Drug­mak­ers fun­nel pay­ments to high-pre­scrib­ing doc­tors

Modern Healthcare - - NEWS - By Bob Her­man

Nearly one-quar­ter of Medi­care’s top-pre­scrib­ing physi­cians re­ceived con­sult­ing fees or other fi­nan­cial perks from man­u­fac­tur­ers of the drugs they pre­scribed in 2013, re­new­ing nag­ging ques­tions about con­flicts of in­ter­est in med­i­cal de­ci­sion­mak­ing.

More than 400 physi­cians pre­scribed at least $1 mil­lion worth of drugs in the Medi­care Part D drug ben­e­fit pro­gram, and 23% of them ac­cepted some form of a non-re­search pay­ment from the cor­re­spond­ing drug­maker in 2013, ac­cord­ing to a Mod­ern Health­care anal­y­sis of the CMS’ re­cent Part D data re­lease and of the Open Pay­ments data­base.

For in­stance, Dr. Gavin Awer­buch, a neu­rol­o­gist based in Sag­i­naw, Mich., billed Medi­care in 2013 for more than $6.4 mil­lion worth of Sub­sys, a pain re­liever for can­cer pa­tients. That was the sec­ond-high­est to­tal for one doc­tor pre­scrib­ing a sin­gle drug. In­sys Ther­a­peu­tics, the maker of Sub­sys, paid Awer­buch more than $56,000 that same year for an ar­ray of ser­vices, in­clud­ing $4,100 for a Sub­sys-re­lated speak­ing en­gage­ment.

The Jus­tice Depart­ment in­dicted Awer­buch last year, ac­cus­ing him of fraud­u­lent pre­scrib­ing of un­needed med­i­ca­tion. His case is pending. Calls to Awer­buch, In­sys and state pros­e­cu­tors were not re­turned.

The Mod­ern Health­care anal­y­sis found that some physi­cians and provider groups pre­scribe large vol­umes of brand-name drugs from phar­ma­ceu­ti­cal firms and ac­cept money from those same man­u­fac­tur­ers. About 17% of the al­most 36,000 providers in the Part D data­base who pre­scribed $100,000 or more of a sin­gle drug re­ceived money from the maker of that drug. The same holds true for 20% of the 2,200 physi­cians who pre­scribed at least $500,000 of one drug.

In to­tal, the data­base in­cluded more than 800,000 physi­cians, nurse prac­ti­tion­ers and other providers. Acte­lion Phar­ma­ceu­ti­cals, Cel­gene Corp. and Teva Phar­ma­ceu­ti­cals USA were among the drug­mak­ers that ap­peared of­ten in both data­bases.

Some ex­perts say th­ese cor­re­la­tions sug­gest an un­holy link­age be­tween pre­scrib­ing be­hav­ior and in­dus­try pay­ments to doc­tors. But oth­ers cau­tion that it’s hard to draw con­clu­sions with­out more de­tailed in­for­ma­tion about the physi­cians’ prac­tices and the na­ture of the fi­nan­cial re­la­tion­ships, such as whether the pay­ments are for re­search or mar­ket­ing pur­poses.

“It is frankly mag­i­cal think­ing to be­lieve that those two things are not re­lated,” said Eric Camp­bell, a Har­vard Med­i­cal School so­ci­ol­o­gist who stud­ies con­flicts of in­ter- est in health­care. “It’s just com­pletely not in the realm of re­al­ity to deny— when you see over and over that the high­est-paid speak­ers are among the ranks of the high­est pre­scribers—that there isn’t a re­la­tion­ship there.”

“It’s an enor­mous prob­lem,” said Dr. Steven Nis­sen, chair of car­dio­vas­cu­lar medicine at the Cleve­land Clinic. He co-pub­lished re­search in 2007 that found Avan­dia, a for­mer block­buster di­a­betes drug made by Glax­oSmith-Kline, was as­so­ci­ated with in­creased risks for heart at­tacks. “I be­lieve it is in­com­pat­i­ble with our roles as in­de­pen­dent de­ci­sion­mak­ers,” he said.

