Mail Order Meds with Chris Hamby

The F.D.A. finally rolls back a 38-year-old policy that limited blood transfusions from gay and bisexual men. The U..S. Preventive Services Task Force recommends that women start getting regular mammograms at 40, rather than the previously recommended 50. A new study shows that Black Americans are far less likely to be treated for opioid use disorder. This is America, dissected Dr.

Abdul El-Sayed.

If you've listened to a podcast in the last three years, which, of course, you have. Or if you've even just watched anything on television, you've probably seen a lot of ads that sound like this.

Since 2020, depression, anxiety, and ADHD have risen sharply. That jump in illness has happened way faster than our ability to treat it. And that's where today's story sits. At that intersection between skyrocketing mental illness rates and telemedicine, one of the ways that we're trying to expand treatment for mental illness is through telemedicine. Rather than having to travel miles and meet someone face-to-face, we can use the magic of the internet to facilitate a visit. That would otherwise not have happened.

And there's no doubt that telemedicine has been critical to getting treatment out to folks who otherwise would not get it. And if you're a regular listener on the show, you know that. One of my biggest concerns, with the sunsetting of the Covid public health emergency that took place last week, is that it might curtail access to the type of telemedicine that so many people rely on. But just like every cloud has a silver lining, every rose has its thorns, and that's that it created the space for companies offering. We'll just say, less than safe treatments in less than regulated ways see male pattern baldness or erectile dysfunction. Their treatments are well-characterized and relatively safe.

But what about when the treatments still aren't all that well understood? what if those treatments are habit-forming? The ethics of these online treatment companies are complicated. Think about it. Medicine is built around a model where the treatment is supposed to be predestined.

You come in with a set of symptoms, your provider is supposed to do a history and physical exam, come up with a differential diagnosis, pursue their diagnosis with a set of tests. And then, if a treatment is necessary, write a script for it. The clinician isn't usually paid to write you a specific script for a specific medicine. Right up front, they go where the diagnosis leads them, rather than starting with the medicine they're supposed to prescribe and then working backwards.

These treatment-specific online models do the opposite. They put the physicians who work there in a tough ethical position, or worse, those doctors put themselves in that position. But honestly, treatments for baldness or PE, they're not that dangerous, Doctors know exactly how to prescribe them. And you've never really heard of a Viagra addiction.

Well, at least not to the medication anyway. But when it comes to online mental health treatment, the explosion in telemedicine treatment has led to a phenomenon. That, well beyond all of the others, sparked a bit of my concern. And that one that's mail-order. Ketamine, See, while there is strong evidence demonstrating that ketamine can be effective in treating serious, treatment-resistant depression, the evidence-based treatment protocols are focused on larger, more limited doses under serious clinical observation. And you can't do that through an online model.

So instead, these online providers are prescribing smaller, more frequent doses, which just isn't what the data has never mind safe. And when it comes to side effects, ketamine is decidedly not Viagra or baldness treatment. Ketamine is habit-forming, meaning you can get addicted to it. It also has some serious side effects, like incontinence. The F.D.A. hasn't approved either the form nor the treatment course. Because there's another piece here.

The F.D.A. oversees manufactured drugs. But mail-order ketamine is synthesized in small batches by a class of smaller outfits called compounding pharmacies, which, you guessed it, the F.D.A. doesn't regulate. There are definitely people who have benefited from expanded access to ketamine. And I think it's critical that we have more treatments available, not less, but I also think we owe it to patients. To address the ways that people who seek to profit off of them can exploit them when they're in a place of desperate need. Because, well, capitalism.

So just in case you lost me here, let me summarize you've got a mind-altering, chemically addictive medication with a serious risk of side effects. Being pushed by physicians who are employed specifically to write scripts for it, and being mixed in compounding pharmacies. Out of view of the F.DA, what could go wrong? And that's the question our Guest Today set out to ask. In his reporting in The New York Times, he interviewed over 40 patients, two dozen doctors and medical professionals to understand the promise and perils of online ketamine.

