CNN Features NABR, FBR President in Coverage of FDA Nicotine Research

This morning, Matt Bailey, NABR and Foundation for Biomedical Research (FBR) president, expressed concerns in an article by CNN covering the recent decision by the Food & Drug Administration (FDA) to end nicotine studies with primates.

Countering claims by Justin Goodman, Vice President of Advocacy and Public Policy of the animal rights organization the White Coat Waste Project (WCW), that such research is a misuse of federal tax dollars, Bailey said, “Research into the effects of nicotine is indeed a public health issue, especially given the rise in popularity of vaping devices among teenagers.” Adding, "My understanding is that the research project in question aimed to determine whether there is or is not a safe level of nicotine absorption by young people." "That's an important question," said Bailey.

Bailey also addressed concerns regarding additional regulatory burden, saying any efforts to augment animal care must be done without impeding the speed of finding breakthroughs. "Additional oversight efforts need to be balanced by efforts to reduce the significant amount of regulatory burden felt daily by research scientists in the US."

"Animals played a role in the development of each of the top 25 most prescribed drugs in America," Bailey said. Adding that our pets, farm animals and wildlife also benefit from medical treatments developed in part from animal research, he noted, "Farm animals and wildlife are routinely vaccinated against any number of diseases, but those vaccines wouldn't be available without animal research. So if you love animals, you really should support animal research."

"Undoubtedly, some will argue that this recent action by the FDA is a reason to end research with animal models. But given the inextricable role humane and responsible animal research plays in the health of the overall population, and the health of the animals about which we care so deeply, that is a very dangerous proposition," he said.

Please click here to read Bailey’s interview by CNN

Time is Running Out to Register for NABR’s Next Webinar!

Time is running out to sign up for NABR's next webinar! If you would like to attend and have not yet reserved your spot for “The 2017 USDA Inspection Data: Celebrating a New Milestone in Compliance?”, scheduled for next Tuesday Feb. 6 at 12:30 p.m. (EST), please do so immediately.

NABR collects information from the USDA’s Animal Care Inspection System database each year to review the inspection results for the previous fiscal year. Our efforts this year were complicated by a lack of access to the searchable database which could be used to download data into spreadsheets for what would have been a relatively straightforward analysis of the actual inspection data. The new Public Search Tool provides data efficiently, but the data is difficult to analyze. Fortunately, with our analysis, we will provide you with valuable insight into the inspection process.

Join NABR next week on Tuesday, Feb. 6 as we look at FY2017 data and compare it to analyses from previous years. Our findings will demonstrate how the research community continues to improve compliance with the letter and spirit of the regulations. This information will help you manage your own animal care and use program in the coming fiscal year. As always, registration is complimentary for dues-paying NABR members and subscribers. Nonmembers are welcome to attend, but a fee will be applied

 

USDA-ACIS Database Lawsuit Dismissed

Last year, on February 3, 2017, in response to a privacy lawsuit about the Horse Protection Act (HPA), the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) removed from its website the Animal Care Information System (ACIS) database. The ACIS database consisted of documents concerning inspection and licensing of animal research facilities.

A coalition of animal rights groups and activists, including People for the Ethical Treatment of Animals (PETA), Delcianna Winders, Physicians Committee for Responsible Medicine (PCRM), Born Free USA, Massachusetts Society for the Prevention of Cruelty to Animals, and Beagle Freedom Project (BFP) filed a lawsuit alleging the removal of ACIS information violated the Freedom of Information Act (FOIA). As the lawsuit progressed, APHIS continued to review, update, and repost the documents, completing an official review and republishing many of the documents on its website in September 2017. APHIS then filed a motion to dismiss PETA’s lawsuit on various grounds.

On January 18, 2018, U.S. District Judge Christopher Cooper dismissed the case, finding PETA’s claims were moot, considering most of the documents had by this time been reposted by APHIS. Regarding the documents that were not reposted, the judge dismissed without prejudice PETA’s complaint, finding those documents could be obtained with a normal FOIA request by PETA, which would allow APHIS to decide whether the documents should be redacted or withheld.

Matthew R. Bailey, FBR President, said exactly that when he spoke to the media last year: “I would certainly agree that protection of personal information is of utmost importance, given the rich history of targeting individuals involved in animal research.” Read the 12-page opinion dismissal here.

European SHAC Animal Rights Extremists Sentenced

Two members of the European-based animal rights group, Stop Huntingdon Animal Cruelty (SHAC), were sentenced last week for terrorism acts.

