niman

Dr. Henry Niman PhD New CDC Vaping News And Information

Vaping-associated Illness* Data Lable Value Confirmed and Probable Cases Total Confirmed 20 Total Probable 15 Deaths 1** Most Recent 10/2/2019 Age Range 15-70 Median Age 20 Gender 11 female, 24 male Regions of State Impacted Statewide Reports Under Investigation Total 35 Most Recent 10/9/2019 Age Range 14-63 Median Age 20 Gender 9 female, 26 male Regions of State Impacted North, Central *Chart Updated Every Tuesday **Part of Probable Cases https://www.nj.gov/health/fhs/tobacco/vaping/index.shtml

Lung Injury Outbreak Data As of Tuesday, October 15, 2019, 83 cases of vaping-related lung disease have been reported in Utah, with an additional 11 potential cases being investigated. The state has also reported one death associated with the outbreak. Given the evidence, vaping THC cartridges or “carts” is likely the driver of this outbreak of severe lung injury. The UDOH recommends people do not vape THC cartridges until we learn more. Most Utah cases are in their 20s or 30s. The median age in Utah is 26, which is three years older than the current national median age of 23. Men account for 83% of the Utah cases while women account for 17%, which is similar to case demographics seen in other states. Among Utah cases, 90% were hospitalized. More than half of cases were admitted to an intensive care unit (ICU) and many were diagnosed with acute respiratory distress syndrome (ARDS). The majority of cases required breathing assistance during their illness, most through a CPAP or BiPAP mask but some through intubation for ventilator support. The majority of cases in Utah have symptom onset dates beginning in late July. Ninety-two percent of cases self-reported vaping THC cartridges and 66% self-reported vaping nicotine. Sixty percent of cases also self-report vaping both substances (60%). Substance # of Cases Percentage Any THC cartridges 49 of 53 92% Any nicotine 35 of 53 66% Both THC & nicotine 32 of 53 60% THC only 17 of 53 32% Nicotine only 3 of 53 6% Most THC products were acquired through friends, online, and in-person dealers. A small percentage of THC products were acquired at out-of-state dispensaries or purchased at vape shops in Utah. Nicotine products were acquired mostly at vape shops in Utah. The UDOH Utah Public Health Laboratory (UPHL) has been working with state and national laboratories to test products used by case patients. Thirty-nine samples were tested at the UPHL for several chemical compounds including illicit drugs (e.g., opioids, fentanyl, and methamphetamines), cutting agents, and biologic toxins. Of the 39 products tested by the UPHL, 19 were THC cartridges and 20 were nicotine e- juices. Almost all THC cartridges tested contained vitamin E acetate, a known cutting agent. In contrast, no nicotine products tested showed any unexpected compounds. Samples Tested Containing THC Containing Nicotine Containing Vitamin E THC Samples 19 100% 5% 89% Nicotine Samples 20 0% 100% 0% https://health.utah.gov/lung-disease-investigation/lung-injury-outbreak-data

Ohio Vaping Investigation Update (Information will be updated each Tuesday and Thursday at 2:00 p.m.) Information updated as of 2:00 pm October 15, 2019 Number of cases: 32 Age range: 15-65 years (median age: 21 years) Gender: 11 Female, 21 Male (66% Male) Number of hospitalizations: 29 (91%) Number of deaths: 0 Counties: Butler, Cuyahoga (5), Franklin (6), Hamilton (2), Jefferson, Lucas, Mahoning, Medina (2), Miami, Montgomery, Portage, Richland (2), Summit (3), Tuscarawas, Union (2), Warren, Wayne Additional illness reports under investigation: 35 https://odh.ohio.gov/wps/portal/gov/odh/know-our-programs/tobacco-use-prevention-and-cessation/news-and-events/

Since June 2019, CDPH has received reports that 133 people in California who have a history of vaping were hospitalized for severe breathing problems and lung damage, and three people have died. https://www.cdph.ca.gov/Programs/CCDPHP/Pages/Vaping-Health-Advisory.aspx

Current Cases: 11* (Age range: 16–44 years)*As of October 10, 2019 (Case count updated every Thursday) https://doh.sd.gov/News/ecigarettes.aspx

Lung Disease Among E-cigarette Users – Oct. 15, 2019 DSHS has identified 119 Texas cases of severe lung disease in people who report vaping before developing symptoms, including one death. State health officials are gathering more information about 21 other possible cases to determine whether they are consistent with the symptoms and substance use seen in cases in Texas and 48 other states. Patients range in age from 13 to 75 years old, with a median age of 22 years. About one-quarter of the people affected in Texas are minors. Three-quarters are male, and nine in ten report vaping THC or marijuana, possibly in conjunction with other substances. Almost all were hospitalized with many requiring intensive care. Respiratory symptoms include difficulty breathing, shortness of breath and coughing. Some people have also experienced nausea, vomiting and diarrhea. Clinicians should ask patients with these symptoms about a history of vaping, gather as much information as possible about suspected cases, and report them to DSHS. Nationally, 1,299 cases have been reported, and DSHS is working with the Centers of Disease Control and Prevention, the Food and Drug Administration and other states to gather evidence about what the cases have in common and determine a cause. Until we know more about the cause, people should consider not using e-cigarettes. If you do vape and experience symptoms like those reported, seek medical care promptly. Regardless of the ongoing situation: Youth and young adults should not vape. Women who are pregnant should not vape. Adults who do not currently use tobacco products should not start vaping. Case counts will be updated each Tuesday. News Release Updated Health Alert Latest Information from CDC Vaping-Associated Severe Lung Disease in Texas Public Health Region Number of Cases 1 (Panhandle) 1 2/3 (North Texas) 55 4/5N (East Texas) 4 6/5S (Southeast Texas) 31 7 (Central Texas) 12 8 (South Texas) 3 9/10 (West Texas) 3 11 (Rio Grande Valley) 8 Not yet determined 2 Total 119 Figure 1: Cases of vaping-associated severe lung disease in Texas, as of 10/15/19 https://www.dshs.texas.gov/news/updates.shtm#vaping

