FDA Commissioner Nomination Moves through Senate HELP Committee

The nomination of Scott Gottlieb, President Donald Trump’s pick to head the U.S. Food and Drug Administration (FDA), was voted out of the Senate Health, Labor, Education and Pensions (HELP) Committee yesterday morning by a vote of 14-9. The vote was scheduled to occur on Wednesday morning but it was postponed for 24 hours due to Senator Patty Murray (D-WA) and other committee Democrats expressing concern over Gottlieb’s financial holdings.

Gottlieb is a physician and managing director of T.R. Winston & Co., a Los Angeles-based bank focused on healthcare. He is also a clinical assistant professor at New York University’s School of Medicine, a resident fellow at the American Enterprise Institute, and is on the product investment board of GlaxoSmithKline. Gottlieb served as FDA’s deputy commissioner for medical and scientific affairs under President George W. Bush.

As NABR reported earlier this month, Gottlieb was vetted by the Senate HELP Committee on April 5. Gottlieb’s nomination now advances to the full Senate for confirmation but a date for that vote has not yet been scheduled.

Government Shutdown Unlikely Due to Short Term Extension

Congress must approve a spending bill or short-term extension by today, Friday, April 28, at midnight or the current stopgap spending bill will expire and the government will be forced to shut down. Previously there was a holdup amongst Democrats on the spending bill because President Donald Trump wanted to include funding for the construction of a wall on the United States-Mexico border. However, Trump has now stated that he will approve a spending bill without this language and that funding for the wall is an issue that will be revisited at a later date.

Republicans, who have a majority in both the House and the Senate, have maintained that a government shutdown is unlikely. According to NPR, the heads of the House and Senate Appropriations Committees have endorsed the idea of passing a short-term spending bill that would extend government funding until May 5 and give policymakers more time for negotiations.

As of this afternoon, Democrats are threatening to oppose the one week extension bill if Congress passes a healthcare bill before the weekend. If the short term spending bill passes tomorrow, Congress will need to vote on another spending bill or extension by May 5 to once again avoid a government shutdown.

Media Outlet Takes Animal Rights Group to Task

“Just who is the group protesting live animal training in Fargo,” asked KVLY in Fargo, North Dakota on April 6, 2017. In a report televised by the news outlet, Valley News questioned the animal rights group protesting lifesaving trauma training at North Dakota State University (NDSU).

The Physicians Committee for Responsible Medicine (PCRM) has sought to end such training and education at NDSU because it involved the use of animals. PCRM even erected a billboard questioning NDSU’s use of pigs for these programs just last year. KVLY asked the question, “who is the PCRM,” and investigated whether PCRM practices “responsible medicine.” According to the news report, PCRM promoted the use of the Heimlich maneuver as a way to save drowning victims, something the American Heart Association notes as “unnecessary and potentially dangerous.”

To watch the news coverage mentioned above, click here and feel free to share it with your friends, family, colleagues, and on social media.

Recording of Last Week’s NABR Webinar is Now Available Online

Did you miss last week’s NABR webinar? Want to watch it again? Interested in hosting a lunch-and-learn opportunity for your staff?  NABR’s April 11 webinar, "USDA Animal Search Tool – Deactivated: The Impact on the Research Community" is now available online for on-demand viewing.

Please click here to view "USDA Animal Search Tool – Deactivated: The Impact on the Research Community." You will need your NABR members-only log-in credentials to watch the presentation.

You can find all of NABR’s past webinars, including this one, in an online library in the Members Only section of our website.

If you have problems logging in or have any questions about the webinar, please contact us at info@nabr.org.

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.

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.

“We Wanted Them to Live in Fear”: Animal Rights Activist Admits to Bombing

Rodney Coronado, once an activist for the Animal Liberation Front, last week admitted to the Lansing State Journal that he was behind the 1992 bombing of the office of a Michigan State University animal science professor. Richard Aulerich, who was specifically targeted, was studying environmental impacts on mink reproduction. Coronado targeted Aulerich’s laboratory because he thought the study was being supported by the fur industry. “I won’t sugar coat it,” he said to the State Journal. “We were about psychological warfare. We wanted researchers like Aulerich never to know when they came to work and opened their office door whether there had been an attack. We wanted them to live in fear.”

According to the article, Coronado fled after the attack and was on the run for over a year. Police eventually caught up with him and he agreed to plead guilty to aiding and abetting arson in exchange for having several other charges dropped. He spent over four years in prison.

Coronado’s bomb destroyed decades of research and caused over $1 million in damages.

This bombing happened fourteen years before enactment of the Animal Enterprise Terrorism Act (AETA) in 2006. To read recent news coverage about Coronado and the Michigan State bombing, please click here.

Registration is Open for NABR’s April Webinar!

When you received the news earlier this month that the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) removed from its website “inspection reports, regulatory correspondence, research facility annual reports, and enforcement records,” you most likely and understandably had a few questions. What happened? Why? How does this impact me and my institution? What now?

Although some of the data is back online, USDA’s action will certainly impact registered research facilities and licensed dealers who supply animals to research facilities. Join NABR on Tuesday, April 11 for our next exclusive webinar that will examine the current status of the database and how it may affect your institution and animal rights activity. NABR’s staff will share expert analysis including examples of how NABR uses information in the database to provide advice and support to institutions like yours. You will get an in-depth look at the USDA’s database, the information contained, and learn how you can make sense of the tremendous amount of data contained within.

Due to its timely nature, this webinar is expected to fill up fast — reserve your spot and register today!

New Drug in Development that Could Permanently Lower Cholesterol

Researchers are working on a treatment that could help millions of Americans achieve better lifelong health. Recent studies with mice have shown that a new injection disables a certain gene, resulting in lower cholesterol levels and a reduced risk for heart disease. This development is especially significant since heart disease is the United States’ most expensive disease.

In 2005, researchers found that people born with natural mutations involving this gene have very low cholesterol levels. The preliminary drug mimics this naturally-occurring mutation and prevents the body from making cholesterol-enabling proteins. Compared to existing cholesterol-lowering drugs that are extremely expensive and require multiple injections every two to four weeks, this new one-time treatment offers a radically different alternative, which has been more effective in trials than the existing antibody drugs. It also results in few to no side-effects, which is a huge bonus for people who are sometimes sensitive to certain drugs.

This injection treatment would permanently alter a person’s DNA so before it can be applied to humans, researchers must continue to test its safety. These mice studies seem very promising, according to Lorenz Mayr from the pharmaceutical company AstraZeneca. However, human trials are still at least a decade away, and in the meantime animal models are propelling this research forward.