Perspective

‘We don’t know’: CDC lacks key answers about vaping lung injuries

 
Anne Schuchat
 
Ned Sharpless

Federal lawmakers questioned health officials in two hearings this week about lung injuries and deaths related to vaping in the United States.

However, Anne Schuchat, MD, CDC principal deputy director, and Ned Sharpless, MD, acting FDA commissioner, could not answer every question, explaining that the outbreak was only recently detected and investigators are having difficulty keeping up with it.

Many questions, few answers

Specifically, lawmakers asked Schuchat and Sharpless who is being impacted by the lung injuries and what e-cigarette brand is to blame. They also wanted to know how to stop the outbreak before it gets worse.

E-cigarette 
Federal lawmakers questioned health officials in two hearings this week about lung injuries and deaths related to vaping in the United States.
Source:Shutterstock

“We know that a significant part of this outbreak is impacting youth,” Schuchat said at the House Subcommittee on Economic and Consumer Policy hearing on Tuesday. “But we don’t know the cause. No single product, brand, substance or additive has been linked to all cases. Whether the products in one state are the same problematic products in another state or if it’s manipulation of the product is what’s going on, we don’t know. ... The epidemic is moving faster than our data-gathering processes and we are really losing people in the meantime.”

Symptoms are not universal

There was also little information about how patients with lung injuries related to e-cigarette use can be recognized and treated, according to Schuchat.

Although symptoms include cough, shortness of breath and chest pain, they can also include nausea, vomiting and fatigue. Additionally, the duration of symptoms can take several days to several weeks to appear, Schuchat said.

“The respiratory symptoms these patients have are very nonspecific and their X-ray findings are diverse,” she noted, adding that although steroids and corticosteroids have helped some patients, physicians may also need to individualize treatment for patients based on their symptoms.

Schuchat emphasized that patients should be followed after discharge, and that clinicians should conduct pulmonary function tests “to see if the lungs’ function return to expected levels of a healthy person before the injury occurred.”

Mistakes were made

According to the FDA’s website, a rule that went into effect Aug. 8, 2016, required all manufacturers of e-cigarettes to file premarket tobacco product applications with the FDA within 2 years. The applications are required to contain information about the product’s health risks, the product’s ingredients and how the it is made, among other items.

One lawmaker criticized the federal agencies’ shortsightedness in allowing e-cigarettes on the market without completing those applications.

“There was clearly a massive regulatory failure that allowed for this to happen," Rep. Joe Kennedy III, D-Mass., said during the House Committee on Energy and Commerce hearing on Wednesday. “Nobody thought that there would be the possibility of diversion or illicit use or that there could be adverse health impacts?”

Sharpless acknowledged that the government should have regulated the products sooner, but he also defended the agency, saying that “since I have been at the FDA, we have greatly accelerated the review date, we have done education campaigns, we will be issuing guidance ... we’re going to catch up.”

Rep. Paul Tonko, D-N.Y., also wanted to know why e-cigarette manufacturers were not required to file their premarket tobacco product applications.

“The data back then suggested that e-cigarette use was lowering or leveling off among children,” Sharpless responded. “That was before the explosion that we have seen the past 2 years. When the FDA began to appreciate that this rocket was taking off, we stepped up our enforcement and educational activity. In retrospect, we should have acted more urgently.”

The FDA said it has sent out more than 8,000 warning letters and levied more than 1,000 fines against manufacturers and retailers for marketing and sales practices that have increased the accessibility and appeal of e-cigarettes among youth.

Another lawmaker, Rep. Janice D. Schakowsky, D-Ill., said she didn’t “feel a sense of urgency” from the FDA and CDC to curb the use of e-cigarettes and the vaping illnesses.

“We have a strong sense of urgency,” Sharpless responded, adding that the FDA plans to remove all e-cigarettes products with flavors such as bubble gum and cotton candy from the market in the near future.

Recommendations for physicians, patients

As the CDC investigation into the lung injuries continues, Schuchat said physicians have a role in reducing the risk to children.

“We recommend that doctors ask their patients not only ‘do you smoke cigarettes?’ but also ‘do you use e-cigarettes or vaping products?’ We think it is important for clinicians and parents to educate themselves about the types of products that are out there and to ask the right questions,” she said.

According to the CDC, 12 deaths and 805 hospitalizations have been linked to e-cigarette use. However, Schuchat said during the hearings that the number of hospitalizations is expected to be “hundreds higher” as the CDC continues its investigation. by Janel Miller

Editor's Note: This story has been updated from an earlier version to reflect updated death and hospitalization numbers from the CDC.

 
Anne Schuchat
 
Ned Sharpless

Federal lawmakers questioned health officials in two hearings this week about lung injuries and deaths related to vaping in the United States.

However, Anne Schuchat, MD, CDC principal deputy director, and Ned Sharpless, MD, acting FDA commissioner, could not answer every question, explaining that the outbreak was only recently detected and investigators are having difficulty keeping up with it.

