Mail & Guardian (Johannesburg) - June 26, 1998
Andy Duffy

The group, established by the Medicines Control Council (MCC), is working closely with Virodene's private owners to eliminate potential scientific problems with the drug before a formal application goes to the MCC to begin trials.

The experts' work will continue as long as they are needed. The drug's new owners believe they are just weeks from securing the MCC's approval for human trials.

The company that has just bought the rights to the drug, Virodene Pharmaceutical Holdings (VPH), hopes it can clear that obstacle within weeks. It wants to include the refined results of its original illegal human trials as evidence that the drug works.

If or when the MCC committee is satisfied, an official application to begin tests on healthy humans will be submitted.

MCC chair Helen Rees says the creation of the special committee and its extensive efforts for a private company are "unusual". But the government has identified the treatment of Aids as a priority, she says, and the council is duty- bound to help the development of a potential treatment. She adds, however, that no other potential treatments are currently enjoying such MCC attention. It is also understood that former MCC chair Peter Folb proposed the creation of a special committee last year in part because of the political and public flack the MCC was catching over its opposition to Virodene's trials.

Folb is believed to have come under intense personal pressure from both Deputy President Thabo Mbeki and Minister of Health Nkosazana Zuma over the issue. Folb quit as chair two months ago. He declined to comment this week.

The special committee, formerly chaired by Rees, includes a toxicologist, clinician, pharmacologist and public health specialists - all leaders in their field, Rees says, who have spent "hundreds of person hours" on the Virodene project.

"The committee has spent an enormous amount of effort giving them scientific feedback," she adds. "Council can't write [their application] for them. This is really to direct them about where they're going wrong.

"[Its creation] was unusual but it became clear to the MCC that there was public confusion about what was going on ... The MCC was seen as being obstructive and difficult."

The council under Folb blocked four applications by Virodene's researchers to begin clinical trials. It claimed the researchers had flouted procedures and that the drug was actually dangerous. The council also called in the police to probe continued Virodene sales.

Such opposition was particularly embarrassing for Zuma. She had personally arranged for Virodene's researchers - and some of their human guinea pigs - to go before the rest of the Cabinet to appeal for public funding. Several Cabinet members stood up to applaud following the Virodene presentation.

The MCC's stance put it on a collision course with Mbeki and other high-ranking African National Congress officials. Folb quit after Zuma decided to replace the council with a new regulatory authority, due to start up in September.

The Virodene researchers have now met the concerns of the special committee about the drug's dosage and toxicity (its main component is a harmful industrial solvent). The committee has still to be convinced that it actually works. Zuma is overseas and a representative from Mbeki's office could not be reached for comment.

But Rees says there has been no pressure from Zuma or anyone else in government on the committee's work or the drug's development. "What everyone recognises is that the MCC's scientific decision has to be seen to be beyond reproach," she adds.

VPH also this week dismissed any link between itself and the government. "The ANC and government have done nothing tangible for Virodene that I can see," says VPH manager, Joshua Nxumalo.

Nxumalo says he did not help arrange meetings between Virodene's researchers and senior government officials - contrary to the claims of other VPH shareholders. He says he is merely a businessman, representing a consortium of other black businesses that now control VPH.

His background, however, is a curious one, pointing to both military and intelligence work for the ANC. Nxumalo, known as the general, says he went into exile from 1976 to 1989 and became a senior Umkhonto weSizwe (MK) commander operating out of Swaziland and Mozambique, reporting directly to the party's national executive committee.

The ANC's detailed submission last year to the Truth and Reconciliation Commission on its MK structures in that period does not, however, name Nxumalo among its operatives.

Nxumalo says he went into business in 1992. Months before the 1994 elections, he joined the National Party in its last-ditch efforts to win votes in Soweto - but he says he was actually working undercover as a "mole".

"It was an intelligence matter," Nxumalo adds. "I fought for years to destroy them [the NP]. This was a strategic move to sabotage them." Nxumalo says his partner and sole commander in the project was former Robben Island inmate Vronda Banda, a friend he had known since childhood.

Banda was shot dead in March 1997, around the same time Leonard Radu, deputy police commissioner and former ANC security chief, was killed in a car crash. Reports at the time speculated that Band and Radu had been working to dig out informers in the ANC's ranks.

The ANC, however, says Banda was a real NP member, and that it did not sanction any pre-election initiative to infiltrate the NP. Nxumalo says: "He [Banda] was a loyal cadre; his loyalty was beyond question."

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