Monkeys Leading the Way Towards Development for Paralysis

By now you probably thought you had seen all of the medical accomplishments that have come from important studies with monkeys. But there’s now more to be proud of. The Foundation for Biomedical Research (FBR) recently covered exciting research with nonhuman primates (NHP) that could help more than 250,000 Americans.

Over 250,000 Americans have suffered from spinal cord injuries (SCI) that have left them with paralysis. With the assistance of monkeys, researchers at the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland have developed a wireless device that gained movement in their lower limbs. The device, which stimulates muscle movement by connecting nodes and the spinal cord, was developed with rhesus macaque monkeys and built on past findings from rodents. Information gained from these studies will hopefully lead to improved quality of life for people who are paralyzed.

This exciting new development shows promise advances that will allow many to function more independently and experience a better quality of life. To read more, please read FBR’s coverage by clicking here. Spread the word about the importance of monkeys in biomedical research by sharing this story with your friends, family, colleagues, and on social media.

State Legislatures to Return to Business Soon

With 2016 coming to a close, state legislatures from coast-to-coast will be bustling with activity in the coming weeks. Legislatures will soon adjourn to begin their 2017 legislative sessions. Some states have already begun prefiling legislation and NABR is actively scanning these bills to analyze any potential impact to biomedical research.

For more information on the political make-up of your state legislatures please click here.  To view a calendar of the projected session dates of the state legislatures across the country in 2017, please click here.

Several threats to the ability to find cures and therapies through ethical and humane animal research were seen in 2016 and NABR expects 2017 to be a particularly busy year in the states. Please continue to check www.NABR.org for updates on pertinent state legislation and check your inbox for the latest edition of the NABR Update.  You can also follow us on Twitter for the late breaking news.

Hill Action on ‘Cures’ and CR

21st Century Cures Act

SUMMARY:

The 21st Century Cures Act is a major health care and research reform package with strong bipartisan support passed by Congress today, December 7, 2016. According to The Hill, it is expected to be signed into law by the President very quickly. Passage of the Act is considered a victory for biomedical researchers, pharmaceutical companies and patients. In addition to mental health and opioid addiction aid and provisions affecting patients, the Act contains several features important to the biomedical research community, including measures intended to advance research and expedite approval for lifesaving cures.

Highlights of the “Cures” Act include an authorization for increased funding for the National Institutes of Health (NIH), acceleration of the Food and Drug Administration (FDA) drug approval process, and prioritization for the development of innovation projects that support research discovery at the NIH and FDA. It also provides for the review of regulations and policies affecting researchers using animal models, with an emphasis on reducing administrative and regulatory burden.

The Act authorizes the following funding for biomedical research, although actual appropriations are still required and may vary annually.

 
KEY AUTHORIZATIONS:

  • $4.796 billion of funding for the National Institutes of Health (FY 2017-2026)
  • $1.8 billion for cancer research (FY 2017-2023)
  • $1.511 billion for BRAIN (FY 2017-2026)
  • $1.455 billion for the Precision Medicine Initiative (FY 2017-2026)
  • $500 million of funding for the FDA (FY 2018-2026)
  • $30 million for regenerative medicine research using adult stem cells (FY 2017-2020)

 

AWARD OF RESEARCH GRANTS:

The Act simplifies the application and approval process for researchers and reduces burdens on recipients.

Specifically, the Act provides for the following provisions related to NIH grants—

  • Implement measures to reduce burdens on the monitoring of subrecipients of grants, including an exemption from subrecipient monitoring or the implementation of alternative grant structures which remove the need for such monitoring.
  • Establish considerations to modify the timelines for the reporting of financial conflicts of interest and ensure they are appropriate for the award.
  • Avoid duplication of procedures and requirements between the agency and the department, requiring the Secretary of Health & Human Services (HHS) and the Director of the NIH to evaluate expenditure reporting to minimize burdens on funding recipients.
  • Creates the “Next Generation of Researchers Initiative” to foster a new crop of investigators. The Initiative will promote research independence and increase opportunities for funding and mentorship, and will enhance workforce diversity for young researchers.

