Afraid of ghosts

AFRAID OF GHOSTS

Common sense doesn’t seem to be on the agenda when it comes to the U.S. regulatory response to recent THC-related vaping illnesses.

By George Gay

By the end of the U.S.-held Global Tobacco & Nicotine Forum (GTNF) in September, I was in a state of confusion, though to be fair and to put that into context, I should point out that a state of confusion is my spiritual home. One of the messages that came across loud and clear at the forum—and that I have no reason to doubt—was that a huge amount of great science has been carried out into vaping and vapor devices.

In the case of the U.S. Food and Drug Administration (FDA) and its contractors, such research presumably dates back to at least August 2016 when vapor devices were “deemed” by the FDA to be tobacco products and part of its remit while in the case of the vapor industry, it dates back considerably further. So far, so good.

But the other dominant message to emerge was that the vaping environment in the U.S. was in utter chaos. Now, unless you’re the sort of person who believes that great science causes utter chaos—an idea that is not as outrageous as it might seem—it is rather difficult to square these two messages.

The more I thought about this while dozing my way back to the U.K., the more I wondered whether the chaos might be caused not by the great science but by a surfeit of great science. I know, I know—the forum was told that you can never have too much data, too much science, but taken to its logical conclusion, such an idea is patently silly unless you have an unending supply of scientists to interpret that data and an endless amount of time in which to interpret it, which is not the case here.

Let me describe how science can be overcooked using a modified joke from a book by Thomas Cathcart and Daniel Klein titled Plato and a Platypus. A couple who both lecture at the same university are driving home together through the countryside when the woman, who is employed by the philosophy department, says, “I see they’ve shorn the sheep” to which her husband, a scientist, replies, “On this side.” When I imagine this scene, I see the FDA as the scientist stopping the car, getting out, donning rain boots and trudging across the field to look at the other side of the sheep, indifferent to the fact that they are meanwhile dying of exposure.

While common sense can lead you astray at times, it can be useful, and it was worrying to see that it had been almost expunged from the thinking processes of those who are in the driving seat of vapor policy. The FDA has been rightly praised for attending forums such as the GTNF, but there has to be more to such interaction than mellifluous words about the future.

In his poem, “Autumn Journal,” which was written between August and December 1938, Louis MacNeice described international negotiators as “Eating dinner in the name of peace and progress.” MacNeice knew that such dinner meetings were going to deliver not peace and progress but simply form an agreeable-for-the-diners prologue to death and destruction. The words need to be put into positive action that transcends mastication.

What is it in the makeup of humans that allows us to identify the road that needs to be taken but not to take it? Much of the talk at the GTNF was about peace and progress but not peace and progress now—later, seemingly after the death and destruction has been allowed to run its course. But we can have it now. We can cut down our scientific workload by relying on our experience. As Cathcart and Klein pointed out, we don’t need to inspect the other side of the sheep. Farmers don’t shear sheep on one side only, and even if they did, not all of the sheep could be made to stand with their shorn side to the road. It’s common sense—in fact, it’s science.

OK, to be fair, the current situation is not entirely the fault of the FDA but of the law that dumped tobacco into its lap. And there was qualified support for the FDA from some forum participants who argued that it was necessary to work with the FDA since it was the only game in town. According to my observations, there was a continuum of FDA policy acceptance with the major manufacturers with the most U.S. exposure at the high acceptance end and smaller manufacturers with exclusive U.S. exposure at the other.

This is not news, and it shouldn’t be surprising because the major companies that manufacture both tobacco and nicotine products can afford to work with the FDA both financially and time-wise given that, in large part, what they lose on the nicotine swings they gain back on the tobacco roundabouts, which is not the case with smaller nicotine-only players.

In fact, the forum exuded what I perceived as a higher than usual undercurrent of industry division with allegations that the major manufacturers were reasonably happy with the current situation because the direction of travel was such that small manufacturers were likely to be overtaken and ground underfoot by the FDA’s complex, expensive and late-to-market (it still wasn’t finalized at the time of this article’s writing) premarket tobacco product application (PMTA) process. Indeed, a representative of one major manufacturer said that he understood why these allegations arose in the U.S. and suggested that the system could well end in wiping out smaller players.

Although the GTNF is an international forum, the focus this year was very much on the U.S., in no small part because it was held (Sept. 24–26) in Washington, D.C., but also because three major threats were converging on the local vapor industry: the long-running issues raised by the use of flavors in e-liquids, the uptake of vaping among young people and the then-recent issue of pulmonary illness that had occurred among a relatively small number of vapers.

Those opposed to vaping were trying to connect these issues in various ways with dubious to ludicrously low levels of justification, often using the sort of extreme language worked up during the early days of Juul so that we now have an “epidemic” or “explosion” of vaping among young people and a “plague” of pulmonary illness.

