X-Message-Number: 7659
Date: 06 Feb 97 22:50:09 EST
From: "Steven B. Harris" <>
Subject: Visser in Hot Water (Told You So)

   independent online 
   the star 
   Ban on testing of 'wonder' Aids drug 
   Staff Reporters and Sapa 
   Widespread scepticism about the Aids drug Virodene has
deepened following a ban on further research and testing imposed
by the Medicines Control Council yesterday. 
   Council chairman Professor Peter Folb announced the moratorium
after investigations found that Virodene PO58 contained a highly
toxic industrial solvent, dimethylformamide (DMF), which can
cause fatal liver damage and has been linked to the development
of cancer. 
   "Aids patients may be at special risk of developing some of
these complications because of their disturbed immunity," Folb
   This meant further tests and research on humans had to be put
on hold until the serious and unresolved safety issues had been
sorted out, he added. The announcement fuelled the scepticism
which had greeted the announcement of the drug. 
   Aids Consortium co-chairman Dr James McIntyre welcomed the
council's statement, saying it vindicated the cynicism of the
minister and the researchers. 
   He said that while people in the Aids community had been
sceptical of the claims all along, the news was most devastating
to Aids patients whose "trust has been abused". 
   "In the weeks following the announcement, many Aids organisat-
ions dealt with patients who called to say they wanted the cure,
they needed the cure," he said. 
   Medical ethics expert Dr Reuben Sher said he had felt the
researchers of the drug - Professor Dirk du Plessis, Dr Callie
Landauer, Olga Visser and Eugene Olivier - "had acted illegally
from day one". 
   He said he was pleased a moratorium had been placed on
research until claims made by the researchers had been resolved. 
   Vincent Hlongwane, spokesman for Health Minister Dr Nkosazana
Zuma, said the ministry would not comment until it had received
the council's report. 
   He could not say what would happen to the R3,7-million
requested by the researchers, saying the decision rested with the
   Joel Netshitenzhe, a spokesman for President Mandela, said the
Cabinet would wait for further facts from Zuma before coming to a
   DP Gauteng health spokesman Jack Bloom said the decision was a
severe indictment of Zuma, who sponsored the research of Virodene
and its high-profile presentation to the Cabinet. 
   "Minister Zuma has now been involved in yet another Aids
fiasco, cruelly raising the hopes of Aids victims. Her role in
this matter reflects badly on her judgment and indeed on her
suitability to continue as minister in such a highly sensitive
portfolio," Bloom said. 
   A spokesman for the research-ers, Larry Heidebrecht, said the
group would meet last night to formulate a response. 
   According to the council statement yesterday, it unanimously
agreed that expectations that could not be realised should not be
raised among patients before the required minimum scientific and
ethical standards were met. 
   "The council will work with the researchers and advise them in
order to achieve this." 
   There were serious unresolved issues with regard to Virodene
because it contained DMF. In general, solvents were highly toxic,
Folb said. 
   The researchers had given the council their full co-operation
in its review of the work done on DMF so far. 
   "The serious and unresolved safety issues in the use of
Virodene must be sorted out before any further work can be
considered and before patients, who previously received Virodene,
may be further exposed to the drug," Folb said. 
   The council report is the latest development in the stormy
tale of Virodene PO58, which began two weeks ago when Pretoria
University researcher Visser and cardio-thoracic surgeons Du
Plessis and Landauer asked the Cabinet for R3,7-million for
further preliminary trials. 
   Their work with the formula suggested a possible breakthrough
in the fight against Aids, in particular that the preparation
could pull back even full-blown Aids sufferers from the brink of
death, they said. 
   Folb said: "Since the investigators (researchers) and the
council agree that the best interests of safety of patients with
HIV infection and Aids are paramount, and that the study must
meet essential standards, it was decided that the present work
cannot proceed until there is a realistic prospect of it 
producing a meaningful result." 

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