A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics
S. Mulangu and Others
N Engl J Med 2019; 381:2293-2303
We thank the members of the PALM Consortium Study Team (see the Supplementary Appendix) for their many contributions in conducting the trial under very challenging field conditions, the members of the data and safety monitoring board (Lisa A. Cooper, M.D., M.P.H. [chair], Scott Hammer, M.D., Dave DeMets, Ph.D., M.Sc., Ann Sarah Walker, Ph.D., M.Sc., Mesia Kahunu, Pharm.D., Ph.D., Amadou Traore, M.D., M.Sc., Albert Faye, Ph.D., Salim Abdulla, Ph.D., M.Sc., and Rebecca DerSimonian, Sc.D., and Sally Hunsberger, Ph.D. [coexecutive secretaries]) for their oversight, the WHO and their coordinating committees (see Table S11), Anthony Fauci (NIAID), Robert Redfield (Centers for Disease Control and Prevention [CDC]), and Peter Salama and Michael Ryan (WHO) for leadership guidance, CDC staff (including Raimi Ewetola, Alstead Forbes, and Laetitia Vahaviraki) and the WHO staff (including the incident manager and field coordinators, supply and logistic teams, and Global Outbreak Alert and Response Network clinician experts) for in-country support, Raoul Kamanda and colleagues from the DRC Ministry of Health for invaluable support, and, most important, the patients themselves for their extraordinary bravery and altruism in participating in a trial of these experimental countermeasures.
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Peter Salama
Medical epidemiologist and Executive Director of WHO's Division for Universal Health Coverage. Born in Melbourne, VIC, Australia, on Dec 22, 1968, he died of a suspected heart attack in Geneva, Switzerland, on Jan 23, 2020, aged 51 years.
UMN INTERVIEW IN 2018...VACCINATIONS?
Salama also provided more details on the use of therapeutics in this outbreak. Thirteen patients have been given the experimental monoclonal antibody treatment mAb114, with positive results, and one patient has been started on remdesivir. More patients are expected to be given remdesivir, an experimental antiviral drug, in the next 2 days.
Finally, Salama recounted the details of angry youths who burned down a health center in the village of Manbangu after they learned of a local death from Ebola. He said community outreach has been strengthened in that village and vaccinations have resumed.
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Mike Ryan at the WHO took over in March 2020 and said this...
“We’re not ready,” Ryan said. “If we can’t stop Ebola” — referring to the ongoing outbreak in northeastern DRC, on the cusp of beginning its 16th month — “what hope do we have of stopping … Disease X?”
He was on the monitoring board of the ebola Remdesivir trial. Died in 2021. Wonder if he was an early vax for covid adopter. Wonder if he is in VAERS. Died of a brain hemmorage. Wonder if he would have spoken out against Remdesivir for SARS-COV-2? Had to have known Fauci through his AIDS research.
Stephen
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June 2020
CONCLUSIONS
In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)
---------------
Nov. 2020
Gilead Sciences, which makes remdesivir, has questioned the WHO's findings. In in an emailed statement, the drugmaker said: "We are confident that doctors on the front lines recognize the clinical benefit of Veklury based on robust evidence from multiple randomized, controlled studies."
ORIGINAL ARTICLEVOL. 381 NO. 24, DEC 12, 2019
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics
S. Mulangu and Others
N Engl J Med 2019; 381:2293-2303
We thank the members of the PALM Consortium Study Team (see the Supplementary Appendix) for their many contributions in conducting the trial under very challenging field conditions, the members of the data and safety monitoring board (Lisa A. Cooper, M.D., M.P.H. [chair], Scott Hammer, M.D., Dave DeMets, Ph.D., M.Sc., Ann Sarah Walker, Ph.D., M.Sc., Mesia Kahunu, Pharm.D., Ph.D., Amadou Traore, M.D., M.Sc., Albert Faye, Ph.D., Salim Abdulla, Ph.D., M.Sc., and Rebecca DerSimonian, Sc.D., and Sally Hunsberger, Ph.D. [coexecutive secretaries]) for their oversight, the WHO and their coordinating committees (see Table S11), Anthony Fauci (NIAID), Robert Redfield (Centers for Disease Control and Prevention [CDC]), and Peter Salama and Michael Ryan (WHO) for leadership guidance, CDC staff (including Raimi Ewetola, Alstead Forbes, and Laetitia Vahaviraki) and the WHO staff (including the incident manager and field coordinators, supply and logistic teams, and Global Outbreak Alert and Response Network clinician experts) for in-country support, Raoul Kamanda and colleagues from the DRC Ministry of Health for invaluable support, and, most important, the patients themselves for their extraordinary bravery and altruism in participating in a trial of these experimental countermeasures.
------
Peter Salama
Medical epidemiologist and Executive Director of WHO's Division for Universal Health Coverage. Born in Melbourne, VIC, Australia, on Dec 22, 1968, he died of a suspected heart attack in Geneva, Switzerland, on Jan 23, 2020, aged 51 years.
UMN INTERVIEW IN 2018...VACCINATIONS?
Salama also provided more details on the use of therapeutics in this outbreak. Thirteen patients have been given the experimental monoclonal antibody treatment mAb114, with positive results, and one patient has been started on remdesivir. More patients are expected to be given remdesivir, an experimental antiviral drug, in the next 2 days.
Finally, Salama recounted the details of angry youths who burned down a health center in the village of Manbangu after they learned of a local death from Ebola. He said community outreach has been strengthened in that village and vaccinations have resumed.
--------
Mike Ryan at the WHO took over in March 2020 and said this...
“We’re not ready,” Ryan said. “If we can’t stop Ebola” — referring to the ongoing outbreak in northeastern DRC, on the cusp of beginning its 16th month — “what hope do we have of stopping … Disease X?”
-------------
Scott Hammer (deceased.)
https://investor.siga.com/node/7366
He was on the monitoring board of the ebola Remdesivir trial. Died in 2021. Wonder if he was an early vax for covid adopter. Wonder if he is in VAERS. Died of a brain hemmorage. Wonder if he would have spoken out against Remdesivir for SARS-COV-2? Had to have known Fauci through his AIDS research.
Stephen
--------------
June 2020
CONCLUSIONS
In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)
---------------
Nov. 2020
Gilead Sciences, which makes remdesivir, has questioned the WHO's findings. In in an emailed statement, the drugmaker said: "We are confident that doctors on the front lines recognize the clinical benefit of Veklury based on robust evidence from multiple randomized, controlled studies."