To register or not to register Ivermectin

Regulator BOMRA not willingly to budge Francistown based Physician applied for registration under compassionate use Matter reached parliament - but thrown out

The most topical debate is whether the medical regulator, BOMRA can register and allow for the inclusion of Ivermectin drug among the many drug concoctions administered on locals who have been diagnosed COVID- 19 positive. The official position is that the drug is not available in the country as it is still to be registered with the regulatory body. BOMRA has called for a dossier as they feel the available data on the surface for this drug is still not enough for them to make a position. A group called Botswana COVID- 19 Ivermectin Intervention Group ( BCIIG), which composes of multidisciplinary scientists, healthcare professionals and community members are arguing to the contrary. They say there is no cure for COVID- 19, and patients are given different concoctions of drugs hence their asking for the inclusion of Ivermectin as research has shown that it works even better than some preferred drugs. The positive thing that has come out of this is that a Physician based in Francistown, Dr Kgosidialwa who is part of BCIIG has submitted yet another application to have the Ivermectin drug registered. In his letter to BOMRA which was a follow up to the previous application a month ago, he has requested to register under compassionate use. BCIIG members comprising Dr George Mokone, Dr Mpho Mogodi and Dr Mighty Kemelo told this publication they have conducted a series of meetings with all the key stakeholders. “We decided to go on a multi- pronged approach because more people continue to die”. The group said they have had cordial meetings with BOMRA. “But some of us are not happy with their response because they told us that they are a Regulating body, and do not administer medications and they referred us to the Ministry of Health and Wellness”. The BCIIG said for the medication to be registered either the manufacturer or whoever is interested in that medication should submit a dossier for everything that they need. They argue that with Ivermectin, although scientific research shows that it is successfully being used in many countries including the first world, the position taken by the Regulator makes it very difficult for interested parties because the drug is no longer under the company Merck. They say this is an expensive process, the manufacturer cannot actually support. “BOMRA advised us that we should conduct a clinical trial, and what we are saying is that, the evidence that we already have from other researchers around the world is enough to help us make a decision for this country. “But our argument much as we would love to do those trials, it takes a lot of time and resources, right now we do not have a funder and no one seems to be committing because one would have thought that we will partner with Health to do it but it does not seem so”.

TRIALS

The evidence is there, so many trials have been done all over the world and all show the same thing, that there is a benefit in mortality, transmission rate, the need for hospitalisation as of today over 19000 people have been involved only in trials. “To us BOMRA is just the system, from BOMRA one has to go to the ministry, then Presidential Task Force, Technical committee of the Task Force, all those layers and these cause all the delays while the pandemic is real and we are asking for those responsible to consider one of the cheapest means to assist fighting this virus. “Our position is that the most important thing is for the Task Force to consider embracing all possibilities as we are very convinced that lives could be saved.

EMBARRASSMENT

On Wednesday morning emotions were raised high, accusations and counter accusations became the order of the day with people raising concerns on social media as to why one of the most listened to programs morning show ‘ Masaasele’ on RB1 had to be cut off while some researchers advocating for the Ivermectin drug had come for an interview.

IN FACT, MANY ACCUSED THE STATION FOR BEING BIASED.

BG investigations found that it was a question of misunderstanding among the parties from the original planning of the story to its execution and that being the case the best way was to suspend the show. The show started with guests being introduced and taking a few questions before the 7 am news bulletin. But, it is said the Show Producer called the Coordinator of the Task Force Dr Kereng Masupu asking for direction. Both the guests and Masupu confirm that he was called. Masupu told BG that he never advised for the show to be called off, but instead acknowledged his committee having met with BCIIG as well as asking them to contact BOMRA. “I also asked the RB1 officer why they have not observed agreed protocols on how COVID matters should be communicated on their platform. But, I never asked them to cut off the show”. As if that was not enough, the issue of cutting the program reached parliament as MP for Sefhare- Ramokgonami Dr Kesitegile Gobotswang asked the responsible minister to explain why such an important show was cut off. However, his request was shot down by the Speaker Phandu Skelemani who said it was not part of the business of the day advising him to follow the stipulated procedures. General Manager News and Current Affairs, Sakaeyo Jannie explained that this was an error from “our part as RB1 we misled ourselves that our guests were researchers from the UB who were coming to present their findings only to learn that this is not what we expected. “Our officers erred - they brought a wrong thing from what they wanted hence the decision to cut short the show. “I sincerely apologise to the public because even if they were researchers, we should have verified our facts before advertising the show and subsequently airing it”.