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Evaluating Ebola Therapies — The Case for RCTs

THE NEW ENGLAND JOURNAL OF MEDICINE                                                                                 Dec. 3, 2014
By Edward Cox, M.D., M.P.H., Luciana Borio, M.D., and Robert Temple, M.D.

...Studying investigational therapies for EVD presents scientific, practical, and ethical challenges. Not surprisingly, there has been substantial debate about the best and most appropriate study approaches.2,3 It is generally agreed that a trial with a concurrent control group, in which patients are randomly assigned to receive the test drug plus the best available supportive care (BASC) or to BASC alone, would be the most efficient and reliable way to evaluate the safety and effectiveness of candidate products.

 Some people in the health care community, however, have argued against such trials, urging instead use of a historical control — that is, making investigational drugs as widely available as their supply allows and then comparing mortality rates among treated patients with rates that would have been expected absent the drugs, on the basis of past experience with EVD.

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Positive results spur race for Ebola vaccine

With trials under way, scientists are working out how to give vaccines in affected regions

NATURE   By Ewan Callaway                                                                                                 Dec. 2, 2014

Safety trials of Ebola vaccines are starting to return results: at least one is known to be safe and to summon an immune response against the virus.

The challenge now is to use the results to guide the larger studies that will reveal whether the vaccines work.

“The immune responses are there,” says infectious-disease researcher Adrian Hill, director of the Jenner Institute in Oxford, UK. “The tough call is whether they’re enough to protect humans against Ebola.”

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http://www.nature.com/news/positive-results-spur-race-for-ebola-vaccine-1.16468

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To halt Ebola's spread, researchers race for data

DISCOVER MAGAZINE    By Kari Lydersen                                                                              Dec. 2, 2014
.....redicting the trajectory of Ebola rather than playing catching-up could do much to help prevent and contain the disease. Some experts have called for prioritizing mobile treatment units that can be quickly relocated to the spots most needed. Figuring out where Ebola is likely to strike next or finding emerging hot spots early on would be key to the placement of these treatment centers.

But such modeling requires data, and lots of it.  And for stressed healthcare workers on the ground and government and non-profit agencies scrambling to combat a raging epidemic, collecting and disseminating data is often not a high priority.

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Obama: Ebola still priority as public focus shifts

ASSOCIATED PRESS                                                                                                        Dec. 2, 2014 

BETHESDA, Maryland  — Declaring the "fight is nowhere close to being over," President Barack Obama on Tuesday heralded strides in the effort to confront Ebola in West Africa and in protecting the U.S. against the spread of the deadly virus. He said squelching the disease remains an urgent priority even if the American public's attention has shifted elsewhere.

"We cannot let down our guard, even for minute," Obama said. "We can't just fight this epidemic, we have to extinguish it."

Obama spoke after touring the National Institutes of Health in Washington's Maryland suburbs where he witnessed advances in Ebola-fighting research. He highlighted the NIH's progress in developing an Ebola vaccine, calling the initial results "exciting" while cautioning that there are "no guarantees" about the vaccine's ultimate success.

NIH researchers last week reported that the first safety study of a vaccine candidate found no serious side effects, and that it triggered signs of immune protection in 20 volunteers. U.S. health officials are planning much larger studies in West Africa to try to determine if the shots really work...

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Obama to urge Congress to loosen purse strings for Ebola fight

REUTERS  -- By Roberta Rampton                                                                      Dec. 2, 2014

WASHINGTON --President Barack Obama on Tuesday will press Congress to approve $6.18 billion in emergency funding to help fight the Ebola outbreak in West Africa and prepare U.S. hospitals to handle future cases.

U.S. President Barack Obama speaks next to Ebola response coordinator Ron Klain (L) as he hosts a meeting with his Ebola response team in the Roosevelt Room of the White House in Washington, November 18, 2014. Credit: Reuters/Larry Downing

Most of the request is aimed at the immediate response to the disease at home and abroad. But the package also includes $1.5 billion in contingency funds - money that could become a target if lawmakers decide to trim the bill.

"That is the part of the package that is most at risk," said Sam Worthington, president of InterAction, an alliance of U.S. non-governmental aid groups.