 

DRUG APPROVAL PROCESS:

FDA is granted authority by the Emergency Use Authorization (EUA) to strengthen the nation’s response to chemical, biological, radiological, or nuclear (CBRN) threats through the use of unapproved medical products. 21st Century Cures clarifies this authorization by allowing the use of conditionally approved medications. It also expands the use of these unapproved countermeasures to animal drugs and animals.

 
REDUCTION OF REGULATORY BURDEN:

The Act aims to reduce administrative and regulatory burden for biomedical researchers. Two other bills (H.R. 5583 and S. 2742) were previously introduced in the 114th Congress to alleviate regulatory burden in research, but no action was taken. The language of the “Cures” Act states in Sec. 2034, page 69 that not later than 2 years after enactment, “the NIH Director shall collaborate with the Agriculture Secretary and Food and Drugs Commissioner to complete a review of the policies and regulations for the care and use of laboratory animals. As appropriate, they shall revise and reduce burden placed on investigators, while protecting research animals and maintaining the integrity and credibility of research findings.”

The Director of the NIH shall seek input of experts and shall—

  • “Identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;
  • Take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and
  • Take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.”

The Act also provides for a review by research funding agencies regarding the policies covering the disclosure of financial conflicts of interest and make any revisions necessary to harmonize these policies.

 
RESEARCH POLICY BOARD:

One year after enactment, a research policy board will be established to advise government officials about the effects of regulations on researchers. The board will consist of the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the Secretary of HHS, the Director of the National Science Foundation, and other secretaries and directors that support or regulate scientific research, as well as 9 and 12 members from nonprofit scientific organizations. The board will conduct assessments of regulatory policies and offer suggestions for improvement. The board will then submit a report to selected federal offices and Congressional committees containing their formal recommendations.

Continuing Resolution

The House Appropriations Committee has introduced a continuing resolution (CR) that will fund the government at its current spending levels through April 28, 2017. The current $1.07 trillion budget cap level will be maintained.

The CR will provide $872 million for biomedical research in 2017, which serves as the first installment of National Institutes of Health (NIH) funding in the 21st Century Cures Act, a landmark healthcare reform bill passed today by the Senate that is headed to the President’s desk for his signature. Of this funding, $352 million will be allocated to the NIH for innovation purposes, $500 million to states for grants to tackle opioid abuse and addiction, and $20 million to the Food and Drug Administration to modernize regulations.

As stated in Section 1001 of the CR, allocations for 2017 NIH innovation funds are broken down as follows:

  • $300 million for cancer research
  • $40 million for the Precision Medicine Initiative
  • $10 million for BRAIN
  • $2 million for regenerative medicine research using adult stem cells

In addition, the CR provides disaster assistance and relief for those affected by contaminated drinking water such as the Flint, Michigan community. It also provides funding to the Defense and State Departments to combat terrorism, as well as a waiver for the requirement that the Secretary of Defense be a civilian for 7 years before being nominated and confirmed as Secretary of Defense.

The bill is being reviewed by the House Rules Committee this afternoon. It is expected that the House will vote on Thursday, followed by a Senate vote on Friday. The CR must be passed by both chambers and signed by the President before December 9th which is when the current spending bill expires.

Please continue to check your email and www.NABR.org for the latest news from NABR. Please also follow NABR on Twitter to get breaking news instantly.

Join Us for NABR’s First Webinar of 2017!

2017 is just around the corner, which means that NABR is now reviewing last fiscal year’s animal research facility inspection results.

Each year, NABR obtains this information from USDA’s Animal Care Inspection System database and provides an analysis so you can make the most of the upcoming year. We invite you to join us on Tuesday, January 10, 2017 for "The 2016 USDA Inspection Data: What a Difference a Decade Makes." We will reveal this data… with a special twist. We will be comparing last fiscal year’s results to what was reported a decade ago, and the results may surprise you. This information is certain to help you manage your animal care and use program in the coming fiscal year. Start off 2017 on the right foot and join our latest webinar to see just how far the research community has come in the last ten years.

We anticipate a high number of registrants for this webinar so please register ASAP to guarantee your spot!

 

register now

 

 

*This webinar is a complimentary service for NABR member institutions. Unlimited numbers of interested participants from member institutions may register free of charge. Interested participants from non-member institutions must be pre-approved and will be charged an access fee of $379/person. All major credit cards accepted.

