[Ip-health] The Rise of Unregulated Drug Trials in South America

Joana Ramos jdr at ramoslink.info
Mon Sep 26 10:59:25 PDT 2011

The Rise of Unregulated Drug Trials in South America
Kelly Hearn | September 21, 2011
The Nation


.... A generation ago, most human testing took place in American 
academic institutions. Now it's a global game dominated by corporations, 
called contract research organizations (CROs), that help Big Pharma 
bring new molecules from the lab to your medicine cabinet. More and more 
drug companies are turning to CROs for assistance with trial design and 
recruitment, regulatory compliance, marketing and branding---last year 
the CRO market was worth $20 billion, an estimated 100 percent jump from 
a decade ago. And CROs, in turn, are increasingly running trials in the 
developing world because doing so is cheaper and faster: regulations 
aren't as onerous, patient recruitment is easier and informed consent is 
less clearly defined.

The Food and Drug Administration is clearly unable to keep up with the 
astounding surge of outsourcing in recent years. According to the FDA, 
the number of trials in developing countries has grown 8 percent a year 
since 1997. A 2010 report by the inspector general of the Department of 
Health and Human Services (HHS) notes that 40 to 65 percent of clinical 
trials on FDA-regulated products in 2008 took place overseas. Of nearly 
6,500 foreign trial sites that year, the FDA inspected only 
forty-five---less than 1 percent...


Although recent coverage of American drug studies in the developing 
world has tended to focus on India and Africa, trials south of the US 
border have quietly spiked. The HHS report found that Central and South 
America had the highest number of subjects per site and accounted for 26 
percent of all subjects enrolled in foreign trials.......


"Drug companies come to Latin America because they think IRBs will be 
less strict and knowledgeable," says Miguel Kottow, a Chilean 
bioethicist. Many critics cite the case of Carlos Vallejos, a former 
Peruvian health minister who now heads INEN, the public cancer hospital, 
while remaining a major shareholder in a private health insurance 
company serving cancer patients.

But Agueda Muñoz del Carpio Toia, a bioethics professor who teaches at 
Peru's Catholic University and chairs its IRB, believes Peru has strong 
regulations and a competent IRB system, though she concedes that the 
country should be more vigilant against financial conflicts of interest. 
"We need better ways to identify and deal with these problems," she 


Joana Ramos, MSW
Independent Health Policy Consultant
Portuguese Medical Interpreter
Seattle WA
tel. 206-229-2420 <tel:206-229-2420>


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