Abigail Alliance v. von Eschenbach
From Wikipedia, the free encyclopedia
Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach is an ongoing United States Federal court case as of 2007. A final ruling in this case may have significant implications for patient's rights, drug regulation, and the conduct of clinical trials in the United States.
[edit] Events to date
Abigail Burroughs was a college student diagnosed with head and neck cancer. During the later phases of her treatment, Abigail's father, Frank Burroughs, sued the FDA for access to cetuximab, case of Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach. At that time, cetuximab was available experimentally only for patients participating in colon cancer clinical trials. The argument made by the Abigail Alliance in court is that terminal cancer patients have a Constitutionally protected right to access to experimental medications before the FDA approves them. Specifically, the Abigail Alliance argues that the FDA should license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing.[1]
In May, 2006, the U.S. Court of Appeals for the District of Columbia ruled in favor of the Abigail Alliance, and found that the US Constitution protects the right of terminally ill patients to access treatments that are not approved by the Food and Drug Administration. On March 1, 2007, the U.S. Court of Appeals was scheduled to rehear the case at the request of the FDA. This case has the potential to radically alter the conduct of clinical cancer research, since the initial Court of Appeals ruling essentially condones unfettered access to experimental drugs by terminally ill patients, who would then have little incentive to enter Phase II and Phase III clinical trials testing new cancer drugs. While clinical trials restrict access by terminally ill patients to new drugs, they also protect patients by collecting safety and efficacy data on new drugs under controlled circumstances. The expected success rate of cancer drugs at the Phase I stage of clinical testing is 6%. Implementing the changes proposed by the Abigail Alliance could have the potential to expose terminally ill patients to the toxicity of many unapproved treatments, with a very low expected success rate.[2][3] From its inception, the US Government has charged the FDA with a mission of overseeing testing of new drugs. Challenges to this core definition, as in the Abigail Alliance court case, would likely require broad changes to the FDA's operating mandate.[4] The Americal Society of Clinical Oncology (ASCO) filed an amicus brief to the U.S. Court of Appeals in advance of the March 1 hearing, supporting the FDA. ASCO proposes that the Constitution does not guarantee the right to access unapproved medications, and that the court case threatens the cancer clinical trial enterprise.[5]
