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DEPARTMENT OF DEPARTMENT OF HEALTH HEALTH & & HUMAN HUMAN SERVICES SERVICES

Program Support Center Center ProgramSupport Public Service Public Health HealthService Freedomof Freedom of Information Information Office Parklawn Building, Building, Room Room 17A-46 5600 FishersLane Fishers Lane Rockville, Maryland20857 Rockville, Maryland 20857 PH: 301-443-5252 PH: 301-443-5252 Fax: 301-443-0925 Fax: 301-443-0925

FOIA Case Number: Number: FOIACase ------'-' March 11, 2005 2005
Mr.

Dear Mr. response to your yourj | letters letters addressed addressed This is in response (FOIA) Officer, U.S. Department of to the Freedom of Information Act Act (FOIA)Officer, U.S_Department of Health and Human information Human Services (DHHS). (DHHS). You You requested requested all information pertaining to UCLA-Malariotherapy Studies. Studies. Records responsive responsive to your your pertaining request are in the possession possession of of the Office Office for for Human Research request Human Research Protections (OHRP). Your letters were referred to me because office Protections (OHRP). letters because my office FOIA authority authority for for OHRP. OHRP. serves as the FOIA records maintained maintained by OHRP. OHRP. Please note that that the Enclosed are the records documents contain contain deletions. deletions. Specifically, Specifically, I removed information, information, the the documents disclosure of which which would constitute constitute a clearly unwarranted unwarranted invasion of disclosure of personal privacy and/ and/o r identify identify a confidential source. source. If, If, after your your personal or review, you believe the deleted information should be made available to review, should issue you a formal denial which which you, please contact contact my office office and I will will issue advises you of your right to appeal. appeal. Because the cost of responding request was less than there responding to your request than $25, there is no costcost. If you have any questions, or if I may be of further assistance, If questions, further assistance, hesitate to contact please do not hesitate contact me.
<:.:::..

Sincerely yours, yours,

)arlene Christiar Freedom of Information Officer Public Health Service

Enclosures Enclosures

A ssurance Assurance O versight Oversight

06/30/2003

System S y s t e m

Oversight Record Oversight Record Printout Printout

Institute: U CALIFORNIA LOS ANGELES City: LOS ANGELES

State: CALIFORNIA Type: IRPT Type: IRPT Compliance Coordinator: Coordinator: Borror Assurance: M O O 1127 MOOl127
C o m m e n t s : malariotherapy Comments:

Ctry: U

Date Date Opened: Opened: 02/24/2003 02/2412003 Date Resolved: Resolved: 06/30/2003 06/30/2003 Case: Case:

Description: OHRP read press reports regarding a UCLA researcher being involved in experiments infecting AIDS patients in China with malaria. OHRP inquired of UCLA the status of this situation. UCLA said they had determined that their investigator was not engaged in human subjects research, but had received additional information information and was reopening their investigation. They found that Dr. Fahey was 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" F1LB FILE COpy COPY EDIT1m' DO NOT RELEASE

Max Benavidez Benavidez (maxb(a>support.ucla.edu) Max (maxb@support.ucla.edu) (310) 794-6868 (310) 794-6868

For Immediate Use: Immediate Use: April 2003 April 15, 2003

UCLA REVIEW ITS UCLA MEDICAL MEDICAL INSTITUTIONAL INSTITUTIONAL REVIEW BOARD BOARD (MIRB) (MIRB) ISSUES ISSUES ITS DETERMINATION IN THE FAHEY FAHEY CASE CASE REGARDING CLAIMS ABOUT ABOUT DETERMINATION IN THE REGARDING CLAIMS MALARIOTHERAPY STUDIES FOR FOR HIV MALARIOTHERAPY STUDIES HIV March 30, 2003, the UCLA UCLA Medical Medical Institutional Institutional Review Review Board Board (MIRB) (MIRB) issued issued its On March 30, 2003, determination determination regarding regarding a complaint complaint about about Dr. John John Fahey Fahey and allegations allegations that he participated participated in malariotherapy research research at UCLA. UCLA. malariotherapy The MIRB MIRB determined determined that that Dr. Dr. Fahey Fahey while while not not personally personally involved involved in the the clinical clinical trials, The trials, was involved in evaluating data and biological samples brought to UCLA from China by Dr. was involved evaluating data biological samples brought UCLA China Xiao Peng Fogarty International Since Dr. Chen's was performed performed Xiao Peng Chen Chen under under the the Fogarty International Program. Program. Since Chen's work work was part of the the Fogarty Program at UCLA UCLA and was was under under Dr. Fahey's Fahey's supervision, supervision, the the MIRB MIRB as part Fogarty Program determined Fahey was subjects research. research. determined that that Dr. Fahey was engaged engaged in human human subjects According to the According the MIRB, MIRB, in not getting prior approval from from UCLA, Dr. Fahey violated Federal regulations as well as UCLA policy for the protection of human research subjects by allowing Dr. Chen to conduct research at UCLA in a program funded funded to UCLA. Dr. Fahey did not, however, directly participate in clinical trials where malariotherapy was administered to Chinese subjects. The Board determined that Dr. Fahey and his laboratory participated only indirectly 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 future Fogarty scholars and others under his direction will have appropriate UCLA IRB approval prior to conducting any research activities at UCLA or using UCLA property, resources, material, or funding. Dr. Fahey's Fahey's involvement in Dr. Chen's research will be reported to the U.S. Department of Health and Human Services - Office Office for Human Research Protections (DHHS-OHRP), to the Fogarty International Program, and to UCLA's Executive Vice Chancellor. This reporting is consistent with UCLA's Multiple Project Assurance (MPA) and with Federal regulations. As a follow-up follow-up to the MIRB's MIRB's findings in this case, UCLA's Executive Vice Chancellor will insure that appropriate institutional measures are in place to insure future future compliance with UCLA policy for Office of for the Fogarty Scholars. UCLA also will be responsive to the U.S. Office Human Research Protections' Protections' review of this matter. UCLA has never approved any research pertaining to malariotherapy studies for HIV. -UCLA-