Many questions, few answers

Specifically, lawmakers asked Schuchat and Sharpless who is being impacted by the lung injuries and what e-cigarette brand is to blame. They also wanted to know how to stop the outbreak before it gets worse.

E-cigarette 
Federal lawmakers questioned health officials in two hearings this week about lung injuries and deaths related to vaping in the United States.
Source:Shutterstock

“We know that a significant part of this outbreak is impacting youth,” Schuchat said at the House Subcommittee on Economic and Consumer Policy hearing on Tuesday. “But we don’t know the cause. No single product, brand, substance or additive has been linked to all cases. Whether the products in one state are the same problematic products in another state or if it’s manipulation of the product is what’s going on, we don’t know. ... The epidemic is moving faster than our data-gathering processes and we are really losing people in the meantime.”

Symptoms are not universal

There was also little information about how patients with lung injuries related to e-cigarette use can be recognized and treated, according to Schuchat.

Although symptoms include cough, shortness of breath and chest pain, they can also include nausea, vomiting and fatigue. Additionally, the duration of symptoms can take several days to several weeks to appear, Schuchat said.

“The respiratory symptoms these patients have are very nonspecific and their X-ray findings are diverse,” she noted, adding that although steroids and corticosteroids have helped some patients, physicians may also need to individualize treatment for patients based on their symptoms.

Schuchat emphasized that patients should be followed after discharge, and that clinicians should conduct pulmonary function tests “to see if the lungs’ function return to expected levels of a healthy person before the injury occurred.”

Mistakes were made

According to the FDA’s website, a rule that went into effect Aug. 8, 2016, required all manufacturers of e-cigarettes to file premarket tobacco product applications with the FDA within 2 years. The applications are required to contain information about the product’s health risks, the product’s ingredients and how the it is made, among other items.

One lawmaker criticized the federal agencies’ shortsightedness in allowing e-cigarettes on the market without completing those applications.

“There was clearly a massive regulatory failure that allowed for this to happen," Rep. Joe Kennedy III, D-Mass., said during the House Committee on Energy and Commerce hearing on Wednesday. “Nobody thought that there would be the possibility of diversion or illicit use or that there could be adverse health impacts?”

Sharpless acknowledged that the government should have regulated the products sooner, but he also defended the agency, saying that “since I have been at the FDA, we have greatly accelerated the review date, we have done education campaigns, we will be issuing guidance ... we’re going to catch up.”

Rep. Paul Tonko, D-N.Y., also wanted to know why e-cigarette manufacturers were not required to file their premarket tobacco product applications.

“The data back then suggested that e-cigarette use was lowering or leveling off among children,” Sharpless responded. “That was before the explosion that we have seen the past 2 years. When the FDA began to appreciate that this rocket was taking off, we stepped up our enforcement and educational activity. In retrospect, we should have acted more urgently.”

The FDA said it has sent out more than 8,000 warning letters and levied more than 1,000 fines against manufacturers and retailers for marketing and sales practices that have increased the accessibility and appeal of e-cigarettes among youth.

Another lawmaker, Rep. Janice D. Schakowsky, D-Ill., said she didn’t “feel a sense of urgency” from the FDA and CDC to curb the use of e-cigarettes and the vaping illnesses.

“We have a strong sense of urgency,” Sharpless responded, adding that the FDA plans to remove all e-cigarettes products with flavors such as bubble gum and cotton candy from the market in the near future.

Recommendations for physicians, patients

As the CDC investigation into the lung injuries continues, Schuchat said physicians have a role in reducing the risk to children.

“We recommend that doctors ask their patients not only ‘do you smoke cigarettes?’ but also ‘do you use e-cigarettes or vaping products?’ We think it is important for clinicians and parents to educate themselves about the types of products that are out there and to ask the right questions,” she said.

According to the CDC, 12 deaths and 805 hospitalizations have been linked to e-cigarette use. However, Schuchat said during the hearings that the number of hospitalizations is expected to be “hundreds higher” as the CDC continues its investigation. by Janel Miller

Editor's Note: This story has been updated from an earlier version to reflect updated death and hospitalization numbers from the CDC.

    Perspective
    Michael Siegel

    Michael Siegel

    The CDC appears to be doing everything it can to undermine the connection between black market THC vape cartridges and the severe lung disease outbreak. They have yet to issue a clear warning to youth not to vape marijuana. Instead, they have merely told the public not to use e-cigarettes. More than 80%, and perhaps 90% of the observed cases for which information has been provided have reported using or have been found to have used THC vape cartridges. But the CDC refuses to release the percentage of cases in which THC use has been reported, and every time they mention THC, they immediately emphasize that no single product has been found to be associated with all the cases.

    In an outbreak investigation, one almost never finds a single exposure for all the cases. I believe that we know enough right now to issue a clear warning to youth that they need to refrain from vaping marijuana, period. The message to just stop vaping altogether is so vague that people are largely going to ignore it, especially young people.

