Government Ineptitude

BIOTERRORBIBLE.COM: In the aftermath of man-made bio-terror generated pandemic, the government and media will be feeding the public any number of different scapegoats allegedly responsible for the pandemic that will likely kill millions.

While some scapegoats (see below) are indeed plausible, it is much more likely that the live pathogens or agents responsible for the pandemic will likely be dispersed via A) chemtrails by government airplanes or drones, B) by the U.S. Postal Service via Tide detergent samples, C) by the government and medical establishment via tainted vaccines, or by D) the portable petri dish commonly known as the Trojan condom.

Bio-Terror Scapegoats: Africa, Agriculture (Food & Animals), Airports & Air Travel, Al Qaeda, Bio Labs, Bio-Terrorism Is Easy, Bio-Terrorists (Bio-Hackers), Black Market, Bugs & Insects, Censorship / Lack Thereof, Domestic Terrorists, Exotic Animals (Zoonosis), Government Ineptitude, Mail-Order DNA, Mexico, Missile Shield Failure, Mutation, Natural Disaster, No Clinical Trials (Vaccines), and The Monkeys.

Title: Institute Responsible For Anthrax Accident In California, In Charge Of Safety And Security At Chicago Biodefense Laboratory
June 22, 2004
Sunshine Project

Abstract: Non-Profit Watchdogs Renew Call for a Moratorium on Construction of Biodefense "Hot Zones"

Southern Research Institute, the military biodefense contractor recently in the news for sending live anthrax to the Children's Hospital of Oakland (CA), is also in charge of safety and security for a major new $30 million biodefense facility being built at the Department of Energy's Argonne National Laboratory near Chicago.

The new Ricketts Regional Biocontainment Laboratory is funded by the National Institute of Allergy and Infectious Disease (NIAID) and is named after Howard T. Ricketts, a celebrated pathologist who acquired typhus in the course of research and died at age 39. It will begin biodefense work with studies of anthrax (Ames strain) and Yersinia pestis, the causative agent of plague.

Southern Research Institute, with major labs of its own in Frederick, Maryland and Birmingham, Alabama, has a $75 million annual budget including biodefense contracts from an impressive roster of Pentagon agencies. Its Frederick, Maryland facility is located near the Army's biological weapons research headquarters at Fort Detrick, yet despite its biodefense prominence, Southern Research in Frederick does not maintain an institutional biosafety committee that complies with federal research rules. (And Southern Research in Birmingham has not honored requests for records of its institutional biosafety committee.)

"Southern Research's incompetence is plain to see. Its own house is in dangerous disarray and does not comply with federal research rules," said Edward Hammond, Director of the Sunshine Project. "That threat is bad enough; but even after leaking anthrax, the institute is still developing biosafety and operating procedures for new high containment labs."

According to a national coalition of biodefense watchdogs, formed in 2002 to monitor the US biodefense program, the Southern Research situation epitomizes their concern that biodefense laboratories are proliferating unsafely and with unsound planning, and that this could result in health, environment, and international security problems.

The watchdogs also point to Southern Research's links to classified biodefense research. (Southern Research's facilities and personnel have "secret" clearance.) "Public interest groups seeking information about military biodefense programs are being stonewalled by the Army and other agencies." says Steve Erickson of Citizen's Education Project in Salt Lake City, which monitors the Army's Dugway Proving Ground. "That Southern Research and other secretive military contractors are also insinuating themselves into civilian biodefense programs is cause for concern that we are witnessing a steady erosion of openness and accountability, not only at Pentagon labs; but at academic institutions and in work funded by the National Institutes of Health."

Two other Department of Energy (DOE) labs that design and develop the nation's nuclear weapons are also building new biosafety level three biodefense facilities. Both Lawrence Livermore and Los Alamos Labs have been sued by local community groups under the National Environmental Policy Act (NEPA). Inga Olson, Program Director at Tri-Valley CAREs, one of the groups that sued DOE, warns "Biodefense dollars are flowing like champagne at a wedding - into everywhere from nuclear weapons labs to children's hospitals - everyone wants a piece of the action. But a far more sober look is needed at whether the rapid spread of labs, pathogens, and bioweapons knowledge poses a greater threat than the problem we are trying to solve."

"After all," says Mary Wulff of Citizens for a Safe Lab in Hamilton, Montana (where NIH is building a new biosafety level four facility), "the Bush administration continues to rely on fear generated by the anthrax attacks and shaky allegations against other countries, like Iraq, to push billions and billions through Congress. Instead of an informed national discussion, the government's actions are based on fear and unsound information. The importance of reigning in knee-jerk reactions is underscored by the nearly tragic exposure of workers at Children's Hospital in Oakland, California."

