NAFDAC insists on clinical trials of products

Left with few options and considering the highly infectious new variants/second wave of COVID-19 and increasing fatality, some Nigerians have resorted to use of herbal cures. They also want to hear from government what the official position is with herbal alternatives.

Some Nigerians insist that considering current challenges of procuring conventional medicine, isn’t it time government advanced herbal cures to contain the ruthless new variants of COVID-19?
The Federal Ministry of Health had assured that only a handful of COVID-19 vaccine would arrive late January. But last week, the Nigeria Governor’s Forum (NGF) announced a new arrival time of February ending, even with some element of probability.

At the moment, some universities have come up with claims of herbal cures for COVID-19. From University of Ibadan, University of Lagos, Nnamdi Azikiwe University Awka, University of Abuja, University of Benin, University of Maiduguri and lately, University of Jos, there have been claims of major breakthroughs on fighting COVID-19. Not forgetting Prof. Maurice Iwu of Bioresources Development Programme (BDP), Prof Olukemi Odukoya of University of Lagos.

Director General of government-owned Nigerian Natural Medicine Development Agency (NNMDA), Victoria Island, Lagos, Mr. Samuel Oghene Etatuvie, told The Guardian that herbal medicine is relevant in efforts to contain COVID-19. The pharmacist said traditional herbal medicines are naturally occurring, plant-derived substances with minimal or no industrial processing that have been used to treat illness within local or regional healing practices.

Listing properties in herbs, he said they contain certain active compounds, which have antimicrobial or antiviral, anti-inflammatory, and immunostimulatory activities, such as Andrographis paniculate (Andrographiloid), ginger (6-gingerol), Garcinia kola (kolaviron) neem (quinine), and turmeric (curcumin). He said these herbal compounds are known to have the capacity to modulate or boost the immune response and, therefore, they are believed to have beneficial effects on preventing or treating COVID-19.

In response to why government is yet to try this on COVID-19, the NNMDA boss blames it on lack of political will on the part of government.

On what have been the challenges, especially in advancing claims by universities and renowned professor, Etatuvie said some of the challenges include: inadequate funding of research, regulatory status of herbal medicine, duration of clinical trials, evaluation of safety and efficacy, quality control, safety monitoring and inadequate or poor knowledge about traditional medicine.

Etatuvie said the National Agency for Food and Drug Administration and Control (NAFDAC) as a regulatory authority is yet to take steps to protect the health of consumers by drafting guidelines for the registration and control of herbal medicinal products and related substances in Nigeria.

A professor of pharmacognosy at the University of Lagos, Olukemi Odukoya, told The Guardian that herbal medicine has done its bit in efforts to contain COVID-19.

Odukoya assured: “COVID-19 is a new disease. Within this pandemic, some herbal medicines have been enlisted to manage the symptoms of COVID-19 as well as boost immune status of the individual. I’m also aware that research is actively on in NAFDAC with our universities on clinical trials of some products.”

Must herbal medicines go through clinical trials, a major hurdle, before they are used? Odukoya said not all herbal medicines will go through clinical trials as some will be used as adaptogens.

A professor of ophthalmetry and chairman, Lagos State Traditional Medicine Board (LSTMB), Adebukunola O. Adefule Ositelu, said great works have been done and many are now being done. She said many products from medicinal plants have been compounded and sent to NAFDAC for approval from all over the nation.

“As you know, we have no right to claims of cure until adequate scientific analyses and clinical trials have been convincingly done. We are heavily endowed with many indigenous medicinal plants that have anti viral, anti inflammatory, mucolytic and good/ strong immune boosting properties,” she said.

Ositelu added: “NAFDAC is fully engaged. They are busy right now with products sent to them for listing, analyses and approval. Our tertiary institutions have worked tirelessly in the past mostly, just for promotional exercises as our plight is, ‘publish or perish’. Late Prof. Sofowora and his team at University of Ife will be ever in the forefront on such marvelous works on medicinal plants.”

A virologist and chairman, Expert Review Committee on COVID-19, Prof. Oyewale Tomori, told The Guardian: “Herbal medicine could be relevant in the clinical aspects of managing COVID-19, especially in indirectly assisting or fortifying the body to overcome infections.
“Many of the products (herbal medicine) serve as immune boosters improving the body’s ability to combat diseases, and not necessarily as having direct effect on the COVID-19 virus itself. You will notice that many of these cures have been also ‘claimed’ to cure Ebola, Lassa and now COVID-19.”

