Bending The Rules Of Clinical Trials
By Pauline W. Chen, M.D.
Louise (not her real name), a scientist and avid runner in her 50s, first noticed the strange pangs under her right ribcage a few weeks before we met. Her CAT scan revealed a liver so riddled with islands of tumor that the radiologist called them “too numerous to count.” None of the standard surgical, radiologic or chemotherapy treatments would help, and her doctor told her that she had two, maybe three, months to live.
Louise came to us for a second opinion. I swallowed hard before going into her exam room to summarize my findings. It was, and still is, not easy for me to tell patients they are dying.
But her reaction surprised me. Instead of a grim silence or even tears, she simply smiled. “I want to become a grandmother,” she said, looking over at her pregnant daughter-in-law, who was just beginning to show. Louise knew she was going to die from the cancer; she wanted only to live long enough to see her grandchild born.
For the rest of the afternoon, Louise’s plea played over and over in my mind. I wanted to offer something — anything — that might increase her chance of survival by a few months. No standard therapy would work, so I wondered if a clinical trial, a study of a new drug or treatment, might hold some promise.