The national coalition of nonprofit groups is calling for a moratorium on new biodefense labs until comprehensive national assessment is conducted, and transparency guarantees in place, and a binding and open federal system exists to review dual-use research with biological weapons agents (Sunshine Project, 2004).

Report: America Is Not Ready To Defend Against Bioterrorism
December 16, 2004
Daily News Central

Abstract: Three years after 9/11, America is not ready to respond effectively to a bioterrorist attack, according to a report issued by Trust for America's Health (TFAH). This is the second year in a row that TFAH has conducted a review of bioterrorism and public health preparedness."Ready or Not? Protecting the Public's Health in the Age of Bioterrorism -- 2004" examined 10 key indicators to gauge state preparedness and determine America's overall readiness to respond to bioterrorist attacks and other health emergencies.

Not Enough Improvement
Over two-thirds of states and D.C. achieved a score of six or less. Florida and North Carolina scored the highest, achieving nine out of the possible 10 indicators, and Alaska and Massachusetts scored the lowest, at three out of 10.

Although direct comparisons are difficult because the indicators were modified to reflect the changed expectations of additional time and funding, in this year's report, 34 states and D.C. obtained higher scores, nine scores remained the same, and seven scores declined.

The scores demonstrate continued incremental progress; however, preparedness is still lagging behind goals and expectations. With most states still in the middle range of the scale and no states meeting all of the indicators, there are still major areas of vulnerability that leave Americans at risk.

Overall, the report found that many basic bioterrorism detection, diagnosis, and response capabilities are still not in place. This report found that more than three years after 9/11 and the anthrax tragedies, we've only made baby steps toward better bioterrorism preparedness, rather than the giant leaps required to adequately protect the American people, said Lowell Weicker, Jr., TFAH Board President and former three-term U.S. Senator and Governor of Connecticut.

What Will It Take?

The conclusions of this study demand an answer to the big question here: What will it take to make bioterrorism and public health preparedness a real national priority?

Some of the report's major concerns include the following:

1. Nearly one-third of states cut their public health budgets between Fiscal Year 2003 and 2004, and federal bioterrorism funding decreased by over $1 million per state in 2004;

2. Shifting federal priorities and programs are distracting from improvement efforts, and there is little, if any, accountability to the public;

3. Only six states -- Florida, Illinois, Louisiana, and three undisclosed states -- have achieved "green" status for the Strategic National Stockpile, which means that they are recognized as being adequately prepared to distribute vaccines and antidotes in an emergency;

Brain Drain Imminent

4. Only five public health labs report sufficient capabilities (facilities, technology, and/or equipment) to fully respond to a chemical terrorism threat, and only one-third of states report sufficient bioterrorism lab response capabilities;

5. Nearly 60 percent of states do not have adequate numbers of laboratory scientists to test for anthrax or the plague if there were to be a suspected outbreak;

6. Two-thirds of states do not electronically track disease outbreak information by national standards, causing serious delays in reporting making early warning of disease threats difficult;

7. The public health workforce is on the brink of a "brain drain" as the baby boomers retire and next-generation recruitment efforts suffer;

8. Concerns remain that states are unprepared to implement a quarantine, although every state except Alaska has adequate statutory authority to quarantine in response to a hypothetical bioterrorism attack scenario;

9. Although planning for a flu pandemic, which is often viewed as requiring a similar response to a bioterror attack, has improved, 20 states still do not have publicly available response plans in place; and

10. Based on model estimates, a pandemic flu hitting the U.S. could result in 89,000 to 207,000 deaths and could cost the economy between $71.3 and $166.5 billion. Sixteen states could face over 5,000 deaths and 33 states would face over 10,000 people hospitalized in the first wave of the disease hitting the U.S.

'Flash Distracting from Substance'
"Germs in the hands of terrorists is a frightening proposition. Americans deserve to know how their tax dollars are being used to better protect the homeland," said Shelley A. Hearne, DrPH, Executive Director of Trust for America s Health. "Sadly, what we found is that public health professionals have been left to juggle competing priorities with limited resources, and that flash is distracting from substance. We need to focus on fixing the fundamentals and get back to the tried-and-true basics."

During a news conference announcing his resignation earlier this month, departing HHS Secretary Tommy Thompson highlighted the importance of bioterrorism preparedness issues, saying, "for the life of me, I cannot understand why the terrorists have not attacked our food supply, because it is so easy to do," and that a pandemic flu is "a really huge bomb out there that could adversely impact on the health care of the world."

