House Appropriations Committee Marks-Up FY18 Agriculture Appropriations Bill

Last Wednesday the full House Appropriations Committee considered the Agriculture, Rural Development, Food & Drug Administration, and Related Agencies Appropriations Bill for FY18 to fund the U.S. Department of Agriculture (USDA) and Food & Drug Administration (FDA).

The Animal and Plant Health Inspection Service (APHIS) was appropriated $906 million, $96 million more than the President’s requested amount, but $40 million short of the FY17 funding level. The FDA will receive $2.8 billion, the same as in FY17. The bill also appropriates $60 million to the FDA as part of the 21st Century Cures initiative enacted last winter. Including revenue from user fees, total funding for the FDA is $5.2 billion, $490 million more than in FY17. The USDA will not resume funding the renewal of Class B licensed dealers in FY18. The report requires that most of a $400,000 increase be used to establish an Institutional Animal Care and Use Committee (IACUC) by the Agricultural Research Service (ARS). The committee also addressed the February 3 removal of data from the USDA’s Animal Care Inspection System database, noting in the report that the USDA “must utilize the resources provided in this bill to promptly finish reviewing the information on its website, restore all legally permissible records previously removed, and resume posting on the USDA website.”

To read the FY18 agriculture appropriations bill, click here. The committee’s report on the bill can be found here.

House Labor-H Subcommittee Passes FY18 NIH Appropriations Bill

On Thursday, July 13, the House Labor, Health and Human Services, Education, and Related Agencies Subcommittee of the House Appropriations Committee passed the FY18 National Institutes of Health (NIH) appropriations bill. It now heads to the full committee for consideration.

The bill provides $34.6754 billion in base funding for the NIH and includes the full $496 million designated for FY18 in the NIH Innovation Account established in the 21st Century Cures Act, for $35.1714 billion in total FY18 funding. This marks a $1.1 billion increase from last year; the final FY17 omnibus provided $33.732 billion in base funding and $34.084 billion including money appropriated for 21st Century Cures. The bill rejects the President’s proposal with regards to facilities and administration expenses. The bill also specifies that, “None of the funds made available by this Act may be used to conduct or support research using human fetal tissue if such tissue is obtained pursuant to an induced abortion.” Critical research endeavors were also provided increases:

• $1.8 billion, a $400 million increase, for Alzheimer’s disease research
• $336 million, a $76 million increase, for the Brain Research through Application of Innovative Neurotechnologies (BRAIN) initiative
• $400 million, a $80 million increase, for the All of Us research initiative (formerly called the Precision Medicine Initiative)
• $300 million for the Cancer Moonshot
• $10 million, an $8 million increase, for regenerative medicine research
• $12.6 million for the Gabriella Miller “Kids First” pediatric cancer research initiative.

Federal Bill Introduced to Prevent Veterans Administration from Using Dogs in Studies

Wednesday evening it was announced that Reps. Dave Brat (R-VA) and Dina Titus (D-NV) have introduced the Preventing Unkind and Painful Procedures and Experiments on Respected Species Act of 2017, or PUPPERS Act.

Likely the result of recent attention on experiments by the Veterans Administration (VA) highlighted by the White Coat Waste (WCW) Project, the bill is relatively straightforward. The PUPPERS Act states the Secretary shall not “purchase, breed, transport, house, feed, maintain, dispose of, or experiment on dogs as part of the conduct of any study that causes significant pain or distress” by the VA. “Pain or distress” is defined in the legislation as research classified in category D or E by the U.S. Department of Agriculture (USDA).

Aside from Brat and Titus, the bill is currently sponsored by Reps. Brian Mast (R-FL), Ted Lieu (D-CA), Dan Donovan (R-NY), and Brendan Boyle (D-PA). Click here to read more coverage in The Hill.

