Public Health

New long COVID clinical trials, FDA approves postpartum depression pill & RSV shot for babies [Podcast]

. 10 MIN READ

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AMA Update

New long COVID clinical trials, FDA approves postpartum depression pill & RSV shot for babies

Aug 9, 2023

HHS forms the Office of Long COVID Research and Practice, and the NIH launches new long COVID clinical trials. AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, discusses these new long COVID developments, along with a study with insights into the maternal health crisis in the U.S. and the FDA’s approval of a pill to treat postpartum depression. Plus, NIAID’s new director, the new head of the CDC and ACIP’s RSV shot recommendation for babies. AMA Chief Experience Officer Todd Unger hosts.

Speaker

  • Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association

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Unger: Hello and welcome to the AMA Update video and podcast. Today, we have our weekly look at the headlines with the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia in Chicago. I'm Todd Unger, AMA's chief experience officer, also in Chicago. Welcome, Andrea.

Garcia: Todd, thanks for having me back. It's good to be here.

Unger: Well, since we talked last, there have been two noteworthy developments concerning long COVID. The first is that the Department of Health and Human Services formed the Office of Long COVID Research and Practice. Andrea, what can you tell us about that?

Garcia: Yeah, so that Office of Long COVID Research and Practice is officially charged with coordinating the response to those longer term effects of COVID across the government. Right now, there are about 14 different federal departments involved with long COVID, including over a dozen operating and staffed divisions within HHS.

Ultimately, the office's goal is to improve the quality of life for people living with long COVID and to reduce disparities related to it. HHS Assistant Secretary for Health, Admiral Levine, will be leading that Office for Long COVID Research and Practice. We've been talking more lately about those ongoing threats of long COVID and the need to address it. So the formation of this office is certainly welcome news.

Unger: Absolutely. And the second long COVID development brings even more good news. And it has to do with the launch of new clinical trials. What do we know about that?

Garcia: Yeah, so this news comes out of the National Institute of Health. They've launched long COVID clinical trials through the RECOVER Initiative, which is that $1.15 billion nationwide research program that is designed to understand, treat and prevent long COVID. The clinical trial is going to study multiple treatments across five different focus areas. And enrollment just kicked off for those first two trials at the end of July.

One trial is looking at whether taking up to a 25-day course of paxlovid could ease long COVID. And the other is looking at treatments for brain fog and other cognitive problems. In the coming months, I think we can expect to hear more about those remaining studies. So this is definitely something else that we're going to continue to follow.

Unger: That's great and great news for those out there that are suffering still from long COVID symptoms. On a separate topic, another health crisis that we've been following closely is maternal health in the U.S. A new study shed more light on the severity of this issue. Andrea, what were some of the findings?

Garcia: Yeah, so that study was from the March of Dimes. And I think there were two takeaways that really drove headlines. The first was that nearly 1 in 10 women who gave birth in the past year lived more than 30 minutes away from the closest birthing hospital, with that burden being particularly high for those living in rural areas. The second was that more than a third of U.S. counties are maternity care deserts. That means they don't have a hospital or a birthing center that offers obstetric care or they don't have any obstetric physicians.

And this care gap is actually increasing. According to that March of Dimes study, about 300 birthing units closed in the U.S. since 2018, and 70 closed in just the past year. All of this leaves patients with fewer and fewer options. And the lack of access to care exacerbates other factors that we know contribute to adverse maternal outcomes, including poor insurance coverage, underlying chronic conditions, and of course, structural racism.

Unger: Wow. Those are some pretty shocking numbers. We'll continue to report on that. Andrea, we still have a lot of work to do there. And slightly better news, though, on a related topic, the FDA just approved a pill to help postpartum depression. Tell us more about that and what it could mean for people suffering from this condition.

Garcia: Yeah, well, that was really good news. Todd, last Friday, the FDA approved zuranolone, which will be marketed under that brand name Zurzuvae. As you've noted, this is the first oral medication to treat postpartum depression in adults. It's designed to be taken for two weeks. And clinical trial data showed that it began to ease those symptoms of depression in as little as three days. That's faster than general antidepressants.

