Congress Questions NIH Director on Animal Research Regulatory Burden

On July 25, the Health subcommittee of the House Energy & Commerce (E&C) committee held a hearing titled "21st Century Cures Implementation: Updates from FDA and NIH." A recording of the hearing can be viewed on the House E&C YouTube site. The intent of this hearing was to get an update from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) on their implementation of the 21st Century Cures Act.

Of interest to the animal research community is Section 2034(d) of the 21st Century Cures Act, enacted on December 13, 2016, which reads, “Not later than 2 years after the date of enactment of this Act, the Director of National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input of experts, as appropriate.”

On March 14 the NIH put out a Request for Information (RFI) regarding animal care and use in research in an effort to comply with Section 2034(d) of the 21st Century Cures Act. However, in his written testimony submitted prior to the hearing, NIH Director Francis Collins included a section on reducing administrative burden and increasing efficiency, but did not mention animal research.

Two members of Congress on the Health subcommittee asked pointed questions of the Director on this issue. The first question came just after the 40:00 mark from Chairman Michael Burgess (R-TX), who asked, “We tried to identify ways to get regulations and policies that were inconsistent, and to give you some flexibility to move past some of these that are over-lapping and unnecessarily duplicative to relieve some of the administrative burden. I think the Act asked you to review that, so can you perhaps share with us where you are in the review and how NIH has identified some opportunities to relieve the burden on investigators?”

While Dr. Collins’ answer initially focused on how the NIH deals with grants, near the end of his answer he mentioned animal care and use by stating, “We’re looking right now at animal care and use and the oversight that is necessary, of course, to be sure that we’re dealing with animals in an ethical way. Some of those of those particular oversight mechanisms are now being reviewed. We put out an RFI and got 19,000 comments back from people who have opinions about how we might streamline these processes. Those are a few examples.”

Later, just after the 2:21:00 mark, Rep. “Buddy” Carter (R-GA) pushed Dr. Collins for a more direct answer by asking, “I wanted to ask about one of the initiatives of 21st Century cures, and that was to really review the regulations and policies with respect to research with laboratory animals. As I understand it you are working with USDA now and the FDA to try to complete a review of that. I wanted to ask you if you could tell us the current status of that review and when do you anticipate the completion of that review?

Dr. Collins replied, “We did put out an RFI back in March to ask for comments in this area in terms of whether the oversight that we currently apply to animal experimentation is sufficient or whether it has areas that are overly bureaucratic, which has been a concern. Obviously, we are deeply concerned about maintaining our ethical responsibilities in terms of how we take care of animals that are subjected to various experimental approaches, from which we learn a great deal that has led to many medical advances. We got 19,000 responses to that request and they are currently being sorted at the moment. We would expect to have, based upon those, a draft set of recommendations about animal care and use sometime probably in September. We will then need to have responses to that. So, we would hope to have a final version of this by December, or early in 2019.”

Rep. Carter pressed further asking, “Any opportunities that you’ve identified thus far that may help you?

Again, Dr. Collins highlighted grant issues by stating, “…I think there are concerns that some of the requirements that we put on grant applicants, in terms of animal care and use, could be delayed until the award is actually made as opposed to asking them to have all those things in place when they submit an application. That can add a lot of time and effort, and obviously our concern is that if we’re actually going to make the award we want to be sure that the animal care is being done in the best possible way. That is one area. Obviously, there are differences of opinion here and we’re seeing those in 19,000 responses and at some point, we have to try to come down on what we think is a fair and balanced approach.”

New Insulin Pill Shows Positive Results in Rodent Models

A new insulin pill has shown positive results in a Harvard study with rodents, researchers say. While the concept of the insulin pill is not new, there are currently no products available on the commercial market. The biggest challenge with an insulin pill is that the digestive system tends to break down and destroy insulin itself.

The Harvard researchers tried a new approach with their version of the insulin pill by dispersing the insulin in liquid made from choline and geranic acid. When administered to rats, their blood sugar levels fell by about half, the effects lasting four hours. The researchers theorize the suspension of the insulin in the choline/geranic acid liquid prevents the digestive system from destroying the medicine, allowing it to be absorbed into the blood stream.

The researchers concluded, “Evidence from cell and animal studies supports a promising prospect of development of the formulation into a clinical product." You can read the full findings online via Proceedings of the National Academy of Sciences.

Are We on the Cusp of Finding an AIDS Vaccine?

With the help of nonhuman primates (NHP), French researchers may be close to answering the nearly 40-year old riddle that is AIDS.

On July 6, AFP reported that scientists had successfully tested the vaccine dubbed HVTN705 or "Imbokodo" in monkeys, shielding them from infection and triggering an immune response. It now moves to the next phase where it will be tested in 2,600 women in southern Africa. The results from the trial are expected in 2021 or 2022.

While we must be cautiously optimistic that Imbokodo will be successful in humans, this represents a great leap forward, thanks to the assistance of NHP models. A Harvard Medical School professor notes in the article that in the nearly 40-year history of AIDS, this is just the fifth vaccine concept to make it to the efficacy stage in people.

The Independent, The Telegraph, Science Alert, and ScienceDaily also featured coverage.

Targeted Professor Pens Letter Defending Her Research

Dr. Tania Roth, the University of Delaware researcher who has recently found herself targeted by the People for the Ethical Treatment of Animals (PETA), wrote a piece in Delaware Online standing up for her neuroscience research and the vital role that animals play in medical advancement.

Besides breaking down the legal and regulatory framework she must follow, Roth very astutely notes, “The use of animal models in the research process is pivotal, and provides us with the tools necessary to better study the brain. By understanding basic neuroscience, where scientific knowledge begins, we can discover breakthroughs that will eventually lead to new therapies and offer hope to children and families all around the world.”

