FDA ends nicotine addiction experiment on squirrel monkeys

Earlier this month, the FDA announced it was permanently ending nicotine addiction experiments on monkeys that were part of the agency’s potential effort to force cigarette manufacturers to lower the nicotine content of their products. In a November 2017 letter to Commissioner Gottlieb, CASAA commended this decision and urged the FDA not to resume these misguided studies or rely on their flawed results to inform public policy that affects more than 38 million Americans.

Presently, the biggest mistake made in tobacco and nicotine research is taking research results that may only inform theory or provide foundational knowledge and using them to support policy. This practice is not only grossly unscientific, it is a recipe for the construction of harmful policies.

The results of human studies (See Donny [2016] et al., and Benowitz [2015] et al.) on low nicotine cigarettes have already shown equivocal results in support of the FDA’s proposal to drastically reduce nicotine levels. In spite of these weak human study results, the FDA states it plans to rely in part on unreliable nicotine studies using monkeys to inform a policy that will significantly reduce the amount of nicotine in cigarettes.

A non-human animal that does not choose to smoke and is forced to live in a controlled, sterile and highly stressful captive environment is incredibly unlikely to adequately inform questions about the complex behavior of human smokers who have considerably more complex brain functioning and live in a much more complex world.

The use of animals in studies putatively designed to inform tobacco policy is misguided, unreliable, and unethical. CASAA strongly objects to them on this basis. The scientific justification for conducting these studies in the first place is extraordinarily weak and results have no place informing decision making on policy matters that stand to have an impact on a considerable number of people.

CASAA urges the FDA to discard these animal studies from considerations related to policy making on both scientific and ethical grounds. Moreover, if it is to accept animal studies for consideration, CASAA urges the FDA to accept only those with the highest scientific standards and justification, and then only used for informing basic concepts and theories related to the policy in question, not for informing the potential implementation of any particular policy.

–From Consumer Advocates for Smoke-Free Alternatives Association, Students for Sensible Drug Policy and Not Blowing Smoke in a letter to FDA Commissioner Scott Gottlieb