OPERATOR: Good afternoon, thank you for standing by. Welcome to CDC’s briefing. Today’s conference is being recorded. If you have any objection, you may disconnect at this time. Your lines are in listen only mode until the question and answer session. At that time you may hit star followed by the question. It is now my pleasure to turn the conference over to KD Hoskins at CDC. Thank you, you may begin.

SHARON KD HOSKINS: Thank you, Michelle. Thank you all for joining us on the update on the lung injury investigation among people who use e-cigarette or vaping products. We are joined by Dr. Anne Schuchat – Principle Deputy Director of the Centers for Disease Control and Prevention. Dr. Schuchat will provide this week’s update on our support for the lung injury investigation. We are also joined today by Dr. Judy McMeekin, Deputy Associate Commissioner for Regulatory Affairs at the US Food and Drug Administration.

In addition, during our Q&A session, Dr. Brian King, from CDC’s response team, will join us to answer any additional questions that you may have. I’ll now turn the call over to Dr. Schuchat.

ANNE SCHUCHAT: Thanks so much, KD. Thank you all for joining us today. Unfortunately, the outbreak of pulmonary injury associated with e-cigarette use, or vaping, is continuing at a brisk pace. CDC is continuing our investigation together with state and local health departments and Federal partners including FDA. We are getting more information about cases that occurred earlier this year as well as more recent ones, and we’ve unfortunately surpassed 1,000 lung injury cases in this outbreak.

As of October 1, 2019, 1,080 lung injury cases associated with use of e-cigarette, or vaping, products have been reported to CDC from 48 states and the U.S. Virgin Islands. This lung condition is serious, and we continue to learn of additional deaths. There have been 18 deaths confirmed and reported to CDC from 15 states and we know that additional deaths are under investigation.

The increase of 275 cases since last week is a combination of new patients becoming ill in the past two weeks and recent reporting of previously-identified patients.

Consistent with the case definition, all reported patients have a history of using e-cigarettes or vaping products.

As we have continued to get data for additional cases, the trends we reported last week persist. Most patients report a history of using THC-containing products and most patients are male and young people.

Out of the 1,080 cases, approximately 70% of patients are male. Approximately 80% of patients are under 35 years old. More than one-third of patients, or 37% are under 21 years old.

We have continued to assess what products patients have used and now have information for 578 patients with information on substances used in e-cigarette, or vaping, products in the three months prior to symptom onset we found that about 78% reported using THC-containing products and 37% reported using only THC-containing products. About 58% reported using nicotine-containing products and 17% reported using only nicotine-containing products.

I wish we had more answers regarding the specific harmful products or components that are causing these illnesses. Let me describe some of the recent actions we are taking to help get answers.

Recently, CDC has deployed additional staff to several states to assist with the investigation. We’ve conducted broad outreach to the clinical community to increase awareness of this illness We’ve worked with clinicians and medical examiner community to provide timely updates, engage on their experience in caring for patients, and review assessments of those that have died from this concerning illness. We’ve convened clinical professional societies, both primary care and specialty, to help strengthen detection, reporting and management of cases. This ensures that our response and our interim clinical recommendations are informed by their direct experience caring for these patients. Together with FDA and public health partners, CDC has developed a comprehensive laboratory plan for continued testing of products, aerosol testing of substances produced by the products, and clinical/pathology lung specimens from patients. We hope that this laboratory effort will provide additional information on the products, potential substances and clinical findings associated with e-cigarette use or vaping. CDC is also leveraging the Laboratory Response Network to receive samples- this is an existing laboratory preparedness and response capability that has been a core component to the nation’s public health response infrastructure for 20 years. CDC continues to use various platforms to ensure the public is aware of the most current information on this outbreak, including weekly updates to our website and through social media, as well as through routine telebriefings like this one.

I can’t stress enough the seriousness of these lung injuries associated with e-cigarette use, or vaping. This is a critical issue and even while we learn more, we need to take steps to prevent additional cases.

Given continued occurrence of life threatening new cases, CDC recommends that people refrain using e-cigarette, or vaping, products, particularly those containing THC. Regardless of this investigation, e-cigarettes should not be used by youth, young adults, pregnant women, or people who have not previously used tobacco products.

