The following are the transcripts and audio files of the CDC telebriefings regarding the outbreak of the so-called “vaping-related” lung illnesses.

Transcript of August 23, 2019, Telebriefing on Severe Pulmonary Disease Associated with Use of E-cigarettes

Friday, August 23, 2019

OPERATOR: Welcome and thank you for standing by. All participants are in listen-only mode until the question-and-answer session. At that time, please press star-one. Please unmute your phone and record your name at the prompt. I would like to inform all parties that today’s conference is being recorded.  If you have any objections you may disconnect at this time.  I’ll turn the call over to kathy harben, thank you you may begin.

KATHY HARBEN: Thank you, Denise.  And thank you everyone for joining us today for an update on the investigation of severe pulmonary disease among people who use e-cigarettes.  We’re joined today by cdc’s Ileana Arias, senior scientific advisor and acting deputy director for non-infectious diseases at CDC, she will provide an update on cdc support for the investigation.  We’re also joined by Dr. Jennifer Layden, l-a-y-d-e-n, she’s chief medical officer and state epidemiologist with the illinois department of public health.  We’re also joined by Mitch Zeller, he’s director of the Center for Tobacco Products at FDA.  During our q&a session we’ll be joined by Dr. Brian King with CDC’s Office on smoking and health and by Dr. Josh Schier,  who’s with the division of unintentional injury prevention.  I’ll turn the call over to Dr. Arias.

DR. ILEANA ARIAS: thank you all for joining us to learn about what cdc knows, what it doesn’t know about the current situation and what it is we’re doing to try to learn more. Before i do that, i would like to extend cdc’s condolences to the family and friends upon the death of the illinois resident who had pulmonary illness with the use of e-cigarettes. The cdc understands and are concerned about the severity of the illnesses that appear to be associated with e-cigarettes and vaping and we’re happy to fill you in on what it is we’re planning to do in response.  Cdc is currently providing consultations to state health departments about a cluster of pulmonary illnesses having to do with vaping or e-cigarette use.  Many states have alerted to possible but not confirmed cases, and investigation into these cases are ongoing.  In addition, fda is working with cdc and state health officials to gather information on any products or substances used and providing technical and laboratory assistance, fda encourages the public to submit detailed records of any unexpected tobacco or e-cigarette health or product issues to the fda via the online reporting portal.  While some cases appear to be similar and linked to e-cigarette product use, more information is needed to determine what is causing the illnesses.  A little bit about the latest information that we have.

As of 5:00 p.m. yesterday, August 22nd, there were 193 potential cases, but again not all are confirmed of severe lung illness associated with e-cigarette product use reported by 22 states (CA, CT, IL, IN, IA, MN, MI, NC, NJ, NM, NY, PA, TX, UT, WI and additional states pending verification).  These were reported between June 28th and August 20th of this year.  One death has been reported in Illinois.  Cdc and states have not identified the cause, but reported cases have reported e-cigarette product use or vaping.  Available evidence does not suggest that an infectious disease is a principle cause of the illness.  Investigators haven’t identified any product or compound linked to all of the cases.  In many cases patients report a gradual start of symptoms, including breathing difficulty, shortness of breath and/or hospitalization before the cases.  Some have reported gastro intestinal illnesses as well.  In many cases patients have reported use of THC-containing products while speaking to health care professionals in follow-up interviews by health department staff.  However, no specific product has been identified in all cases nor has any product been conclusively linked to the illnesses.

Even though cases appear similar, it isn’t clear if these cases have a common cause or if they are different diseases with similar presentations.  The state departments of health are investigating the possible cause of the illness by testing patient specimens and e-cigarette products as well.  Specifically, the wisconsin and illinois departments of health have asked cdc for assistance investigating the illnesses in their states.  The investigation is ongoing and more information will be shared as it is available.  Cdc has notified u.s. health care systems and clinicians about the illnesses and what to do — and what to watch for via a clinician outreach and communication outreach activity message.  For information about a specific state we ask you to contact that state’s health department.  For information on electronic cigarettes we ask you to visit our website, www.cdc.gov/e-cigarettes.

Now I’ll turn the call over to Dr. Jennifer Layden with the illinois department of public health.

DR. JENNIFER LAYDEN: We here at illinois department of public health offer our condolences to the friends and family in the recent death of an illinois resident. Illinois is reporting 22 cases of individuals hospitalized with severe unexplained respiratory systems after reported vaping or e-cigarette use. The illinois department of public health is working across the state to investigate 12 additional individuals.  Yesterday we received a report of the death of an adult who had been hospitalized with unexplained illness after reported vaping or e-cigarette use.  We’re working with the cdc, fda to investigate products and devices that individuals have reportedly used.  In addition to interviewing individuals we are also working to educate our residents through community and public health partners and using social media.  Thank you.

MITCH ZELLER: This is Mitch Zeller from the food and drug administration.  I want to thank cdc and the illinois department of public health for their partnership in this investigation and ability to gather on the phone today.  The fda is saddened and concerned by the reported death related to the investigation of respiratory illnesses following the use of vaping products.  Our agency is committed to continuing to work closely with cdc and state health officials working as quickly as possible to gather more information about all of these cases.  In particular fda will continue to provide technical and laboratory assistance to help identify any products or substances used in these cases.  Our department of emergency operations is coordinating our activities and the agency is participating in regular meetings with cdc and all state health officials.  We have received some product samples, and we’re analyzing those samples to see whether they contain nicotine, substances such as THC, or other chemicals or ingredients.

The results of the testing will be shared with states to aid in their ongoing investigation.  Fda is also working to investigate the brand and type of vaping products and devices and whether any of them are products that would fall within fda’s regulatory authority, as well as where they were obtained.  We don’t have any information to share at this time, however the agency will continue to communicate with the public about this issue.  Let me close by saying as we work to protect the public health, fda encourages the public to submit as detailed reports as possible of any tobacco or e-cigarette product or health issues to our online reporting portal, and it’s www.safetyreporting.hhs.govexternal icon..  Thank you very much.

HARBEN: Thank you to all of our speakers.  Denise, we’re now ready for questions.

The first question comes from mike stoby with associated press, your line is open.

STOBBE/AP: hi, thank you for taking my call.  May i ask, the person who died in illinois can you say if it was a male or female and what his or her age was or at least whether they were in their 20s or 30s and what day did they die and what was he or she vaping?  Could you say whether that person had a preexisting condition that made them more susceptible to something like that and of the 193, how many were vaping thc?  Thank you.

LAYDEN: this is dr. Layden from illinois.  The illinois resident we are not providing additional information to help protect the identity and confidential health information.  The individual was an adult. Of our cases in Illinois the range of ages have been from 17 to 38 with a median age of 23, and the majority of cases have been men.  At this time we don’t have additional information as to the product that has been smoked.

>> the next question comes from sarah overmire with politico.  Your line is open.

OWERMOHLE/Politico: thank you for taking my question.  I wanted to know if among the cases there was a sense of how often the person was vaping, if they were vaping a certain amount each day or if they were new users, and among those 193 cases if there were other trends aside from them being teens and young adults?

SCHIER: This is josh schier.  Right now states are leading their own specific epidemiologic investigations and we’re providing assistance as needed. We’re currently assisting right now at the state’s request.  Cdc is working on a system to collect, aggregate, and analyze data at the national level to better characterize this illness, right now we refer you to specific states for details on their own specific investigations.

>> next question, please.

>> that comes from — one moment.  That comes from lena sun, your line is open.

SUN/Washington Post: hi, thanks for taking the call.  I know that every state is doing its own investigation but since they are reporting to cdc, the basic details, surely since you know there are 193 cases, you could break it down to how many were vaping ingredients with thc, how many were straight nicotine cartridges, and i have another question, which is how much investigation is there looking into the vape juice and possible aerosolized lipid droplets going into the lung.

SCHIER: Thank you for your question.  The first question, i would emphasize we’re working rights now with states to collect, aggregate and analyze that data, this is all specific state data, state-owned data, so we are currently right now developing a system and planning for collecting and analyzing this data at the national level but we don’t have it.  We don’t have it right now.  As to the second question, I would probably ask the fda to comment.

ZELLER: Fda is beginning laboratory analysis based upon some of the samples that have been sent.  Droplets and lung deposition and pulmonary delivery would require additional different kinds of studies, some of which we have in the field just to better understand how e-cigarettes and electronic nicotine delivery systems perform.  But as regards to these particular cases, our laboratory analysis is first simply trying to identify what the compounds are that are present in this product that will be one piece of the puzzle.  Won’t necessarily answer any questions about causality but it’s a starting point and an important piece of the puzzle.

>> next question, please.

>> matthew vitis from “reuters,”  your line is open.

LAVIETES/Reuters: can you explain why there’s a sudden up surge of these cases?  Some of these products have been around for better part of a decade.  So can you just explain, does the cdc know why there’s this sudden up surge?  And — yeah, that should be it.

>> dr. King, are you able to answer that?

