Friday, November 24, 2006

Gendicine (update)

Gendicine, as I noted in a previous post, is the world's first commercially approved gene therapy and is available in China. Today's issue of Science has a useful update on Gendicine entitled "Splicing Out the West?" (subscription needed). Here is a brief excerpt:

As these projects advance in China, gene therapies in North America and Europe are struggling to complete premarket clinical tests. After a U.S. patient died in a 1999 gene therapy trial and two children in French trials developed leukemia in 2002, the U.S. Food and Drug Administration (FDA) tightened controls on experiments, says James Norris, head of the U.K.-based International Society for Cell & Gene Therapy of Cancer. Western companies say they are making progress but have not yet brought a single gene therapy to market.

Some see this as a sign that China is catching up with, or even surpassing, the West. "I think the future of gene therapy will be in China," says Andre Lieber, a gene therapy researcher at the University of Washington (UW), Seattle. But he warns that recent claims of success should be read with caution. There is a "problem" with interpreting clinical studies done in China, Lieber says. Often the primary data are published only in Chinese--raising a barrier to nonspeakers--and even when they appear in English, critical information may be missing.

Intellectual-property rights may be problematic, too. Some researchers in the West have questioned claims of independent innovations made by Chinese drug companies; this could limit sales outside China. Finally, critics argue that the Chinese regulatory system is not rigorous and that Gendicine, for one, was approved with scant evidence of efficacy. With drugs to treat cancer, "the bar is a lot lower than in the United States to get approval," says Frank McCormick, director of the University of California, San Francisco, Comprehensive Cancer Center.