UNIVERSITY O OF CALIFORNIA, LOS ANGELES ANGELES UNIVERSITY F CALIFORNIA,

BERKELEY' DAVIS IRVINE LOS ANCELES ANGELES MERCED BERKELEY IRVINE LOS MERCED RIVERSIDE RIVERSIDE SAN DIEGO DIEGO SAN FRANCISCO FRANCISCO

^ ^
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UCLA UCLA
SANTA BARBARA CRUZ SANTA BARBARA SANTA SANTA CRUZ

OFFICE FOR PR0TECI10N PROTECTION OF RESEARCH SUBJECTS BOX 951694 LOS ANGELES, CALIFORNIA 90095-1694

June 24, 2003 Michael A. Carome, MD Associate Director-Regulatory Affairs Affairs Office Office for Human Research Protections Department of Health and Human Services The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 RE: Human Research Collaboration on Malariotherapy: John Fahey, MD Nll-I 36086 NTH grants TW 00003 and AI AI36086

Dear Dr. Carome, This letter serves as a final report regarding a violation of the University of California, California, 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 in in China on malariotherapy. The Board determined that Dr. Fahey, while not personally involved in the clinical trials, was involved in evaluating coded 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 performed as part of the Fogarty Program at UCLA and was under Dr. Fahey's Fancy's supervision, the IRE IRB determined that DL Dr. Fahey was engaged in human subjects research. As noted above, the Board could not identify identify any information information indicating Dr. Fahey's direct participation participation in clinical trials where malariotherapy was administered to Chinese subjects. The Board determined that Dr. Fahey and his laboratory participated only indirectly in the research by allowing the testing of Dr. Chen's coded samples. The IRB accepted Dr. Fahey's assurances that he will ensure that future future Fogarty scholars and others under his direction will have appropriate UCLA IRB approval or certification certification of exemption prior to conducting any research activities at UCLA or using UCLA property, exemption research resources, material or funding. funding.

o:/inquiry/fahey/OHRP fahey inquiry 030623 o:linquiry/fahey/OHRP fahey

Allegations Regarding Malariotherapy

Research Research

page 2

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

Judith L. Brookshire ~~ Director cc: Director Division of Compliance Oversight Kristina Kxistina Borror, OHRP Executive Vice Chancellor Daniel Neuman Vice Chancellor-Research Chancellor-Research Roberto Peccei Chairperson Carmine Clemente, MIRB1 Chairperson Robert Figlin, MIRB2 MJRB2 John Fahey, MD Associate Director Steven Peckman

o:/inquiry/fahey/OHRP o:linquiry/fahey/OHRP fahey fahey inquiry 030623

3 ~

f/'' 4'.
....... vlCb.

DEPARTMENT HEALTH & HUMAN SERVICES DEPARTMENT OF OF HEALTH & HUMAN SERVICES

Office of the Secretary Secretary Office of Public Health and Public Health and Science

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

Office for Protections for Human Human Research Research Protections The Tower The Tower Building Building Suite 200 1101 Wootton Wootton Parkway, Parkway, Suite Rockville, Maryland20852 Maryland 20852 Rockville, Telephone: 301-435-8072 Telephone: 301-435-8072 FAX: 301-402-2071 FAX: email: kborror@osophs.dhhs.gov email: kborror@osophs.dhhs.gov

March 19, 2003 Judith L. Brookshire Director Office Office for Protection of Research Subjects Box 951694 Los Angeles, CA 90095-1694 RE: Research Project: Human Research Collaboration on Malariotherapy Malariotherapy PI: John John Fahey, M.D. M.D. Project Number: NIH Grants Grants TW 00003and 00003 and AI AI36086 36086 Dear Ms. Brookshire: The Office Office for Human Research Protections (OHRP) has received your letter of June 24, 2003 concerning the above protocol, which was submitted in partial fulfillment fulfillment of the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(b)(5). Your report and the corrective actions described appear to be appropriate under HHS regulations and your institution's institution's Assurance of Compliance. OHRP appreciates your continued commitment to the protection of human research SUbjects. subjects. Please do not hesitate to contact me should you have any questions. Sincerely, Sincerely,

6iL~

Kristina C. Borror Director Division of Compliance Oversight

Borror. Kristina Borror, Kristina

From: From: Sent: Sent: To: To: Cc: Cc: Subject: Subject: Importance: Importance: Peckman, Steven[SPECKMAN@OPRS.UCLA.EDU] [SPECKMAN@OPRS.UCLA.EDU] Peckman, Steven Wednesday, April 200310:48 AM Wednesday, April16, 16, 2003 10:48 AM Carome, Carome, Michael Michael Brookshire, Judith; Borror, Kristina Brookshire, Judith; Borror, Kristina RE: UCLA -Allegations Allegations Regarding Malariotherapy Research n China RE: UCLA Regarding Malariotherapy Research ini China
High High

Dear Mike and Kristina, The UCLA IRB found that Dr. Fahey while not personally involved in the malariotherapy clinical trials, was involved in evaluating evaluating data and biological samples brought to UCLA from China by Dr. Xiao Peng Chen under the Fogarty International International Program. Program. Since Dr. Chen's work was performed as part of the Fogarty Fogarty Program Program at UCLA and was under Dr. Fahey's Fahey's supervision, the IRB determined that Fahey Fahey was engaged in human subjects subjects research. We could not find any evidence that Dr. Fahey directly participated in clinical trials where malariotherapy was administered administered to Chinese subjects. sUbjects. The IRB IRE determined that Fahey Fahey and his laboratory laboratory participated participated only indirectly in the research by allowing the testing of Chen's samples. I will will forward forward a a full full report report shortly. shortly. if you have any questions. Sincerely, -steve Steven Peckman Director-Human Subjects Subjects -Research Associate Director-Human Research Protection of Research Subjects Office for Protection University of California, Los Angeles tv) 310.825.5344 (v) (f) 310.794.9565 (f) speckman@oprs.ucla.edu speckman@oprs.ucla.edu Original Message----Message -----Original From: Carome, Michael [mailto:MCarome@OSOPHS.DHHS.GOV] [mailto:MCarome@0S0PHS.DHHS.GOV] Sent: Monday, February February 24, 2003 1:37 1:37 PM To: 'Peckman, 'Peckman, Steven' Cc: Borror, Kristina Subject: RE: UCLA - Allegations Regarding Malariotherapy Research in China Steve, Thanks for the update. Mike Michael A. Carome, M.D. Director for Regulatory Regulatory Affairs Associate Director Office for Human Research Research Protections The Tower Building Building 1101 Wootton Parkway, Parkway, Suite 200 Rockville, MD 20852 Tel: 301-402-5567 301-402-5567 Fax: 301-402-2071 E-mail: rncarorne@osophs.dhhs.gov mcarome@osophs.dhhs.gov We will await await your follow-up follow-up report. Please do do not not hesitate hesitate to to contact contact me me Please