KING: this is brian king.  We do know that e-cigarettes do not emit a harmless aerosol. they can include a variety of potential harmful ingredients, including ingredients that are harmful in terms of pulmonary illness. That said it’s possible that the reported cases could have been occurring before this investigation was even initiated in an event that we weren’t necessarily capturing them, but now there’s increased diligence in terms of the current investigation that we’re better able to capture those.  That being said, the available science does suggest that the constituents in the aerosol could be problematic. We know there’s a variety of intended and unintended constituents in these products so as we continue with the investigation it’s important to keep all option opens and identify a variety of ingredients. At present we haven’t isolated a specific source but we know there’s a variety of constituents in e-cigarette aerosol that could be problematic in terms of illness.

>> next question, please.

>> michael nedelman cnn.

NEEDLEMAN/CNN: thank you, i was curious to know the 192 number, including illinois seem to be reporting sort of, you know, concern versus — 22 and then another dozen.  So just curious what that really means since you haven’t necessarily confirmed to be related to any e-cigarette in particular.  Is there something applied to what we think as quote/unquote cases that are tainted?

SCHIER: This is josh schier from cdc, it was hard to hear your question.  Is there a possibility you could repeat it but focus it better?  There was a lot of background noise.

NEEDLEMAN/CNN: I can definitely repeat that.  The cdc is reporting these numbers in aggregate, the 193 number, a number of state health departments, including illinois, are reporting some sort of, you know, confirmed under investigation, or something of that nature, they haven’t necessarily confirmed due to a certain substance in e-cigarettes.  These are all under investigation in a sense, i’m curious if there’s a standard being applied to these numbers when we’re counting them as a potential case versus under investigation?  How that language is being applied.

SCHIER: Thank you.  That’s an excellent question.  Right now as we mentioned states are leading their own systems of epidemiologic investigations, but the cdc is working with states to harmonize that.  And we’re working to help states harmonize again their investigation and collect data so hopefully we can look at it in a more standardized fashion. Those data collection tools will be going out this weekend.

>> next question, please.

>> allison aubrey from npr, your line is open.

AUBREY/NPR: thanks a question for dr. Layden of the cases in your state can you say how many are linked to people using — vaping thc, how many people using nicotine, and also just circling back to you dr. King, if i heard you correctly, what you’re saying is, it’s possible this could have been happening all along but we’re just now hearing about it, just now capturing it, it’s possible in the ten years since vaping has become a big thing that it may have been happening and you didn’t know about it?  I just wanted to know if you could reiterate that to make sure i understand it correctly.  You mentioned there were multiple constituents that could cause lung harm, if you could name one or two.  Those are my questions.

>> go ahead, dr. King.

DR. KING: yes. So there’s a variety of harmful ingredients identified, including things like ultrafine particulates, heavy metals like lead and cancer causing chemicals. And flavoring used in e-cigarettes to give it a buttery flavor.  Diacetyl and it’s been related to severe respiratory illness.  That being said we haven’t specifically linked any of those specific ingredients to the current cases but we know that e-cigarette aerosol is not harmless.  In some cases these could have occurred but now we’re monitoring in such a fashion that we are picking them up. But we have to continue with the investigation to determine if they are intended or unintended in these particular cases.  We note that a variety of individuals use a number of substances, including THC, particularly young adults so we continue to investigate that as well.  But the bottom line is there’s a variety of things in e-cigarette aerosol that could have implications for lung health.  A review recently identified a number of adverse health effects associated with e-cigarette use.  It’s possible some of these cases were already occurring but we were not picking them up but we continue to investigate.

DR. LAYDEN: At this point unfortunately we have not identified a specific product that is consistent across all cases. The consistent information is that all patients have vaped in recent months.

>> next question, please.

>> courtney norris from tbs news hour your line is open.

NORRIS/PBS Newshour: thank you for doing this call.  I’m looking for a little bit more clarity in where you all are at, if you can say anything more on the concerns of THC vaping as well as nicotine and if the patients in illinois have done both or one or the other, just again any more distinction from you experts is helpful.

ZELLER: this is mitch zeller, from fda, i’ll start.  I think it’s important for everybody to understand that as closely as the federal agencies and the state health departments have been working together, we find ourselves in the early stages of these investigations trying to piece together the facts.  As illinois said in their press release, many of these cases have involved the presence of compounds like THC, and we need to get to the bottom of every single case.  And at times we are reliant on case reporting that is incomplete, and requires time to gather basic information like the name of the product that was used, where it was purchased, and then how the product was used.  Was it used as intended or was some other compound added?  And those kind of facts need to be strung together for every single one of these cases so that we can see if there are any kind of patterns that emerge.  So please understand that we’re at a relatively early stage in this ongoing investigation but that state government and the federal government are throwing a lot of resources at this to try to answer your questions, which are all good questions.

>> next question, please.

>> that comes from kate sayer with the chicago tribune.  Your line is open.

SAYER/Chicago Tribune:  hi, i actually think maybe some of that was covered, my question was covered.  But one more thing, any thoughts to the — there’s been some — the results of like a black market, amateur made vapes and not necessarily the ones people buy, can you speak to that at all?

>> dr. Layden or dr. Schier?

>> go ahead, dr. Layden.

DR. LAYDEN: This is dr. Layden, i can only speak to the illinois investigation. We have had cases that have reported the use of THC product oils, we are actively investigating to try to identify where purchased, but reiterate the message from the fda that these investigations are very time intensive and we rely on the information we gather from the affected individuals.

>> and dr. Schier?

SCHIER:  i want to emphasize that again these are state-led investigations. CDC is actively working right now to develop a — to develop a way to collect, aggregate and analyze that data at the national level because we think it will potentially help identify the illness and ideologies to inform laboratory testing. At this time we don’t have any information or ability to comment on that.

>> next question, please.

>> that comes from joy benedict with cbs news your line is open.

BENEDICT/CBS: yes, a couple of quick questions.  One, i was wondering as somebody else said we seem to be seeing a lot of cases very, very quickly, like they’re multiplying, do we have any idea how long the patients have been using these products or what their dosage was, were they using a different dosage when they all of a sudden become affected?  And finally of the 192 other patients i guess that have survived, do we have any idea what their conditions are?  Is this something they’re going to recover from, or do you expect — hopefully there aren’t any more deadly cases like the one in illinois but is that a possibility?

>> dr. Schier are you still on the line?  Or dr. Layden speaking specifically for illinois?

DR. LAYDEN: . Here in illinois we have seen some cases recover, we have individuals who are continuing to need medical care and attention. As to the frequency and type of use, that’s information that we’re trying to gather to understand what the potential risks are in association with this illness.

>> thank you.  We have time now for just two more questions.

>> the next question comes from erika edwards with nbc news.  Your line is open.

EDWARDS/NBC: thank you.  I’m wondering if you have a list of those 22 states you mentioned, as well as the numbers of confirmed and potential cases in each state, thank you.

>> we’ll see what we can provide.

>> next question.  The final question.

>> the last question.  Yes.  The last question comes from bryant furlough with lancet, your line is open.

FURLOW/Lancet: thank you.  Previously we were told 15 states were reporting hospitalizations, i believe you said earlier 22, i wanted to make sure a list will be provided which states those are, and secondly, are you testing for pesticide residue in the thc vaping fluid? lastly i understand not one model was used by the patients but what about classes of vaping products?  Were voltage known and were patient ct and imaging consistent with pulmonary burns.

ZELLER: this is mitch zeller let me take part of that related to product usage.  And the questions that you asked would be all part of our product-specific inquiry starting with how is the product being used, was it being used as intended, was it being modified or altered in some way, how is the product purchased.  The specific question pesticides we will have to get back to you on, i don’t know if those are being tested for in our laboratories or not.

HARBEN: i’m not sure that we have anyone on the phone who can address the clinical level of questions that you asked of the last part of your questions.  I think we would need to follow-up offline on that one.

HARBEN:  Thank you.  I want to give a special thanks to all of our speakers for joining us on very short notice this afternoon.  Thank you all also to the media who have joined us, if you have follow-up questions you can call us at 440-639-3286 or email us at media@cdc.gov.  We’ll be working to get a transcript up later tonight.  There’ll also be an audio recording available on our website.  Thank you very much.

>> that does conclude today’s conference.  Thank you for participating.  You may disconnect at this time.  Speakers allow a moment of silence and stand by for your post conference.

SOURCE LINK

Transcript of September 6, 2019, Telebriefing: Investigation of Pulmonary Disease Among People Who Use E-cigarettes

Friday, September 6, 2019

Operator: Welcome, and thank you for standing by. All participants are in listen-only mode until the question-and-answer session. At that time, please press star-one. Please unmute your phone and record your name at the prompt. I would like to inform all parties that today’s conference is being recorded.  If you have any objections you may disconnect at this time.  I’ll turn the call over to Kathy Harben, thank you may begin.

