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MoH bans microbicide clinical trials
By Esnart
Submitted on 17 February, 2010 - 14:57
ShareThisThe Ministry of Health has banned all microbicide clinical trials in Zambia. This is according to a letter dated December 29, 2009, addressed to a Dr J. Stringer -- an official at the Centre for Disease Research, written and signed by health permanent secretary, Dr Velepi Mtonga.
Dr Mtonga stated that the ministry would not approve any clinical trials until such a time that safer and more efficacious methods were available. This means the embattled Microbicide Development Programme (MDP) in Mazabuka has suffered a major setback following the ban. Dr Mtonga cited the findings of the HPTN 035 where the gels were found to be about 70 per cent ineffective in reducing the risk of HIV infections.
Dr Mtonga further stated that the recent findings from the PRO 2000 whose results were released in December last year, had also proved to be very risky to trial participants. The ban by the Ministry of Health follows a request by Dr Stringer to conduct a study for MTN 003 phase 2 B safety and effectiveness of Tenofovir 1 per cent gel which is an ARV-based microbicide.
Mazabuka MDP Project coordinator, Rose Kasonde, refused to comment particularly on the disapproval by government to give authority to her organisation to conduct a test of the ARV-based microbicide in Lubombo area in chief Naluama’s area.
Dr Kasonde told ZANIS in Mazabuka yesterday, she was not aware of the disapproval because her office had not yet received a letter from the Ministry of Health. But Mazabuka district medical officer, Keith Mweebo confirmed receipt of a letter from the health permanent secretary, disapproving and banning all microbicide clinical trials in the country.
Dr Mweebo said MDP management should be honest enough and tell the truth because they were written to, through the Centre for Disease Research in Zambia. The letter is also copied to UNZA Research Ethics Committee and the director Pharmaceutical Regulatory Authority.
