• NAFDAC’s insistence on clinical trials for traditional medicines before approval divides researchers
• Herbal medicine regulation deserves separate, independent agency, say practitioners
The lack of encouragement for local herbal cures and remedies for diseases by the Federal Government (FG) and its agencies, especially the National Agency for Food and Drug Administration and Control (NAFDAC), has raised concerns among practitioners.
Indeed, traditional medicine has become the mainstay of big economies like the United States, India, China and even Ghana.
Unconfirmed report suggests that the FG and its agencies receive lots of grants from Western countries and do not feel incentivized to look for local remedies. Unfortunately, Nigeria is not benefitting from the global herbal/traditional medicine market, which is said to be worth over N141 trillion.
According to the report published by Business Fortune Insight in February 2022, the global herbal medicine market size was $185.86 billion in 2020 and is projected to grow from $230.03 billion in 2021 to $430.05 billion in 2028 at a compound annual growth rate (CAGR) of 11.32 per cent during the 2021-2028 periods.
THE Guardian investigations revealed that it took over 50 years before Artemisinin from Chinese salad plant could be accepted by the World Health Organisation (WHO), and Western markets, more especially, as a ‘cure’ for malaria.
Artemisinin is the active ingredient in Artemisinin-based Combination Therapies (ACTs) globally approved by the WHO for malaria treatment.
Archaeological findings indicate that qinghao (Artemisia annua) has been used as a traditional remedy in China for over two thousand years. However, it took over four decades of research on the biochemistry, physiology, and breeding of Artemisia annua, before the West accepted the drug.
Herbal medicine and COVID-19
Investigations also suggest that Nigerians and indeed Sub-Saharan Africa practically survived COVID-19 because of the use of herbal remedies such as concoction of garlic, ginger, lemon, turmeric and onions, among other items.
The West had predicted that COVID-19 would decimate Africa because of weak health systems in most countries. It was projected that human bodies would litter the streets of major African cities if nothing was done urgently.
WHO and NAFDAC also condemned the Madagascar herbal COVID-19 cure. But the active ingredient from the product, Artemisinin, has now been approved for the treatment of COVID-19 and other diseases.
NAFDAC had, in May 2022, announced a disclaimer to the IHP Detox tea cure for COVID-19 produced by Bioresources Development and Conservation Group (BDCG). Similarly, the agency, in 2020, at the peak of the COVID-19 pandemic, disclaimed Pax Herbals’ Cugzin COVID-19 cure.
Disclaiming Cugzin, a Pax Herbal medication, NAFDAC had on May 2, 2020, noted: “… We wish to inform the public that PAX CVD PLUS has not been registered nor listed for treatment of COVD-19, neither have we registered nor listed any other remedy for COVID-19.
“To set the records straight, at no time did the Director-General of NAFDAC, Prof Mojisola Christianah Adeyeye, or anyone in the Agency appoint any expert or staff to work with PAXHERBAL on any project.”
Pax Herbal Cugzin had earlier been produced under the brand name ‘CVD PLUS’ before it was rebranded to ‘Paxherbal Cugzin’.
Pax Herbal is a Nigerian alternative medicine product manufacturing company founded by Fr. Anselm Adodo, in 1996, at Ewu Monastery, Esan Central Council of Edo State.
NAFDAC had on May 29, 2022, debunked the claim of the efficacy of IHP Detox Tea for the cure of COVID-19 patients, purportedly made by the Chief Executive Officer of BDCP, Prof. Maurice Iwu, in a national newspaper, not The Guardian.
NAFDAC’s Director General, Prof. Mojisola Adeyeye, in a media statement signed by the agency’s Resident Media Consultant, Sayo Akintola, in Abuja, stated: “Only NAFDAC has the mandate to make any pronouncement on the quality, safety and efficacy of all regulated products that show satisfactory scientific evidence.”
Preliminary findings of a clinical study on IHP Detox tea by medical doctors at the College of Medicine University of Lagos (CMUL)/Lagos University Teaching Hospital (LUTH) Idi-Araba found the product safe and effective in treating COVID-19 patients.
The findings were presented at CMUL/LUTH in May 2022. A team from WHO was there during the presentation. Interestingly, the WHO has refused to make any statement on the findings up till now.
Similarly, preliminary findings of clinical trials of IHP Detox tea by doctors at Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, showed the product was safe and effective in treating COVID-19 patients.
THE organisation denounced media reports ostensibly circulated at the instance of the promoters of IHP Detox Tea, which claimed that the herbal medicine was the only product approved by the agency for treatment of the virus.
International Centre for Ethnomedicine and Drug Development (InterCEDD), makers of Interceded Health Products (IHP), is a subsidiary of BDCP, which is a non-governmental non-profit organisation.
