Tuesday, December 5, 2023

Smoking kills but for our lawmakers its e-cigarettes which face the butt

A big tobacco dustup has happened in the US at perhaps the most eclectic conference in Washington. And strangely, it has triggered no debate in India, one of the world’s biggest markets for tobacco.

Why? No one has an answer.

The annual E-Cigarette Summit in Washington on May 17, 2022, attended by consumer advocates, vape owners, academics, researchers, regulators and industry executives, raised some very, very pertinent questions at the Food and Drug Administration (FDA) of the US, an agency often blamed for lack of transparency. Worldwide, a big debate is on between the cigarette lobby and the vaping companies, the last drawing flak for all the wrong reasons. 

The Summit heard out the voices.

Matthew Holman, the director of the Office of Science at the FDA’s Centre for Tobacco Products (CTP), and Kathleen Crosby, the director of CTP’s Office of Health Communication and Education, draw huge flak during the Q&A sessions from attendees who asked the FDA why it has continued to communicate so poorly the “continuum of risk”—the idea that some nicotine products are significantly safer than others.

Was it deliberate, asked many?

So what was the moot question. Many asked now that the FDA was authorising some vapour products through its often-criticised and onerous tobacco production application (PMTA), why was the public still so massively misinformed about e-cigarettes? Why do e-cigarettes continue to draw flak, continue to be subject of ban in some of the world’s biggest markets like India?

In India, the ban came through the enactment of the Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019. But many have argued that the entire process was wrong and convoluted, and it was in total contrast to the prevailing law for regular cigarettes and tobacco products. So why did the Health Ministry in India push the ban? 

Worse, the Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (COTPA) does not put a ban on the production, supply, distribution and sale of cigarettes and tobacco products. It is common knowledge that the COTPA was instead enacted to prohibit advertising and regulate production, supply and distribution of cigarettes and tobacco products. Provisions were also made to regulate sales of cigarettes and tobacco products. The government’s control was simply limited to cigarette and tobacco advertisements, and regulate trade and production. Now many (read bureaucrats and lobbyists) felt the Indian government should exercise more control over the tobacco market and hence a declaration came under section 2 of the existing act.

So let’s shift to the deliberations that took place in Washington. 

Two prominent speakers—David Ashley, a former director of the Office of Science at CTP, and Vaughan Rees, director of the Centre for Tobacco Control at Harvard—agreed that vaping had a place in ending combustible smoking. But it was still facing objections, bans across the world. 

“What’s the ethics of doing that—misleading people?” they asked.

Marc Slis, a vape shop owner in  Michigan, was quoted giving a fiery speech about how the FDA’s bureaucracy was driving adults back to cigarettes. Robin Mermelstein, a distinguished professor of psychology at the University of Illinois Chicago, applauded previous tobacco control efforts but he said there should be more communications to discuss relative risks among nicotine products. 

Dr. Jasjit Ahluwalia, a physician and public health scientist at Brown University, referenced a recent study in the Filter Mag that suggested 60 percent of doctors in the US think nicotine causes cancer, and argued that the FDA wasn’t just failing to combat the misinformation, but may even be contributing to it. 

Dr Ahluwalia had a serious point of view. He felt since so much public messaging on vapes now revolves around mental health—referencing Crosby’s earlier presentation about the FDA linking nicotine withdrawal to short-term anxiety and depression in its youth prevention campaigns—people might easily start to believe that nicotine is the direct cause of those conditions. And that would not be right.

Crosby responded that her department is careful to link short-term anxiety and depression to nicotine withdrawal, not nicotine itself. Yet Ahluwalia urged better messaging, even comparing the FDA’s communications with those of the Truth Initiative, the prohibition-leaning NGO which has plastered the internet and empty storefront windows with fake advertisements for a “Depression Stick,” a satirical vaping product whose name purports to be honest with the user.

Clive Bates, former director of the United Kingdom’s Action on Smoking and Health, asked panellists if many in tobacco control simply had it backwards—was nicotine not a cause of anxiety and depression, but a treatment?

“Is it ever right to exaggerate risks to get the behaviour change you want?” Bates was quoted. “Is it okay to imply, by omission or commission, that vaping is as harmful as smoking just because you want to deter young people from using these products? What’s the ethics of doing that—misleading people to get behaviour change?” His question was answered not by the FDA representatives, but by Dr. Kevin Gray, a professor of psychiatry and behavioural sciences at the Medical University of South Carolina, who said that nicotine was not a good way to modulate those unpleasant feelings.

“Despite what people like you think, we do try our best to communicate that stuff.”

Shifty Enforcers

In a space intended to open up constructive dialogue, the frustration of the audience—and the panelists—was typically palpable. Slis, the vape show owner, lambasted the PMTA process while sharing a stage with Holman, who repeatedly deflected, implying there was only so much under his and the FDA’s control. “Go down the hill here to the Capitol, because they wrote the law,” Holman said. “We have jurisdiction over the product[s] that Congress gave us jurisdiction over, [and] we just got jurisdiction over synthetic nicotine. We didn’t choose that. Congress wrote a law, and now we’re responsible for implementing it,” Holman was quoted in top US magazines which covered the event.”

Sitting next to Holman on the panel, Bates conceded the point to an extent, but suggested that the FDA has far more space to interpret its implementation of laws—and conduct its communications—in a way that supports harm reduction.

“There are a lot of restrictions on what we can say, how we can say it, the process we have to go through in order to say it publicly that are really challenging,” Holman said. “And despite what people like you think, we do try our best to communicate that stuff.”

“No,” Bates deadpanned. “I do think you try your best.”

A range of global experts have stressed that aggressive measures are urgently needed to facilitate quitting smoking among smokers who want to quit.

The experts stated this at the 2022 E-Cigarette Summit, held in Washington DC, USA to address issues of tobacco addiction, health risks to young people, nicotine use and management in relation to smoking cessation.

In his presentation titled; The Risk Continuum: Nicotine and Public Health, Professor Emeritus of Medicine, University of California San Francisco, Neal Benowitz, said nicotine has effects on every part of the body and some clinical research suggests its potential harm.

“There is a continuum of risk. Non-combusted nicotine use, while not harmless, is much less harmful than cigarette smoking.

“Nicotine, alcohol and cannabis all have substantial perceived benefits for users. Nicotine is potentially more addictive than other drugs, but severity of addiction depends on the delivery system. High addiction liability may pose particular risks to youth. Alcohol and cannabis can be addictive and those with use disorders are probably more dangerous than non-combusted nicotine,” says Benowitz.

Professor Dorothy Hatsukami, department of psychiatry and associate director of cancer prevention and control for the Masonic Cancer Center at University of Minnesota, said the approach that will lead to the greatest reduction in the prevalence of smoking is likely to be reducing the addictiveness of cigarettes.

Presenting on the topic; “Nicotine Product Standard for Combusted Tobacco: Support and Barriers,” Hatsukami said cigarettes are killing more than 480,000 smokers each year in the US alone. “Recently, researchers have been systematically and comprehensively examining the potential effects of a nicotine level product standard for cigarettes. To date, results from randomised clinical trials indicate that, compared to smokers assigned to smoking normal nicotine content cigarettes.

“Those who are assigned to very low nicotine content (VLNC) cigarettes reduce the number of cigarettes per day, and as such lower exposure to toxicants and cigarette dependence. They also exhibit a comparatively higher rate of cessation and quit attempts,” she said during the conference.

(Shantanu Guha Ray is a Wharton-trained journalist and award-winning author. He lives in Delhi with his wife and two pets.  He won the 2018 Crossword award for his book, Target, which probed the NSEL payment crisis.)

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