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.

Senate Confirmation Hearings Set to Begin Soon for HHS Secretary

The Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to hold a hearing on Wednesday, January 18 to consider the nomination of Representative Tom Price (R-GA) as Secretary of Health and Human Services (HHS).

Before any appointed Cabinet member can be confirmed, the Senate must hold a hearing with the committee that has jurisdiction over the agency related to the position; in this case, the HELP committee has jurisdiction of the Secretary of HHS. Following this hearing, on a date yet to be determined, the Senate Finance Committee will hold a hearing in which they are expected to vote to send the confirmation to the Senate floor. A final vote to confirm Price as Secretary will occur on the Senate floor. According to Roll Call, “it is the Finance Committee that has primary responsibility for the Health and Human Services nomination, since it has jurisdiction over taxes and entitlement programs like Medicare and Medicaid.”

President-elect Donald Trump has at the time of this writing not announced a selection for Agriculture Secretary or Director of the National Institutes of Health (NIH). Please watch for updates from NABR throughout the nomination and confirmation process.

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.

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.

Ambitious Research of Retina Regeneration Being Developed with Zebrafish

Diseases such as glaucoma, macular degeneration, and retinal degeneration used to spell the end of sight for those afflicted.  The National Institutes of Health’s (NIH) National Eye Institute (NEI) has granted $1.9 million to Vanderbilt University and Vanderbilt University Medical Center to fund retina regeneration research to help patients with those conditions. As expected, animal research is going to play an important role in those studies.

Part of the Audacious Goals Initiative developed by NEI to push the envelope to tackle some of the most difficult eye diseases through regenerative medicine, the idea is to use stem cells to replace damaged retinal tissue and restore sight. Ed Levine, Ph.D., one of the head researchers, is very optimistic about the potential of this research.  “This is very early work,” he explains, “but we already have hints that it is possible because many fish species have the capacity to regenerate cells.”  Levine has teamed up with James Patton, Ph.D., who has researched the retinal regeneration capacities of zebrafish.  The goal is to understand how zebrafish can regenerate their cells and attempt to recreate that regeneration in mouse models.  The hope is that from mice, the therapies could eventually be applied to humans.

This research is just another example of how animal models can be used to better the lives of individuals with terminal, debilitating diseases. To read more about this exciting study, please click here.

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