zondag 11 november 2007

Merck's unethical, failed HIV-vaccine trials: frantic hunt for human guinea-pigs in South Africa

Nov 11 2007 -- JOHANNESBURG. South African journalist S’Thembiso Hlongwane reports in the "City Press" newspaper that a frantic search has been launched for participants in "Phambili", the Merck pharmaceutical company's failed HIV-vaccine trial which was stopped abruptly last month.

It is not known how many of the 800 people participating in the countrywide HVTN-503 vaccine trial through the Medical Research Council of South Africa have now contracted HIV/AIDS in the belief that they were immune due to the ineffective vaccine.

Merck company stocks:

At Soweto's Phambili-clinic alone, 308 people were recruited - yet only 220 have thus far responded to their plea to report back to check whether they have been infected with HIV-AIDS.

Countrywide 800 people had enrolled, in Soweto, Cape Town, Klerksdorp, Medunsa and Durban.

Volunteers who became infected with HIV during this highly unethical study were "referred for HIV evaluation and to the appropriate medical sources for treatment and care," a Soweto-clinic director told the Soweto-based newspaper's journalist.

Authorities are keeping their mouths firmly zipped up about how many people may have become infected with the deadly HIV/AIDS-infection due to these trials.

Instead they issue reassuring messages that ''these HIV-infected would also be offered continued immunological and virological follow-up for an extended period. '

Prominent South Africans such as Archbishop-Laureate Desmond Tutu and Justice Edwin Cameron had publicly endorsed the shelved vaccine trials by the "HIV Vaccine Trials Network" and the "SA Aids Vaccine Initiative"

Last month the trials were suddenly halted in SA after sister-trials in the US and Australia found that 'it provided no protection against HIV-infection.'

The trial was designed to find out if the vaccine could prevent HIV infection in HIV-negative people -- and whether it could also reduce the virus levels in those who do become infected during the study. It is not known why this unethical trial was approved by the SA medical authorities.
  • HIV is a deadly infection which, while it can be staved off for many years with huge dollops of medication, eventually does kill the patient of Acquired Immune Deficiency Syndrome, AIDS.
The director of the Soweto Phambili clinic, Busi Nkala, is now sending around urgent cell-phone messages, appealing to participants of the HVTN 503 vaccine trial, dubbed Phambili, to contact them urgently.
  • “When the trail was stopped last month we had recruited 308 people. To date only 220 have responded to our urgent plea,” said Nkala. “We invite you to come to Phambili clinic as soon as possible,” reads an SMS the clinic has sent out to ­participants. Besides the SMSes, officials from the clinic have also tried to reach the participants by visiting them at home.

Nkala said the cancellation of the trial took them by surprise. “We are shocked because we were very optimistic that this vaccine trial would bring us closer to a vaccine that can contain HIV,” she said. Nkala declined to disclose how many of the participants had tested HIV positive. “At this stage we are not sure how many have contracted HIV.”

  • Neliswa Kubheka (26), who was part of the Soweto clinic trial, said she was not worried about her ­status because she had been 'faithful to her partner'. “The stopping of the trial is a setback in the fight against HIV. When I enrolled I was aware of the risk associated with the study,” said Kubheka.

Nkala said the vaccine had been billed as the world’s most promising Aids vaccine candidate.“The trial was at the most advanced clinical stage of any HIV vaccine trial on the African continent.” Nkala said the vaccine’s safety 'had been borne out in earlier testing."

Researchers said volunteers who became infected with HIV during the study were being referred for HIV evaluation and to the appropriate medical sources for treatment and care.

  • These HIV-infected people would also be offered continued immunological and virological follow-up for an extended period."

Throughout both the HVTN 503 and HVTN 502 studies, volunteers were counselled about prevention strategies for avoiding exposure to HIV. Volunteers will continue to be advised on this essential need during follow-up meetings.

However -- how well-informed are these councillors themselves, judging from the fact that one participant had told City Press that she "was not worried because she had been faithful to her partner...'

About 5.4 million South Africans -- one in nine people are infected with HIV/AIDS.

The 'South African AIDS Vaccine Initiative' , partnered by the Nelson Mandela Foundation, was formed in 1999 as a lead programme of the Medical Research Council of South Africa. Primary funding was received from the Department of Health, the Department of Science & Technology, and the state-run companies Eskom and Transnet, the European union and the platinum mining company Impala Platinum.


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