In a new report by Daniel R. Levinson, the HHS inspector general, finds that 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites.
Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled at foreign trial sites. In 2008, the FDA inspected 1.9 percent of domestic clinical trial sites, while just 0.7 percent of foreign clinical trial sites were similarly audited. Mr. Levinson’s investigators found that the F.D.A. was 16 times more likely to audit a domestic site than a foreign one.
Not surprising. Not shocking. And not all about money – although that’s a crucial variable. But not in the way some people think.
Representative Rosa DeLauro believes the report, “highlights a very frightening and appalling situation … By pursuing clinical trials in foreign countries with lower standards and where F.D.A. lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.”
Wrong. Pharma companies field clinical trials in other nations because they can recruit patients there. Perhaps Ms. DeLauro should spend 20 minutes speaking with someone from Quintiles before she shoots from the hip and hits her foot. As far as “lower standards” are concerned, she should also get a briefed on EU standards that are certainly on par with our own. Mr. Levinson’s report found that most foreign clinical trial sites and subjects were in Western Europe.
Mr. Levinson pointed out that the agency was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing.
IG Levinson suggested that the agency demand that drug companies submit their applications in a standardized electronic format. A database controlled by the F.D.A. of foreign clinical trial sites would help identify sites and investigators for audits.
“As sponsors increase the number of foreign clinical trials in support of F.D.A. marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained,” Mr. Levinson wrote.
He encouraged the F.D.A. to develop more cooperative inspection agreements with foreign governments, inspect more clinical trials in more countries and encourage companies to register their foreign trials before they are conducted.
The agency largely agreed with Mr. Levinson’s suggestions and said it was testing a new computer system that would help track foreign clinical trial sites.”
Sound advice – but it only goes so far. The real solution lies in educating the American public to the importance of participating in clinical trials and significantly increased funding for the FDA.
