Siga Technology: Health Agency Plans Summit on U.S. Biological Threat Preparations Friday, Feb. 5, 2010 WASHINGTON
-- The U.S. Health and Human Services Department next week plans to conduct a summit with other government entities as it works to reassess the nation's strategy for producing treatments for biological weapons materials and other public health threats (see GSN, Feb. 3). (Feb. 5) - The Obama administration has planned a conference next week to review the development and procurement of biological threat countermeasure as part of an initiative launched last year by U.S. Health and Human Services Secretary Kathleen Sebelius, shown in December (Chip Somodevilla/Getty Images).
The two-day conference will examine federal policies and activities from initial research all the way through government approval of the sale of vaccines and other agents and suggest what improvements, if any, should be made to the system. The workshop is the latest step in an ongoing review of the country's medical countermeasure development and procurement effort launched by HHS Secretary Kathleen Sebelius last year (see GSN, Dec. 2, 2009).
Countermeasures are usually defined as drugs and vaccines that ward against chemical, biological, radiological, and nuclear agents and emerging infectious diseases. "We want to have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling and more effective distribution practices," Sebelius said of the effort Monday during the department's fiscal 2011 budget rollout. "Our ultimate goal is to have the kind of biodefense system that is so dependable and robust that potential terrorist give up and say, 'It's not worth the effort,' and when Mother Nature strikes we are ready to respond."
The evaluation is being led by Nicole Lurie, assistant secretary for preparedness and response, and will be completed "by the end of the first quarter of 2010," Sebelius said. It was ordered in the wake of the government's response to the H1N1 influenza outbreaks last summer -- when development of a vaccine progressed slower than originally expected. The spread of H1N1 drew attention to the government's reliance on outdated technology, such as using chicken eggs to grow vaccines, "an unpredictable process we've used for the last 50 years," the HHS secretary said Monday.
The review was also spurred by the fact the government has failed to successfully develop a second-generation anthrax vaccine nearly nine years after the 2001 anthrax mailings despite spending tens of millions of dollars on the effort, according to Eric Toner, a senior associate with the University of Pittsburgh's Center for Biosecurity. "A new anthrax vaccine has been on top of everybody's list of the countermeasures we need the most," Toner said in an interview last week. "After all this time we still don't have that and they've had to cancel the contract. Now's the time to go back and relook at this, relook at the process." In 2006, the government canceled an $877.5 million program for production of an anthrax vaccine that was being run through Project Bioshield (see GSN, Dec. 20, 2006).
President Barack Obama acknowledged the HHS examination in his first State of the Union address last week. "We are launching a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease -- a plan that will counter threats at home, and strengthen public health abroad," the president told lawmakers. The day before Obama's speech the U.S. government received a failing grade from the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism for failing to move aggressively with a plan to "rapidly recognize, respond and recover" in the event of a biological attack. A White House official said last week the timing of the announcement was purely a coincidence. Toner countered that there was "no doubt it was directly in response" to the report card issued by the WMD panel. "The initiative he referred to was announced in December. That's ongoing, but I can't imagine that we would have put the sentence in the speech had not the report card been all over the news for the last two days," he said. Other experts in the biodefense field disagree with that assessment. The administration is "so upset they're not upset. They don't even take [the report card] seriously," said Barry Kellman, president of the International Security and Biopolicy Institute. "Frankly, a lot of people are reacting that way."
"The government has 60 programs, is spending billion of dollars and has hundreds of people working on this issue," he said in an interview last week. "To say this effort is an F is ridiculous." The Pipeline The existing countermeasure development pipeline, as established in 2004, begins with the National Institutes of Health or a research entity within the Defense Department conducting basic research on a drug or vaccine before transferring the materials to the Biomedical Advanced Research and Development Authority at Health and Human Services. The authority then provides financial and managerial support for companies to develop the treatments. The licensed end product would be purchased through Project Bioshield, which was intended to receive about $5.6 billion over 10 years to purchase medicines designed to protect U.S. citizens from the effects of a WMD attack. To date, the effort has purchased about $2 billion worth of countermeasures for the Strategic National Stockpile, which stores medical supplies in the event of a bioterrorism incident or other public health emergency. The administration and Congress shifted roughly $609 million in fiscal 2010 from Project Bioshield's Special Reserve Fund, including a $305 million transfusion to the advanced development authority (see GSN, Jan. 8). The fiscal 2011 spending plan unveiled Monday transfers $476 million from the Special Reserve Fund to the same office so that it might take research to the preproduction stage for drugs and therapies for medical emergencies. White House spokesman Nick Shapiro said there are four goals the initiative hopes to produce: a concerted approach to medical countermeasure development; a focus on multiuse products; an emphasis on innovation and disruptive technologies; and the establishment of new and more effective public-private partnerships. "Prior government efforts have been mostly unable to counter market forces driving private industry toward more profitable products outside of key public health needs," Shapiro told Global Security Newswire in an e-mail message last week. "Our new approach will turn this around. We will pursue a business model that leverages market forces and reduces risk to attract pharmaceutical and biotechnology industry collaboration with the U.S. government." A successful model, according to Shapiro, can be applied "more broadly to the urgent need for novel medical countermeasures in global health, provide a pathway toward more affordable and effective pharmaceuticals here at home, and ensure that the United States remains at the forefront of global biotechnology." The Obama administration's approach "says all the right things" but it is "unclear how they're going to overcome the impediments that have plagued the program in the past," according to Jonathan Tucker a senior fellow with the James Martin Center for Nonproliferation Studies.
