CDC Telebriefing - Update On EVALI 10/25/19

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Media Advisory

For Immediate Release: Friday, October 25, 2019, 1:00 p.m. ET
Contact: Media Relations
(404) 639-3286

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CDC Telebriefing: Update on Lung Injury Associated with E-cigarette Use, or Vaping

What:

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) will give updates on the investigation into cases of lung injury associated with e-cigarette use, or vaping.

Who:

• Anne Schuchat, MD (RADM, USPHS, RET), Principal Deputy Director, CDC
• Mitch Zeller, JD, Director, Center for Tobacco Products, FDA

When

Friday, October 25, at 12:00 p.m. ET

Dial-In  

Media: 888-795-0855

Non-Media: 888-972-6892

INTERNATIONAL: 1-517-308-9298

PASSCODE: CDC Media

Important Instructions
If you would like to ask a question during the call, press *1 on your touchtone phone. Press *2 to withdraw your question.

You may queue up at any time. You will hear a tone to indicate your question is pending.

TRANSCRIPT
A transcript and audio will be available following the briefing at CDC’s web site: www.cdc.gov/media.

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Audio

https://www.cdc.gov/media/releases/2019/a1025-telebriefing-update-lung-injury.mp3

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OPERATOR: Welcome.  Thank you for standing by.  Today’s call is being recorded.  If you have any objections you may disconnect at this time.  All participants are in listen-only mode until the question and answer session.  At that time press star one to ask a question.  I would like to turn the call over to Amy Heldman.  You may begin.

MODERATOR: Thank you, Sandy.  Thank you all for joining us for an update on the lung injury investigation among people who use e-cigarette or vaping products. My name is Amy Heldman and I’m from CDC’s Division of Public Affairs.  I will be moderating today.  We are joined by Dr. Anne Schuchat, Principle Deputy Director of the CDC, who will provide this week’s update. We are also joined by Mitch Zeller, Director, Center for Tobacco Products, FDA.  Dr. Brian King from CDC’s lung injury response will also join us to help answer additional questions you may have.  Now, I will turn it over to Dr. Schuchat.

