DV Journal

The Biden administration’s 11th-hour proposal to force tobacco manufacturers to slash nicotine levels — made just days before President Biden’s exit — was viewed as a political stunt by many public health officials.

Meanwhile, tobacco reduction experts like Jed Rose, the head of the Rose Research Center, say the opportunity for real progress in the fight to get more Americans to stop smoking is on the horizon. More science is needed and more accurate information provided to the public.

It starts with understanding why people smoke.

“Smokers don’t just value the nicotine in their bloodstream,” Rose said, referring to the chemical behind the addiction. “There are sensory cues that become pleasurable to smokers. People who get IV feedings do not feel their hunger satisfied. Likewise, a smoker wants to smoke a cigarette to feel satisfied.”

Rose knows what he’s talking about. More than 40 years ago, he fell into a career working on smoking cessation by accident when he took a temporary job while awaiting a fellowship connected to his doctorate in learning processes underlying anxiety.

In the 1980s, he was named the lead inventor of the nicotine skin patch, along with his physician brother Daniel and the late Murray Jarvik. Rose says he’s studied the most effective strategies for smokers who want to quit.

(Spoiler alert: cold turkey is not one of them, Rose says.)

It turns out, Rose says, the old saw about quitting smoking cigarettes being harder than quitting hard drugs isn’t too far off the mark.

“It’s a really difficult question: Why it’s so much harder to quit smoking,” Rose said. “On a behavioral level, smoking actually helps people to behave more normally. It helps you concentrate better on tasks, helps thinking, reduces anxiety under stress. It enables people to feel they can cope more normally in life. That is harder to give up than ‘feeling high’ such as you get with cocaine.”

Rose was involved in the development of the medicine varenicline, commercially known as  Chantix, which the National Institutes of Health indicates has an effective rate of 40 percent to 60 percent in helping people quit smoking.

Throughout the years, Rose’s research has focused primarily on developing practical tools to help people quit smoking. Giving smokers nicotine replacement methods to wean themselves away from nicotine in cigarettes is only part of the equation. It is essential to replace the sensory and behavioral aspects of smoking with less harmful substitutes.

That’s why it’s so confounding that health regulators keep throwing up roadblocks against electronic delivery devices that research shows improve the likelihood that a person will quit smoking traditional cigarettes.

“It takes more than nicotine to address the addiction,” Rose said. “It’s the feeling of inhaling something. There’s a holistic approach. It’s not just substituting nicotine or another drug but also the behavioral substitution.”

The Food and Drug Administration has approved several pharmaceutical products for nicotine replacement therapy, such as skin patches, chewing gum and lozenges. There are also nicotine sprays and inhalers.

FDA’s population modeling shows that stopping smoking by reducing nicotine in cigarettes is predicated on a 67 percent increase in the use of non-combusted nicotine products as off-ramps from cigarettes.

The day after publishing the cigarette nicotine reduction standard, the FDA authorized 10 flavors of a nicotine pouch product as a less harmful alternative for adults who smoke.

For those looking for a non-drug approach, the FDA has blessed companies to market transcranial magnetic stimulation (TMS) in which a magnetic coil held over one’s head delivers magnetic pulses to the brain. TMS can be used to treat obsessive-compulsive disorders, depression and addictions such as smoking.

However, the agency has authorized marketing only for a limited number of heat-not-burn devices or other electronic delivery systems such as e-cigarette cessation — despite evidence from Rose and other researchers showing they can get smokers to quit.

In February 2024, Nancy Rigotti published an editorial in the New England Journal of Medicine calling on U.S. public health agencies and the medical community to recognize the value of electronic cigarettes. She based her opinion on comments on research done in Switzerland, which found that study participants who had access to e-cigarettes were more likely to abstain from traditional cigarettes than those who received just smoking-cessation counseling. A recent independent review of the evidence by the Cochrane Library concluded that e-cigarettes were more effective than traditional nicotine replacement methods such as the nicotine patch or gum.

“It is now time for the medical community to acknowledge this progress and add e-cigarettes to the smoking-cessation toolkit,” Rigotti wrote. “U.S. public health agencies and professional medical societies should reconsider their cautious positions on e-cigarettes for smoking cessation. The evidence has brought e-cigarettes to a tipping point. The burden of tobacco-related disease is too big for potential solutions such as e-cigarettes to be ignored.”

However, unintentional and intentional misperceptions about e-cigarettes are rampant, and Rose said the FDA, which regulates such products, is doing little to correct the record. The results are devastating: Surveys show that 80 percent of smokers mistakenly believe that e-cigarettes are just as harmful or even worse than traditional cigarettes.

“Many smokers will not avail themselves of products that can save their lives because nobody is correcting their misperceptions of e-cigarettes,” he said. “It’s costing lives.”

How can Americans lead healthier lives?

Solutions include reforming the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), along with replacing cigarette smoking with safer nicotine delivery systems.

InsideSources recently hosted the “Common Sense Public Health Roundtable” at the National Press Club in Washington, D.C., where three public health professionals laid out simple solutions that could pack a real public health punch.

