Faith in the system

Laura Bush

I am the trusting sort. When people lie, I miss the clues. So I’m terrible at following crime shows. Trying to figure out who the bad guys are, and who is manipulating whom to get what–I just don’t get it.

In the most unsettling mystery movies, too, the people you believed in the most–like the cops–turn out to be the criminals. That makes me queasy.

That’s why I’m having such a hard time with the Vioxx case. Are FDA the good guys or the bad guys?

One of two things must have happened. Either FDA was doing everything it could to protect us, and was simply unable to with the data it had; or some other concern took precedence over public safety. Neither option is very comforting.

I know FDA has the delicate job of balancing the risks and benefits of every new drug. But I am concerned about the apparent suppression of internal dissent. Some suggest that the agency may have been reluctant to upset Big Pharma by forcing the withdrawal of a blockbuster drug. FDA has been trying to foster open dialogue with the industry; maybe too much cooperation isn’t good, if it breeds a need to please.

Or perhaps they were just reluctant to question an approved product, afraid that the public would lose faith in agency decisions. On the contrary, I believe that admitting mistakes, particularly in view of new data, will increase the public’s trust.

If, on the other hand, the agency was simply unable to protect us better, changes are needed. FDA has announced new measures to improve drug safety (see page 20). These include a review of postmarket programs, which is critical, because the existing adverse events reporting system is clearly insufficient. If these measures are implemented openly and thoughtfully (not just for appearances), FDA will be able to restore the public faith.

And we won’t have to wonder who the good guys are.

Laura Bush, Managing Editor

lbush@advanstar.com

COPYRIGHT 2004 Advanstar Communications, Inc.

COPYRIGHT 2005 Gale Group

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