DR. ANNE SCHUCHAT: Thanks so much.  Thank you all for joining us as CDC continues investigating this multi-state outbreak of lung injury associated with the use of e-cigarette or vaping products, together with state and local health departments and federal partners including the FDA.  As of October 22, 2019, CDC received reports of 1,604 lung injury cases associated with the use of e-cigarette or vaping products, for which we are now using the acronym EVALI – that is E-V-A-L-I.  These injury reports come from 49 states, the District of Columbia, and the U.S. Virgin Islands.  Thirty-four deaths have been confirmed in 24 states.  This week’s numbers represent an increase of 125 cases of lung injury compared with what we reported last week.  Although the epi curve which we have posted online suggests that the trajectory may be leveling off or even declining, you may wonder if the peak of cases has passed.  This pattern may or may not be confirmed with additional time.  There may be less intensive investigation of possible cases by the health departments, fewer cases from earlier in the year being reported in to the public health system, or lags in data reporting to the CDC.  It is also possible that our consumer warnings about the risks associated with the use of e-cigarette or vaping products that contain THC are having an effect or that enforcement actions by local or federal authorities are impacting supply chains in some geographic areas.  We also don’t know what the upcoming influenza and winter respiratory infections season may do to the risk of lung injury among people who use e-cigarettes or vaping products.  As we continue this investigation, we also want to provide a brief update about characteristics of patients who have died from EVALI.  So far, patients whose lung injury led to death ranged in age from 17 years to 75 years but tended to be older than other patients with lung injury.  The median age for fatal cases was 45 years, compared with a median of 23 years for patients who survived lung injury, a difference that is statistically significant.  Based on the information available so far, about a quarter of fatalities have occurred in people under 35 years of age.  The vast majority of patients with EVALI, including those who died from their lung injury, had a history of use of e-cigarette, or vaping, products that contained THC.  With data now available for more than 860 patients with EVALI, about 85 percent had a history of using e-cigarette or vaping products that contained THC.  Around 10 percent reported exclusive use of nicotine containing products.  Product histories were available for relatively few fatal cases or a relatively small number of fatal cases, but the vast majority, but not all, had a history of use of vaping products that contained THC.  At the national level, we don’t yet have information on where products were acquired.  But this past Tuesday, a report in the MMWR from Utah’s investigation found that most patients there had gotten THC-containing vaping products from informal sources or online, rather than from brick and mortar stores or dispensaries.  The Utah data are fairly consistent with the pattern of product use described in the Illinois and Wisconsin investigations where about 89 percent of patients reported getting THC-containing products from friends, family, illicit dealers, or off the street.  Although these new data continue to point to THC exposures as important, at this time FDA and CDC have not identified a single specific compound, substance, product or brand that is causing these lung injuries.  And it may be that there is more than one cause of the lung injuries in this outbreak.  As such, we recommend that you do not use e-cigarette, or vaping, products that contain THC.  And since the specific compounds or ingredients causing lung injury are not yet known, the only way to be sure that you are not at risk is to consider refraining from use of all e-cigarette, or vaping, products while our investigation continues.  Adults who are using e-cigarettes for smoking cessation should weigh all risks and benefits and consider using FDA-approved nicotine replacement therapies.  I’d like to add a call to action to our nation’s youth.  Many have been in social networks connecting and sharing their concerns about vaping and the outbreak we have been reporting.  I hope that through greater awareness and perhaps listening to the voices of young people who have experienced lung injuries firsthand that many youth are quitting vaping and hopefully many others will never initiate this behavior.  Independent of this outbreak, e-cigarettes should never be used by youth, young adults, or pregnant women.  There is no safe tobacco product.  All tobacco products including e-cigarettes, carry risks.  If you are a patient with EVALI or lung injury who stopped using e-cigarette or vaping products, don’t go back to vaping after you leave the hospital or start to feel better.  We think your lungs are weakened based on the lung injury and resuming the use of e-cigarette or vaping products has the potential to cause recurrence of symptoms or worsening of lung function.  Consider evidence-based tobacco-product cessation strategies that include behavioral counseling and FDA-approved cessation medications.  For people struggling with marijuana addiction, effective therapy-based treatments are available.  To find treatment resources, you can talk to your health care provider or call SAMHSA’s help line at 1800-662-HELP or go to the web to findtreatment.samhsa.gov.  If people continue to use e-cigarette, or vaping products, they should carefully monitor themselves for symptoms and see a healthcare provider immediately if symptoms develop.  CDC’s goal and priority are to find out what is causing this outbreak and to provide the American public with data-driven and science-based recommendations.  We will continue to work 24/7 to find the answers to this outbreak.  And we are now intensifying the laboratory testing that is occurring as part of this investigation, in collaboration with the FDA and state and local public health agencies.  In the meantime, I want to be clear — lung injury following e-cigarette or vaping product use is serious and potentially fatal, but it is preventable.  Now I’d like to invite Mitch Zeller from FDA to provide an update on their results.

