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.
AMA Update
Mifepristone, Marburg virus, new COVID variant and RSV vaccine news with Andrea Garcia, JD, MPH
Apr 12, 2023
Featured topic and speakers
In today’s AMA Update, AMA Vice President of Science, Medicine and Public Health Andrea Garcia, JD, MPH, covers the latest on the Marburg virus outbreak, new coronavirus variants XBB.1.16 and XBB.1.9.1, plus Pfizer's RSV vaccine. Also discussing what physicians and patients need to know about Texas U.S. District Judge Matthew Kacsmaryk's ruling to suspend the FDA's approval of mifepristone. AMA Chief Experience Officer Todd Unger hosts.
Learn more at the AMA COVID-19 resource center.
Speaker
- Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association
Transcript
Unger: Hello and welcome to the AMA Update video and podcast series. 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. Good morning, Andrea.
Garcia: Good morning. It's good to be here.
Unger: Well let's dig in to the biggest headline of the week, talking a lot about mifepristone and two recent court rulings. Andrea, where do things stand now? And what do physicians need to know?
Garcia: Yeah. So to give a little background, mifepristone was approved by the FDA back in 2000. That's nearly 23 years ago. It was approved for use in medical termination of pregnancy in the first 10 weeks of gestation. And we know that about half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen. It's also commonly used to help manage miscarriages.
And for now, I think the important thing to know is the drug is still available. But a federal judge in Texas issued a preliminary injunction that stays the FDA approval of misoprostol nationwide beginning this Friday. And then meanwhile, we saw a competing ruling out of Washington state. And that ruling preliminarily enjoined FDA from altering the status of miscarriages and from pulling it from the market, specifically in 17 states and DC that are a party to that lawsuit.
So really conflicting decisions. We've seen the Biden administration appeal that Texas decision and request an emergency stay of that injunction. And we know a federal appeals court is likely to weigh in this week, though many expect that this is ultimately going to go to the Supreme Court to resolve this conflict.
Unger: And that is really confusing. Andrea, the AMA has weighed in. Would you talk to us about the point of view here?
Garcia: Yeah. So the AMA issued a statement on Friday evening about the Texas ruling, specifically, saying that decision really flies in the face of science and evidence. It threatens to append access to a safe and effective drug that's been used by millions of people for more than 20 years. It goes on to say that it's going to cause harm to patients and undermine the health of the nation. And really by rejecting medical facts, the court has intruded into the exam room, has intervened in those decisions that belong to patients and physicians.
Unger: In addition to that kind of injection into the physician's office and that relationship, there is a lot of concern that this decision could undermine the FDA's authority in general. Talk to us more about that.
Garcia: And so that's exactly right. If that Texas decision stands, it could set a precedent for allowing courts to overturn longstanding regulatory decisions by the FDA. And certainly we could see other drugs at risk of being subject to similar decisions. The AMA points out in its statement that substituting the opinions of individual judges and courts in the place of extensive evidence-based and scientific review of the efficacy and safety through this well-established FDA process is reckless and dangerous. We also have to remember that in addition to termination of pregnancy, mifepristone is regularly used in combination with misoprostol as one of the most effective regimens for medication management of miscarriage. And this decision could end that use for countless patients already struggling with the loss of a pregnancy.
Unger: Well, we'll continue to keep tabs on this story as it evolves. Andrea, something else we're watching, we've been talking about for the past couple of weeks the Marburg virus. There's been a new CDC alert issued. What do physicians need to know now?
Garcia: Yeah. Just for those who may not be familiar, Marburg is a rare but highly fatal viral hemorrhagic fever. It's similar to Ebola. Late Thursday, shortly after we talked, CDC issued a health advisory about those outbreaks in Equatorial Guinea and Tanzania. The agency's warning says that all although there are no cases in the U.S., and the current risk here is low, physicians should be on the lookout for any imported cases. So physicians suspecting that someone is sick with Marburg virus should take a detailed travel history.
Infected patients should be managed under isolation until there's a negative test. And of course, notify state or local health departments immediately. We know symptoms can include fever, headache, muscle and joint pain, fatigue, loss of appetite, GI symptoms and unexplained bleeding. So we've been talking about this for a couple of weeks. We talked last week about taking that travel history. And certainly that's consistent with this health alert from the CDC.
Unger: I hope that the risk stays low for us here. But in some ways, that was the word, particularly, about COVID too initially. Is this something that we don't need to be worried about now or we need to be worried about?
Garcia: Well, I think—keep in mind that Marburg is different from COVID. It's not contagious until symptoms appear. It spreads mainly through direct contact with an infected person's blood or other bodily fluids or with an infected animal. It doesn't spread through the air like COVID does.
