FDA announcement regarding termination of primate study leaves many questions unanswered

On Friday, January 26, the US Food and Drug Administration (FDA)—the agency charged with protecting public health via oversight of food, drugs, and medical devices—issued a statement about its decision to terminate a nicotine research project at the National Center for Toxicology Research (NCTR). The research had been the focus of campaign by an anti-animal research group. It drew media attention last Fall when the FDA’s Commissioner responded quickly to a complaint from British chimpanzee researcher Jane Goodall. Yet, the scientific community, and science organizations that have written in opposition to this decision have received little response. Foremost amongst our concerns about recent events, is the general lack of transparency, and the fact that the FDA had already begun steps to cease this project before a public announcement was made. Together they set a number of worrying precedents. Among them, they raise questions about science policy in a federal agency and concerns that the FDA can be swayed by animal rights groups without disclosure to the public and consultation with other credible stakeholders.

Timeline of events surrounding FDA’s nicotine research project

Why has only select information been made available, without context, in the public explanation?
In addition to the FDA’s recent press release about their termination of the study, documents about the animals in the study were also made publicly available by the agency. Whether these documents are similar to the ones released via the FOIA to the White Coat Waste Project, is currently unknown. What we do know, through a source familiar with the research at the NCTR, is that the records and account of events provided by the FDA leave out important information, including correspondence and records that show that the scientific team leading the study halted the work in July – months before the FDA Commissioner’s  problematic public “halt” of the study following an equally problematic letter from Jane Goodall. Why has only specific information been made public?

An answer to this can perhaps be derived from careful reading of the released documents and the FDA press release. Doing so highlights a larger issue that merits broader consideration.

 “a generalized lack of adequate oversight that could lead to similar issues for other protocols and procedures, as well as several reported repeat deficiencies that occurred under the third-party animal welfare contractor used during the study.”

Specifically, the issue raised here is not with the scientific questions the research sought to answer. Nor was it in regard to the study itself. Rather, issues with third-party veterinary care during routine procedures and outside of the oversight and control of the PI seem to be the primary cause for these 4 monkeys’ deaths. Importantly, third-party veterinary care is under direct oversight of the FDA and these repeated deficiencies therefore lie squarely on the shoulders of the FDA.

Many things remain vague: Where are the monkeys going? What is the procedure and timeline for investigation of the entire FDA animal research program? What exactly is the new oversight council and what will it do?
Now that the study has been terminated, what happens to the animals? In the press release, it is stated that the animals involved in the now terminated study will be moved to a sanctuary. Again, many questions remain, particularly those relating to how the well-being of these animals will be assured in the long-term, and the external oversight and public transparency about the arrangements being made.

The FDA has also begun a “third-party investigation of the agency’s animal research programs, starting with those conducted at NCTR. This investigation, which has been initiated, will ensure not only that we have identified all significant concerns, but also help us identify ways to address any remaining or future issues for the entire animal program.”

Here again, pertinent information is missing. Does the statement actually include the entirety of FDA’s animal research, regardless of species or location? Further, who are the members of this third-party investigation and what are their qualifications?

Finally, the FDA has also “established a new Animal Welfare Council to provide centralized oversight of all animal research activities and facilities under the agency’s purview. This Council will advise the agency on its approach to animal welfare issues and ensure alignment of animal studies with the agency’s mission.

Who are the members of the Animal Welfare Council and what are the relevant qualifications? What is their mission statement, operating procedures and who has oversight over them? How will this be different from oversight and review in other federal agencies? How will public transparency of their mission, policies, and recommendations be ensured?

The American Psychological Association released a statement Monday with many questions that reflect concerns from both scientific and public health perspectives. Among other questions, APA asks:

“Why were FDA’s standing scientific bodies, in particular the Science Advisory Board to the National Center for Toxicology Research, apparently not consulted in the decisions to close the study or to pursue new forms of oversight of animal research?”

Further, the organization urges FDA transparency, concluding with:

“Looking forward, the APA will seek answers to the questions noted above and calls on the FDA to adopt a transparent and scientifically-informed approach to sponsoring and overseeing animal research.”

APA also released a factsheet about nicotine and tobacco research—one that provides accurate information about why animal studies are conducted and why it is important to inform public health.

The development of sound science policy is not easy. Such policy should be made through public consultation, or at least through a process in which the decisions, rationale, and facts are in public view. It remains to be seen whether that will occur here. However, continued discounting of vested interest parties, and in this case the scientists most qualified to do, does a disservice to the science, the animals used for research, and to public health that depends on sound science and science policy.

Speaking of Research