The Ministry of Health must be meticulously transparent about trial drugs. The media also must be responsible as it prints headlines announcing the existence of ‘treatments’ for COVID-19. This is not the time to raise false hopes. This is a time for treatments, experiments and maybes.
We all want a cure, vaccine or effective treatments for COVID-19. The pressure for this is huge. The drug company that develops a vaccine or cure first will win the billion-dollar lottery. We must always be aware of the huge profits on the table and the unethical steps that may be taken around the world to grab a portion of it.
If a drug is ‘experimental’ or ‘shows promise’ or has shown ‘encouraging results’ then we must USE THESE WORDS at all times. We must not scrap the qualifying adjectives and claim that a drug “works”.
Gilead Sciences holds the patent on Remdesivir. They have signed a non-exclusive, licensing agreement with five generic manufacturers. These five companies will make more of the drug available to specific worldwide Covid-19 patients in various markets. However, on their own website, www.gilead.com/purpose/advancing-global-health/covid-19, Gilead says, “Remdesivir has not been approved by the [American Food and Drug Administration] FDA for any use, and the safety and efficacy of Remdesivir for the treatment of COVID-19 are not yet established.”
And yet, one of our newspapers ran a headline saying, “Patients show recovery after Remdesivir treatment.” Inverted commas don’t matter to skim readers that focus on a headline’s words only. A base message from that headline could be “Remdesivir works.” But, we don’t know that to be true, yet.
One local doctor who is not a clinical trial physician, commented on his (un-vetted) preliminary results from only two COVID-19 patients after using Remdesivir. What criteria are being used to gauge ‘improvement’? Is this the same criteria being used by other worldwide hospitals using Remdesivir? Who says that the changes in these patients’ condition weren’t going to happen whether Remdesivir was used or not? What are the side-effects in a year or in two years? There are too many unanswerable questions because this is an experimental drug, at least for now. It must not be sugar-coated.
We must be more careful. Overly optimistic reports that are not diluted with disclaimers could be considered reckless. Because of social media there is lightning-fast information dissemination (whether it is false or true). This means that in a pandemic, posting accurate material is vital.
Last week, a medical professional adamantly denied that data on Remdesivir would be collected. In fact, all data collected from patients using it will be sent to the drug manufacturer. And there is nothing wrong with this. Promising drugs have been used on potentially terminal patients. Namibia may be a very small part of a necessary global data collection exercise during an unprecedented medical emergency.
Even for tried and true drugs, patients’ results are sent in to be a part of the data bank. This information can help find dosage levels, conditions, or possible allergic reactions.
The biggest concern is that our officials don’t read documentation. They don’t usually and study competing arguments before making decisions. They will decide on this issue based on ‘briefings’ from officials who were ‘briefed’ by people with varying skill levels and priorities. Namibia must not be gullible in this big ticket medicine deal.
While use of Remdesivir is one thing, we should step back (for now) from any experimental drug program that is asking for upfront millions for a COVID-19 cure that doesn’t yet exist. Cautions from the Ministry of Health about a new vaccine pre-purchase program are in order.
Our resources are limited. Will we buy thousands of doses of experimental Remdesivir for the relatively low number of critical COVID-19 patients? Is there a risk that the country might not have enough money left for the experimental vaccine for the uninsured Namibian masses when it becomes available? Our decision-makers face these tough questions.
Patients offered any experimental treatment must not only sign consent forms. They must give informed consent to such treatment. They must know and understand, not just sign. COVID medicines and vaccines are being rushed in labs all around the world. Corners will be cut. Anything that comes out will be an experiment. We must not fool ourselves on that point.
Recall that the Russians made an unethical premature announcement that they had a cure. Where is it? US President Donald Trump told people to drink disinfectants. Trump and others started taking hydroxychloroquine and lopinavir/ritonavir treatment arms months ago. These were all discredited cure fads. We must manage the risks of any new treatment or vaccine transparently and carefully while we move ahead on the basis of data and science.