More questions than answers
THE situation has raised several questions: Why are FG and NAFDAC paying lip service to herbal/traditional medicine? Are clinical trials necessary before approval of natural cures? Who should sponsor the capital project? What should FG and its agencies like NAFDAC be doing towards promoting herbal remedies? What is the way forward towards fast-tracking the development of novel herbal cures like IHP tea and Cugzin for the benefit of Nigerians?
A source in one of the agencies under the Federal Ministry of Science and Technology, who preferred anonymity told The Guardian: “I think a thorough investigative report needed to be done on the issues raised in this call, especially to ascertain the cause of recent comments of NAFDAC on IHP Detox Tea and Pax Herbals’ Cugzin for COVID-19. I am saying this because I am aware of the official document (2022 Appropriation) in the public domain that states FG has appropriated funds for capital projects to carry out Clinical Research on Herbal Therapies made with Nigerian Medicinal Plants.
“This investigation needed to be done vis-a-vis the procedures stipulated by WHO and NAFDAC for carrying out Clinical Research on Herbal Therapies which entails TMK (Traditional Medicine Knowledge), literature reviews on the plant’s ingredients, pre-clinical analysis of the therapies, observational studies on human, then the phases of clinical trials (1-4) in order to establish the fact from rumours.”
FG paying lip service
HOWEVER, Minister of Health, Dr Osagie Ehanire, in his remarks at the National Traditional, Complementary and Alternative Medicine (TCAM) held on June 4, 2022, in Abuja, which he made available to The Guardian, said: “Traditional Medicine is all we had in our part of the world, before the emergence of orthodox medicine; and the same goes indeed for all cultures and civilizations, who all have their background in traditional medicine. Orthodox Medicine over time evolved from a foundation of Traditional Medicine in ancient Greece, which is well known by those who studied the History of Medicine.
“Applying scientific tools to this ancient knowledge over countless generations is what yielded Orthodox Medicine of today. Therefore, continued interest and research into Traditional Medicine is the right way to go, for further development of these ancient Arts. There need not be a conflict between orthodox and traditional medicine; we must instead, seek to look into the medical knowledge and skills of our forefathers for greater value addition we can derive from it, in line with the aspiration of this administration, to explore all avenues for Universal Health Coverage.”
Ehanire said the good part of traditional medicine comes from the efficacy found in potions derived from herbs and barks: one example is Quinine, which is derived from tree bark extract used by native medicine practitioners in South America.
“Our country is abundantly blessed with fauna and flora, thousands of which are unique to our environment, and have yet unexplored medicinal properties, which our forefathers harnessed over countless generations, for health benefits to our people. It is of critical importance to begin classification and documentation of this body of knowledge, lest it is lost or degraded over time, due to neglect,” he said.
However, a foremost advocate of herbal medicine in Nigeria and Director of Pax Herbals Clinic in Ewu, Edo State, Rev Fr Anselm Adodo, told The Guardian there is a need for more enlightenment and clarification on the role of government agencies in the regulation, development and verification of herbal medicine.
Adodo said NAFDAC is responsible for the regulation of food and drugs. “This means they ensure that food and drugs are safe for public consumption. However, people often ask, is herbal medicine food or drugs? First, NAFDAC does not regulate agricultural products sold in the local market, such as tomato, pepper, mango, yam, beans etc. However, when these are packaged to be sold in supermarkets and stores, they require its certification,” he said.
Adodo said, on the other hand, pharmaceutical drugs with specific health claims must also be certified by NAFDAC as safe.
He said there is a need for more enlightenment so that the general public and herbal practitioners can be better informed.
“In my meetings with traditional medicine practitioners, they often ask if herbal medicine is classified as food or drugs. There is a need to clear this confusion so that the public is better informed. I have the impression that NAFDAC assumes that their Nigerian clients are uneducated and uninformed, making them treat their clients high-handedly and with little respect. I noticed that when clients from Asia or Europe approach NAFDAC, they are treated with more respect than Nigerians. Of course, this is just part of a general attitude problem among Nigerians, but in my view, it creates a profound lack of mutual respect and trust. People that are privileged to be in an administrative position of authority need be reminded that they are public servants and not ‘public masters’,” Adodo said.
On why FG and NAFDAC are paying lip service to herbal/traditional medicine, Adodo said it is good to acknowledge that there has been a lot of progress in the efforts of the government to officially integrate herbal/traditional/alternative medicine into the national health system. He said the Bill on Traditional Medicine has reached an advanced stage and may soon be passed by the National Assembly. “I commend those working behind the scenes, often with great inconvenience and personal sacrifice, to see that the bill sees the light of day.
Unfortunately, this bill has taken too long to pass due to the Nigerian factor and unnecessary bureaucratic bottlenecks, which have frustrated stakeholders. The reality is that there are many conflicting interests and forces within government circles working for and against traditional herbal medicine. Some are business interests who want to protect their trade, and some feel threatened by the financial effect of a blooming herbal medicine industry on their profession. Some who have been benefiting from the status quo do not want any change in policy, as it will affect them financially. There is so much internal politics of ego and greed, which has resulted in what we now call ‘lip service,” he said.
