essentially every drug would be approved but without any reassurance of a reasonable expectation of benefit and that we would be exposing people to the burden of risk with potentially a false hope of efficacy. Trust in the process would erode, and companies could have greater liability in situations where they had not rigorously evaluated benefit. The question then becomes, “Who in society bears the cost?” Mr. Hutt responded by emphasizing, again, that approval would require separation in the clinical trial between the active agent and a placebo. Dr. Strom remarked that 50 percent of studies would be positive in that direction—showing benefit—when in fact the drug does nothing. Mr. Hutt said that the p-value ought to be in the labeling so that patients know the results of the clinical trial. With regard to false hope, Mr. Hutt reemphasized that his proposal is based on freedom of choice and the assumption that people are intelligent and capable of being educated.

Dr. Slavin remarked that the debate between Mr. Hutt and Dr. Strom misses the point. Rather than dissipating our energies in deciding who is going to make decisions about whether drugs can be used or not, there are more immediate issues such as risk communication and trust that can and should be addressed now.



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