Monday, May 3, 2010

The National Cancer Institute's Broken Clinical Trials Program and The New York Times

There was an editorial in The New York Times last week on a report by the Institute of Medicine on the NCI's clinical trials program and its difficulties. The editorial made the point that the clinical trials effort is at the heart of transferring technology to cancer patients, and that it needs fixing.

The IOM report and the editorial missed the major problem, however. So did the letters to the editor on Sunday 2 May from Drs Doug Blayney and Alan Lichter, on behalf of the American Sociey of Clinical Oncology, and from Dr  Bruce Chabner, Clincal Director at Massachusetts General Hospital Cancer Center in Boston.

Blayney and Lichter extoll the virtues of the clinical cooperative groups and claim that the problem is money. They are underfunded, they say. True. Chabner points out that the  NCI's cooperative group program is no longer the main instrument for developing new treatments anyhow. Also true. (In fact they never were. But that's another story.)

But everybody missed the main source of the problem: over regulation.

Apparently this is too much of a lightning rod for people to discuss in public. Over regulation, in the name of patient safety, affects both cooperative group and industry studies. In the name of protecting patients from harm they stifle new developments and instead "protect" patients from access to new treatments.

I refer the reader to an editorial I wrote on this subject in 2009 for Nature Reviews Clinical Oncology and reprinted on this blog shortly thereafter. Pumping money into the archaic mechanisms of doing clinical trials in NCI's cooperative groups won't do an ounce of good if the structural problems aren't fixed first.

1 comment:

  1. Today I learned from an article by Malcolm Gladwell in the May 17, 2010 The New Yorker that you developed CMF chemotherapy. I have recently been treated with CMF at MSKCC for estrogen-receptive breast cancer that had metastasized into a sentinel node. I was unprepared for the significant cognitive side effects of CMF, and shocked when I saw just how little research has been done quantifying the full impact of CMF. Have you ever done such research? Was it ever part of the initial research protocols to see how these chemicals might be affecting women's cognitive abilities? Or was the sole outcome the removal of cancer? I ask this question sincerely, because now that cancer is a chronic disease, in part due to your research and clinical work, shouldn't patients be fully prepared for the impact of cancer treatments?