May 13, 2013 Jerry A.

Menikoff, MD, JD Director Office for Human Research Protections Department of Health and Human Services (HHS) 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 Dr. Menikoff: This is to request that your office review the following information and provide me with answers to two questions regarding participation by University of California Los Angeles employees in AIDS research conducted in China by the Heimlich Institute of Cincinnati, Ohio. 1) According to an August 6, 1997 letter from John L. Fahey MD, Director of UCLA's Center for International Research in Disease, the research was supported by NIH grants TW 00003 and AI 36086. Would you please determine whether those grants were properly administered and provide me with your opinion? 2) In 2002/2003, UCLA conducted a related investigation at which time the university responded to an inquiry from your office. Would you please determine if UCLA's response adequately complied with federal reporting guidelines and provide me with your opinion? My request is based on the following documents -- please click the links to download the files, which are text-searchable pdfs. File One: 126 pages of records provided by UCLA in response to a public records request for responsive documents re: UCLA's 2002/2003 investigation: http://db.tt/viY1LyWe File Two: 20 pages of responsive records provided by HHS on March 11, 2005 in response to a FOIA request for all information re: UCLA's 2002/2003 investigation: http://db.tt/JtzmO2ER The file includes correspondence between UCLA and two employees of your office: former Associate Director of Regulatory Affairs Michael A. Carome MD (now Deputy Director of Public Citizen's Health Research Group) and Kristina C. Borror PhD, your office's Director of Compliance Oversight. File Three: 602 pages I recently obtained from the Henry J. Heimlich Archival Collection. Per the last page of the file, the records were donated to the University of Cincinnati Health Sciences Library by Henry J. Heimlich MD (my father) and by the Deaconess Association Foundation: http://db.tt/KHn9neQA You may also access the three files and a related May 6, 2013 investigations request I submitted to UCLA via this link: http://bit.ly/10dvp4l File Three, which is arranged chronologically, includes selected documents from the Heimlich Institute's malariotherapy research prior to the work in China followed by voluminous records documenting the experiments in which Chinese HIV+ and AIDS patients were infected with malaria. The file contains far more information than may be summarized in this letter, but I wish to bring these points to your attention.

Please be advised that, prior to providing copies to me, redactions were made by a University of Cincinnati librarian to de-identify confidential patient information. Unredacted records may be inspected at the the library. Also, there are many thousands of pages in the collection -- due to time restrictions, there are many other documents I have yet to access. The parenthetical numbers refer to the page numbers of File Three. Prisoners were used as research subjects and infected with malaria (118-120 and 127-128, 152-153) Active IV drug users were used as research subjects and infected with malaria (various pages) Security guards were hired to oversee patients, raising concerns about consent (130-132) Numerous descriptions of seemingly chaotic patient care, haphazard follow-up, unexplained patient deaths, etc. (various pages) Acknowledgment that the research was conducted in apparent violation of Chinese law (131) May 7, 1996 letter from the Eleanor Naylor Dana Trust -- a Park Avenue foundation that was the primary funder of the China experiments -- confirming the first payment ($50,000) to the Heimlich Institute (197); a July 25, 1996 letter from the Dana Trust confirms a pending $100,000 payment (213) In a August 8, 1996 letter to Dr. Heimlich on UCLA letterhead, John L. Fahey MD of UCLA asks to participate in the work and suggests that Chinese doctors involved in the experiments could be assisted by UCLA's Fogarty program and could be provided with medical supplies (214) Dr. Heimlich's report of his September 24-27, 1996 visit to UCLA's immunology department hosted by Dr. Fahey and involving other UCLA staff with a description of UCLA's partnership with the Heimlich Institute's malariotherapy experiments in China, UCLA designing the research and providing laboratory tests of blood samples, and that Our Chinese colleague, Dr. Chen Xiau [sic] Ping is invited, at the expense of UCLA, to spend three months in 1997 studying in Dr. F's laboratories. Dr. F. will have Hong Bass contact Dr. Chen and provide his laboratories in Guangzhou with training and assistance. He will also provide reagents for laboratory studies to Chen without cost. (232-237) In a November 6, 1996 letter to Dr. Heimlich, Dr. Fahey states he has invited Dr. Chen to take UCLA's Fogarty course the following Spring and invited Chen to bring blood samples with him for testing at UCLA (250-251) Records mentioning Dr. Fahey's direct communications with David Mahoney, Chairman of the Dana Trust (238 and 250-251) UCLA staffers analyzed patient records and blood samples (numerous pages) In a March 6, 1997 letter to Dr. Heimlich on UCLA letterhead, Dr. Fahey writes, (We) we are looking forward to meeting Dr. Chen Xiao Ping and having him here this spring. We had told him that we would be pleased to help him analyze any specimens that he brings from China in connection with HlV studies conducted there. It occurred to us that you might like to have him visit you in Cincinnati and I would like to help you in any way that I can. Certainly our association has been stimulating and mutually rewarding. (279) In an August 6, 1997 letter to Dr. Heimlich, Dr. Fahey wrote, We would appreciate an acknowledgment and credit to the support provided by NIH grants TW 00003 and AI 36086. (316) November 13, 1997 letter from Dr. Fahey to Dr. Chen discussing Fahey's recent visit to China; his meetings with Chen and his colleagues; the malariotherapy experiments; and his suggestions about patient selection (356-358) Dr. Fahey is identified as Principal Investigator in a 1998 malariotherapy fundraising prospectus produced and circulated by Deaconess Associations, the parent corporation of the Heimlich Institute (407-419) Najib Aziz MD of UCLA identified as obtaining permission from the Centers for Disease Control and Prevention (CDC) to ship blood samples in 1999 (469 per Chen, 496 per Heimlich) and 1997 blood sample testing records (317-322) Dr. Fahey's review of journal articles about the China experiments intended for publication and publishing suggestions from late 1990s through 2002 (various pages)

