Senate Commerce Committee Unanimously Advances OSTP Nominee

The Senate Committee on Commerce, Science, and Transportation advanced the nomination of Dr. Kelvin Droegemeier for Director of the White House Office of Science and Technology Policy (OTSP) on Wednesday during their executive session. The committee voted unanimously to advance Droegemeier, who is expected to face a full Senate vote later this month.

Droegemeier was Vice President for Research at the University of Oklahoma-Norman from 2009 until August of 2018. He also served on the National Science Board under both Presidents George W. Bush and Barack Obama. Droegemeier is currently Secretary of Science and Technology for the state of Oklahoma.

During his August 23 confirmation hearing, Droegemeier indicated his strong support for the U.S. research community by stating, “We need to make sure we are the strongest research center in the world.”

Rally for Medical Research This Week, September 12 and 13

The American Association for Cancer Research (AACR) is hosting their annual Rally for Medical Research in Washington, DC on September 12 and 13 to call on Congress to make funding for the National Institutes of Health (NIH) a national priority. The event is also an opportunity for individuals and organizations to showcase why they support medical research and how it positively impacts lives every day. You can read more about the event at the Rally for Medical Research’s Facebook page or web site.

Can’t make it to Washington next week but still want to help? Please print an “I Rally For...” sign, fill it out, and post in on social media like Facebook, Twitter, and Instagram with the hashtags #IRallyFor and #RallyMedRes. If using Twitter, remember to tag NABR (@NABRorg) and our sister organization the Foundation for Biomedical Research (FBR)(@researchsaves), as well.

Mark your Calendars for NABR’s October Webinar

NABR will be hosting our next webinar, “Advocating for Sound Public Policy: The Challenges and Opportunities for Participating in the Process” on Tuesday, October 9. In this webinar, we will discuss what constitutes sound public policy, how NABR engages in that process, and —most importantly— what NABR members can do to assist.

For example, in the past year, the research community has been afforded opportunities to respond to Requests for Information (RFI) on reducing regulatory burden from the USDA, the NIH, and the FDA. These RFIs have provided the research community an excellent opportunity to advocate for the development and implementation of improved regulations, policies, and guidelines.

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." During that hearing NIH Director Dr. Francis Collins responded to questions concerning the regulatory relief mandate in the 21st Century Cures Act. In this webinar we will discuss how NABR formulates responses to those RFIs and we will review how the research community can participate in these processes, draft their own responses, and engage in the policy process to have a significant impact on the environment in which we all work.

Click here to reserve your spot!

Opinion Piece by FBR, NABR President in Houston Chronicle: Animal Research is Crucial to Pets and their Owners

On August 21, the Houston Chronicle featured an opinion piece by NABR and Foundation for Biomedical Research (FBR) President Matthew Bailey discussing how pet lovers should be supportive of animal research. Further exemplifying FBR’s Love Animals? Support Animal Research campaign, Bailey’s piece titled, “Animal research is crucial for pets and their owners,” shows directly how researchers are doing everything from helping eradicate cancer to developing new anti-inflammatory drugs, so our pets can live lover, happier, and healthier lives.

“Animal research has already saved, and will continue to save, millions of pets' lives. Without animal research, how many of our cats would be dying prematurely of leukemia? Or how many of our dogs would be unable to run and play because of debilitating arthritic pain,” writes Bailey. Bailey notes how researchers are testing a cancer vaccine with dogs, working on helping cats with failing kidneys, and searching for the first definitive non-invasive diagnostic test for feline infectious peritonitis. Please take a moment to leave a positive comment in support of Bailey’s opinion piece by clicking here.

President Trump’s Nominee for Science Advisor Committed to Science Over Politics

Nature reported on August 23 that President Donald Trump’s nominee for the White House Office of Science and Technology Policy (OSTP), Meteorologist Dr. Kelvin Droegemeier, said that science should be conducted without political influence or interference.

Droegemeier was Vice President for Research at the University of Oklahoma-Norman from 2009 until August of 2018. He also served on the National Science Board under both Presidents George W. Bush and Barack Obama. Droegemeier is the current Secretary of Science and Technology for Oklahoma.

During his August 23 Senate Commerce, Science, and Transportation Committee nomination hearing, Droegemeier stated, “Science never provides immutable evidence about anything. I think science is the loser when we tend to vilify and marginalize other voices. We need to have everyone at the table.” The quote was from a segment where Droegemeier was questioned about climate change, though his attitudes towards science trumping politics is important and interesting to note especially since it is regarding an equally controversial research topic.

