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Tonight at 11 PM ET Dr. Henry Niman PhDMajor New Development In The Vaping Emergency

'A direct, toxic chemical injury': What vaping does to the lungs Despite the recent surge in vaping-related illnesses, doctors suspect they've seen such ca A new study shows how vaping can lead to chemical injury in lung tissue. Andrew Kelly / Reuters file Oct. 2, 2019, 5:01 PM EDT By Erika Edwards Toxic chemical burns may be behind the hundreds of vaping-linked illnesses spiking across the country, according to new images of lung tissue taken from people who got sick after vaping. The images and resulting analysis from pathologists were published Wednesday in the New England Journal of Medicine. The findings provide a better understanding of what's actually happening to the lungs in these cases. They're also meant to give other doctors a frame of reference for what the vaping-related lung injuries look like under a microscope, as well as help in diagnosis. It looks like the kind of injury that we normally see when a person is exposed to a spilled drum of toxic chemicals at their workplace. "It looks like the kind of injury that we normally see when a person is exposed to a spilled drum of toxic chemicals at their workplace," said Dr. Brandon Larsen, an author of the study and a surgical pathologist at the Mayo Clinic in Scottsdale, Arizona. He and his team are often called upon to examine lung tissue for a second opinion, or in cases that have perplexed other physicians. These images of lung tissue show severe chemical injuries caused by vaping unknown substances. On the top right is a cross section of a small airway. The pink circular structure is the airway wall. Pathologists explain there should be nothing in the middle of that structure so air can flow easily. Instead, the image shows widespread inflammation and injury, inhibiting oxygen flow. The New England Journal of Medicine Larsen and colleagues examined lung biopsy samples from 17 patients with lung illnesses linked to vaping, a small portion of the 805 cases confirmed by the Centers for Disease Control and Prevention. But their sample is similar to what's seen nationwide: Most of the patients in the Mayo Clinic study were men, between the ages of 19 and 67. And nearly three-quarters had vaped marijuana or cannabis oil. Previous investigations suggested that an accumulation of oil in the lungs was to blame, and many patients were diagnosed with a condition called lipoid pneumonia. That occurs when inflammatory cells with abnormally high levels of fatty substances, called lipids, collect in the lungs. But the Mayo researchers found no evidence to suggest lipoid pneumonia, at least in those 17 cases. Related "What appears to be going on in the lung itself is a direct toxic chemical injury, like a chemical fume injury or a poisonous gas injury," Larsen told NBC News. Public health investigators looking into the cases nationwide haven't been able to pinpoint any single ingredient that would explain the type of chemical injury shown in the Mayo study. However, the CDC has reported that a majority of patients said they used products containing THC (marijuana's psychoactive ingredient), and many said they got those products from friends, dealers or elsewhere off the street. Many investigators suspect that counterfeit vapes play a role in the problem. Doctors are learning more about the mysterious illnesses in real time, as patients arrive at the hospital with symptoms: difficulty breathing, cough, fever, fatigue and sometimes vomiting and diarrhea. Recommended But although there's been a surge in cases in recent months, some clinicians say they've seen such illnesses in the past. Indeed, two of the patients in the Mayo study had fallen ill before 2019. "We’ve seen this before," said Larsen. "We just had so little experience with it before that we weren’t sure what we were looking at." Long-term consequences Most patients with vaping-related lung injuries are able to recover with steroids and/or supplemental oxygen. But some have succumbed to the illness. On Wednesday, Alabama health officials confirmed that a resident died from a vaping-related lung illness, the first in that state. That brings the total number of deaths so far to 17, nationwide. Deaths have also been reported in California, Florida, Georgia, Illinois, Indiana, Kansas, Minnesota, Mississippi, Missouri, Nebraska, North Carolina and Oregon. The person who died in North Carolina was actually a resident of Virginia, health officials said Tuesday. For those who survive the illness, it's unclear whether they will continue to have breathing difficulties. "We don’t know what the long-term consequences will be," Larsen said. "But I will not be shocked when we discover 20 years from now that some patients have chronic lung disease because they’ve been vaping." https://www.nbcnews.com/health/vaping/direct-toxic-chemical-injury-what-vaping-does-lungs-n1061151