Original Message----Message -----Original From: Steven [mailto:SPECKMAN@OPRS.UCLA.EDU] [mailto:SPECKMAN@OPRS.UCLA.EDU] From: Peckman, Peckman, Steven Sent: Monday, Monday, February February 24, 24, 2003 2003 1:27 PM Sent: To: Carome, To: Carome, Michael Michael Subject: UCLA UCLA - Allegations Allegations Regarding Malariotherapy Research in China Subject: Regarding Malariotherapy Research China Importance: High Importance: High Dear Mike, Dear Mike, The UCLA OCLA IRB determined determined in in December December 2002 2002 that that Drs. Drs. Fahey Fahey and not The and Aziz Aziz did did not appear be engaged engaged in human human subjects subjects research research related related to the the anonymous appear to be anonymous allegations allegations of ' ^^^^^fc The The Board, Board, however, however, received received additional additional information and information and the the matter matter is reopened reopened and under under review. review. will keep keep you you informed informed of of our our further further findings. findings. I will contact me me if you you have have any contact any questions. questions. Sincerely, Sincerely, Steve Steve Steven Peckman Peckman Steven Associate Director-Human Director-Human Subjects Subjects Research Research Associate Office Subjects Office for Protection Protection of Research Research Subjects University of California, California, Los Los Angeles Angeles University 310.825.5344 (v) 310.825.5344 310.794.9565 (f) 310.794.9565 speckman@oprs.ucla.edu speckffian@oprs.ucla.edu Please do do not not hesitate hesitate to to Please

Borror, Kristina Kristina Borror,

From: From: Sent: Sent: To: To: Subject: Subject: Carome, Michael Michael Carome, Tuesday, March March 04, 04, 2003 20034:55 PM Tuesday, 4:55 PM Borror, Kristina; Kristina; El-Hinnawy, EI-Hinnawy,Patricia; Patricia; Schwetz, Schwetz, Bernard BernardA A Borror, FW: New New York York Times, Times, 03/04/03 03/04/03 FW:

The s story below r relates a m matter OHRP by by UCLA. UCLA. Mike Mike The t o r y below e l a t e s tto o a a t t e r rreported e p o r t e d tto o OHRP

March 4, 4, 2003 2003 March Malarial Treatment Treatment for for Chinese Chinese AIDS AIDS Patients Patients Prompts Prompts Inquiry Inquiry in in U.S. Malarial U.S. By DONALD DONALD G. G. McNEIL McNEIL Jr. Jr. By The University University of of California California at at Los Los Angeles Angeles is is investigating investigating The whether two two of of its its researchers researchers aided aided experiments experiments in in China China in in which whether H.I.V. patients patients were were deliberately deliberately injected injected with with malaria malaria in in an an effort effort to to H.I.V. kill the the AIDS AIDS virus. virus. kill The China China research research was was done done from from 1993 1993 to to 1996 1996 at at the the request request of Dr. Dr. The Henry J. Heimlich, Heimlich, now now 83, the the inventor inventor of the the Heimlich Heimlich maneuver, maneuver, which Henry can save save people people who who are choking. choking. can Dr. Heimlich, who has has courted courted controversy controversy in several several fields fields of medicine, medicine, Dr. argues that that inducing inducing high malarial malarial fevers fevers can stimulate stimulate the immune immune argues system to fight fight AIDS, AIDS, Lyme Lyme disease disease and cancer. cancer. In the early early 1990's, 1990's, he he system fund-raising parties in Hollywood, Hollywood, raising raising tens tens of thousands thousands of of held fund-raising dollars from from movie movie stars stars and agents agents to pursue pursue a malaria AIDS AIDS cure. cure. dollars The Centers Centers for Disease Disease Control Control and Prevention Prevention opposes opposes malarial malarial therapy, therapy, The and some some medical medical experts experts have have harshly harshly criticized criticized him for experimenting and experimenting humans in China China when when it was was unthinkable unthinkable that that such such a trial trial would would have on humans approved in the United United States. States. been approved U.C.L.A. 's medical board board overseeing overseeing human tests tests is investigating investigating two two U.C.L.A.'s Dr. John Fahey Fahey and Dr. Dr. Najib Aziz, based on information information researchers, Dr. that a university spokesman spokesman declined declined to describe. describe. that Cincinnati Enquirer Enquirer published published an article article in which which Dr. Dr. On Feb 16, The Cincinnati described his work in China China and said said Dr. Dr. Fahey Fahey was involved. involved. Heimlich described The Web Web site site for Dr. Dr. Heimlich's Heimlich's Institute Institute at the Deaconess Deaconess Hospital Hospital in in The Cincinnati still still says says U.C.L.A. U.C.L.A. helped helped with the research. Cincinnati letters and e-mail e-mail messages supposedly supposedly written written by Dr. Dr. The article quoted letters Fahey that, The The Enquirer Enquirer said, said, detailed detailed how the two doctors doctors set up the the Fahey analyzed data, provided provided test test chemicals, visited the test experiments, analyzed site in China and offered to find find research research grants. In another another document site Enquirer quotes, Dr. Dr. Fahey Fahey asks asks his his Chinese Chinese colleagues colleagues to refrain The Enquirer from from naming him or Dr. Dr. Aziz as an author of a research paper. international AIDS conferences conferences in 1996, 1996, The paper, presented at two international publiShed in the Chinese Medical Medical Science Science Journal in 1999 1999 and still still published available on the Heimlich Institute Institute Web Web site site at at available www.heimlichinstitute.org, lists lists Dr. Dr. Heimlich and three Chinese Chinese doctors www.heimlichinstitute.org, as authors. H.I.V.-positive Chinese men men and women who who A later paper describing 12 H.I.V.-positive injected with malaria and then had had their their immune immune responses responses measured, were injected released in 2000 by the Center for AIDS Control and Research in in released thanked Dr. Dr. Heimlich, Dr. Dr. Fahey and Dr. Dr. Aziz for their Guangzhou, China, thanked help with the "pilot "pilot study." 1

