Senators call on FDA to not risk biasing study findings in favor of opioid use

De­mo­c­rat Sens. Ed Markey of Mass­a­chu­setts and Joe Manchin of West Vir­ginia are call­ing on FDA Com­mis­sion­er Rob Califf not to per­mit the use of en­riched en­roll­ment ran­dom­ized with­draw­al (EERW) re­search to de­ter­mine the long-term ef­fi­ca­cy and tol­er­a­bil­i­ty of opi­oids in chron­ic pain pa­tients.

The let­ter ex­plains how such EERW re­search can bias opi­oids in fa­vor of ap­proval and un­der­es­ti­mate their ad­verse ef­fects as of­ten­times par­tic­i­pants who do not tol­er­ate the neg­a­tive side ef­fects of the opi­oids do not move in­to the dou­ble-blind por­tion of the tri­al and do not af­fect the re­sults.

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