The CMS cau­tioned that pay­ments to providers from drug­mak­ers and biotech­nol­ogy com­pa­nies don’t nec­es­sar­ily mean there is a con­flict of in­ter­est. The agency said in a writ­ten state­ment that it has “a range of tools” in place to track fraud­u­lent be­hav­ior and odd pre­scrib­ing pat­terns. “In­for­ma­tion about fi­nan­cial re­la­tion­ships alone is not enough to de­cide whether they’re ben--

efi­cial or im­proper,” ac­cord­ing to the CMS. “Just be­cause there are fi­nan­cial ties doesn’t mean that any­one is do­ing any­thing wrong. Trans­parency will shed light on the na­ture and ex­tent of th­ese fi­nan­cial re­la­tion­ships and will hope­fully dis­cour­age the devel­op­ment of in­ap­pro­pri­ate re­la­tion­ships.”

There are some caveats in an­a­lyz­ing the Part D and Open Pay­ments data. Not all the physi­cians listed equate to one in­di­vid­ual physi­cian. In some in­stances, all the providers in one med­i­cal group bill Medi­care un­der one doc­tor’s name. Some physi­cians may then ap­pear to be pre­scrib­ing higher amounts of cer­tain drugs than is ac­tu­ally the case.

In ad­di­tion, the data are some­what in­com­plete and there are in­con­sis­ten­cies in provider in­for­ma­tion be­tween the two data­bases. The Open Pay­ments data­base, cre­ated by the Physi­cian Pay­ments Sun­shine Act pro­vi­sion of the Af­ford­able Care Act, does not pro­vide spe­cific provider iden­ti­ties for 60% of re­ported pay­ments. Con­se­quently, Mod­ern Health­care’s anal­y­sis cov­ers only the $1.4 bil­lion of iden­ti­fied pay­ments. Also, the Open Pay­ments data­base ac­counts only for the last five months of 2013, mean­ing that pay­ments from drug com­pa­nies to providers are po­ten­tially even higher. The next round of Open Pay­ments data will go live June 30.

Dr. Mark McClel­lan, a for­mer CMS ad­min­is­tra­tor and now a se­nior fel­low at the Brook­ings In­sti­tu­tion, said some as­so­ci­a­tions be­tween spe­cific drug pre­scrib­ing pat­terns and pay­ments “will lead to fur­ther ques­tions.” But, he added, with­out know­ing the full de­tails of ev­ery re­la­tion­ship, it may be “hard to reach de­fin­i­tive con­clu­sions about whether par­tic­u­lar providers or prac­tices are good or bad.”

Whether there is ac­tual bias in pre­scrib­ing pat­terns “is po­ten­tially wor­thy of a bit more in­ves­ti­ga­tion,” said Dr. Aaron Kes­sel­heim, a phar­ma­coeco­nomics fac­ulty mem­ber at Brigham and Women’s Hos­pi­tal in Bos­ton. For ex­am­ple, do high pre­scribers of par­tic­u­lar drugs at­tract phar­ma­ceu­ti­cal com­pa­nies to them, or do drug com­pa­nies seek out physi­cians who then be­come high pre­scribers?

Nis­sen said he con­sults with drug­mak­ers and helps them with re­search but has a per­sonal pol­icy of re­ject­ing any pay­ments that con­sti­tute in­come, such as speak­ing fees or hon­o­raria.

He ap­pears in the Open Pay­ments data­base, re­ceiv­ing $5,412.48 from Amarin Pharma, a car­diac-fo­cused drug firm based in Bed­min­ster, N.J. Most of that amount was do­nated to the Cleve­land Mu­seum of Nat­u­ral His­tory, while the re­main­der cov­ered his ba­sic ex­penses for an out-of-town re­search meet­ing. Nis­sen ap­pears in the Medi­care Part D data­base twice, and nei­ther list­ing in­volves drugs from Amarin.

The ques­tions be­come more con­cern­ing when drug­mak­ers ben­e­fit fi­nan­cially from the pre­scrib­ing habits of doc­tors they are pay­ing. But some physi­cians of­fer con­vinc­ing ar­gu­ments about the le­git­i­macy and so­cial value of drug­mak­ers’ pay­ments to them.

