- In time, we also must ask how much safer we’ve made ourselves based on the lessons we learned after 9-11
- A prize-based system is better for stimulating development of the countermeasures we need to thwart future threats
- In the future, the bigger threat may come from the deliberate misuse of engineered organisms
The ghastly bombings in Boston followed by envelopes laced with the lethal poison ricin that were sent to the U.S Capitol and the White House, renew fears about our vulnerability to these kinds of terrorist acts. It invites unwelcome memories of 9-11.
Speculation is widespread about the potential origins of these attacks, and whether they could be related (seems unlikely). Investigations are underway and a suspect in the ricin attacks is now in custody. In time, we also must ask how much safer we’ve made ourselves based on the lessons we learned after 9-11. And whether there are still precautions we should heed.
When it comes to bioterrorism, it’s a mixed bag. Programs enacted after 9-11 helped shore up our defenses. But in their current form, they’re not as well equipped to promote development of the kinds of technologies that we need to thwart modern day threats. These threats may not come from established agents of bioterror, but new strains of bugs engineered for deadly purposes.
Programs were started after 9-11 to underwrite the federal development of medical countermeasures. The centerpiece of the effort was Project Bioshield.
Congress passed the Bioshield Act in 2004. Its aim was to fund the purchase of vaccines and treatments aimed at thwarting bioterrorism. A key element of the Act was to allow stockpiling of countermeasures. Some of these agents would be approved for government purchase based on testing in animals alone. It’s not feasible to infect people with deadly bugs like smallpox just to enable human testing.
Since the 2001 anthrax attacks, the feds have allocated nearly $50 billion to address the threat of biological weapons. A lot of the funding also goes to Biomedical Advanced Research and Development Authority (BARDA), established in 2006 to help companies through the mid (and high risk) stages of drug development.
BARDA is part of the Department of Health and Human Services. It provides funding through contracts to mostly mid and later-stage efforts to develop new types of countermeasures. But the government’s foray into this sort of venture investing has been bumpy.
The Bioshield and BARDA funding has proven useful for scaling up the manufacture of vaccines and other countermeasures that were already in advanced stages of development, but needed additional money to make their manufacture economically feasible or possible in the first place. But these programs have been less successful at financing early stage ventures aimed at developing completely novel agents. It hasn’t really been their mission.
For one thing, taking on the kind of risk inherent in the early stages of drug development is not an exercise well suited to government work, where political pressures often cause an aversion to risk taking.
Some government programs, like the Defense Advanced Research Projects Agency (DARPA) have success at financing innovative, early ventures. But they tolerate a lot of failures along the way. Over the past decade, BARDA and Bioshield have not been so lucky. The intense political scrutiny that these efforts have undergone (often stoked by companies that lose out on contracts and complain to Congress) has made the government executives managing the programs understandably skittish. This has rendered the entire process adverse to the kind of risk taking that’s required for successful drug discovery.
A better approach to stimulating development of the kinds of countermeasures we need to thwart future threats may be a prize-based system.
This isn’t a new idea. It’s been long advocated by left-leaning policy analysts and critics of pharmaceutical patents and the lucrative monopolies that patents confer. The idea is that publicly funded cash awards would be offered for firms that develop products that meet a certain public health purpose.
That sort of system isn’t likely to match the success of our market-based model for ordinary drug development. But when it comes to medical countermeasures, there’s no natural market for the products (the only purchaser is the government). A prize system could work well alongside than contract-based programs under BARDA. The contracts are effective at scaling up established technology. The prizes could be used to create incentives for early-stage endeavors.
For one thing, a prize-based system may be less prone to political intrusion than a grant-making process.
Ideally, lucrative prizes for successful countermeasures would still be coupled to smaller grants or contracts that would offset some of the costs of development. But those small grants could be disbursed more easily since they would be for modest amounts – just enough to get a promising program started. The combination of small seed grants, and rich rewards to successful endeavors, could create the mix of incentives that will entice entrepreneurs to chase these endeavors.
Right now, few companies are dedicated to working in this space. The ones that do often rely on federal money to fund the work, and the promise of stockpiling if they succeed. In many cases, these are companies re-purposing existing technologies rather than developing brand new agents with the singular aim of thwarting bioterrorist threats.
The result is that the companies chasing these high risk, lower reward endeavors are often small firms that are otherwise capital constrained (and need the BARDA funding as a bridge.) Among the firms developing countermeasures to ricin are mostly very small companies like Soligenix. It’s worth noting that — because ricin can’t be easily weaponized — it isn’t on thelist of 12 priority agents for which BARDA has been tasked with developing countermeasures. (This list is referred to as the Material Threats Determination).
BARDA and Bioshield have played a highly valuable role in enhancing our preparedness. But we must also re-imagine these programs to confront evolving risks.
The ricin laced envelope sounds like a crude attack based on the public reporting. Ricin is a highly toxic substance. A very small amount can kill an adult. And there’s no reliable test for exposure, no approved vaccine, and no antidote once exposed. But ricin generally has to be injected or ingested to kill. Large quantities would need to be inhaled to cause death. For this reason, it isn’t considered a weapon of mass attack, but has been used as a tool for targeted assassination.
(Ricin was used in the 1978 assassination of Bulgarian dissident Georgi Markov. The author, who had defected nine years earlier, was jabbed by an umbrella while waiting for a bus in London. He died four days later.)
In the future, the real threat may not be established bioweapons like ricin or anthrax. These agents, while deadly, have limitations. To be weapons of mass attack, these agents must be dispersed on a mass scale. That doesn’t only require knowhow with the bioagents, but with the technical means for weaponizing them and dispersing them over a wide area.
In the future, the bigger threat may come from the deliberate misuse of engineered organisms. These are biological agents that can be engineered to spread from person to person, like a deadly form of flu or a re-engineered version of smallpox.
As I noted in a commentary in the Wall Street Journal, DNA synthesizers for making weaponized bugs are small, cheap and easy to procure. The technical means for harnessing these tools is relatively straightforward. The instruction sets for making these kinds of deadly organisms can be found on the Internet.
Rogue regimes and lone villains could exploit these scientific methods for deadly aims. In the extreme, such an attack could play like the creepy plot of the 1995 film “Twelve Monkeys,” where a wicked scientist engineers a virus that nearly drives mankind to extinction.
With the advent of what some have called “garage biology,” such scenarios are no longer wildly implausible. The most recent attacks only serve to reinforce the existence of evil motives that continue to search for these means of wicked ends.