Pharma Startup Promotes False Claim that PHE Author Had Tobacco Ties

A California company planning to pursue drug approval for an inhaled nicotine replacement therapy product appears to also run a website containing false allegations that a scientist commissioned by Public Health England had financial ties to the tobacco industry.

The company, Respira Technologies, Inc., has also engaged in a smear campaign suggesting Juul Labs and other vaping product manufacturers may be responsible for causing some of the “EVALI” lung injury cases, and has encouraged the U.S. Food and Drug Administration (FDA) to adopt standards that would prevent most consumer vapor products from being authorized for sale.

RespiRx: the ``first ‘vapor style’ Nicotine Replacement Therapy”

Respira Technologies says it intends to submit an FDA application next year for its nicotine replacement therapy device called RespiRx. The company met with FDA officials in November to discuss its plan to seek approval from the agency’s Center for Drug Evaluation and Research (CDER) through the Investigative New Drug Application pathway.

“We are very pleased with the productive and collaborative discussion with FDA and have confidence that FDA’s guidance will help us achieve our goal to end the death and disease caused by smoking,” said Respira founder and CEO Mario Danek.

Despite a 2020 Respira press release describing its RespiRx device as the “first ‘vapor style’ Nicotine Replacement Therapy,” the device isn’t a true vaping product that uses heat to evaporate flavored e-liquid. While it superficially resembles a pod-style vape, the RespiRx is a nebulizer that delivers a measured dose of inhalable, nicotine-containing mist.

Smearing Juul and other vape manufacturers by name

But while Respira Technologies seems outwardly confident its product will succeed on its merits, the company clearly believes consumer vaping products pose a threat to the future of its nebulizer. Respira has opposed PMTA authorization for e-cigarettes unless they meet standards the company itself has delineated. Respira is also connected to a FUD campaign suggesting that consumer vaping products pose huge, unproven health risks.

In 2019, Respira launched a citizen petition, asking the FDA to institute specific standards for products submitted through the PMTA pathway, including a nicotine limit and a standard for harmful and potentially harmful constituents (HPHCs). Respira also requested the FDA establish “a voluntary, fast track pathway for the approval of ENDS products that deliver meaningful reductions in HPHCs versus currently marketed ENDS products.”

Respira links its own website to a site called “Vaping Fact Checker” that attempts to tie nicotine vaping to the 2019 “EVALI" lung injury outbreak. A page on the site (see image below) titled “EVALI Linked Products" shows Juul, SMOK and Suorin products and implies that they have caused or could cause “EVALI.”

“Many EVALI patients used products thinned with vitamin E acetate,” says Vaping Fact Checker. “Additives like vitamin E acetate are associated with patients suffering from EVALI and need to be avoided. However, vitamin E acetate wasn’t confirmed in every EVALI case suggesting there are other vaping related deleterious characteristics or compounds that result in EVALI.”

In analyses by the FDA and CDC, and in many other studies of “EVALI” patients and the products they used, no nicotine vaping product has been linked to a single vaping-related lung injury. Iowa Attorney General Tom Miller and dozens of academic experts recently requested the CDC change the “EVALI” name to reduce confusion caused by the misleading reference to “e-cigarettes.”

Claiming that Juul, for example, contains some constituent that could cause any form of acute respiratory distress syndrome ("EVALI" is a type of ARDS) is pure speculation with no evidence to back it. Millions of people regularly use Juul products without any acute lung response, and no case of "EVALI" has been tied to Juul use—or use of any other nicotine vaping product.

The Vaping Fact Checker website has its own URL, which is accessible via a tab on Respira Technologies’ site; and Respira’s website is linked on the Vaping Fact Checker site. Some information on Vaping Fact Checker's pages appears to have been modified from a document on Respira’s own site, and is also used in a 2020 LinkedIn post by the company's CEO Mario Danek, which he reposted on LinkedIn as recently as November 2021.

Accusing Public Health England scientists of Big Tobacco ties

Under the heading “Myth Busting,” the Vaping Fact Checker website claims that “one of the authors” of Public Health England's 2015 e-cigarette evidence review has “financial ties” to tobacco company Philip Morris International. (See image below.)

In the PHE report’s “declaration of interests,” all six of the authors—Ann McNeill, Leonie Brose, Robert Calder, Sara Hitchman, Peter Hajek and Hayden McRobbie—specifically deny having links to any tobacco company. The Vaping Fact Checker claim amounts to a declaration that one of these PHE-commissioned researchers lied and concealed financial ties with a tobacco company.

British tobacco harm reduction advocate Clive Bates has followed and been part of the debate over the 2015 PHE report from the beginning. Bates is director of Counterfactual Consulting and a former director of Action on Smoking and Health (ASH) in the UK.

“It is both offensive and preposterous to claim that the experts undertaking Public Health England's evidence reviews were somehow compromised by tobacco industry interests,” Bates told Vaping360. “They are all scientists of the highest standing with no conflicts of interest.”

In fact it appears the author of the Vaping Fact Checker claim has (either accidentally or deliberately) confused the PHE review with a separate paper authored by a group of experts led by drug researcher David Nutt. The Nutt co-authors and the PHE-commissioned researchers arrived at the same estimate of harm caused by vaping versus smoking—that vaping is approximately 95 percent less harmful.

“It is possible [Vaping Fact Checker] is lazily or cynically confusing estimates made by Public Health England and the Royal College of Physicians with the multi-criteria decision analysis exercise undertaken by David Nutt and colleagues,” says Bates. “This structured process of expert estimation attracted accusations of tobacco industry influence from academics and journalists who disliked the findings. But this was not the basis of the PHE or RCP findings which were independent judgements.”

On its own site, Respira also describes features of the Nutt paper while implying it was Public Health England’s work, referencing a 2015 BMJ article that attempted to disparage the PHE report by comparing it to the Nutt paper. The BMJ author suggested Nutt and his co-authors didn’t employ stringent scientific methods, and implied tobacco industry influence. (The Respira and Vaping Fact Checker sites also reference an unsigned editorial in The Lancet that made similar points.)

Vaping Fact Checker, however, specifically attributes the supposed faults of the Nutt paper and the claimed tobacco industry conflict of one of its authors to the scientists employed by PHE. The website directly accuses a PHE-commissioned author (without naming them) of having ties to the tobacco industry. “One of the authors and one of the study’s sponsors have financial ties to Phillip [sic] Morris International,” Vaping Fact Checker writes.