Imagine if there were a very low-alcohol drink that could help wean some heavy drinkers off alcohol. A researcher conducts a clinical trial among pregnant women who are heavy drinkers, in which half are randomized to receive a supply of very low-alcohol beverages, and the other half are asked what they like to drink and then provided with a three-month supply of, say, vodka.
This would obviously be an unethical research design because the standard care for pregnant women who drink alcohol is not to supply them with a trimester’s supply of vodka.
If that scenario troubles you, then you should be equally troubled by an actual clinical trial that was carried out using a similar protocol. Just substitute cigarettes for alcohol.
In a National Institutes of Health-funded clinical trial last month in the journal Preventive Medicine, investigators at the University of Vermont randomized pregnant women who smoked to either continue smoking their usual brand or to switch to a very low-nicotine content cigarette brand, which some research suggests could be helpful in smoking cessation. Moreover, researchers supplied pregnant smokers in the control group with free cigarettes, incentivizing them to continue smoking.
Although the study inquired whether the subjects intended to quit smoking and excluded those who did, the subjects randomized to the control group were nevertheless instructed to continue smoking their usual brand of cigarettes. They were also supplied with free cigarettes to smoke during the study period. The researchers asked about their preferred brand and provided it at no cost.
This trial raises the question of whether it is ethical to have a control group of pregnant smokers that is instructed to continue smoking.
The key criterion in determining whether instructing a control group to continue doing a behavior known to be harmful to them is whether or not they are being offered “usual care.” In other words, if usual care for pregnant smokers being treated by obstetricians were to give them a free supply of cigarettes if they did not express an initial desire to quit or did not think they were going to stop, then this trial would have been ethical.
However, usual care for pregnant smokers who did not express an initial desire to quit is not to do nothing. And it is undoubtedly not to instruct them to continue smoking!
According to the guidelines set forth by the Preventive Services Task Force, usual care for pregnant smokers is “advise them to stop using tobacco, and provide behavioral interventions.”
To meet basic ethical standards in medical research, the control arm of the study would consist of advising the patients to quit smoking and providing behavioral interventions to help them quit smoking. Instructing the patients to continue smoking as usual is not consistent with this usual care guideline.
Absent a physician’s clear recommendation to quit smoking and absent being provided with a behavioral intervention to enhance the chances of smoking cessation, this clinical trial failed to provide even a minimum standard of medical care and is therefore unethical human subjects research.
The primary ethical principle of medicine is “to do no harm.” Here, physicians were harming by providing deadly cigarettes to pregnant smokers, knowing that these cigarettes would invariably cause harm to the fetus. Some of the effects that smoking has on the fetus are inhibiting growth, damaging the lungs and brain, raising the risk for birth defects, raising the risk for stillbirth and SIDS, and increasing the risk of low birth weight.
It is one thing for these harms to occur if a woman makes an informed choice to smoke during pregnancy and buys her cigarettes. It is another thing for physicians to facilitate this damage by supplying those cigarettes for free throughout 12 weeks of the pregnancy.
Why, in 2025, is research being conducted on smokers that violates ethical principles? One possibility is that the anti-tobacco movement has largely given up on smokers. There is no better example than the many health groups pushing for electronic cigarette bans despite millions of smokers quitting use of these devices. The American Lung Association has gone as far as stating that if you quit smoking by switching to e-cigarettes, you haven’t actually quit smoking, even though you are no longer using cigarettes! Given that switching to vaping is now one of the most popular and effective methods for smoking cessation, this advice is actively discouraging smokers from quitting.
If the product being studied were alcohol, no institutional review board would allow a control group of pregnant heavy drinkers to be provided with a free, three-month supply of vodka. Here, however, the institutional review boards were apparently not concerned about pregnant smokers being supplied with cigarettes.
In 2025, we are apparently more concerned with youth hitting cherry vapes than we are about helping the nation’s 28 million smokers to reduce their risk of disease and death.
