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 This email address is being protected from spambots. You need JavaScript enabled to view it..  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.

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