Monday, 6 October 2014

EBOLA

IT has been touted as the future of medicine and the last hope of the common man. It is tested, trusted and cheap but not without limitations. It is a goldmine, through which countries like China, India and United States are raking in billions of dollars annually.     
     Industrialized countries such as Australia, France, Germany, and the United States are not left out. There is a growing recognition of the important role that traditional medicine plays in their overall health care. Countries like China and India have integrated traditional medicine into their healthcare system and complimentary medicine. 
     In fact, traditional has since been endorsed by the World Health Organisation (WHO). Medicinal plants have played a key role in the world health care with about 80 per cent of Africans depending on phytomedicine which has shown a wide range of uses in the treatment of diseases, especially priority diseases of Africa such as Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), malaria, sickle cell anaemia, diabetes and hypertension. 
       The usage of plants, plants extracts or plant-derived pure chemicals to treat disease in Nigeria has become a therapeutic modality, which has stood the test of time. Today, several pharmacological classes of drugs include a natural product prototype.
      According to Wikipedia, Traditional African medicine is a holistic discipline involving indigenous herbalism and African spirituality, typically involving diviners, midwives (Traditional Birth Attendants), and herbalists. 
      Practitioners of traditional African medicine claim to be able to cure various and diverse conditions such as cancers, psychiatric disorders, high blood pressure, cholera, most venereal diseases, epilepsy, asthma, eczema, fever, anxiety, depression, benign prostatic hyperplasia, urinary tract infections, gout, and healing of wounds and burns.
       Diagnosis is reached through spiritual means and a treatment is prescribed, usually consisting of an herbal remedy that has not only healing abilities, but symbolic and spiritual significance. 
      Traditional African medicine, with its belief that illness is not derived from chance occurrences, but through spiritual or social imbalance, differs greatly from Western medicine, which is technically and analytically based.
       In the 21st century, modern pharmaceuticals and medical procedures remain inaccessible to large numbers of African people due to their relatively high cost and concentration of health centres in urban centres.
      Indeed, traditional medicine has become a catchword among the peoples in all countries in Africa. This has been due partly because the use of herbal remedies has gained popularity worldwide and the exploitation of these remedies has become a multimillion industry. 
       At the Alma Atta Declaration of 1978, it was resolved that traditional medicine had to be incorporated in the health care systems in developing countries if the objective of the “Health for All by the Year 2000” was to be realized.   
       The Declaration of Alma-Ata was adopted at the International Conference on Primary Health Care (PHC), Almaty (formerly Alma-Ata), Kazakhstan (formerly Kazakh Soviet Socialist Republic), September 6 to 12, 1978. It expressed the need for urgent action by all governments, all health and development workers, and the world community to protect and promote the health of all people. It was the first international declaration underlining the importance of primary health care. The primary health care approach has since then been accepted by member countries of the WHO as the key to achieving the goal of “Health For All” but only in third world countries at first. This applied to all other countries five years later. 
      Notwithstanding this strategy, African countries did not come near the objective at the end of the 20th century. Therefore, the Member States of the WHO African Region adopted a resolution in 2000 called “Promoting the role of traditional medicine in health care systems: A strategy for the African Region”. This strategy provides for the institutionalization of traditional medicine in health care systems of the member states of the WHO African Region. 
        Furthermore, the then Organisation of African Union (OAU) now African Union (AU) Heads of State and Government declared the period 2000 - 2010 as the African Decade on African Traditional Medicine. 
        The strategy aims to build the knowledge base for national policies and strengthen quality assurance, safety, proper use and effectiveness of traditional and complementary medicine through regulation. It also aims to promote universal health coverage by integrating traditional and complementary medicine services into health care service delivery and home care.        
      In addition, the Director General of the WHO also declared August 31 every year as African Traditional Medicine Day. Also, the 2014 World Health Assembly (WHA), in May, approved WHO’s traditional medicine strategy 2014 to 2023. 
