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Pharmaceuticals

Preparedness For Ebola Questioned

Pharmaceuticals: U.S. is working to accelerate drug and vaccine clinical trials

by Britt E. Erickson , Andrea Widener
October 16, 2014 | APPEARED IN VOLUME 92, ISSUE 42

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Credit: CDC/Athalia Christie
Health care workers suit up before they enter an Ebola treatment facility in Liberia.
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Credit: CDC/Athalia Christie
Health care workers suit up before they enter an Ebola treatment facility in Liberia.

Ebola virus is raging out of control in three West African nations, where it has killed about 5,000 people. One patient—who contracted the virus in Liberia—has died in the U.S., and at least two workers who cared for him at a Dallas hospital have come down with the deadly infection. Fears are escalating about the disease spreading in the U.S., and the blame game has started over why treatments or vaccines are not readily available.

No vaccines or drugs are approved by FDA to prevent or treat Ebola. Investigational products are in the early stages of development. Such products have not yet been fully tested for safety or effectiveness, and they are in limited supply.

In Congress, the House of Representatives Energy & Commerce Committee is questioning why the U.S. government hasn’t done more to increase the supply of potential treatments and get the products to patients who need them. At a hearing this week, lawmakers grilled government leaders for information about their response efforts and preparedness plans.

“Ebola has been on the world’s radar screen since March, and yet the United States and the international community are still scrambling to stay ahead of and stop this outbreak,” Committee Chairman Fred Upton (R-Mich.) said.

Officials from the National Institutes of Health and FDA said that they are working with governments and private companies around the world to accelerate the development and testing of products that could control the outbreak. “There is a critical need to develop improved diagnostics, as well as safe and effective therapeutics and vaccines, for Ebola,” testified Anthony S. Fauci, director of NIH’s National Institute of Allergy & Infectious Diseases (NIAID).

To that end, NIAID and several companies are ramping up efforts to test new drugs and vaccines in human clinical trials as soon as possible. For example, NIAID is working with Mapp Biopharmaceutical in San Diego to test the safety and efficacy of the drug ZMapp in human volunteers. NIAID is also working with BioCryst Pharmaceuticals in Research Triangle Park in North Carolina to begin human clinical trials on BCX4430, a drug that interferes with the reproductive process of the Ebola virus, by early next year. In addition, NIH plans to evaluate brincidofovir, developed by Chimerix of Durham, N.C., in the coming months.

In a parellel effort, NIAID is working with Glaxo­SmithKline in London to test a potential vaccine, which entered a small Phase I study at the NIH Clinical Center in Bethesda, Md., last month. NIH is also working with the Department of Defense and NewLink Genetics of Ames, Iowa, to test another potential vaccine, which was developed by the Public Health Agency of Canada.

With elections in the U.S. just a few weeks away, campaign ads paid for by liberal groups are blaming the shortage of Ebola drugs and vaccines on Republican budget cuts. NIH Director Francis S. Collins got into the fray last week when he told reporters that a vaccine would likely have been available by now if NIH’s budget hadn’t been pared in recent years.

But many people are questioning that statement, given unknowns in the science surrounding Ebola treatment and the high failure rate of many drug trials. “It’s dangerous to make the correlation that more money equals more cures,” says Benjamin W. Corb, spokesman for the American Society for Biochemistry & Molecular Biology. “Biomedical research, sadly, doesn’t work in such a clear-cut way.”

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Comments
Michael Bendixson (October 17, 2014 11:47 AM)
Considering how many different strains are currently present and its potential for an outbreak, it is important that we attack this virus from all possible angles. It may turn out that a combination of these different therapeutics is the best way to prevent and cure the illness. I for one am glad to see that we are trying so many different forms of treatment.
Charles (October 21, 2014 9:43 PM)
While more money may not equal more cures, it is almost a guarantee that less money will equal less cures. Taken to the extreme, no money certainly assures no cures.

Republican funding for fences, ID papers, and religious education curricula seem unlikely to address the challenges of the last century, much less the present one.
Larry Gatlin (October 22, 2014 3:14 PM)
There are many companies and institutions working on Ebola therapies and while this article probably was not intending to list them all it did begin a list so since many were mentioned perhaps the list should have been more comprehensive including Sarepta, http://www.businessweek.com/articles/2014-10-20/ebola-sareptas-promising-experimental-drug-goes-overlooked and probably others.
Ken Baer (October 24, 2014 10:25 PM)
From the beginning, the response to EBOLA was unsatisfactory. For the poor response and bad strategy, CDC&P Director Tom Frieden should have been fired/replaced, but OBAMA did nothing. Frieden's failure to immediately quarantine people is a disaster. The failure of OBAMA to block all flights from west Africa to the United States, was and continues to be a disaster. People contracting EBOLA must be isolated from healthy people, and contained - quarantined. Nigeria did this immediately to protect their population. Frieden's failure is upside down. His reasoning is backward. We must prevent any entry of EBOLA infected individuals; they cannot be allowed to enter the United States. For Frieden to say that the virus must be considered on a global level only is idiotic; it does not contain the disease; this strategy allows the virus to spread and it doesn't prevent its introduction here. Frieden's reasoning goes against all previously successful action to prevent spread of disease. Congress should act and act quickly to put a person in charge who knows what they are doing. EBOLA is lethal. Anyone contracting it will usually die.

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