If you are concerned about your health after using an e-cigarette product, contact your health care provider, or you can also call your local poison control center at 1-800-222-1222.

I’d like now to invite Dr. Judy McMeekin of the FDA to share an update about the FDA’s findings.

JUDY MCMEEKIN: Thank you Dr. Schuchat, for those important updates and for the continued collaboration. My name is Dr. Judy McMeekin and I serve as the FDA’s Deputy Associate Commissioner for Regulatory Affairs. The FDA continues to work closely with our federal, state, and local partners as quickly as possible to gather more information about these destructing incidents. This is a critical public health investigation and collaboration is integral to our success. Today I want to provide a few updates on our extensive work. We remain focused on better understanding whether there is a relationship between any specific products or substances and the reported illnesses. Work includes collecting critical details about the products or substances involved, where they were purchased, and how they were being used. Based on our analysis of samples from the state, there does not currently appear to be one product or substance involved in all of the cases. For example, in many cases, but not all, patients have acknowledged recent use of products containing THC. And some have reported the use of e-cigarettes containing nicotine or both THC products and nicotine products. We are leaving no stone unturned in following all potential leads regarding any particular product, constituent, or compound that may be at issue. The FDA’s work to investigate the illnesses includes field sample collections, in coordination with state, sample analysis, criminal and civil investigations, and coordination with state and federal partners. The FDA has received or collected over 440 samples from 18 states to date. And those numbers continue to increase. We are working quickly and thoroughly to analyze the samples. As noted in a recent telebriefing, investigating this crisis is FDA’s top priority. Our investigators and agents are following every possible lead, which includes traveling throughout the country and attempting to gather any available evidence, including devices, pods, cartridges, diluting agents and more. The FDA is focused at identifying the products making people ill and following the supply chain to the source. The FDA is not pursuing any actions associated with personal use of any vaping products. Our interest is in the supply chain. But as acting FDA Commissioner Sharpless has said, if we determine that someone is manufacturing or distributing elicit adulterated vaping products that caused illness or death for personal profit, we would consider that to be a criminal act. Getting to the bottom of these respiratory illnesses is a top priority for all of the federal and state agencies involved. And we’re committed to taking appropriate action as the facts emerge. Thank you for your time.

SHARON KD HOSKINS: Thank you. Michelle. We are now ready to take questions.

OPERATOR: Thank you. At this time if you would like to ask a question, you may press star 1. Please state your first and last name when prompted. Again that is star 1 for any questions. One moment, please. Dr. John Torres from NBC news, you may go ahead, sir.

NBC/DR. JOHN TORRES: Yeah, this is Dr. John Torres, thank you for taking the question here. Do you believe it’s the black market devices that are mostly responsible for these vaping-related lung injuries?

ANNE SCHUCHAT: Thank you for that question. You know, we do have a lot of concerns about black market sources. I think it’s premature for us to rule out other concerning products. The Illinois and Wisconsin report from last week did find that most of the individuals had gotten their THC-containing products from informal sources off the street, not from brick-and-mortar shops. But at this stage in the investigation, we really need to keep an open mind and recognize that sources in one part of the country may not be the same as elsewhere. There is a lot we do not know about what’s in various e-cigarette or vaping products and what harms they can have. But i think this black market concern is a high one for us.

OPERATOR: Thank you. Our next question comes from Lena Sun from WAPO, you may go ahead.

WASHINGTON POST/LENA SUN: That would be “The Washington Post,” thank you. I have two questions. One for the FDA. It’s been a while since you’ve shared any of your findings with us of what you discovered in all of the sampling. I was wondering if you could offer a little bit more detail. And the second question is for both of you- the New England journal this week published a letter from Mayo Clinic pathologists who said that they didn’t see any evidence of markers for lipoid pneumonia in 17 of their patients. That contradicts or is in conflict with the MMWR that CDC put out a couple of weeks ago from North Carolina, where there were five patients diagnosed with lipoid pneumonia based on the lipoids and macrophages found in the lungs. Lipoids and macrophages were also found in the lungs of 6 patients with the University of Utah. I was wonder, Dr. Schuchat, if you could sort of help us understand that and whether the discrepancy could be a function of the way those biopsies were processed and is the CDC analyzing some of these autopsy results and analyzing? Is there anything you can share with us?

