COMMENTARY - Unlucky Jim
By ROBERT OLDHAM
February 16, 2005; Page A14 I'd been treating Jim for kidney cancer for years. He experienced a spread of the cancer to his bones and received radiation therapy. A spread to the lungs prompted Interleukin 2 therapy, the only known curative treatment for advanced kidney cancer. Subsequently, he received Thalidomide, Interferon, and Gemzar plus Interleukin 2 as sequential therapeutic trials. In spite of these, his cancer continued to grow and spread.
I tried to obtain BAY 43-9006, a promising new drug, but Bayer Pharmaceuticals and the National Cancer Institute told me it was not available for Jim. Subsequently, a Phase III trial of BAY 43-9006 opened but it randomized patients with advanced cancer to this drug against a placebo treatment for 50% of the patients.
I believe randomizing patients with advanced cancer to a sugar pill to prove a drug works is not ethical. Jim agreed. So no BAY 43-9006 for Jim.
Sugen developed an interesting new drug for cancer called SU 11248. Sugen was then acquired by Pharmacia which was soon acquired by Pfizer
. When I called to see if Jim could get SU 11248, I was told it was available only at Sloan Kettering and that he was too sick for this trial. So no SU 11248 for Jim. (Dr. Robert J. Motzer of Sloan Kettering has stated that "this is the first drug in the last 20 years . . . that has really shown activity" in kidney cancer.)
Because none of the promising new drugs for kidney cancer were available, I looked to all the newly approved drugs. Based on a promising study from Nashville, Tenn., Jim was given Iressa and Avastin. The lung nodules began to shrink! Alas, after several treatment cycles, they began to grow again. Next, he was treated with Tarceva and Navelbine, with no response. Cancer growth persisted and Jim died on Monday, two years after developing kidney cancer.
Did he benefit from the treatments he received -- from those approved for kidney cancer, as well as from those approved for other cancers and used "off label"? Yes.
Did he get access to the newest drugs which might have saved or prolonged his life? No. And did our cancer research and treatment programs work optimally for Jim? No. The FDA sets the regulations for the testing of new drugs, and drug development companies tightly adhere to these rules. So, Jim remained protected -- unto death -- from the potential toxic effects of these drugs.
What possible harm could have come to Jim, in the last months of life, if he'd been able to try BAY 43-9006 or SU 11248? Jim was like thousands of cancer patients each year who want access to new drugs. But by restricting access, we elevate our caution above their lives.
Goodbye Jim -- you fought the good fight. I only wish I could have given you more weapons for your struggle.
(Postscript: Jim was 69 and in vibrant good health prior to this cancer. I have cared for many Jims over the last 25 years where a similar story could have been written.)
Dr. Oldham is a physician in Thomasville, Ga.
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