WASHINGTONA US court of appeals rulingthat terminally ill patients have no constitutional right to obtain experimental drugs proven safe in phase I trialsleaves the emotional issue as contentious as ever, medically, ethically, and legally.
Last month, FDA saw protesters in front of its Rockville, Maryland, offices for the first time since the AIDS actions of the 1980s and 1990s. The demonstrators urged faster drug approvals, greater access to experimental drugs, and specifically, fast approval of Dendreon's prostate cancer agent Provenge (see photograph).
In a new twist, the demonstration included not only cancer patients and their supporters but also individual investors in Dendreon. The company is currently working with FDA to provide survival data on Provenge that could lead to the drug's approval.
Participating in the protest rally were members of the Abigail Alliance for Better Access to Developmental Drugs, which filed suit against the FDA in 2003.
On August 7, the full Circuit Court of Appeals for the District of Columbia ruled 8-2 against the Abigail Alliance.The decision overturned a 2006 ruling by a three-judge panel of the Circuit Court, which sided 2-1 with the Alliance, which plans to appeal the new decision to the US Supreme Court.
The Abigail Alliance is named for Abigail Burroughs who died of head and neck cancer and was denied early access to cetuximab (Erbitux). In its legal complaint, the Alliance and the nonprofit Washington Legal Foundation argued that FDA policy "violates the constitutional privacy and liberty rights of terminally ill patients," specifically the Fifth Amendment guarantee against deprivation of life without due process.