NAFDAC DG Sheds Light On Chloroquine, Herbals, Masks and Covid19
Professor Mojisola Christianah Adeyeye was appointed on the 3rd of November 2017 by the President of Federal Republic of Nigeria as the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC).
Prof. Adeyeye, before her present appointment, was the founding Chair of Biopharmaceutical Sciences and Professor of Pharmaceutics and Drug Product Evaluation at the College of Pharmacy, Roosevelt University in Schaumburg, Illinois, where she spent 7 years. She was Professor of Pharmaceutics and Manufacturing for 21 years at Duquesne University in Pittsburgh, PA , USA. She is Senior Fulbright Scholar and Specialist and 2008 AAPS Fellow. Professor Adeyeye is Fellow of Nigerian Academy of Science and Nigeria Academy of Pharmacy.
She earned her B.Pharm degree from University of Nigeria, Nsukka, Nigeria and MS and PhD from University of Georgia, Athens, GA, USA. Her research interests include pre-formulation, early phase development of solid, semisolid and liquid dosage forms, and IND-based and intellectual property-driven late phase drug product development.
She has mentored over 15 PhD and M.S candidates. She has 5 patents, over 60 peer-reviewed manuscripts, book chapters and books, and more than 150 scientific presentations. She is the founder of a socially conscious start-up company –Elim Pediatric Pharmaceuticals. She used her university lab for the early phase R&D and partners with contract manufacturing organizations for the clinical and registration batches.
In this interview with ENIOLA AKINKUOTU (of Punch), the Director-General, National Agency for Food and Drug Administration and Control, Prof Moji Adeyeye, talks about the role of NAFDAC in the fight against Covid-19 and other trending issues
In February, you raised the alarm about a possible drug shortage due to the effect of COVID-19 on global trade. Do you still nurse that fear?
The COVID-19 pandemic, I would say, slapped us in the face as a country. It was a slap to wake us up from our sleep or our comatose state in terms of drug security. I mentioned it over and over again that a country that has drug insecurity is a country that is at risk. It is a national security issue too because if we have to depend on other nations for the simplest materials then we are in trouble and we were in trouble before COVID-19.
But since COVID-19, the government has realised huge deficiencies in the health system including in the pharmaceutical industry. And I think in early March or late February, there was a conference in which the Governor of the Central Bank of Nigeria brought about 300 people together including ministers, bankers and other stakeholders on how the country could move forward amid the crashing crude oil price.
And the CBN Governor, Mr. Godwin Emefiele, stated that Nigeria had problems in terms of the pharmaceuticals and I was very pleased because this is what I had been singing for the last two years. What this means is that the CBN was willing to assist the pharmaceutical industry so that we could compete with others across the world. There is also an intervention and infrastructure fund being provided.
So, as we speak, various pharmaceutical companies are speaking with banks to access these funds that will be given at a low-interest rate. Our pharmaceuticals are hampered because they have to import everything except water. These are barriers. So, for the government to realise that this industry has been hampered for decades is a big issue.
The Ministry of Trade and Investment has also been involved in talks with the pharmaceutical companies and NAFDAC is the go-between. So, the ministry has also been very involved in ensuring that the pharmaceuticals get raw materials because the CBN has to work with them to ensure that if they have to freight some materials due to the lockdown, the government can step in. African Development Bank is also talking to us on how they can assist in areas of priority.
There have been talks about local herbal solutions to COVID-19. How many samples or possible cures have been received by NAFDAC?
Let me state categorically that we have not received any COVID-19 local herbal sample in NAFDAC for testing. On Thursday, we received a letter of intent to submit evidence that a product was available not to cure but support in treating some symptoms. So, that is the only thing we have received so far in terms of a herbal solution relating to COVID-19. Right now, there is no cure for COVID-19. Even the Chloroquine is under clinical trial studies. Until you have evidence, you cannot lay claim to a cure.
But Prof Maurice Iwu said he had a herbal solution to COVID-19. Why is NAFDAC not having any talks with him?
