Saturday, February 18, 2006

On predictable results

The CEO of Eli Lilly complains that pesky regulators have actually started doing their jobs in evaluating the side effects of new drugs:
The side effects of new drugs are receiving more attention than they deserve, said Eli Lilly & Co. Chief Executive Sidney Taurel on Thursday, unnecessarily delaying the regulatory approval process.

Asked in an interview why regulators have slowed down the approval of new drugs, Taurel told Reuters there was too much emphasis on drugs' side effects, as opposed to their benefits.
So where did that movement toward actually addressing side effects come from? One of the pharmaceutical industry's top lobbyists provides the answer:
"We've created an impression with the American public that when a drug is approved, it's perfectly safe," said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, a lobbying organization for brand-name drug companies. "We have not done a good job about educating the patients of America that all drugs come with significant side effects."

Mr. Tauzin said the industry was "beginning to make progress and turn things around." He said it was addressing its image crisis by being more careful with its advertising, by pledging more disclosure of clinical trial results and by working to make low-priced drugs available to poor and uninsured Americans.
To summarize: pharmaceutical companies admit to having wrongly created an expectation that consumers could trust that medicine on the market would be safe, based in large part on the role of regulators in granting approval. But in acknowledging that fact, the industry never expected regulators to try to give some legitimacy to the expectation. And now that actual regulation is taking place, the industry is crying foul and demanding that the balance be shifted back toward favouring approval with less consideration of side effects.

There probably is a strong case to be made for a relatively streamline system to get drugs to market - provided, of course, that approval accompanied by reason to believe that the side effects are receiving due attention at some point in the process. But since it's hard to have any confidence in that prospect for now, nobody should be able to blame regulators for approaching new drugs with caution. And that goes doubly for the pharmaceutical companies whose actions led to reasonable suspicion in the first place.

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