Frank Burroughs believes his daughter Abigail, who died of cancer two weeks ago, might have lived if she had had access to experimental drugs being tested on other patients in clinical trials.
Abigail, who graduated from high school three years ago, had neck and throat cancer. Her doctor told the family that two drugs currently undergoing trials had a significant chance of helping her beat the disease. But the drugs' manufacturers were reluctant to let her join a trial, Burroughs told a House committee today.
"We worked very hard to acquire the drug on a compassionate use basis, but got nowhere," he said in a hearing before the House Government Reform Committee.
It usually takes years of clinical trials before drugs receive approval from the Food and Drug Administration. Drug makers are reluctant to admit terminally ill patients because FDA rules require them to include all patients' results in statistics of a drug's performance. Including patients who are already dying skews the results, the drug makers say.
The FDA has a "compassionate use" exception under which companies can give experimental drugs to dying patients without including their statistics. But many more patients want the drugs than receive them.
Abigail Burroughs never received the two drugs she hoped to try — ImClone Systems' C-225 and AstraZeneca's Iressa. A third company offered her an experimental drug, but she was too sick to travel to the place where the trial was being held.
Wider Access Sought
Abigail's father and other relatives of terminally ill patients want wider access to experimental drugs when conventional treatment seems to be failing. Among the possible solutions are:
Relaxing the controls on who can receive test drugs.
Absolving companies of legal liability if treatments fail.
Providing financial assistance for dying patients who cannot afford the experimental drugs.
Fred Santino's wife died waiting for word on whether ImClone would allow her to be treated. At the House hearing, he demanded an answer from the company's CEO, Sam Waksal, who was present.
"How can you ignore a dying mother, Mr. Waksal?" Santino asked. "How can you ignore a dying mother? All we wanted was a yes or no."
"There is no answer to give to husbands and fathers and other family members to patients who have died of cancer," Waksal responded.
ImClone and other drug companies say they give millions of dollars worth of drugs away to dying patients who are not in the trials.