Dogs Get Cancer, Too

Did you know that companion animals, like dogs and cats, naturally develop many of the same diseases as humans? Statistics show that over 4.2 million dogs naturally develop cancer each year, in comparison to 1.7 million humans. Dogs are actually a very important model for studying diseases, such as cancer, because not only do many dogs naturally develop cancer in their lifetimes, but cancer tumors in dogs are similar to those found in humans affected with the disease. A recent Forbes article discusses the importance of dogs in the biomedical research community’s mission to find a cure for cancer in both humans and animals.

Dogs are also excellent models for cancer studies because they live in the same types of environments as humans, meaning they are exposed to the same bacteria, household products, noises and other stimuli as we are. Dogs also age more quickly than humans. Have you ever heard the saying, “1 human year equals 7 dog years?” Well, for studying diseases like cancer, this popular belief becomes useful. Because the lifespan of a dog is shorter, it experiences the different stages of cancer much more rapidly than humans. This allows researchers to collect invaluable data in a speedier manner than when collecting data from human cancer patients.

Mice, which make up ~95% of all animals used in biomedical research, are excellent models for most areas of research, but dogs provide a unique model for finding cures and treatments for cancer in both humans and animals.

Please follow this link to read the full Forbes story about the importance of dogs in finding a cure for cancer in humans and animals.

Dr. Francis Collins will Continue as NIH Director

President Donald Trump announced last night that Dr. Francis Collins, M.D., Ph.D., will continue to serve as Director of the National Institutes of Health (NIH) under the Trump Administration. Collins, a physician-geneticist, has served in this role since 2009, leading the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Cancer Moonshot, and other large research projects. Before his appointment as NIH Director by President Barack Obama in August 2009, Collins led the Human Genome Project.

“Dr. Collins has been, and will continue to be, a strong partner in making the case for a sustained federal commitment to medical research. I look forward to working with him to ensure NIH has the resources it needs to advance progress toward new, life-saving treatments and cures,” Senator Roy Blunt (R-MO), Chairman of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, stated in a press release.

Collins is the first NIH Director since the 1970s to serve under two presidents. Because he was confirmed by the Senate during the Obama Administration he will not need to be reconfirmed.

Click here to read the White House’s press release.

NIH Official Educates PETA About the Applicability of Animal Research

Under the Freedom of Information Act (FOIA), NABR has obtained a response from the National Institutes of Health (NIH) to PETA regarding their recent letter which alleges the use of animals in federally-funded research is “misleading.”

PETA’s letter, dated April 5, expressed concern about applicability of animal research to humans and stated that “the U.S. Food and Drug Administration reports a 92 percent failure rate of clinical trials for new pharmaceutical drugs following preclinical success in animals.” The letter also referenced a recent PETA report that claims to highlight ways to reduce the federal budget by slashing animal research funding.

In the NIH’s response to PETA, Michael Lauer, M.D., Deputy Director for Extramural Research at the NIH, declared the importance of research with animals and explained that numerous medical advancements have resulted from research with animals including vaccines, blood transfusions, treatments for breast cancer and epilepsy, in vitro fertilization, organ transplants, and more.

Lauer specifically stated that “research using animal models continues to make significant contributions to human and animal health. Although research based on animal models needs to improve and has limitations, it is not justification for eliminating powerful tools that have arguably saved millions of Americans…In our view there is no consensus that animal models should be eliminated—rather, we want to build on prior successes and learn from prior failures.”

NIH’s response to PETA also described the strict federal and institutional regulations in place to ensure that animals are used only when necessary and that the well-being of animals is maximized.

Click here to read PETA’s letter and report. Click here to read NIH’s response.

Registration Open for NABR’s July Webinar “Q&A with the USDA”

Do you have questions about the U.S. Department of Agriculture’s inspection and reporting process? Join Drs. Elizabeth Meek and Bill Stokes, the USDA Eastern and Western Region Assistant Directors for Animal Welfare Operations, on July 18th for NABR’s most requested webinar, “Q&A with the USDA: The Fifth Edition.” NABR members will have the unique opportunity to ask questions directly to the leadership of Animal Care’s Animal Welfare Operations who are responsible for the oversight of the inspection and reporting process of animal research facilities.

