All publications of Melchor II . Maynila , Pilipinas
A Question of Information Integrity in Modern Medicine
"The WHO cited a scientific study published last week suggesting that proposed COVID-19 drug hydroxychloroquine may do more harm than good in halting its study to review data."
Why is this worrisome? Why should this be pried upon? In this Covid-19 epoch, getting infected is akin to: you getting conscripted to the middle of a battlefield and the ONLY gun you have in hand auto-detonates if you pull the trigger, so your commander advised/ordered you not to use it. But what if the “auto-detonation” info was just hearsay? You heeded his command and died in the middle of war because you practically had a low chance of fighting back; you weren’t deployed barehanded, however you were persuaded against using your gun. What if that soldier was your family member?
Several previous research papers showed Hydroxychloroquine as promising. It’s on the guidelines of nearly every IDS and Pulmonologist for ~3 months. Only this recent one was significantly contradictory. Even Remdesivir, the now FDA-authorized drug, was formerly reported, throughout different studies, as ineffective or at most mildly, and was feeble when compared to HCQ. Remdesivir was fortunate to have been the only one expedited to approval. Now, HCQ is deprived of a chance to be proven when the massive clinical trials were stopped by WHO.
Here in the Philippines, we don’t have Remdesivir (scarcely if we do) or the luxury of those other drugs they’re currently recommending, nor will we be a priority of those finite exports (i.e Favipiravir), particularly in a pandemic when those are gold dust; hardly, only very few privileged patients can be given so. What percentage of our population can afford those Monoclonal antibodies anyway? Asian countries (e.g India) prioritized their citizens and dependent neighbors when they rejected the western nations’ request/demand to increase the export of HCQs they massively produce. Although they eventually yielded, the supply for those avaricious states was deemed insufficient. Those western nations have stacks of stocks of Remdesivir but almost to nil production of HCQ. Remdesivir was fortunate to have been the only one expedited to approval.
Be reminded that if you would review the “best” NEJM paper for Remdesivir, you’ll find that even with some confounders, the only dependent variable they can come up to conclude significant is the time to recovery improvement of 15 to 11 days — that doesn’t really make much of a difference in a viral pandemic for a drug, which also comes with adverse reactions. It’s rather close to an insubstantial absolute risk reduction, considering the high probability that Sars-cov-2, an RNA virus, could promptly mutate its way toward resistance, let alone in this global contagion. Although it might momentarily be helpful somehow, we shouldn’t be complacent along this mediocrity. Let this not be allowed to have a chilling effect on the other trials.
The succeeding NEJM-published study on Remdesivir was about a comparison of a 5-day to a 10-day course and revealed no significant difference. Well, the main previous paper inferred that it would require a mean of 11 days to convey improvement. The new study focused on a 5 and 10 days course research alone and no placebo control. Generally, it could independently imply that a 5-day course would be enough. But why invest on an incompletely designed trial in the first place? A violation of ethical consideration cannot even be argued here since there’s no drug yet that is established as standard treatment. What if supposedly a portion of data (hint: placebo) could have been deliberately omitted for the sake of a marketing scheme? Do you wonder if a “0-day course”/no treatment would have made any difference? What we’re looking forward to is a drug study with a clear statistical significance of ensuring recovery within 1 week from the start of drug administration, immediately preventing further transmission or at least one that could prevent progression to severity. Those residual organ damages from recovered critical patients are appalling. If no drug could fulfill this criterion, HCQ - the most promising among about a hundred of drugs tested early in the pandemic - which is now unfortunately deprived of clinical trials, would appear to be our temporary hope (if not option) for long.
Meanwhile, there is no other potential remedy in the horizon, even research about Ivermectin or the decoy, hrsACE-2, lags so far behind. Let's be realistic and practical because what else do we have at store, if not perhaps of a glimmer?
In conformity with WHO, hereafter up to the distribution of discovered vaccine (obviously not soon for us), our patients would be hesitantly or no longer be given “guns” to fight this Covid-19 war. It should sow alarm especially in the upcoming months, when this pandemic is going to be a gloom to us southern and underdeveloped Asian countries; with very limited testing facilities/capacity, we're spiralling to a doom. Yes, HCQ is too great of a risk and should be well avoided for severe/critical patients, nonetheless the same goes for many other common drugs. Yet, if ever HCQ is actually a treatment or at least a limiting factor to curb progression to severe/critical stage, those who will have been saved by HCQ are blood on the hands of WHO. Their appraisal might have overrated the Lancet paper of Mehra et al, which they used as the sole basis, and have overlooked all the other related papers. The randomized clinical trial for HCQ should be continued. We were clasping to a hope for its success. It already took months and there were at most only 3 weeks left before the HCQ clinical trials would’ve reached conclusion. How long will they be reviewing the draft data? Strange? Was Remdesivir favored to have been the only one expedited to approval?
Please read: An open letter to Mehra et al and The Lancet
However this message may end up to, it should at least guide us to realize that it is our duty to scrutinize every paper we’re getting fed with.