However, like COVID initially, there's no specific vaccine or treatment for the disease. CDC indicates that early intensive supportive care can keep people from getting seriously ill or dying. So it's important to identify those cases early. CDC's also said there's no evidence to suggest that the outbreak in Tanzania and Equatorial Guinea are related. Most experts seem to think right now that these two outbreaks represent two independent animal-to-human spillover events.
Unger: Well, we'll continue to keep people updated as we learn more. Andrea, what is the update with COVID this week? I read there is a new variant to watch. We haven't talked about something like that in a while.
Garcia: We know people out there are getting tired of COVID, but there are a couple of variants out there that the WHO has said that we need to keep an eye on. The first is XBB.1.1.6. And it's largely fueling an outbreak in India right now. We know from news reports that India's health ministry has conducted mock drills earlier this week to check preparedness of hospitals to deal with rising COVID cases. Health officials have also said that this variant has been in circulation for months. So while many cities in India have seen that sharp rise in cases in recent weeks, it hasn't led to an increase in hospital admissions, which is good news.
Unger: And what about the other variant that you mentioned?
Garcia: So on March 30, the WHO added one more variant under monitoring to the list. This is XBB.1.9. It has spike mutations that are similar to XBB.1.5 and XBB.1.16, including those linked to immune escape and increased transmissibility. Though, XBB.1.5 still makes up nearly all of the coronavirus in the U.S., we're seeing that proportion of XBB.1.9 rising slowly. And the recent CDC data shows it makes up about 5.1% of samples. That's up from 3.9% the previous week.
Unger: All right. Again, we'll keep an eye on that, Andrea. We also learned more about COVID compared to the flu. Tell us more about that.
Garcia: There were a couple of new studies published that suggest the COVID Omicron variant infection is deadlier than flu. One of those findings looked at U.S. veterans hospitals during the fall and winter of 2022 and 2023 and showed that there was a 61% higher rate of death in those patients with Omicron than hospitalized flu patients. That was published in JAMA. And that analysis found that mortality risk was greater among those unvaccinated users of the VA health system.
And then the second study showed that Israeli adults hospitalized with flu were 55% less likely to die within 30 days than those admitted for Omicron in the 2021, 2022 flu season. So this really highlights the importance of vaccination. That risk of death declined with an increasing number of COVID vaccines. And we heard one of the study authors say that this double whammy of overlapping flu and COVID epidemics will increase the complexity of disease, of course that burden on the health system. And there's one basic step that people can take that can alter that trajectory of either epidemic, and that's getting vaccinated for flu and COVID, especially if you are older or have underlying illnesses.
Unger: Absolutely. And speaking of that vaccination, turning our attention to the third leg of that tripledemic that we talked about months ago, RSV, I read that we were also making some headway on a vaccine for that virus. What's going on there?
Garcia: Yeah. So CNN reported that the RSV vaccine by Pfizer showed exciting promise in a lead stage trial. And we know the results of that company-funded trial in adults 60 years and older were published last Wednesday in the New England Journal. It showed the vaccine prevented RSV-associated lower respiratory tract illness. That includes acute bronchitis and pneumonia. And it prevented RSV-associated acute respiratory illness. Separate interim results showed that the vaccine candidate when given during late stage pregnancy was also effective against RSV-associated illness in infants, which is a really important finding.
Unger: So what are the next steps there?
Garcia: So we're going to see Pfizer seek FDA approval for its vaccine for older adults. And in a separate request, the company is asking the FDA to approve that vaccine with pregnant people to protect infants. The company says it expects that decision to be made in August. We know that in March, vaccine advisors to the FDA voted in favor of approving those RSV candidates from Pfizer and Glaxo for adults over 60. Those vaccines would be the first, if we see that FDA for RSV—if we see the FDA commissioner agree with those advisory committee opinions.
Unger: Well that is exciting news. It seems like we haven't heard as much about RSV lately. I feel like everyone I know, their kids have some other thing going on right now. Is RSV still a problem?
Garcia: So not so much right now. And last Thursday, the CDC said that all indicators show that we've returned to pre-pandemic seasonality in the U.S., after two years of irregular onsets and peaks. Usually cases of RSV, which we know can cause severe illness and death in the young and old, rose in October before waning in April.
However, during the two years of the pandemic, that circulation pattern changed. Data show that RSV cases in the most recent season started in June and peaked in November. While cases in the previous year started spreading in May and lasted through January. Researchers said it's not clear if that return to the pre-pandemic pattern will continue in their surveillance in the year ahead. But they will continue to keep an eye on it.
Unger: All that returned to human contact kind of throws everything back up for, I guess, more normal patterns. I guess overall that's good news to end on. Andrea, thank you so much for being with us today. We'll be back soon with another AMA Update. And you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today and 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.
