Report Raises Concern Over Foreign Drug Trials

By: Laura Strickler
Topics: News

A new report raises alarms about the lack of US government oversight into thousands of foreign clinical trials for drugs sold in the United States.

(Credit: CBS/iStockphoto)

This story was written by Investigative Producer Laura Strickler

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.

The report 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.

Dr. Kevin Schulman, a professor of medicine and business at Duke University, says the report shows there is no global policing of drug trials.

"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."

And 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.

Rep. 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 unacceptable."

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."

The 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 States.

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.

It 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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by mahal-kita June 24, 2010 2:00 AM EDT: Ultimately, conducting offshored clinical trials is about bringing new treatments to market cheaper, which is a major monetary benefit to Big Pharma executives, their lawyers, and their lobbyists' ballooning compensation packages. Concern for patients is secondary.; Reply to this comment


by jlewisacro June 23, 2010 5:17 PM EDT: The comments of Dr. Kevin Schulman of Duke University are simply not in line with the findings of the report issued by the Office of the Inspector General. Ironically, we note that Dr. Schulman also serves as an associate director of the Duke Clinical Research Institute, which boasts that more than 60 countries ? from Argentina to Venezuela ? have participated in its clinical trials.

The Association of Clinical Research Organizations (ACRO) endorses the OIG?s recommendations for improving the FDA?s oversight of non-US clinical trials. (You may find our full comments on the report at www.acrohealth.org). But the OIG report contains no evidence of fraud, issues of participant safety, questions of research quality or lax local regulation. Nor does the OIG in any way recommend that foreign trials be limited. In fact, the OIG report notes that ?sponsors may realize benefits from conducting research abroad, such as?the ability to conduct larger trials in less time.?

Ultimately, conducting clinical trials on a global basis is about bringing new treatments to market faster, which is a major public health benefit that Dr. Schulman and other critics should not ignore.; Reply to this comment