Testing of new drugs on terminally-ill patients comes under attack in the US
a critical change to us medical regulations, which allows doctors to test new drugs on some patients without their consent, has been criticised by ethicists after 24 patients died in the first clinical trial performed under the new rules.
Researchers are usually required to acquire a patient's informed consent before administering any experimental treatment, a standard that has formed a cornerstone of us medical policy for the past 50 years.
However, in 1996, the us Food and Drug Administration ( fda) regulations were amended to allow the testing of new therapies on critically-ill patients in emergency care.
Because there isn't time to secure direct consent under these circumstances, the rule changes required that the public be informed of experimental trials and a follow-up study after the completion of the trials. Illinois-based drugs firm Baxter Healthcare became the first company to use the amendment, in trials of a new blood substitute called HemAssist. But it halted the study after 24 out of 52 patients who were undergoing this treatment died.
Although the mortality rate was only slightly higher than can be expected in conventionally-treated emergency cases, medical ethicists have attacked the rule change which allowed the trial. "People get involved in something to their detriment without any knowledge of it," said George Annas, a professor of health law at Boston University's School of Public Health.
Speaking to the press in the us, Arthur Caplan, director of the Centre for Bioethics at the University of Pennsylvania said: "I know people are enamoured of it. But public notification means nothing." A spokesperson for Baxter Healthcare said it was in favour of gaining consent from the patient directly wherever possible.
However, testing lifesaving therapy for emergency patients would be impossible without the revised fda rules, it said.
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