Vaping-related lung injuries resemble chemical burns, study finds By ANDREW JOSEPH @DrewQJoseph OCTOBER 2, 2019 RICHARD VOGEL/AP The airways and lungs of some patients with a vaping-related illness appeared damaged in ways similar to those exposed to chemical spills or harmful gases, researchers reported Wednesday. The study did not provide any clues as to the kind of chemicals that might be causing the condition, but the authors said signs of damage were consistent. “What all these appeared to represent was some sort of toxic chemical fume injury, or chemical burn if you will,” said Dr. Brandon Larsen, a pathologist at Mayo Clinic Arizona and senior author of the paper, which was published in the New England Journal of Medicine. The report — based on biopsies — did not find any evidence to back some earlier suggestions that lipids, or fats, inhaled through vaping might be a possible contributor to the condition. The findings could offer a potential new approach to identifying new cases. “We wanted to understand the spectrum of changes that can be seen so that we can help provide diagnostic criteria for pathologists in the laboratory who are seeing these biopsies and for clinicians who are sending biopsies to the lab,” Larsen said. Health officials have said that many people suffering from the condition have been vaping cartridges acquired from informal sources like dealers or friends. It’s possible that a contaminant or additive could be the culprit, though experts are still not certain that’s the case. More than 800 confirmed and probable cases of the injury have occurred in the United States, according to federal data released last week, with at least a dozen deaths linked to the illness. Biopsy images from patients with vaping-associated lung injury.THE NEW ENGLAND JOURNAL OF MEDICINE For the new report, Larsen and colleagues examined biopsies from 17 patients suspected of having or confirmed to have vaping-associated lung injury, two of whom died from the condition. About 70% of the patients said they had vaped marijuana, echoing survey data released last week by health authorities that found 87% of a group of patients had vaped THC products. In all of the 17 cases, the researchers found signs of pneumonitis — inflammation of the lungs — and damage to the airway and lung tissue, suggesting, they wrote, the condition might be caused by “one or more inhaled toxic substances.” https://www.statnews.com/2019/10/02/vaping-related-lung-injuries-resemble-chemical-burns-study-finds/

In preferred embodiments, the tobacco or botanical is heated to about 300.degree. C. at most. In other preferred embodiments, the tobacco or botanical is heated to about 200.degree. C. at most. In still other preferred embodiments, the tobacco or botanical is heated to about 160.degree. C. at most. It should be noted that in these lower temperature ranges (<300.degree. C.), pyrolysis of tobacco or botanical does not typically occur, yet vapor formation of the tobacco or botanical components and flavoring products does occur. In addition, vapor formation of the components of the humectant, mixed at various ratios will also occur, resulting in nearly complete vaporization, depending on the temperature, since propylene glycol has a boiling point of about 180.degree.-190.degree. C. and vegetable glycerin will boil at approximately 280.degree.-290.degree. C. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=29&f=G&l=50&co1=AND&d=PTXT&s1=pax.ASNM.&OS=AN/pax&RS=AN/pax