Vaping-Associated Lung Injuries: Cases by County Data for the week of Oct. 9. These statistics are updated weekly. County Confirmed and Probable Cases by County Hennepin 13 Dakota 7 Ramsey 7 Anoka 7 Washington 7 Scott 3 Wright 3 Itasca 3 Stearns 2 Beltrami 2 Benton 1 Blue Earth 1 Cass 1 Chippewa 1 Clay 1 Goodhue 1 Jackson 1 Mower 1 Saint Louis 1 Watonwan 1 Wilkin 1 TOTAL 65* *City of residence missing for one probable case Hennepin County Cases by City Health Board City Health Board Confirmed and Probable Edina 0 Richfield 0 Bloomington 0 City of Minneapolis 4 Other Hennepin County 9 Total Hennepin County 13 https://www.health.state.mn.us/diseases/lunginjuries/countydata.html

Number of confirmed or probable cases: 72Number of people under review: 31Updated Monday, 14-Oct-2019 09:49:45 CDT https://www.health.state.mn.us/diseases/lunginjuries/index.html

Illness in Clark County residents linked to vaping FOR IMMEDIATE RELEASE: 18 September, 2019 LAS VEGAS – Two additional Clark County residents have been identified as having severe respiratory illness linked to e-cigarette products. The Southern Nevada Health District reports both cases are individuals ages 18 or older. Clark County’s first confirmed case was in a person under the age of 18. A pulmonary infection that would provide an alternative diagnosis has not been identified. All three were hospitalized but are now recovering from their illnesses. One of the individuals reported using e-cigarettes with nicotine products only. Two of the individuals reported using tetrahydrocannabinol (THC) products, and one also reported using cannabinoid (CBD) oils. All three individuals reported purchasing or acquiring their products from different sources, including friends, retail outlets, and through online purchases. “While the cause of this outbreak is still unknown, there is an undeniable association with the use of e-cigarette products,” said Dr. Joe Iser, Chief Health Officer for the Southern Nevada Health District. “My continued recommendation is for people not to use any vaping products or e-cigarettes.” The Health District further recommends these products never be used by youth, young adults, pregnant women, and people who do not currently use tobacco products. People who currently use tobacco products who wish to quit smoking should use FDA-approved therapies. Symptoms associated with the reported illnesses include: Respiratory symptoms (cough, shortness of breath, or chest pain) Gastrointestinal symptoms (nausea, vomiting, or diarrhea) Non-specific symptoms (fatigue, fever, or weight loss) People who use e-cigarettes and experience any of these symptoms are advised to seek medical care right away. People seeking help quitting tobacco products, including e-cigarettes, can contact the Nevada Tobacco Quitline at 1-800-Quit-Now or 1-855-DÉJELO-YA (1-855-335-3569) from a Nevada area code. There have been 380 cases of lung illness associated with the use of e-cigarette products, or vaping, reported by the Centers for Disease Control and Prevention. The CDC’s case report was revised to only include confirmed and probable cases. Previously reported numbers included possible cases still under investigation by local and state health departments. Seven deaths have been reported; the most recent occurring in California. These numbers are changing frequently. The CDC continues to report that it has not identified any specific substance or e-cigarette product that is linked in all cases. Many but not all patients report using e-cigarette products that contain THC. Some have reported the use of e-cigarette products containing only nicotine. Up to date information on the outbreak is available on the CDC website.

Two additional Clark County residents have been identified as having severe respiratory illness linked to e-cigarette products. The Southern Nevada Health District reports both cases are individuals ages 18 or older. Clark County’s first confirmed case was in a person under the age of 18. A pulmonary infection that would provide an alternative diagnosis has not been identified. All three were hospitalized but are now recovering from their illnesses. One of the individuals reported using e-cigarettes with nicotine products only. Two of the individuals reported using tetrahydrocannabinol (THC) products, and one also reported using cannabinoid (CBD) oils. All three individuals reported purchasing or acquiring their products from different sources, including friends, retail outlets, and through online purchases. https://www.southernnevadahealthdistrict.org/news-release/illness-in-clark-county-residents-linked-to-vaping/

Running totals for Nevada vaping cases

What was it about vaping that killed Mr. Steffen, who had used e-cigarettes and nicotine cartridges that he bought from Walgreens or Walmart? https://www.nytimes.com/2019/10/14/us/vaping-victim.html

Target Audience Physicians Nurses Pharmacists Veterinarians Physician Assistants Health Educators Other Clinicians

Presenter Lieutenant Commander David Siegel, MD, MPH (USPHS)Clinical Team, 2019 CDC Lung Injury Emergency ResponseNational Center for Chronic Disease Prevention and Health PromotionCenters for Disease Control and Prevention

Overview During this COCA Call, clinicians will learn about updates to prior interim recommendations for U.S. health care providers caring for patients with suspected or known lung injury associated with e-cigarette or vaping products as published in MMWR on October 11, 2019. Webinar Objectives Call Materials Presenters Call Information Additional Resources Review what CDC has learned so far about e-cigarette or vaping product use associated lung injury. Discuss CDC’s updated interim guidance for health care providers.