Dr. Val­lerie McLaugh­lin, a car­di­ol­o­gist at the Uni­ver­sity of Michi­gan Health Sys­tem in Ann Arbor, pre­scribed more than $4.8 mil­lion of Tr­a­cleer to Medi­care ben­e­fi­cia­ries in 2013—mak­ing her the sixth-high­est pre­scrib­ing physi­cian of a sin­gle drug. She also re­ceived $40,491 in clin­i­cal con­sult­ing fees, meals and travel from Acte­lion Phar­ma­ceu­ti­cals, the Swiss con­glom­er­ate that man­u­fac­tures Tr­a­cleer. None of the pay­ments were di­rected to char­i­ties or other third par­ties.

Tr­a­cleer treats pul­monary ar­te­rial hy­per­ten­sion (PAH), a rare type of high blood pres­sure that af­fects the lungs and is po­ten­tially fa­tal.

McLaugh­lin told Mod­ern Health­care that her pre­scrib­ing pat­terns and her pay­ments from Acte­lion “re­flect the large vol­ume of pul­monary ar­te­rial hy­per­ten­sion pa­tients I see and man­age in one of the coun­try’s largest PAH pro­grams.” Eighty of her pa­tients use Tr­a­cleer, and she pre­scribes other, les­s­ex­pen­sive ther­a­pies for PAH when ap­pro­pri­ate, she said.

“I pre­scribe many and var­ied treat­ments for PAH, based on guide­lines and a shared-de­ci­sion model with pa­tients, in­clud­ing Tr­a­cleer, which was the first oral ther­apy ap­proved for PAH back in 2001,” McLaugh­lin said. “Many pa­tients have done well on the drug for many years.”

She de­fended the pay­ments from Acte­lion, say­ing that none were re­lated to mar­ket­ing and that physi­cians’ paid con­sult­ing with drug­mak­ers is ben­e­fi­cial for drug devel­op­ment. Many of her re­ported pay­ments from Acte­lion also were re­lated to Op­sumit, a PAH drug made by Acte­lion that was ap­proved by the Food and Drug Ad­min­is­tra­tion in 2013.

“It’s in the best in­ter­est of clin­i­cal-care de­liv­ery for bio­med­i­cal com­pa­nies to be ad­vised by the knowl­edge­able, ex­pe­ri­enced ex­perts,” McLaugh­lin said. “I have treated PAH pa­tients and have been in­volved in clin­i­cal tri­als in PAH for 20 years. My con­sult­ing is re­lated to drug devel­op­ment and clin­i­cal trial de­sign. All of my con­sult­ing en­gage­ments are dis­closed to and ap­proved by the Uni­ver­sity of Michi­gan.”

Acte­lion said in a writ­ten state­ment that pay­ments to McLaugh­lin were for clin­i­cal re­search and sci­en­tific con­sult­ing work. “Only a por­tion of the pay­ments in the CMS data­base went to Dr. McLaugh­lin per­son­ally,” ac­cord­ing to the com­pany. “The de­ci­sion by physi­cians to use Tr­a­cleer, or any other drug for PAH, is based on their in­de­pen­dent med­i­cal judg­ment as to what is best for their pa­tient. Acte­lion does not pro­vide in­cen­tives to physi­cians for pre­scrip­tions.”

Acte­lion made pay­ments to other top physi­cian pre­scribers as well. Eight of the 30 high­est Medi­care Part D pre­scribers in 2013 were listed for their pre­scrib­ing of Tr­a­cleer, the patent for which ex­pires this year. Five of those physi­cians re­ceived some type of con­sult­ing pay­ment, speak­ing fee or gen­eral re­im­burse­ment from Acte­lion, ac­cord­ing to Mod­ern Health­care’s anal­y­sis.

World­wide sales of Tr­a­cleer to­taled $1.68 bil­lion in 2013, $445 mil­lion of which came from Medi­care.

