Animal Models a Game-Changer for the Dental Field

Biomedical research is an essential component of virtually every aspect of medicine, but did you know that it’s helping make some pretty significant strides in the dental field? Studies using mice, rats and other animals have led to treatments for diseases that affect many of us. Procedures and discoveries for oral cancer, gum diseases like gingivitis, dental implants, and everyday procedures that occur while you are in the chair at the dentist’s office have been developed using animal models.

Perhaps the most annoying dental issue for many people is the incidence of cavities, damage within a tooth caused by bacteria. Cavities are usually treated by removing the decayed portion of the tooth and “filling” it with substances like gold, silver, an amalgam of various metals, or a composite resin. This procedure, as most would agree, can often be painful, burdensome and expensive depending on the size and location of the cavity. According to the U.S. Center for Disease Control and Prevention (CDC), 91% of Americans over the age of 20 experience a cavity at least once during their lifetime.

However, an exciting new study recently reported by the Guardian could someday result in fillings being unnecessary. This study has helped scientists to develop a therapy that promotes repair and rebuilding of the cells within teeth. When a sponge was soaked in a drug used to treat Alzheimer’s disease and then inserted into the teeth of mice infected with cavities, the tooth material began to regenerate. While the therapy showed great success for tooth regeneration within mouse models, more research is required before the results can be applied to humans, since cavities in humans are much larger. If this therapy is successful in humans, the need for fillings could someday be eliminated—a very welcome concept for the many people who dread trips to the dentist to have cavities filled.

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Study with Lab Mice Shows Reversal of Osteoporosis

According to the National Osteoporosis Foundation, approximately 54 million Americans have osteoporosis or low bone mass, placing them at risk for osteoporosis. Approximately one in two women age 50 and older will break a bone due to osteoporosis and the complications can be serious. The disease is responsible for two million broken bones and $19 billion in healthcare costs each year. Experts expect that number will reach $25.3 billion by 2025. Osteoporosis is a serious problem and thanks to a study from the Children's Medical Research Institute (CRI) at the University of Texas Southwestern, a new cure could be on the horizon.

Scientists at UT Southwestern’s CRI gave daily doses of Teriparatide (PTH), a drug approved for limited use in osteoporosis treatment, to female mice modeling osteoporosis in postmenopausal women. They also gave recombinant Osteolectin, a bone-forming growth factor that promotes the formation of new bone from skeletal stem cells in the bone marrow, to mice without ovaries. Both groups of mice exhibited increased bone volume and reversed any loss that occurred. This research could have big implications for other regenerative medicine-centered studies.

To learn more about this study, please click here.

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.

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.

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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.

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.

The World’s Five Deadliest Diseases and the Animals Helping to Fight Them

The critical need for animals in research has been well-established, but do you know its impact on the world’s deadliest diseases? In the on-going effort to emphasize the benefits of animal studies in treating the world’s five deadliest diseases, NABR has released a brief, easy to digest review of animals in the research to cure coronary artery disease, stroke, lower respiratory infections, chronic obstructive lung disease (COPD), and lung cancer.  Shockingly, 22 million people per year, or 40% of all deaths in the world, occur because of these five diseases.  While these numbers can make the future look bleak, there is hope.

Many animals such as dogs, rabbits, mice, cats, and even ferrets and guinea pigs have contributed to incredible medical breakthroughs which have saved countless lives from these afflictions, and continue to help search for cures every day.  However, it is not just human lives that these animals are saving, animals have also greatly benefited from the research as well.

Dogs were instrumental in developing coronary artery bypass surgery and Taylor, a Doberman-German shepherd mix, was the first to receive open heart surgery to fix a rare congenital defect.  Now even more pets are undergoing the surgery to greatly improve their health and extend their lives.

With animal research breakthroughs, medical treatments are being developed right now to help save the lives of both people and animals, just like Taylor, who are struggling with chronic, severe illness.

Click here to read more about the role animals have played in improving the lives of millions of people afflicted with the five deadliest diseases in the world. Feel free to share this resource with your friends, family, colleagues, and on Facebook and Twitter.

Mouse Models Help Researchers Prepare for the Future of Space Travel

As if it was a scene taken straight out of a movie, the United States aims to put a man on Mars in the next two decades.  Mars, at its closest point, is 33.9 million miles away, and animal research is showing that the long trip to the Red Planet could have health implications for astronauts and space travelers.

Using mouse models, researchers have found that exposure to cosmic rays, which are abundant in space, could lead to something dubbed “space brain.”  Mice exposed to energetic, charged particles, similar to cosmic rays, developed conditions leading to mental impairment and dementia. They also showed decreased levels of “fear extinction,” the way in which the brain stifles traumatic associations. These decreased levels could make one more prone to anxiety which could become problematic on the three year trip to Mars.

Without the use of animal models, it would become almost impossible to test the effects of space travel on astronauts’ bodies. Author of the study and professor of radiation oncology at the University of California, Charles Limoli, explains, “Exposure to these particles can lead to a range of potential central nervous system complications that can occur during and persist long after actual space travel – such as various performance decrements, memory deficits, anxiety, depression, and impaired decision-making.”  An astronaut’s job in space is so complicated that any decrease in performance can spell disaster for a whole mission.

Thankfully, with the use of animal models, it becomes easier to study the rigors of space travel.  While the results from these studies are only an approximation to the effects of space on humans, it is a vital first step towards further exploration of outer space and ensuring the safety of our intrepid astronauts.

To read about this study, please click here.

Are Mice the Key to Unlocking a Vaccine Against Breast Cancer?

Scientists may have found a new way to protect high-risk individuals from developing breast cancer, a disease that will impact about 1 in 8 women in her lifetime.  According to recent news coverage, researchers from the Messerli Research Institute at the University of Veterinary Medicine Vienna and from the Medical University of Vienna have successfully tested a vaccine with artificial HER2 antigens.  HER2 proteins cause breast cancer tumors to grow and it is present at above normal levels in about 30% of breast tumors. Thanks to research with mice this new vaccine could be on its way to patients to prevent breast cancer.

The immune system does not attack mutated cancer cells.  However, artificial tumor antigens, otherwise known as mimotopes, can stimulate an immune response. Unfortunately, these mimotopes need to have a carrier to be effective and with past carriers the mimotopes have changed their structure, decreasing their effectiveness in the body.

Researchers have found the vaccine is much more effective if the HER2 mimotopes are paired with particles of a virus.  The viral particles are too small to cause disease but are enough to cause an aggressive immune response.  This immune response is associated with the mimotopes and the body then begins to attack breast cancer cells.  In mouse models, those vaccinated with the antigen were shielded at significant levels from growing tumors; while the control group developed the cancer.

This potential vaccine could protect people and those who have had breast cancer in the past.  And, in a surprising twist, it can also be used in man’s best friend.  The HER2 protein performs similar functions in human and canine breast cancer.  The research team found that the protein corresponds about 90% between dogs and people.

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