Update: Interim Guidance for Health Care Providers Evaluating and Caring for Patients with Suspected E-cigarette or Vaping Product Use Associated Lung Injury — United States, October 2019 Date: Thursday, October 17, 2019 Time: 2:00pm-3:00pm (Eastern Time)

COCA call scheduled for 2 PM ET 10/17/19 on Early Release MMWR on Interim Guidance on EVALI (vaping) https://emergency.cdc.gov/coca/calls/2019/callinfo_101719.asp

Since June 2019, CDPH has received reports that 132 people in California who have a history of vaping were hospitalized for severe breathing problems and lung damage, and three people have died https://www.cdph.ca.gov/Programs/CCDPHP/Pages/Vaping-Health-Advisory.aspx

Since June 2019, CDPH has received reports that 126 people in California who have a history of vaping were hospitalized for severe breathing problems and lung damage, and three people have died. https://www.cdph.ca.gov/Programs/CCDPHP/Pages/Vaping-Health-Advisory.aspx

Cases reported in Tennessee (as of October 10, 2019): 49* *Evidence of respiratory illness, with no other cause identified, and report vaping in the last 90 days https://www.tn.gov/health/cedep/vaping-illness.html

Transcript of CDC Telebriefing: Lung Injury Investigation Press Briefing Transcript Wednesday, October 11, 2019 Audio recording media icon[3 MB] Please Note: This transcript is not edited and may contain errors. Operator (Jill): Good morning. Welcome, everyone to today’s conference call. At this time your lines are on listen only until the question and answer portion. You will be prompted to press star one. Record your name and affiliation when presented to be introduced to ask your question. The conference is being recorded. If you have any objection, you may disconnect at this time. I will turn it over to our host. You may proceed. Moderator (Amy Heldman, CDC): Thank you so much. Thank you all for joining us for an update today on the lung injury investigation among people who use e-cigarette or vaping products. I’m from the CDC’s division of public affairs. I will be your moderator today. We are joined by Dr. Ann Schuchat, who will provide us with this week’s update. We are joined by Dr. Ned Sharpless, who will join us during the first portion and will drop off before the QA portion. We are joined by Dr. Rom Koppaka from CDC’s response team and Mitch Zeller who will help during the question and answer portion for questions you may have. I will turn this call over to Dr. Schuchat. Dr. Ann Schuchat, CDC: thank you so much for joining us today. CDC continues investigating this multi-state outbreak of lung injury associated with the use of e-cigarette or vaping products. Cases continue to rise. It saddens us all that more people are becoming sick. As of October 8, 2019, 1,299 lung injury cases associated with the use of e-cigarette or vaping products have been reported to CDC from 49 states, the district of Columbia and the u.s. virgin islands. This is an increase of 219 cases since last week that have been reported to us as of Tuesday. Alaska is the only state with no reported cases as of yet. As of October 8, 26 deaths had been confirmed and reported to the CDC from 21 states. Unfortunately, we have had a death reported in a very young person this week. So the age range for deaths is now 17 to 75 years. Our condolences go out to all the families affected. As i have stated before, this lung injury outbreak is serious and we continue to learn of additional deaths being investigated. As we have continued to get data for additional cases, the trends we reported last week persist. Most patients report a history of using thc containing products and most patients are male and young adults. Among the 1,043 patients with data on sex and age, 70% are male and 80% are under 35 years old. I think it’s worth mentioning that 15% of the patients with lung injury are under 18 years old. We have continued to analyze what products patients reported using and have information for 573 patients with data on both thc and nicotine use in e-cigarette or vaping products in the three months prior to their symptom onset. Among these patients we found that 76% reported using thc containing products with or without a history of using nicotine containing products. 58% reported using nicotine containing products. 32% reported exclusive use of THC containing products. And 13% reported exclusive use of nicotine containing products. Although THC containing products appear to be implicated in these injuries, the specific exposures responsible for the lung injuries have not been identified, nor have nicotine containing products been excluded as a possible cause. Our goal and priority is to find out the sources and root causes for these illnesses and this outbreak and to provide the American public with data driven and science based recommendations. When we first distributed advice for clinicians in august, the guidance was based on limited data from the experience clinicians had caring for a small number of patients. Today based on the new information we have gained from consultations with clinical specialists and review of a large number of cases reported from across the country, we are releasing interim guidance that is updated for clinicians regarding e-cigarette or vaping product use associated with lung injury. In today’s MMWR, the interim guidance provides clinical considerations, including the initial clinical evaluation including radiologic testing. Suggested criteria for hospital admission and treatment. More specific information and time lines regarding patient follow-up, including for patients discharged. Special consideration for high risk groups and clinical and public health recommendations. Let me describe what we know as of today about the clinical presentations of patients. Based upon data submitted to CDC from 339 patients, most patients about 95% initially experienced respiratory symptoms like cough, chest pain or shortness of breath. A large proportion, 77%, have gastrointestinal symptoms like abdominal pain, nausea, vomiting and diarrhea. Nearly half or 47% of patients required transfer to intensive care units. More than one in five or 22% required mechanical ven1tilation, which is being hooked up to a breathing machine. 80 of the patients with full clinical information were teenagers under 18. And more than half, or 56% of them were cared for in the intensive care unit. Almost one in three, or 29%, were incubate and required mechanical ventilation. The report provides additional data about the treatment experience of patients. Out of 287 patients for whom we had information, 88% received treatment with corticosteroids. We only had follow-up information for 140 of them. 82% were reported to have improved. We don’t know how many of these might have improved without corticosteroid treatment and we don’t know yet whether there are negative consequences like worsening infection risk for treatment with corticosteroids. We have added guidance about the importance of addressing patients’ needs to avoid e-cigarette or vaping products during and after their hospitalizations. Clinicians alerted us to concern that patients treated for a lung injury who resumed the use of e-cigarette or vaping products might experience a recurrence or worsening of symptoms or lung injury. We want to look at this in more detail, but now are recommending clinicians incorporate advice on discontinuing use of e-cigarette or vaping products as an integral part of care during hospitalizations as well as at outpatient follow-up. We’re aware of a handful of individuals who have been re-admitted for clinical care after discharge for lung injury. We need to understand these occurrences better and look forward to gathering more information and sharing that when we get it. National findings suggest products containing THC particularly those obtained off the street or from unknown sources are linked to most of the cases and play a major role in the outbreak. Given continued occurrence of life-threatening new cases, cdc recommends that you do not use e-cigarette or vaping products that contain THC. People should not buy any type of e-cigarette or vaping