File Two: Response from Dept. of Health and Human Services to FOIA request for all records re: UCLA's 2002/03 investigation of employees and the Heimlich Institute's "malariotherapy"

7/30/2019 File Two: Response from Dept. of Health and Human Services to FOIA request for all records re: UCLA's 2002/03 i

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Enclosures

< : . : : : .. Sincerely yours,

Because the cost of responding to your request was less than $25, thereis no cost- If you have any questions, or if I may be of further assistance,please do not hesitate to contact me.

Enclosed are the records maintained by OHRP. Please note that thedocuments contain deletions. Specifically, I removed information, thedisclosure of which would constitute a clearly unwarranted invasion ofpersonal privacy and/ or identify a confidential source. If,after yourreview, you believe the deleted information should be made available toyou, please contact my office and I will issue you a formal denial whichadvises you of your right to appeal.

This is in response to your letters addressedto the Freedom of Information Act (FOIA)Officer, U.S_Department ofHealth and Human Services (DHHS). You requested all informationpertaining to UCLA-Malariotherapy Studies. Records responsive to yourrequest are in the possession of the Office for Human ResearchProtections (OHRP). Your letters were referred to me because my officeserves as the FOIAauthority for OHRP.

Dear Mr.

Mr.

FOIACase Number: ------'-'March 11, 2005

PublicHealthServiceFreedomof InformationOfficeParklawn Building,Room17A-45600FishersLaneRockville,Maryland20857PH:301-443-5252Fax:301-443-0925

ProgramSupportCenterEPARTMENT OF HEALTH & HUMAN SERVICES,stvie

DEPARTMENT OF HEALTH & HUMAN SERVICES

FOIA Case Number:March 11, 2005

Dear Mr.

Program Support Center

Public Health Service

Freedom of Information Office

Parklawn Building, Room 17A-4

5600 Fishers Lane

Rockville, Maryland 20857

PH: 301-443-5252Fax: 301-443-0925

This is in respo nse to y o u r j | letters addressedto the Freedom of Information Act (FOIA) Officer, U.S. Department ofHealth and Human Services (DHHS). You requested all informationpertaining to UCLA-Malariotherapy Studies . Records responsive to yourrequest are in the possession of the Office for Human ResearchProtect ions (OHRP). Your letters were referred to me because my officeserves as the FOIA authority for OHRP.

Enclosed are the records maintained by OHRP. Please note that the

documents contain delet ions. Specifically, I removed information, thedisclosure of which would constitute a clearly unwarranted invasion ofpersonal privacy and/or identify a confidential source . If, after yourreview, you believe the deleted information should be made available toyou, please contact my office and I will issue you a formal denial whichadvises you of your right to appeal.

Because the cost of responding to your request was less than $25, thereis no cost. If you have any ques tions, or if I may be of further ass ist ance,please do not hesitate to contact me.

Sincerely yours,

)arlene ChristiarFreedom of Information OfficerPublic Health Service

Enclosures


2/21

EDIT1m' F1LB COpyDO NOTRELEASE

Comments: malariotherapyDescription:OHRP read press reports regarding a UCLA researcher being involved in experiments infecting AIDS patients in China withmalariOHRP inquired of UCLA the status of this situation. UCLA said they had determined that their investigator was not engaged inhuman subjects research, but had received additional information and was reopening their investigation. They found that Dr. Faheywas involved in evaluating coded data and samples from this study and therefore was engaged in human subjects research. UCLA'scorrective actions appear appropriate.

Assurance: MOOl127Compliance Coordinator: Borror

Date Opened: 02/2412003Date Resolved: 06/30/2003

Case:

Ctry:U

Institute: U CALIFORNIA LOS ANGELESCity: LOSANGELESState: CALIFORNIAType: IRPT

Oversight Record Printout06/30/2003ssurance

OversightSystem

Assurance 06/30/2003

Oversight

System Oversight Record Printout

Institute: U CALIFORNIA LOS ANGELES

City: LOS ANGELES

State: CALIFORNIA Ctry: U Date Opened: 02/24/2003

Type: IRPT Date Resolved: 06/30/2003

Compliance Coordinator: Borror Case:

Assurance: MOO 1127

Comments: malariotherapy

Description:

OHRP read press reports regarding a UCLA researcher being involved in experiments infecting AIDS patients in China with malari

OHRP inquired of UCLA the status ofthis situation. UCLA said they had determined that their investigator was not engaged in

human subjects research, but had received additional information and was reopening their investigation. They found that Dr. Faheywas involved in evaluating coded data and samples from this study and therefore was engaged in human subjects research. UCLA's

corrective actions appear appropriate.

EDITED" FILE COPYDO NOT RELEASE


3/21

-UCLA-UCLA has never approved any research pertaining to malariotherapy studies for HIV.

As a follow-up to the MIRB's findings in this case, UCLA's Executive Vice Chancellor willinsure that appropriate institutional measures are in place to insure future compliance withUCLA policy for the Fogarty Scholars. UCLA also will be responsive to the U.S. Office ofHuman Research Protections' review of this matter.

Dr. Fahey's involvement in Dr. Chen's research will be reported to the U.S. Department ofHealth and Human Services - Office for Human Research Protections (DHHS-OHRP), to theFogarty International Program, and to UCLA's Executive Vice Chancellor. This reporting isconsistent with UCLA's Multiple Project Assurance (MPA) and with Federal regulations.

The MIRB accepted Dr. Fahey's assurances made on December 30, 2002, that he will ensurethat future Fogarty scholars and others under his direction will have appropriate UCLA IRBapproval prior to conducting any research activities at UCLA or using UCLA property,resources, material, or funding.

According to the MIRB, in not getting prior approval fromUCLA, Dr. Fahey violatedFederal regulations as well asUCLA policy for the protection of human research subjects byallowing Dr. Chen to conduct research at UCLA in a program funded to UCLA. Dr. Fahey didnot, however, directly participate in clinical trials where malariotherapy was administered toChinese subjects. The Board determined that Dr. Fahey and his laboratory participated onlyindirectly in the research by allowing the testing of Dr. Chen's samples.

The MIRB determined that Dr. Fahey while not personally involved in the clinical trials,was involved in evaluating data and biological samples brought to UCLA from China by Dr.Xiao Peng Chen under the Fogarty International Program. Since Dr. Chen's work was performedas part of the Fogarty Program at UCLA and was under Dr. Fahey's supervision, the MIRBdetermined that Dr. Fahey was engaged in human subjects research.

On March 30, 2003, the UCLA Medical Institutional Review Board (MIRB) issued itsdetermination regarding a complaint about Dr. John Fahey and allegations that he participated inmalariotherapy research at UCLA.

UCLA MEDICAL INSTITUTIONAL REVIEW BOARD (MIRB) ISSUES ITSDETERMINATION IN THE FAHEY CASE REGARDING CLAIMS ABOUTMALARIOTHERAPY STUDIES FOR HIV

For Immediate Use:April 15, 2003

Max Benavidez ([email protected])(310) 794-6868

Max Benavidez (maxb(a>support.ucla.edu) For Immediate Use:(310) 794-6868 April 15, 2003

UCLA MEDICAL INSTITUTIONAL REVIEW BOARD (MIRB) ISSUES ITSDETERMINATION IN THE FAHEY CASE REGARDING CLAIMS ABOUT

MALARIOTHERAPY STUDIES FOR HIV

On March 30, 2003, the UCLA Medical Institutional Review Board (MIRB) issued itsdetermination regarding a complaint about Dr. John Fahey and allegations that he participated inmalariotherapy research at UCLA.

The MIRB determined that Dr. Fahey while not personally involved in the clinical trials,was involved in evaluating data and biological samples brought to UCLA from China by Dr.Xiao Peng Chen under the Fogarty International Program. Since Dr. Chen's work was performed

as part of the Fogarty Program at UCLA and was under Dr. Fahey's supervision, the MIRBdetermined that Dr. Fahey was engaged in human subjects research.

According to the MIRB, in not getting prior approval from UCLA, Dr. Fahey violatedFederal regulations as well as UCLA policy for the protection of human research subjects byallowing Dr. Chen to conduct research at UCLA in a program funded to UCLA. Dr. Fahey didnot, however, directly participate in clinical trials where malariotherapy was administered toChinese subjects. The Board determined that Dr. Fahey and his laboratory participated onlyindirectly in the research by allowing the testing of Dr. Chen's samples.

The MIRB accepted Dr. Fahey's assurances made on December 30, 2002, that he will ensure

that future Fogarty scholars and others under his direction will have appropriate UCLA IRBapproval prior to conducting any research activities at UCLA or using UCLA property,resources, material, or funding.

Dr. Fahey's involvement in Dr. Chen's research will be reported to the U.S. Department ofHealth and Human Services - Office for Human Research Protections (DHHS-OHRP), to theFogarty International Program, and to UCLA's Executive Vice Chancellor. This reporting isconsistent with UCLA's Multiple Project Assurance (MPA) and with Federal regulations.

As a follow-up to the MIRB's findings in this case, UCLA's Executive Vice Chancellor willinsure that appropriate institutional measures are in place to insure future compliance with

UCLA policy for the Fogarty Scholars. UCLA also will be responsive to the U.S. Office ofHuman Research Protections' review of this matter.

UCLA has never approved any research pertaining to malariotherapy studies for HIV.

-UCLA-


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o:linquiry/fahey/OHRP fahey inquiry 030623

As noted above, the Board could not identify any information indicatingDr. Fahey'sdirect participation in clinical trials where malariotherapy was administered to Chinesesubjects. The Board determined that Dr. Fahey and his laboratory participated onlyindirectly in the research by allowing the testing ofDr. Chen's coded samples. The IRBacceptedDr. Fahey's assurances that he will ensure that future Fogarty scholars and othersunder his direction will have appropriate UCLA IRB approval or certification ofexemption prior to conducting any research activities at UCLA or using UCLA property,resources, material or funding.

This letter serves as a final report regarding a violation of the University of California,Los Angeles (UCLA)Federal Wide Assurance (FWA) 00004642. As previously noted,the UCLA Institutional Review Board (IRB) conducted an inquiry into allegations aboutresearch collaboration between UCLAProfessor John Fahey, MD and investigators inChina onmalariotherapy. The Board determined that Dr. Fahey, while not personallyinvolved in the clinical trials, was involved in evaluating coded data and biologicalsamples brought to UCLA from China byDr. Xiao Peng Chen under the FogartyInternational Program. Since Dr. Chen's work was performed as part of the FogartyProgram at UCLA and was under Dr. Fahey's supervision, the IRE determined that DLFahey was engaged in human subjects research.

