For­eign threats to NIH re­search: Sen­ate Fi­nance Com­mit­tee digs in

Chi­na, Rus­sia and Iran were sin­gled out in a Sen­ate Fi­nance Com­mit­tee hear­ing on Wednes­day as coun­tries that are look­ing to ei­ther un­der­mine or usurp sci­en­tif­ic re­search con­duct­ed with US tax­pay­er funds.

Chuck Grass­ley Twit­ter

Com­mit­tee Chair­man Chuck Grass­ley (R-IA) made clear that Chi­na is “by far the most pro­lif­ic of­fend­er,” of­fer­ing the ex­am­ple of at­tempts by Chi­nese re­searchers to steal ge­net­i­cal­ly mod­i­fied corn seeds in Iowa and send them back to Chi­na.

“Re­searchers who are se­cret­ly sup­port­ed by a for­eign gov­ern­ment while work­ing on US re­search projects can be more sus­cep­ti­ble to the in­flu­ence and con­trol of the for­eign par­ent. We must know who is fi­nan­cial­ly sup­port­ing re­searchers to bet­ter un­der­stand whether they might be more ded­i­cat­ed to se­cur­ing the in­ter­ests of an ad­ver­sary than to rig­or­ous sci­en­tif­ic and med­ical ad­vance­ment,” Grass­ley said.

As part of ef­forts to com­bat such abus­es, Sen. John Cornyn (R-TX) said he will in­tro­duce a bill next week, called “Se­cure Our Re­search Act,” which would es­tab­lish an in­ter­a­gency work­ing group to set up a com­pli­ance frame­work to pro­tect fed­er­al­ly fund­ed re­search from for­eign in­ter­fer­ence, es­pi­onage and ex­fil­tra­tion.

Michael Schmoy­er HHS

Capt. Michael Schmoy­er, di­rec­tor of the Of­fice of Na­tion­al Se­cu­ri­ty (ONS) at the De­part­ment of Health and Hu­man Ser­vices (HHS), ex­plained the ex­tent of the prob­lem to the com­mit­tee. Since the spring of 2017, ONS be­came “acute­ly aware of spe­cif­ic chal­lenges re­lat­ing to the threat of for­eign in­flu­ences on HHS, and specif­i­cal­ly NIH, re­search in­tegri­ty. We be­came in­volved in two whole-of-gov­ern­ment work­ing groups, led by the FBI, to ad­dress the chal­lenges since some for­eign gov­ern­ments have ini­ti­at­ed sys­tem­at­ic pro­grams to un­du­ly in­flu­ence and cap­i­tal­ize on U.S.–con­duct­ed re­search, in­clud­ing that fund­ed by NIH.”

More specif­i­cal­ly, Louis Ro­di, deputy as­sis­tant di­rec­tor of home­land se­cu­ri­ty in­ves­ti­ga­tions in the De­part­ment of Home­land Se­cu­ri­ty, point­ed to Chi­na, Iran and Rus­sia as be­ing in­volved in the largest num­ber of on­go­ing in­ves­ti­ga­tions re­lat­ed to ei­ther the trans­mis­sion of tech­ni­cal da­ta from the US or the trans­fer of for­eign na­tion­als to the US.

Louis Ro­di LinkedIn

“As of May 2019, there are 357,863 F-1 [visa] Chi­nese stu­dents in the Unit­ed States with 181,980 such stu­dents en­rolled in STEM-re­lat­ed aca­d­e­m­ic pro­grams at U.S. in­sti­tu­tions. There are al­so 11,323 F-1 Iran­ian stu­dents and 6,196 F-1 Russ­ian stu­dents, with the re­spec­tive STEM stu­dent break­down of 9,057 for Iran and 2,008 for Rus­sia,” Ro­di wrote in writ­ten tes­ti­mo­ny.

He of­fered the hy­po­thet­i­cal ex­am­ple of an Iran­ian stu­dent com­ing to the US to study civ­il en­gi­neer­ing, but in re­al­i­ty that stu­dent might be work­ing to study con­crete to aid the Iran­ian nu­clear pro­gram. “So that would be a con­cern to us, us­ing our tech to build these bunkers,” he said. He al­so of­fered the ex­am­ple of an Iran­ian stu­dent com­ing to the US to learn how to weld ti­ta­ni­um for ag­ing Iran­ian air­planes.