product, particularly those containing THC, off the street. Individuals should not modify or add any substances to e-cigarettes or vaping products that are not intended by the manufacturer, including products purchased through retail stores. Given that a small percentage of patients have reported exclusive use of e-cigarette or vaping products containing nicotine and many people with these lung injuries report combined use of THC and nicotine containing products, we cannot exclude the possibility that nicotine containing products play a role in this outbreak. Regardless of the ongoing investigation, e-cigarettes should never be used by youth, young adults or pregnant women. There is no safe tobacco product. The use of any tobacco products, including e-cigarettes carry a risk. Adults should not start using e-cigarette or vaping products. If adults are using e-cigarette or vaping products to quit cigarette smoking, they should not return to smoking cigarettes. We recommend they use evidence-based guidance. For patients who have addiction to marijuana or thc containing products, cognitive behavioral therapy, contingency management, motivational enhancement therapy and multidimensional family therapy have been shown to help. Treatment resources can be found at 1-800-662-4357. I can’t stress enough the seriousness of these lung injuries associated with the use of e-cigarette or vaping products. This is a critical issue. And even while we learn more, we need to take steps to prevent additional cases. We are not seeing a meaningful drop-off in new cases. Unfortunately, many more people have been hospitalized with lung injury each week since we first advised the public about the national outbreak. We have seen cases from all but one state and continue to learn of more deaths from this condition. We urge clinicians to report illnesses consistent with lung injury in people who have used e cigarette or vaping products to their state or local health departments. We’re working very closely with the FDA and other partners. I now invite the acting commissioner from the FDA, Ned Sharpless, to provide an update. Dr. Ned Sharpless, FDA: Thank you for those important updates and for your leadership in the continued collaborations between CDC and FDA on this topic. The FDA continues to work with our federal, state and local partners as quickly as possible to gather more information about these distressing incidents. This is a critical public health investigation. Collaboration is critical to our success. I am pleased to be joining you from the forensic chemistry center in Ohio. It’s at the front lines of investigating this public health crisis. It serves as the FDA’s premiere national forensic laboratory for analyses related to criminal and regulatory investigations. I had the opportunity today to see the firsthand work that the staff are doing to quickly and thoroughly test samples in order to get to the bottom of this very complex investigation. Our staff are using state-of-the-art methods to assess the presence of a broad range of chemicals, including nicotine, thc and others, metals, cutting agents and other additives, pesticides and other toxins. The samples collected from states totaling more than 700 include a range of vaping products and product parts, including product labels, devices, products that contain liquid and used containers collected from consumers, hospitals and from other state health officials. Our work remains focused on better understanding where there’s a relationship between any specific product or substances and the reported illnesses. Based on our testing of samples to date, there does not appear toe be one product or substance involved in all of the cases. It may be there’s more than one cause to this outbreak. We do not — we do know that thc is present in most of the samples tested. Which is why FDA issued an updated consumer safety alert last week warning consumers not to use vaping products that contain THC and not to modify or add any substances, including thc or other oils to vaping products. However, the investigation is not limited to THC. We are following all potential leads regarding any particular product, constituent or compound that may be the issue. The FDA is working to investigate the illnesses, include field samples, criminal and civil investigation and coordination with state and federal partners. Investigating this is FDA’s top priority. Our investigators following every possible lead which includes traveling throughout the country to gather any available evidence, including devices, pods, diluting agents and more. I had the opportunity to tour two international mail facilities where mail from more than 180 countries arrives daily. It is part of the FDA’s mission to inspect, detect and intercept illegal products, including those that are unapproved, counterfeit or potentially dangerous. This includes illicit opioid products, medical devices and over-the-counter products as well as products labeled as dietary supplements that may contain harmful ingredients. As part of the FDA’s investigation into these lung illnesses, we are collaborating with border agents regarding vaping products at these entry locations. I want to stress the FDA is focused on identifying the products that are making people ill and following the supply chain to its source. FDA is not pursuing any enforcement actions associated with personal use of any vaping products. Our interest is in the supply chain. As i said before, if we determine that someone is manufacturing or distributing illicit vaping products that cause illness or death for personal profit, we would consider that to be a criminal act. Getting to the bottom of the illnesses is a top priority for all of the state and federal agencies involved. And we’re committed to taking appropriate actions as the facts emerge. Thank you for your time and interest in this critical question. Will not be able to join for the q & a portion of the call. Back to Amy. Moderator: Thank you, sir. Jill, we are ready for the QA portion. If you could please let me know when ready. Operator: Thank you. At this time, if you wish to ask a question, please press star one on your touch tone phone. Ensure you record your name and affiliation to be introduced. Our first question will come from Eden David with ABC News Medical Unit. Your line is open. Eden David, ABC News Medical Unit: Thank you so much for your time and for that information. I have a two-part question here. Just to be very specific, are they recommending you stop vaping and using e-cigarettes until a cause of injury and death is discovered? Because press releases will always say, you may want to or you may consider. Dr. Schuchat, CDC: based on the evidence from the investigation at this point, we recommend people do not use e-cigarette or vaping products containing THC. Eden David, ABC News Medical Unit: Okay. But in terms of — that’s specifically for THC products, not in general? Dr. Schuchat, CDC: It’s important to say that we cannot exclude the possibility that nicotine containing products may have some role. Because there’s a small percentage, 13% in today’s report, that have only used e-cigarettes or vaping products that contain nicotine. We can’t rule out them as a potential problem. Individuals should — may want to consider refraining from using those in light of that potential. But i think it’s important for us to stress that there is no safe tobacco product. The use of any tobacco products, including e-cigarettes, carries a risk, regardless of our investigation, e-cigarettes should never be used by youth, young adults or pregnant women. We have additional recommendations about those who may be using products for cessation. Moderator: Thank you. Next question, please. Operator: Thank you. Mike Stobbe with the Associated Press. Your line is open. Mike Stobbe, Associated Press: Thank you you for taking my call. I had two questions. Commissioner Sharpless made a point of talking about a visit to an IMF. I was wondering if there’s more information about the 700 samples that FDA received. Have they been able to trace back the origins of those? Are most