Kathy Harben:  Thank you, Cedric, and thank you all for joining us today for an update on the investigation of pulmonary disease among people who use e-cigarettes. We’re joined today by CDC’s Ileana Arias, PhD, Senior Scientific Advisor and Acting Deputy Director for Non-Infectious Diseases, who will provide an update on CDC’s support for the investigation. We are also joined by Dr. Dana Meaney Delman, the Incident Manager for the response to this outbreak. We also have representatives from states, who will be talking about their work.  Dr. Daniel Fox is with Pulmonary & Critical Care Medicine, WakeMed Health & Hospitals in North Carolina, Dr. Jonathan Meiman is chief medical officer with the Wisconsin Department of Health Services, and Dr. Jennifer Layden is chief medical officer and state epidemiologist with the Illinois Department of Public Health. In addition, Mitch Zeller, JD, director, Center for Tobacco Products at FDA. We will also have other folks with the CDC joining us during the Q&A session. They will introduce themselves when they first begin speaking.

I’ll now turn the call over to Dr. Arias.

Dr. Ileana Arias: Thank you, Kathy, and thank you all for joining us today for this briefing. At CDC, we know, and we share people concerns about the severity of these illnesses associated with the use of e-cigarette products, which is also known as “vaping.” As you know, in addition to the death in Illinois already reported, we learned just this week of another death that occurred in July in Oregon and another in Indiana.  In addition, we are aware of 1 other death that is under investigation as a possible case. We are keeping the families and friends of all those affected by this illness in our thoughts, and CDC, FDA, and our state partners are working around the clock to find out what is making people sick.

We also appreciated you help in getting relevant information out to the public. Again, thank you for your service. We continue to learn more about these cases of lung disease associated with the use of e-cigarette products. While we don’t have all the answers yet, we are getting clearer about the things we should be looking at to understand the situation. The focus of our investigation is narrowing, and that is great news, but we are still faced with complex questions in this outbreak that will take time to answer. Today, several publications are being released about what is known so far. These publications describe some of the cases that have been reported and include an interim outbreak case definition to help health care providers and state and local public health departments identify and report confirmed and probable cases as the investigation continues.

Please know that we are working tirelessly to understand these and other avenues to understand these illnesses and their cause and to learn how they can be prevented. To give you an update on the status of the investigation, and steps that we have been taking, and where we are going in the future, I would like to introduce Dr. Dana Meaney Delman, who is serving as the incident manager of CDC’s response to this outbreak.

Dana Meaney Delman: Thank you, Dr. Arias. I’m pleased to be with you today to share an update on this multistate investigation of illnesses associated with e-cigarette use.  As we work to identify what is causing otherwise healthy young people to become ill, state health officials and doctors are finding clinical similarities that will help doctors identify patients more quickly. And, while the investigation is ongoing, CDC has advised that individuals consider not using e-cigarettes because as of now, this is the primary means of preventing this type of severe lung disease.  And of course e-cigarette use is never safe for youth, young adults, or pregnant women.

Several reports will be released today that describe lung illnesses associated with the use of e-cigarette products in over 60 patients in several states, including North Carolina, Wisconsin, and Utah. Patients reported similar symptoms, displayed similar clinical presentations and findings, and all reported using e-cigarette products in the 90 days prior to developing symptoms, most within a week or so before symptoms developed.

Many of these patients reported recent use of THC-containing products, and some reported using both THC- and nicotine-containing products. A smaller group reported using only nicotine products. No specific e-cigarette device or substance has been linked to all cases, and e-cigarette include a variety of chemical and additives; consumers may not know what these products contain. Particularly, products obtained from social sources or off the street, it is difficult to know what is contained in these e-cigarette products.

CDC, states, and other partners are actively investigating, but so far, no definitive cause has been established.  Clinical information from the largest cohort of patients from Il and WI, combined with that of other patients from other states, has helped define the clinical picture of what we are dealing with. As Dr. Layden and Meiman mentioned in their articles to be published in the New England Journal of Medicine today, these cases may be some of the most severe and the full spectrum of illness may be broader. We are thankful to Drs Layden and Meiman for their important contribution to our knowledge base.

At this time, more than 33 states and 1 jurisdiction health departments have reported possible cases of lung illness associated with the use of e-cigarette products and additional states are investigating potential cases.  As mentioned by Dr. Arias, 3 deaths have already been reported, and 1 death is under investigation. We are hoping to have more information about these deaths later today. It is very important that other causes of lung illnesses, such an infection, be ruled out before any lung illness is considered a confirmed or probable e-cigarette associated case.  CDC has worked with Il and WI and other states to create a case definition to classify cases in a consistent way.  Once state investigators have examined the medical records of potential cases and contacted the clinical care team, they will have the information they need to determine if a case is confirmed or a probable case.  CDC has begun receiving these data from states and will update the actual number of cases next week on our website. We appreciate your patience as possible cases are carefully analyzed to ensure they meet the appropriate confirmed or probable case definition. We are aware of over 450 total possible cases, including the 215 already reported.

Based on the clinical and laboratory evidence to date, we believe that a chemical exposure is likely associated with these illnesses. However, and I really want to stress this, more information is needed to determine which specific products or substances are involved. We are aware that some laboratories have identified Vitamin E acetate in product samples, and we have connected those laboratories with the FDA Forensic laboratories to compare results. At this time, no one device, product, or substance has been linked to all cases. Continued investigation is needed to better understand if a true relationship exists between any specific product or substance and the illnesses observed in patients. To find the answer we will need to combine information about e-cigarette use, and product sample testing and the clinical information from patients.

CDC, FDA, states, clinicians, and other partners are hard at work investigating these cases. The reports released today are a step toward finding more answers. CDC has mobilized a multidisciplinary team of subject matter experts for this multistate investigation. At their invitation, CDC also deployed staff to Wisconsin and Illinois, the first states to report cases. We are helping to assist with their state investigations. CDC is extremely closely with the U.S. Food and Drug Administration to help facilitate e-cigarette product sample collection from those patients who are clinically ill.

On August 30th, CDC published recommendations for clinicians, public health officials, as well as for the public, and distributed an interim outbreak case definition to state epidemiologists to use. This is available in today’s MMWR. CDC has also provided data collection tools and established a national database to collect data from any and all cases that meet this case definition. We need as much data as possible to fully understand the extent of the problem and to identify the cause of these illnesses. CDC encourages clinicians to report possible cases of e-cigarette-associated lung illness to their local or state health department for further investigation. If e-cigarette product use is suspected as a possible cause for a patient’s pulmonary disease, a detailed history of the substances used, the source of the substances, and the devices used should be obtained, and efforts should be made to determine if any remaining product, devices, and liquids are available for testing. CDC also encourages local and state health departments to notify CDC about possible cases promptly and to contact CDC for the most recent versions of the surveillance case definitions, reporting guidelines, and case investigation forms.

Most importantly, while this investigation is ongoing, people should consider not using e-cigarette products. People who do use e-cigarette products should monitor themselves for symptoms (e.g., cough, shortness of breath, chest pain, nausea, vomiting, or others) and promptly seek medical attention for any health concerns. Regardless of the ongoing investigation, people who use e-cigarette products should not buy these products off the street and should not modify e-cigarette products or add any substances that are not intended by the manufacturer.  E-cigarette products should never be used by youth, young adults, pregnant women, or by adults who do not currently use tobacco products.

If you are concerned about your health or the health of a loved one who is using an e-cigarette product, contact your health care provider, or your local poison control center at 1-800-222-1222.

You can also submit detailed reports of any unexpected health or product issues related to tobacco or e-cigarette products to the FDA via the online Safety Reporting Portal. We encourage the public to visit CDC’s outbreak webpage, which will be updated, at www.cdc.gov/e-cigarettes, for the most up-to-date information.

Please know that CDC, FDA, state, and clinical partners are working hard to understand why people are getting sick. We will continue to share what we know and what we don’t know to help health departments, clinicians, and the public respond to this outbreak. After today’s publication, I hope that like me, other physicians will be able to identify e-cigarette associated pulmonary illnesses. Thank you very much.

Moderator: We’ll now go to Dr. Daniel Fox with WakeMed.

