National Agency for the Control of AIDS (NACA) and Nigeria Centre for Disease Control (NCDC) have refuted the claim by one Maduike Ezeibe, a Professor of Veterinary Medicine and Clinical Virology at the Michael Okpara University of Agriculture, claiming to have discovered a new drug for the cure of HIV/AIDS.
In a statement jointly signed by NACA Director-General, Dr Sani Aliyu and CEO NCDC, Dr Chikwe Ihekweazu the duo stated that having examined the facts, the study of the claimant was published in two little known, fee-charging ‘predatory’ journals and involved less than ten patients.
Both Aliyu and Dr Ihekweazu said it is necessary to make the clarification because there was really no basis for a claim to cure AIDS in the study.
“We are concerned that the publicity given to these claims will stop patients with HIV 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 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 the treatment of humans and animals. We call on all academics to follow legal and scientifically acceptable methods in conducting their research and to avoid making premature claims that are capable of derailing the huge progress made in the last two decades in the war against HIV/AIDS.
“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. We continue to support the hard and diligent work being done by scientists in our 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 explained.
The duo faulted the clinical trial done by the claimant stating thus: In the “clinical trial” as reported, there was no evidence of the use of controls, which is the basis of all efficacy trials. Without controls, you can neither have randomization nor blinding, two other critical factors in studying the effects of new medicines. Critically the primary outcome measured in this study was based on plasma viral load levels that are known to fluctuate in patients, even in the absence of any intervention. It is also worth noting that virological suppression (viral load less than 50 copies/ml) was not achieved in six or eight of patients.
“There appeared to be no medical doctor involved in the execution of this study and there was no evidence on where or how the patients were treated or monitored during this study, their clinical and treatment status at the beginning or at the end of it, the statement read.
They stated that: Clinical trials are conducted in a series phases – each phase is designed to answer a separate research question. These include; 1.) Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety 2.) Phase II: The drug or treatment is given to a larger group of people to see if it is effective 3.) Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, comparing it to commonly used treatments, and Phase IV: Studies are done to gather information on the drug’s effect in various populations and any side effects associated with long-term use,” they summated.
But, “the authors of this study did not state what phase their study was and the results of previous phases, if these were done. One critical issue is that there was no evidence from the publication that the authors obtained ethical clearance from an appropriate body in Nigeria to conduct this study and only ambiguous evidence that ‘informed’ consent was sought from the evidently vulnerable patients,” read the statement.