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âField trials are indispensable. . . . If, in major medical dilemmas, the alternative is to pay the cost of perpetual uncertainty, have we really any choice?â
âDonald Frederickson, MD, former National
Institutes of Health (NIH) director 3
My life and the lives of some of my closest relatives continue thanks to the interventions of modern medicine, a scientific art that has marched forward in fits and starts on a bedrock of clinical research. The drugs that enabled me to survive an emergency cesarean section, those that allow my son to breathe despite allergic asthma, the other ones that correct a hormonal deficit in my mother have been administered to us with success and confidence in part because theyâve been tested in hundreds and perhaps thousands of human subjects in experimental trials. Not only that: these successfuldrugs emerge from a slurry of countless other failed drugs, each of which was also tested on scores of warm bodies, some of which may have been harmed by their shortcomings.
Thereâs nothing terrible about the truth that medical research imposes burdens. But generally speaking, we donât like to know it. We donât like to see it. The very notion of experimenting upon humans sounds sinister. And yet, if anything, we only want ever more drugs to help or enhance us, and more data to assure our trembling selves of their safety and effectiveness. The response to these contradictory desires has been the same since the mid-1800s, when scientists hell-bent on dissecting animals skirted the outcries of British antivivisectionists by cloaking their slicing in secrecy. Today, savvy drugmakers loudly publicize new medical products, but conduct the required experimentation quietly. And so, while we exult in, bicker over, and complain about the products of medical researchâhow much do the drugs cost? who pays? what are the side effects?âthe vast business of percolating new drugs burrows underground.
If the history of human experimentation tells us anything, from the bloody vivisections of the first millennium to the Tuskegee Syphilis Study, it is that the potential for abuse will fall heaviest on the poorest and most powerless among us.
The trend within the drug industry to conduct their experimental drug trials in poor countries is, as yet, in its infancy. But it is growing fast. Major drugmakers such as GlaxoSmithKline, Wyeth and Merckâalready conducting between 30 and 50 percent of their experiments outside the United States and Western Europeâplan to step up the number of their foreign trials by up to 67 percent by 2006, according to USA Today . And while armies of clinical investigators in the United States shrink, dropping by 11 percent between 2001 and 2003, those abroad fatten, increasing by 8 percent over the same period, according to a 2005 study by the Tufts Center for Drug Development. âThe outsourcing of drug research is beginning to accelerate,â reported the Washington Post in May 2005. 4
And all the pressures on the profit-driven industry, pushing it toward speed and ever-lower costs; Americansâ contradictory love of new drugs and skittishness about participating in the experiments that make them possible; the increasing desperation of hordes of patients in developing countries deprived access to useful medicines; and the immediate financial needs of the cash-strapped public hospitals and clinics meant to serve them suggest the trend will only grow over the coming years. Many leaders in developing countries, faced with crumbling facilities, minuscule budgets, and towering health crises make arrangements for more industry trials, not fewer.
It is a trend that cries out for public review. Thatâs because the consequences of the multinational drug industryâs trek into the developing world go far beyond the fates of the patients roped into their trials and then discarded afterward. After all, many will be helped, at least for
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