Lung Damage From Vaping Resembles Chemical Burns, Report Says Doctors at the Mayo Clinic examined samples of lung tissue from 17 patients, all of which looked as if the people had been exposed to toxic chemicals, the researchers said. Image Four examples of severe vaping-related injury. In two of these cases, the patients died.CreditCreditLarsen et al., New England Journal of Medicine By Denise Grady Oct. 2, 2019Updated 5:19 p.m. ET The lung damage seen in some people who have become ill after vaping nicotine or marijuana products resembles a chemical burn, doctors from the Mayo Clinic reported on Wednesday. Their findings are based on samples of lung tissue from 17 patients around the country whose biopsy specimens were sent to Mayo to be examined under the microscope by experts in lung pathology. Two samples came from patients who died. “All 17 of our cases show a pattern of injury in the lung that looks like a toxic chemical exposure, a toxic chemical fume exposure, or a chemical burn injury,” said Dr. Brandon T. Larsen, a surgical pathologist at the Mayo Clinic in Scottsdale, Ariz. “To be honest, they look like the kind of change you would expect to see in an unfortunate worker in an industrial accident where a big barrel of toxic chemicals spills, and that person is exposed to toxic fumes and there is a chemical burn in the airways.” The findings were published on Wednesday in The New England Journal of Medicine. More than 800 cases of lung illness in 46 states have been linked to vaping, and 16 people have died. The majority have vaped THC, the psychoactive ingredient in marijuana, but some say they have vaped only nicotine. Medical investigators have been unable to identify exactly what is causing the lung damage, or even how many harmful substances are involved. They do not know whether the source is the liquids being vaped, or a toxin released from the materials used to make vaping devices. It is also unclear whether some devices used in vaping may be defective. Last Friday, the Centers for Disease Control and Prevention identified several names of THC-related products in prefilled cartridges that they said patients had reported using before becoming ill. Dank Vapes, Moon Rocks, Off White and TKO were among those listed by health officials who interviewed patients in Wisconsin and Illinois. But officials said they did not know if vaping illnesses or deaths in other parts of the country were related to the same THC labels identified in those two states. Officials also said that Dank Vapes was not an actual brand, but just a label and packaging that anyone selling THC vaping liquid could buy and stick on a product. The extensive use of prefilled THC cartridges suggests they might play an important role in the outbreak, the C.D.C. said. According to the C.D.C. report last week, of 771 patients nationwide in the outbreak, 91 percent had been hospitalized; 69 percent were male; and a little more than 60 percent were between the ages of 18 and 34. Of the 13 known deaths at the end of last week, the C.D.C. said that nearly 60 percent were of men, and the median age was 50 years old. Nebraska, Virginia and New Jersey reported deaths this week, bringing the total to 16. Many of the patients who died were older with underlying illnesses, although few details have been released in some states. https://www.nytimes.com/2019/10/02/health/vaping-illnesses.html

Pathology of Vaping-Associated Lung Injury TO THE EDITOR: Figure 1.Histopathology of Acute Lung Injury Associated with Vaping. Despite the accumulating data on the clinical and imaging features of vaping-associated lung injury,1,2 its pathology is poorly understood. We reviewed lung biopsies from 17 patients (13 men; median age, 35 years [range, 19–67]), all of whom had a history of vaping (71% with marijuana or cannabis oils) and were clinically suspected to have vaping-associated lung injury. Presentation was acute or subacute in all cases, with bilateral pulmonary opacities; all but two patients presented in 2019. Eleven met the criteria for a “confirmed” diagnosis of vaping-related lung injury; the remaining six met the criteria for a “probable” designation. In all cases, histopathological findings showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, usually bronchiolocentric and accompanied by bronchiolitis (Figure 1; also see the Supplementary Appendix, available with the full text of this letter at NEJM.org). No histologic findings were specific, but foamy macrophages and pneumocyte vacuolization were seen in all cases and may be useful diagnostic clues in an appropriate clinical context. Pigmented macrophages were sometimes present but were never a dominant feature. Neutrophils were often prominent, but eosinophils were rare and granulomas were not seen. In two cases, bronchioloalveolar lavage fluid was available and contained abundant foamy macrophages. Despite treatment with glucocorticoids and maximum supportive care, two patients with diffuse alveolar damage died. To date, few reports of vaping-associated lung injury have included histopathological findings. Our cases corroborate many of these descriptions and provide some preliminary insight into the pathogenesis of this injury. Much recent attention has been given to the possibility that vaping-associated lung injury may represent exogenous lipoid pneumonia.3 However, none of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found2; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed.3,4 The significance of this observation remains unclear, particularly in patients with a known vaping history; until more data accumulate, our observations suggest that this finding should be interpreted with caution, as it may simply be a marker of exposure and not necessarily a marker of toxicity. Although it is difficult to discount the potential role of lipid, we believe that the histologic changes instead suggest that vaping-associated lung injury represents a form of airway-centered chemical pneumonitis from one or more inhaled toxic substances rather than exogenous lipoid pneumonia as such, but the agents responsible remain unknown. Yasmeen M. Butt, M.D. Maxwell L. Smith, M.D. Henry D. Tazelaar, M.D. Laszlo T. Vaszar, M.D. Karen L. Swanson, D.O. Mayo Clinic, Scottsdale, AZ Matthew J. Cecchini, M.D., Ph.D. Jennifer M. Boland, M.D. Melanie C. Bois, M.D. James H. Boyum, M.D. Adam T. Froemming, M.D. Mayo Clinic, Rochester, MN Andras Khoor, M.D., Ph.D. Isabel Mira-Avendano, M.D. Mayo Clinic, Jacksonville, FL Aiyub Patel, M.D. UnityPoint Health, Peoria, IL Brandon T. Larsen, M.D., Ph.D. Mayo Clinic, Scottsdale, AZ [email protected] Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on October 2, 2019, at NEJM.org. 4 References 1.Layden JE, Ghinai I, Pray I, et al. Pulmonary illness related to e-cigarette use in Illinois and Wisconsin — preliminary report. N Engl J Med. DOI: 10.1056/NEJMoa1911614. Free Full Text Google Scholar. opens in new tab 2.Henry TS, Kanne JP, Kligerman SJ. Imaging of vaping-associated lung disease. N Engl J Med. DOI: . Free Full Text Google Scholar. opens in new tab 3.Maddock SD, Cirulis MM, Callahan SJ, et al. Pulmonary lipid-laden macrophages and vaping. N Engl J Med. DOI:. Free Full Text Google Scholar. opens in new tab 4.Davidson K, Brancato A, Heetderks P, et al. Outbreak of electronic-cigarette–associated acute lipoid pneumonia — North Carolina, July–August 2019. MMWR Morb Mortal Wkly Rep 2019;68:784-786. Crossref. opens in new tab Medline. opens in new tab Google Scholar

