Introduction: On February 2nd, 2017, some Nigerian newspapers were awash with the story of purported discovery of HIV/AIDS “cure” by a group of researchers led by Professor Maduike Ezeibe a professor of veterinary medicine at the Michael Okpara University of Agriculture, Umudike Abia state. This is not the first time that a Nigerian researcher will come out with a claim of HIV/AIDS cure. There have been previous claims by Dr Jeremiah Abalaka of the Gwagwalada Specialist Hospital (now University of Abuja Teaching Hospital), Dr Jacob Abdullahi (Winners Medical, Diagnostic and Research Institute), Professor Isaiah Ibeh (University of Benin) – and others (not to forget claims by His Excellency Sheikh Professor Alhaji Dr. Yahya A.J.J. Jammeh the ousted president of the Gambia).

On Friday, 10th February, 2017, Professor Ezeibe was interviewed on the Good Morning Nigeria show of the Nigeria Televesion Authority (NTA). The DG of Nigeria’s Agency for the control of AIDS (NACA), CEO of Nigeria’s Centres for Disease Control (NCDC) and the DG of Nigeria’s Institute for Medical Research (NIMR) were at various times asked questions during the NTA program.

A lot of commentators watching the program and tweeting were not keen on the valid points being raised by the heads of these agencies. Rather, they chose to “attack” the system.

The findings of the research led by Professor Ezeibe were published in the British Journal of Medicine & Medical Research (note that this journal is not indexed in Pubmed, and although it bears the title “British”, there is absolutely nothing British about the journal).

Some Nigerians have called for the federal government to support, rather than disparage ‘our researchers’. While this is a good call, “Our researchers” should be able to provide answers to the simplest of all questions.

My questions for Professor Ezeibe

Structure of the Virus:

According to the research article;

What made HIV/AIDS incurable is small size (110 nm) of its causative agent, Human immune deficiency virus (HIV). The small size enables HIV cross physiological barriers to “hide” in cells of the brain, bone marrow and testes, where existing antiretroviral medicines (bigger molecules) cannot reach. Since it destroys lymphocytes (cells responsible for clearing infections from organs that are inaccessible to medicines), nothing was known that could terminate its infections. So, the infection was said to be in “sanctuary”

My question for Professor Ezeibe: Really? Is that the reason for HIV being incurable?

Mechanism of Action of the “Drug”:
According to the research article;

Aluminum-magnesium silicate (AMS) molecular platelets (Nanoparticles) are smaller (0.96 nm thick) than HIV. So, the Nanoparticles cross physiological barriers, to act on every organ/tissue. Their edges are positively charged and their surfaces negatively charged while HIV is positively charged and abnormal (infected/cancer) cells, negatively charged therefore, the AMS-Nanoparticles mop HIV from all organs/tissues with their surfaces and adsorb onto infected cells with their edges. They destroy the infected cells, by the mechanism AMS disintegrates drug-capsules, so that even infections in the “sanctuary cells” are unmasked and adsorbed out. When 100% of population of invading HIV is adsorbed out its infection terminates.

My question for Professor Ezeibe: That means the “drug” can act against ALL “negatively-charged” infected cells and viruses which are larger than 0.96nm thick [sic]? Exactly what part of the HIV life cycle does your “drug” target?

Research Methodology

According to the paper;

Ten HIV/AIDS patients who volunteered for the trial, by writing through their physicians, were classified according to their sexes. Each patient was placed on oral medication, with Antivirt® A for one month, at dose rates of 50 mg of the MSAMS/kg body weight and 7.5 mg of MSAMS stabilized Ampicillin trihydrate/kg body weight, daily. Thereafter, they were on Antivirt® B, at dose of 50 mg/kg, daily, till they tested HIV negative.

My Question for Professor Ezeibe: What is/was your definition of an HIV-negative test?

The paper went on to state as follows:

When a patient’s viral load became undetectable, he/she was tested by HIV-confirmatory tests (antigen and antibody) and treatment-duration before he/she tested HIV negative was recorded.

