Eighty percent of the drugs entering the U.S. market in 2008 were
tested overseas but the FDA says they only inspect 0.7 percent of
foreign clinical trial sites, according to a new report from the Health
and Human Services Inspector General. Critics say this makes it more
difficult for regulators to verify clinical results.
notes a growth in trials in places like India, China, Eastern Europe
and South America. For example, the report cites particularly large
trials in Peru.
A CBS News analysis of current
clinical trials show more than 4,000 clinical trials today are taking
place in third-world countries.
Kevin Schulman, a professor of medicine and business at Duke
University, says the report shows there is no global policing of drug
"Where data is questionable most of the time,
that doesn't become public," Schulman said. "If someone in eastern
Europe is fabricating data there's no database to say 'Don't use them
for a different clinical trial.' There's no way to know."
Schulman says testing drugs in countries with inadequate health care
could skew results. For example, he says reviewers might ask if a
patient visited a hospital after taking a drug, but in some poor
countries patients might not be able to afford to go to a hospital.
Rosa DeLauro (D-Conn.) called the report "very frightening" and said,
"The FDA also must improve its system for overseeing foreign clinical
trial data because an inspection rate of 0.7 percent is dangerous and
The report notes that early phase
trials are increasingly being conducted overseas with no FDA oversight
raising ethical concerns. "Early phase trials may pose more risk for
subjects because the drugs or biologics have not been tested widely in
humans and because they are being tested in an otherwise healthy
population, the members of which have nothing to gain therapeutically."
The pharmaceutical trade association, PhRMA released a
statement regarding foreign trials, "Is it ethical to conduct such
studies outside of the U.S.? In a word: Yes. Consistent with PhRMA's
Principles on Conduct of Clinical Trials and Communication of Clinical
Trial Results, our member companies are committed to adhering to Good
Clinical Practice guidelines around the world."
pharmaceutical industry has increasingly moved trials to foreign
countries to avoid multiple layers of regulation and high costs. Today,
more than half of all pharmaceutical study sites are outside the United
Schulman says it's increasingly difficult to
find out where drugs are tested. "People seem to be trying to hide the
origin of this data because of this issue," he said.
also appears to be hard for the FDA to find the data. The report notes
that during the Inspector General's investigation the "FDA was unable
to provide detailed clinical trial data for 29 of the 129 applications
within our review."
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