Chris Hamby joined me to talk about his findings. Here's my conversation with Chris Hamby. All right, can.

I was, you know, I think, well, first, a lot of people may not be aware of ketamine as a treatment for mental health disorders in the first place. But I had, you know, read a few articles about that. You know, it's, you know, along with some other sort of psychedelic-like drugs gaining in popularity. But I assume that this was something you had to receive in the clinic. And thanks to some pandemic-era rule waivers, it is actually was possible is still possible to do it at home. And so, you know, I saw some of these, you know, they're advertising on social media. Some of the companies that have sort of sprung up or grown substantially since the pandemic.

This is a drug that has been available on the street for some time and certainly has high abuse potential. All in this moment where you've got a changing regulation for purposes that are well beyond the circumstances of this particular medication. You're in the midst of the pandemic and people.

And telemedicine made that possible. And then, in a circumstance where the common use has sort of gotten well beyond what we'd normally expect in terms of a new therapy, right? And so this perfect storm really does highlight a number of dynamics in this moment in healthcare. And it's, I think, a really, really important window into how those forces can come to bear and some of the consequences on that. So can you tell us a little bit about ketamine?

What are its origins, what's it used for therapeutically, and then what is the more common usage on the street?

It's on the WHO's list of essential medicines and is frequently used, especially in the developing world. And so it has been used in that context for quite a long time. But that is at significantly higher doses, and obviously just once given to the care of a medical professional during.

More recently, there has been interest in it as a mental health treatment.

And at lower doses, it is, it's called. It's not technically a psychedelic, according to whom you ask, but it is a dissociative anesthetic, and it can engender a state. You know, visualization, sort of an out-of-body experience. Some people describe it, you know, at these lower doses. And it is showing quite a bit of benefit in some, albeit early research, indicating that it can sort of be sort of a mental reset for some patients, it's most of the research has focused on patients with pretty severe and complicated situations.

Most of the research has been on treatment-resistant depression, as you said, so people with significant depression that has not responded to other, more traditional therapies over time. And the research tends to focus on.

Infusions given in a clinic, and it's usually a time-limited series of maybe half a dozen over a few weeks. And most of the research really is looking at that. There's been some research on how do you extend those antidepressant effects beyond that, sometimes with periodic booster doses. But what we've seen with the at-home use is really sort of a different treatment paradigm.

That is beyond what there has really been a lot of research on, which is. Taking either a tablet or a lozenge that dissolves in the mouth over a period of time, and taking it more frequently and for a longer period of time. And there's just really not a lot of research to indicate whether that is, you know, on really the safety and efficacy of that long-term. And there are some indications that it could be problematic in various ways.

And yeah, it causes, you know, as I said, some people find the dissociated sort of experience. It's almost like a psychedelic in some ways to be pleasant. Some people I've talked to find that horrifying, you know, so it just depends really on the person. But it does sort of have a history of, at least among some subset of users causing addiction and abuse.

And the fact that that spectrum is so fuzzy is really what makes this a moral and ethical question. Because at the end of the day.

About ketamine use for therapeutic purposes is based on a very particular kind of regimen involving infusions, under very direct supervision by professionals who know what to look out for. And you have this change in regulation that then opens up Pandora's box in terms of all of these new pseudo-experimental uses. But are hitting the market as if this is how ketamine ought to be used out in the community. And that's the place where I think there should be a lot of discomfort about what this story tells us. Can you tell us a little bit about what was that regulatory change, what was it intending to target?

And then how did it get monetized, in effect, by, to say, the Ketamine Industrial Complex, to turn into this far bigger phenomenon?

Another area that I didn't really realize until I got into this a little bit further is that a lot of this is actually. It sort of opened up a business for a new industry of sorts, or a new sort of product for an existing industry, the compounding pharmacy industry.

So when you have these in-clinic infusions, the clinics are usually purchasing a pre-approved version of ketamine, which is usually a vial of liquid. Like a medical professional would give in an operating room, and the medical professional at a mental health clinic will administer this by IV or injection. But the at-home use, doctors either cannot or are not willing to prescribe. Send someone home with a vial of ketamine, which obviously could be quite.

