Hii ni kitu ya zamani kidogo. Nashangaa inaibuka sasa hivi. Suala hili pia lilimtia matatani Thabo Mbeki mwaka ikisemekana kuwa alikuwa na ubia katika utengenezaji wa dawa hii.
Soma hapo chini:
[Virodene, a dosage form of the industrial solvent dimethylformamide
(DMF), has been hotly debated in South Africa some years ago. The
SA DRA refused to approve clinical trial proposals. Apparently the researchers moved their trials to Tanzania, where they have now been asked to leave as the trials did not have correct approvals.
The SA Mail and Guardian noted that SA Health Minister
Tshabalala-Msimang actually visited the clinic in Tanzania where the trials were taking place...
Any Tanzanian E-drugger who can tell us more what happened?
From: Kaiser Daily HIV/AIDS Report - Sat, 8 Sep 2001; M&G website
www.mg.co.za Copied as fair use. NN]
--
Tanzania to Expel Two South Africans For Importing 'Controversial'
AIDS Drug
The Tanzanian government has ordered two South Africans, charged with illegally importing the "controversial" AIDS drug Virodene PO 58 and
four other drugs, to leave the country by Saturday, the Dar es Salaam
Daily News reports. According to Tomric News Agency/AllAfrica.com,
Jacques Siegfried Visser and Khamalo Bafana are employed by Virodene Pharmaceutical Limited of South Africa, which has been conducting "disputed" clinical trials of Virodene PO 58 at the Lugalo Military Hospital in Dar es Salaam without the approval of the National Institute for Medical Research. The two South Africans were arrested in July, and Pharmacy Board inspectors confiscated and impounded all documents relating to the drugs, as well as any remaining batches of PO 58, which was banned in South Africa in 1997. The drug has failed to prove effective in clinical tests in Great Britain and Germany,
where it was determined that the drug was a derivative of the industrial solvent dimethylformamide (DMF), a finding that was met with
"widespread public outcry" in Tanzania (Tomric News Agency/ All Africa.com, 9/5). Visser maintained that institute approval was not necessary because his group had "worked closely" with the Tanzanian military and police to test the drug on 64 HIV patients. He added that the trial, held in Dar es Salaam between September 2000 and March 2001, was "properly approved" and "conducted with the highest ethical standards" (Kaiser Daily HIV/AIDS Report, 8/15). According to Tomric News Agency/AllAfrica.com, after failing to win approval for
PO 58, Virodene also imported the drugs PO 59, PO 60, PO 61 and PO 62, none of which were registered with the Tanzanian Pharmacy Board
(Tomric News Agency/AllAfrica.com, 9/5).
----
SA Aids quacks given the boot
JUSTIN ARENSTEIN, ONGERI JOHN, Nelspruit | Friday
THE Tanzanian government this week ordered the deportation of
two South Africans accused of secretly testing a discredited
anti-Aids drug on human guinea pigs.
Tanzania's Ministry of Home Affairs said on Wednesday that
Jacques Zigi Visser and Themba Khumalo appeared to have
conducted illegal medical trials with various versions of the
controversial Virodene drug on patients at Lugalo military hospital in Dar es Salaam.
Virodene's active ingredient is a highly toxic industrial solvent,dimethyl formamide (DMF), which has been banned for human
use in South Africa and elsewhere due to dangerous side effects.
Medical researchers writing in the journal Aids Research and
Human Retroviruses in 1997 also warn that DMF might actually
activate HIV.
Four years ago the African National Congress was seriously
embarrassed when its close links with Visser and his ex-wife,
Olga Visser, the "inventor" of the drug, emerged publicly.
Tanzania's home affairs permanent secretary Bernard Mchomvu
said on Wednesday the country's National Institute for Medical
Research (NIMR) never gave permission for the tests at Lugalo
and a second private clinic owned by the country's inspector
general of police, Omar Mahita.
Mchomvu said none of the Virodene formulas used in the trials
had been registered with Tanzania's Pharmacy Board. "And
finally, neither of the South Africans has a legal immigration
status in Tanzania. Their visas and permits have all expired. They have therefore been ordered to leave the country by Saturday, or face deportation."