The extremists were directly involved in a series of attacks against employees connected to the Cambridge, UK-based Huntingdon Life Sciences (HLS). These attacks included threatening HLS  employees and destroying their vehicles by setting fire bombs. Seven other SHAC members were jailed for similar crimes in 2009, and collectively they will serve a 50-year sentence.

The two defendants in this case, Natasha Simpkins and Sven Van Hasselt, were sentenced to two years and five years, respectively.

Members of SHAC USA were also convicted in 2006 for similar crimes against employees of a HLS lab in New Jersey. Among those was Kevin Kjonaas, who served six years for violating the Animal Enterprise Protection Act (AEPA), precursor to the Animal Enterprise Terrorism Act (AETA). Kjonaas is now director of operations at the animal rights group the Beagle Freedom Project (BFP).

Sign-Up Today for NABR’s First Webinar of 2018!

Please mark your calendar and join us on Tuesday, February 6 for NABR's first webinar of 2018, “The 2017 USDA Inspection Data: Celebrating a New Milestone in Compliance?”

Each year, NABR obtains information from the USDA’s Animal Care Inspection System database to review the inspection results for the previous fiscal year. This year, that effort was complicated by lack of access to the searchable database which could be used to download data into spreadsheets for what would have been a relatively straightforward analysis of the actual inspection data. The new Public Search Tool provides data efficiently, but the data is difficult to analyze. Fortunately, with our analysis, we will provide you with valuable insight into the inspection process.

We invite you to join NABR on Tuesday, February 6 when we look at the data from FY 2017 as we compare it to analyses from previous years. Our findings will demonstrate how the research community continues to improve its compliance with the letter and spirit of the regulations. This information will help you manage your own animal care and use program in the coming fiscal year. As always, registration is complimentary for dues-paying NABR members and subscribers. Nonmembers are welcome to attend.

Over 40 Scientific, Medical Organizations Write to Congress Supporting VA’s Canine Research

The amount of opposition to proposals by Reps. Dave Brat (R-VA), Dina Titus (D-NV), and freshman Brian Mast (R-FL) to cease funding at the U.S. Department of Veterans Affairs (VA) continues to rise. Today, over 40 organizations in science and medicine wrote to Congress in a letter asking them not to end funding for critical research programs for our nation's veterans.

The letter sent to Appropriations Committee Chairmen Rep. Rodney Frelinghuysen (R-NJ) and Sen. Thad Cochran (R-MS) discusses the importance of dogs to scientific progress for humans and animals and encourages Congress not to pass further impediments on research for veterans at the VA. It echoes sentiments already expressed by veteran, military, veterinary, scientific, and medical organizations like the American Association for Laboratory Animal Science (AALAS), American Brain Coalition (ABC), American College of Laboratory Animal Medicine (ACLAM), Federation of American Societies for Experimental Biology (FASEB)The American Legion, American Physiological Society (APS), American Psychological Association (APA), American Veterinary Medical Association (AVMA), Association of the U.S. Navy (AUSN), Friends of VA (FOVA), Iraq & Afghanistan Veterans of America (IAVA), National Defense Committee, Paralyzed Veterans of America (PVA), Square Deal for Veterans, and the Vietnam Veterans of America (VVA). VA Secretary David Shulkin, MD even weighed-in about the issue back in September in a USA Today op-ed.

Currently Congress is considering H.R. 3197 (the PUPPERS Act) and a similar amendment to the House-passed homeland security “minibus,” which seek to end funding for VA studies involving canines.

To read the organizational letter to Congress, please click here.

BREAKING NEWS: President Nominates Next HHS Secretary

Today President Donald Trump (R) nominated Alex Azar to fill the vacancy left by Tom Price as Department of Health and Human Services (HHS) secretary. "He will be a star for better healthcare and lower drug prices," the President announced via Twitter this morning.

Azar, who served as general counsel and then deputy secretary at the HHS under former President George W. Bush, left the pharmaceutical industry in January after almost a decade. Azar, the former president of the U.S. arm of Eli Lilly in Indianapolis, is familiar with the regulatory process and according to former Secretary Mike Leavitt, “understands the process and he knows the levers and how you make it work and where the potential roadblocks are.” He is a pragmatic and highly competent leader, according to POLITICO. Even though he has strong ties to Vice President Mike Pence, Domestic Policy Council Director Andrew Bremberg and HHS acting Secretary Eric Hargan, Azar is described as low-key, a vast difference from President Trump and his replacement at HHS, Price.

