A lawsuit has been reinstated by the U.S. Court of Appeals that will allow terminally ill patients access to experimental drugs, with only preliminary testing.
The Associated Press reports the "Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the Food and Drug Administration in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but that have yet to be approved. 'Barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation,' Judge Judith W. Rogers wrote in the 2-to-1 opinion from the panel of the United States Court of Appeals for the District of Columbia Circuit."
"Providing access shouldn't be solely an FDA decision," said Frank Burroughs, President of the Abigail Alliance. "The decision is the patient's decision, in consultation with their doctor, knowing at the time the known risks and benefits," said Burroughs, who founded the group after his daughter, Abigail, died of cancer in 2001.
Prescription drugs, and those designed to fight potentially fatal diseases in particular, must go through three phases of clinical trials, often taking years to complete.
Phase 1 trials generally involve small test groups (sometimes only 20 people) and focus on safety.
Phase 2 trials establish the drug's effectiveness.
Phase 3 trials focus on any side effects and adverse reactions to the drug and involve larger test groups and are the largest studies.
Drugs that pass all three phases are then submitted to the FDA for New Drug Application (NDA) approval.
What does this mean for terminally ill patients?
For terminally ill patients, the wait for approval can be lengthy. There is also the possibility that patients may die anyway, therefore making the possible risks of a drug less of a hurdle. In other words, these patients may want to act as test patients in Phase 1 trials. To date, the FDA has prohibited terminally ill patients access to possible life-saving medications that it has not approved.