Dear Dr. Carome,

RE: Human Research Collaboration onMalariotherapy: John Fahey, MDNll-I grants TW 00003 and AI 36086

Michael A. Carome, MDAssociateDirector-Regulatory AffairsOffice for Human Research ProtectionsDepartment of Health and Human ServicesThe Tower Building1101Wootton Parkway, Suite 200Rockville, MD 20852

June 24, 2003

OFFICE FOR PR0TECI10N OF RESEARCH SUBJECTSBOX951694

LOS ANGELES, CALIFORNIA 90095-1694

SANTABARBARA SANTACRUZ

UNIVERSITY OF CALIFORNIA, LOS ANGELES UCLABERKELEY' DAVIS IRVINE LOS ANGELES MERCED RIVERSIDE SANDIEGO SANFRANCISCO

UNIVERSITY OF CALIFORNIA, LOS ANGELES ^ ^ UCLA

BERKELEY DAVIS IRVINE LOS ANCELES MERCED RIVERSIDE SAN DIEGO SAN FRANCISCO \\ VMiM " / ! SANTA BARBARA SANTA CRUZ

OFFICE FOR PROTECTION OF RESEARCH SUBJECTS

BOX 951694LOS ANGELES, CALIFORNIA 90095-1694

June 24, 2003

Michael A. Carome, MDAssociate Director-Regulatory AffairsOffice for Human Research ProtectionsDepartment of Health and Human ServicesThe Tower Building1101 Wootton Parkway, Suite 200Rockville, MD 20852

RE: Human Research Collaboration on Malariotherapy: John Fahey, MDNTH grants TW 00003 and AI36086

Dear Dr. Carome,

This letter serves as a final report regarding a violation of the University ofCalifornia,Los Angeles (UCLA) Federal Wide Assurance (FWA) 00004642. As previously noted,the UCLA Institutional Review Board (IRB) conducted an inquiry into allegations about

research collaboration between UCLA Professor John Fahey, MD and investigators inChina on malariotherapy. The Board determined that Dr. Fahey, while not personallyinvolved in the clinical trials, was involved in evaluating coded data and biologicalsamples brought to UCLA from China by Dr. Xiao Peng Chen under the FogartyInternational Program. Since Dr. Chen's work was performed as part ofthe FogartyProgram at UCLA and was under Dr. Fancy's supervision, the IRB determined that Dr.Fahey was engaged in human subjects research.

As noted above, the Board could not identify any information indicating Dr. Fahey'sdirect participation in clinical trials where malariotherapy was administered to Chinese

subjects. The Board determined that Dr. Fahey and his laboratory participated onlyindirectly in the research by allowing the testing ofDr. Chen's coded samples. The IRBaccepted Dr. Fahey's assurances that he will ensure that future Fogarty scholars and othersunder his direction will have appropriate UCLA IRB approval or certification ofexemption prior to conducting any research activities at UCLA or using UCLA property,resources, material or funding.

o:/inquiry/fahey/OHRP fahey inquiry 030623


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o:linquiry/fahey/OHRP fahey inquiry 030623

cc: Director Division of Compliance Oversight Kristina Borror, OHRPExecutive Vice Chancellor Daniel NeumanVice Chancellor-Research Roberto PecceiChairperson Carmine Clemente, MIRB1Chairperson Robert Figlin, MIRB2John Fahey,MDAssociate Director Steven Peckman

Sincerely,

~~Director

Please do not hesitate to contact me or Steven Peckman, Associate Director-HumanSubjects Research at 310.825.5344 if you have any questions.

page 2llegations Regarding Malariotherapy ResearchAllegations Regarding Malariotherapy Research page 2

Please do not hesitate to contact me or Steven Peckman, Associate Director-HumanSubjects Research at 310.825.5344 if you have any questions.

Sincerely,

Judith L. BrookshireDirector

cc: Director Division of Compliance Oversight Kxistina Borror, OHRPExecutive Vice Chancellor Daniel NeumanVice Chancellor-Research Roberto PecceiChairperson Carmine Clemente, MIRB1Chairperson Robert Figlin, MJRB2John Fahey, MD

Associate Director Steven Peckman

o:/inquiry/fahey/OHRP fahey inquiry 030623


6/21

Sincerely,6iL~Kristina C. BorrorDirectorDivision of Compliance Oversight

OHRP appreciates your continued commitment to the protection of human research SUbjects.Please do not hesitate to contact me should you have any questions.

The Office for Human Research Protections (OHRP) has received your letter of June 24, 2003concerning the above protocol, which was submitted in partial fulfillment of the requirements ofDepartment of Health and Human Services (HHS) regulations at 45 CFR 46.103(b)(5). Yourreport and the corrective actions described appear to be appropriate under HHS regulations andyour institution's Assurance of Compliance.

Dear Ms. Brookshire:

RE: Research Project: Human Research Collaboration onMalariotherapyPI: John Fahey, M.D.Project Number: NIHGrants TW 00003and AI 36086

Judith L.BrookshireDirectorOffice for Protection of Research SubjectsBox 951694Los Angeles, CA 90095-1694

March 19, 2003Telephone: 301-435-8072FAX: 301-402-2071email: [email protected]

Office for Human Research ProtectionsThe Tower Building1101Wootton Parkway, Suite 200Rockville, Maryland20852

Office of the SecretaryOffice of Public Health and Science....... vlCb.f / ' ' ' 4 ' . DEPARTMENT OF HEALTH &HUMAN SERVICES3 .~

...#.........

DEPARTMENT OF HEALTH & HUMAN SERVICES

Office of the Secretary

Office of Public Health and Science

Office for Human Research ProtectionsThe Tower Building

1101 Wootton Parkway, Suite 200

Rockville, Maryland 20852

Telephone: 301-435-8072FAX: 301-402-2071

email:[email protected]

March 19, 2003

Judith L. BrookshireDirectorOffice for Protection of Research SubjectsBox 951694Los Angeles, CA 90095-1694

RE: Research Project: Human Research Collaboration on Malariotherapy

PI: John Fahey, M.D.

Project Number: NIH Grants TW 00003 and AI36086

DearMs. Brookshire:

The Office for Human Research Protections (OHRP) has received your letter of June 24, 2003concerning the above protocol, which was submitted in partial fulfillment of the requirements ofDepartment of Health and Human Services (HHS) regulations at 45 CFR 46.103(b)(5). Yourreport and the corrective actions described appear to be appropriate under HHS regulations and

your institution's Assurance of Compliance.

OHRP appreciates your continued commitment to the protection of human research subjects.Please do not hesitate to contact me should you have any questions.

Sincerely,

Kristina C. BorrorDirectorDivision of Compliance Oversight
mailto:[email protected]:[email protected]:[email protected]


7/21

1

M chael A. Carome, M D.Associ ate Di rector f or Regul atory Af f ai r sOf f i ce f or Human Research Prot ect i onsThe Tower Bui l di ng1101 Woot t on Parkway, Sui t e 200Rockvi l l e, MD 20852Tel : 301- 402- 5567Fax: 301- 402- 2071E- mai l : r ncar orne@osophs. dhhs. gov

M keThanks f or t he updat e. We w l l awai t your f ol l ow- up r epor t .St eve,

- - - - - Or i gi nal Message- - - - -Fr om Car ome, M chael [ mai l t o: MCarome@OSOPHS. DHHS. GOV]Sent : Monday, February 24, 2003 1: 37 PMTo: ' Peckman, St even'Cc: Bor r or , Kr i st i naSubj ect : RE: UCLA - Al l egat i ons Regardi ng Mal ar i otherapy Research i nChi na

St even PeckmanAssoci at e Di r ector- Human Subj ects Resear chOf f i ce f or Prot ect i on of Resear ch Subj ect sUni ver si t y of Cal i f orni a, Los Angel es310. 825. 5344 tv)310. 794. 9565 (f)speckman@opr s. ucl a. edu

- st eveSi ncer el y,I w l l f or war d a f ul l r epor t shor t l y. Pl ease do not hesi t at e t o cont act mei f you have any quest i ons.

We coul d not f i nd any evi dence t hat Dr . Fahey di r ect l y par t i ci pat ed i ncl i ni cal t r i al s where mal ar i otherapy was admni stered to Chi nese sUbj ect s .The I RE determned that Fahey and hi s l aborat or y par t i ci pat ed onl yi ndi r ect l y i n t he r esear ch by al l ow ng t he t est i ng of Chen' s sampl es.

The UCLA I RB f ound t hat Dr . Fahey whi l e not per sonal l y i nvol ved i n t hemal ar i ot herapy cl i ni cal t r i al s, was i nvol ved i n eval uat i ng dat a andbi ol ogi cal sampl es brought to UCLA f romChi na by Dr . Xi ao Peng Chen underthe Fogar t y I nternat i onal Program Si nce Dr . Chen' s work was per f ormed aspar t of the Fogar t y Programat UCLA and was under Dr . Fahey' s supervi s i on,the I RB determ ned that Fahey was engaged i n human subj ects research.

Dear M ke and Kr i st i na,Highmportance:

Peckman, Steven [[email protected]]Wednesday, April 16,200310:48 AMCarome, MichaelBrookshire, Judith; Borror, KristinaRE: UCLA - Allegations Regarding Malariotherapy Research in China

From:Sent:To:Cc:Subject:

Borror. KristinaBorror, KristinaFrom: Peckman, Steven [ SPECKMAN@OPRS. UCLA. EDU] Sent: Wednesday, Apri l 16, 2003 10:48AM

To: Carome, Mi chaelCc: Brookshi re, J udi th; Borror, Kri sti naSubject: RE: UCLA - Al l egati ons Regardi ng Mal ari otherapy Research in Chi na

Importance: Hi gh

Dear Mi ke and Kr i st i na,

The UCLA I RB f ound t hat Dr . Fahey whi l e not personal l y i nvol ved i n t hemal ar i ot her apy cl i ni cal t r i al s, was i nvol ved i n eval uat i ng dat a andbi ol ogi cal sampl es br ought t o UCLA f r om Chi na by Dr . Xi ao Peng Chen undert he Fogart y I nt ernat i onal Progr am. Si nce Dr . Chen' s work was per f ormed aspar t of t he Fogart y Progr am at UCLA and was under Dr . Fahey' s supervi si on,t he I RB det ermi ned t hat Fahey was engaged i n human subj ect s r esear ch.

We coul d not f i nd any evi dence that Dr . Fahey di r ect l y par t i ci pat ed i ncl i ni cal t r i al s wher e mal ari ot her apy was admi ni st er ed to Chi nese subj ect s.

The I RB deter mi ned t hat Fahey and hi s l abor at ory part i ci pated onl yi ndi r ect l y i n t he r esear ch by al l owi ng t he t est i ng of Chen' s sampl es.

I wi l l f or war d a f ul l r eport shor t l y. Pl ease do not hesi t at e t o cont act mei f you have any quest i ons.

