FAS Strategic Security Blog

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.

Today the Federation of American Scientists launched ReallyReady.org, a comprehensive emergency preparedness website that addresses the inaccuracies and incomplete information on the Department of Homeland Security’s (DHS) preparedness site, Ready.gov. ReallyReady was developed in two months by FAS intern Emily Hesaltine for the price of a domain name. In comparison, it took millions of dollars and over five months to create Ready.gov.

A thorough analysis of Ready.gov is available on the site. It is a critique of the inaccurate information, generic advice, unnecessarily lengthy descriptions, and repetitive information found throughout Ready.gov, examples of which were mentioned in a previous blog entry, Ready or Not: Ready.gov Gets a Facelift.

ReallyReady.org also includes clear and accurate information for families, businesses, and individuals with disabilities. It is important to note that ready.gov does not contain sufficient information for people with disabilities despite being told that they might be in violation of Federal law. We developed our page using information from the National Organization on Disability’s Emergency Preparedness Initiative.

We hope the information will serve as a model for the essential changes that need to be made to Ready.gov. We recommend that DHS request the assistance of scientific, military, and emergency response experts to make these alterations. The Department of Homeland Security has declared September National Preparedness Month. Before then, FAS hopes to see Ready.gov updated so that it is more useful to the public that has paid for it, especially since a 20 year-old college student was able to single-handedly complete the same task in only two months.

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.
Continue reading »

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.

FAS has added two new sections to its biosecurity resource page. The first section contains information and text on all US laws, pending legislation, and international treaties relating to biosecurity and bioterrorism. We have also launched a page that contains reports on various biosecurity issues from a wide variety of sources including the National Academies, Government Accountability Office and Congressional Research Service. Each page has a customized search engine that allows you to search within the documents listed.

You can find both sections on our Biosecurity Resource Page
Please let us know if you notice anything missing or would like us to link to your efforts.

The Government Accountability Office released a progress report on the production of a safe effective vaccine against anthrax. We have posted copies of the May 9th report and the highlights on the FAS website.

The report, like their past reports on this issue, cites continued disorganization on the part of the government. Namely, they note that there has been little progress in the area of testing of the current vaccine for safety, effectiveness and reliability. The GAO had previously noted that there has been no long-term safety data, no studies on the optimum number of doses, and inadequate human clinical data. The GAO called upon the Director of Homeland Security to form a strategic plan for the development and safety testing of the vaccine including interagency cooperation.

In 2004, the Department of Health and Human Services awarded a contract for $877.5M for 75 million doses of anthrax vaccine to VaxGen, Inc, a company that had not previously developed and marketed any drugs or vaccines. The contract was noteworthy because it was the first award for bioterrorism countermeasure production under the Project Bioshield.

The GAO noted that the biotech community is watching the anthrax vaccine development and production carefully and warned that if it fails, companies will be less than eager to get involved with government contracts to produce future countermeasures.