Dr. Daniel Fox: Good morning. Thank you all for having me, thanks to all those who are on the call.  So, what we have seen here in North Carolina, is we were anxious to report and discuss and make known to the public, and the CDC has been, as well as our state health department has been instrumental in helping us coordinate the messaging and get this to the place where it needs to be.  What we wanted to report and what we have seen has been a cluster of five cases that will be reported later today. Each of these cases featured a pulmonary illness in a relatively young person.  Ranging in age from 18-35 from what we saw here in North Carolina.  The symptoms that these patients were experiencing were being short of breath, having some GI or gastrointestinal symptoms of nausea and vomiting and fevers.  Even though this frequently can show up as an infectious-appearing illness, it ended up not being an infection.  And as a result of the work-up that was done and the history that was taken, one of the things that was found in common with all of these cases is that all patients were using vaped substances in e-cigarettes.  They all had abnormal chest x-rays and developed a need for a lot of oxygen.  And that varied across each patient.  But a couple of them required intensive care status to be cared for.  During the work-up and the history, all the patients that we saw had used or consumed THC through their vaped, vaping devices through the e-cigarette.  And that seemed to be a common feature.  Some used smoked THC as well.  And most used nicotine-containing products as well.  All of our patients underwent evaluation, and after the clinical evaluation we found a certain type of pneumonia that was noninfectious.  It’s called lipoid pneumonia.  Basically, can be, it can occur when either oils or lipid-containing substances enter the lungs.  So we are, we have been very thankful and are very appreciative to the CDC for helping us get this message out.  I think take-home messages here for the public is that vaping cartridges, particularly those vaping cartridges that may not be, that may have been purchased off the street or, where the substances in them are not entirely clear, we do not believe are safe and pose a risk to our patients, particularly our young patients.  For our providers, doctors and nurses need to inquire about vaping as a part of the history and to consider noninfectious pneumonias.  In this case, lipoid pneumonias, in cases of respiratory failure, where this is a part of the history.  And to continue to just try to spread the message about the rise, the rapid rise in vaping, that is occurring, particularly in younger patient populations.  This is not being used as a way to get off of cigarette, cigarettes or traditional tobacco products.  But is an alternative way to delivering substances.  So just trying to get the message out about that.  And with that, I’ll conclude my portion and pass, pass the baton here to Dr. Meiman.

Dr. Jonathan Meiman:  Thanks.  I want to thank everyone for the opportunity to talk today about the joint investigation between Wisconsin and Illinois that’s being detailed in the New England Journal of Medicine article that’s being released today.  What I want to do is give our listeners a brief overview of how we came to recognize this cluster of illnesses and how we approached the investigation, and I’ll hand it over to Dr. Layden to discuss the findings contained in our report.  I want to first thank the clinicians of the Children’s Hospital of Wisconsin who first recognized the cluster of illnesses and brought it to the attention of public health, and I want to thank the colleagues at the Wisconsin Department of Health Services, the Illinois Department of Health, and the CDC for their significant efforts and help in investigating the cluster in order to prevent future cases.  This health concern first came to the attention of public health in Wisconsin on July 10.  When we were contacted by the children’s hospital of Wisconsin.  Regarding five patients who were admitted over the previous four weeks, with kind of progressive shortness of breath, fatigue and other symptoms.  All of these patients had evidence of lung disease.  Chest imaging.  And all of them had reported e-cigarette use, of multiple products, over the days, weeks and in some cases months prior to the onset of their symptoms.  Extensive work-ups that were performed in the hospital for infectious causes, as well as some other possible causes, such as auto-immune disease were negative.  So, over the next two weeks we received several additional reports from children’s hospital.  And so, the Wisconsin Department of Health Services summarized what we knew, and we issued an alert to clinicians on the 20th of July.  At that point we didn’t have an indication of the scale or the geographic extent of the cluster.  But shortly after issuing that alert, we were contacted by a physician in Illinois treating a patient with a very similar clinical symptom.  And also stating history of e-cigarette use.  So, at that point we notified the Illinois Department of Public Health and launched a joint investigation on August 1.  Soon thereafter, given the likelihood that this was a larger, multistate issue, the Wisconsin Department of Health Services issued an alert to other state health departments, describing what we had observed.  After that alert was put out, we started to receive numerous reports of similar illnesses from clinicians in Illinois and Wisconsin.  So, the CDC was contacted at that point.  Who provided an epidemiologist assistance field team to both Illinois and Wisconsin on August 20 to help investigate the cases in both states.  So early on in this investigation, both of our states, we developed a case definition to identify patients with pulmonary disease linked to e-cigarette use and that definition was further refined over a week with assistance from the council of state, territorial epidemiologists and the CDC.  And for any patients that met that case definition we requested medical records, which were analyzed by a team of physicians using a standardized process to really kind of characterize the patients’ symptoms, describe the laboratory and findings from imaging.  Get any history on reported drug exposures, describe the treatments they received in hospital and as well as the course of their illnesses and their medical outcomes.  We also administered a standardized interview to patients who met the case definition to get more detailed information on the types of e-cigarette products used in a three months before their symptoms began.  The Illinois Department of Health also conducted a retrospective review of their visits over the previous 18 months to any other cases of unexplained respiratory illnesses. The goal to try to determine if the cluster of cases we were observing were a true increase or an increase of awareness of recognition by medical providers.  This information was synthesized by Illinois and Wisconsin, in coordination with CDC to provide a thorough description of the 53 patients from both states so at that point I’ll hand it over to Dr. Layden, to describe some of our summary findings.

Dr. Jennifer Layden: Thank you Dr. Meiman. I want to start off by thanking our numerous partners who have and continue to tirelessly work on this investigation, including numerous colleagues at our state agencies, local health departments, and clinical partners, as well as investigative colleagues at the CDC.  Thank you to the leadership at IDPH for supporting these efforts. And thank you to the continued partnerships with Wisconsin Health Department, the CDC, and the FDA.

As we review our findings and continue our investigation, I want to recognize that these are not just cases or data points, but these individuals are individuals who are suffering from severe and serious illness, and we want to do what we can, everything we can to assist with the larger investigation and prevent additional illnesses.

Our report that’s going to be published in the New England Journal of Medicine describes the clinical presentation of the first 53 cases reported in Illinois and Wisconsin.  All cases meet the case definition, the working case definition.  That’s published in MMWR and the New England Journal.

What we have found so far is that the majority of people who have become ill are generally healthy, are young – a median age of 19 years and the majority have been men. Patients have had symptoms for days to weeks before admissions, with the median being 6 days. At time presentations, the majority have respiratory symptoms, constitutional symptoms such as fever and fatigue sometimes weight loss, and GI symptoms.  All patients have abnormalities seen on lung imaging, apparent in both lungs.  Infections have not been identified as the source of the underlying lung illnesses.  Among our 53 patients, nearly all patients were hospitalized, 98% and of note and interest, 72% of the patients were seen as outpatient prior to their final admission for symptoms.

Among the patients that were hospitalized, over half of the patients required intensive care management and 32% of the patients required mechanical ventilation to help their breathing.  Among the patients in this case series, all reported using e-cigarette product use in the last 90 days.  The majority reported using a THC-based product.  In majority also reported using a nicotine-based product.  Patients did report a range of products and devices, and at this time no one product has been associated with all the cases.  It is important to note that exposure information is self-reported and sometimes limited by a patient’s recollection or ability and willingness to share information.  So, we do need to be cautious in our interpretation of the data in recognize that this is a preliminary report.  Patients who do use e-cigarette products and have symptoms, they should seek medical care, and we ask clinicians to continue to report possible cases to public health authorities.  This investigation is ongoing, and we want to thank all of the public health partners, clinical partners for their work and dedication in an effort to ultimately identify what is causing these illnesses.  We will continue to work with the CDC and continue to send samples to the FDA when collected.  At this time I would like to turn it over to Mitch Zeller, with the FDA.

Mitch Zeller: I want to thank all FDA colleagues at the CDC, Illinois, Wisconsin, North Carolina and all of our public health partners for their tireless work as we work on this ongoing investigation.  And on behalf of FDA, our thoughts go out to the families of those individuals who have passed away of respiratory illnesses following the use of vaping products.  FDA is working closely with our partners at the state and federal level and as quickly as possible, to get more information about these cases, including information to help identify the products, or the substances in these products that may be causing these illnesses.  Here’s where weigh are — and we are in a critical fact-gathering stage of this investigation.

And as you’ve heard from all the speakers, more information is needed to better understand whether there’s a relationship between any specific products and any specific substances in those products and the reported illnesses.  We have been and we will continue to provide laboratory assistance to state public health officials by analyzing samples of products obtained by the states as part of their ongoing investigations.  The number of samples that FDA has received continues to increase.  We now have over 120 samples for testing.  The FDA laboratory is analyzing these samples for the presence of a broad range of chemicals.  This includes nicotine, THC, other cannabinoids along with cutting agents, additives, pesticides, opioids, toxins.  In many cases but not all patients have acknowledged recent use of THC-containing products.  Some have reported the use of e-cigarettes containing nicotine.  Some have reported that they used both types of products.  The samples we’re continuing to evaluate show a mix of results and no one substance or compound, including vitamin e acetate has been identified in all of the samples tested.  It’s important to emphasize that identifying any compounds that are present in the samples will ultimately turn out to be one piece of the puzzle.  But will not necessarily answer questions about causality and it makes all of our ongoing work that much more critical.  The results from the FDA laboratory analysis will be shared with the respective states to aid in their investigations.  And it will help further inform the federal response.  We absolutely understand the interest in the specifics of all of these ongoing investigations, and we’re committed to providing updates to the public while still maintaining the integrity of these ongoing investigations.  FDA encourages the public to submit detailed reports of any unexpected tobacco or e-cigarette-related health or product issues to FDA, via our online safety reporting portal and we hope that all the media on this call will provide the url in your reporting.  And that is www.safetyreporting.hhs.gov.  Just, just one closing thought.  And that is that FDA is going to leave no stone unturned in following any potential leads regarding any particular constituent or compound that may be at issue.  And we’re committed to taking appropriate actions as the facts emerge.  Thank you.

