Still Here, February 25: Links and transcript

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The words Still Here are in a white slightly serif font highlighted in yellow to the left of a Caladrius bird, The Sick Times' mascot, wearing yellow headphones. The bird is perched on a black box accented by a white circle. In the upper left hand of the cover image is The Sick Times' purple logo. The background is black.
The cover image for Still Here: A Podcast From The Sick Times. Art by Sophie Dimitriou.

Summary

Biotech company Invivyd has the only monoclonal antibody cleared for emergency use authorization in the U.S.: Pemgarda. The medicine, a monoclonal antibody, could be behind a paradigm shift in how we approach COVID-19 and Long COVID. Plus, while millions of Mexicans live with Long COVID, a lack of information has hindered their attempts to seek care.

In this episode of Still Here: Invivyd chairman Marc Elia speaks with co-host Miles Griffis about his recent op-ed for The Sick Times about how bureaucracy is killing people with Long COVID and the role of monoclonal antibodies in the ongoing pandemic. And freelance health and science reporter Annika Hom speaks with co-host Betsy Ladyzhets about efforts to establish a national clinical guideline for treating Long COVID in Mexico.

Also in this episode: A phase III Long COVID clinical trial testing a combination of the HIV drug Selzentry (Maraviroc) and the statin Lipitor (Atorvastatin), and the latest COVID-19 trends. 

Find our Long COVID news and commentary podcast on Spotify, Apple Podcasts, Pocket Casts, Amazon Music, iHeartRadio, or listen below and jump to the start of the podcast transcript.

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Still Here overlaps with The Sick Times’ newsletter, which publishes weekly.

Mentioned in this episode (in order of appearance):

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Transcript

Intro (0:00) 

[Instrumental snippet of theme song, the Rude Mechanical Orchestra’s rendition of “Which Side Are You On?” begins playing.]

Betsy Ladyzhets: Welcome to Still Here, a Long COVID news and commentary podcast from The Sick Times.

Miles Griffis: Hi. I’m Miles Griffis.

Betsy Ladyzhets: And I’m Betsy Ladyzhets. 

[Instrumental ends]

Betsy: We’re the co-founders of The Sick Times. 

Miles: Many public health authorities are ignoring the ongoing COVID-19 pandemic.

Betsy: But here at The Sick Times, we’re not. So we continue to bring you the latest Long COVID news and commentary each week.

Miles: Without pandemic denial, minimizing, or gaslighting.

Betsy: And we’ll do that on our website, social media platforms, newsletter, and, of course, this podcast. Our producer James is out this week, so it is just Miles and I on the recording.

But as always, shout out to James for helping us put scripts together and editing so that we sound professional.

Miles: [chuckles] And then we’ll talk about a couple of stories that we published on The Sick Times recently.

In this episode, we speak with Mark Elia, chairman of the board of the biotech company Invivyd, as he discusses his recent op-ed.

Then we’ll speak with Annika Hom, a journalist based in Mexico, who reported on people with Long COVID facing gaslighting and erasure. Clinicians in Mexico say that government-approved clinical guidelines could bring better care to people in Mexico with Long COVID.

Betsy: And alongside that, we’ll also share some Long COVID research updates.

Today’s research update includes a new clinical trial studying an HIV drug and a statin in combination. Now, our COVID-19 forecast.

[Sound of thunderclap and light rain]

Betsy: We continue to be in the midst of a winter surge, which has been going on later in the season than usual. But at least in a sort of a different pattern than the last couple of years, you know, this winter, the COVID wave kind of started after Thanksgiving, but has continued through February.

And levels have not really gone down significantly at all in the last couple of weeks.

Both wastewater and healthcare metrics have kind of plateaued through late January and into early February.

And the situation by region is also a bit unclear. There are kind of different patterns across different wastewater and healthcare sources, which to me is really just indicating, you know, we’re still at high levels across the United States.

And across the board, just a lot of disease going around right now.

It’s always good to check your local or state wastewater dashboards and local or state public health departments where you can often find COVID-19 and other infectious disease data that is more specific to your community.

And we have links to those and advice about kind of following those trends on our website.

Miles: Yeah. And I know we’ve been talking a lot about flu this winter. How are those and other seasonal disease numbers looking?

