6. Letter From the Director of the National Institute of Allergy and Infectious Diseases (Krause) to the Ambassador to Zaire (Constable)1

Dear Mr. Ambassador:

I am writing to update you on the status of our collaborative research effort to study Aquired Immunodeficiency Syndrome (AIDS) in Zaire, which is of highest priority for the welfare of U.S. and Zaire citizens and the global community. The U.S. collaboration involves two components: 1) direct collaboration by two U.S. Public Health Service (PHS) agencies, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) in direct cooperation with Zairian health officials and physicians; and 2) an NIAID sole-source research contract under negotiation with the Institut de Medicine Tropical (IMT), Antwerp, to provide bilingual epidemiologic and clinical research and training capability not available in the USA or Zaire. This collaborative effort is well under way and has already resulted in two landmark articles with joint Zairian-Belgian-NIAID-CDC authorship accepted for publication in Science and The Lancet.2

In response to questions raised by the NIH Initial Review Group which met in early May and the U.S. Embassy in Zaire, the proposed workscope of the NIAID–IMT contract has been substantially revised.3 Dr. Jon Mann, CDC Medical Epidemiologist assigned to Kinshasa hand-carried a copy of the revised workscope for internal Embassy use.4 Discussions with CDC’s Drs. Joe McCormick (arrival June 8) and Jon Mann (arrival June 11) should have clarified NIAID and USPHS positions and laid to rest concerns about NIAIDCDC cooperation and Zairian sensitivity to Belgian participation.

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Because NIAID/NIH has had minimal scientific exchange and collaborative research activities in Zaire in the past, I would like to take this opportunity to summarize the NIAID domestic biomedical research mission in AIDS and Sexually Transmitted Diseases, the NIH authority to engage in international research, and scientific justification for Zairian-USA-Belgian collaboration. This information should expedite Embassy clearance of the proposed NIAID–IMT research contract.

NIH is the USPHS agency responsible for biomedical research and research training. NIAID responsibilities include Tropical Medicine and Sexually Transmitted Disease research. AIDS is currently the nation’s most urgent public health problem and the USPHS reports regularly to the Executive Branch and Congress on research activities and advances. Under the authority of the International Health Research Act (1960), NIH can carry out or sponsor health research overseas provided there is immediate or potential health benefit to U.S. populations. The recent identification of HTLV–III Virus (NIH) and LAV Virus (France) as highly-suspect causative agent(s) precipitating AIDS in U.S. populations should very rapidly result in the development of diagnostic laboratory tests and make it practical to do definitive clinical studies on the epidemiology and pathogenesis of AIDS. The Science article in press indicates that Zairian patients with AIDS have LAV-positive serum. In addition, approximately five percent of Zairian women have LAV-positive serum. The Lancet article presents strong preliminary evidence that, in Zaire, heterosexual transmission of AIDS (male to female; female to male) occurs.

Patterns of transmission, risk factors, sex ratios of AIDS cases, complications of AIDS, and survival rates appear to differ dramatically in USA patients and Zairians (whether in Belgium or Zaire). Haitians may form an intermediate group. To date, Canadians, Europeans, and Latin Americans appear to have the same type of risk factors as USA citizens. Zaire and Haiti, therefore, appear to offer unique international research opportunities. Haiti and Zaire will be prime candidates for collaboration in the evaluation of anti-viral agents, immune stimulating agents and vaccine candidates which will be developed at NIH or with NIH research funding. This will be particularly true if HTLV–III Virus and/or AIDS patients in these countries are “different” than in USA populations. There is a particularly urgent need to evaluate the true risk (if any) of heterosexual transmission of AIDS, which has profound implications for sexually-active Americans, especially those resident in or traveling to Central Africa.

