Thoughts on off label use by a former pharmaceutic
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Posted On: 09/08/2020 7:17:25 AM
Thoughts on off label use by a former pharmaceutical rep. (Me) The Leronlimab portion is at the end.
Off label use absolutely happens all the time. Here are a couple from memory...
Neurontin was used off label so much for the treatment of different kinds of pain that Pfizer got in huge trouble for trying to lean in and capitalize on it. They marketed toward those off label uses, which is a big no-no, and got hit with hundreds of millions of dollars in fines.
(Ahhh sweet, sweet pain relief. I didn't sell anything related to this at the time but I remember thinking about how great it would be if one of my drugs would start getting prescribed like wildfire for some use that I didn't even have to, or even could legally, talk about. Sadly my stable of drugs at the time was a patch for overactive bladder, a patch for testosterone, and a genital wart gel. The glorious world of pharmaceuticals is not all boner pills and swanky dinners, my friends.)
I sold Nasacort AQ which in an intranasal corticosteroid (like Flonase or Rhinocort AQ or Nasonex) and often found doctors using it for patients who were taking other drugs via transdermal patches. Spraying it on that area would relieve the irritation and redness of the skin caused by some patches.
(By the way, selling this drug was maddening. It was equally effective as Flonase and didn't smell like you'd just snorted a line of concentrated, powdered rose petals. Not sure why anyone would like to go through the day unable to get the smell of their grandmother's bathroom out of their nose but I was just the Nasacort AQ rep, what did I know?)
Back in the day Requip and Mirapex were the only two drugs approved at the time for Restless Leg Syndrome. My company had Mirapex and I once attended a dinner event with a key opinion leader from the area. One doctor I called on for other drugs admitted at that dinner that he'd been treating all of his RLS patients with Lyrica, a drug without an RLS indication. I even followed up a year later out of curiosity and he still hadn't tried one of the only two drugs actually tested in that population. Crazy.
So it exists. But the almost completely consistent trend you would see sprinkled throughout any off label use you'd become aware of is that the drug being utilized in an off label manner was understood. The mechanism of action was understood, the safety profile, the dosing. Having that understanding allowed the doctors to make a few connections, or leaps of logic, and that allowed them to be comfortable making the decision to use a drug on someone off label.
We won't have that luxury right away. Unless they've taken a very deep dive into Covid treatments, or are intimately aware of the ongoing research into HIV treatments, they won't know enough about Leronlimab to both believe it could work AND know that it would be safe to try.
Of course that will come with exposure.
As an approval for Covid hits doctors will scramble to get up to speed with it. At that point they may realize that it's a monoclonal antibody, and an extremely safe one at that, and start putting two and two together for other MAB conditions. But it won't happen immediately. Many doctors aren't going to try something right away no matter how amazing it sounds. Everyone has their comfort level with new technology and while there will be a lot of early adopters there will always be a lot of laggards too.
I don't see any significant off label use happening for Leronlimab until there is a much greater level of scientific/medical community understanding. We'd likely see some off label use in HIV right away as doctors who have been following closely for that indication are eager to try it. We may see it in other emergency conditions related to the cytokine storm fairly quickly too. I don't see that as being in large numbers at first because we are still going to be relatively uknown.
But I highly doubt (outside of someone like Dr. Lalezari in NY) that we'll see any real off label use in anything like MS or Alzheimers any time soon. Not to mention that we are probably going to be under a bit of a supply strain for the first six months to a year as Covid soaks up available vials today and HIV supply needs to get backfilled to prepare for its approval in the next six months or so.
I could very well be wrong, by the way. Wouldn't be the first time. And I do think we reach a point where it does see quite a bit of off label use. Just not right away.
Off label use absolutely happens all the time. Here are a couple from memory...
Neurontin was used off label so much for the treatment of different kinds of pain that Pfizer got in huge trouble for trying to lean in and capitalize on it. They marketed toward those off label uses, which is a big no-no, and got hit with hundreds of millions of dollars in fines.
(Ahhh sweet, sweet pain relief. I didn't sell anything related to this at the time but I remember thinking about how great it would be if one of my drugs would start getting prescribed like wildfire for some use that I didn't even have to, or even could legally, talk about. Sadly my stable of drugs at the time was a patch for overactive bladder, a patch for testosterone, and a genital wart gel. The glorious world of pharmaceuticals is not all boner pills and swanky dinners, my friends.)
I sold Nasacort AQ which in an intranasal corticosteroid (like Flonase or Rhinocort AQ or Nasonex) and often found doctors using it for patients who were taking other drugs via transdermal patches. Spraying it on that area would relieve the irritation and redness of the skin caused by some patches.
(By the way, selling this drug was maddening. It was equally effective as Flonase and didn't smell like you'd just snorted a line of concentrated, powdered rose petals. Not sure why anyone would like to go through the day unable to get the smell of their grandmother's bathroom out of their nose but I was just the Nasacort AQ rep, what did I know?)
Back in the day Requip and Mirapex were the only two drugs approved at the time for Restless Leg Syndrome. My company had Mirapex and I once attended a dinner event with a key opinion leader from the area. One doctor I called on for other drugs admitted at that dinner that he'd been treating all of his RLS patients with Lyrica, a drug without an RLS indication. I even followed up a year later out of curiosity and he still hadn't tried one of the only two drugs actually tested in that population. Crazy.
So it exists. But the almost completely consistent trend you would see sprinkled throughout any off label use you'd become aware of is that the drug being utilized in an off label manner was understood. The mechanism of action was understood, the safety profile, the dosing. Having that understanding allowed the doctors to make a few connections, or leaps of logic, and that allowed them to be comfortable making the decision to use a drug on someone off label.
We won't have that luxury right away. Unless they've taken a very deep dive into Covid treatments, or are intimately aware of the ongoing research into HIV treatments, they won't know enough about Leronlimab to both believe it could work AND know that it would be safe to try.
Of course that will come with exposure.
As an approval for Covid hits doctors will scramble to get up to speed with it. At that point they may realize that it's a monoclonal antibody, and an extremely safe one at that, and start putting two and two together for other MAB conditions. But it won't happen immediately. Many doctors aren't going to try something right away no matter how amazing it sounds. Everyone has their comfort level with new technology and while there will be a lot of early adopters there will always be a lot of laggards too.
I don't see any significant off label use happening for Leronlimab until there is a much greater level of scientific/medical community understanding. We'd likely see some off label use in HIV right away as doctors who have been following closely for that indication are eager to try it. We may see it in other emergency conditions related to the cytokine storm fairly quickly too. I don't see that as being in large numbers at first because we are still going to be relatively uknown.
But I highly doubt (outside of someone like Dr. Lalezari in NY) that we'll see any real off label use in anything like MS or Alzheimers any time soon. Not to mention that we are probably going to be under a bit of a supply strain for the first six months to a year as Covid soaks up available vials today and HIV supply needs to get backfilled to prepare for its approval in the next six months or so.
I could very well be wrong, by the way. Wouldn't be the first time. And I do think we reach a point where it does see quite a bit of off label use. Just not right away.
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