Congress Introduces Bill to Encourage USDA Transparency

After hearing concerns from the biomedical research community, Congressman Rod Blum (R-IA) has introduced H.R.3136, the Enforcement Transparency Act (ETA).

This NABR-supported legislation would require the U.S. Department of Agriculture (USDA) to release the guidelines used in the formulation of any civil penalties for violations of the Animal Welfare Act.  At present, requests under the Freedom of Information Act for the penalty guidelines worksheet used by Investigative and Enforcement Services (IES) at the Animal and Plant Health Inspection Service (APHIS) have been denied.  Further, Congressional requests to the department for such information have been ignored.  H.R.3136 will provide the research community and the public a much greater understanding of how penalties are calculated for enforcement actions by USDA.

Please contact your Congressman today and urge him or her to cosponsor and support this common-sense legislation.  Click here to use NABR's Capwiz system to send an email directly to their offices or click here to locate your representative.

Animal Activist Pressure Results in House Appropriations Report Language

A months-long, multi-pronged campaign by a variety of animal rights groups against some National Institutes of Health (NIH)-supported research projects involving nonhuman primates has resulted in a reference made in the report accompanying the House Committee on Appropriations bill for FY 2016. Included with many other comments and issues raised in the 263-page report, is this paragraph:

Review of Maternal Deprivation Studies.—The Committee is aware that prominent experts and animal advocacy organizations have raised concerns about the scientific and ethical justifications for maternal deprivation studies involving baby monkeys being conducted in both intramural and extramural NIH funded laboratories. The Committee is further aware that the NIH Office of Laboratory Animal Welfare opened an investigation in response to these allegations on September 9, 2014. The investigations consulted with research investigators, the USDA, nonhuman primate center scientists, veterinarians, animal care staff and other relevant experts. As a result of the investigation, several modifications were made to the protocol and several procedures removed. Accordingly, the Committee requests NIH to conduct a review of its ethical policies and processes with respect to nonhuman primate research subjects, in consultation with outside experts, to ensure it has appropriate justification for animal research protocols and to provide an update on these efforts in the fiscal year 2017 budget request.

U.S. Fish & Wildlife Service Labels Captive Chimpanzees Endangered

The U.S. Fish and Wildlife Service (FWS) has announced on their website a new rule elevating the status of captive chimpanzees in the U.S. from “threatened” to “endangered.” This new ruling effectively means that biomedical research with the chimpanzee model may become difficult, if not impossible, to conduct.  Of the 36 proposed species for relisting, only captive chimpanzees would have an impact on scientific discovery. It is perplexing how reclassifying captive chimpanzees in the U.S. as endangered, which have been purpose bred for research, would result in any material benefit to the species in the wild. Ongoing research projects involving the chimpanzee model are now required to request a “take” permit from the U.S. Fish and Wildlife Service, a potentially lengthy process that will likely result in the discontinuation of  a number of current studies.

In 2013, NABR provided recommendations to the agency, explaining the past, current, and future potential benefits of chimpanzee research on both human and ape health.

Chimpanzees have been an important part of medical advancement in the United States for decades. The contribution the species has made to medicine benefits nearly every child born in America today. Most children get their first dose of the Hepatitis B vaccine at birth, and the Hepatitis A vaccine is typically administered at age 1. Without the chimpanzee model, which naturally carries the virus, researchers would not have been able to produce vaccines for either Hepatitis A or Hepatitis B.

The Service acknowledges in its rulemaking notice that chimpanzees suffer from many of the same diseases humans do by stating, “…diseases, including Marburg virus, polio, anthrax, pneumonia, human respiratory syncytical virus, and human metapneumovirus have resulted in widespread death of chimpanzees, even within national parks.” To suggest that medical research with the chimpanzee model does not benefit both the human and chimpanzee species simply is inaccurate.

