NABR Update_February 8, 2019

NABR Update_February 8, 2019

February 8, 2019

ILAR VA Dog Study: Your Comments Needed

As previously reported, the provisional committee for the Institute for Laboratory Animal Research’s (ILAR) Assessment of the Care and Use of Dogs in Research Funded by or Conducted at the U.S. Department of Veterans Affairs (VA) was updated to include experienced laboratory animal veterinarians Christian Newcomer and Nancy Figler Marks, translational neuroscientist William Potter, vascular surgeon Rodney White, and expert in law and animal ethics Margaret Foster Riley. The Statement of Task for the study has also been updated after ILAR’s review of submitted comments.

The second meeting of the committee has been scheduled for Thursday, February 14 from 8:30am to 10:30am EST. The agenda is similar to that of the first meeting, including presentations from representatives of the VA on the study context and expectations for the study. After the presentations, there will be a public comment session. If institutions have comments, there will be a sign-up sheet at the beginning of the meeting. Alternatively, individuals and institutions are always welcome to submit their comments to the committee via the website at any time.

OLAW Investigation Gives VA Dog Research Clean Bill of Health

In 2017, the White Coat Waste Project (WCWP) began a campaign against the VA canine research program. In response, the National Institutes of Health’s (NIH) Office of Laboratory Animal Welfare (OLAW), began an investigation into the allegations made by WCWP. OLAW’s investigation included site visits and an assessment of compliance with The Guide for the Care and Use of Laboratory Animals and the Public Health Service (PHS) policy.

One VA site, which was the focus of the WCWP campaign, was found to have “responded appropriately to the allegations of animal welfare concerns, record keeping, and reporting inconsistencies. During the site visit, OLAW found that the facility not only executed and implemented, but has consistently maintained, the appropriate corrective measures in response to the animal welfare concerns.” The report continued, “OLAW determined that the visited VAMCs are effectively supporting the humane programs of animal care and use at their institutions and conducting research with dogs and other vertebrate species in compliance with the PHS Policy, and all applicable rules and regulations.”

The entirety of OLAW’s report can be found here.

VA Inspector General to Investigate Canine Program

As part of the White Coat Waste Project’s (WCWP) continued campaign against the dog studies at the Veteran’s Administration (VA),  Rep. Brian Mast (R-FL), Rep. Ted Lieu (D-CA), Rep. Vern Buchanan (R-FL), and Rep. Dina Titus (D-NV) wrote to the VA Inspector General asking for an investigation. Despite the findings in OLAW’s investigation, the VA Inspector General has announced that there will be an investigation performed by the inspector general. This is also in addition to the review taking place on the program at the National Academies of Science.

If WCWP claims to be a taxpayer watchdog group, they are getting results that are counterproductive to their stated goal as their efforts are costing the taxpayer significantly more money. VA Secretary Robert Wilkie has continued to be an outspoken supporter of the canine research program.

President Trump in his State of the Union Address: HIV and Cancer Research are Priorities

In his State of the Union Address on February 5, President Trump indicated that it would be a goal of his administration to end the HIV/AIDS epidemic in America while also supporting further developments in cancer treatment, particularly for children. President Trump also called for the elimination of HIV transmissions in the United States by 2030. The President’s proposed budgetwill ask Congress for $500 million over the next 10 years to address childhood cancers.

Decades of animal research have gone into combating both HIV/AIDS and cancer. This goal is in direct conflict with concerted attacks by animal rights groups on the transport of laboratory animals and proposed legislation that would grind non-human primate (NHP) research to a halt. Two of the most common models used for this research, the canine model and NHP model, have been under assault for years. It is more important than ever for the research community to be engaged with Congress on these issues.

