Bitchy little tyrant is an understatement! Thank you for posting the document even if it is triggering to read.
You hope for reason in the room in the early stages of a global pandemic. Instead we have ““Approval is OUT OF THE QUESTION!!!” and “I HATE THEM” and by contrast the true voice of reason in Jay Lalezari: (email to Debra Birnkrant with cc to Jeff Murray dated March 27th, 2020)…let that date sink in….
“Sadly, we are on the verge of an unmitigated disaster threatening millions of lives. Given the known benign safety profile of Leronlimab and the above cytokine results, one could reasonably hope that early treatment with Leronlimab in hospitalized patients could reduce progression to ventilator dependence in some or even many patients. Accordingly, my conscience compels me to propose 2 ideas:
First, Cytodyn would like permission to start enrolling pts on the phase II trial in patients with
mild/moderate disease immediately. Our PI, Dr. Seetham, Is ready to start tonight.
Second, I’d like to propose the admittedly unprecedented idea of an emergency conditional approval based on known safety and accumulating cytokine data. This would allow doctors to treat hospitalized patients immediately and hopefully lessen the looming tidal wave of icu admissions for ventilator support. Formal approval, of course, would remain conditional on the results of the RCTs. Such conditional approval now would not entail any reimbursement to Cytodyn for providing drug in this dire situation. Further, such conditional approval would not preclude clinicians from treating their patients with other modalities or investigational antivirals.
We all know the drug is safe.
Those cytokine results strongly suggest this drug might help avert a national disaster associated with ventilator shortages.
Respectfully, Jay Lalezari, MD
Medical Director, Quest Research”
That was March 27th 2020!!! Now we have the perspective of hindsight. Millions died; scores of physicians, nurses and other medical professionals were hollowed out through the experience and left the profession, if they didn’t die first.
This reminds me of Oppenheimer…the important story behind the history is the cost of suppression of free speech. He saw the future, actions could be taken to forestall catastrophe but his voice was suppressed. Conventional estimates are that 6 billion people will die if global nuclear war is triggered today. Jay’s rational, well considered suggestion was not listened to by the FDA and in particular by Jeff Murray. Hate meant millions died. I hope when he meets his maker he will get a vision of the millions that died because of his prejudice and failure to listen to the data and reason. Jay had something reasonable and helpful to say on behalf of humanity and that voice was suppressed. There is absolutely no reason Cytodyn should have been denied an EUA, it met the criteria in spades…safe and may be effective.
You hope for reason in the room in the early stages of a global pandemic. Instead we have ““Approval is OUT OF THE QUESTION!!!” and “I HATE THEM” and by contrast the true voice of reason in Jay Lalezari: (email to Debra Birnkrant with cc to Jeff Murray dated March 27th, 2020)…let that date sink in….
“Sadly, we are on the verge of an unmitigated disaster threatening millions of lives. Given the known benign safety profile of Leronlimab and the above cytokine results, one could reasonably hope that early treatment with Leronlimab in hospitalized patients could reduce progression to ventilator dependence in some or even many patients. Accordingly, my conscience compels me to propose 2 ideas:
First, Cytodyn would like permission to start enrolling pts on the phase II trial in patients with
mild/moderate disease immediately. Our PI, Dr. Seetham, Is ready to start tonight.
Second, I’d like to propose the admittedly unprecedented idea of an emergency conditional approval based on known safety and accumulating cytokine data. This would allow doctors to treat hospitalized patients immediately and hopefully lessen the looming tidal wave of icu admissions for ventilator support. Formal approval, of course, would remain conditional on the results of the RCTs. Such conditional approval now would not entail any reimbursement to Cytodyn for providing drug in this dire situation. Further, such conditional approval would not preclude clinicians from treating their patients with other modalities or investigational antivirals.
We all know the drug is safe.
Those cytokine results strongly suggest this drug might help avert a national disaster associated with ventilator shortages.
Respectfully, Jay Lalezari, MD
Medical Director, Quest Research”
That was March 27th 2020!!! Now we have the perspective of hindsight. Millions died; scores of physicians, nurses and other medical professionals were hollowed out through the experience and left the profession, if they didn’t die first.
This reminds me of Oppenheimer…the important story behind the history is the cost of suppression of free speech. He saw the future, actions could be taken to forestall catastrophe but his voice was suppressed. Conventional estimates are that 6 billion people will die if global nuclear war is triggered today. Jay’s rational, well considered suggestion was not listened to by the FDA and in particular by Jeff Murray. Hate meant millions died. I hope when he meets his maker he will get a vision of the millions that died because of his prejudice and failure to listen to the data and reason. Jay had something reasonable and helpful to say on behalf of humanity and that voice was suppressed. There is absolutely no reason Cytodyn should have been denied an EUA, it met the criteria in spades…safe and may be effective.
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