Posted: Sat Oct 06, 2007 10:13 pm Post subject: Abigail Burroughs - Experimental Drugs
In 2001, Abigail Burroughs died of squamous cell skin cancer after a two year battle. She and her father fought the manufacturers of two experimental drugs to provide her with medications which appeared promising and had passed phase I human trials. The manufacturers refused.
The two drugs in question are Erbitux and Iressa, both of which are now approved for (and are effective for) the treatment of basal and squamous cell skin cancer.
Abigail's father has been fighting ever since to make drugs which have passed phase I clinical trials available to terminally ill patients...
The FDA and drug manufacturers oppose the proposal. The FDA's argument is two-fold. First, they argue that it would allow drug manufacturers the ability to commercial sell drugs which have not received approval yet. Second, and this is where the manufacturers agree, they argue that it would undermine the efficacy of the trials. Rather than finding appropriate test groups, these drugs would be made available soley on the criteria of the condition of the patient. If they failed for the patient the drug might not receive approval despite the fact that the drug was not an ideal choice for that patient.
This is a classic case of individual rights vs. the greater good. On this issue I think I side with the FDA. But if I had cancer I'm certain I would feel differently.
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