of these coming from overseas? Are they mostly produced or coming from entities in the united states? My second question was, have you come up with a name for this condition or disease or injury? What is it? Thank you. Dr. Schuchat, CDC: Thanks. Let me begin and i will let Mitch expand about the IMF facility. The first comment i want to make is that there may be more than one cause and more than one source for problematic exposures here. I think before we make a general conclusion, we’re still under the impression here that the source of illness in one part of the country may not be the same as in another part of the country. We have to keep an open mind. I will answer the name question and then let Mitch talk about the particular source of products that FDA is tracing. In today’s MMWR, we began using the phrase evali, which currently stands for e-cigarette or vaping product use associated lung injury. I guess we will see if that sticks. I can say that that’s what the team is using right now. More importantly, the national center for health statistics is working right now to develop an icd 10 coding so that clinical episodes and fatalities that have this condition can be linked systematically. Mitch, would you like — the FDA want to answer the question about produ products? Mitch Zeller, FDA: Sure. The tracing back the supply chain remains a work in progress. We have information that we can share about some of the laboratory analysis that has been done to date. Let me give you some numbers and some percentages. We have received or collected over 725 samples from 23 states plus the u.s. virgin islands. That’s a number that’s only going to increase. So it’s — it is roughly about half of the states where cases have been reported. Of the samples that we have received, we have been able to initiate testing for over 300 of the samples that we have received. So for those roughly 300, those are samples that represent products that were collected from 18 of the 23 states plus usvi that we have samples from. I can give you a further breakdown on some of the things that we are finding. 79 nicotine containing products have had analysis begin. 225 THC containing products have had analysis begin. I can give some information on THC concentrations and vitamin e acetate concentrations. All of this analysis is going to continue. So the number of samples that we have been able to do these additional analysis on will increase. The first 28 samples where we have been able to assess THC concentrations, the range is between 13 and 77%, with a mean concentration of 41%. For the vitamin e acetate, remember from past calls and reports, that in the universe of THC containing products, some of them have — we have found the presence of vitamin e acetate, which is thought to be some kind of cutting or diluting agent. So in the first 37 samples where we have been able to assess the concentration of vitamin e acetate, the range has been between 23% and 88%. The mean there is 50%. We have said all along that we are finding vitamin e acetate in some but not all of the THC products. And as of the last check, vitamin e acetate has been detected in 47% of the thc products for which analysis has begun. These numbers are all a snap shot in time. They are going to change literally every day. Moderator: Thank you. Next question, please. Operator: Thank you. Our next question is from Jane O’donnell of USA Today. Your line is open. Jane O’Donnell, USA Today: Thank you. It’s been interesting to see that the states and localities have banned vaping in many cases, in several cases. I’m wondering if there’s any similar action being taken on the enforcement side for the illegal marijuana, seeing it’s only 13% are nicotine only. Have you been in touch with any areas stepping up enforcement to try to get illegal weed dealers? Mitch Zeller, FDA: This is Mitch from FDA. I will start with that. We are working with partners at all levels and our federal partners include the drug enforcement administration. We are looking at all of our own authorities under the federal food, drug and cosmetic act. As you heard Dr. Sharpless say, as we focus on the supply chain and what i can say from an FDA perspective, while this investigation continues with numbers changing literally every single day, that if one or more of these specific THC vaping products are identified as causing the illnesses, action could be pursued and FDA is prepared to use all of our authorities, including our tobacco product authority to the fullest extent possible to protect the public health. I think what both agencies are trying to emphasize here is this remains an active, ongoing investigation. As we collect samples, do the sample analysis, have boots on the ground doing the investigations and interviewing. And as we take a long and hard look at the supply chain. Moderator: Thank you. Next question, please. Operator: Thank you. Our next question is from Lena sun with “The Washington Post.” your line is open. Lena Sun, The Washington Post: Thank you very much. I have a question for Dr. Schuchat and one for Mitch. Could you talk more about the cases involving recurrence? Is this more confined to the younger patients who have been discharged and then have resumed vaping and now — then got sick again? When you say handful, are you able to be a little bit more specific about the number? The question for Mitch is, you rattled off a bunch of statistics. I wanted to make sure that you said as of last check, vitamin e acetate was found in 47% of the THC products in which analysis has begun. So you had — is that of 225 THC products? If you could clarify that. Also, if you could clarify for which analysis has begun, why does it take so long? What are the other things you are finding? When do you expect to share some of those results with the states that are also conducting the investigations? Moderator: Dr. Schuchat, would you like to go first? Dr. Schuchat, CDC: i would be happy to go first. Give you time there. Thanks for the questions. The issue of readmissions is a relatively new consideration in the outbreak. We have, as i said, a handful. Right now, less than five. We haven’t systematically asked about it and are just beginning to — as you know, we have updated our report form. As we learn more, we are trying to capture important new information. The range of time that I’m aware of for these re-admissions ranges from pretty quickly, like five days after discharge, up to 55 days after discharge. So i think we’re entertaining a number of hypothesize that may be different in individuals. Additional information is being gathered. This is one thing we want the clinicians to be on the lookout. It’s a key reason we stressed the issues in the clinical guidance of follow-up. We recommend seeing people within a week of discharge and beginning the information on treatment — helping people with cessation of either THC or nicotine exposures while they’re in the hospital and also managing that later, longer term. It may be that in some individuals there’s a re-exposure that worsens things. It may be the lung injury weakens the lungs to other insults, whether infectious or otherwise. It may be the pace of steroid tapering, that there’s a resuming of symptoms if the steroids set you up for increased infection risk or set you up for needing a slower taper. Those are just a couple of the hypotheses. It may be different in individuals who get re-admitted quickly versus longer term. As you know, this is a relatively new syndrome that we’re trying to understand on a large scale. This was a particular concern to the clinical group that developed the guidance and to the state and local public health teams that really have been working tirelessly for a couple months now in investigating people. I hope that we learn more. I hope we don’t have more of them. I hope that the clinical guidance that’s issued today will help people with management and prevention of discharges that are too early or making sure there’s the right kind of care afterwards. I do want to mention in the guidelines we talk about the other kinds of things that occur in the next few months, the risk