Is it breakthrough or smooth talk?
MoH invites BCIIG to come up with proposal for the use of Ivermectin under clinical studies Researchers ready, funders not yet clear Question to use or not use Randomized Controlled Trial ( RCT)?
The registration of Ivermectin and its use in Covid- 19 patients remains a source of contention between advocacy group BCIIG and the Ministry of Health and Wellness.
Botswana COVID- 19 Ivermectin Intervention Group, which is made up of multidisciplinary scientists, healthcare professional and community members has lobbied Botswana Medical Regulatory Authority ( BoMRA), MoHW and the Presidential Task Force to register Ivermectin for use in Covid patients.
What seemed like a breakthrough came last week via a letter from Grace Muzila, Permanent Secretary at MoH, to BCIIG titled, ‘ ADVOCACY FOR URGENT CONSIDERATION AND USE OF IVERMECTIN IN COVID- 19 PATIENTS’.
Muzila said the Ministry has noted BCIIG position regarding the use of Ivermectin with keen interest and intends to give it the “necessary attention it deserves”.
Muzila said the ministry has resolved that BCIIG “should come up with a proposal for the use of Ivermectin under clinical studies” as that is in line with World Health Organisation’s recommendation.
BCIIG member Dr George Mokone confirmed that they received Muzila’s letter. “We are working around the clock to meet the requirements as well as prepare to hit the ground running as soon as practically possible”. Mokone said there are three categories of certainty in research, these being, low, moderate, and high.
“If you want to use a drug for treating patients you ideally want to have a high level of certainty that it is efficacious against that which you intend to treat, assuming it is safe and of high quality. Mokone said their study will take for granted that the quality of the drug is not in question as it has been used for over 30 years and it will be procured from reputable vendors. “The gold standard research protocol is to select patients with definite disease, in this case, Covid- 19 and you have to be almost 100 percent certain that the patient has COVID virus, which means the diagnostic method, must be of high certainty as well”. He said in their case PCR test is the gold standard. The study will need two groups; one treated with the drug of study while the other is given a placebo, which looks like the drug but is non- medicinal and harmless. “Both the researcher and the patient must not know which group they are in, they are both blinded to these details- hence the name double- blinded Randomized Controlled Trial ( RCT)”. Mokone revealed that this is the essence of what those opposed to Ivermectin use are asking for, a large RCT. “Our position as BCIIG is that there have been 32 of these RCTs on Ivermectin and Covid- 19, though most are small studies. We are saying they are small for a reason”. He said the Israel study took one year to recruit only about 90 patients. Patients are reluctant to go into an RCT while they know the risk of not taking a drug could expose them to danger, including death as Covid- 19 kills quickly. “It is not that as BCIIG, we cannot do an RCT, we can, but more and more people will die in the meantime”, Mokone said.