      Indeed, all these declarations signify the importance and the approval by governments and international institutions of the need to institutionalize African traditional medicine in health care. 
      In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) is championing the development of traditional medicine with a persistent call for the integration and collaboration between orthodox and traditional medicine practitioners.
     NAFDAC, by the establishing Decree 15 of 1993 as amended, [Act Cap N1, Laws of the Federation of Nigeria (LFN) 2004, is mandated to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs including herbal medicines, medical devices, cosmetics, chemicals and packaged water.
     It is mandatory that herbal medicines be registered in accordance with The Drugs and Related Products (Registration etc.) Decree 19 of 1993, now Cap F33, LFN 2004.
     Consequently, stakeholders in traditional medicine practice in Nigeria including NAFDAC, the Nigeria Institute of Pharmaceutical Research and Development (NIPRD) and the National Association of Nigerian Traditional Medical Practitioners (NANTMP) have called for the institutionalization of traditional medicine into mainstream healthcare delivery systems to tackle deadly diseases such as Ebola Virus Disease (EVD), cancer, diabetes, among others.
      The stakeholders last week at a one day press conference/exhibition, in Lagos, to mark the 2014 African Traditional Medicine Day said with the rising disease burden the continent is facing, there is the need to strengthen the collaboration between both practitioners in order to forestall infectious and non communicable diseases. 
     The experts at the programme organized by NAFDAC said better disease control could be achieved by exchange of information on management of illnesses, materials and technology used in preparation and dispensing. They said it also involves stressing complementary of both systems by referral from one health system to another.
     They appealed to stakeholders in healthcare delivery system that is the Traditional Medicine Practitioners and Convectional Medicine Practitioners (TMPs and CMPs) to collaborate with each other as this would yield positive returns especially in the area of disease control. 
      The theme for 2014 African Traditional Medicine Day celebration is “Collaboration between Traditional Medicine Practitioners and Conventional Medicine Practitioners.” 
         It underscores the World Health Assembly resolution on medicinal plants; the Regional Strategy on Traditional Medicine; the Plan of Action on the Organization of African Unity Decade (2001–2010) for African Traditional Medicine; and the United Nations Convention on Biological Diversity. 
        The adoption and ratification of these policy frameworks by countries of the Region has placed the conservation, rational and sustainable use of medicinal plants in the arena of public health.
     However, the federal government through the federal ministry of health had intensified efforts towards the development of traditional medicine with the integration of herbal medicine into the curriculum of medical schools in the country.
    Minister of Health, Prof. Onyebuchi Chukwu, had also set up several committees to facilitate the integration of traditional medicine into the mainstream of healthcare delivery. 
      Chukwu said that herbal medicine would be introduced as a course of study in Nigerian universities. He admitted that herbs were efficacious in the treatment of malaria, but noted that it needed to be studied as a course in the university.
      The minister contended that for herbal medicine to be accepted and integrated in the treatment of malaria, the practitioners ought to study science courses.
     He listed the subjects as Physiology, Anatomy, Pharmacology, Chemistry, among other subjects.
     “It is only after studying these courses that herbal medicine practitioner can effectively diagnose and treat malaria and other health problems,’’ he said.
      Chukwu said the inability of herbal medicine practitioners to scientifically diagnose diseases posed a great challenge toward the acceptability of herbs for disease treatment.
     He said the Nigerian Institute of Pharmaceutical Research and Development was already carrying out a research on the efficacy of herbs in the treatment of ailments.
     The minister further said that NAFDAC would also have to carry out a test on herbs to further ascertain their medicinal efficacies.
     He charged herbal medicine practitioners to submit their herbs to NAFDAC for scientific test.
       Director General of NAFDAC, Dr. Paul Orhii, in his statement on the occasion of the African Traditional Medicine Day 2014 said this year’s theme is in line with the Traditional Medicines Strategy 2014 to 2023 of the WHO. 
