Scientists Argue that this Genetic Test’s Results are “no better than a coin flip.” The FDA approved it anyway.

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Political violence rocks the 2024 election, as Donald Trump survives an assassination attempt. The Senate Health, Education, Labor, and Pensions Committee held a hearing on medical debt last week, in which your host testified. As H5N1 continues to spread in California, the state of Delaware moves to legalize unpasteurated milk. This is America Dissected. I'm your host, Dr.

Abdullah Hussain.

I remember sitting in my 12th grade biology class when I learned that the human genome had been fully mapped. Even better, one of the leading scientists involved in the project, Dr. Francis Collins, was a Michigander. Finally, we would be able to unlock the, quote, gene for this and that disease. But it was never going to be that easy.

As we've come to understand in the ensuing three decades, most diseases, if genetic at all, have very complex genetic undertones. While diseases like cystic fibrosis, a brutal lung disease, or sickle cell disease, in which malformed red blood cells wreak havoc throughout the body, really do come back to a single gene, most common diseases, like heart disease or type 2 diabetes, are the result of multiple genes interacting with the environment. And while we tend to focus on the genetic part, the environmental piece is usually more important. So why all the focus on genetics? It goes back to our conversation last week about the fact that there just isn't money to be made.

preventing illnesses, though there's a lot to be made treating them. Addressing the environmental factors that cause, say, a heart attack? Well, heart disease is usually the result of a whole series of upstream factors. Hypertension, diabetes, high cholesterol. Fixing those things usually goes back to incentivizing behaviors like eating healthy foods and walking more.

But doing that usually means massive policy change. Policies that do everything from rethinking food subsidies that make ultra-processed foods so artificially cheap, to rethinking community zoning policies that leave us living in sprawled-out neighborhoods without public transit. See, nobody makes money on these, and they're extremely hard to do. well. Compare that to designing a medication to address the downstream consequences of some genetic polymorphism.

If it works, it's a blockbuster drug. Some big pharma company makes billions and everyone praises it. The problem, though, is that that logic has fundamentally reframed the way we think and talk about the causes of illness. We've assented to a level of genetic essentialism for diseases that simply are not genetic. Consider opioid use disorder.

By definition, if there were no opioids, there would be no opioid use disorder. In that way, this is almost the purest form of environmental disease. And though the targeted overprescription of opioids kicked off the overdose epidemic that continues to kill over 100,000 people a year, there are certainly uses for opioids in clinical practice, like acute pain management or care for people with certain chronic pain conditions. And that's what prompted a pharma company called Solved Health to create what they're calling a genetic test for opioid use disorder. Using a combination of 15 different genetic polymorphisms, they claim that their test, called Averted, can predict the probability of opioid addiction.

The idea here is that physicians can administer the test to understand which of their patients might be, quote, safe to prescribed opioids and which might not. But here's the problem. According to 31 scientists who wrote a letter to the FDA demanding that it reverse its decision to approve the drug, it just doesn't work. In fact, a 2021 study found that using these 15 markers performed, quote, no better than a coin flip. That's not the first time experts blasted the test.

The FDA's own advisory panel, a group of independent experts tasked with advising the FDA on approval decisions, voted 11-2 for rejection. See, these tests, they can do real harm. They can give physicians a false sense of security in prescribing opioids to people who test negative for the genetic marker. They can contribute to stigma in people for whom the test may indicate higher risk. And, most importantly, they fail to address the fundamental cause of opioid use disorder, overprescription of opioids.

Perhaps the most damning way to think about this is that if the overdose epidemic was the result of pharma deliberately over-marketing a dangerous substance, you can appreciate how rich it is that now pharma is trying to market a new product to address it. Who wins? There are a lot of possible losers. But who wins? Pharma.

I wanted to get the perspective of someone who's participated in these discussions, and so I reached out to Dr. Elizabeth Joniak-Grant, a sociologist and patient advocate at the FDA. She was on the advisory panel that reviewed Averted and voted for rejecting the approval application. She joined me to discuss the risks of genetic essentialism, the challenges with tests like Averted, and what happens when we don't get the science right. My conversation with Dr.

Elizabeth Joniak-Grant after this break.

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And I'm there both as a sociologist but also to represent sort of a lived experience of a life where I'm often given prescriptions.

