Transcript of December 20, 2019, Telebriefing: Update on Lung Injury Associated with E-cigarette Use, or Vaping

Operator: Good morning and good afternoon and thank you all for standing by. At this time I would like to remind all participants your lines will be placed on listen-only mode until the Q&A section of today’s conference. This call is also being recorded. If you have objections, you may disconnect at this time. I will now turn the call over to Mr. Benjamin Haynes. You may begin.

Haynes: Thank you, Kristy. Thank you all for joining us for today’s update on the lung injury investigation among people who use e-cigarette or vaping products. We are joined by CDC’s principal deputy director, Dr. Anne Schuchat, who will provide today’s update. Following the update Dr. Schuchat will be joined by Dr. Christopher Jones and Dr. Benjamin Blount to take your questions. I will now turn the call over to Dr. Schuchat.

Schuchat: Thanks for joining the call today. As the year draws to a close based on extensive investigations by state and local public health authorities, CDC scientists, our partners at FDA, and expert clinicians, we are able to make more definitive conclusions about the outbreak of e-cigarette or vaping product use-associated lung injury or EVALI. Some of the support for these conclusions comes from CDC-authored articles being released today in the New England Journal of Medicine as well as two articles in today’s early release of the Morbidity and Mortality Weekly Report. As of December 17, 2019, a total of 2,506 patients have been hospitalized for EVALI including reports from all 50 states. Sadly, there have been 54 deaths from 27 states. But based on the data being released today, we can make more definitive statements about the trajectory of the epidemic.

I want to make four points. First, it is clear that the outbreak represented a new phenomenon and not recognition of a common syndrome that had evaded our attention. Today’s report in the New England Journal of Medicine regarding analysis of data from the CDC’s National Syndromic Surveillance Program makes it clear that a sharp rise in emergency department visits began in June 2019. And occurrences peaked in September 2019 consistent with our active case reporting from public health departments around the country.

Second, we are confident that Vitamin E acetate is strongly linked to the EVALI outbreak. In a second report in the New England Journal of Medicine, CDC scientists found Vitamin E acetate in lung fluid washings, what we call bronchioloalveolar lavage samples in 48 of 51 samples of patients with EVALI but not in a variety of comparison patient groups. The patients with EVALI came from 16 different states, suggesting this was not a single local supplier of tainted products. These expanded patient clinical specimen results are consistent with previous work including identification by FDA and others of Vitamin E acetate in THC-containing products collected from patients with EVALI, as well as Minnesota’s recent report that Vitamin E acetate was in seized THC products from 2019 but not in any samples from 2018.

Given all of these findings, including today’s study, we can conclude that what I call the explosive outbreak of cases of EVALI can be attributed to exposure to THC-containing vaping products that also contained Vitamin E acetate. I want to stress that this does not mean that there are not other substances in e-cigarette or vaping products that have or are capable of causing lung injury. We know that a persistent small proportion of EVALI cases do not report use of THC-containing vaping products.

Thirdly, that the outbreak is getting better. While we continue to receive reports of newly diagnosed patients with EVALI, the level of new cases is greatly reduced and has been declining since a peak in September. This is consistent with our new syndromic surveillance data findings that we are reporting today. There are a variety of potential explanations for a true decrease in new hospitalizations. Unfortunately, despite this improvement, we have new issues of concern to share this week.

Fourthly, the reports in today’s MMWR summarize our findings of a concerning phenomenon — readmissions following discharge from the hospital. We had hints of this earlier this fall, but now have a formal analysis to share. We report on dozens of patients who had a significant worsening of symptoms shortly after being discharged from the hospital for EVALI. Our MMWR article describes 31 patients who were readmitted to the hospital a median of four days after discharge and seven patients with EVALI who died shortly after being discharged, a median of three days after discharge. While we don’t yet have all the clinical reasons these patients worsened so suddenly, we did find factors that may be warning signs of which patients are at greatest risk for these problems Patients with chronic diseases, particularly cardiac, chronic pulmonary disease, obstructive sleep apnea, and diabetes were significantly more likely to be readmitted. Older age is also likely a factor.