Si ncer el y,

- steve

St even Peckman

Associ at e Di r ector - Human Subj ects - ResearchOf f i ce f or Prot ect i on of Resear ch Subj ect sUni ver si t y of Cal i f or ni a, Los Angel es310. 825. 5344 (v)

310. 794. 9565 ( f )speckman@opr s. ucl a. edu

Or i gi nal MessageFr om: Car ome, Mi chael [ mai l t o: MCarome@0S0PHS. DHHS. GOV] Sent : Monday, February 24, 2003 1: 37 PMTo: ' Peckman, Steven'Cc: Borr or , Kr i s t i naSubj ect : RE: UCLA - Al l egat i ons Regardi ng Mal ari otherapy Research i nChi na

Steve,

Thanks f or t he updat e. We wi l l awai t your f ol l ow- up r eport .

Mi ke

Mi chael A. Carome, M. D.

Associ at e Di r ector f or Regul at or y Af f ai r sOf f i ce f or Human Research Prot ect i onsThe Tower Bui l di ng1101 Woot t on Parkway, Sui t e 200Rockvi l l e, MD 20852

Tel : 301- 402- 5567Fax: 301- 402- 2071E- mai l : mcar ome@osophs. dhhs. gov

1
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


8/21

2

St even PeckmanAssoci ate Di rector - Human Subj ect s ResearchOf f i ce f or Pr ot ect i on of Resear ch Subj ect sUni ver si t y of Cal i f or ni a, Los Angel es310. 825. 5344 (v)310. 794. 9565 ( f )speckf f i an@opr s. ucl a. edu

Si ncer el y,Steve

I w l l keep you i nf ormed of our f ur t her f i ndi ngs. Pl ease do not hesi t at e t ocont act me i f you have any quest i ons.

Dear M ke,The OCLA I RB det er m ned i n December 2002 t hat Dr s. Fahey and Azi z di d notappear t o be engaged i n human subj ect s r esear ch r el at ed t o t he anonymousal l egat i ons of The Boar d, however , r ecei ved addi t i onali nf ormat i on and t he mat t er i s r eopened and under r evi ew.

- - - - - Or i gi nal Message- - - - -Fr om Peckman, St even [mai l t o: SPECKMAN@OPRS. UCLA. EDU]Sent : Monday, Febr uar y 24, 2003 1: 27 PMTo: Carome, M chaelSubj ect : UCLA - Al l egat i ons Regar di ng Mal ar i ot her apy Resear ch i n Chi naI mport ance: Hi gh

Or i gi nal MessageFr om: Peckman, St even [ mai l t o: SPECKMAN@OPRS. UCLA. EDU] Sent : Monday, Febr uar y 24, 2003 1: 27 PM

To: Car ome, Mi chaelSubj ect : UCLA - Al l egat i ons Regardi ng Mal ari ot herapy Research i n Chi naI mpor t ance: Hi gh

Dear Mi ke,The UCLA I RB det er mi ned i n December 2002 t hat Dr s. Fahey and Azi z di d not

appear t o be engaged i n human subj ect s r esearch r el at ed to t he anonymousal l egat i ons of ' ^ f c The Boar d, however , r ecei ved addi t i onali nf ormat i on and t he mat t er i s r eopened and under r evi ew.

I wi l l keep you i nf or med of our f ur t her f i ndi ngs. Pl ease do not hesi t at e t ocont act me i f you have any quest i ons.

Si ncer el y,St eve

St even PeckmanAssoci at e Di r ector - Human Subj ect s ResearchOf f i ce f or Prot ect i on of Resear ch Subj ect sUni ver si t y of Cal i f or ni a, Los Angel es310. 825. 5344 (v)310. 794. 9565 ( f )speckman@opr s. ucl a. edu

2
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


9/21

A l at er paper descr i bi ng 12 H. I . V. - posi t i ve Chi nese men and women whower e i nj ect ed w t h mal ar i a and t hen had t hei r i mmune r esponses measured,r el eased i n 2000 by t he Cent er f or AI DS Cont r ol and Resear ch i nGuangzhou, Chi na, t hanked Dr . Hei m i ch, Dr . Fahey and Dr . Azi z f or t hei rhel p w t h t he "pi l ot st udy. "

The paper , presented at two i nternat i onal AI DS conf erences i n 1996,publ i Shed i n t he Chi nese Medi cal Sci ence J ournal i n 1999 and st i l lavai l abl e on t he Hei m i ch I nst i t ut e Web si t e atwww.heimlichinstitute.org, l i st s Dr . Hei m i ch and t hr ee Chi nese doctorsas aut hors.

The art i cl e quoted l et t ers and e- mai l messages supposedl y wr i t t en by Dr .Fahey t hat , The Enqui r er sai d, det ai l ed how t he two doct or s set up t heexper i ments , anal yzed data, provi ded test chemcal s, vi si t ed the tes tsi t e i n Chi na and of f er ed t o f i nd r esear ch gr ant s. I n anot her documentThe Enqui r er quot es, Dr . Fahey asks hi s Chi nese col l eagues t o ref r ai nf r omnamng hi mor Dr . Azi z as an aut hor of a r esear ch paper .

On Feb 16, The Ci nci nnat i Enqui r er publ i shed an ar t i cl e i n whi ch Dr .Hei m i ch descr i bed hi s wor k i n Chi na and sai d Dr . Fahey was i nvol ved.The Web si t e f or Dr . Hei m i ch' s I nst i t ut e at t he Deaconess Hospi t al i nCi nci nnat i st i l l says U. C. L. A. hel ped w th the resear ch.

U. C. L. A. ' s medi cal board overseei ng human test s i s i nvest i gat i ng twor esear cher s, Dr . J ohn Fahey and Dr . Naj i b Azi z, based on i nf ormat i onthat a uni vers i t y spokesman decl i ned to descr i be.

The Centers f or Di sease Cont r ol and Prevent i on opposes mal ar i al therapy,and some medi cal exper t s have harshl y cr i t i ci zed hi m f or exper i ment i ngon humans i n Chi na when i t was unt hi nkabl e t hat such a t r i al woul d havebeen appr oved i n t he Uni t ed St at es.

Dr . Hei m i ch, who has cour t ed cont r over sy i n sever al f i el ds of medi ci ne,argues that i nduci ng hi gh mal ar i al f evers can s t i mul ate the i mmunesyst emt o f i ght AI DS, Lyme di sease and cancer . I n t he ear l y 1990' s, hehel d f und- r ai si ng par t i es i n Hol l ywood, r ai si ng t ens of t housands ofdol l ar s f r ommovi e st ar s and agent s t o pur sue a mal ar i a AI DS cure.

The Chi na resear ch was done f r om1993 to 1996 at t he request of Dr .Henr y J . Hei m i ch, now 83, t he i nvent or of t he Hei m i ch maneuver , whi chcan save peopl e who are choki ng.

The Uni ver si t y of Cal i f or ni a at Los Angel es is i nvest i gat i ngwhether two of i t s r esear cher s ai ded exper i ment s i n Chi na i n whi chH. I . V. pat i ent s wer e del i ber at el y i nj ect ed w t h malaria i n an ef f or t t oki l l t he AI DS vi r us.

By DONALD G. McNEI L J r .Mal ar i al Treatment f or Chi nese AI DS Pat i ent s Prompts I nqui ry i n U. S.March 4, 2003

The s tor y bel ow r el at es t o a mat t er r epor t ed t o OHRP by UCLA. M ke

Carome, MichaelTuesday, March 04, 20034:55 PMBorror, Kristina; EI-Hinnawy,Patricia; Schwetz, BernardAFW: New York Times, 03/04/03

From:Sent:To:Subject:

Borror, KristinaBorror, KristinaFrom: Carome, MichaelSent: Tuesday, March 04, 2003 4:55PM

To: Borror, Kristina; El-Hinnawy, Patricia; Schwetz, BernardASubject: FW: New York Times, 03/04/03

The s tory below relates t o a mat te r repor ted t o OHRP by UCLA. Mike

March 4, 2003

Mal ari al Treat ment f or Chi nese AI DS Pat i ent s Pr ompt s I nqui r y i n U. S.

By DONALD G. McNEI L J r .

The Uni ver si t y of Cal i f orni a at Los Angel es i s i nvesti gat i ngwhet her t wo of i t s r esearchers ai ded exper i ment s i n Chi na i n whi chH. I . V. pat i ent s wer e del i ber at el y i nj ected wi t h mal ar i a i n an effor t t oki l l t he AI DS vi r us.

The Chi na r esear ch was done f r om 1993 t o 1996 at t he r equest of Dr .Henry J . Hei ml i ch, now 83, t he i nvent or of t he Hei ml i ch maneuver , whi chcan save peopl e who ar e choki ng.

Dr . Hei ml i ch, who has cour t ed cont r over sy i n several f i el ds of medi ci ne,ar gues t hat i nduci ng hi gh mal ari al f ever s can st i mul at e t he i mmunesystem t o f i ght AI DS, Lyme di sease and cancer . I n t he ear l y 1990' s, hehel d f und- r ai si ng par t i es i n Hol l ywood, r ai si ng t ens of t housands ofdol l ar s f rom movi e st ars and agent s t o pur sue a mal ar i a AI DS cure.

The Cent er s f or Di sease Cont r ol and Prevent i on opposes mal ari al t herapy,and some medi cal expert s have harshl y cr i t i ci zed hi mf or exper i ment i ngon humans i n Chi na when i t was unt hi nkabl e t hat such a t r i al woul d havebeen approved i n t he Uni t ed St ates.

U. C. L. A. ' s medi cal boar d over seei ng human t est s i s i nvesti gat i ng t wor esear cher s, Dr . J ohn Fahey and Dr . Naj i b Azi z, based on i nf or mat i ont hat a uni ver si t y spokesman decl i ned t o descr i be.

On Feb 16, The Ci nci nnat i Enqui r er publ i shed an ar t i cl e i n whi ch Dr .Hei ml i ch descri bed hi s wor k i n Chi na and sai d Dr . Fahey was i nvol ved.

The Web s i t e f or Dr . Hei ml i ch' s I nsti t ut e at t he Deaconess Hospi t al i nCi nci nnat i sti l l says U. C. L. A. hel ped wi t h t he r esearch.

The ar t i cl e quot ed l et t er s and e-mai l messages supposedl y wr i t t en by Dr .Fahey that , The Enqui r er sai d, det ai l ed how t he two doct ors set up t heexper i ment s, anal yzed dat a, provi ded t est chemi cal s, vi si t ed t he t ests i t e i n Chi na and of f ered t o f i nd r esear ch gr ant s. I n another document

The Enqui r er quot es, Dr . Fahey asks hi s Chi nese col l eagues t o r ef r ai n

f r om nami ng hi mor Dr . Azi z as an aut hor of a r esear ch paper .

The paper , present ed at t wo i nt er nat i onal AI DS conf er ences i n 1996,publ i shed i n t he Chi nese Medi cal Sci ence J our nal i n 1999 and s t i l lavai l abl e on t he Hei ml i ch I nsti t ut e Web s i t e atwww. hei ml i chi nst i t ut e. or g, l i s t s Dr . Hei ml i ch and t hr ee Chi nese doct orsas aut hors.