A lot has happened surrounding the enforcement process since last year’s Q& A webinar. New terms, “critical noncompliance” and “focused inspection” have been introduced, and access to information on the inspection process has been changed. To better understand what impact these and other changes may have on your institution, take advantage of this unique opportunity provided only to NABR members.

Please submit your questions in advance to info@nabr.org. They will be reviewed and formatted to prevent duplication and will be answered in the order they are received. As per our policy, all questions will remain anonymous. The webinar is scheduled for one hour but we will continue the discussion until all questions have been addressed. Click here to register for this exclusive, Members Only webinar, “Q&A with the USDA: The Fifth Edition.”

The “Magic” that Saved Jimmy Kimmel’s Son Made Possible by Animal Research

This blog post was originally published by the Foundation for Biomedical Research on May 4, 2017:

Addressing his television audience on Monday night, Jimmy Kimmel tearfully thanked the doctors and nurses who saved the life of his son, born last week with a congenital heart condition called Tetralogy of Fallot (TOF) with Pulmonary Atresia (PA). The rare disease is characterized by four main heart defects that can be corrected by a series of operations over several years—all made possible by decades of research with laboratory animals.

At Cedars-Sinai, where Kimmel’s wife Molly McNearney delivered the baby, the couple’s doctor performed an echocardiogram on the newborn to confirm that his bluish complexion was the result of a cardiovascular defect. The device, which Kimmel accurately likens to a sonogram of the heart, was developed with experimental research using animals. In the 1950s, researchers credited with pioneering the echocardiogram made medically significant discoveries about the origin of echo signals within the organ by using models procured from calves. Today, scientists rely on animals, from rodents and rabbits to dogs and pigs, to perform experimental research that result in technological improvements to the equipment—potentially raising its efficacy in detecting heart problems in human patients like Kimmel’s baby.

Tetralogy of Fallot must be treated surgically. The infant was taken by ambulance to Children’s Hospital Los Angeles, where Doctor Vaughn A. Starnes “went in there with a scalpel and did some kind of magic that I couldn’t even begin to explain,” Kimmel said. “He opened the valve, and the operation was a success.”

It certainly does look like magic.

The procedure, a Blalock–Taussig shunt, increases blood flow to the lungs thereby alleviating the patient’s cyanosis, or the blue coloring that often presents as a symptom (most commonly of skin on the face and extremities). It involves joining the subclavian artery to the pulmonary artery, which the surgical research team first performed successfully with dogs before adapting the instruments for use on humans. This revolutionary development in medical science is lifesaving for infant patients, and it’s also used in the treatment of dogs themselves that are born with congenital heart conditions.

Each year, four of every 10,000 babies are diagnosed with Tetralogy of Fallot. With corrective surgery, most will thrive, just like Kimmel’s baby: “Six days after open heart surgery we got to bring him home, which was amazing,” the comedian said. “He’s doing great; he’s eating; he’s sleeping; he peed on his mother today when she was changing his diaper; he’s doing all the things he’s supposed to do.”

Kimmel’s son will have a second open-heart surgery in three to six months, and when he reaches adolescence, will undergo a third and final procedure that doctors expect will be minimally invasive. Each will likely require a cardiopulmonary bypass—which mimics heart and lung function for the duration of surgery, keeping the patient alive. The device is an adaptation of early “heart-lung machines;” among the first iterations was a model created in the 1920s by research with canines. The cardiopulmonary bypass enabled the first human heart transplant in 1967—a medical milestone made possible, again, by research with dogs.

Thanks to the skill and expertise of pediatric cardiologists, working with cutting edge science and medicine developed through animal research, more than 63,000 children have been given a new chance at life with successful heart transplants. Many thousands more, including Kimmel’s son, have been successfully diagnosed and treated thanks to research performed with animal models.

