Congress Holds Hearing on Funding for Indirect Costs

Last Tuesday, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing titled, "The Role of Facilities and Administrative Costs in Supporting NIH-Funded Research." The hearing served as another forum for lawmakers to discuss the Administration’s budget proposal to cut indirect costs at National Institutes of Health (NIH) funded institutions from 30 percent to 10 percent.

Although there were no mentions of animal research, the hearing caused a stir by lawmakers on both sides of the aisle. Subcommittee chairman Rep. Tom Cole (R-OK) said, “I just want to make sure as we go forward that we don’t throw out the baby with the bathwater, looking for savings and disrupting what’s really a pretty complex, now 70-year-old ecosystem that has produced extraordinary benefits for the American people.”

According to an update by Congressional Quarterly (CQ), witness Keith Yamamoto, vice chancellor for science policy and strategy at the University of California, San Francisco (UCSF), expressed concern about cutting funding for indirect costs. He said at the hearing: “I spend all my time kind of chasing down regulatory compliance reports. That really is the biggest problem. Not only is it very wasteful of resources, but it really changes the way, the time and energy one can put into thinking about science.”

The full hearing and witness list is available on the subcommittee’s website.

USDA FOIA Logs Posted

The U.S. Department of Agriculture (USDA) has published on its website a list of all Freedom of Information Act (FOIA) requests that were submitted to the department in 2017. NABR is analyzing the documents and will report any findings of interest to the biomedical research community.

FOIA was enacted in 1966 to promote transparency and ensure accountability of government officials and agencies. The law permits the public to request records owned by federal agencies, such as the U.S. Department of Agriculture, the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).

To review NABR’s analysis of FY 2016 FOIA requests from animal rights groups please click here (log-in required).

NABR President Rebuts PETA Letter to The Hill

As you’ll recall, last week shortly after National Institutes of Health (NIH) Director Dr. Francis Collins said in an interview that “Animals are still crucial to our understanding of how biology works,” People for the Ethical Treatment of Animals (PETA) fired back with a letter to The Hill calling for a systematic review of animal studies at the NIH. This letter, “A need to rethink spending on animal-based research at NIH,” is part of PETA’s call to defund the NIH because of its use of animal models in lifesaving and live-improving research.

Today, NABR’s President Matt Bailey penned a response letter to The Hill discussing not only the benefits of animal research in medical discovery from conditions like HIV/AIDS, malaria, cancer, and Alzheimer’s, but covering the immense economic impact of taxpayer funded studies. The United States’ investment in research, specifically with the NIH, supports 350,000 jobs and produced $60 billion in new economic activity in 2015.

Take a moment to read Bailey’s letter and share it with your friends, family, colleagues, and on social media and encourage others to do the same.

NIH Director’s Interview Runs Counter to PETA’s Anti-Animal Research Letter in The Hill

Dr. Francis Collins, Director of the National Institutes of Health (NIH), explained the importance of animal models in research during an interview with the Washington Examiner last week. The interview focused on proposed cuts to the NIH in President Donald Trump’s budget, as well as information regarding research projects by the NIH.

The reporter stated, “PETA came out this year supporting budget cuts to the NIH, saying that cutting testing on animals would achieve significant savings. What can you tell us about where animal testing stands?” Dr. Collins emphasized the importance of using animals in an ethical and responsible manner, and affirmed that animal studies are a necessary step toward discovering new therapies and cures for diseases: “Animals are still crucial to our understanding of how biology works. Anybody who has looked at the kind of oversight that applies to that I think will be impressed by how much attention goes toward any protocol that we fund that is going to involve animals for research. It has to have veterinarians and members of the public looking constantly at the conditions under which the animals are cared for and how we do everything possible to avoid the creation of unnecessary pain… Animals are still crucial to our understanding of how biology works.”

Click here to watch (or read) the full Washington Examiner interview with Dr. Collins.

Shortly after the interview was published, Emily Trunnell, who is employed by People for the Ethical Treatment of Animals (PETA) published a letter-to-the-editor in The Hill titled, “A need to rethink spending on animal-based research at NIH,” which argued animal studies do not provide results that are useful for humans and that failure rates for news drugs is greater than 95%. Trunnell called for alternative technologies to be used in place of animals, and requested a systematic review by the NIH for all animal experiments. Meanwhile Appropriations committees in Congress are voting to increase the NIH budget.

Spending Bills Approved and Advanced on Capitol Hill

Late last week the Senate Appropriations Committee approved a $20.5 billion agriculture spending bill. The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act will fund programs at the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) for FY2018. The bill includes a $4.8 billion increase to the amount proposed in President Donald Trump’s budget blueprint, but $7.9 billion less than the previous year’s funding level. Of interest to the animal research community is the allocation of $953.2 million for the USDA Animal and Plant Health Inspection Service (APHIS), the agency that regulates and inspects animal research laboratories. This is $143.2 million above Trump’s budget request for APHIS and $7 million above the funding level for FY2017. The bill was approved by the Senate Agriculture Appropriations Committee on Tuesday.

Also last week the House Appropriations Committee passed a $156 billion Labor-HHS-Education spending bill for FY 2018. The Labor, Health and Human Services, Education, and Related Agencies Bill contains $21.6 billion more than the amount proposed by Trump and $34.7 billion more than the funding level for FY2018. The spending bill contains $35.2 billion for the NIH ($8.6 billion increase to the Trump’s budget proposal and $1.1 billion increase to FY 2017 allocation) and was approved by the subcommittee on July 13. The bill contains language that directs the NIH to develop a plan to speed up the process of transferring retired research chimpanzees to retirement sanctuaries.

Please stay tuned for more important updates from NABR during the Appropriations process.

NABR Releases FY2016 FOIA Analysis – Government Costs Increase

NABR has prepared a review of federal Freedom of Information Act (FOIA) requests that were submitted by animal rights organizations in Fiscal Year 2016. FOIA was enacted in 1966 to promote transparency and ensure accountability of government officials and agencies. The law permits members of the public to submit requests for records in the possession of federal agencies, such as the U.S. Department of Agriculture, National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).

In FY 2016, both USDA’s Animal and Plant Health Inspection Service (APHIS) and the NIH received a significant number of requests from animal rights activists. As outlined in further detail in NABR’s FY2016 FOIA Analysis (log-in required), these agencies received 12% more requests from animal rights groups than the previous year, and the cost for the government to respond to the requests increased by 20%.

NABR believes animal rights activists will continue to submit broad requests for large amounts of data about research facilities in FY 2017 in part because of the USDA’s decision on February 3 to temporarily remove the Animal Care Inspection Service (ACIS) database. NABR will continue to monitor FOIA requests submitted to federal agencies and, when possible, alert members if they are named in the requests. Research facilities should carefully review all information submitted to federal agencies. To read the full FY2016 FOIA Analysis, please click here (log-in required).

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.

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.

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.

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