On whether clinical trials are necessary before approval of natural cures, Adodo said: “I want to make it clear that I am disappointed about the lack of creativity, independent-mindedness and flexibility that characterises the issue of a clinical trial in Nigeria. There are three stages in herbal medicine production. First is the raw materials stage. That is the stage where you simple dry leaves, barks, roots, and stems of plants and use them as teas, infusions, and decoctions. Some of these materials are put into teabags or capsules. Most herbal products in Nigeria are registered and sold in this form. The second stage is the production of crude extracts. This is a more complex process involving removing the fibres and chaff in the raw materials to have a more concentrated and smaller dose of the active ingredients. The crude extract is then put into soft gels or tablets. This makes it easier to determine the activity of the product and control the dosage, but it also means that some of the benefits from the fibre and chaff would have been lost, which does not happen in the first stage.
“We have so many experts in Nigeria who can design clinical trial protocols for the different categories of herbal formulations and drug development based on local realities if our primary goal is to have a good local healthcare system for the people. If we do this, even the WHO will come to understudy what we are doing and learn from it.”
National Chairman, Clinical Pharmacists Association of Nigeria (CPAN), Dr. Joseph Madu, told The Guardian: “My take is that NAFDAC is a regulatory body established by law and mandated to regulate foods and drugs administration and control using some predetermined processes and procedures. Such standard operating procedures for the regulation of packaged foods, devices, herbal products and pharmaceuticals are globally accepted to be in public health interest.
“I do not think that NAFDAC will clamp down on, or discourage local herbal cures despite their efficacy and acceptance. NAFDAC officials do not have such powers but they have veto powers to safeguard the health of the nation.”
He continued: “They may not bother about public acceptance as that does not translate to efficacy or safety, but it is their responsibility to assure the safety and appropriateness of drugs, packaged foods, devices and pharmaceuticals or related products through verifiable scientific methods.
“One thing we usually get wrong in this part of the world is when we see modern medicines approval as a political issue. No, that is not true. There is no space for politics in science.”
Madu said the FG established NAFDAC to regulate foods and drugs administration and control, including herbal products. “If NAFDAC is not living up to expectation, I don’t think we will blame it on the FG, except if the FG does not release the needed support such as funds to NAFDAC. This can affect the work of the federal parastatals including NAFDAC.
“However, it is important to note that NAFDAC cannot just approve a product just because it is allegedly discovered by a Nigerian professor, or because of its public acceptance. This is because even a placebo can be claimed to be effective in curing disease in the eyes of the public,” he said.
The pharmacist said clinical trials are necessary before the approval of all drugs including herbal remedies.
To him, a research institute, university; pharmaceutical companies, states Federal Government or even individuals could sponsor the trials. Madu said it is not the duty of NAFDAC to sponsor clinical trials, except the management picks special interests to do so.
ON what FG and its agencies like NAFDAC should do, Adodo said: “If the FG is serious about the development of herbal/traditional medicine. The time is ripe to have a specialised agency or an independent unit within NAFDAC to focus on regulating herbal medicines: both the practice itself and the products need to be regulated. This means that the practitioners, the products and herbal clinics/centres are to be licensed. There are three aspects to this regulation: The practice/discipline itself, that is, the herbal practitioner, then the product, that is, the herbal medicine, and then the herbal clinic, the place where the sick is attended to.
As you can see, such a unit or agency will work with primary health care centres in the ministry of health in every state, especially in the local governments, with the Nigeria Natural Medicine Development Agency (NMDA), and the Nigeria Institute of Medical Research (NIMR). These are my personal opinions as one who has been fully involved in practising and developing traditional medicine for over 23 years. Therefore, herbal medicine regulation deserved a separate and independent agency.”
He said the way forward, towards fast-tracking the development of novel herbal cures like IHP tea for the benefit of Nigerians is for the government to effectively fund research institutes such as the National Institute for Pharmaceutical Research and Drug Development (NIPRD), as well as universities.
“Individuals who are wealthy can also be encouraged to sponsor research in the development of our herbal remedies,” Madu said.
The clinical pharmacist said NAFDAC too cannot be exonerated and should encourage the development of homemade remedies, as some of them have been found to be effective, safe and efficacious.
He said it is the duty of NAFDAC to ensure that all the necessary parameters are investigated. “For instance, a product may be able to cure a disease but may not be safe when used in certain categories of persons such as pregnant women, the elderly, breastfeeding moms or children.
“The case of Thalidomide, which led to limb deformities in children born in the 1960s is still fresh in the eye of the world. Some products may also not be efficacious when combined with other remedies or foods, or when used in certain comorbid conditions. All these and many more must be fully cross-checked before approval of a drug for use in humans,” Madu said.