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This precaution was not enforced with TGN1412,perhaps because the doses,according to the drug manufacturer,“were500 times smaller than what had proved safe in animals'''The affair is as unprecedented as it is shocking.Simon Best,,chair of the U.K.BioIndustry Association,said,“If you think about the number of Phaselt1ials carTied out in this country,you've never heard of anything having such a terrible impact”Phase l trials,such as the one above,are carried out merely to determine a drug's toxicity, its efficacy being examined at subsequent Phase2 and Phase3 trials. Phase l trials can often signal the end for new medicines:if volunteers show signs of 111 effects,research is stopped.Ray Noble,a medical ethicist,says that about20 percent of new drugs go no further than this stage,but points out that no drug has been pulled as quickly as TGN1412.
In the TGN1412 case,all the volunteers in the trial received a
payment equivalent to$3,500.Such hefty sums have been heavily criticized by medical ethicists and drug trial experts“People should be recompensed for the time they take out of their lives to become involved in a trial,but that is a different matter from paying inducements,''said Janet Derbyshire of the Medical Research Counci1.According to Noble,“People who are designing these trials have to make sure they do not offer so much money that