Fresh rumble over court judgement on Abalaka’s HIV vaccine claim 

ABOUT 16 years after the Federal Government placed a ban on the use of his controversial HIV vaccine, Dr. Jeremiah Abalaka, appears not ready to give up the fight. He is still insisting that efficacy of his vaccine is not in doubt.

Buoyed by a November 14, 2014 judgement which voided the ban on his vaccine, Abalaka, is excited about what he described as the ‘triumph of rule of law over crass abuse of power at the expense of global HIV/AIDS pandemic.”

This development is, however, not without concerns, as the Nigerian Medical Association (NMA) and the Nigerian Academy of Science (NAS) have raised technical queries over the issue.

   Similarly, in separate interviews with The Guardian,  the Director General, National Agency for the Control of AIDS (NACA), Prof. John Idoko and the Country Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS) for Nigeria , Dr. Bilali Camara ,have drawn attention to the need  to separate scientific issues from legal processes.

Camara argues that a court judgement does not necessarily validate a scientific process.

   Camara told The Guardian: “The following questions are essential for any vaccine trial to take place and be accepted scientifically: Is there a protocol designed to support Abalaka’s HIV vaccine trial; who has approved that protocol; which medical ethical review board has approved it; who has followed-up on the rolling-out of that protocol; which agency was following up the implementation of the vaccine trial; where were the results of Abalaka’s vaccine trial published; and in which medical journal? This is not a political or legal issue but a medical ethics issue and should be treated that way.”

   On his part, Idoko said: “Science is about the truth. Scientific discoveries are not made or pronounced by the court.”

At a press conference in Abuja,  Abalaka said he was willing to work with the various and interested governments under a negotiated agreement whereby he would divulge his vaccines recipe to their chosen and acceptable representatives of relevant professionals. He said he would thereafter organize a workshop with practical sessions on the production, storage and administration of the vaccines.

He suggested the creation of a national (or state) emergency vaccination programme for HIV control.  He said the agency should be an independent one directly under the Presidency or the state governor, as the case may be, funded by the governments with private sector contributions.

    Asked why he ventured into administering the vaccines directly on humans against known protocols, he said: “A lot of factors informed my choice of using the blood of HIV infected persons to produce my vaccines. I had no HIV cultures in any laboratory. I had no chimpanzees and Macaque monkeys for experimentation.  I had no training in virology or vaccine research and development. I had no training in recombinant technology either.

   “But glaring and challenging to me, even now, is the fact that seven years after the virus was discovered, those with these resources, funds and expertise had by 1991 not succeeded in developing effective and safe HIV vaccines. Worse still, we were told even in 1991, that the chances of developing safe and effective HIV vaccines in the next 10 years were, and are still very low. And yet, the infection was said to be universally fatal and is still spreading rapidly, especially when sexual contact remains its major route of transmission.

    “And it dawned on me that I should think of a way of using the many HIV infected persons that still abound to try and develop safe and effective HIV vaccines. Though a surgeon by training and specialty, I also had some training in immunology having acquired a post graduate degree in immunology from the prestigious University of Ibadan in 1974. The knowledge from that training and a WHO-sponsored workshop that I attended in October 1974 in far away Geneva formed the solid foundation on which I built the concept of my innovatory approach of developing safe and effective HIV vaccines.”

    When The Guardian sought to know if he was now ready to subject his claim to National Agency for Foods, Drug Administration and Control (NAFDAC) regulation, he said: “NAFDAC has an enabling decree, law or act that set it up. When you and I talk about drug, it is not the same as drug in the NAFDAC Act. If you read the NAFDAC Act, which I have read, it gives them what the government says a drug is. And I will tell you the definition of drug as used in the NAFDAC Act.  It is anything of animal, vegetable or mineral origin given for the treatment, amelioration of any diseases. It must be of animal, vegetable or mineral origin. You need to see the NAFDAC Act.  For me as a layman, a drug is anything. Water can be a drug.  If you have lost a lot of water and you come to the hospital, we give you water. The person who is hungry and is sick because of that, the drug he needs is food. When you have people who need blood to be given to them in hospital-I am sure all of us here must have heard that at least people are given blood transfusion. That blood is never given to NAFDAC for registration. Have you heard of it, that blood transfusion that we give everywhere, every day is registered with NAFDAC?

   “If I am to take this man’s blood and give to this man who is sick, do I take it to NAFDAC? Or do I take his blood to NAFDAC and apply for registration- a process that takes three years, when this man is bleeding? No! That is why, in case of those who don’t know, that is why anything of human origin, NAFDAC doesn’t register.  If you are to have a kidney transplant now, nobody goes to NAFDAC for the kidney that would be given to you. That is why NAFDAC does not include anything of human origin.  If it is to do, doctors would not give blood transfusion, and cannot do transplant. All the blood transfusion that is being done, private and public all over the country are not registered with NAFDAC.

