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REMDESIVIR DOES NOT SAVE LIVES, DECREASES RECOVERY BY ONLY 4 DAYS, FUNDED BY U.S. TAXPAYERS

https://bit.ly/2YO8bFr

Lawrenceville, NJ (Dr Charles Simone) – The U.S. taxpayer played the major role in funding the discovery of remdesivir and its use in treating coronaviruses.

Now the U.S. taxpayer is being told to pay $3,120 for five doses of remdesivir to decrease recovery time by a mere four days for hospitalized COVID-19 patients.  Developed countries, the US Medicaid program and the Department of Veterans Affairs will pay only $2,340 for a five-day course. Countries in the developing world will get the drug at greatly reduced prices via generic manufacturers.  The bean counters forecast that Gilead will make $4 billion to $8 billion a year into 2023 (Cowen and Baird, SVB Leerink). 

We shut down our entire country and economy to prevent COVID-19 patients from dying, not to prevent them from spending a few extra days in the hospital.  Remdesivir does not save lives. But Dexamethasone, an old and very inexpensive drug actually saves lives. Let’s focus on saving lives.

April 29, 2020 headline reads: NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19  (https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19).  The placebo-controlled study of 1000 patients (68 sites – 47 in U.S. and 21 in Europe and Asia) showed that remdesivir does not save lives and defines “recovery” as being healthy enough to leave the hospital or return to normal activity level. The study excluded the sickest patients, and included patients with “lung involvement” requiring oxygen or mechanical ventilation.   This study was stopped prematurely by the National Institute of Allergy and Infectious Diseases because of an “interim” analysis which generally means “that a drug’s benefit is so undeniable that it would be unethical to continue the study.” But H. Clifford Lane, NIAID’s clinical director, said this was incorrect. The data come from a preliminary final analysis, a point at which the study would normally end.

May 16, 2020 – Another study published in Lancet this time randomized, double-blind, placebo-controlled of 237 COVID-19 patients from 10 hospitals in Hubei, China (158 remdesivir, 79 placebo), showed “no clinically significant benefits.”  https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931022-9

September 16, 2015 Gilead filed a provisional U.S. patent for the compound GS-5734 (same chemical structure as remdesivir) US 10 , 251 , 904 B2 and it was then filed on September 16, 2016 and finally issued April 9, 2019.  Issuance payment was made on April 30, 2020. (The dates are correct). (http://freepdfhosting.com/cfa87ce3b1.pdf )

October 26, 2015 submitted – March 2, 2016 published:Therapeutic efficacy of the small molecule GS-5734 [remdesivir] against Ebola virus in rhesus monkeys (as well as “other pathogenic RNA viruses, including filoviruses, arenaviruses, and coronaviruses”)published in Nature https://www.nature.com/articles/nature17180.  Most of the researchers are from U.S. government facilities: United States Army Medical Research Institute of Infectious Diseases, Frederick, Maryland 21702; United States Army Medical Research Institute of Infectious Diseases, Therapeutic Development Center, Frederick, Maryland 21702; the Centers for Disease Control and Prevention. Research was done in Fort Detrick in the highest security laboratory.  But the two patents that were finally issued to Gilead lists only Gilead employees on the patents specifically the one directed to coronaviruses.