Developments Yesterday on Capitol Hill

A couple of important developments broke in Congress yesterday evening after we sent the NABR Update to our members. The "21st Century Cures Act" passed in the House of Representatives and Congress is expected to adopt a long-term stopgap spending bill to fund the federal government. Read more details below.

Landmark Healthcare Reform Bill Passes House

Last night, the “21st Century Cures Act” passed in the House of Representatives by a vote of 392-26. The bipartisan omnibus health care package was first introduced in May 2015 by Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) and consists of measures to expedite and improve research for lifesaving cures. It also includes reforms for the Food and Drug Administration (FDA), Medicare, Medicaid, mental health and other health care issues. Most notably, the act will provide $4.796 billion of funding for the National Institutes of Health (NIH) between FYs 2017 and 2026.

Highlights of the bill include:

  • $30 million to expand clinical research for regenerative medicine using adult stem cells, between FYs 2017 and 2020
  • $1.8 billion for cancer research, between FYs 2017 and 2023
  • $1.455 billion for the Precision Medicine Initiative, between FYs 2017 and 2026
  • $1.511 billion for Brain Research Through Advancing Innovative Neurotechnologies Initiative, between FYs 2017 and 2026

“21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need. The White House has expressed its enthusiastic endorsement of this critical legislation. So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow,” said Upton and Diana DeGette in a press release by the House Energy and Commerce Committee. The next step for the bill is a vote in the Senate, which is expected to pass the bill without amendment early next week.

Long-Term Spending Bill Inevitable

Additionally, it is now expected that Congress will adopt a new longer-term stopgap spending bill. Although, according to the Hill, Speaker Paul Ryan (R-WI) recently stated that Congress prefers a short-term Appropriations bill to fund the government into President-elect Donald Trump’s administration, Congress is simply running out of time to complete action. Yesterday, Republicans in the House and Senate contended that a new longer-term Continuing Resolution (CR) stretching into at least April will be inevitable because of the Senate’s tight schedule, which will include important votes confirming President-elect Trump’s Cabinet members. Congress has until next week (December 9), when the current CR expires, to approve the new long-term CR.

Please continue to check your email and www.NABR.org for the latest news from NABR. Please also follow NABR on Twitter to get breaking news instantly.

President-elect Names HHS Secretary Nominee

Rep. Tom Price (R-GA) has been nominated by President-elect Donald Trump (R) to serve as the incoming U.S. Secretary of Health and Human Services.

Price has represented the 6th district of Georgia since 2004, following twenty years as an orthopedic surgeon. He currently presides as chair of the House Committee on the Budget and serves on the House Committee on Ways and Means. He is also a member of the Congressional Health Care Caucus and the Doctors Caucus. He received his undergraduate and M.D. degrees from the University of Michigan and completed his residency at Emory University, where he later held an academic appointment and trained residents at Atlanta’s Grady Memorial Hospital.  "There is much work to be done to ensure we have a health care system that works for patients, families, and doctors; that leads the world in the cure and prevention of illness; and that is based on sensible rules to protect the well-being of the country while embracing its innovative spirit,” said Price in a statement released upon nomination.

Dr. Price has been a critic of the Affordable Care Act (a.k.a. Obama Care), which some predict will be a major point of focus during his U.S. Senate confirmation hearing.  Nature reports there's evidence Price has pushed to cut federal spending overall, but his plans and positions on biomedical research issues and funding will likely become clearer during his upcoming confirmation hearings. Confirmation hearings for nominations will begin in 2017.

The Five Most Expensive Diseases and the Animals Helping to Combat Them

The United States spends over one trillion dollars each year on healthcare, but did you know that over 80% of this spending results from combatting just five diseases? NABR has compiled a must-see review of the United States’ five most expensive diseases—heart disease, diabetes, dementia, cancer and obesity—which collectively, cost the country $832 billion per year. This massive expense, paired with an aging population and rising health concerns, confirms that animal research will continue to play a vital role in not only curing disease but also in keeping the cost of healthcare down.

Animal studies involving mice, rats, dogs, cats and other species have paved the way for medical discoveries that have saved countless lives from the aforementioned diseases, while helping to decrease healthcare costs for everyday Americans.

With healthcare costs at $193 billion, heart disease ranks as the most expensive disease in the U.S. Thankfully with the development of coronary bypass surgery through studies with dogs, the mortality rate of heart disease has decreased by 50% in the past 30 years.

