Dr. Abraham Morgentaler

You know what happened in women is that... All their hair fell out.

You know what happened in women is that... All their hair fell out.

It's rare. It's one of the risks in women, of course. But what happened is there's no FDA-approved testosterone product in women. And FDA has a funny relationship to medicine. FDA does not regulate the practice of medicine. They have nothing to do with what healthcare providers do or how they manage things except for making pharmaceutical products available on the market.

It's rare. It's one of the risks in women, of course. But what happened is there's no FDA-approved testosterone product in women. And FDA has a funny relationship to medicine. FDA does not regulate the practice of medicine. They have nothing to do with what healthcare providers do or how they manage things except for making pharmaceutical products available on the market.

they govern the pharmaceutical industry, and they will say straight out, we are not involved in the practice of medicine. Somehow, along the way, some kind of institutional part of medical education got tied into the FDA in a way that I think is actually unhealthy. So for example, I organize and speak at a lot of continuing medical education events.

they govern the pharmaceutical industry, and they will say straight out, we are not involved in the practice of medicine. Somehow, along the way, some kind of institutional part of medical education got tied into the FDA in a way that I think is actually unhealthy. So for example, I organize and speak at a lot of continuing medical education events.

It is part of the requirements, we call them CME, part of the requirement before that all speakers say whether or not they're going to be speaking about anything that is considered off-label. Off-label means using medicine in a way that the FDA didn't say is okay. So let's say a drug like, I don't know, the new GLP-1s. Great example. So they start off with whatever the first indication was.

It is part of the requirements, we call them CME, part of the requirement before that all speakers say whether or not they're going to be speaking about anything that is considered off-label. Off-label means using medicine in a way that the FDA didn't say is okay. So let's say a drug like, I don't know, the new GLP-1s. Great example. So they start off with whatever the first indication was.

I don't know, weight loss, diabetes. Diabetes, yeah. But it could be, it turns out there's incredible data that some of these medicines are good for other things, right? Like kidney function and- Heart disease. Right. But unless the drug company has applied for essentially permission from the FDA to state that as one of the benefits- then it's not, then the FDA won't give that as an indication.

I don't know, weight loss, diabetes. Diabetes, yeah. But it could be, it turns out there's incredible data that some of these medicines are good for other things, right? Like kidney function and- Heart disease. Right. But unless the drug company has applied for essentially permission from the FDA to state that as one of the benefits- then it's not, then the FDA won't give that as an indication.

So every drug, every time you pick up a medicine, it's got a label inside, right? Inside the box or whatever. And with a lot of fine print and all these scary things that can happen. And part of what it says is indications. That's what the FDA says the pharmaceutical company can promote that drug for. But that doesn't change the ability to use it.

So every drug, every time you pick up a medicine, it's got a label inside, right? Inside the box or whatever. And with a lot of fine print and all these scary things that can happen. And part of what it says is indications. That's what the FDA says the pharmaceutical company can promote that drug for. But that doesn't change the ability to use it.

And so physicians have discovered that all sorts of medicines have benefits and uses beyond what the label says. So at these conferences, and many of them are in guidelines.

And so physicians have discovered that all sorts of medicines have benefits and uses beyond what the label says. So at these conferences, and many of them are in guidelines.

So, for example, one of the treatments in my field, erectile dysfunction, is for people who don't respond to Viagra, Cialis, often the next line is medicine that the man injects in his penis that gives him an erection, more powerful than Viagra. And what is that medicine called? So usually it's a combination. The most potent is a combination of three, and we call it Trimix.

So, for example, one of the treatments in my field, erectile dysfunction, is for people who don't respond to Viagra, Cialis, often the next line is medicine that the man injects in his penis that gives him an erection, more powerful than Viagra. And what is that medicine called? So usually it's a combination. The most potent is a combination of three, and we call it Trimix.

But Trimix has never been approved by the FDA. So it's off-label. You can't pick it up at a pharmacy like Walgreens or Rite Aid. You have to go to a companion. You have to go to a companion. But it's been around now since the 1980s. It's standard treatment.

But Trimix has never been approved by the FDA. So it's off-label. You can't pick it up at a pharmacy like Walgreens or Rite Aid. You have to go to a companion. You have to go to a companion. But it's been around now since the 1980s. It's standard treatment.

So if I was giving a lecture that involved a comment about that, I would have to say ahead of time to the organizers of a CME event, I'm going to be discussing something off-label. But the off-label part for a lot of people say, well, that's kind of iffy. No, it's not. It's standard medicine. Often. Often.

So if I was giving a lecture that involved a comment about that, I would have to say ahead of time to the organizers of a CME event, I'm going to be discussing something off-label. But the off-label part for a lot of people say, well, that's kind of iffy. No, it's not. It's standard medicine. Often. Often.