The nomination comes at a crucial juncture for the agency as it faces many questions about drug approval, pricing, importation, and the hotly contested debate over Obamacare.

The Hill reports that the nomination process will not be easy for Azar with Democrats in the Senate. He is likely to face tough questions and opposition about his former post as a pharmaceutical executive and drug pricing.

To read more on this breaking story, click here. Please also visit CNBC and POLITICO as news breaks.

AETA Upheld in Appellate Case of Animal Rights Activist Who Released Minks

Wednesday marked the first time a Federal Circuit Court of Appeals has upheld a conviction under the Animal Enterprise Terrorism Act (AETA), which was signed into law in 2006. In a 23-page opinion, the Seventh Circuit found the AETA constitutional, ruling against the claims of animal rights activist Kevin Johnson who trespassed with Tyler Lang onto the property of an Illinois farm in 2013 and set 2,000 minks and foxes loose, causing up to $200,000 of physical damage in addition to the cost of the animals and profits.

The AETA is a critical tool for law enforcement as it is the only federal law specifically designed to protect individuals involved in research from threats, acts of vandalism, property damage, criminal trespass, harassment and intimidation that place them in reasonable fear of death or serious bodily injury. Since its enactment in 2006, the frequency and severity of illegal actions in the U.S. has decreased significantly.

This appellate case arose after Johnson entered a conditional guilty plea and was sentenced to 36 months in prison, but turned to the courts to challenge the AETA arguing that he was being unfairly targeted as an animal rights activist. His challenge was overruled by District Court Judge Amy J. St. Eve in 2015 and the Seventh Circuit came to the same conclusion earlier this week.

The Seventh Circuit Court, in a decision authored by Judge Anne Claire Williams, rejected Johnson’s claim of unfair prosecution stating that “While it may be true that the people most often prosecuted under AETA are animal rights activists, this does not mean the law is vague and is being enforced in a discriminatory manner. Instead, it may simply mean that animal rights activists are the persons who are most often violating the law.”

The Court was also unconvinced by Johnson’s claims that the use of the term “terrorism” in the title of the law was “utterly unreasonable” finding that “Given the serious harms the statute was trying to address, including arson, bombing, and death threats, it was in no way arbitrary or unreasonable for Congress to include the word ‘terrorism’ in the non-codified title of AETA.” In addition, the opinion noted that “It is beyond question that Defendants' conduct of releasing 2,000 minks, destroying their breeding cards, spraying a caustic substance on farm equipment and spray painting ‘Liberation is Love’ on the barn of the mink farm ‘falls squarely in the core of what is prohibited by’ AETA.”

This decision is the latest in a string of legal challenges to the AETA that have been rejected by the Federal Appeals Courts. To read the full story, click here. For more information about NABR’s role in the passage of the AETA and the protections it provides to the biomedical research community, click here.

Yesterday’s Presentation of “Reducing Burden: Options and Opportunities” Now Available for On-Demand Viewing

Did you miss yesterday’s NABR webinar, “Reducing Burden: Options and Opportunities?" Do you want to watch it again? You’re in luck! It has been posted in the Members Only section of our website for on-demand viewing.

Please click here to view "Reducing Burden: Options and Opportunities."  You will need your NABR members-only log-in credentials to watch the presentation.

If you have problems logging-in, please contact us at info@nabr.org.

American Brain Coalition (ABC) Writes to FDA About Importance of Primate Research

The American Brain Coalition (ABC) has sent a letter to U.S. Food & Drug Administration (FDA) Commissioner Scott Gottlieb, MD about the importance of primate research and concerns about the FDA’s decision to halt primate nicotine studies. The studies could potentially increase researchers’ understanding of nicotine addiction in adolescents. FDA announced the studies would be halted until an investigation is conducted, shortly after receiving a letter from Jane Goodall, PhD, about her presumed concerns about the welfare of the animals and doubts about the necessity of the research.

ABC’s letter reiterates the importance of animal research in helping to understand and treat the 50 million Americans affected by neurological and psychiatric conditions. The letter expresses concern that Goodall may have inaccurately described the care the animals received, and also argues that she does not address why she thinks primates are an improper model for the research. The letter reads, “Dr. Goodall paints an overly broad and quite distorted picture of the legal use of animals in research. ABC hopes that the FDA will take the necessary steps to reject false representations of the use of animals in neuroscience research and confirms its support of life-saving research and the advancement of scientific knowledge.”

ABC's full letter is available here.

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