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AMA Update
Malaria, PFAS, plus the latest from the FDA and CDC with Andrea Garcia, JD, MPH
Jul 12, 2023
Featured topic and speakers
In today’s AMA Update, what you need to know about toxic 'forever chemicals' contaminating drinking water. AMA Vice President of Science, Medicine and Public Health Andrea Garcia, JD, MPH, also covers recent FDA approvals for a new Alzheimer's drug and a blood test for pregnant women. Plus, updates on malaria cases in the U.S. and CDC's three vaccines recommended for the fall. AMA Chief Experience Officer Todd Unger hosts.
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. Welcome back, Andrea.
Garcia: Thanks. It's good to be here.
Unger: Well, let's start off today with some big news about a new treatment for Alzheimer's disease. Andrea, what do we need to know?
Garcia: Last week we saw the FDA fully approve the Alzheimer's drug Leqembi. And it's a pretty big deal because it's the first time that a drug designed to slow the progression of the disease has been granted that full regulatory approval. And that also clears the way for Medicare to begin coverage of the treatment, which makes the drug more accessible. We know that Alzheimer's Association has been a vocal advocate for the drug's approval and praised that decision by the FDA.
Unger: Andrea, how many people could this potentially impact?
Garcia: So according to the Alzheimer's Association, there are about 6.7 million adults aged 65 and older in the U.S. that have the disease. The drug is approved for people with mild cognitive impairment or early stage Alzheimer's. So it's estimated that there are about 1.5 million people in the U.S. who fall into that category. Leqembi is given intravenously every two weeks, so patients will need to go to a hospital or a clinic for the infusion.
Unger: Is this a game-changer for those that have the disease?
Garcia: Well, it's not a cure and it does not stop Alzheimer's. However, in a phase three clinical trial, researchers found that the treatment did slow that progression of the disease by 27% over an 18-month period in patients who do have mild cognitive impairment or early stage disease.
There are also some side effects to be aware of. About 12.6% of patients who received the treatment in the trial developed brain swelling, and that was compared to about 1.7% in the placebo group. And about 17% in that treatment group experienced brain bleeds compared to about 9% in the placebo group.
So before starting the drug, it's recommended that patients get genetic testing so clinicians can better understand their risk for the side effects. And experts are also recommending that patients get periodic brain scans to monitor for any side effects as well.
Unger: Well, thank you for that update there. Now, let's talk a little bit about RSV. The FDA also approved two RSV vaccines for older adults, which we talked about in our last episode. But now it's official because the CDC has recommended them as well. Tell us more, Andrea.
Garcia: Yeah. So that's right. Late last week, the CDC director endorsed the Advisory Committee on Immunization Practice's recommendation for the use of those new RSV vaccines from both GSK and Pfizer. And those are for people aged 60 years and older. And just a reminder—the ACIP recommendation was for use in a shared clinical decision-making approach.
This endorsement does follow approval from the FDA. We know that RSV is often associated with babies and children, but it can be dangerous for seniors as well. In the U.S., as many as 160,000 older adults are hospitalized each year with RSV. Thousands die.
Those numbers have been really trending in the wrong direction. We've seen RSV hospitalizations among seniors in the most recent season higher than they've been for the last six years based on CDC data. So these vaccines will be an important tool this fall. FDA is still reviewing a maternal RSV vaccine that would protect infants. And I don't think we're going to see a decision on that probably until August.
Unger: All right. Well, we'll keep tracking that. Andrea, we also talked last week about malaria and the CDC's recent health advisory last week. Any updates there?
Garcia: Yeah, there are a few more stats to share. So so far seven cases of malaria have been detected in the U.S. in the past two months. Again, this is the first local spread in the country in 20 years. There are six cases identified in Florida. The seventh case was in Texas, according to the CDC. Those are believed to be locally acquired.
There's also a concern for the potential rise in imported malaria cases here in the U.S. with increased international travel expected this summer. I think in better news, the CDC is reporting that those recent cases in the U.S. have received treatment and are improving.
Unger: Andrea, what do physicians need to know right now in regard to malaria?
Garcia: Yeah, so physicians should consider the diagnosis of malaria in any person with a fever of unknown origin. And that's regardless of international travel history, but particularly if they've been to an area with recent locally acquired malaria.