Dr. office assistant assistant said would not not speak speak to the the press. press. Dr. Dr. Dr. F'ahey's Fahey's office said he he would Aziz, his laboratory, laboratory, refused comment. Aziz, reached reached at at his refused to comment. Barbara Lohr, a spokeswoman spokeswoman for Institute, said said Dr. Dr. Barbara Lohr, for the the Heimlich Heimlich Institute, Heimlich forward Heimlich was was on on vacation vacation and and would would not not comment. comment. However, However, he he did did forward answers to malarial answers to some some e-mailed e-mailed questions questions and and sent sent documents documents defending defending malarial therapy. therapy.

On April April 29, 1993, noting On 29, 1993, noting that that Dr. Dr. Heimlich Heimlich was was encouraging encouraging the the use use of malaria to treat disease and malaria treat Lyme Lyme disease and AIDS, AIDS, C.D.C. C.D.C. officials officials issued issued a memorandum "cannot be justified." It cited cited studies studies memorandum saying saying the the practice practice "cannot be justified." showing that malaria malaria victims victims in in Zaire Zaire received received no showing that no protection protection from from H.I.V. H.I.V. infection have gotten gotten sicker sicker more more quickly quickly having having both. both. infection and and may may have Deliberately giving patients patients malaria malaria risked them, the the C.D.C. Deliberately giving risked killing killing them, C.D.C. said. said.
Dr. Heimlich went went ahead ahead nonetheless, nonetheless, in conjunction conjunction with with Chinese Dr. Heimlich in Chinese scientists led by were scientists by Dr. Dr. Chen Chen Xiao Xiao Ping. Ping. Eight Eight men men with with H.I.V. H.I.V. were injected with malaria, After injected with vivax-strain vivax-strain malaria, two two in in 1993 1993 and and six six in 1995. 1995. After three three weeks weeks of fever fever cycles, cycles, the the malaria malaria was was killed killed with with the the drug drug chloroquine. chloroquine.

The in 1996, reported then alive The study, study, which which ended ended in 1996, reported then that that all all eight eight were were alive and normal CD4 counts; the the H.I.V. H.I.V. virus virus cripples cripples the the immune immune system and had had normal CD4 counts; system by destroying destroying CD4 CD4 cells. cells. Dr. Dr. Heimlich Heimlich said said on on Feb. Feb. 21 21 that, that, as of his by his last contact contact with with his his Chinese Chinese colleagues colleagues in 2001, 2001, one one man man was was dead dead of last non-AIDS-related causes non-AIDS-related causes and and the the rest rest were were alive. alive. It is difficult, from such short-term data. difficult, however, however, to draw draw conclusions conclusions from such short-term data. It typically typically takes takes at least least eight eight years years from from infection infection with with H.I.V. H.I.V. for for a healthy adult adult to develop develop symptoms; symptoms; it was whether the men later healthy was unknown unknown whether the men later received antiretroviral therapy. received antiretroviral therapy. Dr. Peter Public Dr. ~eter Lurie, Lurie, a former former AIDS AIDS researcher researcher now now with with Ralph Ralph Nader's Nader's Public Citizen enough Citizen Health Health Research Research Group, Group, called called the the follow-up follow-up period period "not "not enough to say say anything" Heimlich's use use of human subjects to to anything" and and said said that that Dr. Dr. Heimlich's human subjects test his test his theory theory was was "outrageous." "outrageous."
Dr. Mark Siegler, Siegler, director director of the the Center Center for Medical Ethics Dr. Mark for Clinical Clinical Medical Ethics at the University Hospital, said said that that injecting injecting patients the University of Chicago Chicago Hospital, patients with with a dangerous fight another another was was done done 50 years ago in this this country country dangerous disease disease to fight years ago but would but would not not be be tolerated tolerated now. now. Dr. that malarial malarial fevers fevers can can be used used against Dr. Heimlich Heimlich has has long long argued argued that against syphilis, Lyme disease, disease, AIDS AIDS and and cancer. cancer. syphilis, Lyme

Before the penicillin, blood blood from from people people with vivax Before the invention invention of penicillin, with vivax malaria, sometimes malaria, sometimes provided provided by by the the United United States States Public Public Health Health Service, Service, was injected treatment for for late-stage syphilis that that had the was injected as a treatment late-stage syphilis had reached reached the brain. In the the late with Lyme Lyme disease brain. late 1970's 1970's some some Americans Americans with disease went went to Mexico for for "malaria "malaria treatment." Mexico treatment."
In its its 1993 1993 paper, paper, the the C.D.C. C.D.C. said said no no clinical clinical trials trials had had ever ever proved proved malaria anecdotal reports reports on on syphilis syphilis patients malaria treatment treatment worked worked and and anecdotal patients called it unpredictable. unpredictable. called

Dr. Lurie Lurie said had been been "relegated "relegated to the Dr. said malarial malarial cures cures had the status status of leeches." leeches." Prominent AIDS researchers say say Dr. Dr. Heimlich's Heimlich's theory theory doesn't doesn't make make Prominent AIDS researchers scientific sense. sense. Syphilis Syphilis and and Lyme disease, which which are are caused caused by by scientific Lyme disease, spirochetes, are antibiotics. AIDS, contrast, is spirochetes, are now now treated treated with with antibiotics. AIDS, in contrast, caused by a retrovirus, caused retrovirus, which which does does not not live live outside outside cells cells as a spirochete does; does; it incorporates itself into into a cell's spirochete incorporates itself cell's DNA. DNA. Cancers Cancers pockets of abnormally abnormally rapid rapid cell cell growth have many many causes, causes, but but are are pockets growth - have thought to stem stem from damage to a cell's have thought from damage cell's DNA. DNA. Also, Also, many many Africans Africans have 2

