File One: Chronology of 2002/03 UCLA investigation of employees and the Heimlich Institute's "malariotherapy" experiments in China (documents obtained via public records request to UCLA); direct download at: http://db.tt/viY1LyWe

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(Certain files req. i the Adobe Acrobat reader, which may be downloaded for free.)
October 2,2002
Steven Peckman, Associate Director
Human Subjects Research
Office for the Protection of Research Subjects
University of California Los Angeles
10945 LeConte Ave., suite 2107
Los Angeles, CA 90095
Dear Mr. Peckman:
A matter serious matter has been brought to my attention by colleagues at UCLA. This letter is to express my
concern regarding UCLA's support and participation in experimental AIDS research trials using human
subjects that have been carried out in Guangzhou, China, since 1994. These experiments consist of giving
malaria to people already suffering from HIV and full-blown ADDS.
It is unclear how UCLA can maintain an Office for the Protection of Research Subjects, meanwhile
participating in ongoing offshore human experiments which have been denounced as medical atrocities by the
World Health Organization, Public Citizen, and prominent bioethics professionals. Yet numerous documents
indicate the participation of UCLA researchers, the use of school lab facilities, and the use of UCLA's name
for fundraising for this discredited work.
As your office must be aware, these experiments have been conducted under the direction of Dr. Henry J.
Heimlich, known for the Heimlich maneuver, with the participation of two UCLA researchers, Dr. John L.
Fahey and Dr. Najib Aziz. The project director in China is a former UCLA postdoctoral student, Dr. Xiao
PingjCJben.
At least three clinical trials have taken place and three scientific articles have been submitted to international
AIDS conferences describing the research. These papers acknowledge the participation of Drs. Fahey and
Aziz and the use of UCLA laboratories, as well as the financial support of Dr. Fahey.
Meanwhile, Dr. Heimlich, the Heimlich Institute, and DeacomsiiJlQspJta^jsmdatiflns, all of Cincinnati,
Ohio, aggressively promote and fundraise for this work and enthusiastically tout their affiliation with UCLA
and Dr. Fahey.
Since the early 1980s, Dr. Heimlich has advocated an experimental treatment which he calls
"malariotherapy," based on the theory that raising the body's temperature stimulates the immune system. To
accomplish this, malarial human blood is injected into patients to bring on a high fever, causing body
temperatures as high as 105 degrees. After several weeks of induced malarial fevers, the subject's malaria is
treated with medication.
At various times, Heimlich, who has no training or background in immunology, has promoted
"malariotherapy" as a multipurpose treatment to cure cancer, Lyme disease, and AIDS.
(As the source of his theories, Heimlich cites Austrian psychiatrist Julius Wagner-Jauregg. In the early 1900s,
Dr.Wagner-Jauregg advanced fever therapy as a cure for neurosyphilis in the days before antibiotics. In
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1927, he won the Nobel Prize for ti. .. work, although more recent researcn has questioned the reliability of
his studies and conclusions. Later in life, Wagner-.Iauregg became a Nazi eugenicist)
Heimlich has engaged in "malariotherapy" experiments outside of U.S. borders. According to an article in
the Cincinnati Post, "In December 1987, (Heimlich) treated three advanced cancer patients in a Mexico City
hospital by infecting them with malaria." In the early 1990s, Heimlich conducted additional human studies in
Mexico, this time injecting malarial blood into Americans suffering from Lyme disease. The Centers for
Disease Control warned against Heimlich's Lyme disease theory as ineffective and dangerous.
In the 1990s, Heimlich promoted "malariotherapy" for Lyme disease in numerous articles in the popular
press. However, Heimlich's current fundraising materials and web site contain no mention at all of Lyme
disease. The outcome of Heimlich's Lyme disease and cancer patients is unknown and no information is
presented in his current online materials. Searches on Medline and PubMed produced no journal articles on
his "malariotherapy" trials for Lyme disease or cancer. It is unknown whether Heimlich continues to
advocate "malariotherapy" for Lyme disease or if he has chosen to drop that disease from his list
In the early 1990s, Heimlich proposed that induced malaria should be tested as a treatment for AIDS. On
April 29,1993, the Centers for Disease Control issued a public health alert which stated "the use of induced
malaria infection in HIV-infected individuals cannot be justified." A 1994 article in the Los Angeles Times
described in detail Heimlich's methods and fundraising. The article also included critical comments from
AIDS experts such asTJr. Anthony Fauci from the National Institutes of Health who called Heimlich's
malaria treatments "quite dangerous and scientifically unsound." (This article also contained angry
comments from American Lyme disease patients who had undergone Heimlich's "malariotherapy" in
Mexico.)
The China "malariotherapy" experiments using HIV-positive subjects have been ongoing since the mid-1990s
and appear to be growing more extreme. The most recent "malariotherapy" research paper states that
malaria had been induced in a patient with full-blown AIDS who was suffering from additional
complications:
Case 12 was a full-blown AIDS patient with complicated ulcer of external genitalia, pneumocystis carinii pneumonia
(PCP, clinical diagnosis) with dispnea, needed oxygen inhalation. (From "Impact of Acute Vivax Malaria on the
Immune System of HIV-Positive Subjects" by Chen et al, 2001, which acknowledges the participation of Drs.
Heimlich, Fahey, and Aziz.)
The Heimlich Institute is a nonprofit corporation promoting Heimlich's work and is a member organization
of Deaconess Associations Inc., a hospital and health care services provider in Cincinnati. The China malaria
experiments, along with the participation of UCLA and Dr. Fahey, are promoted on the Heimlich Institute
web site, in interviews with Heimlich, and in online fundraising newsletters for the Heimlich Institute.
From the Heimlich Institute web site:
Our clinical studies in China continue to prove the benefits that malariotherapy has for HIV patients and to elucidate the
interaction of malaria with HIV. To this end, the Heimlich Institute is working in conjunction with UCLA, gathering and
analyzing data to show what immunological factors are responsible for the benefits derived from malariotherapy for HIV.
From a 1998 interview with Heimlich by Dr. John McDougall, a well-known advocate of so-called alternative
therapies:
Heimlich: We have an AIDS project now in China..We presented the results in 1996 at the National Institutes of Health
and then at the AIDS Conference in Vancouver. As a matter of fact, UCLA has just joined with us in this project.
(later in the interview) McDougall: Can you say (the patients) are cured?
Heimlich: We can say that the immune cells, which fight off the virus in AIDS, but ordinarily gradually diminish year
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after year, have increased and stay eased. Now, with UCLA working with us doing viral loads, measuring the actual
virus, within the next five to six months, we should know that answer. The patients are in China, the blood is being
analyzed at UCLA. We want to treat the next 100 patients immediately. We are now seeing funds, grants, to do that
From "Caring World," the Heimlich Institute's online fund raising newsletter, Fall 1999:
HOW YOU CAN HELP SAVE LIVES: MALARIOTHERAPY RESEARCH TO TREAT HIV/AIDS ($1.2 MILLION)
Since 1994, Dr. Heimlich and his colleagues at the University of California at Los Angeles (UCLA) have been piloting
the use of malariotherapy as a potential cure for HIV infection...To date, 18 patients are in various stages of
malariotherapy treatment. Follow-up data collected shows a substantial increase in CD-4 T~cell levgls, and patients have
remained asymptomatic for more than three years. The malariotherapy treatment takes only three weeks and no
additional treatment has been required. To validate and replicate these findings, Dr. Heimlich's research team requires
support that will enable them to offer this potentially invaluable treatment to additional patients. At $10,000 per patient,
$1,200,000 would provide funds to test another 120 patients, and validate the use of malariotherapy to treat HIV.
In 1996, Professor John Fahey, of UCLA, asked to join the Heimlich Institute in this research project. UCLA is currently
conducting our laboratory studies. Having recently returned from visiting our colleagues in China, Dr. Fahey is very
positive about the results of these three-year clinical studies....The Heimlich Institute plans to extend malariotherapy to
the treatment of cancer and other diseases that may be curable by strengthening the immune system.
From "Caring World," Winter 1998:
After Dr. Heixnlichrpreiented the Heimlich Institute's results of treatment at the National Institutes of Health (NIH) and
at the XI International Conference on AIDS in Vancouver, UCLA requested to join the Heimlich Institute in this project.
Since then, the Heimlich Institute and our colleagues in China are working closely with John L. Fahey, MD, director for
the Center for Interdisciplinary Research in Immunology and Disease at UCLA. Dr. Fahey's laboratories are carrying
out independent verification of the immunological results obtained in China as well as providing technical support.
Recently, Dr. Fahey visited Dr. Chen and found patients' treatment progressing extremely welL
Dr. Fahey and Dr. Aziz's contributions to the Chinese "malariotherapy" projects are also acknowledged in
the following scientific articles:
From Chen, Heimlich, et al: "Phase-1 Studies of Malariotherapy for HIV Infection" Chinese Medical
Sciences Journal, Dec. 1999,
p.228
Acknowledgments - Many special thanks are given to Dr. John L. Fahey for providing a part of financial support,
suggestions, and comments, to Dr. Najib Aziz, Dr. Pari Nishanian, and Mrs. Haripi Nishanianfor many helps in testing
ofcytokine, activation markers, and HIV P24 antigen.
p,225
HIV P24 antigen (immuno-complex dissociation method, abbreviated to ICD, Coulter Corporation, USA) were measured
by ELISA in the University of California at Los Angeles (UCLA), USA
From Chen et al: "Impact of Acute Vivax Malaria on the Immune System of HIV-Positive Subjects"
Presented at 6th International Conference on AIDS in Asia and the Pacific, Melbourne, Australia, Oct. 5-11,
2001
Acknowledgments - Our special thanks should be given to Dr. John L Fahey for his helps (sic) in research design,
generous donation of reagents for flow cytometry and cytokine quality control measurement and for review of the
manuscript to Dr. Naji Aziz for technological guidance ofcytokine measurement; both work at Center for
Interdisciplinary Research in Immunology and Disease, Departments of Medicine and of Microbiology and Immunology,
UCLA School of Medicine, Los Angeles.
On his web site, Heimlich states that he obtained institutional review board approval for these experiments:
Institutional Review Board approval was obtained for this study...Informed consent to participate in this clinical
prospective study of malariotherapy for HIV infection was obtained.
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The facts are not so simple. In Ma .994, for his first experiments in China, Heimlich obtained Institutional
Review Board (IRB) approval from the Great Lakes College of Clinical Medicine (GLCCM), a center for so-
called "alternative health" therapies, with whom Heimlich had close ties. On March 9,2000, The Food and
Drag Administration (FDA) issued a 14 page warning letter to GLCCM. This letter detailed a variety of IRB
procedural failures and prohibited the GLCCM IRB from approving new studies and from adding new
subjects to ongoing studies.
Heimlich states that he obtained informed consent from the research study's Chinese subjects. Yet a number
of the FDA criticisms of the GLCCM IRB were directed at whether these subjects in Heimlich's China
" malariotherapy" studies were adequately informed before providing their consent to participate in the
study. From the FDA's warning letter to GLCCM:
The consent form does not adequately describe the procedures to be followed. The actual procedure involves injection of
blood from a malaria-infected person into the study subjects. There is no description of the steps taken to screen malaria
parasite donors for pathogens.
The duration of the study is described as "unlimited " The longterm risks of the study and the frequency of follow up are
not defined.
The risks of receiving blood from another person are not described. The possibility of receiving blood-borne pathogens is
not discussed. . -
There is no description of the consequences of a subject's decision to withdraw from the research, such as during the
stage of malaria infection.
There is no description of the lifelong risks associated with malarial infection, other than ruptured spleen and death.
The consent form lacks the identity of whom to contact in the event of research-related injury to the subject.
The consent form lacks an explanation of whom to contact for answers to questions about research subjects' rights.
Use of the wording "You understand,.." is inappropriate. The subjects may certify that they understand the statements in
the consent form and are satisfied with the explanation provided by consent process, but many will not comprehend the
underlying scientific and medical significance of all the statements, nor are they in a position to judge whether the
information provided is complete. Subjects should not be required to certify such understanding or completeness of
disclosure.
The consent form contains exculpatory language in which the prospective subject is made to waive or appear to waive any
of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents
from liability for negligence.
Heimlich responded to the FDA criticisms in a May 4.2000 letter, obtained through the Freedom of
Information Act. In his letter, among other criticisms, Heimlich challenges the FDA's authority as well as
accusing the FDA investigator of "ethnic bias" for questioning the conditions under which Chinese research
subjects were injected with malaria.
Heimlich also states:
In 1996, following presentations at the NIH (Bethesda, MD) and the 12th World AIDS Conference (Vancouver), a
leading AIDS authority, a professor from a major U.S. university's immunology department, asked to join this effort.
Their doctors also made regular trips to the research site in (FDA redaction) to provide independent
evaluation of the quality of research being done by our colleagues in . They also provided independent
corroboration of the results from .
Heimlich's previously cited quote from "Caring World" makes it reasonably certain that he was referring to
UCLA and Dr. Fahey. Here, in his letter to a federal agency, Heimlich claimed these affiliations in order to
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legitimize his proj ect
I n May 2000, GL CCM termi nated I RB approval of Heunlich's project and, shortly thereafter, the GL CCM
I RB itself ceased operation. None of this information is provided on the Heimlich I nstitute or Deaconess web
sites. As cited above, the Heimlich I nsti tute web site continues to advertise that his study has IRB approval ,
despite havi ng lost this approval over two years ago.
Meanwhile, criticism of the Heimlich-UCLA "mal ari otherapy" experi ments by the legitimate medical
community has not been timid, both in the US and abroad.
From the New England J ournal of Medi ci ne, September 18,1997:
Acceptance of a standard of care that does not conform to the standard in the sponsoring country results in a double
standard in research. Such a double standard, which permits research designs that are unacceptable in the sponsoring
country, creates an incentive to use as research subjects those with the least access to health care. What are the potential
implications of accepting such a double standard? Researchers might inject live malaria parasites into HIV positive
subjects in China in order to study the effect on the progression of HIV infection, even though the study protocol had
been rejected in the United States and Mexico. (Citation: Heimlich HJ, Chen XP, Xiao BQ, et aL CD4 response in HIV
positive patients treated with malaria therapy. Presented at the llth International Conference on AIDS, Vancouver, B.C.,
July 7-12,1996. abstract)
From a 1999 letter tothe Worl d Medical Association from Drs. Peter Luri e and Sidney Wolfe of Public
Citizen:
We are writing to express alarm at the current draft revised version of the Declaration of HelsinkL...The proposed
Declaration is stunningly complacent. There seems to be no recognition of recent abuses in international research (e.g.,
Dr. Henry Heimlich's injection of live malaria into HIV-positive persons in China after the study was opposed in the
United States, (and) the well-documented failings of Institutional Review Boards (IRBs)....
From "Human Subject Research. Ethics and the Developing Worl d" by Dr. Farhat Moazam, Aga Khan
University Hospital, Karachi :
In another study in 1997, patients with HIV infection were deliberately inoculated with plasmodium vivax to produce
symptomatic malaria. The objective was to study the effects on their immune systems. This was a collaborative research
undertaken by two hospitals in China and the Heimlich Institute in Cincinnati As part of the protocol, subjects could not
participate in any HIV therapy for the duration of the study and the follow-up period. Institutional Review Boards of the
host country had approved the research as ethical, something that would have been highly unlikely if the study had been
undertaken in the sponsoring country.
From "Ethics in International Health Research: A Perspective from the Developing World." by Dr. Z.
Ahmed Bhutta, World Health Organization Working Paper Report, Commission on Macroeconomics and
Health, 2002:
The fact remains that doctors are every bit as human or inhuman as other inhabitants on this planet and come in all
shades and colors. The recent guidelines for regulation of human experimentation must be seen in the backdrop of
atrocities committed by doctors upon vulnerable subjects within recent memory. The highly controversial trials of
induction of malaria in HIV patients (Heimlich et al 1997) and the trovafloxacin trial in Nigeria (Boseley 2001, Stephens
2000 & 2001) are two recent examples. Few also recognize that Radovan Kradzik, who stands accused of master minding
the worst possible mass genocide in Europe in the post second world war era, is also a psychiatrist by training. Thus the
regulation of human subjects research would require more than an appeal to basic human good and abject faith in the
beneficence of the medical profession.
Clearly unscrupulous and opportune research which exploits the vulnerability and want of a given population, must be
condemned. The case of the Trovan drug trial in the midst of a meningitis outbreak in Nigeria (Stephens 2000) and the
induction of malaria in HIV patients ( Heimlich et al 1997) are examples where the need for ethical guidelines and
minimal universal ethical standards for research becomes absolute.
From "I nternati onal Research Ethics Guidelines Under Threat" Udo Schuklenk, I ssues in Medical Ethics,
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J uly-September 1999:
A number of international clinical research efforts have disregarded the currently applicable international research
ethics guidelines in vital respects. More than once, researchers have been caught red-handed and often red-faced by an
alert international community of activists, concerned medical professionals and bioethicists. Unfortunately, the powerful
US bioethics community's response has been to propose further dilutions of ethical standards in research instead of
improving the standards of research clinical trials undertaken in developing countries. A US-based researcher, Henry
Heimlich, injected live malaria parasites into HFV-infectedpeople in the People's Republic of China after his research
proposal was denied approval in the USA. This contravened CIOMS guidelines requiring that western researchers in
developing countries provide clinical care meeting the standards of care in their home country.
UCLA cannot be unaware of the discrimination facing AIDS patients in China. Having AIDS in China brings
with it a terrible stigma. Those infected with HIV and AIDS are often rejected by their families and
ostracized by their community. Medical care is either unavailable or of poor quality. These are terribly
vulnerable people. Under these circumstances, protecting the rights of experimental research subjects
becomes that much more crucial.
Are Heimlich and his colleagues adequately protecting the rights of their subjects? If the FDA criticisms of
the GLCCMIRB and their consent forms are any indication, that protection is in doubt Furthermore,
injecting malaria into people already sick with another disease, meanwhile denying them access to other
AIDS treatments, is reminiscent of the Tuskegee syphilis research atrocities. Yet, according to Heimlich.
Chen, et al. denying-other treatments to their Chinese research subjects was a condition of participation in
their study:
Criteria for acceptance included asymptomatic HIV infection, absence of other concurrent infections and willingness to
not participate in other HIV therapies for duration of the treatment and follow-up period. (Emphasis added)
Staging such experiments in the United States or in any developed country is unimaginable. Not only would
the research be condemned immediately, but the organizers would be discredited and held legally
accountable. However, when it comes to these research subjects in China, it is a different story.
International criticism of these experiments has not affected fundraising for "malariotherapy." From the
Deaconess web site:
With your support, the Heimlich Institute can continue its important research into treatment for HIV/AIDS, cancer,
cystic fibrosis, asthma and many other health conditions. We already have evidence that these methods work, but further
studies are needed to substantiate these procedures and treatments. The Institute, which is a non-profit organization,
depends on funds from free-thinking individuals and organizations to continue its commitment to saving lives.
A visitor to the Heimlich Institute/Deaconess web sites, which are linked together, would have to go elsewhere
to learn about the condemnation that has greeted the Heimlich malaria experiments. It appears not even
potential donors are entitled to informed consent.
Given the nature of these studies, it is startling that this work is being used as a fundraising vehicle. For a
major hospital and health services provider to do so places that institution in conflict with its fundamental
purpose, which is to provide medical care. And Deaconess cannot claim any separation from the Heimlich
fundraising since all funds raised by the Heimlich Institute are directly paid to Deaconess.
For UCLA to lend its name and credibility to the fundraising by Heimlich and Deaconess since 1994 is
incomprehensible. How much money has been raised to carry on these grotesque experiments? Also, the 1999
paper by Chen, Heimlich, et al, states: _
Funding for this study was provided by Eleanor Dana Charitable Trust, David Mahoney, Chairman.
Was UCLA involved in obtaining the Dana Trust funding? And, since Dr. Fahey has been acknowledged as
providing financial support, are UCLA funds being used to finance these research trials? Are California
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taxpayers aware that their public t.versity is affiliated with medical atrocity experiments?
Heimlich is now expanding his "malariotherapy" trials into Africa. (See "Caring World," Spring 99.
Summer 01). At the end of this month, he is making a keynote presentation at the PanAfrica AIDS
Conference in Nashville, Tennessee. Is UCLA partnering with Heimlich's "malariotherapy" experiments on
desperate African AIDS patients?
It goes without saying that the global AIDS emergency calls for creative responses by the medical community.
Yet this very urgency has created opportunities for the exploitation of vulnerable populations by researchers
whose ambition may blur their ethical judgement
That human experiments of this kind were conceived, let alone carried out, is reason enough to justify the
need for strict international research standards and oversight The fact that a leading American university
and a major hospital continue to participate in such notorious work, long after that work has been
overwhelmingly denounced, only reinforces that need.
I respectfully urge UCLA, Dr. Fahey, and Dr. Aziz to reconsider their participation in these shameful
experiments and to sever ties with them. I also request that UCLA make an immediate statement regarding
its participation in this work and to fully disclose all financial and scientific records associated with these
experiments.
In order to protect my privacy and that of my colleagues, I prefer to submit this letter under a pseudonym.
Thank you for your attention to these concerns. I look forward to your reply.
Sincerely,
"Dr.
Bob
Smith"
email:
bek
smith@volny.cz
voicemail
&
FAX:
(978)
477-
8349
cc: Dr. Albert Carnesale, Chancellor
UCLA
Dr. Irvin S.Y. Chen, Director
UCLA AIDS Institute
Dr. Jeffrey F. Miller, Chairman
UCLA Microbiology , Immunology & Molecular Genetics Dept.
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Janet M. Young, Ph.D, Progi. ^1 Officer, Division of AIDS National institute of Allergy and
Infectious Disease
National Institutes of Health
Ann Namkung, M.P.H., Division of AIDS National Institute of Allergy and Infectious Disease
National Institutes of Health
James L. Pahls, Chairman,
Deaconess Associations 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
Carl Eriksson
UCLA International Health Interest Group
Dr. Leonard Madu, Director
PanAfrica AIDS Conference 2002
CONTACT LIST
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Peckman, Steven
Peckman, Steven
Friday, October 04, 2002 10:25 AM
Brookshire, J udith
'Roberto Peccei'; 'Daniel Neuman'; 'Robert Figlin'; 'Carmine Clemente'
FW: Letter prepared by "Dr. Bob Smith-
High
Chi na AI DS Resea. . .
FYI r egar di ng t he at t ached emai l ,
St even Peckman
As s oci at e Di r ect or - Human Subj ect s Resear ch
Of f i ce f or Pr ot ect i on of Res ear ch Subj ect s
Uni ver si t y of Cal i f or ni a, Los Angel es
310. 825. 5344 ( v)
310. 794. 9565 ( f )
speckmanOopr s. ucl a. edu
Or i gi nal Message
Fr om: Fahey, J ohn [ mai l t o: J LFahey@mednet . ucl a. edu]
Sent : Thur sday, Oct ober 03, 2002 1: 14 PM
To: Peckman, St eve; I r vi n S. Y. Chen ( E- mai l ) ; Az i z , Naj i b ( BOL) ; Xi ao
Pi ng Chen ( E- mai l ) ; Al ber t Car nesal e ( E- mai l ) ; Roger Det el s ( MD
( E- mai l ) ; J eanne McDer mot t ( E- mai l ) ; Schmi dt , El ai ne, - Mi l l er , J ef f F.
( BOL) ; J anet M. Young ( E- mai l ) ; Ann Namkung ( E- mai l ) ; Laur i e K. Doepel
( E- mai l ) ; Ral ph E. Wes l ey ( E- mai l ) ; Rober t S. Lawr ence ( E- mai l ) ;
Zul qui f ar A. Bhut t a ( E- mai l ) ; Kat hr yn Mont gomer y ( E- mai l ) ; Hyakudai
Sakamot o ( E- mai l ) ; Dar r yl R. J . Macer ( E- mai l ) ; Geor ges B. . Kut ukdj i an
( E- mai l ) ; St ephen Sodeke ( E- mai l ) ; J . H. Br yant ( E- mai l ) ; Fogar t y
I nt er nat i onal Cent er ( E- mai l ) ,- J er emy Ri f ki n ( E- mai l ) ; Shang Chuan
( E- mai l ) ; Vi ct or Zhenyu Li u ( E- mai l ) ; T. C. Lee ( E- mai l ) ; Ver n Leong
( E- mai l ) ; Er i ksson, Car l ; Gl enn McGee ( E- mai l ) ; Cat her i ne A. Mar co
( E- mai l ) ; Ar t hur Zucker ( E- mai l ) ; St uar t J . Youngner ( E- mai l ) ; Bar ney
Gr aham ( E- mai l ) ; ' bob- smi t h@vol ny. cz' ; Henr y J . Hei ml i ch ( E- mai l )
Subj ect : Let t er pr epar ed by " Dr . Bob Smi t h-
I mpor t ance : Hi gh
I have r ecei ved a l et t er pr epar ed by " Dr . Bob Smi t h" . I woul d pr ef er t o
r es pond di r ect l y t o a known i ndi vi dual r at her t han t o " Dr . Bob Smi t h" .
However , I wi l l say t hat I amnot i nvol ved i n t he mal ar i a st udy and no UCLA
f unds have been used t o suppor t t he mal ar i a st udy of Dr . Hei ml i ch. I f t he
st at ement s at t r i but ed t o Dr . Hei ml i ch ar e cor r ect , t hen t hey ar e
mi sr epr esent at i ons and I wi l l ask Dr . Hei ml i ch t o cease usi ng my name and
t hat of UCLA i n t hat manner .
Si ncer el y,
J ohn L. Fahey, MD
From:
Sent:
To:
Cc:
Subject:
Importance:
UCLA-Heimltch
4
Peckman, Steven
From: Brookshire, J udith
Sent: Friday, October 04, 2002 11:11 AM
To: Peckman, Steven
Subject: Message from Levey and Robinson
Importance: High
J ust to let you know - they called again to see what we have found out and asked again if we could do this asap. i told
them that in order to thoroughly look into this it would take some time, i suggested they talk to dr fahey and forwarded his
email to them (their request) with a cc to fahey
Peckman, Steven
From: Brookshire, J udith
Sent: Friday, October 04,2002 3:17 PM
To: Daniel Neuman (E-mail); Roberto Peccei (E-mail); 'Levey, Gerald'; Alan Robinson (E-mail)
Cc: Robert Figfin MD (E-mail); Carmine Clemente (E-mail); Peckman, Steven
Subject: Allegation Letter from "Dr. Bob Smith"
Importance: High
The response to and review of the allegation letter of October 2, 2002 from "Dr. Bob Smith" will take some time. We are
reviewing the citations, articles, etc., as well as the documentation that we have on file. In order to respond completely to
each of the allegations, the IRB will have to ask Dr. Fahey defined and specific questions (e.g., did he receive sample
tissues from the research, etc.). By taking a proactive and comprehensive approach, we will be in a much better position
to answer the inquiries that are certain to follow from the feds.
At this point, however, we don't believe there is any substance to the allegations, but the IRB will have to provide a
complete review of all allegations before a determination can be made and a response drafted to the complainant, federal
agencies and others cited in the cc list.
We will contact you as soon as we have information and a determination is made.
