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• W2125772903 abstract "Book Review Health AffairsVol. 29, No. 10: Comparative Effectiveness Research Is There A Lack Of Ethical Integrity In Drug Clinical Trials?Trudo Lemmens Affiliations Trudo Lemmens ( [email protected] ) is an associate professor in the faculty of law at the University of Toronto, in Ontario, Canada. PUBLISHED:October 2010Free Accesshttps://doi.org/10.1377/hlthaff.2010.0542AboutSectionsView PDFPermissions ShareShare onFacebookTwitterLinked InRedditEmail ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsDownload Exhibits TOPICSClinical trialsEthicsPharmaceuticalsAccess to careMarketsGovernment programs and policiesFor-profit statusInstitutional review boardsSystems of careClinical researchDuring the past decade, the pharmaceutical clinical trials industry has come under increased scrutiny in the wake of the deaths and serious injuries of research subjects in trials in Canada, India, Nigeria, the United Kingdom, and the United States, to name but a few countries. Yet despite widespread calls for more transparency and better regulatory oversight, only limited information is available in any country about what goes on in this section of the drug industry.For that reason alone, Jill Fisher’s book on ethical integrity in the clinical trials enterprise is a welcome and timely contribution. Fisher, an assistant professor in the Center for Bioethics and Society at Vanderbilt University, formerly lived and worked in Arizona, and the book’s focus is on sociological fieldwork conducted primarily in the southwestern United States. Her account examines the clinical trials dynamic within the specific social and health care context of that region, as well as within the political, economic, and social contexts of the entire nation. For her book, Fisher interviewed physicians, research staff, administrators, and research subjects working at private practices, contract research organizations, site management organizations, and for-profit investigative sites. Arguably missing from the picture are institutional review board (IRB) members charged with reviewing clinical trial protocols and protecting the rights and well-being of research subjects. For-profit IRBs are key players within the drug industry, 1,2 and the voices of members of these IRBs would have been especially interesting in light of the book’s focus on ethical integrity in clinical trials. A key characteristic of the US clinical trials industry, Fisher writes, is how it fits within “medical neoliberalism.” That is her phrase for a medical market that she describes as characterized by limited state involvement, growing privatization of health services, commodification of health, and a fundamental trust that combining individual choice and market mechanisms will result in high-quality health care. I found that the book’s strength lies precisely in its narrative description of the interactions, motivations, and self-justifications invoked by various actors within this setting, and in Fisher’s discussion of how ethical problems within the US clinical trial industry are connected to problems within the health care system in general. She aims to demonstrate that the clinical trials industry has been set up and structured to exploit the vulnerability of research subjects in the inequitable, privatized US health care market.Some of the most compelling aspects of the book can be found in the stories that introduce and illustrate each chapter. Many of these stories reflect the often deep personal tensions that can exist between professional and institutional pressures and people’s desire to act with moral integrity. Fisher uses these stories in part to explore what underlies the self-perceptions, the self-justifications, and the often hidden symbolic roles and complex motivations of different players.She discusses, for example, how physician-researchers’ enthusiasm for the model of the physician-researcher as successful commercial “entrepreneur” might come from a desire to gain social status from playing an important and dynamic role in a presumably important societal enterprise. Embracing that role also allows them to ignore their loss of professional independence when they participate in rigidly organized clinical trials. In many such trials, physician-researchers become “pharmaceutical emissaries” who are, in fact, little more than passive data gatherers. Fisher also notes—as does a substantial body of literature in publications such as the Journal of the American Medical Association3 and the New England Journal of Medicine4,5 —that many of these clinical trials have become a key part of marketing strategies. Coordinators and monitors rationalize their roles as protecting either research subjects or the integrity of drug development; they unconsciously underplay the pressures to promote enrollment and compliance by research subjects. The most striking account is that of the young man who enrolls his mother, suffering from dementia, in a short trial to test the safety of an Alzheimer’s drug—one from which it is unlikely she will benefit. Fisher describes how, even after the physician dispels the son’s hope for a magic bullet that will save his mother from Alzheimer’s, the young man enthusiastically endorses the trial out of his belief that his mother will benefit from having access to new technology and from receiving care in the clinical trial setting.This illustrates well what Fisher