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Since the beginning of life on earth, diseases have existed. They emerge and multiply according to environmental changes and complications over time, especially bordering on social or group conducts, physiological behaviours and sanitary conditions, in the case of humans and animals, environmental conditions, soil contents and agricultural practices, in the case of plants. There are more numerous causes of diseases than have so far been discovered. Diseases are not known until they emerge, and as they do so, scientists research into them to determine their causes and manufacture their cure. Many, perhaps most, diseases ravage life for a very long time and on a frightening scale before their cures are found. Some of such diseases have existed for ages, yet their specific cures have either not yet been found or they have just been found, but they have not been sufficiently tested and applied to determine their efficacy and safety according to the rules of medication. Such diseases prominently include Sickle Cell Anaemia or Sickle Cell Disease (SCD), which has claimed umpteen lives without any specific cure until very recently. “I also lost a very close friend and classmate to the disease when we were in the secondary school five years ago. He was the son of Justice Abdul Aboki, a judge of the Kano State High Court,” Jamilu Mohammed, a resident of Garki, Abuja recalled, saying, “We used to address him simply as Daddy and I can still recall that whenever it struck him, the colour of his eyes would change to blue, he would be weak and portions of his body would develop some rashes. Some sicklers have swollen body. Daddy died at the age of 20.” In the United States, it is called the African-Americans disease or poor men’s disease. Every other place in the world, it is called Sickle Cell Disease (SCD) or Sickle Cell Anaemia. Sickle Cell Disease is found to be on the scale of front row serious killer ailments such as cancer and HIV/AIDS. Most sicklers, especially in most African communities, shy away from public exposure. Currently, between 14 million and 16 million people are said to be suffering from the disease worldwide. Out of this number, 10 million are in Africa, which includes the four million in Nigeria. Sickle Cell Disease, according to scientific research, is a genetic blood disorder caused by a point mutation on the globin chain of the haemoglobin molecule.
The disease causes the production of abnormal haemoglobin which contains portions that stick together after the release of oxygen. These result in the production of stiff, abnormally shaped red blood cells, which do not flow freely through the blood vessels. The sickle shaped cells create clogs in the blood vessels, which prevent the flow of normal hemoglobin and oxygen around the body. The situation results in severe pain or “crisis,” ulcers, blindness, organ and tissue damage and breakdown, which eventually leads to stroke, especially in young infants, and acute chest pain. Research in the field warns that repeated crisis can also result in damage to the kidneys, lungs, bones, eyes and central nervous system. The most feared complication for children with the disease is stroke, which is said to affect infants as young as 18 months. Many children with the disease do not survive infancy or early childhood. Some scientists say patients below the age of 20 are at higher risk of death than those above that age. Adults with SCD, the research reveals, often experience a reduction in quality of life due to severe physical problems such as pain, hard-foot syndrome, acute lung complications that can result in death. Further, frequent episode of severe pain, crisis and hospital admissions, significantly affect the lives of the patients of the disease by limiting their ability to participate in normal activities. The socio-economic and psychological implications are that it consequently retards their economic and social advancement, deprives them of joy of living life to the fullest and instilling the fear of early death in them. Researches into blood groups have shown that persons in the SS blood group are both patients and carriers of the disease, those in the AS blood group are only carriers, while those in the AA blood group do not have it at all. So, in a married couple, if both the husband and wife belong to the SS group, the children they would bear would also be in the SS group, completely patients of the disease. If a member of the couple belongs to the SS group, while the other belongs to the AS group, there are higher chances that more of their children would belong to the SS. If both members of the couple belong to just AS, most of the children could be in the AS, while some could be SS members. A wholly AA group couple’s children would be safe from the disease.