ANNE SCHUCHAT: Yeah. Thank you for those two questions. I’ll answer the second one first. Then we’ll let the FDA talk about the additional laboratory results. Yeah, the report in the New England journal is quite helpful. A series of 17 patients with pathologic analysis. You also mentioned the small number, the five or six cases for North Carolina in the Utah report. I think its early days in understanding the full clinical spectrum and the pathology of lung injury following e-cigarette use or vaping. The part of the plan that I mentioned, the laboratory testing plan, includes pathology specimens with controlled specimens to try to get a better feel for the spectrum of conditions. The North Carolina report that was in our MMWR came from a group of clinicians in North Carolina and I think it was very helpful in raising questions and alarms. I think we really have the feeling right now, that there may be a lot of different nasty things in e-cigarette or vaping products. And they may cause different harms in the lung. We also know that pathology analysis needs to be done quite carefully with the appropriate stains and appropriate controls and we hope over the months ahead that we’ll learn a lot more about the spectrum of lung conditions that these exposures are having. I think the main point that I’d like to make is these are really serious injuries in the lungs and we don’t know how well people may recover from them, whether lung damage may be permanent. So the glimpses that pathologists are getting are helpful in trying to get to some kind of pathogenesis, but we have a lot more to learn. Let me go to Dr. McMeekin on the FDA question.

JUDY MCMEEKIN: Sure. Just as a follow-up. This is a complex investigation unlike any we’ve seen and the FDA is working quickly and thoroughly in testing the samples. Many of the samples have contained little to no liquid, which limits the number and types of tests that are able to be conducted on each submission. The samples we are continuing to evaluate show a mix of results and no one substance has been identified in all of the samples tested.

OPERATOR: Thank you. Our next question comes from Mike Stobbe with the Associated Press. Go ahead, sir.

AP/MIKE STOBBE: Thanks Dr. McMeekin. Can you talk a little more of the samples, did you say 340? Was that the number? How many were you able to analyze and did you say even if no single substance was seen in all of them, is there a substance or chemical or anything that has been found most often? And Dr. Schuchat can you say a little bit more about the deaths and how many of those 18 autopsies were performed and what’s the median age and did they all vape the same thing or did they ll have a pre-existing condition? Any light to shed on those?

JUDY MCMEEKIN: I just want to clarify that the FDA has received or collected over 440 samples from 18 states to date and those numbers continue to increase. Our samples include both devices and products that contain liquid collected directly from consumers, hospitals and from state offices. Thank you.

AP/STOBBE: Whoa, I’m sorry. She didn’t answer the question, though, can you say a little more about what has been found most often in those samples and how many of them you have been able to analyze?

JUDY MCMEEKIN: So our testing is not complete. However, preliminary results are revealing some products contain THC in concentrations ranging from 14% to 76% and some THC products that also contain a combination of THC and vitamin E acetate ranging from 31 to 88%.

ANNE SCHUCHAT: So mike, as to the deaths, I don’t have individual line list underlying conditions. What I can tell you, though, is that the median age is nearly 50. It’s 49-and-a-half. So the fatalities that we are seeing tend to be a bit older than the overall disease burden. That probably isn’t that surprising. The other thing I can — the other thing that I can say is that the age range of fatalities that I’m aware of that have been reported to us is in the 20s to in the 70s. And so as you know, we don’t provide individual identifiable information, but it’s as old as the 70s that one of the deaths was apparently. But again the average age or the median age excuse me is almost 50. A bit higher than we are seeing in the overall population. The small numbers of deaths we have information on so far, I mean, it’s small in terms of statistics. It’s very large in terms of tragedy. But there is a higher proportion of female represented amongst fatal cases preliminarily than in the full population of people affected where we have about 70% male. I think that it wouldn’t be surprising for older people potentially with underlying conditions to not withstand an insult like this, a lung injury as well. But again, with only data on you know less than two dozen deaths, it may be too early to draw conclusions. We do think that the proportion hospitalized in intensive care units is just terrible with this condition and that we really want to prevent it. Next question operator.

OPERATOR: Thank you. Dan Vergano with Buzzfeed News. You may go ahead, sir.

