Serious questions about cancer research were raised in a 25 April New York Times editorial. The editorial cites a report issued by the National Academy of Science’s Institute of Medicine (IOM) that warns about deficiencies for conducting cancer studies sponsored by the National Cancer Institute (NCI). The Times emphasized the importance of government sponsored research stating it was industry sponsored research could be more biased and that government funded cancer studies were more like to take on the rare diseases with little commercial potential. The IOM report also also stated the obvious: that government funding sometimes comes with beauracracy that hinders research. Except this time its worse. The Times states:
“So it is especially worrying to hear the experts say that the system — run by the Cancer Institute at the National Institutes of Health — is so mired in cumbersome procedures that it needs to be completely overhauled.”
This touched off a lively discussion in the 2 May “Letters to the Editor” section of the Times. Two oncologists with the American Society of Clinical Oncology cited a shortfall in funding to NCI’s cooperative group program. Another researcher with the Massachusetts General Hospital Cancer Center states that while the cooperative group program is important, it is no longer the exclusive route to drug development. And a researcher at Case Western Reserve cited the lack of enrollment into clinical trials to be a significant barrier to research. About five years ago a reader poll in Applied Clinical Trials about 50% of the respondents cited enrollment difficulties as the primary barrier to all clinical trials- five times the number that cited regulatory burdens. Finally, a researcher argued that NCI has too strong a focus on tumors and not the immune system. He might have a point as discussed in the next paragraph. Clearly there are serious questions being asked about cancer studies.
This week wasn’t all bad news. The Dendreon Corporation received FDA approval for Provenge, a therapeutic vaccine that fights prostate cancer, and is hopefully one of the answers. Provenge is the first therapeutic vaccine (officially “autologous cellular immunotherapy”) approved by FDA to fight cancer. It uses the body’s own immune system to attack the tumor. This could spur further research and approvals of therapeutic vaccines. It also could provide more private sector funding of cancer trials.Dendreon is based in Seattle, close to the home of this Blog. I certainly hope that the approval will also provide a shot in the arm for cancer studies and other clinical trials in the Pacific Northwest life sciences industry.
I have been fortunate to know some of the GxP professionals who have worked at Dendreon over the years. I know how hard they have worked and offer my congratulations for a job well done.
FDA Press Release May 3rd on safety review of commonly used prostrate cancer drugs.