Undoubtedly, we're all critically aware of quality issues with supply chain for raw materials, excipients and even APIs - particularly from developing countries like China. Clearly there is work to do across vendors to raise quality standards and oversight for critical materials to be used in drug (& food) manufacturing.
Now we have a new HHS report that calls into question clinical trial results as well from some of these developing areas - China and Russia in particular were identified. It likely is not a surprise that clinical trial work is being outsourced to areas besides the US and Western Europe due to much lower costs. It may be a surprise to what extent this is occuring. The HHS report found that 80% of all drugs approved in the US in 2008 relied on some foreign trial data, 78% of all study enrollees were at foreign sites, and 10 new drugs had no US derived data at all.
This is seen to be a dangerous situation by some. Congresswoman Rosa DeLauro of Connecticut states, "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of the public health."
Not too comforting if it can be taken at complete face value. It would be nice to see exactly what quality corners are being cut to assess that portion of the claim. Aparently, there is less liability to worry about in these countries and informed consent is more "cloudy" shall we say.
One of the problems with cost is that many US and Western clinical investigators don't want to do trials anymore - trial investigators have dropped by 5.2 and 6.1 percent respectively in each geography. While numbers have blossomed in Eastern Europe (up 16%), Asia (up 12%) and Latin America (up 10%). US investigators want to make money and don't want increased reporting requirements - especially income disclosure requirements imposed by new sunshine legislation - 24% say they are less likely to participate in a trial as a result of financial disclosure.
Hmmm! Sounds like we're not going to be seeing a change in this trend anytime soon.
By the way, PhRMA disputes that there is any difference in regulatory standards for clinical trials regardless of location. See PhRMA website for the complete statement.
Posted by Bruce Lehr June 23rd 2010.
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