J udy
Judith L. Brookshire, Director
Office for Protection of Research Subjects
University of California, Los Angeles
(310)825-8714
jbrook@oprs.ucla.edu
Subject: Letter prepared by "Dr. Bob Smith"
From: "Fahey, J ohn" <J LFahey@mednet.ucla.edu>
Dat e: 10/3/2002 4:14 PM
To: "Peckman, Steve" <speckman@oprs.ucla.edu>, "Irvin S. Y. Chen (E-mail)" <rtaweesu@ucla.edu>, "Aziz,
Najib (BOL)" <naziz@ucla.edu>, "Xiao Ping Chen (E-mail)" <chenxping@netease.com>, "Albert Carnesale (E
mail)" <chancellor@conet.ucla.edu>, "Roger Detels (MD (E-mail)" <detels@ucla.edu>, "J eanne McDermott (E
mail)" <mcdermoj@mail.nih.gov>, "Schmidt, Elaine" <elaines@support.ucla.edu>, "Miller, J eff F. (BOL)"
<jfmiller@ucla.edu>, "J anet M. Young (E-mail)" <jy6r@nih.gov>, "Ann Namkung (E-mail)" <an107z@nih.gov>,
"Laurie K. Doepel (E-mail)" <niaidnews@niaid.nih.gov>, "Ralph E. Wesley (E-mail)" <treemont@aol.com>,
"Robert S. Lawrence (E-mail)" <rlawrenc@jhsph.edu>, "Zulquifar A. Bhutta (E-mail)"
<zulfiqar.bhutta@aku.edu>, "Kathryn Montgomery (E-mail)" <kmontgomery@nwu.edu>, "Hyakudai Sakamoto
(E-mail)" <sakamoto@chs.nihon-u.ac.jp>, "Darryl R. J . Macer (E-mail)" <Macer@sakura.cc.tsukuba.ac.jp>,
"Georges B. Kutukdjian (E-mail)" <g.kutukdjian@unesco.org>, "Stephen Sodeke (E-mail)"
<femisodeke@tubioethics.org>, "J . H. Bryant (E-mail)" <cioms@who.ch>, "Fogarty I nternational Center (E
mail)" <ficinfo@nih.gov>, "J eremy Rifkin (E-mail)" <jrifkin@foet.org>, "Shang Chuan (E-mail)"
<swc@ucla.edu>, "Victor Zhenyu Liu (E-mail)" <vicliu@ucla.edu>, "T. C. Lee (E-mail)" <tclee@uceng.uc.edu>,
"Vern Leong (E-mail)" <leongC@email.uc.edu.com>, "Eriksson, Carl" <eriksson@ucla.edu>, "Glenn McGee (E
mail)" <mcgee@bioethics.net>, "Catherine A. Marco (E-mail)" <cmarco2@aol.com>, "Arthur Zucker (E-mail)"
<zuckera@ohio.edu>, "Stuart J . Youngner (E-mail)" <sxy2@po.cwru.edu>, "Barney Graham (E-mail)"
<bgraham@mail.nih.gov>, "'bob-smith@volny.cz'" <bob-smith@volny.cz>, "Henry J . Heimlich (E-mail)"
<heimlich@iglou.com>
I have r ecei ved a l et t er pr epar ed by " Dr . Bob Smi t h" . I woul d pr ef er t o
r espond di r ect l y t o a known i ndi vi dual r at her t han t o " Dr . Bob Smi t h" .
However , I wi l l say t hat I amnot i nvol ved i n t he mal ar i a st udy and no UCLA
f unds have been used t o suppor t t he mal ar i a st udy of Dr . Hei ml i ch. I f t he
st at ement s at t r i but ed t o Dr . Hei ml i ch ar e cor r ect , t hen t hey ar e
mi sr epr esent at i ons and I wi l l ask Dr . Hei ml i ch t o cease usi ng my name and
t hat of UCLA i n t hat manner .
Si ncer el y,
J ohn L. Fahey, MD
Subject: RE: UCLA-Heimlich China AIDS Research
From: "Peckman, Steven" <SPECKMAN@OPRS.UCLA.EDU>
Dat e: 10/9/2002 11:38 AM
To: "'bob-smith@volny.cz'" <bob-smith@volny.cz>
CC: "Albert Carnesale (E-mail)" <chancellor@conet.ucla.edu>, "Irvin S. Y. Chen (E-mail)"
<rtaweesu@ucla.edu>, "Miller, J eff F. (BOL)" <jfmiller@ucla.edu>, "'J LFahey@mednet.ucla.edu'"
<J LFahey@mednet.ucla.edu>, "Aziz, Najib (BOL)" <naziz@ucla.edu>, "J anet M. Young (E-mail)"
<jy6r@nih.gov>, "Ann Namkung (E-mail)" <an107z@nih.gov>, "Fogarty I nternational Center (E-mail)"
<ficinfo@nih.gov>, "Victor Zhenyu Liu (E-mail)" <vicliu@ucla.edu>, "Vern Leong (E-mail)"
<leongC@email.uc.edu.com>, "Eriksson, Carl" <eriksson@ucla.edu>, "Shang Chuan (E-mail)" <swc@ucla.edu>,
"Henry J . Heimlich (E-mail)" <heimlich@iglou.com>
Dear " Dr . Bob Smi t h" ,
On behal f of t he Uni ver si t y of Cal i f or ni a, Los Angel es ( UCLA) , Of f i ce f or
Pr ot ect i on of Resear ch Subj ect s ( OPRS) , I t hank you f or t he emai l r egar di ng
Dr s . Fahey and Azi z. The OPRS suppor t s f eder al l y mandat ed human r esear ch
r evi ew commi t t ees cal l ed I nst i t ut i onal Revi ew Boar ds ( I RBs ) . The char ge of
t he I RB i s t o ensur e t he pr ot ect i on of t he r i ght s and wel f ar e of al l human
subj ect s par t i ci pat i ng i n UCLA r esear ch. I assur e you t hat t he UCLA and our
I RBs t ake compl ai nt s r egar di ng r esear ch ver y ser i ousl y.
I n or der t o addr ess your concer ns, t he I RB wi l l conduct an i nqui r y and I
wi l l f ol l ow- up wi t h an emai l t o you r egar di ng t hei r f i ndi ngs. Pl ease do not
hesi t at e t o cont act me i f you have any quest i ons.
Si ncer el y,
St even Peckman
Associ at e Di r ect or - Human Subj ect s Resear ch
Of f i ce f or Pr ot ect i on of Resear ch Subj ect s
310. 825. 5344 ( v)
310. 794. 9565 ( f )
speckman@opr s. ucl a. edu
Peckman, Steven
From:
Sent:
To:
Cc:
Subject:
Importance:
Sensitivity:
Peckman, Steven
Wednesday, October 09, 2002 2:15 PM
'Fahey, J ohn'
Brookshire, J udith
Allegations regarding Malariotherapy
High
Confidential
fahey inquiry UCLA-Heimlich
021OO8.doc China AIDS Resea...
Dr . Fahey,
At t ached pl ease f i nd cor r espondence r el at ed t o t he I RB i nqui r y of t he al l egat i ons made by
"Dr . Bob Smi t h". Pl ease do not hesi t at e t o cont act me i f you have any quest i ons.
Si ncer el y,
St even Peckman
310. 825. 5344 (v)
310. 794. 9565 (f )
speckraan@oprs . ucl a. edu
DIVIDER
jp
K MEMORANDUM
OFFICE FOR PROTECTION OF RESEARCH SUBJECTS
2107 Ueberroth Building
169407
October 31, 2002
TO: Medical Institutional Review Board 2 (MTRB2)
FROM: Steven Peckman, Associate Director-Human Subjects Research
RE: Complaint About Human Research Collaboration on Malariotherapy
John Fahey, MD
[REVIEWERS: Clemens & M.A. Allen]
The Office for Protection of Research Subjects (OPRS) received an allegation of non-compliance
with human research regulations regarding the above referenced research. Dr. Fahey responded
to the allegations.
The MIRB2 review of the allegations and Dr. Fahey's response is scheduled for November 6,
2002. Please do not hesitate to contact me if you have any questions.
Enclosures: 1. Staff Evaluation of Dr. Fahey's response (001)
2. S. Peckman's October 8,2002 letter to Dr. Fahey (009)
attachments
a. October 2,2002 letter from "Dr. Bob Smith". (014)
b. Henry Heimlich May 4,2000 correspondence to Jane Henney, FDA, supplied
by "Dr. Bob Smith". (024)
c. Xiao Ping Chen, et.al., Impact of Acute Vivax Malaria on the Immune System
of HIV-positive Subjects, supplied by "Dr. Bob Smith". (028)
3. Dr. Fahey's October 17,2002 response and October 25,2002 fax (040)
o:/inquiry/fahey/fahey to KB 021031
STAFF EVALUATION
John Fahey, MD
Date: October 31, 2002
Staff: Steven Peckman
John Fahey, MD
Answers are from Dr. Fahey's October 17, 2002 response regarding an inquiry into the allegations of
October 8,2002.
with human research regulations regarding the above referenced research. The OPRS and the
UCLA Institutional Review Boards (IRBs) collaborate with investigators and University
administration to ensure the protection of the rights and welfare of human subjects in UCLA
research as well as compliance with federal, State, and local laws and policies. To this end, the
OPRS and IRBs are required through the University's federal assurance to address allegations
regarding human subject research performed under the auspices of UCLA. Investigators are
provided with an opportunity to respond to complaints prior to IRB review.
Enclosed please find the letter of complaint from "Dr. Bob Smith" and two referenced articles
not available on the Heimlich Institute's website. Please respond in writing to the following
issues by October 16, 2002.
PI Response
This is written as a response to your letter of October 8,2002 concerning "Complaint About
Human Research Collaboration on Malariotherapy."
1. The complainant indicates that you may be a co-author of "three scientific articles [that] have
been submitted to international AIDS conferences describing research" related to
malariotherapy in collaboration with Dr. Henry Heimlich. Please clarify whether you are
acknowledged as co-author on any scientific papers, published or presented, regarding
malariotherapy. If so, please provide the UCLA IRB with a copy of each article/paper for
review.
PI Response
I am not acknowledged as a co-author of "three scientific articles" and have no knowledge of being
cited on any manuscripts, articles or abstracts "[that) have been submited to international AIDS
conferences describing research" related to malariotherapy in collaboration with Dr. Henry
Heimlich.
2. The complainant indicates that the Heimlich Institute website promotes the "participation of
UCLA and Dr. Fahey" regarding malaria experiments in China. The website indicates, "Our
clinical studies in China continue to prove the benefits that malariotherapy has for HIV
patients and to elucidate the interaction of malaria with HTV. To this end, the Heimlich
Institute is working in conjuction with UCLA, gathering and analyzing data to show what
o:/inquiry/fahey/fabey eval 021031
COMPT.ATNT f ahpv mal ar i nt - hpr anv am
page 2
immunological factors are responsible for the benefits derived from malariotherapy for HTV.
It is our desire to analyze malaria parasites to determine how to duplicate their ability to
stimulate the immune system with synthetic products that cause the same effects in the
immune system".
1
Please clarify whether you are or have been "working in conjunction"
with the Heimlich Institute. If so, please provide a detailed description of the work.
PI Response
I have not been "working in conjunction" with the Heimlich Institute.
3. The complainant references an interview where Dr. Heimlich indicates, "We have an ADDS
project now in China. We presented the results in 1996 at the National Institutes of Health
and then at the AIDS Conference in Vancouver. As a matter of fact, UCLA has just joined
with us on this project.... Now, with UCLA working with us doing viral loads, measuring
the actual virus. Within the next five to six months we should know that answer. The
patients are in China, the blood is being analyzed at UCLA. We want to treat the next 100
patients immediately. The patients are in China, the blood is being analyzed at UCLA."
2
Please clarify whether you received human biological samples from Dr. Heimlich's project.
If so, please outline in detail the nature of the work you did with the samples.
PI Response
I did not receive human biological samples from this project. When Dr. Xiao Ping Chen, the Principal
Investigator for the project in China, came to UCLA for the Fogarty International AIDS Training and
Research Program (AITRP) (5-T22 TW00003) in 1997, he brought serum samples obtained during a
malarial study conducted in China before any contact with UCLA. Dr. X.P. Chen performed several
immunological tests on his samples and took his remaining samples back to China when be returned.
Contrary to Dr. Heimlich's statement, we did not (and do not) measure "the actual virus".
Dr. X.P. Chen was trained to do ELISA tests for neopterin, p
2
m, sTNF RII and IL-2. HIV
p24 antigen measurements were demonstrated by Dr. Paxi and Hripi Nisbanian. The
UCLA Fogarty AITRP did provide reagents for testing of Dr. X.P, Chen's samples at
UCLA as a part of the immunology laboratory training.
a. Please clarify whether your work was acknowledged in scientific presentations, papers, or
articles for the work Dr. Heimlich refers to in the interview.
PI Response
I am not acknowledged in scientific presentation, papers or articles for the work Dr. Heimlich
refers to in the interview.
1
Malaria and AIDS Epidemics in Africa, http://www.heimlichinstitute.org/aidsafrica.html. accessed October 8,2002.
2
John McDougall, Interview with Henry Heimlich, MD, The McDougall Newsletter. July-August 1998,
http://www.drmcdougall.com/newsletter/iulv aua 1 .html accessed October 8,2002.
o:/inquiry/fahey/fahey eval
r nMPT. ATNT f ahpv mal ar j or . hpr anv
002
page 3
4. The Heimlich Institute newsletter indicates in 1998, "The Heimlich Institute and our
colleagues in China are working closely with John L. Fahey, MD, director for the Center for
Interdisciplinary Research in Immunology and Disease at UCLA. Dr. Fahey's laboratories
are carrying out independent verification of the immunological results obtained in China, as
well as providing technical support. Recently, Dr. Fahey visited Dr. Chen and found
patients' treatment progressing extremely well."
3
Please clarify the nature of-the work
including "technical support" you and/or your laboratory conducted or supplied for the China
research.
PI Response
Dr. Xiao Ping Chen was a Visiting Scholar at UCLA from 03/24/97 to 05/31/97, receiving
training in ADDS research under an existing Fogarty ADDS International Training and
Research Program (AITRP) at UCLA. In addition to ADDS epidemiology, pathogenesis
and clinical design classes, Dr. X.P. Chen was particularly interested learning the
immunologic methods used in ADDS research.
We did not "carry out independent verification of the immunological results obtained
in China".
"Technical support" included instruction in immunologic laboratory methods, and
reagents for practice testing and quality control.
I had no contact with patients and could not have reported that patients' treatments
were progressing extremely well.
The "nature of the work" at UCLA was training in immunologic laboratory
methods, clinical trial design, ethics of patient recruitment and information,
necessity to have approval of all applicable Institutional Review Boards before
undertaking a clinical research project, and quality control and quality assurance
procedures. Similar training was provided to all Chinese Fogarty AITRP trainees who
came to UCLA and contact was maintained with them during the two years following
return to China. We did supply reagentr, for setting up quality control procedures for
immunologic testing in Guangzhou.
5. The Fall 1999 newsletter notes under the heading How You Can Save Lives. "Since 1994,
Dr. Heimlich and his colleagues at the University of California at Los Angeles (UCLA) have
been piloting the use of malariotherapy as a potential cure for HTV infection.... To date, 18
patients are in various stages of malariotherapy treatment. Follow-up data collected shows a
substantial increase in CD-4 T-cell levels, and patients have remained asymptomatic for
more than three years.... To validate and replicate these findings, Dr. Heimlich's research
team requires support that will enable them to offer this potentially invaluable treatment to
additional patients. At $10,000 per patient, $1,200,000 would provide funds to test another
120 patients, and validate the use of malariotherapy to treat HTV. ..."* Please clarify whether
3
The Heimlich Institute, Heimlich Institute Using Malariotherapy to treat HIV/AIDS Infection, Caring World, vl, nl, Winter 1998,
http://www.heimlichinstitute.org/media/CaringWorldWinter98.pdf accessed October 8, 2002.
4
The Heimlich Institute, Malariotherapy Research to Treat HIV/AIDS (SI.2 million), Caring World, vl, n3, Fall 1999,
http://www.heimlichinstitute.org/media/CaringWorldFall99.pdf. accessed October 8, 2002.
COMPT.ATNT f ahpv ma l a r i n t - h p r a w
nm
page 4
you collaborated in the pilot malariotherapy research as indicated in the article. If so, please
outline the timeline of your participation and the work performed.
PI RESPONSE
I did not collaborate in the pilot malariotherapy research as indicated in the article. Dr.
Heimlich's account mixes two research studies they didone of which (1994) used a poor
method to measure CD4 T cell levels. Thus, the claimed changes in CD4 T cell levels are
not reliable. I did offer training in immunologic laboratory methodologies to Dr. X.P. Chen
in 1997.
a. Please clarify whether you participated in fund raising for the Heimlich Institute's
malariotherapy research. If so, please outline the nature of your participation.
PI RESPONSE
I did not participate in fundraising for the Heimlich Institute's malariotherapy research.
b. The same article also indicates, "In 1996, Professor John Fahey, of UCLA, asked to join
the Heimlich Institute in this research project. UCLA is currently conducting our
laboratory studies. Having recently returned from visiting our colleagues in China, Dr.
Fahey is very positive about the results of these three-year clinical studies.... The
Heimlich Institute plans to extend malariotherapy to the treatment of cancer and other
diseases that may be curable by strengthening the immune system." Please clarify
whether you asked to join the Heimlich Institute research project in 1996 and whether you
did join the project. If so, please outline the nature of your participation since that time.
PI RESPONSE
I did not ask to join the Heimlich Institute research project in 1996. I did offer training in
research on AIDS, mainly inununolgic laboratory methodology, to the Chinese scientists of
the Center for AIDS Control and Research, Municipal Health and Anti-Epidemic Station
of Guangzhou, Guangzhou, People's Republic of China. Similar training was conducted
for other Chinese scientists from other research institutions in China.
c. Additionally, the complainant provides Dr. Heimlich's response to the Food and Drug
Administration [please see attached] that may refer to your participation in the research as
indicated in the newsletter: ".. .In 1996, following presentations at the N1H (Bethesda,
MD) and the 12
th
World AIDS Conference (Vancouver), a leading AIDS authority, a
professor from a major U.S. university's immunology department, asked to join in this
effort. Their doctors also made regular trips to the research site in [x] to provide
independent evaluation of the quality of the research being done by our colleagues in [x].
They also provided independent corroboration of the results from [x]."
5
Please clarify
whether the statements refer to you or individuals affiliated in your laboratory.
5
Letter from Henry Heimlich to J ane Henney, FDA, May 4,2000: http://research-vvatch.weblOOO.com/Heimlich FDAl.html
rriWDT JTMT faho-ir mal ari nHi oranv C\f\A
page 5
PI RESPONSE
If the deleted names refer to visits by John L. Fahey to the Municipal Health and
Anti-Epidemic Station of Guangzhou, I can say that I was obtaining information on the
value of the training program provided by the Fogarty AITRP at UCLA. There was no
"independent corroration" of the results.
(i) If so, please outline in detail whether you or individuals from your laboratory or
Center "made regular trips to the research site in [x] to provide independent
evaluation of the quality of the research" or provided "independent corroboration of
the results."
PI RESPONSE
I and individuals from my laboratory did not "make regular trips to the research site in
Guangzhou to provide independent evaluation of the quality of the research" or provide
"independent corroboration of results". I did make trips to China in 1998 and 1999 to visit
seven Chinese trainees in their home institutions as a normal follow-up to the International
AIDS Research Training acquired at UCLA. Guangzhou was included.
(ii) Additionally, please comment on whether your examination of the results was in a
professional capacity resulting in co-authorship on scientific articles, papers, or
presentations.
PI RESPONSE
There was no activity in any capacity resulting in co-authorship on scientific articles,
papers or presentations.
6. An article by Xiaoping Chen, et.al., Phase-1 Studies of Malariotherapy for HIV Infection,
acknowledges you "for providing a part of the financial support, suggestions, and
comments.... Please clarify whether you provided financial support for the referenced
research.
PI RESPONSE
I did not provide financial support for the referenced research. We did supply kits for
establishing immunology laboratory capacities and for establishing quality control
procedures.
a. If so, please clarify whether UCLA funds were provided for the research.
b. If so, please provide a detailed outline of the UCLA funds provided for the research.
6
Xiaoping Chen, Phase-1 Studies of Malariotherapy for HIV Infection. Chinese Medical Sciences Journal. December 1999, provided
by complainant.
oi/inquiry/fahey/fahey eval
page 6
PI RESPONSE
Funding was fro the Fogarty training grant 5-T22-TW00003 for supplies which are allowed
by Fogarty International Center policy to be sent for continued in-country training. UCLA
funds were not provided for research.
7. The complainant references a presentation at the 6
th
International Annual Conference on
AIDS in Asia and the Pacific by Xiao Ping Chen, et.al., that acknowledges your help in
research design and work on the research, Impact of Acute Vivax Malaria on the Immune
System of HIV-positive Subjects [please see attached article].
7
Please clarify whether you
assisted in the research design of the clinical trial.
PI RESPONSE
I did not assist in the research design of the clinical trial "Impact of Acute Vivax Malaria"
beyond the feedback provided to all international scholars for the hypothetical research
project description they are required to prepare during the training period at UCLA.
a. Please clarify whether you "donated reagents for flow cytometry and cytokine quality
measurement" or whether you performed laboratory tests for this research or any other
malariotherapy research.
PI RESPONSE
We did donate reagents for flow cytometry and cytokine quality control measurements as
part of the in-country training. My colleagues and I performed no laboratory tests for this
research.
8. If you received any research materials obtained from subjects in malariotherapy research,
such as biological samples, please clarify whether the materials included direct or indirect
identifiers that could be linked back to the subjects/donors. If so, please describe the direct or
indirect identifiers.
PI RESPONSE
I did not receive any research materials from subjects in malariotherapy research. The
samples from a prior study that were independently brought by Dr. X.P. Chen to UCLA
and tested by Dr. X.P. Chen were identified only by serial numbers (1,2,3, etc.) and could
not be linked back to the subjects.
9. Please outline any other information provided to you with the samples.
PI RESPONSE
None.
7
Xiao Ping Chen, et.al.. Impact of Acute Viva Malaria on the Immune System of HIV-positive Subjects,
http://www.aidsvaccine2001 .ore/Posters/149.1 .a.pdf. accessed October 8,2002.
n n c
page 7
10. If you or members of your laboratory visited China in order to provide services, information,
or guidance related to the malariotherapy research, please clarify whether any UCLA funds
were expended. If so, please outline the fund sources.
PI RESPONSE
I did not visit China in order to provide services, information or guidance related to
malariotherapy research. My two follow-up training visits to Dr. X.P. Chen and other
Fogarty International trainees elsewhere in China were funded by a Fogarty grant 5-T22-
TW00003. Dr. Najib Aziz's visit in 1999, for Immunology laboratory personnel training
related to AIDS research, was in response to an invitation and was paid for by the
Municipal Health and Anti-Epidemic Station, Guangzhou.
11. The complainant indicates that Dr. Xiao Ping Chen is a former UCLA post-doctoral student.
Please clarify whether Dr. Chen worked in your laboratory or was your student.
PI RESPONSE
Dr. Xiao Ping Chen was appointed as a Visiting Scholar, not as a postdoctoral student or
an employee. He was one of eight international AITRP scholars at UCLA, who trained in
my laboratory for two months in 1997.
a. If so, please clarify when he was at UCLA.
PI RESPONSE
He was at UCLA 03/24/97 to 05/31/97.
b. Please clarify whether he worked with the Heimlich Institute and/or on malariotherapy
while under your supervision.
PI RESPONSE
He did not work with the Heimlich Institute while under my supervision. Dr. X.P. Chen
included Chinese serum samples from a prior malariotherapy study in the laboratory
training exercises at UCLA.
c. Please describe in detail the nature of his work with the Heimlich Institute while at
UCLA.
PI RESPONSE
See l i b above.
n r n / n T * T *TT f .* V <-% . **. - ! ~ -~ - ^ 4 - V . ^ ^ - . ^ - ^ - .
page 8
12. Please provide any other information you think is pertinent to the review of the allegations.
PI RESPONSE
Training of Dr. X.P. Chen essentially ended in 1999, and Dr. Chen was notified in
February 2000 that there would be no further support [From Fahey fax 10/24/02]
o:/inquiiy/fahey/fahey eval
P f \ T n T Tl T X I T f V i n v T O 1 n * i ' ^ t - Vi >- o . - i ' nnn
K- MEMORANDUM
2107 Ueberroth Buildine
169407
October 8, 2002
J ohn Fahey, MD
Department of Microbiology and Immunology
12-262 Factor Building
174718
Dear Dr. Fahey,
with human research regulations regarding the above referenced research. The OPRS and the
UCLA Institutional Review Boards (IRBs) collaborate with investigators and University
administration to ensure the protection of the rights and welfare of human subjects in UCLA
research as well as compliance with federal, State, and local laws and policies. To this end, the
OPRS and IRBs are required through the University's federal assurance to address allegations
regarding human subject research performed under the auspices of UCLA. Investigators are
provided with an opportunity to respond to complaints prior to IRB review.
Enclosed please find the letter of complaint from "Dr. Bob Smith" and two referenced articles
not available on the Heimlich Institute's website. Please respond in writing to the following
issues by October 16, 2002.
1. The complainant indicates that you may be a co-author of "three scientific articles [that] have
been submitted to international AIDS conferences describing research" related to
malariotherapy in collaboration with Dr. Henry Heimlich. Please clarify whether you are
acknowledged as co-author on any scientific papers, published or presented, regarding
malariotherapy. If so, please provide the UCLA IRB with a copy of each article/paper for
review.
2. The complainant indicates that the Heimlich Institute website promotes the "participation of
UCLA and Dr. Fahey" regarding malaria experiments in China. The website indicates, "Our
clinical studies in China continue to prove the benefits that malariotherapy has for HIV
patients and to elucidate the interaction of malaria with HTV. To this end, the Heimlich
Institute is working in conjuction with UCLA, gathering and analyzing data to show what
immunological factors are responsible for the benefits derived from malariotherapy for HTV.
It is our desire to analyze malaria parasites to determine how to duplicate their ability to
<*'
o:/inquiry/fahey/fahey inquiry 021008
John Fahey, MD
Complaint Regarding Malariotherapy
page 2
stimulate the immune system with synthetic products that cause the same effects in the
immune system".
1
Please clarify whether you are or have been "working in conjunction"
with the Heimlich Institute. If so, please provide a detailed description of the work.
3. The complainant references an interview where Dr. Heimlich indicates, "We-have an AIDS
project now in China. We presented the results in 1996 at the National Institutes of Health
and then at the AIDS Conference in Vancouver. As a matter of fact, UCLA has just joined
with us on this project.... Now, with UCLA working with us doing viral loads, measuring
the actual virus. Within the next five to six months we should know that answer. The
patients are in China, the blood is being analyzed at UCLA. We want to treat the next 100
patients immediately. The patients are in China, the blood is being analyzed at UCLA."
2
Please clarify whether you received human biological samples from Dr. Heimlich's project.
If so, please outline in detail the nature of the work you did with the samples.
a. Please clarify whether your work was acknowledged in scientific presentations, papers, or
articTesfor the work Dr. Heimlich refers to in the interview.
4. The Heimlich Institute newsletter indicates in 1998, "The Heimlich Institute and our
colleagues in China are working closely with John L. Fahey, MD, director for the Center for
Interdisciplinary Research in Immunology and Disease at UCLA. Dr. Fahey's laboratories
are carrying out independent verification of the immunological results obtained in China, as
well as providing technical support. Recently, Dr. Fahey visited Dr. Chen and found
patients' treatment progressing extremely well."