An­other drug­maker that made sig­nif­i­cant pay­ments in 2013 to top pre­scribers of its drug was Is­rael-based Teva Phar­ma­ceu­ti­cal In­dus­tries and its U.S. sub­sidiary. Four­teen Medi­care providers billed at least $2 mil­lion for Co­pax­one, a costly mul­ti­ple-scle­ro­sis drug made by Teva. Half of those providers re­ceived hon­o­raria or other

“It is frankly mag­i­cal think­ing to be­lieve that those two things are not re­lated. It’s just com­pletely not in the realm of re­al­ity to deny—when you see over and over that the high­est-paid speak­ers are among the ranks of the high­est pre­scribers— that there isn’t a re­la­tion­ship there.” Eric Camp­bell So­ci­ol­o­gist Har­vard Med­i­cal School

pay­ments from Teva.

“We value our on­go­ing col­lab­o­ra­tion and re­search part­ner­ships with health­care pro­fes­sion­als,” Teva said in a writ­ten state­ment. “In­dus­try sup­port for med­i­cal ed­u­ca­tion, clin­i­cal data and re­search al­lows for con­tin­ued in­no­va­tion that benefits pa­tients.”

Co­pax­one’s global sales were $4.3 bil­lion in 2013. The costs to Medi­care rep­re­sented about $1.1 bil­lion of that to­tal.

Ex­perts say that while con­sumers gen­er­ally view doc­tors and nurses as hav­ing high eth­i­cal stan­dards, public per­cep­tions of fi­nan­cial con­flicts of in­ter­est have the po­ten­tial to erode that trust. “Out­liers can in­flu­ence trust in the broader pop­u­la­tion,” said Stephanie Mo­rain, a health pol­icy ethi­cist at the Johns Hop­kins Ber­man In­sti­tute of Bioethics.

On the other hand, a study pub­lished last year in the Jour­nal of Law, Medicine & Ethics found that pa­tients saw drug com­pa­nies pay­ments to doc­tors for con­sult­ing or speak­ing en­gage­ments as a sign that those doc­tors are rec­og­nized ex­perts in their field.

Har­vard’s Camp­bell said it’s “com­pletely in­ap­pro­pri­ate” for aca­demic physi­cians and depart­ment heads to do mar­ket­ing work for drug com­pa­nies. But he ac­knowl­edged that many con­sumers may see such pay­ments as ev­i­dence of a physi­cian’s “level of skill as a clin­i­cian and un­der­stand­ing what’s in the field.”

How­ever, it’s less eth­i­cally de­fen­si­ble for physi­cians to take pay­ments for mar­ket­ing and pro­mo­tional ac­tiv­i­ties rather than for re­search be­cause those ac­tiv­i­ties gen­er­ally don’t have any sci­en­tific pur­pose, Kes­sel­heim said. His depart­ment has a pol­icy that bars its mem­bers from en­ter­ing per­sonal con­sult­ing re­la­tion­ships with drug com­pa­nies. While drug com­pa­nies fund re­search stud­ies, Kes­sel­heim and his col­leagues have full con­trol over the re­sults and their pub­li­ca­tion.

Nis­sen said the U.S. “des­per­ately” needs a com­par­a­tive ef­fec­tive­ness or­ga­ni­za­tion like the United King­dom’s Na­tional In­sti­tute for Health and Care Ex­cel­lence, which con­ducts bind­ing na­tional as­sess­ments of which drugs are the best and worst buys. That alone wouldn’t elim­i­nate con­flicts of in­ter­est, he said, but it could spur physi­cians to more closely an­a­lyze the value of the drugs they pre­scribe.

“I be­lieve we need a vi­brant phar­ma­ceu­ti­cal in­dus­try to de­velop prod­ucts to save lives. It’s clearly ap­pro­pri­ate to get a re­turn on in­vest­ment from R&D,” Nis­sen said. “But we are not do­ing a good job of bal­anc­ing those com­pet­ing pri­or­i­ties.”

“It’s an enor­mous prob­lem. I be­lieve it is in­com­pat­i­ble with our roles as in­de­pen­dent de­ci­sion­mak­ers.” Dr. Steven Nis­sen Chair­man of car­dio­vas­cu­lar medicine Cleve­land Clinic

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