Portal de Periódicos da CAPES

Outsourcing Big Pharma

2010; Project HOPE; Volume: 29; Issue: 3 Linguagem: Inglês

10.1377/hlthaff.2010.0122

2694-233X

Dinesh Sharma,

Global Public Health Policies and Epidemiology

Book Review Health AffairsVol. 29, No. 3: Child Obesity: The Way Forward Outsourcing Big PharmaDinesh Sharma Affiliations Dinesh Sharma ( [email protected] ) is a senior fellow at the Institute for International and Cross-Cultural Research, St. Francis College, in Brooklyn Heights, New York. PUBLISHED:March 2010Free Accesshttps://doi.org/10.1377/hlthaff.2010.0122AboutSectionsView PDFPermissions ShareShare onFacebookTwitterLinked InRedditEmail ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsDownload Exhibits TOPICSClinical trialsPharmaceuticalsEthicsPharmaceutical companiesMarketsMedical researchTechnologyPrescription drug costsCost reductionDeveloping countriesAlmost one-third of human clinical drug trials are outsourced by the top twenty pharmaceutical companies to countries with low- and middle-income economies. During the past two decades, as drug pipelines have shrunk and cost-cutting pressures have steadily strengthened, clinical trials have been outsourced to increasingly far-flung populations around the world. And the trend toward global outsourcing is likely to continue. Emerging economies with large pools of talented scientists, improved low-cost infrastructure, and the growing health needs of an underserved population will continue to be ideal destinations for clinical trials. In When Experiments Travel , Adriana Petryna has written a timely book. It provides an important anthropological perspective on the issues surrounding clinical trials and how to make medical research more transparent and accessible to the general public. Although it does not deal with the political economy of clinical trials (and that topic is outside its purpose), the book uncovers key drivers of the market expansion. Similarly, it does not belabor any policy prescriptions for the future. Instead, it describes the right to health care as a public good—one that, despite the pace of globalization and technological complexity, ought to make medicine more just and humane for populations around the world. This is recommended reading for anyone wrestling with the issues of health care from a global perspective and trying to grasp how scientific evidence is collected through clinical trials overseas. The book represents a bold and praiseworthy attempt at uncovering the day-to-day mechanisms involved in outsourcing clinical trials and urging that the process needs to be more accessible to the general public.Petryna’s different academic approach to the subject is an addition to the growing list of books trying to understand the context, complexity, and pathways of clinical trials undertaken abroad. She relies on qualitative interviews and narrative data to decipher how trials are negotiated overseas. As such, she is able to contribute a behind-the-scenes view of how these trials are negotiated in low- and middle-income countries. As she notes, there are regulatory, political, cultural, and economic forces at work in these countries that differ from those in the West. Petryna provides specifics by focusing on trials in Brazil and Poland. Clinical trials outside the United States are longstanding and bring economic benefits to many countries. As Time magazine reported from one country in August 2008, “There are currently some 400 clinical trials underway in India, where the business is expected to be worth $1 billion to $1.5 billion by 2010. For western drug companies, it’s a boon: India’s vast pool of qualified, English-speaking doctors and lower labor costs make clinical trials up to 50 percent to 60 percent cheaper here.” Given that the price of developing a single drug therapy is estimated to be $800 million (excluding sales and marketing costs), pharmaceutical companies increasingly are shifting clinical research to India and other developing countries. It is a big business—and a growing one—as underlined by the subtitle of Petryna’s book, Clinical Trials and the Global Search for Human Subjects . In the book, the author wrestles with “global formations of social and institutional structures” involved in contracted medical research. Early on, she sets forth her belief that when highly charged political and economic environments exist, “ethical variability” permeates the scientific process of conducting trials as well as the “arts of drug development” in low-to-middle-income countries, including how to handle safety data carefully, what to publicly report, and—just as tellingly—what not to publicly report. She then outlines underlying drivers of globalized trials that range from cost cutting to market expansion.Petryna suggests that there might be several problems with these trials. As in any international research setting, language issues arise when using standardized protocols to translate clinical interviews. Corruption might exist in the host societies, along with an overwhelming need to cater to multinational clients. Poverty and deep inequities often drive patients to consent to clinical trials because of their limited treatment options and the handsome cash incentives for participating; the inequities also continue to motivate patients to comply with drug regimens despite side effects or the lack of desired outcomes. In considering these issues, the book offers a unique entry into an existing thicket of controversies and debate. According to an American Medical Association survey of nearly 700 researchers published in the February 2004 Journal of Medical Ethics , “Fewer than six in 10 trial protocols in developing countries get reviewed by an ethics committee.” In China, only one in ten trial protocols got an ethics review, according to a 24 April 2008 article in the journal Trials , which reported that “four in five of those protocols failed to discuss informed consent adequately.” There are also serious concerns about the inability