The deportation order is not the first clash with Tanzanian
authorities for either Visser or Khumalo.
They were arrested for allegedly illegally importing the PO58,
PO59, PO60, PO61 and PO62 versions of Virodene to Tanzania
in July last year after the NIMR refused permission for human
testing of PO58. Quantities of all five versions of the drug were
confiscated during a raid on Viro- dene Pharmaceutical Holdings
(VPH) offices by health ministry inspectors in Tanzania's central
Shinyanga region.
Inspectors also seized a consignment of Oxyhumate drugs at Dar
es Salaam International airport shortly afterwards, including a
carton marked for a Dr Balele at the Lugalo hospital. The
consignment was marked as being imported by the Tanzania
chief of defence forces, sparking an ongoing investigation into the
trials.
VPH is a South African-registered company set up to develop and
market a commercial version of Virodene as an anti-Aids
medication. The compound was patented as an anti-Aids drug by
medical technician Olga Visser after she stumbled on it while
working on freezing animal organs for medical research. Virodene
has, however, not yet been approved for use by any regulatory
authority in the world.
An attempt to fast-track its approval and registration by the
Medical Control Council (MCC) in South Africa in 1997 unleashed
a political storm after the then health minister, Nkosazana
Dlamini-Zuma, gave the bid her public support, organised a
special presentation to the Cabinet and lobbied the issue in
Parliament despite MCC concerns about Virodene's safety.
The controversy forced Thabo Mbeki, who was deputy president
at the time, to publicly deny that the African National Congress or its leadership were funding or otherwise commercially involved
with Virodene.
Dlamini-Zuma continued to meet with VPH officials, however, and
her successor, Dr Manto Tshabalala-Msimang, recently visited
the Tanzanian clinic where Virodene trials are being conducted.
Tshabalala-Msimang's spokesperson Jo-Anne Collinge insisted at
the time that the visit was part of an official tour of Tanzania and
the link with Virodene purely coincidental.
Olga Visser, who remains a close business partner, insisted on
Wednesday that Virodene continued to enjoy the highest political
support both in South Africa and Tanzania.
She also dismissed the Tanzanian deportation order as "rubbish"
and "mischief by someone with an agenda".
"I met with Tanzania's inspector general of police two days ago,
and both Themba and Zigi met with senior officials today. Nothing
has been said about deportations. There was some trouble with
the NIMR a while ago, but that has been sorted out," she said.
Visser has previously insisted that NIMR approval was not
necessary because all trials were in military or police hospitals.
Mchomvu insisted, however, that both Khumalo and Visser were
in Tanzania illegally after their visas expired. Khumalo's
exemption certificate issued for South African pass-port number
4247-303-94 expired last Friday, while Visser's visa in South
African passport number 4041-888-52 expired on June 21.
"All the relevant authorities, including the health, defence and
national service ministries, and the State House have reviewed
this matter. The order to leave Tanzania stands," said Mchomvu.
VPH has, meanwhile, conducted initial tests on Virodene in the
United Kingdom, the Czech Republic and Germany but has yet to
release the results.
Court papers from a bitter ownership and patent dispute between
VPH shareholders indicate that the company had attempted to
sell the drug in Portugal, Ghana, Kenya and Mozambique.
Shareholders are also demanding to know exactly who is funding
the trials and who the "secret" majority shareholder is after VPH
agreed to sell a stake in the patent rights to former Umkhonto
weSizwe cadre Ngelezi Zaccheus Mngomezulu for R5-million.
"The money was never transferred, but the Vissers are being
funded by someone and must have spent at least R10-million on
these recent trials," said disgruntled shareholder Charles Fourie.
"In fact, Zigi called me from Tanzania just two weeks ago to offer to buy us all out for $5-million (R42,5-million)."
Both Visser and Khumalo were unavailable this week.
South African foreign affairs deputy director for Tanzania, Adriaan Smuts, confirmed that he had received "vague" reports on the deportation.
"Our high commissioner Theresa Solomon spoke briefly with
Khumalo on Wednesday and asked for clarification, but he has
failed to revert to us. We have therefore put an official on the
matter," said Smuts. - African Eye News Service