The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed that it has commenced clinical trial study on two of the approved herbal drugs for treatment of Covid-19.
Director General of NAFDAC, Prof. Mojisola Adeyeye made the disclosure in a statement signed by the Agency’s Resident Media Consultant, Sayo Akintola on Sunday, May 29, 2022.
The NAFDAC boss explained that three herbal formulations were approved for clinical trial studies during the COVID-19 Pandemic. She said while two studies have commenced including IHP Detox Tea, the third clinical trial study is yet to start.
She therefore, denounced the claims of efficacy of IHP Detox Tea for the cure of COVID-19 patients purportedly made by the Chief Executive officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu on one of the national dailies (the Guardian Newspaper of 28th March 2022).
‘’Only NAFDAC has the mandate to make any pronouncement on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence’’, Adeyeye said.
The Agency frowned at the media reports ostensibly circulated at the instance of the promoters of IHP Detox Tea which claimed that the herbal medicine was the only product approved by the Agency for the treatment of COVID-19.
In a letter to the Chief Executive officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu, by the regulatory body, the Director General of NAFDAC, Prof Mojisola Adeyeye said that NAFDAC is the only authorized Agency by law that is allowed to make any pronouncement on safety and efficacy of all regulated products with satisfactory scientific evidence (Clinical Trial).
‘’Therefore, it is worrisome that such unguided statement is made without the stated fact that no product can be approved by NAFDAC without satisfactory clinical evidence’’, she noted in a tone laden with grief.
According to her, the IHP Detox Tea clinical trial study at CMU/LUTH and NAUTH, approved for Prof Iwu’s company, was only a pilot study, (that is still ongoing), with a small sample size that is inadequate to make pronouncement on safety and efficacy of the product.
She insisted that only a NAFDAC approved Phase 3 Clinical Trial with enough sample size can be used to make such claims on efficacy, after regulatory approval of the study outcomes.
Prof. Mojisola Adeyeye noted with dismay that the World Health Organisation WHO team and other well-meaning individuals in the research space have found the claim of efficacy of the IHP Detox Tea misleading, and the Agency is saddled with the responsibility to provide oversight and deter such inaccurate information on regulated products in the country.
She disclosed that preparatory to the WHO team’s visit to Nigeria for the study, NAFDAC officials on inspection of the clinical trial site of IHP Detox Tea had found some lapses.
‘’We discovered some seventeen (17) lapses during our inspection visit. We passed the lapses to them as compliance directive to address.’’, she said, adding that the company was yet to respond to the identified lapses by the regulatory authority before making pronouncement that the product is efficacious for the treatment of COVID-19 patients.
She however, asked Prof Iwu to retract the statement on the same newspapers and any other platform used for such improper and misleading representation of the IHP Detox Tea study within 48 hours from the receipt of the letter and inform the Agency on the action to avoid further regulatory sanctions.
In his response, Prof. Iwu admitted that NAFDAC is the only authorized Agency by law that is allowed to make any pronouncement on quality, safety and efficacy of all regulated products with satisfactory evidence.
Reiterating his profound gratitude to the Agency for the kind approval of the pilot study protocol during the peak of SARS-COV2 pandemic, Prof Iwu urged the newspapers that published the report to make the necessary correction.
He noted that being an unsolicited and independent editorial decision of the newspaper, ‘’we are not in a position to compel the newspaper to retract its story nor retract a story not published by us or at our instance’’.
He averred that the publication under reference was neither an advertisement nor authored by his organization or its functionary or employee.
In a letter dated May 17, 2022, and addressed to the DG NAFDAC, Prof. Mojisola Adeyeye, Prof Iwu pointed out that from the text of the publication, it appears to be an opinion of the journalist who wrote the story, as he admonished the newspaper to correct the said misinformation that is capable of misleading members of the public.
‘’We have however, drawn the attention of the editor of the concerned newspaper to the observation of NAFDAC for their necessary correction’’, he said.