In a revelation that has stunned public health observers, pregnant women in a government-funded U.S. clinical trial are being given free cigarettes and explicitly instructed to continue smoking as part of research intended to support a federal nicotine reduction mandate.
The trial, led by Dr Sarah Heil at the University of Vermont, split pregnant women into an intervention group and a control group. 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. All participants had their cigarettes paid for with Federal funding.
Women who continue to smoke during pregnancy put themselves and their unborn child at risk of serious har. As Dr Mike Siegel of Tufts University points out, these risks include “inhibiting growth, damaging the lungs and brain, raising the risk for birth defects, raising the risks for stillbirth and SIDS, and increasing the risk of low birth weight”.
“It is one thing for…harms to occur if a woman makes an informed choice to smoke during pregnancy and goes out and purchases cigarettes”, Siegel continued, “it is another thing for physicians to facilitate this damage by actually supplying those cigarettes for free throughout 12 weeks of the pregnancy”.
“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” Siegel continued.
“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”.
“Cost is known to be a stimulator for smoking cessation. Here, the healthcare team was taking away that potential barrier to continued smoking and essentially playing the role of an enabler”.
