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November 5, 2018

Gottlieb: Do Teen Vapers Need Big Pharma Intervention?

The public meeting referred to in the article has been postponed until Jan. 18 at 9:00 a.m. EST. The links in the article still work to register for the streamed broadcast.

The FDA is so concerned about the teen “vaping epidemic” that it may ask pharmaceutical companies to get involved.

The federal agency that is known for its close relationship with the pharma industry is holding a public meeting on Dec. 5 to discuss drug interventions for teen nicotine “addiction.” The meeting is at the FDA White Oak campus in Silver Spring, MD. You can register to attend in person or to watch the event streamed live online. The webcast will also be archived on the FDA’s website after the event.

The FDA will also open a docket for public comment on several questions the FDA wants to explore. Anyone can respond to those questions at the Regulations.gov site. The docket number is FDA-2018-N-3952. You can also mail comments, according to the instructions in the federal register. [Note: the docket was not live yet as of Sunday afternoon.]

The Dec. 5 meeting will focus on “the potential role of drug therapies to support cessation among youth, and the issues impacting the development of such therapies for children,” FDA Commissioner Scott Gottlieb said in a statement Friday.

“This hearing will also give us an opportunity to discuss the need for drug therapies to support youth cessation of other tobacco products, including combustible products, such as cigarettes or cigars, or smokeless tobacco products,” said Gottlieb. “All of these tobacco products pose serious dangers to teens’ and adolescents’ health.”

Combustible products do pose a threat to the health of all users, but e-cigarettes pose no proven health risks. The biggest risk is that vaping teens will switch to smoking, and that doesn’t seem to be happening. While research does show that the same teen “risk-takers” are likely to try either nicotine product (or both), there is no evidence that e-cigarettes are driving a measurable shift to smoking.

For teenagers, experimenting with cigarettes can lead some to lifelong use, and half of those long-term smokers will die prematurely. Yet the FDA has never issued a call to action for the pharma industry to develop novel quit-smoking medications for youth. Why? Even now, more teenagers are daily smokers than daily vapers. Sure, the FDA’s request for comments mentions that opinions on pharma interventions for teen smokers are also welcome, but that is clearly an afterthought.

The FDA and anti-smoking groups were never much concerned about nicotine’s supposed effects on teenage brain development until the nicotine that kids used came from e-cigarettes. Go ahead and search for any mention of that supposed concern in pre-vaping era publications about youth smoking. It doesn’t exist — even though the rodent studies that supposedly prove the nicotine/brain development connection had been around for years.

In fact, concern over youth nicotine use in general is almost entirely a vaping-driven fear. Before vapor products came along, the FDA, Truth Initiative, Campaign for Tobacco-Free Kids, et al, confined their fears to the proven deadly effects of smoking, like heart disease and cancer. But with vaping — since there are no proven health risks to focus on — the primary talking point became “highly addictive” nicotine and its “potential” to damage adolescent brain development.

And make no mistake, potential is all that the science shows. The only proof that human teenagers’ brains are affected by nicotine use are studies on “adolescent” rats. (Fun fact: there are equally persuasive studies that show caffeine affecting adolescent brain development.)

There has been no long-term research on how the effects of teenage nicotine use — if there are any effects — impact human beings over time. Yet that has become the number one argument for restricting or banning vapor products that have helped millions avoid the proven deadly consequences of smoking.

“We cannot risk a whole generation of kids getting addicted to nicotine,” said Gottlieb in his statement. “We must put strategies in place now to help those who are already addicted quit.”

What’s going on here?

The four pillars of the FDA’s comprehensive plan to address nicotine and tobacco were reducing nicotine levels in cigarettes; regulating e-cigarettes; reviewing the agency’s application process; and working to “have medicinal nicotine and other therapeutic products play a greater role in helping more smokers try to quit with help, to quit successfully, and to stay quit.”

And together they would be a “package deal,” said Gottlieb back in July of 2017 when he announced the plan. The largely forgotten component of Gottlieb’s plan is the initiative to encourage innovative pharmaceutical interventions for “nicotine addiction.” It may turn out to be as important as the others, or maybe even the most important.

“That’s why I’m also asking our Center for Drug Evaluation and Research to examine possible steps we can take to address the performance of medicinal nicotine products,” he said in that 2017 speech, “including the speed with which the nicotine is delivered, and other possible innovations in treatments that could help more smokers use FDA-approved products to quit smoking.”

Then came the JUUL “epidemic,” and everything changed. Or maybe nothing changed. You’re forgiven if you suspect that this was Gottlieb’s intention all along. The commissioner spent the decade before his appointment by President Trump working as a venture capitalist specializing in healthcare investments. He has, shall we say, pharma connections.

But he claims he never thought it would come to this. The very idea that the FDA would desperately seek pharma help for vaping teenagers…shocking!

“That the FDA finds that we need to hold such a hearing ‒ to discuss ways to use drug therapies to treat teen addiction to nicotine ‒ underscores the deeply troubling nature of the public health problem that we’re confronting,” said Commissioner Gottlieb in his statement Friday.

Sure, deeply troubling. But the moment the commissioner declared teen vaping to be an epidemic, didn’t he guarantee that pharmaceutical interventions were inevitable? If vaping is an epidemic, it must be a disease that needs to be cured. Approving products for curing diseases is the FDA’s job, and Gottlieb is committed to his role as FDA commissioner.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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