So I kept pushing through graduate school and did my PhD. And then about that time, they said, yeah, you know what? I don't think you're really going to get much better. So I decided, as all good graduate students do, to keep pushing through, get that dissertation done, and then try to start doing teaching. I was trained as an ethnographer.

I did research for years with unhoused youth in Hollywood. So I was always very active in the field, doing interviews. And that's kind of a passion of mine for collecting data. And I tried teaching for a while, loved it, but my body just couldn't do it. I could not work a full-time job.

It made everything worse, pain-wise. And so I had to take a break and regroup and figure out what could still give meaning to my life, what was I capable of. And a friend of mine who was also a sociologist and was doing this amazing blog, she was living for a year without mirrors, said, you know, why don't you write a blog post? Because we'd had this lengthy conversation about how she said how she would always notice things about herself and her physicality when looking in the mirror. And I said, wow, that's really different than my experience.

I said, I look in the mirror and think, oh, my shoulder's not in the right position. Oh, I need to relax my neck muscles. Oh, all these things I kind of learned through physical therapy. And after I did that, I had kind of a good response to it. And I decided that I wanted to try and get more involved and advocate for patients.

I was really, really fortunate to be married and to have good insurance and to have the ability to kind of pursue massage and aquatic therapy and all these things that help manage chronic pain that a lot of patients can't do. I also, as a sociologist, have a lot of skills in being able to look at my personal experience, but to also talk to a bunch of other patients and bring all that information together in a way that I can still kind of get the themes of what's going on with a bunch of people. And so I started reaching out to advocacy groups to see how I could get involved. And one of them mentioned I could go down to the FDA for a public listening session about drug development for fibromyalgia. And so I got on a plane and I went.

And I was a little bit loud. I had a lot of opinions. And after that, they invited me to apply to their patient representative program. And that's sort of where it all kicked off from.

But once in a while, you kind of need to get your headspace out of being reminded of everything that's wrong with your body and move away from that from time to time.

How does their ability to go to appointments impact things, or their ability to pay for treatments or not pay for treatments? And so I really try to look at people in this whole biopsychosocial way of where their pain comes from. Because I know that by being able to change the way that I live my life and the social obligations that I have on me, the way that I work, the way that I parent and these types of things, I've been able to make my pain far less. So you do have these abilities to impact your pain, but I think it's a very rare opportunity that people are in a social position or to be able to even attempt to do some of those things. And I think that gets missed a lot.

Doctors are very quick to say, oh, you know what? Aquatic therapy, it's great. You need to do this. Or, you know, PT three times a week. And there's not an understanding of, one, does my insurance cover it?

Two, how much does it cost? Three, can I get time off work to even go? What am I going to do with kids in the meantime? What am I going to do with spouses in the meantime? And so, until all those pieces are really looked at and considered, PT doesn't matter.

Because if you think about where opioids come to, it is this medical essentialism that tells us that the way to treat pain is through a medication. Right? And you take this medication, it treats the pain, and that's what pain is. And, yeah, you can numb a certain level of pain with opioids without actually thinking about all the long-term consequences. And, you know, one of the main topics that we're going to get to today is this genetic risk test for opioid addiction.

Which what we're doing now is we're appealing to a level of genetic essentialism to understand who might be most likely to suffer the consequences, the long-term consequences, of our attempt to essentialize pain.

And so it was going to look at 15 of them and could say that it could give an assessment of whether or not a person was high risk of developing opioid use disorder or low risk of developing opioid use disorder. So that was kind of the crux of what they were claiming to be able to do.

I, after reading through lots and lots and lots of information that came my way, was not convinced that this was going to be worthwhile. I think, first off, with any type of genetic testing, I get concerned because, again, it's trying to locate everything in the individual, right? If you have pain, if you have opioid use disorder, if you have any issues, so to speak, it's you. It's just you and only you. And now it's going down to even the more basic level of who you are.

It's in your genes. Right. And so, like you were saying, it essentializes all these things. But even more so specifically for this test, there was a lot of debate, with the committee basically saying that these particular snips that they chose were not correlated with opioid use disorder really whatsoever. There were a lot of experts who know a heck of a lot more about this stuff than I do, who said, in fact, that all they were really looking at was nothing.