of influenza and other respiratory infections and a reminder we are recommending vaccine and other recommended vaccines with people with lung disease. Let me go to Mitch for the answer to your other questions. Lena Sun, The Washington Post: Thank you. Mitch Zeller, FDA: Thanks. If i haven’t answered all your questions, please repeat them. To clarify, the 47% of the THC products where vitamin e acetate was identified was of the first 225 THC products that have gone through analysis and for which analysis has begun. We have begun to share information with the states. That began literally yesterday and that sharing will continue. These are samples provided by the states. This is state data. But we have begun the process of sharing more granular information on a state level with the states that literally started yesterday. As to the pace of the laboratory analysis and the overall numbers and why does it take this amount of time, there’s one fundamental and important point to make that we made on past calls. That is, we have over 725 samples. But as we have said in the past, many of the samples either have no liquid in them or very, very little. When there’s no liquid, there’s nothing to test. When there’s very little liquid, that puts an extreme limit on the number and types of tests that we’re able to perform. We will continue to put more samples into the battery for testing. We’re still faced with the reality that i can’t give you a number because i don’t have it, but many of the samples that we received contain little or no liquid, which either makes testing impossible or makes it extremely limited. Lena Sun, The Washington Post: Thank you. I guess my overall question is, do either of you get the sense that you may never get to the bottom of what’s causing this outbreak? Moderator: Go ahead. Dr. Schuchat, CDC: I was going to say, i think that there will be multiple causes and potentially more than one root cause. I do think that the phenomenon we’re seeing is going to have an explanation. But it may not be tomorrow. It may take a few months to really understand the portion of illness that’s due to some new risky practice in the preparation of these materials or other causes. Mitch Zeller, FDA: What i would add from the FDA perspective is, this is an extraordinarily complicated investigation with a great diversity of products and intervening acts or actors that could be modifying these products along the way, especially for the great majority of the cases that involve THC and the presence of oils and other compounds. We are going to leave no stone unturned to try to get to the bottom of this. At the end of the day, we agree with CDC, it may be there’s no one cause, no one causative agent, but multiple. But we are working closely with our colleagues at CDC and the states to get the answers to this as quickly as we can. Everybody needs to be reminded of the extraordinary complexity of this ongoing investigation. Operator: thank you. Our next question is from Jonathan Serrie with fox news. Jonathan Serrie, Fox News thank you for taking my question. Vaping associated lung injuries share many of the same symptoms as influenza. What are your concerns with this overlap as we go into flu season? What is your best advice to clinicians on the front lines to differentiate between the two? Dr. Schuchat, CDC: Yes. Thanks. Let me begin. Of course, we do recommend that everybody six months and over have an influenza vaccine and the vaccines are available now. So that is the best way for individuals to protect themselves from influenza. We do recommend testing for influenza as part of the initial workup. Testing for flu is another respiratory pathogen as well as consideration of treatment that’s consistent with the flu treatment. Dr. Rom Koppaka, CDC: Thank you. That’s exactly correct. We recommend that clinicians maintain a high index of suspicion for influenza and other respiratory infections in all individuals with respiratory symptoms who also have a history of use of e-cigarettes or vaping products. As part of maintaining that index of suspicion is consideration that any given individual may have lung injury, they may have an infection or they may have both. As part of the process of evaluating and managing patients, it may be necessary up front to treat for more than one process at a time while testing is done, while a patient’s course is followed to provide a better indication of which of those possibilities is at play. It’s really about clinicians maintaining a very high index of suspicion throughout for both lung injury as well as potential infectious causes. Moderator: thank you. Next question. Operator: thank you. Our next question comes from Denise Grady with the “New York Times.” Denise Grady, New York Times: i would like to ask two questions. The first one, i just want to be clear about the same thing that lena asked you about. The patients who have come back, is it known for sure whether or not some or all of those patients got out of the hospital and then began vaping again? Or is it only known that they got out of the hospital and then got sick again? The second question i just would like to ask i guess is, are there some of these patients who actually do have both an injury from vaping and also some kind of serious respiratory infection going on at the same time? Thanks. Dr. Schuchat, CDC: thank you. We do not know whether individuals who were re-admitted continued or restarted use. At this point, all we know is that they were re-admitted. That information is being gathered. Of course, we’re trying to more systematically if people are re-admitted. In terms of — before the question about the infection, recall that our case definition for this condition that we developed over the summer asked people to rule out infections as the cause of the respiratory illness. That was a safer thing to do in the summer when the winter respiratory viruses are less common. It was a way in young people who aren’t usually coming down with acute respiratory symptoms to hone in on the e-cigarette and vaping exposures. It may be more complicated to understand now that we have — expect to see a higher frequency of infectious respiratory symptoms to understand this. Dr. Koppaka, CDC: thank you. When the surveillance case definition, the definition that we use when we determine whether cases should be included in the numbers that we report, that was a two-part definition. We defined individuals who are said to have confirmed evali, lung injury associated with the use of e-cigarettes or vaping products, are individuals that have the characteristics associated with this syndrome and where it was possible by clinicians to exclude infection as contributing to the clinical or pathological finding. There were also — there are many cases where it just is not possible with the information available or with the testing that we have to completely exclude that an infectious cause was also at play. Those we defined as probable cases where it was mostly ruled out. The numbers that we report comprise both of those groups. It’s people confirmed as well as probable. As we enter the fall and winter where the incidents of influenza and other respiratory viral and bacterial infections increases, it will be increasingly difficult to fully exclude the possibility of infection. It’s therefore critical that health care providers maintain a high index of suspicion for both infection as well as evali and to design treatment that could cover for both possibilities. Moderator: Great. That’s all the time that we have for questions today. I would like to thank everyone for joining the call. We’re going to conclude. If reporters have additional questions for CDC, call us at 404-639-3286 or e-mail [email protected]. A transcript and audio will be up later today for you. If you subscribe to our media list, the MMWR that was discussed, was sent out. Thank you all so much for joining. Operator: that does conclude today’s conference call. We thank you all for participating. You may now disconnect and have a great rest of your day. https://www.cdc.gov/media/releases/2019/t1011-lung-injury-investigation.html

