Misinformed Consent in Clinical Trials

            The global health problem I chose is the difficulty of providing informed consent in clinical trials. I also read an academic article about communication and miscommunication in informed consent and what the article calls “therapeutic misconception” (Sankar). I also address the issue as it occurs in clinical trials overseas, as in the documentary shown in class Outsourced: Clinical Trials Overseas. I discuss how there are different extremes in a society that has accepted biomedicine and has a well establish structure of governance compared to a society where biomedicine is a relatively new concept and how pharmaceutical companies exploit the novelty of biomedicine in a community to bypass normal biomedical regulations regarding informed consent. I will be using the concepts of Power, Biopower, and Cultural Perception to analyze this global health issue and suggest possible solutions to this complex issue by drawing on examples from class, from the academic article I read, and from personal experience.

            This article used transcripts from a phase 1 cancer research trial to study communication and miscommunication in informed consent. A central concept in this study is therapeutic misconception, where a subject confuses a research protocol with prescribed treatment for their condition. The article offered several explanations for this misconception, but suggested that it is most frequently attributed to patients who are desperate enough for treatment that they distort or ignore statements by the researcher that the clinical trial is not intended to treat their condition, rather than by the researcher failing to properly clarify the distinction. This research revealed that the theoretical paradigm governing informed consent and its analysis might also contribute to therapeutic misconception in conjunction with the idealized notions of the subjects.            

            A medical anthropological perspective on this issue of miscommunication in informed consent would frame this problem based on how the actors involved (researchers, subjects and the subjects families) respond to the problem. It would also take into account the communities in which this problem occurs. In class, we learned about miscommunication in informed consent occurring in clinical trials being conducted by Clinical Research Organizations in India, where most subjects were living in poverty and participating in the clinical trial was the only means for them to gain access to treatment for their medical condition. In addition, many participants were illiterate; the informed consent forms they signed would not have provided them with any information regarding informed consent and most likely signed the forms simply as a means to gain access to treatment. A medical anthropologist would study this situation and analyze the community’s access to resources to maintain and restore health. Most importantly, medical anthropology determines which actors have the power to make health based decisions: where resources for health are allocated, who has access to these resources and who doesn’t, and specifically for the clinical trials in India, who is authorized to recruit subjects for research and who is responsible for determining the extent to which informed consent must be understood.

            The Global Health Watch approaches the problem of therapeutic misconception by framing it under a larger topic it calls the Pharmaceutical Endeavour. The Global Health Watch explains that the leadership of the pharmaceutical industry “rests mainly with the Big Pharmas, the top 20 or so multinational corporations with annual revenues measured in tens of billions of dollars” (Global Health Watch 3). In addition, there are approximately 61 companies that had sales of over 1 billion dollars in the year 2007. These companies taken together largely control the global trade of pharmaceuticals and are becoming increasingly influential in the distribution and utilization of drugs world wide, including the determining of which drugs are being researched, which ones aren’t, and the funding, intensity, and location of said research.

            Big Pharma and other top pharmaceutical distributors earn their sales by selling medicine and as for profit companies, are driven by their business models and accountable to their shareholders to make a profit. The Global Health Watch states that despite the many and sometimes revolutionary contributions pharma companies have made to health solutions, “there is increasing concern about diminishing health returns, even a referenced to Pharmageddon ‘the prospect of a world in which medicines and medicine produce more ill-health than health, and when medical progress does more harm than good’”. This concern relates to the exploitation of human subjects in unethical overseas clinical trials, where pharmaceutical companies are pushing research in order to produce a new drug as soon as possible and are foregoing the necessary steps required to ensure the safety of participants.

