In the fifth part of the series on the efficiency of public health agencies in Nigeria, the Civic Media Lab examines Nigerian government funding for clinical trials in the last five years and the roadblocks
The Civic Media Lab found that Nigerian government budgeted for a total of eight human-related clinical trials of locally produced drugs between 2015 and 2019 with no evidence of commercial output.
These eight projects shared N464.24m within the years under view. Interestingly, CML findings show that seven of the provisions were two reoccurring line items.
The description: “Clinical Trials Outgrowers of Plants for Sustainability,” first appeared in 2016. From 2017 to 2019, it was merged with: “Clinical Trials Outgrowers of Plants for Sustainability (Development and Production of Anti Sickling and Anti Epilepsy Drugs).” It received the approval of some N348m within the four budgeting cycles it appeared in.
The project description: “Clinical Evaluation of Natural Medicinal Therapies,” first came up in 2017. In 2019 it was lumped with another project detail to read: “Clinical Evaluation of Natural Medicinal Therapies and Development of Clinical Research Facility.” The line item was assigned N65.35m in the three fiscal years it appeared in. The projects found occurred in two ministries – Health and Science and Technology.
NIPRD’s Clinical Trial
IN 2015, the Nigeria Institute for Pharmaceutical Research and Development (NIPRD), budgeted N50m for “Ethical Review/NIPRD Special Project/Phase 11 & 111 Clinical Trials for Medicinal Products for Management of Malaria, Sickle Cell, Diabetics, Ebola and Lasser Fever.“ Civic Media Lab found no commercialized drug from NIPRD for any of the ailments listed in the line item. Between 2013 and 2016, the agency obtained patents for three products to combat malaria, manage diabetes and treat Ebola.
In 2013, the agency filed a trademark for Niprimal, an antimalarial drug it said has no side effect on pregnant women.
In 2016, the institute applied for a trademark for Nipribol, a fixed-dose combination – two or more potent ingredients in a single tablet, for fighting the Ebola virus.
Why the institute would budget for a clinical trial for sickle cell in 2015 after it had developed the drug 17 years back is grey. Its sickle cell anaemia drug Niprisan was developed in 1998 and it had received a patent for the drug in the USA in 2003. Quartz Africa, in a report, detailed the inability of the federal government to commercialise the product, despite having a 14-year patent for its sale and distribution.
CML could not establish when its antidiabetic drug, Nipridab was registered but according to this report, Nipridab, Niprimal and an immune booster, Niprimune, were registered and commercialised as early as 2014.
Another piece published in 2016, a year after NIPRD received N50m for its clinical trials, said only Niprisan had been registered with NAFDAC and was commercially available. A source in the Sickle Cell Foundation, which has a representative of the Minister for health – the supervising ministry of NIPRD on its board, said it does not recommend the drug to its members.
According to the source, the routine drugs recommended by the foundation are Paludrine– a drug imported from the UK, folic acid and Penicillin V. “If anyone wants, they can take it as a supplement but we don’t recommend it,” the source said.
In a news story published in December 2019, the Director-General of NIPRD, Peter Adigwe, is paraphrased as saying the institute had five drugs on the verge of commercialisation and 22 others in different stages of development.
The institute did not make any other provision for clinical trials except in 2015. There are three mandatory clinical trial phases and a fourth non-routine phase for further tests before a drug can be approved in Nigeria. With the institute’s decision to lump different clinical trials together in phases it described as ‘phase 11’ and ‘phase 111’, it is guesswork to say what stage of testing what drug was in. None of the product trademarks yielded any search result on the institute’s site.
SHESTCO’s Clinical Trials
NIPRD has obtained trademarks for its products; this is the reverse with the Sheda Science and Technology Complex. The complex, which has three advanced laboratories, has said in different media appearances that it is developing or has developed products to combat sickle cell anaemia, epilepsy, blood pressure and cancer.
The institute has received approval for an estimated N348.89m for clinical trials. In 2016, SHETSCO asked for “Clinical trials out growers of plants for sustainability”. It received an approximated N34.96m for the said purpose.
The then director of the complex’s chemistry advanced lab, Orishadipe Abayomi, said in a publication that Sheda had concluded lab trials for its sickle cell formula and was ready to move to the clinical phase. The agency, which housed the failed project to commercialise Niprisan, was billing the government for the development of their anti-sickling product.
IN 2017, the complex received approval to draw down on an estimated N181.96m for a modified line item which read: “Clinical trials out growers of plants for sustainability (Development and production of anti sickling and anti-epilepsy drugs to provide pro-poor healthcare services).”
At an April 2017 expo put together by SHEDA’s supervising ministry –the Federal Ministry of Science and Technology, the then head of the complex, Professor Sunday Thomas, said the agency had successfully tested its anti-epilepsy drug on mice. This was the last clear update CML found on the complex’s clinical trials. Once again, its website had no other valuable information.
Minus the phrase: ‘Pro-Poor Healthcare Services’, the clinical trial line item in SHEDA’s 2018 budget remained unchanged. The complex was given a budgetary provision of an approximated N84.46m for the said intent. In 2019, the phrase: ‘Pro-poor Healthcare Services’, was returned and the project earned a budgetary approval of N47.5m.
NNMDA’s Clinical trials
The Nigeria Natural Medicine Development Agency (NNMDA), in 2017 and 2018, was allowed N8m and N26m correspondingly for a vaguely named line item: “Clinical Evaluation of Natural Medicinal Therapies.”
Coincidentally, the last update on the agency’s website was in 2017. CML was unable to find trademarks or patents developed by the agency, which has the task of safeguarding Nigeria’s medicinal plants. In 2019, the sum allocated to clinical evaluation of natural medicinal therapies was upgraded to N31.35m and another description,‘Development of Clinical Research Facilities’, was added to the line item.
Dependence on WHO
While the Nigerian government waits on the World Health Organisation to provide a certified cure for the COVID-19 virus, Madagascar’s president, Andry Rajoelina, approved the use of a herbal drink – COVID-Organics for the treatment of positive cases in the country. As at the time of its announcement, the success rate was 52.33 per cent, with 101 recoveries out of 193 confirmed cases and no deaths. There are now 142 recoveries out of 527 cases and 2 deaths.
Rajoelina went on to offer African countries the drug, using the evidence of its success rate in his country as evidence of its efficacy, an action regional bodies like the Economic Community of West African States (ECOWAS) initially condemned.
The Nigerian government did not offer Nipribol to Congo DR, to deal with the Ebola outbreak in the country which started in August 2018 and is only just petering out. But Nigeria has now received COVID-organics and it subjecting it to clinical tests by the country’s food and drug agency, NAFDAC.
The WHO’s regional body in Africa had earlier said it is ready to collaborate with the Indian Ocean territory on clinical trials for the drug which was developed by the Malagasy Institute of Applied Research. The country’s president has also come out to berate the WHO for offering him a bribe to poison the drug, a move that led him to exit his country from the World body.
At the time this article was written, Nigeria had recorded 7,839 confirmed cases, 2,263 recoveries – a ratio of 28.9 per cent and 226 fatalities, excluding multiple deaths in some Northern states in the country. NIPRD has since the virus started, made hand sanitisers, while SHEDA said it would manufacture ‘aptamer-based test kits,’ which can detect COVID-19 in less than 30 minutes.