FDA Commissioner Califf’s Anti-Misinformation Campaign Must Start at Home

 

In a recent interview with CNBC, FDA Commissioner Dr. Robert Califf said that “misinformation” is driving down U.S. life expectancy, which is now three to five years lower than in other developed countries.  Dr. Califf said that combating misinformation is one of his top priorities, and he called for more regulation by “specific authorities at FDA, FTC and other areas to root out misinformation.”

The Commissioner should put his own agency in order first.  U.S. life expectancy has declined for decades largely because some half-million Americans per year have died from burning tobacco and inhaling smoke.  This tragedy has been going on so long that today few see it as a crisis.  For proof, do a Google News search for “crisis” and here’s what you get: banking crisis, housing crisis, plastics pollution crisis, mental health crisis and opiate overdose crisis.  All of these are serious problems, but their severity pales in comparison with smoking-related deaths.

Today, smokers can avoid premature death by switching to e-cigarettes and vaping products.  The British government has seized on this fact, announcing, “One million smokers will be encouraged to swap cigarettes for vapes under a pioneering new ‘swap to stop’ scheme designed to improve the health of the nation and cut smoking rates.  As part of the world-first national scheme, almost 1 in 5 of all smokers in England will be provided with a vape starter kit alongside behavioural support to help them quit the habit as part of a series of new measures to help the government meet its ambition of being smokefree by 2030 - reducing smoking rates to 5% or less.”

Yet here in the U.S., rather than encouraging smokers to switch, the FDA has taken millions of vape products off the market; the only products the agency has approved for sale have been tobacco-flavored.  Imagine if the FDA approved a drug to help people suffering from alcoholism, but only if the product is bourbon-flavored!

The chart, showing data from the National Cancer Institute’s Health Information National Trends Survey (HINTS), reveals the extensive damage caused by the federal government’s campaign against e-cigarettes.  In 2020, only 10% of American adult smokers believed correctly that vaping was less harmful than smoking; two-thirds believed vapes were the same or more dangerous, and a quarter didn’t know. 

Who can blame smokers for not switching from cigarettes to products that most believe are as bad or worse for their health?   

A lot has been written about the 2022 Reagan-Udall Foundation report that criticized FDA tobacco regulations, but for me, the most egregious and deadliest regulatory misstep has been the government’s successful misinformation campaign against safer and satisfying smoke-free alternatives, and against nicotine itself.  Dr. Califf is correct in saying that “misinformation is driving life expectancy in the U.S. down,” but it is his own agency that is spewing the misinformation that dissuades smokers from stepping away from the fire.  It is long past time for the FDA and other public health agencies to reverse course and give smokers the tobacco truth.

 

Different Strokes for Different Smokes: More Evidence That All Quitting Options Are Vital

 

Investigators at the University of Nebraska Medical Center in Omaha and the University of California San Francisco have published an important study in JAMA Network Open on “Exposure to toxicants associated with use and transitions between cigarettes, e-cigarettes, and no tobacco.”

Hongying Dai and colleagues looked at 55 tobacco exposure biomarkers (mostly toxins) in the urine of adult smokers, vapers and dual users in the first wave of the Population Assessment of Tobacco and Health Study.  They compared this data with urine samples from the same participants one year later in Wave 2, when the participants may or may not have changed their tobacco use status.

While Dai and coauthors “found complex patterns and heterogeneous health outcomes associated with transitions between cigarettes and e-cigarettes,” the results can be succinctly summarized.  First, “transitions from dual use or exclusive cigarette use to exclusive e-cigarette use and transitions from any tobacco use to no use” were associated with sharp declines in toxins. Second, “transitions from exclusive e-cigarette use to cigarette use or dual use” were associated with “moderate to large effect” increases in toxin levels.  And third, “transition from exclusive cigarette smoking to dual use of cigarettes and e-cigarettes” didn’t provide any meaningful change in urinary toxins.