Better Bio-Game Plan Needed

To improve bioterrorism and public health preparedness, TFAH recommends the following:

1. Building a better bio-game plan, with consistent, measurable standards for improvement that require demonstration of how funds were used to achieve progress. In anticipation of the reauthorization of the Public Health Security and Bioterrorism Response Act of 2002, a systematic review of preparedness gaps should be conducted;

2. Getting back-to-basics, by building on fundamental components of a comprehensive public health system that is fully prepared to meet both emergency and ongoing challenges from threats of terrorism to the flu and cancer;

3. Conducting practice drills to assess capabilities and vulnerabilities, to help identify gaps and improve coordination of roles and responsibilities; and

4. Limiting liability to encourage vaccine development and protect health care workers. The report was supported by grants from The Robert Wood Johnson Foundation (RWJF), the Bauman Foundation, and the New York Community Trust. The report and state -specific information is available on TFAH's Web site (Daily News Central, 2004)

Title: Bedfellows At The Biosecurity Board
Date: October 30, 2006
Sunshine Project

Abstract: How US science's nouveau riche bioweapons constituency is flexing its muscle to carve up safety and security rules.

Karl Rove would probably be impressed by the brand of government "oversight" being developed by the
National Science Advisory Board on Biosecurity (NSABB). Like a Bush administration investigation of itself, on last Wednesday (October 25th) an NSABB working group moved to creatively thwart its charge. Although it was formed to recommend biosecurity rules to govern the new field of synthetic biology, the working group will instead assault regulation of a wide range of biodefense and biotech risks.

The working group's outlook is more political than technical. Its science is a veneer that disguises the maturing political muscle of a constituency of bioscientists that has become accustomed, perhaps addicted, to lavish federal biodefense funding. This constituency is challenging the regulations that apply to it and has allied itself with those seeking to block effective regulation of the emerging field of synthetic biology. As such, it will pose a major long-term obstacle bringing under control the wild proliferation of dangerous biodefense research in the US.

The working group's politics deftly unite two distinct scientific camps under the same banner. One camp is synthetic biology, a burgeoning, dangerous science that currently is an unregulated Wild West free-for-all, a condition that many practitioners believe is desirable. The working group also tapped a deep vein of discontent among its other camp, infectious disease researchers. Specifically, the researchers that receive biodefense handouts; but who resent being required to comply with the Select Agent Rule, a law designed to protect the public from bioterrorism.

In biodefense, the synthetic biologists (who use DNA like building blocks) and the infectious disease bug jockeys (who work with full-blown dangerous microbes) usually don't get along very well. The synthetic crowd scoffs at the bug jockey's focus on vaccines and pills for specific microbes, dubbing the narrow approach a "Maginot Line" after the inflexible border defenses that failed to protect France from German invasion in 1940. Genetic tweaks and new bugs, the synthetic biologists say, can outflank these countermeasures. A subtext, of course, is that synthetic biologists think they should get a bigger piece of the biodefense pork pie from the federal budget.

The bug jockeys, on the other hand, argue that the synthetic guys are a bunch of nerdy engineers whose science of using genes like tinker toys is young and unproven. The bug jockeys claim that they can deliver here and now, whereas the synthetic folks are still in scientific diapers, working out basic principles of their discipline. Perhaps interesting down the road, the bug jockeys say, but what counts is the present. (Neither group questions the wisdom of the government bankrolling tens of billions of dollars in biodefense research at hundreds of places across the country.)

What unites these two quarrelling factions? Apart from the fact that their science is potentially dangerous, the two share an appetite for tax dollars and a disdain for federal security rules. The latter point has led to an NSABB marriage of convenience: The synthetic biologists want to shake pressure for new regulation while the bug jockeys want to assassinate the existing Select Agent Rule, enabling both to do as they please with less "interference" from Uncle Sam.

Thus was born a politico-scientific Coalition of the Willing that aims to invade federal rulemaking to take down what they perceive as a threat: biosecurity legislation designed to protect the public. By hijacking the NSABB, they are on well on their way to Mission Accomplished. And because the current political leadership of the US holds itself to its own unique (nonbinding) standards and sees little reason to reign in dual-use research for safety, security, or treaty compliance reasons, the NSABB working group probably won't have to waterboard anybody in the US government - unless there are radical changes in officialdom.

The specifics of the working group recommendations? They include unusual and dubious arguments about taxonomy, gene sequences, and law. These have far broader implications than the working group apparently paused to contemplate. More on that later.

From an unsurprising "finding" that microbial taxonomy systems are imperfect, the working group leaps to the illogical conclusion that this is justification to eviscerate government regulation of (but not cash handouts for) research with biological weapons agents. That's quite a jump. Considering the recommendations carefully, however, it is clear that the working group's intellectual shortcomings - its recommendations don't logically follow from its findings - stem from an attempt to paper over the distinctions between the need for synthetic biology regulation and the need for the select agent rule.

