Abbott’s cancer drug Xinlay didn’t show itself to be better than a placebo in clinical trials. No matter, Abbott intends to press for FDA approval anyway. According to the Wall Street Journal (Abbott Pushes Stalled Drug) Abbott will argue that “enough data exist to prove that the drug has bioactivity and few side effects.”
It’s a fairly desperate maneuver by Abbott. As the Journal says,
Xinlay is central to Abbott’s foray into the lucrative cancer market and is the first drug in five years to emerge from the company’s own labs. Some analysts believe Xinlay could reach about $1 billion in annual sales if approved. If Xinlay fails, Abbott would be left with a big hole in its pipeline.
In general I’m in favor of the approval of borderline drugs for serious diseases. Patients and their physicians should have the choice to try therapies that might work for them. But you can bet that if the drug is approved Abbott’s sales team will do all it can to portray the drug in a favorable light. It will be up to the medical journals, physicians, payers, and patients to keep Abbott in line.September 12, 2005