Court Denies Terminally Ill Patients Access to Experimental Drugs
Terminally ill patients do not have the right to obtain access to unapproved prescription drugs that potentially are lifesaving, even if their physicians say the treatments offer the best chance of improved health, the U.S. Court of Appeals for the District of Columbia Circuit ruled on Tuesday, the Baltimore Sun reports (Baltimore Sun, 8/8).
In 2003, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation filed a lawsuit against FDA to obtain access to experimental medications for terminally ill cancer patients.
The lawsuit asked FDA to provide a special initial approval of experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options. FDA argued that programs currently exist to provide experimental medications to terminally ill patients and that increased access to such treatments would lead to unacceptable risk.
In May 2006, a three-judge panel of the court ruled that terminally ill patients should have access to experimental medications that have not reached Phase II clinical trials. According to the 2-1 decision, which reversed the dismissal of the lawsuit by a lower court, "barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation." FDA appealed the decision and asked the full court to rehear the case. In November 2006, the court vacated the decision and agreed to rehear the case (California Healthline, 2/13).
In the majority opinion, Judge Thomas Griffith wrote, "Terminally ill patients desperately need curative treatments," but "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit" (AP/Washington Times, 8/8).
Griffith added that the right of self-defense "cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process" (Pollack, New York Times, 8/8).
"We conclude there is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill," Griffith wrote.
The court suggested that patient advocates pursue the issue in Congress rather than the courts.
The two dissenting judges said that the ruling ignored the Constitution's protections for an individual's right to life and espoused "a dangerous brand of paternalism" that put the government's interest before the individual's (Savage, Los Angeles Times, 8/8).
In the minority opinion, Judge Judith Rogers wrote that the courts have established the right "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private and to control one's own body even if it results in one's own death or the death of a fetus," but "the right to try to save one's life is left out in the cold despite its textual anchor in the right to life" (AP/Washington Times, 8/8).
Frank Burroughs, founder of the Abigail Alliance, said the group was "dumbfounded that most of the justices tragically missed the merits of the case" (New York Times, 8/8). Burroughs said he expects legislation allowing access to experimental drugs in certain situations to be introduced in this congressional session (AP/Washington Times, 8/8).
FDA spokesperson Julie Zawisza said that the agency was happy with the ruling because it upheld the agency's "role in facilitating appropriate treatment access to investigational therapies while at the same time protecting the public at large by requiring that drugs are proven to be safe and effective before they may be marketed to U.S. consumers" (Los Angeles Times, 8/8).