In addition to the difficulty of administering it via that route. But so you have, like, this whole industry really that can take is exempted from a lot of regulatory requirements that normal drug manufacturers are required to meet. Because the idea initially was that they would make small amounts of sort of specialized medicines for patients who, for one reason or another, couldn't take an F.D.A. approved version of a drug. Maybe they had an allergy to one of its ingredients, or they couldn't swallow a pill or something like that. But the compounding pharmacy, really, the industry has really has seized on this and is able to compound. Tablets and lozenges, which there's no FDA approved tablet or lozenge of ketamine that you can get.

But so it sort of gives these compounding pharmacies sort of a lot of rain to do this and to ship across the United States, really, and so they've sort of filled this space. You have a lot of telehealth companies advertising in this area, you have a lot of, well, maybe not a lot of. But at least some even just smaller practitioners who have sort of come up in this space and realized that. With Telehealth, you can see a significant number of patients fairly quickly. And so even just individual providers in areas like family medicine have started doing this and seeing patients across the country.

And they are significant providers.

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You know, the context I want folks to understand about compounding pharmacies is that the assumption is that these are pharmacies that are mixing. A particular formulation of a medication. For patients with a far closer level of superfluosity than they are for people who are a particular physician who's ordering medications compounded this way, and this isn't like your usual CVS. This is meant to be a local kind of shop that does a very boutique kind of medication for people who are needing a very unique kind of formulation. And what's happened now is that with the advent of the internet and then the easing of regulations. You've got the situation where a compounding pharmacy can say, you know what, we can sell huge amounts of this stuff, right?

Because we've lined up a bunch of loopholes and we found a physician who is willing to pedal huge amounts of this stuff with very, very little oversight. In your piece in the Times, you talk about one. Dr. Smith, Can you tell us a little bit about that practice? And what they are doing in terms of being able to take these loopholes, line them up and then put a significant amount of?

And I think, in his view, is actually thinks that it is a very beneficial thing to a lot of patients. He's been pretty outspoken about, you know, feeling like. This should be a more broadly accessible therapy for a lot of patients. And he has really sort of starting relatively early on in the pandemic, kind of stuck his neck out there to provide this service to patients. Actually, there's a thriving Reddit community on this for therapeutic ketamine use that has just exploded in the last few years. And he has, really, he frequently posts on there.

He, you know, interacts with patients, a lot of people recommend him on there. And so basically, out of a small office in South Carolina. He has been seeing in the last few years, by his count, more than 3000 patients, I believe in 44 states.

And you know, a lot of the times he does end up prescribing them ketamine to be taken at home and so it will be shipped to their home. And some services, like Mind. Bloom is one of the big, sort of Silicon Valley startup type companies that is in this space. Will have more spaced out doses, and they typically require you to interact with some sort of guide. Or, you know, you have to be a little bit monitored and have a blood pressure cuff when you're taking it. But a lot of other sort of smaller practices, like Dr.

Smith Don't really require that, they will just check in with you once a month. For what patients told me was anywhere from a 15 to 30 to 45 minute appointment. And it may or may not be Dr. Smith himself. And they will just sort of check in how you're doing and, in many cases, renew the prescription.

And so, you know, you have a significant number of people who are taking ketamine every three days, at pretty substantial doses for a pretty long period of time. And you know, I think I spoke with Dr. Smith a couple of times and he was very forthcoming and is, you know, I think, feels like he is really helping a lot of people. And I did speak with some of his patients who recounted to me that they have had some of the side effects that are associated with this. But that are often minimized, which are bladder damage, often temporary, but sometimes permanent. And then experiencing addiction or issues with abuse. And, you know, I think, Dr.

Smith obviously said that that was unacceptable and that if he found out about that, he would take action. But that his feeling is that. We should not allow questionable decisions by a few people to limit access to something that could really help a lot of people, so that's where.