A l at er paper descr i bi ng 12 H. I . V. - posi t i ve Chi nese men and women whower e i nj ect ed wi t h mal ar i a and t hen had t hei r i mmune responses measur ed,r el eased i n 2000 by t he Cent er f or AI DS Cont r ol and Research i nGuangzhou, Chi na, t hanked Dr . Hei ml i ch, Dr . Fahey and Dr . Azi z f or t hei rhel p wi t h t he "pi l ot study. "

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Pr omnent AI DS r esear cher s say Dr . Hei m i ch' s t heor y doesn' t makesci ent i f i c sense. Syphi l i s and Lyme di sease, whi ch ar e caused byspi r ochet es, ar e now t reat ed w t h ant i bi ot i cs. AI DS, i n cont rast , i scaused by a r et r ovi r us, whi ch does not l i ve out si de cel l s as aspi r ochet e does; i t i ncor por at es i t sel f i nt o a cel l ' s DNA. Cancer s -pocket s of abnor mal l y r api d cel l gr owt h - have many causes, but ar et hought t o st em f r om damage t o a cel l ' s DNA. Al so, many Af r i cans have2

Dr . Lur i e sai d mal ar i al cur es had been "r el egat ed t o t he st at us ofl eeches. "

I n i t s 1993 paper , t he C. D. C. sai d no cl i ni cal t r i al s had ever pr ovedmal ar i a t r eatment wor ked and anecdot al r epor t s on syphi l i s pat i ent scal l ed i t unpr edi ct abl e.

Bef or e t he i nvent i on of peni ci l l i n, bl ood f r om peopl e w t h vi vaxmal ar i a, somet i mes pr ovi ded by t he Uni t ed St at es Publ i c Heal t h Ser vi ce,was i nj ect ed as a t reat ment f or l at e- st age syphi l i s t hat had r eached t hebr ai n. I n t he l at e 1970' s some Amer i cans w t h Lyme di sease went t oMexi co f or "mal ar i a t r eatment . "

Dr . Hei m i ch has l ong ar gued t hat mal ar i al f ever s can be used agai nstsyphi l i s, Lyme di sease, AI DS and cancer .

Dr . Mar k Si egl er , di r ect or of t he Cent er f or Cl i ni cal Medi cal Et hi cs att he Uni ver si t y of Chi cago Hospi t al , sai d t hat i nj ect i ng pat i ent s w t h adanger ous di sease t o f i ght anot her was done 50 year s ago i n t hi s count rybut woul d not be t ol er at ed now.

Dr . ~et er Lur i e, a f or mer AI DS r esear cher now w t h Ral ph Nader ' s Publ i cCi t i zen Heal t h Resear ch Gr oup, cal l ed t he f ol l ow- up per i od " not enought o say anyt hi ng" and sai d t hat Dr . Hei m i ch' s use of human subj ect s t ot est hi s t heor y was " out r ageous. "

I t i s di f f i cul t , however , t o dr aw concl usi ons f r om such shor t - t er m dat a.I t t ypi cal l y t akes at l east ei ght year s f rom i nf ect i on w t h H. I . V. f or aheal t hy adul t t o devel op sympt oms; i t was unknown whet her t he men l at err ecei ved ant i r et r ovi r al t her apy.

The st udy, whi ch ended i n 1996, r epor ted t hen t hat al l ei ght wer e al i veand had nor mal CD4 count s; t he H. I . V. vi r us cr i ppl es t he i mmune syst emby dest r oyi ng CD4 cel l s . Dr . Hei m i ch sai d on Feb. 21 t hat , as of hi sl ast cont act w t h hi s Chi nese col l eagues i n 2001, one man was dead ofnon- AI DS- r el at ed causes and t he r est wer e al i ve.

Dr . Hei m i ch went ahead nonet hel ess, i n conj unct i on w t h Chi nesesci ent i st s l ed by Dr . Chen Xi ao Pi ng. Ei ght men w t h H. I . V. wer ei nj ect ed w t h vi vax- st rai n mal ar i a, t wo i n 1993 and si x i n 1995. Af t ert hr ee weeks of f ever cycl es, t he mal ar i a was ki l l ed w t h t he dr ugchl oroqui ne.

On Apr i l 29, 1993, not i ng t hat Dr . Hei m i ch was encour agi ng t he use ofmal ar i a t o t reat Lyme di sease and AI DS, C. D. C. of f i ci al s i s sued amemor andum sayi ng t he pr act i ce " cannot be j ust i f i ed. " I t ci t ed st udi esshow ng t hat mal ar i a vi c t i ms i n Zai r e r ecei ved no pr ot ect i on f r om H. I . V.i nf ect i on and may have got t en si cker mor e qui ckl y havi ng bot h.Del i ber at el y gi vi ng pat i ent s mal ar i a r i sked ki l l i ng t hem t he C. D. C.sai d.

Bar bar a Lohr , a spokeswoman f or t he Hei m i ch I nst i t ut e, sai d Dr .Hei m i ch was on vacat i on and woul d not comment . However , he di d f or war danswer s t o some e-mai l ed quest i ons and sent document s def endi ng mal ar i alt her apy.

Dr . F' ahey' s of f i ce assi s t ant sai d he woul d not speak t o t he pr ess. Dr .Azi z, r eached at hi s l abor at or y, r ef used t o comment .Dr . Fahey' s of f i ce assi st ant sai d he woul d not speak t o the pr ess. Dr .Azi z, r eached at hi s l aboratory, r ef used to comment .Barbara Lohr , a spokeswoman f or t he Hei ml i ch I nst i t ut e, sai d Dr .Hei ml i ch was on vacat i on and woul d not comment . However , he di d f orwardanswers t o some e- mai l ed quest i ons and sent document s def endi ng mal ar i alt her apy.

On Apr i l 29, 1993, not i ng that Dr . Hei ml i ch was encour agi ng t he use of

mal ar i a t o t r eat Lyme di sease and AI DS, C. D. C. of f i ci al s i ssued amemorandum sayi ng t he pr act i ce "cannot be j ust i f i ed. " I t ci t ed st udi esshowi ng t hat mal ari a vi ct i ms i n Zai r e r ecei ved no pr ot ect i on f r om H. I . V.i nf ect i on and may have got t en si cker more qui ckl y havi ng bot h.Del i ber at el y gi vi ng pat i ent s mal ar i a ri sked ki l l i ng t hem, t he C. D. C.sai d.

Dr . Hei ml i ch went ahead nonet hel ess, i n conj unct i on wi t h Chi nesesci ent i st s l ed by Dr . Chen Xi ao Pi ng. Ei ght men wi t h H. I . V. werei nj ect ed wi t h vi vax- st r ai n mal ari a, t wo i n 1993 and si x i n 1995. Af t ert hr ee weeks of f ever cycl es, t he mal ari a was ki l l ed wi t h the dr ugchl oroqui ne.

The st udy, whi ch ended i n 1996, r eport ed t hen t hat al l ei ght wer e al i veand had nor mal CD4 count s; t he H. I . V. vi r us cr i ppl es t he i mmune syst emby dest r oyi ng CD4 cel l s. Dr . Hei ml i ch sai d on Feb. 21 t hat , as of hi sl ast cont act wi t h hi s Chi nese col l eagues i n 2001, one man was dead ofnon- AI DS- r el ated causes and t he rest were al i ve.

I t i s di f f i cul t , however , t o dr aw concl usi ons f rom such shor t - t er m dat a.I t t ypi cal l y takes at l east ei ght year s f rom i nf ecti on wi t h H. I . V. f or aheal t hy adul t t o devel op symptoms; i t was unknown whet her t he men l at err ecei ved ant i r et r ovi r al t her apy.

Dr . Pet er Lur i e, a f or mer AI DS resear cher now wi t h Ral ph Nader' s Publ i cCi t i zen Heal t h Research Gr oup, cal l ed t he f ol l ow- up peri od "not enought o say anythi ng" and sai d that Dr . Hei ml i ch' s use of human subj ect s t ot est hi s t heory was "out r ageous. "

Dr . Mar k Si egl er , di r ect or of t he Cent er f or Cl i ni cal Medi cal Et hi cs att he Uni ver si t y of Chi cago Hospi t al , sai d t hat i nj ecti ng pat i ent s wi t h adangerous di sease t o f i ght another was done 50 years ago i n t hi s count r ybut woul d not be t ol erated now.

Dr . Hei ml i ch has l ong argued t hat mal ar i al f evers can be used agai nstsyphi l i s , Lyme di sease, AI DS and cancer .

Bef or e t he i nvent i on of peni ci l l i n, bl ood f rompeopl e wi t h vi vaxmal ar i a, someti mes pr ovi ded by t he Uni t ed St at es Publ i c Heal t h Servi ce,was i nj ect ed as a t r eat ment f or l ate- st age syphi l i s t hat had r eached t hebr ai n. I n t he l ate 1970' s some Amer i cans wi t h Lyme di sease went t oMexi co for "mal ari a t r eat ment . "

I n i t s 1993 paper, t he C. D. C. sai d no cl i ni cal t r i al s had ever pr oved

mal ar i a t r eatment worked and anecdotal r eport s on syphi l i s pat i ent scal l ed i t unpr edi ctabl e.

Dr . Lur i e sai d mal ari al cur es had been " r el egat ed to t he stat us ofl eeches. "

Promi nent AI DS researcher s say Dr . Hei ml i ch' s t heory doesn' t makesci ent i f i c sense. Syphi l i s and Lyme di sease, whi ch ar e caused byspi r ochet es, ar e now t r eat ed wi t h ant i bi ot i cs. AI DS, i n cont rast , i scaused by a r et r ovi r us, whi ch does not l i ve out si de cel l s as aspi r ochet e does; i t i ncor porates i t sel f i nt o a cel l ' s DNA. Cancer s -pockets of abnormal l y r api d cel l growt h - have many causes, but aret hought t o stem f rom damage t o a cel l ' s DNA. Al so, many Af r i cans have

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Dr . Hei m i ch, whose maneuver , i nt roduced i n 1974, i s cr edi t ed w t hsavi ng t he l i ves of many choki ng vi ct i ms, has of t en pr ovokedcont rover sy. He ar gues t hat i t shoul d be used i n dr owni ng cases t o cl earwat er and on vi ct i ms of ast hma and cyst i c f i br osi s t o cl ear mucus. Hi si nst i t ut e i s devot ed t o si mpl e l i f esavi ng sol ut i ons, and i t cr edi t s hi mw t h i nvent i ng a chest dr ai n val ve, an esophagus- r epl acement oper at i on,t r acheal oxygen t ubes and a met hod t o r est or e swal l ow ng t o st r okevi cti ms.