Last year we shared the emotional story of Lincoln Seay, an infant who survived open-heart surgery and a heart transplant after he was diagnosed with a rare congenital disorder called heterotaxy syndrome. Manifestations of the condition vary, but, as in the case with Tetralogy of Fallot, it is often associated with cyanosis. Lincoln’s inspirational story serves as another testament to the lifesaving power of modern medicine developed with animal subjects. It also hints at the potential medical breakthroughs on the horizon thanks to promising new research (with zebrafish)!

Like many pediatric cardiologists, Lincoln’s surgeons faced challenges that make their success all the more remarkable: the seven-month-old went into cardiac arrest as they waited for the donor organ needed for his transplant—which necessitated an emergency surgery to compress his heart. This, followed by the transplantation, is especially tough on the tiny body of an infant patient.

It’s not easy for family members in the waiting room, either.

All over the world, scientists and researchers rely on animal models to discover more about how to detect and treat congenital heart defects—offering infants like Lincoln, and Kimmel’s son, a second chance at life. The innovations in medical devices and surgical techniques that result from this work have enabled healthcare providers to perform magic, one baby’s beating heart at a time.

Guest author: Chris Kane is a writer with a background in non-profit communications.

$2 Billion Increase for NIH in Omnibus Spending Bill

House and Senate leadership reached an agreement around 2:00 A.M. Monday morning on a spending bill that would fund the federal government for the remainder of FY 2017, which ends September 30, 2017. The spending bill contains an increase of $2 billion for the National Institutes of Health (NIH), which is 6.2 percent above the funding level provided in FY 2016. In total, the U.S. Department of Health and Human Services (HHS) would receive $2.8 billion more in funding than the amount that was allocated for FY 2016.

Also in the spending bill is $153.4 billion for programs at the U.S. Department of Agriculture and U.S. Food and Drug Administration, a $12.8 increase from FY 2016 levels.

Of interest to the animal research community is a provision that would prohibit any federal funds from being used to carry out activities related to the issuance or renewal of licenses under the USDA’s Animal Welfare Act to Class B dealers who sell dogs and cats for research, experiments, teaching or testing. The provision repeats a similar provision included in spending bills last year. The prohibition on funding does not apply to all Class B license activities.

Senate Labor-HHS-Education Appropriations Chairman Roy Blunt (R-MO) praised the omnibus spending bill and lauded the importance of funding medical research by stating in a press release: “The funding provided in this bill reflects the priorities of the American people, and puts us on track to maintain a robust, sustained federal commitment to medical research. I urge my colleagues to support this bipartisan bill, and I’ll continue working to ensure NIH has the resources it needs to give hope to more families battling cancer, Alzheimer’s disease, and other chronic diseases.”

The agreement comes just a few days after legislators scrambled to avoid a government shutdown. Funding for FY 2016 expired in December, and the continuing resolution that was keeping the government operating throughout the past several months expired on Friday, April 28. To prevent a shutdown, Congress approved a one week extension, which expires this Friday, May 5 at midnight. The deal reached last night by House and Senate leadership has been reported as a bipartisan agreement.

The spending bill is expected to pass both the House and Senate before Friday’s midnight deadline. To read the full 1665-page text of the bill, click here. Stay tuned for more Updates from NABR about the spending bill and NIH funding.

Artificial Womb Developed for Lambs May Help Premature Babies

Animal research is once again contributing to amazing progress in the medical field—this time to save premature babies.

In a recent study at Children’s Hospital of Philadelphia, lambs at the age equivalent to 23 weeks in human pregnancy were placed in an “artificial womb” after birth, where they lived for four weeks. The lambs grew and developed normally in the artificial womb, which looks similar to an incubator and contains amniotic fluids and other essential nutrients necessary for protection and growth. This is exciting news for human medicine because in the United States around 30,000 babies are born before they reach 26 weeks.

Since it takes 39-40 weeks for a human baby to fully develop, critically premature babies born at 26 weeks develop diseases like cerebral palsy, paralysis, blindness and mental retardation about 90 percent of the time. The artificial womb, which is expected to be tested in human babies within three to five years, could prevent the necessity for certain procedures and surgeries.

To read more about the study and watch a video of a lamb in the artificial womb, click here.

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