Outsourced Clinical Trials; Critics question ethics of testing in poor countries

Some pharmaceutical companies are cutting costs by conducting clinical trials outside the U.S., thus also avoiding strict policies put in place here. Consumers may start to wonder if drugs in the U.S. will be less safe when companies are increasingly seeking other nations to conduct trials in, places like Eastern Europe, Africa and Asia. Maybe its good science, or maybe its just great profits. Today we have three articles which discuss many of these concerns.

Published online in April over at Outsource portfolio is the first of two articles, "the first critiquing the second", both in reference to a report on the dangers involved with outsourcing clinical trials. The report is from the "Center for Research on Multinational Corporations". 
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The second article criticized the centers paper for a lack of evidence, but said the guidelines in the report had merit, in particular these proposed guidelines; the number of regulatory tests or inspections done on non-traditional areas should be hiked. In order to obtain 100 percent transparent along these lines, all audit results should be made 100% public. Also, disclosing all parties involved in each study, including all contractors and subs.

In the third article, "a must read" Ben Hirschler from Reuters covers the pros and cons of outsourcing in more detail. The author points out the increase of outsourcing clinical trials to other countries like Poland and Hungary, look at the numbers;

In the United States, the widespread "off-shoring" of research was highlighted in a report last year by the inspector general of the Department of Health and Human Services, which revealed just how reliant the country has become on foreign testing. In 2008, a total of 78 percent of all subjects participating in trials to support drug applications submitted to the Food and Drug Administration (FDA) were enrolled at foreign sites -- and as more experimental medicines move through the pipeline the numbers are set to increase further. In Europe, the picture is similar, with 61 percent of patients in pivotal trials submitted to the European Medicines Agency (EMA) between 2005 and 2009 coming from third countries. A further 11 percent of patients were enrolled in studies in Eastern European countries that are now members of the European Union. The number of Polishh the pipeline the numbers are set to increase further. In Europe, the picture is similar, with 61 percent of patients in pivotal trials submitted to the European Medicines Agency (EMA) between 2005 and 2009 coming from third countries. A further 11 percent of patients were enrolled in studies in Eastern European countries that are now members of the European Union. The number of Polish patients involved in such trials rose fivefold over the period, while Hungary was up 3-1/2 times.

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More From The Author; Drug makers seeking global guinea pigs
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"Off-shoring" clinical trials helps drug makers cut costs
Growing reliance on Eastern Europe, Asia, Latin America
U.S. doctors worried by decline in U.S. trial subjects
Critics question ethics of testing in poor countries
The Polish port city of Gdansk is famous for its shipyards. Hungary's fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world. In fact, Poland and Hungary together accounted for 21 percent of all subjects studied in the pivotal 18,000-patient trial -- more than double the United States and Canada combined.

A few years ago that would have been unthinkable. Major drug companies, with an eye on the commercial promise of the world's largest and most profitable market, would have run half their tests on a major cardiovascular medicine like this in U.S. hospitals under the supervision of U.S. doctors.

Today, the clinical trials business has gone global as drug makers seek cheaper venues for studies and cast their net further afield for big pools of "treatment-naive" patients who are not already taking other drugs that could make them unsuitable subjects for testing new ones. And it is not only the practicalities of running big clinical trials as efficiently and cheaply as possible that is driving the change. The drug industry is also paying a lot more attention these days to the promise of emerging markets, whose healthcare authorities, just like those in the United States and Western Europe, are keen to see cutting-edge science conducted in their backyards.
"The motivation to involve lots of patients is very high in Eastern European countries and also in Asia," says Dr. Ivan Horvath, head of interventional cardiology at the University of Pecs. "There are three factors driving this. Our patients get access to a new drug, which is free during the trial. It is also very important for scientific reasons. And we get paid."

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Of Interest: From The January 2011 Issue Of Vanity Fair; Deadly Medicine

Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.