Synthetic biology may be new; but challenges to taxonomic conventional wisdom are not. Evolution happens. Genes turn up in new places, by the hand of man and through the many ways that biodiversity moves itself. The novel possibilities of synthetic biology are thus not without precedent in nature, in the sense that taxonomy is always encountering the difficult-to-classify and is currently incapable of fully describing naturally occurring diversity.

No matter what is cooked up in a synthetic biology lab, that doesn't change the fact that there are diseases out there that can kill you. Scientists know what most of them are, and can reasonably define them. Hence the need for the Select Agent Rule is unaltered by the powers to manipulate, even create, dangerous forms of life (and nucleic acids) that is possibly offered by synthetic biology.

But don't tell the NSABB working group, because that would get in the way of its political agenda. That the working group's logic doesn't parse is unsurprising in view of the fact its science is merely a pretext to table a pre-emptive attack on regulation of synthetic biology and the extant Select Agent Rule. For good measure, the working group adds a pork barrel recommendation to loosen controls on smallpox virus and DNA that suffers from the same logical flaws as the other recommendations.

And, in an easy to overlook item, the working group suggests that biosafety of synthetic DNA can be handled by the failed genetic engineering oversight system known as the NIH Guidelines, designed three decades ago and declining ever since. It's another failure of the logic to parse. The synthetic biologists literally argue that their science antiquates biodefense before it like the Nazi blitzkrieg through Belgium outmoded the Maginot Line. But then they go on to reason that, for biosafety, the scientific equivalent of the Treaty of Versailles (NIH Guidelines) is sufficient to keep the peace!

In the long run, this quagmire of faulty scientific-legal verbiage won't stop the real risks of biodefense proliferation. It would take an intelligence failure of a very different type than Iraq in order for NSABB to be allowed to thwart its charge and debilitate proper federal oversight of dual-use research. But that may be exactly what NSABB does. Certainly that's the way that its working group on synthetic biology is heading. And if it is an indicator of how biodefense researchers, a sort of bioscience nouveau riche, intend to flex their political muscle, then we may be in for many more dangerous years before the wild excesses of the biodefense boom are brought under control (Sunshine Project, 2006).

Title: Obama Gets 'F' On Stopping Spread Of Weapons Of Mass Destruction
January 26, 2010
Fox News

Abstract: A bipartisan, independent commission on stopping the spread of weapons of mass destruction says that the Obama administration has failed in its first year in office to do enough to prevent a germ weapons attack on America or to respond quickly and effectively should such an attack occur. In a 19-page report card being published Tuesday, the Commission on the Prevention of Weapons of Mass Destruction, Proliferation and Terrorism, chaired by former Senators Bob Graham, a Democrat from Florida, and Jim Talent, a Missouri Republican, gives the new administration the grade of "F" for failing to take key steps the commission outlined just over a year ago in its initial report.

Specifically, the commission concludes that the Obama administration, like the three administrations before it, has failed to pay consistent and urgent attention to increasing the nation's ability to respond quickly and effectively to a germ attack that would inflict massive casualties on the nation. The commission repeated its warning that unless nations acted decisively and urgently, it was more likely than not that a WMD will be used in a terrorist attack somewhere in the world by the end of 2013, and that the terrorists' weapon of choice would be biological, rather than nuclear.

The administration's delayed response to the H1N1 virus, the report concludes, demonstrated that the United States was "woefully behind in its ability to rapidly produce rapidly vaccines and therapeutics, essential steps for adequately responding to a biological threat, whether natural or man-made." Even with time to prepare, the report noted, the epidemic peaked "before most Americans had access to vaccine." And a bio-attack, it warned, would have no such warning.

The administration's lack of urgency was also reflected in its lack of priority on producing and distributing enough vaccines and other medical countermeasures for Americans, its reluctance to insist that hospitals have enough surge capacity to treat people who would be infected in a bioterror attack, and the lack of a national plan to coordinate federal, state and local efforts following a bioterror strike, the document asserts.

Ultimately, the commission chairman and vice chairman say, the "lack of preparedness" and "consistent lack of action" reflect "a failure of the U.S. government to grasp the threat of biological weapons." Unlike its effort to prevent a nuclear attack, the Obama administration has shown "no equal sense of urgency" about preventing or responding to germ warfare that might cause comparable death and suffering, the commission concludes. The report assigns 17 grades that it says highlight the issues of greatest priority in protecting Americans from WMD. The commission gave the administration a "D+" for its efforts to tighten oversight of high-containment labs in which experiments involving the deadliest pathogens are conducted.

