In conclusion, we are disappointed by the Panel’s hesitancy to make a recommendation in support of ivermectin, one of the safest, low-cost, and widely available drugs in the history of medicine. While we are thankful for the commitment made to closely monitor the findings of RCT’s near to completion, we struggle to identify an explanation for this level of cautiousness in the setting of escalating and uncontrolled case counts, hospitalizations, and deaths from COVID-19. This cautious approach may be partly related to the fact that none of the therapeutic agents introduced by FDA emergency use authorization during the pandemic has shown a reliable or meaningful impact on any patient centered outcome. The evidence in favor of Ivermectin is growing rapidly; it now includes approximately 32 controlled trials with 20 of them RCT’s with a large majority showing statistically significant impacts on time to viral clearance. Numerous groups worldwide have performed similar meta-analyses of these trials and concluded that ivermectin is a highly effective therapy for COVID-19 and/or should be widely adopted for use. We need careful, considered judgment of the risks vs. benefits to society of recommending a safe and lowcost medicine like ivermectin in the setting of persistently increasing morbidity and mortality of COVID-19 in the community. Why does the Panel’s opinion diverge from these other expert meta-analyses? Further, why does the Panel’s opinion diverge from the expert peer reviewers (two of whom we were told were FDA employees) that has now accepted our manuscript and its conclusions for publication?
To paraphrase the patient association Hersenletsel.nl, “waiting for the perfect evidence to be obtained" is no longer tenable when 4,000 patients are dying each day in our country. If we put the safety and potential of ivermectin against the ever-increasing impact of the virus, now is the time to more strongly support the adoption of this therapy. Patients do not have time to wait, and we as healthcare providers in society do not have that time either. We plead with the Panel to rapidly re-review and re-consider the current strength of their recommendation.
Sincerely,
The Front Line Covid-19 Critical Care Alliance Pierre Kory, MD Keith Berkowitz, MD Paul E. Marik, MD Howard Kornfeld, MD G. Umberto Meduri, MD Fred Wagshul, MD Joseph Varon, MD Scott Mitchell, MBChB Jose Iglesias, DO Eivind Vinjevoll, MD
[-] massimaux | 1 points | Jan 19 2021 17:00:32
Conclusion
In conclusion, we are disappointed by the Panel’s hesitancy to make a recommendation in support of ivermectin, one of the safest, low-cost, and widely available drugs in the history of medicine. While we are thankful for the commitment made to closely monitor the findings of RCT’s near to completion, we struggle to identify an explanation for this level of cautiousness in the setting of escalating and uncontrolled case counts, hospitalizations, and deaths from COVID-19. This cautious approach may be partly related to the fact that none of the therapeutic agents introduced by FDA emergency use authorization during the pandemic has shown a reliable or meaningful impact on any patient centered outcome. The evidence in favor of Ivermectin is growing rapidly; it now includes approximately 32 controlled trials with 20 of them RCT’s with a large majority showing statistically significant impacts on time to viral clearance. Numerous groups worldwide have performed similar meta-analyses of these trials and concluded that ivermectin is a highly effective therapy for COVID-19 and/or should be widely adopted for use. We need careful, considered judgment of the risks vs. benefits to society of recommending a safe and lowcost medicine like ivermectin in the setting of persistently increasing morbidity and mortality of COVID-19 in the community. Why does the Panel’s opinion diverge from these other expert meta-analyses? Further, why does the Panel’s opinion diverge from the expert peer reviewers (two of whom we were told were FDA employees) that has now accepted our manuscript and its conclusions for publication?
To paraphrase the patient association Hersenletsel.nl, “waiting for the perfect evidence to be obtained" is no longer tenable when 4,000 patients are dying each day in our country. If we put the safety and potential of ivermectin against the ever-increasing impact of the virus, now is the time to more strongly support the adoption of this therapy. Patients do not have time to wait, and we as healthcare providers in society do not have that time either. We plead with the Panel to rapidly re-review and re-consider the current strength of their recommendation.
Sincerely,
The Front Line Covid-19 Critical Care Alliance Pierre Kory, MD Keith Berkowitz, MD Paul E. Marik, MD Howard Kornfeld, MD G. Umberto Meduri, MD Fred Wagshul, MD Joseph Varon, MD Scott Mitchell, MBChB Jose Iglesias, DO Eivind Vinjevoll, MD
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