My Question for Professor Ezeibe: Exactly what antigen and antibody “confirmatory” tests did you use? What is the principle of these tests?

Results

As seen from the published paper, CD4 counts for participant M1 improved from 300 (month 0- baseline) to 4680 (month 8).

My Question for Professor Ezeibe: What was the units of measurement of the CD4 count? What methodology was used for the CD4 count enumeration?

At months 8 and 10, some research participants had HIV viral loads of Zero (0).

My Question for Professor Ezeibe: What methodology was used for the viral load tests that gave a viral load test result of zero (0)?

According to the research article;

The patients were on the Antivirt® medication for ten months without noticeable side effects. That means, the regimen is safe. The regimen being so safe may be because AMS is an inactive substance (chemically). It terminates viral infections by a physical effect (adsorption onto viruses and onto virus-infected cells).

My Question for Professor Ezeibe: What is your definition of “noticeable side effects”? Did you consider that within the 10 months of your experiment on humans, there may have been some “unnoticeable” side effects? Was there any follow-up after the 10 months? Did you perform any organ function tests for the research participants? Any haematological tests? Any immunological tests (asides CD4)?

We generally know that before any humans are subjected to trial drugs, the experimental drug is first tested in-vitro (for efficacy) then on animal models (for toxicity and efficacy-as the case may be), then on apparently healthy volunteers, before a case-control clinical trial. Granted, you agreed (on NTA) that your “drug” was tested on chickens previously.

My Question for Professor Ezeibe: Were the chickens infected with HIV?

Assuming (without conceding) that in-vitro experiments were carried out in HIV virus cell cultures to determine the effect of the “drug” formulation on the virus.

My Question for Professor Ezeibe: Has your team published the findings of these in-vitro experiments in any journals? Is it possible for Nigerians to see the results of these in-vitro experiments?

Apart from the 10 patients whose results was published, you stated that the “drug” has been tested on over 500 other patients.

My Question/Plea: It is hoped that your team is still in possession of the relevant records of all these 500 HIV-infected individuals?

Consent

According to the research article;

Each patient consented for the clinical trial by writing through his/her physician.

My Question for Professor Ezeibe: Is that the new method for obtaining informed consent for a clinical trial? It is hoped that you have copies of the consent letters written by the physicians? Complete with the full names and addresses of the physicians.

Ethical Approval

According to your article;

The clinical trial was conducted in accordance with the Helsinki declaration of 1964, as operational in Nigeria

The assumption is that by the Helsinki declaration of 1964; you did the following;

Wrote a research proposal with full description of your proposed research protocol.
Submitted the proposed protocol to NHREC (through your institution) for ethical approval
Got NHREC approval to carry out the clinical trial
Submitted your findings to your institutional ethical committee?

Patent

According to your article;

The MSAMS was patented by the Nigerian government, as broad-spectrum antiviral medicine.

My Question: Broad spectrum antiviral medicine? What exactly does that mean? Was the submission for patent for animal viruses (such as Newcastle disease virus) or for Human viruses (such as HIV)? Or maybe the “medicine” is a one-size-fits-all?

In conclusion, I wish to add my voice to the voice of numerous Nigerians who have called on the Federal Government of Nigeria to support and encourage our researchers. However, my loudest call is for Nigerian researchers to do the needful – cross the T’s and dot the I’s.

References:

Ezeibe et al., : HIV/AIDS Recovery Rates in Male and Female Patients, Treated with Medicinal synthetic Aluminum-magnesium silicate.. BJMMR, 18(11): 1-7, 2016; Article no.BJMMR.29018

http://www.journalrepository.org/media/journals/BJMMR_12/2016/Nov/Ezeibe18112016BJMMR29018_1.pdf

Accessed 11-Feb-17

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DISCOVERY OF HIV/AIDS “CURE” BY A NIGERIAN PROFESSOR: My Questions for Professor Maduike Ezeibe – Rawlings Datir