http://sellingsickness.com/medical-devices-under-scrutiny/
February 20-22, 2013
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Hyatt Regency Washington on Capitol
Hill
Washington D.C.
MEDICAL DEVICES UNDER SCRUTINY
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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