Den folgenden Artikel habe ich im Oktober 2006 im "viennese ethnomedicine newsletter"
INSTITUTE FOR THE HISTORY OF MEDICINE, MEDICAL UNIVERSITY OF VIENNA
quondam ACADEMIA CAESAREO - REGIA IOSEPHINA 1785
department of ethnomedicine (volume IX number 1) publiziert. ISSN 1681-553X

A Case Behind the International AID(S) Business:
Corruption Siphons AIDS Money

The artist John Kilaka reflects on the mounting evidence of procurement scandals at the ministry of Health in Tanzania which allegedly granted a single supplier with exclusive rights to provide HIV/AIDS laboratory equipment for National AIDS Control Programmes. This led to a broad public discussion with several front-pages in the national Kiswahili and English Press. Kilaka shows through his painting that market monopolization and corruption are directly connected to the suffering of the people at the grass roots. Institutionalized human greed is interfering with the immediate needs of the downtrodden in the villages. These needs are: Best
and affordable technologies and effective use of funds allocated for serving the health of the masses. The cry for life is opposed by international industries striving for market control and corrupt local elites struggling for financial gains.

During the last decade antiretroviral drugs (“AIDS drugs”) have turned HIV/AIDS into a chronic disease as opposed to what once was regarded as a death sentence. Nevertheless, still only a minority of roughly one in six Africans who are in urgent need for treatment have access to these life saving drugs by December 2005 (UNAIDS 2006). At present many countries say that they want to scale up treatment and prevention rapidly leading to full access.
The realization of the human right for treatment was again demanded by People Living with HIV/AIDS at the XVI International AIDS Conference (International Aids Conference 2006). Therefore a lot of equipments and tests are procured and the door for manipulation and corruption seems to be wide open.


The piece of Tinga Tinga art deals with the procurement irregularities concerning special laboratory devices – the so called CD4 counters – and John Kilaka specifically chooses one of the
most dramatic cases within the procurement scandals. The issue was discussed and documented
for several weeks in the country’s English (The Citizen No. 511, This Day No. 174, No. 104) and Kiswahili (Rai No. 666, No. 667) press. The daily Tanzanian newspaper This Day (No. 174) reported on its front-page: “A Dar es Salaam businessman with exclusive rights to supply HIV test kits – at hiked prices – is behaving like a gagged man against press probes, This Day can reveal. Mr. Bharat Rajan, CEO of Biocare Health Products Limited, is currently directing all questions to the Ministry of Health as if it were part of his outfit. Mr. Rajan’s firm currently supplies almost every equipment and reagents from a global fund to fight Aids, Tuberculosis and
Malaria to the Ministry of Health and Social Welfare at fictitiously high prices … … investigations by This Day have established that Rajan’s Biocare has supplied the ministry with chemistry analyzers, hematology analyzers and FACS Count cd4 count machines which are said to be costly because they use expensive reagents.”
CD4 counters are special flow cytometers and used all over the world as “gold standard” to determine the immune-status of HIV/AIDS patients by counting CD4 positive blood cells (also called T-helper lymphocytes). CD4 positive cells represent the backbone of the immune-system. The number of these cells slowly decreases in the HIV infected individual. To know the CD4 count of somebody who is HIV infected is an essential help in determining when to start and to monitor life saving treatment by antiretroviral drugs. The brown box in Kilaka’s painting with the letters “FACS” on it symbolizes a FACS Count (Fluorescence activated cell sorting) which is the brand name of Becton Dickinson’s CD4 counter (BD Biosciences, USA) and obviously the favorite machine of the Ministry of Health of Tanzania. (Private Health Laboratory Board, August 2006; Rai No. 671; This Day No. 174).

