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Marcia Angell Trial

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Marcia Angell's article suggests that the research community should amplify their commitment and practice of the Declaration of Helsinki of the World Health Organization. Suggesting the use of a placebo group for the control experiment in clinical trials infringes ethical standards. She infers that ethical principles are challenged and dodged by sponsoring agencies instead of compliance, as well as enforcement of the code of ethics. Harold Varmus and David Satcher acknowledge the difficulties involved in conducting medical research but disagree, defending the trials adhering to the Declaration of Helsinki. Also endorsing the observance of the Belmont report principles.
Angell recognizes the temptations of overlooking ethical standards …show more content…
She explains that strict adherence to the clinical trial edicts requiring "randomized, double-blind, and placebo controlled"(Angell 849) trials can result in an ethically flawed study. Studies are conducted in the developing countries because researchers can get away with the gray areas of the ethical codes since there would not be approval to conduct such research in sponsoring countries. Angell identified the wording in the Declaration of Helsinki to be problematic. For example, "best" can be twisted to define "best locally available" treatment and circumvent the requirements of Department of Health and Human Services, W.H.O., and others. For this reason, providing subjects protection no less than comparable to that of the sponsoring country. As long as the goal is to accomplish results as quickly as possible and with least resistance, Angell believes "we have not come very far from Tuskegee, after all" (Angell 494). In contrast, Varmus & Satcher used the AIDS Clinical Trials Group protocol 076 result (i.e. zidovudine), which is cost prohibitive for Third World countries, in lieu of the placebo control group. Their aim is to demonstrate why the placebo trials are needed and by default, ethical. Their argument is that the most convincing rationale is that placebo controls offer conclusive answers to questions about the safety and significance of an …show more content…
autonomy, beneficence, justice) to support the new system of protection, but also address the inherent tension between them. Angell, Varmus, and Satcher all agree that autonomy is an uncontested requirement. Angell seems to be more concerned with justice as she warns against using "local standard of care"(Angell 848) to exploit and withhold advanced treatment options. Varmus & Satcher confirm focus seems to have shifted from beneficence to justice. However, Varmus & Satcher state that conducting research in collaboration with the developing country is the way to adhere to all three principles especially beneficence. Angell rebuttals that all humans regardless of their physical location respond similarly to the same treatment and that the desire to conduct trials in developing countries is attractive due to cost savings and fewer restrictions. Doing this is reducing beneficence according to Angell. Varmus & Satcher advocate that conducting trials in developing countries even if it could not be offered in US because it may be a beneficence; risks minimized and benefits maximized to both research subjects and others. Nevertheless, they do not support a trial in which the indigenous population could not benefit from the outcome since it would not qualify as

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