Mild symptoms of malaria we know include fever, chills and headaches. But those more severe symptoms are difficulty breathing, fatigue, confusion and even seizures. Physicians should routinely obtain a travel history and consider malaria in a symptomatic person who traveled to an area with malaria in the weeks to months preceding symptom onset.
Unger: Andrea, what, by way of treatments, are the options here?
Garcia: So I think it's important to remember that treatment recommendations for malaria are not really a one size fits all. They really vary by species and severity. So the best approach here is to look at the CDC's malaria diagnosis and treatment guidelines for U.S. clinicians. And those provide very specific instructions, so we'll include a link to that in the episode description.
Malaria is a medical emergency. And if it's not diagnosed and treated promptly, it can progress to severe disease, and it can even be life-threatening. In its most severe form, it can lead to mental status changes, seizures, renal failure, acute respiratory distress syndrome or even coma.
So anyone who has symptoms should be urgently evaluated in a facility such as an emergency department. And physicians should order a microscopic examination of thin and thick blood smears, and as well as a rapid diagnostic test if available.
Unger: All right. Well, thank you for that. Andrea, we've had a lot of discussions with different folks about maternal mortality and concerns about that. There is some good news here. The FDA recently approved a blood test that can help pregnant women. What's the news there?
Garcia: We've talked a lot about the growing problem of maternal morbidity here in the U.S. And now, we've seen the FDA approve a blood test that can identify pregnant women who are at imminent risk of developing preeclampsia. And that's a leading cause of disability and death among childbearing women. But it's also a condition that disproportionately affects Black women in the United States.
That new test offers an early warning to help identify which pregnant women have symptoms and who will go on to develop that life-threatening disease within the next two weeks. To what extent the test will improve outcomes and save lives really isn't clear because we don't have effective treatments for preeclampsia, which typically eases after birth.
However, the test can tell with up to 96% accuracy who will not develop that disease and within the next two weeks. And so those individuals can be discharged from the hospital. Those two-thirds of women who get a positive result who will progress to severe preeclampsia, their babies may need to be delivered early. In either case, it's better to know. And I think that is how blood test is going to be helpful.
Unger: All right. Thank you. And hopefully, that will lead to improved outcomes. Last headline for the week has to do with the U.S. water supply, and it's pretty concerning. Andrea, what do we need to know about that?
Garcia: There was a new study from the U.S. Geological Survey, and it showed that almost half of tap water in the U.S. is contaminated with chemicals known as forever chemicals, or PFAS. And the number of people drinking contaminated water may be even higher than what the study found because researchers weren't able to test for all PFAS. There are more than 12,000 types and this study only looked at 32.
These are a family of ubiquitous synthetic chemicals. They linger in the environment and in the human body, and exposure is linked to health problems like some cancers, high cholesterol, obesity, thyroid disease, decreased fertility, liver damage and even interference with the body's natural hormones.
Unger: So that's pretty concerning. And I guess the question is should people be scared of their drinking water? What do you in this case?
Garcia: Yeah. So most people in the U.S. have been exposed to some PFAS, and there's ongoing research to really determine how the different levels of exposure are linked to these various health effects. Those highest concentrations in drinking water were found in the Great Plains, the Great Lakes, the Eastern seaboard, and then Central and Southern California. It's really important for people to understand their risk of exposure.
And if your water is contaminated, a carbon water filter can help, but that filter has to be changed regularly. And households could also use reverse osmosis filtering systems, but those can be expensive.
Unger: Well, given the extent of the problem, is the EPA involved at all yet?
Garcia: So the EPA has proposed the first national drinking water standards for six PFAS chemicals. And those proposed limits would set the allowable levels for these chemicals. If finalized, that proposed regulation will require public water systems to monitor for these chemicals. And it will also require those systems to notify the public and reduce PFAS contamination if those levels exceed those proposed regulatory standards. A final decision on that proposed regulation is expected later this year.
Unger: Well, thank you, Andrea. We'll continue to follow that as well. And as always, Andrea, we appreciate you keeping us up to date. That wraps up today's episode. We'll be back with another AMA Update soon. And you can find all of our episodes at ama-assn.org/podcasts. Thanks for joining us today. 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.
