BENEDICT TEMBO, Lusaka
GOVERNMENT is in the process of commencing the safety trial of the Sondashi Formula (SF2000), the first of the two trials which should have been carried out five years ago.
In 2000, former Cabinet minister Ludwig Sondashi announced he had â€œdiscovered a cure for HIV and AIDS.â€
In 2008, the government, through the then Ministry of Science, Technology and Vocational Training, availed funds for the research and development of the formula.
The evaluation, led by the late Patrick Chikusu showed encouraging signs, but was scientifically inconclusive.
Dr Sondashi, the innovator, engaged the Council for Scientific and Industrial Research (CSIR) of South Africa, and NEPAD/SANBio to validate his observations that the SF2000 â€œcuresâ€ HIV/AIDS.
NEPAD/SANBio then adopted the SF2000 as its flagship project for research in herbal medicines under the indigenous knowledge systems (IKS).
Minister of Higher Education Michael Kaingu, in a ministerial statement to Parliament on the SF2000 on December 3 this year, said the research was under the stewardship of the CSIR, which was the IKS node.
â€œBy October 2010, NEPAD/SANBio had completed investigations covering the chemistry of the potential active ingredients in the SF2000, the laboratory-based efficacy (whether the medicine actually works) and toxicology (safety of the medicine – whether it is poisonous to the user) studies,â€ Dr Kaingu told Parliament.
He said the CSIR and NEPAD/SANBio then handed over a dossier of the results to the then Ministry of Science, Technology and Vocational Training.
â€œBased on the encouraging observations from the laboratory investigations carried out under NEPAD/SANBio, Zambia was required to carry the mantle further by conducting two critical studies sequentially,â€ Dr Kaingu said.
(a) The human safety trial and
(b) The efficacy in human trial.
Dr Kaingu reported that in order to move the research work forward, the ministry appointed a steering committee, which comprised NEPAD/SANBio, the National Institute for Scientific and Industrial Research, and the CSIR.
The other Zambian institutions in the committee were:
1.The Tropical Diseases Research Centre (TDRC);
2. The University of Zambia (UNZA);
3. The National HIV/AIDS/STI/TB Council (NAC);
4. The Directorate of Disease Surveillance, Control and Research (DSCR) of the Ministry of Health (DSCR);
5. The Zambia Medicines Regulatory Authority (ZAMRA);
6. The National Science and Technology Council (NSTC); and
7. The Directorate of Science and Technology, Ministry of Higher Education (DST).
â€œThis team was selected to represent the multi-sectoral nature of the research. There was need for the team to always keep in mind the end product of the research, hence, the involvement of all parties at the beginning of the research,â€ Dr Kaingu explained.
â€œMr Speaker, it might seem disheartening that five years later the safety trial, which was supposed to be the first of the two trials is yet to be carried out. I wish to inform the House that several factors impeded progress of the project,â€ he said.
Among these factors Dr Kaingu cited were:
1. An intellectual property rights (IPR) dispute, which was only resolved in 2012. The main issue was how to share the intellectual property amongst the many players. This is still a contentious issue in research and development work, especially in the research work that is funded with public financing.
2. Delay in the manufacture and production of capsules for the trial. The consortium partner, Medical Research Council of South Africa, who had the capability to process crude SF2000 and place the processed material into capsules, had pulled out. This was after the NEPAD/SanBio project came to an end.
He said the ministry only released K800,000 against an actual clinical trial budget of K2.4 million.
â€œThis created some difficulties in trying to readjust the original budget,â€ he said.
Dr Kaingu also said failure to find a good manufacturing practices (GMP) certified facility to produce the capsules at an affordable price was another challenge.
â€œMr Speaker, despite these huddles, I am pleased that we have managed to overcome most of them and are now ready to conduct the first of the two trials, which is the safety trial,â€ he said
A South African company, Afriplex, has processed and produced 23,000 capsules of the SF2000 raw materials into the required packaging for the trials.
Dr Kaingu has assured Zambians that the trial the country is about to embark on is only a safety trial.
â€œAnd that this trial is not designed to confirm whether the Sondashi Formula works against the HIV virus in humans or not. This trial will be done on healthy males, who are participating in this trial on voluntarily basis. The confidentiality and safety of our participants is of paramount importance to all of us involved in this research work,â€ he said.
Dr Kaingu said the efficacy trial, which will tell us whether the SF2000 works or not, will be the second research.
He said the ministries of Higher Education and Health are committed to ensuring that the trials are carried out.
â€œIn support of this research, my ministry has acquired pilot-scale equipment for filling and polishing capsules for the National Institute for Scientific and Industrial Research (NISIR),â€ he said.
Dr Kaingu said the equipment will soon be installed and commissioned.
â€œWe shall, thus, be able to produce capsules for research within the country. This will definitely reduce the cost in doing health-related research. My ministry and the Ministry of Health will work together to acquire any other pieces of equipment or machinery that our scientists will require to establish a complete pilot production line for herbal medicines such as the Sondashi Formula,â€ he said.
Dr Kaingu reiterated Governmentâ€™s support for science, technology, and research.
â€œWe are alive to the fact that without science and technology, our country is unlikely to develop in a manner we want it to. It is our intention to work with all stakeholders in the advancement of science, technology and research, and to ensure that the result of our research is the advancement of the social and economic status of all Zambians, and humanity at large,â€ he said.
BENEDICT TEMBO, Lusaka