Harben:   Thank you.  All of our speakers, before we go to the Q&A, I want to just let people know that MMWR and the MMWRs and a CDC press release are on their way out.  If they are not already out.  All of the materials and the remarks on our telebriefing today are embargoed until 1:00 p.m. eastern time today.  And we do ask you as you always do and have, to respect that.  And we will have a transcript posted later this afternoon.  So now we will start our Q&A.  Cedric, can you take it away?

Operator: Sure.  As a quick reminder, if you’d like to ask a question, please press star then 1.  Remember to unmute your phone and record your name and media affiliation when prompted.  Once again if you’d like to ask a question, please star 1.  First question comes from Mike Stobbe with the Associated Press. your line is open.

Mike Stobbe, Associated Press: Hi.  Thank you for taking my call.  First, I just wanted to make sure I heard correctly the update of cases.  Did you say 450, 4-5-0 and 33 states?  Or did you say 32 states and a territory?  We’d love to see the list and where they are and when the first cases had onset of symptoms.  And then the second question was, I know that you all have said that some cases had only vaped nicotine.  But is this all self-report?  Has there been some biological testing or lab testing that confirmed that they had only vaped nicotine?  Or is it possible they vaped THC, but just didn’t admit it?  Thank you.

Dr. Ileana Arias: Thanks for the question.  So just to clarify, there were 33 states and one jurisdiction, and those will be listed on our website, by around 1:00 p.m. today.  I think your other question had to do with onset of symptoms.  But just to clarify the other number, as of right now, we know about 450, 450 total possible cases, meaning some of these are still under investigation by states.  So, the 450 that we aware of are currently being investigated.  As I mentioned in my remarks earlier.  This is pretty complicated because it requires exclusion of other illnesses.  And it requires medical record review.  So you’ll see that in the case definition, the MMWR that’s why it takes so long to determine whether these are true cases.  I think I’ll turn it to Jen and to john to see if they could answer the onset of symptoms, since you had some of the earliest cases.

Dr. Jennifer Layden:  Sure, this is Jen Layden from the Illinois department of public health.  Our initial case occurred in mid April and through August.

Harben: Next question please.

Operator: Thank you, our next question comes from the Lena Sun with the Washington Post.  Your line is open.

Lena Sun, Washington Post: Thank you, I have a couple questions I wanted to clarify.  What is the total number of deaths?  Either been reported or under investigation?  And then my second question had to do with lipoid pneumonia.  Maybe you could just answer the first one.

Dr. Ileana Arias: We are aware of three confirmed deaths and one death under investigation.

Lena Sun, Washington post: Total, right?  Including the Illinois case that’s already been reported, right?

Dr. Ileana Arias: Yes, that’s total.

Lena Sun, Washington Post: okay.  Total and one under investigation.  I was wondering if you could comment on the marker of lipid-laden macrophages, it seems to be an indication of this disease?  Lipoid pneumonia.  But not all of the patients in the Wisconsin and Illinois series seemed to have had bronchoscopies.  Is that something that clinicians should be considering?  Even though I know it’s an invasive procedure but it does provide some clinical evidence and since lipoid pneumonia is pretty rare, especially in young people whether that would be a marker of this disease?

Dr. Daniel Fox: So this is dan fox from North Carolina.  Down in WakeMed.  So, all of our cases that we performed bronchoscopy on did have findings of the lipid-laden macrophages and stained the fluid positive for lipid-containing substances.  That’s how we arrived at the diagnosis, with some fairly characteristic imaging. It is a rare diagnosis, we probably underrecognize it.  Across all populations.  But i think if there’s clinical uncertainty, that could be of some value to clinicians.  You know, who are struggling to make a diagnosis.  And I’ll let other, other folks chime in as well.

Dana Meaney Delman:  Thanks so much.  This is dana at CDC.  I just want to mention I don’t think we yet know the clinical significance of the lipid-laden macro-phages and we don’t know if the lipids that have been detected within the cells are endogenous or exogenous.  Meaning did they come in through the body or were he they already present in lung issues, in terms of bronchoscopy and invasive procedure, I think it’s an individual decision that depends on the clinical condition of the patients and it’s too early to know if the lipid-laden macrophages will be a range of pathologic illnesses.

Lena Sun, Washington Post: Thank you

Harben: Next question, please.

Operator: Our next question comes from with NPR, your line is open.

Allison Aubrey, NPR: So, an editorial being published alongside today points out that you know, teams that a lot of these young adults are mixing multiple ingredients as you pointed out.  Many are using THC and nicotine at the same time and you sort of making the point like when you mix ingredients and you have potential contaminants you may create new agents that may be toxic.  If it turns out you can’t pin this to a single compound or additive or — how do you begin, where do you go from there?  Is it possible that each of these cases kind of just reflects the new habits that young vapers have?  Of vaping multiple things?  A lot of it from black market?

Dana Meaney Delman: This is Dana.  I’ll start, maybe our FDA colleagues can join in as well.  I think that’s why our recommendations right now are, are recommending at least until we continue the investigation of more information, to avoid use of e-cigarettes, but emphasizing that things should not be added and things should not be mixed.  We’re hoping that we do in fact determine what this, what this might be.  But that’s, that’s I think too premature at this point.  I’m going to turn to our FDA colleagues to see if they have any comment?

Mitch Zeller: I would just completely echo what was just said.  If you’re, with these increasing reports, if you’re thinking of purchasing one of these products off the street, out of the back of a car, out of a trunk, in an alley, or if you’re going to then go home and make modifications to the product yourself using something that you purchased from some third party or got from a friend, think twice.

Harben: Next question, please.

Operator: Thank you.  Our next question comes from Helen Branswell with STAT. Your line is open.

Helen Branswell, STAT: Hi, thank you very much for taking my question.  I’m wondering how you make sense of the fact that this seems to be happening now and seems to be new.  Am I correct in assuming that you actually think this is a new phenomenon as opposed to something that had been unrecognized before?  And related to that, I reached out to the European CDC and to an organization in Europe called the European monitoring centers for drugs and drug addiction.  They’re not recording any cases there.  And I’m wondering how you make sense of the fact that this seems at this point to be a U.S.  phenomenon.

Dr. Ileana Arias: So, I’d love first, dr. Layden and Dr. Mineman to comment.  I think we’re all wondering whether this is new or just newly recognized.  Until we really have more information from our state partners, looking backwards in time to see if some of these cases have been discovered, it’s hard to know with certainty.  They’ve done some surveillance work that might be helpful.  I don’t know if you want to comment.

Dr. Jennifer Layden: Sure, thanks, dana this is Jen Layton from the Illinois Department of Public Health.  I echo that, I think the findings are preliminary and i don’t think we can say if it’s a new or newly recognized phenomenon.  We’ve used something called syndromic surveillance, a way to monitor for e.d. or emergency room department visits for certainly potential public health threats or conditions.  We look ford severe respiratory illness among the age range similar to what we’re seeing.  And looked at 2018 and 2019.  What it appears at this time.  Although again I would caution that this is preliminary, is that it does appear to be an increase of cases.  Starting May, June of 2019.  That’s higher than it was in 2018.  So, it would suggest that it’s a new phenomenon.

Harben: Next question, please.

Operator: Next question comes from Ann Thompson with NBC News.  Your line IS Open.

Ann Thompson, NBC News: Thank you.  And to follow up on that, I think that’s the question we’re asking here is; I mean what’s driving this increase?  Is it faulty products?  Is it more users?  Is it doctor awareness?  What’s behind these growing numbers?  Thank you.

Dr. Ileana Arias: And we completely agree.  Those are the questions we’re asking as well.  We really like to get to the bottom of what is causing these illnesses.  I think it’s premature to know at this point.  That’s why we’re working tirelessly around the clock.

Harben: Next question, please

Operator: Thank you, the next question comes from Kate Thayer with the Chicago Tribune, your line is open.

Kate Thayer, Chicago Tribune: Hi, thank you.  Can you tell us anything more about the death, ages, where the — additional investigation is, and what they were vaping?

Dr. Ileana Arias: So thanks.  We have, we have seen and spoken with our colleagues in Indiana, who are putting out a press release with regard to the information they’re willing to share.  So I think you can find that information online.  We can’t really speak yet to the additional death under investigation, as we really don’t know if this is related or not.

Harben: Next question, please.

Operator: Thank you, our next question comes from Bryant Furlow with The Lancet Respiratory Medicine.  Your line is open.  Your line is open.

Bryant Furlow, The Lancet Respiratory Medicine: Has the absence of an ICD10 code for vaping devices complicated syndromic case recording and will an ICD 10 code for vaping devices generally be forthcoming?

Dr. Ileana Arias: So, Jen and John I know you have some of these codes for your syndromic surveillance.  Do you want to comment on that?