Click here to read Roth’s piece, and please take a moment to leave a comment in support of Roth.

NIH Issues RFI on Assessing the Safety of Relocating At-Risk Chimpanzees

The National Institutes of Health (NIH) issued a Request for Information (RFI) on June 11 in the Federal Register titled, “Input on Report from Council of Councils on Assessing the Safety of Relocating At-Risk Chimpanzees.” This RFI stems from the 2015 decision by NIH Director Francis Collins that all NIH-owned chimpanzees should be retired and relocated to the chimpanzee sanctuary, Chimp Haven, in Keithville, LA. However, many of the NIH-owned chimpanzees are of an advanced age and relocation has caused unnecessary stress on several of them. Additionally, there have been an alarming number of deaths of retired chimpanzees after relocation to Chimp Haven during the past several years.

The NIH posted the notice in the Federal Register to inform the research community, and other interested parties, that it has received a report from the Council of Councils Working Group on Assessing the Safety of Relocating At-Risk Chimpanzees. The NIH will consider the recommendations in the report and is inviting the public to comment in response the RFI. This RFI is open for public comment for a period of 60 days and comments must be submitted by August 10, 2018. Comments must be submitted electronically here: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=72.

National Review Provides Positive Coverage of Animal Research and Testing

Research with animal models continues to be critically important for breakthroughs in modern medicine. Yet, it is frequently under assault by recognizable and lesser known animal rights groups who oppose the use of animals in ethical and humane research. Yesterday, the National Review printed a piece that we think you should read, covering the benefits of animal research and explaining why science needs animals for lifesaving and life-improving research.

A recent discovery in gene therapy to repair spinal cord damage in rats was notably highlighted as a prime example how animal research is vital.

Please click here to read yesterday’s National Review piece and feel free to share it with your friends, family, colleagues, and social media.

Positive Change in Public Attitudes on Animal Testing and Research

According to a Gallup Poll released last week, 54% of Americans view medical testing on animals as morally acceptable. While this number still represents a significant decrease from 65% in 2001 when Gallup began tracking responses on this topic, it demonstrates a modest increase from last year’s results of 51%.

Public support is one reason why NABR’s sister organization, the Foundation for Biomedical Research, developed the "Love Animals?" campaign, which is aimed at animal lovers everywhere. Contact info@fbresearch.org for your copy.

FBR President Pens Thought-Provoking Piece in The Washington Times

The Washington Times ran an opinion piece by Foundation for Biomedical Research (FBR) President Matthew Bailey on Wednesday detailing the discoveries that animal research delivers to both humans and their beloved pets. The piece starts with the story of Dover, a 7-year-old bull mastiff suffering from lymphoma which caused him to go blind. Dover was enrolled in a clinical trial at Tufts University and the results were fantastic. The treatment restored the dog’s sight overnight and currently his cancer is in remission.

Take another example from the University of Pennsylvania, where researchers are working to save dogs with osteosarcoma, a type of bone cancer. Researchers there have developed genetically-modified bacteria that, once injected, enables the dog’s own immune system to attack the tumors. At University of California, Davis they have tested a treatment for heart disease which affects 1 out of 7 cats. UC Davis and Kansas State University have also teamed up to develop an antiviral drug to combat feline infectious peritonitis.

It is important for the research community to showcase stories like these because they illustrate the focus of FBR’s latest campaign, “Love Animals? Support Animal Research”  because animal lovers should be the most ardent supporters of animal research. Animal research not only saves human lives, but also many pets, as well. Forty-three million U.S. households have a dog, thirty-one million have a cat, and ninety percent of those Americans consider their pets part of their family. Unfortunately, our beloved pets suffer from cancer, diabetes, kidney and heart disease, and other ailments, just like their human counterparts. But animal research can provide hope for our furry family members while providing a foundation of scientific data and understanding to treat humans. To read Bailey’s piece click here and be sure to visit www.FBResearch.org to learn more about FBR’s “Love Animals? Support Animal Research” campaign.

Non-Human Primates Critical to Development of New Migraine Medication

The Hill reported on May 17 that the Food and Drug Administration (FDA) has approved a new medication to prevent migraine headaches. The new drug is called erenumab-aooe, trademarked as Aimovig, and is produced by Amgen and Novartis. In trials, Aimovig helped patients experience at least a 50 percent reduction in the total number of days in which they suffered a migraine.

Nonhuman primate (NHP) research was critical to testing the drug’s safety for pregnant woman and their unborn children. The FDA states, “No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation. Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses.”

Nonhuman primates have been, and will continue to be, critical to medical research. The Foundation for Biomedical Research (FBR) provides an excellent white paper and brochure on this topic, and we encourage you to read both.

USDA-APHIS Will Not Recognize Third-Party Inspections and Certifications

On May 25, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) released a statement which reads, “it will not establish new criteria for recognizing third-party inspection and certification programs when determining the Agency’s own inspection frequency under the Animal Welfare Act (AWA).”

APHIS had announced a series of public listening sessions starting in December of 2017 to hear feedback from the regulated community and others. APHIS also posted a Federal Register notice in January 2018 asking for written comments through March 21. In the end, APHIS received over 35,000 written comments, many of which were submitted by animal rights groups. APHIS asserts the vast majority of comments they received expressed concern with AWA compliance being in jeopardy if third-party inspections were utilized.

APHIS continues to support its risk-based inspection system when determining the frequency of their AWA inspections. You can view the listening session comments here and the Federal Register comments here.

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