            The issue of informed consent in clinical research trials is a complicated one. Medical Anthropological concepts help shed light on this problem in a number of ways. Perhaps the most visible aspect of informed consent illuminated by medical anthropology is the concept of Power. As we learned in the third week of class, power is the main determinant of health. When a researcher is informing a subject about an experiment, it is important that the researcher clearly defines the goal of the study. Sankar’s article describes the therapeutic misconception as confusion of goals between the researcher and the subject, “Whereas the goal of medical care is symptom relief or cure for the patient, the goal of research is hypothesis testing for the investigator.” In an informed consent session, the researcher has power over the subject with regards to explain truthfully the goals of the study, and to make sure the subject understands that they are participating in a clinical research study and are not receiving medical care based on any sort of analysis of their individual medical condition. This power is restricted by a stringent set of guidelines. For example, Sankar reports that, “Government regulation of human subjects research lists eight basic elements that informed consent to research must address.” These basic elements are: Statement that the study involves research, description of risks, description of benefits, disclosure of alternative treatments, statement of confidentiality, explanation of compensation for injury, whom to contact with questions, statement that participation is voluntary and subject has the right to withdraw at any time (Code of Federal Regulations Title 46 “Common Rule” 2009). This law protects human subjects in clinical trials in the United States. In other countries with fewer regulations and oversight, informed consent can be “given” even though the participant does not understand the implications of being a subject in a research trial or that they are participating in a research trial and not medical therapy.

            A second concept discussed in class that sheds light on a new aspect of this global health problem is biopower. As with power, biopower varies between regions and countries, based on laws, regulations, and oversight. Biopower is the governing of people through their bodies. Individuals with wealth tend to have more control over the governance of their bodies than individuals in poverty. Wealthy individuals are more likely to have received higher-level education and have access to licensed physicians when seeking medical help. One could point to the fact that these individuals submit their own biopower to that of their medical physician, but the key difference is that they have a choice of physician and access to other resources to inform themselves. In contrast, poverty stricken communities, such as the individuals shown in the documentary video from class Outsourced: Clinical Trials Overseas, have no access to these resources and are desperate for treatment. They have little choice of where to seek medical help, or whom they should contact when seeking medical advice.

            A third concept discussed in class that applies to this issue is how cultural perceptions affect a health issue. A particular model for cultural perceptions is the Health Belief model, which states that individuals weigh their perceived susceptibility to a problem against their perceived seriousness of the consequences of this problem to determine the perceived threat to themselves. In addition, they weigh the benefits of a specific action (such as joining a clinical trial) against the perceived barriers to taking that action to determine their outcome expectations. Their perceived threat measured against their expectations of the outcome of taking action determines their perceived ability to carry out an action. With regards to informed consent, individuals in a community with limited access to resources and poor literacy rates my not understand what is meant by the concept of informed consent, so when a clinical trial is started in such a community, the cultural perceptions of the health issue can determine which members opt to participate in the trial, without fully knowing what they are becoming involved in.

            Using the concepts learned in class to apply to a specific problem has enhanced my understanding of the concepts and also my awareness of the complexities of global health and medical anthropological studies. Clinical trials happen all over the world, so the same rules for informed consent are not equally adhered to in India as in the United States. When applying the concept of Power to the issue of informed consent, my understanding of the concept change in that I interpreted the relationship between those with power and those lacking it differently. During the quarter I always interpreted the government and wealthy companies as the institutions associated with power and the authority to determine the allocation of resources, and this is still true. However based on the article I read discussing informed consent and therapeutic misconception, I learned that individuals, specifically the researchers, can wield power and influence others, specifically the participants, with or without being actively aware of their influence on the other persons perceptions and goals. It has led me to understand that the concept of power is not always a plain and simple relationship, but that it can occur consciously and unconsciously, with or without intent, but it is always influential.

            The same can also be said for biopower. This concept was more difficult for me to understand at first, and applying it to a problem gave me greater insight. Biopower is not self evident in the way that power can sometimes be, it is a much more nuanced form of governance, except for in extreme situations, like slavery for example when one person is said to be the physical property of another person. When applying biopower to the issue of informed consent, one must consider a multitude of factors. In the article by Sankar, the participants involved in the trial were terminally ill with cancer, and had exhausted all other treatment options. They’re ability or willingness to participate in the study could have been governed by whether or not they had health insurance coverage. Without insurance, their consent may have been out of desperation if they had no other options for treatment, despite being told that the study was not intended to treat their symptoms. Or, if they had insurance they may have volunteered in an effort to lead to future discoveries to save future generations from their experience.

