/ 7 July 2006

Health department DG frees seized Rath drugs

Department of Health Director General Thami Mseleku ordered the release of a shipment of tablets, imported by controversial Aids quack Matthias Rath, after Port Health officials in Cape Town had impounded it about five weeks ago.

Mseleku’s intervention raises new questions about the Department of Health’s close relationship with Rath, whose claim that his vitamin supplements can “reverse Aids” has earned him national and international condemnation.

It also begs the question whether Mseleku had encouraged officials answering to him to break the law by irregularly releasing the shipment. Port Health is a subdirectorate of the health department. A Port Health official who wanted to remain anonymous said: “We stopped the pills because [the consignment] was non-compliant with certain regulations. But then we were told to release the substance by the department.”

Department officials, speaking on condition of anonymity, say Rath, a German national, imported two pallets, about 5 000 bottles, of his multi-vitamins into South Africa in May. Port Health withheld the tablets because the Rath Foundation imported them as a “food supplement” while they contain a schedule two substance, N-acetylcysteine; because Rath did not have the right import permit; and because there was no pharmacist or doctor to receive the consignment.

Unlike food supplements, scheduled substances need to be registered with the Medicines Control Council (MCC) and can only be dispensed by a doctor or a pharmacist. Rath’s tablets are not registered with the MCC, the officials say. N-acetylcysteine breaks down phlegm in the lungs and in large doses is used to fight paracetamol poisoning.

Department spokesperson Sibani Mngadi this week confirmed that the consignment had been stopped on the basis that “some of the tablets contained a scheduled substance”, but said it was released on the department’s instruction, after legal correspondence was received from the Rath Foundation requesting it to be released under the care of a pharmacist.

Mngadi said releasing it to a registered pharmacist meant the law had been complied with — a claim disputed by the officials with whom the Mail & Guardian spoke.

Although Mngadi did not confirm Mseleku’s personal role, two sources within the department have confirmed the director general’s personal involvement. Said one: “This is the second time it’s happened. The consignment gets withheld because we have problems with the content of the tablets because it doesn’t comply with the Medicines Act and then we’re told to ignore our concerns and ignore the law we’re supposed to enforce. What if something happens to somebody who takes these pills?”

The chairperson of the MCC, Professor Peter Eagles, also confirmed it this week: “I know the DG gave permission for these tablets’ release by Port Health … Just phone his office and ask him; he will tell you.”

Eagles added: “If the law enforcement personnel of the department are asked by the DG or the health minister to set aside their concerns around imported medicines, then the DG takes full responsibility when something goes wrong. The health minister has the overall say and she can delegate that authority to the DG. Whoever makes the decision, they are responsible for that decision.”

Eagles said he believed a report on the holding and subsequent release of the Rath vitamins would be discussed by the MCC board on Friday.

According to officials who spoke to the M&G, the law enforcement unit of the department investigated the Rath shipment already held by Port Health. They concurred that the consignment of tablets contravened the Medicines Act. After Mseleku’s intervention, law enforcement sent a fax to Port Health and ordered the release of the pills.

The Rath Foundation supplied a pharmacist into whose care the consignment was released. The Rath Foundation this week refused to identify the pharmacist. One of the department’s officials, speaking on condition of anonymity, claimed that the pharmacist did not have registered premises. “That in itself is also a problem — how can we control from where and to whom these tablets are distributed?”

The M&G has learnt that another consignment of Rath’s pills arrived in South Africa on Wednesday. Although Port Health again considered it not to comply with the law, one of the officials said this consignment was not held back as the same issues were at play.

The Treatment Action Campaign’s, Nathan Geffen this week said: “For a long time the evidence has suggested collusion between the department and Matthias Rath. This incident confirms it.”

The Medicines Act requires that all medicine containing schedule two substances must be registered with the MCC. “That is what the law requires and the DG cannot grant exemptions to that law. Only the MCC can authorise that exemption … It smacks of irregularity,” said Jonathan Berger, a lawyer with the Aids Law Project.

Rath started operating in South Africa early last year using South African National Civic Organisation and Traditional Healers’ Organisation members and infrastructure to advertise and distribute his multivitamins as an alternative treatment to anti-retrovirals (ARVs). Rath believes that anti-retroviral therapy is “extremely toxic and kills people”.

On arrival in South Africa, he met with Health Minister Manto Tshabalala-Msimang and in May last year she said: “I can’t stand on a pedestal and say it [ARVs] is all good. It is obviosuly critical to educate people on the side-effects of anti-retrovirals and if by doing so I endorse Dr Rath, then I don’t know.” Shortly afterwards she said she would distance herself from Rath “only if it can be demonstrated that the vitamin supplements that he is prescribing are poisonous for people infected with HIV”.

Rath distributes his multi-vitamins, called Vitacell, in townships in the Cape, KwaZulu-Natal and the Eastern Cape.

A spokesperson for the Rath Foundation this week referred comment to the department.