    “Have you ever heard NAFDAC complain that the blood administered on somebody at National Hospital was not registered with it?  Bleeding, as we call it in medical practice, is a private affair involving four parties: the person who needs the blood, the person who is to donate the blood, the doctor who says that blood transfusion must be given, and the lab man who says that the blood is compatible. That is all! NAFDAC never comes in. So, whenever you talk about drugs, all these vaccines that are registered with NAFDAC, if it is vaccine, it is of animal origin.  They grow them in monkey kidneys. Therefore, it comes under the definition of NAFDAC. “

He went on: “My HIV Vaccine is purely human blood.  No chemical is added to it. So, by the operations of the law that we have now, it has nothing to do with NAFDAC.  That is about that. 

   “I am not going to apply to NAFDAC to use human blood product.  That is an aberration. Did you hear the judge say that I must go and register my drug with NAFDAC? That is point number one. Number two, even if I were to register with NAFDAC, you want me to go and register with NAFDAC? Which is more important, registration with NAFDAC or the life of the person? We are talking about HIV. There is no drug that you apply to NAFDAC today that you get the registration certificate next tomorrow, next six months, next year or so. It is a long process. 

   “So,which one is more important to you?  We have been with an epidemic, with a pandemic! Are you dealing with human life or registration with NAFDAC?  What is the issue here? As far I am concerned, NAFDAC applied to be joined in the case, and they were joined in the case. You are trying to be holier than the Pope fighting for NAFDAC. They couldn’t call one single witness…

    “NAFDAC is a busy body when it comes to blood transfusion and human blood product. It has nothing to do with them.”

When his reaction was sought, spokesman at NAFDAC, Dr. Jimoh Abubakar, told The Guardian, that a clear position on the issue would be taken by NAFDAC management and made known soon.

President of the Nigerian Medical Association (NMA), Dr Kayode Obembe, however raised queries about Abalaka’s claim.

     He told The Guardian: “The first questions to ask are: under which regulatory agency is he operating? In which books or journals have his results been published? Which scientific laboratory analyzed the components of the vaccine? When l have these answers, l will know the proper classification to place him.”

     Also, Regional Virologist and Laboratory Coordinator of the World Health Organization, Prof Oyewale Tomori, said a court judgement does not necessarily translate to scientific verdict.  

Tomori, a professor of virology and President of the Nigerian Academy of Science (NAS), told The Guardian that he would study the court papers and make a more detailed response. 

Former Vice President of the World Federation of Science Journalists, Mr, Diran Onifade told The Guardian: “We haven’t seen the court judgement, but it needs to be set aside at the highest level. It is simple. Ordinary pure water is regulated. If you want to package ordinary kunu, registration is required, not to talk about vaccine administration. A court is a court. A court has given judgement.  An appeal is urgently needed to set aside the judgement.

“Blood is of human origin. Water is required, so is vaccine. This is a public health issue. So, I don’t know what he is talking about.”

     But speaking on his vaccine and  the November court judgement, Abalaka  stressed: “You may recall that some 13 to 16 years ago precisely 1999 and 2002, I was at the centre of a global medical storm for daring to stun the world with the news of my solo development of safe and effective HIV preventive and therapeutic vaccines developed in defiance of, and disregard for the egotistic guidelines laid down by the United Nations Program on HIV/AIDS (UNAIDS) and for insisting that a desperate medical crisis like the HIV/AIDS requires a desperate medical measure or response without regard for guidelines or protocols. After all, by tradition and logical reasoning, methodology and guidelines ought to follow an invention that gives birth to it, and not the other way round.

   “The climax of the controversy surrounding my HIV vaccines development was the poignant decision taken by the Nigerian Federal Government of the Obasanjo era through its then Minister of Health, Dr. Tim Menakaya who, vide a World Press Conference on July 20, 2000, announced the President’s approval of ‘suspension of the use of all drugs/vaccines claimed to prevent  or cure HIV/AIDS in the country until such a time as  proper guidelines for assessment and verification of the claims are approved and applied to the products.

   “That suspension forced me and me alone out of over 20 claimants of herbal and religious cures for HIV/AIDS, to sue the President and his Attorney General. Along the line, and at its instance, NAFDAC was joined as the 3rd Defendant in the suit, which started as Suit No. FHC/ABJ/CS/236/2000 and ended with as Suit No. FHC/MKD/CS/75/2012 with a landmark judgement delivered on Thursday November 13, 2014 by Hon. Justice Binta Nyako of the Federal High Court, Makurdi Division and which said judgement is the basis of this press conference.”

He went on: “You will recall that in my anxious bid to convince the doubting Thomases, especially the Nigerian government and some of my outspoken professional colleagues/arm chair critics of the safety and efficacy of my HIV preventive vaccine, I repeatedly challenged them to organize a public forum and bring a suitable HIV-infected person of my blood group and with no clinical or laboratory evidence of other infections so that I could take his blood and inject myself with it as guinea pig in order to ascertain or disprove the efficacy of my HIV preventive vaccine. 

