Let Patients Decide How Much Risk They’ll Take

Recently a Wall Street Journal article http://online.wsj.com * noted: “. But rampant misalignment of incentives is hampering technology in the U.S. health industry. “
“Start with the Food and Drug Administration, which places the highest premium on “protecting the public health,” according to the agency’s website. The agency believes this goal is best accomplished through detailed oversight, ponderous review and ultimately control.”
“That doesn’t work for entrepreneurs and investors, who want rapid returns on what they invest, at a pace faster than what the FDA allows. The pharmaceutical industry seeks large markets with high returns, and the major payers, including insurance providers, require evidence of cost effectiveness. Physicians and other prescribers have limited and dwindling resources to participate in research, and instead are encouraged to push standard treatment protocols, even when they are of questionable efficacy.”
“Which is why it’s time to try a new solution. The government and entrepreneurs should be allowed to carve out their own turf and let patients choose their own level of risk.”
“That’s exactly the point: Some patients are very willing to take a calculated risk, but misaligned incentives in the industry are driving potential stakeholders with new solutions out of the business. While the FDA does a commendable job, there is no reason it should have the sole responsibility for access to lifesaving treatment. Institutional review boards and human-subject research protocols provide extremely high levels of protection overseeing clinical trials in the U.S. and Europe. These bodies have weeded out the charlatans in the industry, and the ultimate determinant of success will be patient satisfaction.”
* to read the full WSJ article “Let Patients Decide How Much Risk They’ll Take” by Kevin J. Tracey, highlight and click on open hyperlink http://online.wsj.com/articles/kevin-tracey-let-patients-decide-how-much-risk-theyll-take-1406499046
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Jonathan M. Metsch, Dr.P.H., is Clinical Professor, Preventive Medicine, Icahn School of Medicine at Mount Sinai; and Adjunct Professor, Baruch College ( C.U.N.Y.), Rutgers School of Public Health, and Rutgers School of Public Affairs and Administration
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