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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
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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. The expected success rate of cancer drugs at the Phase I stage of clinical testing is 6%.
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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
331:. On August 7, 2007, the Court issued an 8-2 decision against the Abigail Alliance, reversing the previous panel decision, thereby upholding the previous court decision that found no constitutional right to unapproved drugs by terminally ill patients. Judge
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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.
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Frank
Burroughs, Abigail's father, vowed to pursue an appeal to the Supreme Court, but the Supreme Court declined to accept the case, which effectively ended the case with the existing FDA regulations intact.
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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
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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."
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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
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testing. If successful, the suit would have eliminated FDA prohibitions on selling unapproved drugs, and left the decision entirely in the hands of drug manufacturers.
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proposed that the
Constitution does not guarantee the right to access unapproved medications, and that the court case threatens the cancer clinical trial enterprise.
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241:. The argument made by the Abigail Alliance in court was that terminal cancer patients have a constitutionally protected right to access to
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Jacobson P, Parmet W (2007). "A new era of unapproved drugs: the case of
Abigail Alliance v Von Eschenbach".
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The FDA requested that the Court of
Appeals rehear the case. The American Society of Clinical Oncology (
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brief to the U.S. Court of
Appeals in advance of the March 1 hearing, supporting the FDA's position.
237:. At that time, Erbitux was available experimentally only for patients participating in colon cancer
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protects the right of terminally ill patients to access treatments that are not approved by the
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Griffith, joined by Sentelle, Henderson, Randolph, Tatel, Garland, Brown, Kavanaugh
484:"BioTime, Inc. Appoints Andrew C. von Eschenbach, M.D. to its Board of Directors"
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410:"No right to experimental drugs for dying patients: Supreme Court - Yahoo! News"
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Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
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Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
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Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
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Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
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Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
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Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
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United States Court of Appeals for the District of Columbia Circuit cases
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277:, Commissioner of the FDA from 2006 to 2009, and later a Director at
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Abigail Alliance for Better Access to Developmental Drugs, et al v.
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United States Court of Appeals for the District of Columbia Circuit
598:, 445 F.3d 470 (D.C. Cir. 2006) (panel opinion) is available from:
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217:, 552 U.S. 1159 (2008) was resolved in early 2008 when the
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ruled in favor of the Abigail Alliance and found that the
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Abigail Alliance for Better Access to Developmental Drugs
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568:"Court Rejects the Right to Use Drugs Being Tested"
362:, 9th ed. (2008) Richard A. Epstein. (pp. 42)
325:U.S. Court of Appeals for the District of Columbia
295:U.S. Court of Appeals for the District of Columbia
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273:The von Eschenbach referred to in the case is
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270:new drugs under controlled circumstances.
556:Amicus brief by ASCO, filed February 2007
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102:2004 WL 3777340 (D.D.C. Aug. 30, 2004);
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566:Pollack, Andrew (August 8, 2007).
219:Supreme Court of the United States
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18:Abigail Alliance v. von Eschenbach
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358:Cases and Materials on
289:Progression of the case
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323:On March 1, 2007, the
275:Andrew von Eschenbach
507:445 F.3d 470
394:495 F.3d 695
490:. November 9, 2011.
167:Janice Rogers Brown
151:A. Raymond Randolph
139:Douglas H. Ginsburg
572:The New York Times
434:2007-02-21 at the
171:Thomas B. Griffith
163:Merrick B. Garland
147:Karen L. Henderson
111:Subsequent history
327:reheard the case
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415:January 14,
339:dissented.
312:) filed an
215:cert denied
694:Categories
630:OpenJurist
367:References
225:Background
117:. denied,
577:April 23,
285:company.
267:Phase III
646:Text of
594:Text of
546:cite web
536:April 7,
470:17213404
432:Archived
347:See also
263:Phase II
191:Majority
84:Citation
68:Reargued
664:Findlaw
612:Findlaw
329:en banc
279:BioTime
247:Phase I
235:Erbitux
199:Dissent
179:en banc
76:Decided
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552:link
538:2007
466:PMID
450:JAMA
417:2008
318:ASCO
310:ASCO
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265:and
123:U.S.
115:Cert
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