3
Please clarify the nature of the work
including "technical support" you and/or your laboratory conducted or supplied for the China
research.
5. The Fall 1999 newsletter notes under the heading How You Can Save Lives. "Since 1994,
Dr. Heimlich and his colleagues at the University of California at Los Angeles (UCLA) have
been piloting the use of malariotherapy as a potential cure for HIV infection.... To date, 18
patients are in various stages of malariotherapy treatment. Follow-up data collected shows a
substantial increase in CD-4 T-cell levels, and patients have remained asymptomatic for more
than three years.... To validate and replicate these findings, Dr. Heimlich's research team
requires support that will enable them to offer this potentially invaluable treatment to
additional patients. At $10,000 per patient, $1,200,000 would provide funds to test another
120 patients, and validate the use of malariotherapy to treat HIV.. .."
4
Please clarify whether
1
Malaria and AIDS Epidemics in Africa, http://www.heimlichinstiiute.org/aidsafrica.htiril. accessed October 8, 2002.
2
John McDougail, Interview with Henry Heimlich, MD, The McDoucall Newsletter. July-August 1998,
http://www.drmcdougall.com/newsletter/iulv aug I .html accessed October 8.2002.
3
The Heimlich Institute, Heimlich Institute Using Malariotherapy to treat HIV/AIDS Infection, Caring World, vl .nl , Winter 1998,
http://www.heimlichinstitute.org/media/CaringWorldWinier98.pdf accessed October 8, 2002.
4
The Heimlich Institute, Malariotherapy Research to Treat HIV/AIDS (S1.2 million). Caring World, vl. n3. Fall 1999,
http://www.heimlichinstitute.org/media/CaringWorldFall99.pdf. accessed October 8. 2002.
o:/inquiry/fahey/fahey inquiry' 021008
A i n
John Fahey, MD
page 3
you collaborated in the pilot malariotherapy research as indicated in the article. If so, please
outline the timeline of your participation and the work performed.
a. Please clarify whether you participated in fund raising for the Heimlich Institute's
malariotherapy research. If so, please outline the nature of your participation.
b. The same article also indicates, "In 1996, Professor J ohn Fahey, of UCLA, asked to join
the Heimlich Institute in this research project. UCLA is currently conducting our
laboratory studies. Having recently returned from visiting our colleagues in China, Dr.
Fahey is very positive about the results of these three-year clinical studies.... The
Heimlich Institute plans to extend malariotherapy to the treatment of cancer and other
diseases that may be curable by strengthening the immune system." Please clarify
whether you asked to join the Heimlich Institute research project in 1996 and whether you
did join the project. If so, please outline the nature of your participation since that time.
c. Additionally, the complainant provides Dr. Heimlich's response to the Food and Drug
Administration [please see attached] that may refer to your participation in the research as
indicated in the newsletter "...In 1996, following presentations at the NIH (Bethesda,
MD) and the 12
th
World AIDS Conference (Vancouver), a leading AIDS authority, a
professor from a major U.S. university's immunology department, asked to join in this
effort. Their doctors also made regular trips to the research site in [x] to provide
independent evaluation of the quality of the research being done by our colleagues in [x].
They also provided independent corroboration of the results from [x]."
5
Please clarify
whether the statements refer to you or individuals affiliated in your laboratory.
(i) If so, please outline in detail whether you or individuals from your laboratory or
Center "made regular trips to the research site in [x] to provide independent
evaluation of the quality of the research" or provided "independent corroboration of
the results."
(ii) Additionally, please comment on whether your examination of the results was in a
professional capacity resulting in co-authorship on scientific articles, papers, or
presentations.
6. An article by Xiaoping Chen, et.al., Phase-I Studies of Malariotherapy for HIV Infection,
acknowledges you "for providing a part of the financial support, suggestions, and
comments...."
6
Please clarify whether you provided financial support for the referenced
research.
5
Letter from Henry Heimlich to Jane Henney, FDA, May 4,2000: http://research-watch.webl000.com/Heimlich FDAI.html
6
Xiaoping Chen, Phase-1 Studies of Malariotherapy for HIV Infection, Chinese Medical Sciences Journal. December 1999, provided
by complainant.
Âi rnr * T V T f ^Kmp ma l a - r i n f h p r a n ^ m i
John Fahey, MD
page 4
a. If so, please clarify whether UCLA funds were provided for the research.
b. If so, please provide a detailed outline of the UCLA funds provided for the research.
7. The complainant references a presentation at the 6
th
International Annual Conference on
AIDS in Asia and the Pacific by Xiao Ping Chen, et.al., that acknowledges your help in
research design and work on the research, Impact of Acute Vivax Malaria on the Immune
System of HIV-positive Subjects [please see attached article].
7
Please clarify whether you
assisted in the research design of the clinical trial.
a. Please clarify whether you "donated reagents for flow cytometry and cytokine quality
measurement" or whether you performed laboratory tests for this research or any other
malariotherapy research.
8. If you received any research materials obtained from subjects in malariotherapy research,
such as Biological samples, please clarify whether the materials included direct or indirect
identifiers that could be linked back to the subjects/donors. If so, please describe the direct or
indirect identifiers.
9. Please outline any other information provided to you with the samples.
10. If you or members of your laboratory visited China in order to provide services, information,
or guidance related to the malariotherapy research, please clarify whether any UCLA funds
were expended. If so, please outline the fund sources.
11. The complainant indicates that Dr. Xiao Ping Chen is a former UCLA post-doctoral student.
Please clarify whether Dr. Chen worked in your laboratory or was your student.
a. If so, please clarify when he was at UCLA.
b. Please clarify whether he worked with the Heimlich Institute and/or on malariotherapy
while under your supervision.
c. Please describe in detail the nature of his work with the Heimlich Institute while at
UCLA.
12. Please provide any other information you think is pertinent to the review of the allegations.
7
Xiao Ping Chen, et.al.. Impact of Acute Viva Malaria on the Immune System of HIV-positive Subjects,
httn://www.aidsvaccine2001 .ore/Posters/149. l.a.pdf. accessed October 8.2002.
o:/inquiry/fahcy/fahey inquiry 021008
John Fahey, MD
pages
I look forward to receiving your response. Please contact me at 825-5344 or
speckman@oprs.ucla.edu if you have any questions.
/' f
nterelyfN
Steven Peckman
Associate Director-Human Subjects Research
Enclosures: 1. October 2,2002 letter from "Dr. Bob Smith".
2. Henry Heimlich May 4,2000 correspondence to J ane Henney, FDA, supplied
by "Dr. Bob Smith".
3. Xiao Ping Chen, et.al., Impact of Acute Vivax Malaria on the Immune System
of HIV-positive Subjects, supplied by "Dr. Bob Smith".
Please forward all requested responses to:
Steven Peckman
2107 PVUB
169407
T . ~- *^*-V./^T*^ v-*^ n i i
FDA_Reply
3MSTBAJGHT
SIRST
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SIM5MM1
WX5IW5M403
Benefiting
Humanity
Through
Health
and
Peace
Page 2 of 2
May 4,2000
Dr. Jane E Hcnney
Commissioner, Food & Drag Administration
S6O0 Fishers Lane
RockvillcMD 20857
Dear Dr. Henney:
Enclosed are copies of two pages sent to the Great Lakes College of Clinical Medicine
(GLCCM) from Steven Masiello. Director of the Office of Compliance and Biologies
Quality, Center for Biologies Evaluation and Research, at the Food & Drag
Administration (FDA), who challenges our IRB approval. We have an earlier, letter from
the FDA indicating that the FDA has no authority over our research, since we are "not
interested in developing a 'product' or filing an investigation*] application ('IND')..."
On what authority, therefore, is Mr. Masiello challenging our IRB approval? If the FDA
has riosuch authority, kindly rescind Mr. MasieUo's demands immediately.
Furthermore, siaiements in Mr. MasieUo's letter are inaccurate, defamatory and ethnically
biased. 1 ask that you investigate this matter and take appropriate action regarding the
responsible FDA employee.
Quotes from the FDA letter are in (bold), followed by responses and clarifications in
standard print.
FDA 7A: The protocol is inadequate in that it does not describe what testing is
done to screen the malarial parasite donors.
Our protocol states that: 1) the blood should only contain. 2) that
repeated thick and thin blood smear examination for parasites other than desired
Plasmodium should be carried out, 3) negative antibody screens for syphilis, hepatitis,
HIV, CMV, and any other infections suggested by history and physical examination are
required. This is in accordance with standard blood screening procedures used for
transfusion blood.
FDA 7A: The direct injection of blood from a malaria parasite donor into a
study subject would not be permitted in the VS. because cultured
malaria parasites are available.
In the Uniled Slates, from 1931 to 1965. U.S. Public Health Service laboratories provided
malaria blood for the direct injection of blood from malaria parasite donors into tens of
thousands of neurosyphilis patients. The safely and effectiveness of the procedure was
reported from the Harvard School of Public Health in a peer-reviewed medical journal.
Affiliated with Deaconess Associations toe.
NEXTPAGE
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FDA_Reply
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Page 2 of 5 ( Redact i ons by FDA)
Vienna's Wagner von Jauregg won the 1927 Nobel Prize in medicine for discovering
malariotherapy. The procedure was discontinued only alter malariotherapy eradicated
neurosyphilis, and penicillin cured early syphilis.
Page 1 of2
The Heimlicfa Institute met with the head of malariology a : ;
He informed us that can be cultured, but "--^ânnoL The reasons why
we chose to use.' should be obvious to the FDA. Furthermore, we have
concspondeace from the Centers for Disease Control (CDC) offering to provide us with
malarial blood for injecting into patients receiving malariotherapy in the United States.
In light of the above, the FDA investigator's lade of knowledge and his apparent ethnic
bias in assuming that the government or physicians would undertake a
procedure "that would not be permitted in the U.S." certainly deserve rebuke.
FDA 7B: The statement in the response letter that "Che IRB's approach (to this
studyjjvas no different than If the research was conducted in the
TJ-S." demonstrates that the IRB appears to lack the expertise or
experience to ascertain the acceptability of proposed research in terms
of Institutional commitments and regulations, applicable law, and
standards of professional conduct and practice.
That is a false and prejudicial statement (see below). The IRB statement is correct. The
FDA investigator's biased statement is without basis in fact.
FDA 7 0 We reject your position that the IRB was able to consider the
community attitudes of the population in which the research
was to be conducted.
The IRB approval was given with the knowledge that Dr. Hcimlich has had an ongoing
fifty-five-year relationship with the people of ud is known by the U.S.
government to be an authority or" culture. He was officially named a
wh '
The FDA investigator's false
accusation againsi GLCCM, without knowing the facts, is. again, evidence cf bias againsi
GLCCM and the ~
FDA 7C: Given the great differences between = -and American cultures,
we do not accept that the GLCCM was capable or understanding
Utudes about the research. This is one ixason, among
many, that the academic institution iaJZ that was associated with
the research, as referenced in your response letter, should have
obtained governmental and approval from n local IRB (or equivalent
body).
The FDA investigator makes the ridiculous and biased assumption that IRB approval
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FDA_Reply
PREVIOUS PAaF
Page 4 of 5 (Redactions by FDA)
Page! of 2
research to determine its risk-benefit ratio aod to supervise the progress of the research,
particularly with regards to patient safety. HowcuUbe*%iappropfiaie
w
toseek
additional IRB supervision (above that required)?
- FDArfg^ The IRB file for this study did rt contain t f cei translation or
;
;
?%^^
v
^ tke protocol or consent form. l a genera!, wheat study subjects are
Boo~Eaglisfa speakers, the IRB mast assure that the consent form
translation is accurate.
If the English-speaking Director cannot accurately translate the protocol and
consent forms into who can? The FDA investigator speaks of non-English
speakers in the U.S. Is he not aware thai in j not a foreign language?
FDA7F: Please describe the IRB's efforts to determine that this study had been
approved by the appropriate office in the- ; . and by
the locaflhstitutioB(s) where the research was conducted.
As previously indicated, the position of the FDA investigator is ludicrous, and hi*
statement is fake and ethnically prejudicial. He fails to understand that the government
of '; ; would not kowtow to US IRB approval. The
authorities conducted their own rigorous, scientific evaluation and confirmed CLCCM's
decision by providing their own approval. Again, can the FDA investigator provide a
rationale explanation of how having additional IRB oversight not be of benefit to patients
enrolled in this study?
FDA: The IRB should rescind approval of this study and defer the human subject
protection responsibilities to the responsible ' authorities. Please
provide documentation that the IRB has informed the tinical
investigator of his responsibility to obtain appropriate government
and local institutional approval for the research.
In view of the above, such a statement to the jlinica] investigator is highly
inappropriate and insulting. It would act against American interests in ' and
interfere the important research being carried out.
The IRB approval was granted to the Hcimiicfa Institute, not to the government.
To inform the government that a VS. IRB approval is withdrawn is insulting.
What would the FDA investigator think if the.- JuTormed him a IRB
approval of work done in the VJS. had been rescinded?
In conclusion, an FDA investigator has taken action to remove an IRB from a study
outside FDA authority. The study does not require FDA approval because it is not a
drug, nor a device am) it is not being developed as a commercial product. Furthermore.
the FDA approval is not required because the study is being conducted by scientists
outside of the United States. The FDA investigator's demands delay an important
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FDA_Repl y
Page 2 of 2
scientific study, interfere with sound, tboroagb IRB review of this same study, and
defame me principal iirvestigator.ooworlceis and the rRBwfa^
The FDA investigator's actions nise the question of bias against OLCCM regarding his
investigation of ibeir other IRB approvals. We ask you. Dr. Henney, to take immediate
action vis-a-vis your employee and the unwarranted barm to our research that his bias and
false accusations are causing.
/
cc Great Lakes College of Clinical Medicine
Institutional Review Board
FDA REPLY LETTER
BACK TO UCLA TFTTFl?
http://research-watch.weblOOO.com/HeimIich FDA3.html
i r vcwmr o
Impact of acute vivax malaria on the immune system
of HIV-positive subjects
Xiao Ping Chen, Bin Quan Xiao, Wen Jim Shi, Hui FangXu, Kai Gao, Ji Li Rao, Zhou Bin Zhang
Summary
Background A beneficial interaction of malaria and HIV co-infection has been reported in a hospital-based
study and in a well-controlled cohort study in Africa. In our previous studies there was an increase in total trend
of CD4 cell counts in HIV-positive subjects during two years follow up to malariotherapy (therapeutic vivax
malaria).
Methods Total 12 HIV-1-positive patients were grouped by CD4 cell count baselines: total group (TG) for all
represented CD4 range at 1217-15/uL, sub-group 1 (SGI) for 5 with CD4 counts 2: 500/uL, sub-group 2 (SG2)
for 5 with CD4 counts at 499-200/uL. Two patients with CD4 counts <200/uL were not included as a subgroup
for statistic analysis. Plasmodium vivax was intravenously injected into the HIV patients to induce therapeutic
malaria and the malaria was terminated with chloroquine after 10 fever episodes. ELIS A was used to measure the
plasma levels of cytokines and soluble activation markers including TNF-a, INF-y, sTNF-RII. NPT, sIL-2R and
P2M. Row cytometry was used to measure the levels of CD4+, CD8+, CD25+, CD4+CD25+, HLA-DR+,
CD8+HLA-DR+lymphocytes and percentage of apoptotic CD4 cells. Samples were taken and tested at the first
pre-malaria (prel), second pre-malaria (pre2), first malarial fever episode (fl), fifth episode (f5), tenth episode
(flO), daylO after termination of malaria (pdlO), 1 month (ml) and 3 months (m3) follow up.
Findings Levels of plasma TNF-a, sTNF-RII, NPT and sIL-2R significantly elevated during malaria and
sharply reduced to baselines post malaria in all groups but much stronger responses of these factors were seen in
SG2 than in SGI (p=0.081,0.001,0.013, 0.020) during malaria. In TG, CD4 number, CD25+and CD4+CD25+
percentages decreased (not significantly for CD4, significantly for other two) during malaria then rebounded to
over baseline levels post malaria. CD4 percentage and CD4/CD8 ratio increased either during or post malaria
(p=0.048 for %CD4 at m3). In SGI, CD4 and CD8 numbers significantly decreased during malaria then
rebounded to baseline levels post malaria. In SG2, CD4 number and percentage, CD4/CD8 ratio, CD25+and
CD4+CD25+percentages increased either during or post malaria (p<0.001for %CD4 at m3). Changes of
HLA-DR+and CD8+HLA-DR+percentages were somewhat different among different groups. Percentage of
apoptotic CD4 cells rose during malaria (p=0.015) then sharply reduced to lower than the baseline in all groups
(p=0.148forTG).
Interpretation Relatively stronger responses of CD4 cell (especially its percentage) and CD4/CD8 ratio
elevation and much stronger responses of plasma cytokines and immune activation markers to therapeutic acute
vivax malaria were seen in HIV-positive subjects with CD4 baseline level at 499~200/uL. The effects on CD4
cells and other phenotypic changes might follow from the cytokine responses.
Center for AIDS Control and Research, Municipal Health and Anti-Epidemic Station of Guangzhou,
Guangzhou, P. R. China (XP Chen MD, PhD, BQ Xiao PhD. WJ Shi PhD, HF Xu MD, K Gao BS, JL Rao MD,
ZB Zhang MD)
Correspondence to: Dr. Xiao Ping Chen, Center for AIDS Control and Research at Municipal Health and
Anti-Epidemic Station of Guangzhou, No. 23. 3"
1
Zhongshan Road, Guangzhou 510080, P. R. China (e-mail:
chenxping@netease.com)
l
Introduction
Infections by human immunodeficiency virus (HIV) and malarial parasite represent major public health
problems in the developing world especially in sub-Saharan Africa. Immune suppression induced by HIV, which
leads to the emergence of other protozoan parasitic diseases,
1
was expected to promote the prevalence of malaria
or trigger more severe manifestation of the disease. On the other hand, malaria was known to impair
T-lymphocyte function,' hence was anticipated to facilitate the progression of HIV infection to acquired
immunodeficiency syndrome (AIDS). Therefore a possible harmful interaction between both infections has been
hypothesized in recent years. But there are no evidences to support this hypothesis among over 30 available
reports on this topic recently reviewed by Chandramohan and Greenwood.
3
On the contrary, a hospital-based
study conducted in Zaire
4
indicated that none of 41 children with malaria and AIDS died but among the
remaining 71 children with AIDS without malaria, 25 died; there were no deaths in malaria patients with
symptomatic HIV infection compared to 14% in non-HTV infected children. Furthermore, a well-controlled
cohort study
5
conducted in Uganda demonstrated that median survival of HIV-infected children with at least one
documented malaria episode was significantly longer than that of those without a documented malaria episode.
Moreover, a significantly greater proportion of children without malaria developed clinical symptoms of CDC
AIDS Category C than those with malaria and had a significantly decreased hazard to category C with each
episode of malaria. Greenberg and colleagues also observed in Zaire that patients with the dual infections who
had more malarial episodes did not progress to AIDS as fast as those who had fewer episodes.
6
These phenomena
were consisient-with the results from animal model studies
7
in which HIV-likc virus infection prevented death of
animal from cerebral malaria and coinfection of malaria delayed the progression of the viral infection to animal
AIDS, and paralleled with the results of our previous clinical studies
8>
of malahotherapy (therapeutic vivax
malaria) for HIV infection in which 8 HTV-1-infected persons who received malariotherapy experienced CD4
cells increase and neopterin (NPT) decrease in total trend and remained clinical well during 2-3 years follow up.
All these findings suggest a beneficial (instead of harmful) interaction between HIV and malarial parasite in
human.
Our present study focused on the early impact of the therapeutic acute vivax malaria on the immune system
of HIV-positive persons and on possibly different immune responses among patient groups stratified by CD4 cell
baseline levels. This study was approved by the review board of Guangdong Provincial Committee of Science
and Technology (China), a scientific and ethic combination committee at province (state) level.
Methods
Patient selection
Twelve Chinese HIV/AIDS patients (all were HIV-1 positive and confirmed by Western blot) who were naive of
any kinds of ami-retro viral therapy and stratified by CD4 cell count baselines were selected for the studies. All
patients signed informed consent. Patients were numbered according to descending order of CD4 cell count
baselines and grouped as total group (TG) for all 12 patients representing CD4 cell range 1217~15/uL,
sub-group 1 (SGI) for 5 patients (case 1~5) with CD4 counts Z 500/uL, sub-group 2 (SG2) for 5 patients (case
6-10) with CD4 counts at 499-200/uL. Two patients (easel 1-12) with CD4 counts <200/uL were not included
as a subgroup for statistic analysis (table 1). Case 4,9, 11 and 12 got HIV fromsexual transmission, the others
got HIV frominjecting drug use (sharing needles). Ages were 22-35 years old at entry. Case 9 and 12 are female
and the others are male. Case 12 was a full-blown AIDS patient with complicated ulcer of external genitalia,
pneumocystis carinii pneumonia (PCP, clinical diagnosis) with dyspnea, needed oxygen inhalation. There were
no symptoms in the other 11 HIV-positive individuals (case 11 was classified as an AIDS patient according to
1993 CDC AIDS definition). All patients had no history of malaria.
Therapeutic malaria induction
Blood donor with vivax malaria was tested for HIV-1, HI V-2. hepatitis A, B, C, D, E, F, G and syphilis and all the
results were negative. Ten milliliter of heparinized whole blood containing 10
7
Plasmodia vivax (Pv) was
intravenously injected into each HIV/AIDS patient to induce therapeutic malaria. Chloroquine was used to
terminate malaria after 10 febrile episodes (except patient 4 and 12 whose malaria naturally disappeared before
completion of the course of malariotherapy) based on our research protocol.
Laboratory measurements ' "
2
ELISA was used to measured the plasma levels of cytokines and immune activation markers (procedures
followed manufacturer's instructions, results were calculated by AssayZa computer program) including tumor
necrosis factor-a (TNF-a), soluble TNF-a receptor-II (sTNF-RII) (both reagents from Genzyme Corporation,
Cambridge, USA), DsT-y (Coulter Immunotech, Marseille, France), P-2-microglobulin ({32M, tested only in case
2, 5, 6 and 10), neoptenn (NPT) (both Diagnostica GmbH, Berlin, Germany) and soluble interleukin-2 receptor
(sIL-2R, Endogen Incorporation, Wobum, USA). Flow cytometry (Coulter EPICSELITE cytometer and
Coulter Immunotech reagents) was used to measure the percentages and absolute counts of CD4+and CD8+
T-lymphocytes, percentages of CD25+, CD4+CD25+, HLA-DR+and CD8+HLA-DR+lymphocytes and of
apoptotic CD4+cells (propidium iodide stained and measured sub-Gl peak). All these parameters in 20
HIV-negative age-matched healthy subjects were tested with the same methods for the flow cytometry quality
control. Data of the quality control are listed in table 2. Samples were taken and tested at first tune of pre-malaria
(pre 1), second time of pre-malaria (pre2, at least one week interval between pre 1 and pre2), at first malarial fever
episode (fl), fifth fever episode (f3), tenth fever episode (flO), daylO after termination of malaria (pdlO), 1
month (ml) and 3 months (m3) follow up.
Statistical analyses
Mean values of two pre-malaria results of all parameters (except percentage of apoptotic CD4 cells) as baseline
data were compared with that tested at other time points using paired-samples T test. Data were compared
between subgroups using independent-samples T test. SPSS 8.0 computer program was used for all statistical
analyses. All significant tests were two-tailed. p=0.05 was used as statistically significant cut off value.
Results
Changes of plasma levels of cytokines and soluble activation markers
Levels of plasma TNF-a, sTNF-RII, sIL-2R and NPT significantly elevated during malaria and sharply declined
to baseline levels in all patient groups including the total group (TG) of 12 patients (figure 1, a, b, c and d).
Interferon-Y (IFN-y) at most testing time points in all 12 patients was undctectable either at baseline or during or
post malaria. Level of {32M increased during malaria and sharply returned to baseline post malaria in all tested
patients (case2, 5, 6 and 10, data not shown). Much stronger responses of plasma TNF-a (p=0.081 at 5),
sTNF-RII (p<0.001 at f5), sIL-2R (p=0.040, 0.020 at f5 and flO) and NPT (p=0.013 at flO) were seen in SG2
compared with SG1 during malaria even though there were no differences in levels of these factors at baseline or
post malaria between these subgroups (figure 1, a, b, c and d).
Changes ofT-lymphocyte subsets
In SGI, the CD4 (p=0.033 at f5) and CD8 (p=0.013, 0.012 at f5 and flO) cell counts significantly declined
during malaria, and recovered to around the baseline levels post malaria (figurela, figure 3a). CD8 percentage
increased at fl (p=0.050) and pdlO (p=0.040) but recovered to around baseline level at other time points (figure
3b). Changed patterns of CD4 percentage (figure2b) and CD4/CD8 ratio (figure 2c) were similar to that of CD4
and CD8 counts (but not significant). Intriguingly, in SG2, the percentage (figure2b) and absolute count (figure
la) of CD4 cells as well as CD4/CD8 ratio (figure 2c) apparently increased during malaria and still remained
higher levels post malaria (significantly higher in level of CD4 percentage at m3, pO.OOl). Total trend of CD8
cell count decreased during or post malaria (not significant, figure 3a). Total trend of CD8 percentage (figure 36)
also seemed of reduction except a relatively higher level seen at pdlO (p=0.313). In TG, CD4 percentage
(p=0.048 at m3) and CD4/CD8 ratio increased either during or post malaria. CD4 count declined during malaria
and rebounded to over baseline level post malaria (but not significant). The total trend of CD8 count decrease
either during or post malaria (not significant) with relatively stable of CD8 percentage.
Changed patterns of percentages of apoptotic CD4 cells (among total CD4 cells) were very similar in all
groups including TG, SGI and SG2: remained relatively unchanged at f5 (p=0.980), significantly increased at
flO (p=0.015), apparently decreased to lower than baseline level post malaria in spite of no statistical
significance compared with the baseline (figure Id, there was no significant difference in apoptotic CD4
percentage between the HIV-positive patients at post-malaria and the HIV-negative controls but there was
significant difference between the two groups before the patients received malariotherapy, table 2).
The total trends of lymphocyte counts (figure 3c) and percentages (figure"id) decreased either during or post
malaria in all groups. Total white-blood cells"(WBC) decreased during malaria then recovered to baseline levels
3
post malaria in TG and in SG1, remained stable within the whole course in SG2 (data not shown).
Changes of lymphocyte phenotypes
In SGI, percentages of CD25+(p=0.026 at f5) and CD4+CD25+(p=O.033 at flO) cells declined during malaria
then rebounded to higher than the baselines (not significant, figure 4, a andb). HLA-DR+percentage (figure 4c)
remained relatively stable except a big variation at flO and a higher level at pdlO (p=0.039j:"CD8+HLA-DR+
percentage increased either during or post malaria (not significant, figure4d). In SG2, the total trends of CD25+
and CD4+CD25+percentages increased but HLA-DR+and CD8+HLA-DR+percentages decreased either
during or post malaria (not significant, figure 4, a, b, c and d). In TG, CD25+(pO.OOl at fS, figure 4a) and
CD4+CD25+percentages (p=0.020 at f5, figureAb) decreased during malaria then rebounded to higher than
(p=0.085, 0.038 respectively at m3) baselines post malaria. Percentage of HLA-DR+lymphocytes remained
stable during malaria, decreased to lower than the baseline post malaria (not significant, figure 4c). Percentage of
CD8+HLA-DR+lymphocytes increased during malaria, at pdlO and ml (not significant) and returned to
baseline level at m3 (figureAd).
