{UAH} Covidex hasn't passed science test, & that is a problem

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  Written by DAMALIE NAMPONYE, MD

The Covidex herbal drug

I read a story in The Observer with dismay that a pharmacist, Pamela Achii, and the director of research at the Natural Chemotherapeutics Institute, Dr Grace Nambatya, attempted to override the National Drug Authority (NDA), which is tasked with approving drugs that are used in Uganda.

I am also surprised that NDA has approved Covidex, a drug that has not been subjected to any studies, skirting the authority's own established protocols.

Equally concerning is that 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?

Ms. Achii is quoted to have stated that "the remedy [Covidex] has the berberine plant as an active ingredient and its effectiveness has been proven in Covid-19 studies found elsewhere."

I was not able to find any published data showing the effectiveness of berberine in the treatment of Covid-19 anywhere. Furthermore, I found issue with pharmacologist Patrick Ogwang, the doctor behind Covidex, applying for emergency use authorization after skirting the established protocols that the National Drug Authority has put in place.

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.

Despite what Nambatya says, science has for centuries relied on the actual use of clearly laid-down formats to conduct research and come up with conclusions.

As scientists, we rely on studies to reach conclusions to safely recommend interventions; randomized controlled, double-blinded studies are utilized by scientists the world over to make conclusions about hypotheses. Skirting these protocols can result in actual harm to the public.

Nambatya relies on her relative, whom we don't know if she would have improved even without Covidex, as other patients have done, as anecdotal evidence to generalize the effectiveness of a drug without any proof whatsoever that Covidex works.

Another ingredient mentioned in The Observer article is Warburgia. Dr. Nambatya states she knows Warbugia very well, adding that it works in Covid-19. (There are no published studies to that effect).

Nambatya further states that Ogwang was her staff member, and that she knows him very well and she respects him. And because of that, we should trust her word that Covidex works. Sorry, but that's not how science works.

I initially wanted to thank the NDA for doing what's right for the citizens of Uganda, and also for all those who work for the NDA, because any risk to any Ugandan is a risk to all Ugandans, especially with a highly contagious disease like Covid-19.

In a pandemic like this one, Uganda needs to rely on experts at the NDA to do what is right. In the end, however, NDA has agreed to be bullied into approving a drug that has not been found to be effective.

On June 29, 2021, the NDA granted Covidex an approval, explaining later in a press statement, that it had partly based its decision on "published literature and safety studies conducted by the innovator."

In science, we rely on published studies in peer-reviewed journals. We do not rely on safety studies done by innovators who have a clear conflict of interest.

To my fellow Ugandans, please continue to do what's already been proved to work: observe the SOPs, wear a mask, social-distance, and wash hands.

The author is a diplomat, American Board of Pediatrics.

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"When a man is stung by a bee, he doesn't set off to destroy all beehives"

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