You may have already read this, but here's what the ABA has to say:
FROM THE MAY 12, 2006 ABA JOURNAL eReport
A RIGHT TO SELF-PRESERVATION?
Ruling on Use of Unapproved Drugs Could Have a Major Effect
BY MOLLY McDONOUGH
Health law and policy experts say a federal appeals court ruling that creates a new constitutional right to "self-preservation" could spawn a host of legal and medical ethics issues.
The ruling by a divided panel in Washington, D.C., held that terminally ill patients ought to have access to experimental drugs.
Many expect the decision won’t stand, even as legislation and policy initiatives move forward to give terminally ill patients more of the early access to promising drugs that they seek.
In the May 2 ruling, the U.S. Court of Appeals for the District of Columbia Circuit ruled 2-1 that terminally ill patients have the right to try investigational drugs not yet approved by the Food and Drug Administration. The decision says such patients may be able to gain access to "Phase 1" drugs—those medications that have been deemed safe enough for further and broader-based clinical trials.
"Barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on his right of self-preservation," Judge Judith W. Rogers wrote for the majority.
But that decision drew a sharp dissent from Judge Thomas B. Griffith, who opined that "the majority has provided no evidence of a right, deeply rooted in our nation’s history and traditions, to procure and use experimental drugs."
Abigail Alliance v. Eschenbach, No. 04-5350.
The plaintiffs, the Alexandria, Va.-based Abigail Alliance for Better Access to Developmental Drugs, and their legal team from the Washington Legal Foundation are optimistic the decision will result in greater access to experimental drugs.
"It’s a move forward for literally tens of thousands of patients every year who have run out of options," says Frank Burroughs, president of the Abigail Alliance, which was founded in 2001 after Burroughs’ daughter Abigail lost her battle to obtain promising new cancer drugs, and then her battle with cancer.
More practically, says Richard A. Samp, the Washington Legal Foundation’s chief legal counsel, "It’s very possible that this decision will prod the FDA to make changes voluntarily."
Indeed, the FDA issued a conciliatory response to the decision from Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs.
"We remain sympathetic to the desire of terminally ill patients to gain access to experimental treatments when they have exhausted other therapeutic options, and are exploring a number of new efforts to improve how we make investigational drugs available through expanded access programs," Gottlieb said.
But Gottlieb noted that the FDA "is studying the opinion and will consult with the Department of Justice regarding next steps."
Those next steps could be an appeal.
Despite the appellate court ruling, "these plaintiffs have an uphill battle," says Charity Scott, director of the Center for Law, Health & Society at Georgia State University College of Law in Atlanta.
Scott acknowledges that the Abigail Alliance presents "compelling human stories with very human faces."
"It’s their plea of last resort," she says of the terminally ill. "We understand their anguish."
But Scott says the majority takes a creative view of the history of drug regulation. "It’s accurate," she says. "People [had] been able to buy drugs or snake oil without government regulation" until the formation of the FDA at the turn of the previous century.
Scott says, however, that it hasn’t been until more recently that the scientific community understood the risks of drugs that are relatively new inventions. And there is strong support in case law for government to protect the community from harm.
The opinion by Rogers, who was joined by Chief Judge Douglas H. Ginsburg, restricted the due process protections to a narrow group. "Where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient’s informed access to potentially lifesaving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the due process clause," Rogers wrote.
In his dissent, Griffith argued that the proper route for change is in the legislative arena—notthrough the courts. "In my view, the majority’s approach injects courts into unknown questions of science and medicine, and does so contrary to the expressed will of Congress and the executive and to the deference courts owe the democratic branches on such controversial matters," he wrote.
As it happens, in addition to the suit against the FDA, the Abigail Alliance has filed a citizens’ petition with the agency seeking a policy change. It also is working with Sen. Sam Brownback, R-Kan., on federal legislation aimed at changing the FDA’s approval system for treating terminally ill patients. The Access, Compassion, Care and Ethics for Seriously Ill Patients Act, also known as the
Access Act, was introduced in November.
"There are many people who suffer from terminal illnesses right now who are unable to find a place in existing clinical studies and are unable to qualify for compassionate use programs," Samp says. "I am reasonably hopeful that the D.C. Circuit’s decision will mean that there will be much greater opportunity for people suffering terminal illnesses to gain access to investigational drugs."
The decision overturns a district court ruling and sends the case back to the lower court for a hearing and possibly a trial. Because the majority found access to experimental drugs is a fundamental right, the burden would shift in the lower court to the FDA to prove that it has a compelling interest to deny individuals access to such medications.
That’s an onerous prospect, according to the dissent and some health law and policy experts, who say courts should not be expected to evaluate on a case-by-case basis whether experimental drugs are potentially lifesaving.
"I think the dissent was excellent and I think the majority was wrong," says Don Kennedy, who faced similar litigation when he was an FDA commissioner in the 1970s. In that case,
United States v. Rutherford,442 U.S. 544, the U.S. Supreme Court ruled against terminally ill cancer patients seeking access to cancer treatment with laetrile. That drug was found to be ineffective against cancer.
"The majority tried to distance itself from
Rutherford, and I think not very successfully," Kennedy says.
Jesse Goldner, a Saint Louis University law professor who co-authored the book
Ethics and Regulation of Research with Human Subjects, says, "The majority is certainly pushing the envelope," but the notions presented are "not totally crazy."
But the questions that the decision leaves unanswered leave Goldner uncomfortable. Pressing for early access to drugs that have unknown effects "would be a radical change in the way in which we process applications to market drugs," he says.
Judge Griffith outlined what he saw as one of the more "vexing" questions raised by the majority decision: What potential must a treatment have for the Constitution to mandate access?
"Because the majority does not answer this last question, the district court faces an impossible task on remand," Griffith wrote. "Although the government most likely will show that it has a compelling interest in regulating access to drugs with unknown toxicity and the potential to hasten death, the unknown risks and benefits of these experimental drugs will make nearly impossible a judicial examination of whether some level of access short of a prohibition would be more narrowly tailored to protect the majority’s constitutional right of access."
[size=none]©2006 ABA Journal
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