Betsy: We’ve been talking about how this winter has been kind of a record flu season. That continues to be the case.

Doctors’ visits for flu-like symptoms, which is a metric that’s been used for a long time to measure the status of flu season, those are the highest they have been in two decades.

So a lot of people going to the doctor for fever, cough, sore throat, and other respiratory symptoms.

It does seem like these are mostly seasonal flu cases, based on the testing that the CDC does of test samples from people who’ve gone to doctors’ offices about the flu, as well as wastewater testing.

But folks continue to be very concerned about the bird flu, H5N1, which we know is spreading a lot in animals and could easily, easily jump to humans or evolve to spread more easily among humans.

There was a bit of news on that front this week too.

So the CDC put out a report about veterinarians who work with dairy cows. The CDC had done testing of 150 of these veterinarians and found that a couple of them had evidence of H5N1 infection, who had not reported it previously.

So just showing that the virus has continued potential to jump from animals to humans. There were also new human cases reported in a couple of different states.

As we’ve been saying, you know, as far as we know, these cases are all coming from animals into humans.

But the worry is very clear and it continues to be another reason why it’s good to, you know, wear high quality masks, indoors, prioritize good ventilation, prioritize testing, and all of the other COVID-19 and infectious disease precautions that we know folks at least who listen to this podcast probably are taking.

Maybe not so much otherwise.

Miles: Well said. And now for our top stories.

Next we’ll speak with Mark Elia, who wrote an op-ed this [past] week in The Sick Times called, “Bureaucracy is killing people with Long COVID.” Stay tuned for that.

[instrumental segment of theme song plays]

The Sick Times: Invivyd Chairman Marc Elia: The bureaucracy is killing people with Long COVID (5:12)

Miles: So today, we’re joined by Mark Elia, who has served as a member of Invivyd’s Board of Directors since June 2022 and as chairman of the board since July 2022.

Invivyd is a biotech company specializing in monoclonal antibody treatments for COVID-19.

He recently wrote an op-ed for The Sick Times this week, where he shared his experience with Long COVID and made calls for change in the pharmaceutical industry titled, “Bureaucracy is killing people with Long COVID.”

Welcome to Still Here, Marc.

Marc Elia: Thank you very much. It’s a pleasure to be here.

Miles: I just wanted to thank you for, you know, bravely sharing your experience with Long COVID.

It’s never easy. And I know our readers and listeners really appreciate when people share their experiences.

So yeah, I just wanted to first ask, how long have you been living with Long COVID and how has it sort of informed your role at Invivid?

Marc: Sure.

Happy to share. And actually, my involvement with Invivyd long preceded both experiencing symptomatic COVID-19 and then Long COVID.

So indeed, I was one of the founding investors in the original private company back in July of 2020.

And I was going in[to the pandemic], you know, different facets, personally and professionally, thinking, you know, I’m going to sneak through this pandemic unscathed by masking and being careful and being a thoughtful person. Because nobody really wants a terrible virus like SARS-CoV-2 if they can help it.

But eventually, I think the back-to-school during the Delta wave got me. And I had what I think the clinician would tell you was a mild to moderate course of COVID-19.

But eight, nine days later, I woke up at about 10 p.m. clearly thinking I was dying, took myself to the ER and was diagnosed with diffuse bilateral pulmonary emboli.

I had no risk factors and I was an athlete and there was no reason to suspect that I should have a thrombotic event.

With clots like that, you know, luckily there are excellent medicines.

And I was hopeful that with some days of heparin and then months of a factor 10a inhibitor, life would more or less go back to normal.

But, you know, maybe other people who have gone through Long COVID would appreciate that, you know, you can have these moments in which you feel almost normal.

And then seemingly out of nowhere, your body violently disobeys you, right?

And whether that’s cardiac issues like, you know, a racing heart or feelings of lightheadedness and dizziness and difficulty with sleep and honestly, the most banal term people have ever conjured, post-exertional malaise, which should really be renamed, “Careful, if you do something you think you can do because it’s clearly what your old self did, your body’s not going to be at all happy, you know, and sometimes for days on end.”

So that started within days of leaving the hospital.