      Orhii said this new strategy focuses on three strategic sectors: to build the knowledge base around Traditional Medicine and Complimentary Medicine (T&CM) through appropriate national policies; strengthen quality assurance, safety, proper use and effectiveness of T&CM by regulating these products, practice and practitioners; and promote the universal health coverage by integrating T&CM services appropriately. 
       Orhii who was represented by Director of Laboratory Services, NAFDAC, Mrs. Stella Denloye, said about 80 per cent of the population in developing countries and the African Region use traditional medicine for their PHC needs. 
      He said despite this high patronage, traditional medicine is often stigmatized by the practitioners of conventional medicine, so much so that in some countries it is even illegal to practice it. 
      Orhii, however, said with the global resurgence of interest in traditional medicine and increasing need for expanded health care, there is the need to institutionalize traditional medicine in the health systems worldwide including Nigeria.
       Orhii said regulation is the key to ensuring that only good quality, safe and effective traditional/herbal medicines are available to consumers especially if T&CM is to be integrated into the nation’s healthcare system. 
       He commended the efforts of TMPs whose products are listed with NAFDAC including those who legitimately market and distribute their products in Nigeria.
     Orhii said for successful implementation of the aspects of the mandate relating to herbal medicines, the Agency in collaboration with other stakeholders has established regulations, standards and guidelines for regulation of herbal medicinal products in Nigeria; a National Committee to advise the it on herbal medicinal products; and an Expert Committee on Verification of claims by Herbal practitioners. 
       Orhii commended the effort of this committee on progress made thus far.  “Guidelines for the Verification of Claims of Herbal Medicines in Nigeria have been adopted while eight products have been approved for the verification exercise,” he said.
      Orhii said NAFDAC is in constant discussion with stakeholders to ensure compliance and the Agency has banned illegal advertisements of herbal products and bogus claims of cure for disease states whose advertisements contravene section 2 of the Food and Drug Act (Cap 150), which controls and regulates advertisement.
      Orhii warned unpatriotic Nigerians who continue to engage in illegal advert of their products in National TV/Newsprints and those making claims not evaluated by NAFDAC thereby misleading the unsuspecting public to desist because NAFDAC would deal decisively with anyone found to contravene.
     He appealed to the print and electronic media to help the Agency address this anomaly. “The media has a role to play and a responsibility to the Nigeria public. Therefore, insist to see a NAFDAC approval before publishing or airing any advert from the Traditional Medicine Practitioners,” he said. 
     A professor of medicine at the College of Medicine University of Lagos (CMUL)/Lagos University Teaching Hospital (LUTH) and an advocate of traditional medicine, Prof. Adebukola Adefule Ositelu, delivered a paper titled “Collaboration between Traditional and Conventional Medicine Practitioners.”
    Ositelu who is also a consultant ophthalmologist said if traditional medicine were not existing the Whitemen would not have met anybody alive in Africa. “I am standing here today still alive all because of traditional medicine. I declare to the glory of God because he is the one that planted all these things,” she said.
     Ositelu said 61 per cent of 877 conventional drugs of choice could be traced to natural medicine.
      She said that she had discovered a very efficacious drug for glaucoma and cataract from bitter kola (Garcinia kola, orogbo in Yoruba and akuilu in Ibo). “The solution is what I am using for my eyes,” the professor said.
     Ositelu urged NAFDAC to go to the universities and collate all the researchers have been able to achieve in terms of local studies on natural products and develop them into helpful drugs.
     The professor said the major challenge towards the development of traditional medicine in Nigeria is that the practitioners are afraid to disclose their secrets because they fear people might steal them. She also blamed lack of organization and coordination among practitioners and regulating agencies, dishonesty, poor funding and inferiority complex. “The solution for Africa is in Africa not in America,” Ositelu said. 
        She said jute botanically called Corchorus olitorius (Ewedu in Yoruba), prepared and taken according to directives has been revealed to prevent and possibly, cure the deadly Ebola virus.
     Ositelu also alleged that the popular United States drug for treating Ebola virus, ZMapp, was made of bitter kola.
