Vol. 7, No. 2, February 2011
“Can You Handle the Truth?”
“When Experiments Travel: Clinical Trials and the Global Search for Human Subjects” Adriana Petryna, 2009, 258 pages, Princeton University Press, $26.95 Review by Norman M. Goldfarb “When Experiments Travel: Clinical Trials and the Global Search for Human Subjects” is yet another attack on the pharmaceutical industry and the clinical research enterprise, this time masquerading as a scholarly work. The book makes valid points about a very timely and important topic, but they are tainted by bias and misinformation. Too harsh? We can let book speak for itself: “These economics have occasioned the pervasive phenomenon of what are known as floater sites. The operators of fly-by-night investigative sites promise many patients, routinely underbid for contracts, and are not particularly concerned with achieving standards of full regulatory compliance.” (A Google search for “‘floater sites’ ‘clinical research’” finds 23 citations, all originating with the author, so it appears that the author coined the term “floater sites.”) “The U.S. Bureau of Prisons — in what philosopher Stephen Toulmin interprets as an apparent move to absolve itself from future liability and brashly display its own ability to self-regulate — ‘changed its policies, so as to exclude effectively all research by drug companies and other agencies from federal prisons.’” “…when a therapeutic gets hot…‘it’s like a cattle stampede. Sponsors with different drugs compete in that therapeutic area, and this leads to a hyperdemand for investigators. And good investigators cannot compete…’” “Today, more than 60 percent of Poland’s pharmaceutical market is controlled by foreign companies. Imports undercut the competitive and price-lowering prospects of their Polish equivalents.” “There is a long tradition of ‘dumping’ items before they are proven to be safe or effective (the global thalidomide disaster being the most famous example)…” [The drug was marketed in 46 countries. Patients in Germany, the country that originated thalidomide, shared the harm.] “Some [Brazilian] academic researchers I knew were critical of the ways national agencies acquiesced to the inadequate terms of foreign trials. A culture of complicity among various institutions, I was repeatedly told, makes patient-centered research difficult to craft. They wondered why CONEP [National Bioethics Commission of Brazil] had not yet advocated for lifelong treatments for patients on trials for lifesaving medicines…” “Only when the company suddenly withdrew the study drug did the researchers I spoke to learn that their department head had given into the company’s demand to reserve its right to withdraw the drug at any time. This had even been written in the consent forms that the patients had signed.” “Except in cases where individuals chose to be identified, I have maintained their anonymity to the extent possible by using pseudonyms and creating composite characters and entities that do not refer to any specific businesses.” (This information is buried in the acknowledgements section near the end of the book.) Subscribe free at www.firstclinical.com © 2011 First Clinical Research and the Author(s)
The book consists of six chapters:
Introduction: Experimental Fields
Ethical Variability
Arts of Drug Development
The Global Clinical Trial
Pharmaceuticals and the Right to Health
Conclusion: The Future of Global Medicine
The back cover of the book offers complimentary quotes from three prominent anthropologists, none with any apparent expertise in clinical research. The book is available in bookstores. Reviewer Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information, consulting and training services. Contact him at 1.650.465.0119 or
[email protected].
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