Patients must have an immediate need and a life-threatening disease or condition to gain access to unapproved trial drugs. If eligible, the manufacturer and the patient's doctor must make special arrangements to get the drug for the patient.
While Gant's way of obtaining the drug was unique, Caplan said it is unlikely that this will set a precedent in getting trial drugs.
"Every case is a huge maelstrom of hope, begging, corporate self-interest, slow bureaucratic due process, media spotlighting and public frustration," Caplan said. "It is simply very hard to solve access issues with a single policy given the many interests besides the patients that are in play in these cases. Each winds up being unique."
Gant said she is "excited" to obtain the drug for compassionate use, which she will begin taking in one to two weeks. But she also feels guilty that so many other women do not have the same opportunity.
"I really hope this opens up a dialogue about compassionate use for people with cancer," Gant said. "I'm not afraid to die, but I couldn't do it without one last fight. I'm a fighter and an advocate."