One Bug, One Drug: Boston University's March to Irrelevance

The heavily populated Boston neighborhoods of Roxbury, South End and South Boston may soon share their home territory with some of the world's deadliest pathogens -- the latter in a controlled environment, of course.
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The heavily populated Boston neighborhoods of Roxbury, South End and South Boston may soon share their home territory with some of the world's deadliest pathogens - the latter in a controlled environment, of course - for reasons that made little sense seven years ago when proposed and make utterly no sense now by failing to adapt to new National Institutes of Health perspectives on high biosecurity-level research.

Boston University intends to locate its National Emerging Infectious Disease Laboratory and its top-level BSL-4 lab - funded by NIH - in Roxbury. The seemingly laudable goal stated in its title is to prevent or counter emerging infectious diseases. But the reality is they will be working mostly with bioweapons agents such as Ebola, Marburg and other nasty viruses.

Roxbury citizens have been up in arms against this idea from the start, and lest they seem to be motivated by a misguided "NIMBY" attitude, they have had the active support of groups ranging from Nobel laureates to local law firms, and public interest groups.

Opposing citizens summarize their concerns better than we could in leading off their website :

The lab would pose catastrophic health and safety risks to the Greater Boston Area, create a potential terrorist target, undermine public health by diverting research funds to military purposes, [and] operate without community or public oversight ....

How did BU get to this place? The enterprise is in many ways a creature of the 2004 Bioshield act, which provided funding to such high biosecurity level labs to purchase drug and vaccine countermeasures against biological weapons, and that target, rather than emerging natural pathogens, was its primary aim. Either way, the research will be hobbled by four words inserted by the crafters of the legislation that are much like a contractual "poison pill," virtually guaranteeing that most countermeasures developed there - or anywhere else - will never do most of us any good at all.

The language in Bioshield strongly suggests that the developed counter-measures have "no significant commercial market." The purpose of that strange proviso was either to prevent commercial firms from using public Bioshield money to create drugs from which they would profit - or for a different sinister reason, to appease the big drug companies who may not want the government to pay for countermeasures that would compete with their marketed products. This led to the concept known in the biodefense community as "one bug, one drug": If you design a drug to cure anthrax, it must not be of broader spectrum and saleable to counter any prevalent pathogen. If against plague, it must cure only plague.

Problem: not one of the most feared Category A bioweapons agents is a public health threat in the United States. They are minor threats even in their "home" countries. The horror-show hemorrhagic fever virus Ebola? Less than 50 deaths a year on average and 300 in the worst years in Africa, zero in the U.S. The same for Marburg. Compare that to the death toll from malaria of more than 800,000 or from AIDS of more than 1.4 million in Africa alone, year in, year out. Even in Africa, the death toll and range of the hemorrhagic fever viruses is unchanging, so they should be classified as rare, not emerging, unless that changes.

The problem is that deliberate attacks that kill thousands are terrifying and demand immediate response. A biological weapons attack that killed 18,000 of us could launch a war and would certainly bring the massive response of 9/11. In fact, terrorists don't have the resources to launch such a bioweapons attack, and a hostile nation would be afraid to do so because of that guaranteed counterpunch, so it is of such low probability it does not merit the enormous financial resources we have thrown at it. Yet 18,000 is the number of Americans who now die every year from Staph infections, a number that is increasing because of the widely feared MRSA, methicillin resistant Staphylococcus aureus.

But wait. Isn't there some way to cover both aspects of the biological threats we face, bioweapons and emergent natural pathogens? There is, and that strategy has been here all along, as we and many others have been arguing for years. Recently, the NIH's National Institute of Allergy and Infectious Diseases embraced it :

Although the focus of this updated Strategic Plan continues to be on basic research and its application to product development, there is a shift from the current 'one bug-one drug' approach toward a more flexible, broad spectrum approach. This approach involves developing medical countermeasures that are effective against a variety of pathogens and toxins, developing technologies that can be widely applied to improve classes of products, and establishing platforms that can reduce the time and cost of creating new products.

Given its name, you might think that Boston's National Emerging Infectious Disease Laboratory would be ahead of the game. Apparently not. Its website recently identified "some of the organisms that will be studied." Five of the seven listed are Category A bioweapons agents, all except one causing rare diseases. Presumably this proferred list is representative. Biodefense vaccines appear to be the major focus, and vaccines inevitably have such drawbacks as questionable efficacy when they can't be tested in humans and short shelf-life. Finally, there's "one drug" against "one bug." Even if successful, a vaccine would work against only one bioweapons agent, sometimes against only one strain. Witness the need for new vaccines each year for the annual flu to envision the chances of failure in the moment we may desperately need it.

By contrast, the broad-spectrum approach to antibiotic and antiviral drugs would immediately apply to public health and to biodefense. More important in the long term, this new strategy also calls for new platforms for rapidly developing vaccines and countermeasures for new or emerging viruses and bacteria. The zero-sum game of biodefense versus public health can become a clear win-win.

BU's apparent struck-in-the-past strategy that requires regular use of aerosols and a BSL4 lab is not merely money-wasting, it's dangerous, because there are no cures or vaccines for these live viruses. Serious accidents have happened and continue to happen in the nation's high biosecurity level labs.

The new vaccine technologies involve such strange-sounding creations as bacterial ghosts and toll-like receptors, but they are completely safe. None of them require live viruses or bacteria, since they make use of only non-infectious parts of pathogens. Using these technologies, experimenters can work in low biosecurity BSL-2 and BSL-1 labs without fear of becoming infected or endangering those in the surrounding community.

We believe it is clear that the Boston lab needs to be re-focused on these new, safe vaccine technologies and drugs for infectious diseases of substantial public health concern. And given its revised Strategic Plan, the National Institutes of Allergy and Infectious Disease may be amenable.

Finally, let's address the remaining "elephant in the living room." At the end of a vaccine or drug development project, live pathogens would be required in order to test efficacy. These end-game dangerous experiments require the highest level of biological security. If they did not, such intensive precautions as making researchers don "space suits" with external air supply and keeping labs at negative air pressure so they would suck in air, not let it out if there is a leak, would never have been developed. Don't such facilities have to wind up in somebody's backyard, if not the center of Boston?

No. Here is our suggestion. Create a giant BSL-3 / BSL-4 servicing complex whose sole function is testing countermeasures against live deadly pathogens on behalf of researchers developing them elsewhere, and build it far from any population center, in the desert or on an uninhabited coastal island. In addition to the physical barriers, for added insurance those who research highly contagious viral killers and other deadly pathogens would work in days-long stints and then remain in quarantine for a short period afterward. This would cover multiple risks that are currently unattended, such as working on the live 1918 pandemic flu virus that killed 40 million people around the world and could potentially do it again if accidentally reintroduced. Against the chance of an outbreak that could kill millions this level of added protection seems to us a must.

The results would be of universal benefit. We could substantially reduce the number of BSL-3 labs scattered throughout cities - now in everybody's backyard - and eliminate the need for all planned urban-area BSL-4 labs. That would be a big win for Boston University, too, which now is pushing for a facility that poses more potential risk than benefit for public health.

(One of us, Lynn Klotz, is working with scientists and Roxbury residents to propose an alternative vision for the Boston University labs.)

Klotz and Sylvester are the authors of Breeding Bio Insecurity: How U.S. Biodefense Is Exporting Fear, Globalizing Risk, and Making Us All Less Secure, University of Chicago Press, Oct. 15, 2009.

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