FDA Moderna vaccine update, new sickle cell anemia treatment, plus naloxone & lung cancer screenings

. 11 MIN READ

AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.

The American Cancer Society lung cancer screening recommendations have been updated and the U.S. saw an increase in infant mortality rates for the first time in more than two decades. AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, discusses these developments, along with announcements from the FDA about a potential cure for sickle cell anemia and how to correctly administer the Moderna COVID-19 vaccine.

Plus, a Medscape survey on how concerned physicians are about artificial intelligence, the Biden-Harris administration asking schools to carry naloxone, and a study on the experience of using the 988 Suicide and Crisis Lifeline. 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 back, Andrea.

Garcia: Thanks, it's good to be here.

Unger: Well, Andrea we have a veritable potpourri of medical updates today, including lung cancer screening, infant mortality, vaccines and more. Let's get right into it and start with some news from the American Cancer Society. It recently updated its lung cancer screening guidelines, and the change has big implications for both patients and physicians. Andrea, what do we need to know?

Garcia: Well, Todd, the American Cancer Society now recommends an annual lung cancer screening for adults aged 50 to 80, who either currently smoke or formerly smoked with a 20-pack-year smoking history. Let's break that recommendation down a bit and talk about what's changed.

I think first, it's important to note that a pack-year is equal to the number of packs a person smokes per day. One pack is generally 20 cigarettes and that's times the number of years the person smoked. So previously, American Cancer Society guidelines recommended lung screenings for adults aged 55 to 74, with at least a 30-pack-year history, who either currently smoke or quit smoking less than 15 years ago. This update marks the first change to those lung cancer screening guidelines in about a decade.

Unger: So interesting, just for clarification on that pack-year-- it's a new term for me. If you smoke two packs a day for 10 years, that's the-- math there is a 20-pack-year history. So that's a new update for everyone to pay attention to. Why the change, Andrea?

Garcia: Well, essentially, the organization widened the age range for the recommendation and decreased the pack-year history from 30 to 20. They also eliminated that requirement of having quit smoking less than 15 years ago. There are a couple of reasons for that.

First, I think we know that quitting smoking lowers the risk of lung cancer over time, compared with those who continue smoking. But with that being said, that risk of lung cancer is still higher among people who have quit than among those who have never smoked. With this new criteria, there are about additional 5 million adults who are now recommended for screening.

The hope is that making screening for lung cancer available to more people could potentially save lives. But it's important for people to consult with their doctor about the potential benefits and harms of yearly screening with low-dose CT scans.

Unger: All right, that's definitely a change physicians are going to want to talk to their patients about. Let's switch gears now and talk about another big development that recently concerned the maternal mortality crisis in the U.S., which is a topic that we've been following closely. Andrea, tell us more about that.

Garcia: Well, according to a report from the National Center for Health Statistics, for the first time in more than two decades, the U.S. actually saw an increase in its infant mortality rate in 2022. The report showed that the overall infant mortality rate rose 3% from 2021 to 2022. Additionally, the mortality rate for neonatal infants rose 3% and the rate for post-neonatal infants rose 4%.

Earlier this year, you spoke to Dr. Fryhofer and Dr. Plenty about maternal mortality data from the CDC that showed a similar concerning trend. And while this report from NCHS is different, it really underscores the same point and that is that we're heading in the wrong direction. So I would encourage people to check out that interview with Dr. Fryhofer and Dr. Plenty. They offer valuable insights into what's causing this crisis and what we need to do to reverse it.

Unger: Well, thanks for that perspective, Andrea. And we're going to include a link to the interview that Andrea recommended in the description of this episode. Andrea, two announcements out of the FDA have also been driving a lot of headlines. One was about sickle cell anemia. Why don't we start with that, about what the story is there?

Garcia: Yeah, so last week, we saw the FDA convene external advisors around a gene-editing treatment for sickle cell. The primary focus of the discussion of that meeting was around safety, with questions concerning the risk of off-target editing or the potential to alter regions of the genome other than the intended ones. This treatment is known as exa-cel and is jointly developed by Vertex Pharmaceuticals and CRISPR Therapeutics.

If it goes on to be approved by the FDA, which seems likely at this point, it'll be the first treatment for a genetic disease using CRISPR gene-editing technology. It's a big deal. Sickle cell disease is a debilitating disease that affects an estimated 100,000 people in the U.S.