And that it was essentially any of it would be confounded by ancestry.

Ancestry really impacts genetics. Right. And any type of genetic testing and most of genetic tests are basically developed out of Europeans, white Europeans, mostly northern Europeans, I believe. And they have found that as soon as you start to have other people in there with other ancestry, that a lot of the findings don't hold. And so this was another big problem, because their sample was 92 percent, I think, white, which, especially as a sociologist, I have a problem with the lack of diversity in trials and clinical trials.

And then, honestly, when I looked at it from a patient perspective, because that's why I sit on these advisory committees. Right. I'm there to say, OK, how does this impact a patient? You say, this improves things by three points. What is three points mean in a patient?

Right. Does that mean sleeping an extra 20 minutes? or what are we talking about? And when I looked at it from a patient perspective, what it basically meant with once they did all the math and did all the statistics is that if someone came back, if the test came back and said, yes, you are, you are high risk for developing opioid use disorder. What that means is that individual would have roughly a four percent chance of developing opioid use disorder, assuming, again, that these were the right snips that needed to be pulled.

And I said to myself, you know what they're saying? Basically, you're high risk or low risk. We know what it's like to deal with pain and opioids and things like that. And what we're really saying is you're either a four percent risk or you're a one percent risk of having future problems with this. And is that information useful to patients?

Is that useful to parents? And I really came up strong on the way of saying, no, I think it's going to be. I think there's going to be a lot more risks and problems that come with utilizing a test like that than benefits.

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And I'd love you to walk through some of the scenarios you could see playing out if this kind of a test was in regular clinical use.

Most states have laws about how many opioids and what duration you can prescribe opioids. Chronic pain patients have been subjected to forced tapering of opioids. So, and really, even with all of this sort of deprescribing or less and less prescribing of opioids. Right. We're still seeing opioid overdoses going up immensely.

And I know that you're aware of this. A lot of listeners are probably aware of this. But this is because right now. Right. It went through heroin was being a main cause of it.

But now it's really fentanyl. And we're seeing more and more and more xylosine. And I speak of this because I also work in the opioid data lab. And these are the things that we're looking at. These are the things we're trying to understand.

You know, why? Why are we still seeing? You know, if this was the cause, if it was all about doctors over prescribing, you know, why? Why are we still having issues with overdose and such? And so I think understanding kind of what's going on is really important to understand some of the dangers that that we can anticipate coming.

You know, we talk a lot about unintended consequences, but the more work I do in this field, I feel like it's less unintended consequences and more ignored consequences, likely and likely consequences that are ignored. So for some of these, I think one of the major issues is that any time we have a test like this and the results are bifurcated into either. And to be fair, they changed it. They made it. It was high risk and low risk.

And now they show you a graph of sort of a continuum, and they changed it to elevated risk and non elevated risk, which to me kind of made me chuckle, because to me, that's just a semantic thesaurus game that they did. People have a tendency to go, oh, you're, you're either A or you're either B. People like life to be in categories. People like to make things simplified. And, you know, clinicians, too.

And so. I'm really concerned that this will be treated as objective and definitive. You know, clinicians have always generally preferred signs over symptoms. They like to see that a bone is broken on an X-ray, not really respond to sort of what what patients are reporting as their symptoms. And I think patients really aren't familiar with genetic tests and what the difference is between diagnostics and screenings and risk assessments.

I think that's one of the biggest things. What will patients do with this information if it's not really clearly explained to them?

You know, and and they they've come out and said FDA has come out and said, oh, well, you know, one of the things they need to do is we need to do patient education. But as we we know. It's impossible to do patient education, oftentimes with the time crunches that a lot of clinicians are under. You know, already they're not doing evaluations that they should be doing for deciding who they need to be more careful with, with prescribing opioids. These things aren't happening already.

So now we're going to add another thing to the pile and say, OK, now we've added number four. And by the way, yep, keep doing one, two and three, even though most of you really aren't ever doing one, two and three. And that's what's going to help keep number four from being a problem. And so that's one of the big struggles I have is I don't think patients are going to get the information. I look at, you know, I think of prenatal testing, how long and how much work it's taken for people to realize that those are just screenings.