Information on case 11 and 12
In case 11, the pattern of cytokine responses was very similar to that of SG2. Percentage of CD4 cells increased
during malaria then returned to baseline level post malaria, but CD4 cell count remained relatively unchanged in
the whole_course. Percentage and number of CD8 cells and CD4/CD8 ratio remained relatively stable in the
whole course. Percentages of CD25+and CD4+CD25+lymphocytes decreased and percentages of HLA-DR+
and CD8+HLA-DR-r lymphocytes increased either during or post malaria. The pattern of response of apoptotic
CD4 was similar to that of SGI or SG2. Case 12 (with full-blown AIDS) had only two medium malarial fever
episodes, then the fever and malaria parasitemia naturally disappeared without using any anti-malaria
medications. This patient experienced increase of percentage and number of CD4 cells from 1.2% and 15/uL at
baseline to 4.1% and 41/uL at ml post malaria with relative stabilization in levels of CD8 cells and lymphocyte
phenotypes. Percentage of apoptotic CD4 cells sharply decreased from 22.1% at baseline to 6.5-2.1% post
malaria with apparent clinical improvement: disappearance of PCP and ulcer of external genitalia as well as
normalization of activities during the three months follow-up. Very weak cytokine responses were seen in this
patient, but relatively lower levels of TNF-a, sIL-2R and NPT post malaria.
Discussion
It is very interesting that the response patterns of T-lymphocyte subsets and phenotypes to acute vivax malaria
arc quite different between HIV-positive subjects with different CD4 cell baselines (SG 1 above 500/uLand SG2
at 499-200/uL). In SGI patients, the down-regulation of CD4 cell number and percentage, CD4/CD8 ratio,
CD25+and CD4+CD25+cell percentages and up-regulation of CD8+HLA-DR+cell percentage were seen
during malaria even if these parameters recovered to (CD25+and CD4+CD25+percentages to higher than)
baseline levels post malaria. In contrast, in SG2 patients up-regulation of CD4 cell number and percentage,
CD4/CD8 ratio, CD25+and CD4+CD25+cell percentages and down-regulation of CD8 cell number, HLA-DR+
and CD8+HLA-DR+cell percentages were seen during and remained changed in the same direction post malaria.
In a cross-sectional study,
10
the percentages of CD4 and CD8 cells and ratio of CD4/CD8 were not different
between HIV-negative persons infected with Pv or Plasmodium falciparum (Pf) or dually infected with the both
parasites and the control population without malaria; but the absolute counts of CD4 cells, C08 cells and total
lymphocytes were generally lower and the percentages of CD25+and HLA-DR+cells were significantly higher
in (either Pv or Pf or dual Pv and Pf) malaria patients than the controls. These phenomena when compared to our
data in HIV+patients suggest very different responses of lymphocyte subsets and phenotypes to acute malaria
among individuals with different HIV and immune status. We postulate that besides of damage or reproduction
of the cells, these sharp responses during malarial phase at least partially represent redistribution " of
lymphocytes such as CD4 cells transfer from lymph nodes and other lymphoid tissues into the peripheral blood
stream in (at least most) SG2 patients or from peripheral blood to lymphoid tissues in SGI patients.
It has been known that plasma level of sIL-2R reflect the activity of IL-2 in vivo and that IL-2 gene expression
in vivo and IL-2 production of peripheral blood mononuclear cells (PBMCs) to stimulation of mitogens in vitro
decrease in HIV-positive subjects.
lJ
The finding of our present study indicates that HIV infected persons have
strong sIL-2R (reflecting IL-2)response to acute vivax malaria. This is consistent with the result in our previous
4
report that therapeutic acute vivax malaria induced apparently elevated plasma IL-2 level in HIV-infected
individuals after cure of malaria.
9
In a well-controlled in vitro study
l4
, complex malaria antigens derived from Pf
induced as effective cell proliferation and cytokine (IL-2 and IFN-y) production from PBMCs from AIDS
patients as those from HTV-negative healthy subjects. But single malaria antigen MSP-1 derived from Pf and
other antigens and mitogens had none of these effects. Our results indicate a much stronger response of TH 1-type
cytokines (IL-2 and IFN-y reflected by their activity markers sIL-2R and NPT which are easierfor measurement
than the cytokines proper
12
) and one proinflammatory cytokine (TNF-a) to acute vivax malaria in patients with
more advanced than in those with relatively earlier HTV infection. These in vivo phenomena contrast with in
vitro measurements with other antigens or mitogens which indicate more impaired response with advance HIV
infection suggest that malaria parasite which contains complete malaria antigens induces effective cytokine or
immune response against malaria infection in HIV/AIDS patients and this response might be also efficacious
against infections by other organisms, which was observed in our present study that the patient with full-blown
AIDS experienced clinical improvement with disappearance of PCP and ulcer of external genitalia.
Multiple studies have shown that HIV infection induces uninfected CD4 cell apoptosis besides of inducing
death of infected cells.
15
'
17
In (HlV-negative) patients with malaria, increase of T-lymphocyte apoptosis was also
reported.
18,
" We did observe the "pile up" effect of CD4 cell apoptosis of HIV and Pv coinfection during malaria,
but after cure of malaria, the percentage of apoptotic CD4 cells sharply reduced from a high level to a nearly
normal level (0.7+1.1%; the nonnal control level was 0.30.2%, table 2). The decrease of percentage of
apoptotic CD4-GC11S post malaria might be attributed to strengthened IL-2 and IFN-y activities. It has been known
that TH 1-type cytokines (IL-2 and IFN-y) prevent and TH2-type cytokines (IL-4 and IL-10) promote CD4 cell
apoptosis."
0,21
We have found that acute vivax malaria provokes high activities of TH 1-type cytokines in
HIV-positive persons. Studies by other researchers have indicated that malaria promotes activities of TH 1, some
TH2-type (IL-10 but not IL-4) and proinflammatory cytokines (TNF-a, IL-1 and IL-6) in HIV-negative
subjects.
22
'
27
We demonstrate that malariothcrapy effectively stimulates HIV-infected persons to produce all or
most these cytokines, which was reflected by elevation of |52M level during malaria, and these cytokines act on
the immune systems which arc at different levels of impaired immune function induced by HIV, leading to a new
balance of the immune systems, such as resulting increase of IL-2 levels after termination of malaria in patients
whose IL-2 levels are lower before malaria infection (this was demonstrated in our previous study), which blocks
apoptosis and stimulates production of CD4 cells reflected by elevated count and percentage of CD4 cells and
percentages of CD25+ (IL-2 receptor a chain) and CD4+CD25+ cells as well as declined percentage of apoptotic
CD4 cells. It should be noted that in our present study, increased percentage was more obvious than increased
number of CD4 cells, which was due to significant reduction of lymphocyte (due to the decrease of its percentage
since WBC number returned to baseline level post malaria, data not shown). The decrease of lymphocyte
percentage (from 43.39.2% at baseline to 32.78.8% at m3 post malaria in TG) seemed to normalize the
parameter which was significantly higher at baseline than the control (table 2).
It was shown that HLA-DR was significantly increased while CD2S was significantly decreased in
HIV-infected individuals
28
(the same phenomena were also found in our present study, table 2). Several reports
29
'
30
indicated that prognostically significant immune markers of HIV infection included decreased CD4 number
and percentage, decreased CD4/CD8 ratio and CD25+ total lymphocytes, increased percentage of HLA-DR+
total lymphocytes and increased sIL-2R, NPT, TNF-a, sTNF-RIl and p2M. Our present and previous studies
found that increased mean levels of CD4 number and percentage and CD4/CD8 ratio (more apparent in patients
with CD4 baselines at 200-499/uL), increased CD25+ and CD4+CD25+ percentages, decreased apoptotic CD4
percentage and CD8 number, decreased HLA-DR+ and CD8+HLA-DR+ percentages and remained relatively
unchanged plasma activation marker levels including sIL-2R, NPT, TNF-a, sTNF-RII and p"2M were seen in
HIV-positive subjects after termination of therapeutic malaria. It should be noted that no complications were
observed in 20 HIV-infected patients who received malariotherapy in spite of marked rise in levels of the plasma
activation markers during 1030 day malarial phase. Also, it was found that the patients had milder malarial
symptoms and parasitemia with progressively lower CD4 T-cell baseline levels (unpublished data). All these
phenomena further support the concept of beneficial interaction between HIV and malarial parasite in human,
which is consist with the findings in animal model studies.
There might be a mutually inhibitive effect between the two pathogens, either through immune responses in
the dually infected persons or/and through the components of the pathogens proper, because there is
cross-reactivity of anti-malaria antibodies and HIV tests including shared antibodies against pi 7, p24, p31, p51,
5
p55, p66 and pi60 . We here propose a hypothesis that malaria parasite is a special and strong natural
immune regulator which has dual effects: when the host has a relatively normal level of immune status, it down
regulates immune function, when host is at relatively lower immune status, it up regulates immune functions; but
when host is at a very low level of immune status, it just gives rise to a transient and weak immune response.
Therefore, based on our studies, malariotherapy seems more suitable for treatment of HIV-positive patients with
CD4 cell level at 499-200/uL.
Contributors
Xiao Ping Chen independently proposed the idea of malariotherapy for HIV-positive patients in early 1993 and contributed to the
research design, clinical observation, laboratory measurements, data interpretation and wrote the paper. Bin Quan Xiao contributed
to the research design and data interpretation. Wen Jun Shi contributed to all laboratory measurements. Hui Fang Xu contributed to
clinical observation and a part of laboratory measurements. Kai Gao contributed to most laboratory measurements. Ji Li Rao
contributed to a pan of clinical observation and a pan of laboratory measurements. Zhou Bin Zhang contributed to a pan of
laboratory measurements.
Acknowledgements
We acknowledge Dr. Henry J. Heimlich for his successful cooperation with us in the pilot study of malariotherapy for HIV infection
during 1993-1996. He independently proposed the same idea of malariotherapy for HI V infection (he mentioned he had the idea in
1992). Dr. Heimlich works at the Heimlich Institute in Cincinnati, USA. We appreciate Dr. Fu Yuan Kuang and Ms. Bi Qiao Chen
(head nurse) for providing excellent medical care for the HIV/AIDS patients while hospitalized; both work at Guangzhou Yishou
Hospital, Guangzhou. China. Our special thanks should be given to Dr. John L. Fahey for his helps in research design, generous
donation of reagents for flow cytometry and cytokine quality control measurement and for review of the manuscript, to Dr. Naji
Aziz for technological guidance of cytokine measurement; both work at Center for Interdisciplinary Research in Immunology and
Disease, Departments of Medicine and of Microbiology and Immunology, UCLA School of Medicine. Los Angeles, USA. We
thank Dr. Qing Yu Kong for help in flow cytometry measurement, working at the First Affiliate Hospital, Sun Yat-Sen University of
Medical Sciences, Guangzhou, China.
This study was supported by Guangdong Provincial Committee of Science and Technology priority grant (1997003, China),
Department of Health of Guangdong Province 1997 grant (China), Guangzhou Municipal Committee of Science and Technology
priority grant (1999Z10202, China).
References
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Royal Soc TropMedHyg. 2000; 94: 171-172.
7
Total group TG
Subgroup
Case No.
CD4 count*
1
1217
2
1043
SGI
3
688
4
663
5
590
6
348
7
290
SG2
8
260
9
234
10
208
11
144
12
15
*CD4 ceD count baseline=mean value of two pie-malaria measuremenis (prel andpre2)
Table 1: CD4 T-cell baseline levels of HIV-f patients prc-malariotherapy and the patients grouping
HTV- (n=20) HIV+ (n=12)
Parameters Range Mean+SD Range McanSD high/low - P
#CD4 463-1658 8051284 15-1217 475+371
I
O.001
%CD4 25.6-50.7 33.15.7 12-27.6 16.783
I
<0.001
#CD8 224-1261 814292 482-1584 1072381 0.127
%CD8 21.5-39.1 32.5+4.6 32.4-67.8 43.4+S.6
t
0.001
CD4/CD8 ratio 0.7-2.4 1.10.4 0.03-0.8 0.402
I
<0.001
%apcptoticCD4 0.1-0.8 0302 0.9-211 3.45.9
t
0.004
%CD25+ 32- 6. 7 4.51.0 23-5.8 3.9l.l 0.442
%CD4+CD25+- 22-5. 8 3.50.9 0.4-3.9 2.41.0
I
0.031
%HLA-DR+- 13.6-352 21.75.4 20.9-53.0 36.610i
t
O.001
%CD8-fHLA-DR+ 15-7.5 4.01.8 11.8-38.4 18.98.4
t
O.OOl
#r/mphocyte 1041-4134 2478823 130CM450 2546+554 0.431
% lymphocyte 20.0-53.0 35.0U.O 29.0-58.0 433+92
t
0.019
#WBC 2700-12800 7380+2404 2900-12200 6048+2566 0.170
#=number, %=percentage. "?" means parameter in HIV-positive subjects higher than in HrV-negative subjects.
"I" means parameter in HTV-posinve subjects lower than in HTV-flegative subjects.
Table 2: Immunological parameters in Guangzhou, China: Nonnal vahies in comparison with data for HIV-positive
subjects
200
180
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Figure I: Dynamics of plasma TNF-a and soluble immune activation markers (O: TG; D: SGI; O: SG2)
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Figure 2: Dynamics of CD4 cell count and percentage, CD4/CD8 rati o and apopotic CD4 cell percentage ( O: TG; D: SGI; O: SG2)
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UNIVERSITY OF CALIFORNIA, LOS ANGELES
BERKELEY DAVIS IRVINE LOS ANGELES RIVERSIDE SAN DIEGO SAN FRANCISCO
Center for Interdisciplinary Research
in Immunology and Disease (CIRID)
October 17, 2002
UCLA
Steven Peckman
2107 PVUB
MC 169407
Dear Mr. Peckman,
RECEIVED
If jV. 1 *
OCT 2 1 2002
OPRS
SANTA BARBARA SANTA CRUZ
Department of Microbiology. Immunology and
Molecular Genetics
UCLA School of Medicine
650 Charles Young Drive South
Box 951747
Us Angeles. CA 90095-1747
Phone: 310-825-6568
Fax:310-206-1318
E-mail: jlf2hey1amednel.ucb.edu
This is written as a response to your letter of October 8,2002 concerning "Complaint About
Human Research Collaboration on Malariotherapy".
Item 1) I am not acknowledged as a co-author of "three scientific articles" and have no
knowledge of being cited on any manuscripts, articles or abstracts "[that] have been
submitted to international AIDS conferences describing research" related to
malariotherapy in collaboration with Dr. Henry Heimlich.
Item 2) I have not been "working in conjunction" with the Heimlich Institute.
Item 3) I did not receive human biological samples from this project. When Dr. Xiao Ping
Chen, the Principal Investigator for the project in China, came to UCLA for the Fogarty
International AIDS Training and Research Program (AITRP) (5-T22 TW00003) in
1997, he brought serum samples obtained during a malarial study conducted in China
before any contact with UCLA. Dr. X.P. Chen performed several immunological tests
on his samples and took his remaining samples back to China when he returned.
Contrary to Dr. Heimlich's statement, we did not (and do not) measure "the actual
virus".
Dr. X.P. Chen was trained to do ELISA tests for neopterin, (3
2
m, sTNF PJI and IL-2.
HIV p24 antigen measurements were demonstrated by Dr. Pari and Hripi Nishanian.
The UCLA Fogarty AITRP did provide reagents for testing of Dr. X.P. Chen's samples
at UCLA as a part of the immunology laboratory training.
a) I am not acknowledged in scientific presentation, papers or articles for the work Dr.
Heimlich refers to in the interview.
Item 4) Dr. Xiao Ping Chen was a Visiting Scholar at UCLA from 03/24/97 to 05/31/97,
receiving training in AIDS research under an existing Fogarty AIDS International
Training and Research Program (AITRP) at UCLA. In addition to AIDS epidemiology,
Page 2 of3
Steven Peckman
October 17,2002
pathogenesis and clinical design classes, Dr. X.P. Chen was particularly.interested in
learning the immunologic methods used in AIDS research.
We did not "carry out independent verification of the immunological results
obtained in China".
"Technical support" included instruction in immunologic laboratory methods, and
reagents for practice testing and quality control.
I had no contact with patients and could not have reported that patients' treatments
were progressing extremely well.
The "nature of the work" at UCLA was training in immunologic laboratory
methods, clinical trial design, ethics of patient recruitment and information,
necessity to have approval of all applicable Institutional Review Boards before
undertaking a clinical research project, and quality control and quality assurance
procedures. Similar training was provided to all Chinese Fogarty AITRP trainees
who came to UCLA and contact was maintained with them during the two years
following return to China. We did supply reagents for setting up quality control
procedures for immunologic testing in Guangzhou.
Item 5) I did not collaborate in the pilot malariotherapy research as indicated in the article. Dr.
Heimlich's account mixes two research studies they didone of which (1994) used a
poor method to measure CD4 T cell levels. Thus, the claimed changes in CD4 T cell
levels are not reliable. I did offer training in immunologic laboratory methodologies to
Dr. X.P.Chen in 1997.
a) I did not participate in fundraising for the Heimlich Institute's malariotherapy
research.
b) I did not ask to join the Heimlich Institute research project in 1996. I did offer
training in research on AIDS, mainly immunologic laboratory methodology, to
the Chinese scientists of the Center for AIDS Control and Research, Municipal
Health and Anti-Epidemic Station of Guangzhou, Guangzhou, People's Republic
of China. Similar training was conducted for other Chinese scientists from other
research institutions in China.
c) If the deleted names refer to visits by John L. Fahey to the Municipal Health and
Anti-Epidemic Station of Guangzhou, I can say that I was obtaining information
on the value of the training program provided by the Fogarty AITRP at UCLA.
There was no "independent corroboration" of the results.
i) I and individuals from my laboratory did not "make regular trips to the
research site in Guangzhou to provide independent evaluation of the quality of
the research" or provide "independent corroboration of results". I did make
trips to China in 1998 and 1999 to visit seven Chinese trainees in their home
institutions as a normal follow-up to the International AIDS Research
Training acquired at UCLA. Guangzhou was included.
ii) There was no activity in any capacity resulting in co-authorship on scientific
articles, papers or presentations.
Page 3 of3
Steven Peckman
October 17, 2002
Item 6) I did not provide financial support for the referenced research. We did supply kits for
establishing immunology laboratory capacities and for establishing quality control
procedures.
a & b) Funding was from the Fogarty training grant 5-T22-TW00003 for supplies
which are allowed by Fogarty International Center policy to be sent for continued
in-country training. UCLA funds were not provided for the research.
Item 7) I did not_assist in the research design of the clinical trial "Impact of Acute Vivax
Malaria" beyond the feedback provided to all international scholars for the hypothetical
research project description they are required to prepare during the training period at
UCLA.
a) We did donate reagents for flow cytometry and cytokine quality control
measurements as part of the in-country training. My colleagues and I performed
no laboratory tests for this research.
Item 8) I did not receive any research materials from subjects in malariotherapy research. The
samples from a prior study that were independently brought by Dr. X.P. Chen to UCLA
and tested by Dr. X.P. Chen were identified only by serial numbers (1, 2, 3, etc.) and
could not be linked back to the subjects.
Item 9) None.
Item 10) I did not visit China in order to provide services, information or guidance related to
malariotherapy research. My two follow-up training visits to Dr. X.P. Chen and other
Fogarty International trainees elsewhere in China were funded by a Fogarty grant 5-
T22-TW00003. Dr. Najib Aziz's visit in 1999, for Immunology laboratory personnel
training related to AIDS research, was in response to an invitation and was paid for by
the Municipal Health and Anti-Epidemic Station, Guangzhou.
Item 11) Dr. Xiao Ping Chen was appointed as a Visiting Scholar, not as a postdoctoral student
or an employee. He was one of eight international AITRP scholars at UCLA, who
trained in my laboratory for two months in 1997.
a) He was at UCLA 03/24/97 to 05/31/97.
b) He did not work with the Heimlich Institute while under my supervision. Dr. X.P.
Chen included Chinese serum samples from a prior malariotherapy study in the
laboratory training exercises at UCLA.
c) See 1 lb above.
J ohr$i. Fahey, MD
i.4.'Wta*2 17: 28 318- 285- 1316
CI KI D AT UCLA
PAGE B2/ 02
SEHKJil J: DAVIs IIWIVU LOS *N( . ! i S MURCXL'
1
- IIIVERSHM-. VAN 1)1 W) SAN FKA.NC15UI
UCLA
NA.VTO IURBARA SANTO CRUZ
MEMORANDUM
I J EPAHTMI L NTOF MICROIIIOLUCY A VI) tM.VR'VOLOCV
LI-LA SCHOOL Or MFDICINE
4.1.204 CENTfK FOU HEALTH SCIENCES
(flO CHAHLES E YOUNG DIL SOL TH
!. !* AKCF.I.KS. CALIFORNIA 0<W!?S.Htf3
F.UC:<JIO>2-nMU5
DATE: October 24, 2002
TO:
FAX:
FROM:
RE:
Steven Peckman
Office of Protection of Research Subjects
(310)794-9565
Dr. J.L. Fahey
Addendum to J.L. Fahey letter of October 17,2002 responding to
S. Peckman letter of October 8,2002.
Item 12: Provision of additional information:
Training for Dr. X.P. Chen essentially ended in 1999, and Dr. Chen was
notified in February 2000 that there would be no further support.
Sincerely,
JLF/plg
DIVIDER
e&
fJP
MEMORANDUM
In Immunology and Disease (CIRID)
UCLA Sdhool of Medicine
Center for the Health Sciences
174718
November 5,2002
William F. Friedman, MD, FAAP, FACC
Senior Associate Dean for Academic Affairs
Dean's Office
David Geffen School of Medicine at UCLA
12-138 CHS, Box 951722
Los Angeles, CA 90095
Dear Dr. Friedman,
The UCLA ADDS International Training and Research Program conducted training activities
with Dr. Chen Xiao Ping, but did not conduct research projects with the Center for ADDS Control
and Research, Municipal Health and Anti-Epidemic Station in Guangzhou, China. The training
activities with Dr. Xiao Ping Chen and his staff were completed by February 2000.
Thus, it would be appropriate to request that Dr. Henry Heimlich omit future reference in
interviews or publications to UCLA's "association with" malariotherapy or other research
projects at that site, or with the Heimlich Institute.
John i^Fahey, M.D. d
JLF/pg
i l ? *- ^ *% - Vi ^ -\>r D4S
lud*
MEMORANDUM
November 26,2002
UCLA School of Medicine
174718
Steven Peckman
2107 PVUB
MC 169407
L
RECEIVED
DEC 0 2 2002
OPRS
Dear Mr. Peckman,
You and your associates may have read the November 22,2002 edition of the Daily Bruin, with
a repetition of allegations from the "Bob Smith" letter.
I have reviewed my responses of October 17 and 24 to your letter of October 8, 2002 to
determine the clarity of my earlier responses to your specific questions and whether relevant
issues were addressed.
The fact is that Dr. Xiao Ping Chen and The Municipal Health and Anti-Epidemic Station in
Guangzhou had two separate relationshipsone with Henry Heimlich and the Heimlich
Institute, and one with J ohn L. Fahey and UCLA. The association of Dr. X.P. Chen with Dr.
Henry Heimlich began early in the 1990's and focused on clinical studies of malarial therapy.
The second and separate relationship that Dr. X.P. Chen and The Municipal Health and Anti-
Epidemic Station in Guangzhou had was with Dr. J ohn L. Fahey and UCLA. This was a direct
relationship. It was never conducted through or with Dr. Heimlich. The Fahey/UCLA-
Chen/Guangzhou project was for education, training and capacity building for ADDS research at
Guangzhou under the Fogarty ADDS International Training and Research Program (AITRP). It
was initiated in 1997 and completed in 1999. It did not involve the conduct of any clinical trial.
It was not for malarial therapy. We knew of Dr. Chen's interest in various therapies for HIV
infection, but we made it clear to him that we would not be (and were not) involved in the
conduct of malarial or other specific research. In this context, he understood that we would not
be listed as an author. Dr. X.P. Chen wrote the quoted acknowledgements without input or
review by us. We presume he appreciated the financial support for his travel to Los Angeles and
living expenses while here in the AIDS International Training and Research Program (AITRP).
Dr. Heimlich apparently did not make the distinction between the UCLA training of the Chinese
investigators and the conduct of research projects which he initiated with Dr. X.P. Chen. Dr.
Heimlich was not involved in the UCLA-Guangzhou relationship. Of course, I did not know
f a hpv T I l Aâr^rt^hanv 043
Page 2 of2
Steven Peckman
November 26,2002
what Dr. Heimlich was writing or saying until after October 2,2002, and was not aware that he
was including us and UCLA in his view of the malarial research project. Consequently, we have
acted with UCLA authorities to have reference to UCLA omitted from the Heimlich Institute
materials. See two attached letters of November 5 and 7,2002.
I hope this effort to provide additional information is appropriate to the IRB review procedures.
Sincerely,
John L. Fahey," "^^
Enclosures (2)
cc: William F. Friedman, MD
Alan G. Robinson, MD
Irvin S. Y. Chen, Ph.D.
JefferyF. Miller, Ph.D.
f ahov mal ar i ot haov
044

B MEMORANDUM
169407
December 10, 2002
John Fahey, MD
174718
Dear Dr. Fahey,
On behalf of the UCLA Medical Institutional Review Board (MIRB) I thank you for your
response regarding allegations related to malariotherapy research. Your responses were reviewed
during the meeting of November 6, 2002. The Board agreed that you do not appear to be
engaged in human subjects research related to the allegations from "Dr. Bob Smith". The MIRB
expressed concern that Dr. Heimlich posted information on his website that may imply your and
UCLA's involvement in such research and welcomed your response that he is being asked to
remove such references.
Though the MIRB determined after consideration of the information provided, you were not
involved in the malariotherapy research, the Board noted additional issues. The MIRB requests
your response to the following issues by January 3, 2003:
1. Your response indicates that Dr. Xiao Ping Chen came to UCLA in 1997 as part of the
UCLA Fogarty International AIDS Training and Research program. Dr. Chen brought to
UCLA anonymized blood samples from Chinese subjects who participated in malaria
research. The samples were analyzed as part of Dr. Chen's immunology laboratory training.
Please clarify for the Board whether Dr. Chen's analysis of the samples was intended to
contribute or develop publication of any findings related to malariotherapy research or other
research.
a. If so, please clarify whether Dr. Chen had UCLA IRB approval or a UCLA certified
exemption from IRB review for the research use of the samples. If he had UCLA
approval, please forward the approval number with your response. PLEASE NOTE:
The UCLA Multiple Project Assurance with the DHHS-Office for Human Research
Protections requires UCLA IRB approval or certified exemption for the prospective or
retrospective use of human biological materials for research purposes.
o:/inquiry/fahey/fahcy inquiry 021210
John Fahey, MD
page 2
b. As noted above, research with biological materials obtained from living individuals
requires UCLA IRB approval or Certification of Exemption. Please assure the Board that
you will require UCLA IRB approval or Certification of Exemption from individuals who
wish to work with human biological samples or data for research purposes and work in
your laboratory or participate in scholarly programs under your supervision, such as the
Fogarty International grant.