Les Hol­lie NIH

Les Hol­lie, chief of in­ves­tiga­tive op­er­a­tions at HHS’ Of­fice of In­spec­tor Gen­er­al, ex­plained how he’s over­seen 16 al­le­ga­tions of non­com­pli­ance, which dealt with prin­ci­pal in­ves­ti­ga­tors that failed to re­veal con­nec­tions to for­eign gov­ern­ments.

In writ­ten tes­ti­mo­ny, Hol­lie of­fered two ex­am­ples of re­cent­ly re­solved re­search in­tegri­ty in­ves­tiga­tive cas­es: One in­volved a doc­tor who worked in a lab­o­ra­to­ry at Iowa State Uni­ver­si­ty, which re­ceived re­search grants for an ex­per­i­men­tal HIV/AIDS vac­cine. The doc­tor fal­si­fied sci­en­tif­ic da­ta to make it ap­pear an ex­per­i­men­tal HIV/AIDS vac­cine neu­tral­ized, or con­trolled, the HIV/AIDS virus in rab­bits, and he con­t­a­m­i­nat­ed rab­bit blood sam­ples with hu­man an­ti­bod­ies to make it ap­pear the rab­bits pro­duced neu­tral­iz­ing an­ti­bod­ies against the HIV/AIDS virus. The da­ta were used in a grant ap­pli­ca­tion and progress re­ports to NIH. In 2015, the doc­tor was sen­tenced to 57 months in fed­er­al prison and re­quired to pay more than $7 mil­lion in resti­tu­tion.

Lawrence Tabak NIH

The oth­er ex­am­ple was a doc­tor who found­ed two com­pa­nies, Gen­Phar and Vax­i­ma, to per­form re­search and pro­duce vac­cines for dis­eases such as Ebo­la, Mar­burg virus and Dengue virus. The com­pa­nies re­ceived NIH funds for biode­fense re­search and vac­cine de­vel­op­ment, but ac­tu­al­ly used the funds for oth­er pur­pos­es, in­clud­ing the con­struc­tion of a com­mer­cial of­fice build­ing and to pay lob­by­ists and oth­ers who were seek­ing to se­cure more fed­er­al fund­ing on the doc­tor’s be­half. In 2017, the doc­tor was sen­tenced to 70 months in fed­er­al prison and or­dered to pay over $3 mil­lion in resti­tu­tion.

Lawrence Tabak, prin­ci­pal deputy di­rec­tor at NIH, added: “The num­bers are small but the prob­lem is im­por­tant. We’ve been work­ing with 61 in­sti­tu­tions, and that num­ber will un­doubt­ed­ly in­crease.”

But Tabak al­so point­ed out how this is­sue is not al­ways black and white and there are sit­u­a­tions in which “hon­est mis­takes were made by re­search in­ves­ti­ga­tors who were un­aware of the re­quire­ment to dis­close oth­er fund­ing sources (both do­mes­tic and in­ter­na­tion­al) or af­fil­i­a­tions with for­eign en­ti­ties.”

Oth­er sen­a­tors and wit­ness­es al­so not­ed the ad­vance­ments made by for­eign-born sci­en­tists in the US.

Sen. Lamar Alexan­der (R-TN) said in a state­ment: “Sci­en­tists from oth­er coun­tries have played an im­por­tant role in re­search fund­ed by the Unit­ed States gov­ern­ment—since 2000, 33 Amer­i­cans who were born in oth­er coun­tries have won No­bel prizes in chem­istry, med­i­cine and physics. Un­for­tu­nate­ly, at­tempts by for­eign gov­ern­ments to in­flu­ence our fed­er­al­ly fund­ed re­search and steal in­tel­lec­tu­al prop­er­ty from the Unit­ed States threat­ens the in­tegri­ty of sci­en­tif­ic re­search.”

Sen. Steve Daines (R-MT) al­so ex­pressed “re­al con­cerns” with Chi­na steal­ing re­search and com­mer­cial­iz­ing that re­search. “Chi­na is open­ing its phar­ma­ceu­ti­cal mar­ket to bet­ter align with in­ter­na­tion­al stan­dards, but you look at the Made in Chi­na 2025: they don’t want to build an open mar­ket but to build a do­mes­tic mar­ket. Chi­na is grad­u­at­ing eight times more STEM grads than what we pro­duce in the US, and I think we’re un­der­es­ti­mat­ing the com­pet­i­tive threat,” he said.

The com­mit­tee was ex­pect­ed to hold a clas­si­fied brief­ing on the mat­ter Wednes­day af­ter­noon.

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

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From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

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