Terminally Ill Patients Do Not Have Right To Use Experimental Medications

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Terminally ill patients do not have the right to obtain access tounapproved prescription drugs that potentially are lifesaving, even iftheir physicians say the treatments offer the best chance of improvedhealth, the U.S. Court of Appeals for the District of Columbia Circuitruled 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 FDAto obtain access to experimental medications for terminally ill cancerpatients. The lawsuit asked FDA to provide a special initial approvalof experimental medications that appear effective and allow their saleand distribution to terminally ill patients who have no other approvedtreatment options. FDA argued that programs currently exist to provideexperimental medications to terminally ill patients and that increasedaccess to such treatments would lead to unacceptable risk.

InMay 2006, a three-judge panel of the court ruled that terminally illpatients should have access to experimental medications that have notreached Phase II clinical trials. According to the 2-1 decision, whichreversed the dismissal of the lawsuit by a lower court, "barring aterminally ill patient from the use of a potentially lifesavingtreatment impinges on this right of self-preservation." FDA appealedthe decision and asked the full court to rehear the case. In November2006, the court vacated the decision and agreed to rehear the case (Kaiser Daily Health Policy Report, 2/13).

Ruling Details

In the majority opinion, Judge Thomas Griffith wrote, "Terminally illpatients desperately need curative treatments," but "their deaths cancertainly be hastened by the use of a potentially toxic drug with noproven therapeutic benefit" (AP/Washington Times, 8/8).

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Griffithadded that the right of self-defense "cannot justify creating aconstitutional right to assume any level of risk without regard to thescientific and medical judgment expressed through the clinical testingprocess" (Pollack, New York Times,8/8). "We conclude there is no fundamental right 'deeply rooted in thisnation's history and tradition' of access to experimental drugs for theterminally ill," Griffith wrote. The court suggested that patientadvocates pursue the issue in Congress rather than the courts.

Dissenting Opinion, Other Comments

The two dissenting judges said that the ruling ignored theConstitution's protections for an individual's right to life andespoused "a dangerous brand of paternalism" that put the government'sinterest before the individual's (Savage, Los Angeles Times,8/8). In the minority opinion, Judge Judith Rogers wrote that thecourts have established the right "to marry, to fornicate, to havechildren, to control the education and upbringing of children, toperform varied sexual acts in private and to control one's own bodyeven 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 despiteits textual anchor in the right to life" (AP/Washington Times, 8/8).

FrankBurroughs, founder of the Abigail Alliance, said the group was"dumbfounded that most of the justices tragically missed the merits ofthe case" (New York Times, 8/8). Burroughs said he expectslegislation allowing access to experimental drugs in certain situationsto be introduced in this congressional session (AP/Washington Times, 8/8).

FDAspokesperson Julie Zawisza said that the agency was happy with theruling because it upheld the agency's "role in facilitating appropriatetreatment access to investigational therapies while at the same timeprotecting the public at large by requiring that drugs are proven to besafe and effective before they may be marketed to U.S. consumers" (Los Angeles Times, 8/8).

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