Smallpox:  Two Hospitals Balk at Bush Immunization Plan

Two U.S. teaching hospitals have announced they are opting out of the voluntary U.S. plan to immunize up to 10 million emergency health care workers across the United States against smallpox, the Washington Post reported today (see GSN, Dec. 17).

Emergency workers and intensive care personnel at Virginia Commonwealth University in Richmond and Grady Memorial Hospital in Atlanta will not be required to take the vaccine, officials at those hospitals said.

Officials at three other medical facilities, Children's Hospital of Philadelphia, Emory Medical Center in Atlanta and the University of Iowa Hospitals and Clinics are considering not immunizing their personnel, the Post reported.

Grady Memorial is closely linked with the U.S. Centers for Disease Control — which is responsible for running the immunization program — but officials there cited the vaccine’s dangerous side effects, particularly among those with suppressed immune systems.  The vaccine could spread from immunized hospital workers to patients who may be more at risk of adverse reactions, one official said.

“I don’t like to cause disease,” said Carlos del Rio, chief of medicine at Grady Memorial.  “If, say, a patient with AIDS became infected, that would be a disaster,” he added.

Virginia Commonwealth University officials questioned whether the vaccine is necessary at all, noting the incremental approach to immunizations in the U.S. plan.

“There is a lack of logic to the current proposal,” said Richard Wenzel, chairman of the internal medicine department at Virginia Commonwealth.  “If our government in all its intelligence thinks smallpox exists in enemy hands, why would we creep up on that policy?  We would rush to vaccinate everybody right now,” he added.

The CDC expects some hospitals to choose against the inoculation program, but most will probably cooperate, said CDC head Julie Gerberding.

“This is a voluntary program,” she said.  “We understand not all hospitals will choose to participate,” she added (Ceci Connolly, Washington Post, Dec. 18).

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U.S. Response I:  Biological Defenses Stall at Pentagon

By David McGlinchey
Global Security Newswire

WASHINGTON — U.S. regulators have failed to license any new drugs for biological defense in the past 12 years, despite an enormous contribution of finances and resources from the U.S. Defense Department, the Pentagon’s top microbiologist said last week.

“That is not a happy story for me to have to tell to senior leadership,” said Anna Johnson-Winegar, deputy assistant to the U.S. defense secretary for chemical and biological defense, at a Dec. 16 meeting on the issue.

New drug licensing rules, some bureaucratic restructuring and a new study underway all offer hope that problems will be solved, she said.

Funding for Pentagon research on medical defenses such as vaccines increased more than 400 percent from 1996 to 2002, to more than $160 million, Johnson-Winegar said.

The “complex and challenging” science needed to develop the medicines, however, hinders the quick results that Congress and defense officials want to see and congressional staffers have asked why the United States is funding the same efforts year after year, she added.

A shortage of scientific researchers that have the expertise to develop vaccines and biological warfare treatments have also hampered efforts, according to Johnson-Winegar.

Rules and Restructuring

The future holds promise, however, especially in the form of new rules from the Food and Drug Administration, Johnson-Winegar said.

In May, FDA officials announced a rule change that, in select cases, allows researchers to determine the effectiveness of a drug using only animal testing (see GSN, May 31).  Previously, the agency required developers to test new drugs in human trials before licensing them, but it was often considered unethical to expose a person to a disease simply to test a vaccine.

The new regulations “should help,” according to Johnson-Winegar.

“We will rely heavily upon animal models” when developing vaccines, said William Raub, deputy assistant Health and Human Services secretary for planning and evaluation, during testimony to Congress in June.  The rule change “creates a better defined path for the kind of evidence a sponsor would need with animal models in those instances where it’s unethical to expose humans to the actual disease,” he added.

A proposal to realign the structure of the Pentagon’s chemical and biological management and acquisitions efforts presents another opportunity to make biological defense research more efficient, according to Johnson-Winegar.  Pentagon officials plan to license a smallpox vaccine by 2006 and FDA licensing on military vaccines for botulinum toxin and tularemia is scheduled for 2012, she said.

