By Prof. Olobayo O. KUNLE
The ongoing pandemic has been exceptional in many ways especially in providing us with the kind of time that we could only have dreamt of due to the lockdown by various governments. This has brought out the ingenuity and rekindled the innovative spirit in many of us. The suddenness and novelty of the situation has thrown every assumption and calculation out of the window.
Even countries with the most beautifully laid out emergency response plans and robust health systems have been fazed by this once-in-a-generation pandemic. Suddenly references to 1918 seem like talking about yesterday while incidents from the 16th and 17th centuries look like not so long ago. So with all of our technological prowess and unbelievable advances in science and technology, pictures of masked people walking through the world’s major cities look almost indistinguishable from those of people in the same situation over a century ago. A stark reminder that we are still basically human after all, as dependent on air as always.
After being blind-sided by the disease, scientists all over the world have been revving their intellectual and technological engines to fight the virus and the complications resulting from its disruption of human physiology. Although work is ongoing on the development of new drug molecules, drug repurposing and vaccine development form the major thrust in the fight against the virus. There is no doubt that although our lives and our world as we knew it before COVID will not return, man will eventually get a handle on this disease by taming and managing it, or completely defeating it by eradicating the virus.
Africa, just like the rest of the world, has been active in the fight against COVID. Coming from the positive examples of China, the continent has sought to leverage on its comparative advantage in terms of indigenous knowledge and diverse flora to develop interventions against the disease.
I am convinced that, as a general principle, nature, embedded in the flora has the solution to most of mankind’s physical ailments. There is therefore the strong probability that there are plants that harbour the secret to defeating COVID.
Probably because of this realisation, a number of Nigerians have made claims to having herbal preparations for the treatment and even cure of COVID. These claims have come from a diverse group ranging from health professionals, academics, Traditional Medicine Practitioners to those without any background in drug development. While some of the claims are made in the conventional media, others are in the social media while a large proportion are by word of mouth.
In discussing these claims, a peculiarity of phytomedicines must be borne in mind. As a general rule, while nature’s destructive forces are deployed rapidly and with high intensity (as in earthquakes and volcanic eruptions for example) it does not hurry in building or creating. It builds systemically, generally slowly but almost always perfectly. Look at the 40-week gestation period for the human embryo for example or the length of time it takes to build an anthill.
Flowing from this the medicinal value of plants tend to be seen or achieved over a period of time – slow and steady. This is why they are most beneficial when used consistently over a period as happens in disease prophylaxis or consumed as food. This is what our cultural practices over time systematized through diet, exercise and some religious practices. The result of this is a strengthening of body defences against attack. This can be attributed to the usually very low levels of the medicinally active principles in plants.
The present flurry of claims for the treatment of COVID is akin to the situation in the early days of HIV/AIDS about thirty years ago. The public space was awash with claims. And there were people who, considering the disease a death sentence and the absence of any approved treatment, were ready to try anything to be healed of the disease. Times such as this, are times when it will be easy for charlatans to exploit the natural anxiety of humans to do all within their power to preserve health and life. A case of try something before COVID gets you.
Interestingly in the case of HIV/AIDS, phytomedicines and other indigenous interventions lost out when the dust settled and the panic was gone. Today about two decades down the line, in spite of the many claims at the time, there is no local medicine that is widely recognized and used either within or outside the country for the treatment of HIV/AIDS. Rather we import ARVs (antiretrovirals) at great financial cost.
In approaching and managing the claims currently being made with respect to COVID, we must avoid the pitfalls of the HIV era.
One important thing we must ensure in all that we do in dealing with this disease, is that a claim of therapeutic activity can only be made based on facts. Such facts are universal and must be based on principles that are acceptable to the targeted audience or consumers of the product to be developed. We must think global if we want the end products of our endeavour to be global.
This implies that we should decide upfront, if our claimed herbal interventions are for our individual use, our family and friends, our immediate community, the country or the world at large. My understanding with the various pronouncements that have been made in the past few weeks is that the claimants are pitching their products/preparations to all Nigerians at the minimum and eventually the international community. If so, we must think national and eventually global.