BUZZFEED/DAN VERGANO: Thank you very much. Two questions. The first is, is this syndrome defined well enough that you can say the onset is rampant? You say you still have cases going on? Does that mean there are products out there still making people sick? The second question is what advice do you have for adult smokers who switch from tobacco to e-cigarettes as a way to wean themselves off?

ANNE SCHUCHAT: Yes, thank you for those two questions. We are concerned that risky product is still available and that’s one of the reasons that we have intensified our recommendations or warnings. We haven’t seen a measurable drop-off in the occurrence of new cases and so we don’t feel that either individuals have changed their behavior or the products are gone. We know that there have been — that there is a lot going on to try to get risky products off the market. But we are worried there are plenty of risky products still out there. Now I think the special case of adults who have used e-cigarettes to help stop smoking cigarettes, we really don’t want people to turn to smoking cigarettes. Obviously, there is a lot of individual decision-making involved with adults who are currently using e-cigarettes and we recommend they consult with their healthcare provider. There are a number of FDA approved cessation devices or strategies that together with counseling can be helpful. We really don’t want people to go back to smoking cigarettes. Our recommendations are having intensified as we continue to see new cases, but we really don’t want people who are adult smokers to go back to smoking cigarettes.

BUZZFEED/DAN VERGANO: Is it established from the new cases that the onset of this illness is rapid, people smoke and within a week they show up in the ER, or is it unclear that there may be longer term cases of onset?

ANNE SCHUCHAT: What I would say from the information that is available so far is many people are long-time users or frequent users and may or may not have changed their habits. The symptoms, the time of symptoms to hospitalization can be fairly short in terms of a week or so. And the — but the question of which was the exposure or was it can accumulate exposure that led to the condition, we don’t know. What I meant by saying so many cases, you know of the 275 new cases this week, about half of them were hospitalized within the past two weeks suggests to me that there have been risky exposures out there in the past month or so despite the warnings we’ve made.

OPERATOR: Thank you. Our next question comes from Helen Branswell for STAT News. You may go ahead.

STAT/HELEN BRANSWELL: Thank you very much for taking my question. I want to ask the other side of the time line. Dr. Schuchat, you said some of the 275 newly reported cases are old cases that have been reported into the system. Can you talk about how far back you are seeing cases now because, of course, you know, it’s the big question is, has this always been happening and is this is just being the seen now? I’m just wondering if you think there was a point where it started or as evidence accumulates you are seeing cases further and further back?

ANNE SCHUCHAT: Yes. Thank you. What we call the epidemic curve of the curve that shows the date of admission and the state date of symptom onset for individual cases, I believe we’re intending to be posting that each week on our website. That goes back to March 31st of this year, but what I would say is in the literature, we know that there is sporadic cases of the, of a condition that sound like it’s the same thing. But what we’ve seen is this increase in cases in terms of the epidemic curve that we have, it’s really June/July where we start to see a lot of cases. There are just a handful in the March/April/May time line compared to what we started to see June/July and of course in August. There is probably some recognition bias in terms of the summer because we have been raising the alarm on this. But you know there – there’s probably been isolated cases for much longer than going back. But I refer you to the website for that curve.

OPERATOR: Our next question comes from Denise Grady from the New York Times, you may go ahead.

NEW YORK TIMES/DENISE GRADY: Hi, thank you. In examining the — what people are vaping, are you looking at the devices as well as the fluids or other things that people are vaping? And is there any concern or much information about whether there is something going on with the devices, themselves?

ANNE SCHUCHAT: Let me begin and then I’ll let FDA continue. The Illinois-Wisconsin group found that there was a common pathway in terms of pre-filled cartridges but not in terms of devices. But what I can say is that based on the intensive interviews that have been done in a couple of the states we’re modifying, simplifying and honing in our interview form to understand, to get better information about those devices and products. In terms of the testing in addition to testing substance, we think it’s important for us to test the aerosol that the substances produce. But in terms of device testing, let me let FDA make any comments that they’d like to.

JUDY MCMEEKIN: Sure. Our samples include both devices and products that contain liquids, collected directly you know from the consumers and states. Many of the samples like I said contain very little to no liquid and that really limits the number and types of tests that we’re able to conduct.