of patients in poor, underserved populations with a high burden of disease to voluntarily opt out of trials. Supporters of outsourcing clinical trials, on the other hand, make equally persuasive arguments that cover the gamut of thorny issues—economic, ethical, technological, and medical—including that drug manufacturers have their financial health on the line and are motivated to ensure that the trials are ethical and scientifically rigorous. The debate has been pushed further by other clinical trial defenders, who claim that critics of outsourcing should focus on the potential benefits of taking part in clinical trials rather than simply undermining the credibility of volunteers by saying they are somehow unequipped to make their own medical decisions. Additionally, the issue of outsourcing clinical trials has demanded urgent attention because there are no regulatory agencies fully equipped and trained to effectively monitor global drug trials overseas. There are international and country-specific guidelines, regulations, and laws, but the extent to which they are implemented is not clear. Not unlike in the banking industry, the economics of innovation has sped ahead while the ethical, regulatory, and legal systems are lumbering to catch up. It seems clear that the Food and Drug Administration (FDA) just does not have the staff or the infrastructure for effectively monitoring clinical trials worldwide. Just in Brazil and Poland, for instance (the two countries that are looked at closely in When Experiments Travel ), in each country there are currently 1,500–2,000 clinical trials under way, according to the FDA’s tracking Web site, http://www.clinicaltrials.gov . Both countries recently relaxed regulatory and legal constraints, making it easier to collect clinical trial data. Petryna, who had done earlier research in Eastern Europe and Latin America, is an associate professor of anthropology at the University of Pennsylvania. She comes at this topic by presenting an ethnographic study that outlines the “new geographies of pharmaceutical capital and power that facilitate experimentality—a convoluted reality whose quality is not solely dependent on standardized modes of compliance or procedure, but on how commercial, regulatory, and scientific priorities are set both here and abroad” (p. 188). Consistent with the critical ethnographic tradition, Petryna argues that “the benefits deriving from globalized research are arguably uncertain, and its risks are unevenly distributed and its costs unjust.” She calls for a multifaceted strategy for several public health objectives: disclosing risk, deterring harm (going hand-in-hand with creating safety), and providing adequate compensation for individuals and institutions similar to those created by tobacco legislation.Petryna documents the pathways through which scientists are working to offset some of the damaging effects of local clinical trial practices, although, she says, these efforts might not be enough to guarantee patients’ fundamental right to health. According to the author, drugs have to be viewed as a public good. Their value has to be understood within the broader social and cultural framework—they are not just an avenue for maximizing profit. There is evidence that big pharmaceutical companies with deep pockets are spending some of their brand capital (the value and competitiveness of the company name) on building socially responsible capital, whether it is negotiating generic pricing for branded products or offering health checkups in poor areas. As anthropologist Paul Rabinow has noted, the challenge for social scientists is to identify instances of this and to “investigate how ‘capital’ from one market is converted into ‘capital’ (or advantage) in another.” This is the “new pharmaceutical modus operandi,”according to Petryna.In her concluding chapter, the author argues that public-private partnerships have been around as long as privately endowed philanthropic organizations have existed. They certainly are not new to the drug industry. She cites several examples, such as Merck’s partnership with the Task Force for Child Survival and Development and Pfizer’s joint program with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Petryna contends, however, that these initiatives are “missing an understanding of local cultures and health systems” and might largely be public relations moves to blunt criticisms for clinical trials gone awry. She claims that the vaguely defined notion of creating “value” in the health care domain seems to capture the motives and agendas of multiple players: corporate marketers, activists, and public health officials. It seems to fold “them into a new ethos of collective responsibility” within the ever-expanding yet confusing global health architecture.Borrowing from the works of legal anthropologists (notably Annelise Riles), Petryna suggests that novel transnational formations emerge and often function outside of formal contract agreements. She notes: “Networks and partnerships deploy a universal lexicon and are diffused and sometime chaotic.” As a means to mobilize social action, these global and somewhat fragmented social networks can hold governments and corporate interests accountable. In the meantime, though, public-private initiatives need to keep their shared eye on what’s happening, she argues, doing so by reforming drug pricing, patent law, intellectual property regimes, and the health care infrastructure. As Petryna sees it (p. 197), “Standards of medical care and of research must be approached from transnational perspectives. Neglected people and their plights should inspire pathways of medical innovation, not drive them away.” Loading Comments... Please enable JavaScript to view the comments powered by Disqus. DetailsExhibitsReferencesRelated Article MetricsCitations: Crossref 2 History Published online 1 March 2010 Information Project HOPE—The People-to-People Health Foundation, Inc. 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