Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, November 15, 2012

Selling Sickness: People Before Profits

February 20-22, 2013
register today!
Hyatt Regency Washington on Capitol Hill
Washington D.C.

Overtreatment, over-marketing, conflicts-of-interest and all the trappings of disease-mongering pertain not just to medical treatments, education, publishing, screening and drugs, but, increasingly, to medical devices, both the kind that are used IN the body and ON the body. It is clear from current scandals and investigations in the US and UK that the device approval and oversight systems are, according to the BMJ, “fragmented, poorly regulated [and] market driven,” and that, shockingly, “financial incentives prioritize manufacturers’ interests over those of patients, with no requirement for clinical evaluation of a devices’ safety or effectiveness.”
Digging into the background of medical devices is eye-opening for someone already familiar with medicines and their scientific and regulatory problems. It’s a whole new world of engineering and chemistry, radiation and plastics, chips and tags, etc.
What isn’t new is the revelation of a patchwork and antiquated approval and regulatory system based on levels of risk that seems more appropriate to tongue depressors than hip implants. We’ll be sure to take a look at this topic next February at “Selling Sickness, 2013.”

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