The full impact the new FWS ruling will have on biomedical research is unclear.  However, it would be unfortunate, even grave, should an infectious disease outbreak occur where human lives are at stake and a chimpanzee model could expedite development of life-saving medicines.

 

Members of U.S. House and Senate Sign Letters Supporting NIH Funding

A total of 169 House members, including 29 Republicans, signed a March 25 letter supporting increased funding for NIH in FY 2016. The bi-partisan letter, organized by Reps. David McKinley (R-WV), Susan Davis (D-CA), Andre Carson (D-IN), and Peter King (R-NY), requests that NIH receive “at least $32 billion” in FY 2016. The House letter, which was sent to the chairs and ranking members of both the full House Appropriations Committee and its Labor-HHS subcommittee, states “it is critical that the United States make forward-thinking investments that promote medical breakthroughs as well as our international leadership in biomedical research.”

Similarly, a total of 54 senators, including 12 Republicans, signed a March 27 letter requesting the chairs and ranking members of the Senate Appropriations Committee and Labor-HHS subcommittee “maintain a strong commitment” to funding for NIH. The Senate letter, led by Senators Bob Casey (D-PA) and Richard Burr (R-NC), does not mention a specific funding level for NIH but urges appropriators “to consider the tremendous benefits of a sustained investment in the NIH.”

House Appropriations Subcommittee Hears NIH Director Testimony

On Tuesday, March 3, NIH Director Francis Collins appeared before the House Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies to discuss details of the agency’s FY 2016 funding request. He was accompanied by National Institute for Allergy and Infectious Disease (NIAID) Director Anthony Fauci and other institute directors.

A webcast of the hearing may be found at the subcommittee’s website and Dr. Collins’ written testimony is available here.

Harold Varmus to Step Down as Head of NIH’s National Cancer Institute

Dr. Harold Varmus announced today that he will be stepping down as the Director of the National Institutes of Health’s (NIH) National Cancer Institute (NCI) after nearly 5 years at the post.  He will leave NCI at the end of March.  Douglas Lowy, NIH’s Deputy Director and long-time NCI intramural researcher, will become acting director.

Varmus, who won the 1989 Nobel Prize in Physiology or Medicine, served as NIH’s director from 1993-1999 and returned in 2010 to oversee NCI’s work.  He plans to return to New York City to continue research into cancer care.

To read more news about Dr. Varmus and his resignation, please click here.  You can also find Varmus’ letter to NCI staff here.  NIH’s press release can be read here.

Scientific Societies Support NIH Nonhuman Primate Research

The nation’s largest primatological scientific society, the American Society of Primalogists (ASP), has made a strong statement in support of the scientist and research under attack by PETA.  The January 21 letter from the ASP Board of Directors to Rep. Lucille Roybal Allard (D-CA) and the NIH Director can be found at ASP’s website.  The American Psychological Association (APA), the largest scientific and professional organization representing psychology in the U. S., also expressed their strong support for the targeted psychology researcher and his work to interested members of Congress and the NIH.  The APA Science Directorate statement is available online along with their January 21 letter. Speaking of Research subsequently posted NIH’s defense, the scientific society letters of support and their own comments about the necessity of responsible nonhuman primate research.

Regrettably, PETA is not listening.  Despite NIH’s transparent review of the subject research with clear explanation of its purpose and benefits, and respected scientists’ support for it, PETA went ahead with its January 27 “briefing” and vegan lunch on Capitol Hill to which congressional staff were invited.  Approximately 40 people attended, including PETA and other animal rights organization members; staff from the offices of December 22 letter writers; and other congressional staff, some of whom were curious to see how PETA would conduct itself.  The event was sponsored by Rep. Roybal-Allard, who made a statement (written copy unavailable).  The only other speakers were PETA representatives:  actor James Cromwell, University of New Mexico professor emeritus John Gluck, College of William and Mary anthropology professor Barbara King and neuroscientist Kathleen Roe from PETA’s laboratory investigation division.   No mention was made by speakers of NIH’s review of the work and official response.  According to Nature’s complete report of the event, despite NIH and scientific community support for the research involved, neither Rep. Roybal-Allard nor PETA are satisfied and intend to continue pursuing the issue.  The only other media coverage of PETA’s briefing to be found was a National Public Radio (NPR) blog posting by speaker Barbara King, who seemed to confuse this staff lunch briefing with a congressional hearing on the record.

