Project BioShield: Is the Shield Cracking?

06 Oct, 2006    ·   2124

Ajey Lele argues that the present failure of Project Bio Shield can be attributed to mismanagement and quick midcourse correction is consequently essential.


Following 9/11, the anthrax attacks in the United States (US) in the fall of 2001 killing five people shocked the world. Within the US these attacks exposed its lack of preparedness to handle 'biological' emergencies. This attack highlighted the necessity for the US to expand its medical stockpiles to prepare against any future biological attack. The need was also felt to improve medical countermeasures like easy availability of drugs for treating human and animal diseases, vaccines, blood and blood products, diagnostic tests, and detection tools that could prevent, diagnose, and treat illnesses due to a bioterror attack.

As part of the ongoing war on terror the Bush administration decided that it needed a balanced programme to handle emergencies arising out of any biological weapons attack. This gave rise to the most ambitious biodefence project in US history entitled Project BioShield. It was aimed at exploiting the countries' best medical and scientific brains to find new drugs and develop vaccines, and address policy related issues.A permanent funding source was created under which the federal government could buy medical supplies from private companies worth $5.6 billion over 10 years, including "next-generation" countermeasures against anthrax, smallpox, and other infectious agents, besides antidotes against chemical and radiological threats. The aim was to protect the health of all US citizens.

However, according to a New York Times report (18 September 2006) the project has largely failed to deliver. It is surprising that the US democracy, known for its professional approach, has failed to take this concept to its logical conclusion. The President had first proposed Project BioShield in his 2003 State of the Union address, which was approved by Congress in 2004. This law was to provide new tools to improve medical countermeasures and protect US citizens against chemical, biological, radiological or nuclear (CBRN) attack.

On paper, Project BioShield, which is part of the US strategic plan, is one of the best-structured presidential directives that provide a comprehensive framework for biodefense. The directive stipulates roles and responsibilities, and fully integrates the programmes and efforts of various Federal communities like national security, medical, public health, intelligence, diplomatic, and law enforcement into a focused national endeavor against biological weapons threats. Also, care has been taken to factor in new agriculture and food programmes to guard against disease, pests, or poisonous agents that could be delivered by acts of terrorism to cause a health and economic crisis.

Unfortunately, this well-conceived Bioterrorism defence programme is facing great criticism in the US. The reasons for its failure (though partial) are manifold. First, industry analysts feel that developing medicines for use after a biological attack remains a risky business, with long development times, slim profit margins and devastating lawsuits if a drug fails. Second, for industry it is not an attractive market, and it is possible that another company may develop a better product, leading the government to change its purchasing policy. Third, it is not possible to test the new drug since healthy humans cannot be infected with diseases like anthrax or smallpox only to test the drug on them. So, in reality, companies cannot know if a drug can protect people or not unless an attack occurs.

Over the last two years the efforts and investments by a few medical companies indicates that only a small fraction of the anticipated remedies are available, but overall the project has failed to deliver. This is mainly because the project has failed to draw participation by the major pharmaceutical companies. It appears that government officials did not select capable companies for jobs like production of anthrax vaccine. Currently, the project appears to be embroiled in a battle between a few biotech businesses. Also, there are reports that some developed vaccines have started decomposing.
Essentially, the problems with such projects are intrinsic. The nature of science places limitations on overall project management. Medical discovery is essentially an unpredictable process. However, this does not provide any excuse for BioShield to fail. The present failure is a result of bad management and a few individuals/companies trying to take advantage of market uncertainties. It needs noting that the entire project grant is available for a period of ten years; only one fifth of that period is over. The need of the hour is to carry out a quick midcourse correction. Otherwise an opportunity to handle the consequences of bioterrorism and the opportunity to revolutionalize the entire healthcare structure will be squandered.

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