MITCH ZELLER: Thanks so much, Dr. Schuchat, for the important CDC updates and the ongoing collaboration between our agencies.  FDA continues to work closely both with CDC and other federal, state, and local partners on this critical public health investigation.  All of the agencies are working as quickly as possible to get to the bottom of what is it that’s causing these people to become ill.  In particular, we continue to focus on better understanding whether there is a relationship between any specific products or substances and the reported lung injuries.  This work includes following up with patients and health care professionals to collect important details about the products or substances involved, where they were purchased, and how they were being used.  FDA and CDC are also tapping a number of their laboratory resources across the country to ensure a wide range of testing is conducted on samples collected, including analyzing the substances and the samples and the aerosol produced by the products.  We continue reaching out directly to states that submitted samples and are providing them high level aggregate data in the form of status reports on our preliminary analytical findings.  Additionally, as this investigation evolves, FDA and CDC are continuing to revise how samples are received from the states and collected to ensure appropriate testing.  As we have noted before, state of the art methods are being used to assess the presence of a broad range of chemicals including nicotine, THC and other cannabanoids, opioids, additives, pesticides, poisons and toxins.  FDA has received or collected over 900 samples from 25 states to date.  Those numbers continue to increase.  The samples collected directly from consumers, hospitals, and from state offices include vaping devices and products that contain liquid as well as packaging and some nearly empty containers.  We are working quickly and thoroughly in testing all the samples that we received.  Many of the vaping liquid products received or collected by FDA have undergone some evaluation and additional testing on these and other samples continues daily.  While additional testing is likely on many of these products, many samples have contained little to no liquid.  When that happens, it limits the number and the types of tests that were able to be conducted on each of the submissions.  We have not found that there is one product or substance involved in all the cases.  However, we do know that THC is present in most of the samples being tested.  It’s important to stress as we have stressed on prior calls that identifying any compounds present in the samples is but one piece of the puzzle and will not necessarily answer questions about causality, which makes our collective ongoing work at the federal and state levels so important.  For example, work is also ongoing to link additional samples with specific patients.  Connecting the products and how they were used to specific patients is critically important to our investigation to determine to the extent possible the cause or the causes of these injuries.  FDA’s worked to investigate lung injuries also including work with state and federal partners to identify products making people ill and following the supply chain back to the source.  For example, we are collaborating with customs and border protection regarding potentially illicit vaping products at international mail facilities across the U.S. that receive mail from more than 180 countries.  Depending on the facts determined during this ongoing investigation, FDA can pursue actions using its authorities under the federal Food, Drug and Cosmetic Act.  If one or more specific THC sample are identified as causing injuries, multiple federal and state authorities including the FDA could pursue action with respect to those products.  We are prepared to use our authorities including tobacco product and drug authorities to the fullest extent possible as the facts emerge – in order to protect the public health.  What continues to be clear to all federal, state, and local partners is that the outbreak is complex, and the investigation is evolving.  Every day we are gathering more information and every day we seek to use that information to better understand the relationship between any specific products or substances and the reported illnesses.  We are committed to working to answer these and other critical questions just as quickly as we can, but we also recognize that it will likely take some time.  Importantly, the diversity of the patients and the products or substances they have reported using and the samples being tested may mean ultimately that there are multiple causes of these injuries.  We want to assure the public that we are following all potential leads regarding any particular product, constituent, or compound that may be at issue.  We’re committed to taking appropriate actions as the facts emerge and conclusions can be drawn.  Thank you very much.

MODERATOR: Thank you so much.  This is Amy Heldman again.  I would like to thank our speakers from CDC and FDA.  Operator, we are now ready for our Q&A session.

OPERATOR: We will now begin our question and answer session.  If you would like to ask a question over the phone lines press star-one from your phone, unmute your line and speak your name when prompted.  Your name is required to introduce your question.  If you would like to with draw your question press star-2.  Again, if you would like to ask a question press star-1.  One moment as we wait for questions.
Our first question comes from Allison Aubrey from NPR News.  Your line is now open.

Allison Aubrey, NPR News: Hi.  Thanks for taking my question.  This question is for Mitch Zeller.  Can you let us know if so, far anything has been recovered from this international mail facility?  Have you found anything suspicious?  Did you take anything?  Are you studying anything?  What has turned up by visiting and working with customs and border patrol to look at this international mail facility?  The second question is the vaping epidemic, the outbreak of lung illnesses has brought into light the wider problem of vaping among teens.  I’m wondering if there is anything you can share with us about whether the FDA is in the process of writing some kind of new policy that would ban flavored vapes.

MITCH ZELLER: I’ll take your questions in reverse.  I can only address both of your questions in a very general way.  It’s a matter of public record ever since a White House announcement last month that the agency has been working on a guidance policy to address the flavors issue.  That remains a work in progress.  Nothing more that I can say about that other than it’s our highest priority to complete and to be able to have the administration release that policy.  On your first question, again, I can only talk generally, not specifically about the nature of an ongoing investigation.  I can’t go into details about what has been gathered and collected through any particular mechanism or investigative technique other than to say that it is critically important that we get answers to the supply chain questions and be able to get back to the source, especially for illicit product of how they got into the marketplace.  Whether it was domestically produced or came in internationally.  So as this investigation continues, especially as relates to illicit activity and the potential use of either civil or criminal authorities that we and other federal agencies have under various statutes, we need to keep our answers very general and hope you all can respect that.