FDA Commissioner Leaving Agency in March

After almost six years leading the Food and Drug Administration, Commissioner Margaret A. Hamburg announced that she will be leaving the post in March, leaving behind a legacy of improving food safety and speeding-up drug approvals.  Dr. Stephen Ostroff, FDA’s chief scientist, is expected to be her temporary replacement.

Hamburg said in an interview that she is leaving the FDA because “this is a difficult and demanding job where you’re buffeted by all sorts of points of view.”  Several controversial issues were tackled by FDA during her tenure such as the approval of Plan B morning-after contraceptives for teens and tackling compounding pharmacies.

Please continue to visit www.NABR.org for more updates.

Discussion with Dr. Anthony Fauci, Director of NIH’s NIAID, Featured on CSPAN

Yesterday evening, CSPAN aired a special Q&A interview with Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

In this hour long discussion, Dr. Fauci gave pointers for scientists and researchers when speaking to the public and elected officials.  He also spoke about his upbringing, his medical career at the NIH, his experience with the HIV/AIDS epidemic, the recent Ebola crisis, and his relationship with several U.S. Presidents and Congress.

To view the episode, please click here.

114th Congress Convenes in Washington

Thirteen new U.S. Senators and 58 House members were sworn in on Tuesday when the 114th U.S. Congress opened for business. Having gained the majority in the Senate and increased their numbers in the U.S. House of Representatives, Republicans now control both houses of Congress for the first time since 2006.

Rep. John Boehner (R-OH) was re-elected to his third term as Speaker of the House, despite a last-minute challenge for the position. He was selected on the first ballot although 25 members from the Republican Party’s conservative wing voted against him.

The most significant changes on Capitol Hill are taking place in Senate leadership. Republican Majority Leader Mitch McConnell of Kentucky, who took over the top Senate position from the Democrats, will enjoy a 54-46 voting margin. All committees are switching from Democratic to Republican Party chairs. New chairs of key committees affecting NABR members are:

Agriculture -- Senator Pat Roberts (R-KS) takes over this committee, which has jurisdiction over the Animal Welfare Act (AWA). He previously chaired the House Agriculture committee for 20 years.

Appropriations -- The gavel of the powerful panel responsible for drafting approximately one-third of the federal budget returns to Mississippi's Senator Thad Cochran, who was just re-elected to a seventh term.

Budget – In a surprise move, Wyoming's Mike Enzi became chairman of the Senate Budget Committee after Senator Jeff Sessions of Alabama stepped aside. Sessions had been the top Republican on the committee the last four years.

Environment & Public Works -- Oklahoma's Senator James Inhofe replaces Senator Barbara Boxer (D-CA), who previously chaired this committee with responsibility for bills affecting federal product safety and testing requirements. Sen. Inhofe, along with Sen. Dianne Feinstein (D-CA), was a champion of the federal Animal Enterprise Terrorism Act (AETA). As NABR members will also recall, the committee now chaired by Inhofe is the same committee in which a hearing on legislation to prohibit the use of chimpanzees in biomedical research (the Great Ape Protection Act) was previously held.

Health, Education, Labor and Pensions – Senator Lamar Alexander of Tennessee takes the reins here. The former education secretary under President George H.W. Bush, governor and president of the University of Tennessee, has said modernizing the National Institutes of Health and Food and Drug Administration is a necessity.

The full listing of committee assignments for Republican Senators is available here. The Democratic member list for Senate committees is posted here.

Please continue checking your email and www.NABR.org for legislative updates.

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