‘Dis­clo­sure op­tional’

Fi­nan­cial con­flict rule not strong enough, many say

Modern Healthcare - - The Week - Andis Robeznieks

HHS re­ceived mostly neg­a­tive re­ac­tions to its up­dated fi­nal rule aimed at “pro­vid­ing a frame­work for iden­ti­fy­ing, man­ag­ing and ul­ti­mately avoid­ing” fi­nan­cial con­flicts of in­ter­est among sci­en­tists con­duct­ing gov­ern­ment-funded re­search.

In par­tic­u­lar, Sen. Chuck Grass­ley (R-Iowa) is con­demn­ing a pro­vi­sion that makes the pub­lic In­ter­net post­ing of fi­nan­cial con­flicts op­tional. Un­der the pro­vi­sion, when in­di­vid­u­als con­duct­ing fed­er­ally funded re­search have a sig­nif­i­cant fi­nan­cial in­ter­est in the re­search, their in­sti­tu­tions can put that in­for­ma­tion on a pub­licly ac­ces­si­ble web­site or wait un­til some­one re­quests fi­nan­cial dis­clo­sure in­for­ma­tion and then dis­close it in writ­ing within five busi­ness days.

“Mak­ing the method of dis­clo­sure op­tional hurts pub­lic ac­cess,” Grass­ley said in a news re­lease. “An in­sti­tu­tion that doesn’t want to dis­close in­for­ma­tion read­ily will be able to opt for the writ­ten re­quest, know­ing that re­quir­ing a re­quest in writ­ing is a bar­rier. … This is a missed op­por­tu­nity to in­ject trans­parency where it’s re­ally needed. With less pub­lic scru­tiny than we could have had, we’ll lose a valu­able layer of over­sight.”

The rule ap­plies to any in­sti­tu­tion ap­ply­ing for or re­ceiv­ing an HHS pub­lic health ser­vice grant and takes ef­fect Aug. 24, 2012. Ac­cord­ing to fig­ures sup­plied by the Na­tional In­sti­tutes of Health, in fis­cal 2010, gov­ern­ment fund­ing of re­search that is sub­ject to con­flict of in­ter­est dis­clo­sure reg­u­la­tion to­taled more than $25.1 bil­lion—81% of the NIH’s to­tal $30.8 bil­lion bud­get for that year.

The new rule fea­tures reg­u­la­tions pro­posed last year and also in­cludes “ma­jor changes” to reg­u­la­tions con­cern­ing dis­clo­sure, pub­lic re­port­ing and re­searcher train­ing, ac­cord­ing to an HHS news re­lease. A summary on the NIH web­site lists new changes such as low­er­ing the thresh­old for dis­clo­sure of pay­ment for ser­vices or eq­uity in­ter­ests to $5,000 from $10,000; re­quir­ing travel-ex­pense re­im­burse­ment dis­clo­sure; and re­quir­ing the dis­clo­sure of the name of the or­ga­ni­za­tion with which the re­searcher has a fi­nan­cial con­flict of in­ter­est, the na­ture the con­flict and the value of the in­ter­est.

“The NIH is com­mit­ted to safe­guard­ing the pub­lic’s trust in fed­er­ally sup­ported re­search that is con­ducted with the high­est sci­en­tific and eth­i­cal stan­dards,” Na­tional In­sti­tutes of Health Di­rec­tor Dr. Fran­cis Collins said in the HHS re­lease. “Strength­en­ing key pro­vi­sions of the reg­u­la­tions with added trans­parency will send a clear mes­sage that NIH is com­mit­ted to pro­mot­ing ob­jec­tiv­ity in the re­search it funds.”

Dr. Sid­ney Wolfe, di­rec­tor of the Pub­lic Cit­i­zen Health Re­search Group, said he was trou­bled by Collins’ state­ment in light of the op­tional pub­lic-post­ing pro­vi­sion.

“That’s hypocrisy,” Wolfe said in an in­ter­view, adding that “to pre­serve the pub­lic trust,” the pub­lic needs to be fully in­formed.

Wolfe said the only pos­si­ble rea­son for such a pro­vi­sion would be “to keep peo­ple in the dark,” and added how it also con­tra­dicts state­ments made by Collins in an es­say he co-wrote ti­tled “Man­ag­ing Fi­nan­cial Con­flict of In­ter­est in Biomed­i­cal Re­search” that was pub­lished in the May 24, 2010 edi­tion of the Jour­nal of the Amer­i­can Med­i­cal As­so­ci­a­tion.

“The pub­lic may not al­ways un­der­stand the in­tri­ca­cies of rig­or­ous science, but most in­di­vid­u­als quickly grasp the con­cept of bias,” Collins wrote. “Plain and sim­ple, Amer­i­cans do not want fi­nan­cial con­flicts of in­ter­est to in­flu­ence the fed­er­ally funded re­search they hope will yield bet­ter ways to fight dis­ease and im­prove health.”

The As­so­ci­a­tion of Amer­i­can Med­i­cal Col­leges gave the up­dated rule a pos­i­tive re­cep­tion. “To­day’s fi­nal rule from the NIH is an important step for­ward on the path to strength­en­ing the in­tegrity of biomed­i­cal re­search through en­hanced re­quire­ments for dis­clo­sure and trans­parency,” Dr. Dar­rell Kirch, AAMC pres­i­dent and CEO, said in a news re­lease.

Grass­ley be­gan in­ves­ti­gat­ing univer­sity dis­clo­sure of re­searchers’ out­side fi­nan­cial in­ter­ests in 2007, and he noted in­stances where prom­i­nent psy­chi­a­try pro­fes­sors at Emory, Har­vard and Stan­ford uni­ver­si­ties who were con­duct­ing NIH-funded re­search failed to dis­close their fi­nan­cial in­ter­ests.

“Emory, as other schools, is com­mit­ted to en­sur­ing the in­tegrity of our re­search,” a univer­sity spokes­woman said in an e-mail. “We are ex­am­in­ing and re­vis­ing our poli­cies and pro­ce­dures to en­sure com­pli­ance with the new reg­u­la­tions.”

Stan­ford and Har­vard of­fi­cials de­clined to com­ment.

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