Dr . Hei m i ch' s Web si t e r esponds t o some of t hese cr i t i ci sms, ar gui ngt hat Af r i cans ar e of t en i nf ect ed w t h t he f al ci par um st rai n of mal ar i a,whi ch can be so r api dl y f at al t hat i t must be t reat ed i mmedi at el y.Chr oni c mal ar i a weakens t he i mmune syst em and shoul d not be compar edw t h a shor t , del i ber at e vi vax- st rai n i nf ect i on, i t sai d.

"A l ot of m cr o- or gani sms don' t do wel l i n a hi gh f ever , " sai d Dr . Mer l eA. Sande, a Uni ver si t y of Ut ah AI DS r esear cher who has a t r eat mentpr ogr am i n Uganda. "But I don' t have any r eason t o t hi nk mal ar i a woul dsuppr ess t he AI DS vi r us. "

AI DS and mal ar i a s i mul taneous l y.AI DS and mal ar i a si mul t aneousl y."A l ot of mi cr o- or gani sms don' t do wel l i n a hi gh f ever , " sai d Dr . Mer l eA. Sande, a Uni ver si t y of Ut ah AI DS r esearcher who has a t r eat mentpr ogr am i n Uganda. "But I don' t have any reason t o thi nk mal ari a woul dsuppr ess t he AI DS vi r us. "

Dr . Hei ml i ch' s Web si t e r esponds t o some of t hese cr i t i ci sms, argui ngt hat Af r i cans ar e of t en i nf ected wi t h t he f al ci par um st r ai n of mal ar i a,whi ch can be so r api dl y f at al t hat i t must be t r eat ed i mmedi atel y.

Chroni c mal ar i a weakens t he i mmune syst em and shoul d not be compar edwi t h a short , del i berate vi vax- st r ai n i nf ecti on, i t sai d.

Dr . Hei ml i ch, whose maneuver , i nt r oduced i n 1974, i s credi t ed wi t hsavi ng t he l i ves of many choki ng vi ct i ms, has of t en pr ovokedcont r oversy. He ar gues t hat i t shoul d be used i n dr owni ng cases t o cl earwater and on vi ct i ms of asthma and cyst i c f i br osi s t o cl ear mucus. Hi si nsti t ut e i s devot ed t o si mpl e l i f esavi ng sol ut i ons, and i t credi t s hi mwi t h i nvent i ng a chest dr ai n val ve, an esophagus- r epl acement operat i on,t r acheal oxygen t ubes and a method to rest ore swal l owi ng t o st r okevi ct i ms.

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A serious matter has been brought to myattention' _ .... _ .. -UCLA.This letter is to express myconcern regardingUCLA's supportand participationin experimental AIDS research trials using humansubjects that havebeencarried out inGuangzhou, China, since 1994.1

This is aSignificantly-abbreviatedversion of a full-length letterto you. Mycomplete letter, alongwith considerablesupportingdocumentationand a contact list, maybefound atthefollowingwebaddress:

DearMr. Peckman:

StevenPeckman, Associate DirectorHumanSubjects ResearchOfficefor the Protection of Research SubjectsUniversityofCalifornia los Angeles10945LeConteAve., suite 2107LosAngeles, CA 90095

-----OriQinalMessage-----From .._Sent: Tuesday, October 01, 2002 9:53 PMTo:[email protected]: UCLA-Heimlich China AIDS Research

Steven PeckmanAssociate Director-Human Subjects ResearchOffice for Protectionof Research SubjectsUniversityofCalifornia, los Angeles310.825.5344 (v)310.794.9565 (f )[email protected]

Sincerely,

Onbehalf ofthe University ofCalifornia, los Angeles (UCLA),Office forProtectionof Research Subjects (OPRS), I thankyoufortheemail regardingDrs. FaheyandAziz. The OPRS supports federallymandatedhumanresearchreviewcommittees called Institutional Review Boards (lRBs). The chargeofthe IRB is to ensure the protection of the rights andwelfare ofall humansubjects participating inUCLA research. I assure youthat the UCLA and ourIRSs take complaints regarding researchvery seriously.Inorder to address your concerns, the IRSwill conduct an inquiry and Iwill follow-upwith anemail to you regarding their findings. Pleasedo nothesitate to contactme if you have any questions.

Dear. f 1 I I ' - - _ ~Subject:Peckman, Steven [[email protected]. October 09, 2002 11:39AMAlbert Carnesale (E-mail); IrvinS. Y. Chen (E-mail); Miller, J eff F. (BOl);'J [email protected]'; Aziz, Najib (BOl); J anetM. Young (E-mail); Namkung, Ann(NIH.AN107Z); Fogarty InternationalCenter (E-mail);Victor ZhenyuLiu (E-mail);Vern Leon(E-mail); Eriksson, Carl; ShangChuan (E-mail); HenryJ . Heimlich (E-mail)RE: UCLA-HeimlichChinaAIDS Research

From:Sent:To:Cc:

Carome, MichaelCarome, MichaelFrom:Sent:

To:Cc:

Subject:

Peckman, Steven [[email protected]]Wednesday. October 09, 2002 11:39 AM

Albert Carnesale (E-mail); Irvin S. Y. Chen (E-mail); Miller, J eff F. (BOL);'J [email protected]'; Aziz, Najib (BOL); J anet M. Young (E-mail); Namkung, Ann(NIH.AN107Z); Fogarty International Center (E-mail); Victor Zhenyu Liu (E-mail); Vern Leon(E-mail); Eriksson, Carl; Shang Chuan (E-mail); Henry J . Heimlich (E-mail)

RE: UCLA-Heimlich China AIDS Research

Dear'

On behalf of the University of California, Los Angeles (UCLA), Office forProtection of Research Subjects (OPRS), I thank you for the email regardingDrs. Fahey and Aziz. The OPRS supports federally mandated human researchreview committees called Institutional Review Boards (IRBs). The charge ofthe IRB is to ensure the protection of the rights and welfare of all humansubjects participating in UCLA research. I assure you that the UCLA and ourIRBs take complaints regarding research very seriously.

In order to address your concerns, the IRB will conduct an inquiry and I

will follow-up with an email to you regarding their findings. Please do nothesitate to contact me if you have any questions.

Sincerely,

Steven PeckmanAssociate Director-Human Subjects ResearchOffice for Protection of Research SubjectsUniversity of California, Los Angeles310.825.5344 (v)310.794.9565(f)[email protected]

Original Message-Fronrr * ^* B ^^M * MSent: Tuesday, October 01, 2002 9:53 PM

To:[email protected]: UCLA-Heimlich China AIDS Research

Steven Peckman, Associate DirectorHuman Subjects ResearchOffice for the Protection of Research SubjectsUniversity of California Los Angeles10945 LeConte Ave., suite 2107Los Angeles, CA 90095

Dear Mr. Peckman:

This is a significantly-abbreviated version of a full-length letterto you. My complete letter, along with considerable supportingdocumentation and a contact list, may be found at the following webaddress:

A serious matter has been brought to my attentionUCLA. This letter is to express my concern regarding UCLA's supportand participation in experimental AIDS research trials using humansubjects that have been carried out in Guangzhou, China, since 1994.

l
mailto:[email protected]:[email protected]:[email protected]:'[email protected]'mailto:[email protected]:[email protected]:'[email protected]'mailto:'[email protected]'mailto:[email protected]:[email protected]:[email protected]:[email protected]:'[email protected]'mailto:[email protected]


13/21

2AnnNamkung, M.P.H.,

J anetM.Young, Ph.D, ProgramOfficerDivisionofAIDS National Institute ofAllergy and InfectiousDisease National Institutes of Health

Dr. J effrey F. Miller, ChairmanUCLA Microbiology, Immunology& MolecularGenetics Dept.

Dr. IrvinS.Y. Chen, DirectorUCLA AIDS Institute

cc: Dr.Albert Carnesale, ChancellorUCLA

email: ------- ..voicemail & FAX: ._-- __

Sincerely,

lamn order to protect my privacy _-- submitting this letter under a pseudonym.Thank you for your attention to these concerns. I look forward toyour reply.

Meanwhile, Dr. Heimlich, the Heimlich Institute, and DeaconessHospital Associations, all of Cincinnati, Ohio, aggressively promoteand fundraise for this work and enthusiastically tout theiraffiliation with UCLA and Dr. Fahey.Thorough details and all substantiating documents may be found atthe web address given above. Thank you for continuing this letteronline.I respectfully urge UCLA, Dr. Fahey, and Dr. Aziz to reconsidertheir participation in these shameful experiments and to sever tieswith them. I also request that UCLA make an immediate statementregarding its participation in this work and to fully disclose allfinancial and scientific records associated with these experiments.

It is unclear how UCLA can maintain an Office for the Protection ofResearch Subjects, meanwhile participating in ongoing offshore humanexperiments which have been denounced as medical atrocities by theWorld Health Organization, Public Citizen, and prominent bioethicsprofessionals. Yet numerous documents indicate the participation ofUCLA researchers, the use of school lab facilities, and the use ofl:lCLA's name for fundraising for this discredited work.As your office must be aware, these experiments have been conductedunder the direction of Dr. Henry J . Heimlich, known for the Heimlichmaneuver, with the participation of two UCLA researchers, Dr. J ohnL. Fahey and Dr. Najib Aziz. A former UCLA postdoctoral student, Dr.Xiao Ping Chen, is the project director in China.At least three clinical trials have taken place and three scientificarticles have been submitted to international AIDS conferencesdescribing the research. These papers acknowledge the participationof Drs. Fahey and Aziz and the use of UCLA laboratories, as well asthe financial support of Dr. Fahey.

These experiments consist of giving malaria to people alreadysuffering from HIV and full-blown AIDS.These experiments consist of giving malaria to people alreadysuffering from HIV and full-blown AIDS.It is unclear how UCLA can maintain an Office for the Protection ofResearch Subjects, meanwhile participating in ongoing offshore humanexperiments which have been denounced as medical atrocities by theWorld Health Organization, Public Citizen, and prominent bioethicsprofessionals. Yet numerous documents indicate the participation ofUCLA researchers, the use of school lab facilities, and the use ofUCLA's name for fundraising for this discredited work.

As your office must be aware, these experiments have been conductedunder the direction of Dr. Henry J . Heimlich, known for the Heimlichmaneuver, with the participation of two UCLA researchers, Dr. J ohnL. Fahey and Dr. Najib Aziz. A former UCLA postdoctoral student, Dr.Xiao Ping Chen, is the project director in China.

At least three clinical trials have taken place and three scientificarticles have been submitted to international AIDS conferencesdescribing the research. These papers acknowledge the participationof Drs. Fahey and Aziz and the use of UCLA laboratories, as well asthe financial support of Dr. Fahey.

