The Federation of American Scientists has added a fifth Case Study to our Dual-Use Research education series. This new case study focuses on the work of Dr. Stuart Levy of Tufts University School of Medicine in antibiotic resistance. Dr. Levy is also a member of the National Science Advisory Board for Biosecurity (NSABB).

Dr. Levy’s lab identified a gene in Yersinia pestis, the causative agent of plague, that was similar to an E. coli multiple antibiotic resistance gene. A non-virulent strain of Y. pestis overexpressing the gene was resistant to several common antibiotics, including those typically used to treat plague infection. The case study includes a history of antibiotics and resistance, a description of the experiments as well as an in-depth interview with Dr. Levy discussing the work, its implications, and his perspectives on dual-use research. Dr. Levy is also one of the members of the NSABB, which is involved in developing strategies for oversight of dual-use research.

FAS is has also launched a survey for the case studies. To thank participants for completing the survey, we will enter them into a drawing for an 8GB iPod nano. Click here to go to the case studies or here to go directly to the survey. The survey is open through May 31, 2007.

The first four case studies include an introduction to biosecurity, the poliovirus synthesis experiments conducted in Eckard Wimmer’s laboratory at the State University of New York at Stony Brook; the porous particle development work of David Edwards at Harvard University; and the mousepox experiments conducted by two Australian researchers, Ron Jackson and Ian Ramshaw.

The Federation of American Scientists Biosecurity Project has prepared a brief online survey to collect feedback on our “Case Studies in Dual-use Biological Research.” To thank participants for completing the survey, we will enter them into a drawing for an 8GB iPod nano. Click here to go to the case studies or here to go directly to the survey. The survey is open now through May 31, 2007.

If you have any colleagues, students or friends involved in biological research or biosecurity, please let them know about the Case Studies and the survey. Thank you for your feedback!

The first four case studies include an introduction to biosecurity, the poliovirus synthesis experiments conducted in Eckard Wimmer’s laboratory at the State University of New York at Stony Brook; the porous particle development work of David Edwards at Harvard University; and the mousepox experiments conducted by two Australian researchers, Ron Jackson and Ian Ramshaw.

We include in-depth interviews with the researchers to document their personal experiences and present the details of their experiments, the implications for biosecurity, and the aftermath of publication. We also include commentary and analysis, accounts of the public reaction, and a discussion of scientist’s roles and responsibilities. The ultimate purpose of the case studies is to vividly illustrate the challenge and ethical complexities of conducting biology research in “an era of bioterrorism,” and to illustrate how government, the public, the scientific community, and law enforcement have interacted in the past and need to cooperate in the future.

Last month, there were three significant congressional committee hearings dealing with the Department of Homeland Security biodefense budget for FY’08. The Science and Technology Directorate’s budget request reached $799.1 million including $142.6 million for Administration and $656.5 million for research, development, testing and evaluation. A big chunk of that budget, $228.9 million was requested for Chemical and Biological security. The Department as well as the directorate has been significantly restructured in the past year after a, shall we say, rocky couple of years. It will be interesting to see what happens with the budget and how the reorganization of the biosecurity programs will play out. On the whole, they appear to be taking steps in the right direction to clean up their act.

Jerry Epstein from the Center for Strategic and International Studies testified before the Committee on Science and Technology regarding the FY’08 Biodefense budget at the Department of Homeland Security. Notably, Epstein comments on the transfer of the Biowatch program to the Office of Health Affairs, the creation of the Biomedical Advanced Research and Development Authority within the Department of Health and Human Services, and comments on classified biodefense research.

Undersecretary for Science and Technology Hon. Jay Cohen testified before the House Appropriations Committee, Subcommittee on Homeland Security. Admiral Cohen discussed the restructuring of the S+T directorate, fiscal responsibility within the agency, and their focus on etting products out of their research and development programs.

Dr. Jeffrey Runge, Chief Medical Officer for the Departments Office of Health Affairs also testified before the House appropriations Committee Subcommittee on Homeland Security where he discussed the new role of the Office of Health Affairs in BioWatch and how they will be cooperating with the S+T directorate. Dr. Runge was the Chief Medical Officer for the Department and in January of this year, the CMO office was renamed the Office of Health Affairs and given a larger role in directing the Departments Biosecurity Programs.

Representatives Lowey (D-NY) and Emanuel (D-IL) are circulating a Dear Colleague letter to be delivered to the President asking him to update the Congress on the National Strategy on Pandemic Influenza. Released 8 months ago, the strategy includes over 300 activities designed to prepare the nation for a potential influenza pandemic. However, many of the activities will also prepare the nation for other public health emergencies including bioterrorism events. Since the activities are tied to benchmarks, Congress is looking to ensure that plans are moving forward.

