PLUS

Prior to the presentation of the diabetic foot ulcer drugs, Heberprot-P at Garki Hospital in Abuja, the Cuban Ambassador to Nigeria, Carlos Trejo Sosa, noted that Nigeria can become a point of reference in West Africa with the application of the novel drugs. The Medical Director of NISA Premier Hospital, Dr. Ibrahim Wada and the Cuban expert, Prof Garcia Herera, speaks with Stanley Nkwazema about diabetes and foot ulcer

TYhe NISA Premier Hospital boss, Dr. Ibrahim Wada, said, “I am Dr. Ibrahim Wada, a gynaecologist in Abuja with NISA Premier Hospital. I am also involved in NISA pharmaceuticals I think to be honest with you, I have gone to Cuba a few times myself. I have seen significant advancement in there, medicine, medical technology, and the expertise are overwhelming. I am very satisfied with the knowledge that combining the Cuban expertise with the Nigerian expertise will go a long way to help solve our healthcare issues.”

The Cubans in Abuja and certification of drugs
Wada added, “The truth of the medication is like a wonder drug; a magic drug that is undergoing verification at NAFDAC in Abuja. In terms of registration, it is about 90 per cent completed and will become fully registered. The NAFDAC DG is aware of this medication and at the moment we are on the trial phase where we are to use it to see how efficacious it is for reversing the progress of the diabetic foot ulcer and also to such an extent that many people who would have had their foot amputated don’t have to face that consequence anymore. We have the experts here and they will explain in details the progress being made. I am very happy with the association and collaboration with the group and it is good for Nigeria.”
The long-awaited medication for the intervention against Diabetic Ulcer Heberprot-P may have been found after all if the demonstration and other measures presented in Nigeria recently by Prof. Aristides Herrera, the Rector of the Matanza Medical Sciences University of Cuba is proved beyond doubt. According to records 16 million people in Africa die of diabetes mellitus. In Nigeria, five million people die of this disease and between 15 and 20 per cent of patients have had an amputation.
Prof Herrera, who spoke exclusively to THISDAY in Abuja recently demonstrated to Nigerian doctors and specialists the favourable results obtained in Cuba, from the application of the drug, as well as in European countries such as the United Kingdom, Belarus, Russia, among others. Also, the scientist highlighted the legacy of the Cuban Commander-in-Chief, Fidel Castro, by referring to one of his phrases: “The future of our country will be of the men of science.”
“These ideas prevail today when we see that Heberprot-P has become the leading product of the Centre for Genetic Engineering and Biotechnology (CIGB) of Cuba, because this drug has managed to enter the international market, especially in the first world. The CIGB is the largest exporter of goods in Cuba. It is a dynamic development institution that has reached a high level of research, production, and commercialization of biological products obtained from modern biotechnology,” Herrera added.

The Cuban professor/specialist, Dr. Aristides De Garcia

Why interest in Nigeria
“For us to be here in Nigeria is like a dream come true because our Cuban people in the extreme have Nigerian blood also and we try to pay the debt with the history, that is why we came here to Nigeria to help the people to improve the quality of life and reduce the amputation of legs because of diabetic ulcer,” Dr. Garcia stated.

The wonder drug and discovery
Speaking further, he noted, This drug was discovered in 2001 and the clinical trial and we started the use in Cuba in 2007. The drug had clinical trials phase 1, 2, 3 and 4 still rolling with the post-marketing surveillance. It is the most effective in the most severe diabetic foot ulcer and also the lesser ones. This drug is a replacement therapy because diabetic patients don’t have epidermal growth factor that’s why the whole healing process is strong and now nothing in the patient is inflamed and it will no longer be amputated.”

Using the drugs in Cuba and its efficacy
The drugs are being used in many countries to good effect as Garcia would explain further. “We have more than forty-six countries including the European Union member countries; we have Turkey, Slovenia, Russia, Slovenia, and Belarus. We are doing some clinical trials in Italy France, Spain and Great Britain. In Russia and Belarus, the two countries have concluded the trials. They have equally registered it. In Slovenia, the process is almost concluded. In Spain, France, Italy they have all started the phase 2 of the process, same for the United Kingdom.
“This drug was isolated in the 1970s, this drug is an epidermal growth factor produced by biotechnology through a DNA technique. It is a replacement therapy for diabetic patients. These diabetic patients suffer wounds because of neuropathy and ischemia because they don’t have the factor to improve for patients who stay with the wound for a very long time. We put it through and the healing process improved and the speed also improved. But the longer the wound stayed open, gangrene comes in and the next stage will be the amputation of the leg. But according to an international expert, if you lose a limb, you lost a life. When we put it through in the clinical trial we noticed that the healing process improved and the patients’ quality of life also improved.”

Working in Nigeria
“We are here in Nigeria for a short while because we are doing the presentation so that we can introduce the drug/product and finish this stage with NAFDAC and we are also going to evaluate some patients in Garki hospital. After that, the Nigerian doctors that were trained in Cuba will still carry on with the clinical process. We are still going to come back as quickly as possible to share our experiences with the Nigerian doctors on the healing process, the treatment of diabetic ulcer and how to avoid amputations. In the presentations that we made, there were representatives from the Minister of Health, NAFDAC, the two hospitals, NISA and Garki, the University of Abuja and the Teaching hospitals, the representatives of diabetic society, the patients with diabetic foot ulcer and I think the NMA,” he said about their work in Nigeria.