They're just saying if further tests need to be done. Right. Like they're not often they're not, they're not definitive. And it took so much work and so much education and a lot of grassroots work for people to realize that that's what those tests are. So this is, this is the thing that really, really concerned me.

I think also, too, some of my colleagues raised. they were concerned that if certain patients were seen as low risk or non elevated risk, that they would then be seen as safe. And, you know, clinicians, what we found in some of the work that I was involved in is that they really have a fear of legal liability. They aren't comfortable prescribing opioids. It's stigmatized to prescribe opioids.

Patients who take opioids are stigmatized. So I'm less concerned that this would lead to people just suddenly prescribing opioids all over again. I think that's less of a concern. However, I do think that it would lead to under prescribing.

One of the one of the very obvious things is that these results take 24 to 48 hours. So what happens in the interim? Does somebody get a one day prescription if they need opioids? Do they not? Do they have to wait until results come back?

What if results are taken on a Friday? Does that mean results don't come in until a Monday? Like all the practicalities that come with making these decisions. And just before, you know, people that are listening think I'm all pro opioid and I think opioids are the best thing ever. I don't.

But I do think that they have a place in medicine. I know for me, I have a bleeding disorder. I can't take NSAIDs. They are contraindicated for me. And so oftentimes I'm left with opioids or sometimes gabapentins.

There are other people with issues like Crohn's and things like that. So I think opioids have a place. I don't think they're the only thing. But I think to just say, you know, they're all bad and no one should ever get them is short sighted. I also think that tests like this, as much as they're meant to only be used in certain scenarios and only voluntarily and only with acute patients, with patients with acute pain or surgical pain, I don't think it's going to stay in those boundaries.

We have. we've seen time and time and time again where guidelines come out or, you know, legislation comes out that says, OK, this is the only way that this should be used. And before we know it, chronic pain patients are being impacted again and again and again. In my state of North Carolina, you know, prescribing limits. legislation came out and they said this is just for opioid, naive patients, that for acute pain you get a five day prescription, for surgical you get a seven day prescription.

And actually it reduced prescription, the most for chronic non-cancer pain patients, who were not even mentioned in any of the legislation. And so I don't see this as a potential consequence. I see it as a very likely one when we look at history, for sure.

Where do you feel the pain? How's the pain? Is it stabbing the last 14 days? Well, I've been doing really great the last 14 days, but the three months before were terrible. So, so much gets lost.

And I have been fortunate to have care from doctors who will meet with me for 30-minute appointments, 45-minute appointments. One of my best specialists, he actually, for the first year that I saw him, I went in every three months, and he always made me start from the beginning of how I got hurt and what happened in the years after, because he said, I need to put the pieces together. And there will be information that will pop up from you. that's different each time, just a little bit here and there. that will help me understand what we're dealing with with you and what might be certain things that I can try.

And it was so refreshing to have that approach. And I've been really fortunate with my care, but I know that that's rare for so many people to have that experience. And I think, too, with these tests, I am really concerned about them serving also a gatekeeping function to sort of like, it's supposed to be voluntary, but will it really be? And yes, it'll start off at Centers for Excellence. And will it probably be voluntary there?

Yeah, I think so, because they're Centers for Excellence. But when it goes out to the masses is when I get really concerned, because there is a ton of data out there. I've been involved in studies that show that when patients ask questions about opioid prescribing, whether it's amounts or, you know, why am I getting this or why am I not getting that? Clinicians tend to view them negatively. They tend to view them as possibly having opioid use disorder or as being drug seeking.

And so and patients know this. So there's a lot of mistrust sometimes in these doctor patient interactions. And I worry that when a test like this comes along, that just massively oversimplifies what's at play, that that is only going to exacerbate the problem.

It will be rolling out into centers for excellence, which are, you know, special places where things are very controlled and generally very well done. There will be a lot of post-marketing analysis and studies. They want to do a study where they look at how do clinicians use this on the ground? How is this impacting patient experiences? Again, these will be studies that are done by the sponsor or the company.

who the company who put this test together. And, beyond that, when this is happening and what those studies are going to look like and how they're going to be conducted, I really couldn't tell you. I am not privy to any of that information. We'll just have to see.