      Previous studies by Nigerian and British researchers had confirmed that high intake of local vegetables could prevent, correct or treat health disorders such as diabetes, cancers, arthritis, obesity, high blood pressure, haemorrhoids/pile, gallstones, stroke, among others.
        Ositelu said that because of the mysterious nature of the disease, of which has been established came to humans through the consumption of bush meats, some group of people went into prayers and got divine remedy to the disease.
   According to her, “normally, most of us down the south of this country don’t eat Gorillas, bats and Monkeys. This became worrisome to us how we can contract this disease transmitted through these animals whereas; we do not consume them and we do not go around with them because they are not pets. 
   “So, some group went into prayers; a particular one went into reservation to pray and after praying, something was released. The remedy is: take a good quantity of Ewedu, rinse and wash it with liquid vinegar, blend it and cook only with drinkable water for five minutes. Then, first thing the next morning, freshly made, just take 25cl of the herb in an empty stomach once a week for prevention. For cure, take it daily for five to seven days.”
   Reacting to a question whether the herbal concoction has been tested and confirmed with any patient, the furious Ositelu said: “We have everything here in the country but the only problem we have is that we don’t make use of them. When we discover something, people don’t care and take it seriously. We look down on ourselves so much and we don’t value whatever we have. 
      “They are doing experimental test of the drugs they invented abroad from our bitter kola and they are using it. It is only here that we want to prove and make things difficult for ourselves. This is a release by God to His people and if you want to take it, good, if you don’t want, it’s left for you. There is no room for argument because the wisdom of God transcends other things.”  
     President General National Association of Nigerian Traditional Medical Practitioners (NANTMP), Prof. T.O. Omon Oleabhiele, said traditional medicine is a goldmine, which should be tapped as foreign exchange earner. He said traditional medicine could surpass crude oil revenue if well harnessed. “It will give employment to the youths,” he said.
      Oleabhiele advised members to report any suspected Ebola case because their collaboration will help save lives.
      He further stated: “I thank the federal government through NAFDAC for all the efforts being made to reform traditional medicine into an organized sector. In the past there use to be talks on how to develop traditional medicine but there was however little or no action. Today the reverse is the case. Today all the practitioners are feeling the action by NAFDAC.
    “I therefore use this opportunity to commend the federal government in combating the Ebola virus disease and on the constitution of a committee to investigate herbal cure. This shows the sincerity of government to develop herbal medicine.
    “…We are convinced that with Dr. Paul Orhii in the forefront of the development of Traditional Medicine, at last we are being taken to the promise land.”
       On the role of NAFDAC in the collaboration between traditional medicine and conventional medicine practitioners, Director, Drug Evaluation and Research Directorate NAFDAC, Mrs. Titi O. Owolabi, said: “Since the early 1970s, the WHO has repeatedly advocated for the recognition of Traditional Medicine Practitioners as PHC providers and for the integration of traditional medicine in national health systems. Given the increasing popularity of traditional medicine globally, it is imperative that medical and other healthcare personnel collaborate with Traditional Medicine Practitioners to understand traditional medicine practices and products. This is important for two reasons.
    “First it is important for health personnel to have an understanding of all the health services their patients may be accessing. Secondly, health personnel especially general practitioners, nurses and pharmacists are often used by patients as information source for all health and related issues. An understanding of traditional medicine will enable them advice patients appropriately.
     “NAFDAC’s role in the collaboration between TMPs and CMPs is basically in the regulation of the products manufactured, sold or advertised for diagnosis, treatment, mitigation or prevention of any disease, disorder by either of these groups of practitioners. NAFDAC provides adequate information to TMPs, CMPs and consumers.
     “NAFDAC facilitates a functional collaboration between THPs and biomedical researchers that is required for the validation of the claims ofTMPs. Such collaborations will facilitate the assessment of the quality, safety and efficacy of the plant raw materials and the finished medicinal products.”
