COVID-19: Why local solution remains uncertain

As several countries are reporting progress in the search for homegrown solutions to COVID-19, in terms of prevention, testing, treating and managing patients, the situation appears different in Nigeria, which is yet to publicly accept any indigenous solutions to the disease.

Earlier this year, professor of Pharmacognosy and President/Founder of Bioresources Development Group (BDG), Prof. Maurice Iwu, on March 2, presented a drug for possible prevention and treatment of COVID-19 to the Minister of Science and Technology, Dr. Ogbonna Onu, and the Minister of State for Health, Dr. Adeleke Olorunnimbe Mamora, in Abuja. Up till now, there has not been any positive feedback on the drug.

The ministers allegedly refused to conduct clinical trials on the drug registered by the National Agency for Food and Drug Administration and Control (NAFDAC) or try it on COVID-19 patients.

Similarly, last week, NAFDAC, FMoH and the Presidential Task Force (PTF) on COVID-19 openly rebuked Pax Herbal Clinic in Ewu, Edo State, for claiming to have herbal remedy for COVID-19.

The irony is not limited to local drugs, but also to locally manufactured test kits. Two weeks ago, the Nigerian Institute for Medical Research (NIMR) in Yaba, Lagos, launched the country’s first set of local Ribonucleic Acid extraction kits to help expand the country’s capacity to test for COVID-19.

About the same time, the FMST unveiled an indigenous test kit, RNA Swift, for the detection of Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2), the causative agent of COVID-19, with a view to enhancing capacity and effectively managing the pandemic and save foreign exchange.

Iwu said “I do not believe the matter has become politicised; it will be unfortunate if it is politicised. I think the weaknesses in our system and gaps in perception of the regulatory process are manifesting, as people are concerned with the safety and efficacy of medicines. It may appear tedious and sometimes difficult, however, we need to improve on the efficiency of the process to save lives.

“We approached the Federal Government for support in developing a ‘drug,’ an active pharmaceutical ingredient, not a herbal product, which we found to be effective in laboratory studies to be active against SARS Coronavirus and later found also active against SARS Coronavirus-2, the virus that causes COVID-19.

“The herbal products – IHP-Detox Tea and Immunovit-IHP – have been fully listed by NAFDAC and in public use since 2016. Since the outbreak of COVID-19, we have recommended them as re-purposed agents for the treatment and management of the infection based on scientific evidence.

“The reports we are getting from users of the products have been overwhelmingly positive. Many cases of people, who used IHP-Detox Tea, reported conversion from SARS CoV-2 positive to negative results.

“There are reports of many symptomatic cases that were resolved. Several health professionals use IHP-Detox as possible pre- and post-exposure prophylactic. But all these reports are treated as anecdotal until the products are subjected to controlled clinical trials.” Iwu noted that the process of drug development takes time and the solutions would be accepted based only on verifiable evidence. “IHP-Detox Tea, for example, has received wide acceptance in Nigeria and overseas. The science is sound, but we still need verifiable clinical data on the product.

“I believe that most of the claims are based either on the conceptual similarity of symptoms of COVID-19 with the activities of their products or the literature information on the ingredients, not on empirical data, which is not acceptable. Over time, the evidence based on safe use and efficacy will emerge.

“We are still going ahead with our plan for the clinical trials of IHP-Detox Tea, although Andrographis is one of the most extensively studied natural products and the plant that yielded of the active compound and has been clinically evaluated in several studies.” He stated that drug development is an expensive and highly technical process, but when successful, it would not only save foreign exchange, but also generate enormous rewards for the country, adding: “The bigger benefit to the country actually goes beyond monetary gains, as national, continental and racial pride and confidence are intangible, but immeasurable.

“The job creation potential and other tangible benefits are enormous. We have four farms, but these are not enough, so engage farmers for outsourcing some of our raw materials for the manufacture of IHP-Detox Tea. Having such globally accepted phytomedicines will spin off projects in agriculture and other businesses.”

He wonders why some people are against such discoveries, noting: “People want proof of safety and efficacy. It is also difficult to accept that a discovery of a drug for COVID-19 is based solely on ‘traditional medicine,’ when the disease itself was only recently identified. Even when we announced our patents for Coronavirus, we had to define that we were referring to SARS CoV and still subjected the compounds again to antiviral activity against SARS CoV-2, the causative agent for COVID-19.”

Director General of NIMR, Prof. Babatunde Salako, stated: “The kits have been tested in-house by those who developed them, but their results have to be reproduceable by others. To my knowledge, there is only one test kit developed locally that is a rapid test kit, but the Nigeria Centre for Disease Control (NCDC) has not started using rapid test kit in Nigeria.

“The other two claims really are RNA Extraction Kits and not test kit, as some people may want us to believe. I believe NCDC made this clarification recently.” He clarified that there is a process for it to be used and both NCDC and NAFDAC need to be convinced of the claim by validating it before it can be registered for use, a procedure is currently ongoing.

He said because local production would reduce cost and obviate the need to use foreign currency on buying kits, emphasis should be on local manufacturing on the long run, as this would also create more jobs. Salako does not believe people are against such discoveries, reckoning that they only needed to be convinced that it is truly Nigerian-made and effective.

A pharmacist and Chief Executive Officer of Halamin Herbal, Dr. Ben Amodu, commended efforts at manufacturing COVID-19 test kits and drugs, but bemoaned the fact that the process is too slow.

“We have products that will speak for themselves in the clinical trials, which we are set to do in Abuja. This will also reduce the so-called politics, as evidence is the end of argument. We need to do clinical trials, which is the norm worldwide. So, let us wait, except where we can show evidence of cure, which we are gathering.”

