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Posted On: 04/14/2021 12:12:48 PM
Post# of 148892
Re: KenChowder #86602
Here it is ...
Dr. Woodcock,
As you are well-aware, the rest of the world looks at the US FDA as the “gold standard” for therapeutic evaluation. As such, the world is currently looking to your agency as COVID has reached a crescendo in Hungary, Chile, Brazil, India, Canada, Philippines, Romania, and many other countries that are ill-equipped for a pandemic surge. The world needs the US FDA to take emergent action.
I’ve attached a pdf regarding leronlimab. I suspect you’re familiar with its contents - but the data speaks for itself. Yes, the Ns for the statistically significant values are small. But, you admitted on your update with Dr. Susan Bailey that the therapeutic trials were underpowered to succeed. Unfortunately, we can’t fix that now.
This presents an ethical conundrum: Does the FDA withhold leronlimab from the entire world and condemn thousands of people to certain death while a larger trial is done or does the FDA provide an EUA - perhaps while carefully guiding a phase 4 type of trial?
We are both physicians. One of the central tenets of the Hippocratic Oath is to “first do no harm.” And, when it comes to leronlimab, safety has been demonstrated repeatedly in trials for COVID-19 and HIV.
As such, I’d argue that not providing an EUA for a drug showing safety and a multitude of statistically significant positive data (on top of the eIND patients removed from ECMO, the recent published case report of the UK patient removed from ECMO after 70+ days, the former Philippines president “Erap” Estrada being extubated within 48 hours of receipt of leronlimab, reportedly excellent data from the OLE extension of CytoDyn’s trial, the unassailable science of Dr. Bruce Patterson, etc) is an ethical violation of first do no harm.
These patients are receiving the worst possible harm - death - because of FDA inaction. And why? The data supporting an EUA for leronlimab is far better than convalescent plasma, remdesivir, baricitinib, and hydroxychloroquine - all of which received an EUA. I just don’t see any objective reason for leronlimab to not receive an EUA.
Please reconsider providing an EUA for leronlimab. The world needs US FDA leadership now more than ever.
Best regards,
John
Dr. Woodcock,
As you are well-aware, the rest of the world looks at the US FDA as the “gold standard” for therapeutic evaluation. As such, the world is currently looking to your agency as COVID has reached a crescendo in Hungary, Chile, Brazil, India, Canada, Philippines, Romania, and many other countries that are ill-equipped for a pandemic surge. The world needs the US FDA to take emergent action.
I’ve attached a pdf regarding leronlimab. I suspect you’re familiar with its contents - but the data speaks for itself. Yes, the Ns for the statistically significant values are small. But, you admitted on your update with Dr. Susan Bailey that the therapeutic trials were underpowered to succeed. Unfortunately, we can’t fix that now.
This presents an ethical conundrum: Does the FDA withhold leronlimab from the entire world and condemn thousands of people to certain death while a larger trial is done or does the FDA provide an EUA - perhaps while carefully guiding a phase 4 type of trial?
We are both physicians. One of the central tenets of the Hippocratic Oath is to “first do no harm.” And, when it comes to leronlimab, safety has been demonstrated repeatedly in trials for COVID-19 and HIV.
As such, I’d argue that not providing an EUA for a drug showing safety and a multitude of statistically significant positive data (on top of the eIND patients removed from ECMO, the recent published case report of the UK patient removed from ECMO after 70+ days, the former Philippines president “Erap” Estrada being extubated within 48 hours of receipt of leronlimab, reportedly excellent data from the OLE extension of CytoDyn’s trial, the unassailable science of Dr. Bruce Patterson, etc) is an ethical violation of first do no harm.
These patients are receiving the worst possible harm - death - because of FDA inaction. And why? The data supporting an EUA for leronlimab is far better than convalescent plasma, remdesivir, baricitinib, and hydroxychloroquine - all of which received an EUA. I just don’t see any objective reason for leronlimab to not receive an EUA.
Please reconsider providing an EUA for leronlimab. The world needs US FDA leadership now more than ever.
Best regards,
John
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