Friday, September 19, 2008

NBT Article on Balancing Efficiency and Safety

The latest issue of Nature Biotechnology has an interesting News Feature piece on the FDA's Office of Oncology products. How do you strike a sensible balance between efficiency and caution? Here is a sample:

The US Food and Drug Administration often finds itself between a rock and a hard place when balancing safety and efficacy decisions for therapies targeting life-threatening conditions, but the recent approval of cancer drug Avastin (bevacizumab) for breast cancer seems to have brought out a wider than usual array of critics, with some taking surprising positions. The Genentech drug, in use since 2004 for colon cancer, was approved by the FDA this February for HER2-negative patients. The approval was based on progression-free survival data—a surrogate clinical trial endpoint that many oncologists would like to see used more often. But that decision went against an advisory committee's advice, raising the suspicions of Senator Charles Grassley (R-IA), who is calling for an investigation into using surrogate markers in drug approvals (Box 1). At the same time, a vocal minority of companies, patient advocates and researchers continues to argue that the Office of Oncology is raising the bar too high for cancer drugs with novel mechanisms. Who is right?