When money meets medicine and re­search

The Oklahoman (Sunday) - - BUSINESS -

Septem­ber did not go well for Memo­rial Sloan Kettering Can­cer Cen­ter.

At the be­gin­ning of the month, The New York Times and ProP­ub­lica re­vealed that the cen­ter’s chief med­i­cal of­fi­cer, a no­table can­cer re­searcher and physi­cian, had failed to dis­close mil­lions of dol­lars of pay­ments he’d re­ceived from phar­ma­ceu­ti­cal and biotech com­pa­nies.

In re­cent years, he’d pub­lished dozens of ar­ti­cles in lead­ing med­i­cal jour­nals that made no men­tion of his ex­ten­sive ties to in­dus­try.

For in­stance, he pub­lished an ar­ti­cle in The New Eng­land Jour­nal of Medicine about a clin­i­cal trial of an ex­per­i­men­tal can­cer med­i­ca­tion pro­duced by the drug­maker Roche. When asked by the jour­nal to dis­close any fi­nan­cial in­ter­ests he held that could bear on the re­search, he re­sponded that he had “noth­ing to dis­close” — even though Roche had paid him more than $3 mil­lion for con­sult­ing work and for his stake in a startup com­pany it had ac­quired.

Two years later, he par­tic­i­pated in a clin­i­cal study of an­other Roche ex­per­i­men­tal can­cer drug, ad­min­is­ter­ing the ther­apy to his pa­tients. When the re­sults of the trial were later re­vealed, he wrote in a blog post that those re­sults were “in­cred­i­bly ex­cit­ing.” That same day, Roche an­nounced it was scrap­ping plans to de­velop the drug. I could go on, but I think you get the point. And so, too, did Sloan Kettering’s chief med­i­cal of­fi­cer. Less than a week later, un­der heavy pres­sure, he re­signed.

Later in the month, the Times and ProP­ub­lica pub­lished an­other story about con­flicts and

Sloan Kettering. This one in­volved a spinoff com­pany the cen­ter had started. Sev­eral board mem­bers were in­vestors, and two of the cen­ter’s prom­i­nent sci­en­tists held stock in the com­pany.

Sloan Kettering had given the new com­pany the ex­clu­sive right to use its ar­chive of 25 mil­lion pa­tient tis­sue sam­ples. The story ques­tioned whether this ar­range­ment was proper and whether the non­profit cen­ter had re­ceived fair value in this deal, which pro­vided a vir­tual trea­sure trove of med­i­cal data to a com­pany dom­i­nated by in­sid­ers.

Un­der­stand­ably, these episodes have shaken Sloan Kettering to its core. They’ve dam­aged the pub­lic’s trust in the cen­ter and im­per­iled its rep­u­ta­tion as a global leader for can­cer re­search and treat­ment. (I’d guess they’ve also led the cen­ter to can­cel its sub­scrip­tions to the Times.)

Pre­dictably, one re­ac­tion to Sloan Kettering’s trou­bles has been a call — led by the Times — to pro­hibit doc­tors from re­ceiv­ing any pay­ments from in­dus­try. While this might seem like a sen­si­ble so­lu­tion, in re­al­ity, it would be dev­as­tat­ing to the de­vel­op­ment of much-needed new drugs.

The in­sights that physi­cians and re­searchers pro­vide to in­dus­try are vi­tal at ev­ery step of the process of cre­at­ing and test­ing new ther­a­pies.

To ask these ex­perts to work on these projects with­out re­mu­ner­a­tion is not only in­equitable, but non­sen­si­cal. With­out some abil­ity to be com­pen­sated for their thought, ex­per­tise and ef­fort, most will turn their time and at­ten­tion to other projects.

And re­mov­ing medicine’s lead­ing ex­perts from the drug de­vel­op­ment process would be like try­ing to send a rocket into space with­out physi­cists.

Don’t get me wrong: I’m not say­ing that what hap­pened at Sloan Kettering is OK. It’s just that we need mea­sured so­lu­tions to a com­plex prob­lem.

Clearly, no doc­tor should be work­ing on a clin­i­cal trial — or pub­lish­ing pa­pers about one — when he’s si­mul­ta­ne­ously be­ing paid by the drug com­pany spon­sor­ing that trial. Nor should board mem­bers or se­nior sci­en­tists at a non­profit like Sloan Kettering be ne­go­ti­at­ing a deal with a com­pany in which they have a stake. And $3 mil­lion sounds like an aw­ful lot of money for physi­cian-re­searcher to re­ceive for a side gig from a drug com­pany.

That said, there are only so many lines that can be drawn. Those lines will, of ne­ces­sity, be some­what ar­bi­trary. They will not an­tic­i­pate ev­ery po­ten­tial con­flict. Like all rules, they will also beget un­in­tended con­se­quences and prob­lems. And, of course, un­eth­i­cal peo­ple will still find ways to evade them.

In­stead, I’d sug­gest the best so­lu­tion is dis­clo­sure. We should fo­cus our en­ergy on en­sur­ing these po­ten­tial con­flicts are out in the open for all to see. With trans­parency, pa­tients can make in­formed choices.

Like­wise, it al­lows in­sti­tu­tions and reg­u­la­tors to mon­i­tor and, when needed, con­trol or elim­i­nate those con­flicts. The many play­ers in this game must also work more closely to share in­for­ma­tion.

In­sti­tu­tions need to know when their sci­en­tists are work­ing with in­dus­try. So do the jour­nals pub­lish­ing sci­en­tists’ work and the govern­ment agen­cies fund­ing their re­search.

There is no re­al­is­tic way to pre­vent all im­proper be­hav­ior. But our best hope lies in us­ing sun­shine to pre­vent most of it — and, ul­ti­mately, to catch any bad ac­tors who were ac­cus­tomed to hid­ing in dark­ness.

A physi­cian and med­i­cal re­searcher, Prescott is pres­i­dent of the Ok­la­homa Med­i­cal Re­search Foun­da­tion and can be reached at om­rf­pres­i­dent@omrf.org.

Stephen Prescott omrf-pres­i­dent@ omrf.org


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