NOT SO FAST

Providers fear big hit on re­search ini­tia­tives, ad­vances in care

Modern Healthcare - - Front Page - Jes­sica Zig­mond

Won­der and dis­ap­point­ment. Two con­stants in the world of sci­ence, both were felt last week af­ter a judge’s rul­ing closed off mil­lions of fed­eral dol­lars for hu­man em­bry­onic stem-cell re­search and threat­ened the fu­ture of this field of sci­en­tific study.

In the nearly year-and-a-half since Pres­i­dent Barack Obama over­turned an Au­gust 2001 or­der by Pres­i­dent Ge­orge W. Bush that limited fed­eral fund­ing for hu­man em­bry­onic stem-cell re­search, sci­en­tists have gained grow­ing mo­men­tum in this area of biomed­i­cal ex­plo­ration and dis­cov­ery, which has the po­ten­tial to cure spinal chord in­juries and dis- eases such as di­a­betes, Alzheimer’s and Parkin­son’s (March 22, p. 17).

But on Aug. 23, that mo­men­tum came to a halt af­ter U.S. District Judge Royce Lam­berth granted a pre­lim­i­nary in­junc­tion that pre­vents HHS’ guide­lines for hu­man stem-cell re­search—which al­low fed­eral fund­ing for em­bry­onic stem-cell re­search—from tak­ing ef­fect. The Obama ad­min­is­tra­tion is ex­pected to ap­peal.

“NIH has been work­ing with great en­ergy and in­tel­li­gence to put for­ward guid­ance that is sci­en­tif­i­cally and eth­i­cally sound,” Francis Collins, di­rec­tor of HHS’ Na­tional In­sti­tutes of Health, told re­porters in a tele­con­fer­ence a day af­ter the rul­ing was an­nounced. “And as you know, that has re­sulted in the ap­proval now of many lines for fed­eral fund­ing—a to­tal of 75 now—most of them new, some from the Bush era,” he added. “They’ve all been re­viewed rig­or­ously and found to be el­i­gi­ble sci­en­tif­i­cally and eth­i­cally, but this de­ci­sion po­ten­tially places all of this in jeop­ardy.”

Robert Kass, vice dean for re­search at Columbia Uni­ver­sity Med­i­cal Cen­ter in New York, said he was dis­ap­pointed by the de­ci­sion. He also said most of the work at Columbia—and other med­i­cal schools—is funded through the NIH.

“The re­view process has been stopped and put in limbo,” Kass said. “What that means for re­searchers is it’s like a freeze frame. You have to stop, and it’s very dis­rup­tive.”

The process to re­ceive fund­ing from the NIH is a long and ar­du­ous one that in­cludes var­i­ous stages of re­view, both for a grant pro­posal to be ac­cepted and funded, and again an­nu­ally while the work of the grant is con­ducted. As a re­sult of the pre­lim­i­nary in­junc­tion, the NIH’s Collins ex­plained, 50 grants that were pend­ing peer re­view have now been pulled and will not be con­sid­ered be­cause they in­volve hu­man em­bry­onic stem-cell re­search. Also, an es­ti­mated $15 mil­lion to $20 mil­lion worth of pro­pos­als that have passed the first stage of peer re­view and were scored with high pri­or­ity for NIH coun­cil con­sid­er­a­tion in the next month have been stopped. Sep­a­rately, there are 22 grants for projects to­tal­ing $53 mil­lion that will be up for an­nual re­view.

“The in­junc­tion would place a freeze on the re­newal of those awards, which were due to be done by the end of Septem­ber, and there­fore would stop re­search in its tracks,” Collins said, adding later that about $131 mil­lion worth of grants al­ready awarded this year is un­af­fected — “un­til, of course, they have to come back and ask for their next year’s al­lo­ca­tion.”

A threat­ened fu­ture

Richard Hynes, a pro­fes­sor at the Mas­sachusetts In­sti­tute of Technology, called the rul­ing “mis­guided.” Hynes also is an in­ves­ti­ga­tor at the Howard Hughes Med­i­cal In­sti­tute and served as a co-chair for the Na­tional Academy of Sci­ence com­mit­tee that cre­ated guide­lines for em­bry­onic stem-cell re­search in 2005. He said the de­ci­sion hinged on fund­ing and will com­pro­mise the fu­ture of the biomed­i­cal re­search com­mu­nity.

“It will stop bright young peo­ple from go­ing

A re­searcher works to con­cen­trate bone mar­row into a stem-cell-rich con­cen­trate. A judge’s rul­ing could block mil­lions of dol­lars in fed­eral fund­ing for hu­man em­bry­onic stem-cell re­search.

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