Amgen gets body blow

Another one - this time from a panel of advisers to the FDA, which voted 15-2 in favor of prescribing new restrictions for those anemia drugs made by the Thousand Oaks-based drug company, as well as by Johnson & Johnson. The FDA usually follows the recommendations of its advisory panels, so this could be a very big deal. The basic question is to what degree the drugs raise the risk of heart attacks, strokes and death when used at high doses? From Bloomberg:

"What data do you have to show me that this is not Miracle- Gro for cancer?'' asked Otis Brawley, a hematologist at Winship Cancer Institute in Bethesda, Maryland. Brawley also asked why the company didn't provide full responses to FDA requests for data. Amgen vice president Roy Baynes replied that academic researchers, like those on the panel, often don't turn over full results to the FDA, either. Richard Pazdur, head of the FDA's oncology office, said Amgen had "an obligation'' to provide full data, considering the safety controversy that arose three years ago, when a similar panel hearing was held.

Amgen shares got hammered today - down more than 9 percent, to $57.33. By the way, in case you think none of this has anything to do with you because you're not an Amgen shareholder or you don't use one of thse drugs, keep in mind that Amgen's Epogen and J&J's Procrit together were the single biggest drug expense for Medicare in 2005, costing a cool $2 billion.