Khayelitsha trials set to continue

Top government health officials seem poised to let the Dr Rath Health Foundation off the hook for conducting illegal clinical trials on people with HIV in Khayelitsha.

Health director general Thami Mseleku told Health-e that a preliminary report submitted to his office by the health department’€™s Law Enforcement Directorate had not ‘€œfound anything wrong with what is happening there (in Khayelitsha)’€.

Health-e investigations have revealed that at least two HIV-positive women in Khayelitsha died within weeks of being convinced to discard their medication in favour of vitamins touted as an AIDS cure by the Dr Rath Health Foundation Others say they were told to strip to their underwear, photographed and had blood taken without giving consent. Others have been advised to stop taking their antiretrovirals and rather take the Rath Foundation products.

Mseleku said it was now up to the Medicines Control Council (MCC), which he said was an independent body, to investigate the matter further.

However, the health department’€™s director of nutrition, Lynne Moeng, broke ranks and criticised the inadequate labelling on Vita Cell, one of the Rath Foundation products, as well as the high dosages being prescribed.

She said the label had failed to indicate the Recommended Daily Allowance (RDA), the dosage a consumer can safely use without adverse effects, as well as the recommended dosage for different ages.

‘€œ’€¦for the public, it (the label) actually means nothing,’€ she said.

Moeng said taking high doses of vitamins would among others cause nausea and vomiting and impair liver function.

‘€œAnd for a person who is already immuno compromised (HIV positive) that would immediately deteriorate one’€™s condition,’€ said Moeng.

She pointed out that a recent World Health Organisation Consultation meeting on Nutrition and HIV/AIDS in Africa, in which South Africa participated, adopted a policy statement that advised against the use of excessive levels of vitamins.

Moeng added that any ‘€œhealing’€ claims should be scientifically proven. ‘€œAnd if it has health claims then that’€™s a medicine. It immediately makes it a medicine and it should be registered and there should be studies which prove that this has worked for this, that and that,’€ she said.

Moeng said that there were regulations stipulating that a high dose vitamin should be registered with the MCC

However, Mseleku differed: ‘€œ’€¦a complementary product does not have to go through all those processes’€.

Meanwhile, Rath has started a political party, Allianz fur Gesundheit, Frieden und Soziale Gerechtigkeit (alliance for health, peace and social justice), and is campaigning in the German general elections to be held next month.

Rath has been flying ‘€œpatients’€ from Khayelitsha to his election rallies in Germany where they have been addressing supporters.

He claims on the party website that, together with his “allies”, the traditional healers and the South African government, they are fighting for the effective and inexpensive treatment of patients with natural products.

The Treatment Action Campaign (TAC) is preparing to face the health minister and MCC in court after both failed to act against Rath and his foundation.

‘€œWe have received no response from the health minister or MCC despite our two week deadline being exceeded,’€ said TAC spokesperson Nathan Geffen.

‘€œWe will file as soon as papers are ready unless the health minister and MCC act before then,’€ said Geffen.

The Dr Rath Health Foundation, led by Rath, claims that its vitamin products can reverse the course of AIDS and says on its website that it is conducting a ‘€œclinical trial’€ in the township.

Rath has since pronounced that ‘€œThe end of the Aids epidemic is now possible ‘€“ Millions of lives can be saved now ‘€“ naturally’€.

However, the Foundation does not have the approval of the MCC to conduct a trial, has not registered its products with the MCC and makes unsubstantiated claims about their healing powers — all in violation of the Medicines and Related Substances Control Act.

MCC registrar Dr Humphrey Zokufa declined to comment on the MCC’€™s ‘€œinvestigation’€ into the Rath Foundation’€™s activities, failing to answer a list of questions he had initially agreed to answer.

Zokufa claimed that the health department’€™s  Law Enforcement Directorate had started the investigation in April this year and that it was not yet complete. The MCC was informed of the Rath Foundation’€™s activities in February.

The health department has also failed to comment on claims in Rath’€™s community newspaper ‘€œYou Can’€ that ‘€œthe Dr Rath Health Foundation Africa has the support of our Minister of Health and our Government’€.

The newspaper is being distributing in the townships across the Western Cape.

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