A Foundational Call to Action

 

Now is the time for all good men and women to come to the aid of the Foundation for a Smoke-Free World (FSFW).

The organization was founded in 2017 through a charitable gift from PMI Global Services.  Its mission is simple: “to end smoking in this generation.”  Its founders envision “a world in which combustible tobacco, other toxic forms of tobacco, and smoking-related death and disease are eliminated.”  Contrast that with the U.S. government’s vision of “a world free of tobacco use,” an incorrectly broader behavior blamed by the government for “cancer and suffering.”  

The FSFW not only has a firm grasp on the merits of tobacco harm reduction (THR); it also offers the only substantial funding (currently about $150 million) for legitimate, unbiased THR research. 

The Foundation recently named a new president and CEO, Clifford E. Douglas, whose anti-tobacco credentials are impressive.  He worked to eliminate smoking on airlines and college campuses, and he held high offices in the Coalition on Smoking and Health, the American Lung Association, and the American Cancer Society.  He most recently served as director of the University of Michigan Tobacco Research Network. 

As the FSFW board chair noted, “For decades Cliff Douglas has been a strong and influential voice in the work to eliminate smoking in America and globally.”  What is most remarkable is that Douglas differentiated and focused on the devastating toll of smoking, rather than the broader universe of tobacco use, the term used by prohibitionists to impugn all things tobacco- or nicotine-related.  In short, he came to recognize “emerging efforts around the world related to alternative nicotine products as a complement to traditional tobacco control measures.”

Since its creation, the FSFW has been dogged by claims that it is influenced by its founding sponsor, Philip Morris International.  Mr. Douglas has countered by terminating the receipt of PMI funds, pledging that the Foundation will no longer accept any support from the tobacco or non-medical nicotine industries.  “Any skepticism around our independence can be laid to rest,” he said.

Of course, prohibitionists never rest.  Deborah Arnott, CEO of UK Action on Smoking and Health, said, "Whether it's true or not, [Douglas] will be seen as pursuing PMI's agenda, not that of public health."  Yolonda Richardson, president of the Campaign for Tobacco Free Kids, termed Douglas’s claim “ludicrous”. 

What’s truly ludicrous is that prohibitionists, wearing the sheep’s clothing of “public health”, oppose all funding of THR, no matter its source.  Since 1999, the universities employing me have administered small grants from tobacco companies to conduct THR research.  While this work would not have been possible without such support, attacks from within and outside these institutions have been never-ending.  To quote Carl Sandburg, “If the law and the facts are against you, pound the table and yell like hell” -- about the funding.

I sincerely hope that THR researchers and supporters will stand with Mr. Douglas to make the Foundation a beacon of honesty and accomplishment in the world of public health.

 

Note: For the past year, I have served as an outside grant reviewer for the FSFW.

 

Confusing Communications, Shifting Guidance and Decision Paralysis are Behavioral Norms at the FDA

U.S. health authorities are rightly focused on vaccination as the primary tool to end the Covid-19 pandemic.  However, another “critical tool,” widely used in other developed countries, is “expensive and hard to find” in the U.S., according to ProPublica.  That news outlet is reporting that development and distribution of rapid Covid tests, which should by now be ubiquitous and inexpensive, has been crippled by “an arbitrary, opaque [FDA regulatory] process that meanders on, sometimes long after . . . products have been approved in other countries.”

For those interested in tobacco issues, it is worth noting that ProPublica’s points about FDA treatment of Covid tests and testing companies mirrors the arbitrary and capricious treatment of e-cigarettes and vaping companies.  Following are some examples that will resonate with the vaping community.

1. “In late May, [biotech company] WHPM got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be ‘deprioritized,’ or moved to the back of the line.

“‘We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,’ said [WHPM head of international sales Chris] Patterson.”

2. “Nanōmix, a diagnostics designer based in Emeryville, California, developed a rapid test with the help of a federal grant and submitted it to the FDA in February. In early June, an FDA reviewer sent back a list of questions, giving Nanōmix a deadline of 48 hours to respond. The company couldn’t provide answers that quickly, so it was sent to the back of the line.

“‘We start development on a set of guidance,’ said Nanōmix CEO David Ludvigson. ‘Then they change the guidance after we’re done, and expect us to have conformed to their revised guidance.’”