Animal research has also made strong contributions to understanding and treating diabetes, a disease prominent in both humans and our beloved pets. Other studies involving rats and mice have allowed researchers to develop therapies for dementia, screening and fighting cancer, and tackling obesity.

Without animal research, these diseases would lead to a continued rise in healthcare costs for millions of people around the country. Click here to read more about the role animals play in keeping healthcare costs down for the nation’s five most expensive diseases.

Last Week’s NABR-Exclusive Webinar Now Available for Online Viewing

Last week's NABR webinar, "Help Us Help You: Participating in the Public Policy Process," is now available online for on-demand viewing.  If you missed the webinar or would like to watch it again, it has been posted in the Members Only section of our website.

Please click here to view "Help Us Help You: Participating in the Public Policy Process."  You will need your NABR members-only log-in credentials to watch the presentation.

If you have problems logging in, please contact us at [email protected].

BIO CEO Pens Op-Ed Lauding the Results of Translational Animal Research

Jim Greenwood, CEO of the Biotechnology Innovation Organization (BIO) and board member of the National Audubon Society, has written an enlightening submission to the Capitol Hill news site, The Hill, which highlights the connections humans have with animals.  It is already known that fostering relationships with animals has been scientifically shown to be beneficial for one’s mental health. Now, as Greenwood explains, the relationship goes even deeper.

Animal research has been shown to greatly improve the lives of both humans and animals.  To put this fact in perspective, sixty percent of all human diseases can be spread by animals, and livestock are particularly at risk.  To mediate this problem, scientists have carefully modified the genomes of livestock to make them less susceptible to spreading disease.  One example provided by Greenwood are chickens.  These ubiquitous birds have been modified to prevent the transmission of bird flu to other chickens, which then decreases the threat of a bird flu epidemic in humans.  In addition, other researchers have found ways to combat other deadly diseases, like Ebola and the Zika virus, by using animal models such as cows and mosquitos.

Greenwood goes on to note that animal studies are “key to discovering, developing and manufacturing new treatments for human diseases. Animal models of human diseases have helped scientists understand how and why a particular disease develops and what can be done to halt or reverse the process.”

Research performed with animals has saved the lives of many people and with continued use of animal research, scientists can save the lives of millions more. As Greenwood states, “Today, many people with once-fatal diseases are alive and healthy thanks to scientific breakthroughs made possible by studying animals. Tomorrow, thanks to ongoing advances in animal biotechnology, we can envision an even more hopeful and humane future for our planet, its people and our animal friends.”

To read Greenwood’s op-ed, please click here.

Are Primates Still Important for Medical Progress? The Answer: Yes

Opponents to animal research always ask, “Is research with primates still needed?”  According to Dr. Andrew Jackson of Britain’s Newcastle University’s Institute of Neuroscience in a recent BBC Science & Environment article, primates are still vital for medical research, especially for studies with the brain.

Dr. Jackson has been recently researching the relationship between motion and the brain with rhesus macaque monkeys and a specially designed videogame. The monkeys play the game and when they win, they receive fruit as a reward. All the while, Dr. Jackson studies the monitors to see how neurons react to create the primates’ movement.  He explains that this research could help find ways to restore mobility to people who have suffering from paralysis.  Why a monkey? The research is performed with monkeys, rather than mice because the physiology of a monkey’s brain is much more similar to that of a human.  In addition, mice do not manipulate objects with their front paws like monkeys and people do with their hands.

In the article, an international animal rights group claims that primate research is unnecessary because of the existence of brain neural imaging and computer models, whose data is based of off previous animal studies. As the article notes, soon after publishing arguments in opposition to Dr. Jackson’s study, over six hundred scientists who are actively involved in animal research signed an open letter rejecting those claims.
Those scientists explain that nonhuman primates are very important for medical development and great lengths are taken to ensure their safety and comfort.  Labs come with elaborate enclosures, social groups, and more secluded areas to allow primates to have some time to themselves.  Dr. Jackson concurs that the wellbeing of the animals is very important for the experiments noting that stressed or uncomfortable animals can skew data and make it impossible to perform research.

To read the article, please click here. If you’d like to learn more about the importance of primates in research, please see the resources located on NABR’s website.

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