And, you know, you voiced a lot of concern. And just for listeners, we talked a little bit about this when it, when it happened. But, you know, there has been some promising research about the potential use of MDMA therapy for treatment of PTSD. A lot of a lot of problems with the study design in that research and some really open questions about a substance that both has abuse potential and can be deadly in an overdose. So I'd love to hear a little bit from you about your concerns and what you'd like to see in terms of better understanding the potential impact of this particular substance for for PTSD and other mental ailments.

And then, as I started digging into it, I started feeling a bit deflated.

Unfortunately for me, some of the big concerns were that they had enrolled patients that had had, to me, pretty lengthy experience with with previous use of MDMA. I think 40 percent of of participants in the trial had previous use of MDMA. And that previous use was between one and up to 10 times. So given that and and to me, 10 is 10 was a lot, you know, one maybe could slide. But to me, you know, this is they're sort of pushing this idea that it sort of is this game changer and kind of how your brain works and the method that happens.

And so if you have them coming in saying, well, you need to do these three sessions, and, you know, some people, this is actually session number 11, 12 and 13,, 13.

. Right. Like, how can we say that? And it's really unusual, right, in clinical trials, to enroll people who've already done the thing or use the thing. And also, I felt like it would really downplay any sort of negative side, potentially negative side effects, because if you did MDMA and you hated it or had a terrible experience or it made you feel really sick, or what have you, are you going to be likely to enroll in a clinical trial where they say, OK, now you're going to have to do MDMA three more times?

You're not. And so it felt in that way, for that regard, that that at least in that terms, they were really kind of stacking the deck to have favorable outcomes. The other piece for me that was concerning was sort of allegations of whether or not the data was valid. There was, you know, there was an issue of sexual misconduct that had happened in phase two of the clinical trials. There's very little information of what was done to manage that and to prevent that going forward.

There was also some claims from people in public comments that said that they had been in the study and had had negative experiences, and those experiences were not included in the data set. There were an individual who said, you know, she was suicidal, but the way that they were taking her information, they were seeing it as sort of part of the process of working through the trauma. And so she was seeing this as this really positive thing. And it took her getting sort of moving past the trial and realizing, wait a minute, this was not a good thing for me. This was, this was a detrimental experience in my life.

And so there was. there was a lot of sort of allegations kind of floating around in all these different directions that I was uncomfortable with. And I wanted more information about and unfortunately couldn't really get it. You know, and as the consumer representative who was working with me, you know, said, she's like clinical trials should be the best of the best. Right.

It's kind of like. it's kind of like a first date. Right. If you go on a first date and it's terrible and this is their best impression they have probably don't want to go on the second date. So if things are falling apart and going to hell in a clinical trial, do we really want to start spreading it out to the world already?

Maybe not. Maybe we should slow down. And it was. it was a really tough one. It was very emotional.

There's, you know, PTSD is exhausting. It was kind of triggering for me, too, to hear the stories, because I'm dealing with that as well. And I really felt for the people. I think there's potential there. But I don't think this study that was done in this way, with this type of alternative therapy, which was lacking in description as well.

Is it? and to kind of speak to your one question about, like, what would I be looking for? I think I'd be looking for just more of a controlled study in the sense of, hey, we're taking some evidence based approaches that work for that have been shown to work for PTSD, like maybe EMDR or, you know, certain types of of cognitive behavioral therapy. And we're going to look at those and we're going to look at those, with MDMA added into the mix to do some comparisons across the board. that way.

I think that's something I would have been a lot more comfortable with and would have made more sense to me versus sort of like, well, then, we do this therapy. And that was all the information that we had.

So that was a big thing for me.

And I'm like, OK, so if you're comparing something about about a treatment, that treatment needs to be as uniform as possible. Otherwise, you don't really know what you're measuring. And to your point, right, there is this selection bias that's imposed by allowing people who've had exposure in the past into the trial. And there's the self-selection that happens, as you talked about, with people out of it. And then the other.

the other part of it that was somewhat worrying to me is that you really can't get a solid contrast, because if you got high, you know you got high. And if you didn't get high, which is what happened, if you got the placebo, you kind of know you didn't get high. So in some respects, there is a sense of an inability to truly blind people to the exposure. that is also problematic. And, you know, it very well.

may be the case that MDMA really does help to treat PTSD, but you need to know it. And the way that we do, that is by doing solid, rigorous, well-controlled studies. And these just weren't that. And so I appreciated your courage in being able to call that out and to remind us that our responsibility is to hew to the scientific process. And if you don't have good science, junk in, junk out.

