PopSci examines medical tourism for stem cell therapies, an entirely rational response to the unnecessary costs and delays imposed on medical development by the FDA: "The FDA thinks all stem-cell procedures should undergo clinical trials for safety and efficacy before companies begin selling them as therapies. Its formal review process, the agency maintains, is the only way to protect patients from treatments that are ineffective or downright dangerous. But with multistage clinical trials lasting up to five years and costing as much as $100 million, a growing number of doctors and patients have started pursuing other options. ... In a controversial move in 2005, the FDA reclassified autologous stem cells that are manipulated by growth factors or other compounds as drugs. This criterion holds whether the cells are derived from a patient's own body or from someone else's. Many believe that the policy change gives the agency more authority than Congress ever intended it to have. Grekos's theory is that pharmaceutical companies are pressuring the FDA to treat autologous stem cells as a drug in order to secure their own future profits." Clinical trials are taking place overseas, as the article notes. The quality of therapies offered varies widely, as is true whether or not a market is regulated: this means you have to do some legwork to find out who is well regarded. But at least the option is available - there has to be freedom to experiment and to choose if there is to be rapid progress.

View the Article Under Discussion: http://www.popsci.com/science/article/2010-06/offshore-operations-crossing-atlantic-pursuit-stem-cells

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