Compared to more recently developed CD4 counters on the market, the FACS Count was originally designed for the use in the highly sophisticated environment of clean laboratories in industrialized nations and not for the dusty health centre or outreach program in a developing country in order to closely serve the needy rural population. The FACS Count lacks an additional feature – the CD4 % of total lymphocytes necessary for the proper treatment of children below the age of 7 years (USAID 2006). This is especially important as the proportion of – due to mother-to-child-transmission – infected children is very high in the resource limited
rural African setting with its matured and generalized HIV epidemics and the determination of the CD4% is also requested by the guidelines of the National AIDS Control Programme of Tanzania and by the World Health Organization (WHO 2006).
Although the lowest found list price of the FACS Count (USAID 2006) with 27.000 US$ is comparable to other products on the market; it was reported from different countries that the over the shelf prices were sometimes up to 4 times higher (Partec personal communication 2005, 2006). It is general knowledge that higher prices are found especially after decisions leading to market domination of a single product or after adding additional costs for freight, local
distribution, warranty, service contracts or installation and training.
The FACS Count is a closed system, which means that only the pre-packed original reagents of the manufacturer can be used for this type of machine, which practically eliminates competition in the field of reagents for this technique and therefore national treatment programmes and Ministries of Health would depend on only one supplier.
As internationally often the case, the price of reagents and other consumables are very different
depending on the market share, the level of regional competition, and the local price policy of companies. In some cases the prices for reagents are reportedly 3-25 times higher than those of other manufacturers or the announced minimum price. The Clinton Foundation says that its negotiations with manufacturers like Becton Dickinson have brought the test down to 5 dollars (Carter 2004), but currently in Zimbabwe the cost for one of Becton Dickinson’s CD4 count is US$56 and is revised upward quarterly according to a scientific peerreviewed publication of the University of Zimbabwe and Stanford University (Zijenah et al. 2006).
In John Kilaka’s painting “The FACS Count” bundled money is falling down at an umbrella which covers the people in the villages. Seated in the umbrella are fat men eating good food and counting money which is channeled into their own pockets. Their pecuniary wealth seems to be financed through artificially high prices and cooperation contracts with local distributors (This Day No. 174) who are excluding other competitive high quality products from the national market. International funds and the country’s tax funded budget are feeding some of the politicians, civil servants and so called experts, who eat rich meals and enjoy high quality life, while the rural, uniformed and poverty-stricken men, women and their children under the umbrella are cut off from their constitutional and human rights for proper health care, they are starving and they have no shelter. The smaller brown box on the table of the desperately weeping villagers with the letters “CYFLOW” on it, symbolizes a “CyFlow” which is the brand name of Partec’s CD4 counter, developed and manufactured especially for the use in resource limited settings, while the same key technology is also in use for other applications in the US, Europe, Japan and the rest of the world (see Partec homepage). The well working laboratory equipment is lying idle on the table as its use is blocked. The villagers cannot understand the rationale behind this as already they were perfectly served by the equipment (Partec personal communication 2005, 2006). The CyFlow has many advantages and therefore studies from different authors published in world’s renowned scientific journals and from most reputable scientific groups – including co-operations with Boston Harvard School of Health (Imade et al. 2005), Stanford University (Zijenah 2006), and Center of Disease Control – CDC (Pattanapanyasat et al. 2005) as well as organizations like Doctors without Borders MSF (Fryland et al. 2006) propose the use of this product as one of the solutions to scale up life saving antiretroviral treatment in resource limited settings. A conclusion of a very recent study says: “Although the purchasing price of FACS Count and Cyflow counter are comparable (US$ 30 000 - 50 000), the FACS Count reagents are more expensive than those for the Cyflow. The Cyflow counter also has a high throughput and as many as 200 specimens can be run per day, making it ideal for use in Zimbabwe, a country with one of the highest prevalence of HIV globally. In conclusion, the Cyflow counter is as accurate as the FACS Count in enumerating absolute CD4+ T lymphocytes in the range 1-1200 cells/μL. Cyflow cytometry is relatively affordable, easy to use technology that is useful not only in identifying HIV seropositive individuals who require ART but also for monitoring immunologic responses to ART.” (Zijenah 2006)
A CyFlow CD4 counter can run on a car battery or a solar panel and because of its robustness and portability it can be operated in a rural health centre or in a car by one trained person and its handling is rather simple. Mobile laboratories are already successfully used in Nigeria (Gede Foundation), in Benin (“action pro humanity”/government) and in Lesotho (UNDP). One CD4 test costs worldwide always the same and is at present the least expensive with only 1,75 Euro (2,5 Euro including cd4% per test) and according to the manufacturer in the year 2006 approximately 1.1 million CD4 tests will be distributed worldwide. According to the manufacturer exactly 346 Partec CyFlow devices have been placed in more than 30 African and 10 Asian countries within the past 3,5 years” (Partec personal communication 2005, 2006). Nigeria has decided to use the CyFlow as a national reference method and placed already more than 100 CyFlow units. Partec CD4 counters were mainly ordered by small programmes of local and international NGOs and faith based hospitals but also by some UN programmes (UNICEF, WHO, UNDP). The cost for the Cyflow-SL3 which can directly do the additional feature of CD4% (in order to facilitate treatment of children below 7 years of age) is worldwide always the same with 20.850 Euro and therefore even a bit less than the lowest international price found for a FACS Count (which is lacking to do a direct CD4% of total lymphocytes and therefore cannot directly serve the HIV positive children). This over-the-counter price includes a starter kit containing several hundreds of tests, consumables, an uninterruptible power supply, and at least a one year warranty. Accordinbg to Partec, compared to the FACS Count, the cost for service contracts and consumables are offered at starting prices three times lower than reported for the BD FACS Count. In December 2005 a price guarantee of 10 years was offered to the Ministry of Health in Tanzania (Partec personal communication 2005, 2006). However, numerous letters and offers from the company to co-operate with the national programmes and to develop even better and less expensive ways of CD4 counting never got any response. Instead of answering theses letters, the official Tanzania prohibited the import and use of the CyFlow (Rai No. 671, Private Health Laboratory board 2006) saying that its technical performance is poor and the test results are unreliable, following findings of a research which was reportedly done by Muhimbili University of Health. For unknown reasons this research was never published and requests to present the methods and data were never answered.
The former Minister of Health recently said in a media interview (Rai No. 674) that she had advised her civil servants and university professors last year to purchase various types of machines in order to make the country more independent and to keep the competition going. This advice was ignored by the new Minister of Health who repeatedly in public used the argument of bad technical performance of the CyFlow. He says that his statements are based on the unpublished findings of the Muhimbili University, which contradict more than 30 publications and findings of multi-centre studies confirming the accuracy of the CyFlow (e.g. Cassens et al. 2004).
Media reports say that some of the civil servants and university employees leading investigations in order to decide about registrations of health products in Tanzania have close ties with businessmen dealing with the import of such products (This Day No. 174). The practical result of the malady is that a lot of money is spent for overpriced unreliable equipment which is not working very well in the resource limited rural setting and very few CD4 counts are done subsequently keeping people away from life saving treatment.

