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Expanding Project Bioshield

Originally Published MPMN November 2005

EDITOR'S PAGE

Expanding Project Bioshield

Two years ago, we wrote in support of Project Bioshield, which was signed into law by President George W. Bush in 2004. Under this act, the U.S. government can buy medical countermeasures to terrorism as soon as experts believe that they can be made safe and effective. This is meant to ensure that the private sector devotes efforts to developing these products.

It was a good start. The nation’s smallpox vaccine stockpile has grown from 90,000 doses to 300 million doses. New anthrax treatments that can neutralize the anthrax toxin are also being developed. These include monoclonal and polyclonal antibodies. Other projects are in the works.

But much more needs to be done. This is especially true in the area of detection. A recent GAO report said that we need improved testing methods to accurately determine when an agent has been released and when areas have been decontaminated and are safe.

And not only do we have to worry about bioterrorism, but new natural threats such as infectious disease are looming. For example, the avian flu, known as H5N1, could cause a pandemic if it mutates in such a way that it can be spread from person to person.

One manufacturer recognizes the importance of early diagnosis. FDA recently approved the Directigen EZ Flu A+B test developed by BD Diagnostics. This two-step rapid test can distinguish between flu types A and B in 15 minutes or less. It can also detect avian influenza H5N1 isolates.

The test is an important weapon in fighting the spread of disease. The window of opportunity to effectively start antiviral therapy is only 48 hours from the onset of symptoms, says Michael Towns, MD, the company’s vice president of worldwide medical affairs. “Antivirals can reduce the severity of symptoms, shorten the duration of the illness, and reduce the time period when patients who are ill with influenza are infectious to others,” he says.

“In the event of a human flu pandemic,” explains Elliot Rank, PhD, the company’s director of scientific affairs, “diagnostic tests will be absolutely necessary to ensure proper allocation of limited supplies of antiviral therapies to those at high risk of complications from the flu.”

Partly in order to ensure that more of these products are available to correctly identify either toxins or diseases, Senator Judd Gregg (R-NH) is proposing Project Bioshield II. This bill is meant to resolve concerns some manufacturers expressed in hearings in Congress. They said they needed more federal assistance in developing products to counter biological threats or infectious diseases. These extra funds would allow the companies to continue R&D on other, more profitable, products as well as create new ones to fight biological crises.

Gregg agrees. “We need to broaden our attention to large, experienced companies, with multiple sources of financing, the ability to manufacture, license, and bring to market a product, and do so on a large scale in an emergency,” he says.

Project Bioshield paved the way for manufacturers to offset some of the burden of creating new products. The need for devices to counter or detect terrorism is only going to increase. Bioshield II could strengthen these provisions even further, and should be approved.

Susan Shepard, Managing Editor

Copyright ©2005 Medical Product Manufacturing News

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