On why herbal medicine has not been adequately deployed, Tomori said: “Because we have not had certified clinical trials of the products. A few of the claimed effects have either been studies done in vitro in the lab against the pathogen or a related pathogen or some unverified anecdotal claims made by people who have used the preparations in uncontrolled studies. You cannot compare such studies with approved phase 1 to 3 clinical trials. There are approved and standard processes and procedures for approving new drugs or vaccines for use.

“Announcing uncertified studies on a Dstv channel or a press conference or approved by a Senate of a University is not one of them, nor does it confer legitimacy or authenticity on the product.”

Tomori, who is also the pioneer Vice Chancellor of Redeemer’s University, said the greatest challenge is Nigeria not having the most basic and rudimentary facility to conduct approved clinical trials of these products. He said the greatest challenge is not the researchers but a nation that has never regarded science and technology as tools for orderly development and social advancement and transformation: a nation that has created a toxic environment for research and development.

On the way forward, Tomori said: “Invest in science and technology, build a solid base for scientific training from primary school upwards, massively fund research and encourage industry to participate in sustaining the foundation for research and technological development of our nation. The government should pay a strong attention to making research, science and technology as the tripod for our advancement took underdeveloped to a developed nation status.”

A consultant pharmacist and former President, Pharmaceutical Society of Nigeria (PSN), Olumide Akintayo, strongly supports any safe, efficacious and affordable drug, including those of herbal origin in the quest to contain COVID-19.

He told The Guardian: “The critical issue has always been that a need arises to cross the hurdle of patent safety, which necessitates the insistence that they must be subjected to the pharmaceutical protocol of clinical trials.
“It is relevant to the extent that any claim to remedy of COVID-19 including those of herbal origin are subjected to trials by the appropriate regulatory agency of the Federal Government, which is NAFDAC in this instance.”

Akintayo said: “If everybody who has claimed he has a cure for COVID-19 or any other clinical disease is allowed access to patients or the sick, then we invariably invite morbidity, mortality, drug resistance, adverse drug reactions and therapeutic failure because we would have expertly jeopardised quality control and assurance in the preparations available to consumers of health.

Minister of Health, Dr. Osagie Emmanuel Ehanire

“We must continue to remember that NAFDAC in particular, must ensure a safety mandate in tandem with its enabling Act.”

On why institutions set up by government to develop herbal medicine are not living up to their responsibilities, Akintayo said: “Your guess is as good as mine. Let us avoid a blame game. If however we need to get into it, you might need to find out what level of funding research and development of any endeavour receives from government. The R&D Funds to develop COVID-19 vaccines by Pfizer, Astra Zeneca and each of those other companies was an average of $750 million.

“Given the scenario, what do you expect from NIPRD, FIIRO and NNMDA?”

A professor of pharmacognosy, who was the first to go public with his natural drugs for COVID-19 after presenting them to the Ministry of Health said: “As of Friday January 15 2021, 625 people have successfully treated themselves for SARS CoV-2 infection by combing IHP Detox Tea and the approved Standard of Care. Garcinia IHP and Immunovit were added for the elderly and very sick with 100 per cent success rate. The decision is yours to live or resign to the virus.”
NAFDAC has acknowledged that some herbal medicines may cure COVID-19 but they have to be proven clinically through research before they could be deployed to contain the pandemic.

Director General, NAFDAC, Prof. Mojisola Adeyeye, while reacting to questions from The Guardian on COVID-19 vaccine, herbal medicine and related matters, said: “Applicants, researchers or herbalists work to develop herbal remedies. NAFDAC’s mandate is to ensure that the product submitted by applicant is safe. NAFDAC conducts scientific tests on the products before approval is given for listing or denied. The applicant will need to submit some scientific data to NAFDAC as part of the application for listing; and this takes time and resources. NAFDAC will have to confirm that all the data submitted by applicants such as toxicity and microbial content are consistent with NAFDAC test results. If the results are consistent and the manufacturing site is approved, the product can be listed as safe to use. This is the first stage of testing of the product for public use.

The second stage is the testing for efficacy. The applicant has to do this in order to prove with scientific evidence that what is being claimed for the product as effectiveness in managing one disease or the other is true. This efficacy study involves clinical trial that also takes time and money. NAFDAC and National Ethics Research Committee (NHREC) must approve the clinical trial protocol and the clinical trial site, before the study can take place.

“You cannot say as an applicant that you have a herbal medicine that can cure COVID when you didn’t have a well-designed experiment to prove it. That is why it takes a lot of time and money.”

 

 

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