Pharmaceutical industry: European guinea pigs
23 December 2010
“It’s the next big step in globalisation, and there’s good reason to wish that it wasn't,” remarks Vanity Fair. American pharmaceuticals companies are increasingly testing new drugs in foreign countries, on subjects who do not benefit from the necessary safeguards. The trend has emerged in Third World countries but also in Europe, points out the New York monthly, and it has been reflected in the figures for the number of clinical trial investigators registered with the US Food and Drug Administration, which “fell 5.2 percent in the U.S. between 2004 and 2007 while increasing 16 percent in Eastern Europe, 12 percent in Asia, and 10 percent in Latin America.”
As Vanity Fair explains, delocalization has enabled drug companies to take advantage of conditions that are less strict and less expensive when conducting clinical trials which will “help persuade the US Food and Drug Administration (FDA) to declare the drugs safe and effective for Americans.” In 2008, 80 percent of products submitted for approval to the FDA were tested outside the United States: in all 58,788 trials, of which 876 were conducted in Romania, 589 in Ukraine and 716 in Turkey. Estonia, Poland, Russia, Lithuania, Slovakia and Croatia are also considered to be good locations for off-shore trials.
The lack of proper regulatory framework has meant that many of these trials have proved to be deadly. The magazine sites the example of a flu-vaccine trial conducted in a hostel for the homeless in Grudziadz, Poland. The subjects, who were paid two dollars for participating in the programme, “thought they were getting a regular flu shot. They were not. At least 20 of them died.”