© 2019 - International Centre for Investigative Reporting
COVID-19: Nigeria might not expose Madagascan herbal drug to clinical trials. Here is why
PRESIDENT Muhammadu Buhari has directed the Presidential task force on COVID-19 to order Madagascar‘s COVID-Organics, CVO, a herbal tonic touted as a cure for COVID-19 but the odds stands against the country to carry out proper verification tests on the drug.
Boss Mustapha, Secretary to the Government of the Federation, SGF, who confirmed this during the daily presidential briefing stated that the herbal remedy would be subjected to checks before it is considered fit for consumption.
“The President has given instructions for the airlifting of Nigeria’s allocation of the Madagascar COVID-19 syrup from Guinea Bissau. And he has also given clear instructions that it must be subjected to the standard validation process for pharmaceuticals and there will be no exceptions for this,” he said.
Andry Rajoelina, Madagascar’s President who started promoting the tonic in April, said it is “a preventive and curative remedy against COVID-19“, attributing the recovery of 105 people in his country to the drug.
CVO is produced from the artemisia plant, the source of the ingredient used in a malaria treatment which was developed by the state-run Malagasy Institute of Applied Research.
The World Health Organisation, WHO in a tweet warns against the use of untested remedies in a virtual meeting with 70 traditional medicine experts from countries across Africa on the role of traditional medicine to the COVID-19 response.
Despite the reservations of the global health body, several African countries, namely Nigeria, Guinea-Bissau, Equatorial Guinea and Liberia have ordered for doses of the herbal remedy from Madagascar.
Available data suggest that Nigeria’s research organisations currently do not have the resources to conduct “in vitro” laboratory tests on the herbal remedy before it can be used for clinical trials in line with WHO guidelines.
“In vitro” laboratory tests mean cell cultures are isolated with the coronavirus and is tested with drugs to show an effect against the virus without harming the cells.
Stalled on the tracks
Nigeria is ranked 114 of 118 countries on the 2019 Global Innovation Index which measured each country’s contribution to global research and international patent applications, including mobile-phone application creation and high-tech exports.
The Nigeria Institute for Medical Research, NIMR, is saddled with the responsibility of leading the country’s medical research into finding possible solutions to several outbreaks including the current COVID-19.
Between 2015 and 2019, NIMR had received N160 million ( $410,256 using the official exchange rate of N305 to a dollar) as funding for research purposes from the Federal Government which pales into insignificance when compared to South Africa which spent R38.7 billion ($2.09 billion) on research and development in 2018 according to a National Research and Experimental Development Survey.
South Africa launched the first known biosafety laboratory isolate of SARS-Coronavirus 2, SARS-CoV-2, in Africa on April 1, through a joint effort of the University of the Western Cape and Stellenbosch University.
This means the scientists in South Africa would be able to grow the virus outside the human body and perform research on the drugs to be used for treating COVID-19 directly before proceeding to the clinical trials stage.
Currently, there are no level 3 and 4 biosafety laboratories in Nigeria which are designed to handle respiratory viruses, though the country boasts of level 4 laboratories that can culture non-respiratory viruses.
In an interview, Director General of NIMR, Prof. Babatunde Salako, admitted that to set up a national clinical trial that is wholistic would cost about N200 million which is more than its budget for research in four years.
“Initially, we wanted a national clinical trial that would factor in the six geo-political zones. But that may gulp about N200 million and we don’t have such money. As it stands, we may have to start small. As I mentioned earlier, the major challenge is funding,” he said.
The Federal Ministry of Science and Technology under which NIMR is domiciled was allocated N35 billion by the Federal Government in 2019 for research indicating a notable decline from its 2017 allocation of N65 billion.
Mateon Therapeutics, a US pharmaceutical firm announced that its COVID-19 directed antiviral screening program discovered that artemisinin is highly potent at inhibiting the ability of the COVID-19 causing virus, SARS-CoV-2, to multiply while also having an excellent safety index.
Unrecognised by regulatory agencies
Herbal medicine registration by the National Agency for Food and Drug Administration Control, NAFDAC, is placed on a listing status that is effective for a one year period while other scientific pharmaceutical drugs have the full registration period that lasts for five years.
Johnson Idowu, Director of Research Institute of Traditional and Alternative Medicine, RITAM, speaking to The ICIR said it was worrisome that Nigeria is importing herbal medicine from Madagascar but fails to recognise herbal remedies made in the country.
“It is a shame that we are importing herbal medicine from Madagascar because we have several research institutions, universities and private companies that the country has invested billions of naira annually and they are not asking them questions?
“Does it mean there is nothing to show for all these investments in researches in the country that we have to go outside to import untested herbal medicine we have failed to recognise in the country?” he queried.
He stated that clinical trials had not been conducted on herbal drugs in the country for over twenty years because of the aversion of the regulatory agencies to herbal medicine.
“They are saying we would carry out clinical trials on the Madagascan tonic in six months but for more than 20 years they have stonewalled herbal medicine research in the country. For example, NAFDAC refers to herbal medicine as an unevaluated drug by the agency and that means no doctor in his right mind will recommend alternative medicine for his patients,” he said.
In April, Max Planck Institute of Colloids and Interfaces, based in Germany collaborated with ArtemiLife Inc, a US-based company to test Artemisia annua plant extract and artemisinin derivatives in laboratory cell studies against the novel coronavirus Sars-CoV-2.
Technical Assistant at the Nigeria Natural Medicine Development Agency, NNMDA, Bibinu Daniels told The ICIR that the agency has an Artemisia annua plant in their farm in Delta State with several teams working on its research since 2006.
“We have had teams working on different research studies on artemisia since 2006 and the agency currently has a farm in Delta State where the plant is cultivated but lack of funding has not allowed the development of drugs as clinical trials take time,” he said.
The successful development of a drug from herbal remedy in Nigeria is Niprisan which is used for the treatment of sickle cell anaemia.
The effort by Nigerian scientists was widely regarded as a very significant breakthrough in medicine in 1998 before the conclusion of clinical trials in 2002.
However, commercial production of the drug was bogged down because of lack of financial support to mass-produce the drug.