The authors found that “only a small percentage of [Wave 1] exclusive cigarette smokers and dual users transitioned to exclusive e-cigarette use at [Wave 2] (1.2%and 5.6%, respectively), which could limit ben

efits in moving combustible cigarette smokers to less hazardous, noncombustible e-cigarettes.”  This is an important statement, because it acknowledges less e-cigarette harm by referencing an FDA press release from 2017 (here).  More importantly, it is followed by a solid explanation for the low transition rate to vapor: “low effectiveness in early generations of e-cigarettes in delivering nicotine [the PATH Waves were in 2013 and 2014, when e-cigarettes were not very effective], lack of knowledge among cigarette users to distinguish harmful effects between dual use and exclusive e-cigarette use, or the effects of negative public health messaging [emphasis added, references omitted].”

All of the above is informative, but the real news from this study is demonstrated in the following table.  It reports levels of cotinine – a breakdown product of nicotine – in the urine of participants, according to the product they used at Wave 1, and one year later at Wave 2.  Cotinine levels are widely used to indicate tobacco use levels.  In general, higher cotinine indicates more tobacco use.  Higher cotinine, especially with cigarette combustion, also means greater exposure to toxins. 

 

 

Urinary Cotinine Levels* at PATH Waves 1 and 2, According to Product Use
Wave 1 Product (n users)	Wave 1 Cotinine	Wave 2 Product/Cotinine
		None	Cigarettes Only	E-Cigarettes Only	Dual Use
Cigarettes (247)	158	5
Cigarettes (1820)	2273		2265
Cigarettes (32)	1833			713
Cigarettes (257)	3068				2522
E-cigarettes (44)	16	2
E-cigarettes (14)	502		1942
E-cigarettes (121)	727			470
E-cigarettes (31)	972				2569
Dual use (42)	213	6
Dual use (315)	2690		2628
Dual use (36)	2792			1192
Dual use (252)	3179				3374

*in nanograms per milliliter of urine

 

One can readily see that cotinine levels were high in smokers and/or dual users in both waves.  Cotinine levels among e-cigarette users were much lower, confirming that in 2013-14, the products did not deliver nicotine very effectively.

Everyone in the first four rows of the table smoked cigarettes in Wave 1, so one might expect that their cotinine levels in that wave would be the same.  Instead, there were huge differences between them, depending on where the smokers ended up at Wave 2.  The 247 smokers who had a cotinine level of only 158 ng/ml at Wave 1 quit everything at Wave 2 and had negligible cotinine.  The highest Wave 1 cotinine levels were in smokers who continued to smoke at Wave 2, while the smokers who ended up with e-cigarettes went from 1833 ng/ml at Wave 1 to 713 at Wave 2. 

The same is true for the other two categories: The e-cigarette users and dual users at Wave 1 who quit completely at Wave 2 started out with much lower cotinine levels. 

The take-home message is hugely important.  Tobacco users at Wave 1 may have self-selected their Wave 2 product use based on their cotinine status at Wave 1.  This says that those who quit completely, switched to e-cigarettes, or stayed with cigarettes were entirely different groups of smokers, each with distinct nicotine needs.  Because no one can predict how individual smokers will be able to quit, they should be provided access to all quit-smoking options.

 

 

The CDC Nicotine Brain Fallacy

 

The U.S. Centers for Disease Control and Prevention is out with a false advertisement telling kids that “Nicotine in e-cigarettes can harm brain development.”  The headline says, “It’s not like you can buy a new brain.”  To make it accurate, I’ve added “…for your pet mouse.” 

Let me be crystal clear.  The harm in brain development federal officials talk non-stop about only happens in laboratory torture of mice.  Mouse studies are well known to be of questionable value in predicting human effects.  There is absolutely no scientific evidence to support the claim that nicotine causes harm to human brain development, so it is astounding that federal officials traffic in this false narrative.  This nonsense is an affront to 34 million adult current smokers and 55 million former smokers in the U.S., virtually all of whom started when they were teenagers.  There is no evidence that their brain development was harmed, a fact that was specifically acknowledged by a prestigious nicotine researcher Dr. Neal Benowitz at an international tobacco meeting this week.

I have for years catalogued CDC misinformation campaigns regarding smokeless tobacco (examples here, here, here) and e-cigarettes (here, here, here, here).

Today, CDC’s bungling of Covid-19 facts and guidance is pulling back the curtain on that agency’s tragic shortcomings and its readiness to disregard or “warp” the truth. Educated tobacco users have known the CDC has been lying about and to them for years.