MODERATOR: Thank you.  Next question, please.

OPERATOR: Our next question comes from Denise Grady from New York Times. Your line is now open.

DENISE GRADY, NEW YORK TIMES: Thanks very much.  This is a question I think for Dr. Schuchat.  It seems that with every posting of new information and new numbers and every discussion there seems to be more and more emphasis on the concern about THC and less about nicotine.  Does that — is that — does that seem to be the way this is going?  Are you really thinking ultimately that most of the illness is going to be THC and not nicotine?  Totally apart from the other concerns about nicotine and teenagers and addiction, but as far as the lung disease goes.

DR. ANNE SCHUCHAT: Thank you for the question.  The data do continue to point towards THC-containing products as the source of individuals — the vast majority of individuals’ lung injury.  There are continuing cases that do not report that history.  But I’d like to stress that we don’t know what the risky material or substance is.  THC may be a marker for a way that cartridges were prepared or way that the devices are producing harm.  Whether there are similar activities going on with cartridges that don’t contain THC, for instance, remains to be seen.  So, I think we are seeing the THC as a marker for products that are risky.  But at this time because of the continued presence of cases that only report exclusive nicotine-containing e-cigarette or vaping product use, we feel it is very important for people to consider refraining from use of any kind of e-cigarettes.  As you say, regardless of the investigation, e-cigarettes should not be used by youth, young adults, or pregnant women.  We know that nicotine levels in e-cigarettes are quite harmful for the developing brain which continues to develop through age 25.  But, yes, the data continue to point toward THC probably as a marker for risky contents of the products.

MITCH ZELLER: This is Mitch Zeller.  I just want to add a small point that we have made on prior calls.  Remember that these are self-reports.  It’s the person saying, “I only used the nicotine-containing products.” There is the question of — especially if the report is coming from a teen or someone living in a state where the use of any of the potential compounds is illegal whether, in fact, when they say the only thing I used was a nicotine-containing product turns out to be the case and the reality is these are self-reports and we can analyze the samples, but these are what the individuals are saying.

MODERATOR: Okay.  Great.  Thank you.  Next question, please.

OPERATOR: Our next question comes from Jessie Hellmann from The Hill.

JESSIE HELLMANN, THE HILL: Thanks for doing this call.  I have a question about the guidance the FDA is working on regarding the e-cigarette flavors and I’m sorry if I missed and this question was asked before, but I was wondering if there are exemptions being considered for mint or menthol.

MITCH ZELLER: Unfortunately, I can’t answer that question in any detail.  The only thing I can say generally is that we are continuing to work on the guidance document.  We know the level of public and media interest in the details, but since these are all still deliberations going on, there is nothing that I can say about the specifics about what will appear in the final guidance document.  To reiterate what I said earlier, this is a very, very high priority.  We are all trying to complete work on it as quickly as possible.

MODERATOR: Great.  Thank you.  Next question?

OPERATOR: Our next question comes from Dan Vergano from Buzzfeed News. Your line is open.

DAN VERGANO, BUZZFEED NEWS. Thank you.  I have two questions.  The first one is whether this investigation has turned up any other syndromes or illnesses connected to e-cigarettes or vaping, specifically FDA reported in April that there were seizures connected to vaping.  The second question is whether any sort of surveillance is being done on illicit vaping or e-cigarette products, not just samples connected to specific patients or cases and, if not, why not?

DR. ANNE SCHUCHAT: Let me begin and let the FDA continue.  The cases of lung injury include individuals — actually the majority of individuals report gastrointestinal symptoms, nausea, vomiting, stomach pain, or diarrhea preceding their hospital admissions or the worsening of their lung symptoms.  We are not tracking other conditions.  We are focused on the lung injury.  But the FDA has a safety line or adverse event line.  Let me let Mitch Zeller respond to the rest of your question.