So, you know, really just a couple of weeks after my COVID, it was just very obvious to me that I was no longer the person that I had been, particularly from a physical, just athletic functioning [level] and overall feelings of wellness.

Now, I would say over these four years, there is a gradual but noticeable change for the better.

But you know what that really is? Is it really means these things happen slightly less often than they used to happen.

But it’s totally clear I’m in no way the same.

Miles: Well said.

As I sort of talked about a little bit in the intro in your op-ed, you talk a lot about monoclonal antibodies. Since 2022, you all [at Invivyd] have the only novel monoclonal antibodies available [on the market].

Is that correct?

Marc: That is correct. Yes.

Miles: Can you sort of speak a little bit about the role of monoclonal antibodies and what the future could look like for them for COVID?

Marc: Absolutely. And it’s a great topic because I actually think it’s so fundamentally important.

And that’s because even at the very beginning of the pandemic, if you were very curious or had some local expertise in science and medicine, you could go into the scientific literature and with the right targeted reading, know a lot of things were likely to be true.

One, you could know that human beings do not like to make a very effective, durable memory response when they see a coronavirus. If you knew that an infection wouldn’t give you durable immunity, then a vaccine certainly would not, because it is, generally speaking, sort of a simulation of the infection at lower intensity.

And if the real thing doesn’t excite your immune system to the point of a durable memory suite, likely neither will have vaccines.

Now the nice thing about a monoclonal antibody is it’s a very particular kind of pharmaceutical.

It’s a genetically engineered, you know, so-called biologic, a complex medicine, because it is effectively a improved copy of the antibodies that sit in your serum from having a normal human immune system at all times anyway.

We just, from a SARS-CoV-2 point, don’t have enough of them.

So when we were sitting back in the day thinking about getting what is now Invivyd started, I was looking at the problem thinking, well, whatever vaccines get us, I know we’re going to need more.

And the way to get more in the pharmaceutical industry relative to a virus like SARS-CoV-2 is you can make a monoclonal antibody.

And so we set out to do that.

And indeed, had an early one called adintrevimab, whose activity was abrogated by the Omicron shift. Where other companies sort of decided to walk away from the space or thought that perhaps they couldn’t make one that would last, we at Invivyd sat down and said, “Okay, well, that’s a bummer, but we’ll keep working.”

And indeed, went through all the work to discover and develop pemivibart, which is the generic name for the molecule we currently have authorized under EUA for the prevention of COVID-19, Pemgarda.

But the point is, it’s an underutilized, in my opinion, category.

Partly because I think SARS-CoV-2 is one of the times politics seem to get a little involved in the medicine here.

So the Biden administration was very fond of their, and I’m going to get it wrong, but I think it was boost-test-treat paradigm.

So the idea being you would go out and you would get your serial COVID-19 booster vaccines.

If they didn’t work and you had a breakthrough infection, which of course happens all the time, you would take your rapid antigen test and then a doctor would offer you Paxilobot.

I don’t think in early 2022, and I’m speculating, but I don’t think they thought that there would still be 50,000, 60,000 Americans a year dying. I’d have to believe they didn’t think there’d be millions and millions and millions of people getting damaged all the time.

So when I say it’s regrettable that the politics sort of entered into the fray, I guess what I mean is monoclonals are such a great opportunity to do more.

It’s just that nobody seemed to be interested in doing more.

But what’s a little bit sad about the whole situation is, like I said, you could sort of see all this coming in the year 2020.

So anyway, we view monoclonals as the next step in which, now that the most of the population has some immune experience, either because of vaccination or because they’ve been infected, or both, we can now put something on top of that and really drive your immunity, finally, from a place in which “you’re likely to stay alive” to, I think, what we think is a better place, “you’re likely to stay well.”

Miles: Yeah, I mean, I think a lot of our listeners and people are just sort of aware of this like so much of what was pushed over the past four years from the Biden administration was “we have the tools”, but a lot of times we, you know, we had Paxlovid, we had these things, but a lot of people couldn’t access them.

There was a huge push that vaccines ended the pandemic, but we know many, many people got Long COVID even when they’re fully vaccinated.

And then yeah, we also know that monoclonals are a very promising area that’s been overlooked. We know they’re being studied for Long COVID.

We reported a little bit on people’s difficulty getting Pemgarda and that’s a lot because of this bureaucracy that you read about in your op-ed.

