Sunday, June 17, 2007

The Provenge decision

I am normally very interested in cancer patients getting early and easy access to new drugs or biologicals and often despair at the reluctance of the FDA to facilitate either. But I agreed with their decision not to approve, at this time, the vaccine Provenge for Prostate cancer and wrote an editorial saying so for the July issue of Nature Clinical Practice Oncology where I serve as Editor in Chief. It can be found at the Journal's web site as an early online publication.
Since then I have received both praise and criticism as both sides feel passionately about the issue. For those of you who were surprised by my siding with the FDA, I have not had a change of heart about the general issue of easy access to cancer drugs and dearly hope that the large study the company, Dendrion, has underway to see if survival is really improved , is positive so the vaccine can be approved without any unwieldy baggage.