There were still far too many Federal, state, and local agencies regulating germs in sometimes conflicting ways, it states. The commission also gave Congress a failing grade for failing to consolidate the estimated 82 to 108 committees and subcommittees that oversee some part of the Department of Homeland Security. "Virtually no progress has been made since consolidation was first recommended by the 9/11 Commission in 2004," the report asserts.

The Obama administration disputed the findings of the report Tuesday, arguing that the president has accomplished a "great deal" in his first year in office.
White House spokesman Nick Shapiro cited a recently signed executive order establishing "federal capability to rapidly provide medical countermeasures to supplement state and local response in the event of a large-scale biological attack." He said Obama would launch a new initiative aimed at addressing potential "public health threats" during his State of the Union address Wednesday.

The Graham/Talent WMD Commission, as it is known, is a legacy of the 9/11 Commission, which recommended its creation to examine WMD proliferation threats in its own report. In December, 2008, the WMD commission concluded in its final report that American national security faced ever growing threats from unconventional weapons, and from biological weapons in particular. Its report, "World at Risk," unanimously concluded that bioterrorism was the most likely WMD threat the nation confronted given the exponential growth of biological technology and the stated desire of Al Qaeda and other terrorist groups to acquire such weapons. It called upon the administration to take 13 steps to reduce America's vulnerability to such an attack.

The new report card assesses the progress that the Obama administration has made in implementing its recommendations. The report is not uniformly negative. It gives the Administration high marks -- an "A" -- for the reviews it has conducted into how best to store and secure dangerous pathogens, and two "A-minus" grades for appointing a WMD coordinator and restructuring how the White House oversees homeland security issues. But it warns that such steps are not commensurate with the threat the nation faces from terrorist groups searching for unconventional weapons in asymmetrical warfare.

Robert Kadlec, President Bush's former special adviser on bio-defense policy, declined to comment on the commission's failing grade in the area in which he worked, saying there was still "ample opportunity to provide more focus and resources" for bio-preparedness in the administration's remaining three years. "This is a hard problem which deserves high priority," he said. Two defenders of the administration's policies, both of whom asked not to be identified by name because they were speaking without authorization, said that the Obama White House gave bio-defense and countering nuclear proliferation high priority.

One official said that Obama's second presidential security directive -- the first being the reorganization of the White House national security apparatus -- mapped out a national strategy to defend the nation against biological attacks. He also predicted that the administration would seek increases in its new budget for bio-defense and global surveillance programs.

Having been extended for one more year of work in 2009, the 9-member WMD Commission is disbanding after issuing this final report card. But staff members said that its chairman and vice-chairman intend to form a non-profit organization to continue pressing the government to do more to counter WMD threats
(Fox News, 2010).

Title: $1B Effort Yields No Bioterror Defenses
Date: January 17, 2011

Abstract: The Pentagon is scaling back one of its largest efforts to develop treatments for troops and civilians infected in a germ warfare attack after a $1 billion, five-year program fell short of its primary goal. Even the heavy infusion of research cash and a unified effort by university labs and biotech companies from Boston to California were insufficient to break through limitations of genetic science, according to government officials and specialists in biological terrorism.

Instead, the Pentagon’s next $1 billion for the Transformational Medical Technologies program will focus on better ways to identify mutant versions of Ebola, Marburg, and other deadly viruses. Those are among the genetically modified agents that officials fear could be used by terrorists or rogue states against urban or military targets.

The continued flow of money, even with the shift in strategy, should help Massachusetts and other states retain jobs and research labs focused on this arena.

“There is tremendous potential for further development of a biodefense subcluster in the state,’’ said James D. Rooney, vice president of the Massachusetts High Technology Council.

Among Bay State firms that have received contracts under the germ warfare effort is Worcester-based Microbiotix. Representatives from Microbiotix did not respond to requests for comment.

The new strategy represents a return to the drawing board for an ambitious program conceived after the Sept. 11 terrorist strikes and subsequent mailing of anthrax to members of Congress and media organizations — events that helped US military planners realize that the nation lacked adequate defenses against bioterrorism.

Scientists initially set out to develop new medicines capable of attacking viruses that might be altered by terrorists to make them more deadly. But after more than 50 research projects by more than 100 contractors — including biotech firms, pharmaceutical companies, and universities, including several in the Boston area — only two experimental medicines have shown promise. And even those are far from being ready for limited clinical tests, according to project officials.

“They are trying to come up with new medical technologies that are more difficult to develop,’’ said Crystal Franco, a specialist at the Center for Biosecurity at the University of Pittsburgh Medical Center who specializes in biological defense policy. “They are really trying to push the envelope.