2. Your response to question #6 indicates that you supplied kits for immunologica] tests and
establishing quality control procedures to Chinese investigators for in-country training. It
appears that funding for the supplies was from Fogarty Training grant 5-T22-TW00003. Such
grant awards are to the University and constitute UCLA funds. Please clarify whether the
supplies were given to Dr. Chen as a Fogarty scholar or as a courtesy.
a. If the supplies were given to Dr. Chen as a courtesy, such distribution of material
obtained through a Fogarty award may make the DHHS directly or indirectly engaged in
the research. You should contact Grants Officer Martha Hansen, Office for Contract and
Grants Administration regarding grant requirements. Please provide the Board with
follow-up information regarding your discussions with Ms. Hansen regarding the above
issue.
On behalf of the MIRB, I thank you for your commitment to the protection of the rights and
welfare of human research subjects. Please contact Steven Peckman, Associate Director Human
Subjects Research at 825-5344 or speckman@oprs.ucla.edu if you have any questions.
Sincerely,
Robert A. Figlin, MD
Chair
On behalf of the Medical Institutional Review Board
Steven Peckman
2107 PVUB
169407
DIVIDER
I'.-\A oj u ug jioau
LLLA CAMH.S COUNSEL
21002
311 STRAIGHT
STRET
CINCINNATI
OHIO
45219
513-559-2391
FAX 513-559-Z*03
heim3ich@Qlaj.nom
www.hamllchlnstiujiajrs
Benefiting
Humanity
Through
Health
and
Peace
December 16, 2002
Ms. ParticiaM. J asper
Campus Counsel
Office of the Chancellor
Box 951405
Los Angeles, CA 90095-1405
CD
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Dear Ms. J asper:
Your letter of December 2, 2002 arrived on December 12. Obviously you are unaware of
the relationship between UCLA and myself.
In order to clarify the matter for all concerned, I enclose a portion of correspondence
between UCLA Professor John L Fahey and myself, In addition, correspondence
between Dr. Fahey and his staff with our Chinese colleagues who performed
malariotherapy for HTV/AIDS patients is included. The letters extend over five years,
from August 8, 1996 to February 7, 2001. These letters document Dr. Fahey's extensive
participation to the malariotherapy project of The Heimlich Institute, for which we are
very grateful.
UCLA Professor Fahey's first letter to me at The Heimlich Institute is dated August 8,
1996. He states:
It was a pleasure to see you again in Vancouver and dave a chance to
talk farther about malariotherapy that you have been exploring. The
work is striking and certainly points, towards the possibilities for
resetting the disturbed immune balances of HIV infection by major
immune stimulation.
The two meetings he refers to were at the National Institutes of Health and the 11*
International AIDS Conference. I had been invited to present The Heimlich Institute's
malariotherapy treatment of HTV/AIDS to both conferences..
The next two paragraphs of Dr. Fahey's letter describe how UCLA plans to help me in
our malariotherapy program. Dr. Fahey offers to carry out highly specific laboratory
studies "to assess in selected patients treated with malariotherapy." He also offers to
"develop a means of helping your Chinese colleagues in carrying out their studies"
(malariotherapy)-
Many letters from UCLA confirm that Dr, Fahey and his UCLA staff, over the several
years of our affiliation, fulfilled his promise to provide reagents for malariotherapy
studies. Dr. Chen, principal investigator in China for our malariotherapy program, sent
Affiliated with Deaconees Associations inc.
fahev mal ari othaDV
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the following e-mail, November 21, 1997, to Dr. Najib Aziz, Dr. Fahey' s UCLA associate:: ;
Dear Dr. Aziz:
Dr. Fahey's visit tt Guangzou last month was very helpful to our project
ofmalariotherapyfor HIV infection. Now we eill start the next batch of
clinical trials very soon. So I hope that you send us the following
reagents as soon as you can I ,y federal Express or other express^.
Your objections to The Heimiich Institute using UCLA or Dr. Fahey's name in relation to
malariotherapy totally contradict Dr. Fahey's wishes. Dr. Fahey's letter of August 6,
1997, on UCLA letterhead, provides an extensive analysis and recommendations
concerning each malariotherapy patient treated. Dr. Fahey then states:
Please feel free to use this data in reports and publications. We would
appreciate an acknowledgment and credit to the support provided by
NIH grants TW00003 andAl 36086.
Your decision to prevent ackhowledgmeot of Dr.Fahey's name and UCLA's
participation in malariotherapy conceals their extensive participation in malariotherapy
treatments.
Your letter speaks of "mischaractizations" and "misrepresentations". We are aware of no
statement that I or The Heimiich Institute have published, concerning Dr. Fahey or
UCLA that is inaccurate. IFyou have such a statement, kindly forward it to us.
Furthermore, we ask that you send my letter of December 16, 2002, and the enclosed
correspondent to those on the UCLA staff who receive copies of your letter, and to all
other UCLA staff who are aware of your action.
Address your response and all future correspondence to our attorney, Joseph Dehner,
Frost Brown & Todd, 201 East Fifth Street, Cincinnati, OH 45202.
As you state, the University takes matters such as these seriously. Your prompt response
is, therefore, warranted.
Sincerely,
., ScD.
President
cc: John J
;
Moores, University of California Board of Regents Chairman
Richard C. Atkinson, University of California President
End
fahev mal ari othauv
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&004
UNIVERSITY OF CALIFORNIA. LOS ANCELES
CCLT IKVTNE UDSANCCLeS
nrvEnsioe
SANOICCO
*Center for Interdisciplinary Research
in Immunology and Disease
Augusts. 1996
Henry J . Heimlich, M.D., Sc.D.
President, Heimiich Institute
2368 Victory Parkway
Suite 410
Cincinnati, OH 45206
UMTA IAHARA
UCLA
fcAKTAcmrt
OEPARTMEfn-OF MrCHORIOUX^r AHD JKMLTNOI JCX^-
UCU. SCffOOLOF MEDICINE
COTTER FOR THE HEALTH SCIENCES
10833 LE COWTE AVESTU E
(JUS ANGELi.O.UFO.RKtAflOCKW-17<T
(310)825^568
(310)206-1318 (FAX)
Dear Henry:
It was a pleasure to see you again in Vancouver and have a chance to talk further about
malariotherapy that you have been exploring. The work b striking and certainly points towards
the possibilities for resetting the disturbed immune balances of HIV infection by major immune
stimulation.
I wondered if we could help you. Two contexts come to mind. One is our interest in cytokines
and their products, especially the soluble markers of activation. We have the capacity to measure
most of the cytokines in circulation as wdl as the capacity of peripheral blood mononudear cells
to produce cytokines under various forms of stimulation. These might be interesting to assess in
selected patients treated with malariotherapy.
The second context is in the form of a Fogarty International Center (NTH) AIDS International
Training and Research Program (ATTRP), which we have at UCLA and which is becoming
increasingly involved with studies with intervention and quality control efforts. In this context,
we could, perhaps, develop a means of helping your Chinese colleagues in carrying out their
studies. Assistance with reagents and quality control samples for CD4 measurements as well as .
for other parameters of HTV infection. I would be glad to explore these further with you.
Sincerely,
&
J ohnL.Fa6y,i tD.
Director of *CIR1D at UCLA
JLF/jm
cc: Evelyn Najera, MPH
Hong Bass, M.D., Ph.D.
b:/KeimIicfe
DAVI S
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UCLA
IAKTA lAMAlA
lAKTA CS17I
Centerfor Interdisciplinary Research in
Immunology and Disease
December 16, 1996
FOCJAKTY INTBRNATIONAL AIDS RESEARCH PROGRAM
CIWOATUCU
I2439 FACTOR BUILDING
CENTER FOR HEALTH SCIENCES
1 J3 LB CONTE AVEKUE
LOS ANOELES, CA *X4-J747
TEL (110)125-1510
fax{3I O)625-OS95
Dr. Chen Xiao Ping
Chief; Department of Microbiology
The Municipal Health and Anti-Epidemic Station of Guangzhou
No. 23, 3rd Zhongshan Road
Guangzhou 510080
P.R. China
Fax: 011-86-20-8381-4993
Dear Dr. Chen Xiao Ping:
This is a follow-up to your letter of November 1 2, 1996 addressed to Dr. John L. Fahcy,
Attached is the invitation letter you requested. In addition, I have included an application
form necessary to complete Fogarty Program procedures. Please return this as soon as
you are able.
I will Federal Express the attached so thai you will hsvc originals. In the meantime, if you
have any questions fed free to address them to me, My telephone and fax are listed
above. My e-mail is as follows: enajera@racroimmun.rae<isch.ucla.edu.
I look forward to hearing from you.
Sincerely,
w^ f 8> > 1 ^
Evelyn G.N4jera,MPH
Fogarty Program Manager
Center for Interdisciplinary Research in Immunology and Disease
cc: J ohnL. Fahey,M.D.
Henry J, Keixnlich, M.D.
Poat-l f Fax Note 7071
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UNIVERSITY OF CALIFORNIA, LOS ANCELES x ^^ ^
U C L A
EBtELET DAVIS - WV1NE ' " WJS-ANCgtXS IVE*SIDE , , SAN PtECO S*WfTtANCJSCO
A. Immunology and Disease (CIRID)
DeTAJCIMENT OF MKXOBtOUXIYAND IMMUNOtOOr
UCLA SCHOOLOP MEDICINE
CEKTER POK THE KEAUH SCIENCES
' WUt eoqrrrEAVSNUE
AUg USt 6 , 1 9 9 7 UJSANGEU3
1
CAJIPMA95-l7<7
(310)82^56? .
f3!0)205-!3IS(FAX)
Henry J . Heimlich, M.D., Sc.D.
President
The Heimlich Institute
2368 Victory Parkway, Suite 410
Cincinnati, OH 45206
Dear Henry:
Enclosed are tables of the data obtained pn the samples provided by Chen Xiao
Ping. We have problems with.interpretation because of uncertainty as to when the
samples were obtained in relation to therapy in most of the patients. Hopefully,
you have more exact data, Chen Xiao Ping gave us shifting information at
different times during his stay here.
Patients 4003 and 4004 are probably the clearest Presumably, the first samples
were obtained before malariotherapy, the second samples during malariatfaerapy
and the subsequent samples were after malariotherapy. 4003 had a baseline
neopterin of 6.97 (within the normal range). p
2
M was normal and sTNF-RH was
at the upper end of normal. A marked rise is seen about 3 weeks later during
therapy. About 11 days later, there is substantial subsidence. Subsequently,
values are in the normal range (but gradually falling) in 194 and progressive
increases in 1995 and 1996 until abnormal levels are recorded 9/11/96.
Patient ID 4004 follows a similar course with the exception that his baseline was
elevated in 1993. His post therapy values were generally below baseline and were
mosUy in me normal range in 1995 but were increased again in the 1996 sample.
The other patients present the problems of not knowing if the first values; were
pre-treatment or were obtained during or soon after malariotherapy. The'absence
of certainty about these first values (Do they represent just disease or disease plus
malariotherapy or disease plus some other infection?) presents difficulties' for
interpretation of the subsequent values.
f ahev mal ar i ot haov 020
v-nMi L J ÛL SGL 8l 0 0 "
In the-accompanying griyM'please understand that the "0" time point only
indicates the first sampjeiat we had for patients 4001, 4002, 4005, 4006, 4007
and 4008. We are uncertain about their relationship to maiariotherapy.
Please feel free to use this data in reports and publications. We would appreciate
an acknowledgment and credit to the support provided by NIH grants TW 00003
and AI 36086.
The difficulties outlined above contributed to our concern that Chen Xiao Ping
have a carefully written out experimental plan (in English and in Chinese) in
advance of future maiariotherapy studies. Both versions of the plan should be
available to you (I would be glad to review these).
As you know, I believe that maiariotherapy may act by similar mechanisms to
those operating in the 5-day continuous intravenous IL-2 treatments developed by
Lane, Kovacs and their colleagues. Both malaria and IL-2 stimulate marked
increases in all or almost all cytokihes. EL-2 induces CD4 increases without
reductions in viral load. That is why we have been concerned to help Chen Xiao
Ping have accurate CD4 measurements. He still has to develop a working
relationship with the persons wlio have a flow cytometer at his institution.
Si ncerel y^
7
J ohn L. fahey, MIX
Di rectori es at UCLA
Chair, Clinical Immunology Committee, International
Union of Imiriunological Societies (IUIS)
J LF/dm
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J uno e-mail printed Wed, 6 Nov 2002 15:23:04 . page 1
From: "Chen Xiao Ping" <chenxp@gzsums.edu.cn>
To: "Najib Aziz" <naziz@ucla.edu>
Cc: "Dr. Ere G. Spletzer" <egspletzer@hotmail.com>,
"Dr. Henry J . Heimiich" <Heimlich@lgiou.com>,
"Henry J . Heimiich" <heimlich@juno.com>.
"Debbie" <dmathies@microimmun.medsch.UCLA.edu>
Date: Fri 21 Nov 1997 08:03:39 +0800
Subject: Send reagents
Message-ID: <199711202355.HAA03512@ gzsums.edu.cn >
Received: from mx2.boston.juno.com (mx2.boston.J uno.com [207.205.100.51])
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X-Mailer. Microsoft Internet Mail 4.7Q.1155
Return-path: <chenxp@gzsums.edu.cn>
Dear Dr. Aziz:
Dr. Fahe/s visit to Guangzhou last month was very helpful to our project
of malariotherapy for HIV infection. Now we will start the next batch of
clinical trials very soon. So I hope that you send us the following '
reagents as soon as you can by Federal Express or other express.
1. Kits for flow cytometry including CD4, CD8, CD25, HLA-DR and CD4 PCD
(apaptosis) testings.
2. Kits for activation markers including NPT, B-2-M, TNF-a, IFN-r,
sTNF-aRII, SIL-2R and plussing IL-2 (i f possible, plussing IFN-a. IL-6
and
IL-10) testings.
By the way, t have now another hypothesis that malaria stimulates a shift
from Th2 to Th1 pattern of immune response in HIV patient. I believe that
it will be confirmed by our coming trials.
Best regards.
Dr. Chen Xiao Ping
Research Associate Professor
fahev mal ari othaov 022
uî_rv L M f L S Ll Hl NS hL
009
J uno e-mail printed Wed, 6 Nov2002 15:30:36 . page 1
To: <helmlich@iglou.com>
Cc: "Dr. Eric G. Spletzer" <egspietzer@hotmaiI.com>.
"Henry J . Heimlich" <heimIich@juno.corn>
Date: Thu. 18 Dec 1997 08:27:41 +0800
Subject Re: Patient selection
Message-ID: <199712190035.!AA18221@ gzsums.edu.cn >
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Dear Dr. Heimlich and Dr. Spletzer:
We have 20 HIV patients at hand, among them 3 are sexually transmitted
and
others are drug users. The most important thing right now is that we are
waiting for the reagents from UCLA (and we are dealing with the customs
issue) to screen CD4 levels of the patients due to other criteria of
patient selection, According to the principal of scientific research, we
need the same batch (or the same resource ) of reagents to test patients
before and after treatment Ail things are progressing here in Guangzhou.
The number of tested and officially reported HIV positive patients in
China
is about 2800 by now. All other numbers are estimated and I believe that
nobodies know the exact number. But we can say that HIV/AIDS has been B
real problem in China; in some regions such as Yunnan Province the
problem
has been really severe.
Yes, we have received the funds from the Heimlich Instiute.
Merry Christmas!
Dr. Chen Xiao Ping
>From: Dr, Henry J . Helmlfch <heimIich@lgIou.com>
>To: chenxp@gzsums.e4u.cn
>Subject Patient seiecfion:
>Date: Thursday, December 18,1997 8:57 AM
>
>Dear Dr. Chen,
>
>We received copies of the e-mail concerning the Import of test
>reagents, and are glad to see that things are proceeding. However,
>we are still interested In knowing how patient selection is going,
>especially for the serially transmitted cases.
>
>A recent lecture by R. Peter Piot, Executive Director of the UNAJ DS
>program, stated the following:
fahev mal ari othaDv 023
~>. _ ~ . . . . . u j . is ui_U-\ LAHl - l . a CUUNSKL @) 01 0
J uno e-mail primed Wed, 6 Nov2002 15:30:36 , page 2 .
>
>"In China -on the other hand, dramatic developments with consistent
>increase In HIV infections may be expectedin the coming future.
>The national AIDS committee in China just released estimates projecting
>the number of people living with HIV/AIDS rising from 400,000 at the
>end of 1997 to about 1.2 million by the year 2000. Whereas most of the
>HIV infections in the past occurred in Injecting drug users, the
>dramatic increases in sexually transmitted diseases in China suggest
>that the main mode of transmission of HIV may/apkily changein the
>coming years. STDs are becoming particularly widespread!! China's
>coastal regions with their booming economies, growing cfjspafifes; in
> wealth, and vast population movements. A study.in Yunnan .Province,
>for example, has already shown how easily the epidemic can break out
>of the drug user group to their sex: partners and ultimately their
>children. Here around 7% of the spouses of infected'drug users are
>already infected with H(V. As elsewhere in Asia and the Pacific,
>where the tiger economies are bringing In new wealth, the potential
>also exists for an acceleration of the epidemic."
>
>Do you feel this is accurate?
>
>We hope that everthing else is going well for you and your colleagues,
>
>Happy holidays!
>
>
>Eric G. Spletzer. Ph.D.
>
>P.S. Did the funds we wired make to your account?
f ahev mal ar i ot haov
0 2 4
L. u eu i- \J \J
^L . 1 ^.imi-La ÛLivstL i aon
J uno e-mail printed Wed, 6 Nov2002 15:33:07 , page 1
From; "Chen Xiao Ping" <chenxp@gzsums.edu.cn>
To: "Mathieson, Deborah" <dmathies@microtmmun.medsch.UCLA.edu>
Cc: "Dr. EricG Spletzer" <egspletzer@hotma5.com>,
"Dr Henry J . Heimlteh" <Hemlfch@iglou.com>
"Evelyn" <enajera@miCToimmun.medsch.UCLA.edu>,
"Henry J . Heimlfch" <heimlich@juno.corn>,
"Najlb Azir" <naze@ucla.edu>
Date:Thu 25 Dec 1997 11:30:51 +0800
Subject Re: Dr Fahe/s letter of Nov. 13
Message-ID: <lWl2250334.LAA15457gzsums.edu.cn >
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Dear Dr. Fahey.
Thank you very much for your Setter of November 13 and for your
appreciation of Guangzhou and the Municipal Health and Anti-Epdemic
Station
of Guangzhou.
Yes, the time was too short to arrange a visit for you to Guangzhou
Ytshou
Hospital where HIV patients receive malariotherapy. There are at least
two
clinical doctors specialty staying at the hospftai for the therapy when
patients are during the febrile periods with malarial Infection and some
times I stay there too (by the way,I was a physician for infectious
diseases from 1982 to 1988). All individuals are clear in their
responsibilities In the studies because we have a research contract in
which all participants signed their names.
The technician who is in charge of flow cytometry in Professor Yu Chun
Shan's laboratory now wll to accept HIV positive samples after your
visit
and my contact with him a couple of times. We are plaining to treat 10
patients, among them 8 are drug users, other two are sexually
transmitted;
we have no control group this time according to our protocol. Thank you
again for your reminding us of the CD4 measurements on two blood samples
before starting the treatmen! and other issues.
We are still dealing with the customs tax-free procedure for the
reagents;
It takes a period of time but we will iet you know as soon as we have
delt
it up.
Sincerely, you are warmly welcome to visit Guangzhou again and I suggest
that If possible, please come together with Dr. Helmlich when the
patients
are infected with malaria.
fahev mal ari othaov
025
4- ^ ' J . u ' \J ^
xo. i u I '.I /I j i u i uu " u u i x u LAMJ 'l.S COLNSEL 012
J uno e-mail printed Wed, 6 Nov2002 15:33:07 . page 2
Merry Christmas and happy New Year!
Dr. Chen Xiao Ping .
Chief, Department of Microbiology
The Municipal Health and
Anti-Epidemic Station of Guangzhou
fahPv mal ar i othanv
026
L k . l - 1 L A M r L S L.LIL! >S)f cl
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J uno e-mail printed Wed, 6 Nov20D2 15:38:19 , page 1
From: "Najera Evelyn" <ENAJ ERA@microlmrnun.medsch.ucla.edu>
To: Chen Xiao Ping <chenxp@gzsums.edu.cn>
Cc: "Mathieson, Deborah" <DMATHIES@microlmmun.medsch.uda.edu>.
"Henry J . Heimlteh" <heimlich@J uno.com>
Date: Mon, 12 J an 98 12:04:00 PST
Subject Reagents and customs
Message-ID; <34BA77AS@deans.medsch.ucia.edu>
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Dear Dr. Chen:
I hope you are having a pleasant beginning in 1998. Thank you for the
photos and for your wishes. I will also forward the photos to Matt which
I
am sure he will be pleased to receive.
Thank you for sending such thorough explanation on your customs
situation.
You may also want to speak with 2 of our trainees in China conducting
work
there. They have been able to obtain clearance through customs with the
same documentation I provided to you and DHL. They may be able to
provide
some advise on the procedure from their end:
1) Dr. Hong Wang-School of Basic Medical Sciences
Tel. 86-106-209-1155
Fax 86-106-20S-1436
2) Dr. Xudong Lin-Chinese Academy of Preventive Medbtne
Tel. 86-106-353-8521-71
Fax. 86-106-302-2960
In the meantime, I will discuss this issue with Dr. Fahey and we will be
in
touch with you.
Best Regards,
Evelyn
From: Chen Xiao Ping
To: Mathleson, Deborah
Cc: Najb Aziz; Dr. Eric G. Sptetzer; Dr. Henry J . Heimlch; Evelyn;
Henry
f ahpv mal f l ri oMhsnv 027
J . U . L. f j I oiu iuo iJ au LI.IJ \ CAMELS CUL.NSEL 014
J HeimMch
Subieet: Reagents and customs
Date-Wednesday. J anuary 07.1998 9:1BAM
Dear Dr. Fahey:
It is complicated to deal with customs duty-free in China. We have not
known the procedure unfa'! just now. We need in advance your donation
Known e
P
(by egress, not by fax) In which all reagents and the* values should
be
listed before you ship them. After we receive your donation letter, we
need
to apply customs duty-free at Guangdong Provincial Government with your
letter and only we get the approvement from the government can we let you
know the time to ship reagents. The customs authorities will let us
know when reagents reach Guangzhou Customs. Finally we need to go there
to deal with the duty-free procedure with your letter and
documentation of the government and then take the reagents .
Each time we need to do all things mentioned above. So we hope you ship
each time as many as you can. But we are urgent to need the reagents for
flow cytometry, because they have to be real time testing.
An officer who is in charge of the issue at the government suggested that
your donation letter should be written as follow (as reference, and he
also suggested to have your signature in the letter, because you had a
visit to our station and we have the document of your visit):
Donation Letter
Date...
Chen Xiao Ping. MD
The Municipal Institute for Preventive Medicine of Guangzhou
The Municipal Health and Anti-Epidemic Station of Guangzhou
No. 23.3rd Zhongshan Road
Guangzhou 510080, The People's Republic of China
ph: (20)83828291
fax: (20) 83615255
We are please-d 10 know inat rnaianouierapy for niv/Aiuo has been
at your institute and some good results have been attained from the
atudy.
In order to promote the global research of AIDS prevention and treatment
we decide to provide some reagents to help the research. Thestreagentt
are
purchased by Fogarty AIDS enternational Traineng and Research Program at
UCLA and are given as a gift to the Municipal Institute for Preventive
Medicine of Guanzhou, the Municipal Health and Anti-Epidemic Station om
Guangzhof for special use on the research of matartotherapycor HIV/AIDS.
Supplies have no commercial value and cho not be sold in ChinaH
Specifically the shipped package contains:
Item Description Quantity Cost
f s h p v raalarinthanv
028
We hope you accept them.
Sincereiy,
J ohn L Fahey, MD
Director, Fogarty Progam
Director, Professor, CIRID
But you may write it In a formal and beautifu! English. Thank you.
Happy New Year!
Dr. Chen Xiao Ping
f a hpv ma l a r i n t h a n v 029
J . O . ^ , I ' . I A . H U i u o , : osu III;LA CAMPUS COUNSEL
S3 016
J uno e-mail printed Wed, 6 Nov 2002 15:o4:34 , page 1
To: "Evelyn" <enaJ era@mlcraimnWmedseh.UCLA.edu>
Cc: "Najib Aziz" <J aziz@ucia.edu>.-Mathieson.
Deborah" <dmathies@mcrolmmun.medsch.UCLA.edLi>,
"Dr. Eric G. Spletzer" <egspletzer@hotmall.com>,
"Dr. Henry J . Heimllch" <Hetrrtiich@iglou.com>,
"Henry J . Heimiich" <heimlteh@juno.com>
Date: Sun, 18 J an 1998 19:00:19+0800
Subject Reagents-urgent
Message-ID: <1998O119015SJ AA15106@ grsums.edu.cn >
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Dear Evelyn:
Thank you for your email of J an. 13 and for your all efforts on the
issue
of reagents. I have again contacted the officer at Guangdong Provincial
Government. He explained that it is the local government that manages the
issue of customs duty-free ( not the Central Government) and he implyed
that we should deal with the issue according to the regulations of
Guangdong Government net Beijing (local) Municipal Government.
We are very urgent to have the reagents for flow cytometry because they
are
real time testings and now we watt them for our clinical trial. Please
send
us the donation letter first by fax and than by express.! will let you
know the lime to ship the reagents (especially the ones for cytom etry)
through E-mail as soon as posible. Thank you again.
Best wishes
Dr. Chen Xiao Ping
fahev mal ari othaDv 030
oi u tua zaau UC1. A CAMFLS COLNHKI .
Lg] 01 7
J uno e-mail printed Man, 16 Sep 2002 1(U4:05 , page 1
To: "Dr. EricQ. Spletzer" <egspletcer@hotmail.com>,
"Dr. Henry J . Heimich" <Heimlich@iglou.com>,
"Henry J . Hemiich" <heimlch@juno.com>
Data: Sun, 8 Mar 1998 20:00:30 +0800
Subject: Fw. shipment return back to UCLA
>From: Nafib Aziz <naziz@ucla,edu>
>To: chenxp@g2sums.edu.cn
>Subject shipment return back to UCLA
>Date: Friday, March 13, 1998 6:31 AM
>
>DearDr.Chen.
>
>Unfortunately the shipment to you (Air Bi!i#1077268426}return back to
my
>tab by AIRBORN EXPRESS today AIRBORN EXPRESS has written to us that the
>items In the package are unacceptable commodtties by China and rejected
> from IEX Gateway. There are problems with the DHL Worldwide Express ,
>Federal Ejcpress. I am trying to find way to ship these Items back to
you
>soon. If you have any question regarding shipment please Email me .
