There have been claims on various social media platforms suggesting that the herbal medicine, Nibima, has been approved by the Food and Drugs Authority (FDA) as cure for COVID-19.
These claims follow a press statement the FDA released on February 1, 2021 about the herbal medicine and COVID-19.
Fact-Check Ghana has verified the claims and conclude they are completely false. Below, the team explain in details the press statement of the FDA concerning the herbal medicine, Nibima, and COVID-19.
Not approved for COVID-19 treatment; at least not yet
On the Monday, February 1, 2021, the FDA issued a press statement indicating that, the Authority and the National Medicine Regulatory Agency (NMRA) have “approved Cryptolepis Sanguinolenta, locally known as Nibima for clinical trials” on COVID-19.
The statement was released following a clinical trial application that was submitted by researchers from the School of Public Health of Kwame Nkrumah University of Science and Technology (KNUST). This was after the School had conducted a laboratory study on the herbal medicine and found results that necessitates the need for a clinical trial.
The statement concluded that the FDA hopes “data from the study [the clinical trial] may be useful to inform policy or be used for scientific judgement and opinions in relation to COVID-19”.
Thus, from statement, the Authority did not state or suggest that the Nibima has been approved for treatment or as cure for COVID-19.
Indeed, following the misinformation making rounds on various social media platforms suggesting that the herbal medicine has been approved as cure for COVID-19, KNUST issued a statement to clarify that Nibima has not been approved for COVID-19 treatment.
“The KNC19 team wishes to inform the public that, the herbal remedy in question has not been approved presently for COVID-19 management but rather for a phase II clinical trial on COVID-19 patients,” the statement said.
Approved for clinical trial, what does it mean?
According to Ghana’s Public Health Act, 2012, Act 851, all medicines, herbal medicinal products, cosmetics, medical devices or procedures must be approved by the FDA through clinical trials.
Clinical trials are controlled research studies performed on human beings with the aim of evaluating a medical, surgical, or behavioural intervention. Clinical trial is primarily the way researchers conclude if a new treatment, drug or diet or medical device is safe and effective for humans.
The Public Health Act requires that a person or organisation hoping to approve a medicine, cosmetic or procedure must submit an application for a clinical trial to the FDA, which is what the researchers of KNUST’s School of Public Health have done.
However, before submitting an application, the person or organisation seeking to approve a medicine, cosmetic or procedure must submit evidence of laboratory investigation into the medicine, for the FDA’s verification
“On the receipt of an application, the Authority shall conduct investigations to authenticate the safety, efficacy, purity and quality of the drug, herbal medicinal product, medical device or cosmetic and if it is satisfied that the drug, product or device is reasonably safe, efficacious and of acceptable quality and the application including documents, dossiers and laboratory investigations are complete, the Authority shall within one hundred and eighty days approve the drug, herbal medicinal product, cosmetic or medical device for the purposes of the clinical trial.” (Public Health Act, 2012, Act 851, Section 156 (1)).
Laboratory investigations, as the name suggests, is a research conducted in the laboratory. It usually uses special equipment and cells or animals to find out if a drug, procedure or treatment is likely to be useful in humans. However, it normally does not involve humans.
Thus, in the case of the Nibima herbal medicine, the KNUST researchers after having conducted the laboratory investigations applied for a clinical trial from the FDA. The statement issued by the FDA was the Authority’s announcement to the general public that it had approved the drug for clinical trials.