Would you mind just talking a little bit about these roadblocks to this innovation for the potential of monoclonal antibodies?

Marc: Sure. I mean, it turns out that in some ways the easy part for Invivyd, and maybe for a lot of companies, is discovering and developing one of these things. Working with the federal government and the Food and Drug Administration is its own sort of series of puts and takes.

And then of course, once you are authorized and sort of — across sort of a finish line, you’ve got to actually get out into the community and begin driving awareness and hopefully some sense of appreciation for the possibility embedded in the medicine on the part of HCPs [healthcare providers] and vulnerable people.

And I think a lot of people who are either well but worried or who are unwell with Long COVID appreciate these issues much more clearly and are much more up on the latest thinking and literature than even indeed folks within the federal government. A lot of them are a little deeper into the weeds and a little more motivated than many of their HCPs and care teams.

So, you know, what’s always been a little bit frustrating from an Invivyd standpoint is we stand ready to serve.

We’re more than aware that there’s a lot of people ready to engage. And then there’s any number of elements of machinery between us, right?

That of course, we address best we can in the most ethical and compliant fashion and all that. But over time, what we hope to do is to educate to the point where some more “aha” moments maybe occur in clinical practice and in regulatory, which is, this is not the world’s most sophisticated pharmaceutical premise. Okay, you have a highly active antiviral and you have a pervasive virus. Well, you can make a match without thinking too, too hard.

We’ve done a huge amount of work over the last six to 12 months to improve some of the logistical barriers to access. You could measure that, for example, in the number of centers and infusion centers that are able to deploy our medicine.

That’s great. I think some of those logistical barriers have been dropping.

The goal is that we come to work every day to try to do the most good we can.

Can we get this drug to as many people are appropriate? Can we educate HCPs?

I mean, there are practicing clinicians who will tell people, “Ah, it’s [COVID-19] just a common cold.” And you sort of think, “Oh, God, you’re not looking at the same data we’re looking at.”

And by the way, that’s generally right. So, okay, there’s things we can do there.

And then more broadly, in the long innovative arc, I would like to think that over the next few, you know, quarters and years, our work will be devoted to better, more sort of easy to access, you know, for example, moving from an infused context to something that’s intramuscular “IM” that, you know, kind of kind of looks and feels more or less like a vaccine.

But it’s not. It’s, it’s something altogether a different sort of animal and a little more powerful, we hope.

Stay tuned, right? It has been a longer journey than many of us would have thought, I suppose.

But I think that’s also sort of drug development. So, you know, don’t take anything you see from us as anything other than maximum commitment to that mission.

It’s just, you know, we live in a very complex, very interesting society.

So, you know, we’re grateful for people like you guys who are actually orienting, I think, the broad public to the data that I think we’re all looking at that makes us think, “Hey, wait a minute, this is still basically a raging pandemic with totally unacceptable human consequence on the daily.”

Miles: Yeah, I mean, it feels like so much of the work could do is so, as you said, [happening in] very interesting times and complex times in society. And these are big changes that will have to be made to make these innovations.

A lot of times we feel powerless. What do you think listeners and readers in the public can do to make this change?

Marc: That’s a great question.

I think actually some of what you guys are doing with [The] Sick Times speaks to the heart of it.

It’s about getting organized and getting vocal and visible because one of the incredible aspects of COVID is how broad the damage is and how many different areas of either vulnerable people or areas in modern medicine, you know, whether it’s, you know, oncology, hematology, oncology or transplant or whatever, create highly vulnerable people every day.

But there’s a downside to that unbelievable magnitude of burden, which is there’s no one type of person, right? Because it touches so many diverse people, it’s a little harder to get organized around.

I think what we need is a little more action devoted to Congress, to HHS and FDA, which are organizations, I think undergoing pretty significant change as we speak.

It’s really about priorities and making all of us in this community heard. I don’t know that anyone knows what the future is going to be, but that to me represents opportunity, not a threat, right?

So I think it’s a great time to get a little more involved and a little more vocal.

Miles: Yeah, it’ll be an interesting time.

I’m hopeful that, you know, Long COVID will be centered. We’ve seen some like removal of long COVID data and accommodation information pages taken down.