none of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found2; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury https://www.nejm.org/doi/full/10.1056/NEJMc1913069?query=featured_home

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Vaping-related Lung Injury, Utah, 2019: Investigation to Date Updated September 30, 2019 ------------------------------------------------------------------------------------------------------------------------------------------ Introduction As of Monday, September 30, 2019, 71 cases of vaping-related lung injury have been reported to Utah Department of Health (UDOH), with an additional 10 potential cases under review (see Table 1). Given the evidence outlined below, 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. Table 1. Cases by Case Status and Interview Status, Utah Local Health Departments, Utah, 2019 Local Health District # of Cases # of Cases Under Review Salt Lake 39 3 Utah 11 1 Davis 9 0 Weber-Morgan 5 3 Other LHDs 7 3 Total 71 10 Demographics Men account for 82% of the Utah cases while women account for 18%, which is similar to case demographics seen in other states. Most cases are in their 20s or 30s. The median age in Utah of 26 (range: 14–66) is three years older than the current national median age of 23.

New Updates – Monday, September 30, 2019 As of Monday, September 30, 2019, 71 cases of vaping-related lung disease have been reported in Utah, with an additional 10 potential cases being investigated. Given the evidence outlined below, vaping unregulated THC cartridges or “carts” is likely the driver of this outbreak of severe lung injury. The UDOH recommends people do not vape unregulated THC cartridges until we learn more.

Vaping-Associated Severe Lung Disease in Texas Public Health Region Number of Cases 1 (Panhandle) 0 2/3 (North Texas) 37 4/5N (East Texas) 3 6/5S (Southeast Texas) 16 7 (Central Texas) 5 8 (South Texas) 3 9/10 (West Texas) 2 11 (Rio Grande Valley) 7 Not yet determined 2 Total 75 Figure 1: Cases of vaping-associated severe lung disease in Texas, as of 10/1/19

SC Cases of Severe Pulmonary Illness Associated with E-Cigarette Use, or Vaping Confirmed or Probable 12 https://www.scdhec.gov/severe-pulmonary-disease-associated-e-cigarette-use

Updated October 1, 2019 In Oregon, eight cases have been reported, two of which resulted in death.

