Money in clinical research creates ethical concerns because of its potential to distort judgments (Thompson 1993). Nowhere has money’s potential to distort judgments been more obvious than in the reaction to the tragic adverse reactions in the trial of TGN1412 – the TeGenero drug tested by Parexel (Associated Press 2006; Caplan 2006; Panja 2006; Waldman 2006; Goodyear 2006). Six participants were stricken by a massive inflammatory reaction (Suntharalingam 2002).
Almost all press reports and commentaries have mentioned that the healthy research participants were paid ï¿½2000 for enrolling in a phase one trial of a new agent produced by a for-profit company, as if this necessarily signified the trial was ethically questionable (Associated Press 2006; Caplan 2006; Waldman 2006; Goodyear 2006). The payment and profit status of the company alone, however do not make the trial ethically suspect (Emanuel 2004). Rather than relying on financial considerations as indicators of ethical problems, ethical analysis should focus on pertinent substantive issues, such as the research design, the risk/benefit ratio, and the informed consent process.
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