Feds Step Up Superbug Dialogue

With the unstated goal of reducing health care costs in the future, the U.S. government put forth proposed changes today to the way it works with companies to fight new disease threats.

The feds are urging the Food and Drug Administration to set up centers to make vaccines quickly.  A report from the U.S. Department of Health and Human Services was critical of the nation’s overall ability to respond to new outbreaks, noting that it is too slow. The report also outlines a plan for providing help to academic researchers and biotechnology companies in the development of promising new drugs and vaccines.

"At a moment when the greatest danger we face may be a virus we have never seen before...we don't have the flexibility to adapt," Health and Human Services Secretary Kathleen Sebelius said at a news briefing.

These statements and actions are occurring against a backdrop of growing concern over the NDM-1 bacteria, which is said to be resistant to almost all antibiotics and described by the greater press as "a new horrible superbug." According to news reports published by the online news channel English.xinhuanet.com, however, that particular “superbug” is already three years old and may not be as horrible as feared. "Our first isolate was on Jan. 9, 2008 ... Other isolates are from 2007," said Dr. Mark Toleman, a coauthor of a paper published in The Lancet Infectious Diseases last week.

The paper garnered worldwide attention since some of the isolates are proved to be resistant to all existent antibiotics. "Isolate" is a term used by scientists that means sample. This means the NDM-1 bacteria's appearance could go back three years, giving researchers at least some experience of dealing with it. Nevertheless, notes the paper, the “potential of NDM-1 to be a worldwide public health problem is great, and coordinated international surveillance is needed.”

The HHS report suggests providing clearer guidance to industry on what kinds of tests are needed for regulatory approval of new drugs and vaccines‹something industry has asked for‹and says new teams should be set up at FDA to help this. HHS and the Department of Defense should set up Centers for Innovation in Advanced Development and Manufacturing, it said. "These centers will provide assistance to industry and government by advancing state-of-the-art, disposable, modular manufacturing process technologies," the report said. "Finally, in public health emergencies, these centers may augment existing United States manufacturing surge capacity against emerging infectious diseases or unknown threats, including pandemic influenza."

It takes months to make a vaccine against influenza using current processes, notes Reuters in a separate report. “While companies are working to modernize their abilities, any big changes are still years away.”

As with The Lancet Infectious Diseases report, the HHS report also calls for better surveillance to give a much quicker heads-up when new diseases emerge. For example, several published studies indicate that H1N1 had been circulating for weeks or months before it was detected.

Sebelius confirmed that there has been little investment in "regulatory science," or studying the best ways to test new products. "Because of this under-investment, we are often testing and producing cutting-edge products using science that is decades old," Sebelius said.