Engineering Ethics University of Illinois University of Illinois at Urbana - Champaign
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Drug Testing in Humans

For a medicinal drug to be proven safe and effective, it must be tested in people. Currently such testing is done by pharmaceutical companies and doctors under the close supervision of the Food and Drug Administration (FDA). Prior to FDA approval, a proposed new drug must undergo three phases of testing. In Phase I, the drug is given to a limited number of healthy volunteers to check for serious side effects. In Phase II, the drug is given to a group of sick volunteers to check for effectiveness and additional side effects. A control group receives either a placebo, or in the case of a very serious disease, the best available alternative treatment. In Phase III, the drug is given to a much larger population of sick people to obtain a better reading on effectiveness, interactions with other drugs, rare side effects, and the like. FDA oversight is needed for the process because of the enormous conflict of interest drug development unavoidably poses for the manufacturers. Whereas drug companies no doubt want to make sick people healthy, the companies also want to make a profit. The temptation to rush a new drug to market without adequate testing is simply too great, partly because the costs of developing and testing (in the hundreds of millions of dollars) are so enormous.

However, problems remain even with the most careful oversight. In the end, the trials approach humans both as people needing treatment and as abstract subjects for research. Medicine and research do not always recommend the same actions. For example, research concerns itself with measuring the effectiveness and risk of a drug against a carefully specified control group. Such experiments take a great deal of time, and tend to lengthen the approval process. Treatment, however, concerns itself with healing as many people as possible as quickly as possible. As soon as experimental trials show significant promise, there may be good reason to begin giving the drug to the control group and the distribute it to as many people as possible. These actions shorten the approval process, but increase the risk that unforeseen negative effects will arise. Right now, current approaches tend to tip the balance toward "treatment" in cases of terminal illnesses like AIDS or heart disease, while the "research" approach finds more rigorous use with less critical illnesses.

Another key issue involves informed consent. Some drugs have very sophisticated modes of action carrying poorly understood risks that are difficult to explain to volunteers. Adequate safeguards need to be put in place for children, prisoners, and the mentally ill. Some opponents of human drug testing believe such safeguards are impossible to realize in practice, and worry that researchers concerned with advancing their careers or securing grants will skew the direction of the research away from the best interests of the patients. FDA policies in these areas continue to evolve.