“I had, of course, injected myself six times with HIV-infected blood in the privacy of my laboratory and have remained negative till date, having taken a shot of my preventive vaccine. They all refused because they knew that if they faced the challenge and as they feared and dreaded, I came out unscathed after administering the wild HIV on myself, they would have permanently dug their own grave and buried not only all their objections, but attempts to safeguard the economic interest of the West and their worldwide campaign for antiretroviral drugs.”

    He accused the Nigerian government of mishandling his HIV vaccines development, noting that government should rather work with him to make the most of the vaccine.

He stressed: “As a result of the arbitrarily handling of my HIV vaccines development by our successive governments since 1999, Nigeria and indeed the whole world, have unduly remained at crossroads as far as the war against the HIV is concerned and in consequence, millions of lives have been, and continue to be needlessly and avoidably lost to HIV/AIDS. On my part and without prejudice to other pending suits on my development of  HIV vaccines, I am prepared to bury the hatchet, my many years of facing repeated persecutions notwithstanding. 

    “The whole world would have benefitted and millions of lives that have been lost to HIV would have been saved all these past 16 years or so.  The point must be made clear again and again that I do not claim, and I have never claimed to have discovered cure or prevention for AIDS. I have only developed safe and effective vaccines for the prevention and treatment of HIV, the causative agent of AIDS.

“Indeed, HIV and AIDS are two very widely different conditions. While HIV infection is curable and preventable, AIDS, the late terminal stage of HIV infection is not. In other words, the syndrome AIDS is advanced HIV infection plus one or more other opportunistic conditions such as infections and/or cancers. As such, it is preposterous and unscientific for any person to have claims to have discovered cure or prevention of AIDS, the late terminal stage of advanced HIV infection.”

    A copy of the judgement obtained by The Guardian noted: “It is not recommended that any drug untested should be administered to patients anyhow. However, HIV/AIDS has been declared a killer and all hands should be on deck looking for cure and/or prevention and if an effort is being made with existing and promising results, it is the responsibility of any responsible agency or government to be excited about it and do all it can to facilitate the development.”

The court states: “Since the government is not doing anything to help them, then I think it is only proper for the persons so infected to have the right to decide for themselves whether to use the plaintiffs vaccine or not. Consequent upon this, I find that the ban of the use of the plaintiff’s vaccine is illegal, null and void but its use must be at the discretion of the patient.” On its part, the Network of People Living with HIV/AIDS in Nigeria (NEPWHAN) has called on the Attorney General of the Federation and Minister of Justice to appeal the November court judgement that voided the ban on Dr Jeremiah Abalaka’s HIV vaccine claim.

The Association also wants all the other defendants in the suite to appeal the judgement and asked for stay of action on the execution of the judgement.

National Coordinator of NEPWHAN, Edward Ogenyi, who addressed a press conference on the matter in Abuja, also called on President Goodluck Jonathan to sign the anti-HIV/AIDS discrimination bill into law. The bill, which has since being passed by the National Assembly is pending on the desk of the President, awaiting assent.

     The association and its partners said: “It is no longer news that Nigeria has the second highest burden of HIV in the world with over 3.5 million Nigerians living with HIV. Exactly ten years after the removal of user fees for HIV treatment by former President Olusegun Obasanjo in 2005, people living with HIV today are back to paying for services. Those who are unable to pay for those services are left to face options which include going without treatment and even seeking for traditional, spiritual and other forms of treatment for HIV.

      “It is on record that over 1.2 million Nigerians who are eligible for HIV treatment have no access to antiretroviral drugs while several thousands who were on antiretroviral drugs have stopped taking their medications due to reintroduction of user fees. As if the deteriorating HIV response in Nigeria were not enough, a Federal High Court sitting in Makurdi, Benue State has nullified the ban on the purported HIV cure vaccine being peddled by Dr. Jeremiah Abalaka.

“The Federal government of Nigeria on July 20, 2000 placed a ban on the use of the purported HIV vaccine reported to have been discovered by Dr. Jeremiah Abalaka because there is a protocol followed worldwide before trials are conducted on human beings. The stages of any drug trial are from laboratory to animals, to humans. Nowhere in the world are trials started with human subjects.”

    Also speaking, the National Secretary of the Association, Mr. Victor Omoshehin, noted that since the HIV vaccine claim had not undergone the needed clinical trials, it could not be said to be safe for human use.

He noted: “drugs and vaccine claims/trials are not issues to be deliberated upon and decided in court, but should be in the realm of medical ethics and scientific evidence; that the judgement by the Federal High Court in Makurdi is capable of sending  gullible Nigerians living with HIV/AIDS to face extortion and eventual death; that ban or suspension on unsubstantiated HIV cure claims would not stand the test of time if government does not provide treatment for those who are living with HIV as an alternate to quacks; that Nigeria would be saved this confusion if the Federal Ministry of health takes leadership and provides clear direction.”

      The association, therefore, called on all persons living with HIV/AIDS in Nigeria to avoid the use of any HIV vaccine claimed to have been discovered.

Among the groups that attended the briefing and lent their voices to the call for appeal of the court judgement were the Nigerian Labour Congress (NLC),  Association for Family and Reproductive Health (AFRH) and the Civil Society (CiSHAN)