MITCH ZELLER: Our part of the investigation in addition to some boots on the ground is primarily the sample analysis.  The reports of seizure that some attention was paid back in the spring, those are reports some of which go back seven, eight, nine years.  Right now, we are working closely with CDC and the states to better understand what’s going on as you heard Dr. Schuchat describe with the cases of pulmonary illness.  Various federal agencies are funding a variety of prospective studies on all aspects of how products are designed, how products are being used.  I’m talking more about electronic nicotine delivery systems including e-cigarettes.  So that we can better understand how the products work.  What we know about the ingredients in the products, what we know about the aerosol, what we know about the levels of compounds in the aerosol as delivered and inhaled.  Those are studies that have been in the works for quite a while.  Whenever the researchers have completed their work and they’re ready to publish, they publish, and you all do a great job of reporting on that as those papers are ready for publication.  I would say that’s all in parallel to this ongoing and very complicated investigation related to pulmonary illnesses.  We try to get to the bottom of what is the cause or causes of these acute cases of injury and death.

MODERATOR: Next question, please.

OPERATOR:  Our next question comes from Julie Mazziotta from People Magazine. Your line is now open.

JULIE MAZZIOTTA, PEOPLE MAGAZINE: Hi, thank you.  I was curious if there is any research into whether the devices themselves are causing the lung issues rather than the vaping cartridges and the pods.  I have spoken to doctors who speculated that the heating device and the metal particles it releases may also be an issue.

DR. ANNE SCHUCHAT: Thanks.  This is Dr. Schuchat and then FDA may have additional comments.  We do have concerns about the devices themselves and whether heavy metals or other dangerous compounds may be released in the process of the heating that occurs or the battery-operated device.  So, the CDC has developed some assays to be testing the aerosols which would be testing both what is coming from the device as well as what is in the liquid.  FDA has other work, I think, that they could describe.

MITCH ZELLER: What I would add to that is you have heard both agencies say now on these calls that at the end of the day there could be multiple causes and that when we complete our chemistry analysis of the substances and the compounds, we have tried to describe that as just one piece of the puzzle.  There could be other factors and other causes.  We know that for the THC products, as you have heard Dr. Schuchat describe and has been reported, a whole bunch of these products are being purchased off the street.  We don’t know what kind of modifications are being made to those devices on top of the compounds that are being inserted and inhaled.  Modifications to the devices themselves by the intermediary who is selling the device off the street or the end user themselves.  We are trying to unravel all of that as product analysis and sample analysis continues.  We don’t have anything definitive to share with you.  All of that remains ongoing work.

MODERATOR: Thank you.  We have time for at least one more question.  Next question, please, operator.

OPERATOR: Our next question comes from Ivan Couronne from AFP.  Your line is now open.

IVAN COURONNE, AFP: Thank you very much.  A question for Mitch Zeller.  I understand there is no single substance or cause found yet, but do you have a short list, and have you made progress in narrowing the list of potential targets?

MITCH ZELLER: No.  We do not have a short list.  On prior calls we have reported within the world of the THC cases the frequency with which  for the samples that we have been able to do the analysis on which is a subset of all samples and a subset of all cases, the frequency with which we are seeing Vitamin E acetate for the samples that we have been able to do sufficient analysis, Vitamin E acetate is showing up in roughly half of the cases where the person reported that they used a THC product and we were testing a THC product.  We know that percentage has been higher at a state level, as a couple of the states have reported.  But there is no short list of compounds.  We continue to do all of the chemistry and all of the analysis as we try to figure out what’s going on causing these illnesses.

MODERATOR: Thank you.  Next question, please.

OPERATOR:  Our next question comes from Mike Stobbe from The Associated Press.  Your line is open.

MIKE STOBBE, ASSOCIATED PRESS: Thanks for taking my call.  This is for Dr. Schuchat.  You said at the beginning you were talking about the epi curve.  What proportion of the 125 cases reported in the last week had a recent onset of symptoms and is that proportion different than the weekly updates previously or is the proportion getting larger and larger or smaller and smaller of new cases, new illnesses in the mix?  Second question is – I think you mentioned of the deaths you only have information for a small percentage on what they vaped.  Can you say of the 34 how many do you have information on how many of them do you know what they vaped?  And, I’m sorry, one more.  You said something about we are intensifying the lab investigations.  Could you be more specific?  What’s going on?  What’s the intensification?  Thank you.