terms the “procedural misconception” underlying much trial participation. She uses the term to highlight the fact that patients (and their relatives) often do not fully grasp what is going on in the clinical trial setting; make up their minds about participating before even speaking to a trial recruiter; and create their own justification for enrolling, even when they finally understand that they will not benefit from any treatment.Fisher’s book is an important contribution for several reasons. It provides health policy analysts and participants in the political debate with yet another angle from which to expose the troubling inequity of the US health care system. Indeed, only true free-market ideologists can find it acceptable that in a wealthy country with excellent health care facilities, so many people become guinea pigs in clinical trials of unproven therapies as a substitution for normal access to health care.Fisher rightly suggests that being able to promote ethical standards in research seems to require an equitable health care context. It will be interesting to see whether the recently enacted health reform legislation can deliver on this front and how, over time, this will change the dynamics of US clinical trials.Although some readers may critique it as speculative, Fisher’s revealing reading of why various people act the way they do in a clinical trial context should be a basis for further reflection among regulators, health policy scholars, patient advocates, and everyone else involved in debates surrounding medical research. As Fisher points out throughout the book, much of the moral dimension of the practices and behavior of those participating in the clinical trial setting comes down to matters of choice. Yet the choices people make are almost always determined—largely unconsciously—by the social, economic, political, and health care context that surrounds them. Unless we expose and examine those factors, we cannot truly comprehend the ethical desirability of the actions taking place.Fisher observes that those employed in the clinical trial sector construct their sense of moral integrity through uncritical acceptance of pharmaceutical companies’ claims about the enormous costs and important benefit of all new drug development. The patients who participate in research to earn money, or to obtain access to health care, buy into the market rhetoric and submit themselves as largely passive, commodified objects. Even when research participants feel exploited, they create justifications for their actions—like the son who enrolled his mother in an Alzheimer’s trial—in a way that exposes the limits of truly informed, autonomous decision making.Fisher does not discuss in much depth how her analysis might inform the ongoing debate on the ethics of clinical research or regulatory policy. Yet her analysis is an excellent basis for critical questioning of the emphasis on individual choice as one of the main guiding principles in ethics and public policy. Individual choice takes place in a context. Unless we critically assess the moral dimensions of this context—as Fisher has done here for clinical drug trials in the southwestern United States—and also critically question the presumptions that underlie it, we cannot meaningfully debate the moral dimensions of the choices made by the various actors in those trials.From a public policy perspective, this means that policy makers and regulators have to question more critically the rhetoric of pharmaceutical product development. They need to ask if such drug development truly is a fundamentally distinct commercial activity, focused on creating innovative and beneficial products and contributing to better and more affordable health care. Fisher gives us yet another reason for arguing that regulators have to stop acting as if clinical research is necessarily a humanitarian enterprise with an inherently worthy ethical dimension. Nor is it, I would argue, an enterprise that can adequately regulate itself on the basis of a misguided trust in the concept of informed consent.NOTES1 US Department of Health and Human Services, Office of Inspector General . Institutional review boards: a time for reform [Internet]. Washington (DC) : HHS ; 1998 Jun [cited 2010 Aug 30]. (DHHS Publication; no. OEI-01-97-00193). Available from: http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf Google Scholar Google Scholar 2 Emanuel EJ , Lemmens T , Elliot C . Should society allow research ethics boards to be run as for-profit enterprises? PLoS Med [serial on the Internet]. 2006 ; 3 ( 7 ): e309 [cited 2010 Aug 30]. Available from: http://clinicaltrials.ploshubs.org/article/info:doi%2F10.1371%2Fjournal.pmed.0030309 Google Scholar 3 Angell M . Industry-sponsored clinical research: a broken system . JAMA . 2008 ; 300 : 1069 – 71 . Crossref, Medline, Google Scholar 4 Sponsorship, authorship, and accountability [editorial] . N Engl J Med . 2001 ; 345 : 825 – 7 . Crossref, Medline, Google Scholar 5 Bodenheimer T . Uneasy alliance—clinical investigators and the pharmaceutical industry . N Engl J Med . 2000 ; 342 : 1539 – 44 . Crossref, Medline, Google Scholar Loading Comments... Please enable JavaScript to view the comments powered by Disqus. DetailsExhibitsReferencesRelated Article Metrics History Published online 1 October 2010 Information Project HOPE—The People-to-People Health Foundation, Inc. PDF download" @default.
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