Harsher penal­ties needed for pay­ment dis­clo­sure vi­o­la­tions

Be­sides trans­parency, strong penal­ties needed for not re­port­ing doc pay­ments

Modern Healthcare - - NEWS - Su­san Chi­monas, Fred­er­ica Stahl and David Roth­man

No one has been more ef­fec­tive than Sen. Chuck Grass­ley (R-Iowa) in pro­mot­ing trans­parency in medicine. From 2004 to 2010, he in­ves­ti­gated undis­closed con­flicts of in­ter­est be­tween physi­cians and phar­ma­ceu­ti­cal and de­vice com­pa­nies. His find­ings helped lead to the Physi­cian Pay­ments Sun­shine Act. Be­gin­ning March 31, 2014, com­pa­nies must report to HHS all pay­ments over $10 to physi­cians; the pay­ment in­for­ma­tion will be made pub­licly avail­able the fol­low­ing Septem­ber.

The Sun­shine Act will bring un­prece­dented trans­parency to physi­cian-in­dus­try ties, but will it re­solve the prob­lems Grass­ley un­cov­ered? To an­swer this ques­tion, we an­a­lyzed five cases Grass­ley high­lighted for Congress. All re­vealed physi­cians sig­nif­i­cantly un­der­re­port­ing com­pany pay­ments to their aca­demic med­i­cal cen­ters and the Na­tional In­sti­tutes of Health. What were the con­se­quences of ex­po­sure? Did sun­light dis­in­fect?

Grass­ley took his lead from news­pa­per ex­posés. His first case be­gan with a New York Times report on Dr. Melissa DelBello, a Univer­sity of Cincin­nati psy­chi­a­trist. Af­ter pub­lish­ing a study sup­port­ing atyp­i­cal an­tipsy­chotic use in chil­dren, DelBello be­came a con­sul­tant and speaker for As­traZeneca, which man­u­fac­tures que­ti­ap­ine, an atyp­i­cal an­tipsy­chotic. DelBello de­clined to tell the Times how much in­dus­try fund­ing she re­ceived.

Trou­bled, Grass­ley asked UC for DelBello’s con­flict-of-in­ter­est dis­clo­sures. He also asked As­traZeneca to report her earn­ings. Dis­crep­an­cies emerged: As­traZeneca paid DelBello $238,000 in 2003, but she dis­closed only $100,000 to UC. Her un­der­re­port­ing vi­o­lated NIH guide­lines.

What came of this? The con­se­quences were min­i­mal. The univer­sity en­tered the lapses in DelBello’s per­son­nel file but did noth­ing more. The NIH took no ac­tion, and DelBello still re­ceives government fund­ing.

Grass­ley’s next case was Dr. Joseph Bie­der­man, a psy­chi­a­trist at Har­vard Med­i­cal School. As the Bos­ton Globe re­ported, Bie­der­man had NIH fund­ing to study at­ten­tion deficit dis­or­der and Eli Lilly and Co.’s med­i­ca­tion ato­m­ox­e­tine. Bie­der­man would not di­vulge his pay­ments from Lilly.

Grass­ley again in­ves­ti­gated, learn­ing Bie­der­man had un­der­re­ported his Lilly earn­ings to Har­vard in 2000, when he stud­ied ato­m­ox­e­tine with NIH funds. Har­vard promised an in­ves­ti­ga­tion. The NIH pledged “ap­pro­pri­ate ac­tions.”

Yet lit­tle hap­pened. Har­vard im­posed mi­nor penal­ties on Bie­der­man: no in­dus­try ac­tiv­i­ties for one year; prospec­tive ap­proval of ac­tiv­i­ties for two ad­di­tional years; and un­spec­i­fied “train­ing.” The NIH never com­mented, con­tin­u­ing Bie­der­man’s fund­ing through March 2010.

Grass­ley’s third case was Dr. Alan Schatzberg, Stan­ford Univer­sity’s psy­chi­a­try chair. As the San Jose Mer­cury News re­ported, Schatzberg co-founded Cor­cept Ther­a­peu­tics to li­cense mifepri­s­tone for treat­ing de­pres­sion. Schatzberg sat on Cor­cept’s board of direc­tors and held stock worth $12 mil­lion while lead­ing NIH-funded re­search on Cor­cept’s prod­uct.