Based on these new data and discussions with clinical experts, todays CDC is issuing updated guidance to help clinicians carefully prepare for discharge and have a new EVALI discharge readiness checklist among materials that we are distributing today. We also recommend earlier follow up of patients. Optimally at 48 hours post discharge, to make sure to catch any clinical worsening before it is too late. The four reports today have much more detail which we’ll be happy to address in the questions. But I want to stress that this is a serious clinical condition affecting young people across the country. It is completely preventable. The outbreak has required the tireless response of the public health and clinical community. I want to thank all the partners across the nation as well as CDC staff for their hard work on this response. We’re happy to answer questions.

Haynes: Thank you, Dr. Schuchat. Kristy, we’re now ready for questions.

Operator: Thank you. At this time if you would like to ask a question, please press star-1 on your touchtone phone. Please ensure your phone is unmuted. You will be allowed to ask one question and one follow up question. One moment while we wait for questions to come in. Our first question comes from Dan Vergano of Buzzfeed news. Your line is open.

Buzzfeed: Hi. Thanks for doing this. I’m wondering when we will see some kind of action to remove Vitamin E acetate from these things and can you even do that given they are an illicit program not like lettuce that’s legally sold that you can take action against?

Schuchat: This is Dr. Schuchat. Let me say we have put out messages about the concern about Vitamin E acetate. As you point out, we haven’t been telling people to put Vitamin E acetate into these products and illicit products in many states aren’t necessarily well controlled. A number of states that do regulate cannabis-related products have taken steps to make sure that Vitamin E acetate isn’t included or to even test for it. Next question?

Operator: Thank you. Our next question comes from Carla Johnson of the Associated Press. Your line is open.

AP: On the rehospitalizations and deaths, is there reason to believe that these were medical mistakes that were made, that people were released too early, and is that why CDC is issuing this new guidance?

Schuchat: I think I would not say these are medical mistakes. I think it is important to say that clinicians have been working very hard to address a new syndrome responsively and carefully. What CDC and the state health departments have been doing is trying to gather information quickly and feed it back so that we can continually improve. The vast majority of people who were discharged from the hospital have not been readmitted. But in the 31 episodes of people who were rehospitalized we wanted to understand if there were any warnings. And so we do think that a more systematic readiness evaluation before discharge and attention to a number of factors that might predict worsening are attended to. So I think the medical community has been doing a terrific job with this. But we are committed at CDC to update our guidance as soon as we have actionable information. That’s really what we are doing today.

AP: And a follow up?

Schuchat: Sure.

AP: Is there any evidence that these patients returned to vaping after going home? The ones who were rehospitalized.

Schuchat: Yeah, thanks. I think there is some anecdotal information in particular states or localities. We don’t have that synthesized. Again, in a previous MMWR and telebrief we talked about the very important counseling that should start in the hospital and this isn’t just a medical issue. This is a behavioral issue and attending to whether it’s addiction to THC or issues that really would help a person get off of the vaping products, that that needed to be part of the in-hospital care. So we don’t have the systematic analysis of individuals, but we do have some anecdotal reports about that. I think it is likely there are a variety of factors here. The medical conditions that showed up were particularly important to note. You know, hopefully will help clinicians clue into those as they are readying patients for discharge. Next question?

Operator: Thank you. The next question comes from Lena Sun of The Washington Post. Your line is open.

WAPO: Thank you. Dr. Schuchat, could somebody walk us through the, in the Vitamin E acetate report there’s mention about how this could be causing the lung injuries. I was wondering if somebody could explain that in English. There is a section I didn’t understand at all. What happens in the lungs that this could be causing the injury — but in layman’s terms?

Schuchat: Yes. Let me give you a very general layman’s terms explanation. I need to caution by saying we do not know the precise mechanism by which Vitamin E acetate causes lung injury. The two theories that were offered in the paper included one that is a chemical change that will disrupt surfactant, which is the material on the lining of the lungs that might interfere with the lung’s ability to expand. The second is a chemical injury caused by a by-product of Vitamin E acetate. When Vitamin E acetate is heated to very high temperatures it is possible for a substance called ketene to be released. That in old reports can be associated with lung harm. Those are two theories, potentially one or both may be operating and there may be other possible approaches. From the early reports in the outbreak there were questions about lipoid pneumonia and the oil gumming things up with the macrophage response. There are different possibilities out there, but the two in the paper are really about that interfering with the lungs blowing up or expanding like a balloon that could lead to some downstream harms. And then the ketene metabolite.

WAPO: Thank you. I had a follow up.

Schuchat: Okay.