      Why are herbal medicines regulated? Owolabi who is also a pharmacist said: “To perform NAFDAC’s Primary objective of protecting and promoting public health through the performance of statutory regulatory and control functions and activities on regulated products including herbal medicines and to ensure that only good quality, safe and efficacious herbal preparations get to the market.”
     On the role of NAFDAC in regulatory control in herbal medicines, Owolabi explained: “NAFDAC sets standards and appropriate guidelines for production, listing and registration of herbal medicinal products. Guidelines for listing of herbal medicines define basic criteria for the evaluation of quality, safety and efficacy of herbal medicines.Assessment of the Good Manufacturing Practice (GMP) and Good Hygiene Practice (GHP) of herbal medicinal products’ manufacturing sites is carried out by the Drug Evaluation and Research Directorate (DER).
     “GMP is a quality system that ensures product are consistently produced and controlled according to quality and safety standards appropriate to their intended use as required   by the product specifications. 
    “The GMP and GHP assessment of herbal medicine factories reduce the adverse risk of unsafe, poor, quality herbal medicine and to build in safety and quality into the production process and eliminate contamination. 
     “NAFDAC performs acute toxicology test as a safety parameter for simple herbal medicinal preparations
     “Registration / licensing of regulated products (herbal medicinal products inclusive) is an important tool by which NAFDAC controls the manner in which these products are imported, manufactured, exported, advertised, distributed, offered for sale or used in Nigeria.  The Registration and Regulatory Affairs Directorate of NAFDAC coordinates the registration of herbal medicines in Nigeria.
     “NAFDAC grants listing registration status which is valid for two years to herbal medicinal products and five years for full registration with prove of efficacy from clinical trial studies.”
     She said herbal medicinal products to be considered for registration or listing are categorized as: herbal medicinal products manufactured locally; imported herbal medicinal products; and homeopathic herbal medicinal products. 
      Owolabi said NAFDAC does not register extemporaneous preparations that is, preparations that are made by the practitioner and given to the patient on a one-to-one basis within the locality of its preparation.
      She said NAFDAC has put in place guidelines to ensure that herbal medicinal products are advertised within the provisions of the law and that it should be noted that Registration of a herbal medicinal product does not confer advertisement permit. 
     The pharmacist further explained: “A separate approval by the Agency shall be required if the product is to be advertised.  NAFDAC may also withdraw the certificate of registration in the event that the product is advertised without express approval of the Agency. 
     “NAFDAC stipulated that all herbal medicinal preparation meet labelling, safety, quality and purity in order to be registered by NAFDAC.
     “Although the claims of herbal medicines in Nigeria market have not been evaluated by the regulatory body NAFDAC hence the mandatory disclaimer notice       “These claims have not been evaluated by NAFDAC which must be on all listed herbal medicinal product. 
    “National Expert Committee on the Verification of Claims for Herbal Medicines has been set up to verify the claims of herbal products.
     “Eight products are being listed for the 1st phase of the verification exercise. 
    “NAFDAC has intimated the stakeholders on its intention to upgrade the status of listed products to full registration for products with proven efficacy through extended safety evaluation.”
      Owolabi explained: “The role of NAFDAC in the regulation of herbal medicines cannot be over emphasized as it is important for all producers to adhere to these guidelines in listing of herbal medicines for the safety of Nigerians
      “The effective regulation and control of herbal medicines requires close liaison with appropriate national institutions that are able to keep under regular review, aspects of production and use, as well as evaluative studies of the efficacy, toxicity, safety, acceptability, cost as in other drugs used in modern medicines.”
     A paper published in Research Journal of Pharmacology recommended teamwork amongst ethnobotanists, ethnopharmacologist, physicians and phytochemists as a must for the fruitful outcome on medicinal plant research.         
       The author, Ekeanyanwu Chukwuma Raphael, said although, there are some problems limiting the development of phytomedicine such as lack of standardization, efficacy and quality control of plants used, extinction of some plant species and lack of funds and others; these problems when fully addressed will help the future development and harmonization of phytomedicines.
    The paper is titled “Traditional Medicine 

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