What’s the health care system to do when thousands of individuals, many of them between the ages of 18 and 34, arrive at hospitals across the country with serious, previously unknown breathing problems that may be related to their use of e-cigarettes and vapes? Maybe take a lesson from Hippocrates: First, do no harm.
Reports of this lung problem, now being called e-cigarette or vaping product use associated lung injury (EVALI), began emerging in June 2019. The Centers for Disease Control and Prevention says that more than 2,600 cases have been reported from every state except Alaska, the District of Columbia, and one U.S. territory; dozens of deaths have been confirmed. The supposed culprits in these illnesses range from vaping THC to using modified equipment, inhaling black-market liquids and, most recently, vitamin E acetate, a chemical used as an additive or thickening agent in some vaping products.
The knee-jerk reaction by some states has been to pull e-cigarettes and vapes off the market. Even the federal government has suggested it might push for a ban on some vaping and e-cigarette related products. But these products have been shown to be effective at helping smokers quit — more effective, in fact, than any other nicotine-replacement therapy on the market, including nicotine patches and nicotine gum.
We don’t need to ban vaping. What we need to do is the research needed to build a better vape.
Taking the wrong action — meaning action not backed by scientific evidence — could do more harm than good. For instance, bringing down the regulatory hammer before we understand EVALI could lead those who use e-cigarettes or vapes as replacements for cigarettes to return to smoking or purchase black-market vaping liquids, which may make the problem worse.
By building a better vape that can be used as an effective cigarette replacement without getting people sick, we can ensure that these nicotine therapies continue to help people quit smoking traditional cigarettes — which we know causes cancer and other diseases — without creating a new public health crisis. But doing this will require a combination of research, innovation, and regulatory oversight.
To a certain extent, the research has already begun. The Food and Drug Administration and the CDC are now collecting samples of e-liquids connected to EVALI cases in hopes of determining if there are any toxic ingredients these samples have in common. But often there’s barely enough liquid left in the cartridges in question to test, leaving researchers unable to determine what the toxic ingredient could be, let alone draw connections between ingredients from liquid to liquid.
I believe that the biggest hurdle lies in how the scientific community predicts what is actually toxic to humans. For instance, many ingredients in e-liquids, such as vitamin E acetate, flavorings, propylene glycol, and glycerin, are seen as safe for humans to ingest or put on their skin, but we don’t know the risks of inhaling large amounts of them over time. Much of the current research is done in animal models, which are slow, expensive, and don’t necessarily predict toxicity in humans.
To learn whether these ingredients are contributing to the EVALI problem, the FDA will need to test them specifically in human lung tissue. But studying just cells from human lungs — or in the case of the CDC’s most recent findings, in samples of lung fluid — doesn’t provide accurate data, as it doesn’t include mucus or the lung conditions that can affect the absorption of inhaled drugs.
As a biomedical engineer who works on formulating inhaled drug therapies for lung diseases, I spend a lot of time thinking about how to build accurate models of the human lung and what features to include: mucus, types of cells, fluid, blood circulation, and the like. To study if my treatments actually work, I need both an accurate model of the lung disease I am trying to treat and the accurate dose of inhaled therapy that would be administered to someone. Without measures of these two things, a study won’t hold up in the lab.
When it comes to EVALI, we don’t have either one.
If e-cigarette companies want to stay in business, they need to invest in the research needed to make safer products. It’s possible that a single ingredient or component could be replaced to make vaping safer. It could be that vape pens themselves give off toxic fumes when heated and reheated at high temperatures. Or it could be something else. But we won’t truly know until vape manufacturers are willing — or forced by the government — to invest in the research.
We have an opportunity here to avoid making the same mistakes with vaping as we did with cigarettes. By waiting too long to invest in research into cigarette toxicity, we caused a global lung cancer epidemic, the effects of which are still being felt today.
Regulatory and scientific processes are underway to ensure that the health risks of vaping are known earlier. Banning e-cigarettes and vaping devices may halt some illnesses related to their use, but it won’t further our understanding of the cause of these illnesses. In fact, there are other products, like inhaled insulin, that also cause mysterious lung injuries. What we need is to invest in research that gives us a clearer picture of exactly what’s going on in the lungs when we inhale any type of drug or additive.
By doing that we can increase the overall safety of inhaled medicine, which includes building a better vape: one that can help cigarette smokers quit without risking the dangers of EVALI.
Diane Nelson, Ph.D., is a postdoctoral fellow in Carnegie Mellon University’s chemical engineering department studying the effects of drugs and toxins on the pulmonary system with funding from the Burroughs Wellcome Fund. She was named a 2018 STAT Wunderkind in recognition of her research.