Regulation: Sell Help not Hope
By Paolo Bianco & Douglas Sipp,
Nature
| 06. 16. 2014
Untitled Document
Modern medicine depends on products that must pass rigorous tests for safety and efficacy before being marketed to patients. Such requirements are in place for drugs and other medical products across the world. Over the past decade, however, some have called to weaken or even undo this key protection.
Think tanks in the United States are using stem cells to promote broader deregulation; these moves are influencing policy in other countries. Some argue that stem-cell products and procedures should not be governed by drug regulatory agencies at all; others want to bypass requirements that treatments must be shown to work before they are sold.
'Free-to-choose' reasoning pits the scientific method against unrestrained market forces. But there is little correlation between business success and efficacy in poorly regulated markets; the billions of dollars in revenue from nutritional supplements and homeopathy bear testament to that.
A loosening of the regulatory strictures would enable companies and practitioners to generate revenue from untested products and procedures. Patients would, in effect, pay to serve as research subjects. Worse, with no requirement to demonstrate...
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