Authors and Affiliations of Nature paper: Travis K. Warren1,2 , Robert Jordan3, Michael K. Lo4, Adrian S. Ray3, Richard L. Mackman3, Veronica Soloveva1,2 , Dustin Siegel3, Michel Perron3, Roy Bannister3, Hon C. Hui3, Nate Larson3, Robert Strickley3, Jay Wells1 , Kelly S. Stuthman1 , Sean A. Van Tongeren1 , Nicole L. Garza1 , Ginger Donnelly1 , Amy C. Shurtleff1 , Cary J. Retterer1 , Dima Gharaibeh1 , Rouzbeh Zamani1 , Tara Kenny1 , Brett P. Eaton1 , Elizabeth Grimes1 , Lisa S. Welch1 †, Laura Gomba1,2 , Catherine L. Wilhelmsen1 , Donald K. Nichols1 , Jonathan E. Nuss1,2 , Elyse R. Nagle1 , Jeffrey R. Kugelman1 , Gustavo Palacios1 , Edward Doerffler3, Sean Neville3, Ernest Carra3, Michael O. Clarke3, Lijun Zhang3, Willard Lew3, Bruce Ross3, Queenie Wang3, Kwon Chun3, Lydia Wolfe3, Darius Babusis3, Yeojin Park3, Kirsten M. Stray3, Iva Trancheva3, Joy Y. Feng3, Ona Barauskas3, Yili Xu3, Pamela Wong3, Molly R. Braun5, Mike Flint4, Laura K. McMullan4, Shan-Shan Chen3, Rachel Fearns5, Swami Swaminathan3, Douglas L. Mayers1 †, Christina F. Spiropoulou4, William A. Lee3, Stuart T. Nichol4, Tomas Cihlar3 & Sina Bavari1,2
1 United States Army Medical Research Institute of Infectious Diseases (USAMRIID), Frederick, Maryland 21702, USA.
2 United States Army Medical Research Institute of Infectious Diseases, Therapeutic Development Center, Frederick, Maryland 21702, USA.
3 Gilead Sciences, Foster City, California 94404, USA.
4 Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
5 Boston University School of Medicine, Boston, Massachusetts 02118, USA. †Present addresses: LOKET Consulting, Clarksburg, Maryland 20871, USA (L.S.W.); Cocrystal Pharma, Tucker, Georgia 30084, USA (D.L.M).  

Nov 9, 2015 – By using Vero E6 cell line that Shi obtained from Ft Detrick USAMRIID, Shi transformed the virus to seek humans.  Later this COVID-19 virus was found to have gp120 from HIV that causes immune system failure and is a critical target for vaccine development – published in Nature Medicinehttps://bit.ly/3eI11bK

LOOK AT THESE DATES:

September 16, 2015 Gilead filed a provisional U.S. patent for the compound GS-5734 omitting all government researchers.

October 15, 2015 the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and some others publish in Nature the research done to discover remdesivir and its treatment.

Nov 9, 2015 the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) gives Shi Zheng-Li, Wuhan bat researcher, the Vero E6 cell line that enabled Shi to transform COVID-19 to seek humans – published in Nature Medicinehttps://bit.ly/3eI11bK

Dr Simone’s Recommendations

1. The U.S. taxpayer played the major role in funding the discovery of remdesivir and its use in treating coronaviruses. Now the U.S. taxpayer is being told to pay $3,120 for five doses of remdesivir to decrease recovery time by a mere four days for hospitalized COVID-19 patients.  The bean counters forecast that Gilead will make $4 billion to $8 billion a year into 2023. We shut down our entire country and economy to prevent COVID-19 patients from dying, not to prevent them from spending a few extra days in the hospital. 

2. Even in a pandemic crisis, the Food and Drug Administration must be truthful and demand proper scientific data before approving any medicine for a treatment.

It is difficult to determine the accuracy of a placebo-controlled trial of 1000 in 68 sites – 47 in U.S. and 21 in Europe and Asia with different languages and coding systems, regulatory and ethical practices of every country. 

This study was stopped prematurely by the National Institute of Allergy and Infectious Diseases because of an “interim” analysis which generally means “that a drug’s benefit is so undeniable that it would be unethical to continue the study.”  But H. Clifford Lane, NIAID’s clinical director, said ‘this was incorrect. The data come from a preliminary final analysis, a point at which the study would normally end.’

The NIH sponsored trial should not have been stopped. 

3. The NIH must present truthful data.  Why did the NIH stop their trial prematurely? It was not a matter of life or death which is what we need to know. It was a matter of who could walk out of the hospital sooner and even then, if the trial continued, maybe there would be no difference.

4. Investigate why the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) gave Shi Zheng-Li the Vero E6 cell line that enabled Shi to transform COVID-19 to seek humans while at the very same time the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) engaged in research to find a possible treatment (remdesivir).

5. Repeal the 1980 Bayh-Dole Act that allows federally funded scientists to patent their findings.  These patents belong to the U.S. taxpayer.  By repealing the Act it would also eliminate Other Transaction Agreement (OTA) that prevents the government from being able to use march-in rights that normally allows the government to ensure taxpayer-funded products can be accessed at a reasonable price.

© 2020 Charles B. Simone, M.MS., M.D.