NAFDAC, Pax Herbal and healthcare politics

The social media has gone agog twice in eight weeks on issues arising from claims form Pax Herbal, a trado-medical and pharmaceutical ministry run by Catholic Benedictine monks, and disclaimers from National Agency for Food and Drug Administration and Control (NAFDAC).

On May 1, 2020 The News Express reported that Fr. Anselm Adodo the Director of Pax Herbal Clinic and Research Laboratories, Ewu, Edo State had announced the development of ‘CVD PLUS’ for the cure of COVID-19 symptoms.

On May 3, 2020, during an interview on Sunrise Daily the Director General of NAFDAC, Prof Mojisola Adeyeye, reacted to claims of herbal COVID-19 remedies. In her statement, as at the 3rd of May, NAFDAC had received only one (1) application from one company for a product. And “as the agency that has been saddled with the mandate of safeguarding the health of the citizenry, NAFDAC will continue to make sure that only medicinal product (including herbal remedies) that have proven safety data will be approved for use by the public.”

After over eight weeks, on the 10th of July, 2020, Fr Anselm Adodo, the Director of Pax Herbal was quoted to have said “We at PaxHerbals 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. Pax Herbal Cugzin will help to boost body immunity, as there is yet no officially approved drug for the cure of COVID-19.”

Very quickly, in response to the Fr. Adodo’s press release, NAFDAC’s Director General responded that “NAFDAC is currently processing twenty-one (21) herbal medicinal products for “safe to us” or listing status. Many of the applicants claim that their products are immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19. However, no clinical study has been done yet on any of the products to prove their claim of efficacy. …Pax Herbal applied for listing of Pax Herbal Cugzin capsules 290 mg which was APPROVED by NAFDAC and LISTED AS ‘SAFE TO US’ (Capitalization mine). …However, as part of the labelling of the product, and in line with global practice, a Disclaimer is on the product label which clearly states that the claims have not been evaluated by NAFDAC.”

Issues that thisdialogue have brought to the fore are as follow: Firstly, NAFDAC is correct to disclaim as they have done that the statement “circulating in the social media that NAFDAC has approved Pax Herbal product ‘specifically for treating symptoms associated with Coronavirus is wrong and inaccurate.” This is because NAFDAC must wait for proof of clinical trials to show that Cugzin specifically responds to COVID-19.

Secondly, Herbal practitioners have been at the forefront to scientifically respond in the fight against COVID-19, while the western trained scientist are waiting for the West to tell them what is good to use. Besides, there have been 21 formal submission improvements on the earlier announcement by NAFDAC that only one company submitted claims for verification. Lastly, NAFDAC has formally said that Cugzin from Pax Herbal is ‘safe to use’, which means that it is okay for human consumption. The disclaimer seems to beonly saying that NAFDACwill not be responsible if it does not cure COVID-19.

From the dialogue, as a researcher in the area of traditional medicine, it is exciting that Nigeria has a ‘safe to use’ herbal product. What this means is that it is not like the other claims that people have been posting on the social media during this pandemic. If people have been using what has no NAFDAC approval I am sure that they will use Cugzin that has NAFDAC approval for listing.

What is lacking is the seeming lack of enthusiasm in the narrative of NAFDAC to observe the claims of the producer in drug trial. It has been alleged that some Isolation Centers have been using different measures, simply because they are safe, and not because they can cure COVID-19. If this is the case, why is there no enthusiasm to try Cugzin, especially now that we know and trust NAFDAC’s statement that it is safe?

This is the time for people to be encouraged to volunteer to use that which is safe and give feedback’s on what the results are. I see lot of useful data from herbal products going to be wasted because people will use herbal products without proper record or feedback. In two year’s time, NAFDAC will resume this dialogue when the approval will have to be renewed, and we will still be at the level of disclaimer.

NAFDAC should be excited and should champion research into the use of an established ‘safe to use’ remedies. NAFDAC has done its bit, and if they really have the interest of Nigerians at heart, they should be championing the drug trial of Cugzin. Since there is no known approved cure, why do we want to wait for vaccine trial when we can try that which has been established as safe? NAFDAC must work with researchers to gather data on the use andelicit feedback on listed regimens as a matter of social responsibility.

It is important to point out the need for formal study to prove the efficacy of Cugzin. While that is going on, Cugzin may be used just like the remedies that are prescribed and used in Isolation Centres, not because they are cure for COVID-19, but because they are safe and may just help with COVID-19.

We have to stop playing politics with traditional medicine in Nigeria. Researchers have shown that traditional medicine is readily being patronized; it is popular, and the first point of call for many Nigerians. It has come to stay, and it can only be better. Thus there is need for better collaboration and record-keeping in Nigeria. NAFDAC should please make their position clearer that Cugzinis safe to use, and government can begin to recommend the use because it is safe. Let us hope that it will cure COVID-19.

Dr. Akin-Otiko is a research fellow in African Traditional Medicine and Religion at the Institute of African and Diaspora Studies, University of Lagos.