Foundations: Give ill access to experimental therapy

Supreme Court appeal sought over clinical trial access

Two foundations that seek to establish a constitutional right to experimental therapy for the seriously ill will challenge a recent decision in a federal appeals court that favors the FDA's more cautious approach to access to experimental drugs.

The Fredericksburg, VA-based Abigail Alliance and the Washington, DC, Legal Foundation lost their bid in the U.S. Court of Appeals for the District of Columbia in late 2007 to give terminally ill patients access to therapies that have gone no further than Phase I clinical trials. The court said these patients do not have a constitutional right to the drugs.

Writing the majority opinion, Judge Thomas Griffin acknowledged that "[t]erminally ill patients desperately need curative treatments," but that their deaths could "be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."

Griffin wrote for the 8-2 majority, which overturned a decision made by a three-judge panel from that court in May 2006, ruling that terminally ill patients do have such a constitutional right.

Judge Judith Rogers, writing the minority opinion, described the ruling as "startling." The decision, she said, left the right "to try to save one's life. . . out in the cold despite its textual anchor in the right to life."

The case is now headed for the Supreme Court, which may or may not grant a hearing.

While the decision is currently focused on anticarcinogenic drugs, the use of combination therapies to treat some cancers — such as nanoparticle delivery systems and adjuvant use of radiological equipment — and the prevalence of heart disease suggest that devices and diagnostics could become entangled should the Supreme Court rule in favor of the plaintiffs.

Abigail Alliance and the Washington Legal Foundation filed the case in 2003 in response to an incident involving Abigail Burroughs, who died of cancer of the head and neck in 2001 after attempting to persuade the FDA to allow her to try a pair of anticarcinogenics drugs. Burroughs' father established the Abigail Alliance after his daughter's death.

The FDA in 2006 published a notice in the Federal Register that proposed to amend regulations to expand access to investigational drugs. The notice points out that existing regulations permit such access so long as "there is no satisfactory alternative drug or other therapy available" and that the drug is under investigation in a clinical trial, that the trial is completed but the drug is not yet commercially available, or the sponsor is "actively pursuing marketing approval. . . with due diligence."

The proposed regulation would redefine unreasonable risk "in the context of the disease or condition to be treated," and would allow the use of Phase I clinical trials to serve as a pretext for access so long as preliminary evidence "suggests possible effectiveness" and failing any such clinical data, "the case for the potential benefit may be based on preclinical data or on the mechanism of action."