So we don’t love that start.

[Marc and Miles laugh]

Anything can happen in the coming weeks.

And this is Marc Elia. Thank you for coming on Still Here today. We really appreciate your time.

Marc: It’s a pleasure.

The Sick Times: Without clear clinical guidelines in México, people with Long COVID face gaslighting and erasure (18:36)

Betsy: Our second story in the podcast this week discusses Long COVID in Mexico.

Mexicans with Long COVID have largely been left to fend for themselves, journalist Annika Hom found in her story published on Tuesday.

Advocates and clinicians told her that better guidelines from the government could help, particularly as many people rely on state-funded clinics for health care.

Annika, thank you for joining us. Could you start by introducing yourself and talking about what led you to pitch us this story?

Annika Hom: Yeah.

Thank you so much for having me. I’m a freelance journalist.

I work in Mexico City.

I cover health and science and got started in that city in 2020, [after] covering COVID-19 in San Francisco.

And so what really interested me about Long COVID in Mexico was it was looking through some studies and I found one being used by a Mexican doctor, Luis Del Carpio-Orantes, that was basically characterizing Long COVID in Mexico.

And in the studies, he and the co-authors were saying that it’s still not being recognized as a disease in Mexico.

And so that sort of led me to do some more research and see what has changed in some other really helpful articles, like one in the UNAM, one of the main colleges there, and Palabra.

And they had kind of talked about what it was like in Long COVID, having long COVID in Mexico, but I wanted to see what solutions were coming out and what was new.

Betsy: Makes sense, yeah.

So I know you talked to some patient advocates about their experiences getting diagnosed with Long COVID and trying to get health care. So what were some of the things they told you or some of the challenges that they have been facing?

Annika: I think similar to everyone else in the world who experiences Long COVID, stigma is a big thing.

So in Mexico, it’s the stigma of having Long COVID or just not being believed at all.

And I heard, both from doctors and some people experiencing Long COVID, is that there are even some doctors in the clinics who don’t take it seriously or believe that it exists.

And so a lot of it is being gaslit that that is not what they have or just being kind of taken on this journey where, you know, go into a test or try this or this diagnosis and being prescribed measurements or medications that don’t help alleviate any symptoms. And just going down this rabbit hole of and kind of being gaslit about what they’re experiencing while at the same time, you know, shelling out sometimes a bunch of money to pay for their costs.

I spoke to Lepe Medina — his private insurance couldn’t be cost-efficient with Long COVID because they didn’t recognize it, for example.

So those are the consequences.

Betsy: Yeah.

And I know you talked about solutions.

And one of those that your story highlights is to have a national clinical guideline for Long COVID. So could you talk more about what that is and why that would be important or why that would be helpful for improving care for people?

Annika: Sure, yeah.

So generally, national clinical diagnostic guidelines are tools in the medical community, which basically take a bunch of research that was rigorously vetted for particular disease and kind of rolled [it] into a guideline of best practices to diagnose that disease and to treat it.

The idea being that it’s disseminated within the country so clinicians or doctors, or whomever, can look at that and kind of cut to the chase of, this is the best way to address this for people experiencing this, and this is also the best way to care for them, because the point is to optimize the care.

And so for Long COVID, in some other countries around the world, like South Korea, or the U.S., have accepted these and formulated their own to help manage and optimize the care for people experiencing Long COVID.

But Mexico still has yet to do that. But things that could include would be best practices for physical rehab or cognitive rehab and speech therapy, [for example].

Betsy: Nice. Yeah.

So what’s some of the progress that has been made towards that kind of guideline so far? And from the people you talked to, the clinicians and the patient advocates, what do they want to see, both from Mexico’s government, as well as from the international Long COVID community, to better support them?

Annika: So the progress has been minimal, but there are a lot of doctors who work on Long COVID in Mexico who have been calling for the creation of clinical practice guidelines for a long period, for years now, and there is a lot of support for that.

In particular, the doctor mentioned in the beginning, Luis Carpio-Orantes, has submitted and formulated a clinical practice guideline for a long period and sent it to the government agency in Mexico, the Centro Nacional de Excelencia Tecnológica en Salud, for approval in 2023.

But yeah, the process in general, it took a long time, but so far there has not been any movement upon that.