Information updated as of 2:00 pm October 1, 2019 Number of cases: 22 Age range: 15-59 years (median age: 21 years) Gender: 7 Female, 15 Male (68% Male) Number of hospitalizations: 22 Number of deaths: 0 Counties: Butler, Cuyahoga (2), Franklin (4), Hamilton (2), Jefferson, Lucas, Montgomery, Portage, Richland (2), Summit (3), Tuscarawas, Union (2), Wayne Additional illness reports under investigation: 19

Total reported patients statewide: 101 (Updated: 10/1/2019) Breakdown of reported patients by region: Western New York: 28 Central New York: 9 Capital Region: 18 Northern New York: 1 Metropolitan Region (outside of NYC): 22 New York City: 20 Out of State: 3* *Patients treated at hospitals in NYS but are residents of another state.

Mississippi Cases Last updated October 1, 2019. Outbreak Cases 5 Since September 17, 2019 Deaths 1 Age Range Under 18 years: 0 18–34 years: 5 35+ years: 0 Healthcare providers: Report suspected cases to MSDH at 601-576-7725 or 601-576-7400 after hours, weekends and holidays. https://msdh.ms.gov/msdhsite/_static/14,0,418.html

Number of confirmed or probable cases: 55Number of people under review: 29Updated Tuesday, 01-Oct-2019 10:20:15 CDT

As of 10/01/2019, the Michigan Department of Health and Human Services has identified 24 (14 confirmed and nine probable) cases of severe lung disease associated with vaping.

Lung Injury Associated with E-Cigarette Use, or Vaping* - Florida Year Reported Cases Year-to-Date Deaths Year-to-Date 2019 39 1 Report last updated on October 1, 2019 with data from January 1, 2019 - September 28, 2019. FLHealthCharts.com is provided by the Florida Department of Health, Division of Public Health Statistics & Performance Management. Data Source: Florida Department of Health, Division of Disease Control and Health Protection, Florida Bureau of Epidemiology. Data Note(s) The counts here represent the cases of Lung Injury Associated with E-Cigarette Use, or Vaping reported into Florida's reportable disease surveillance system, Merlin. Legal authority: Pursuant to section 381.0031(6), Florida Statutes, and Rule 64D- 3.041, Florida Administrative Code, the Department and its authorized representatives, when deemed necessary to protect the public’s health, may conduct epidemiological investigations and follow-up to confirm the diagnosis, treatment and causes of any disease or condition to determine appropriate methods of outbreak and communicable disease control. * Includes vaping using an electronic device (e.g., electronic nicotine delivery system (ENDS), electronic cigarette, e-cigarette, vaporizer, vape(s), vape pen, dab pen, or other) to inhale substances (e.g., nicotine, marijuana, THC, THC concentrates, CBD, synthetic cannabinoids, flavorings, or other substances), with or without smoking of any plant, chemical, or substance.

Press Releases 09/26/2019 Department of Public Health Reports 18th Case of Lung Injury Related to Vaping Commissioner Adding Vaping-Related Lung Disease to List of Reportable Health Conditions; Recommends Residents Consider Not Using Vaping Products The Connecticut Department of Public Health (DPH) today is reporting that it has learned of five more Connecticut residents who were ill with lung injuries possibly related to using e-cigarettes or vaping, bringing the total to 18 cases that have been reported to DPH. All of the patients who had been hospitalized with vaping-related lung injury have now been discharged from the hospital. Of those who were hospitalized, half required treatment in an intensive care unit. The 18 cases involve residents from six of our counties: Fairfield (9), New Haven (5), Hartford (1), New London (1), Tolland (1), and Windham (1). The age breakdown of the patients is as follows: Under 18 years of age (4) 18 to 34 years of age (11); 35 years of age and older (3). https://portal.ct.gov/DPH/Press-Room/Press-Releases---2019/Department-of-Public-Health-Reports-18th-Case-of-Lung-Injury-Related-to-Vaping

At a glance As of Oct. 02, 2019 9 outbreak cases 6 hospitalizations 0 deaths

Current Cases as of October 1, 2019 Confirmed 1* Probable 9 Under Investigation 6 Total 16

