Supreme Court Should Hear Appeal in Lawsuit To Expand Access to Experimental Rx for Terminally Ill Patients, Op-Ed States
The U.S. Supreme Court on Friday will consider a request to hear an appeal in a lawsuit against FDA that seeks access to experimental medications for terminally ill cancer patients, a case that has raised "profound issues regarding the right of individuals to make their own health care decisions," Steven Walker, co-founder of the Abigail Alliance for Better Access to Developmental Drugs, writes in a Wall Street Journal opinion piece.
Terminally ill patients "search for clinical trials of new drugs that might extend their lives," but most do not qualify or "learn the trial is fully enrolled and closed, or too far away," Walker writes. In addition, some terminally ill patients who enroll in trials "face a 50-50 chance of getting a placebo," he writes, adding, "Many are allowed to die without being told about or offered the active drugs."
FDA "commonly insists on statistically comparing the timing and severity of the deaths of untreated (placebo) patients with those of patients who receive the potentially effective drug," a practice that "renders the FDA's vaunted 'science' for drugs intended to treat terminal illnesses little more than a crude measurement of the height and accrual rate of two piles of bodies," according to Walker. He adds, "No terminal patient has the time needed to wrestle with the FDA in court if they first have to establish a right to do so."
Walker writes, "FDA and a majority of the D.C. Circuit Court of Appeals think terminally ill Americans are excluded from the fundamental right to pursue life," concluding, "The Supreme Court now has the opportunity to ... correct those egregious judgments" (Walker, Wall Street Journal, 1/11).