Droegemeier also emphasized the need to be competitive in research regarding China, telling the Committee, “We need to make sure we are the strongest research center in the world.” This is an interesting point since The Scientist reported on August 21 that primate research is dropping in the west while China is positioning itself to be a global leader in that sphere.

The Committee is set to vote on August 29 on whether to advance Droegemeier’s nomination to the full Senate.

DC Circuit Court Affirms Denial of Primate Import Data to PETA

A unanimous decision by a three-judge panel of the D.C. Circuit Court of Appeals has upheld the denial of primate importation data to PETA.  PETA requested primate importation data from the Centers for Disease Control (CDC) under the Freedom of Information Act (FOIA) in 2014.  In response to PETA’s FOIA request, the CDC notified ten affected importers, seven of which objected to the disclosure of the information to PETA. The CDC ultimately withheld information about the number of nonhuman primates in each shipment, the size of their crates, and the airline carrier used under Exemption 4 of the FOIA. FOIA Exemption 4 protects from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.”

The CDC argued that disclosing the information to PETA would harm the importers, as information about the number of primates imported, the size of the crates and the airline carrier used is maintained by the importers as confidential and the release may result in competitive harm, including disruption of supply routes.

As NABR members know, animal rights organizations, including PETA have long targeted airlines, in an attempt to pressure them into refusing to ship nonhuman primates for research.  The Court of Appeals recognized the risks associated with shipment noting that “knowing in the abstract which airlines transport nonhuman primates is very different than knowing which importers have relationships with which airline carriers, and which airline carriers are willing to transport which species of nonhuman primate along which routes and from which countries.”

The D.C. Circuit Court upheld CDC’s denial of the information to PETA and the Court of Appeals has now also affirmed that decision.

This case highlights the importance of understanding the FOIA and its impact on research.  NABR encourages all members to ensure they have a reviewed the FOIA Guide, Responding to FOIA Requests: Facts and Resources, which was jointly produced by NABR, FASEB and SfN.

Research!America Offers Novel Civil Engagement Initiative

Research!America has rolled out a novel bipartisan civic engagement initiative that is providing $1,000-$3,000 grants to student science policy groups. The goal is to better engage the next generation of scientists in the public policy process and impressing upon policymakers the importance of science in the 2018 midterm elections. The grants can be used for “lab tours, roundtable discussions, and policy briefings with candidates; host community science events and Pub Nights; support social media engagement including Twitter chats; conduct media outreach; and organize webinars highlighting the benefits of federally funded research.”

This initiative is born from the necessity to get researchers, particularly young researchers, involved in the public policy process to protect and promote their work. Lawmakers take input from the scientific community seriously, however researchers are often reluctant to engage in the policy process and share their work. Research!America’s civic engagement initiative is a creative way to incentivize communication with legislators that the research community needs.

WaPo Covers Animal Personhood Case in Oregon

The Washington Post reported on a lawsuit in Oregon that could have ramifications for the animal personhood movement, filed by the Animal Legal Defense Fund (ALDF). A horse, formerly named Shadow, now re-named Justice, was found to be severely underweight and ill at a veterinarian exam last year. Its previous owner pled guilty to criminal neglect last summer.

Now, the ALDF has filed a lawsuit against the former owner, in the horse’s name. The lawsuit is claiming negligence and is seeking $100,000 in damages for pain and suffering. Animal personhood could have sweeping and disastrous effects on biomedical research, agriculture, and pet ownership.

There have been numerous previous attempts to obtain legal personhood for nonhuman primates (NHPs), and more recently, elephants. The elephant personhood lawsuit in Connecticut has so far been a failure for animal rights activists, though the Nonhuman Rights Project (NhRP) is seeking a review of the Superior Court Decision. Many readers will remember the infamous “monkey selfie” case, brought by the People for the Ethical Treatment of Animals (PETA), which ultimately failed to grant copywrite rights to nonhumans.

Matthew Liebman, Director of Litigation at ALDF, told WaPo that he hoped this case would be different: “There have been a lot of efforts to try to get animals not only to be protected but to have the right to go to court when their rights are violated. Those haven’t found the right key to the courthouse door. And we’re hopeful that this is the key.”

However, animal law experts, like Richard L. Cupp, a Pepperdine University law professor, have argued that these types of personhood lawsuits are extreme and dangerous. If any animal protected under Oregon’s anti-cruelty law can have a lawsuit filed on their behalf, animal litigation could overwhelm the courts. Cupp expounds on the point, “Once you say a horse or dog or cat can personally sue over being abused, it’s not too big a jump to say, ‘Well, we’re kind of establishing that they’re legal persons with that.’”

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.