AIDS simultaneously. AIDS and and malaria malaria simultaneously. lot of don't Merle "A lot of micro-organisms micro-organisms don't do do well well in in a high high fever," fever," said said Dr. Dr. Merle A. Sande, Sande, a University University of AIDS researcher has a treatment treatment A. of Utah Utah AIDS researcher who who has program in Uganda. Uganda. "But don't have have any any reason think malaria malaria would would program "But I don't reason to think suppress suppress the the AIDS AIDS virus." virus." Dr. Heimlich's some of these these criticisms, criticisms, arguing arguing Dr. Heimlich's Web Web site site responds responds to some that infected with with the the falciparum falciparum strain strain of malaria, that Africans Africans are are often often infected malaria, which can can be immediately. which be so rapidly rapidly fatal fatal that that it must must be be treated treated immediately. Chronic malaria compared Chronic malaria weakens weakens the the immune immune system system and and should should not not be compared with a short, short, deliberate deliberate vivax-strain vivax-strain infection, infection, it said. said. with Dr. Heimlich, Heimlich, whose whose maneuver, maneuver, introduced introduced in 1974, 1974, is credited credited with with Dr. saving the of many many choking choking victims, victims, has has often often provoked provoked saving the lives lives of controversy. clear controversy. He He argues argues that that it should should be used used in drowning drowning cases cases to clear water and asthma and and cystic cystic fibrosis fibrosis to clear clear mucus. His water and on on victims victims of asthma mucus. His institute is devoted devoted to simple institute simple lifesaving lifesaving solutions, solutions, and and it credits credits him him with inventing a chest an esophagus-replacement operation, with inventing chest drain drain valve, valve, an esophagus-replacement operation, tracheal oxygen tubes tubes and and a method method to restore restore swallowing stroke tracheal oxygen swallowing to stroke victims. victims.

3 3

Carome, Michael Carome, Michael

From: From: Sent: To: Cc: Peckman, Steven [SPECKMAN@OPRS.UClAEDUJ [SPECKMAN@OPRS.UCLA.EDU] Wednesday. October 09, 2002 11:39 AM Wednesdav. Albert Carnesale (E-mail); Irvin S. Y. Chen (E-mail); Miller, Jeff F. (BOL); (BOl); 'JLFahey@mednet.ucla.edu'; 'JlFahey@mednet.ucla.edu'; Aziz, Najib (BOL); (BOl); Janet M. Young (E-mail); Namkung, Ann (NIH.AN107Z); Fogarty International International Center (E-mail); Victor Zhenyu Liu (E-mail); Vern Leong (E-mail); Eriksson, Carl; Shang Chuan (E-mail); Henry J. Heimlich (E-mail) RE: UCLA-Heimlich China AIDS Research

Subject: Subject: Dear' Dear .

f1II'--_~

On behalf of the University of California, los Los Angeles (UCLA), Office for Protection of Research Subjects (OPRS), I thank you for the email regarding Drs. Fahey and Aziz. The OPRS supports federally mandated human research review committees called Institutional Review Boards (IRBs). (lRBs). The charge of the IRB is to ensure the protection of the rights and welfare of all human subjects participating in UCLA research. I assure you that the UCLA and our IRBs IRSs take complaints regarding research very seriously. In order to address your concerns, the IRS IRB will conduct an inquiry and I will follow-up with an email to you regarding their findings. Please do not hesitate to contact me if you have any questions.

Sincerely,
Steven Peckman Associate Director-Human Subjects Research Office for Protection of Research Subjects University University of California, Los los Angeles 310.825.5344 (v) 310.794.9565(f) 310.794.9565 (f) speckman@oprs.ucla.edu Original Message-----OriQinalMessage----From Fronrr * ^ * B ^ ^ M * M Sent: Tuesday, October 01, 2002 9:53 PM To: speckman@oprs.ucla.edu speckman@oprs.ucla.edu Subject: UCLA-Heimlich China AIDS Research Steven Peckman, Associate Director Human Subjects Research Office for the Protection of Research Subjects University Los Angeles University of California los 10945 10945 LeConte Ave., suite 2107 Los Angeles, CA 90095 Dear Mr. Peckman: This is a significantly-abbreviated Significantly-abbreviated version of a full-length letter to you. My complete letter, along with considerable supporting documentation documentation and a contact list, may be found at the following web address:

.._

_ .. A serious matter has been brought to my attention' attention _ .... UCLA. UCLA. This letter is to express my concern regarding UCLA's support and participation participation in experimental AIDS research trials using human subjects that have been carried out in Guangzhou, China, since 1994.
l 1