And the FDA, feeding on a panic that it started and that has now been supported by the Trump administration, is planning, in effect, to ban the use of most flavors in vapor devices. In fact, the FDA would protest that it is not planning such a ban, but it is in all but name. The FDA’s acting commissioner, Norman E. “Ned” Sharpless, told a U.S. House Energy and Commerce subcommittee in September that based on the fact that “youth” e-cigarette users had cited fruit and menthol/mint flavors as being the most popular, it intended “to enforce existing law that limits the marketing of such products. [The] FDA intends to prioritize enforcement action such that flavored e-cigarette products will be expected to exit the market unless and until manufacturers of these products provide scientific evidence demonstrating that marketing their products is appropriate for the protection of the public health,” he said.

What Sharpless didn’t say was that the scientific evidence required is beyond the scope of most manufacturers and that the timeline for supplying such evidence is derisory. One forum participant brought up an important but mostly overlooked aspect of the U.S.’ long-running young people vaping saga by pointing out how official press notes often lacked age definitions when talking about young people. “Kids,” she said, could sometimes encompass people who were one day short of their 21st birthdays.

Indeed, official press notes often conflate “kids” with “youth,” it is not unusual to see “teens” used to refer to people not all of whom are teenagers, and “children,” though thankfully not yet “babies,” like “kids” can seemingly be used to take in what most people would call young adults.

Meanwhile, another young people issue derives from the oft-stated—at the forum and elsewhere—idea that, put in various ways, everybody agrees that young people should not vape. We shall never lift the confusion if we insist on making claims that are comforting but wrong.

If everybody agreed that young people should not vape, they would not vape because even the young people concerned would be in agreement. Since vaping began, there have been people who have been making money out of getting vapor devices into the hands of young people and others who have been indifferent to whether this trade happens or not.

With the pulmonary illness issue, however, we have entered new territory. At the time of the forum, hundreds of people had taken ill and 12 had died as a result of this illness. Information was sketchy at that time, and I’m not even sure that it is right to refer to a single illness or whether what was on display was a number of similar illnesses, but it seemed that one factor linking those who had fallen ill was vaping.

At this point, the moral panic that was worked up by the FDA in its contacts with the media over Juul was re-engaged and, it would seem, moved up into passing gear by the U.S. Centers for Disease Control and Prevention (CDC). The first victim of this panic was great science, which was quickly abandoned and replaced by the sort of conjecture that should have been quickly dismissed by everybody who didn’t also believe in ghosts.

But this should not be allowed to underestimate the damage caused by such conjecture. As the freethinker Madame du Deffand apparently once said when asked whether she believed in ghosts, “No, but I’m afraid of them.”

Despite the fact that huge numbers of people in the U.S. and elsewhere have been vaping with nicotine for more than a decade with, as far as I am aware, few serious ill effects outside those caused by exploding batteries, the CDC apparently came to the conclusion that this outbreak of acute illness that had occurred only in the U.S. and Canada (one case) could be due to vaping with nicotine alone.

The first item on its list of advice concerning the illness was that people should “consider refraining from using e-cigarette or vaping products, particularly those containing THC [tetrahydrocannabinol]. If you are an adult who used e-cigarettes containing nicotine to quit cigarette smoking, do not return to smoking cigarettes,” was the second bit of advice.

This advice was based on legitimate concerns, but, in my view, it went too far in including nicotine-containing devices that have helped millions of smokers quit combustible cigarettes, which, we are told, cause more than 400,000 deaths in the U.S. annually. And neither was the advice justified by adding that former smokers should not return to smoking cigarettes.

I’m certain that the CDC believes that nicotine is addictive, so how does it expect vapers to give up their vapor devices without going back to cigarettes or at least some tobacco product? Perhaps it would point to nicotine replacement products as the way out, but only if it inhabits a parallel universe.

At the time of this article’s writing, the CDC was saying that about 77 percent of people who had contracted the illness had reported using products containing THC and that about 36 percent had reported exclusive use of THC-containing products. About 57 percent had reported using nicotine-containing products and about 16 percent had reported exclusive use of nicotine-containing products.

Now given that these figures are based largely on self-reporting by people who are seriously ill and, in some cases, perhaps not wanting to divulge what they bought and consumed, common sense has to suggest that the problem would seem to lie with the THC-containing products.

But unfortunately, the CDC’s approach is to stop the car, get out, put on the rain boots and go trudging across the field to check the sheep’s underbellies. OK, few people would probably mind that this is how it chooses to spend its time but for the fact that in the meantime, it has stopped and perhaps reversed the clock ticking away the switch from smoking to vaping with nicotine.