1.3 million reasons why vaping blunder should imperil FDA chief’s job

juulcig-300x159When the reviews of 2018 get written, here’s hoping that health experts castigate the federal Food and Drug Administration and Scott Gottlieb, its chief, for a major blunder that continues to harm the well-being of the nation’s teenagers and young adults.

That’s because Gottlieb and his agency held a regulatory door wide open as the maker of the e-cigarette device Juul stormed through, campaigning to hook teen-agers and collegians on vaping. That’s the practice of using e-cigarettes to catalyze commercially prepared solutions to get a high, typically from nicotine, a powerfully addictive substance that carries a range of risks, especially for the young.

Big Tobacco loves Juul so much that, as a holiday gift, Altria, a major player in the industry, has cut a $12.8 billion deal with the e-cigarette maker that includes a $2 billion bonus to be split by the company’s 1,500 employees.

The small Juul device, which looks a little like a computer flash drive, became a rage among the nation’s youth, as did vaping. Researchers ended the year by reporting that more than 1.3 million high schoolers began using e-cigarettes in the last year, getting a wallop of addictive nicotine that can be the equivalent to smoking a pack of cigarettes. The vaping-nicotine increase was “the largest annual jump in the use of any substance, including marijuana,” seen in the 44 years that experts at the University of Michigan have monitored how kids use and abuse substances, including alcohol and drugs.

The UM data, combined with other information from the federal Centers for Disease Control and Prevention, and news reports about vaping’s soaring reach and influence among the young led to a stark announcement by U.S. Surgeon General Jerome Adams. “I am officially declaring e-cigarette use among youth an epidemic in the United States,” he said at a news conference. “Now is the time to take action. We need to protect our young people from all tobacco products, including e-cigarettes.”

Adams pledged the resources of his staff to campaign against e-cigarettes, especially Juul, and vaping.

The action follows a dithering response by Gottlieb and the FDA. The agency stalled a planned crackdown on vaping devices and their liquid products, regulatory enforcement muscled through by the Obama Administration. Instead, Gottlieb said more study was needed to see if the benefit that e-cigarettes may have in helping adults get unhooked from tobacco cigarettes outweighed risks to youngsters with the devices’ use.

That delay, however, allowed Juul — with powerful social media and youth “influencer” campaigns — to become a smash hit among the young. The company dominates the market and has seen its value soar into the billions. Juul also is now making even more worrisome alliances as it seeks to grow in the face of intense regulatory scrutiny.

The FDA gaffe looks worse by the minute and requires careful watching in 2019, as Big Tobacco maneuvers to buy its way into Juul and to expand its tentacles in the e-cigarette trade. This is occurring even as those same companies are hunting for opportunities in the merchandising of increasingly legal marijuana. Although it is beyond passé to automatically see marijuana as a gateway to abuse of harder and dangerous drugs, with the nation already in the throes of an opioid crisis the prospect of wider dope use by kids is not good.

Further, addiction experts and parents and teachers already are expressing alarm about vaping and nicotine abuse. Nicotine is highly addictive and carries its own health harms, especially for the developing brains of the young. As Juul and other e-cigarette makers have conjured a fantasy of how cool and alluring vaping can be, youthful users have responded with abandon. And experts say they’re uncertain how to reverse the nicotine addictions they’re seeing in heavy vapers.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the wreckage that’s inflicted on their lives by smoking. It is the leading cause of preventable death, inflicting an array of diseases on 16 million Americans who live with smoking-related illnesses. These include lung and other cancers, as well as heart and respiratory diseases.

If Gottlieb, as he has written, was so convinced that smoking is terrible, and that addictive nicotine plays a critical role in its harms, why did he risk the health, now and in the future, of millions of young people? Researchers already had started to build evidence that not only do e-cigarettes deliver big doses of nicotine, but they also serve as a gateway to use by youths of regular cigarettes with heightened cancer and other disease risks attributable to burning tobacco. What sense, even giving regulators the benefit of the doubt, did it to make to wager the fate of the young on harm-reductions among adults? What sane public officials calculates risks like these?

Gottlieb has been a well-received FDA chief, because he has been outspoken about sensible policies at his agency. But the pro-industry bend of this commissioner — also in pushing notions like faster and less rigorous approval for prescription drugs and medical devices — belie his expressed wish to protect the taxpaying public to the max.

President Trump, who never made excellence, experience, or deep integrity a virtue for appointment to the highest offices in his administration, seems to be shedding at year’s end many of his top officials. Competence may not matter as much as it ought to the president. But it should to parents, grandparents, uncles, aunts, teachers, and a ton of grown-ups who have watched with growing horror the e-cigarette and vaping phenomena. Their rapid and unchecked rise alone may be more than enough cause for a lot of FDA staff, including the commissioner, to be gone — and none too soon.

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