Total reported patients statewide: 123 (Updated: 10/11/2019) Breakdown of reported patients by region: Western New York: 31 Central New York: 12 Capital Region: 20 Northern New York: 2 Metropolitan Region (outside of NYC): 30 New York City: 25 Out of State: 3* *Patients treated at hospitals in NYS but are residents of another state. https://www.health.ny.gov/prevention/tobacco_control/campaign/e-cigarettes/

He Tried E-Cigarettes to Quit Smoking. Doctors Say Vaping Led to His Death. Months after John Steffen died in Nebraska, officials said his death was part of a mysterious outbreak of vaping-related deaths and illnesses. Image Gathered around the family dining room table were relatives of John Steffen, who have been told that he died of a vaping-related illness. From left, they are Dulcia Steffen, his daughter; Kathleen Fimple, his widow; and Ebony DeBolt, his granddaughter.CreditCreditTerry Ratzlaff for The New York Times By Julie Bosman Oct. 14, 2019, 3:00 a.m. ET 26 OMAHA — In the spring, Kathleen Fimple buried her husband, John, and by the fall, she had reluctantly settled into her new life as a widow. She accepted what the doctors told her: that he had died at 68 from respiratory failure and pulmonary disease after years of smoking cigarettes, coupled with a bout of pneumonia. She went back to work. She canceled a trip around Europe that the couple had planned to take this month. Then she got an unexpected call from a doctor at Nebraska’s health department. The department was investigating her husband’s death and would come to conclude that he had actually died of a vaping-related illness. The news made headlines across the state: John Steffen, a tall, bearded father of three who loved to fish, watch the Cornhuskers play football and sing in a baritone so beautiful it could make heads swivel at Mass on Sundays, was the first such case in Nebraska. He was one of at least 29 people across the country whose lives have been claimed in the outbreak. Mr. Steffen’s death deepens the medical mystery surrounding vaping-related illnesses, since most people who have been sickened by vaping have used products containing THC, but Mr. Steffen is believed to have exclusively vaped nicotine. Since the announcement, his family has been beset by fresh anguish and questions. What was it about vaping that killed Mr. Steffen, who had used e-cigarettes and nicotine cartridges that he bought from Walgreens or Walmart? And perhaps most painfully: Would he still be alive if he hadn’t taken up vaping? “It frightens me, because we don’t know what effect vaping has,” said Dr. Fimple, an education administrator in state government, as she sat with her daughter, Dulcia Steffen, in her living room this month. Dr. Fimple nodded in the direction of an e-cigarette package on the coffee table, a crumpled item found while sorting through her husband’s belongings. “It’s like looking at a gun with a bullet,” Ms. Steffen said. ‘I don’t want to quit’ As a teenager growing up on a dairy farm in northeast Nebraska in the 1960s, Mr. Steffen picked up smoking casually, and kept the habit into adulthood. During winters, he would sometimes light up next to the kitchen stove, blowing smoke into the exhaust fan. “He would say, ‘I love it and I don’t want to quit,’” Dr. Fimple recalled. “Eventually, he reconciled that smoking was bad.” Mr. Steffen had two sons from his first marriage, and the daughter he had with Dr. Fimple, Dulcia, would beg him to stop smoking. When Dulcia had her own daughter 15 years ago, she took pictures of the baby and tucked them into her father’s packs of cigarettes. “He would see her face every time he pulled out a cigarette,” Ms. Steffen said. “I was like, O.K., I’ve tried all the little tactics.” As he approached middle age, Mr. Steffen, who worked as a land surveyor, was beginning to face complicated medical problems. Doctors told him he had atrial fibrillation, a heart ailment. He learned he had non-Hodgkins lymphoma and endured chemotherapy. After decades of smoking, he was diagnosed with chronic obstructive pulmonary disease. “He figured he was going to die from lung cancer,” Dr. Fimple said. Only one thing helped Mr. Steffen ditch smoking for good: an e-cigarette. After he began five years ago vaping nicotine — e-cigarette brands like Mistic, blu and Juul that were sold over the counter at big-box retailers and drugstores — he never picked up another cigarette. But just as he had smoked a cigarette several times an hour, now he began to vape several times an hour. Earlier this year, Mr. Steffen was unable to shake a cold. He could not go to Sunday Mass because his cough was so ferocious that it would practically rattle the walls of the church. He went to the doctor in April and got antibiotics, which did little to help his cough. At a second visit in May, a chest X-ray revealed pneumonia. Mr. Steffen was taken to the hospital and given more medication. Nothing seemed to help. His