Note that many of the documents held by the Cincinnati library originated from UCLA -correspondence on university letterhead, e-mails from UCLA accounts, and other documents. Presumably those records were readily available to the 2002/2003 investigators. However, in File One, there's no reference to most of those documents. Therefore it's unclear if they were included in the 2002/2003 investigation. In fact, based on File One, apparently the only UCLA letters and e-mails included in the investigation were supplied by Dr. Heimlich. In what must have been a surprise to the university, he sent those in response to a December 2, 2002 letter from UCLA Campus Counsel Patricia Jasper. Her letter demanded that he stop claiming UCLA and Dr. Fahey participated in the Heimlich Institute's malariotherapy trials, presumably based on Dr. Fahey's assurances that such claims were false. From Dr. Heimlich's December 16, 2002 reply to Ms. Jasper (emphasis added): 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 correspondence1 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 HIV/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 in the malariotherapy project of The Heimlich Institute, for which we are very grateful. It's unclear what efforts, if any, were made by UCLA investigators to obtain the remainder of the correspondence. Per File Two, in response to media reports published in Spring 2003, your office contacted UCLA and requested information about the investigation. In response, apparently the university provided no records (correspondence, interviews, reports, etc.), just a brief June 24, 2003 letter to Dr. Carome from Judith L. Brookshire, Director of UCLA's Director Office for Protection of Research Subjects, with assurances that the matter had been resolved. From an April 16, 2003 UCLA statement about the findings of the 2002/2003 investigation: Dr. 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.... It's unclear on what evidence and on whose testimony UCLA arrived at this determination. As mentioned, documents in File One identify a number of UCLA employees. But it's unclear if any of them were contacted or interviewed for the investigation. And what about Drs. Chen, Heimlich, and Heimlich Institute Research Director Eric Spletzer PhD, who, per File Three, frequently corresponded with UCLA employees about the China trials? Were any of them interviewed? File Three also chronicles the six-year relationship between the Heimlich Institute and employees of UCLA's immunology department. Was there a financial arrangement? Did it involve NIH funds? And what about Dr. Chen's participation in UCLA's Fogarty program, funded by the NIH? Drs. Heimlich and Chen had been working together for about five years when, in his August 8, 1996 letter to Heimlich, Dr. Fahey asked to participate in the Heimlich Institute's work -just after the start of the Dana Trust funding.

1 Please note that the records provide to Ms. Jasper by Dr. Heimlich included the August 6, 1997 letter from
Dr. Fahey stating the research was supported by NIH grants TW 00003 and AI 36086.

In the same letter, Fahey suggested that Chinese doctors involved in the project participate in the Fogarty program. A few months later, in a November 6, 1996 letter, he informed Dr. Heimlich he had invited Chen to UCLA. According to Heimlich's report of his three-day visit with UCLA's immunology department in September 1996, that invitation was part of their arrangement. Finally, I'd appreciate clarification regarding a letter dated March 6, 2003 from Dr. Borror to Ms. Brookshire at UCLA. In the letter (which may be found in File Two, page 6), Dr. Borror states, The Office for Human Research Protections has received your letter of June 24, 2003. Undoubtedly the three and a half month backdating was a typographical error. For my records, would you please provide me with a record confirming the date Dr. Borror's letter was sent? Thank you for your consideration and I look forward to your reply. Please feel free to communicate with me by via e-mail. Sincerely,

Peter M. Heimlich 3630 River Hollow Run Duluth, GA 30096 ph: (208)474-7283 e-mail: peter.heimlich@gmail.com website: MedFraud.info blog: The Sidebar cc: Kristina Borror, Director, Division of Compliance Oversight, OHRP Daniel R. Levinson, Inspector General, Department of Health and Human Services