[Source: Health and Life Sciences Daily, August 8, 2007]
The New York Times (8/8, A12, Pollack) reports, "A federal appeals court ruled yesterday that patients with terminal illnesses do not have a constitutional right to use medicines that have not yet won regulatory approval. The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came in a closely watched and emotional case that pitted desperate patients willing to try unproven, even risky, therapies against those arguing that drugs should be proved safe and effective before they are made available." The case was filed against the FDA "in 2003 by the Abigail Alliance for Better Access to Developmental Drugs," which "argued that forcing patients to wait years for a drug to go through the process of clinical trials deprived dying patients of their right to self-defense, and violated the Fifth Amendment clause stating that people cannot be deprived of life, liberty or property without due process of law." Judge Thomas B. Griffith, writing for the majority, said that "a right to experimental drugs was not deeply rooted in the nation's history and tradition."
The Wall Street Journal /AP (8/8, D2) notes that Judge Griffith also said, "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."
The Los Angeles Times (8/8, Savage) adds, "Julie Zawisza, an FDA spokeswoman, said the agency was pleased 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.'" She also "said that 'on a limited basis,' some patients and their doctors were permitted to obtain new drugs that were in clinical trials."
On its Web site, USA Today (8/8, Winter) reports, "In a stinging dissent, Judge Judith Rogers called the ruling 'startling.' She said 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." Rogers was joined by Chief Judge Douglas H. Ginsburg.
Bloomberg (8/8, Larson) reports that Frank Burroughs, Abigail Alliance president, said, "The Abigail Alliance is dumbfounded that most of the justices tragically missed the merits of the case." He continued, "We are going to appeal to the Supreme Court." During the past six years, the Abigail Alliance has pushed "for early access to 16 drugs for cancer and other life-threatening illnesses," and each drug "eventually won FDA approval, including ImClone Systems Inc.'s colon cancer drug Erbitux (cetuximab), Novartis AG's leukemia medicine Gleevec (imatinib), and Bayer AG's kidney cancer treatment Nexavar (sorafenib)." The problem, Burroughs said, is that the "FDA and Congress get on the safety issue soap box, and they forget about the people who have a very different risk-benefit perspective."
The case is Abigail Alliance for Better Access to Developmental Drugs, et al. v. U.S. Food and Drug Administration, et al (pdf).