And before this, the only cure involved a bone marrow transplant and intensive chemotherapy. This new gene-editing treatment offers an alternative, and in clinical trials, symptoms of the disease went away and participants appeared to be cured. In that FDA committee meeting, members said that the benefits of this treatment outweighed the risk, and we should expect to see a decision from the FDA on this around December 8.

Unger: Well, that's nice to have such good news to share and your words. That is a big deal. Andrea, there's a second piece of news out of the FDA. This one was about the Moderna COVID-19 vaccine. What's the story there?

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Garcia: Yeah, that's right. The FDA shared some important information with clinicians last Friday about how to correctly administer the Moderna COVID-19 vaccine. And this is specific to patients aged six months to 11 years old. In that alert, the FDA said that clinicians should ensure that they're withdrawing and administering the correct volume of the vaccine, which is 0.25 milliliters.

This announcement comes on the heels of FDA hearing that some clinicians were not aware that the single-dose vial of the Moderna COVID-19 vaccine contains more than 0.25 milliliters of the vaccine. So as a result, they were withdrawing the entire contents of the vial and administering it to patients. Clinicians should discard the vial and the excess volume after extracting a single dose.

That excess volume should not be used to administer an additional dose. And partial doses from multiple vials should never be combined to make up a dose for a patient. The FDA has not identified any safety risks associated with administering that higher dose to this age group, and no serious adverse events have been identified to date.

Unger: Well, thank you for that update. That's really important news and it's important to spread the word on that. Andrea, the next story is about artificial intelligence or AI, which is a topic we've also been following closely. A new survey looked at how concerned physicians really are about it. What's the answer to that?

Garcia: So this survey from Medscape was done on about 1,043 physicians from different specialties. And they found nearly two out of three were either very or somewhat concerned about AI driving diagnosis and treatment decisions. However, I think that's not to say that physicians aren't excited about the technology's potential.

The survey showed that 42% of physicians were enthusiastic about AI's future in the workplace, and 56% were enthusiastic about AI as an adjunct in diagnosis and treatment. I think it's too early to tell how exactly AI will be used to support physicians, but insights like these certainly will be valuable in helping to shape its role.

In a recent speech to the National Press Club on the physician shortage, we saw AMA President Dr. Jesse Ehrenfeld also raise AI. And he really underscored that AI, like any technology, must work for both physicians and patients. And to ensure that, he said that physicians need to be consulted in the design and development of AI tools. That way, it will be an asset and not a burden.

Unger: And what a great speech from Dr. Ehrenfeld. And that message, again-- like so many things in the technology world-- to make sure that they work for doctors and not the other way around. So important to have physicians at the table. They do bring such valuable perspective, and the topic of AI, of course, is no exception.

And another story that drove headlines this week was the Biden-Harris administration calling on schools to stock naloxone. What did the White House have to say about that?

Garcia: In a letter to educators, we saw the director of the White House Office of National Drug Control Policy, Dr. Rahul Gupta, along with the Secretary of Education, say that every school in the U.S. should carry naloxone. That letter also noted that faculty and students should be prepared to use the nasal spray to stop an overdose.

You spoke to Dr. Gupta recently about the emerging threat of xylazine. In that interview, Dr. Gupta reiterated the essential role that naloxone plays in combating the drug overdose epidemic. To make the biggest impact, this lifesaving tool really needs to be widely accessible. And this letter to educators is a step towards helping to achieve that.

Unger: And if you didn't see that episode with Dr. Gupta, I encourage you to watch that one as well. Such great work that he and the team are up to there, and such important work on naloxone. Andrea, for our final story, there was a new study in JAMA Network Open that looked at the 988 Suicide and Crisis Lifeline, and its findings drove a lot of headlines. What did the study show?

Garcia: One of the key takeaways was that among people with serious psychological distress who had used that 988 lifeline, only about 30% of them were very likely to use it again. Launching this 988 lifeline was undoubtedly a milestone, but this study really shows that there might be areas for improvement. One positive takeaway from the study was that people with serious and moderate psychological distress were more likely to be aware of the lifeline.

I think with that being said, though, that awareness overall was still under 50%, which is an indication that it could certainly benefit from much greater awareness in general. We've talked before about the state of mental health in the U.S. The need for tools like the 988 lifeline is certainly greater than ever. Hopefully, this study helps to inspire action to get out the word about the lifeline and to make it even more impactful.

Unger: Andrea, thanks so much for joining us, as always. That wraps up today's episode. If you enjoyed this discussion, you can support more programming like it by becoming an AMA member at ama-assn.org/join.

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 today. Please take care.


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

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