Fresh concerns over unverified HIV cure claims

From Dr. Jeremiah Abalaka with his controversial vaccine for Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), in 1999, Dr. Paul Olisa Ojeih in 2000, Prof. Isaiah Ibeh of University of Benin, Edo State, in 2013, and now Prof. Maduike Ezeibe, Michael Okpara University of Agriculture, Abia State, there have been harvest of unverified cure claims.

However, the most interesting thing is the manner in which the claimants present their findings and the harsh reaction of government agencies to these claims.

Unfortunately, no headway has been made despite these myriads of claims of possible cures for HIV.

The National Agency for Food and Drug Administration (NAFDAC) under the leadership of its immediate past Director General, Dr. Paul Orhii, made efforts set up a national committee made up of professors of medicine to verify the cure claims. Unfortunately, the committee could not do much due to lack of funds.

NAFDAC had in September 2011 arrested the Managing Director of Winners Medical Diagnostics and Research Institute, Dr. Jacob Abdullahi for dealing in expired medicines claimed to be cure for HIV.

Also, the Nigerian Medical Association (NMA), Pharmaceutical Society of Nigeria (PSN), National Agency for the Control of AIDS (NACA) and the Nigerian Academy of Science (NAS) have called for clinical trials to test the efficacy of these HIV cure claims.

Orhii had told The Guardian back then: “What we have done is that we have formed a committee of professors of medicine in Nigeria to see what we can do. We are meeting to work out ways of doing clinical trials for all the cure claims in Nigeria. This is because if you allow everybody to make claims of cure for HIV we will be doing ourselves a lot of harm.

“If you claim that you have cure, we will find a doctor who has patients and re-evaluate it, and do a blinded trial so that the Intellectual Property Right (IPR) is protected. When we have finished the screening, we will then begin the approval process.”

Besides Abalaka and Ezeibe other Nigerians believe they have a cure for HIV.

Why all these claims? Is a cure for HIV possible? What are the procedures for presenting cure findings? What is the federal government doing to address the issue?

Nigeria has one of the highest burdens of HIV in the world and second only to South Africa in the continent. According to NACA, there are about three million Nigerians living with HIV and only about one million are on the free treatment programme of the federal government.

According to the latest estimates by the World Health Organisation (WHO), HIV continues to be a major global public health issue, having claimed more than 35 million lives so far. In 2015, 1.1 (940, 000–1.3 million) million people died from HIV-related causes globally.

There were approximately 36.7 (34.0–39.8) million people living with HIV at the end of 2015 with 2.1 (1.8–2.4) million people becoming newly infected with HIV in 2015 globally.

Sub-Saharan Africa is the most affected region, with 25.6 (23.1–28.5) million people living with HIV in 2015. Also sub-Saharan Africa accounts for two-thirds of the global total of new HIV infections.

Unfortunately, there is no cure for HIV/AIDS, but a combination of drugs, approved and recommended by the WHO has been used to prevent new infections, especially in mother to child transmission. The drugs have also been shown to effectively reduce the virus to near-zero levels, thereby making it hard to be transmitted. The WHO now recommends the drugs for all HIV positive persons to stop new infections. But the WHO insists the drugs are not cures.

There also vaccines under development but none has shown enough promise to be deployed for mass therapeutic or preventive uses.

Meanwhile, professor of Veterinary Medicine and Clinical Virology at the Michael Okpara University of Agriculture, Abia State, Maduike Ezeibe, the latest HIV cure claimant, was shouted down by NACA and the Nigeria Centres for Disease Control and Prevention (NCDC) for allegedly not following laid down procedures before going public with his findings.

But the Senate Committee on Primary Health Care and Communicable diseases has urged relevant government agencies, including NACA and the National Primary Health Care Development Agency (NPHCDA) to interface with the cure claimant in order to subject his claim through scientific means.

The Committee led by Senator Mao Ohuabunwa, during the 2017 budget defence session of NPHCDA inquired into reasons why the agencies have refused to dialogue with the professor before dismissing his claims without going through normal scientific measures in ascertaining or disproving such studies, in accordance with world standards.

The Senate Committee’s members had since advised on the possibility of interfacing with the cure claimant to further verify his claims to be either true or false.

The committee questioned the rationale behind NACA’s dismissal of the claim without recourse to Ezeibe. Similarly, The Senate committee queried the Executive Secretary of NPHCDA, Dr. Faisal Shuaib, if he was aware of the claim to which he replied in the affirmative.

Shuaib said he was in agreement with his NACA counterpart that the study quoted by Ezeibe did not conform to standard ethical protocols for clinical trials.

Director General of NACA, Dr. Sani Aliyu, told the committee that the study quoted by Ezeibe did not show evidence that he obtained ethical clearance from an appropriate body in Nigeria to conduct the study, and quoted only ambiguous evidence that informed consent was sought from the evidently vulnerable patients. “We are concerned that the publicity given to these claims will stop patients from taking life-saving antiretrovirals and give them false hope of a cure. It will be a great disservice to this vulnerable group of patients for the media to disseminate these claims in absence of sound scientific evidence,” Aliyu said.

FG Initiates Enquiry
The National Health Research Ethics Committee (NHREC), Federal Ministry of Health, said it had requested University of Agriculture, Umudike, Abia, to provide details of the clinical trial of the claim for cure of HIV/AIDS.

The Chairman of the committee, Prof. Clement Adebamowo, made this known in a statement in Abuja.