Grass­ley’s in­ves­ti­ga­tion un­cov­ered in­ac­cu­ra­cies in Schatzberg’s dis­clo­sures to Stan­ford and a lu­cra­tive li­cens­ing agree­ment be­tween Stan­ford and Cor­cept. How could Stan­ford man­age Schatzberg’s con­flicts, Grass­ley asked the NIH, while main­tain­ing a fi­nan­cial in­ter­est in the com­pany and the re­search out­come? In re­sponse, Stan­ford sought a new psy­chi­a­try chair and re­moved Schatzberg from the NIH grant—although it later re­in­stated him as prin­ci­pal in­ves­ti­ga­tor. Schatzberg still re­ceives NIH fund­ing and re­cently served as pres­i­dent of the Amer­i­can Psy­chi­atric As­so­ci­a­tion.

Dr. Karen Wag­ner, a Univer­sity of Texas Med­i­cal Branch at Galve­ston psy­chi­a­trist, be­came Grass­ley’s fourth case. Wag­ner was de­posed in a 2006 law­suit charg­ing Glax­oSmithK­line with “per­sis­tent fraud” in re­search­ing and mar­ket­ing its an­tide­pres­sant parox­e­tine. Glaxo paid Wag­ner to pro­mote parox­e­tine while she re­ceived NIH fund­ing to study it. In her de­po­si­tion, Wag­ner de­nied know­ing how much Glaxo paid her. Grass­ley learned that, from 2002 to 2005, Wag­ner dis­closed to the univer­sity only $600 of $88,927 from Glaxo. The univer­sity promised to in­ves­ti­gate. The NIH stated “they were never told of Wag­ner’s con­flicts.” Yet again, noth­ing hap­pened. The NIH took no ac­tion. Wag­ner re­mains a Univer­sity of Texas Med­i­cal Branch pro­fes­sor.

Grass­ley’s fifth and most no­to­ri­ous case in­volved Dr. Charles Ne­meroff, Emory Univer­sity’s psy­chi­a­try chair. The New York Times re­ported Ne­meroff had lu­cra­tive Glaxo ties even as he used NIH fund­ing to study the com­pany’s an­tide­pres­sants. Emory told Grass­ley it had rep­ri­manded Ne­meroff in 2004 for vi­o­lat­ing univer­sity and NIH con­flict-of-in­ter­est poli­cies—to which Ne­meroff pledged to “recom­mit him­self.” How­ever, Grass­ley’s in­ves­ti­ga­tion re­vealed that, from 2004 to 2008, while con­duct­ing NIH-funded re­search on Glaxo prod­ucts, Ne­meroff failed to report to Emory re­ceiv­ing $500,000 from the com­pany.

Im­me­di­ately af­ter Grass­ley pre­sented the case to the Se­nate, Ne­meroff re­signed as psy­chi­a­try chair. The NIH froze his grant and im­posed strin­gent fund­ing con­di­tions on Emory. Emory pro­hib­ited Ne­meroff from sub­mit­ting NIH grants for two years.

Yet, soon there­after, as­sisted by the Na­tional In­sti­tutes of Men­tal Health’s di­rec­tor, Ne­meroff be­came chair of psy­chi­a­try at the Univer­sity of Mi­ami, where he was free to ap­ply for fed­eral fund­ing. He re­cently re­ceived an NIMH grant.

Grass­ley’s probes of in­di­vid­ual malfea­sance and weak in­sti­tu­tional over­sight built sup­port for trans­parency. But will the Sun­shine Act be suf­fi­cient to rem­edy con­flicts of in­ter­est in medicine? Prob­a­bly not. Even in the most egre­gious cases, the physi­cians es­caped largely un­scathed, and the NIH was re­luc­tant to in­ter­vene.

What could make the Sun­shine Act ef­fec­tive? Med­i­cal and gov­ern­men­tal bod­ies should im­ple­ment strin­gent con­flict-of-in­ter­est poli­cies, us­ing Sun­shine Act data to ver­ify physi­cians’ dis­clo­sures. They must also im­pose strong penal­ties for vi­o­la­tions. Trans­parency by it­self is not enough. Peo­ple be­have bet­ter when watched, but only if mis­be­hav­ior has con­se­quences.

Su­san Chi­monas, left, is as­so­ciate di­rec­tor of re­search at Columbia Univer­sity’s Cen­ter on Medicine as a Pro­fes­sion; Fred­er­ica Stahl is prod­uct man­ager and data sci­en­tist at Med­dik; and David Roth­man, who has con­sulted for the state of Texas in its lit­i­ga­tion against John­son & John­son for Med­i­caid fraud, is di­rec­tor of CMAP.

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