Dr. Jennifer Layden: I think in a more general question is it’s hard to comment on the impact of ICD codes related to vaping inn and specifically in regards to our investigation –looking back in time we chose not to use terms of vaping.  Because we thought with the increased awareness, there may be more reporting of a use, of vaping in a recent months, so we really focus more on the clinical presentation.  But on the larger scale, certainly the more specific queries we can have to vaping I think will help us to understand potential not only pulmonary illnesses, but other potential adverse events.

Harben: Next question, please.

Operator: Our next question comes from Nikki Kean with Pharmacy Practice News, your line is open.

Nikki Kean, Pharmacy Practice News: Thank you.  Can you talk a little bit about the clinical course of the patients once they’re hospitalized?  What are the treatments that are being used and how long are they on ventilation?

Dr. Ileana Arias: So I don’t know if our colleagues Jen or John or others want to comment on that.  I think you have the largest cohort of patients; you probably have the best information.

Dr. Daniel Fox: I’m Dan Fox, WakeMed, our cohort is smaller.  I don’t know if they were going to chime in or not.  But I can talk briefly about that while they’re hopefully going to chime in as well.  So, when the clinical course tends to be as they described.  There’s a prodrome of several days where folks are not feeling well.  Typically, are often misdiagnosed as having either bronchitis or viral illness before they present to the hospital for a higher level of care.  The way that we evaluated our patients is we would either be called from the emergency department or from the floors and then as the pulmonary consult team or the intensive care team, we would recognize the syndrome.  When patients required intensive level care and mechanical ventilation or respiratory support, they were typically on ventilator between two and seven days.  The treatments are not known for how to treat this.  All of our patients received some antibiotics, although ultimately infection was felt not to be the cause.  And all of our patients also received some, some type of steroid, either prednisone as a treatment.  Although at this point we don’t know if that’s helpful or not.

Dr. Jonathan Meiman: This is John Meiman.  We have a larger case series.  But I would say that’s kind of what was just described as broadly consistent about mechanical ventilation, assistance of a breathing machine.  The remainder needed some other support, whether that’s supplemental oxygen.  And you know over half of the 53 patients were admitted to the intensive care unit.  As far as treatments received, the vast majority did get antibiotics at some point.  Either you know during the hospitalizations or before hospitalization.  And the vast majority also received steroids.  But as was just pointed out.  Although clinical improvement was observed on steroids, we can’t say with certainty you know that this was an effective treatment in this case.

Nikki Kean, Pharmacy Practice News: So, no other medications were given?  And did the patients then go home without any signs of the pneumonia?  There was no clinical signs of damage to the lungs, permanent damage?

Dr. Jonathan Meiman: in our case series, focused on the presentation in the hospital.  The question about the long-term findings is something that’s going to have to require additional investigation, whether there are any long-term effects, as far as what patients receive at home, a lot of the ones started on steroids continued to receive them as an outpatient after discharge.

Harben: Thank you.  We have — I’m sorry, we have time for two more questions.  If there are questions in the queue?

Operator: next question comes from Jane O’Donnell with USA Today.  Jane, your line is open.

Jane O’Donnell, USA Today: Hi, I wanted to I’ll say this three in a row quickly.  The 53, how are you described them?  Are they the ones you looked most closely at?  I missed that part.  You said the majority of those 53 do also involve THC in addition to nicotine, often in addition to nicotine and then all five cases in North Carolina also involved THC.  But it isn’t clear that the 450, if many of those involved THC, if not most?

Dr. Ileana Arias: I think these are the types of information that we’re looking to collect.  We have preliminary information, but it’s really coming in as we speak.  To we haven’t been able to analyze yet this specific exposures.  As I mentioned, this requires interview with the patients and that can take some time.  So at this point we don’t have the specifics around that.  That number of 450.

Jane O’Donnell, USA Today: But the 53 are, could you just explain again, those are, what are those exactly?  I know they’re in the report today.

Dr. Jennifer Layden: Hi this is Jen from Illinois Department of Public Health.  These are 53 cases that have been reported to Illinois or Wisconsin.  That meet the current case definition.  So, are probable or confirmed cases.  It takes extensive review of medical records and other information to identify someone that is a probable or confirmed case.  And these 53 are the first cases that have met the classification.

Jane O’Donnell, USA Today: Got it. Thank you.

Harben: Last question.

Operator: Yes, the last question comes from Angelica Lavito from CNBC.

Angelica Lavito, CNBC: I want to ask about the terminology that you suggest using in our reporting.  You’re saying that a lot of these cases have THC and nicotine.  Some, one or the other.  But you’re telling people not to use e-cigarettes, would you use recommend using vaping more broadly or how could we communicate this more accurately?

Dr. Ileana Arias: Our perspective at this moment is until we have a cause and while this investigation is ongoing, that we’re recommending individuals consider not using e-cigarettes.  And that broad recommendation is because we do have a diversity of product as you heard.  Some containing THC and some containing nicotine.  As more information comes about and we can now down the specific e-cigarette products, we intend to revise that.

Angelica Lavito, CNBC: Okay.  And then very quick.  I know I want to be crystal clear, on that 215 and 450.  Is it 215 cases and 450 additional or is it total?

Dr. Ileana Arias: 450 are the total cases being evaluated under investigation.  The 215, is what was formally reported to CDC.  So, 450 includes the 215.

Angelica Lavito, CNBC: Okay, Thank you, so much.

Harben:  Thank you to all of our speakers for joining us today.   If reporters have follow-up questions, you can call us at 404-639-3286, or e-mail us at media@CDC.gov.  Thank you, everyone, for joining us.  This concludes our call.

OPERATOR: Thank you, that does conclude today’s conference.  We appreciate you attending.  You may disconnect at this time.

SOURCE LINK

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

Thursday, September 19, 2019

Operator: Welcome and thank you all for standing by.  All participants will be on the listen-only mode until the question and answer session of today’s call.  At that time you can press star 1 to ask a question from the phone lines.  I’d also like to inform parties that the call is being recorded.  If you have any objections, you may disconnect at this time, and I would now like to turn your call over to moderator KD Hoskins.

Moderator:  Thank you for all of you for joining us for an update on the update lung injury among people who use e-cigarettes or vape.  We are joined today by CDC Dr. Anne Schuchat, principal deputy director, who will provide an update on our support of the investigation.  We are also joined today by Mitch Zeller, who is director of the FDA center for tobacco products, and also Dr. Jennifer Layden, chief medical officer and state epidemiologist for the Illinois department of public health.  In addition, during our Q&A session today, Dr. Ileana Arias, PhD., senior scientific advisor and acting deputy director for non-infectious diseases at CDC, along with Dr. Brian King, who is the chief science officer for the response, and deputy director for research translation in office of smoking and health.  I’ll now turn the call over to Dr. Schuchat.

Dr. Schuchat: Thanks so much.  Thank you, all for joining us today for this briefing.  I’d like to update you on the national public health investigation and CDC’s efforts so far.  I want to stress that we at CDC are very concerned about the occurrence of life-threatening illness in otherwise healthy young people reported from around the country.  We’re working closely with state and local health departments, FDA, and the clinical community to learn as much as we can to try to stop this outbreak.  And I wish we had more answers.  We plan to update our national numbers on cases every Thursday but realize this is a very dynamic investigation and we are committed to sharing new key information as it emerges.  As of September 17th, 530 confirmed and probable cases of lung injury associated with e-cigarette product use, or vaping, were reported to us by 38 states and one territory.  Sadly, seven deaths have been confirmed in and reported to us from six states, California, Illinois, Indiana, Kansas, Minnesota, and Oregon.  And we do expect others.  As you know, this past Monday, September 16th, CDC activated our emergency operations center.  We did this to enhance the inter-agents response and strengthen coordination of this multistate outbreak of cases of lung injury associated with e-cigarette product use, or vaping.  This is a complex investigation.  It spans many states, involves hundreds of cases, and a wide variety of substances and products.  States are classifying cases and reporting them to CDC on a regular basis.  CDC is working 24/7 with the states to try to find on answers.  I’d like to stress how challenging this situation is, as patients may have been exposed to a variety of products and substances, may not know the contents or sources of these products, and in some instances may be reluctant or too ill to fully disclose all the details of interest.  CDC has made it a priority to find out what is causing this outbreak of vaping-related injuries and deaths.  As such, we have been working with states and the FDA to collect information about recent e-cigarette product use among patients and to test the substances or chemicals within vaping products used by the patients.  And you will hear more about that from Mitch Zeller at the FDA.  Although the investigation continues, no consistent e-cigarette or vaping product, substance, additive, or brand has been identified in all cases, nor has any one product or substance been conclusively linked to lung injury in patients.  Based on available data to date, nearly three-quarters of the cases are male.  Two-thirds of the cases are in people between the ages of 18 and 34 years.  16% are younger than 18 years of age and 17% are 35 years or older.  In all, based on what we have to date, more than half of the cases are under 25 years of age.  Patients typically report symptoms such as cough, shortness of breath, or chest pain.  Some also describe nausea, vomiting, or diarrhea, fatigue, fever, or abdominal pain.  As I said, we have not identified the cause of the lung injury in this outbreak.  And note that many patients have described use of multiple types of products.  Initial published data from select states show most patients have reported a history of using e-cigarette products containing THC.  Many patients have reported using products containing THC and products containing nicotine.  And some have reported the use of e-cigarette products containing only nicotine.  CDC is still working to understand more about the exposures of these patients and if this trend is reflected in the full National picture of cases in addition to the earlier reports.  Clearly more information is needed to better understand whether there’s a relationship between any specific products product or substance and the reported lung injuries and deaths.  Until we know more, if you are concerned about these specific health risks, CDC recommend that you consider not using e-cigarette or vaping products.  If you have recently used an e-cigarette or vaping product and you have symptoms like those reported in this outbreak, we recommend you see a health care provider as soon as possible.  Anyone who uses an e-cigarette or vaping product should not use or buy these products off the street and should not modify or add any substances to these products.  Regardless of this investigation, certain people should not use e-cigarettes or vaping products.  In particular, youth and young adults, women who are pregnant, and adults who do not currently use tobacco products.  If you are an adult who is using e-cigarettes containing nicotine to quit cigarette smoking, do not return to smoking cigarettes.  Contact your health care provider to discuss the range of evidence-based treatments, including counseling and FDA-approved medications.  The e-cigarette or vaping-related lung injuries we have been describing are serious.  People are dying.  And CDC wants to protect Americans to keep you healthy and safe.  We ask you to take these recommendations seriously.  Now i would like to invite Mitch Zeller to share more information about FDA’s work so far.

