ZIFFPAGE TITLEBy Deborah Gage Print
The drug maker's best-seller has some nasty side effects. A voice recognition system helps patients, doctors and pharmacists manage the risk.Cash Cow in a Pill">
Cash Cow in a Pill
Right now, however, Celgene can't afford to stop selling Thalomid. For 2005, the company projects that around 76% of its revenue will come from Thalomid sales, down from 82% in 2004. One reason the 2005 percentage isn't lower is that in October the FDA delayed approval of Revlimid.
The FDA wants more time to review Celgene's risk management program. Lerner speculates the agency fears that Revlimid, like Thalomid, could cause birth defects, despite the absence of evidence for that notion in tests with animals. So Celgene is building a S.T.E.P.S.-like risk management system called RevAssist to control access to the drug. Lerner declines to discuss how RevAssist will work because its features are under discussion with the FDA.
Regardless of whether the FDA forces Celgene to change S.T.E.P.S., doctors who prescribe Thalomid expect it to become more widely used in January, when the drug, which can cost $1,500 a month, is covered by Medicare and more patients can afford it.
Northwestern's Bennett believes wider availability of Thalomid will mean more danger of side effects, although Celgene spokesman Brian Gill says the side effects are tolerable, well documented and clinically manageable.
But Bennett says the FDA has few resources to track drugs it has already approved, particularly when they are prescribed off-label for diseases like cancer that may kill people anyway.
One suggestion, from Gliklich, is that the FDA create "safety registries"databases that the agency could use to study a sample of people who are taking an already approved drug.
"You don't need every patient for blood clots in a S.T.E.P.S. program," Gliklich says. But he believes the registries would allow the FDA to study the new problems that inevitably crop up after a drug is approved and doctors start prescribing it off-label for unapproved treatments.
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