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There Is An Urgent Need For An Improved Infrastructure To Share Health Data, Researchers Say

DESIGN & TREND  by Randall Mayes                                                                             Nov. 29, 2014

Over the last decade, we have witnessed the emergence of Superbugs, various strains of bird flu and now Ebola, which do not have geographical borders.

Consequently, there is a pressing need for international cooperation to control these pandemics.

In a new study, researchers have identified obstacles that are currently preventing the world from sharing health data, reports Science Daily.

While performing a literature search for the study, an international group of researchers discovered over 1,400 scientific articles related to sharing public health data. From those articles, they found two broad categories that need to be addressed.

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http://www.designntrend.com/articles/28008/20141129/urgent-need-improved-infrastructure-share-health-data.htm

Link to article  in Science Daily
http://www.sciencedaily.com/releases/2014/11/141125102102.htm

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Scientists: 'Positive' results in 1st human trial of experimental Ebola vaccine

CNN -- By Laura Smith-Spark                              Nov. 27, 2014

The first human trial of an experimental Ebola vaccine has produced promising results, U.S. scientists said, raising hopes that protection from the deadly disease may be on the horizon.

All 20 healthy adults who received the vaccine in a trial run by researchers from the National Institutes of Health in Maryland produced an immune response and developed anti-Ebola antibodies, the NIH said Wednesday.

None suffered serious side effects, although two people developed a brief fever within a day of vaccination.

The vaccine is being developed by the NIH's National Institute of Allergy and Infectious Diseases and British pharmaceutical giant GlaxoSmithKline. The process has been fast-tracked in light of the current catastrophic Ebola outbreak in West Africa, which has claimed more than 5,000 lives.

http://www.cnn.com/2014/11/27/health/ebola-outbreak/

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The Race for an Ebola Vaccine

Description of efforts by the big drug companies to develop an Ebloa vaccine
THE NEW YORKER    By Vauhine Vara                        Nov. 25, 2014

"...why this race to create an Ebola vaccine among Merck, GlaxoSmithKline, and Johnson & Johnson—three of the world’s biggest drug manufacturers? For years, pharmaceutical companies didn’t invest much in vaccines, partly because they were so costly and complicated to produce: they’re often made out of live bacteria, which are notoriously difficult to work with. But, over the past several years, companies have realized that the difficulties of making vaccines could be an asset, because they can make it more difficult for generic-drug companies to create copycat versions than for prescription drugs. The vaccine market has also been growing more quickly than the prescription-drug market. The World Health Organization estimates, based on various sources, that global vaccine sales rose from five billion dollars in 2000 to twenty-four billion dollars last year...."

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http://www.newyorker.com/business/currency/race-ebola-vaccine

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Here’s How the Ebola Vaccine Trial Is Doing

TIME MAGAZINE By Alexandra Sifferlin                          Nov. 25, 2014
 By  Alexandra Sifferlin                       

Scientists are scurrying to get their Ebola vaccines through the necessary safety trials before they can be used widely. That includes the University of Maryland School of Medicine, which recently kicked off the latest step in their research: figuring out the appropriate dosing for the vaccine that’s both effective and safe.

The University of Maryland is one of a handful of institutions involved in the testing of an experimental but promising vaccine developed by the National Institutes of Health’s Vaccine Research Center (VRC) and GlaxoSmithKline (GSK). The hope is that the vaccine will pass through early trials needed by end of December so that the World Health Organization (WHO) and a panel of outside experts can decide whether to move on to a large efficacy trial, which would mean vaccinating a lot of people in West Africa to see how well it works.

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U.S. Buys Up Ebola Gear, Leaving Little for Africa

Manufacturers Strain to Meet Demand Amid Rising Anxiety

WALL STREET JOURNAL                                                                                                       Nov. 25, 2014
 By Drew Hinshaw in Accra, Ghana, and Jacob Bunge in Chicago

Protective suits were running low in Sierra Leone this month, when a Christian charity decided to ship some over. The charity turned to American medical-wear suppliers, which came back with bad news: The suits needed to treat Ebola are running low in America, too.

A worker wearing Personal Protective Equipment has his name written on his suit before leaving an Ebola treatment center in Guinea last week. Agence France-Presse/Getty Images

“There’s been some sleepless nights,” said Jennifer Mounsey, director of corporate engagement for World Vision, the Christian humanitarian group based in Monrovia, Calif. “We’re all sweating bullets.”

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