A PLEA TO THE FDA
You watch the ambulance pull out of the small town hospital emergency bay with your wife of 34 years, having just chatted for a few moments as the crew prepared her for the 100 mile ride to a large hospital, better able to handle the possibility that her lung function may continue to deteriorate. It would not be a surprise at this point. You've already watched her deteriorate over the last few days, not wanting to believe what you were seeing with your own eyes. It was not a pleasant chat, what with a Bipap mask force feeding 15 litres of oxygen per minute to her. Even at that rate, the crew is struggling to keep her oxygen saturation at 90, the magic number. You cry, even though she begs you not too. She is obviously scared. You tell her not to give up. And they whisk her away. No use following the ambulance. There's no visitation whatsoever at the Covid ICU unit where she's headed. Your mind is racing. You fear you many never see your mate again. The thought devastates you. You do your best to contact friends and family. It's a battle to hold back the tears with every call, a battle you usually lose. Her lungs continue to lose the fight with Covid and her own immune system. Just one day later you get the call. They need to intubate her. You feel sick. Again, a short conversation, this time on the phone, through the woosh of the Bipap. The topic remains unspoken but you both realize this could be your final conversation....ever. You exchange "I love you's", and off she goes into a drug induced coma. The emotional pain you are feeling is nearly unbearable. Once intubated, her chances of survival have dropped to 33-50%. And many that do survive are forever dependant on a ventilator, a result of the damage their lungs have sustained. Many wind up in long term care facilities. A few are lucky enough to have a loved one willing and able to keep them home and deal with the ventilator. You get daily phone updates from her doctors. The rest of the time you pray the phone does not ring, for fear it will be THE CALL. The call you dread, the call that will change your life forever.
This nightmare that my wife and I lived through is being experienced by thousands of our fellow Americans every day. But it doesn't have to be that way. There is a drug that has proven to help people that are in the very situation that my wife was in....intubated and in critical condition. Leronlimab is a monoclonal antibody owned by an American company called Cytodyn. It has yet to be approved for Covid19 treatment by our FDA. In a recent phase 3 trial, Leronlimab reduced mortality in this group by 82%. This drug has saved the lives of countless Covid patients with one foot already in the grave, and numerous medical papers have been published documenting as much. Use of Leronlimab has resulted in zero serious adverse events in this trial and numerous previous trials. And yet, our FDA sits on its hands while our fellow Americans are dying each and every day. There is not enough Leronlimab available to treat the entire world, and while our FDA fiddles, other countries are looking into acquiring quantities of Leronlimab for their citizens. Will the FDA be held accountable if this drug winds up saving lives in the Philippines, Brazil, Canada, the U.K.....instead of the United States?
My wife is one of the lucky ones. I was able to get Leronlimab for her under the FDA's paperwork laden Emergency Investigational New Drug procedure. She was not expected to survive. But she did. Not only that, she was also able to wean off the ventilator. She is home now, working to regain her strength and happy to be alive.
During the EIND process, FDA employees told my wife's doctor that they were not sure Leronlimab would benefit her, but they were confident that it would not harm her. Is there any reason, therefore, not to make this drug available to American patients and doctors? RIGHT NOW! What is the FDA waiting for?
To our Food and Drug Administration, I pray that you approve this drug and make a survival story like ours possible for thousands of our fellow Americans. Please do your job!
Mark S, Jamestown ND
A letter I posted on Facebook. Please share.