Dear Colleague:

Please join us in sending the attached letter to President Bush requesting an update on the progress made in federal efforts to prepare for a possible pandemic flu outbreak.

Public health experts tell us it is a question of when, not if, an influenza pandemic will strike. The World Health Organization (WHO) has reported that the avian flu has infected 258 people worldwide, killing 154 of them, with the most recent deaths occurring in Egypt just last month.

On May 3, 2006, President Bush released the federal government’s National Strategy for Pandemic Influenza Plan (NSPI) to coordinate federal efforts to prepare for a potential outbreak. The plan contains more than 300 activities to be performed by various federal agencies that are tied to specific accountability measures and timelines.

In our judgment, the eight months since the release of the NSPI are sufficient for the federal government to have made significant progress in executing at least a portion of its directives. While the status of many of the NSPI recommendations are listed on the federal pandemic flu website, not all of the relevant information has been made public.

Congress has a responsibility to carefully monitor the progress of the Administration in achieving the goals of its own plan. If you would like to sign this letter or have any questions, please contact Jean Doyle in Rep. Lowey’s office at jean.doyle@mail.house.gov, or Lauren Aronson in Rep. Emanuel’s office at lauren.aronson@mail.house.gov.

The same day that President Bush signed the Pandemic and All-Hazards Preparedness Act into law, the government canceled their contract for the production of 75 million doses of anthrax vaccine. The contract, with VaxGen, was the most significant from the much criticized Bioshield program. But the cancellation was anticipated by many after VaxGen, who has never brought a vaccine or drug to market missed several deadlines and, most recently, had their application for testing their vaccine in humans rejected by the FDA.

The company only has one other product in its pipeline, a new smallpox vaccine, but they do not have a contract to produce it. So, after shelling out approximately $175 million of its own cash, they have been left at the table with the bill. This scenario is precisely why no large pharmaceutical companies bid on the anthrax vaccine contract when it was offered. It was simply too much of a gamble. Granted, VaxGen’s 5 year time line for production of a next generation vaccine was overly ambitious by most standards, and they have no one to blame but themselves for signing a contract that there was little chance of completing on time.

The US will continue to stockpile the previously available anthrax vaccine from Emergent BioSolutions even though its safety has been a topic of concern for some time and that it has to be delivered in several doses over 6 months.

The cancellation of the contract and the passing of the Pandemic and All-Hazards Preparedness Act represent a welcome step back and reevaluation of how the US has been approaching countermeasure development. Amongst several provisions, the act calls for a reorganization of the Bioshield program and establishes the Biomedical Advanced Research and Development Authority, or BARDA, under the Department of Health and Human Services, which will be tasked with organizing vaccine and therapeutic development for potential bioterror agents. Having a more organized and accountable system for spending the $5.6 billion dollars in Bioshield funding will most certainly be a step forward.

Earlier this month, The Department of Homeland Security added two new sections to the Ready.gov website, one for people with disabilities and another for seniors. However, when you take a close look at them, you will notice that all they have done is shuffled the information they already had on the site onto two new pages. There is no new information on the web pages themselves.

What they have also done is supplied two new downloadable brochures that have very good information for seniors and people with disabilities. Kudos DHS! It is absolutely puzzling to me, however, that they have not taken the information from their brochures and simply added it to the new web pages. It would take very little time to do this and having two different sets of information on the site, one on the web page itself and one in the brochure, will almost certainly lead to confusion.

We applaud their efforts to improve their site and hope they will move quickly to rectify the shortcomings we identified in our previous analysis. We have formally offered DHS the content of reallyready.org at no cost, but have yet to hear word if they are going to take us up on our offer.

Finally, we have received several suggestions that we change the graphics on our nuclear threat page from a reactor because it implies that nuclear reactors pose a threat of nuclear explosion. This is an excellent point. The graphic was taken directly from ready.gov and we have changed it on our site to reflect the reality of a nuclear threat.

On Monday, the Department of Homeland Security (DHS) issued a press release announcing that it had updated its citizen preparedness web site, Ready.gov, with “special preparedness information for pet owners, senior citizens, and individuals with disabilities and special needs,” and “increased state and local information.” Through a meticulous comparison of the new Ready.gov to a version archived by FAS in early June, we found that the changes are largely cosmetic.