Vanda Pharmaceuticals Files Complaint Against FDA

On February 5, Vanda Pharmaceuticals, Inc. filed a complaint against the Food and Drug Administration (FDA), claiming that the FDA is requiring “unnecessary and unethical animal studies.” Vanda is currently working through the FDA development process for tradipitant, however FDA has placed a partial clinical hold on this drug and will not allow it to enter human clinical trials lasting longer than 12 weeks until nonrodent models are utilized. Tradipitant has currently been evaluated via “a three-month rat study, a six-month rat study, and a three-month dog study at doses up to 300 times the intended human equivalent dose.” The FDA has made a non-binding, but not uncommon, recommendation for a 9-month canine study which Vanda feels is unnecessary. On February 6, shares of Vanda Pharmaceutical stocks plummeted more than 19%. This is not Vanda’s first interaction with the FDA.

Redesigning the Rodent Bioassay for the 21st Century

On February 20, the Society for Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will be holding a “Colloquium on Redesigning the Rodent Bioassay for the 21st Century.” The colloquia will take place at the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland from 8:30am-12:45pm. The goal of the colloquia is to begin a conversation “between stakeholders on the utility of the chronic rodent bioassay for regulatory risk assessment”.

This public workshop will be free to attend. However, attendees that are not federal employees must preregister. Attendees can attend in person or online via webcast.

Emergency Preparedness Bill Introduced in House of Representatives

Rep. Dina Titus (D-NV) and co-sponsor Rep. Peter King (R-NY) have announced plans to introduce the Providing Emergency Plans for Animals at Risk of Emerging Disasters (PREPARED) ActHR1042. The bill would require United States Department of Agriculture (USDA) regulated facilities to submit annual emergency contingency plans. The bill mirrors regulation considered by the USDA in 2012. In a 2013 Federal Register Notice, the USDA announced that the regulation would be stayed indefinitely, pending additional review, “In this document, we are issuing a stay of those regulations in order that we may undertake a review and analysis of such requirements. We intend to conduct this additional review to further consider the impact of contingency plan requirements on regulated entities, taking into account a reexamination of any unique circumstances and costs that may vary by the type and size of businesses.”

The Humane Society of the United States (HSUS) is supporting the bill, citing research animal deaths after Tropical Storm Allison in 2001 and Hurricane Sandy in 2012. It should be noted institutions that suffered losses in these storms, as with most animal research institutions, did have emergency plans in place.

NhRP Elephant Rights Case

In December 2018, Justice Tracey Bannister of Orleans County, New York presided over the habeas corpus hearing for an elephant residing at the Bronx Zoo, represented by the Nonhuman Rights Project (NhRP). The Wildlife Conservation Society (which runs the Bronx Zoo), requested that the case be moved to Bronx County (where the zoo and elephant are located). Justice Bannister subsequently issued an order to transfer the elephant’s case to Bronx County.

In response to this order, NhRP filed a “Motion for Leave to Reargue”. This motion was filed because the NhRP believes that the decision to grant the Transfer Order was “based on numerous misapprehensions of the law and facts.” Both parties (NhRP and the Wildlife Conservation Society) argued their positions on February 1.  As of yet, there has been no announcement on the outcome of these arguments.

PETA Sued for Defamation

The owners of the dog who starred in “A Dog’s Way Home,” Paws for Effect, are suing People for the Ethical Treatment of Animals (PETA) for defamation. They claim that PETA fabricated their allegations of animal abuse. According to the lawsuit, PETA emailed Sony Pictures (distributor of “A Dog’s Way Home”) stating that Paws for Effect had citations under the Animal Welfare Act, when none such citations existed.

This is not the first time PETA has been accused of spreading misinformation. PETA’s reliance on, in their own words, controversial tactics in their public campaigns is “to get the animal rights message out to as many people as possible.” While such misinformation is often easy to debunk, PETA’s emotional misinformation can still have a damaging effect on public perception, which in turn has an effect on how Congress perceives the issues.

Virginia Mandatory Adoption Bill: Stalled in Committee

The Virginia mandatory adoption bill, HB2590, has been left in the Committee on Agriculture, Chesapeake and Natural Resources, where the committee recommended “laying on the table.” This action postpones further action, though it does not completely eliminate the bill from consideration. However, the chances of this bill seeing additional activity during this session is low considering the Virginia legislature adjourns on February 23.

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