No free lunch

Doc groups set rules to check con­flicts of in­ter­est

Modern Healthcare - - The Week In Healthcare - Andis Robeznieks

The Coun­cil of Med­i­cal Spe­cialty So­ci­eties has de­vel­oped a vol­un­tary code for in­ter­ac­tions with com­pa­nies in the for-profit health sec­tor, stat­ing that it did so to help main­tain the “ac­tual and per­ceived in­de­pen­dence” of its mem­ber or­ga­ni­za­tions and the 650,000 physi­cians those or­ga­ni­za­tions are said to rep­re­sent.

The code has been signed by only 13 of the coun­cil’s 32 mem­ber groups, but ad­di­tional so­ci­eties are ex­pected to sign on to the code once the lead­er­ship of those groups re­view and ap­prove it. “Mem­bers and pa­tients count on So­ci­eties to be au­thor­i­ta­tive, in­de­pen­dent voices in the world of sci­ence and medicine,” the Code’s pre­am­ble states. “Pub­lic con­fi­dence in our ob­jec­tiv­ity is crit­i­cal to car­ry­ing out our mis­sion. We know the pub­lic re­lies on us to min­i­mize ac­tual and per­ceived con­flicts of in­ter­est.”

The code gives guid­ance on dis­clos­ing and man­ag­ing con­flicts of in­ter­ests, pub­licly dis­clos­ing sources of fi­nan­cial sup­port, de­vel­op­ing in­de­pen­dent ed­u­ca­tion pro­grams and ad­vo­cacy po­si­tions, and pro­hibit­ing so­ci­ety lead­er­ship from hav­ing di­rect fi­nan­cial re­la­tion­ships with for-profit health­care com­pa­nies.

Amer­i­can Psy­chi­atric As­so­ci­a­tion Med­i­cal Di­rec­tor and CEO James Scully Jr., who also serves as pres­i­dent of the coun­cil, said the or­ga­ni­za­tion was mo­ti­vated by the In­sti­tute of Medicine’s re­port from last April, Con­flicts of In­ter­est in Med­i­cal Re­search, Ed­u­ca­tion, and Prac­tice, which rec­om­mended that med­i­cal so­ci­eties de­velop codes on this sub­ject.

They were also mo­ti­vated by con­gres­sional in­quiries from Sen. Chuck Grass­ley (R-Iowa) and oth­ers seek­ing in­for­ma­tion about med­i­cal col­leges’ poli­cies on fac­ulty con­flict of in­ter­est, Scully said, adding the coun­cil was also pushed into ac­tion by med­i­cal stu­dents who com­plained about the per­ni­cious and ubiq­ui­tous pres­ence of drug com­pany lo­gos and spon­sor­ship of so­cial and ed­u­ca­tional events.

“They led the way,” Scully said. “It was the stu­dents who said: ‘Hey, what are you guys do­ing?’ I still hear from my (APA) mem­bers who just don’t be­lieve they can be in­flu­enced by drug-com­pany mar­ket­ing, but stud­ies show you are in­flu­enced—even if you’re not aware of it.”

Scully added, how­ever, that mem­bers of med­i­cal so­ci­eties in par­tic­u­lar and health­care pro­fes­sion­als in gen­eral were aware of what the pub­lic per­cep­tion was, and he cited a 2008 New Yorker mag­a­zine car­toon as par­tic­u­larly damn­ing. “It showed a doc­tor all decked out like a NASCAR race­car driver with drug com­pany lo­gos all over his white lab coat,” Scully said. “That was telling.”

He also said that the med­i­cal so­ci­eties had more or less be­gun mov­ing in this di­rec­tion in­de­pen­dently—par­tic­u­larly the Amer­i­can Col­lege of Physi­cians, Amer­i­can Academy of Fam­ily Physi­cians, and the So­ci­ety of Tho­racic Sur­geons—but it was de­cided that the coun­cil should de­velop a stan­dard code that all med­i­cal so­ci­eties could adopt. “Ev­ery­body’s been work­ing on it,” Scully said.

The tho­racic sur­geons and Scully’s own group, the Amer­i­can Psy­chi­atric As­so­ci­a­tion, haven’t adopted the code yet, but most of the mem­ber or­ga­ni­za­tions are ex­pected to do so by the end of the year, Scully said, not­ing that the APA board is ex­pected to vote on the code at a Septem­ber meet­ing.

He added that, even with­out for­mal adop­tion of the code, peo­ple at­tend­ing the APA’s an­nual meet­ing be­ing held May 22-26 in New Or­leans will no­tice a dif­fer­ence from years past. “If you come to our meet­ing in New Or­leans, you’ll see a much lower drug com­pany pres­ence,” Scully said, ex­plain­ing that there will be no more banners with drug com­pany lo­gos on them, pro­gram pre­sen­ter’s Power Point slides are checked for ev­i­dence of bias to­ward a par­tic­u­lar com­pany or prod­uct, and they will no­tice that in­dus­tryspon­sored ed­u­ca­tion pro­grams dur­ing the meet­ing are be­ing phased out. “We’re down to two,” he said. “We used to have 30 or 40.”

The new code in­cludes a sec­tion on so­ci­ety meet­ings and, while cor­po­rate sup­port is still al­lowed, the code states that so­ci­eties will not so­licit cor­po­rate sup­port­ers’ sug­ges­tions on pro­gram topics, speak­ers or con­tent. It pro­hibits com­pany-con­trolled pre­sen­ta­tion ma­te­ri­als and the use of com­pany lo­gos on slides. It also states that “so­ci­eties will not seek sup­port for prod­uct-spe­cific topics,” and that groups must “make rea­son­able ef­forts to achieve a bal­anced port­fo­lio of sup­port.”

The coun­cil task force was formed in the spring of last year and went through “many, many drafts” of the code be­fore hav­ing the coun­cil’s board ap­prove it on April 17, Scully said. “The process was in­tense and there were good, po­lite de­bates and, in the end, we worked to­ward con­sen­sus,” he said. “The code wasn’t handed down from the mount.”

Med­i­cal so­ci­eties are not the only ones rolling out new con­flict-of-in­ter­est poli­cies. The U.S. Food and Drug Ad­min­is­tra­tion also re­leased a “draft guid­ance” on April 21 that it said would “ex­pand trans­parency and dis­clo­sure” of when FDA ad­vi­sory panel mem­bers’ re­ceive con­flictof-in­ter­est waivers.

In the draft, the FDA is propos­ing to ex­pand the in­for­ma­tion dis­closed, and post on the In­ter­net the type of con­flict in­volved and the fi­nan­cial in­ter­est of any com­pany or in­sti­tu­tion as­so­ci­ated with that con­flict.

An FDA news re­lease noted that, at times, it is ap­pro­pri­ate for the agency to seek ad­vice from ex­perts who may be bi­ased, and the news re­lease ad­dresses this is­sue by quot­ing from a let­ter from FDA Com­mis­sioner Mar­garet Ham­burg sent to se­nior agency of­fi­cials.

“In my view, it is clearly bet­ter for the agency in ful­fill­ing its pub­lic health mis­sion when ad­vis­ers have no con­flicts of in­ter­est,” Ham­burg stated in the let­ter. “FDA staff should search far and wide for ex­perts who have the req­ui­site knowl­edge with­out con­flicts of in­ter­est. At the same time, how­ever, I rec­og­nize the fact that many of the top au­thor­i­ties in spe­cific ar­eas may have con­flicts of in­ter­est.”

New rules pro­posed by physi­cians’ groups will help min­i­mize con­flicts of in­ter­est such as free din­ners given by drug com­pa­nies.

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