DR. ANNE SCHUCHAT: Thanks so much for those questions.  In the past weeks, we were seeing about half of the cases that we were hearing about were of recent onset.  I don’t have those data for this week.  We are working, trying to get them.  The second question was about the — history.  We’ve only got exposure history for about 19 fatal illnesses at this point.  And so, it’s fairly small numbers but the data so far look quite similar to the overall picture.  And then in terms of an intensification, as we have mentioned, we have been — our laboratory has been standardizing some assays in order to be able to measure the components of aerosols.  We have also been standardizing some assays in order to measure pathology specimens.  So, what our current portfolio is to test for specific vaping-related substances in body fluids including lung fluid from biopsies or blood or urine, to test pathology specimens including lung biopsy or autopsy specimens from patients with lung injury.  And then we have a backdrop of control specimens.  To offer the aerosol emission testing of the EVALI-associated products from the liquids as well as the full products.  That complements what FDA is doing which is testing the liquids themselves or the devices.  Whether — you know, we are going to need to put the pieces of the story together around an individual patient’s lung injury.  Obviously, the clinical records have information on x-rays and lab tests and the imaging.  CTs and so forth.  But we’re hoping that our aerosol testing, and enhanced pathology testing will round out the picture.  I need to caution that these results may come in slowly and will be important to interpret carefully.  That’s why there’s been an effort to validate assays as well as get control specimens for comparison.  Thank you.

MODERATOR: Thank you.  Now we’ll take the last question, please.

OPERATOR: our last question comes from Dawn Kopecki.  Your line is now open.

DAWN KOPECKI, CNBC: Thank you.  My question is what are your theories as to why this cropped up out of nowhere in March with no prior real knowledge of this being a problem?  Vaping has been going on for years.  Is it something that was making people sick that doctors just weren’t catching or do you suspect some sort of change in the supply chain that made this a factor all of the sudden in March and nowhere in the world except for the U.S.?  Thank you.

DR. ANNE SCHUCHAT: Thanks.  There are a number of good questions in your comments.  We are aware of older cases that look similar to what we are seeing now.  But we do not believe that this outbreak or surge in cases is due to better recognition.  We think that something riskier is in much more frequent use.  There are a couple of factors to consider.  One is that the supply chain now has a lot of risky product.  They may be locally produced or produced centrally, and we don’t have information to say it’s all one way or the other.  It may end up being a mix of them.  We know that there has been practices around use of cutting agents to essentially increase the profit from selling cartridges and that the practice may have become more widespread.  Anecdotally, there is information about YouTube videos showing people how to do this that might have skyrocketed that practice.  I also need to point out that the backdrop — this outbreak is occurring in a backdrop of skyrocketing use of nicotine-containing e-cigarettes among youth and the frequency of their use is substantial and has increased greatly over the past two years.  And so, whether individuals who are more frequently using e-cigarettes and become addicted to nicotine start experimenting with other products and are vaping with THC now as well, that may be sort of laying a fertile ground for the expanded use of risky products.  There have been a couple of things that have changed.  Obviously in the past year increased use of the nicotine-containing e-cigarettes that can be used very discreetly, and we believe a diversified supply chain of other vaping products.  But those are theories.  I think we need to learn more.  As you heard, the FDA is working hard on supply chain issues, as are other authorities in the state and local areas.  So, with that, I think that’s the best I can say with why now.  I don’t know if Mitch wants to add anything.

MITCH ZELLER: No.  I don’t really have anything to add.  I take the point Dr. Schuchat made about the epidemic use of e-cigarettes and especially flavored e-cigarettes by kids.  I think that we need to be careful not to conflate the two issues of what had been going on for a number of years with the increased use of e-cigarettes and especially flavored e-cigarettes by kids.  As you heard Dr. Schuchat describing, this more recent development of pulmonary illness seems to mostly involve the use of illicit products.

MODERATOR: Thank you so much.  So that’s the end of our Q&A session.  I would like to thank everyone for joining the call today.  The transcript and audio from today’s telebriefing will be posted to the CDC newsroom later today at CDC.gov/media.  If you have questions call the media line at 404-639-3286 or email us at [email protected].  Thank you so much.

OPERATOR: Thank you for your participation in today’s conference.  You may disconnect at this time.

https://www.cdc.gov/media/releases/2019/t1025-lung-injury-investigation.html