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.

Researchers Using Dog Cancer Drug Against Kids’ Brain Cancer

Could the antidote for glioblastoma, one of the deadliest forms of brain cancer, in children be a current treatment for dogs?  That’s what researchers at Children’s Mercy Hospital in Kansas City are trying to figure out. According to an article in The Kansas City Star, it could be.

Researchers for human or animal health have often worked separately.  However, a collaboration between the two could lead to remarkable results. The Kansas City Area Life Sciences Institute brought together over 300 scientists and student-researchers to coordinate efforts on immunotherapy for cancer treatments. That matchmaking birthed a relationship between Children’s Mercy and Elias Animal Health, a Missouri company testing immunotherapy treatments for osteosarcoma in dogs at the veterinary health centers at Kansas State University and the University of Missouri. According to the article, protocols for glioblastoma are in development. Children’s Mercy and Elias Animal Health are planning to apply for a Phase 2 trial with the U.S. Food and Drug Administration (FDA).

Glioblastoma kills about 60%-70% of kids within two years, even when treated with standard care like chemotherapy, radiation, and surgery. The hope for the success of this partnership is immense; both the human and veterinary angles have something to offer.  Pre-clinical human studies are often conducted with mice are cost-effective but those with higher order species like dogs offer more predictable results. Animal health studies cost less and move more quickly than government-regulated human trials.

Please click here to read more about this possible groundbreaking partnership and please share it with your friends, family, and colleagues on social media.

FDA Commissioner Nomination Moves through Senate HELP Committee

The nomination of Scott Gottlieb, President Donald Trump’s pick to head the U.S. Food and Drug Administration (FDA), was voted out of the Senate Health, Labor, Education and Pensions (HELP) Committee yesterday morning by a vote of 14-9. The vote was scheduled to occur on Wednesday morning but it was postponed for 24 hours due to Senator Patty Murray (D-WA) and other committee Democrats expressing concern over Gottlieb’s financial holdings.

Gottlieb is a physician and managing director of T.R. Winston & Co., a Los Angeles-based bank focused on healthcare. He is also a clinical assistant professor at New York University’s School of Medicine, a resident fellow at the American Enterprise Institute, and is on the product investment board of GlaxoSmithKline. Gottlieb served as FDA’s deputy commissioner for medical and scientific affairs under President George W. Bush.

As NABR reported earlier this month, Gottlieb was vetted by the Senate HELP Committee on April 5. Gottlieb’s nomination now advances to the full Senate for confirmation but a date for that vote has not yet been scheduled.

Government Shutdown Unlikely Due to Short Term Extension

Congress must approve a spending bill or short-term extension by today, Friday, April 28, at midnight or the current stopgap spending bill will expire and the government will be forced to shut down. Previously there was a holdup amongst Democrats on the spending bill because President Donald Trump wanted to include funding for the construction of a wall on the United States-Mexico border. However, Trump has now stated that he will approve a spending bill without this language and that funding for the wall is an issue that will be revisited at a later date.

Republicans, who have a majority in both the House and the Senate, have maintained that a government shutdown is unlikely. According to NPR, the heads of the House and Senate Appropriations Committees have endorsed the idea of passing a short-term spending bill that would extend government funding until May 5 and give policymakers more time for negotiations.

As of this afternoon, Democrats are threatening to oppose the one week extension bill if Congress passes a healthcare bill before the weekend. If the short term spending bill passes tomorrow, Congress will need to vote on another spending bill or extension by May 5 to once again avoid a government shutdown.

Media Outlet Takes Animal Rights Group to Task

“Just who is the group protesting live animal training in Fargo,” asked KVLY in Fargo, North Dakota on April 6, 2017. In a report televised by the news outlet, Valley News questioned the animal rights group protesting lifesaving trauma training at North Dakota State University (NDSU).

The Physicians Committee for Responsible Medicine (PCRM) has sought to end such training and education at NDSU because it involved the use of animals. PCRM even erected a billboard questioning NDSU’s use of pigs for these programs just last year. KVLY asked the question, “who is the PCRM,” and investigated whether PCRM practices “responsible medicine.” According to the news report, PCRM promoted the use of the Heimlich maneuver as a way to save drowning victims, something the American Heart Association notes as “unnecessary and potentially dangerous.”

To watch the news coverage mentioned above, click here and feel free to share it with your friends, family, colleagues, and on social media.

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