News Scan for Nov 25, 2013

News brief

Questions raised about need for DoD biodefense plant

Construction has begun on a plant in north Florida that will enable the Department of Defense (DoD) to produce its own vaccines and drugs against potential bioterror threats, an effort that appears to duplicate Department of Health and Human Services (HHS) efforts, the Los Angeles Times reported.

To pay for the DoD initiative, the Obama administration has quietly shifted millions of dollars that had been budgeted for masks and other equipment for combatting chemical and biological weapons, the story said, citing government documents and defense specialists.

The effort goes against a 2009 report by a bipartisan commission that strongly recommended that government agencies contract with private manufacturers, saying "contract manufacturing is less costly and timelier than constructing and operating a dedicated facility."

In an interview with the Times, the DoD's James B. Petro said the Florida facility is needed to manufacture drugs that the military could not rely on HHS or others to provide. Petro is a top aide to Assistant Secretary of Defense Andrew C. Weber, who has championed the Pentagon initiative.

But in congressional testimony last month, retired Major General Philip K. Russell, MD, who once directed the Army's Medical Research and Development Command, said the duplicative manufacturing efforts by separate federal departments constitute "an enormous amount of wasted effort."

In March the DoD awarded its initial contract for the facility, worth as much as $358.9 million, to Nanotherapeutics Inc. of Alachua, Fla., the Times reported.
Nov 23 LA Times story


FDA approves new hepatitis C drug

The US Food and Drug Administration (FDA) has approved simeprevir (Olysio), a new treatment for chronic hepatitis C infection, according to a Nov 22 news release. The drug is the third protease inhibitor to be approved over the past few years to treat chronic hepatitis C, which health officials say infects about 3.2 million Americans.

Olysio blocks a specific protein needed for hepatitis C replication and is designed for use as a component of a treatment regimen. In clinical studies it was combined with peginterferon-alfa and ribavirin.

The drug is aimed at adults with decreased liver function, including cirrhosis, who have not received treatment for their infection of for whom earlier treatment was not effective. The drug was reviewed under the FDA's priority review program, which speeds review of drugs that provide safe and effective therapy when no alternative exists or offer improved treatment compared with other available drugs.

Clinical trials showed that adding Olysio provided better response rates as well as sustained virologic response than when peginterferon-alfa and ribavirin were used as a two-drug regimen. Its most common side effect was rash (including photosensitivity), itching, and nausea. The drug is marketed by Janssen Pharmaceuticals, based in Raritan, N.J.
Nov 22 FDA news release
Nov 6 CIDRAP News story covering several new hepatitis C drugs


Polio workers kidnapped in Pakistan

Pakistani officials said 11 schoolteachers who were administering polio vaccine to children in the tribal area of northwestern Pakistan have been kidnapped by militants, NBC News reported Nov 23.

The teachers had just finished vaccinating children in Sepah village in the Bara subdivision of the Khyber tribal region when they were abducted by gunmen, according to a local official. They have been taken to an unknown location, he added.

"There has been strong resistance against polio vaccines in this area," said Shamsher Khan. He said the militants are affiliated with Mangal Bagh, whose Taliban-affiliated group Lashkar-e-Islam largely controls the area. He said Bagh's group fears that polio vaccination campaigns are a Western plot to make area males infertile.

A separate official said 14 polio cases have been reported in the Bara subdivision this year because of the inability of vaccination teams to reach children there.
Nov 23 NBC News report

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