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.
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