Study to Hasten Licensing

Johnson-Winegar spoke Monday to a new committee that was established to hasten licensing processes for biological warfare medicines.

The 2002 National Defense Authorization Act directs the Pentagon to aggressively accelerate biological research programs and to invest in new technologies against the most dangerous biological warfare agents, including anthrax.  The Pentagon should take advantage of advancements and technology in the private sector, the legislation says.

The legislation also calls on the Pentagon to establish a study through the U.S. Institute of Medicine and the National Research Council to investigate “review and approval processes for new medical countermeasures for biological warfare agents.”

The 17 members of the Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents — including doctors, researchers, lawyers and consultants — gathered in Washington for the first time this week to begin that study.

An interim committee report is planned for spring 2003, and a complete report, due in December 2003, is intended to suggest faster methods for biological research in the Defense Department, according to the legislation.  The committee has also been asked to identify factors that are slowing the development of biological warfare drugs, the Institute of Medicine said in a statement describing the study’s scope.

The study shows that the United States is turning its attention to the licensing process for biological defense drugs, and that effort now has the attention of “senior leadership in DOD [and the] interest and support of Congress,” Johnson-Winegar said.

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Anthrax:  Decontamination Costs Exceed Previous Estimates

It will cost hundreds of millions of dollars and at least one more year to fully decontaminate all of the buildings that were tainted with anthrax during the 2001 attacks, the Baltimore Sun reported today.  The lasting effects of the attacks far exceed previous expectations, according to the Sun.

“The economic costs are huge,” said Dorothy Canter, chief scientist for biological terrorism issues at the U.S. Environmental Protection Agency.  “It’s in the hundreds of millions of dollars for the cleanup alone,” she added.

No precise estimate of total decontamination costs is available yet because work is still ongoing, officials said.  The U.S. Postal Service has estimated that it will cost more than $100 million to decontaminate the Brentwood Road postal facility in Washington and a contaminated mail-sorting center in Hamilton, N.J. (see GSN, July 2).  It will cost more than $40 million to fully decontaminate Capitol Hill office buildings, according to the U.S. Environmental Protection Agency (see GSN, March 7; Scott Shane, Baltimore Sun, Dec. 18).

The project to decontaminate the Brentwood facility — which includes a construction site, a testing ground and a chemical plant — is uniquely complex and the largest of the decontamination projects, Postal Service officials said (see GSN, Dec. 16).

“Ever worked on one of those Rubik’s Cubes?” John Bridges, the Postal Service’s on-site commander in chief, said earlier this week, describing the cleanup project.

Technicians this week began recovering thousands of spore strips and air and surface samples from the facility, which will be tested to determine the success of the decontamination project, according to the Washington Post.  The results of those tests are expected to be made available to an independent committee for review next month.  If the project is successful, the facility’s 1,600 employees might return by spring, the Post reported.

“We don’t want to claim victory too early,” Bridges said.  “We’re very excited it went off without a hitch,” he added (Manny Fernandez, Washington Post, Dec. 18).

Months of experiments to find the best ways to kill anthrax spores have increased decontamination costs, officials said.

“We’ve never had to do anything like this in history,” said Barbara Johnson, president of the American Biological Safety Association.  “The government is erring very, very much on the side of safety.  It’s a very conservative approach, but I don’t think there’s any other choice,” she added.

A conservative approach has been taken to ensure that workers will be safe when they re-enter decontaminated buildings, officials said.  Postal workers, in particular, have been vocal about concerns that they were needlessly exposed to risks during the attacks, according to the Baltimore Sun (see GSN, Dec. 9).

“Some people are ready to go back,” said Dena Briscoe, a postal employee and president of Brentwood Exposed, an advocacy group representing workers of the closed facility.  “But a lot of people still have fears.  Some people just wish the building could be abandoned,” she added.

