Tom (a pseudonym), a physician living near Boston, belonged to this group. He had developed a cytomegalovirus infection in his retina and was slowly going blind, but each time he visited the clinic he pressed me for information about saquinavir and asked me to tell him when the clinical trial would begin. His father begged me to persuade Hoffman-LaRoche to bend its rules and admit Tom. I said that I would try but had little hope of succeeding, explaining that the trial was designed to assess the drug’s safety, and if Tom’s vision got worse while he was taking the protease inhibitor we would have to report it to the drug company as an “adverse event.” Although we might suspect the infection of his retina to be the cause, Hoffman-LaRoche would have to list “declining vision”—and the F.D.A. would have to consider it—as a possible side effect of the drug.
Saquinavir proved to be strikingly effective against H.I.V. Within a few months, the immune systems of most patients who had taken the drug improved and the amount of H.I.V. in their bodies decreased. They gained weight, and had fewer infections. Tom, who had been denied admission to the trial, soon lost his sight and, not surprisingly, became clinically depressed. I assured him that I would make every effort to see that he did not suffer. He developed seizures, and a brain scan revealed a large mass with the characteristics of a lymphoma. He refused further treatment, was placed on a morphine drip at home, and died with his family at his bedside.
At the time, newspapers were filled with stories of AIDS patients whose lives had been saved by the protease inhibitors. It was later discovered that the drugs caused significant side effects in some patients, including an increased risk of diabetes and elevated cholesterol, but, when used with other anti-viral drugs, protease inhibitors helped reduce the death rate from AIDS in the United States by at least seventy per cent. It is possible that Tom would still be alive if he had been able to take saquinavir.
* bachelor of science from St. Joseph's University in 1963
* MD from Georgetown University School of Medicine in 1967
* Residence at Pennsylvania Hospital in general surgery and urology
* taught urology at the University of Pennsylvania School of Medicine.
* chair of the department of urology at The University of Texas M. D. Anderson Cancer Center
* founding director of the Prostate Cancer Research Program in 1996
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