Study says trend raises ethical, medical issues
WEDNESDAY, Feb. 18 (HealthDay News) -- A new report contends many clinical drug trials are now being run outside the United States and in far reaches of the globe, and that the trend raises troubling ethical and medical issues.
The implications of this, according to Dr. Kevin A. Schulman, senior study author, are that drugs are being tested on people who may not align with the types of patients in the United States who would ultimately use the drug.
"At the end of the day" with such a scenario, added Schulman, a professor of medicine and business administration at Duke University, in Durham, N.C., "would [the potential drug] work the same way here? We may not know the answer to that question."
Dr. Robert M. Califf, a Duke University medical professor who is rumored to be one of President Barack Obama's candidates to head the U.S. Food and Drug Administration, which oversees clinical trials in the United States, was a co-author of the research. Their report appears in the Feb. 19 issue of the New England Journal of Medicine.
Their review of a U.S. government clinical trials registry and of 300 published reports in major medical journals revealed this: A third (157 of 509) of Phase 3 trials -- typically the largest and most significant trial in the development of a drug -- led by major U.S. pharmaceutical companies were being conducted entirely outside the United States. In addition, half of the study sites (13,521 of 24,206) used in these trials were located overseas, with many in Eastern Europe and Asia.
At the same time, the researchers found, the number of FDA-regulated investigators running trials abroad has increased by 15 percent each year, while the number of U.S.-based investigators declined 5.5 percent annually.
Several forces are pushing trials elsewhere, the researchers noted: cost (a trial at a top medical center in India may cost less than one-tenth per patient what it would cost at a second-tier U.S. center); faster approval times; and less red tape.
"One reason the industry is going abroad is the fact that there are complicated regulations [in the U.S.] discouraging pharmaceutical companies, although the main driving force is cost," said Adil Shamoo, a biochemistry and bioethics professor at the University of Maryland at Baltimore and editor-in-chief of Accountability in Research.
But what happens to the rights of human subjects, and to the types of drugs being developed?
"Are their rights being protected? Are they being given unfair financial inducements to participate?" Schulman asked. "That's very hard to govern and regulate and even to understand."
"The public and potential volunteers in the U.S. are more aware of their rights in the U.S. than in populations elsewhere," added Shamoo. "If we have a hard time reporting adverse events in this country, can you imagine how that would be in poor countries?"
Another consideration is whether drugs approved via trials overseas would actually be available at a reasonable cost in those countries.
And whether overseas trials even test drugs that are needed in those countries is also a question, the study authors said, citing, for example, that drugs for overactive bladder and fibromyalgia are being developed in countries where diseases like malaria and tuberculosis are prevalent.
"There's a huge benefit to research being conducted in the U.S.," Schulman said. "At a national level, we need to understand which therapies Medicare should pay for and which are effective in a Medicare [older] population, and we can only answer those questions if we do the research here."
Reacting to the report, FDA spokeswoman Karen Riley said the agency weighs in on clinical trials in many venues, and "is doing a number of things to enhance foreign oversight."
She added, "There is no prohibition against doing research in the developing world, and FDA expects sponsors and researchers to follow the applicable laws and regulations of the country or countries in which the trials will be conducted. Fortunately, international standards have been almost universally adopted. The next step for countries is to enforce these standards."
The U.S. National Institutes of Health has more on clinical trials.
SOURCES: Adil Shamoo, Ph.D., professor, biochemistry and bioethics, University of Maryland, Baltimore, and editor-in-chief, Accountability in Research; Kevin A. Schulman, M.D., professor, medicine and business administration, Duke University, Durham, N.C.; Karen Riley, spokeswoman, U.S. Food and Drug Administration; Feb. 19, 2009, New England Journal of Medicine
All rights reserved