appetite, weak before he had entered the hospital, dwindled even further. One Friday morning, a week into his hospital stay, he woke up unable to move his right arm. His family said that when a hospital chaplain visited his room, Mr. Steffen was blunt. “I think I’m dying slowly,” he told her. She asked if he was afraid to die. “No,” he answered. “I just wish it would happen a little quicker.” That afternoon, a doctor pulled Dr. Fimple aside. “I don’t think he’s going to make it through the afternoon,” she recalled the doctor saying. Dr. Fimple began calling immediate family members. Their daughter and one of Mr. Steffen’s sons sped to the hospital; Dulcia found her father barely conscious, struggling to breathe, his skin turning blue. “His hands were like ice,” she said, wiping away tears. He died about 15 minutes later. A Tip and an Investigation By late September, Dr. Matthew Donahue, an internal medicine specialist at the state’s health department, was in the thick of an investigation. He had received a tip from Kathy Dietsch, a high school classmate of Mr. Steffen’s, who called Nebraska’s health department in late summer — around the time that the outbreak of vaping-related illnesses was first drawing national attention. She had seen Mr. Steffen vaping at a high school reunion in 2014 and had heard about his death. Ms. Dietsch, who lives in Omaha, worried that her phone call to the state would “open a can of worms” for Mr. Steffen’s family. But she said she had a nagging hunch. “I felt that somebody needed to check it out,” she said. Dr. Donahue called Dr. Fimple and broke the news: The state was looking into the possibility that Mr. Steffen had died from illness tied to vaping. “I don’t think so,” she said, recalling what she had been told while he was ill. “He had pneumonia.” Dr. Donahue, trying to piece together Mr. Steffen’s medical history, began pressing her with questions. Was Mr. Steffen around asbestos in the weeks before he died? Did he have a cough? Could he have vaped THC? As part of the investigation, the state health department contacted the doctors who had treated Mr. Steffen, and studied his medical records. There was no autopsy after Mr. Steffen’s death, typical under the circumstances. The official cause of death was acute respiratory failure as a consequence of chronic obstructive pulmonary disease. Days later, Dr. Fimple was stunned to see a news bulletin on her computer screen at work announcing that Nebraska had for the first time identified a resident’s death related to vaping: a man in his 60s who had died in Douglas County in May. She picked up the phone and dialed Dr. Donahue. “Is that my husband?” she asked. He said that it was. Since then, Dr. Fimple has been searching for answers. In their home in Omaha, Mr. Steffen smiles down from family portraits on the walls. The family room is full of his things: a beloved brown leather armchair, a safe where he kept his hunting rifles, a coyote pelt. Public health officials believe there are more cases like Mr. Steffen’s, people who were sickened by vaping before the outbreak emerged in August, but whose doctors had probably not considered vaping as a cause. Dr. Thomas Safranek, the state epidemiologist, said that if the health department hadn’t received a tip, it “wouldn’t have had a clue” that his death was tied to vaping. They used the criteria from the Centers for Disease Control and Prevention to determine the connection, including chest X-rays in Mr. Steffen’s medical record that showed the “ground glass” appearance of his lungs that doctors have tied to vaping. Investigators say they have not pinpointed what is making people sick, whether it is the liquid being vaped, a material in vaping devices themselves, or something else. The C.D.C. says that nearly 1,300 people have become ill after vaping. “The majority of people who have had a vaping-associated pulmonary illness do appear to have used THC- or CBD-related products, but there are a substantial portion — up to 30 percent — where the patient only used a nicotine-containing vape device,” said Dr. Hilary Faust, a pulmonologist who has treated patients with vaping-related illness. “We don’t know what exactly is causing the injury.” Asked to comment on Mr. Steffen’s case, Juul Labs, the e-cigarette company, said in a statement: “We appreciate the work of the C.D.C., F.D.A., and state public health authorities, and are confident that they will get to the bottom of this issue.” Representatives for Mistic and blu did not respond to requests for comment. Dr. Safranek said that given Mr. Steffen’s history of smoking, he probably would have suffered a premature death from that habit alone. “It’s a question of, what would have gotten him first, the vaping or tobacco?” Dr. Safranek said. “In his case, it looks to me like he would have been better off sticking with tobacco.” ADVERTISEMENT https://www.nytimes.com/2019/10/14/us/vaping-victim.html