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--- covid-19:treatments:drug_therapies:remdesivir [2022/01/06 11:23]
mathew
+++ covid-19:treatments:drug_therapies:remdesivir [2022/02/16 16:17] (current)
leonardo [Wuhan Gang]
@@ Line 25: / Line 25: @@
 ===== Timeline of Remdesivir Research and Usage During the COVID-19 Pandemic =====
   * Jan 19, 2020: The first known U.S. COVID-19 patient was treated with remdesivir.((May 13, 2020 | [[:The Gateway Pundit]] | [[https://www.thegatewaypundit.com/2020/05/first-case-covid-19-us-treated-remdesivir-late-january-two-weeks-later-china-mass-producing-drug-firm-gilead-sciences-dr-fauci-middle/?fbclid=IwAR0UKDGqzXywE27oROwUn29PMd8EZgdjjKD6n_vC_yYmfkLV9kW07OCNycs|The First Case of COVID-19 in the US Treated with Remdesivir Was in late January – Two Weeks Later China Was Mass Producing the Drug – The Firm Gilead Sciences and Dr. Fauci Are In the Middle]]))
+  * April 15, 2020: A study on 12 total [[:rhesus macaque]]s is released claiming a "clear clinical benefit" in reduction of COVID-19 symptoms.((Apr 15, 2020 | Williamson et al | https://doi.org/10.1101/2020.04.15.043166))
   * June 13, 2020: The Health Ministry of [[:India]] allows for the use of remdesivir under an [[:emergency use authorization]].((June 13, 2020 | News 18 | [[https://www.news18.com/news/india/health-ministry-okays-remdesivir-under-emergency-use-authorization-hcq-for-early-course-of-covid-19-2668145.html|Health Ministry Okays Remdesivir Under Emergency Use Authorization, HCQ For Early Course of Covid-19]]))
+  * June 25, 2020: Remdesivir becomes the first drug approved (under the name [[:Veklury]]) by the [[:European Medicines Agency]] for the treatment of COVID-19 through a conditional marketing authorization.(([[:European Medicines Agency]] | https://web.archive.org/web/20200707071109/https://www.ema.europa.eu/en/medicines/human/EPAR/veklury))
+  * July 10, 2020: [[:FranceSoir]] notes the evolution of the lens through which remdesivir studies were evaluated, which appears like cherry-picking for significance.((July 10, 2020 | [[:FranceSoir]] | [[https://www.francesoir.fr/societe-sante/remdesivir-does-european-medicines-agency-endanger-our-health | Remdesivir: does the European Medicines Agency endanger our health?]]))
+  * August 2, 2020: Professor [[:Didier Raoult]], the first Western researcher to test the use of [[:hydroxychloroquine]] on COVID-19 patients, reveals that a Gilead-funded French doctor threatened his life.((Aug 2, 2020 | [[:Great Game India]] | [[https://greatgameindia.com/gilead-death-threats-hcq/|Gilead Sent Death Threats To Kill HCQ As COVID-19 Cure, French Dr Testifies In Parliament]]))
+  * August 19, 2020: [[:China]] reaffirms its protocol of using [[:chloroquine]] to treat COVID-19 patients, rejecting the use of remdesivir.((Aug 19, 2020 | National Health Office of China | [[http://www.nhc.gov.cn/yzygj/s7653p/202008/0a7bdf12bd4b46e5bd28ca7f9a7f5e5a.shtml|Notice on Issuing the New Coronavirus Pneumonia Diagnosis and Treatment Plan - Trial Version 8)]]))
+  * October 12, 2020: [[:Uganda]] approves remdesivir to treat COVID-19.((Oct 12, 2020 | MONITOR |[[https://www.monitor.co.ug/uganda/news/national/new-drug-to-curb-rising-covid-19-deaths-2463446| New drug to curb rising COVID-19 deaths]]))
+  * October 23, 2020: The U.S. [[:Food and Drug Administration]] approved remdesivir to treat hospitalized COVID-19 patients making remdesivir the very first approved FDA drug during the pandemic.((Oct 23, 2020 | [[:Times of India]] | [[https://timesofindia.indiatimes.com/home/science/fda-approves-first-covid-19-drug-remdesivir-all-you-need-to-know/articleshow/78824557.cms|FDA approves first Covid-19 drug remdesivir: All you need to know]]))
+  * Apr 7, 2021: Hospitals in Mumbai suffer remdesivir shortage as COVID-19 cases spike.((Apr 7, 2021 | [[:Times of India]] | [[https://timesofindia.indiatimes.com/city/mumbai/mumbai-hospitals-patient-families-flag-remdesivir-shortage/articleshow/81940578.cms| Mumbai: Hospitals, patient families flag Remdesivir shortage]]))
+  * Apr 28, 2021: Retired Colonel Sanjay Pande (India) complains that the U.S. is dumping expensive remdesivir on India.((Apr 28, 2021 | [[:Twitter]] | [[https://twitter.com/ColSanjayPande/status/1387585560592539648?s=20|@ColSanjayPande]]))
+==== Emergency Use FOIA ====
+You might be surprised to hear that about 20% of Gilead’s 2021 revenue came from sales of remdesivir, which enjoyed USD 5.6 billion in sales. As far as they are concerned, remdesivir is a runaway success.
