More Harm by Medical Harm Reduction: Fetal Nicotine Effects

by Clark Miller

June 12, 2019

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 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 this new report – pregnant women, trusting in authoritative assurances that vaping is a safe alternative to cigarette smoking – seem to be turning to use of e-cigarettes based on their concerns for the fetus during pregnancy, continuing use of nicotine by another means instead of stopping,  in the belief they are reducing risk. But with no diminished prenatal risk, due to the known effects of exposure in utero to effects of nicotine use by the mother.

From the Centers for Disease Control Morbidity and Mortality Weekly Report

Nearly half of women who used EVPs around the time of pregnancy (45.2%) reported using the products because they perceived EVPs to be less harmful to them than regular cigarettes or that EVPs would help them with quitting or reducing smoking. Notably, the proportion of these users was approximately twice that of those who had used EVPs >3 months before pregnancy (27.4%). This suggests that women are aware of the harms of smoking during pregnancy, and, perceiving EVPs to be a safer alternative during pregnancy, might be using EVPs to mitigate those harms. This finding was consistent with an Internet survey of perceptions and prevalence of e-cigarette use among 445 pregnant women: among 67 pregnant women who reported using cigarettes or e-cigarettes, 50 (74.6%) reported switching from cigarettes to e-cigarettes or beginning use of e-cigarettes upon learning they were pregnant (4). Among those who switched, 23 (46%) reported that they believed e-cigarettes were safer for them or their child than cigarettes, and nine (18%) reported switching to quit smoking cigarettes (4). A smaller clinical trial assessing smoking cessation among 103 pregnant smokers found that a similar proportion of women (14%) reported using e-cigarettes for smoking cessation during pregnancy (5).

vaping adult

In this report on the related research, the public health problem is attributed by Patricia Folan, director of the Center for Tobacco Control at Northwell Health in Great Neck, N.Y. to advertising, “The pervasive advertising of these vape products has caused many to perceive these devices as a ‘safe and effective’ means of quitting smoking”.

But it’s not just advertising, 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.

It may be that a populace struggling to understand how modern medicine and its representation in mass media function, must tolerate some ambiguity and fluidity in the meaning of and outcomes that can be expected when public healthcare funds are diverted to investment in a medical gold standard.

For example. Although the medical gold standard, not so long ago, for use of Schedule II opioids to treat all pain, including common (centralized) chronic pain, (against all relevant longstanding lines of evidence) did result in a predictable lethal public health epidemic that is worsening –

Overdose deaths US trend The Guardian

(from The Guardian – November 29, 2018)

STAT opioid deaths

–    there is a new medical gold standard as determined by medical, research, and pharmaceutical authorities and disseminated by a collaborative media and health institution education campaign: the use of substitute opioids (buprenorphine and methadone) disseminated by medical professionals and serving as “anti-addiction” medications and “treatment” for compulsive opioid use and the unfortunate opioid epidemic that, from all accounts, was caused by drug company executives and their sales representatives. No wonder provision of the addictive, diverted and abused substitute opioids has  become a new medical gold standard !

Except . . . it turns out that the “evidence” for effectiveness of the gold standard medical harm reduction and anti-addiction treatment never existed, instead was fabricated out of results that never supported the confident, authoritative conclusions of benefit at all, due to obviously confounding factors that invalidate those constructed claims. And that consistently, all relevant lines of accumulating evidence contradict and invalidate the claims of benefit.

SAMSHA bupe client trends2

The more medical gold standard  fix provided to diseased brains, the more deaths mount.

Overdose deaths US trend The Guardian

(from The Guardian – November 29, 2018)

Science is hard!

And who would pretend to understand the complex research findings and studies that are better left to our top, trusted medical authorities, institutions, and expert media reporters to critically analyze and use to inform the public about medical issues and the effective treatments – the medical  gold standards a vulnerable and trusting public relies on to protect health and life?

We must all  maintain respect for and trust in those qualified authorities to increase efforts to help a public beset by lethal epidemics understand the nature of medical gold standards and how they work to protect lives and the public well-being.

Without those reassuring messages carefully constructed for a public at risk and made ill, there may exist the risk, I fear, of emergence of much more dangerous, cynical, uncontrolled ideas about the meaning and expected outcomes of medical gold standards:

 

That they function to divert public healthcare resources away from evidence-based approaches for the non-medical problems driving lethal epidemics, to maintain their continued use for invalidated, sham medical “treatments” that predict harm

That they represent harm-predicting levels of incompetence and reckless disregard for public safety that run through America’s most trusted institutions

That they reveal failure and craven abdication of watchdog and public protector roles by the institution entrusted to critically evaluate, probe, expose, and decry betrayal of the public interest and well-being by any institution – the watchdog press essential to the functioning of a healthy democracy

That the branding and advertising of a medical “gold standard” represents the work of vested interests with the cultural capital to create “knowledge” and “truth” as whatever is needed to protect status, power, and continued control of cultural capital

That fundamentally the construction and use of fabricated medical “gold standards” represents individual and institutional pathology – pathological levels of diminished capacity for critical thought, for intellectual integrity and courage, for research literacy and intelligence, for ethical reasoning and behavior

 

Those are disturbing ideas posing risk of radical disruption and change.