Meanwhile, Dr. Heimlich, the Heimlich Institute, and DeaconessHospital Associations, all of Cincinnati, Ohio, aggressively promoteand fundraise for this work and enthusiastically tout theiraffiliation with UCLA and Dr. Fahey.

Thorough details and all substantiating documents may be found atthe web address given above. Thank you for continuing this letteronline.I respectfully urge UCLA, Dr. Fahey, and Dr. Aziz to reconsidertheir participation in these shameful experiments and to sever tieswith them. I also request that UCLA make an immediate statementregarding its participation in this work and to fully disclose allfinancial and scientific records associated with these experiments.

In order to protect my privacy ^"^ I amsubmitting this letter under a pseudonym.

Thank you for your attention to these concerns. I look forward toyour reply.

cc: Dr. Albert Carnesale, Chancellor

UCLA

Dr. Irvin S.Y. Chen, DirectorUCLA AIDS Institute

Dr. J effrey F. Miller, ChairmanUCLA Microbiology, Immunology & Molecular Genetics Dept.

J anet M. Young, Ph.D, Program OfficerDivision of AIDS National Institute of Allergy and InfectiousDisease National Institutes of Health

Ann Namkung, M.P.H.,

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3

Dr. Leonard Madu,DirectorPanAfricaAIDS Conference 2002

Carl ErikssonUCLA International Health InterestGroup

Vern Leong, PresidentUniversity of Cincinnati Asian-AmericanAssociation

Victor Zhenyu Liu, PresidentUCLA ChineseStudents and Scholars Association

ShangChuan, PresidentUCLA AssociationofChinese-Americans

Andrew Signorile,ChairmanThe Eleanor NaylorDana Charitable TrustDrs. SidneyWolfe &PeterLurie, DirectorsPublic Citizen, Health Research Group

Dr.Charles Bernstein,ChairmanDeaconess Hospital Ethics Committee

J ames LPahls, Chairman,Deaconess Associations Inc.& BoardMember, The Heimlich Institute

Division of AIDS National Institute of Allergy and InfectiousDisease National Institutes of HealthDivision of AIDS National Institute of Allergy and InfectiousDisease National Institutes of HealthJ ames L. Pahls, Chairman,Deaconess Associations Inc.& Board Member, The Heimlich Institute

Dr. Charles Bernstein, ChairmanDeaconess Hospital Ethics Committee

Andrew Signorile, ChairmanThe Eleanor Naylor Dana Charitable Trust

Drs. Sidney Wolfe & Peter Lurie, DirectorsPublic Citizen, Health Research Group

Shang Chuan, PresidentUCLA Association of Chinese-Americans

Victor Zhenyu Liu, PresidentUCLA Chinese Students and Scholars Association

Vern Leong, PresidentUniversity of Cincinnati Asian-American Association

Carl ErikssonUCLA International Health Interest Group

Dr. Leonard Madu, DirectorPan Africa AIDS Conference 2002

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15/212/20103

Letters writtenbyDr. Faheyon UCLA stationarydetail howdoctors helpedDr. Heimlich setupthe experiments,analyzeddata, providedchemical reagents, mademultiple trips to the test locations inChina, reviewed testprotocols and offered to obtain funding throughgrants atUCLA.

Butdocuments obtained bythe Enquirer showthedoctors have beenactive in themalariaexperiments since1996.

BothDr. FaheyandDr. Aziz deny involvement inDr. Heimlich's malaria studies, and UCLA officials say they haveaskedDr. Heimlich"to omit UCLA fromall references relating to malaria studies orother Heimlich Instituteresearch.Anyclaims ofanaffiliationwith UCLA are inaccurate."

Hisexperiments - which seek to destroy HIV, theAIDS-causing virus, by inducing highmalarial fevers- have beencriticizedbytheCenters for DiseaseControl and the FoodandDrugAdministration and condemned by otherhealth professionals and human rights advocates as amedical "atrocity."

The investigationonce again raises questions about Dr. Heimlich'swork atCincinnati's nonprofitHeimlich Institute,which is partneredwith Deaconess Hospital. (This is thesame Dr. Heimlichwhodevelopedthe Heimlichmaneuver, used to expel food fromthe throats of choking victims.)

Dr.HeimichA medical oversightboard atthe University ofCalifornia Los Angeles wants to knowwhetherdoctors J ohn Faheyand NajibAziz violateduniversity policies that regulate tests onhumans.

o [photo]Twoprominent LosAngeles AIDS researchers are being investigated for taking partinacontroversial medical experimentwith Cincinnati physicianHenryHeimlichto infectAIDS patientsinChinawithmalaria.

By Robert AnglenThe Cincinnati Enquirer

Experimentinfects AIDS patients inChinawithmalariaScientists linked to Heimich investigatedSunday, February 16, 2003

-----Original Message-----From:. .Sent: Tuesday, February 18, 200312:42PMTo: Wood, Robert(HHS/OS);Halaska,Terrell (HHS/OS)Subject: AIDS ResearchersInvestigated

From: Schwetz, BernardASent: Wednesday, February 19,20038:24AMTo: Borror, Kristina; Lin, Melody; Carome, MichaelSubject: FW:AIDS Researchers InvestigatedKristina--dowe have anythingto dowith this study? Bern-----Original Message-----From: Wood, RobertD. (OS)Sent: Tuesday, February 18, 20031:17PMTo: SurgeonGeneral; Schwetz, BernardA (FDA)Subject: FW:AIDS ResearchersInvestigated

Borror, Kristina

Page 1 of 4essageMessage Page 1 of 4

Borror, Kristina

From: Schwetz, Bernard A

Sent: Wednesday, February 19, 2003 8:24 AM

To: Borror, Kristina; Lin, Melody; Carome, Michael

Subject: FW: AIDS Researchers Investigated

Kristina-do we have anything to do with this study? Bern

Original Message

From: Wood, Robert D. (OS)

Sent: Tuesday, February 18, 2003 1:17 PM

To: Surgeon General; Schwetz, Bernard A (FDA)

Subject: FW: AIDS Researchers Investigated

Original Message _ _ _ _ _ _ _ _ _ _From: IBM^I, ,^ -B |B^ 0_____p^ B

" " ^

l

Sent: Tuesday, February 18, 2003 12:42 PM

To: Wood, Robert (HHS/OS); Halaska, Terrell (HHS/OS)

Subject: AIDS Researchers Investigated

Sunday, February16,2003

Scientists linked to Heimlich investigated

Dr. Heimlich

Experiment infects AIDS patients in China with malaria

By Robert AnglenThe Cincinnati Enquirer

Two prominent Los Angeles AIDS researchers are being investigated for taking part in acontroversial medical experiment with Cincinnati physician Henry Heimlich to infect AIDS patientsin China with malaria.

A medical oversight board at the University of California Los Angeles wants to know whetherdoctors J ohn Fahey and Najib Aziz violated university policies that regulate tests on humans.

The investigation once again raises questions about Dr. Heimlich's work at Cincinnati's nonprofitHeimlich Institute, which is partnered with Deaconess Hospital. (This is the same Dr. Heimlich whodeveloped the Heimlich maneuver, used to expel food from the throats of choking victims.)

His experiments - which seek to destroy HIV, the AIDS-causing virus, by inducing high malarial fevers- have beencriticized by the Centers for Disease Control and the Food and Drug Administration and condemned by otherhealth professionals and human rights advocates as a medical "atrocity."

Both Dr. Fahey and Dr. Aziz deny involvement in Dr. Heimlich's malaria studies, and UCLA officials say they haveasked Dr. Heimlich "to omit UCLA from all references relating to malaria studies or other Heimlich Instituteresearch. Any claims of an affiliation with UCLA are inaccurate."

But documents obtained by the Enquirershow the doctors have been active in the malaria experiments since1996.

Letters written by Dr. Fahey on UCLA stationary detail how doctors helped Dr. Heimlich set up the experiments,analyzed data, provided chemical reagents, made multiple trips to the test locations in China, reviewed testprotocols and offered to obtain funding through grants at UCLA.

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Dr. Heimlichbegansoliciting funds for malaria treatmentofcancer, AIDS and Lyme disease inthe late 1980s.

"It is charlatanismof the highestorder," Dr. Lurie says ofmalariotherapy. "It is exploiting the lackof decentmedical care inChina."

PublicCitizen is a 32-year-old, nonprofit group foundedbyconsumer advocate RalphNader. The HealthResearchGroup provides oversightconcerningdrugs, medical devices, doctors and hospitals and occupationalhealth. Itworks to identify andban unsafe or ineffective drugs, medical devices and procedures.

Officialswith the Pan Africa Conference could notbe reached.However, Peter Lurie, a formerAIDS researcherand nowaphysician with Public Citizen's Health ResearchGroup inWashington, D.C., calls themalariotherapystudies dangerous andunnecessary.

"Theydon't question mywork," hesays, adding thathis tests offer a chance to end the scourge ofAIDS.

Malariotherapyresearch was the topic of Heimlich'spresentation to the respected PanAfrica AIDS Conference inNashville, Tenn., lastOctober.

Dr.Heimlichsays his critics aremotivatedbypolitics rather than legitimate medical concern.

Heoften isatodds with medical professionals. One ofhis mostpublic fights has beenwith the American RedCross over theagency's refusal to adopt theHeimlichmaneuveras the first response indrowning rescues insteadof traditional CPR.

Fromhis Cincinnati institute onStraightStreet, the83-year-old Dr.Heimlichsolicits private donations formalariotherapy researchand distributes a quarterly newsletterabout his work to "promote peaceful solutions tointernational problems." He is the father of HamiltonCounty Commissioner Phil Heimlich.

Foryears, Dr. Heimlichhas beencriticized bystate, federal and international health organizations overmalariotherapy. Despite this, Heimlichproudlycontinues his work inChina and says hewants to expandmalariotherapy toAfrica.

"Dr. Fahey is anoutstanding professional. Hewas involved intheoriginal work inChina,"Dr. Heimlichsays. "Heis a renowned scientist involved inAIDS research. Heasked to contribute. He did anexcellentjob."

Dr. Heimlich,who has credited Dr. Faheyforhis support, says he has no ideawhy thedoctors would say theyarenot involved. Hesays they provided technical assistance for years and usedtheir labs to analyze data andsuggestways to proceed.

Contacted athis California home, Dr. Faheywould notcomment. He also didnot respond to ane-mail detailingthe contents ofhis letters to Dr. Heimlichand Dr. Chen. Dr. Aziz alsowould notcomment.

"I wondered ifwe could help you ...we could, perhaps, developameans ofhelping your Chinese colleagues incarryingout their studies,"Dr. Faheywrote. "Assistancewith reagents and quality control samples for (test)measurements aswell as for other parameters ofHIV infection."

In another letter to Dr. Heimlich, datedAug. 8, 1996, Dr. Faheydescribed themalaria experiments - calledmalariotherapy - as "striking" and offered to help continue research through UCLA.