The Postal Service has begun testing biological agent detectors, which can identify about 12 biological agents such as anthrax, at Baltimore’s main postal facility, the Sun reported.  Evaluators plan to install detectors in an additional 14 facilities for further analysis, Postal Service spokesman Bob Novak said (Shane, Baltimore Sun).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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U.S. Response II:  Pentagon Monitors Disease Outbreaks

A U.S. Defense Department initiative implemented after the Sept. 11 terrorist attacks is currently monitoring medical information from more than 300 military medical facilities around the world, the Pentagon said in press release yesterday (see GSN, Sept. 5).

The Electronic Surveillance System for Early Notification of Community-based Epidemics, known as ESSENCE, monitors 313 U.S. military medical centers to detect disease outbreaks before they spread, said Army physician Col. Patrick Kelly.

The program compares incoming medical reports to old statistics, Kelly said.  The effort began as a pilot project in the Washington area, but was expanded in the aftermath of Sept. 11, he added.

ESSENCE II, a partnership between the Pentagon and Johns Hopkins Applied Physics Laboratory in Maryland, monitors medical information from civilian hospitals in the United States as well as school absenteeism and veterinary hospitals.

“We will really be doing our job if we have systems that are sensitive enough to pick up problems early,” Kelly said (Gerry Gilmore, Defense Department release, Dec. 17).

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U.S.-Russia:  Lugar to Press Russians for Biological Weapons Information

By Bryan Bender
Global Security Newswire

WASHINGTON — The United States must step up pressure on Russia to provide information on a vaccine-resistant form of anthrax that Russian scientists agreed to provide to U.S. authorities more than five years ago, according to U.S. Senator Richard Lugar (R-Ind.), incoming chairman of the Foreign Relations Committee.  Russia has failed to hand over the strain or fully explain the reasons for the continued delay, he said.

The problem of the genetically engineered pathogen — believed to be resistant to the anthrax vaccine now being given to U.S. military personnel — is characteristic of the former Soviet biological weapons program.  That effort remains shrouded in secrecy despite expanding U.S.-Russian cooperation to dismantle other elements of the former Soviet arsenal and to shift its weapons scientists to peaceful pursuits, Lugar said in an interview with Global Security Newswire Friday.

He said he will “try to make some headway” on disposition of the anthrax strain, as well as greater transparency on other biological weapons issues, in a Thursday meeting in Washington with Russian Foreign Minister Igor Ivanov.

Lugar most recently sought the anthrax information during a trip to Russia last summer, during which he visited a variety of projects that are being funded by the Cooperative Threat Reduction program he helped initiate in the early 1990s to secure former Soviet nuclear, chemical and biological weapons and expertise (see GSN, Sept. 9).

The U.S. Defense Department entered into a contract in 1997 with the Russian State Research Center for Applied Microbiology, which developed the genetically engineered anthrax strain, to obtain a sample that U.S. scientists could study.  U.S. bioterrorism experts fear that the ultimate biological weapon would be one that is resistant to available vaccines or other drugs and are scrambling to find out as much as they can about so-called “designer” pathogens that might exist.

“We were promised the material, but in August were denied this antidote information,” Lugar said.  “We still don’t have the material.”  Russian officials at the time blamed export restrictions for holding up the deal.

Furthermore, the Russian biological weapons complex has been less than forthcoming in other areas, according to Lugar.  For example, four facilities associated with the program remain off-limits to Western officials.  One of them, Kirov 200, was on Lugar’s itinerary during his recent trip to Russia, but after hours of waiting with little or no explanation, he was barred from touring the secret facility (see GSN, Aug. 19).

Lugar said future cooperation on the anthrax strain, and a more open approach to addressing biological threats in general, is absolutely necessary if Russia wants to maintain its biological industry and control its expertise.  Both goals are dependent on U.S. nonproliferation funds to pay scientists’ salaries, keep the laboratories active in commercial and other nonmilitary projects, and otherwise help them to remain afloat.