ADPH confirms state's first death from vaping-associated illness FOR IMMEDIATE RELEASE CONTACT: Jamey Durham (334) 206-5634 The Alabama Department of Public Health (ADPH) has confirmed the state's first death from a vaping-associated injury. The deceased is an adult male in East Alabama. The death comes as the Centers for Disease Control and Prevention (CDC) continues its investigation of a multistate outbreak of lung injury associated with vaping. The CDC is investigating more than 805 lung injury cases in 46 states and 1 U.S. territory. Twelve deaths have now been confirmed in a total of 10 states (Alabama is not included in this number). Those seeking medical attention due to potential vaping-associated injury should immediately inform healthcare providers they used a vaping/e-cigarette product (i.e., vape pens, liquids, refill pods and cartridges). Patients have experienced symptoms that include cough, shortness of breath and fatigue, with symptoms growing worse over a period of days or weeks before admission to the hospital. Other symptoms may include fever, chest pain, nausea, abdominal pain and diarrhea. Most of the cases are among adolescents and young adults. ADPH is asking persons who sought medical care for a potential vaping-related injury to contact Mr. Durham if they have any vaping/e-cigarette products that can be obtained for testing purposes. ADPH recommends that all consumers consider refraining from the use of e-cigarettes and vape products until national and state investigations into vaping-related deaths and illnesses are complete. Two-thirds of the cases being investigated by the CDC involve patients who are 18 - 34 years old. As of October 1, there were 19 Alabama residents under investigation. Of the 19 reports, 4 cases have been identified and 9 other reports are still under investigation in Alabama; 3 have been identified as probable cases; 1 confirmed case (the deceased), of lung disease associated with vaping. National counts will be updated on Thursday. Those who choose to continue the use of e-cigarettes and vape products should not buy these products off the street or from unregulated sources. Consumers should avoid modifying or adding any substances that are not intended by the manufacturer. Consumers with nicotine addiction who have used e-cigarettes as a method to quit smoking should not return to the use of conventional cigarettes. ADPH has requested that health care providers report any cases of suspected serious respiratory illness they treat among patients who use electronic cigarettes or other vaping devices. State Health Officer Dr. Scott Harris said, “The use of any tobacco product is unsafe. While this current outbreak is being investigated, the safest option is to refrain from using any e-cigarette or vape product. Furthermore, there is no situation in which these devices should be used by pregnant women or youths.” Alabama law now prohibits the sale or transfer of vaping products or electronic nicotine delivery devices to minors. Free help is available for individuals who are ready to kick the tobacco habit at 1-800-QUIT-NOW (1-800-784-8669) or quitnowalabama.com. The Quitline provides individualized coaching to help any type of smoker or tobacco user, including e-cigarettes and vape, to quit. In addition, the Quitline offers up to eight weeks of free nicotine patches to those medically eligible and enrolled in the program. Quitline coaching services are available seven days a week from 6 a.m. to midnight. For additional information on electronic cigarettes and their health effects, visit www.cdc.gov/tobacco/basic_information/e-cigarettes/index.htm. For more information on quitting tobacco, please visit ADPH Tobacco Prevention and Control at alabamapublichealth.gov/tobacco. County health departments throughout Alabama provide a wide range of confidential and professional services. Contact your local county health department for additional information. Mission: To promote, protect, and improve Alabama's health Vision: Healthy People. Healthy Communities. Healthy Alabama. - 30 - 10/02/2019 ALABAMA DEPARTMENT OF PUBLIC HEALTH RSA Tower 201 Monroe Street, Suite 910, Montgomery, AL 36104 Phone: (334) 206-5300 | Fax: (334) 206-5520

The Alabama Department of Public Health (ADPH) has confirmed the state's first death from a vaping-associated injury. The deceased is an adult male in East Alabama. http://alabamapublichealth.gov/news/2019/10/02.html

DPH has identified the state’s first death from a vaping-associated illness. The patient had a history of heavy nicotine vaping, but no reported history of vaping THC. https://dph.georgia.gov/