Introduction

Patients with undiagnosed glioblastoma multiforme – an advanced form of brain cancer – typically arrive at the doctor's office complaining of headaches and weakness; a good many might also have experienced a seizure. Within a year, approximately half will be dead.

Progress against glioblastoma has been halting, and even modest improvements in treatment, like a median extension of survival of two and a half months, are greeted as breakthroughs. And so it was that, in 1992, a 51-year-old woman, whose husband was a prominent lawyer and chair of the board of the San Diego Cancer Center, was diagnosed with glioblastoma. Conventional therapies were unsuccessful in controlling her disease, and the woman sought enrollment in a gene-transfer study being planned at the San Diego Cancer Center. The problem was that the protocol had not yet been reviewed by the RAC, which met every three months; the patient was expected to live no more than two.

A former client of the woman's husband knew Iowa's Senator Harkin, and offered to contact him to see whether political pressure might be brought to bear. Shortly thereafter, Harkin forwarded a letter to NIH head Bernadine Healy requesting that she waive normal RAC review, though the developer of the intervention, Ivor Royston, had previously stated that he was “not optimistic that this therapy will work for his patient.”

RAC members bristled at Healy's involvement; they furthermore considered the supporting preclinical data insufficient to justify the protocol.