Nysha Recent News

Public Heallth and Policy News

November 30, 2016

By Mendy Hecht, Hamaspik Gazette

U.S. Army starts Zika vaccine tests

As reported in Gazette #141, the U.S. Army’s Walter Reed Army Institute of Research (WRAIR) has been working on a Zika vaccine since February 2016.  A prototype was developed this July, and the first of five Phase I human trials projected then for late 2016 is now underway.

On Nov. 7, the Army announced a study of 75 adults, 25 of which are getting the experimental Zika Purified Inactivated Virus (ZPIV) vaccine.  Four additional Phase 1 studies to evaluate the vaccine are expected to launch in the coming months.  Studies are expected to end by fall 2018.

England rolls out global Ebola response team

In early November, the British government announced the formation of an Ebola global rapid-response team.  The group of professionals, including doctors, nurses and infectious disease experts, are equipped to be on the site of any outbreak of the deadly virus, anywhere in the world, within 48 hours.  Its purpose is to assist and backup local health authorities in keeping any Ebola outbreak small and under control.

The 2014 Ebola epidemic killed 11,315 people, mostly in Liberia and other African nations.

For its part, the U.S. Centers for Disease Control (CDC) has kept an Ebola rapid-response team on 24/7 standby since the 2014 Texas case.  That team will only respond to domestic outbreaks, though. 

In the wake of the Zika virus outbreak in Florida and elsewhere this past summer, the CDC also now maintains a domestic Zika rapid-response team.

“New” auto-injector returning in 2017

In the wake of the recent public uproar over news that prices for the life-saving EpiPen auto-injector devices were increased by their maker by over 480 percent since 2009, a “new” emergency medical device for severe allergic reactions is said to be returning to the market.

The Auvi-Q device, which like the EpiPen injects allergy patients with a life-saving dose of epinephrine, was recalled in 2015 due to potential under-dosing in severe crisis situations.

But now, according to Auvi-Q inventor Kaleo, the injector is slated to be reintroduced to the market in the first half of 2017.

Auvi-Q has a voice prompt system that guides users through the injection process, as well as a needle that automatically retracts following injection, the company says.

Mylan, the company that manufacturers EpiPens, responded to the criticism by saying it would offer a savings card to cover up to $300 in costs for its two-pack injector set.  It also said it would expand eligibility for its patient assistance program.   EpiPens can cost as much as $700 for a pack of two auto-injectors before insurance.

Kaleo did not offer information on how much Auvi-Q would cost, but said it is committed to affordability.  At the time of its recall in October of 2015, Auvi-Q cost around $400 per set.

Theranos shifting away from blood tests

Embattled blood-testing company Theranos announced in early October that it would be shutting down its blood-testing facilities and trimming its employee body by over 40 percent. 

The California-based startup, whose trailblazing blood-drop testing technology stood to revolutionize blood testing at its 2003, was rocked by a number of setbacks earlier this year.

Those included the voiding of two years’ worth of customer blood tests, the federal shuttering of a Theranos lab in Newark, California, loss of a planned business partnership with pharmacy retail giant Walgreens, and a potential industry ban for founder Elizabeth Holmes.

The company now says it will now be focusing on developing new blood-testing devices, particularly its prototype miniLab device, which has yet to be approved by federal regulators.

U.S. gov’t grantee gets 2016 chemistry Nobel

In early October, Sir James Fraser Stoddart of Northwestern University, one of the few Americans and even fewer U.S. academics to ever earn British knighthood, was awarded the 2016 Nobel Prize in chemistry.  Since 2010, Sir James has received over $2 million from the National Cancer Institute (NCI), one of the National Institutes of Health (NIH)’s 27 divisions.

Sir James’ groundbreaking work on the design and production of molecular machines earned him the coveted prize, along with Jean-Pierre Sauvage of France and Bernard L. Feringa of the Netherlands.  Molecular machines are tiny molecules—1,000 times thinner than a hair—with controllable movements that can perform tasks when energy is added.

According to NIH Director Francis Collins, M.D., Ph.D., molecular machines have the potential to deliver drugs within the body—“for example,” he said, “by applying them directly to cancer cells.”

1st of 18 “artificial pancreas” devices approved

According to non-profit JDRF (formerly the Juvenile Diabetes Research Foundation), some 18 portable and wearable devices are currently in various stages of early development that function as artificial pancreases of sorts.

On September 28, the FDA approved the first of these—the Medtronic MiniMed 670G device—for usage by people with type 1 diabetes.  However, the device will not be available until spring of 2017.

Diabetes is a disorder in which the body can’t automatically regulate levels of glucose, a key sugar in food that the body’s cells need for growth and function.  In type 1 diabetes, the pancreas does not produce enough insulin, a hormone that cells need to absorb glucose. 

People with type 1 can manage their diabetes by dosing themselves with insulin across each day to match the current glucose level as measured by handheld blood glucose monitors.  Because blood glucose levels rise or fall with the level of carbohydrates in food eaten, type 1 is ideally managed by matching the amount of each insulin dose to the amount of carbohydrates just eaten.

Medtronic’s new device is unlike existing insulin pump devices, which have been around for years in a growing and ever-improving number of forms.  Insulin pumps are largely operated manually, though many have automatic functions.  The innovation of the new device is that it constantly monitors blood glucose levels and automatically pumps in matching insulin levels of insulin—potentially freeing users from constant glucose-level checks and insulin dosings.

“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), said in a press release.