>Thanks
>Najib Aziz
f ahev mal ar i ot hauv 031
1A 0 i U
<^
D
" " UCLA CAMPl.S COINSEL
018
J uno e-mail printed Mon, 16 Sep 2002 10:55:04 , page 1
From: "Chen Xiao Ping" <chenxp@gzsuma.edu.cn>
To: "Najib Aziz" <naziz@ucla.edu>
Cc: "Brian Ma" <pacbridge@aol.com>,
"Henry J . Heimfch" <heimfich@juno.com>,
"Dr. Henry J . Heimlich" <Heimlich@iglou.com>.
'Dr.Eric G. Spletzer" <egsplatzer@hoimail.com>,
<dmathies@microimmun.medsch.UCLA.edu>
Date: Sat, 11 Apr 1898 11:07.01 +0800
Subject: Re: Reagents
Dear Dr. Aziz:
I received the first pacicage of reagents on April 9 (you sent on March
31).
It took 9 days to reach me, I do not know whether these reagents are
still
useful because al! bagged ice dissolved when 1 received them. But t can
test them using blood samples taken from normal people before the
ciinical
trial. Any way, I must thank you very very much, you have done your best
I
do not begin the treatment until I receive your second package of
reagents.
Thank you again.
Best regards to you. Dr. Fahey and my other friends at UCLA!
Dr. Chen Xiao Ping
Director, Center for AIDS Control & Research
>From: Najib Aziz <naziz@ucla.edu>
>To: chenxp@gzsurns.edu.cn
>Cc: dmathies@microimmun.medsch.UCLA.edu; Dr.Eric G. Spietzer
<egspletzer@hotma8.com>; Dr. Henry J . Heimlich <Helmlich@ig!ou.com>;
Henry
J . Heimlich <heirnltch@juno.com>
>Subject Reagents
>Date: Saturday, April 11,1998 12:18 AM
>
>Dear Dr. Chen;
>
>The rest of your requested items shipped on Wednesday April 8 ,1998 and
you
>will have the package by Tuesday Apri 14,1998, This package has the
>following items:
>-lFN-gamma ElA one kit (96 tests)
> -sTNF-RII ElA one kit (96 tests)
>-slL-2RElA one kit (96 teats)
>-Coulter Manual CD4 count one kit (50 tests)
>-Propidlum Iodide onevial.
>The shipment number is 8392048830{(DHL woridwWe Express). If you have
any
>question regarding the shipment, please E-mail me.
>Thank You
>Najtb
f ahev mal ar i ot haw
032
i i . ' J 3 - ' U i :
u:28 h.u 310 2Ub 2390 LCLA CAMPUS COINShi
Subject: R Viral Load Testing
Date: Fri, 25 Sep 1998 16:02:33 4)700
From: chenxp <chcnxp@gaums.edu.cn>
Organization: chenxp
To: HI Heimlich <heimiich@iglou.com>
HJ Hei ml i ch wr ot e:
> Dear Dr. Chen
r
>
> He hope to approach the person sponsoring our nalariotherapy for HIV
> research soon for more funding. This foundation has told that we will
> not be able to get any funding for additional patients until Dr.
> F.exnlich and Dr. Fahey present the results on the current patients,
> especially the viral loads. In order to set up this funding
r
we must
> know as soon as possible About the viral loads. What arrangemenss have
> you made for the viral load testing? Have you talkdd to Dr. Fahey yet?
> If you have not had a chance to talk to him, please do so as soon as
> possible.
>
> I hope things are going well for you and your coworkars. We look
> forward to .hearngg from you soon.
>
> Best wishes,
>
> Eric
IS
mbcr *l iu
Dear Dr . Hei ml i ch and Dr . Spl et zer :
Thank you f or your emai l . Shi pment of HI V sampl es i s compl i cat ed. We
wi l l di scuss t he det ai l ed about vi r al l oad t est i ng when Dr . Fahey vi si t s
Guangzhou next mont h. Her e at t aches Dr . Fahey' s emai l .
Best r egar ds and wi shes.
Chen Xi ao Pi ng, MD
At t ached:
Subj ect ; Let t er
Dat e: Fr i , 18 Sep 98 12: 01: 00 PDT
Fr om: "J ohn L- Fahey, H. D. " <j l f aheySmdcr oi j i anun. i i i edsch. ucl a. edu>
To: "Chen Xi ao Pi ng, M- D. " <chenxpegr sums. edu. cn>
Sept ember I B, 1998
Dear Dr . Chen,
I amwr i t i ng t o ar r ange a vi si t wi t h you i n Guangzhou on Wednesday,
Oct ober 28, 1998. I amanxi ous t o know how al l of your wor k i s goi ng.
I t wi l l be i nt er est i ng t o l ear n about your r ecent st udi es of RXV
I nf ect i on and of t he pr ogr ess of t he mal ar i al t ner apy st udy-
Some of t he r eagent s t hat wo sent wer e t o measur e CD25 and HI A- DR
expr essi on on l ymphocyt es. Al so, ki t s f or TXT*., TNF- RI I , neopt er i n and
b2M det er mi nat i ons wer e pr ovi ded. I amsendi ng under separ at e cover
dat a
obt ai ned at UCLA on t he l evel s of t hese f act or s i n a r ef er ence HI V
negat i ve popul at i on as wel l as i n HI V posi t i ve i ndi vi dual s. Ke know
t hat t her e ar e subst ant i al l y f ewer KI V+ per sons i n Guangzhou. However ,
i t woul d be i nt er est i ng t o r evi ew your pr el i mi nar y dat a wi t h bot h HI V-
and HI V+ popul at i ons i n Guangzhou. We do not expeat t hat t he dat a woul d
Df2 9/25/W35 AW
f ahev mal ar i ot hanv
033
-_. --w.fc.vj i_j_^ UI VJ cvu zoav ILL \ C'VIHh'LS CGI !SSE1
be t he same i n bot h l ocat i ons, but a l ook at t he i ni t i al dat a mi ght be
advant ageous at t hi s t i , par t i cul ar l y i f mor e r eagent s wi l l be needed.
Separ at el y, of cour se, t her e i s t he i nt er est i n t he cl i ni cal and
l abor at or y st at us of t he par t i ci pant s i n your st udy of mal ar i al t her apy.
I t woul d be i nt er est i ng t o know how many f ebr i l e epi sodes each of t he
r eci pi ent s had and any ot her cl i ni cal mani f est at i ons of t he mal ar i al
i nf ect i on or of HI V i nduced AI DS. Al so, t he CD4 T- cel l l evel s and et her
l abor at or y par amet er s t hat you have been abl e t o measur e shoul d be qui t e
I nt er est i ng. I do hope t hat you wi l l be wi l l i ng t o shar e t hat wi t h me.
We can di scuss t he shi pment of sampl es f or vi r al l oad det er mi nat i on. I t
woul d be r easonabl e t o wai t unt i l I have vi si t ed Guangzhou bef or e
sendi ng
any sampl es her e. I woul d be gl ad t o t al k mor e wi t h you about t hat and
any ot her mat t er s t hat you wi sh dur i ng my vi si t t o Guangzhou on Oct ober
My t r avel pl ans cal l f or ar r i vi ng on t he sane mor ni ng t r ai n as l ast
Mar ch, but I shoul d r et ur n t o Hong Kong by t he eveni ng t r ai n on t he
28t h. That shoul d pr ovi de 5 or 6 hour s t o r evi ew dat a, meet your
col l eagues and di scuss f ut ur e pl ans. I r egr et mi ssi ng t he oppor t uni t y
t o have one of t he f abul ous di nner s t hat Guangzhou i s f amous f or but I
l ook f or war d t o t hat an anot her vi si t .
Si ncer el y,
J ohn L. Fahey, M. D.
Di r ect or , CI RI D at UCLA
Chai r , Cl i ni cal I nr aunol ogy Ci mmittee, I
Uni on of I mmunol ogi cal Soci et i es ( I UI S)
J LF/ kw
cc: Hong Bass, M. D. , Ph. D.
Naj i b Azi z, M. D.
Bar bar a Her ed
2Q. . . .
I nt er nat i onal
9/25/98 8:35 AW
f ahev mal ar i ot haov 034
" "
rAA

i u
*
VD
^
u u
ICLA CAMPLS CCH NSEL, gj
2 t
J ohn L. Fahey, M.D.
From: John !_ Fahey, M.D.
To: Chen Xiao Ping, M.D.
5* ^
in Immunology and Disease (CtRID)
November 10. 1S98
VIA EMAIL
Chen Xiao Pings-MB.
Department Of Microbiology
The Municipal Health and AM-Epidemic Station of Guangzhou
No.23,3rdZhongshanF.
Guangzhou 51008Q. P.R.<2hina
Dear Dr. Chen,
I want to follow-up on some of the many topics that we discussed on .my visit on October 28th to the Municipal
Health and Anti-epidemic Station in Guangzhou.
First of all, congratulations on your appointment as head of Ihe HlWAiDS Program In tho Municipal Health and
Anti-epidertc Station of Guangzhou You certainly have developed substantial resources.far equating HIV/AIDS
and have developed innovaHveapproaches to therapy. This certainly must be one of the most dynamic Centers
for HrvVAiDS research and education In all of China. I 1o hope you ure eble to continue eoing your excellent work
with malarial therapy:
It was fdrid of you to suggest using my name among Ihe author W She paper asserc^Sng d^from the 2nd study.
However, ft is mare appropn^
aspec^the study h a ô v ê ^
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.
t am quae willing to provide assistance in manuscript review end preparation of manuscripts that may be aimed at
international or US Journals. We are anxious that the finding s be dearly presented in a balanced manner so that
they can be readily Judged by the many people Interested in the treatment of HlV/AiOS.
I know thai you wiil need some more reagents. Ws would bo giad to send you some more reagents for your flow
cytometry. it was not dear to me when I was there what the spedficineeds were, t gather you may need more
send,you more reagents In the future as they become necessary,
T e l $ | c f ^
vwtfscussed on October28th. You have made a good s##4$^|f oW people ehou dbis;testi#*#'rtocmatoe
tmfihiiywwanttD get serf* MRi ptefi ^
representative persons In a control population.
Also, whan you obtain Wood from reference populations you willwantto save both p.asma and PBMC from those
controls In the same manner that you are saving PBMCs from the HIV* population. Thii will provide you with
Page 1
f ahpv raaaarinthanv
035
l i / 1 3 / U ,L
u : z a l<AA Ml ) 20i 2330 UCLA CAMPl S COIJ ISSKL \&V2Z
materials collected under the same drcumstances for the assays to be done subsequenlly on the stored PBMCs.
I think you deserve Qreat congratulations for your plan of obtaining 50m! of Wood on each of the testing dates
This should provide for current and future testing of both cells and plasma. I think this is setting important
precedent for other clinical studies in Asia.
We look forward to seeing the data that you promised to send. We were intrigued with the fever charts and very
impressed. They are striking and dearly Illustrate what you mean by febrile'episodes and indicate the extent of
biologic response to the malarial parasttes. The Information on specific dates on when the chlocoguln is given and
when subsequent blood samples are taken also help us to have a dear picture of the progress of the study. if the
data that you already have on the WBC count, differential and the other data in a single table In the tabular format
that we discussed and outlined on October 2flth, It will certainly facilitate making J udgments about tests where the
results appeared to changed substantially during tha malarial period as weD as subsequently. We hope to be of
assistancein this data analyses. The data for the CD4 and COS measurements obtained at the 1 month and 3
month time points after the end of malarial infection w3( also be interesting to see.
I greatly appreciated all the data you shared with us on this visit. I want to assure you that we regard this as
confidential information. My colleagues and I will help with the analysis but not share it with others. You should
report your result directly to Dr. Heimlich and not through me.
I want to congratulate you on organizing the data of the patients in the order from highest to lowest CD4 levels.
That certainly fedlitates discerning the types of changes that may occur in the different groups stratified by CD4
levels.
I believe that you have reagents'for neopterin, soluble TNâ-receptor 2 and b2M measurements. We would be
glad to provide reagents for additional tests aftar you have conducted tests for those parameters in November and
December. We would prefer to defar sending additional reagents b&cause we do not want the reagents to get out
ofda* before you zee able to use them. thus, it would be better to send the reagents'lateron when your current
test arecompleted.'
:
. " .
The shipment of frozen plasma samples from Gudngihou to Los Angeles is certainly a high priority. We are
checking into obtaining a shipping container for this. As soon as it is obtslned,.we wS! send it off to you.
Your assistance in answering aU of our questions is much appreciated. They were designed lo hdp us understand
the study since we are some distance from all the action. v& appreciate the dedication that you and your
colleagues have to ma'kjng this a successful study.
Sincerely.
J ohnL.Fahey,M.D.
Director. CIRID at UCLA
Chair, Clinical Immunology Committee, taxational
Union of Immunological Sodeties (IIHS)
J LF/kw
cc: Barbara Hered
Najtb Azk, M.D.
Hong Bass. MX)., PhD.
Page 2
f ahpv raasariothanv 036
LA. / L73 / \34.
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XJ: J U I - AA aiu 20b 2390
1 2 : 1 1 310- 2as - 131
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'
LCLA CAMPIS COINSKI
CIRID AT UCLA
/
UNI VERSI TY OF CAL I FORNI A, LOS ANGELES
UCLA
kCUXXTT DAVIS fltvtfC U3sKCELCt UVXWCDC MKOCEOO
tt*nuxosoo
Center for interdisciplinary Research
in Immunology and Disease {ClR1D)
November 6, 1998
Chen Xiao Piag, MJ 3.
Department of Microbiology
The Municipal Health nod Anti-Epidemic Station of Guangzhou
No.23,3rdZhongshanRd.
Guangzhou SI0080, PJR. China
Fax: (020)83815255
Dear Dr. Chen,
oawnwEyrroF wjcxootouwr AKD IMMUNOLOGY
UCXA SCHOOL. OF MEDICINE
CENTOS PC* THS HEALTH SCIENCES
I0CULECONT2 AVENUE.
LOS, AJVOELES. OaI f OMf l A*Ws.rU7
CJ[C)*25-G5 ...
f310) 206-1318 (FAX)
1 want to thank you very much for your kindness in providing such excellent assistance to Dr. Hong Z. Bass and
myself during our visit on October 28* to you at the Municipal Health and Anti-Epidemic Station in
Guangzhou, The two banquets were just marvelous. Once again, I appreciate the opportunity to enjoy the
excellent Cantonese cuisine at Hubtn Restaurant. The hotel accommodations were fine. We were able to get to
the station in good time on the 29* and have a comfortable return trip to Hong Kong.
I was very impressed with all the progress you have made in your studies of malarial therapy in HIV infection.
I think most people do not really Appreciate how much work it is to carry out a clinical trial of this type.
Extensive work is required to identify subjects, organize the study to begin at a certain date and have all the
resources available including extensive clinical, laboratory and administrative support. Then to maintain
continued follow-up contact, obtaining blood samples, seeing that appropriate analyses are done and that the
dai* is collected is an enormous task. You have only a small staff to assist you in this. So, a great range of
responsibilities M directly on you. In addition, there ars the challenges of seeing that all the laboratory tests
arc well developed and that suitable controls are being obtained and reference populations tested, eg. those
without HTV infection. This requires a variety of laboratory skills and technologies which you have organized
in Guangzhou. They seem to be working effectively and I was impressed with the extensive data already
obtainedin the study.
Again, congraniiations on developing such an interesting study and seeing that it is well underway. This study
is sure to address a number of very important questions relating to HTV infection and to the novel approach of
using malarial therapy. Clearly, me therapy is having an impact on the immune system and future tests on
samples to be collected in ccminc months will establish the dimensions of daages on the immune parameters
of HTV infection. My congratulations to those in the Municipal Health and Anti-epidemic Station of
Guangzhou who have supported you in such a way as to make this important study possible.
Also, my thanks for yoor hospitality; I look forward to my next visit to Guangzhou.
Sincerely,
Ck~ * 4
J ohnL.Fahey,M.D.
Director, CIRID at UCLA
Chair, Clinical Immunology Committee, International
Union of Immunological Societies (TULS)
JIJFVkw
f
fahev mal ari othanv
037
a J 33i5U l-AA 3i U 2UB 2390 UCLA CAMPI S
024
Subject:
Date: Tuc, 17 Aug 1999 06:43:51 -0700
From: "John L. Fahey, M.D." <jjfahey@microimmun.medsch.ucla.edu>
To: Chen Xiao Ping <chenxp@gzsums.edu.cn>
CC: "tisimIich@igLou.com"' <heimlich@iglou.com>, "'naziz@ucla-edu"
,
<naziz@ucia.edu>
Center for Int erdi sci pl i nary Research
in Immunology and Di sease (CIRID)
August 17, 19 99
Chen Xi ao Pi ng, M. D.
The Muni ci pal Heal t h and Ant i - Epi demi c St at i on of Guangzhou
No. 23, 3r d Shongshan Rd.
Guangzhou 5L0Q80, P. R. Chi na
Dear Dr . Chen:
I want t o acknowl edge t hat I have your l et t er of J une 8 and t he i nf or mat i on
on t he 9 mont h CD4 l evel s dat a f or f ol l owi ng mal ar i al t her apy f or HI V/ AI DS.
Thank you f or t he t abl e.
I n eval uat i ng CD4 change f ol l owi ng mal ar i al t her apy, t her e ar e sever al
quest i ons: How many show a CD4 i ncr ease? Decr ease? No change? Axe CD4
changes t r ansi t or y or sust ai ned. What i s t he def i ni t i on of si gni f i cant
change i n number of CD4 T cel l s ( 100, 150 or 200 cel l s/ mm3) or % ( 3, 4, 5
or ? ) . One way i s t o make i t .
Because t her e i s a subst ant i al var i abi l i t y i n ser i al measur ement s i t i s not
appr opr i at e t o say t hat pat i ent s r esponded wi t h sust ai ned hi gher or Lower
l evel s of CD4 unl ess t hat change i s ver i f i ed. Thus, a conf i r med di r ect i onal
change r equi r es t wo sequent i al measur ement s document i ng t he i ncr ease or
decr ease i n r el at i on t o basel i ne. Exampl e of mai nt ai ned l ower l evel s of CD4
T cel l l evel s mi ght be pat i ent 2 at band 9 mont hs and pat i ent 3 at 1, 3, 6
and 9 mont hs. Exampl es of unchanged l evel s coul d be pat i ent s 3 and 10. The
whol e CD4%i ncr ease i a seen i n pat i ent 5.
We can di scuss t he basi s f or sel ect i ng CD4 200/ mra3 or 5%or some ot her l evel
as mar ker s of change when we get t oget her i n Hong Kong. The key l i e i n t wo
por t i ons of your own dat a. We can l ook at t he t wo measur ement s bef or e
t her apy i n each of your 11 subj ect s. Al so, we can l ook at your dat a an
ser i al anal yses i n t he same week of 5 nor mal subj ect s. We can r evi ew
di f f er ences bet ween measur ement s i n t hese compar i sons.
I n usage t he def i ni t i on of an i ncr ease or decr ease of 5%or of 200 cel l s/ mrn3
i s par t i al l y pr esent ed by Kovacs, Lane, et al . i n t hei r Kew Engl and J our nal
of Medi ci ne paper s, I t hi nk you have a copy of t hat paper . Al so, i n t he
ongoi ng ACTG 328 pr ot ocol eval uat i ng t her apeut i c ef f ect s of I L- 2, a change
of t hat di mensi on i s on of t he cr i t er i a i n t he pr ot ocol desi gn. Thi s i s a
pr ot ocol we shar ed wi t h you when you wer e her e. However , you can est abl i sh
ot her l i mi t s on t he basi s of t he dat a t hat you have now accumul at ed. I hope
t hi s i s hel pf ul .
Si ncer el y,
J ohn L. Fahey, M. D.
Di r ect or , CI RI D at UCLA
Cc: Dr . Henr y Hei ml i ch
Dr . Naj i b Azi z
1
rl
f
1
1 l/7/?n02 9:34 AM
f s he v ma l s r i n l - h a n v
03 8
.i d: 31 P AA J 1U 2US 2390 UCLA CAMPLS COLNSHL
g)025
J uno e-maa printed Sun, 10 Nov2002 10:59:25 . page 1
From: chenxiaoplng <ohenxping@netease.com>
To: "Henry J . Heimllch, MD, ScD" <heimlich@J uno.com>
Cc: "J ohn L Fahey, M.D." <jjfaheymicroimmun.meds^..ucla.ediJ >
Date: Wed, 7 Feb 2001 9:3223 +0800
Subject Declaration letter to editor
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Dear Dr. Heimlich,
Please you write a letter to declare that you agree to publish our paper
"Impact of acute vivax malaria on the immune system of H!V+subjects".
The letter format should like as follow:
Dear Editor:
I declare that I participated in the work of the paper titled "Impact of
acute wax malaria on the immune system of HIV+subjects" written by
Chen XP, Heimlich HJ , Xiao BQ, Shi WJ , Xu HF, Gao K and Rao J L and that I
have seen and approve the final version. I aiso declare that I have no
conflict of interest in connection with this paper, other than any noted
in-the covering letter to the editor.
Your signature (the signature need not be dated, in case the paper is not
accepted for publication so that it can be used for submission to another
journal.
Piease mail this declaration letter to me by express as soon as you can
If you agree to publish this paper. If you have any idea to change the
contents and view points, please emae me as soon as possible. Thank you.
Sincerely,
Chen, Xiao Ping, M.D.
Center for AIDS Control and Research
Municipal Health and Anti-Epidemic Station of GZ
chenxping@natease.com
f a h p v ma a l r i n f h a n v
03 9
DIVIDER
Peckman, Steven
From: Fahey, J ohn [J LFahey@mednet.ucla.edu]
Sent: Tuesday, December 17, 20021:15 PM
To: Peckman, Steve
Subject: RE: IRB investigation statement
Dear Steve,
Yes. I t i s correct.
J ohn L. Fahey, MD
> Ori gi nal Message
> Fr om: Peckman, St even [ SMTP: SPECKMAN@OPRS. UCLA. EDU]
> Sent : Tuesday, December 17, 2002 11: 38 AM
> To: ' J LFahey@mednet . ucl a. edu'
> Subj ect : FW: I RB i nvest i gat i on st at ement
>
> Dear Dr . Fahey,
> I s i t cor r ect t hat Dr . Azi z di d not par t i ci pat e i n t he mal ar i ot her apy
> r esear ch?
>
> Si ncer el y,
> - st eve
>
> St even Peckman
> Associ at e Di r ect or - Human Subj ect s Resear ch
> Of f i ce f or Pr ot ect i on of Resear ch Subj ect s
> Uni ver si t y of Cal i f or ni a, Los Angel es
> 310. 825. 5344 (v)
> 310. 794. 9565 (f )
> speckman@opr s. ucl a. edu
DIVIDER
Peckman, Steven
From: Elaine Schmidt [elaines@support.ucla.edu]
Sent: Wednesday, November 27, 2002 12:12 PM
To: bob-smith@volny.cz
Cc: Ed Chiao
Subject: RE: Statements Request
Bruin Bruin
statementl.doc statement2.doc
Dr. Smith,
Per your request, I've attached the two statements released to the Daily Bruin last week.
Sincerely,
Elaine Schmidt
Senior Media Relations Officer
UCLA Health Sciences Media Relations
924 Westwood Blvd., Suite 350
elaines@support.ucla.edu
(310) 794-2272 phone
(310)794-2259 fax
Original Message
From: bob-smith@volny.cz [mailto:bob-smith@volny.cz]
Sent: Tuesday, November 26, 2002 8:33 PM
To: Elaine Schmidt
Cc: Ed Chiao
Subject: Statements Request
Dear Ms. Schmidt,
There was an article in the 11/22/02 Daily Bruin regarding UCLA and
the Heimlich "malariotherapy" clinical trials. The article mentioned
that UCLA released statements on 11/20 and 11/21 regarding this
matter.
I'm interested in getting copies of these statements. I contacted
one of the reporters, Ed Chiao, who suggested I get in touch with
you. Is it possible for you to fax copies to me?
Thank you for your time and consideration. I look forward to your
reply.
Sincerely,
Dr. Bob Smith
FAX: (775)458-5877
55
UCLA STATEMENT TO DAILY BRUIN:
UCLA wishes to respond to your questions regarding an anonymous message emailed to
members of the campus community. Dr. John Fahey was never involved in Dr. Henry
Heimlich's malaria studies.
Dr. Fahey and Dr. Najib Aziz helped to train Dr. Chen Xiao Ping of the People's Republic of
China and other international scholars how to conduct and evaluate AIDS research studies. This
was performed under the auspices of the UCLA/Fogarty AIDS International Training and
Research Program.
When Dr. Chen returned to China, he conducted malarial studies in conjunction with Dr
Heimlich. Dr. Chen acknowledged the immunology training by Dr. Fahey in his research paper.
However, Dr. Fahey was not a co-author and did not collaborate on the malaria studies.
Since these allegations have surfaced, UCLA intends to ask Dr. Heimlich to omit UCLA from all
references relating to the malaria studies or other Heimlich Institute research. Any claims of an
association with UCLA are inaccurate.
-UCLA-
SECOND STATEMENT TO DAILY BRUIN
The UCLA/Fogarty AIDS International Training and Research Program offers a three-month
visiting-scholars course to a select group of researchers from leading AIDS control programs and
universities in developing countries. The goal is to build these scientists' AIDS research
expertise so they can help control the epidemic when they return home.
In the spring of 1997, Dr. Xiao Ping Chen participated in the program, then returned home to
China after graduation.
A standard part of the UCLA/Fogarty program is follow-up in the scholars' own countries. Dr.
Fahey visited Dr. Chen and five other Fogarty scholars in China the next year to provide follow-
up training during one- or two-day visits at each site. He did not, however, participate in any of
their research studies.
-UCLA-
DIVIDER
Peckman, Steven
From: Hansen, Martha [mhansen@resadmin.ucla.edu]
Sent: Tuesday, December 17, 2002 4:20 PM
To: Peckman, Steven
Subject: Letter to Dr. Fahey
St eve,
I ' mwr i t i ng about t he l et t er dat ed Dec. 10 t o Dr . J ohn Fahey f r omDr . Rober t
Fi gl i n of t he MI RB. Dr . Fahey cont act ed me as advi sed i n I t em2 on page 2
of t he l et t er . I have r ead 2a. sever al t i mes but amuncl ear on what i ssue
i s i n quest i on t hat woul d r equi r e consul t at i on wi t h me about t he gr ant
r equi r ement s.
Coul d you gi ve me a cal l t o hopef ul l y el i mi nat e t he conf usi on so I can
r espond t o Dr . Fahey? As you know, Dr . Fahey i s asked t o submi t a r esponse
t o OPRS by J an. 3 so I hope we can speak soon. Thank you.
Mar t ha Hansen
Sr . Cont r act and Gr ant Of f i cer
UCLA Of f i ce of Cont r act and Gr ant Admi ni st r at i on
phone: ( 310) 794- 0236
f ax: ( 310) 794- 0631
mhansenSr esadmi n. ucl a. edu
6
K MEMORANDUM
Department of Microbiology. Immunology and Molecular Genetics
David Gefien School of Medicine ai UCLA
174718
December 30,2002
RECEIVED
JAN 0 6 2003
OPRS
Steven Peckman
2107 PVUB
MC 169407
RE: Response to the OPRS letter of December 10, 2002
Dear Mr. Peckman,
1. It was my understanding that Dr. Xiao Ping Chen probably intended to use the
analyses of his anonymized blood samples to contribute to a research publication
on malariotherapy.
a. Dr. X. P. Chen did not have UCLA IRB approval or UCLA certified
exemption from UCLA IRB review. He was not aware in April/May 1997
of that requirement.
b. Please be assured that I will require UCLA IRB approval or Certification of
Exemption for any and all individuals who wish to work with human
biological samples or data for research purposes and work in my laboratory
or participate in scholarly programs under my supervision, such as the grant
from the Fogarty International Center.
