November 19, 2013 Sally J. Rockey PhD Deputy Director for !tramural Re"earch Director, #ffice of !

tramural Re"earch Natio$al %$"titute" of &ealth 'N%&( 9000 Rockville Pike )ethe"*a, +aryla$* 20,92 Dr. Rockey.hi" i" to re/ue"t that the N%& revie0 the follo0i$1 i$formatio$ a$* to provi*e me 0ith a *etermi$atio$ 0hether Sai$t 2oui" 3$iver"ity 'S23( i" i$ complia$ce 0ith N%& 1ui*eli$e". 4rom St. Louis University Under Fire for Work with Doctor Who Infected AIDS Patients with Malaria by Sam 2evi$, Riverfro$t .ime", September 9, 20135ith the "upport of a Natio$al %$"titute" of &ealth 1ra$t, Sai$t 2oui" 3$iver"ity i" part$eri$1 0ith a co$trover"ial 6hi$e"e *octor 0ho o$ce i$fecte* 7%DS patie$t" 0ith malaria a" part of a 0i*ely critici8e* practice. .he *octor i$ /ue"tio$ i" 9iaopi$1 6he$ of 6hi$a:" ;ua$18hou %$"titute" of )iome*ici$e a$* &ealth ';%)&(, 0hich i" part$eri$1 0ith the 6e$ter for 5orl* &ealth a$* +e*ici$e at Sai$t 2oui" 3$iver"ity to *evelop treatme$t" for malaria. .hi" collaboratio$ i" $o0 faci$1 "cruti$y after Peter &eimlich << "o$ of the ma$ behi$* the =&eimlich ma$euver= << be1a$ rai"i$1 /ue"tio$" about 6he$:" pa"t. 'Peter( &eimlich, i$ a 'Ju$e 20, 2013( letter to S23, outli$e" i$ *etail 6he$:" =e!perime$t"= o$ 7%DS patie$t" that i$volve* i$*uci$1 hi1h malarial fever", a$* a"k" the u$iver"ity to reevaluate it" part$er"hip. ....he =malariotherapy= e!perime$t" i$ 6hi$a, co$*ucte* for over a *eca*e by Dr. 6he$ i$ co$>u$ctio$ 0ith 6i$ci$$ati:" &eimlich %$"titute, have bee$ calle* =atrocitie"= by the 5orl* &ealth #r1a$i8atio$. +e*ical e!pert" have co$*em$e* the 0ork a" =charlata$i"m of the hi1he"t or*er.= Re"earch "ub>ect" i$clu*e* pri"o$er" 0ho 0ere co$trolle* by hire* 1uar*". %$ o$e ca"e, a 0oma$ 0ith full<blo0$ 7%DS, "ufferi$1 from p$eumo$ia a$* hooke* up to o!y1e$, 0a" i$fecte* 0ith malaria. .he 6i$ci$$ati $/uirer e!plai$e* &e$ry &eimlich:" "o<calle* =malariotherapy= i$ 2003 thi" 0ayCincinnati s Dr. !enry !ei"lich says "alaria can #e used to cure AIDS$ cancer and Ly"e disease throu%h a &rocess called "alariothera&y. Dr. !ei"lich has #een shar&ly critici'ed #y state$ federal and international health or%ani'ations for these e(&eri"ents. ...'S23:"( "chool of me*ici$e 0a" a0ar*e* a ?@AA,AB0 Natio$al %$"titute" of &ealth 'N%&( 1ra$t, to =i*e$tify $ovel a$timalarial *ru1 tar1et" a$* compou$* cla""e" that kill the para"itic microor1a$i"m that cau"e" malaria, 0hich afflict" more tha$ o$e billio$ people a$* kill" about 1 millio$ a$$ually.= 7 "poke"0oma$ co$firm"...that thi" 1ra$t i" part of the ;%)& pro>ect. .he N%& 1ra$t i" 1R017%10AB9,<01 0hich i" a*mi$i"tere* by the Natio$al %$"titute of 7ller1y a$* %$fectiou" Di"ea"e" 'N%7%D(.