In March 2019, I inaugurated the Nigerian Herbal Medicine Product Committee. It is a national and professional committee and Prof Iwu is one of the members. The goal of the committee was again to wake us up from our slumber and to know that we have good biodiversity, come out of our shell, and to collaborate. The goal was to bring herbalists together with researchers and university professors.
Prof. Iwu is one of the members. We had a meeting in September last year and he was there but nothing has been brought to our attention thus far. So, when I heard this claim of his treatment for COVID-19, I didn’t doubt whether it works or not but the thing is that nothing has been brought to NAFDAC and no one has submitted it to us for the initial evaluation and subsequent clinical trial. Nothing has been brought to us.
We understand that scientific solutions were sent to the USA for analysis, is there any feedback from them?
I don’t know about this one but it is possible. However, if it is going to be used in Nigeria, the least that can be done is that it passes through the regulatory agencies. I was in the US for 37 years and I did a lot of research on HIV/AIDS for children and I came home for the clinical trial. The FDA approved and it was agreed that I would do a clinical trial in Nigeria which I did. Everything has to be done in order. There is no short cut in regulatory science. If you have an interesting herbal product, the place to go is NAFDAC. We will do preliminary investigations, look at toxicity, microbial contents and we will determine if it will be used.
Science is such that when you reach an outcome, you must be able to trace back your step to the origin. The researchers and herbalists must have confidence in each other and we are doing that. That is part of the mandate of the committee I inaugurated last year. We have drafted confidentiality agreements that NAFDAC is supervising. Then we get intellectual property lawyers that help them to protect their product. Nigeria has lost billions of dollars over the years because we don’t know how to protect our intellectual properties. Our parents died with the knowledge they had because they didn’t want to divulge such content. So, we are trying to build the confidence of the herbalists and researchers. This is what we are working on so that when the product is out, everyone will be pleased.
Some weeks ago, you said no other state has shown interest in chloroquine clinical trial except Lagos. Is that still the situation now?
First of all, chloroquine was reported to be effective in hospitalised patients and patients being treated under clinical trial design before Covid-19 came to Nigeria. chloroquine didn’t just come out of the blues. It was because they found out in China where it started that chloroquine was given to some Covid-19 patients and it worked for them and that was what led to my statement some six weeks ago and Lagos State embraced that approach to use chloroquine and hydroxyl-chloroquine in the clinical trial setting.
I believe some other states are using chloroquine for a hospitalised setting and not for a clinical trial because for a clinical trial you will have to write a protocol and Lagos State submitted their protocol to us. We vetted it back and forth and now they are about to start. It has to be well designed because whatever comes to the scientific world must be defensible. That is the essence of clinical trial treatment planning. It has to be well thought out. How many patients will give us a statistical result that will be interpreted well and give a level of confidence? So, these are the kind of things that go into the clinical trial protocol.
So, we have come alongside Lagos State to review their protocols and they are about to start. I have not seen any other protocol developed by another state but that doesn’t mean the states are not using chloroquine for those who are hospitalised because a person with Covid-19 can be hospitalised and they give it to him or her. That is not necessarily a clinical trial setting but it can be in a clinical trial of sorts because whatever Lagos State will get, it can be extrapolated as effective even without an official clinical trial protocol that NAFDAC reviewed but if some of the states use it in hospitalised patients and not for just anybody on the street which is what we also don’t understand. You don’t just take chloroquine and start using it. A person must be guided by a medical doctor who will refer the Covid-19 case to NCDC before steps are taken.
You asked some pharmaceuticals like May & Baker to start producing one million tablets of chloroquine. Was there a guarantee from the government that these drugs would be purchased? If not, who will pay for it?
That is a good question but you know it is often said that if you don’t take a risk, you may not know how exciting life can be. When you have a first aid kit, it is not everything in the kit that you use. If aspirin is in a first aid kit and nobody uses it for two years and it expires, it is still part of the first aid kit. That was my intent when I envisaged the way the pandemic would be. I discussed with NCDC that it is better for us as a country to have something set aside just in case. If it is never used, then so be it but somehow we would have compensated the company.