NIH does not have the authority to “train for the sake of training,” transfer technology, or strengthen institutions. Zairian proposals to date have fallen into this category and in the normal course would be disapproved or referred to USAID for consideration. During the [Page 15]December 1983 visit of Professor Lurhuma (former Dean of Medical School, University of Kinshasa) to NIH, NIAID’s Assistant Director for International Research did offer to help Zaire develop a Tropical Medicine Field Research Program for consideration by USAID and/or other funding sources (WHO/EEC). NIH is supportive of Zairian counterparts and their quest for increased self-sufficiency in biomedical research and clinical practice. The USPHS-Zaire collaborative project and the revised IMT–NIAID workscope specifically provide for training of Zairian physicians in the areas of specialized diagnostic procedures, microbiologic techniques, and treatment protocols.

NIAIDCDC–Zaire cooperation in AIDS will undoubtedly lead to the study of the role of diseases like malaria, tuberculosis, and filariasis, and nutritional status in AIDS. Long-term cooperation with NIAID in Tropical Medicine in Haiti has been expanded since 1983, largely due to the scientist-to-scientist relationships established during exchange of information and collaboration on AIDS.

Let me now summarize why IMT and Belgian participation is necessary to the cooperative research effort in Zaire. I shall also indicate how NIAID will manage the proposed research contract. Federal Contract Law does not permit NIH to award foreign research contracts without the determination that there are no qualified U.S. sources and that the foreign source is uniquely qualified to comply with the workscope. IMT met these well-established and rigid NIH scientific criteria. Under the provisions of the sole-source contract currently under negotiation between NIAID and IMT, IMT staff and activities will be directly supervised and continuously monitored by NIH project personnel. The IMT principal investigator will be required to submit quarterly reports to NIAID. This is a standard NIH cost-reimbursable contract, under which the contractee is paid for work already done provided NIH finds it satisfactory. NIAID/NIH can suspend or terminate the contract unilaterally at any time.

U.S. clinicians and investigators experienced and qualified to conduct AIDS research are heavily committed to the domestic research effort. The chances of finding Francophone Americans with these qualifications to relocate in Zaire are remote. At present, no U.S. biomedical research group has an established collaborative working relationship in Zaire. The pertinent unique qualifications of IMT necessary for the Zairian AIDS study include:

1) Long-term knowledge and experience in working with Congo/Zaire, and medical archives and serum banks (dating back at least twenty years) collected in the course of their long association;

2) IMT and Belgian scientists were active in investigations on Kaposi Sarcoma and possible AIDS in Zairian citizens before NIH or CDC became involved. Ninety-eight percent of the AIDS cases in Bel[Page 16]gium are Zairians, either resident or those who have sought sophisticated analysis and treatment heretofore unavailable in Zaire.

3) In Kinshasa, IMT has, by agreement with the government of Zaire, an established laboratory which has been carrying on AIDS investigations independently of CDC and NIH.

In contrast to limited U.S. biomedical research experience in Zaire, U.S. and Belgium have a long history of scientific exchange and cooperation. For example, NIH and Belgium have an agreement in principle, negotiated in 1981, to cooperate in tropical medicine. This was before AIDS was recognized as a serious problem in either country. Belgian and U.S. investigators were actively engaged in bilateral AIDS research before the importance of the disease in Zaire was recognized. NIAID views the involvement of Belgian, other European, and Haitian scientists in AIDS research in Zaire as the logical extension of our domestic and bilateral research efforts in the USA, Europe, and the Caribbean.

NIH research administrators and external scientific consultants have determined that while there are a few Zairian scientists having sufficient biomedical research training to participate actively in NIAID contract research, Zairian institutions do not have the research facilities, the capital for cost-reimbursable contracts, or the administrative structure to provide NIH with the strict fiscal accountability we require, by law. This procedure will expedite the research. At the same time, we are committed to a generously collaborative research effort on AIDS that will involve the Zaire physicians in an active way.