Dr. Faheyforwarded this e-mail.datedNov.10.1998.toDr.Aziz and UCLA School of Medicine researcherBarbaraHered.

"I greatlyappreciated all of thedata yousharedwith us onthis visit," Dr. Faheywrote to ChenXiao Ping, thedoctoroverseeing theexperiments for Dr. Heimlich inChina. "I want to assureyou thatwe regardthis asconfidential information. Mycolleagues and I will gladly helpwith theanalysis butnot share itwith others. Youshould reportyour result directly to Dr.Heimlich."

Page 2 of4essageMessage Page 2 of4

"I greatly appreciated all of the data you shared with us on this visit," Dr. Fahey wrote to Chen Xiao Ping, thedoctor overseeing the experiments for Dr. Heimiich in China. "I want to assure you that we regard this asconfidential information. My colleagues and I will gladly help with the analysis but not share it with others. Youshould report your result directly to Dr. Heimiich."

Dr. Fahey forwarded this e-mail, dated Nov. 10, 1998, to Dr. Aziz and UCLA School of Medicine researcherBarbara Hered.

In another letter to Dr. Heimiich, dated Aug. 8, 1996, Dr. Fahey described the malaria experiments - calledmalariotherapy - as "striking" and offered to help continue research through UCLA.

"I wondered if we could help you ... we could, perhaps, develop a means of helping your Chinese colleagues incarrying out their studies," Dr. Fahey wrote. "Assistance with reagents and quality control samples for (test)measurements as well as for other parameters of HIV infection."

Contacted at his California home, Dr. Fahey would not comment. He also did not respond to an e-mail detailingthe contents of his letters to Dr. Heimiich and Dr. Chen. Dr. Aziz also would not comment.

Dr. Heimiich, who has credited Dr. Fahey for his support, says he has no idea why the doctors would say they arenot involved. He says they provided technical assistance for years and used their labs to analyze data and

suggest ways to proceed.

"Dr. Fahey is an outstanding professional. He was involved in the original work in China," Dr. Heimiich says. "Heis a renowned scientist involved in AIDS research. He asked to contribute. He did an excellent job."

For years, Dr. Heimiich has been criticized by state, federal and international health organizations overmalariotherapy. Despite this, Heimiich proudly continues his work in China and says he wants to expandmalariotherapy to Africa.

From his Cincinnati institute on Straight Street, the 83-year-old Dr. Heimiich solicits private donations formalariotherapy research and distributes a quarterly newsletter about his work to "promote peaceful solutions tointernational problems." He is the father of Hamilton County Commissioner Phil Heimiich.

He often is at odds with medical professionals. One of his most public fights has been with the American RedCross over the agency's refusal to adopt the Heimiich maneuver as the first response in drowning rescues insteadof traditional CPR.

Dr. Heimiich says his critics are motivated by politics rather than legitimate medical concern.

Malariotherapy research was the topic of Heimlich's presentation to the respected Pan Africa AIDS Conference inNashville, Tenn., last October.

"They don't question my work," he says, adding that his tests offer a chance to end the scourge of AIDS.

Officials with the Pan Africa Conference could not be reached. However, Peter Lurie, a former AIDS researcherand now a physician with Public Citizen's Health Research Group in Washington, D.C., calls the malariotherapystudies dangerous and unnecessary.

Public Citizen is a 32-year-old, nonprofit group founded by consumer advocate Ralph Nader. The HealthResearch Group provides oversight concerning drugs, medical devices, doctors and hospitals and occupationalhealth. It works to identify and ban unsafe or ineffective drugs, medical devices and procedures.

"It is charlatanism of the highest order," Dr. Lurie says of malariotherapy. "It is exploiting the lack of decentmedical care in China."

Dr. Heimiich began soliciting funds for malaria treatment of cancer, AIDS and Lyme disease in the late 1980s.

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UCLA officials acknowledge thatDr. Faheyand Dr. Aziz helpedtrain Dr. Chenalongwith other international

BothDr. Lurieand Dr. Bronstonsaythey are surprised thatAIDS researcherswould continue to be involved inmalaria experiments afterall of thecontinued negative publicity and criticismthat Dr. Heimlich receives.

"These results ...confirmmalariotherapyis safe and can be effective for HIV infectedpatients," Heimlichsaid inhis PanAfrica presentation.

Dr. Heimlichsays before being treatedwith malaria, eightmaleAIDS patients inChina had T-cell counts thatrangedfrom269 to 1,868.Two years aftermalariotherapy, theT-cell counts inthose patients were 570 to 2,063.

T-cells are a commonwayto measure the severity of HIV. Ina healthy person,T-cell counts are usuallyabove1,000.When counts fall below200, patients are considered to have full-blownAIDS.

Dr. Heimlichcontends theChina experiments haveprovedthatmalariaworks to combatAIDS. Hesays thatmalaria strengthens the immunesystemand increases T-cells inAIDS patients.

Dr. Bronstonorganized a petitionagainst Dr. Heimlich in 1994overmalaria experiments to treat Lymedisease,whichwere being conducted inMexico. The experiments resulted ina groundswell of protestfromthemedicalcommunity.

"Indeed, there is evidence that it is very dangerous," hesays.

Los Angeles physicianPaulBronston, who serves as the national chair of the Ethics and Professional PolicyCommittee for theAmerican College ofMedical Quality, says there is stillnoevidence that theexperiments haveanymerit.

"No evidence currently exists to indicate thatmalaria infectionwouldbeneficiallyaffect the course ofHIVinfection," Campbellwrote. "In fact, SUbstantiveconcerns havebeen raisedregarding the possibility thatmalariatherapy could (worsen) thecourse ofHIV infection."

In 1993, theU.S. Centers for DiseaseControl and Prevention questioned Dr. Heimlich's research. CarlosCampbell, CDC's chief ofmalaria studies atthe time, said therewas noevidence to support Heimlich'sconclusions.

"We askyou," Dr. Heimlichwrote to FDA Commissioner J ane Henney, "to take immediate action vis-y-vis youremployee and the unwarrantedharmtoour research that his bias and false accusations are causing."

Dr. Heimlichcalledthe reportbiased.

In2000, anFDA compliance directordescribedDr. Heimlich's procedures as inadequate. He said theexperiments would not bepermitted inthe United States, that researchers failed to consider community attitudesin China and that therewas nodescription of lifelong risks facing patients injectedwithmalaria.

The reviewboard overseeing Dr. Heimlich'sChina experimentwas formed byan "alternative medicine"groupcalled theGreatLakes College ofClinical Medicine.

Dr. Heimlich insists that hehas approval to conduct his studies through a reviewboardof doctors that issupposed to ensure federal regulations for ethical research are met. Butthat reviewboard was disbanded severalyears ago after the Food andDrugAdministration sharply criticized the Chinamalaria experiment.

Dr. Lurie included Dr. Heimlich'smalariotherapystudies ina September 1997New England Journal ofMedicinearticle about"exploitive" medical procedures indeveloping countries.

"Ever since then he's been coming upwith newmaneuvers," Dr. Lurie says. "Many ormost of themhave notworked. Some are incredibly grandiose."

Page 3 of4essageMessage Page 3 of4

"Ever since then he's been coming up with new maneuvers," Dr. Lurie says. "Many or most of them have notworked. Some are incredibly grandiose."

Dr. Lurie included Dr. Heimlich's malariotherapy studies in a September 1997 New England Journal of Medicinearticle about "exploitive" medical procedures in developing countries.

Dr. Heimlich insists that he has approval to conduct his studies through a review board of doctors that is

supposed to ensure federal regulations for ethical research are met. But that review board was disbanded severalyears ago after the Food and Drug Administration sharply criticized the China malaria experiment.

The review board overseeing Dr. Heimlich's China experiment was formed by an "alternative medicine" groupcalled the Great Lakes College of Clinical Medicine.

In 2000, an FDA compliance director described Dr. Heimlich's procedures as inadequate. He said theexperiments would not be permitted in the United States, that researchers failed to consider community attitudesin China and that there was no description of lifelong risks facing patients injected with malaria.

Dr. Heimlich called the report biased.

"We ask you," Dr. Heimlich wrote to FDA Commissioner J ane Henney, "to take immediate action vis-y-vis your

employee and the unwarranted harm to our research that his bias and false accusations are causing."

In 1993, the U.S. Centers for Disease Control and Prevention questioned Dr. Heimlich's research. CarlosCampbell, CDC's chief of malaria studies at the time, said there was no evidence to support Heimlich'sconclusions.

"No evidence currently exists to indicate that malaria infection would beneficially affect the course of HIVinfection," Campbell wrote. "In fact, substantive concerns have been raised regarding the possibility that malariatherapy could (worsen) the course of HIV infection."

Los Angeles physician Paul Bronston, who serves as the national chair of the Ethics and Professional PolicyCommittee for the American College of Medical Quality, says there is still no evidence that the experiments haveany merit.

"Indeed, there is evidence that it is very dangerous," he says.

Dr. Bronston organized a petition against Dr. Heimlich in 1994 over malaria experiments to treat Lyme disease,which were being conducted in Mexico. The experiments resulted in a groundswell of protest from the medicalcommunity.

Dr. Heimlich contends the China experiments have proved that malaria works to combat AIDS. He says thatmalaria strengthens the immune system and increases T-cells in AIDS patients.

T-cells are a common way to measure the severity of HIV. In a healthy person, T-cell counts are usually above1,000.When counts fall below 200, patients are considered to have full-blown AIDS.

Dr. Heimlich says before being treated with malaria, eight male AIDS patients in China had T-cell counts thatranged from 269 to 1,868. Two years after malariotherapy, the T-cell counts in those patients were 570 to 2,063.

"These results ... confirm malariotherapy is safe and can be effective for HIV infected patients," Heimlich said inhis Pan Africa presentation.

Both Dr. Lurie and Dr. Bronston say they are surprised that AIDS researchers would continue to be involved inmalaria experiments after all of the continued negative publicity and criticism that Dr. Heimlich receives.

UCLA officials acknowledge that Dr. Fahey and Dr. Aziz helped train Dr. Chen along with other international

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E -m a il a t [ an g {_Q_ I ]_@s ; L nc in@_ t i. _f Q l_ 7 ],

After beingadvised of thememos between Dr. Heimlichand Dr. Fahey, UCLA spokesmanMaxBenavidez issueda new statement Friday. Itacknowledges theongoing investigationand says: "UCLA reiterates that theuniversityhas never approvedany researchstudies pertaining to malariotherapyfor HIV."

But this month, theoffice reopened its investigation. Associate DirectorSteven Peckmansays his office receivedadditional information, butwill notcommentaboutit.

TheOffice for theProtection of ResearchSubjects atUCLA,which is responsible for reviewing researchprotocolsand ensuring thatmedical studies are ethical anddo not involve abuse, began investigating Dr. Faheyand Dr.Aziz inOctoberand initially cleared themofwrongdoing.