I asked this company to produce a batch which is about one million tablets. The good thing is that even though it was not embraced in the country, the West African Health Organisation based in Burkina Faso that oversees the health sector in West Africa, was convinced that some people who were ill in Senegal were given chloroquine and recovered. So, WAHO contacted May and Baker. What we didn’t embrace, May and Baker were able to give to WAHO which distributed to the 15 member states of ECOWAS including Nigeria. They found out that this thing works.
If chloroquine works so well, why is it still believed that Covid-19 has no cure?
It is science. You do not claim any cure unless you have done experiments. There has to be a confidence level. The data has to be tested statistically that without any doubt, this drug will work if I repeat an experiment 10,000 times, it will work. There are different confidence levels. So, that is why you cannot claim unless you have done the clinical trial system and analysed it statistically. After that, you can say ‘chloroquine which was used in Nigeria for malaria can be repurposed for Covid-19’. Until then, nobody who is a scientist can claim that it is a cure. It is about the confidence level.
A research institution at the Redeemer’s University produced test kits for Ebola during the outbreak of the virus. Are there similar test kits that have been submitted by Nigerians or Nigerian institutions to NAFDAC for approval?
My understanding is that Redeemers University in Ede does PCR testing. It is not a kit. A kit is something you can carry around with you. But they have the PCR machine where they can analyse samples but it is not like they have a rapid disposable test kit. I believe samples have been sent to them. As regards local manufacturers trying to produce, it hasn’t started, unfortunately. Again, we don’t appreciate what we have as a country. Unless it comes from outside, we don’t have confidence in him.
One Nigerian based in the US developed test kits for malaria and typhoid many years ago. He came home to establish something but got frustrated and left. I happened to meet him two and a half months ago and I challenged him to start looking at home and stop letting the frustration of yesterday to affect today. I contacted him about Covid-19 test kits and he told me he produces in the US. I gave him a pep talk that I was in the US for 37 years and I am not crazy about coming home. I have seen many challenges that can make me go back but I am here.
I have encouraged him to submit his application and we will test it against international standards. If it works then well and if not, he will have to improve on it. So, yes, we can produce kits. God has given us the potential to innovate in Nigeria but the environment must be right. NAFDAC has been reviewing a lot of test kits from across the world. We have about 40 applications and we have approved about 12 or 13 after rigorous reviews because not every test kit can be used in Nigeria. They must have all the certifications also before we can approve them
Thousands of bags of rice sent across the country as COVID-19 palliatives were reportedly bad and not fit for consumption. Has NAFDAC now gone to check some of the rice whether they were expired?
We don’t go about asking customs commands to find out how many bags of rice they have in their warehouses. They invite us to do so. If they don’t invite us, we will not know because we don’t do such monitoring. Where they have invited us, we have gone to take samples and only three customs state commands had invited us as of last week. Three other northern states had invited NAFDAC and those tests are ongoing. My point is that if we are not invited, we cannot act. The one in Oyo command that caused problems never invited us to come take samples. And I believe they were distributed in Oyo and Osun. It is not the state governments but customs that invite us because they are in the various customs commands nationwide. We then inspect and then customs take actions.
This week, you issued a statement on the efficacy of masks for Covid-19. Ahead of the partial suspension of the lockdown, how will consumers be protected from those selling fake or substandard masks?
This is an issue for us and that is why we are taking it seriously. There are two categories of masks- the medical and non-medical. The non-medical will be used for everyone going out while the medical is used in hospitals. For the non-medical, we have to be very careful as regards the type of material that is used.
There are different types of Ankara. Some are thicker than others and the type of material is very important in terms of filtering out particles that a user can breathe in or breathe out. A simple test I have seen online is that if you can blow through a mask and it can extinguish a fire on a cigarette lighter, then it cannot protect you. But if it cannot blow off the fire, then you are protected. So, our job is to do enlightenment because we cannot test every mask since they are not all medical masks but we will try to standardise the use of masks. It doesn’t mean we will sanction anyone but we would rather enlighten people to the quality of masks that they need to buy.