HOLMES REPORT: If FDA sides with companies on lawsuits, it'll lose its bite as a watchdog for consumers

"Who would I rather have deciding which drugs are safe - scientists or trial lawyers?" Robert Goldberg of the Manhattan Institute's Center for Medical Progress asks a question of dubious rhetorical integrity at the end of a column in The Washington Times.

"Who would I rather have deciding which drugs are safe - scientists or trial lawyers?" Robert Goldberg of the Manhattan Institute's Center for Medical Progress asks a question of dubious rhetorical integrity at the end of a column in The Washington Times.

Goldberg is responding to accusations that the Food & Drug Administration's chief counsel, Daniel Troy, had acted inappropriately by suggesting pharma companies enlist his help to fight consumer lawsuits.

Let's deal with Goldberg's false dichotomy first. He chooses to attack trial lawyers because, after years of corporate propaganda, Americans have come to believe that anyone who goes to bat for a child injured as a result of corporate negligence is quite obviously a venal monster. But even if you accept that stereotype, in reality trial lawyers don't get to decide whether drugs are safe - judges and juries do after listening to evidence from all parties.

Goldberg also seeks to imply that the folks on the other side from the trial lawyers - scientists - are paragons of objectivity, making reasoned judgments based on their knowledge. But that objectivity is precisely what critics charge is missing. The FDA, they say, has forgotten that its mission is to protect the public health and now believes its mission is to protect corporate profits. Its scientists are either in the pockets of the drug firms - most of them have worked for big pharma - or under the influence of pro-corporate politicians.

Without wishing to suggest that the FDA has been thoroughly corrupted, there's no doubt that Troy's decision to align with the firms he is charged with overseeing in their battles with the people he is charged with protecting creates the impression of an agency that has lost sight of its mission.

Troy is concerned about suits like one brought against Pfizer, which makes the antidepressant Zoloft. The company is being sued because it failed to warn consumers in its packaging that the product might cause suicide. The FDA failed to require such warnings because, it says, it was worried that patients might forego treatment out of concern about its possible side effects. In other words, the FDA has the same contempt for ordinary consumers that Goldberg apparently has for juries: We can't trust them with accurate information because they might not make the "right" decision.

When people lose confidence in the FDA - as they surely will if it continues along its current path - we shouldn't be surprised if they fall back on the less tidy, but apparently more even-handed, judicial system. That's why all of us - pharmaceutical companies included - have an interest in an FDA that looks and acts like an impartial watchdog rather than an industry lap dog.

  • Paul Holmes has spent the past 17 years writing about the PR business for publications including PRWeek, Inside PR, and Reputation Management. He is currently president of The Holmes Group and editor of www.holmesreport.com.

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