“I would replace the FDA’s human food program, and I would replace it with something that would give both producers and consumers a better choice,” said Dr. Richard Williams. “And that would address food safety and nutrition problems that are plaguing us.” Williams, author of “Fixing Food: An FDA Insider Unravels the Myths and the Solutions,” worked at the FDA for nearly 30 years. “We treat FDA like it’s a revered institution when in fact, it’s like an old company that’s selling outdated products.”

The FDA is 117 years old, Williams noted, and “things are going on that they can’t keep up with.” He said while the most recent problem was the infant formula shortage, there have been a variety of other issues, especially with food safety and nutrition.

Thanks to a lack of innovation and little pressure from the public to improve, the results are underwhelming.

Every year, the FDA goes to Congress and asks for more money, making the same claims: 48 million people are getting sick from food-borne diseases, 128,000 are hospitalized, and 3,000 die Williams noted.

“Nobody ever says, ‘You’ve been saying the same thing every year, and we keep giving you more money, and nothing’s happening,’” said Williams. “They write regulations… They’re out of ideas, and unfortunately, we all pay for this” with taxes, higher food prices, illness, and death.

“Should almond milk be called milk? They spent a couple of years trying to figure that out,” said Williams

“Nutrition is a bigger problem,” he said. “Four out of 10 people are obese in this country.” Half the population will be obese by 2023. And food labels don’t help. Since they started labeling in 1973, “half of us now are diabetic or pre-diabetic. Heart disease and cancer are going up.”

“In 2020, COVID killed 350,000 people in this country. Poor nutrition killed 500,000,” said Williams. And the FDA still uses “old science.”

He suggested the FDA use a model like DARPA (Defense Advance Research Projects Agency) where the bureaucracy is minimal, and the agency can “develop new ideas.”

Among the steps, Williams suggested: Foods made in 3D printers; using robots in food production and intelligent packaging to signal that food is spoiled; and wearable nutrition devices that tell you what to eat and how much.

Clive Bates, editor of “The Counterfactual,” offered a basic yet bold public health policy. “Get rid of all smoking.”

About 480,000 people die from smoking each year, Bates noted, which is a huge number compared to other public health issues. And, he added, “another 16 million live in misery” from smoking-related diseases. Because smoking rates are far higher among lower socio-economic groups, targeting it also adds to social justice efforts. “If you can do something about smoking, you can do something about health disparities, which is a good thing.”

Bates argued the U.S. could do something about it. But it is just choosing not to, as a matter of public health policy.

Since 2010, there have been alternatives to what public health pros call “combustible cigarettes,” new products that provide nicotine without combustion.

“If you get rid of the smoke, you get rid of almost all the toxicant exposure,” said Bates. “People will continue to use nicotine but at much, much lower risk.” Government authorities in Great Britain have pegged the health risk from e-cigarettes, vaping, and other similar products at about 95 percent lower than smoking.

But instead of encouraging smokers to switch to lower-risk alternatives, as the U.K. has done, the FDA has been funding major marketing efforts targeting vaping and e-cigarettes, convincing smokers there is no health benefit from making the change.

As a result, most Americans incorrectly believe vaping is as dangerous as smoking.

One problem, Bates said, is that the FDA doesn’t know how to regulate something that comes with some risk but is far safer than the alternative. He said that vaping isn’t food or medicine; it is more like beer or coffee. It’s something people consume because they enjoy it.

“They don’t really know what they’re doing with these (smoking replacement) products,” he said. It would be better to consider them like coffee or moderate alcohol consumption. It’s pleasurable. It’s fun… It’s a harm reduction strategy. For people to use the products, they have to be appealing. Regulators have problems with that.”

And no, Bates added, the “F” in “FDA” does not stand for “fun.”

Dr. Brian Miller is a fellow at the American Enterprise Institute and a doctor at Johns Hopkins University. He used his real-world experience to discuss the CDC’s failures in the fight against COVID-19.

“I worked on COVID wards, and normally during a pandemic, you go to the CDC for advice,” Miller said. “Well, you’re in the middle of a global pandemic, and people are confined to their homes. You look up the CDC guidance, and the webpage hasn’t been updated. Or they don’t know.”

A pandemic caused by a communicable disease is the CDC’s reason for existence, and yet it wasn’t ready when the real thing happened. Why?

“The CDC’s mission has drifted,” he said. The agency started focusing on “current events” and health issues like the environment or addressing issues like racism and gun violence. Those healthcare issues keep the agency in the headlines but have little to do with the CDC’s job.

“Having an organization that is trying to be all things to all people all the time means that it cannot perform its basic functions, as we discovered during the pandemic.”

For Miller, the first step is obvious. “We should be directing our dollars to policy levers that work,” Miller said. “We should think about directing the CDC’s resources to its core mission and then some of those other funds and staff (could go to other agencies),” he said.

Also, the public should have the right to comment on CDC’s regulations.

“Public opinion still matters,” he said. “And public input matters.”