For immediate release
Speaking of Research response to FDA announcement regarding nicotine research
Late on September 25, as reported by the Washington Post, the US Food and Drug Administration (FDA) made the startling announcement that it has suspended a nicotine research project involving non-human primates; the goal of this research is to build a better scientific approach to preventing and treating smoking and its associated health complications. The FDA has not yet provided evidence or clear justification for why they took this action. This lack of transparency is concerning not only for halting an important research program that had the potential to improve human health, but also for the welfare of the animals involved.
The FDA yesterday began a review of animal welfare at the National Center for Toxicological Research (NCTR) where the research was conducted. The reason given for the review is four animal deaths that occurred over an unspecified time period. Whether the deaths were associated with the research procedures is also unspecified. While it is not clear when the deaths occurred, the article and timing of the announcement followed closely after publicity from a letter by celebrity primatologist Jane Goodall to the FDA Commissioner, stating her opinion that the research should be halted. Furthermore, Dr. Goodall has aligned herself with an anti-animal research group, The White Coat Waste Project, which perpetuates the notion that research addressing the health problems associated with substance use disorders, including problematic tobacco use, in animals is unethical. Together, these events raise the extremely disturbing possibility that the FDA may have relied on claims provided by individuals with no scientific background or expertise in addiction science to make their decision, rather than on sound scientific evidence.
In an open letter posted at Speaking of Research on September 22, dozens of scientific experts, including the many of the nation’s leading scientists conducting research into drug abuse and alcoholism, expressed deep concern over Dr. Goodall’s egregious and unscientific remarks. Research into the biological effects of nicotine using primate models has, and continues to be, critical for understanding and development of medications for tobacco use, which is unquestionably a major public health problem worldwide. That this research could be halted due to political reasons is outrageous, and speaks to the influence of a group opposed to animal research and their celebrity allies over science that impacts the health and care of our citizens.
Dr. J. David Jentsch, a spokesperson for Speaking of Research said:
“Speaking of Research condemns the lack of transparency surrounding the decision to halt important research into understanding addiction. We call on the FDA to provide much greater transparency on this issue, including a full explanation as to why they have cancelled the studies, and information on the findings of any and all inspections of the NCTR facility leading up to this decision.
“We are gravely concerned over the influence that Jane Goodall and the animal rights organization The White Coat Waste Project appear to have over FDA research. Animal research remains a critical component of our understanding of disease and the development of new treatments to tackle them. The FDA must be led by the advice of the research community, not from those minimal understanding of key scientific issues.”