The Bioshield bill signed into law last summer allocated $5.6 billion to the purchase of vaccines with the objective of establishing a market the large pharmaceutical companies would be willing to pursue. The bill was not sweet enough, however, and now proponents on Capitol Hill are drafting new legislation aimed at drawing firms to the table.

This bill's backers are almost certain to propose liability protection for the drugmakers and likely will propose an extension on patents such that regulatory review does not cut into patent life.

More intriguing is an idea being floated for a wild card patent provision. Should a firm develop a winning vaccine or treatment, it would be allowed to select one drug it already has on the market and extend its patent life for a year or two.

The latter two ideas, if passed, could have a substantial impact on the pocket books of patients and social programs forced to wait longer for lower-cost generic drugs.

Meantime, over at the Defense Department, billions are flowing into efforts to enhance detection, develop counter measures and find preventatives like vaccines. Even so, contractors have been griping over the past year the money Congress put on the table is not being spent and they do not have a clear way to connect with potential customers.

Though not a new spending program, AVA or Anthrax Vaccine Absorbed is the biggest issue for Defense Department biodefense at the moment.

Critics say the vaccine makes people ill and Defense had to halt a mandatory program of vaccinations with AVA after a federal judge agreed the drug was not fully approved. A 90-day public comment period on AVA is now running and the matter is certain to come to a head this year.

In a surprise move Defense has asked the Department of Health and Human Services to approve emergency use of AVA under its new Bioshield authority. This does not appear to be the intended use of the provisions of the Bioshield bill, however, and -- should HHS agree to do it -- the move is likely to cause a sharper look at any new Bioshield legislation.

On the non-defense side, money is flowing through the National Institute of Allergy and Infectious Diseases to researchers looking at a range of bioterror agents, and to institutions to build new labs for further research. The Department of Homeland Security has more money to expand the BioWatch monitoring network and money is flowing to states to help the m improve their communications systems and make other biodefense preparations.

Questions have begun to emerge, however, over whether it is practical or desirable to follow the current course. For example, it no longer appears practical to try to devise a vaccine for every possible virus or bacteria that could be used in a bioterror attack.

David Franz former head of the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., told an audience this fall the current system isn't "even close to being agile enough" to deal with genetically engineered organisms and a new approach was needed, with novel vaccines that could be assembled like tinker toys.

A report issued in October by ANSER, a defense think tank, laid bare the strains and compromises being forced on the public health system by biodefense.

Perhaps the most troubling aspect of the today's biodefense programs is what appears to be a lack of specific planning. It isn't that the Defense Department, NIAID and Homeland Security haven't figured out how to move intelligently step by step down the paths they have set for themselves. The worry is they may be on the wrong road.

After Sept. 11, 2001, and anthrax attacks, the Bush Administration reacted with a show of money and a limited amount of planning. BioWatch sensors were put into place without talking to state or local officials about how to actually respond to an alert.

Construction was planned (and continues) for expensive research laboratories to be built within hours of each other without agencies coordinating with each other. Money was thrown at communities for preparedness without standards being set to help them spend it effectively.

An excellent example of "plan later" is the Biodefense Knowledge Center. This organization is designed to help Homeland Security judge the real-world risk of different types of bioterror attacks by combining information from the intelligence agencies with scientific expertise. Better risk assessments should make for better planning - but the center was only dedicated four months ago.

Whether it is concern about the direction of vaccines research, questions on duplicative infrastructure or the negative impact on public health policy, questions are being raised over whether money is being wisely spent. It hasn't even been a year, and Congress already has filched some $5 million from the Bioshield account.

With the financial strains of the war in Iraq, faltering social programs and tsunami relief, it is a good bet Congress will further rethink, and perhaps reprogram, the huge amounts of money being spent on biodefense.

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