Just two weeks ago, National Drug Authority approved selling and use of COVIDEX drug by Ugandans but now after the drug going viral, they want to subject it to clinical trials, what went wrong?
NDA now requires randomized clinical trials on the same drug as an afterthought, which is the very reason it had declined to approve Covidex. Any medication, including one for herbal, should never have been manufactured and put on the market without the approval of NDA.
Moreover, the use of the name Covidex is also unethical as it dupes the public into closely associating the herb with a Covid cure, but the drug has not been shown to be effective using scientific standards.
In science, clinical trials are required before a drug can be approved for use. Moreover, the World Health Organization (WHO) recommends against the use of unproven drugs for treatment or prophylaxis for Covid-19 outside the context of clinical trials.
According to the World Health Organisation, a number of exceptions are listed for use outside clinical trials.
They include: when there’s no proven effective treatment that exists; when it’s not possible to initiate clinical trials immediately; when there’s data providing preliminary support of the drug’s efficacy and efficiency at least from laboratory or animal studies; when the use of outside clinical trials has been suggested by an appropriately qualified scientific advisory committee based on risk-benefit assessment; when the relevant country authorities and a qualified ethics committee have approved use of the drug; when there are adequate resources to mitigate risk; when the patient’s informed consent has been obtained; and lastly, when the emergency use intervention is monitored and the results are documented and shared with the wider medical and scientific community in a timely manner.
The drug commonly known as Covidex has not fulfilled any of the criteria to qualify for use outside the WHO recommendations.
And in a country with limited resources to cater for the health of its citizens, do we want to add managing the side effects associated with an unproven drug to the burden of the already overwhelmed healthcare system of Uganda?
Moreover, there have been no studies to show that Covidex works, and Covidex doesn’t meet any criteria that would allow its use outside a clinical trial. For Ogwang to apply for emergency use is unethical.
To advocate for the use of Covidex despite evidence that it’s not effective, Dr Nambatya gives anecdotal evidence of a 79-year-old patient in the Intensive Care Unit (ICU) who reportedly improved after taking Covidex.