Another hurdle in the government’s effort: such treatments cannot be tested in human clinical trials, which are typically required for Food and Drug Administration approval, because it is unethical to expose people to deadly virus in such a study, requiring animals with similar traits as humans to serve as surrogates.

Alan S. Rudolph, director of science and technology at the Defense Threat Reduction Agency, said in an interview that the agency will now focus more attention on ways of identifying new pathogens. That research could lay the groundwork for further advances in the development of antidotes that could eventually win FDA approval.

The new focus of the program will be making a “cadre of investments that are able to take an unknown sample that may contain different agents, and be able to determine very quickly what is in there,’’ Rudolph said. “It is our intent to continue to grow this capability.’’

He added the ultimate goal will still be to someday develop therapeutic remedies that could treat someone infected with any number of deadly viruses — what the Pentagon called “one size fits all’’ or “one drug, many bugs.’’

In addition to Ebola and Marburg, some of the potential biological threats on the Pentagon’s target list are Lassa, Sabia, Machupo, and Junin, especially modified versions designed to cause more severe symptoms of hemorrhagic fever that are more resistant to traditional drugs.

The difficulty in developing medicines so far, however, demonstrates how much more research is needed, say biological warfare specialists.

It turns out it is easier to modify a germ or virus for an offensive threat than it is to develop an effective defense, they said.

“The offensive capabilities outrun the defensive capabilities as the march of biology continues,’’ said Richard J. Danzig, a former Navy secretary and noted expert on bioterrorism who sits on the Pentagon’s high-level Defense Policy Board.

“The theory behind [the program] was these same advances should empower the defenses,’’ he said. “I think that intuition is worth exploring and investing in, but it is easier to conceive than to execute.’’

Margaret Kosal, an assistant professor at Georgia Tech who worked on the program between 2006 and 2007, said “there is a fundamental need for basic science. The low-hanging fruit has all been picked.’’

One Pentagon contractor involved in the program who was not authorized to speak publicly put it more bluntly: “We’re years away from any reasonable FDA certification, let alone production.’’

Franco said the project’s hurdles also highlight the need for ongoing taxpayer-investment commitments from government, to encourage private-sector focus on such technologies that will generate little in sales, compared to, say, cholesterol and diabetes treatments.

“These are not going to be blockbuster drugs,’’ said Franco. “It is different when the government is your only market. There needs to be incentives for companies to participate, to take it on for the public good’(, 2011).

Title: Pentagon Retools Bio-Effort After $1 Billion Flop
January 18, 2011

It was supposed to come up with antidotes for pathogens that terrorists might use for a mass-casualty bio-attack. But after spending over $1 billion during the last five years, the Pentagon’s Transformational Medical Technology initiative can barely develop drugs ready for a clinical trial. That’s why the officials tasked with running it are setting their research-subsidy targets much lower.

In a shift, the Defense Threat Reduction Agency’s science and technology chief tells the Boston Globe that the bio-initiative will now invest money on early detection of new pathogens. That puts about another $1 billion worth of Pentagon cash closer to where science is, rather than throwing money at crash programs for undeveloped antidotes. Ultimately, the Pentagon wants to develop multi-pronged vaccines that can resist a variety of biological agents — what it calls “One Drug, Many Bugs.” But that’s a long way off: step one is understanding how those sicknesses develop.

The Globe reports that the program has hit one snag after another. Out of nearly 50 research programs, only two (unspecified) efforts to neutralize pathogens like Ebola and Marburg have shown promise, and they’re not ready for clinical trial. Making matters worse for the program, the Food and Drug Administration doesn’t allow experimenting on people, so Transformational Medical Technology would have to make do with animal surrogates.

It’s also become something of an object of fun within the military’s chem-bio community. Our pal Jason Sigger lamented the program’s inability to come up with a lightweight, portable Tricorder-like bio-detection device. The office tasked with coming up with one still sought to buy a Cadillac, one networked into troops’ communications system and that can also detect chemical weapons. “All they need to do is warn the individual that there’s a bad bug nearby,” Sigger wrote.

But don’t expect the Pentagon to steer away from far-out bio-medical research. In 2009, Darpa wanted to create a bank of “universal immunity donor cells” to head bio-outbreaks off at the pass. More recently, in September, it doled out over $5 million so Arizona State University could experiment with growing vaccines with the aid of tobacco plants. “I don’t know if we can pull this off, but I think this basic idea might work,” one of the ASU researchers shrugged when the grant was announced.

Still, according to the Globe, if the military wants to speed up the day when it can deliver mass antidotes for a host of bio-threats, it’s got to subsidize pharma companies’ research in areas that won’t yield the next generation of lucrative “blockbuster drugs.” Bio-defense expert Crystal Franco of the Center for Biosecurity tells the paper, “It is different when the government is your only market. There needs to be incentives for companies to participate, to take it on for the public good.” That is, until someone figures out how to make Viagra stop anthrax (Wired, 2011).