The message to Moscow, Lugar said, is that “if we don’t help you,” these facilities will be “broken, bankrupt and dangerous propositions.”  The threat of terrorists acquiring pathogens from unsecure facilities will pose as much if not more of a national security threat to Russia than the United States, Lugar said.

[EDITOR’S NOTE: Richard Lugar is a board member of the Nuclear Threat Initiative, the sole sponsor of Global Security Newswire, which is published independently by National Journal Group.]

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Smallpox:  At-Risk Troops Might Enter Contaminated Zones

The U.S. Defense Department does not plan to inoculate personnel who are at high risk of side effects from smallpox vaccine, but it will nevertheless deploy those personnel to areas that might experience smallpox attacks, the New York Times reported today (see GSN, Dec. 16).

While the Pentagon will not preventively vaccinate those with skin rashes or other conditions that place them at higher risk of side effects from the vaccine, if a smallpox attack were actually to occur, all unvaccinated U.S. military personnel in that area would be immunized on the spot, said Defense Department spokesman James Turner.

“I think the number of people with these skin conditions is a minority,” he said.

In the meantime, the Pentagon is seeking to separate immunized and high-risk personnel from those who have recently received the vaccine, according to a Nov. 29 Defense Department memo.  If not monitored carefully, a recently inoculated person can infect others who have not been vaccinated.

“Exempt individuals should be physically separated and exempt from duties that pose the likelihood of contact with potentially infectious materials (e.g. clothing, towels, linen) from recently vaccinated people,” the memo says.

Regarding how to separate troops in close quarters on ships and military bases, Pentagon officials have said that each of the military services will craft policies “depending upon their unique situations,” Turner said.

“We give a lot of vaccines to our troops,” he said.  “A lot of these vaccines I’m sure cause similar side effects, and we deal with it,” he added (Denise Grady, New York Times, Dec. 17).

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U.S. Response:  White House Tries to Stop Disposal of Biological Agents

In an effort to preserve information valuable in fighting biological terrorism, the White House has asked U.S. universities to be cautious in destroying laboratory samples, the New York Times reported today (see GSN, Dec. 12).

Anxious to comply with new U.S. laws that require registering dangerous biological materials, university officials have encouraged scientists and researchers to destroy any samples that are not involved in current studies, U.S. officials said.

Problems are arising, however, from mixed messages from U.S. regulators and attempts by university officials to comply with the new laws, according to Ronald Atlas, president of the American Society of Microbiologists.  Scientists are emptying freezers at schools across the country, and officials are concerned about the effect that agent destruction may have, the Times reported.

“I would hope that we could recover any deleterious effect in the long run,” said Barbara Johnson, president of the American Society of Biological Safety.  “But if you had a unique sample that no one had replicates of, that sample’s gone,” she added.

Working with the American Society of Microbiologists, the Bush administration is now attempting to slow housecleaning activities in which agents that are “difficult or impossible to replace” might be destroyed, said Rachel Levinson, of the White House Office on Science and Technology Policy.  She suggested that if universities do not want to hold on to dangerous pathogens in the wake of the new laws, they should transfer them to facilities that are willing to house them.

“Obviously these materials are valuable as research tools, and in terms of developing countermeasures should these agents be used as weapons, or if there’s an unintentional natural outbreak,” Levinson said.  “They’re valuable research tools, and we would not like to see them destroyed,” she added (Diana Jean Schemo, New York Times, Dec. 17).

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Anthrax:  U.S. State Department Begins Cleaning Mail Facility

The U.S. State Department yesterday outlined plans to decontaminate a departmental mail facility in Sterling, Va., where an employee contracted inhalational anthrax during last year’s attacks (see GSN, Oct. 26, 2001).