3. “The FDA reviewer who quit this May described what the delays looked like from the inside. With a background in virology, he could evaluate the hundreds of pages in an application within a few days. But then, something strange happened: The applications would go nowhere for months as higher-up officials seemed paralyzed by indecision.

“‘I could easily process dozens of them, but I ended up with one or two in my queue constantly. They would stay there forever,’ he said. ‘I had a lot of free time.’”

I don’t doubt that much of the FDA’s opposition to smoke-free products is driven by the federal government’s obsession with a “tobacco-free society”, however, the vaping community should find some solace in the fact that confusing communications, “criminal” treatment, shifting guidance, and decision paralysis are cultural and behavioral norms at this federal regulatory agency.

 

 

 

How NIH Funding Undermines Tobacco Harm Reduction

 

Have you ever considered the recent years’ tsunami of research that emphasizes the dangers of e-cigarette and vaping products?  Was this work spontaneously generated?  How was it funded? 

Philip Cole, Elizabeth Delzell and I answered these questions in a manuscript published in 2000 in the journal Epidemiology (available here).  We described how after World War II, universities “changed their mission and became research arms of the federal government…But, with considerable money comes influence and eventually some control. The funds had been flowing for little more than a decade when President Eisenhower, in his 1961 farewell address to the nation, warned universities against accepting encumbered federal funds. He saw that the giving hand already had become the heavy hand. One by one, ever more onerous conditions were attached to federal awards. This has continued to the point that many universities now harbor research programs, sometimes entire institutes, that function essentially as satellites of the federal government.”

The U.S. National Institutes of Health is the primary funding source for researchers at universities countrywide.  In 2018, NIH provided 54,000 awards to 2,900 institutions -- nearly $40 billion in all. 

Research awards have two components.  The first is “direct costs,” which covers actual research.  These funds are managed by the researchers and include salaries for faculty and staff, equipment and other necessary expenses. 

The second component is “indirect costs,” covering things not directly related to the research – items like buildings, utilities and administrative expenses.  These items are managed by university administrators.  For every $100 in direct costs that a researcher gets from the NIH for their project, university administrators take $55-70 for indirect costs.  That is why we wrote that “…the need [for indirect costs] is so great that, perversely, Moneychangers [i.e., administrators] now prefer encumbered research grants, which offset overhead costs, to unencumbered gifts which do not but which do give faculty members freedom to pursue their interests.”

When Uncle Sam gives universities money, there’s always a catch, which we described in our article: “Federal bureaucrats fuel the fires of growth by urging academics to do research consistent with their agency’s mission. Through master agreements, cooperative agreements, requests for proposals and inducements of every sort, professors are led into doing the government’s research.”

It gets worse.  Money is so scarce that “Many universities now are over committed to…the aggrandizement of research, and some have gone so far that research fundraising has become more important than research itself.”

  

This brings us to tobacco research.  As I have noted, the government’s stated mission is “to create a world free of tobacco use.”  In fiscal year 2020, the NIH disbursed 1,489 awards identifying the key word “tobacco” to 303 unique organizations.  The grants totaled $693 million.  Over one-quarter of this money ($186 million) was devoted to research on e-cigarettes and vaping products.  Note in the following chart how increases in this funding have driven the number of research publications.

 

In summary, NIH is the most critical source of support for all American researchers, universities and other academic institutions.  Researchers and administrators recognize the value, if not imperative, of comporting with the government’s tobacco-termination mission.  Despite this oppressive influence, researchers routinely declare that they have no conflicts of interest or bias.

The steady flow of research reports demonizing e-cigarettes and vapor products provides “scientific” evidence to support harsh regulation.  The Tobacco Products Scientific Advisory Committee (TPSAC) that advises the FDA on regulations is currently comprised of seven members who together received $25 million from NIH in fiscal year 2020, and $54 million in other years.  

This blog post was developed from a presentation I gave on “How Institutional Funding in the U.S. Works Against Tobacco Harm Reduction” at the 2021 Global Forum on Nicotine Conference.  The recorded video is available here.  

Note added July 16, 2021: 

I was notified by @phil_w888 via Twitter that the Canadian equivalent of the NIH, the Canadian Institutes of Health Research, announced funding for a project last year on the Health Effects of Vaping.  Incredibly, the description contained the following: 

"Research projects exploring the use of vaping as a smoking cessation tool or as a harm reduction strategy are not eligible for this funding opportunity."