And in letters to Dr. Chen, Dr. Faheyarrangedways to shipreagents forstudies to and fromLosAngeles andGuangzhou, China.

In 1999, Dr. Chenand Dr. Heimlichcoauthored a reportonthemalariaexperiments for the ChineseMedicalSciences Journal. The papernotes that UCLA helpedmeasureserums.

"It is more appropriate ifyou simplyacknowledge assistanceofDr. NajibAziz andmyself insome aspects of thestudy inanacknowledgement paragraph orattheendofyourmanuscript," Dr. Faheywrote. "Youmustunderstand thatwewant verymuch to see this study succeedbutwe thinkthatwe should notbe amongmanuscript authors at this time."

But in his 1998e-mail to Dr. Chen, Dr. Fahey attemptedto discourage theChinese doctor fromnamingUCLAdoctors as authors on a research paper.

"Dr. Chen acknowledged the immunology training byDr. Fahey inhis research paper. However, Dr. Faheywasnot a coauthor and did notcollaborate on themalaria studies,"UCLA officials said ina Nov. 27 statement.

scholars. Butofficials saythedoctors were limitedto teachingmethods for conductingandevaluatingAIDSresearch studies. Officials say thedoctors neverwere involved inDr. Heimlich's studies.

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scholars. But officials say the doctors were limited to teaching methods for conducting and evaluating AIDSresearch studies. Officials say the doctors never were involved in Dr. Heimlich's studies.

"Dr. Chen acknowledged the immunology training by Dr. Fahey in his research paper. However, Dr. Fahey wasnot a coauthor and did not collaborate on the malaria studies," UCLA officials said in a Nov. 27 statement.

But in his 1998 e-mail to Dr. Chen, Dr. Fahey attempted to discourage the Chinese doctor from naming UCLA

doctors as authors on a research paper.

"It is more appropriate if you simply acknowledge assistance of Dr. Najib Aziz and myself in some aspects of thestudy in an acknowledgement paragraph or at the end of your manuscript," Dr. Fahey wrote. "You mustunderstand that we want very much to see this study succeed but we think that we should not be amongmanuscript authors at this time."

In 1999, Dr. Chen and Dr. Heimlich coauthored a report on the malaria experiments for the Chinese MedicalSciences Journal. The paper notes that UCLA helped measure serums.

And in letters to Dr. Chen, Dr. Fahey arranged ways to ship reagents for studies to and from Los Angeles andGuangzhou, China.

The Office for the Protection of Research Subjects at UCLA, which is responsible for reviewing research protocolsand ensuring that medical studies are ethical and do not involve abuse, began investigating Dr. Fahey and Dr.Aziz in October and initially cleared them of wrongdoing.

But this month, the office reopened its investigation. Associate Director Steven Peckman says his office receivedadditional information, but will not comment about it.

After being advised of the memos between Dr. Heimlich and Dr. Fahey, UCLA spokesman Max Benavidez issueda new statement Friday. It acknowledges the ongoing investigation and says: "UCLA reiterates that the universityhas never approved any research studies pertaining to malariotherapy for HIV."

E-mail at ranglentiSjcincinnati.com.

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19/21411612003ttp://www.nexis.com/research/pnews/submitViewTagged

Fahey said that was "the only time specimens frommalariotherapy patients were at UCLA."

In a statement Tuesday, Fahey said he "regrets the misunderstanding this matter has caused." He said hebecame indirectly involved in the so-called malariotherapy research in 1997,when he was training aChinese scientist, Xiao Ping Chen, during a three-month program at UCLA. At that time, Chen wastesting blood serum that was collected several years earlier from patients he had treated in China withmalariotherapy.

A secondUCLA researcher, Najib Aziz, who was included in the board's investigation, was not found tohave broken any rules, Benavidez said. Aziz was working "underDr. Fahey's purview," the spokesmansaid.

University administrators will review the findings to determine whether discipline is required, UCLAspokesman Max Benavidez said.

A statement issued by UCLA's institutional review board, which reviews medical experiments involvinghuman subjects, found that Fahey did not participate directly in the controversial trials, but did, withoutrequisite permission from the board, evaluate data and biological samples brought to the university by aChinese scientist.

The research effort was sponsored by Dr. Henry Heimlich, founder of the Heimlich Institute and creatorof the anti-choking maneuver that bears his name. The malaria studies are regarded with skepticism bymany AIDS researchers, who said the therapy could harm already ill patients by infecting them withanother potentially deadly disease.

The university said Tuesday that the oversight board has determined that microbiology professor John L.Fahey was indirectly involved with the experiments, which seek to use the immune reaction induced bymalaria as a possible treatment for AIDS.

BODY:A UCLAmedical oversight board has found that a researcher violated federal rules by taking part incontroversial medical studies in which AIDS patients in China were injected with malaria-infectedblood.

BYLINE: Rebecca Trounson and Charles Ornstein, Times Staff WritersHEADLINE: Researcher Violated Rules, UCLA SaysLENGTH: 636 wordsSECTION: California Metro; Part 2; Page 4; Metro Desk

April 16, 2003 Wednesday Home Edition

All Rights ReservedLos Angeles Times

Copyright 2003 The Times Mirror Company; Los Angeles Times/ r r " ' - . LexisNexis-

Page 1of6EXIS@-NEXIS View Prir+=ble PageLEXIS-NEXIS View Pr i^ble Page Page 1 of6

LexisNexis

Copyright 2003 The Times Mirror Company; Los Angeles Times

All Rights ReservedLos Angeles Times

April 16, 2003 Wednesday Home Edition

SECTION: California Metro; Part 2; Page 4; Metro Desk

LENGTH: 636 words

HEADLINE: Researcher Violated Rules, UCLA Says

BYLINE: Rebecca Trounson and Charles Ornstein, Times Staff Writers

BODY:A UCLA medical oversight board has found that a researcher violated federal rules by taking part incontroversial medical studies in which AIDS patients in China were injected with malaria-infected

blood.

The university said Tuesday that the oversight board has determined that microbiology professor John L.Fahey was indirectly involved with the experiments, which seek to use the immune reaction induced bymalaria as a possible treatment for AIDS.

The research effort was sponsored by Dr. Henry Heimlich, founder of the Heimlich Institute and creatorof the anti-choking maneuver that bears his name. The malaria studies are regarded with skepticism bymany AIDS researchers, who said the therapy could harm already ill patients by infecting them with

another potentially deadly disease.

A statement issued by UCLA's institutional review board, which reviews medical experiments involvinghuman subjects, found that Fahey did not participate directly in the controversial trials, but did, withoutrequisite permission from the board, evaluate data and biological samples brought to the university by aChinese scientist.

University administrators will review the findings to determine whether discipline is required, UCLAspokesman Max Benavidez said.

A second UCLA researcher, Najib Aziz, who was included in the board's investigation, was not found tohave broken any rules, Benavidez said. Aziz was working "under Dr. Fahey's purview," the spokesmansaid.

In a statement Tuesday, Fahey said he "regrets the misunderstanding this matter has caused." He said hebecame indirectly involved in the so-called malariotherapy research in 1997, when he was training aChinese scientist, Xiao Ping Chen, during a three-month program at UCLA. At that time, Chen wastesting blood serum that was collected several years earlier from patients he had treated in China withmalariotherapy.

Fahey said that was "the only time specimens from malariotherapy patients were at UCLA."

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LOAD-DATE: April 16, 2003In the statement Tuesday, the university reiterated that UCLA "has never approved any researchpertaining to malariotherapy studies for HIV," the virus that causes AIDS.

"He has provided substantial assurances of his compliance in the future," Peckman said.

"The feeling here is that Dr. Fahey made an honest mistake," said Steven Peckman, UCLA's associatedirector for human subjects research.

In the announcement Tuesday, UCLA's review board said Fahey had violated federal regulations andUCLA policy for the protection of human subjects by not seeking approval from the university beforeallowing Chen to conduct research at UCLA.

That November, according to e-mails obtained by the Cincinnati Enquirer and first reported in February,Fahey wrote to Chen to thank the Chinese researcher for sharing his data during the visit.

Chen participated in 1997 in the UCLAIFogartyAIDS international training and research program,which provides training in AIDS control to visiting scholars from developing countries. Fahey thenvisited Chen and other Fogarty scholars in China in 1998, but did not participate in their research,UCLA officials have said.

On his institute's Web site, Heimlich has credited UCLA for its support of the research.

He said he was "not aware if Dr. Fahey followed the proper procedures" in his work at UCLA. "That isbetween Dr. Fahey and UCLA," Heimlich said.

In a statement e-mailed to The Times on Tuesday, he said that available data "indicates thatmalariotherapy offers a safe, promising and inexpensive way to help the millions of people sufferingfrom AIDS throughout the underdeveloped world."

Heimlich, however, appeared undeterred by the controversy. He recently announced that he is workingwith doctors to begin human tests of the therapy in five African nations.

rage Lor 0tAl~\!y-l'H:Al~\!y VH::W r nruaore rageLtvao^iy-iNcyua^ view rririiaoie rage rage / or o

Heimlich, however, appeared undeterred by the controversy. He recently announced that he is workingwith doctors to begin human tests of the therapy in five African nations.

In a statement e-mailed to The Times on Tuesday, he said that available data "indicates thatmalariotherapy offers a safe, promising and inexpensive way to help the millions of people sufferingfrom AIDS throughout the underdeveloped world."

He said he was "not aware ifDr. Fahey followed the proper procedures" in his work at UCLA. "That isbetween Dr. Fahey and UCLA," Heimlich said.

On his institute's Web site, Heimlich has credited UCLA for its support ofthe research.

Chen participated in 1997 in the UCLA/Fogarty AIDS international training and research program,which provides training in AIDS control to visiting scholars from developing countries. Fahey thenvisited Chen and other Fogarty scholars in China in 1998, but did not participate in their research,UCLA officials have said.

That November, according to e-mails obtained by the Cincinnati Enquirer and first reported in February,Fahey wrote to Chen to thank the Chinese researcher for sharing his data during the visit.

In the announcement Tuesday, UCLA's review board said Fahey had violated federal regulations andUCLA policy for the protection ofhuman subjects by not seeking approval from the university beforeallowing Chen to conduct research at UCLA.

"The feeling here is that Dr. Fahey made an honest mistake," said Steven Peckman, UCLA's associatedirector forhuman subjects research.

"He has provided substantial assurances ofhis compliance in the future," Peckman said.

In the statement Tuesday, the university reiterated that UCLA "has never approved any researchpertaining to malariotherapy studies for HIV," the virus that causes AIDS.

LOAD-DATE: April 16, 2003

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Documents

File Two: Response from Dept. of Health and Human Services to FOIA request for all records re: UCLA's 2002/03 investigation of employees and the Heimlich Institute's "malariotherapy"