The agency told him last year that they would be re-reviewing the proposal again this year, and again, that’s like an idea that many professionals, medical professionals in Mexico support.

But yeah, speaking, a lot of other solutions that advocates and clinicians have spoken to me about is — research is a big one, because there is a lot more research being done in other countries around the world around Long COVID.

And so collaborating with Mexican scientists or in messaging, you know, how that might affect Mexicans could be really helpful.

I think that specificity is really wanted by some people I spoke to, when it comes to research in Mexico about Long COVID.

And in general, just I think support in terms of press and just advocacy, I think. Because as mentioned in the comments, it’s shown that there is kind of fatigue from adequate all the time, especially when it feels like the world has moved on or they don’t believe you.

And so I think a lot of people are experiencing long-term events, but I think we really crave support from other people as well.

Betsy: Yeah, I mean, we’re coming up on five years now for a lot of people who got sick in early 2020.

So it’s definitely a long time to be trying to advocate for yourself and trying to advocate for your community. Is there anything else from your reporting that you would want listeners to know or details that didn’t make it into the written story?

Annika: For me, what was most interesting was the clinical guideline.

And I think, yeah, it is really interesting to see how like, yes, like Long COVID is all over the world.

But kind of, as you said, like, there are so many different things in terms of like how a medical system was in another country or even like another city. And so when we’re thinking about solutions or research or just access to resources that might already exist, how that might play a different role somewhere else.

And so like, I think, yeah, like that is kind of what I was thinking about when reporting here in Mexico is just like, you know, like less research in general.

And like, you know, maybe focusing on other diseases, like [dengue], or things that like other countries, you know, are having to deal with. Those are all factors.

Betsy: We really appreciate your reporting and are glad that we’re able to share this story and kind of help to bring even like a little bit more recognition, I hope.

Annika: Yeah, definitely.

Betsy: You can read Annika’s full story on our website, which is thesicktimes.org.

Miles: Next up, we have our research update.

Research (26:58)

[Miles’ voice echoes the word “Research” accompanied with a sound excerpted from the theme song]

Miles: So today in research we are talking about an upcoming clinical trial for Long COVID.

The company running this trial is Health Biotherapeutics, and they recently announced a phase three clinical trial to test a combination of the HIV drug selzentry, also called Maraviroc, and the statin Lipitor.

This is news that was announced last year around the same time in February.

The new update here is that this trial is now, they say according to this press release, that it’ll be starting in March, so next month.

Health Biotherapeutics is formerly IncellDX, which some may remember from earlier in the pandemic.

This was a group that was treating people with Long COVID with sort of experimental treatments and they have sort of hypothesized about this treatment combination for quite a few years now.

So that’s exciting to see that this has been given FDA approvals for a clinical trial to start.

It will go for 32 weeks and include 252 participants.

Betsy: So it’s worth noting that this is not the only clinical trial looking at Maraviroc.

There’s also a trial for this drug supported by PolyBio that’s happening at the CoRE center for complex chronic diseases, and so it’s exciting to see, you know, two different trials looking at this drug because I think that will be really helpful for getting a sense of whether this works for people with Long COVID.

Miles: Participants can pre-enroll for the trial at healthbioai.com and, again, yeah, the project is to start in March 2025 so very soon — a couple weeks now.

Outro (28:46) 

Betsy: That’s all we have for you this week. You can stay up to date with The Sick Times newsletter and our coverage at thesicktimes.org.

[Instrumental theme song excerpt plays underneath the rest of the podcast]

Miles: We’ll continue reporting the information you need to better practice care.

Betsy: Solidarity with everyone still here. 

This podcast and The Sick Times are supported by you. You can help us keep this work going by donating on our website.

Still Here is a production of The Sick Times. We’re a nonprofit newsroom chronicling the ongoing Long COVID crisis. 

Our theme song for this episode is the Rude Mechanical Orchestra’s rendition of Which Side Are You On?, originally by Florence Reece. I’m Betsy Ladyzhets, I’m one of your co-hosts. Miles Griffis is the other co-host. Our excellent producer is James Salanga. Our engagement editor is Heather Hogan and Sophie Dimitriou designed our podcast cover art.

Thank you for listening and catch you next year.

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