2. Supplies were given to Dr. Chen as a Fogarty scholar.
a. Your letter was forwarded to Martha Hansen, Senior Contract and Grant
Officer, concerning Question 2A for grant requirements. After reviewing
the applicable grant guidelines and discussing the questions with the
Assistant Vice Chancellor-Research, Ms. Hansen responded as follows:
/. We understand the test kits were given to Dr. Chen for training
purposes. The grant allows expenditures for training-related
expenses and thus, the kits were an allowable charge on the grant.
Steven Peckman p
age
2
Response to the OPRS letter of December 10,2002
December 30, 2002
2. We understand that Dr. Chen was still considered a Fogart}' Scholar
when he returned to China and continued his training in research
techniques.
3. The sponsor, Fogarty International Center, provided funding for the
training program, but was not a participant in the training program.
Sincerely,
r I
J ohn L. Fahey, MD
(
cc: Martha Hansen
& MEMORANDUM
169407
January 27, 2003
TO: Medical Institutional Review Board 2 (MIRB2)
John Fahey, MD
[REVIEWERS: Clemens & M.A. Allen]
Please find attached additional information regarding the complaint about Dr. Fahey's
participation in Henry Heimlich's malariotherapy research.
The MIRB2 review of the allegations and Dr. Fahey's response is scheduled for January 29,
2003. Please do not hesitate to contact me at 310.825.5344 or speckman@oprs.ucla.edu if you
have any questions.
Enclosures: 1.
12/16/02 Heimlich letter (001)
a. 1/9/03 Fahey point by point response to 12/16/02 Heimlich letter (003)
b. Table 1 ATTRP PostDoc Trainees from China, 1996-99 (010)
c. 10/23/00 email from Fahey to X.P. Chen (011)
2. 12/30/02 Fahey response to MIRB correspondence (013)
3. 12/20/02 (015)
4. 12/16/02 Heimlich to Jasper w/enclosures (016)
5. 12/10/02 MIRB correspondence to Fahey (040)
6. 12/2/02 Jasper "cease and desist" to Heimlich (042)
7. 11/26/02 Fahey to Peckman (043)
a. 11/5/02 Fahey to Friedman (045)
b. 11/7/02 (046)
8. Attached 10/31/02IRB packet
o:/inquiry/fahey/fahey to IRB 030127.doc
Subject: RE: UCLA-Heimlich China AIDS Research
From: "Peckman, Steven" <SPECKMAN@OPRS.UCLA.EDU>
Dat e: 2/6/2003 1:11 PM
To: "'bob-smith@volny.cz'" <bob-smith@volny.cz>
CC: Ed Chiao <echiao@media.ucla.edu>, J eyling Chou <jchou@media.ucla.edu>, "Brookshire, J udith"
<J BROOK@OPRS.UCLA.EDU>
Dear " Dr . Smi t h"
The UCLA I RB det er mi ned i n December t hat Dr . Fahey di d not appear t o be
engaged i n human subj ect s r esear ch r el at ed t o your al l egat i ons. The Boar d
has r ecei ved addi t i onal i nf or mat i on and t he mat t er i s r eopened and under
r evi ew.
I appr eci at e your of f er t o suppl y addi t i onal i nf or mat i on about t he 20 year
hi st or y of Dr . Hei ml i ch' s mal ar i ot her apy. The UCLA I RB, however , has no
r egul at or y aut hor i t y over Dr . Hei ml i ch. We woul d be happy t o r ecei ve and
r evi ew any new document at i on r el at ed t o possi bl e UCLA i nvol vement i n Dr .
Hei ml i ch' s mal ar i ot her apy r esear ch.
On behal f of t he I RB, I t hank you f or your i nqui r y. Pl ease do not hesi t at e
t o cont act me i f you have any quest i ons.
Si ncer el y,
St even Peckman
310. 825. 5344 ( v)
310. 794. 9565 ( f )
Ct MEMORANDUM
169407
February 14,2003 fTxi/^
J ohnFahey, MD '..'
174718
Dear Dr. Fahey,
The Medical Institutional Review Board (MIRB) received additional information regarding your
alleged participation in malariotherapy research and your letters of J anuary 9 & 10, 2003. The
Board was sorry to hear of your scheduled surgery and wishes you the best for a speedy recovery.
The MIRB reviewed the material during the meeting of J anuary 29,2003. The MIRB noted that
the new information may indicate you were "engaged" in human subjects research as defined by
the Federal regulations, 45 CFR 46, and the Department of Health and Human Services-Office of
Human Research Protections (DHHS-OHRP) guidelines. Please note: the MIRB did not
consider your assessments of the malariotherapy research as subject to its inquiry.
The Board requests your response to the following issues related to the conduct of human
subjects research by March 14, 2003.
1. The MIRB previously noted that you do not appear to be engaged in human subjects research
related to the allegations from "Dr. Bob Smith". The JJRB's determination was based in part
on your October 17, 2002 statement, "I have not been 'working in conjunction' with the
Heimlich Institute" and similar statements in response to our October 2002 inquiry. As a
result of the Board's determination, Campus Counsel Patricia J asper sent a letter to Dr. Henry
Heimlich. The MIRB, therefore, was surprised to receive Dr. Heimlich's documentation
indicating your possible involvement in malariotherapy research.
a. For example, your August 8,1996 letter to Dr. Heimlich offers assistance in measuring
cytokine levels "in selected patients treated with malariotherapy." Your J anuary 9, 2003
letter to Ms. J asper indicates the August 8, 1996 correspondence "...is an initial
exploratory letter without commitments. It enabled us to get the address, etc., of the lead
Chinese investigator, Dr. Xiao Ping Chen." Yet, the August 8,1996 letter outlines a dual
intent. The first intent or in your words, "context", offers your laboratory's assistance, as
John Fahey, MD
page 2
noted above. The second "context" offers to ".. .develop a means of helping [Dr.
Heimlich's] Chinese colleagues in carrying out their studies. Assistance with reagents
and quality control samples for CD4 measurements as well as for other parameters of
HTV infection." Please clarify whether Dr. Chen was encouraged to bring biological
samples from the malariotherapy research to UCLA as a result of your August 8,1996
letter and your subsequent recruitment of him for participation in the Fogarty training
grant.
b. Your August 6,1997 letter to Dr. Heimlich included "tables of the data obtained on the
samples provided by Chen Xiao Ping." The letter indicates tests performed at UCLA on
samples 4001,4002,4003,4004,4005,4006,4007, and 4008. The letter informs Dr.
Heimlich to "please feel free to use this data in reports and publications. We would
appreciate an acknowledgement and credit to the support provided by NIH grants TW
00003 and AI36086." Your October 17, 2002 letter to the MIRB, however, indicates
samples "...independently brought by Dr. X.P. Chen to UCLA and tested by Dr. X.P.
Chen were identified only by serial numbers (1,2,3, etc.) and could not be linked to the
subjects." Furthermore, your November 6, 1998 letter to Dr. Chen acknowledges the
difficulty of performing clinical research and appears to indicate the samples are not
anonymous or anonymized but rather coded with direct or indirect codes that could be
linked to direct subject identifiers ["... to maintain continued follow-up contact,
obtaining blood samples, seeing that appropriate analyses are done and that the data is
collected is an enormous task."]. Please clarify whether the above referenced biological
samples analyzed in UCLA facilities were coded, unlinked, or unidentified. If the
samples were coded, please provide a detailed description of the code, e.g., the
information from donors linked to the code, and identify the individuals who held or hold
the links to the code.
Please use the following National Bioethics Advisory Commission (NBAC) definitions'
to guide your response to the request:
Coded Samples: Sometimes termed "linked" or "identifiable," these samples are supplied by
repositories to investigators from identified specimens with a code rather than with personally
identifying information, such as a name or a Social Security number. The code could be used to
link personal identifying information with the sample.
Unlinked samples: Sometimes termed "anonymized," these samples lack identifiers or codes
that can link a particular sample to an identified specimen or a particular human being.
Unidentified Samples: Sometimes termed "anonymous," those specimens for which
identifiable personal information was not collected or, if collected, was not maintained
and cannot be retrieved by the repository.
1
National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance.
Rockville: August 1999.
cx/inquiry/fahey/fahey inquiry 030214
John Fahey, MD
page 3
2. Your September 18,1998 email to Dr. Chen notes, "However, it would be interesting to
review your preliminary data with both HIV- and HIV+populations in Guanzhou. We do not
expect that the data would be the same in both locations, but a look at the initial data might
be advantageous at this time, particularly if more reagents will be needed. Separately, of
course, there is the interest in the clinical and laboratory status of the participants in your
study of malarial therapy. It would be interesting to know how many febrile episodes each of
the recipients had and any other clinical manifestations of the malarial infection or of HTV
induced AIDS. Also, the CD4 T-cell levels and other laboratory parameters that you have
been able to measure should be quite interesting. I do hope that you will be willing to share
that with me." The email also seems to suggest there were identifiers linked to the coded
samples that would enable connecting outcome to possibly identifiable clinical information.
a. Please clarify whether you or other UCLA personnel were provided with any such data
described in your September 18, 1998 email during or after the visit to China. If so,
please explain the nature of the data and describe the method of coding using the NB AC
definitions outlined above.
b. The same email indicates, "We can discuss the shipment of samples for viral load
determination. It would be reasonable to wait until I have visited Guangzhou before
sending any samples here." Please clarify whether such samples were sent to UCLA or
any other facility in the USA.
3. A September 25,1998 email from "Eric" through Dr. Chen's email account to Dr. Heimlich
indicates in part, 'This foundation has told [sic] that we will not be able to get any funding
for additional patients until Dr. Heimlich and Dr. Fahey present the results on the current
patients, especially the viral loads." Your January 9,2003 letter to Ms. Jasper indicates the
email is "Misleading." Please explain why the email is "misleading."
a. Please identify "Eric" and describe his relationship to the Fogarty grant, the
malariotherapy research, or UCLA.
b. Additionally, please describe the nature of the presentation referred to in the email and
whether you participated in such a presentation.
4. Your November 10,1998 email to Dr. Chen requests the exclusion of Dr. Najib Aziz and you
as co-authors on "the 2
nd
study." Rather, you suggest "it is more appropriate if you simply
acknowledge assistance.... we should not be among manuscript authors at this time." Please
explain why you and Dr. Aziz declined co-authorship "at this time."
a. The email also indicates ".. .it will certainly facilitate making judgments about tests
where the results appeared to changed [sic] substantially during the malarial period as
well as subsequently. We hope to be of assistance in this data analyses. The data for the
CD4 and CD8 measurements obtained at the 1 month and 3 month time points after the
ot/inquiry/fabey/fahey inquiry 030214
John Fahey, MD
page 4
end of malarial infection will also be interesting to see." Please clarify if you or Dr. Aziz
were provided with such information.
b. If so, please outline the coding system applied to the data, using the NBAC definitions
described above.
5. Please provide the full title and ERB number, if applicable, for the grant referenced as AI
36086.
6. The MIRB acknowledges your December 30,2002 response wherein you provided assurance
that UCLA IRB approval or Certification of Exemption would be required "...for any and all
individuals who wish to work with human biological materials or data for research purposes
and work in my laboratory or participate in scholarly programs under my supervision, such as
the grant from the Fogarty International Center."
7. Please provide the Board with any other information you think is pertinent to the review of
the allegations.
On behalf of the MIRB, I thank you for your commitment to the protection of the rights and
welfare of human research subjects. Please contact Steven Peckman, Associate Director Human
Subjects Research at 825-5344 or speckman@oprs.ucla.edu if you have any questions.
Sincepelyrv
Robert A. Figlin,
Chair
Steven Peckman
2107 PVUB
169407
Peckman, Steven
From: Carome, Michael [MCarome@OSOPHS.DHHS.GOV]
Sent: Monday, February 24, 2003 1:37 PM
To: 'Peckman, Steven'
Cc: Borror, Kristina
Subject: RE: UCLA - Allegations Regarding Malariotherapy Research in China
Steve,
Thanks f or t he updat e. We wi l l awai t your f ol l ow- up r epor t .
Mi ke
Mi chael A. Car ome, M. D.
Associ at e Di r ect or f or Regul at or y Af f ai r s
Of f i ce f or Human Resear ch Pr ot ect i ons
The Tower Bui l di ng
1101 Woot t on Par kway, Sui t e 200
Rockvi l l e, MD 20852
Tel : 301- 402- 5567
Fax: 301- 402- 2071
E- mai l : mcar ome@osophs. dhhs. gov
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 PM
To: Car ome, Mi chael
Subj ect : UCLA - Al l egat i ons Regar di ng Mal ar i ot her apy Resear ch i n Chi na
I 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 esear ch r el at ed t o t he anonymous
al l egat i ons of "Dr. Bob Smi t h". The Boar d, however , r ecei ved addi t i onal
i nf or mat 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 o
cont act me i f you have any quest i ons.
Si ncer el y,
St eve
St even Peckman
310. 825. 5344 (v)
310. 794. 9565 (f )
106
BERKELEY DAVIS * IRVINE LOS ANCELES MERGED RIVERSIDE SAN DIECO SAN FRANCISCO
VIA FAX & US MAIL
UCLA
February 26, 2003
OFFICE OF THE CHANCELLOR
BOX 9S1405
LOS ANGELES, CALIFORNIA 90O95-14OS
Joseph Dehner, Esq.
Frost Brown & Todd
201 East Fifth Street
Cincinnati, Ohio 45202
Re: Your Client. Dr. Henry Heimlich
Dear Mr. Dehner:
This is in response to Dr. Henry Heimlich
1
s letter to me of December 16,2002.
Please thank Dr. Heimlich for forwarding to us the materials included in his
December 16
th
letter. We were not aware of those materials, and would appreciate his
forwarding to us any additional materials that he may have that relate to the activities of
any UCLA researchers in malariotherapy research.
As requested by Dr. Heimlich, copies of his December 16
th
letter have been
forwarded to those who also received a copy of my December 2, 2002, letter to him.
Sincerely,
;ampus
cc:
Associate Director Peckman
Senior Associate Dean Friedman
Vice Chancellor Peccei
FROST BROWN TODD LLC
2200 PNC Canter
201 E. Fifth Street
Cincinnati, Ohio 45202-4182
J OSEPH J .DEHNER P^SlSSF-eBBi
idehnef@fbtlaw.com Facsimile (513) ^"69Bi February 27, 2003
{513)651-6949 www.frostbrowntodd.com
VIA TELECOPIER - (310) 206-5465
Patricia M. J asper
Campus Counsel
Office of the Chancellor
Box 951405
Re: Dr. Heimlich
Dear Ms. J asper:
; letter of February 26. I have delivered the infonnation to Dr.
Thanks for your gracious
Heimlich.
Sincerely,
J oseph J . Dehner
J J D:cyw
cc: Dr. Henry J . Heimlich, M.D.
CtNlibrtry/1266600.1
"" "N.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Office of the Secretary
Office of Public Health and Science
March 19,2003
Judith L. Brookshire
Director
Box 951694
RE: Research Project: Human Research Collaboration on Malariotherapy
PI: John Fahey, M.D.
Project Number: NIH Grants TW 00003 and AI36086
Dear Ms. Brookshire:
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Telephone: 301-435-8072
FAX: 301-402-2071
email: kborror@osophs.dhhs.gov
The Office for Human Research Protections (OHRP) has received your letter of June 24, 2003
concerning the above protocol, which was submitted in partial 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 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. Borror
Director
Division of Compliance Oversight
Staff Evaulation
John Fahey, MD
Date: March 23, 2003
Staff: Steven Peckman
Complaint About Human Research Collaboration on Malariotherapy
Pi's March 21,2003 response to IRB February 14, 2003 correspondence.
The Medical Institutional Review Board (MIRB) received additional information regarding your
alleeeH nrt-riHnnrmn in malariotherapy research and your letters of January 9 & 10,200:
The MERB reviewed the material during the meeting of January 29, 2003. The MIRB noted that
the new information may indicate you were "engaged" in human subjects research as defined by
the Federal regulations, 45 CFR 46, and the Department of Health and Human Services-Office of
Human Research Protections (DHHS-OHRP) guidelines. Please note: the MIRB did not
consider your assessments of the malariotherapy research as subject to its inquiry.
The Board requests your response to the following issues related to the conduct of human
subjects research by March 14, 2003.
PI Response:
This responds to the Letter of February 14, 2003 from the OPRS.
I understand that an issue for the OPRS is whether the UCLA contacts
1
with Dr. Xiao Ping Chen
and his malariotherapy research were such that UCLA was engaged in human subjects research
as an investigator with Dr. X.P. Chen. Thank you for directing me to the definitions of research
found in 45 C.F.R. 46. I believe that application of those definitions establish that UCLA's
contacts with Dr. X.P. Chen's research did not make UCLA an investigator in that research. In
other words, there was no UCLA research with Dr. Xiao Ping Chen.
As is pointed out in the UCLA OPRS Investigator's Manual for the Protection of Human Subjects,
research is defined in 45 C.F.R. 46 as "a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable knowledge." Human
subjects research is defined as research with subjects who are "living individual(s) about whom an
investigator (whether professional or student) conducting research obtains (1) data through
intervention or interaction with the individual, or (2) identifiable private information." The
UCLA contacts with Dr. X.P. Chen will be explained below and did not amount to a systematic
investigation. In particular, there was no intervention and no interaction with human subjects
conducted by UCLA. In other words, UCLA had no human subjects involvement since any data
received or analyzed at UCLA were not obtained by intervention or interaction with any human
1
By UCLA contacts, I mean any contacts by me or any UCLA personnel of which I am aware.
f = Viznr ma 1 a y -i r*. t- Vi o r a r\^r n a r V o H r.nm
John Fahey, MD
page 2
subject by UCLA. Also, the information which was provided to UCLA was not identifiable
private information.
Identifiable private information is defined by 45 C.R.F. 46.102(f)(2) as information which is
"individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the
investigator or associated with the information)". I most emphatically state that neither I nor, to
my knowledge, any other UCLA contact was provided with any such individually identifiable
information concerning Dr. X.P. Chen's malariotherapy research. The samples brought and the
data provided to UCLA concerning Dr. X.P. Chen's research did_not allow us to ascertain or to
identify the particular individuals who were the source of the samples or data. We did not request
or receive any individually identifiable information for any of the samples or data from
Dr. X.P. Chen's research. (The only samples from that research brought to UCLA were samples
brought by Dr. X.P. Chen to UCLA when he was here in 1997 for Fogarty grant purposes. Those
samples came from a 1994 study previously completed without UCLA involvement) Using the
terms you suggest, all samples and all data provided from Dr. X.P. Chen's malariotherapy
research to his UCLA contacts were unlinked. We could not and did not obtain unidentifiable
private information for any research subject.
The answers to the specific questions in the OPRS February 14,2003 letter are as follows.
{StaffNote:
The DHHS-OHRP Engagement Guidance indicates an institution is engaged in human subjects
research when:
A(5) Institutions whose employees or agents obtain, receive, or possess private information that
is individually identifiable (either directly or indirectly through coding systems) for research
purposes (e.g., obtaining private information from medical records in an individually identifiable
form). (However, see Examples (B)(7) and B(8)for certain activities involving the release of
information and/or specimens to investigators in non-identifiable form.)
Institutions are NOT engaged in human subjects research when:
B(7) Institutions whose employees or agents release information and/or specimens to investigators in
non-identifiable (i.e., non-linkable) form, where such information/specimens have been obtained by the
institution for purposes other than the investigators' research (e.g., nursing home employees provide
investigators with a data set containing medical record information, but the data set contains no direct
or indirect identifiers through which the identity of individual subjects could be ascertained, either by
the investigators or by nursing home personnel; a hospital pathology department releases excess tissue
specimens and relevant medical record information to investigators, but these materials include no
direct or indirect identifiers through which the identity of individual subjects could be ascertained,
either by investigators or by hospital personnel, including the pathology department; consistent with
applicable law or recognized authority, local hospitals or health departments permit State or Local
Health Department investigators to access information for research purposes, but the investigators
f a V i o i ; m a 1 a T" -i n h h o r a m i n a r - V o H
Cn n ?
John Fahey, MD
page 3
record no direct or indirect identifiers through which the identity of individual subjects could be
ascertained, either by the investigators or by local hospital or health department personnel.)
B(8) Institutions whose employees or agents receive information or specimens
for research from established repositories operating in accordance with
(i) an applicable OPRR-approved Assurance;
(ii) OPRR guidance
(see http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm); and
(Hi) written agreements unequivocally prohibiting of release of identifying information to
recipient investigators.}
1. The MIRB previously noted that you do not appear to be engaged in human subjects research
related to the allegations from "Dr. Bob Smith". The IRB's determination was based in part
on your October 17, 2002 statement, "I have not been 'working in conjunction' with the
Heimlich Institute" and similar statements in response to our October 2002 inquiry. As a
result of the Board's determination, Campus Counsel Patricia J asper sent a letter to Dr. Henry
Heimlich. The MIRB, therefore, was surprised to receive Dr. Heimlich's documentation
indicating your possible involvement in malariotherapy research.
a. For example, your August 8, 1996 letter to Dr. Heimlich offers assistance in measuring
cytokine levels "in selected patients treated with malariotherapy." Your J anuary 9,2003
letter to Ms. J asper indicates the August 8, 1996 correspondence "...is an initial
exploratory letter without commitments. It enabled us to get the address, etc., of the lead
Chinese investigator, Dr. Xiao Ping Chen." Yet, the August 8,1996 letter outlines a dual
intent. The first intent or in your words, "context", offers your laboratory's assistance, as
noted above. The second "context" offers to ". ..develop a means of helping [Dr.
Heimlich's] Chinese colleagues in carrying out their studies. Assistance with reagents
and quality control samples for CD4 measurements as well as for other parameters of
HJV infection." Please clarify whether Dr. Chen was encouraged to bring biological
samples from the malariotherapy research to UCLA as a result of your August 8, 1996
letter and your subsequent recruitment of him for participation in the Fogarty training
grant.
PI Response
Regarding my August 8,1996 letter to Dr. H. Heimlich and the contexts:
Do you mean to ask me to explain the two contexts? "Assistance" was meant to be
training. That was in the context that Dr. Heimlich was making unwarranted claims
for Dr. X.P. Chen's research. Dr. Heimlich claimed CD4 T cell increases based on an
unproven methodology (not the methodologyflow cytometry which we and others
in the U.S. were using). Training people to be knowledgeable about AIDS research
i.e., about good and not good methodologies, about quality control, etc.was part of the
Fogarty program.
FoH^-%r TÔT a- r- i n f V i o r a r i n ; n p r V o H
r nm
John Fahey, MD
page 4
No. Dr. Xiao Ping Chen was not encouraged to bring biological samples from
malariotherapy research to UCLA as a result of the August 8,1996 letter and
subsequent recruitment of Dr. X.P. Chen for participation in the Fogarty training
grant
b. Your August 6,1997 letter to Dr. Heimlich included "tables of the data obtained on the
samples provided by Chen Xiao Ping." The letter indicates tests performed at UCLA on
samples 4001,4002,4003,4004,4005,4006,4007, and 4008. The letter informs Dr.
Heimlich to "please feel free to use this data in reports and pubjications. We would
appreciate an acknowledgement and credit to the support provided by NTH grants TW
00003 and AI36086." Your October 17, 2002 letter to the MIRB, however, indicates
samples "...independently brought by Dr. X.P. Chen to UCLA and tested by Dr. X.P.
Chen were identified only by serial numbers (1,2,3, etc.) and could not be linked to the
subjects." Furthermore, your November 6, 1998 letter to Dr. Chen acknowledges the
difficulty of performing clinical research and appears to indicate the samples are not
anonymous or anonymized but rather coded with direct or indirect codes that could be
linked to direct subject identifiers ["... to maintain continued follow-up contact,
obtaining blood samples, seeing that appropriate analyses are done and that the data is
collected is an enormous task."]. Please clarify whether the above referenced biological
samples analyzed in UCLA facilities were coded, unlinked, or unidentified. If the
samples were coded, please provide a detailed description of the code, e.g., the
information from donors linked to the code, and identify the individuals who held or hold
the links to the code.
Please use the following National Bioethics Advisory Commission (NBAC) definitions
2
to guide your response to the request:
Coded Samples: Sometimes termed "linked" or "identifiable," these samples are supplied by
repositories to investigators from identified specimens with a code rather than with personally
identifying information, such as a name or a Social Security number. The code could be used to
link personal identifying information with the sample.
Unlinked samples: Sometimes termed "anonymized," these samples lack identifiers or codes
that can link a particular sample to an identified specimen or a particular human being.
Unidentified Samples: Sometimes termed "anonymous," those specimens for which
identifiable personal information was not collected or, if collected, was not maintained
and cannot be retrieved by the repository.
PI Response
The letter of August 6,1997 is forwarding tables that, I believe, were prepared by Dr. X.P.
Chen.
:
National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance,
Rockville: August 1999.
F-K.-.w m n l -a-î rt*-Knâr\,f r> a /- Ir o H "} C nr>4
John Fahey, MD
page 5
I do not know where the 4000 series of numbers came from. My only information is that Dr.
X.P. Chen brought samples labeled 1 to 51. I do not have any records with tests of samples in
a 4000 series. Dr. X.P. Chen took the data with him. I surmise that Dr. X.P. Chen prepared
the tables.
The samples that were brought by Dr. X.P. Chen to UCLA were tested without any knowledge
of the patients' identification by UCLA personnel. We had no knowledge of a codejust the
numbers 1 to 51 as stated previously. The samples could not he linked by us to any study
subjects. For us, the samples were unlinked. In retrospect, it appears that Dr. X.P. Chen may
have had links between the 1,2 and 3 code and the patients in his study.
The training faculty at UCLA (J.L. Fahey and Najib Aziz) were not investigators in the
Guangzhou studies. Dr. Xiao Ping Chen and his colleagues were the investigators. The studies
were done in Guangzhou, China. We did not secure the samples. We did not code the
samples. We did not have the clinical information. We did not have the patients' names. We
did not have (and do not have) any codes that linked laboratory data to subject identifiers.
Dr. Xiao Ping Chen, the investigator, may have had some means of linking data, but he
did not share that with us.
2. Your September 18,1998 email to Dr. Chen notes, "However, it would be interesting to
review your preliminary data with both HIV- and HTV+populations in Guanzhou. We do not
expect that the data would be the same in both locations, but a look at the initial data might
be advantageous at this time, particularly if more reagents will be needed. Separately, of
course, there is the interest in the clinical and laboratory status of the participants in your
study of malarial therapy. It would be interesting to know how many febrile episodes each of
the recipients had and any other clinical manifestations of the malarial infection or of HIV
induced AIDS. Also, the CD4 T-cell levels and other laboratory parameters that you have
been able to measure should be quite interesting. I do hope that you will be willing to share
that with me." The email also seems to suggest there were identifiers linked to the coded
samples that would enable connecting outcome to possibly identifiable clinical information.
a. Please clarify whether you or other UCLA personnel were provided with any such data
described in your September 18, 1998 email during or after the visit to China. If so,
please explain the nature of the data and describe the method of coding using the NBAC
definitions outlined above.