Title: Congress Continues To Struggle With WMD, Bioterror Legislation
Date: June 25, 2011
Bio Prep Watch

Abstract: Efforts to secure the United States from weapons of mass destruction, particularly biological warfare agents, continue to suffer from a lack of funding, coordination and leadership, a panel of witnesses told Congress on Thursday.

At a joint hearing of the Cybersecurity, Infrastructure Protection and Security Technologies Subcommittee and the Emergency Preparedness, Response and Communications Subcommittee of the House Homeland Security Committee, members sought to move forward a bill on WMD preparedness that stalled in Congress last year.

In testimony before the House, Representative Bill Pascrell, Jr., co-sponsor of the WMD Prevention and Preparedness Act of 2011, called on members to work together in a “bipartisan” manner to “swiftly consider” the bill. In a prepared statement, Pascrell stressed that he hoped “jurisdictional turf battles will not stop the full House and Senate from passing this important legislation as soon as possible.”

Most members and witnesses agreed that the urgency of the bill was matched only by the threat posed to the country from biological weapons. The former 9/11 WMD Commission issued a report last year titled “World at Risk” that warned that a WMD attack is “likely” to occur by 2013. The same report gave the country particularly low grades for bioterrorism preparedness. Since that time, jurisdictional turf battles in Congress and between agencies, funding constraints and a lack of leadership from the White House have hampered efforts to develop a more closely coordinated bioterrorism strategy.

“As the WMD Commission stated in its report, it is unacceptable that now, nearly 10 years after September 11, we do not have a comprehensive national strategy to counter the threat that WMD poses to our country," the committee’s lead-off witness, Representative Bill Pascrell, said. "One year later, and hopefully a little wiser, I hope we will swiftly consider by this committee this legislation, and that jurisdictional turf battles will not stop the full House and Senate from passing this important legislation as soon as possible.”

The vice chairman of the WMD Center, former Senator Jim Talent, praised committee members “for consistently acting with the urgency that we at the WMD Center think is justified by this threat.”

Recalling the failing grade given biodefense efforts and the dire warnings of last year’s report, Talent revealed that a follow-up report will be issued this fall that will more fully explore the failures to integrate detection and surveillance efforts and the necessity for sacrificing jurisdictional turf among numerous committees in order to make progress in protecting the nation from biological threats.

Robert Kadlec, the former special assistant to President George W. Bush for biodefense, said that the nation has spent approximately $50 billion over the last 10 years on biodefense efforts, but that few improvements are discernible. He also pointed out that he was the last special assistant to the president for biodefense policy and that the Obama administration has not named a successor to that post.

“We see how biodefense is managed today, it’s not being seen as a national security priority,” Kadlec said.

Kadlec called for streamlining cross-cutting budgetary proposals across agencies, an emphasis on pre-vaccination of first responders and studies on environmental clean-up efforts should the nation suffer a bioterror attack, arguing that preparedness for biological threats can be a form of deterrence.

At a somewhat more grassroots level, the final committee witness, Sheriff Richard Berdnik of Passaic, New Jersey, one of the six Tier 1 regions considered at greatest risk of a terrorist attack, told House members funding cuts could have a potentially devastating impact on state and local first responders. He added that the nation’s communications system continues to lack interoperability among responders and that there was presently no way to notify the public of a WMD event in a timely manner.

The 2011 bill, introduced on Friday, retains a comprehensive approach to securing the country against weapons of mass destruction, emphasizing prevention, preparedness, protection, response and recovery. New provisions in this year’s bill include establishing a new Special Assistant to the President for Biodefense responsible for crafting a federal biodefense plan and putting together a cross-cutting biodefense budget, and a provision to allow the secretary of Health and Human Services to make surplus vaccines with short shelf lives from the Strategic National Stockpile available to state and local first responders.

Ranking Member Laura Richardson (D-Calif.), in a prepared statement, said that efforts to better integrate state and local first responders would be accomplished “through training, exercise participation, intelligence information, grant funding and inclusion in the preparedness planning process.”

The central theme of the committee’s hearing was repeatedly emphasized by former Senator Jim Talent, who said that “nobody is looking at the whole picture,” and that the U.S. has got to “get somebody in charge,” responsible for coordinating efforts, expenditures and priorities.

Congress and the administration need to reach a degree of uniformity in understanding the urgency posed by biological threats, either man-made or natural, Talent said. Oversight rules by a number of committees continue to make it difficult for agencies to develop the trust and relationships necessary to address the problem, with literally dozens of agencies involved in biodefense issues.