Producing the drug in Nigeria
“The first step is to bring from Cuba, the second step will be a transfer of technology and thereafter, the product is established in Nigeria, We cannot talk about pricing for now because we must finish the clinical demonstration, registration and after that, we can discuss the price. With the people they can discuss that, our own is to teach the people about the product, how to treat the patient and we don’t know anything about the price,” he pointed out.
Experience with diabetic ulcer patients Garcia also talked about the number of patients he had treated.
“I have treated more than 5,000 patients treated not only in Cuba but around the world; I have worked in more than eleven countries of high standard therapy like, China, Malaysia, Philippines, Russia, Indonesia, Vietnam, Belarus, Trinidad and Tobago and was also in Colombia, I have treated more than 5,000 patients. We reduced the amputation rates 3.3 times, reduced the time of healing more than four times, It means for us that 78 per cent of diabetic foot ulcer , the most serious  and that is reduced the rate of amputation. What this means is that out of 100 patients we have saved up to 80 per cent which is very high. When you compare with any available therapy in the market, it is the highest you can get.We use this drug in the most critical patients. All the other drugs come back saying sorry and end up amputating the legs but we have not recorded it with this drug. Everything works for the patient with this drug. We save the limb and save the life. There are no reoccurrences because sometimes when you close the foot with a diabetic ulcer, three months later it is open again and starts giving you problems. In most countries that are not using this drug there is almost a 50 per cent reoccurrence but with this drug, there is only five per cent reoccurrence per people per year,” Garica explained.

Advice to Nigerians
“We hope that this drug will improve the quality of life in Nigeria people specifically the diabetic patients. Nigeria has one of the highest rates of diabetic patients in the West and Sub-Saharan African region. A lot of the diabetic foot ulcer ends up in amputation. That is why we hope that we can make the agreement for this drug to be in the Nigerian market to improve the quality of life of the Nigerian diabetic patients,” he advised.

Any severe or critical case
What does he have to say about handling complicated cases?
“To be honest, we have had serious cases. Here we are starting clinical demonstration. But there are good results; we started a demonstration with two patients, with the assistance of one of the doctors here in Garki hospital. We don’t do injections, we are only doing screening and evaluation of the patients before the treatment starts because we have the Nigerian consultant surgeons trained in Cuban on how to use this medication. We have sent some drugs here for free to test and see the results.
“Our hope is that Nigeria becomes the reference place in the West African region, with the highest standard for treating diabetic foot ulcer. Garki hospital will be the reference hospital for the West African countries to treat diabetic foot ulcers. It is our hope that this will be seriously pursued. We are grateful to Dr. Ibrahim Wada for the invitation the facility for the presentation that we have done and the interest for the workshop. As Cubans, we like to share our experiences and the Cuban health care systems is one of the strongest in the World with statistics that show that things are perfectly done. The infant mortality is almost 4.2, one of the lowest in the world.
“In this condition, we came to Sierra Leone with the Cuban brigade during the Ebola epidemic, we saved a lot of people and now we are trying to share another experience that we have. The Cuban Government is supporting us. Our late leader, Fidel Castro, said the future of Cuba will be a future of sensible men. We have sensed the willingness of our government who through the various programmes a lot of poor people became doctors, professors and all. I can proudly tell you that I am one of them. I have 27 years’ experience. I may look so young but I am a 53 years old man.
“I exercise and live well and do my best. God lifestyle, exercising, avoiding alcohol, prohibited drugs, no smoke. Started my Primary school in 1969m in Cuba and finished my Secondary education in 1979. I also did what we call senior High school from 1979 to 1982 and finished University in 1988 qualifying in vascular surgery in 1992 with my MSC in 1995 and Ph.D. in 2007. I became a Senior Professor and Senior Researcher in 2009. I eventually became the Rector of Matanza Medical Sciences University in 2016,” he added.

How the drug works
Explaining how the drug works, Garcia said, “You keep it stored like other vaccines. Each vial is 75 mg or micrograms; you make the solution of water saline after which you now inject the diabetic foot, after cleaning the wound to remove all the necrotic and infected tissues, when you see that the infection is under control, you then stop the injection. The injection should be 7.5m deep in the wound, this injection target the epidermal growth infection and is done three times per week, only one vial per patient until full granulation or closure of the wound and may use a skin graft if the wound is much.
“We have treated more than 150, 000 patients around the world in more than 45 countries. I personally treated around 5000 patients with wonderful results. One thing is very clear, there are scientific proves and once the drug is certified by NAFDAC that means we are good to go here. Already in conjunction with the relevant bodies, the trial is ongoing and before we come back the results will prove.” He also shared his experience about working with Nigerian doctors.
“They are very good; well-qualified, I must say. We are focusing on two hospitals, the Garki Hospitals, and NISA Premier. They have highly skilled professionals. And mind you most of the doctors have been trained in Cuba and other countries up to the Ph.D. levels,” Garcia said.