NewLink Genetics, of Ames Iowa, Implicated in African Ebola Genocide?

According to those intimately involved in the response to the West African Ebola outbreak, NewLink Genetics owns the rights to a piece of the puzzle needed to quickly test and deploy one of two likely Ebola vaccines and they are holding up the entire process because they are not entirely sure they are going to get rich on it. Other suggest it is incompetence. NewLink seems to be claiming it is just a lot of paperwork. In the end, tough, none of these excuses is convincing. This is one of those cases that gives Big Pharm a bad reputation.

From as story in Science:

Stephan Becker is tired of waiting. The virologist at the University of Marburg in Germany is part of a consortium of scientists that is ready to do a safety trial of one of the candidate vaccines for Ebola. But the vaccine doses he’s supposed to test on 20 German volunteers are still in Canada. Negotiations with the U.S. company that holds the license for commercialization of the vaccine…have needlessly delayed the start of the trial… “It’s making me mad, that we are sitting here and could be doing something, but things are not moving forward,” Becker says.

… it’s inexplicable that one of the candidate vaccines, developed at the Public Health Agency of Canada (PHAC) in Winnipeg, has yet to go in the first volunteer’s arm, says virologist Heinz Feldmann, who helped develop the vaccine while at PHAC. “It’s a farce; these doses are lying around there while people are dying in Africa,” says Feldmann,…

At the center of the controversy is NewLink Genetics, a small company in Ames, Iowa, that bought a license to the vaccine’s commercialization from the Canadian government in 2010… Becker and others say the company has been dragging its feet the past 2 months because it is worried about losing control over the development of the vaccine. But Brian Wiley, vice president of business development at NewLink Genetics, says the company is doing all it can. “Our program has moved forward at an unprecedented pace,” he says. Even if it took another few months, “we would still be breaking a record in terms of getting this into patients.” Wiley says the holdup is “the administrative process”: agreeing on a protocol, getting collaborators to sign the right contracts, securing insurance in case something goes wrong.

Marie-Paule Kieny, a vaccine expert and WHO assistant director-general, disputes that NewLink is dragging its feet. “We have so far been able to resolve issues along the way, to get moving as fast as possible,” she says.

A stock of the Canadian-developed VSV vaccine is stored at PHAC in Winnipeg. The Canadian government owned 1500 doses, 800 to 1000 of which it has donated to WHO; the rest are owned by NewLink Genetics.

Scientists say WHO’s vials could have already been shipped to the research centers planning to do phase I trials. One such trial is scheduled at the Walter Reed Army Institute of Research in Silver Spring, Maryland; other studies, by a consortium that includes WHO and Becker, are on the drawing boards in Hamburg, Germany, in Geneva, and at sites in Kenya and Gabon. PHAC is ready to ship the doses “at a moment’s notice,” a representative says.

But for a clinical trial to start, regulators require information about how the vaccine was manufactured, and that resides with NewLink Genetics, which has been slow to release it, people familiar with the negotiations say. …

Part of the problem may be that NewLink is a small company, with about 100 employees, that has concentrated on immunotherapies to fight cancer in recent years. The Biomedical Advanced Research and Development Authority—a U.S. government agency tasked with speeding up the development of emergency drugs and vaccines—recently sent two staffers to Ames to help NewLink file documents needed by the U.S. Food and Drug Administration, a U.S. government representative says. “Our engagement of outside help has nothing to do with our competence, but with the urgency around this matter,” Wiley says.

Those who are taken ill and die of Ebola are the victims of a natural disaster, until paperwork, incompetence, greed, or some combination of those delays an international response by weeks time. After that, it is something else.

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4 thoughts on “NewLink Genetics, of Ames Iowa, Implicated in African Ebola Genocide?

  1. Greg, why would Big Pharma get a bad reputation because a small biotech firm with just about 100 employees and *not a single product so far*, is possibly not-as-competent with its paperwork?

  2. Where did you get this information? The company is just now starting human testing…that’s not a paperwork issue, that is them following procedures put in place to keep people safe.

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