A Professor of Veterinary Medicine and Clinical Virology at the Michael Okpara University of Agriculture, claim to have discovered a new drug for the cure of HIV/AIDS. An editorial in the newspaper “Leadership”, quoted the professor as saying that the drug, produced with “Aluminium Magnesium Silicate” was tested on ten persons living with HIV. The newspaper reported a clinical outcome of an ability to “reach all cells” and making HIV “a conquered organism”.
According to National Agency for the Control of AIDS (NACA);
The claim for a HIV/AIDS cure is not new. It is also not new to find a scientist using ambiguous scientific methods and practices to buttress this claim, and to find obscure journals increasingly prepared to publish these claims. Following the discrediting of the claims of Dr Abalaka in the late nineties, we had also hoped that the Nigerian press would thoroughly investigate these “AIDS cure”, claims before going to press, given the huge impact that these could have on patients lives.
To examine the facts, this study was published in two little known, fee-charging ‘predatory’ journals and involved less than ten patients. 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 randomisation 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 6 of 8 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.
It is important to note 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. The authors of this study did not state what phase their study was and the results of previous phases, if these were done.
Naca also said;
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.