Opinion: Is COVIDEX a proven & safe treatment for COVID-19?

Last evening, I posted my doubts regarding COVIDEX, the unproven herb by Professor Patrick Engeu Ogwang that is being propagated by some Ugandans as a remedy for COVID-19. Soon after my Facebook post, I was criticized for not being Pan-Africanist and for failing to suggest reliable alternatives. My argument was that we needed data and information regarding the drug so we could really prove its safety, efficacy, and effectiveness. In my post, I wrote (screenshot below):

Immediately after my post, I received a lot of comments criticizing me for being critical! Below are some (see screenshot):

Well, later, exactly 8 hours after my post, a known doctor, Drew Ddembe posted a long Facebook in which he vividly expressed similar doubts and highlighted clear reasons why people should be slow with the herb.

When I read through his post, I felt it had more to offer to many of my readers, both on social media and internet. So I asked for permission to publish the post, and it was granted. And so here is the unedited version of Dbembe’s views regarding the COVIDEX herb. If you aren’t convinced even after reading this, then I surely don’t know what else shall convince you!

Drew Ddembe on COVIDEX, the proclaimed cure for COVID-19

‘Ugandan social media is buzzing with testimonials about a Ugandan “innovation”, Covidex, that they claim treats and cures Covid-19? The general opinion is that, ‘big pharma’ whoever that is, and the big mzungu bwana is attempting to block this product from the market through NDA and Ugandan professional bodies including Mbarara University, the medical board and the Pharmaceutical Society of Uganda!

Let’s assume that the government’s mortality figures are correct (I don’t believe they are) and that only 1 percent of Ugandans with Covid-19 have actually died from it! This would mean that 99 percent of Covid-19 positive people are expected to recover from it! It also means that whatever you give a covid-19 patient will be correlated with a cure simply because they were going to get cured anyway! Correlation is not causation! This includes most of the stuff taken for Covid-19, including Covidex!

If you gave mululuuza (a herb) to all COVID-19 patients, you would conclude that it worked but would have no valid evidence that it did. The sample size statistics required to calculate the minimum sample size required to demonstrate a difference in mortality in a community based intervention with a 1 and a 5 percent margin of error, at 95 percent confidence levels, when the baseline mortality is only 1 percent are beyond this article.

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An interventional trial in a hospitalized or ICU population would require a smaller sample size as the mortality here is higher! Suffice to say that you would need thousands of patients in a randomized controlled clinical trial comparing standard therapy and Covidex in order to demonstrate that it does indeed reduce mortality, hospital length of stay, duration of ICU admission, duration of oxygen requirement, duration of ventilation, other complications etc!

Even a smaller non-randomized phase 2 trial would need hundreds of patients! The creator of this product presented no valid clinical data for efficacy or safety! He has presented no valid data for dosing, no phase 2 data to validate his hypothesis that it’s an effective treatment for COVID-19 in a non-randomized cohort, and no phase 3 data to prove that it’s better than current standard therapy and is safe for human use.

There is no follow up data! The history of medicine is filled with disasters related to this kind of practice! In a presentation circulated on social media, he admits to having administered it, outside of a clinical trial and without any authorization to 3 friends who he claims were promptly cured! This is both unethical as well as illegal and amounts to human experimentation. This kind of practice is barred since the Nuremberg trials and is against ethical practice encoded in the Helsinki principles of human trials designed to protect patients!

All clinical trials have to be prospectively centrally registered to be publishable in any reputable Journal and have to go through an institutional ethics review board and have clinical governance! There was neither! In another country this kind of stuff would get ones board registration cancelled and disciplinary action and criminal action taken!

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Following WhatsApp discussions by medical professionals pointing all of this out, the author wrote a retraction and confession admitting that there really was no evidence and that trials needed to be done! Further statements were published by Mbarara University, his employers who unless his employment contract says otherwise, technically own the IP rights to the product as it was developed on University time.

The pharmaceutical society and NDA, the country’s regulatory body also published their statements and it was agreed that the product be withdrawn!

Then ignorance and politics took over! Conspiracy theories about big pharma and the big mzungu bwana who hated African innovation were circulated. The president allegedly overrode all of the professional bodies and the product is back on the market with no evidence of efficacy or safety despite glowing marketing blurbs and anecdotal testimonials by lay people who don’t realize that they are being sold an experimental product whose efficacy and safety are unproven!

This kind of thing is only fit for Ugandan ‘neddagala lyayo’ where the musaawo’s claim is all that one requires to prove efficacy and peer review, evidence, process or medical ethics do not matter!

The reality is that testimonials however glowing aren’t scientific evidence. They at best can only be hypothesis generating but you cannot skip the science and expect to be taken seriously!

Some claim that medical proof is not required as it’s being marketed as a herbal supplement but that really isn’t true. The moment you make a therapeutic claim you have to prove it to get registered by the NDA. The standards for a therapeutic product differ from those for a supplement. You do not have to prove efficacy for the latter! The name COVIDEX suggests otherwise. It suggests that this is being marketed as a treatment for COVID-19. The claims and testimonials used to market it suggest that it’s being marketed as a drug and not a supplement!

All of this begs the question as to who is protecting the consumer who is being used as a guinea pig for profit! We have to research our products including our local and traditional remedies but we cannot do this by skipping the science or indulging in conspiracy theories!

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The reality is that big bwana mzungu and big pharma don’t really care for Ugandans aren’t a target market for their products at all and they cannot afford them! Until the science, both preclinical and clinical is done properly, they aren’t going to sit up and take notice! They are just going to go out laughing at how delusional you are!

The most recent examples of this is Madagascar with their now forgotten COVID-19 cure that war-marketed in hype and conspiracy workout the science! Let’s do the science if we really wish to be taken seriously, else we just look like ignorant idiots!’ – DREW DDEMBE.

THE END. Do you have any thoughts or reliable information regarding this ‘medicine’, COVIDEX? Share in the comments section or just email me at thecompletey@gmail.com