The Good News

The revised site includes valuable information for seniors and pet owners, a constructive change from the nominal details previously available. The state and local information is more comprehensive, which is good news since familiarity with community response plans is essential to preparedness. Summaries of FEMA’s information on preparedness and response for 12 natural disasters have also been added to Ready.gov. Changes to layout make the site significantly easier to navigate; however, there are still many problems.

The Bad News

Even though DHS claims that its disabilities information is revised, a simple comparison to a 2003 version of Ready.gov demonstrates that not a single word has changed in the past three years. This remains a serious issue because the advice is too broad and does not answer important questions about special considerations to make when developing an evacuation plan or how to create a support network to help you, as the National Organization on Disability suggests. DHS has also failed to rectify inaccurate information on other pages of its site, such as a recommendation to get out of the area if possible during an outdoor chemical attack. Experts at RAND have declared that evacuation should never be considered as a response to this kind of attack. Instead you should go to the upper floor of the closest building and seal yourself into a room (see the RAND study).

Almost all of the material on the “new” site was copied verbatim from the previous version, which means that unnecessarily lengthy descriptions and obvious advice have not been edited out. For example, “Quickly assess the situation,” the first instruction for responding to a nuclear attack, is an innate response that does not need to be dictated to concerned citizens. DHS has made some beneficial first steps with its updates. However, if Ready.gov really aims to prepare the American public for natural disasters and terrorist attacks, more than updating a few pages and changing the color scheme needs to be done. According to DHS the site had 23 million unique visitors from February 2003 to March 2006. People who visit the site deserve accurate and useful information. The revised site is better, but not adequate.

The Center for Arms Control and Non-Proliferation has released their analysis of US Federal Spending on Biodefense from 2001-2007.

The numbers are staggering: Since 2001 the U.S. government has spent or allocated over $36 billion among 11 federal departments and agencies on biodefense. The Bush Administration has proposed $8 billion in biodefense spending for FY ’07, approximately $120 million (or 1.5%) over the ’06 appropriation. Of particular interest was that only 2% of all federal biodefense funding has been devoted to efforts to prevent the development, acquisition, and use of biological weapons by other nations and terrorists.

You can view their analysis here or download it as a PDF

Earlier this month, Representative Mike Rogers (R-MI) submitted the House version (H.R.5533) of the `Biodefense and Pandemic Vaccine and Drug Development Act of 2006′ (BARDA). The bill was introduced in the Senate by Senator Richard Burr (R-NC) (S.2564). The two bills are essentially the same with the exception of two controversial sections included in the Senate, but not the House version. Section 5: Orphan Drug Market Exclusivity for Countermeasures Products and Section 7: Collaboration and Coordination.

The Market Exclusivity section Amends the Federal Food, Drug, and Cosmetic Act to extend the period of market exclusivity from seven years to ten years for certain new drugs, antibiotics, or anti-infective drugs to treat a rare disease or condition caused by a biological agent, toxin, chemical, radiological, or nuclear agent that is deemed by the Secretary to be a material threat to the United States.

The Collaboration and Coordination section provides an antitrust exemption for: (1) meetings and consultations held by the Secretary among persons engaged in the development of countermeasures or pandemic or epidemic products; and (2) agreements resulting from such meetings.

See the extended entry for the full text of Sections 5 and 7.

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In a whopper 231-page report published today, the Weapons of Mass Destruction Commission presented 60 specific recommendations for how to move the nonproliferation and disarmament agenda forward.

The recommendations are familiar to anyone involved in these matters over the past 50 years: reduce the danger of nuclear arsenals; prevent proliferation of weapons of mass destruction; outlaw weapons of mass destruction; etc.

The Weapons of Mass Destruction Commission (WMDC) was established in 2003 by the Swedish Government acting on a proposal by then United Nations Under-Secretary-General Jayantha Dhanapala to present realistic proposals aimed at the greatest possible reduction of the dangers of weapons of mass destruction. The Commission is chaired by Hans Blix, the former Executive Chairman of the UN Monitoring, Verification and Inspection Commission (UNMOVIC), and includes among others William J. Perry, former U.S. Secretary of Defense, Jayantha Dhanapala, the former UN Under-Secretary-General for Disarmament Affairs, and Alexei G. Arbatov of the Russian Academy of Sciences.

The Commission’s report uses the World Nuclear Forces overview co-produced by Federation of American Scientists for the SIPRI Yearbook to describe the status of existing nuclear arsenals, but the report does not dwell on past nuclear arms reductions which are often used by the nuclear weapon states to say they have done enough. Instead, the Commission calls for new and additional actions to curb existing weapons of mass destruction arsenals and prevent new ones from emerging. Commission chairman Hans Blix writes in the foreword that “the climate for agreements on arms control and disarmament has actually deteriorated” in recent years and “nuclear-weapon states no longer seem to take their commitment to nuclear disarmament seriously.”

