As heard on All Things Considered –
“When President Obama signed the Family Smoking Prevention and Tobacco Control Act in 2009, it gave government regulators an important new weapon in its battle against Big Tobacco.
For the first time, the Food and Drug Administration had the power to regulate the manufacturing, distribution and marketing of tobacco products, including the new and then-largely unknown practice of vaping.
Ten years later, e-cigarettes have become dramatically more popular, yet government officials have still not begun regulating the hundreds of vaping products now on the market.”
“What’s taken regulators so long?”
pondered NPR’s Jim Zaorroli in the report.
They may have been slowed, it seems, in any public health efforts to regulate a new, effective nicotine delivery device, by their focus on developing a plan to promote use of vaping as the next best form of medical model “harm reduction”.
Late in 2017 the nation’s top medical journal – Journal of the American Medical Association, JAMA – featured endorsement of an “innovative” plan by the U.S. Food and Drug Administration (FDA) for use of electronic cigarettes, “vaping”, to substitute for that of tobacco cigarettes as a form of medical harm reduction. The message was clear and came from one of the America’s most trusted and authoritative medical institutions: vaping is a much safer alternative to smoking. That message targeted, through mass media dissemination, a vulnerable and trusting public trapped in arguably this culture’s most costly and lethal compulsive substance use problem, the annual half-million deaths due to tobacco use eclipsing those related to alcohol, opioids, and other street drugs combined.
The message would also have been taken as authoritative by America’s medical professionals, who encounter smokers routinely in primary care and other settings and advise them on interventions to help stop smoking. Institutions including top medical journals, medical regulatory agencies, and media have powerful influence on American medical practice, their cultural fabrication of a new medical gold standard for treatment of chronic pain, for example, substituted for clinical and ethical judgment and responsibility and resulted in runaway, medically inappropriate dispensing of Schedule II opioids for the established non-medical condition of common chronic pain generating a lethal public opioid crisis. But that’s another story.
That JAMA-endorsed FDA promotion of use by Americans of vape nicotine delivery devices as medical harm reduction flipped within months, predictably, to a child nicotine abuse and dependence problem, now widely recognized as another public health epidemic.
The public disinformation campaign worked, providing for booming sales and use of vape products. Worked, that is, apart from the worsening child nicotine dependence epidemic.
And apart from the emerging adult vaping illness epidemic.
But it’s not just advertising at work, when e-cigarette use is endorsed as an innovative harm reduction approach in the nation’s leading medical journal, and the same journal endorses a research report – disseminated to American medical practitioners – with claims that vaping is an effective method for stopping cigarette use, repeated in authoritative media outlets.
As reported in JAMA and published in another leading medical research journal, the New England Journal of Medicine (NEJM) the landmark study, a “seminal study” according to medical authorities, establishes that vaping of nicotine is effective for stopping use of tobacco by smoking, affirming vaping as a new medical gold standard for smoking cessation. It’s even more effective than nicotine replacement treatment (NRT), based on critical evaluation of the research study by medical professionals, leading authorities, and major mass media. (Coincidentally, NEJM is the top medical research journal that published another seminal study not long ago – the study establishing that Schedule II opioids were safe and effective to use for all pain, including chronic pain.)
It’s just that – the study in question establishing vaping as a new medical gold standard actually provides no evidence at all of benefit for smoking cessation from either NRT or e-cigarette use, instead points to no benefit. And it turns out that the demonstrably false, unvalidated claims of benefit (of about 10 percent and 20 percent cessation success rates for NRT and vaping, respectively), were based on errors in experimental design and interpretation of the most elementary and demonstrable types.
And now – to add to opioid, alcohol, and other substance use epidemics – a youth vaping epidemic with poor prognosis.
And increasing reports of risk of adult illness and death related to vaping, with no evidence of benefit for cigarette use cessation.
And vaping linked to increased risk and worsening of the current viral pandemic.
As weak and revisionist as the NPR reporting is, it cannot rival the shamelessness of the dog-and-pony-show distraction offered by STAT in which OMG!, we at the FDA were engaged in heroic measures to protect the public based on our estimates of potential for harm, boldly going so far as to seek public comment “about the “availability of flavored e-cigarette liquids” and “the possibility that these flavors could appeal to youth.”
Alas, as decried in the STAT piece by former principal deputy commissioner of the FDA Joshua M. Sharfstein, M.D., professor of the practice in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health –
But enormous damage to public health has already been done. By 2018, 3.6 million kids were vaping, representing a 78% increase in just one year, with more than two-thirds choosing flavored products. In 2019, the FDA found that “more than 5 million youth … used e-cigarettes in the past 30 days and nearly one million reporting daily use.” The agency determined “that while cigarette smoking is at an all-time low among high school students, increases in e-cigarette use have reversed progress made in the decline of overall youth tobacco use.”
Wait . . . in late 2017 the FDA is high-fived in JAMA for its development and proposal of a researched plan for promotion of vaping as an “innovative plan” to reduce public harm and the FDA is shocked – shocked! – in 2018 to be faced with a new public health crisis?
The emerging youth and adult vaping crisis was EMBARASSING for regulators –
Vaping injuries became front-page news, with the imminent risk of injury sharing space with a new appreciation for the explosion of its use among youths. Seizing the moment of crisis, several state health officials took action, with some banning flavors in e-cigarettes and others temporarily banning their sale altogether. A major part of the news, however, became how the FDA had failed.
An Oct. 14 New York Times headline read “E-Cigarettes Went Unchecked in 10 Years of FDA Inaction.” While the headline was later changed to the more accurate phrase “Federal Inaction,” it’s not hard to see why the first draft said “FDA.”
For several years, many advocates had trained their criticism on the FDA for not doing more about electronic cigarettes. A few months earlier, the American Lung Association had given the agency an F for “lack of action” on vaping, even though the lung association knew, or should have known, that there was a lot more to the story.
During the previous decade, the FDA had tried to protect the public, and especially youths, from the potential harms of e-cigarettes. Yet the agency had been stopped by the courts, impeded by the White House, and repeatedly warned to back off by members of Congress. The fundamental problem was not that the FDA had been sitting on its hands. The problem was that its hands were tied.
Maybe the left hand. The right hand was encouraging Americans to vape, and doctors to encourage their patients to vape, in the nation’s top medical journal.
The STAT piece begins with a question posed by students who will become the next generation’s public health leaders –
My public health students often ask an obvious question: Why is it so challenging for regulatory agencies to prevent calamities in the first place?
Identification of the real issues comes from reframing that question:
Why is it so challenging for American medical, media, regulatory, and public health institutions and practitioners to behave in ways that are not compromised, grossly incompetent and malfeasant?
In the context of:
Never evidence and evidence fabricated, on any critical examination, of benefit from use of e-cigs.
Predictable explosion of compulsive use of a highly addictive substance by psychologically vulnerable teens and adolescents, promoted to and targeting them with appealing branding by industries profiting from that use.
Unquestioning compliance and cooperation of American medical practioners armed with unexamined, falsified “research evidence” of benefit and safety.
Just as in the collusion of medical, media, research, and regulatory institutions to fabricate “evidence” that would fuel creation of the opioid crisis with the uncritical compliance of health care professionals.
“Why does it always seem to take a crisis? The beginning of wisdom is to look beyond the regulatory agency alone for the answer.”