WAPO: Given each time you take a look at the lung fluids of EVALI patients and you’re finding pretty much all of them had Vitamin E acetate and now you have a control group where you didn’t find any of it, are you going to be doing more of those comparisons or is this pretty much, you know, it?

Schuchat: Thank you. This is a really important paper, that  provides very helpful information. I think we are of the belief that Vitamin E acetate has caused the EVALI syndrome in the vast majority of patients. There are a couple of other studies that are in progress including testing chemicals from individuals who have other lung diseases or other lung conditions to understand the specificity and then a second would be animal studies. I don’t think we have to hold our breath for those results, but I think they’re helpful to really help us go a little bit deeper in understanding the problem. We certainly have since September been recommending people avoid e-cigarette or vaping products, particularly those containing THC or acquired illicitly. These will round out the story.

WAPO: One more follow up. Can you now say it is not in vaping products containing nicotine? —

Schuchat: Let me say that my conclusion is that the outbreak, the very large increase in cases above what we have seen as a larger baseline than we realized is attributed to what’s happening this past year in the supply with the Vitamin E acetate diluting or tainting the THC-containing products. That doesn’t mean that there are not other chemicals or substances in e-cigarettes or vaping products that can or are causing lung injury. So there is a lot more work to do. The outbreak — this big increase is largely explained by the Vitamin E acetate phenomenon. But that doesn’t mean that vaping products with THC or other substances are safe and it doesn’t mean e-cigarettes that are nicotine only are safe.

WAPO: Thank you.

Operator: Our next question comes from Richard Harris of NPR. Your line is open.

NPR: Thank you very much. This is a point of clarification, please, about understanding the spike in timing. I would like you to connect the dots a little bit. If you have a single spike of increase, it would seem as though that points to a single culprit. That seems to be what you are saying. I want to make sure I understand that’s how you’re tying things together, thanks.

Schuchat: That’s right. When I talk about an explosive outbreak or a spike in cases the June increase in cases, I believe, is related to increased use of problematic substances that I don’t have quantifiable data about exactly what percentage of the THC-containing vaping products had Vitamin E acetate in them at high concentrations. But I believe the practice of diluting THC-containing vaping products with Vitamin E really took off this past year. We also know that, of course, there has been some increases in use of both e-cigarettes and other vaping products in the past couple of years including the past year. I think the behavior is common and the contaminated substances, if you will, became widespread.

NPR: A quick follow up. Have you been in touch with FDA? They have been presumably trying to track down the source of the Vitamin E acetate. Do you know if they have made progress in identifying this bolus of contaminants, essentially?

Schuchat: Let me step back from just the FDA and say there have been enforcement actions around the country taking place in terms of illicit distributors, producers or suppliers. There has been a lot of action on the part of the FDA and DEA in particular locales and other state or local authorities in trying to track back suppliers. There’s also been recognition that the internet and YouTube have been pushing this practice of diluting and making it more perhaps widespread. There’s been action to try get the Vitamin E and other dilutants out of these materials and also to try to track back suppliers. FDA made it clear in their investigation and messaging that they didn’t intend to take enforcement action against a user, but they wanted to get cooperation in terms of testing a product so they could do that back track, but I can’t speak about particular ongoing investigations.

NPR: Thank you.

Schuchat: Next question?

Operator: Thank you. Our next question comes from Kathleen Doheny of WebMD. Your line is open.

WebMD: Good morning. Can we assume that all cases are down just because the emergency department visits are down? Or is there other evidence that all cases are down?

Schuchat: Oh, thank you. There are several — okay. The reports today and yesterday include — you know, today we are reporting on the syndromic or emergency department visits and a few different approaches to using essentially administrative or automated data to look at trends. Yesterday we updated our weekly epidemic curve.

WebMD: Yeah.

Schuchat: It is really based on the active case findings from state and local public health. That has also shown this decline. For several weeks, we were reluctant to overinterpret the decline because there is so much work involved with the collection of data from clinicians and states and gathering the data and pulling it together that we wanted to make sure there wasn’t just a lag or fatigue. We do know some states are batching their reports and we continue to get reports in from several weeks ago. We believe the outbreak spiked in September and it is decreasing. It is not over. There are still new cases coming. And we do think consumers need to be careful and people need to be vigilant and public health is very much focused on this. This might be a long-term problem for us to make sure we prevent as much of this serious lung injury as possible. We have both the active reporting and the syndromic or emergency room department visits. That said, there might be some regional variation that maybe the illicit supply is popping up in an area where it wasn’t and has decreased in another area. We have to be alert to the idea there might be new spikes or surges possibly from other substances that are harmful. This has really been a wake-up call for the public health system and clinicians that there are new threats out there and consumers need to be cautious. When young people are admitted to intensive care units and perhaps damaging their lungs permanently, parents and others really need to take this seriously.

