Prioritise safety of pharmaceutical products over efficacy, expert warns

Notwithstanding the efficacy of some herbal medicines like “Agbo jedi”, which is known for its miraculous effect on malaria, dysentery, headache, typhoid, waist pain and rheumatism, experts have warned that tradomedical products which have not gone through the crucible of clinical trials may not be safe for consumption.

The Chief Research Fellow, Nigerian Institute of Medical Research (NIMR), Dr Greg Ohihoin, speaking in an event organised by Xcene Research in Lagos to create awareness about the role of clinical trials in healthcare intervention in Nigeria, maintained that the safety of pharmaceutical products should be prioritised over their efficacy.

“If a drug is efficacious, but not safe,” Ohihoin said, “it can harm the user while curing the disease.”

“This is one of our concerns with some of the tradomedical products in circulation. We know that these traditional products have some curative powers but in the cause of treatment, they would have damaged the liver or the kidney because they haven’t gone through any clinical trial that ascertains the safety of their dosage. In the end, you are treating malaria with agbo jedi but your liver and kidney are weakening over time.”

Ohihoin said that the solution to the possible contraindications of some herbal medicines churned out every day in Nigeria was to ensure that they are subjected to a systematic testing method that takes to account the efficacy and safety of the products.

“What clinical trial does is to test the safety of any medical intervention before you proceed to test the efficacy.”

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Ohihoin also argued that clinical trials should not be considered an exclusive preserve of regulatory bodies such as the Nigerian Food and Drug Administration and Control (NAFDAC) and the Standard Organisation of Nigeria (SON), stating that the immense disease burden in the country should necessitate robust participation in clinical research by all stakeholders.

“Looking at the global indices about clinical trials, Nigeria is in the rank of countries with the lowest engagement in clinical trials, but Nigeria tops countries with the highest disease burden in Africa and in the world.

“With the high rate of disease burden in Nigeria we expected that all stakeholders will be giddy to engage in research mechanisms that find solutions to the disease burden in Nigeria, but that is not the case. So, it behoves on regulatory bodies to put policies in place that will encourage clinical trials.

“Regulatory agencies should put facilities in place to ensure that clinical trials are effective and result-oriented particularly in a place like Nigeria.”

Speaking about the need to promote research culture in the country, the Clinical Research Associate, Xcene Research, Mr Joseph Oyennu, pointed out that Nigeria’s massive population of over 200 million people makes her extremely vulnerable to disease infection and spread – a position that must be tackled through clinical research.