And so the thing becomes a self-driving outcome. The physician makes money by willingly being less attentive to side effects. The patient gets a medication that they initially jumped on to try and treat what might've been a very debilitating mental illness, but may develop an addiction. And so they have an incentive to keep the thing going. And on net. What has created is a lot of money flow. From someone suffering a debilitating depression to a doctor selling a treatment, and somebody who now has an addiction on top of their mental illness.

That is, at the worst case scenario, the circumstance. Not to mention a lot of the bladder damage, which is really, truly debilitating for folks. I know you interviewed many, many patients for your piece. Can you tell us a little bit about what their experiences were? What was it that you found? In terms of both the good in terms of people who felt like their depression was treated, but also potentially the bad in terms of the side effects that you found? Yeah.

I mean, I will say, and I.

Many of them, obviously, because they only had this expanded access because of Covid. It's still fairly early on, really, to say whether any sort of the magnitude of those benefits or whether they're sustainable. But I think definitely a lot of people feel like, at least in the short term, that it has helped them. But a significant number of people also experienced some of these side effects that have been associated with abuse of ketamine in the past. But that people who are proponents of its broader therapeutic use now generally minimize, which are principally the bladder issues and the risk of addiction and abuse. And it is you do have situations like the one you described, in which patients, if you do find that you have become, you feel like you are addicted to this. You are not likely to tell your doctor that you are abusing the drug, or if you're experiencing bladder symptoms, you may not tell your doctor.

And in fact, I spoke with a number of people who said that, who said that they did not want their prescription to be cut off. And even people who were experiencing pretty significant bladder problems said that they had not told their doctors. Because they felt like the ketamine was working and they were afraid if they were getting cut off, they would go back to the severe suicidality, even in some cases, that they were experiencing before. And it really is complicated risk benefit trade-off in some of these cases. But I think there's just what this really highlights is that when you're doing it at home via Telehealth, there's just there was already. This was a difficult situation and there's just such little support for a lot of these patients right now.

And these are some of the patients suffering from some of the most severe and complicated mental health issues. And they're really sort of taking a very powerful drug that is not an approved first-line therapy for this. And they're really doing it without a lot of supervision. So, you know, I think it's just a very difficult situation to know from their perspective what the right thing to do is. And then you combine that with sort of a number of regulatory gaps.

And it really is, I mean, the phrase that you use, wild West is one that I heard again and again and again.

And especially when you have a treatment that you are positioning as if it's frontline, that has very little evidence behind the particular use that you're offering. And you know that it has the risk for abuse. That poses a number of ethical, frankly moral questions. And there are going to be people who are hurt on the side. It's important that we get these medications out the right way.

And that's the other side of it, which is to say ketamine has evidence behind it. For the treatment of treatment-resistant depression, it is an important medication. I worry that sometimes the blunt tool of policy is just that it's blunt. And so you've got wild swings one way or the other. And the risk is that now the response is that we wildly restrict ketamine access. Even beyond the direction where you've addressed some of these misalignments of incentives that have led to this.

What is the regulatory situation? Like my partner Sara, my spouse, she's a psychiatrist, and she treats patients via telemedicine all the time. It has fundamentally opened up an avenue for treatment.

A number of restrictions around the way that treatments are given and how they're set up. In some respects, the answer is not to shut down telemedicine. The answer seems, to me, to be more about how you address these misaligned incentives. In the ways that a medication with high abuse potential should be formulated and can be formulated. And the assessments that need to happen to watch for these big side effect risks, where is the conversation about regulation now?

I think there are some providers who are seeking to arrive at some voluntary consensus standards to self-regulate part of this field. To try and impose at least something that responsible actors could draw on. There are probably, and I think I've spoken with a number of them. Well-intentioned practitioners who just legitimately don't know what the best practices are because they aren't well-defined. And so really, in the absence of any sort of.

F.DA requirements on prescribing guidelines. Or it really is sort of left up to the physicians at this point to develop best practices in terms of the DEA restricting use by telemedicine.

