Outsourcing Clinical Trials: An Ethical Quagmire

            Adriana Petryna’s article “Clinical Trials Offshored: On Private Sector Science and Public Health” presents a myriad of ethical and practical issues facing the medical and pharmaceutical industries today.  In is not altogether shocking that companies, such as the United States-based contract research organizations (CROs) Petryna describes in her research, should outsource their trials.  The medical field today seems almost to require it, with governing organizations such as the FDA requiring enormous amounts of research and product testing before new drugs enter the market.  However, what is troubling about the current system is the amount of harm that outsourcing causes.

         Petryna describes what has become ‘the paradigm of expected failure.’ Quoting a CRO professional, “In any industrial system, if you spend 10 times as much on repair as on prevention, you are just going to live in a continued cycle of loss. I’ll just say that for every dollar spent on an investigation, 10 dollars are spent on going back and fixing the data after the fact.”  Petryna interprets this as a find-and-fix strategy, with safety problems being detected after the fact.  Thus, the dangerousness of some protocols is typically understated in the original outsourcing contract.  Thus, individuals enrolled in the trials are inherently at more risk than Americans enrolled in equivalent drug trials.

         Furthermore, drug trials are outsourced to countries with economic hardship.  Thus, individuals are selected for to enroll in trials based on desperation for medical care or money.  I cornerstone of modern medical research is informed consent.  Apparently, subjects are informed of the inherent dangers in any clinical trial.  However, can forced consent exist?  I am inclined to say no.  In areas where individuals need to participate to survive, consent is non-existent, automatically adding a moral ambiguity to such trials from the beginning.  Medicine exists to do no harm, but these trials are a perfect example of an industry using suffering to reduce costs and to produce product. 

        In using these people and selecting the impoverished to serve as test subjects, the industry dehumanizes them.  Just like the bio-robots and victims of Chernobyl, such an outlook alienates and isolates individuals, often sick individuals, and robs them of their humanity.  This is a Kantian ethical crisis, treating humans as means to ends rather than the ends themselves.

         However, a key argument can be made for the necessity of such trials: they allow poor individuals in countries with little access to medicine and weak health infrastructure access to potentially life-saving pharmaceuticals.  Considering this, such studies become a moral quagmire.  They dehumanize participants and put them at a greater risk due to their poverty while forcing potentially life-alternating experimentation on them, yet, at the same time, such trials may save lives.  It becomes a question of ethical systems.  Do we use moral values or utilitarian principles to determine whether or not such trials are morally sound?  While I am inclined to see these trials as despicable, I cannot ignore their benefits, both to the populations they exploit and the populations willing to exploit the poor for medical advances.