Two Cheers for the FDA
Only two because the FDA did play an important role in the US Covid 19 testing fiasco.
the first cheer is for extreme speed in approving phase 1 trials of candidate vaccines (vaccine in a person within 2 months of publication of the Sars Cov2 sequence) and phase III trials of Remdesivir (results leaking already) and hydroxychloroquine.
The second and even louder cheer is for the expanded access to Remdesivir policy. I actually predicted that this wouldn’t happen. I was wrong. I guessed there would be consideration of compassionate use in individual cases. I think the reason there is a systematic program is that the FDA and Gilead (the manufacturer) were overwhelmed with requests.
In particular, I note that one onlusion criterion is eligibility for a clinical trial. If one is eligible then one must risk getting the placebo. The logic is that people have the right to standard of care but do not have the right to an experimental drug which is more likely to help than to harm them. I argue for this logic here.
On the other hand, an exclusion criterion is “Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy)”. This doesn’t make much sense. There is good reason to think that antivirals are useful especially if given early before the cytokine storm breaks. I think part of the logic here is first do no harm so an experimental drug can be used only on people who have very poor chances without it (the death rate of the intubated is roughly 66%). Also I guess Remdesivir will soon be in short supply (I think they have enough for 140,000 patients now and basically everyone in the world will want some).
So the expanded access is radical, but I don’t think it is radical enough.
“The second and even louder cheer is for the expanded access to Remdesivir policy.”
The stock market did well yesterday. Gilead’s stock price rose by almost. Why? Good news on Remdesivir keeps coming out.
I don’t understand why a cytokine storm has become an instant assumption among commentators, with very little evidence. A cytokine storm is suggested by the pattern of mortality (very high among young adults with strong immune systems) in the 1918 flu pandemic. But the covid-19 pattern of mortality (very high among the aged, but rare among the young) suggests the opposite: that a weak immune system allows disruption of lung epithelial cells.
The cytokine storm hypothesis is based on correlation of high IL6 levels and bad outcomes in Covid 19 patients A fair amount is known about Sars Cov1 and Mers, and much of the theory is by anology.
Finally there are reports of good results with an antibody called tocilizumab which binds to the IL 6 receptor.
https://science.sciencemag.org/content/early/2020/04/16/science.abb8925
Right now, we still don’t know if Remdesivir does more good than harm. In fact, we don’t even know it does any good. It’s that simple. Economists sometimes talk about experiments and effects ceteris paribus, all other things being unchanged, but they acknowledge that while desirable this is next to impossible. In pharmaceuticals, ceteris paribus is an attainable standard.
Check out this Feb. 12 story about the Chinese biopharma BrightGene:
https://www.genengnews.com/news/coronavirus-chinas-brightgene-manufactures-apis-of-gileads-remdesivir/
A publicly traded Chinese drug developer, BrightGene Bio-Medical Technology Co., said today it has successfully manufactured the active pharmaceutical ingredients (APIs) of remdesivir (GS-5734), the Gilead Science antiviral candidate being tested in China human clinical trials as a treatment for the 2019-nCoV novel coronavirus. “[BrightGene] actively responded to the national call to fight the new coronavirus (2019-nCoV) epidemic, and recently successfully developed and synthesized the technology and preparations for the drug synthesis of [remdesivir] technology,” the company stated today. “The company successfully imitated the development and production of [remdesivir] APIs by virtue of its technical accumulation in the development of high-end APIs and special injections,” BrightGene added in its statement, issued through the Shanghai Stock Exchange. “The company has produced [remdesivir] bulk drugs, and the batch production of Remdesivir preparations is in progress.” BrightGene acknowledged that its marketing of remdesivir “still needs to be authorized” by Gilead, adding, “There are many uncertainties in this process, such as drug approval.” BrightGene did not discuss in its statement what if any efforts the company has undertaken to pursue authorization from Gilead for the imitation product: “If the product can be approved for marketing, it will be supplied to relevant patients mainly through donations during the epidemic.”
“Kaleberg
April 19, 2020 11:46 am
Right now, we still don’t know if Remdesivir does more good than harm. In fact, we don’t even know it does any good”
That statement may hold for that anti-malaria treatment but the progress of experimentation for Remdesivir is further along than your statement implies. I agree that we should wait for the results of the phase III clinical trials before FDA approval. But that may come very soon.