Is the FDA undermining its own study and the experts it sent to review it?

The American Psychological Association has warned that the FDA may be winding down its own primate study, despite having started– but not completed, nor made public– an independent FDA review process. Why the FDA would stop the study before any report has been published will lead many into further questioning the influence that certain animal rights groups appear to have on FDA policy.

Last September, British chimpanzee researcher Jane Goodall wrote to the FDA to criticize one of its scientific research programs aimed at better understanding nicotine addiction and its effects on young people. As reported by the Washington Post, the agency’s head, FDA Commissioner Scott Gottlieb, responded to Goodall with a publicly posted letter in which he indicated the research had been halted.

Squirrel monkey. Source: Wikipedia Commons.

Gottlieb’s response to Goodall raised concerns in the scientific community and beyond. Multiple organizations responded by reaching out to the FDA commissioner. Scientists and scientific organizations questioned the federal agency’s unusual actions in abruptly halting an ongoing and approved study without providing full information about the decision-making process, the nature of the review, and the timeline for a public report.  Speaking of Research published a letter of concern signed by 46 researchers and endorsed by 78 additional scientists, including well-known experts in substance use disorders. We also analyzed the problems in Goodall’s letter to FDA and her previous efforts in various campaigns against animal research.

In a publicly posted letter, the American Psychological Association (APA), American College of Neuropsychopharmacology (ACNP), and College on Problems in Drug Dependence (CPDD) wrote:

“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). Your letter to Dr. Goodall states that ‘currently there are still some areas for which non-animal testing is not yet a scientifically valid and available option.’ We strongly agree with that statement. We also believe that it falls short of fully recognizing and communicating the important role of nonhuman animal research in both basic and applied science.”

Months later, Gottlieb has apparently not responded to concerns raised by the scientific organizations, nor has the FDA provided a public account of the review process mentioned in the Sept. 25 letter to Goodall. In that letter, Gottlieb mentions two review teams:

“After learning of concerns related to the study you [Goodall] 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. 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. 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.”

To date, to our knowledge, there has been no public information about what appears to be a highly unusual, perhaps unprecedented, process. The impetus and criteria for review; the identity, expertise, and selection process for the review teams; the charge, scope, and process for review; the review teams’ reports; the agency’s conclusions; whether these represent a change in policy for FDA research all remain largely unknown.

Now, however, there are indications that the agency was already taking actions to end the research program well ahead of the conclusion of the review or response to the concerns. Today, APA expressed continuing concern and request for response from the FDA in a science alert titled, “FDA Shuts Down Nicotine Research Study, Overlooking Concerns of Scientific Organizations:”

“Update — There are indications that prior to completion of the FDA review and promised report, the agency has already taken multiple steps to effectively end the research program. Even if the reviews are positive, the research cannot be resumed with those animals, and the FDA is preparing to transfer the study animals to new locations, some of which may not ensure adequate protections. This process upends procedures of the National Center for Toxicological Research, which sponsors the research, and ultimately wastes public dollars since the study cannot be followed to its conclusion.

Conclusion  FDA appears to be ignoring the concerns of established scientists and scientific organizations, while placing nonhuman animals at potential risk and failing to fund research in the public interest.”

We have previously expressed concern about the process and potential precedents in the way FDA has approached this research. We call on the FDA to explain its procedures and rationale for this abrupt action, including why it did not seek counsel from experienced substance abuse researchers who were qualified to evaluate a study that had been lauded and highly rated. For a federal agency to suspend and ultimately stop research on a critical public health topic using such an unusual and opaque process is of deep concern for public interests in scientific and medical progress.

We again call on the FDA to provide greater transparency about the motivations and evidence behind its decision to terminate important research. The FDA is in a better position than most to understand the important role that animal studies play in the development of modern treatments. Instead of seemingly pandering to animal rights groups, it should be at the forefront of the scientific community – explaining how and why animals are used to further medical developments.

Speaking of Research


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