WebMD: You say it is declining based on those two things: declining reports from the states overall and declining hospitalizations?

Schuchat: That’s right.

WebMD: Thank you.

Operator: Thank you. Our next question comes from Denise Grady of The New York Times. Ma’am, your line is open.

NY Times: Thank you very much. I’d like to ask you about something that was mentioned in the paper. There was this gradual increase in emergency room visits by very young patients between 10 and 19, even well before the outbreak really started. There’s a suggestion in the report that it could be just due to the increase in using e-cigarettes, nicotine e-cigarettes. Could you talk about that more, please? Is there any more you can elaborate on that? The article mentions there is a need to investigate it further. Will that be done?

Schuchat: It’s important not to overinterpret the graduate rise that the syndromic surveillance detected in the 10 to 19-year-old age group. There are a variety of potential theories. Remember, this is a nonspecific signal. It’s essentially saying e-cigarettes or vaping were mentioned as a chief complaint. It may be that some of those are nicotine poisoning, that some of those are early EVALI cases, but I think you can’t really conclude. It is clear there was a major spike in September from many different sources and that in further review of those clinical records, the severe lung injury was identified. But I think we are really actually very excited about syndromic surveillance and the potential to help us recognize threats earlier and it is likely that most signals will need verification of clinical records and review to make sure we are separating signal and noise and finding specificity in what the signal is about. So I don’t want to overinterpret it. There may be more looks at what it may mean, but it is intriguing, but certainly not conclusive.

NY Times: Thank you. Can I ask a follow up?

Schuchat: Sure.

NY Times: Just a quick one. People went back to the hospital and the deaths, was the seven deaths part of the 31 or was that a separate number?

Schuchat: Thank you for that question. It’s a separate number.

NY Times: Thanks.

Operator: Thank you. Our next question comes from Jamie Ducharme of Time Magazine. Your line is open.

Time: Thank you very much for doing this. I was looking for a little bit more clarity on what could have been to blame for the EVALI patients in your new study who didn’t have Vitamin E acetate in their lung fluid. Those three people who didn’t meet the case report.

Schuchat: Okay, so just those three, right. The article provides a little bit more detail on them. The EVALI diagnosis is essentially a diagnosis of exclusion after you have ruled out infectious agents because they can look quite similar. On further detail, there’s some complexity with each of those patients in terms of the finding of some bacteria that the clinicians didn’t think were causing the problem. The issue of signs of eosinophils which can be a sign of fungal or allergic reaction. A lot of different clinical details. So I wouldn’t say that we know what the cause is of each of those and that maybe they are indicative of a background rate of nonspecific serious lung injury that may be occurring. I don’t think we have a single short answer for that. Dr. Blount may want to expand on that. Ben?

Blount: What we did add in our publication about those three additional cases, I defer to my co-authors for additional comment on those three individuals.

Jim Pirkle: This is Jim. We feel those three patients had clinical courses that could reasonably be explained by other diagnoses. But we intentionally put out a very sensitive case definition in the EVALI response. By doing that we’ll get people that also have other clinical things going on. EVALI might be plus/minus in terms of their diagnoses. We think that was important. We think there is some explanation for the clinical course that doesn’t require saying these patients are really EVALI cases. But it is still a gray area there.

Schuchat: Next question, please.

Operator: Thank you. Our next question comes from Brianna Abbott of Wall Street Journal. Your line is open.

WSJ: Thanks for doing this call. Quick question. When we are referring to THC products that contain Vitamin E acetate how many of these are coming from the illicit market compared to those bought from a licensed retailer?