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

As your your office conducted As office must must be aware, aware, these these experiments experiments have have been been conducted under the the direction direction of Dr. Henry Henry J. Heimlich, known known for for the the Heimlich Heimlich under J. Heimlich, maneuver, with with the the participation participation of two two UCLA UCLA researchers, researchers, Dr. John John maneuver, Fahey and L. Fahey and Dr. Najib Najib Aziz. Aziz. A former former UCLA UCLA postdoctoral postdoctoral student, student, Dr. Xiao Ping Ping Chen, Xiao Chen, is the the project project director director in China. China. At least least three scientific At three clinical clinical trials trials have have taken taken place place and and three three scientific articles have submitted to international conferences articles have been been submitted international AIDS AIDS conferences describing the papers acknowledge acknowledge the participation describing the research. research. These These papers the participation of Drs. Drs. Fahey Fahey and and Aziz Aziz and and the the use use of UCLA UCLA laboratories, laboratories, as well well as the financial financial support support of Dr. Fahey. Fahey. the Meanwhile, Dr. Heimlich, Heimlich, the the Heimlich Heimlich Institute, Institute, and Deaconess Meanwhile, and Deaconess Hospital promote Hospital Associations, Associations, all of Cincinnati, Cincinnati, Ohio, Ohio, aggressively aggressively promote and fundraise fundraise for this this work work and and enthusiastically enthusiastically tout tout their their and affiliation with with UCLA UCLA and and Dr. Dr. Fahey. Fahey. affiliation Thorough substantiating documents documents may may be found Thorough details details and and all substantiating found at the web web address above. Thank Thank you you for for continuing continuing this this letter letter the address given given above. online. online. respectfully urge urge UCLA, UCLA, Dr. Dr. Fahey, Fahey, and and Dr. Dr. Aziz Aziz to to reconsider reconsider I respectfully their participation experiments and and to sever ties their participation in these these shameful shameful experiments sever ties with them. them. I also also request request that that UCLA UCLA make make an immediate immediate statement statement with regarding its participation participation in this this work work and and to fully all regarding fully disclose disclose all financial and scientific scientific records records associated associated with experiments. financial and with these these experiments.
In order order to protect protect my privacy privacy _-^"^ submitting this letter under under a pseudonym. submitting this letter pseudonym.

I am lam

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

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

..

__

cc: Dr. Albert Carnesale, Chancellor UCLA UCLA Dr. Irvin S.Y. Chen, Director UCLA AIDS Institute Dr. Jeffrey Jeffrey F. Miller, Chairman UCLA Microbiology, Microbiology, Immunology Immunology & Molecular Genetics Dept. Janet M. Young, Ph.D, Program Officer Division Division of AIDS National Institute of Allergy and Infectious Disease National Institutes of Health Ann Namkung, M.P.H.,
2

Division and Infectious Infectious Division of AIDS AIDS National National Institute Institute of Allergy Allergy and Disease National Health Disease National Institutes Institutes of Health James L. James L Pahls, Pahls, Chairman, Chairman, Deaconess Associations Deaconess Associations Inc. Inc. & Board Member, The Heimlich Institute Dr. Charles Bernstein, Chairman Deaconess Hospital Ethics Committee Andrew Signorile, Chairman The Eleanor Naylor Dana Charitable Trust Drs. Sidney Wolfe & Peter Lurie, Directors Public Citizen, Health Research Group Shang Chuan, President UCLA Association of Chinese-Americans Victor Zhenyu Liu, President UCLA Chinese Students and Scholars Association Vern Leong, President University of Cincinnati Asian-American Association Association Carl Eriksson UCLA International International Health Interest Group Dr. Leonard Madu, Director Pan Africa AIDS Conference 2002 PanAfrica

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Borror, Kristina Kristina

From: From: Sent: To:

Schwetz, Bernard A
Wednesday, February 19, 2003 2003 8:24 8:24 AM Borror, Kristina; Lin, Melody; Carome, Michael

Subject: Subject: FW: AIDS Researchers Investigated Kristina-do Kristina--do we have anything to do with this study? Bern Original Message -----Original Message----From: From: Wood, Robert Robert D. (OS) (OS) Sent: Tuesday, February Sent: February 18, 18, 2003 2003 1:17 1:17 PM PM To: (FDA) To: Surgeon Surgeon General; Schwetz, Schwetz, Bernard Bernard A (FDA) Subject: FW: Investigated Subject: FW:AIDS Researchers ResearchersInvestigated

-----Original Message----Original Message __________ From:. I B M ^ . I,,^-B|B^0_____p^B""^l From: Sent: Tuesday, February Sent: February 18, 18, 2003 2003 12:42 12:42 PM PM To: (HHS/OS) To: Wood, Robert (HHS/OS); (HHS/OS); Halaska, Halaska, Terrell (HHS/OS) Subject: AIDS Investigated Subject: AIDS Researchers ResearchersInvestigated
Sunday, February 16, 2003 Sunday, February

Scientists l i n k e d to t o Heimlich Heimlich i nvestigated Scientists linked investigated Experiment infects infects AIDS patients patients in China with malaria
By Robert Robert Anglen Anglen The Cincinnati Enquirer Cincinnati Enquirer Two prominent Los Angeles AIDS researchers are being investigated for taking part in a controversial medical experiment with Cincinnati physician Henry Heimlich to infect AIDS patients in China with malaria. A medical oversight board at the University of California Los Angeles wants to know whether doctors John 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 nonprofit Heimlich Institute, which is partnered with Deaconess Hospital. (This (This is the same Dr. Heimlich who developed 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 been criticized by the Centers for Disease Control and the Food and Drug Administration and condemned by other health professionals 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 have asked Dr. Heimlich "to omit UCLA from all references relating to malaria studies or other Heimlich Institute research. Any claims of an affiliation with UCLA are inaccurate." But documents documents obtained by the Enquirer show the doctors have been active in the malaria experiments since 1996. Letters written by Dr. Fahey on UCLA stationary detail how doctors helped Dr. Heimlich Heimlich set up the experiments, analyzed data, provided chemical reagents, made multiple trips to the test locations in China, reviewed test protocols and offered to obtain funding through grants at UCLA.

