Paolo Bianco and colleague Douglas Sipp wrote a very provocative and interesting piece recently published in the journalNature (http://www.nature.com/news/regulation-sell-help-not-hope-1.15409)discussing a movement to permit stem cell medicines, among others, to be sold in the market without the requirement to show much safety and efficacy data permitting the market to determine safety and effectiveness of compounds. Here, patients would basically pay to obtain products and also be research subjects. Certain powerful groups are calling for the deregulation of clinical medicine as a business model to bring innovative products to the marketplace. But before I begin explaining what Bianco and Sipp discuss, we need to cover the current system of regulatory oversight of medical products.
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