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Unapproved or Experimental Drugs Cannot Be Used In Dying Patients? |
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Written by Simon Jones
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Saturday, 11 August 2007 |
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New drugs that are still being tested for clinical safety and efficacy cannot be used even in patients who have no hope of survival, a US Court of Appeals has ruled. The court said the Food and Drug Administration must have approved drugs that can be used in such patients and doctors have no rights to recommend any new drugs.
The Abigail Alliance for Better Access to Experimental Drugs, a patient advocacy group and the free-market Washington Legal Foundation (WLF) had brought a case against the FDA in 2003 saying that the agency's tedious process of approving new drugs might be costing patients' lives.
The Abigail Alliance was incorporated in the state of Virginia in November of 2001 by a man whose daughter Abigail died from cancer at the young age of 21. Abigail was seeking to get treatment by using the EGFR targeted drug C225 (Erbitux) or Iressa. However despite all efforts the girl died in June that year and the Alliance was founded to help terminally ill patients get better access to experimental drugs.
In the lawsuit filed in collaboration with the WLF, the Alliance had alleged that the time taken to approve new drugs was unacceptable.
"At each phase of the clinical trial process, a considerable period of time passes as the drug’s sponsor obtains FDA approval of the proposed study protocols, as investigators carry out the clinical trials, and as the sponsor obtains FDA approval or rejection of the results at each stage," the suit alleged. "On average, the total time for clinical trials and approvals across all stages for a new drug is approximately 6.9 years."
In 2004 a district court had voted to throw out the case, but last May a three-judge panel had overturned that decision. But now the Court of Appeals has rejected the petition in an 8-2 ruling.
"The FDA's policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects," Judge Thomas Griffith wrote. "Although terminally ill patients desperately need curative treatments ... their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."
In a dissent, Judge Judith W. Rogers wrote that it was amazing that the “right to try to save one’s life is left out in the cold.”
Frank Burroughs, the founder of the Abigail Alliance said that the Alliance would take the matter to the Supreme Court.
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