Adebamowo said Ezeibe’s research did not comply with the provisions of the National Code for Health Research Ethics (NCHRE) and the National Health Act 2014.

He said: “The NCHRE is the primary guidance document on ethical regulation of research in Nigeria.” The chairman said that the committee had requested the university to provide list of members and contact information of the Health Research Ethics Committee that reviewed and approved the research conducted by Ezeibe. He added that other documents requested from the university include, copies of duly approved informed consent forms signed by participants in the clinical trials.

Adebamawo said the committee might also request access to the patients who participated in the clinical trials for verification. Other requests made by the committee were the originals and copies of approval of the research by the Clinical Trial Regulatory Unit of the NAFDAC. He said the committee also requested copies of the curriculum vitae, certificates and professional licenses of members of the research team, among others. He explained that the request for professional licenses and certificates of the research team was to ascertain their qualifications to provide clinical care and administer drugs to Nigerians as prescribed by law.

The chairman urged other institutions and researchers to be diligent and abide by the extant regulations in Nigeria and other international codes for ethical conduct of health research. He said, “institutions and researchers should note that when found in violation of the extant regulations for conducting ethical research in Nigeria, NHREC may institute disciplinary measures as empowered by the National Health Act 2014.”

Why NACA, NCDC Dismiss Ezeibe’s HIV/AIDS Cure Claims
Director-General, NACA, Dr. Sani Aliyu, and Chief Executive Officer NCDC, Dr. Chikwe Ihekweazu, in a joint statement, noted: “It will be a great disservice to this vulnerable group of patients for the media to disseminate this claims in the absence of sound scientific evidence. There are long established, tried and tested routes for the discovery, development and validation of modern medicines before they can be registered and used for treatment in humans and animals.”

NACA and NCDC called on all academics to follow legal and scientifically acceptable methods in conducting their research and to avoid making premature claims capable of derailing the huge progress made in the last two decades on the war against HIV/AIDS. The government agencies said millions of lives have been saved as a result of modern antiretroviral treatment and people living with HIV can now look forward to a normal healthy future. They, however, said they would continue to support the hard and diligent work being done by scientists in Nigerian universities and research institutions around the country. “We are always ready to partner with our scientists on all aspects of HIV research provided this is in line with international best practice,” they noted.

NACA and NCDC called on editors of media houses in Nigeria to seek comments from the leadership of relevant government parastatals and professional bodies when it receives new research findings related to their areas of responsibility. “We assure you that we will respond rapidly and constructively to any queries. We also urge the editors of media houses in Nigeria to support their reporters to gain a deeper understanding of the complexities involved in the clinical trial process. In the run up to the next deadline, it is easy to fall into the trap of doing more harm than good, and the consequences of this can be deadly in the health sector. We will support the evolution of robust science journalism in Nigeria,” they noted.

Lessons from India
A nanded-based research centre has claimed that it has transformed at least 200 cases of HIV positive to HIV negative in the last three years using a patented drug ‘HIV-SJ’.

According to a report published in frihost.com, Director of Siddharth Research Centre cum Hospital, Dr. Siddharth M. Jondhale, told PTI that the drug made out of three herbs he used was patented in India, Europe and some other countries.

He has been using the drug on HIV positive patients, including almost terminal aids patients, for the last three years.

Jondhale said: “The results are very encouraging with several patients showed gradual improvement in their health subjectively as well as clinically and there were around 4,000 patients under treatment in the institute.”

Clinically, Jondhale claimed, the HIV-SJ medicine has shown to increase the CD-4 count, regenerate cd-4 cell, destroy the HIV-RNA (ribonucleic acid) and create the new Ribo Nucleic Acid (RNA).

Jondhale said he had made a scientific presentation on the AIDS treatment at the international conference in Brazil, organised by the International AIDS Society six months ago. He has also submitted his paper to British medical journal Lancet, which is yet to accept it.

He has also sent the papers to British Journal of Medicine and New England Journal of Medicine.

Asked whether he has communicated to the Indian Council of Medical Research (ICMR), the findings, he said he wrote a letter to President A P J Abdul Kalam, who had acknowledged saying that he had forwarded his letter to ICMR, India’s National AIDS Control Organization (NACO), as well as to WHO.

Concerns
Some schools of thought are worried that these trends of claims and counter claims by researchers and stakeholders with regards to cure or vaccine for HIV/AIDS have continued to traumatise Nigerians and the world, rather than all concerned evolving a synergy in their research work.

They recalled with dismay that disagreements between Dr. Abalaka and some regulating authorities on test, analysis coupled with Dr. Abalaka’s fear of loss of patent right for his alleged cure for HIV/AIDS rendered his claim a mere smokescreen.

It is believed that for any professional to truly claim a breakthrough in his scientific research, such result must be subjected to laid down procedure of scientific analysis at least, to test the veracity of the claim. It is also believed that in the interest of justice, equity and good conscience, the patent right to any such discovery should be guaranteed before, during and after the necessary scientific analysis.

Stakeholders urged the authorities to investigate the claim and if true insist that traditional/conventional or spelt out procedures be followed as distancing self from the claimants amounts to throwing away the baby with the bathtub.

On the other hand, stakeholders recommend that if the claim is found to be a fluke, or the claimant is discovered to have breached professional ethics, he or she should be made to face disciplinary action; that, it is not enough to disclaim the work. Indeed, Nigerians are waiting to see the consequences of the claim and counter claim.