While the death of al-Qaeda leader Osama bin Laden by U.S. special forces last month was a crippling blow to the organization, former Senator Talent noted that bin Laden's successor, Ayman al-Zawahiri, was an Egyptian doctor with a background in medicine and infectious disease, “One more reason we worry about bioterrorism.”

Such a background could lead to a renewal of interest in biological agents as weapons of mass destruction, a much less complicated and cost effective endeavor than efforts to develop or steal nuclear weapons. Kadlec said in his prepared testimony that Zawahiri, is “one who has and likely still aspires to attack the United States with anthrax.”

An additional highlight of the new bill is elimination of the National Bio-Surveillance Integration Center.

“The bill also eliminates the under-performing National Bio-Surveillance Integration Center," Chairman Daniel Lungren (R-Calif.), said. "The goal of the NBIC was to provide early detection of an event of national significance, such as anthrax. While an effective national bio-surveillance capability is an important component of preparedness and response, NBIC has not fulfilled its mandate due in part to the lack of cooperation of other federal agencies. And we have limited evidence that this situation will improve. This bill rightly realizes that continuing to fund NBIC under the current operations scheme will be money wasted and calls on White House leadership to develop a new plan and program that works effectively and efficiently.”

Ranking Member Richardson also emphasized the importance of public participation and ensuring that at-risk populations are included in planning.

“As the WMD Commission found in its December 2008 report, America needs to move more aggressively to address our vulnerability to a bioterror attack," Richardson said. "As an original co-sponsor of this particular act, I’m proud to take up this bipartisan legislation that addresses this bio-WMD issue from prevention to recovery…One of the key provisions in this bill includes ensuring that we empower our citizens by providing WMD preparedness guidance and early warning systems.”

Overall, the current state of WMD preparedness in the biological sector was bemoaned by Rep. Pascrell, who said that, “As the WMD Commission stated in its report, it is unacceptable that now, nearly 10 years after September 11, we do not have a comprehensive national strategy to counter the threat that WMD poses to our country.”

According to Pascrell, the new legislation “addresses the findings from the Government Accountability Office on the state of our biodefense enterprise. It creates an entirely new top-down approach centered at the White House. This includes establishing a new special assistant to the president for biodefense who will be responsible for crafting a federal biodefense plan and putting together a yearly cross-cutting biodefense budget, which will help streamline agency efforts and improve efficiency. It includes a new provision that will allow the secretary of Health and Human Services to make surplus vaccines with short shelf lives available from our strategic national stockpile to our state and local first responders."

While the WMD Prevention and Preparedness Act of 2011 appears to have a measure of bipartisan support, fiscal constraints and Congressional gridlock make its passage anything but certain.

"Funding for our various Homeland Security State and Local grant programs that help at-risk areas prepare and secure sensitive infrastructure, are under severe funding constraints," Rep. Pascrell said. "Grant programs for our Cops and Firefighters to purchase equipment and ensure they have adequate personnel are slated for cuts” (Bio Prep Watch).

Title: Biodefense Takes Hit In Obama’s Budget
Date: February 16, 2012
Source: Bio Prep Watch

Abstract: President Obama’s recent budget request for 2013 contains mixed news for the biodefense effort in the United States.

The effort for biodefense came under major criticism in 2011 for failing to deliver biodefense threat treatments despite spending approximately $60 billion in the previous decade, Nature reports.

Crystal Franco, a representative of the Center for Biosecurity of UPMC, said that winners for the budget proposal include the Department of Homeland Security, the National Institutes of Health, the Food and Drug Administration and the Biomedical Advanced Research and Development Authority.

The apparent losers include military biological-defense development efforts and public health programs for U.S. Centers for Disease Control and Prevention.

“It’s good news that there is more money for BARDA, and no significant cuts to basic science at NIH or to regulatory science at FDA,” Randall Larsen, the founding director of the WMD Center, said, according to Nature.

The DHS will get an $11 million boost for the BioWatch program, BARDA’s budget would see an increase from $415 million to $547 million and the FDA would receive $346 million for biodefense, which is close to last year’s budget. The CDC would experience a $47 million dip for the Strategic National Stockpile and the Department of Defense’s biological-defense program would see a $257 million cut in the proposed budget.

“Taking money out of the military research budget and leaving NIH funded at $1.3 billion, even though it hasn’t produced a single countermeasure, is pretty tragic,” Phillip Russell, an advisor to the U.S. Department of Health and Human Services, said, Nature reports.

The budget also does not commit any funding to the construction of the National Bio and Agro-Defense Facility in Manhattan, Kansas, which has yet to be constructed (Bio Prep Watch, 2012).