~ Chronic Pain Sufferer Number Used to Justify FDA Approval for Narcotic PainKillers Is Misleading - Zohydro: A Case-in-Point
John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today reports that conflict of interest may be at play in the use - or misuse - of a widely used number cited by drug cmpanies seeking approval for new narcotic painkillers.
This has recently come up in conjuction of the FDA's approval of the drug Zohydro - an approval that more and more health professionals think should be resceinded.
In defense of approving this drug, FDA commissioner Margaret Hamburg cited the statistic that 100 million American adults suffer from debilitating and severe chronic pain.
But this number has been challenged by experts its origins in the 2011 report: "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-transforming-Prevention-Care-Education-Research.aspx)
Moreover, Journal Sentinel/MedPage Today uncovered that 19 experts on the panel that produced the report "...had connections to companies that manufacture narcotic painkillers at the time or in the 3 years prior to their work on the report."
These connections were not disclosed in the report, and the U.S. Senate is investigating the role of these links in the approval of Zohydro (Manchin Confronts FDA Approval of Zohydro and Pay-to-Play Scheme with FDA Commissioner Hamburg Prior to Committee Hearing, http://www.manchin.senate.gov/public/index.cfm/2014/3/manchin-confronts-fda-approval-of-zohydro-and-pay-to-play-scheme-with-fda-commissioner-hamburg-prior-to-committee-hearing)
Phsycians and health advocates are not only debating the safety of the drug, but the 100 million number itself -- using an overstated number to represent the kind of pain extreme measures should be taken for dangerously undermines their entire credibility.
Here is a video of some of that discussion: http://bit.ly/1nFafnp
Source: IOM and COI: Painful Disclosures?, Published: Jun 25, 2014 | Updated: Jun 25, 2014, By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
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