Schuchat: Thank you. In previous reports including extensive studies from Illinois and Wisconsin we have information about sources of where people were getting their THC-containing products that supplement what we have gotten from the national data and it does appear that the vast majority of individuals report getting their products from informal sources like friends, family, acquaintances, online or in person dealers. That doesn’t mean there aren’t individual, pretty well documented episodes where the report is pretty clear that a person got the product from a licensed dispensary, but it sounds like there are more protections involved with the way dispensaries are regulated than with the illicit market. Since the outbreak has occurred a number of states with legal cannabis markets have been really looking at the regulations to see if they need to do additional steps to prevent such a problem.

WSJ: Thank you. Quick follow up. Saying that the conclusion points that the rapid outbreak is mostly due to THC products, what do you make of the small but consistent percent of patients who are reporting only vaping nicotine-related products?

Schuchat: I think there are a couple of factors. I think some of those individuals likely have used THC-containing products and in fact the New England Journal article on Vitamin E acetate, there are a number of individuals in the paper, 11, who did not report using THC but they found THC in nine of those patients in terms of the BAL testing. There is probably some underreporting. In addition, there are pretty well documented episodes anecdotally where there isn’t THC containing use, but there is e-cigarette or vaping use of other things where people have gotten quite ill with a lung injury that’s consistent with our diagnosis. We cannot say all of the substances, additives, adulterants that may cause harm, you can imagine heating to a high temperature material that is not well regulated could lead to lung injury. Partially misinformation and partially other factors.

Schuchat: We have time for two more questions, operator.

Operator: Thank you. One moment. Our next question comes from Eden David of the ABC News Medical unit. Your line is open.

ABC: Hi. Thanks for the updated information. I’m wondering in terms of the trends you have seen and the spikes in September how much of that do you attribute to the increased awareness for this potential cause of illness and symptoms? In essence, how much of these trends you see are just maybe in a sense artificially made to seem bigger just by the fact that providers are more aware of that potential cause for concern?

Schuchat: Thank you. The recognition by Wisconsin and Illinois clinicians in public health that clusters were occurring was critical in alerting the public health system and the nation to this problem. We are pretty sure that the Google trends spike in searches is completely related to the media attention and, in fact, it followed our first telebriefing. However, when the clinical and public health community began to investigate cases they recorded dates of hospitalization and when concrete, careful events occurred. It is clear that there was a peak in September. I believe it would have gone up much further had we not issued reports. I think the peak then is likely due to increasing use of adulterated THC-containing products and the decrease after September 8 is likely due to changes in behavior and interventions by law enforcement, FDA and others in terms of the product supply. Hopefully reduced use of risky products. We don’t think this outbreak is just a question of better recognition. That’s really why the syndromic surveillance is so helpful because it shows this increase in emergency department visits actually before we recognized the national problem and the spike in September is probably as it got worse and worse, more widespread, and there was more recognition, the decrease because of the interventions that have been taken.

Schuchat: Last question.

Operator: Thank you. Our last question comes from Abby Haglage of Yahoo! Your line is open.

Yahoo: Thank you very much. I had a quick clarification question. You mentioned YouTube at one point in regards to Vitamin E acetate. Were you suggesting that videos sort of DIY, how to dilute your vaping liquid is part of the origin of Vitamin E acetate being put into vape liquid?

Schuchat: I’m not an expert in this area, but I would say that communication channels may have led individuals to do sort of copycat. It’s pretty clear when you look at Vitamin E acetate, it’s a goopy, viscous liquid that’s pretty similar in the liquid viscousness to THC oil. So if you were kind of trying to extend your THC oil, it would be a pretty good way to do it. So how word of mouth or social media helped — contributed to this phenomenon, I don’t think right now anyone believes it was a single dealer or single producer that added Vitamin E acetate to THC oil. I think there is a sense that this was a distributed adulterated supply. And how that happened, I can’t provide conclusive comments. But I do believe there were social media factors that likely played a role.

Yahoo: Got it. Thank you.

Schuchat: I was just going to say thank you all for joining us. In addition to thanking the public health and clinical and scientific communities that have been so critical in helping us respond to this outbreak, I really want to thank the media as well. You definitely have helped get the word out to the public. This has been a public emergency that really needed your voice. Thank you for calling in today and our press office has a closing note.

Haynes: Thank you, Dr. Schuchat. I would like to repeat her thanks and thank you all for joining us. If you have additional questions, contact the CDC media office at 404-639-3286 or at media@CDC.Gov. Thank you.

Operator: Thank you. This does conclude today’s conference. Thank you for participating. You may disconnect at this time.