"The Bush administration made a major effort on medical countermeasure development but it didn't get very far." Still, he called the current examination the "first step toward a solution." Toner said the review is "absolutely needed" because "the system hasn't been effective.
Before the 2006 passage of the Pandemic and All-Hazards Preparedness Act, companies interested in medical countermeasures had to bear most of the costs of advanced development, including expensive clinical trials, despite the risk that the product might fail to achieve licensure. The lack of federal funding for advanced development created a financial desert known as the "valley of death" between government-supported basic research and funding under Project Bioshield, according to Tucker.
Successful countermeasure development also has proven difficult because there are few economic incentives for the major pharmaceutical companies to develop biodefense medicines and vaccines for the government, he said. "These are public companies that want to maximize profits," Tucker said. "They're happier selling Viagra than smallpox vaccine." The market for biodefense countermeasures is very small -- essentially limited to government agencies -- and there are major legal liability risks involved if the products have unexpected side-effects.
"You can't infect someone with smallpox to test if an antiviral drug is effective," Tucker told GSN. "So the licensing process has to rely on efficacy studies in animal models. Yet the Food and Drug Administration hat yet to map out a clear path to licensure based on animal studies alone." The Summit There are a half-dozen objectives for the Feb. 11-12 session at the National Academy of Sciences building, according to an Institute of Medicine announcement. They include identifying strategies to "optimize" the federal medical countermeasures enterprise; examining ways to enhance the conversion of early investments in basic science toward potential finished products; and evaluating possible changes to the regulatory oversight process for medical countermeasures. At this time, Health and Human Services does not anticipate the cost of the evaluation will exceed $1 million, with funding being allocated from the advanced development authority, according to an department spokeswoman. Those funds will cover the costs associated with "the development of white papers in three topic areas, several workshops, and associated costs for consolidating and analyzing information from all of the sources to generate a final report for the HHS Secretary," Gretchen Michael, communications director for the assistant secretary for preparedness and response, said in an e-mail message today. In addition to next week's conference, a working group of the National Biodefense Science Board will hold a workshop at the end of February, Michael told GSN. That meeting will examine the emergency medical countermeasure enterprise and strategy through "consideration of a series of case studies," she said. The board will send a report to Secretary Sebelius by March 31 and the assistant secretary will make policy recommendations a few weeks after that, according to Michael. Representatives from the Homeland Security and Defense departments are likely to attend next week's conference, along with officials from various departments within Health and Human Services, such as the Centers for Disease Control and Prevention and the advanced development authority, according to Toner. Michael confirmed that "multiple" agencies with Health and Human will attend the summit, as will members of the Pentagon. Representatives from academia, and the pharmaceutical and biotechnology communities will also attend the workshop, she added. Toner said he could not predict what conclusions workshop participants would reach, adding that Health and Human Services "is trying to be fairly open-minded and look at a whole new approach to developing and acquiring countermeasures. Who know what will come out of it." "I hope the outcome of the review is an increased understanding that the review, while necessary and appropriate, falls short of what is needed to improve global biopreparedness for intentional attacks and will spur, therefore, more far-reaching policy initiatives," Kellman said in an e-mail message this week. He did not elaborate. There will be some "major reform" of the countermeasure development and procurement process but "it's not yet clear how they're going to go about it," according to Tucker.
Fazit: Siga selbst wird bei dem Gipfel bzw. Meetings zugegen sein, da mit mit ST-246 den Smallpox Markt bedient und mit ST-193 einen Wirkstoff für Anthrax. Werden die Ziele so wie ausgegeben, in der nahen Zukunft umgesetzt, wird Siga möglicherweise bereits nächste Woche im Mittelpunkt des Interesses stehen, sei es durch die Vergabe des Auftrages von Barda aus 2009, sei es das weitere Förderprogramme für die Entwicklung der beiden Wirkstoffe aufgelegt werden. Es könnte der Beginn eines neuen Zwischenspurtes für die Siga- Aktie sein. Es bleibt spannend!