+In fact, the US government goes as far as to pay hospitals to use it, with a bonus in the tens of thousands of dollars per patient that uses it, called the “[[New Treatments Add-On Payment]]”. No wonder US hospitals spent over USD 1 billion on remdesivir last year, more than on any other drug.
+So we are faced with the riddle of remdesivir; why is a drug that costs more than $2000 per treatment, which is associated with kidney failure, being given at a time that reason, and research, tells us it can’t have much of an effect?
+The plot thickens, as it turns out the FDA knew.
+The [[Emergency Use Authorization]] (EUA) of remdesivir, released via a Freedom of Information Act (FOIA) request contains an incredibly troubling paragraph;
+//Clinical Virology remains concerned about the disconnect regarding this drugs mechanism of action and the timing of treatment administration. Remdesivir is an analog of adenosine triphosphate that inhibits viral RNA synthesis, and as such, the drug would most likely work early in the infection cycle when SARS-CoV-2 replication is occurring at a high level. Most patients who are hospitalized with COVID-19 are entering the hospital during the second week of infection when viral loads are in decline and the underlying disease is associated with severe lung pathology driven by a hyperactive immune response and cytokine release syndrome. It is not clear that remdesivir will have much of an impact on viral replication this late into the infection cycle.
+//  ((https://www.documentcloud.org/documents/7221603-LEOPOLD-FDA-FOIA-Remdesivir-EUA.html))
+In other words, exactly what we’ve documented in this article so far.
+This paragraph was written on the 4th of May of 2020, only a few months after the official declaration of a pandemic, and almost two years ago. And yet, the vast majority of remdesivir administration was made with this observation being obvious enough that the [[FDA]] reviewers could notice it. I refuse to believe that the [[Gilead]] staff did not understand enough pharmacology not to make this incredibly obvious error. ((https://web.archive.org/web/20220216122144/https://doyourownresearch.substack.com/p/the-remdesivir-riddle?r=6x5ap))
+=== CARES Act Bonus Payments ===
+Report on Medicare Compliance 29, no. 39 (November 2, 2020)
+CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the [[Food and Drug Administration]] (FDA) for COVID-19. **The additional payments are linked to the 20% bonus hospitals already receive for COVID-19 MS-DRGs**, and both require proof of a positive COVID-19 test, according to the fourth interim final rule with comment period (IFC).[1] CMS also raised the specter of post-payment reviews.
+The interim final rule, which implements section 3713 of the Coronavirus Aid, Relief, and Economic Security [[CARES Act]], also said [[Medicare]], Medicare Advantage (MA) and commercial payers must offer FDA-approved vaccines free to patients. Medicare and MA will pay hospitals, physicians, pharmacists and others a fee for the administration of the vaccine and a fee for the vaccine itself.