[photo]

Dr. Heimlich

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"I greatly appreciated all of the data you shared with us on this visit," Dr. Fahey wrote to Chen Xiao Ping, the doctor overseeing the experiments for Dr. Heimiich Heimlich in China. "I want to assure you that we regard this as confidential information. My colleagues and I will gladly help with the analysis but not share it with others. You should report your result directly to Dr. Heimiich." Heimlich." Dr. Fahey forwarded this e-mail, dated Nov. 10, 1998, to Dr. Aziz and UCLA School e-mail.datedNov.10.1998.toDr.Aziz School of Medicine researcher Barbara Hered. In another letter Heimiich, dated Aug. 8, 1996, Dr. Fahey described the malaria experiments - called letter to Dr. Heimlich, malariotherapy - 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 in carrying out their studies," Dr. Fahey wrote. "Assistance with reagents and quality control samples for (test) measurements 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 detailing the contents of his letters to Dr. Heimiich Heimlich and Dr. Chen. Dr. Aziz also would not comment. Dr. Heimiich, Heimlich, who has credited Dr. Fahey for his support, says he has no idea why the doctors would say they are not 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 involved in the original work in China," Dr. Heimiich Heimlich says. "He is a renowned scientist involved in AIDS research. He asked to contribute. He did an excellent job." For years, Dr. Heimiich Heimlich has been criticized by state, federal and international health organizations over malariotherapy. Despite this, Heimiich Heimlich proudly continues his work in China and says he wants to expand malariotherapy to Africa. From his Cincinnati institute on Straight Street, the 83-year-old Dr. Heimlich Heimiich solicits private donations for malariotherapy research and distributes a quarterly newsletter about his work to "promote peaceful solutions to international problems." He is the father of Hamilton County Commissioner Commissioner Phil Heimiich. Heimlich. He often is at odds with medical professionals. One of his most public fights has been with the American Red Heimiich maneuver as the first response in drowning rescues instead Cross over the agency's refusal to adopt the Heimlich of traditional CPR. Dr. Heimiich Heimlich 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 in Nashville, 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 researcher and now a physician with Public Citizen's Health Research Group in Washington, D.C., calls the malariotherapy studies dangerous and unnecessary. Public Citizen is a 32-year-old, nonprofit group founded by consumer advocate Ralph Nader. The Health Research Group provides oversight concerning drugs, medical devices, doctors and hospitals and occupational health. It works to identify and ban unsafe or ineffective ineffective drugs, medical devices and procedures. "It is charlatanism of the highest order," Dr. Lurie says of malariotherapy. "It is exploiting the lack of decent medical care in China." Dr. Heimlich Heimiich began soliciting funds for malaria treatment of cancer, AIDS and Lyme disease in the late 1980s.

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with new maneuvers," Dr. Lurie Lurie says. "Many or most of them have not "Ever since then he's been coming up with worked. Some are incredibly grandiose."

Dr. Lurie included Dr. Heimlich's malariotherapy studies in a September 1997 New England Journal of Medicine article 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 several years 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" group called the Great Lakes College of Clinical Medicine. In 2000, an FDA compliance director described Dr. Heimlich's procedures as inadequate. He said the experiments would not be permitted in the United States, that researchers researchers failed to consider community attitudes in 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 Jane 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. Carlos Campbell, CDC's chief of malaria studies at the time, said there was no evidence to support Heimlich's conclusions. "No evidence currently exists to indicate that malaria infection would beneficially affect the course of HIV SUbstantiveconcerns infection," Campbell wrote. "In fact, substantive concerns have been raised regarding the possibility that malaria therapy could (worsen) the course of HIV infection." Los Angeles physician Paul Bronston, who serves as the national chair of the Ethics and Professional Policy Committee for the American College of Medical Quality, says there is still no evidence that the experiments have any 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 medical community. Dr. Heimlich contends the China experiments have proved that malaria works to combat AIDS. He says that malaria 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 above 1,000. When counts fall below 200, patients are considered to have full-blown AIDS. Dr. Heimlich says before being being treated with with malaria, eight male AIDS patients in China China had T-cell counts that ranged from 269 to 1,868. Two years after malariotherapy, the T-cell counts in those patients were 570 to 2,063. malariotherapy is safe and can be effective for HIV infected patients," Heimlich said said in "These results ... confirm malariotherapy his Pan Africa presentation. Both Dr. Lurie and Dr. Bronston say they are surprised that AIDS researchers researchers would continue to be involved in publicity and criticism that Dr. Heimlich receives. malaria experiments after all of the continued negative publicity UCLA officials acknowledge that Dr. Fahey and Dr. Aziz helped train Dr. Chen along with other international

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scholars. But officials say the doctors were limited to teaching methods for conducting and evaluating AIDS research 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 was not 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 the study in an acknowledgement paragraph or at the end of your manuscript," Dr. Fahey wrote. "You must understand that we want very much to see this study succeed but we think that we should not be among manuscript authors at this time." In 1999, Dr. Chen and Dr. Heimlich coauthored a report on the malaria experiments for the Chinese Medical Sciences 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 and Guangzhou, China. The Office for the Protection of Research Subjects at UCLA, which is responsible for reviewing research protocols and 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 received additional information, but will not comment about it. After being advised of the memos between Dr. Heimlich and Dr. Fahey, UCLA spokesman Max Benavidez issued a new statement Friday. It acknowledges the ongoing investigation and says: "UCLA reiterates that the university has never approved any research studies pertaining to malariotherapy malariotherapy for HIV." E-mail ranglentiSjcincinnati.com. E-mail at at [ang{_Q_I]_@s;Lncin@_ti._fQl_7],