The PHS scientists who have visited Zaire or interacted with Zairian scientists in the USA or at international scientific meetings have consistently been impressed by the active and productive cooperation among IMT, Ministry of Health and Kinshasa University Medical Center investigators. Some concrete indications of current Belgo-Zairian cooperation in AIDS can be cited:

1) The aforementioned article submitted by IMT to Lancet is co-authored by five Zairians (Drs. Kapita Bela, of Mama Yemo Hospital, and Odio Wobin, N. Mbendi, P. Mazebo, and N.N. Kayembe, of the University Medical Center) and acknowledges the assistance of Minister of Health Dr. Tshibasu, Dr. Kalisa Ruti, and other Zairian officials and institutions, as well as members of the American Embassy staff. The article submitted to Science by Dr. Luc Montagnier (Pasteur Institute, France) lists the same five Zairian co-authors and two Belgian co-authors, in addition to CDC and NIAID scientists, and similarly acknowledges assistance rendered by appropriate Zairian officials and institutes.

2) In October, 1983, Zairian physicians of the University Medical Center (Drs. Ditu, Odio and Mbende) cosigned a research agreement with Dr. Joe McCormick (CDC/USPHS) and Drs. Peter Piot and Henry [Page 17]Taelman (IMT), endorsing IMT’s participation and ensuring full participation of Zairian University physicians in studies of AIDS in Zaire.

3) IMT has sponsored the participation of Zairian investigators in a number of international meetings on AIDS, including the WHO meeting (Geneva, November, 1983); the International Symposium on Sexually Transmitted Diseases (Montreal, June 17–20, 1984); and the International Congress of Tropical Medicine and Malaria Meeting to be held in Calgary in September 1984.

4) Finally, IMT and Zairian investigators have continued cooperative AIDS investigations initiated during the joint CDC/NIH/IMT visit to Zaire in October, 1983.

In my nine years as Director of this Institute, it has been our firm tenet, in working with countries the world over, to collaborate closely with national scientists. The NIAID has an enviable record, of which I am proud, of supporting rather than taking advantage of foreign national collaborators. I appreciate and sympathize with your concerns about our treating Zaire as an “AIDS Laboratory”, and hasten to assure you that such would be totally inconsistent with our international research policy.

In view of the national and global concerns outlined herein, I personally urge and request the Embassy’s clearance for NIAID to proceed with the IMT contract and implement the integrated “Study of AIDS in Zaire.” Thank you for your kind attention and consideration.5

Sincerely,

Richard M. Krause, M.D.
  1. Source: Department of State, Subject Files, Health Issues, 1977–1985, Lot 86D184, Agent Orange. No classification marking. Copies were sent to Wyngaarden, Gordon, Wallace, Sell, Mason, Dowdle, Curran, Walsh, and Thompson.
  2. Reference is to Brun-Vézinet, F., Rouzioux, C., Montagnier, L., Chamaret, S., Gruest, J., Barré-Sinoussi, F., Geroldi, D., Chermann, J.C., McCormick, J., Mitchell, S. et al., “Prevalence of Antibodies to Lymphadenopathy-Associated Retrovirus in African Patients with AIDS,” Science, 1984 October 26; 226(4673): pp. 453–456.
  3. In telegram 7471 from Kinshasa, May 14, the Embassy reported that it was “seriously concerned that the ITM proposal for NIH funding of Belgian scientists to do AIDS research in Zaire could mar U.S.-Zairian cooperation. The proposal would insinuate the U.S. into a delicate Belgian/Zairian relationship, including the friction that exists between Zairian and Belgian medical specialists.” (Department of State, Subject Files, Health Issues, 1977–1985, Lot 86D184, Africa)
  4. Not found.
  5. In telegram 10306 from Kinshasa, July 6, the Embassy reported it had received Krause’s letter, stating: “On June 25, we received a letter from Doctor Richard Krause, Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health, making a strong argument for ITM participation in AIDS research. However, as we examined his argument in depth, we found it to be somewhat misleading. We continue to oppose approval of the ITM proposal which we believe could undermine the collaborative research project, damaging our broader relations with the GOZ.” (Department of State, Central Foreign Policy File, D840432–0013) In telegram 16693 from Kinshasa, November 5, the Embassy reported: “The project agreement between the GOZ Ministry of Health and ITM suggests that Belgian activity will be restricted to specialized techniques and training in the clinical domain, and can be effectively integrated into the project.” (Department of State, Central Foreign Policy File, D840707–0227)