+The ball for the newest add-on payments got rolling with the advent of coronavirus therapies. As the regulation explains, the FDA created a program for possible coronavirus therapies called the Coronavirus Treatment Acceleration Program, which includes issuing emergency use authorizations (EUAs) during the PHE. The FDA has issued EUAs for five drugs and biologicals for COVID-19, although only remdesivir and COVID-19 convalescent plasma are eligible for the add-on payment in connection with the inpatient prospective payment system (IPPS). ((https://web.archive.org/web/20220128220840/https://www.jdsupra.com/legalnews/cms-hikes-payment-for-covid-19-19452/))
+==== FDA Early Treatment Approval 2022 Remdisivir aka Vekluty ====
+Today, the U.S. Food and Drug Administration took two actions to expand the use of the **antiviral drug Veklury (remdesivir)** to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.
+“On the heels of the FDA’s recent authorization of two oral antiviral drugs, today’s actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” said [[Patrizia Cavazzoni]], M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers.” ((https://web.archive.org/web/20220215224728/https://www.fda.gov/news-events/press-announcements/fda-takes-actions-expand-use-treatment-outpatients-mild-moderate-covid-19))
+see also FORBES - The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work((https://www.forbes.com/sites/jvchamary/2021/01/31/remdesivir-covid-coronavirus/?sh=5cb83be766c2))
+==== Wuhan Gang ====
+Donald Trump was treated with remdesivir in the way that reason dictates: as soon as possible. [[:Peter Hotez]] commented, matter-of-factly-
+Thread on POTUS therapies; Being asked about mab cocktail from Regeneron and remdesivir and what it means?
+'I think a key point is that use of antiviral drugs, if they are to be effective likely must be administered early in the course of the illness during viral replication.'((https://twitter.com/PeterHotez/status/1312355823889330178?s=20&t=Bp5Prr6eeVTMe-tHn7b5Ug))(())
+And yet almost everyone else got the drug when it was already too late for it to help.
+Dr. [[:Anthony Fauci]] speaks on the clinical trial for potential coronavirus treatment drug remdesivir;
+“What it has proven is that a drug can block this virus ... This drug happens to be blocking an enzyme that the virus uses." ((https://twitter.com/NBCNews/status/1255541788154224641?s=20&t=Bp5Prr6eeVTMe-tHn7b5Ug))((https://web.archive.org/web/20220216133756/https://twitter.com/NBCNews/status/1255541788154224641?s=20&t=Bp5Prr6eeVTMe-tHn7b5Ug))((https://web.archive.org/web/20220216140546/https://twitter.com/PeterHotez/status/1312355823889330178?s=20&t=Bp5Prr6eeVTMe-tHn7b5Ug))
+As a side note, besides Fauci, a cast of characters well known among those who have been investigating the lab leak hypothesis make their appearance. [[:Peter Daszak]] was sure to claim credit for assisting in the development of remdesivir. (60 minutes) ((https://twitter.com/60Minutes/status/1260278403908931588))
+"The breakthrough drug Remdesivir that seems to have some impact on COVID-19, was actually tested against the viruses we discovered under our NIH research," says disesase ecologist Peter Daszak, whose coronavirus research grant was just cut by the NIH" ((https://web.archive.org/web/20220116000225/https://twitter.com/60Minutes/status/1260278403908931588 | 60 Minutes Interview))
+But the real hero in the development of remdesivir is Mr. Gain-of-function himself, [[:Ralph Baric]]. What was his role? Allow him to explain..
+"It's a game changer," says Dr. Ralph Baric, an epidemiologist about data that suggests the experimental drug remdesivir might help patients recover more quickly from the infection.
+"It offers real hope to humans infected with this terrible virus." ((https://twitter.com/DonLemonTonight/status/1255692885523156993?s=20&t=YBf2wiwSH5vVb26ws54BJw))((https://web.archive.org/web/20220216135336/https://twitter.com/DonLemonTonight/status/1255692885523156993?s=20&t=YBf2wiwSH5vVb26ws54BJw))
+((https://web.archive.org/web/20220216122144/https://doyourownresearch.substack.com/p/the-remdesivir-riddle?r=6x5ap))