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Unformatted text preview: thods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic, or therapeutic method exists’’ (World Medical Association 2000:3044).19 Although the ethics was unambiguous, the regulatory weight of the declaration was not. In this latter domain the winners and losers of the placebo debate would be named.20 Pharmaceutical companies, already eagerly expanding operations abroad and calculating the economic advantages of placebo use (placebos lower costs and, many argue, placebo trials produce more unambiguous evidence of efficacy), were scrambling to learn from regulators about the legal enforceability of the declaration and were finding ways to continue using the placebo. Haziness brought clarification of the rules of the game. Dr. Robert Temple, associate director of medical policy of the Center for Drug Evaluation of the U.S. FDA, undercut the regulatory significance of the declaration and threw his support behind placebo advocates. He stated, ‘‘We’ll have to see if the Declaration of Helsinki remains the ethical standard for the worl...
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell University (Engineering School).
- Spring '10