But I think the other thing that makes this approval such a milestone is that zuranolone is explicitly indicated to treat postpartum depression. Having an effective treatment for this condition could help reduce the stigma around it and encourage more people to seek treatment for this serious and potentially life-threatening condition. We know the pill is expected to be available once the DEA completes a 90-day review. That review is required for drugs that affect the central nervous system.

Unger: All right, well, we'll be sure to keep an eye out for that. Andrea, now let's turn to another government agency with big news. The National Institute of Allergy and Infectious Diseases has a new director. Tell us about that.

Garcia: Yeah, so Dr. Jeanne Marrazzo, who's an infectious disease expert at the University of Alabama at Birmingham, will be succeeding Dr. Anthony Fauci this fall as the director of that institute. As you recall, Dr. Fauci stepped down back in December. Dr. Marrazzo has been a principal investigator on NIH grants since 1997. During the pandemic, she was a vocal proponent of getting vaccinated. She appeared on AMA Update with you, as well as on national television to share how people can protect themselves.

She's also an outspoken advocate for LGBTQ patients. She's stepping into this position at a challenging time. In your recent discussion with Dr. Hotez, we know there's this growing anti-science movement in this country, which really has become an epidemic of its own. And she'll certainly need to contend with that. In an interview with CNN, Dr. Fauci had a bit of advice to share. And he said that she should always let her North Star be science, evidence, integrity and honesty. And when she does that, she'll be fine.

Unger: Well, congratulations, Dr. Marrazzo. Andrea, it seems we're in good hands there. And speaking of public health leaders, the new head of the CDC spoke to NPR last week about what's next for the agency. This is really the first time that we've heard from her. What do you think were some of the key takeaways from that interview?

Garcia: Yeah, so Dr. Mandy Cohen is that new director of the CDC. She officially stepped into that position last month. And in her interview with NPR, she talked a lot about the issues around trust and how critical it is for people to be able to trust the CDC.

To that end, NPR highlighted the results of a survey which showed that a quarter of people said they trusted the CDC either not very much or not at all. Dr. Cohen went on to share three important steps that the CDC must take to rebuild that trust with the public.

Unger: Well, let's hear. What are those three steps?

Garcia: So the first was really around the need for transparency and for the CDC to communicate clearly and accurately in a way that people can understand. The second was around performance, and the CDC must follow through, do what it says it's going to do, and the third was around relationships.

The CDC needs to bring together partners to protect people's health and realize that they can't do it alone. I think from this interview, we can start to see where Dr. Cohen's priorities will be going forward. And I'm sure we'll learn even more in the coming months.

Unger: Excellent. Before we go, Andrea, there was an ACIP meeting last week. Some news about a new shot that can protect babies from RSV. We'll be talking with the AMA's ACIP liaison Dr. Sandra Fryhofer about it in more detail this week. In the meantime, what was the headline that was coming out of the meeting?

Garcia: Yeah, so the big news was the ACIP voted to recommend nirsevimab, which is a long-acting monoclonal antibody for infants and older babies who are at increased risk for severe illness from RSV. They specifically recommended one dose for infants younger than eight months who are born during or entering into their first RSV season. And then they went on to recommend that children between the ages of 8 and 19 months who are at increased risk get another dose in their second RSV season. CDC director Mandy Cohen has adopted the ACIP's recommendation. We know RSV is the leading cause of hospitalization among infants.

And nearly all children have been infected by the age of two. This is a major milestone in the fight against RSV. I think the other major vote that took place at that meeting was voting to add it to the Vaccine for Children program, which is going to help ensure equitable access to the therapeutic.

Obviously, Dr. Fryhofer was at the ACIP meeting. She can share more insights into those discussions that occurred. So once your interview is live with her, we'll also include a link to it in the description of this episode.

Unger: Thank you, Andrea. I'm really looking forward to talking with Dr. Fryhofer and getting all the details. Andrea, again, thanks for joining us today and for all your insights.

That wraps up today's episode. And we'll be back soon with another AMA Update. In the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us. Please take care.


Disclaimer: The viewpoints expressed in this podcast are those of the participants and/or do not necessarily reflect the views and policies of the AMA.

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