienna this week, where EMEA transparency rules were discussed, Sjoblom makes the analogy that he wouldn’t wish to know how airbags or brakes in a car work, so long as he gets home safely and comfortably. The same is true of medicines, he says.
“People only want to know if the drug is safe, efficacious and is of high quality.”
His employer and other drugmakers don’t want to publish manufacturing details or minutes and agendas of their drug evaluation meetings prior to regulatory approvals. Such disclosure, they complain, would put them at a competitive disadvantage, Besides, Sjoblom argues, the public doesn’t really care about such details.
Such patronizing won’t work. This is the same industry that is regularly scandalized over cases in which safety data contained in clinical trials was kept hush-hush, breeding a lack of trust. Who knows what useful info is lurking in the minutes? If Sjoblom and his colleagues chafe at such views, they have only themselves to blame. No one forced drugmakers to hide anything.
As to the car analogy, it fails. True, most people only care if a drug is safe and effective. But few have the luxury of a test drive before taking a badly needed medicine. Moreover, looking under the hood is a common practice when purchasing a car, whether at the dealer, the mechanic or in an easily obtained publication. Concerned about features and you can shop for something else.
Sjoblom should consider this next time he drives a family member to the pharmacy.
[tags]EMEA, Safety[/tags]