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/rr"'- . LexisNexis LexisNexisCopyright 2003 2003 The The Times Times Mirror Mirror Company; Company; Los Los Angeles Angeles Times Times Copyright All Rights Rights Reserved Reserved All Los Angeles Angeles Times Times Los April 16, 16, 2003 2003 Wednesday Wednesday Home Home Edition Edition April SECTION: California California Metro; Metro; Part Part 2; Page Page 4; Metro Metro Desk Desk SECTION: LENGTH: 636 636 words LENGTH: HEADLINE: Researcher Researcher Violated Violated Rules, Rules, UCLA UCLA Says Says HEADLINE: BYLINE: Rebecca Rebecca Trounson Trounson and and Charles Charles Ornstein, Ornstein, Times Times Staff Staff Writers Writers BYLINE: BODY: BODY: A UCLA UCLA medical medical oversight oversight board board has has found found that that a a researcher researcher violated violated federal federal rules rules by by taking taking part part in in A controversial medical medical studies studies in in which which AIDS AIDS patients patients in in China China were were injected injected with with malaria-infected controversial malaria-infected blood. blood. university said said Tuesday Tuesday that the oversight oversight board board has has determined determined that microbiology microbiology professor professor John L. L. The university Fahey was indirectly indirectly involved involved with the experiments, which which seek seek to use the immune immune reaction reaction induced induced by by Fahey malaria as as a a possible treatment treatment for for AIDS. malaria The research effort effort was was sponsored sponsored by by Dr. Henry Henry Heimlich, Heimlich, founder founder of the the Heimlich Institute Institute and creator The anti-choking maneuver maneuver that that bears his name. The The malaria malaria studies studies are regarded regarded with skepticism skepticism by by of the anti-choking many AIDS researchers, who said the therapy therapy could harm harm already already ill patients patients by infecting infecting them with many another potentially deadly deadly disease. another by UCLA's institutional review board, board, which reviews medical experiments involving A statement issued by human subjects, subjects, found found that Fahey Fahey did not participate participate directly directly in the controversial controversial trials, but did, without human from the board, board, evaluate data and and biological biological samples brought brought to the university university by by a requisite permission from Chinese scientist. Chinese University administrators will review the findings findings to determine determine whether whether discipline is required, UCLA University spokesman Max Benavidez said. spokesman second UCLA researcher, Najib Najib Aziz, who was included included in the board's investigation, was not found found to A second Benavidez said. Aziz was working working "under "under Dr. Fahey's Fahey's purview," the spokesman have broken any rules, Benavidez said. "regrets the misunderstanding misunderstanding this matter has caused." caused." He said he In a statement Tuesday, Fahey said he "regrets involved in the so-called malariotherapy malariotherapy research in 1997, 1997, when he was training a became indirectly involved three-month program at UCLA. At that time, Chen was Chinese scientist, Xiao Ping Chen, during a three-month testing blood serum that was collected several years earlier from from patients he had treated in China with testing malariotherapy. malariotherapy. Fahey said that was "the only time specimens from from malariotherapy malariotherapy patients were at UCLA." Fahey

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Heimlich, however, however, appeared appeared undeterred undeterred by by the the controversy. controversy. He He recently recently announced announced that that he he is is working working Heimlich, with doctors doctors to to begin begin human human tests tests of of the the therapy therapy in in five five African African nations. nations. with In a a statement statement e-mailed e-mailed to to The The Times Times on on Tuesday, Tuesday, he he said said that that available available data data "indicates "indicates that that In malariotherapy offers offers a a safe, safe, promising promising and and inexpensive inexpensive way way to to help help the the millions millions of of people people suffering malariotherapy from AIDS AIDS throughout throughout the the underdeveloped underdeveloped world." world." from He said said he he was was "not "not aware aware if if Dr. Dr. Fahey Fahey followed followed the the proper proper procedures" procedures" in in his his work work at at UCLA. UCLA. "That "That is is He between Dr. Dr. Fahey Fahey and and UCLA," UCLA," Heimlich Heimlich said. said. between On his his institute's institute's Web Web site, site, Heimlich Heimlich has has credited credited UCLA UCLA for for its its support support of of the the research. research. On Chen participated participated in in 1997 1997 in in the the UCLA/Fogarty UCLAIFogarty AIDS AIDS international international training training and and research research program, Chen which provides provides training training in in AIDS AIDS control control to to visiting visiting scholars scholars from from developing developing countries. countries. Fahey Fahey then which visited Chen and other Fogarty scholars in China in 1998, but did not participate in their visited Chen and other Fogarty scholars in China in 1998, but did not participate in their research, UCLA officials officials have have said. UCLA That November, November, according to to e-mails e-mails obtained obtained by by the the Cincinnati Cincinnati Enquirer Enquirer and and first first reported reported in in February, February, That Fahey wrote to Chen to thank the Chinese researcher for sharing his data during the visit. Fahey wrote to thank the Chinese researcher for sharing his during the In the announcement Tuesday, Tuesday, UCLA's UCLA's review review board board said said Fahey Fahey had had violated violated federal federal regulations regulations and In UCLA policy for the protection of human subjects by not seeking approval from the university before before UCLA policy for protection of human by not seeking approval from allowing Chen to conduct conduct research research at UCLA. UCLA. allowing "The feeling feeling here is that Dr. Fahey Fahey made made an an honest honest mistake," mistake," said said Steven Steven Peckman, Peckman, UCLA's UCLA's associate "The director for for human human subjects subjects research. director "He has provided substantial assurances assurances of his compliance compliance in in the future," future," Peckman Peckman said. "He university reiterated reiterated that UCLA "has "has never never approved approved any research In the statement Tuesday, the university pertaining to malariotherapy studies studies for for HIV," HIV," the virus that causes AIDS. pertaining LOAD-DATE: April 16, 16, 2003 LOAD-DATE:

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from from the the AP AP wire wire service: service:

UCLA says researcher malaria trial trial researcher erred erred with AIDS malaria LOS ANGELES (Reuters) - A University of California at Los Angeles professor federal rules by professor violated federal participating in Chinese tests of a controversial AIDS therapy in which patients were infected with malaria, the university's medical review board said. UCLA Wednesday said microbiology professor Dr. John Fahey was indirectly involved in the clinical trials, evaluating data and biological samples brought from from China without prior approval -- a violation of federal federal regulations and UCLA policy for the protection of human research subjects. The Chinese trials, carried out from from 1993 1993 to 1996, were sponsored by Dr. Henry Heimlich, inventor of the famous anti-choking maneuver. Heimlich believes that inducing high malarial fevers fevers stimulates the immune system, but has said he is not sure Why. why. The method had drawn the ire of the medical establishment and AID advocates, who question the ethics of subjecting already ill people to another deadly disease. Heimlich, 83, told Reuters in a recent interview that doctors from from five African African countries were planning to initiate their own trials of the controversial therapy. UCLA said Fahey's involvement in the research will be reported to the U.S. Department of Health and Human Services, to the international research program used to fund fund his work and to the university's executive vice chancellor. UCLA official official were not immediately available to comment on whether Fahey would be penalized for his actions. Dr. Najib Aziz, another UCLA researcher investigated by the review board, was cleared of any violations. The review board said it has accepted Fahey's assurances that future future scholars and others under his direction will have appropriate approval before conducting research activities at UCLA or using UCLA property, resources, material or funding.