In the first stage of the decontamination process, the State Department plans to remove most of the contents of the facility to reduce the amount of surface area that will need to be decontaminated, the department said in a press release.  Selected heavily contaminated areas of the facility will then be cleaned with a chlorine solution, according to the department.  As a final step, the entire facility is to be fumigated in the summer, the department said (U.S. State Department press release, Dec. 16).

Some local officials criticized State for delaying cleanup for so long after the attacks.  Officials believe the facility became contaminated when an anthrax-tainted letter sent to Senator Patrick Leahy (D-Vt.) was misdirected there, the Washington Post reported (see GSN, Nov. 21, 2001).

“Why has it taken so long to actually do something?” Loudoun County Supervisor James Burton asked yesterday during a meeting with U.S. officials.  “We’re looking at 2004.  Why don’t you do it rather than talk about it?” he asked.

The cleanup of the Sterling facility has been delayed, in part, by efforts to decontaminate State’s diplomatic pouches and other mail facilities, U.S. officials said.  Technicians used Sterling as a staging area to decontaminate more than 46,000 diplomatic pouches from U.S. missions around the world, officials said.  The department also oversaw cleanup of more than 155 mailrooms in and outside the United States, the Post reported.

During yesterday’s meeting with local officials, State officials sought to allay any concerns about the decontamination process.

“We are not coming alone,” said Cedric Dumont, the State Department's medical director.  “We’re coming with the expertise of the United States,” he added (Michael Laris, Washington Post, Dec. 17).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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Smallpox I:  Public Vaccinations Raise Concerns

Experts have raised a variety of medical questions and protests in the wake of U.S. President George W. Bush’s announcement Friday that smallpox vaccine will be offered to emergency responders and, on a voluntary basis, eventually to every U.S. resident, the Washington Post reported today (see GSN, Dec. 13).

“The risk of the vaccine is higher than the risk of us having a case of smallpox,” said Carlos del Rio, chief of medicine at Grady Hospital in Atlanta.  Widespread, pre-emptive smallpox inoculations are comparable to nationwide appendix removal due to fears of appendicitis, del Rio said.

Randall Larsen, director of the ANSER Institute for Homeland Security, applauded Bush’s decision to immunize up to 10 million emergency responders but criticized the public immunization policy.

“I do not think it should be available to the general public any more than a person can walk into a pharmacy and say, ‘Give me some penicillin and tetracycline,’” Larsen said.  “My concern is if a bunch of people go out and start taking it and you have this cute little fifth-grader that dies, it will be on the tube 24-7.  Then people will stop taking it, including first responders and military personnel,” he added.

Other health officials said the smallpox vaccine plan represents a skewed perception of health risks in the United States.

“I’d like the president to have an influenza vaccine campaign that’s comparable,” said William Shaffner, chairman of preventive medicine at Vanderbilt University Medical Center.  “There’s a disease that kills 10,000 to 20,000 citizens of the United States each year,” he added.

Some White House health officials said it is not clear to them how Bush established the public immunization policy (see GSN, Dec. 12).  Top U.S. biological terrorism adviser D.A. Henderson said he was not aware of the policy until a Friday press conference.

“The president was trying to be responsive to (requests from the public) but at the same time making it clear that based on the current level of threat, there is no reason to recommend the general public to be vaccinated,” said Jerome Hauer, director of the U.S. Office of Public Health Preparedness (Ceci Connolly, Washington Post, Dec. 15).

While polls have indicated that a majority of U.S. residents want to receive the smallpox vaccine, federal officials are going out of their way to emphasize that the government is not recommending immunization.

“I want to restate and underscore that it is not the recommendation of the president or of the Department of Health and Human Services” that the general public receive the vaccine, Health Secretary Tommy Thompson said (M.A.J. McKenna, Atlanta Journal-Constitution, Dec. 15).

Publicizing Dangers

Some officials said the public is insufficiently informed about the potential dangers of the vaccine.  The U.S. Health Department has debuted a Web site — www.smallpox.gov — to offer more information and answer questions.