There is a rule going forward. Because what was set to happen was that when the public health emergency ends May 11th, the ability to prescribe this without seeing a patient in person would go away. It would revert back to the pre-pandemic rules. What the DEA has proposed is to have sort of a little bit of a middle ground, where, in general, patients would have to have one in-person referral. But they could continue to do it at home for the most part. And so I've spoken with various providers who were sort of trying to figure out how to navigate that space without totally blowing up their practices. But ultimately, this is an off-label drug that's going to probably continue coming from compounding pharmacies.

So the FDA, I have asked them repeatedly on this.

Not a lot of clarity on what exactly their role is in all of this.

What would you like to see this world look like once this moment of turbulence is over?

Or they have significant side effects. So there's really a lot of issues of drug development there. And you know, you can sort of go down the line about the incentives for certain types of drug development and the way that the F.D.A. approves drugs. And then, you know, in terms of the telemedicine piece from this, I mean, it would be difficult to argue that broader access to.

Be beneficial for some people. But I think we're really trying to figure out what that balance is right now. And I think that that's what the DEA is really grappling with in this rulemaking that's ongoing right now. And they have gotten a lot of comments from the public on that, and it's still open.

And that was really sort of the fundamental issue that I asked pretty much every patient and provider that I spoke with. You know, how do you, you know, how do you strike that balance between access, affordability and safety and efficacy?

And, you know, no one really had the perfect solution. And I think that that's kind of the place that we're in right now.

Is, you know, hopefully, you know. Like I said, I think there are a lot of physicians groups that are trying to be responsible and establish voluntary standards. But that will only get you so far, and there will still be bad actors.

There are, there are just a ton of regulatory gaps, and I think you're always, you're always going to see this tension there. So, and it kind of swings back and forth, and I think during the pandemic it swung pretty far in the permissive end of the spectrum. And you know, I think we may be starting to see a swing back to some degree. But there's always just going to be this, this tough balance that can't be completely addressed by regulatory action.

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And while PREP does exactly the opposite, meaning it reduces mask and HIV infection, which could lead to false negative screening tests. For blood. This is the right move and it's about damn time. And this also might be a good time to remind you that if you haven't given blood lately, I really hope you'll consider it. The U.S. Preventive Services Task Force, which sets policy on disease prevention around the country, has revised its recommendations for mammograms, recommending that mammograms begin at age 40 again.

That's because this is the first revision since 2009, when the task force delayed the age of first recommendation from 40 to 50.

They also recommended mammograms every other year, instead of every year that every other year recommendation. It still stands why the change. Screening is critical to catching early disease to find it before it's too late.

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That's right. And that's largely because people are having fewer kids and having them later. And that's largely because pregnancy before 35 reduces the probability of breast cancer, as does breastfeeding. And, well, people are having kids later, if at all. Finally, a new study in the New England Journal showed that Black Americans are far less likely to be treated for opioid use disorder than white folks.

The study followed nearly 25,000 people who had been treated for opioid overdoses and found that Black patients were less than half as likely to receive treatment for opioid use disorder. In the form of buprenorphine or methadone. While the study looked at filled prescriptions, not necessarily written ones, it paints a dire picture of the way our society deals with drug use differently by race. There's a whole sordid history you have to understand. Before the opioid crisis, there was another drug crisis in the 80s and 90s. the drug was crack cocaine, which hit Black communities hardest.

Rather than empathy, though, we got this.

But as we discussed recently, it was only a matter of time until this crisis hit the Black community. And what this data tells us is something many of us have already known our society still treats drug use differently when it's among Black folks. How else do we explain the fact that Black folks with opioid use disorder are less likely to get medical treatment for their disease? It also speaks to the fundamentally broken way we provide health care in this country. The fact that Black folks are way less likely to have consistent health care throughout their lives. And the ways that the health care system has earned the mistrust of Black folks, both historically, and continues to do so today.

Drug use is a disease. People deserve treatment, not blame, no matter the color of their skin. That's it for today. On your way out, don't forget to rate and review. It really does go a long way.

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