February 11, 2009 4:25 PM
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Court: No Unapproved Meds For The Dying
Terminally ill patients do not have a constitutional right to be treated with experimental drugs, even if they likely will be dead before the medicine is approved, a federal appeals court said Tuesday.
The ruling by the U.S. Court of Appeals for the District of Columbia Circuit overturned last year's decision by a smaller panel of the same court, which held that terminally ill patients may not be denied access to potentially lifesaving drugs.
The full court disagreed, saying in an 8-2 ruling that it would not create a constitutional right for patients to assume "any level of risk" without regard to medical testing.
"Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote for the majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."
Food and Drug Administration approval of drugs generally requires extensive testing that can involve years of trials and thousands of patients.
The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.
Abigail Alliance founder Frank Burroughs pledged an appeal to the Supreme Court. Burroughs' daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.
"What the opinion by Judge Griffith is saying is, 'We don't want to risk one life or a few lives, even at the expense of the lives of hundreds or thousands of people,"' Burroughs said. "The logic of that escapes me."
In a sharply worded dissent, Judge Judith W. 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 wrote.
Rogers was joined by Chief Judge Douglas H. Ginsburg. The case cut across party lines, with conservative and liberal judges taking both sides of the dispute.
A spokeswoman for the FDA did not immediately return a message seeking comment.
The court noted that there are government programs that provide access to experimental drugs in certain situations. It said the matter is not closed and said Congress might be a better venue than the courts to address the issue.
Burroughs said he expects such legislation to be introduced this session. Both the Senate and House have considered such legislation but it languished in committee.
© 2009 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The ruling by the U.S. Court of Appeals for the District of Columbia Circuit overturned last year's decision by a smaller panel of the same court, which held that terminally ill patients may not be denied access to potentially lifesaving drugs.
The full court disagreed, saying in an 8-2 ruling that it would not create a constitutional right for patients to assume "any level of risk" without regard to medical testing.
"Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote for the majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."
Food and Drug Administration approval of drugs generally requires extensive testing that can involve years of trials and thousands of patients.
The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.
Abigail Alliance founder Frank Burroughs pledged an appeal to the Supreme Court. Burroughs' daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.
"What the opinion by Judge Griffith is saying is, 'We don't want to risk one life or a few lives, even at the expense of the lives of hundreds or thousands of people,"' Burroughs said. "The logic of that escapes me."
In a sharply worded dissent, Judge Judith W. 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 wrote.
Rogers was joined by Chief Judge Douglas H. Ginsburg. The case cut across party lines, with conservative and liberal judges taking both sides of the dispute.
A spokeswoman for the FDA did not immediately return a message seeking comment.
The court noted that there are government programs that provide access to experimental drugs in certain situations. It said the matter is not closed and said Congress might be a better venue than the courts to address the issue.
Burroughs said he expects such legislation to be introduced this session. Both the Senate and House have considered such legislation but it languished in committee.
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