Thanks to the FDA, Biden’s cancer moonshot could succeed

Every year, nearly 500,000 Americans die from smoking-related diseases — more than the annual number of people dying of covid-19. Smoking is the leading cause of cancer deaths, with more than 160,000 people perishing every year from cancers directly attributed to tobacco.

FDA Commissioner Robert M. Califf explained at a conference last week that the agency’s proposal to reduce nicotine content in cigarettes is based on nicotine’s extremely high addictive potential. “I think it’s every bit as strong as the opioid addiction,” he said.

Companies know this; they deliberately increased nicotine levels in tobacco products so that smokers crave more cigarettes to fuel their addiction. The FDA contends that the reverse is also true: If cigarettes have such low levels of nicotine that they no longer produce the intended “high,” smokers would either quit or turn to other products that don’t have the cancer-causing chemicals found in cigarettes.

This theory is backed by evidence. A randomized, double-blind trial published in the New England Journal of Medicine found that people assigned to receive reduced-nicotine cigarettes smoked less than those who had standard-nicotine cigarettes. After six weeks, the first group reported lower nicotine-dependence symptoms and minimal withdrawal discomfort. Another study in the same journal projected that lowering the nicotine content to sub-addictive levels could prevent about 8 million deaths in the next 80 years.

Could this effort backfire? Might smokers just smoke more cigarettes to achieve the same effect? Otis Brawley, an oncologist and former chief medical and scientific officer of the American Cancer Society, told me in an interview that this is not likely. “The research shows that the more nicotine is in tobacco, the more people smoke,” he said.

Of course, tobacco companies do not like this proposal and inevitably frame the choice of smoking as a matter of free will. Califf offers a particularly compelling rebuttal: Addiction is a disease that alters the chemistry of the brain, so it is not about individual choice. “The evidence is most people want to stop smoking, but they just can’t,” he said.

Equally important to helping smokers quit is preventing nonsmokers from getting hooked in the first place. Youth e-cigarette use has become an epidemic, with as many as 1 in 4 high school students reporting that they vape. Juul, which controls about a third of the e-cigarette market, has come under fire for targeting children, including through ads on the Cartoon Network and Nickelodeon. Its products have an extraordinarily high level of nicotine: A single Juul pod contains as much nicotine as a pack of 20 regular cigarettes.

Such amounts of nicotine can harm adolescent brain development. In addition, nearly 90 percent of adult smokers began smoking before age 18. The worry is that Juul’s products are not being used primarily to wean adults off cigarettes, but rather to hook teens with nicotine and turn them into adult smokers. The FDA’s decision to ban most Juul offerings came after the company failed to show that the benefits of its products outweigh the harms.

The FDA has also proposed that menthol cigarettes be removed from the marketplace. This, too, could have a profound impact. Researchers estimate that menthol cigarettes are responsible for 10 million more people who smoke and almost 10,000 deaths every year. In 2017, Canada banned menthols, and a subsequent study found that more than 20 percent of menthol smokers quit rather than switch to other tobacco products.

It’s notable that these FDA proposals are resoundingly applauded by the American Heart Association, American Lung Association and numerous other public health groups. Brawley makes the point that these regulatory efforts will reduce cancer mortality and close disparities. “By far, the biggest driver of disparity in cancer deaths is caused by smoking,” he told me. “Even disparities by race are heavily driven by disparities in tobacco use.”

Indeed, these efforts could be the biggest factor in achieving Biden’s moonshot goal of reducing cancer deaths by half in 25 years. As Califf said, “If you want to reduce cancer mortality, this will do far more — if we succeed — than any specific chemotherapy that you can name.”

The road ahead is not easy. A federal judge has ordered a temporary stay in Juul’s favor, and other proposals will almost certainly be held up by lawsuits. But the FDA should be commended for taking bold action that can improve health for generations to come.