More Billions for Biodefense – Are vaccines the answer?

By Allen R. Gibson, HomelandDefenseStocks.com
June 29, 2004

With the recent signing by the President of the Project Bioshield Act of 2004, the federal government has authorized $5.6 Billion dollars in spending over the next ten years to increase American’s security from biological attack.

“Private industry plays a vital role in our biodefense efforts by taking risks to bring new treatments to the market, and we appreciate those efforts,” said the President. “By acting as a willing buyer for the best new medical technologies, the government ensures that our drug stockpile remains safe, effective and advanced.”

Already, the government is considering purchasing large quantities of smallpox and anthrax vaccines – 75 million doses in the case of anthrax - as a key part of the Bioshield initiative. An announcement on the Anthrax purchase is expected shortly. It’s an announcement which VaxGen, who’ve received over $100 million in government contracts so far to develop a new anthrax vaccine, is eagerly awaiting. But is this a case of ‘fighting the last war’ or defending against the last terrorist attack?

A report out of the University of Pittsburgh suggests that the life sciences are at the beginning of a revolutionary period. Scientific understanding of living systems and how to manipulate them is expanding exponentially, fueled by advances in computerization, the global dispersion of bioscientific expertise and biological databases, and substantial investment in biomedical and agricultural research and product development. The report, from The Center for Biosecurity at the U of P, suggests our strategy should be “an ambitious and aggressive scientific research, development, and production (R&D&P) program that delivers the diagnostic technologies, medicines, and vaccines needed to counter the range of bioweapons agents.”

An unfortunate effect of this knowledge explosion, of course, is that new diseases and new potential weapons will be developed right along with, and in most cases faster than the potential cures. And that raises questions as to the effectiveness of vaccinations in defending the civilian population.

The doctors in charge of education for the National Center for Biodefense argue that less money should be spent on vaccine purchase and development, and more on post-exposure treatments. Vaccines, say Drs. Ken Alibek and Charles Bailey, aren’t going to be effective for civilian populations, since no one can know which specific agent to guard against, and the drugs must be administered in advance to be effective. Also, they say in a letter to the editor of the Biosecurity and Bioterror newsletter, it is far easier and takes fewer years to develop a weapons-grade disease than to produce a vaccine against it.

The immediate relevancy of programs other than vaccines was vividly demonstrated this July, when the FBI announced that Ricin compound was introduced into some baby food jars on the west coast. Minute amounts of Ricin can be fatal, and while the baby food incident was not life-threatening, the FBI is still working on an incident that closed a Senate building for three days earlier this year after a deadlier form of Ricin was mailed there. The gaseous form of Ricin was used in the deadly Tokyo subway attacks a few years ago. And no vaccine or cure presently exists.  Which means that new, non-vaccine, treatments are needed now, and will be needed in the future.

One example of how biotech can be repurposed to address the bioterror threat come from Aethlon Medical, who created a ‘Hemopurifier’ machine to strip viruses and toxins out of  the blood of infected patients. Originally designed to treat HIV and Hep C, the company is now working with the National Center for Biodefense at George Mason University to develop filtration devices that could be used by both the military and civilian populations against Class A bioterror agents. The Company will use new FDA rules to test the devices on animal species and extrapolate safety data for humans, since human tests are obviously not practicable.

Part of Bioshield’s response to the speed of response issue is to authorize the National Institute of Health to process approvals for vaccines and treatments much faster. The President says BioShield initiatives will reduce grant turnaround times to 6 months instead of the current 18 to 24. HHS Secretary Thompson has directed the NIH to launch two initiatives -- one to speed the development of new treatments for victims of a biological attack, and another to expedite development of treatments for victims of a nuclear attack. 

The latest announcements follow considerable criticism of the government for not having an organized, coherent chain of command to respond to bioterror attacks. In a report published last November, Elin Gursky, senior fellow for biodefense and public health programs at the ANSER Institute for Homeland Security in Arlington, Va., said “There is a fundamental lack of coherent organizational systems, structures and chains of command,"

Gursky acknowledged the political sensitivities of criticizing the federal government for doling out money, but said practices have to change. She said interviews conducted for the ANSER report revealed widely varying health practices and systems across agencies, and indicated a lack of vision and long-term strategy to deal with biological attacks.

Dr. Carl Schultz, professor of emergency medicine, who is a member of the State of California Disaster Advisory Group and serves on two national task forces on terrorism, says the Anthrax and Ricin incidents at the Capitol served as a wake up call on the state of the country’s preparedness by prompting “…the recognition that the whole public health infrastructure has been badly neglected, and in order to improve our response to a bioterror attack we need to create a very robust public health system. And the government now acknowledges that, and they are hiring and improving lab surveillance and so on.”

Already, the improved coordination among CDC, HHS, and other civil authorities right down to the local hospital level paid dividends during the SARS outbreaks, when lessons learned during the Anthrax attacks were effective in both containing the disease and in informing the public in a way that was both credible and avoided any overreaction or panic.

Further down the road, the payoffs of today’s investments may be much greater. If our ability to fight and contain infectious diseases grows exponentially, as many are predicting, then we may soon be able to provide more help to the parts of the world where diseases such as AIDS and TB are killing millions and ruining countries. Countries that are then prime recruiting grounds for terrorist groups like Al Qaeda, whose ‘marketing’ efforts are designed to appeal to the hopeless. In this respect, at least, preparing to defend ourselves against disease agents may in the end make the whole world a far safer place for every body on the planet. Such an outcome would surely lead to a safer America.

Allen R. Gibson

Allen R. Gibson has over twenty-five years of experience in media and corporate communications.  He has been a reporter, television producer, and marketing communications consultant for public companies in both the US and Canada. 

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