The FDA Commissioner, Scott Gottlieb, made a statement last week that claimed animal welfare concerns had led to his agency’s decision to end a primate research project aimed at better understanding nicotine addiction in adolescents. However, details revealed in the project documents that were also released by the agency last week raise doubts about the rationale for both the decision and the process, and furthermore, raise the possibility of political interference in the scientific endeavors of the federal agency.
In brief, these documents show that just days after the Commissioner received a letter from British chimpanzee researcher Jane Goodall the Commissioner’s office did more than suspend the research pending a new review. They also ordered the facility to conduct a medical procedure that would subject the monkeys to anesthesia (see below and page 24 of FOIA document) – the very same procedure that had already been determined to be related to several of the monkeys’ deaths.
These documents show two things. First, they appear to fly in the face of concern for animal welfare. The Agency ordered surgery be performed on healthy animals ahead of the announced internal review. Furthermore, the Agency’s head office ordered a procedure that involves anesthesia, the very same thing that was involved in three animals’ deaths and which was currently undergoing review within the facility. According to our sources familiar with the research, the internal concerns had already led to a voluntary moratorium on unnecessary anesthesia and surgery.
The surgery ordered by the Commissioner’s office was not to address an urgent medical concern, or an issue related to the animals’ immediate health. It was to remove catheters placed for the research. The released records do not indicate that the catheters were causing any medical complication, nor were the catheter lines obstructed (i.e., the catheter lines that carry fluids were categorized as “patent,” a term used to mean that they are not blocked or otherwise compromised.) Removing patent catheters was not in the approved protocol. That is evidenced by the document showing that solely as a consequence of the Commissioner’s order, the PI was required to ask the facility’s Institutional Animal Care and Use Committee (IACUC) to approve the procedure (see below, and page 25 of FOIA document).
What is curious is that removing the catheters involves anesthesia and surgery. Given that the previously reported deaths of three animals were from complications associated with anesthesia performed by veterinarians, the course of action demanded by the FDA seems counter-intuitive. Fortunately, there is no evidence that removing the catheters resulted in harm to the animals; however, the action appears to have created needless risk to animal welfare.
Rather than providing more clarity, the released documents raise further concerns and questions. In particular, they raise questions about why the Commissioner’s office ordered the surgery and how they balanced consideration of risk and animal welfare. The scientists, animal care staff, veterinarians, IACUC, and administration at the NCTR were clearly operating under orders by Gottlieb’s office and did not themselves initiate the catheter removal, as is shown in the IACUC amendment (image above). One must question, however, why the IACUC approved it and allowed the procedure to go forward given that the IACUC should have the authority to act in the interest of animal welfare. Whether IACUC deliberations included discussion of the potential risk is unknown and does not appear to be included in the public records.
The released documents also reveal that the decision about the research was likely made almost immediately after the letter from Jane Goodall and well prior to the conclusions of the internal review. The documents about the catheter removals likely provide confirmation of that decision. That is because one logical explanation for why the surgery was ordered is that it would be very unlikely that the same animals would continue in research following removal of the catheters. This is simply because the study was specifically interested in comparing “the initiation and long-term maintenance of nicotine self-administration in adolescent and adult subjects.” When the catheters were ordered to be removed, it effectively meant that a new set of monkeys would have to be used to resume the research and answer the original scientific question. At the very least, it would have meant the animals underwent an unnecessary surgery procedure.
In sum, although the FDA’s announcement in September indicated a suspension of the project pending review to inform the decision about whether to continue the research, in reality, it appears that the decision had already been made. Thus, what we see is a pattern of concern surrounding the FDA’s decision-making process and public communication—not only for this study, but more broadly about the entirety of the agency’s animal research program. If it is the case that political expediency, rather than concern about animal welfare, was a primary motivation for the rush to subject animals to anesthesia and surgery, then it is unclear what to expect in the future from the FDA’s new policies and approaches that govern its work.
We add these to the list of questions that remain from the most recent announcement. In Part 2 of our post, we will discuss those questions and further consideration of the records released.
Speaking of Research