Mitch Zeller: Thanks so much, Dr. Schuchat, for those important updates and for the continued strong collaboration between the Centers for Disease Control and Prevention, FDA and our state health partners.  FDA continues to work closely with those partners at the federal and state level and as quickly as possible to gather more information about these distressing incidents.  In particular, we’re keenly focused on better understanding whether there is a relationship between any specific products or substances and the reported illnesses.  As previously noted, there does not currently appear to be one product or one substance involved in all of the cases.  For example, in many cases, but not all, patients have acknowledged recent use of products containing THC.  Some reported the use of e-cigarettes containing nicotine.  Where both THC products and nicotine products.  That’s why our work includes collecting critical details about the products or substances involved, where they were purchased and how they were had he being used.  Today, I’d like to provide you a snapshot of FDA’s work to help gather as much information as possible about these cases.  First in recent, the office of emergency operations activated an Incident Management Group, IMG.  This group serves as the agency’s focal point for emergency management and staffed by experts from across the agency.  This group also coordinates information gathering and sharing within the agency and between FDA, CDC, and the states.  Second, FDA has now collected more than 150 vaping product samples from a number of states for analysis in our forensic chemistry center.  And that number of samples continues to grow.  FDA is analyzing these samples for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids, along with opioids, cutting agents or dilutants and other additives, pesticides, poisons and toxins.  Please note identifying any compounds present in the samples is but one piece of the puzzle and will not necessarily answer questions about causality, and that remains the focus of our ongoing work.  We are leaving no stone unturned in following all potential leads regarding any particular product, constituent or compound that may be at issue.  In that spirit, FDA’s Office of Criminal Investigations, or OCI, which is FDA’s law enforcement arm, began parallel investigative efforts shortly after the emergence of the associated illnesses.  OCI has special investigative skills, and the focus of their work is to identify what is making people sick, as well as a focus on the supply chain.  Let me be clear, OCI is not pursuing any prosecutions associated with personal use of any controlled substances in these cases.  Lastly, we understand everyone’s interest in the specifics of FDA’s investigation, and we are committed to providing updates to the public without unintentionally compromising this ongoing active investigation.  With that in mind, FDA has set up a landing page on our website at FDA.gov to provide public information about our work, as well as resources for consumers, health care providers, and state health departments.  Finally, FDA continues to encourage the public to submit detailed reports of any unexpected tobacco or e-cigarette related health or product issues via FDA’s online safety reporting portal and the Url is www.safetyreporting.hhs.gov.  Getting to the bottom of these respiratory illnesses is top priority for all federal and state agencies involved and we are committed to taking appropriate actions as the facts emerge.  Thank you all for your time and I will now turn the call over to Dr. Layden.

Dr. Jennifer Layden:  Thank you, Mitch.  I want to start off by thanking our federal partners, the CDC and the FDA, in their leadership for the coordination of this multistate outbreak.  Here in Illinois I want to thank the Illinois department of public health director Dr. Ezike to allow us to conduct this investigation, as well as a staff who have worked so hard on this investigation, along with the local health departments and clinicians who have been essential partners in this team effort to identify cases and provide meaningful data to help us identify the cause or causes of these serious illness.  This investigation continues to be a top priority for our state.  As of today, Illinois is reporting 69 cases, which unfortunately includes one individual who has died.  This is up from 52 cases that we reported last week, and we continue to get new reports of cases daily.  This is an extremely complex and novel investigation.  The patients are quite ill, and case patients are using numerous products and devices prior to becoming ill.  No one product or type of products have been definitively linked with these illnesses.  Adding to the difficulty is that some individuals are unable to talk with public health professionals because of the severity of their illness or there’s hesitancy about sharing information about the products they have used, especially if they are illicit products.  This investigation requires an all-hands-on-deck approach.  This is a complicated investigation, and data from states across the country are critical to helping us identify the potential causative substances.  In Illinois, and here at IDPH, we continue to use all our available resources to continue with this investigation.  To help us identify potential sources, we are asking Illinois residents who have recently vaped to fill out an anonymous online survey about their vaping habits.  Identifying differences among people who vape and have become ill and those who have not may help us to advance this investigation.  And to facilitate reporting to health departments, we have simplified the reporting form for clinicians and hospitals and we ask them to continue their efforts to report suspect cases to public health.  This partnership between clinicians and public health has and will continue to be critically important.  And i would like to end, again, by thanking public health officials at all levels and clinicians to for working so hard to identify cases and report to this investigation.  Thank you.

Moderator: And now, Sarah, we’re ready to take questions.

Operator: Thank you.  At this time if you would like to ask a question, please ask star 1.  You will be prompted to unmute your phone and provide your name.  To withdraw your request, press star 2.  One moment, please, for the questions to queue up.  The first question from Helen Branswell with STAT.  Your line is open.

Helen Branswell, STAT: Hi.  Thanks for taking my question.  I was hoping I could ask a couple, please.  This is a fairly big jump in numbers.  And I’m wondering if you think that’s because now people are retrospectively going back and finding case, or do you think some of this is happening in real-time?  And my second question is for Mitch Zeller from FDA.  You mentioned the criminal — the Office of Criminal Investigations becoming involved.  Can you tell us more about what triggers their involvement in something like this?  It seems to imply that somebody thinks something illicit may have been happening?

Dr. Schuchat: Thank you, Helen.  Let me begin, and then we will turn it over to the FDA.  The states continue to get new cases reported in addition to catching up from prior cases.  I think this is an ongoing outbreak and not something that we can consider completed.  Some of the additional cases that are in the numbers this week are of course from several weeks ago.  But there continue to be people with new symptom onset.  That is why we are so keen to get the word out to people.  If you do have concerns about your health risk, please consider from refraining using e-cigarettes or vaping products at this time.  Mitch, would you like to answer the second question?

Mitch Zeller: Sure.  And thanks for the question about our Office of Criminal Investigations.  In cases like this, we typically turn to OCI, as I said in my remarks, because they have special investigative skills, and there are leads to track down.  I want to reiterate that, yes, they are the law enforcement arm of the FDA, but they are not pursuing any leads for personal use of any of these substances.  These are trained and skilled investigators.  And what you’re hearing from CDC, FDA and the states is we are in desperate need of facts and answers to questions.  And the trained investigators in our office of criminal investigations typically get involved in cases like this.  They have been involved from the beginning because they have unique skills that will help us all get answers to the questions that we’re desperately seeking.  Thank you.

Moderator: Next question, Sarah.

Operator: Our next question comes from Matt Richtel with New York Times.  Your line is open.

Matt Richtel, New York Times: Guys, thanks for taking my question.  Mitch, my first question is for you, and I’m wondering, given that many of the cases you’ve confirmed appear to be associated with THC in some way.  Have you considered any enforcement action such as either making it just flatly illegal to sell THC vaping devices or liquid, or those with certain additives which seems to be under your purview under multiple federal law?  And, Mitch, is there a reason you have not provided more concrete numbers of percentages given the enormous concern from consumers and industry about the correct behavior to pursue?

Mitch Zeller: Well, this is Mitch.  I’ll start with your first question, Matt.  At this stage in this ongoing investigation, with all of the levels and the layers of complexity that you have heard us all describe, and at this point an ongoing investigation that has way more questions than answers, it’s really premature for me as a regularity to talk about any possible actions or regulatory authorities that could be called into play until we get more answers to these questions and have a better sense of cause and effect for either licit or illicit products.  In general, though, when it comes to the enforcement side, there are certain enforcement tools and authorities that could come into play but only down the road and only after we have a much stronger sense of what the causative factors are when it comes to products and substances.  And when we have those more definitive answers, then we will be in a better position to answer what is a very fair question, which is how could you possibly use any of your authorities, including enforcement authorities down the road?  When we’re in a position to better answer that question, we will.

