Virodene

Virodene is a controversial AIDS drug developed in South Africa, but rejected by the scientific community. Controversy surrounds the research procedures, political interference and the safety and efficacy of the drug itself, the main active ingredient of which is the industrial solvent Dimethylformamide (DMF).

Michelle Olga Patricia Visser, working as a medical technician at Pretoria Hospital, says she discovered the anti-bacterial properties of DMF while conducting experiments to freeze animal hearts using this substance. In conjunction with her business man husband, Jacques Siegfried "Zigi" Visser, they administered the drug to 11 patients without approval. They were rebuked for these actions and the South African Medicines Control Council blocked further human trials.cite news
first = Schoofs
last = Mark
title = Tanzanian Military Helped Company Skirt Drug Regulations to Test Virodene
url = http://www.aegis.com/news/wsj/2001/WJ010704.html
work = Wall Street Journal
date = 2001-07-19
accessdate = 2007-09-27]

More human trials were conducted in Tanzania in 2000 even after the South African Medicines Control Council ruled that such trials would be unethical and in contravention of the law and refused permission for human trials in 1998. The Tanzania health agency, NIMR, also rejected proposals for human trials, but the Vissers approached the Tanzanian Defence Force directly and conducted the trials in military hospitals.

Calls have now been made in some circles for an investigation of South African President Thabo Mbeki's involvement in support or funding of the company.cite news
title = Investigate Mbeki: TAC
url = http://www.health24.com/news/Health_care/1-918,42249.asp
work = Health24
publisher = Media24
date = 2007-09-26
accessdate = 2007-09-27]

Controversy

Fraudulent credentials

Olga Visser claimed she was a full professor and head of the department of New Technologies in Medicine at Moderna University in Lisbon, Portugal, but officials insist there is no record of her on the faculty or even of such a department.

Human trials

On several occasions the Vissers conducted human trials without any authorisation from the appropriate health authorities.

Political interference

In 1997 the researchers were allowed to make presentations to the South African Cabinet. They received support from Thabo Mbeki, then South African deputy president and Nkosazana Dlamini-Zuma, the health minister at the time. Mbeki even criticised the Medicines Control Council, stating that "it became more and more difficult to understand the attitude adopted by the MCC" and that "I and many others will not rest until the efficacy or otherwise of Virodene is established scientifically" in direct opposition to the rejection of human trials by the Medicines Control Council.Citation
last =Mbeki
first =Thabo
author-link =Thabo Mbeki
title = ANC has no financial stake in Virodene
url =http://www.anc.org.za/ancdocs/history/mbeki/1998/virodene.html
accessdate =2007-09-27]

In the same letter Mbeki went as far as suggesting that parties who caused the controversy surrounding Virodene wanted to create the AIDS pandemic in Sub-Saharan Africa:Quote|Two thirds of those affected world-wide are in Sub-Saharan Africa, including a 2,8 million strong South African contingent.

Often I have wondered whether those who have generated sand storms with the greatest enthusiasm, did not, in fact, seek to achieve precisely this result!|Thabo Mbeki|

Some analysts point out that the mere involvement of senior government officials in a regulatory process for which there exists well established regulatory bodies such as the Medicines Control Council could only ever serve to open up the process to charges of maladministration. [cite news
first = Stephen
last = Mulholland
title = Virodene saga a lesson in how not to conduct affairs
url = http://www.btimes.co.za/98/0329/columns/columns2.htm
work = Business Times
publisher = Sunday Times (South Africa)
date = 1998
accessdate = 2007-09-27]

Funding

ANC

In 1999 it was revealed that several businessmen with close ties to Mbeki —by then President of South Africa— such as Max Maisela, invested heavily into the Virodene companies.cite news
title = Who's bankrolling Virodene?
url = http://www.mg.co.za/articledirect.aspx?area=mg_flat&articleid=144245
publisher = Mail & Guardian
date = 2002-06-22
accessdate = 2007-09-27]

Maisela was on Mbeki's "consultative council" during Mbeki's tenure as Deputy President and at the time of the investments headed Negotiated Benefits Consultants (NBC) which was owned by Worldwide Africa Holdings a company co-founded by Wiseman Nkhuhlu, then presidential advisor to Mbeki.

Reports alleging investment from source close to government again surface in 2007. The fresh reports by the The Saturday Star newspaper suggested investments between 2000 and 2001 that tapered off after the trials in Tanzania were aborted, allegations denied by the Presidency.cite news
title = Govt slams Virodene story
url = http://www.24.com/news/?p=ra&i=676849
work = 24.com
publisher = Media24
date = 2007-09-15
accessdate = 2007-09-27]

Alcor Life Extension Foundation

Initial funding came from the controversial cryonics (low temperature preservation of humans after death) company Alcor Life. The funding came because of the main Virodene founder's research into the freezing and thawing of animal hearts.

References