Cancer patients and others rallied outside the Food and Drug Administration on Tuesday to call for the approval of an experimental prostate cancer therapy and wider access to unapproved drugs.
Dozens of people gathered outside the agency’s headquarters, holding yellow or white signs with sayings such as “The FDA is killing me” and “Delay equals death.”
Many urged the agency to approve Dendreon Corp’s Provenge, a novel vaccine designed to stimulate the immune system to fight advanced prostate cancer.
The FDA often is criticized as being too quick to approve medicines that could be harmful, but demonstrators said the agency was delaying or hindering access to therapies that could be the last option for terminally ill patients.
“People are facing death without a chance. We need change, said Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs.
Bruce Tower, a prostate cancer patient from Texas, received Provenge in a clinical trial. He credits the therapy with slowing his cancer and giving him time with his grandchildren.
“Why should the 30,000 men who will die (from prostate cancer) in 2007 not have the same opportunity?” he said.
Failed to meet goal
Two Dendreon studies of Provenge failed to meet their main goal of slowing the progress of advanced prostate cancer, but one analysis found patients lived about 4.5 months longer.
The FDA has told Dendreon it needs to see more data to show the product works, FDA spokeswoman Karen Riley said. She said the agency is working with Dendreon on the issue.
“We certainly understand patients are anxious to have this drug approved, but science is driving the process,” she said.
The Abigail Alliance and the Washington Legal Foundation have sued the FDA seeking greater access for dying patients to unapproved products such as Provenge that have cleared early safety tests.
In August, an appeals court ruled that terminally ill patients do not have a constitutional right to experimental drugs. The groups plan an appeal to the Supreme Court, but supporters also are lobbying the FDA and Congress to ease access.
Another group called CareToLive, which represents doctors, patients and Dendreon investors, has sued the FDA over Provenge and was an organizer of Tuesday’s rally.
Some patients can take experimental drugs as part of a clinical trial or other programs, but many are excluded. The FDA proposed new rules in December 2006 that officials said would help more seriously ill patients gain access.