Right. And it's very difficult to be able to assess the impact. I really appreciate you taking the time to join us and to share your experiences. Our guest today was Professor Elizabeth Joniak-Grant. We spoke today about the pitfalls of genetic testing for risk of opioid use disorder, as well as a bit about MDMA therapy for PTSD.

Thank you so much for taking the time to join us.

A bystander in the crowd, Corey Comparatore, was killed by a shooter's bullet while protecting his family, as was the gunman from returned fire from the Secret Service. As of Sunday, July 14th, we don't really yet know what drove the shooter to this, and we may never. But that won't stop political spinsters from using this or that detail in his biography to make insinuations. But stepping back, what we do know is that the incident has plunged an ever-worsening state of American political discourse to lows we haven't seen since the 1960s. I shudder to think of what could have happened had the bullet been an inch further to the right.

And I wish him and all affected speedy recovery. And my prayers go out to the Comparatore family. Democracy at its core is a process by which we resort to rules and votes to resolve our political differences. The whole point is to avoid violence. And so, there is, by definition, no room for political violence in a democratic society.

But we also have to take stock of what led us here. Since 2016,, we've been locked into a deepening spiral of meanness, recrimination, and brinksmanship. And this isn't the first time. it's led to deadly violence. As much as some people would like you to forget that it happened, supporters of the former president did try to take over the Capitol on January 6th of 2021 to interrupt the peaceful transfer of power.

The thing about words is that they have power. And when leaders use them to spread hatred, to sow disunity, to destroy public trust, it leads to the consequences. we're watching now. As I've said before, there is no public health without collective action. And in our society, that's founded on unity of purpose expressed in our government and civic institutions.

This doesn't bode well. In these dark times, though, I do want to offer a counterpoint to the political violence that marked this past week. Senator Bernie Sanders, a recent guest on the pod and chairman of the Senate Health, Education, Labor, and Pensions Committee, called a hearing on the scourge of medical debt, at which I was invited to testify. I got to share a bit about our work in Wayne County, eliminating up to $700 million in medical debt on behalf of 300,000 of our residents, and to talk about the insidious causes of medical debt. Here are a couple of clips from my testimony.

Healthcare costs have gone up 25% in just five years. And rather than act on behalf of consumers and push back on rising prices, insurance has just passed the cost onto people through what's called cost sharing in the form of deductibles and co-pays and co-insurance. And that's hit us hard in Wayne County. In response, County Executive Warren Evans made alleviating medical debt and expanding healthcare access a primary goal for our county. In March of 2024, we announced a program, in partnership with Undue Medical Debt, to relieve medical debt for qualifying residents, and is allowing Wayne County to purchase upwards of $700 million of debt for just $7 million.

But we need debt relief nationally. Toward that end, the single best solution is to pursue single-payer health reform, also known as Medicare for All. The conversation throughout was cordial. And, though there were definitely points of disagreement between the senators of either party and their witnesses, there was far more we agreed on. It's a reminder that government can do good things for people.

And if we can focus on challenges our constituents all face and our solemn responsibility to serve them, there's a lot of space for righteous action. But sometimes, instead of focusing on keeping us safe, government does stuff like this.

That's it for today. Thank you so much to Dr. Elizabeth Joni at Grant for joining us. And if you have guest recommendations for the show, share them with us at info at incisionmedia.co. On your way out, please don't forget to rate and review the show.

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America Dissected is a product of Incision Media. Our producer is Andy Gardner-Bernstein. Video editing by Nar Malconian. Our theme song is by Takayoshi Zawa and Alex Naviera. Sales and marketing by Joel Fowler and Nick Freeman at Big Little Media.

Our executive producers are Tara Terpstra and me, Dr. Abdul El-Sayed, your host. Thanks for listening.

This show is for general information and entertainment purposes only. It's not intended to provide specific health care or medical advice and should not be construed as providing health care or medical advice. Please consult your physician with any questions related to your own health. The views expressed in this podcast are those of the host and his guest and do not necessarily present the views of Wayne County, Michigan, or its Department of Health, Human and Veteran Services.