Tuesday, July 24, 2007

Could This Be What's Wrong with Company-Sponsored Clinical Trials?

The website ClinPage recently carried a story about a presentation made by Robert Ruffolo, president of R&D for Wyeth:


ClinPage ooh'd and aah'd about the fantastic results Ruffolo has had at Wyeth--discovery productivity up 500 percent, preclinical productivity up 600 percent, enrolling subjects in trials at 100 percent (vs. 60 percent a year earlier). The author made it clear that any competing company that did not sniff around to see how Ruffolo and Wyeth did all this would be crazy.

The story went on:

And his rivals, Ruffolo says, often express disbelief at the change that Wyeth has imposed on its scientific staff. Said Ruffolo: “I am often shocked by what I hear from our counterparts: ‘Our scientists would never agree to that.’ It’s not a democracy. You want democracy? Go to Russia.” The more profound issue, it would seem, is whether rigid scientific mindsets will be a barrier to further productivity gains at drug companies less interested in top-to-bottom transformation than Wyeth.

Now, isn't this exactly the problem? How far can you shoehorn science into a business-productivity model, before science has been turned on its head completely into marketing and PR? Isn't this at the very heart of what we see that's wrong with commercially-sponsored pharmaceutical research these days? Ruffolo says it's all the fault of FDA and Congress--those wusses are insisting that drugs be super-squeaky-safe, and ignore the bigger question of whether the drugs offer benefit. But when the benefit is so tiny that you need a multicenter trial with tens of thousands of patients enrolled to find any sign of it, maybe Congress and the FDA have it right and it's Ruffolo and his cronies who are the problem.

The article states that Wyeth is now so big on productivity measures that "missing a patient recruitment goal by a single patient might mean missing your bonus." Somehow I have a hard time imaging that any Wyeth worker would be a stickler for the ethics of research and for careful informed consent, when having the patient say no may mean you lose your bonus.

No comments: