Exploitation in Clinical Drug Trials

• Other Authors: Fundora, Danielle Frances (Author)
• Format: Doctoral Thesis
• Language: English
• Published: 2013
• Subjects: Philosophy; clinical trials; exploitation; placebo-control; standard of care
• Online Access: http://hdl.handle.net/2286/R.I.18111

abstract: With the number of internationally-run clinical drug trials increasing, the double standards between those in developed nations and those in developing nations are being scrutinized under the ethical microscope. Many argue that several pharmaceutical companies and researchers are exploiting developing nation participants. Two issues of concern are the use of a placebo control when an effective alternative treatment exists and the lack of drug availability to the country that hosted the clinical trial should the experimental drug prove effective. Though intuitively this seems like an instance of exploitation, philosophically, exploitation theories cannot adequately account for the wrongdoing in these cases. My project has two parts. First, after explaining why the theories of Alan Wertheimer, John Lawrence Hill, and Ruth Sample fail to explain the exploitation in clinical drug research, I provide an alternative account of exploitation that can explain why the double standard in clinical research is harmful. Rather than craft a single theory encompassing all instances of exploitation, I offer an account of a type, or subset, of exploitation that I refer to as comparative exploitation. The double standards in clinical research fall under the category of comparative exploitation. Furthermore, while many critics maintain that cases of comparative exploitation, including clinical research, are mutually beneficial, they are actually harmful to its victims. I explain the harm of comparative exploitation using Ben Bradley's counterfactual account of harm and Larry May's theory of sharing responsibility. The second part of my project focuses on the "standard of care" argument, which most defenders use to justify the double standard in clinical research. I elaborate on Ruth Macklin's position that advocates of the "standard of care" position make three faulty assumptions: placebo-controlled trials are the gold standard, the only relevant question responsive to the host country's health needs is "Is the experimental product being studied better than the 'nothing' now available to the population?", and the only way of obtaining affordable products is to test cheap alternatives to replace the expensive ones. In the end, I advocate moving towards a universalizing of standards in order to avoid exploitation. === Dissertation/Thesis === Ph.D. Philosophy 2013