.hi" i" to re/ue"t that the revie0 i$clu*e but $ot be limite* to1( 7 A02<pa1e p*f file of $e0ly<available recor*" from the 3$iver"ity of 6i$ci$$ati:" &e$ry J. &eimlich 7rchival 6ollectio$. .he recor*" i$clu*e co$"i*erable corre"po$*e$ce e!cha$1e* bet0ee$ Dr. 6he$, the &eimlich %$"titute, a$* 3627 employee" 0ho 0ere i$volve* i$ the CmalariotherapyD e!perime$t". Plea"e click here to *o0$loa* the p*f file. Some co$cer$" rai"e* by the corre"po$*e$ce i$clu*e 'the pare$thetical $umber" corre"po$* to the pa1e $umber" of the p*f file(< Pri"o$er" 0ere u"e* a" re"earch "ub>ect" a$* i$fecte* 0ith malaria '11,<120 a$* 12E<12,, 1@2<1@3( < 7 patie$t mi"*ia1$o"e* a" bei$1 &%FG 0a" i$fecte* 0ith malaria. '11,<121( < 7ctive %F *ru1 u"er" 0ere u"e* a" re"earch "ub>ect" a$* i$fecte* 0ith malaria 'variou" pa1e"( < Security 1uar*" 0ere hire* to over"ee patie$t", rai"i$1 co$cer$" about co$"e$t 'p.130<132( < Numerou" *e"criptio$" of "eemi$1ly chaotic patie$t care, hapha8ar* follo0<up, u$e!plai$e* patie$t *eath", etc. 'variou" pa1e"( < 7ck$o0le*1me$t that the re"earch 0a" co$*ucte* i$ appare$t violatio$ of 6hi$e"e la0 'p.131( 2( 7 Ju$e 20, 2013 letter % "e$t to 2a0re$ce )io$*i SJ, the$<pre"i*e$t of S23, a$* a$ 7u1u"t E, 2013 reply from Raymo$* .ait PhD, S23:" Fice Pre"i*e$t of Re"earch. Plea"e click here to *o0$loa* a p*f file co$"i"ti$1 of both letter". 3( 7ll S23 recor*" a""ociate* 0ith thi" claim reporte* i$ a$ 7u1u"t 21, 2013 7""ociate* Pre"" article, SLU Defends Chinese Malaria )esearch by 7la$ Scher Ha1ier=5e have looke* i$to /ue"tio$" rai"e* by +r. &eimlich about Dr. 6he$:" previou" re"earch a$* have co$firme* that thi" re"earch 0a" *o$e i$ accor*a$ce 0ith the re1ulatory authority of 6hi$a at that time,= 'S23 "poke"0oma$ Na$cy( Solomo$ "ai* i$ a prepare* "tateme$t. B( 7ll S23 recor*" re1ar*i$1 the S23I;%)& pro>ect fu$*e* by N%& 1ra$t 1R017%10AB9,<01 i$clu*i$1 but $ot limite* to the matter" *i"cu""e* above. 4i$ally, thi" i" to re/ue"t that all recor*" be ma*e publicly<available. .ha$k you for your co$"i*eratio$ of my re/ue"t a$* % look for0ar* to your reply. Si$cerely,

Peter +. &eimlich 3A30 River &ollo0 Ru$ Duluth, ;7 3009A ph- '20,(BEB<E2,3 e<mail- Peter.&eimlichJ1mail.com 0eb"ite- http-IIme*frau*.i$fo blo1- http-IIthe<"i*ebar.com cc7$tho$y S. 4auci +D, Director, N%7%D Da$iel R. 2evi$"o$, %$"pector ;e$eral, 3S Departme$t of &ealth a$* &uma$ Service"

December 2, 2013 Dear Mr. Heimlich: Thank you for your letter dated November 1 , 2013 in !hich you e"#re$$ concern about N%H $u##ort for a re$earch #ro&ect that involve$ inve$ti'ator$ at (t. )oui$ *niver$ity +()*, and -hina.$ /uan'0hou %n$titute$ of 1iomedicine and Health +/%1H,. The ()* #ro&ect, !hich i$ currently funded by N%H, i$ e"#lorin' #otential malaria treatment$. Moreover, thi$ #ro&ect i$ #art of a re$earch initiative that #romote$ $cientific collaboration bet!een inve$ti'ator$ in the *( and in -hina, althou'h the N%H doe$ not fund the -hine$e $tudie$. 2art of the N%H revie! #roce$$ of a##lication$ $eekin' re$earch $u##ort involve$ $cientific #eer revie! !hich include$ an evaluation of the inve$ti'ative team to determine if they are 3ualified to conduct the #ro#o$ed re$earch. %n addition, the #rotection of human $ub&ect$ i$ al$o evaluated. The$e factor$ are con$idered by N%H in makin' fundin' deci$ion$. 2lea$e note that thi$ #ro&ect involve$ only animal model$ and doe$ not involve any human $ub&ect$. 4urthermore, N%H monitor$ all a!ard$ to en$ure their com#liance !ith the N%H #olicie$ a$ de$cribed in the N%H 'rant$ #olicy $tatement. The earlier $tudie$ you mention in your letter that #ur#orted to induce malaria in 5%D( #atient$ !ere not funded by N%H $o !e have no additional information on the$e nor do !e have any authority over them. 6ou may !i$h to contact the 7ffice of Human 8e$earch 2rotection$ +7H82,, $#ecifically, Dr. 9ri$tina 1orror !ho head$ the Divi$ion of 8e$earch -om#liance, !ith your concern$ about the ethical treatment of $ub&ect$ in thi$ earlier malaria:H%; !ork< Dr. 1orror may be reached at 2=0:=>3:?132 or kri$tina.borror@hh$.'ov. %n $ummary, N%H believe$ the malaria treatment $tudy !e are currently fundin' !ill aid in the develo#ment of ne! treatment$ for malaria !hich i$ an im#ortant 'lobal health i$$ue. 2rior to fundin', thi$ $tudy, like other$ $ubmitted to N%H, !ent throu'h a ri'orou$ revie! #roce$$. N%H e"#ect$ all funded $tudie$ to be in full com#liance !ith our 'rant$ #olicie$ and ha$ over$i'ht #rocedure$ in #lace to monitor re$earch a!ard$. (incerely,

Sally J. Rockey, Ph.D.

NIH Deputy Director for Extramural Research

OD/NIH/DHHS One Center Drive Building 1, Room 144 Bethesda, MD 2 !"2 # 1$4"%$1 "% &B'D() 1*

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