Dr. Schuchat:  Yeah, thanks.  And let me answer the question about providing more detail about exposures.  We absolutely want to do that.  We are gathering the data from the states.  As you can imagine, it takes a bit more time to get the details of exposures.  And as i mentioned, many people have been exposed to multiple products.  We don’t want to prematurely reassure people that anything in particular in case it were to turn out to have been quite risky.  You know, that has happened before in some outbreaks where we said a certain kind of food and it turned out to be a different kind of food.  In this one, CDC hopes to be able to share more details about the exposures that people reported in the near future.

Matt Richtel, New York Times: Sorry.  Who was speaking there?

Dr. Anne Schuchat: Sorry.  That was Anne Schuchat.

Matt Richtel, New York Times: Thanks.  Okay.  Thanks, guys.

Moderator: Next question, Sarah.

Operator: Our next question is from Evan Brown from Fox News.  Your line is open.

Evan Brown, Fox News: Thank you very much for doing the call.  I think my question might echo one that was previously answered.  But I’ll try anyway.  Is there a belief or what belief do you have that these products may be tampered with in any way?  Vaping has been around for quite a while.  But it just seems like more recently people are getting sick.  Is that — with the involvement of the office of criminal investigations at FDA, is there a belief that something has just gone wrong, or is that no one has really ever looked into this before?

Mitch Zeller: This is Mitch.  I’ll start.  And then defer to colleagues at CDC and Dr. Layden as well if she has perspective from the state level.  I think what you’ve heard from all of us on each of the calls that we have done is that there is no consistent pattern when it comes to what product is being used, practice products, plural, are being used, how they are being used, where they might have been purchased, and/or what might have happened to the products along the way from the time that they were put into the hands of the end user to the moment of aerosolization and inhalation.  There are multiple ways in which multiple different products have been used.  But it’s why part of the advice that you’re hearing from the agencies is be very careful about buying products like this, especially the THC-laced products, off the street.  A number of these cases involve THC.  And in a jurisdiction where the only way that someone can get their hands on a product like that is literally buying it in an alley or on the street, we’re telling you to be very, very careful about doing that because we are all alarmed by the reports involving THC-containing products even if we don’t have THC present in each and every one of the cases that have presented themselves in the dozens of states that have reported illnesses.  And it goes back to the nature of this ongoing investigation.  We need to see what common threads emerge as we do the product analysis.  As the interviews with the patients continue, and as agencies at the federal and state level put their heads together and try to see what is the primary cause and what might the other causes might be.  And we do these calls with you, not because we have brand-new answers to the most important questions, but because we want to update you on where things stand.  CDC giving their latest numbers, our role in an ongoing investigation.  Because it’s important for you all to be able to accurately communicate to the public what’s known and just as importantly, what remains unknown and uncertain.  And I’ll turn it over to CDC and the state at this point.

Dr. Jennifer Layden: Yeah.  Just quickly, I would say that we don’t know if there’s a single exposure that’s the problem or multiple.  So I think the variety of hypotheses are being considered.  At this point it’s a national outbreak, and there may be problematic source material or modifications that are occurring in different places.  So we really need to use caution at this time in terms of our consumer recommendations and have an open mind in terms of the investigation.  Next question, operator?

Operator: Our next question comes from Mike Stobbe with Associated Press.  Your line is open.

Mike Stobbe, Associated Press:  Hi.  Thank you for taking my questions.  If I could ask one for Dr.  Schuchat and one for Mr. Zeller and one for Dr. Layden.  Dr. Schuchat, you gave us demographics, age profiles and a certain percentage are men.  Are the demographics of the cases similar to the demographics of vapors in general?  Is it mostly men, most live those age groups, or is it different in some way?  Mr. Zeller, could you say a little more generally about what the OCI is doing?  Are they interviewing patients?  Are they going to certain types of companies and interviewing or asking for records?  Dr. Layden, you mentioned sometime that one of the challenges is that individuals may be reluctant to talk.  Can you quantify of the 69 cases, how many of those were you unable to get information because the person got sick won’t answer that question.  Thank you.

Dr. Anne Schuchat: Mike, let me take — this is Dr. Schuchat.  Let me take your first question.  The demographics of e-cigarette users and the demographics of people who vape other products may not be identical in terms of nicotine versus THC or other things.  And we have a higher proportion of male in the preliminary data than you see among e-cigarette users where it’s a little closer.  Males have a — are more likely to use e-cigarettes than female in all ages.  It is not as big a discrepancy as the three-fourths we are seeing here.  I want to caution you that the data numbers continue to come in and the numbers are fluid.  I’ll let Mitch do the next question.

Mitch Zeller: I certainly understand the interest in more details.  But we’re trying to balance the need to be transparent with an appropriate position for a regulatory agency with the law enforcement arm to take.  And that is to not discuss the specifics of any ongoing criminal investigation.  We’re using all available resources, and that includes our criminal investigators because of the special skills that they have to first and foremost try to identify as quickly as possible what is making these people sick.  And it’s — it’s just using the investigative skills and training that our OCI investigators have.  Apologies that I can’t go into any more detail than that.

Dr. Jennifer Layden: Okay.  This is Jen Layden from Illinois.  To answer the specific question you asked, I don’t think i can give you an exact percent.  What i can see is with time, as the investigation as evolved, we are having more success in conducting interviews with patients.  Sometimes it requires numerous calls to get a hold of a patient.  And complicating that is they are had he very sick.  They have been sick for several days, two weeks by the time we talk to them.  So, the recall of what they have used, factoring in they have used numerous products, numerous times throughout the day, it is difficult to identify and recall all the products.  But overall, I would say that we have seen reluctance.  But with time, and as the investigation continues, there is more willingness for patients to provide information.

Moderator: Thank you.  Sarah, next question.

Operator: Our next question comes from Lena Sun with Washington Post.  Your line is open.

Lena Sun, Washington Post:  Thank you.  I have a question for Mitch and a question for Dr. Layden.  Mitch, you said that you have now over 150 samples.  I think the last one was 120 samples.  What else have you found in those samples?  Initially you mentioned there was vitamin e acetate.  Is that continuing to be found, or are you finding other possible clues?  And for Dr. Layden, in the Illinois survey that you’re doing, can you talk — explain a little bit more about how you are reaching people and what you are asking them to do and has that started and what are the results you’re seeing.

Mitch Zeller: Well, thanks for the question, Lena.  I’ll go first and then turn it over to Dr. Layden.  There’s not much more i can add to what was previously said on this.  Yes, we are seeing vitamin e acetate in some of the samples.  But our laboratory analysis continues to show a mix of results.  And there’s no one compound, ingredient, constituent, including vitamin e acetate showing up in all the samples tested.  And I’ll just have to leave it at that more general level.

Lena, Sun, Washington Post: You said that before, there was vitamin e as state samples.  Are you seeing more vitamin e acetate now that you are seeing more samples?

Mitch Zeller: I can’t answer that question.

Dr. Jennifer Layden: Hi.  Jen Layden from Illinois.  With regard to our survey, what we are trying to have had is gather more information from people who may also vape but may have not been ill with the goal to compare habits which may help us advance the investigation.  We are using social media efforts to try to reach Illinois residents who are using such products.

Lena, Sun, Washington Post:  Well, are you concerned if they are — if people who have gone sick are reluctant to talk to you because they are worried maybe they will get arrested for using, you know, illicit substances?  Are you concerned that you’re going to get people to take you up on this other offer to let you know what they have been vaping?

Dr. Jennifer Layden: It is certainly possible.  It is an anonymous survey.  We are not collecting any patient identifiers in the hopes that individuals will want to help advance this investigation.

Lena, Sun, Washington Post: Thank you.

Moderator: Next question, Sarah.

Operator: Our next question comes from Kathleen Doney with WebMD.  your line is open.

Kathleen Doney, WebMD:  You can’t say what substance to stay away from.  Is there an expected timeline for that information to become available or evident?

Dr. Anne Schuchat: Thank you.  This is Dr. Schuchat again.  I know that this is very frustrating for the public and the media.  It’s very frustrating for us.  This is a complex investigation.  And i don’t think that we should expect definitive answers imminently.  This may take some time.  That said, the state and local public health, CDC, FDA are working around the clock to get as much information and as many answers as we can soon.  This may turn into finding multiple issues that are of concern rather than a single product or substance.  And so we ask for your patience.  In the meantime, if you are concerned about these health risks, we recommend up consider refraining from using e-cigarettes or vaping products.  Thank you for joining us and thank you for participating in the call.  I believe that was the last question.

Moderator: and if any reporters have follow-up questions, you can call us at 404-639-3286 or email us at media@CDC.gov.  This concludes our call.

Operator: Thank you.  Once again, that does conclude today’s coverages.  Thank you all for participating.  You may disconnect your lines at this time.

SOURCE LINK

RegulatorWatch – September 24, 2019.

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