OPERATOR: Thank you. Our next question comes from Erica Edwards with NBC news.

NBC/ERICA EDWARDS: Hey, thank you. One quick thing, I wanted to confirm what was said about the vitamin e acetate earlier. I believe i heard the percentage was between 31 and 88% of the THC products? And the other question I had was a little bit more broad? I mean, this is not like the other outbreaks of the seasonal flu where we know it’s going to get better in spring? So I’m wondering, do you expect these lung injuries and death to continue rising for the foreseeable future? What is it going to take to get this under control?

ANNE SCHUCHAT: Let me start and I’ll let FDA answer. I just want to qualify a little bit about the testing of the specimens. There can be multiple specimens from an individual patient that were tested. So a range of vitamin E, you need to know that there may be multiple positives from one single person. The other thing is I believe the range that was presented wasn’t all the samples positive but in an individual sample what percentage of that liquid was vitamin E, rather than that full range of samples all had vitamin E or had you know. So let me stop and let FDA comment on the vitamin E results that they shared.

JUDY MCMEEKIN: So, as a reminder, our testing is not complete. However, the preliminary results are revealing some products contain THC at concentrations ranging from 14 to 76% and some THC products that also contain a combination of THC and vitamin E acetate ranging from 31 to 88%. Thank you.

ANNE SCHUCHAT: Thanks. And then I think your second question was a really important one was what is it going take for this to go away. You know, I think there is two issues to consider. One is, individuals using e-cigarettes or vaping products, if there is a decrease in use of potentially risky products, we would hope to prevent cases. And the second thing is identifying those multiple sources that are possibly problematic and getting them out of circulation. I think the second may take a lot longer than the first and to be on the safe side, right now we really want to caution people that it is pretty much impossible for you to know what is in the e-cigarette or vaping product that you are getting, particularly THC-containing products bought off the street or from social sources. And in light of the seriousness of this condition, we really don’t think using this product is safe right now. But i think we really need to work hard to get to the risky product and to ideally have our message be more targeted. But as long as you know people are getting this ill and dying, we want to make sure you know that we’re not optimistic, that tomorrow we’re going to be able to pull all the risky stuff off the market. But thank you for that question, because we are concerned with hundreds of new cases reported each week that we’re looking at a very concerning outbreak. It’s very difficult to control. So operator, last question.

OPERATOR: thank you. Our last question comes from Kathleen Doheny from WebMD. You may go ahead.

WEBMD/KATHLEEN DOHENY: Two quick question. Is there any way to predict if this has peaked? — and what would you say to the legions of people on social media that I see saying, it’s perfectly safe to vape THC that was bought from a licensed dispensary. What would you say to those people?

ANNE SCHUCHAT: The data that we’re getting does not suggest this has peaked. It doesn’t suggest that it is declining and we’ll need more observations. In case this is going up, we wanted to intensify our warnings. We really are taking this very seriously. Obviously, individuals will make choices about their own health and their own behaviors and individual states that have licensed dispensaries are taking steps to assure that what they regulate is safe. So, we’re not interfering with state regulation. We’re just saying that right now, it’s very difficult for a consumer to know what they have.

WEBMD/KATHLEEN DOHENY: even if it’s from a licensed? —

ANNE SCHUCHAT: That’s really a state by state question, I think. And of course, just to reiterate, last week, the Illinois-Wisconsin report found most of the people got their THC containing products off the street, no from a licensed dispensary however that was a geographically focused outbreak. We don’t know if that generalizable yet. Of course, we know there is a lot of conversation out there about what is and isn’t safe. Personally, with all the data that I have been seeing I don’t know what safe is right now. So let me just thank everybody for being a part of today’s telebriefing and thank the FDA and state and local partners who are working so hard to try to understand this and get to the bottom of this, we are really working hard to try to get answers that we hope will be useful, but we think that given the continued occurrence of life-threatening new cases, we’re recommending people refrain from using e-cigarettes or vaping products, particularly those containing THC, particularly those bought off the street. Thank you all.

KD HOSKINS: For reporters, if you have additional questions, you can call us at 404-639-3286 or send us an e-mail at media@CDC.gov. This concludes our briefing.

OPERATOR: thank you, this concludes today’s conference call. You may go ahead and disconnect at this time.