The Blue Ribbon Study Panel on Biodefense recently released its report following a year-long study of how America can and should address biological threats – both man-made and naturally occurring. It is substantive, serious and scholarly. It deserves serious attention by policy makers, health practitioners and political pundits.
Why, you ask? Because the human health and economic impact of a wide-spread biological “event” is not receiving sufficient attention and, as the report says, current programs are wasting time and money that could be spent in a more effective manner. There is one other reason to take the report seriously. If no action is taken on the Panel’s 33 recommendations, it will serve as the basis of a scathing “after action report” – the kind that plaintiff’s lawyers and congressional oversight investigators use as a guidebook for placing blame. Does anyone really think we need more of that?
The Blue Ribbon Study Panel, ably led by Former Governor and DHS Secretary Tom Ridge and Former Senator and Vice Presidential Candidate Joe Lieberman, included former HHS Secretary Donna Shalala, former Senate Majority Leader Tom Daschle, former Representative Jim Greenwood, and former White House Homeland Security Advisor Ken Wainstein. At the report roll-out on October 28, and in Senate testimony that same day, Ridge, Lieberman and Wainstein were effusive about the magnificent staff work performed by Drs. Asha George and Ellen Carlin.
They were also crystal clear that the nation is at significant risk from a bio-related event and the urgency of dealing with that risk is non-existent – largely because of a lack of leadership, a lack of a biodefense strategy and a lack of an “all-inclusive dedicated budget” for biodefense. It is evident the final report was the product of an intense, future-focused discussion resulting in a bi-partisan practical set of workable recommendations, almost all of which could be implemented within current budgetary limits.
The most controversial recommendation, if press coverage is any indication, was the first item recommending that the Vice President be the leader of federal biodefense efforts, primarily through the direction of a White House Biodefense Coordination Council. Dr. Carlin told the journal Nature that choosing to put responsibility in the office of the Vice President, rather than creating a “Biodefense Czar,” would allow biodefense issues “to have both the ear of the president and the ability to coordinate budgets and plans across agencies.”
Senator Lieberman told the House Homeland Security committee last week that the Panel “backed into the idea” of housing this responsibility in the office of the Vice President, but “we wanted someone as close to the President as we could get.” Lieberman also noted that a White house Biodefense Coordination Council would still be needed to get the day-to-day work done. Since the current, un-coordinated approach does not seem up to the task of responding to an incident, the Panel’s high-level collaborative concept is worth a try.
Beyond creating a new and necessary organizational chart for biodefense, the Blue Ribbon Panel’s report is full of substantive findings that should have received greater attention than it did upon initial roll-out. For example, the proposal to integrate human and animal health biodefense strategies – the OneHealth approach – is one that makes a lot of sense (Recommendations #7 and #14). Yet, because cabinet agency “stovepipes” would be affected, even eliminated, there is an administrative reluctance to implement horizontal, multi-agency solutions. Yet, it must be done to gain effectiveness and drive efficiencies. Congress, are you listening?
The recommendations on Medical Countermeasures deserve especially deep review. Governor Ridge told the Senate committee that the existing NIH and FDA system for fast-tracking medical countermeasures, including those that can be developed almost overnight due to the advances in genetic analysis, is so outdated that it is as if both agencies have “process constipation.”
Nothing says it better than these two sentences from page 52 of the Panel’s Report: “A systemic, risk averse culture has emerged that is stifling MCM innovation. If this continues to evolve, progress on biodefense objectives will be curtained and the still nascent biodefence industry will have little incentive to participate.”
Shame on us if we fail to heed the insight this report brings.
One of the panel’s witnesses during its pre-report fact-finding sessions was my friend Dr. Annie De Groot, a University of Rhode Island professor and CEO of the vaccine design firm EpiVax. Dr. De Groot recommended that we move toward technologies that can produce “vaccines-on-demand.” The Panel report highlighted this approach and also specifically called for MCM “that enable using multiple antigens on an existing platform,” and for 10% of new NIH “Innovation” funds and 10% of BARDA funds to be allocated to funding innovative platform technologies.
Dr. Annie De Groot told the Panel this spring that a platform-based, vaccines-on-demand approach would be more responsive to current bio-threat scenarios than expensive, wasteful stockpiles. According to news reports, terrorists already possess the ability to produce “genetically engineered pathogens” that merge the toxic attributes of more than one agent, meaning that stockpiling vaccines against single agents is a concept that is now obsolete, she said. The final report did not go so far as to recommend against stockpiling, but I hope this is an area that Congress explores further.
The Panel also calls for a change in contracting and procurement approaches, even at DOD, which has expanded Other Transactional Authority methods available to it to eliminate cases where candidate vaccines lingered “in advanced development for almost 15 years.” In my opinion, this is intolerable and must be addressed immediately.
Incentivizing development of rapid point-of-care diagnostics and therapeutics is a lofty goal. The Blue Ribbon Panel makes specific recommendations on how these goals can be accomplished and even lays out which Congressional oversight committees ought to be monitoring their activity so as to keep the American public informed. Rarely has such a study gone to the lengths as this one does in Appendix A.
Some of the harshest criticism was reserved for the BioWatch program. For example, the Panel said:
- “The BioWatch program was launched in 2003 with great urgency, but its potential remains unrealized.”
- “The entire BioWatch system is dying for lack of innovation.”
- “DHS R&D efforts are the responsibility of the S&T Directorate. OHA within DHS, however, pursued its own R&D activity in support of the Generation 3 effort, ultimately wasting time and funding.”
- “DOD and DHS must better coordinate their environmental detection efforts and leverage each other’s advances. Together (and with congressional oversight) these departments can develop a detection system capable of meeting today’s threats with 21st century ingenuity and replace the ineffective civilian system currently in place.”
For a group made up of former public officials, those are strong words and one hopes that the kind of in-depth congressional oversight of the BioWatch program, which has been needed for so long, will finally occur. In my view, the Office of Health Affairs has needed a spotlight shined on it for quite some time. Maybe this report will be the impetus for that to occur.
The Blue Ribbon Panel on Biodefense’s report provides a starting place for serious discussion about bio-threats and bio-response. I hope it gets the attention it rightfully deserves.