John Kilaka vividly pictures an ancient game: The “haves” are eating and the “have nots” are
dying!


References
BD Biosciences, San Jose, CA 95131-180, USA, www.bdbiosciences.com

Carter M. (2004) Clinton Foundation secures cut price CD4 and viral load tests for resource limited countries. www.aidsmap.com/en/news/A62F59CF-0590-4FE9-AAD4-E6253B5BF027.asp

Cassens U. et al. (2004): Simplified volumetric flow cytometry allows feasible and accurate determination of CD4 T lymphocytes in immunodeficient patients worldwide. In: Antiviral Therapy 9: 395-405

Fryland et al. (2006) The Partec CyFlow Counter® could provide an option for CD4+ T-cell monitoring in the context of scaling-up antiretroviral treatment at the district level in Malawi. In: Transactions of the Royal Society of Tropical Medicine and Hygiene 100, 10: 980-985

Imade G.E. et al. (2005) Comparison of a New, Affordable Flow Cytometric Method and the Manual Magnetic Bead Technique for CD4 T-Lymphocyte Counting in a Northern Nigerian Setting. In: Clinical and Diagnostic Laboratory Immunology 12, 1: 224-227

International Aids Conference (2006) Closing session of the XVI international AIDS conference, Toronto 2006 – Statement of Activists – PLWHA (www.kaisernetwork.org)

Pattanapanyasat et al. (2005) Evaluation of a New Single-Parameter Volumetric Flow Cytometer (CyFlowgreen) for Enumeration of Absolute CD4+ T Lymphocytes in Human Immunodeficiency Virus Type 1-Infected Thai Patients. In: Clinical and Diagnostic Laboratory Immunology 12, 12: 1416-1424.

Partec GmbH, D-48161 Münster, Germany, www.partec.com

Private Health Laboratory Board of the Ministry of Health (2006) Letter of the Registrar from 21st August 2006, Ref No HC49/421/VOL.V/26.

Rai (Tanzania) 671 August 17-23, 2006, Statement explaining the decision of the ministry by citing the contradicting findings of the ministry of health

Rai (Tanzania) 674, September 7-13, 2006, Corruption Saga in the Ministry of health

Rai (Tanzania) 666, July 13-19, 2006, Mvutano mkali waibuka Wizara ya afya, front page

Rai (Tanzania) 667, July 20-26, 2006, Mafarisayo Wizara ya Afya na fedha za ‘migodi’ ya ukimwi, front page

The Citizen (Tanzania) 511, May 4, 2006, It’s hell over Aids kits, front page

This Day (Tanzania) 104, June 24, 2006, Trouble brews at home over HIV testing kit, front page.

This Day (Tanzania), 105, June 26, 2006

This Day (Tanzania), 174, September 14, 2006, Supplier of suspect HIV/AIDS kits shuts up on media, front page

UNAIDS (2006) Report on the global AIDS epidemic 2006. Joint United Nations Programme on HIV/AIDS (UNAIDS) http://www.unaids.org/en/HIV_data/2006GlobalReport/default.asp

USAID (2006) CD4 machine logistics fact sheets. http://pdf.usaid.gov/pdf_docs/PNADG265.pdf (nowadays 23rd March 2008, this link leads to another producer of CD4 Counters, GUAVA but the FACSCount data sheet is still available at http://www.phishare.org/files/4365_CD4MACHINE_FACTSHEET_FACS.pdf it is a unfortunate policy to change inforamtion under the same link in a way like this!)

WHO (2006) Antiretroviral therapy of HIV infection in infants and children in resource-limited settings: towards universal access. Recommendations for a public health approach. Department of HIV/AIDS, Geneva, Switzerland. http://www.who.int/hiv/pub/guidelines/WHOpaediatric.pdf

Zijenah, L.S. et al. (2006) Affordable flow cytometry for enumeration of absolute CD4+ T-lymphocytes to identify subtype C HIV-1 infected adults requiring antiretroviral therapy (ART) and monitoring response to ART in a resource-limited setting. In: Journal of Translational Medicine 2006, 4, 33.