Daily Archives: October 5, 2017

FDA response to Goodall letter found lacking

On September 25, 2017, Dr. Scott Gottlieb , Commissioner of the U.S. Food & Drug Administration (FDA) replied to a scathing letter from Dr. Jane Goodall, where Goodall denounced what she called the “cruel and unnecessary nicotine addiction experiments on monkeys”. We previously evaluated that letter from Goodall and now do the same with Commissioner Gottlieb’s letter.

The FDA Commissioner’s letter starts with an acknowledged appreciation of Goodall’s opinion and a re-statement of the FDA’s commitment to compliance with the rules and guidance governing the use of animals for research. It is indeed admirable that Commissioner Gottlieb places emphasis on compliance with the long-standing regulatory framework and guidance governing animal research in the US. What is unacknowledged in the letter is that all studies involving animals used in research, including the one that Goodall references, are continually monitored with respect to such compliance.

Gottlieb writes:

“After learning of concerns related to the study you referenced, I directed the Agency to place a hold on the research study earlier this month. Accordingly, at this time, all experimentation involving the monkeys in the study you referenced has been halted.”

Several things are surprising about this approach. Foremost, the vague reference to “concerns” when coupled with the failure to mention the review and oversight mechanisms in place, can give a public impression that is confusing. For example, is Gottlieb saying that his response is driven by Goodall and WCW? Speaking of Research, like the scientific community, supports an effective oversight system that has mechanisms for investigation and correction of animal welfare issues. In this letter, however, the Commissioner appears to bow to celebrity opinion, halting an ongoing experiment without providing evidence or acknowledgement of the continual monitoring that surrounds research. In fact, subsequent media coverage of Gottlieb’s response also conveys the impression that the decision was made directly in response to Goodall’s letter.

This is alarming on many levels. There is, for example, no acknowledgement of contact with the research institution’s federally-mandated review board (Institutional Animal Care and Use Committee, IACUC), no mention of the FDA’s process for review of research, or evaluation of records. Instead, the letter suggests that the federal agency’s decision is a bow to celebrity pressure from Goodall, who is acting on behalf of an anti-animal research organization (White Coat Waste, WCW).

Gottlieb continues:

“I asked for a medical team of primate experts to conduct a site visit to evaluate the safety and well-being of the monkeys and to understand whether there are additional precautions needed.”

This statement and the announcement of “halting” the study, absent any other information, imply that animal health and well-being are in immediate jeopardy. The evidence for that claim is not presented. If the animals were in immediate jeopardy, we would expect that the facility’s personnel would be taking action. Whether that is the case or not cannot be ascertained from Gottlieb’s letter. At the very least, the commissioner’s letter should acknowledge any ongoing efforts by his agency’s personnel—including those at National Center for Toxicological Research (NCTR).

Squirrel monkey. Source: Wikipedia Commons.

The letter can leave readers with the several wrong impressions by leaving out any information about the expertise of the existing veterinary, animal care, and scientific staff at the federal facility. Readers may be left with impression that primate experts—including scientists and veterinarians — are absent at the long-standing federal research facility, the NCTR. That is unlikely to be the case. Further, even when people with a high level of expertise and experience are present, adverse events that require thoughtful review and modifications in procedures sometimes occur. Animal research, like all human endeavors, has potential for error. Research teams, IACUCs, and regulatory bodies all play a role in making sure that those errors are addressed and corrected. Thus, in light of full transparency, actions taken by the institutional IACUC, the scientists, and the facility’s veterinarians, along with further information including the timing and venue for a public report of findings before decisions are taken need to be specified.

Gottlieb’s letter continues:

“I also appointed an independent FDA review team, led by senior career experts and with the guidance of primate veterinarians, to assess the science and integrity of the animal research process for this study. I also asked this team to evaluate whether the re-initiation of the study you referenced is necessary to fulfill FDA’s public health responsibilities, or if the study should be halted indefinitely.”

This is one of the more troubling aspects of the FDA commission’s letter as it is unclear whether he is aware that firstly, this study must have gone through rigorous review in terms of scientific merit, evaluation of the risks to the animals being used as well as the proposed benefit to humans, when it was funded. Secondly, the IACUC at this institution will have vetted all procedures being performed on these animals, including consideration of response and correction should an adverse situation occur.

Finally, separate to this letter, but parallel to this issue, an FDA spokeswoman is quoted as stating, “the agency is also considering creating a wider-ranging function that would provide for even greater oversight of the care of animals in the agency’s possession.”

This statement is alarming in its lack of specificity and requires clarification. Does it mean that FDA is conducting a re-assessment of the existing federal structure for reviewing and conducting all animal research? If so, what is the impetus for the review? How is it different from existing policies? Who is involved in the review? What is the process by which public interests in scientific research that informs public health policy will be protected and scientific objectives balanced with animal welfare? How will the public be assured that the full range of relevant expertise is included in the review? There are many additional questions—all raised by the statement, none addressed, as far as we are aware, by any other materials provided by the FDA.

Finally, it is also important, in light of full transparency that the FDA provides an update about its ongoing lawsuit with WCW. The WCW suit appears to have arisen as a consequence of the FDA’s response to a WCW freedom of information (FOIA) request for records about the NCTR research. At this time, it is unclear whether the FDA’s decision to suspend this ongoing and already scientifically-justified funded research is related to this lawsuit. The Washington Post writes:

“Goodall was enlisted in the fight against the monkey tests by the White Coat Waste Project, an advocacy group that says its goal is to publicize and end taxpayer-funded animal experiments. In January, the organization obtained 64 pages of documents on the nicotine-addiction research from the FDA under the Freedom of Information Act. It is suing the agency to get more information on the research’s costs, as well as veterinary records and photographs and videos of the experiments.”

Speaking of Research is not the only organization concerned with the FDA response. The American Psychological Association (APA), the American College of Neuropsychopharmacology (ACNP), and the College on Problems of Drug Dependence (CPDD), have jointly penned their own letter to the FDA demanding a clear explanation for the suspension of the nicotine research project. Part of it is quoted below:

“As you may be aware, Dr. Goodall’s letter to you came at the behest of an organization, White Coat Waste Project (WCW), that is fundamentally opposed to all research with nonhuman animals. Your decision to suspend the research is extremely troubling because it appears to have occurred without any substantive input from experts in the scientific community who have deep knowledge and understanding of research on substance use disorders. Furthermore, the methods and technologies used in this study have been rigorously validated and commonly used in studies of substance use disorders, including research that is funded by other federal agencies, such as the National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA).”

Speaking of Research shares the APA, ACNP and CPDD’s concerns. We hope the FDA will be forthcoming with an explanation of the suspension of the research project in question. We also hope that they will be taking the evidence of experts over the opinions of prominent celebrity scientists and animal rights groups.

Speaking of Research