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...
Related Articles
By Grace Won, KQED [with CGS' Katie Hasson] | 12.02.2025
In the U.S., it’s illegal to edit genes in human embryos with the intention of creating a genetically engineered baby. But according to the Wall Street Journal, Bay Area startups are focused on just that. It wouldn’t be the first...
By Emma Cieslik, Ms. Magazine | 11.20.2025
Several recent Biopolitical Times posts (1, 2, 3, 4) have called attention to the alarmingly rapid commercialization of “designer baby” technologies: polygenic embryo screening (especially its use to purportedly screen for traits like intelligence), in vitro gametogenesis (lab-made eggs and sperm), and heritable genome editing (also termed embryo editing or reproductive gene editing). Those three, together with artificial wombs, have been dubbed the “Gattaca stack” by Brian Armstrong, CEO of the cryptocurrency company...
By Adam Feuerstein, Stat | 11.20.2025
The Food and Drug Administration was more than likely correct to reject Biohaven Pharmaceuticals’ treatment for spinocerebellar ataxia, a rare and debilitating neurodegenerative disease. At the very least, the decision announced Tuesday night was not a surprise to anyone paying attention. Approval...