    The results of a new poll by Morning Consult demonstrate that the CDC’s misinformation campaign is working. While 60% of respondents believe that Juul is responsible for the outbreak which is absurd since Juul has been around for several years without problems and is used by millions of adults, yet we aren’t seeing many adult cases only one-third

    are aware that THC cartridges are linked to many of the cases. Even worse, one-third of the respondents do not believe that THC vaping has anything to do with the outbreak. This is a demonstration that the CDC has created a widespread misunderstanding and confusion about this outbreak. Unfortunately, this is going to lead to more cases and more deaths that could have been avoided if the CDC had simply been honest in its communications.

    We know from the poll that more than twice as many people think the outbreak is due to vaping e-cigarettes like Juul compared to vaping marijuana. And in fact, the same survey showed that people are no more likely to think that vaping marijuana is associated with the outbreak than to think that vaping marijuana is not associated with the outbreak. So the communication is already a failure, and huge damage has already been done. I fear that because of the misinformation, there are a lot of youth who might otherwise have been dissuaded from continuing to vape THC cartridges who will continue to do so, and as a result, develop severe respiratory diseases.

    This confusion is also leading to bad public policy. Instead of intervening to try to stem the distribution of illegal, black market THC vape cartridges that are filled with oil, policymakers are banning flavored e-cigarettes, which so far as we know, are not clearly associated with the outbreak. Banning these products is going to cause many ex-smokers to return to smoking, and it is also going to create a new black market for flavored e-liquids. Worst of all, it will lead many youths to switch from vaping flavored e-liquids to vaping marijuana, making the outbreak much worse than it already is.

    The most absurd part of the story is that policymakers are actually talking about banning e-cigarettes but leaving the real ones on the shelves. One of the major arguments of supporters of these bans is that youth e-cigarette use is a gateway to smoking. If that is true, then the last thing we should be doing is getting rid of the vapes and keeping cigarettes on the shelves.

    The CDC will not change its misinformation campaign until the evidence becomes so overwhelming that it can no longer hide the facts. It is going to hold on as long as possible in a misguided attempt to cast the blame on all e-cigarettes. It will capitalize on this opportunity to demonize e-cigarettes and say “we told you so” as long as it can. Unfortunately, the damage is already done.

    Reference: Morning Consult. https://morningconsult.com/2019/09/19/as-vaping-related-lung-illnesses-worsen-public-holds-e-cigarettes-like-juul-culpable/. Accessed Sept. 25, 2019.

    • Michael Siegel, MD, MPH
    • Professor, department of community health sciences
      Boston University School of Public Health

    Disclosures: Siegel reports no relevant financial disclosures.

    Perspective
    Harold J. Farber

    Harold J. Farber

    If I could testify at hearing, I would say that we need to take effective action to protect kids from nicotine and tobacco, and I would note that the following evidence-based actions that have been endorsed by the AAP and should be taken:

    • Flavoring agents, including menthol, should be prohibited in all tobacco and nicotine products. The minimum age to purchase tobacco and nicotine products should be increased to 21 years, and the age restrictions strictly enforced. As it is difficult to enforce age restrictions on internet sales, the internet sale of e-cigarettes and e-cigarette solutions should be banned. 
    • The promotion and sale of electronic nicotine delivery systems to youth should be prohibited, including all media that can be viewed by youth, including broadcast, print and electronic (web- or internet-based) media.  In this day and age, these prohibitions need to include paid or otherwise incentivized “influencers.”
    • Point-of-sale tobacco product advertising and product placement that can be viewed by children should be prohibited.
    • Tobacco and nicotine control programs should be adequately funded and the image of tobacco should be changed to the truth of addiction, disease and premature death in place of the lies of glamour, sexiness, attractiveness, independence and excitement.
    • The FDA should stop deferring action and require the pre-market review of all tobacco products introduced to the market after February 2007, which includes Juul and almost all other e-cigarette products. According to The Family Smoking Prevention and Tobacco Control Act of 2009, new product applications can be denied if “there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”  The impact on public health shall be determined with respect to the risks and benefits to the population as a whole. If this standard were honestly applied, flavored e-cigarettes and Juul would be taken off the market because of how it is addicting our youth. Juul uses a patented nicotine salt (nicotine benzoate) that appears to be even more addictive than the already highly addictive freebase nicotine that the other e-cigarette products use.

    After the hearings are over, I hope to see effective action taken to protect our young people from the e-cigarette epidemic that has already claimed more than one out of every four high school students. As an eternal optimist, I am hoping that there will be bipartisan support in Congress to put the health of our young people ahead of tobacco and e-cigarette industry profits. Our next generations deserve no less.

    Reference: The Family Smoking Prevention and Tobacco Control Act of 2009. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/section-910-federal-food-drug-and-cosmetic-act-application-review-certain-tobacco-products. Accessed Sept. 26, 2019.

    Editor's Note: The CDC did not immediately respond to Healio Primary Care’s request for comment.

    • Harold J. Farber, MD, MSPH
    • Associate professor of pediatrics Texas Children’s Hospital

    Disclosures: Farber reports no relevant financial disclosures.