How a flawed UK study is being used to advance a dangerous misunderstanding

Given the current state of ENDS (Electronic Nicotine Delivery Systems) and lack of a clear truth surrounding the issues, the public may need a reminder in how scientific data can be manipulated to force a particular outcome, especially if that outcome drives a harmful agenda.

In an attempt to ensure that ENDS manufacturers maintain profits from their products, a well-publicized claim has been circulated. This claim cites a heavily flawed UK public health study maintaining that ENDS, without exclusion, are 95% safer than combustible products. The problem? It’s simply not true. Unfortunately, the study’s claim is being unabashedly disseminated as gospel even though the facts contained within the study itself, are far from being scientifically objective or even conclusive.

We are now seeing certain ENDS stakeholders utilizing this study as a wedge to discredit the concerns raised by the U.S. FDA, the CDC, physicians and scientists alike. In fact, on February 5th, 2020, Juul’s new CEO, K.C. Crosthwait, submitted written testimony to the House’s Subcommittee on Oversight & Investigations Hearing, citing this very study in support of ENDS.

Furthermore, in a bizarre turn of events, the UK’s PHE (Public Health England) has been heralded as a progressive bastion on this matter whereas the FDA has been painted as an entity beholden to the interests of competing stakeholders. In reality, it was the PHE that was compromised and even admitted to strong conflicts of interest and a lack of hard evidence supporting the conclusion in this controversial study.

Q: So, what exactly is wrong with this study and why can’t this “95% safer than combustion” claim be taken seriously?

A: The Study Contained no Hard Evidence 

The study authors themselves state: “A limitation of this study is the lack of hard evidence” and “Even if data were available for all the harms of all the products on all the criteria, judgments would still be required to assess swing-weights … criterion can be informed by data, how much that worst-best difference matters, requires an act of judgment.”(1)

So, to be clear, the authors acknowledge “a lack of hard evidence” in support of their own conclusion.

A: Conflicts of Interest Abound

One of the authors and one of the study’s sponsors have financial ties to PMI (Phillip Morris International)(2,3). In addition to the original report’s disclosures that listed the potential conflicts of interest, the study’s 12-member committee also had a member with ties to an ENDS manufacturer associated with British American Tobacco and another served as a consultant to an ENDS distributor.

In fact, an infographic depicting the relationships of the authors to public and private entities is provided here: https://www.bmj.com/content/351/bmj.h5826/infographic

Q: What about the data itself, and how was it obtained to reach the conclusion of the study? 

A: The Study Design was Scientifically Biased

The study was commissioned by assembling a 12-person panel utilizing the multi-criteria decision analysis (MCDA). The MCDA results rely on outcomes that are driven by the member’s views and knowledge of the individually contributing experts rather than any scientific data(1).

No wonder US public health officials scoffed at the results of PHE’s study. The notion of “my view is this, but without any empirical data to support this view,” doesn’t actually impart an evidence-based conclusion, much less one espousing a 95% reduction in risk, where tremendous weight is applied for the advancement of public health. Pushing forth a claim that carries such grave responsibility without any empirical proof, is wrong.

Q: Where do we go from here?

Though this “95% safer” claim has already been criticized in several journals such as Lancet and BMJ(2,3), by well-regarded academics(4) and by medical experts and associations, such as the American Lung Association, rather than just summarizing the key troubling elements contained in PHE’s study, we should not lose sight of the actual goal.

We must demand the need for transparent marketing and risk claims, we must embrace real harm reduction technologies and the furtherance of nicotine replacement therapies, and we must expect discoveries to be grounded by ethical behavior and evidence-based science. It would be a disservice to punish innovative companies and bold policies due to the calculated misinformation campaigns from select bad actors.

Those pushing unsupported or weak claims such as the one underpinning PHE’s position will have to prepare to be questioned (or worse), by a more informed public and policymakers alike.

Respira welcomes this quest for truth and is actively innovating towards that end.

References:

1.         Nutt, D. J. et al. Estimating the harms of nicotine-containing products using the MCDA approach. Eur. Addict. Res. 20, 218–225 (2014).

2.         The Lancet. E-cigarettes: Public Health England’s evidence-based confusion. Lancet 386, 829 (2015).

3.         Gornall, J. Public health England’s troubled trail. BMJ 351, 18–23 (2015).

4.         Glantz, S. A. & Bareham, D. W. E-Cigarettes: Use, Effects on Smoking, Risks, and Policy Implications. Annu. Rev. Public Health 39, 215–235 (2018).

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