Abigail Alliance v. von Eschenbach

"Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach" was resolved in early 2008 when the Supreme Court of the United States declined to hear the appeal. Their refusal left standing the appellate court decision, which said that patients have no right to "a potentially toxic drug with no proven therapeutic benefit."cite web |url=http://news.yahoo.com/s/afp/20080114/ts_alt_afp/ushealthcourt_080114172556 |title=No right to experimental drugs for dying patients: Supreme Court - Yahoo! News |accessdate=2008-01-14 |format= |work=]

Background

Abigail Burroughs was a college student diagnosed with head and neck cancer. During the later phases of her treatment, Abigail's father, Frank Burroughs, formed an organization, the Abigail Alliance for Better Access to Developmental Drugs and sued the FDA for access to Erbitux. At that time, Erbitux was available experimentally only for patients participating in colon cancer clinical trials. The argument made by the Abigail Alliance in court was that terminal cancer patients have a Constitutionally protected right to access to experimental medications before the FDA approves them. Specifically, the Abigail Alliance argued that the FDA should license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. [ [http://www.abigail-alliance.org/WLF_FDA.pdf] Abigal Alliance Citizen Petition to FDA] If successful, the suit would have eliminated FDA prohibitions on selling unapproved drugs, and left the decision entirely in the hands of drug manufacturers.

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. [cite journal |author=Jacobson P, Parmet W |title=A new era of unapproved drugs: the case of Abigail Alliance v Von Eschenbach |journal=JAMA |volume=297 |issue=2 |pages=205–8 |year=2007 |pmid=17213404 |doi=10.1001/jama.297.2.205]

Implementing the changes proposed by the Abigail Alliance would have exposed some terminally ill patients to treatments which would ultimately not be approved because of inefficacy and toxicity. Unapproved cancer treatments have a very low expected success rate. [cite journal |author= |title=The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients |journal=Clin Trials |volume=3 |issue=2 |pages=154–7 |year=2006 |pmid=16773958|doi=10.1191/1740774506cn141oa] [cite journal |author=Okie S |title=Access before approval--a right to take experimental drugs? |journal=N Engl J Med |volume=355 |issue=5 |pages=437–40 |year=2006 |pmid=16885545 |doi=10.1056/NEJMp068132] The expected success rate of cancer drugs at the Phase I stage of clinical testing is 6%.

If the Abigail Alliance had been successful in court, the suit would have radically altered the conduct of clinical cancer research, by providing almost unfettered legal access to experimental drugs by terminally ill patients, who would then have little incentive to enter Phase II and Phase III clinical trials, which are used to determine side effects and efficacy of new drugs. While eligibility factors and geography may limit the ability of some terminally ill patients to access new drugs through clinical trials, those trials also protect patients by collecting safety and efficacy data on new drugs under controlled circumstances.

Progression of the case

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. [ [http://pacer.cadc.uscourts.gov/docs/common/opinions/200605/04-5350a.pdf O:SlipWP2005