PI Response
The work was done in Guangzhou. The question about comparing data on
HIV-positive and HIV-negative populations was a quality control issue. Could the 1998
Guangzhou CD4 T cell testing procedures discern the expected differences? I do not
remember seeing the primary data, but rather a statistical rendering of the data from
both groupsmean, SD, etc. I do not recall seeing any information that was
f l V l r t l . TT* - T ^ f A . - . i - V t ^ ^ - l T " * . . * T ^ - f \ r /-\ - *3 r nnc
John Fahey, MD
page 6
individually identifiable. I do not believe any other UCLA personnel saw the primary
data or any individually identifiable information. It seems likely that Dr. X.P. Chen
had identifiers. The method of coding was not shared with me or any other UCLA
personnel. Neither I nor any other UCLA personnel had any identifiers.
b. The same email indicates, "We can discuss the shipment of samples for viral load
determination. It would be reasonable to wait until I have visited Guangzhou before
sending any samples here." Please clarify whether such samples were sent to UCLA or
any other facility in the USA.
PI Response
No such samples were sent to UCLA . I do not know if Guangzhou samples were sent to
any other facility in the U.S.
3. A September 25,1998 email from "Eric" through Dr. Chen's email account to Dr. Heimlich
indicates in part, 'This foundation has told [sic] that we will not be able to get any funding
for additional patients until Dr. Heimlich and Dr. Fahey present the results on the current
patients, especially the viral loads." Your January 9,2003 letter to Ms. Jasper indicates the
email is "Misleading." Please explain why the email is "misleading."
PI Response
The statement is misleading, because it implies that I had, or was going to have, viral
load data. I never had viral load data. It also implies that I was preparing for a
presentation with Dr. Heimlich.
1 never would have participated in it, if I had been requested to do so.
a. Please identify "Eric" and describe his relationship to the Fogarty grant, the
malariotherapy research, or UCLA.
PI Response
Eric Spletzer was an associate of Dr. H. Heimlich in Cincinnati who seemed to be an
employee of the Heimlich Institute. He had no relationship to the Fogarty grant or to
UCLA. E. Spletzer's relationship to malariotherpy research seemed to be as an agent or
representative of Dr. Heimlich in relation to Dr. X.P. Chen.
b. Additionally, please describe the nature of the presentation referred to in the email and
whether you participated in such a presentation.
PI Response
I cannot describe the nature of the presentation referred to in the e-mail. I never heard
of it (or any other presentation with Dr. Heimlich) until December 2002.
r\ r\ r-
John Fahey, MD
page?
4. Your November 10,1998 email to Dr. Chen requests the exclusion of Dr. Najib Aziz and you
as co-authors on "the 2
nd
study." Rather, you suggest "it is more appropriate if you simply
acknowledge assistance.... we should not be among manuscript authors at this time." Please
explain why you and Dr. Aziz declined co-authorship "at this time."
PI Response
"At this time" was a courtesy phrase. The sentence was written to remind Dr. X.P.
Chen that Dr. Aziz and I were not part of the malariotherapyjcesearch study. Dr. X.P.
Chen had repeatedly asked us to be authors. We always refused because it was not our
research. Such requests are not unusual in developing countries where the
investigators believe there is some added recognition if a co-author is from a leading
U.S. or European medical center.
a. The email also indicates ".. .it will certainly facilitate making judgments about tests
where the results appeared to changed [sic] substantially during the malarial period as
well as subsequently. We hope to be of assistance in this data analyses. The data for the
CD4 and CD8 measurements obtained at the 1 month and 3 month time points after the
end of malaria] infection will also be interesting to see." Please clarify if you or Dr. Aziz
were provided with such information.
PI Response
The suggestion for providing assistance in data analysis was a mentoring function. Dr. X.P.
Chen (and Dr. Heimlich) did not appreciate the variability inherent in CD4 T cell and other
measurements. If only one of several post-treatment data points for a patient was higher than
the baseline, Drs. X.P. Chen and Heimlich had been interpreting the data as showing that an
increase in CD4 T cells had occurred. The notion of a confirmed increase, e.g. two sequential
tests showing an increase of more than a pre-determined amount (perhaps, 100/mm CD4 T
cells) over the mean baseline level seemed to be difficult for them to understand or accept. An
example of my effort to educate about the proper techniques of scientific data analysis is my
letter to Dr. X.P. Chen of August 17,1999 and, again, in 2002.
Dr. X.P. Chen wanted very much to show that CD4 T cell levels were increased. A part
of my mentoring function was to help Dr. X.P. Chen focus and understand what was
happening in his study. In that context, I did see data on the study patients, but
without any identifiable private information. In this type of study, good and bad events
can be obscured by using averages. Valid research methodology requires the data on
individual subjects to be evaluated.
John Fahey, MD
page 8
b. If so, please outline the coding system applied to the data, using the NBAC definitions
described above.
PI Response
The data were coded, but I never had access to the code. As far as I was concerned, the
data were unlinked.
5. Please provide the full title and IRB number, if applicable, for the grant referenced as AI
36086. _
PI Response
AI 36086Epidemiology of Cytokine Dysregulation in HIV Disease. 07/01/94 -
01/31/98 plus two-year no cost extension to 01/31/00. HSPC-08-346 was obtained for
blood from normal subjects to establish control standards in laboratory tests for AIDS
and immune function investigations.
6. The MIRB acknowledges your December 30,2002 response wherein you provided assurance
that UCLA IRB approval or Certification of Exemption would be required "...for any and all
individuals who wish to work with human biological materials or data for research purposes
and work in my laboratory or participate in scholarly programs under my supervision, such as
the grant from the Fogarty International Center."
PI Response
Thank you for the acknowledgement.
7. Please provide the Board with any other information you think is pertinent to the review of
the allegations.
PI Response
Any other information: There are various references to, possibly, shipping samples
from China to UCLA for viral load testing. However, no samples were ever shipped.
The UCLA laboratory never did any viral load assaysnot for anybody. I believe Dr.
X.P. Chen set up a viral load test procedure in his labs in Guangzhou. We encouraged
him to do that
f ^Vi ov vn a ~\ a T- -i r\ t- h a r- r wr n a r V p h ^ C fl fl P
Ff
& MEMORANDUM
169407
March 25, 2003
TO: Medical Institutional Review Board 2 (MIRB2)
John Fahey, MD
[REVIEWERS: Clemens & M.E. Allen]
Please find attached Dr. Fahey's response to additional information regarding the complaint
about his alleged participation in Henry Heimlich's malariotherapy research.
The MTRB2 review of the allegations and Dr. Fahey's response is scheduled for March 26, 2003.
Please do not hesitate to contact me at 310.825.5344 or speckman @oprs.ucla.edu if you have any
questions.
Enclosures: 1. Staff Evaluation of Dr. Fahey's response to
2/14/03IRB correspondence (cOOl)
2. 1/26/99 DHHS-OHRP Engagement Guidance (c009)
3. Dr. Fahey's March 21,2003 response (c013)
4. 2/14/03 IRB correspondence (c018)
Attached January 27.2003 packet
5. 1/14/03 Dr. Fahey to Patricia Jasper summary response to
12/16/02 Heimlich letter (001)
a. 1/9/03 Fahey point by point response to 12/16/02 Heimlich letter (003)
b. Table 1 AJTRP PostDoc Trainees from China, 1996-99 (010)
c. 10/23/00 email from Fahey to X.P. Chen (011)
2. 12/30/02 Fahey response to MTRB correspondence (013)
3. 12/20/02 Senior Associate Dean Friedman to Jasper (015)
4. 12/16/02 Heimlich to Jasper w/enclosures (016)
5. 12/10/02 MIRB correspondence to Fahey (040)
6. 12/2/02 Jasper "cease and desist" to Heimlich (042)
7. 11/26/02 Fahey to Peckman (043)
a. 11/5/02 Fahey to Friedman (045)
b. 11/7/02 Friedman to Jasper (046)
8. Attached 10/31/02 IRB packet
o:/inquiry/fahey/fahey to IRB 030127.doc
h i e*
MEMORANDUM
March 30,2003
John Fahey, MD
174718
169407
rKv
Hi
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'If
Dear Dr. Fahey,
The Medical Institutional Review Board (MIRB) thanks you for your cooperation in our review
of the above referenced complaint. During the March 26,2003 meeting the Board reviewed your
March 21, 2003 response regarding your alleged participation in malariotherapy research. After
extensive discussion the Board decided the following:
1. The MIRB notes that it appears from the available information that the samples brought to UCLA by
Dr. Xiao Peng Chen from China for work in the Fogarty Program were coded with indirect links to
personal identifiers. You indicated neither you nor "...any other UCLA contact was provided with
any such individually identifiable information concerning Dr. X. P. Chen's malariotherapy research.
The samples brought and the data provided to UCLA concerning Dr. X. P. Chen's research did not
allow us to ascertain or to identify the particular individuals who were the source of the samples or
data. We did not request or receive any individually identifiable information for any of the samples
or data from Dr. X. P. Chen's research. (The only samples from that research brought to UCLA were
samples brought by Dr. X. P. Chen to UCLA when he was here in 1997 for Fogarty grant purposes.
Those samples came from a 1994 study previously completed without UCLA involvement.)"
While the Board acknowledges the above claim, your response also indicates, "In retrospect, it
appears that Dr. X. P. Chen may have had links between the 1,2, and 3 code and the patients in this
study" and "Dr. Xiao Peng Chen, the investigator, may have had some means of linking data, but he
did not share that with us." As previously documented, Dr. Chen worked on the samples in your
laboratory as part of the Fogarty grant. Therefore, Dr. Chen's work was under your guidance and
authority and he relied on your oversight regarding ethical and regulatory issues. Furthermore,
though you may not have been the principal investigator for the research on the samples, you and the
laboratory participated in the research by allowing the testing of the samples in the laboratory. As
indicated in your December 30,2002 response, it was your "understanding that [Dr.] Chen probably
intended to use the analyses of his anonymized blood samples to contribute to a research publication
on malariotherapy... Please be assured that I will require UCLA IRB approval or Certification of
Exemption for any and all individuals who wish to work with human biological samples or data for
research purposes and work in my laboratory or participate in scholarly programs under my
supervision, such as the Fogarty International Center."
o-Jinquiry/fahey/fahey inquiry 030330
John Fahey, MD
page 2
UCLA policies for human subjects research on existing human biological material or data related to
human subjects were disseminated campuswide in 1996. Additionally, the UCLA Investigator's
Manual for the Protection of Human Subjects was published and distributed in April 1997. The
Manual contains explicit guidance regarding research with human biological material.
Part 1, Section HI of the UCLA Multiple Project Assurance
1
(MPA) with the Department of Health
and Human Services - Office for Human Research Protections (DHHS-OHRP) indicates UCLA will
abide by and our IRBs will prospectively review "all research involving human subjects, and all
other activities which even in part involve such research, regardless of sponsorship, if one or more of
the following apply:
the conduct or recruitment of the research involves institutional resources (property, facility
or funding, including extramural funds administered by the institution), or
the research is conducted by or under the direction of any employee, student or agent of
this institution in connection with his or her institutional responsibilities, or
the research is conducted by or under the direction of any employee, student or agent of
this institution using any property or facility of this institution, or
the research involves the use of this institution's non-public information to identify or
contact human research subjects or prospective subjects."
The DHHS-OHRP January 26, 1999 guidance, "Engagement of Institutions in Research " indicates
in Section A(5): an institution and by extension an investigator is engaged in human subjects
research when, "Institutions whose employees or agents obtain, receive, or possess private
information that is individually identifiable (either directly or indirectly through coding systems) for
research purposes (e.g., obtaining private information from medical records in an individually
identifiable form). (However, see Examples B(7) and B(8) for certain activities involving the release
of information and/or specimens to investigators in non-identifiable form.)" Section B(7) of the
same document states an institution is not engaged in human subjects research if "the data set
contains no direct or indirect indentifiers." Section B(8) is not relevant to this issue.
Dr. Chen appears to have retained links between the codes and individual subjects, and tests were
performed on the samples for research purposes at UCLA using campus resources, property, and
facilities. Additionally, Dr. Chen's work was performed as part of the Fogarty program under your
supervision. Therefore, you as the faculty sponsor and UCLA were engaged in human subjects
research.
UCLA. Multiple Project Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects, May 1,
1998: http://www.oprs.ucla.edu/hurnartfhspcnianual/MPA.htm
2
Director, Division of Human Subject Protections, OPRR. Engagement of Institutions in Research, January 26,1999:
http://ohrp.osophs.dhhs.gov/humarsubjects/assurance/engage.htm
ortnquiry/fabey/fahey inquiry 030330
John Fahey, MD
page 3
2. The Board reminds you that it was your responsibility to determine the nature of the samples that
were being analyzed by Dr. Chen. It appears that your detailed letter to Dr. Heimlich regarding the
data makes clear that you were personally involved in evaluating the data and that Dr. Chen's work
at UCLA was done with your knowledge, approval, and intimate involvement. It, therefore, is
inappropriate to shift the responsibility for the research done at UCLA to Dr. Chen. As the head of
the laboratory and the faculty member in charge of the Fogarty Training Program it was your
responsibility to ensure that activities done in your laboratory, using UCLA resources, were in
accordance with UCLA policies and Federal regulations. Your responsibilities included making
certain that Dr. Chen's work met all of the applicable Federal regulations and campus policies for
human subjects research. In order to avoid future problems, please contact our Office for Protection
of Research Subjects (OPRS) when questions arise regarding human subjects research.
3. The MIRB accepts your December 30,2002 assurance that you will ensure that future Fogarty
scholars and others under your direction have appropriate UCLA IRB approval or certification of
exemption prior to initiating research activities at UCLA or using UCLA property, resources,
material, or funding.
4. Your involvement in Dr. Chen's research will be reported to the DHHS-OHRP, the Fogarty
International Program, and the Executive Vice Chancellor consistent with our MPA and the Federal
regulations.
The Federal regulations and University policy provide investigators an opportunity to respond to
all IRB decisions. If you have additional information relevant to this matter, please submit the
information in writing in the next 30 days. Please contact Steven Peckman, Associate Director
Human Subjects Research at 825-5344 or speckman@oprs.ucla.edu if you have any questions.
Sincerej
UAXOK
Robert A. Figlin,
Chair
cc: Executive Vice Chancellor Daniel Neuman
Dean Gerald Levey, School of Medicine
Vice Chancellor Roberto Peccei
Chair Jeffrey Miller, Microbiolgy, Immunology & Molecular Genetics
Steven Peckman
2107 PVTJB
169407
UNIVERSITY OF CALIFORNIA, LOS ANGELES ^rs^ UCLA
BERKELEY DAVIS IRVINE LOS ANGELES MERCED RIVERSIDE SAN DIEGO SAN FRANCISCO [ PKl i SFl SSSol l SANTA BARBARA SANTA CRUZ
OFFICE OF THE CHANCELLOR
BOX 951405
LOS ANGELES. CALIFORNIA 90095-1405
April 1,2003 VIA UPS OVERNIGHT
Mr. Robert Anglin
Reporter
The Cincinnati Inquirer
312 Elm Street
Cincinnati, Ohio 45202-2754
Dear Mr. Anglin:
In response to your February 18, 2003, request to Mr. Steve Peckman, UCLA's
Associate Director of the Office for the Protection of Research Subjects, for copies of
certain enumerated records related to Dr. John Fahey and/or malariotherapy research,
enclosed please find
1. Copies of ledger entries for expenses incurred against University accounts by
Dr. Fahey. Please note that for financial security reasons, the account numbers and fund
numbers have been redacted; and
2. A copy of the only material transfer agreement (with related correspondence
and other records) maintained by UCLA in connection with research conducted by Dr.
Fahey. There were no such agreements located for Dr. Najir Aziz.
As I receive any additional responsive records, I will review them, and, if not
otherwise exempt from disclosure, will forward them to you.
J
erely,
k/CoJ ,
icia M. Jasper
Campus Counsel
Enclosures as stated
cc: Mr. Peckman, w/o encs.
r
DIVIDER
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Max Benavidez, maxb@support.ucla.edu For Immediate Use
(310) 794-6868 April 15, 2003
UCLA Medical Institutional Review Board Issues Its Determination in the
Fahey Case Regarding Claims About Malariotherapy Studies for HTV
On March 30 the UCLA Medical Institutional Review Board (MIRB) issued its
determination regarding a complaint about Dr. John Fahey and allegations that he participated in
malariotherapy research at UCLA.
The MIRB determined that 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 Chen's work was performed as part of the
Fogarty Program at UCLA and was under Fahey's supervision, the MIRB determined that Fahey was
engaged in human subjects research.
According to the MIRB, in not getting prior approval from UCLA, Fahey violated federal
regulations as well as UCLA policy for the protection of human research subjects by allowing Chen
to conduct research at UCLA in a program funded to UCLA. Fahey did not, however, directly
participate in clinical trials where malariotherapy was administered to Chinese subjects. The board
determined that Fahey and his laboratory participated only indirectly in the research by allowing the
testing of Chen's samples.
The MIRB accepted Fahey's assurances made on Dec. 30,2002, that he will ensure that
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.
Fahey's involvement in Chen's research will be reported to the U.S. Department of Health
and Human Services-Office for Human Research Protections, 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 to the MIRB's findings in this case, UCLA's executive vice chancellor will
ensure that appropriate institutional measures are in place to ensure future compliance with UCLA
policy for the Fogarty Scholars. UCLA also will be responsive to the review of this matter by the
federal government's Office for Human Research Protections.
UCLA has never approved any research pertaining to malariotherapy studies for HTV.
-UCLA- MB200
STATEMENT FROM DR. JOHN L. FAHEY, UCLA PROFESSOR OF
MICROBIOLOGY AND IMMUNOLOGY
John L. Fahey, MD, MS, has never been an advocate for or conducted malariotherapy
clinical trials. He has cooperated fully with UCLA's Medical Institutional Review
Board's investigation involving a Chinese physician who had engaged in malariotherapy
prior to participating in a UCLA training program in advanced ADDS research techniques.
Building on Dr. Fahey's teaching and research experience with AIDS since 1981, the
International training program enrolled more than 30 trainees from India, Thailand,
Vietnam, Brazil, Chile, Mexico, Angola, and Russia, including eight from China, in the
past decade.
Research trainees in the UCLA program, including Chinese physician Dr. Xiao Ping
Chen, were instructed and mentored in techniques using reagents for testing blood serum
from patients with the HIV virus. In 1997, as part of this training, Dr. Chen tested blood
serum he had collected three years earlier from patients he had treated in China with
malariotherapy. This was the only time any specimens from malariotherapy patients
were at UCLA and Dr. Chen was the only trainee in the UCLA program who had ever
engaged in malariotherapy.
UCLA's Medical Institutional Review Board has concluded that this testing by Dr. Chen
should not have occurred without its approval. Standards adopted after 1997 at UCLA
would preclude such approval today. Dr. Fahey is scrupulously complying with these
standards and regrets the misunderstanding this matter has caused. He wishes to put this
episode behind him, and to continue to devote his energies to dealing with the challenges
presented by AIDS worldwide.
Dr. Fahey is traveling to Asia on ADDS-related matters and will not be available for
further comment.
DIVIDER
From: Benavidez, Max '
Sent: Tuesday, April 15, 2003 6:21 PM
To: Carnesale, Albert; Neuman, Dan; Levey, Gerald S.; Eicher, Michael C; Peccei.
Roberto; Jasper, Patricia; Lokman, Lawrence; agrobinson@mednet.ucla.edu; Brook
Judith L.; Peckman, Steven; Miller, Jeffery F.; Dale Tate; Friedman, William F.
Subject: IRB Fahey Case Story In Times Tomorrow
Colleagues:
I want to give you a heads about a story that will appear in tomorrow's L.A. Times
regarding the IRB's findings in the Fahey malariotherapy case. Per our media plan,
we communicated to the Times (to reporter Rebecca Trounson) that the IRB concluded
its inquiry on March 30 in a professional and fair manner and has issued a clear finding in
the case. We provided the approved statement. (Attached for your review.) Steve
Peckman of the IRB was available to answer questions. Trounson did speak to Steve
and one of her main questions was whether or not Dr. Fahey would be disciplined. Steve
noted that the IRB does not mete out punishment and that disciplining faculty is an
institutional issue. Trounson asked me the same question and I told her that the
issue is yet to be determined and, as the statement noted, we would be responsive
to DHHS and that the EVC would put measures in place to ensure future compliance.
We also provided the statement to the Daily Bruin per our plan.
Dr. Fahey's office also provided a statement to both the Times and to the Daily Bruin.
The statement will be posted in the morning on the UCLA Homepage on the "In the
News" section.
Max
BERKELEY DAVIS IRVINE LOS ANGELES RIVERSIDE SAN DIEGO SAN FRANCISCO
UCLA
April 29,2003
Departments of Medicine and of Microbiology,
Immunology and Molecular Genetics
David Geffen School of Medicine at UCLA
650 Charles Young Drive South
Box 951747
Phone:310-825-6568
Fax:310-206-1318
E-mail: jlfahey@mednet.ucla.edu
Mr. Steven Peckman
2107 Peter Ueberroth Building
P.O. Box 951694
Robert A. Figlin, M.D.
Chair, Medical Institutional Review Board
2107 Peter Ueberroth Building
P.O. Box 951694
RE: UCLA Medical Institutional Review Board Investigation of J ohn L. Fahey, M.D.. M.S.
Dear Dr. Figlin and Mr. Peckman,
This concerns Dr. Figlin's March 30,2003 letter to me on behalf of the Medical Institutional
Review Board ("MLRB"). As permitted by Dr. Figlin's letter, I wish to submit additional
information relevant to the above-referenced matter and to have this additional information made
part oftheMIRB's file.
As you know, the conclusion of the MIRB was that there should have been MIRB approval for
Dr. Xiao Ping Chen's analysis of blood serum at UCLA as part of the Fogarty Program in 1997.
That blood serum had been collected three or four years earlier in China from HTV positive
patients treated in clinical experiments using malariotherapy. Those experiments were in no way
connected with me or with UCLA. In fact, I did not even know of Dr. Chen or his experiments
at the time they were conducted. Nevertheless, the MLRB conclusion was that there should have
been MLRB approval for Dr. Chen to analyze the blood samples in 1997 when he was at UCLA
three or four years after those samples were collected. I have furnished the MIRB with multiple
assurances that in the future I will seek MIRB approval for such research work.
Page Two of Two
Mr. Steven Peckman
Robert A. Figlin, M.D.
April 29, 2003
I wish to emphasize that in 1997, at the time that Dr. Chen analyzed the blood samples at UCLA,
it was impossible for me to know that MIRB approval was needed. The best way to illustrate
this is that in 2003, when the MIRB reached its conclusion that such approval was needed, it
relied upon the following authorities which were promulgated after the 1997 event in question:
1. UCLA Multiple Proj ect Assurance ("MP A") with the Department of Health and Human
ServicesOffice of Human Research Protections ("DHHS-OHRP") dated May 1,1998; and
2. The DHHS-OHRP January 26,1999 Guidance, Engagement of Institutions in Research.
Given that these authorities which the MIRB relied upon in reaching its conclusions were only
circulated one and two years after Dr. Chen conducted the blood serum analysis in question, it is
understandable that I had not obtained the approval which the MIRB now has clearly required.
Thank you for your anticipated consideration of these points. Please include this letter with any
materials which are forwarded to the DHHS-OHRP, the Fogarty International Program, UCLA
administrators and any other funding or review source. While I question the apparent conclusion
that in 19971 was somehow responsible for knowing requirements promulgated in 1998 and
1999,1 most emphatically assure you that I am complying with the procedures for MIRB
approval which I now know apply to these matters.
pj
51
B MEMORANDUM
169407
June 10,2003
John Fahey, MD
174718
Dear Dr. Fahey,
Thank you for the April 29, 2003 letter regarding the above referenced complaint. As indicated
in your letter, research conducted on samples brought to UCLA by Dr. Xiao Peng Chen from
China for work in the Fogarty Program occurred in 1997. You question whether the current
Medical Institutional Review Board (MIRB) decision was based on "requirements promulgated
in 1998 and 1999."
The MIRB previously acknowledged that you were not responsible for the conduct of the clinical
trial that predated Dr. Chen's work with the samples in your laboratory. Rather, the Board
determined you were responsible for the subsequent research performed on the samples at UCLA
beginning in 1997. Our March 30,2003 letter outlined the UCLA policies extant at the time of
the research (testing of biological samples at UCLA) that were the basis for the MIRB
conclusions. To reiterate: UCLA policies for human subjects research on existing human
biological material or data related to human subjects were disseminated campus wide in 1996.
As background, the 1988 UCLA Multiple Project Assurance (MPA) was distributed in 1991 to
all investigators as part of the UCLA Policies and Procedures for Research Involving Human
Subjects.
1
The Policies and Procedures included instruction regarding exempt research, limiting
exemption to work with biological material that is "publicly available or if the information is
recorded by the investigator in such a manner that subjects cannot be identified, directly or
through identifiers linked to the subjects." The 1988 MPA served as the basis for the 1996
policy. The Policy document was effective until replaced by the UCLA Investigator's Manual
for the Protection of Human Subjects in April 1997, distributed campus wide, and the renewed
MPA in 1998. The 1999 DHHS guidance was provided to you as further clarification of the
policy and regulation.
The 1988 UCLA Multiple Project Assurance (MPA) was distributed in 1991 as part of the UCLA Policies and Procedures for
Research Involving Human Subjects. Human Subject Policy Committee.
John Fahey, MD
page 2
On behalf of the MIRB, I appreciate your assurances that in the future you will seek IRB
approval for such research. Please contact Steven Peckman, Associate Director Human Subjects
Research at 825-5344 or speckman@oprs.ucia.edu if you have any questions.
Sincerely^
Robert A. Figlin,.
Chair
BERKELEY DAVIS IRVINE LOS ANGELES MERCED MVERSIDE SAN DIEGO SAN FRANCISCO
BOX 951694
LOS ANGELES. CALIFORNIA 90095-1694
June 24,2003
Michael A. Carome, MD
Associate Director-Regulatory Affairs
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
NIH grants TW 00003 and AI36086
Dear Dr. Carome,
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 about
research collaboration between UCLA Professor John Fahey, MD and investigators 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 as part of the Fogarty
Program at UCLA and was under Dr. Fahey'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's
direct 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 Fogarty scholars and others
under his direction will have appropriate UCLA IRB approval or certification of
exemption prior to conducting any research activities at UCLA or using UCLA property,
resources, material or funding.
oJinquiiy/fahey/OHRP fahey inquiry 030623
UCLA
Allegations Regarding Malariotherapy Research
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 Borror, OHRP
Executive Vice Chancellor Daniel Neuman
Vice Chancellor-Research Roberto Peccei
Chairperson Carmine Clemente, MIRB1
Chairperson Robert Figlin, MIRB2
John Fahey, MD
Associate Director Steven Peckman
o/inquiiy/fahey/OHRP fahey inquiiy 030623

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File One: Chronology of 2002/03 UCLA investigation of employees and the Heimlich Institute's "malariotherapy" experiments in China (documents obtained via public records request to UCLA); direct download at: http://db.tt/viY1LyWe

File One: Chronology of 2002/03 UCLA investigation of employees and the Heimlich Institute's "malariotherapy" experiments in China (documents obtained via public records request to UCLA); direct download at: http://db.tt/viY1LyWe