It will then be self-defeating to continue to ridicule the application of universally accepted principles of systematic investigation and data generation. We should be conscious of the fact that nobody will ask for verification or generation of data for the very delicious soup that you make in your house as long as it is provided for you and your family. However, when you want to give to my family or claim its superiority over the one made in my house, the issue of standardization based on agreed parameters for ascertaining your claim will arise. There is therefore no doubt that if we want our herbal products to be acceptable to others, we must accept for them to be assessed. Claims of efficacy cannot be by patriotism or strength of conviction or faith as in religion. It has to be based on verifiable and reproducible facts.
There is a general perception that the requirements for claim verification and standardization of medicines are created to disadvantage products from Africa or Nigeria. This position misses the fact that each country develops its own guidelines which it could decide to align with those by international bodies such as the WHO for universal acceptability. Even then, such international bodies, staffed by nationals of different countries, including Nigeria (a Nigerian was at one time the Deputy DG of WHO) use committees of experts from different countries and backgrounds to develop their guidelines. Such guidance documents are circulated amongst relevant stakeholders for comments and eventual ratification. I am also aware that NAFDAC used a similar approach in developing its current guidelines for the registration of herbal medicines. It should be clear that the verification and registration of herbal preparations for COVID or any other disease condition for use in Nigeria is based on the guidelines provided by NAFDAC and not WHO or any other external body. If there are problems with the process let us therefore look within.
The current guidelines for the registration of herbal medicines (available on the NAFDAC website), I am aware, were developed to deliberately make it easy for claimants to meet the conditions. The conditions for listing only requires that the preparation be assessed as safe for human consumption either by evidence of long history of safe use by humans or the results of laboratory studies. In addition, it requires the provision of evidence that the herbal preparation as presented (formulated) will remain stable and safe for the period specified by the producer as the shelf life (expiry date).
In addition to being simple enough to be quickly met by claimants, I am also convinced that these are necessary steps to protect the health of Nigerians who will ultimately consume the product. As a consumer, I need to know that the products presented to my family and I are safe and that if I store them as directed by the manufacturer it will remain safe.
Of course, additional conditions would need to be met if the claimant wishes to get the regulatory authority’s stamp of approval that the preparation works for COVID. This will include detailed chemistry and comprehensive safety profiling especially if any processing of the material that might change it from its natural state is involved. Other assessments are effectiveness and efficacy studies like animal studies and clinical trials. Clinical trials are simply tests conducted in an organized fashion to determine the safety and efficacy of a preparation in humans who have willingly accepted to be used as subjects. It is the only test that definitively establishes the efficacy of a drug and must be done sooner or later for a product to be widely accepted for use.
While the general mood of the public is that the onus for all of the foregoing should be borne by government or public institutions, the truth is that “he who claims proves” so any claimant should be prepared to prove his claim. Of course, I am aware that cost is a major issue at some point, but I believe that that notwithstanding, the principle should first be made clear.
Getting a product listed is relatively cheap and can be afforded by a majority of the claimants. Going for full registration with specific therapeutic claims would necessarily be quite expensive. To deal with this, I will suggest that the claimant should use the basic information based on which he has made a claim to find willing investors to partner with in the development of the phytomedicine. This will require being realistic that while the initial impetus for the claim or discovery might be altruistic, most claimants hope to eventually make a business out of the claim.
In addition, considering the challenges of our economy and the all-pervasive role of government in its management, an innovation fund should be provided to develop claims that have scaled preliminary but sound testing up to the point of full registration.
The process of getting a product accepted, registered and used in mainstream healthcare whether in Nigeria or any other part of the world cannot be by a vote of the majority of the populace but by following laid down and sound assessment procedures. This is because no health care provider will take the risk of administering a product (whether herbal or synthetic), that has not been guaranteed using universal principles known to him, to his patient.
Let me end by reiterating that drug development, be it herbal or synthetic is a painstaking process. This is justifiably so, as it is critical to ensure that these products that are used by already compromised people, in some cases facing life or death situations, do no harm and in fact improve their health situation. If we must have products that will be acceptable internationally, we must be ready to use universal procedures and accept that faith and patriotism will not get us there. We cannot expect equal recognition for our products while hoping to use unequal standards. Plants already give us a head start, lets press that.
▪ This piece by Prof. Olobayo was first published on www.kaftanpost.com. He is a professor of pharmaceutical technology with the National Institute of Pharmaceutical Research and Development (NIPRD), Idu, Abuja.