Transcript of CDC Telebriefing: Lung Injury Investigation

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 media@cdc.gov.  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.

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