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.

$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.

Government-Funded Researchers Discover Experimental Cure for Marburg Virus with Monkeys

Last week the National Institutes of Health (NIH) made a remarkable announcement about research into cures for Marburg and Ravn viruses, both relatives of the Ebola virus.

MR191-N, a monoclonal antibody derived from a human Marburg survivor, was administered by NIH-sponsored researchers to rhesus monkeys and guinea pigs and showed 100% effectiveness in curing late-stage, lethal-level infections of these viruses. According to the study two doses of the MR-191-N monoclonal antibody was able to provide 100% protection if given up to 5 days after infection. In contrast, other experimental treatments required daily doses for 7 or 14 days beginning closer to the time of infection.

Marburg and Ravn can resemble Ebola in symptoms and outcomes and medicine needs effective treatment and prophylactic measures. Hopefully these new findings prove effective in filling those voids.

To read more about this groundbreaking discovery, please click here.

White House Calls for $1.2 Billion Elimination from NIH Grants

The White House has announced that President Donald Trump is calling for $1.232 billion in funding cuts from National Institutes of Health (NIH) grant programs. As reported in last week’s NABR Update, the President released his budget proposal for funding the federal government on March 16. To offset a major increase in defense and border security funds, Trump has identified ways to decrease nondefense discretionary spending in FY 17. Included in this supplementary proposal are $1.182 billion in reductions to NIH research grants and $50 million in the elimination of Institutional Development Award (IDeA) grants for FY 17.

Trump’s proposed cuts would undermine the FY 17 spending bill that the Senate Appropriations Committee approved last summer, which included $34.1 billion in funding for the NIH.

Several Members of Congress are not optimistic about these cuts occurring, as the fiscal year has already begun. Representative Tom Cole (R-OK), chairman of the House Appropriations Labor-HHS-Education Subcommittee, told CQ, “It's a little late in the process. We've closed out our bills.”

The government is currently operating on a continuing resolution set to expire on April 28, 2017. To avoid a government shutdown, Congress must approve a budget bill before this date.

18% Cut to NIH, 21% Cut to USDA in President’s Proposed Budget; Regulatory Reform Major Focus

President Donald Trump (R) released his FY 2018 federal budget this morning, and included in the proposal is an almost 20% decrease in federal funding for the National Institutes of Health (NIH). Spending for NIH would decrease from the currently appropriated $31.7 billion to $25.9 billion. The budget states that “major reorganization” and structural changes would occur within the NIH to ensure that resources are refocused on high priority research and training. The President also aims to reduce regulatory burden throughout various federal government agencies, including the NIH, in which administrative costs would be reduced and federal contributions to research funding would be rebalanced. The budget states very clearly that the President plans to remove unnecessary and costly regulations, although it is not yet clear which regulations pertaining to biomedical research would be affected. At this afternoon's White House Press Briefing, Press Secretary Sean Spicer stated that the NIH must "focus on efficiencies and doing what we do better." To accomplish this, he used combining facilities as an example.

“America First - A Budget Blueprint to Make America Great Again,” would reduce funding to the U.S. Department of Health and Human Services (HHS) from $84.1 billion to $69 billion, based on the President’s plan to ‘eliminate programs that are duplicative or have limited impact on public health and well-being.” Plans for HHS funding call for reforming public health programs and reforming the Centers of Disease Control and Prevention (CDC) via block grant programs that would give states more power in addressing statewide public health challenges. Additionally, the proposal would make adjustments to the Food and Drug Administration (FDA) initiatives, and includes “a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.”

Funding for the U.S. Department of Agriculture would be reduced by 21 percent, from $22.6 billion to $17.9 billion. The budget would also make major funding cuts in other federal agencies including the U.S. Department of State, Department of Housing and Urban Development and the Environmental Protection Agency. Trump’s primary goal for the FY 2018 budget is to increase federal defense spending by $54 billion, with targeted reductions in other agencies to offset this cost.

The federal government is currently operating on a Continuing Resolution (CR) that is set to expire on April 28, 2017.

Next, the budget proposal will be sent to the Hill, where the House and Senate Appropriations Committees will review it thoroughly. Click here to read the President’s budget blueprint.

New Treatment for Epilepsy Discovered with Animals Shows Promise in NIH-Funded Study

A new drug for epilepsy has recently shown promise in clinical trials.  In a study supported by the National Institutes of Health’s (NIH) National Institute of Neurological Disorders and Stroke (NINDS), researchers found that the drug lorcaserin significantly decreases seizures in zebrafish with the same genetic mutation that causes Dravet syndrome. Dravet syndrome is rare disorder that causes frequents, severe, and drug resistant seizures and developmental delays in children. Other complications include chronic infections, delayed language and speech, and disruptions of the autonomic nervous system. Sadly, the mortality rate for kids with Dravet syndrome is approximately 15%-20%.

Thanks to its success in zebrafish, studies of lorcaserin have advanced to patients and according to a news release, was administered to five children with Dravet syndrome. All five experienced an initial decrease in the frequency of seizures with no serious side effects.  Most notably one child who had multiple seizures daily did not suffer any seizures for two weeks during the study.

This new drug could be a lifesaver and the importance of epilepsy research cannot be understated. According to the Epilepsy Foundation, three million people suffer from epilepsy in the United States alone and there are 150,000 new cases every year.  One-third of those with epilepsy are forced to live with the seizures because there is no treatment that works for them.

To read more about this exciting development, please click here.

HHS Secretary Confirmed by Senate Earlier Today

The U.S. Senate has confirmed Representative Tom Price (R-GA) to be U.S. Secretary of Health and Human Services. Despite efforts by Democrats to delay his confirmation process, he was confirmed early Friday morning by a vote of 52-47.

Sonny Perdue, President Trump’s nomination for U.S. Secretary of Agriculture, will soon be vetted by the Senate Agriculture Committee, although a date for the hearing is yet to be determined. Perdue, a small business owner and veterinarian by training, would oversee a federal department that implements a broad range of programs including USDA’s enforcement of the Animal Welfare Act.

Watch your inbox, visit www.NABR.org, or follow us on Twitter for updates from NABR about Perdue’s confirmation process.

BREAKING NEWS: Dr. Francis Collins to Continue as NIH Director for Now

According to the Washington Post, the National Institutes of Health (NIH) announced late yesterday that Dr. Francis Collins, the current director of the NIH, will remain on the job at least temporarily.

An NIH spokesperson said that Dr. Collins has been “held over by the Trump administration,” however it is unclear whether President Donald Trump (R) will formally reappoint him or if he will serve until a possible permanent director is selected. President Trump has asked some 50 senior members of the Obama Administration to stay on to assist in the transition.

Others rumored to be possible candidates for the top post at NIH have been physician and U.S. Representative Andy Harris (R-MD), biotech billionaire Patrick Soon-Shiong and Geoffrey Ling, former biotech director of the Defense Advanced Research Projects Agency (DARPA).

Dr. Collins, a geneticist, became director of the NIH in August of 2009. Because he was confirmed by the Senate during the Obama Administration he would not need to be reconfirmed if brought onboard by President Trump.

For more information on this breaking news, please see the coverage by the Washington Post, Science, and Nature.

As always, for the latest in news impacting the biomedical research community, please visit www.NABR.org or follow us on Twitter.

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