Amodu, who was a member of the National Expert Committee on Verification of Herbal Cure Claims (NECVHCC) set up in 2013 by NAFDAC, said: “It will help the country preserve scarce expenditure on same materials that are produced in the country and even sold out to earn more foreign exchange for the system.

“Some people are against it for their selfish reasons and some because they do not like those discovering it, but all that will be put to rest once their efficacy is confirmed. It is human to expect such, but they would be the losers, as the country would gain, earn respect and get foreign exchange.”

Pax Herbals, in an official statement, said: “We are happy to confirm that our CVD PLUS, which has been renamed CUGZIN, has been issued a NAFDAC number, as ‘an immune booster and anti-infective.’

“We are aware that there is a lot of anxiety in the land and people are hungry for any reliable immune booster as prevention. PAXHERBAL CUGZIN will help to boost body immunity, as there is yet no approved drug for the cure of COVID-19.”

Director of Pax Herbal Clinic and Research Laboratories at St. Benedict Monastery in Ewu, Fr. Anselm Adodo, told The Guardian that the COVID-19 pandemic has clearly showed that the countries that would attain economic sufficiency, wealth, health and prosperity in the 21st century are those, who depend on their own inner genius and resources.

Adodo said: “If African countries are lagging in almost every aspect of human development index, it is not because the Africa people are less intelligent than other races. On the contrary, Africa is blessed with brilliant and intelligent men and women.

“The biggest challenge for us Africans is mainly a mindset problem. Some people blame this mindset on colonialism, some on foreign religions and some on western education.

“In the past, we used to hear about physicians, who provide health care to the sick; physicians, who genuinely care for the sick. Today, we have more of health specialists or professionals, who help fix our bodies when broken down, so that we can keep on moving. Yes, they may have cured us, but do they really care?”

He said the term ‘traditional’ tends to suggest something illogical, irrational, unscientific, mysterious and old-fashioned, as ‘traditional medicine’ conjures images of paganism, fetishism, idol-worship and ritualism in the minds of the educated, religious elite and the public.

To Consultant public health physician and Executive Secretary of Enugu State Agency for the Control of AIDS (ENSACA), Dr. Chinedu Arthur Idoko, the question of how effective COVID-19 locally sourced test kits are, can only be answered by the sensitivity and specificity of the test results of such kits.

He explained: “The efforts to locally produced and source COVID-19 RNA extraction kits is a good way to go and a first major step to actual testing for COVID-19. These kits are scarce worldwide and efforts and relative successes already recorded to local production is a welcome development.

“It is important to note that the reservations to both local cure for COVID-19 and reliability of locally produced test kits are all part of the age-long saying of a prophet not being accepted at his home/locality.

“Once these products have been subjected to the ideal and necessary protocols/scrutiny to ascertain their validity, there should be no reason not to widely apply it locally to control of the pandemic.

“These products would definitely be cheaper, more accessible and replicable.” He said change is generally difficult to accept or make, as people already used to a way of doing things don’t find it very easy to change course, as well as the issue of the ‘unknown’ and reservations on embarking on a journey the final outcome is yet substantially unverified, just as structures already benefiting from the usual way things are done may not find it very easy accepting the new norm.

Virologist/vaccinologist and Chief Executive Officer of Innovative Biotech Limited in Keffi, Nasarawa State, Dr. Simon Agwale, added that local production is important because it creates jobs.

“From the first reports of the novel coronavirus, SARS-Cov-2, subsequently renamed COVID-19, several research institutes across the world have been working frantically to develop an effective vaccine against the virus.” He stressed that developing and manufacturing vaccines, drugs or diagnostic test kits is not a trivial thing and it is shocking to keep reading about ‘cures’ or ‘vaccines’ or ‘test kits’ without any solid data, noting that there is a well-established process for drug discovery, which is in three phases (discovery, preclinical studies in animal models and clinical trials) and then regulatory approval if the products show to be efficacious in the last stage.

Agwale insisted that one could not make any claim until these procedures are followed. If not, the product should be listed with NAFDAC (that is for herbal preparations) and sold as supplements with disclaimer, emphasising that clinical trials of health products are not done in secret, but has to go through the normal procedure, that is NAFDAC, Institutional Review Board (IRB) or National Ethics Committee, depending on the product, amongst other key steps.

“So, you can see that there is no locally made drugs, vaccines or test kits that currently exist,” he said. Professor of Medical Virology and Hospital Virologist, College of Medicine, University of Lagos (CMUL) and Lagos University Teaching Hospital (LUTH) Idi-Araba, Dr. Sunday Omilabu, said locally developed kits are not yet available, as they are still being developed, explaining that what is available (as at last week) is the extraction kits from NIMR in Lagos and National Biotechnology Development Agency (NABDA) in Abuja, which is just a component, with other components of the test kits still being developed.

“If well developed and made available, it will surely save a lot of foreign exchange for Nigeria, so government should encourage the scientists through funding of the project, while the commercial aspect should be supported by our manufactures, even as the products must be subjected to international standards through third party evaluations and validation.”

Biomedical Technologist at the Department of Biomedical Technology, Federal University of Technology, Owerri, Imo State, Dr. Chidi G. Osuagwu, reckoned that, though some Nigerians might have some traditional medicines that cure COVID-19, and to cure means it has efficacy, in modern medicine, a drug must have, in addition to efficacy, known active ingredient, known mechanism of action and known safety level to be publicly accepted.

“So, our people that make claims tend to run into challenges with fulfilling these conditions. Otherwise, their claims would be said to be anecdotal and discountenanced. In organised and purposive countries, the authorities help those with claims to develop it for national security. Unfortunately, in disorganised and corrupt societies, the claimant might be asked to pay bribe for the claims to be looked at,” he said. “National security, COVID-19 teaches us, requires that all nations should be food and medicine sufficient,” Osuagwu said. (The Guardian)