Has Ethics in Medical Research Completely Disappeared? Study Assigns Half of Pregnant Women Subjects to Continue Smoking

A clinical trial published last week in the journal Preventive Medicine randomized pregnant women who smoked to either continue smoking their usual brand or to switch to a very low nicotine content cigarette brand. The study did inquire whether the subjects wanted or intended to quit smoking and excluded those who did. Nevertheless, after this initial indication of their present intentions, the subjects randomized to the "control" group were instructed to continue smoking their usual brand of cigarettes. The subjects in the "intervention" group were also instructed to continue smoking, but to do so using the very low nicotine cigarette brand.

The Rest of the Story

This trial raises the question of whether it is ethical to have a control group that is instructed to continue smoking, which is knowingly going to cause fetal harm to these pregnant women. 

The answer is a resounding "No." This is unethical research.

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 women smokers being treated by obstetricians was to do nothing to change their smoking behavior if they did not express an initial desire to quit or did not think they were going to quit, 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 certainly not to instruct them to continue smoking!

According to the guidelines set forth by the U.S. Preventive Services Task Force, usual care for pregnant smokers is: "advise them to stop using tobacco, and provide behavioral interventions."

In order to meet basic ethical standards in medical research, the control arm of the study would had to have consisted 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.

The intervention protocol for this clinical trial was also unethical because it offered a treatment that is worse than standard care. These pregnant women, too, were instructed to continue smoking, rather than being advised to quit smoking and provided with behavioral interventions to help them quit smoking.

The only ethical way to conduct this study would have been to offer both groups the minimum standard care, meaning that both groups of patients should have received clear instructions to quit smoking and immediately provided with effective behavioral interventions that have been shown to increase smoking cessation. On top of that standard care, it would have been acceptable to provide one group with very low nicotine cigarettes to use if they were unable to comply with the physician's recommendation to quit smoking.

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.

There are two potential counterarguments to this position but both fail.

First, one could argue that since these women did not plan to quit smoking, no harm was being done by assigning them to a group with instructions to continue smoking. However, this argument fails because these women were knowingly harmed by instructing them to continue a behavior known to harm the fetus and failing to provide the minimum standard of care typically offered to pregnant smokers outside of the research setting.

Second, one could argue that the women were not prevented from quitting smoking if they chose to. However, this lands fall short of the ethical standard. It is not enough to allow nature to take its course if standard practice calls for medical intervention -- namely, the U.S. Preventive Services Task Force's recommendation to advise quitting and provide behavioral modification therapies. 

Since the trial appears to have been completed, I cannot call for a discontinuation of the study. However, I am calling for the retraction of the study for violation of research ethics and some sort of compensation for the study participants.  

Anti-Vaping Physician Claims that a Single Vape Can Cause Severe and Irreversible Lung Disease

In an article posted late last month on Medscape, a physician claimed that using even a single vape can cause severe and irreversible lung damage.

Here is what she writes:

"Vaping has become a global health epidemic affecting everyone from high schoolers all the way to adults. This has gained popularity in recent years, but what people don't know is that vaping has now been shown to be linked to irreversible lung damage. It has been linked to conditions such as bronchiolitis obliterans, which is narrowing and scarring of the small airways due to diacetyl, which is found in nicotine liquid in vapes. Also, vaping has been linked to lung collapse,which can then cause hospitalizations and require patients to have chest tubes, or EVALI, which is a significant, life-threatening disease that can leave patients on a ventilator. 

It's important for us to counsel our patients and to advise our patients that these risk factors do exist when using their vapes every day or even socially on occasion. It only takes one time to try it to end up with any of these irreversible lung conditions."

 

The Rest of the Story

 

The rest of the story is that this physician is, unfortunately, lying. It is simply not true that it takes only one time to try vaping to end up with irreversible lung disease. The claim is ridiculous on its face. Even if you smoke an actual tobacco cigarette you cannot end up with irreversible lung disease. It takes years and years (if not decades) of smoking before you develop irreversible lung damage. So clearly, you're not going to develop irreversible lung disease from a single vape. It's not even clear at this point whether years of vaping will lead to chronic lung disease. There is no evidence that vaping causes bronchiolitis obliterans. Furthermore, the EVALI scare was caused not by e-cigarettes, but by black market THC vape carts that had been laced with vitamin E acetate. 

 

The question is: why does this physician feel a need to completely over-exaggerate the risks of vaping in order to try to dissuade youth from vaping? What this tells me is that subconsciously, she realizes that what she is trying to convince people of is a load of crap and so the only way she can try to make it credible is to actually make it so unbelievable that people's fear overtakes their rational thought processes.

 

Years ago, we tried the same thing with secondhand smoke. We scared people into believing that only 20 minutes of exposure to secondhand smoke could cause you to drop dead from a heart attack. In fact, it was that claim that led me to start this blog in the first place. 

 

Sometimes it is easier for people to believe a huge lie than a smaller one. So the more exaggerated the claim, the more people are likely to believe it. This is because the exaggerated claim generates an emotional response, leading to the person interpreting the response based on their limbic system (the emotional part of the brain) rather than their brain cortex (the rational part of the brain). 

 

Were this physician to advise smokers trying to quit not to use e-cigarettes because of its pulmonary effects, that would essentially be malpractice. Were she to list methods proven effective to quit smoking, but omit e-cigarettes (the single most effect approach to smoking cessation short of quitting cold turkey), that would be tantamount to malpractice. 

 

Whoops.