            Since the study in this article occurred in the United States at a University Hospital, cultural perceptions of the study were likely to be accepting. Few individuals immersed in a culture that practices biomedicine as the primary option for health would condemn an individual for participating in a clinical cancer research trial testing for a new drug effective against cancer. In another culture, such as India, traditional healing systems like Ayurvedic have a larger influence in the community, and so clinical biomedical trials may be viewed differently than in the United States. Also, the idea of informed consent is a well-known concept in biomedical circles and has been the source of much research in an attempt to eradicate the persistent phenomenon of therapeutic misconception. Fortunately for those who take part in these studies in biomedical communities, there are strong laws, oversight, and regulation regarding informed consent, and participants are much more likely to be compensated for any unethical procedures performed by the researcher(s). With regards to India however, where biomedicine is not nearly as widely understood and informed consent in a research setting could be a concept they have never encountered before. Since the concept is novel, it is much less likely for there to be cultural constructs managing informed consent and research ethics, and participants are more likely to be treated unethically without the means to seek compensation or reprimand against the research.

            Looking at the global health problem of informed consent from a medical anthropological perspective, it seems clear that a fundamental change in the driving force behind the pharmaceutical endeavor must occur. Many countries in need of drugs that are available and over used in industrialized countries are instead being targeted by Big Pharma to provide human subjects for clinical research trials, rather than being given the medicine they need, because the actors with the power and authority to distribute these drugs do so in a way that provides the highest economic benefit. This solution in and of itself is not very practical without the political will of governments and other powerful agencies to make it so. On a smaller scale, if for instance a company was interested in doing a clinical trial in an underdeveloped country according to the standards set down by the FDA, several steps could be taken to be certain of a subjects’ understanding of informed consent. Giving informed consent through alternate media sources, such as diagrams, pictures, and videos instead of a written form would make a difference. Perhaps the best practical solution to stop unethical trials in under developed countries would be to disallow studies to be performed in those countries. However, the problem of therapeutic misconception exists even in industrialized countries, though I believe the consequences are less extreme.

            In the clinical trial studied in the article, it was revealed that the researchers, despite following the regulations established for informed consent, still created a therapeutic misconception in some cases that the study would treat subject’s symptoms. In the case of these trials, vocabulary choice was often the reason for fostering the misconception. For example one transcript from the study reveals how the researchers “switch from talking about ‘the tumor’ and ‘the cells’ to describing hypothesized effects of gene transfer to ‘your tumor’ and ‘your cells’”. This demonstrates the power of language in creating misconceptions and how fine a line exists between truly informed consent and the fostering of therapeutic misconception.

            The global issue of informed consent and therapeutic misconception is a complex and pervasive problem in clinical health trials around the world. Like many global health issues, there is no simple solution. Further research needs to be done to continue fine tuning the existing protocol for providing informed consent and to prevent the fostering of therapeutic misconception. Medical anthropological research can be used to provide data about participants in clinical trials and communities that are being used as recruiting grounds for these trials.

           

Works Cited

Communication and Miscommunication in Informed Consent to Research

            Pamela Sankar Medical Anthropology Quarterly , New Series, Vol. 18, No. 4             (Dec., 2004), pp. 429-446 Published by: Wiley on behalf of the American             Anthropological Association

            Article Stable URL: http://www.jstor.org/stable/3655397

Outsourced: Clinical Trials Overseas. 2011. Film. 11 July 2011.             <http://www.aljazeera.com/programmes/faultlines/2011/07/2011711112            453541600.html>.

Global Health Watch 3: An Alternative World Health Report