That is certainly true. Nuclear disarmament has all but disappeared from the arms control agenda, and the nuclear weapons states instead use proliferation to justify their own nuclear weapons which they are busy modernizing and tailoring against the new enemies. Proliferators, in turn, use the offensive military postures of the nuclear weapon states as an excuse to develop their own nuclear weapons.

The Commission’s recommendations are a wide-ranging list of constraints that, if implemented, will constrain all actors, existing nuclear weapon states as well as proliferators. But from the outset, the report is strongly at odds with the policies of several of the major nuclear weapon states, particularly the United States. The Commission is unlikely to have many friends in the current White House, which will almost certainly reject its call for a revitalization of the “thirteen practical steps” to disarmament adopted at the 2000 nuclear nonproliferation treaty review conference, steps that have specifically been rejected by the Bush administration.

Other recommendations include a no-first-use policy for nuclear weapons, an idea the U.S. will almost certainly reject, as will many of the other nuclear powers. A no-first-use policy has been explicitly rejected by the United States and NATO, and Russia has abandoned its no-first-use policy. The report also calls for nuclear weapon states to abandon the practice of deploying nuclear forces in a triad of sea-, land- and air-based delivery platforms, something most of the nuclear powers insist is necessary. The Commission also wants nuclear weapon states to end deployment of nuclear weapons outside their own territories, an indirect call for a withdrawal of the remaining U.S. nuclear bombs from Europe.

With an eye to the new roles that existing nuclear weapon states are creating for their nuclear arsenals against proliferators of weapons of mass destruction, the Commission recommends that nuclear weapons states “refrain from developing nuclear weapons with new military capabilities or for new missions,” and they “must not adopt systems or doctrines that blur the distinction between nuclear and conventional weapons or lower the nuclear threshold.”

Some of the Commission’s recommendations extend to indirect measures, such as a freeze on ballistic missile defense systems, a key priority for the United States and increasingly also other countries. The Commission also wants assurances that Iran will not be attacked or forced to change government in the conflict over the country’s clandestine nuclear weapons program.

Surprisingly, the report does not recommend that India and Pakistan join the non-proliferation treaty, although their absence is said to hurt the regime. Instead, both countries are urged to join a number of other initiatives such as the Comprehensive test Ban Treaty.

The report’s greatest weakness may be that it doesn’t sufficiently incorporate “the other side” of the debate and therefore runs the risk of being seen as a manifesto of arms control proposals from the past that “preach to the choir” rather than presenting new ideas on how to move the agenda forward.

On the other hand, the fact that the Bush administration’s policies – and those of several other nuclear powers i.e. Russia – are so at odds with a revitalized disarmament and nonproliferation agenda suggests how necessary the Commission’s recommendations are. The United States has considerable leverage on these issues, the report acknowledges, but all countries – not only the proliferators – must accept constraints on their own operations if the disarmament and nonproliferation agenda is to move forward. The alternative is indefinite insecurity for all.

Full WMD Commission report

An FBI account of “Bacteriological Warfare in the United States” was obtained by TheMemoryHole.org through the Freedom of Information Act. In all, 709 pages were released relating to bacterial warfare efforts in the US from 1941-1950, some of which are heavily redacted. 1,074 pages have been witheld for further review by other agencies. The account contains a description of a “previously unknown simulated BW attack on the Pentagon” [circa 1950], notes Michael Ravnitzky, who obtained the document for Memory Hole. All 709 pages can be downloaded from their website in 4 parts.

FAS has posted a new a Congressional Research Service report on Avian Influenza and two Biosecurity reports from the military. We also launched a revised chemical weapons resource website.

Congressional Research Service Report entitled “US and International Responses to Global Threat of Avian Flu” from May 1, 2006. It provides an up-to-date account of global H5N1-related human infections and deaths, outlines U.S. government global avian flu programs, and presents some foreign policy issues for Congress. (36 pages)

April 26, 2006 Air Force Policy Directive on Safeguarding Select Agents and Toxins. This directive lays out the Air Force policy on handling biological agents. (7 pages)

April 18, 2006 DoD Instruction on the Minimum Security Standards for Safeguarding Biological Select Agents and Toxins. (28 pages)

Finally, FAS has updated its Chemical Weapons Information Resource Page and will continue to add new content to it in the coming months.