This situation tends to encourage blood test before marriage is contracted by a couple. Until very recently, there was no known specific drug for its cure. Every where in the world it is treated with either traditional medicines or, in the orthodox medical practice, with drugs meant for other ailments, which have some symptomatic similarities and effects with it. In the United States, for instance, a drug called Hydroxyurea (HU), used for the treatment of cancer, was also used for sickle cell disease. This drug, which is the only one approved for the treatment of the disease, is however, very expensive and found to be toxic, and patients treated with it exhibit severe side effects. So, it is said that there has not been any specific drug for the cure of sickle cell in the market, the world over. In July, 2002, Xechem International Inc., a US-based pharmaceutical company, signed an agreement with the National Institute of Pharmaceutical and Research Development (NIPRD) for the research, development, production and worldwide sales and marketing of NICOSAN, said to be the only known cure for the disease now discovered. Before then also, another known cure is said to be a bone marrow transplant to replace defective red blood cells with donor healthy cells. Under this process, treatment has generally consisted of supporting therapies, which includes folic acid, anaemia, penicillin to prevent infections pleumococcal and influenza vaccination, pain killing drugs and intravenous injection fluid. NICOSAN, according to the researchers at NIPRD, is a non-toxic herbal product composed of extracts from tropical plants, each of which is said to be indispensable in the manufacturing of the drug. It is said to have undergone clinical trials conducted in Nigeria by NIPRD and laboratory testing among others by the National Heart, Lung Blood Institute and the Sickle Cell Disease Reference Laboratory at the Children’s Hospital in Philadelphia, U.S.A. Results of these trials are said to have shown that the drug drastically reduced the degree of sickle cell formation, and the frequency and severity of SCD crisis, liver and kidney functions remained normal and patients gained appreciative weight. The clinical studies showed that the drug is an efficacious phytomedicine for the management of SCD. How was the journey to the advent of NICOSAN? In August 2001, the Minister of Science and Technology, Professor Turner Isoun, had led a high profile Nigerian government delegation, comprising, among others, top government officials and scientists, to the United States to sign an agreement between Rutgers University and the Government of Nigeria in the area of Biotechnology. The delegation visited Xechem International Inc. and, consequently, invited its founding chairman and chief executive officer, Dr. Ramesh C. Pandey, for further development and the production of the drug developed by the NIPRD scientists. The drug, as developed by the NIPRD, is a natural herbal preparation coming from Nigerian folklore. Late Reverend Paul Ogunlaye, who was a pastor of the First Baptist Church in Oyo State in 1992, was said to have brought the drug in the form of a herbal recipe to the attention of the former Director General of NIPRD, Professor Charles Wambebe, and his team of researchers at the institute. The institute further researched into it with the financial backing of the Nigerian government and the World Health Organisation (WHO). The research included looking into how the folklore was doing it – mixing and grinding this and that herb, and then producing a decoction that can be given to the sicklers. In the western world, medicinal herbal preparations are called food supplements or, very recently, alternate medicine, not drugs. In China, they are called Chinese traditional medicine. “When I returned to the US and found that there is no drug for it in the market, I got more interested. Then I looked into the present population of those suffering from it in the US, and I found out that it was just between 80,000 and 90,000, who, probably, may have migrated from African countries. There population was concentrated in the US in the areas where there is malaria,” Dr. Pandey revealed. In the United States, genetic and pre-birth screening is said to have drastically reduced the incidence of the disease in recent years. Apart from the over 80,000, an additional two million Americans carry the sickle cell trait. Although NIPRD had done some clinical trials – phase 1, 2A, 2B and placebo-control trials were done by Nigerian doctors and scientists, those data were not accepted overseas. To make the data and, subsequently, the drug, acceptable internationally, it is said that Xechem obtained the required Orphan Drug Designation from the US Food and Drug Authority. A similar designation was granted the company in Europe to cover all 25 countries of the European Union. Now there are five hospitals in the United States, including Children Hospital and Thomas Jefferson Hospital, both in Philadelphia, Sunny-Brooklyn Hospital in New York and Howard University Hospital in Washington DC for the application of the drug towards acceptability. NICOSAN was licensed with the government of Nigeria on 18th July, 2002. The raw materials and its sources are all said to be within the country, although future international market demand could require growing and obtaining more material from overseas. The drug may be launched as soon as the National Agency for Food and Drug Administration and Control (NAFDAC) approves it. “We are looking into the issue of counterfeiting, but I can’t tell you anything specific on that now, admitted Dr. Pandey, explaining, “First, we will make it a prescription drug. So we will know what is going on and how much of it is going out of the company. We may have some pharmaceutical stores to suggest the bulk purchasers. Counterfeiting has been brought to our attention by many people, but we are looking into how to stop it from happening to us.” The researchers believe that with the advent of NICOSAN, Sickle Cell Disease may soon be removed from the class of ailments having no specific drugs to cure them anywhere. As Sickle Cell Anaemia takes its toll on the human race, the global public awaits the efficacy of this drug, its standard maintenance, the height of its safety profile, its broad spectrum capacity and its affordability to patients of the disease who, perhaps, may never have hoped for any specific cure in the near future. That is if it proves itself to be the cherished specific cure for the disease. |