For every 1 million people immunized, one or two people are expected to die, 14 to 52 people are expected to experience potentially fatal side effects and up to 1,000 people would probably suffer serious — but not life threatening — reactions, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

In recent clinical trials of Dryvax — the brand of smallpox vaccine that is to be used in the first wave of emergency responder vaccinations (see GSN, May 16) — “as many as 50 percent of individuals experienced some degree of muscle aches and fatigue, and approximately 10 percent experienced fever,” Fauci said.  “Indeed, about one-third of the vaccine’s [recipients] had symptoms that were significant enough to have them change or alter their normal daily activities for a day or longer,” he added (see GSN, Dec. 10).

If a smallpox outbreak was detected today, a similar but still-unlicensed vaccine made by pharmaceutical company Aventis Pasteur would be used to immunize the general public, Fauci said (see GSN, Oct. 10; State Department release, Dec. 14).

Who Is Getting It

In the next year, people could be vaccinated by participating in a clinical trial.  U.S. officials might also allow people who “feel strongly that they want to have access to the vaccine” to be immunized, according to Julie Gerberding, director of the Centers for Disease Control and Prevention.  In addition, the State Department plans to offer vaccine to personnel stationed in the Middle East, according to the department’s medical director Cedric Dumont.  As part of an effort to vaccinate 500,000 military personnel, defense officials have begun immunizing some in Maryland, said William Winkenwerder, assistant defense secretary for health affairs.

Vaccine recipients — including up to 500,000 domestic health and emergency workers to be immunized at state-run clinics beginning in January — will receive careful attention and specific instructions on how to take care of the inoculation sites on their arms, Gerberding said.

“Already we have trained several thousand clinicians and public health officials in several hours of training in how to organize and conduct the clinics, how to monitor the side effects, how to safely store the vaccine and securely store the vaccine, and all of the other logistic elements necessary to make this program go safely,” she said.

Health officials plan to build two types of smallpox response teams, Gerberding said.  One type, known as public health response teams, will consist of “public health officials, doctors with special knowledge about skin conditions and smallpox, [and] the disease detectives who will help understand the cause and the source of an exposure,” she added.

The other type, health care delivery system response teams, will be responsible for treating smallpox cases once they reach medical facilities and will include both medical personnel and other staff who work in intensive care units, Gerberding said.

Response Strategies

U.S. health officials do not necessarily plan to react to a smallpox outbreak with a “ring vaccination” strategy, according to Tom Ridge, Bush’s nominee to head the new Homeland Security Department.

Current preparations should allow a range of opportunities, and “the response of the country would depend on the circumstances surrounding the detection of smallpox, whether it’s a singular case, an isolated case, or multiple cases,” Ridge said.  Medical workers’ first reaction to a smallpox case, however, is to locate infected people and immunize the people with whom they are in contact.  A decision on further ring vaccinations or a general immunization effort would only come after that, Gerberding said.

Meanwhile, the United States is increasing stocks of vaccinia immune globulin, which could be used to treat the side effects of the vaccine, particularly in a mass vaccination campaign, according to officials (see GSN, Nov. 12).  U.S. officials now have about 2,000 doses of the globulin, known as VIG, and they expect to have 30,000 by summer, Fauci said.  About 100 doses of VIG are needed for every 1 million immunizations, and the United States currently has enough to deal with 27 million inoculations (State Department release, Dec. 14).

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Anthrax:  Forest Search Continues; Chlorine Cleans Brentwood

FBI agents continued searching a forest near Frederick, Md., yesterday, apparently investigating last year’s anthrax attacks (see GSN, Dec. 13).  Divers explored two ponds near two others that have already been searched, according to the Frederick News-Post.  FBI spokesman Chris Murray refused to comment yesterday on what evidence, if any, has been found during the search (Sean Barry, Frederick News-Post, Dec. 16).

The bureau has not established a timeframe for completing its search of the area, Special Agent Barry Maddox said.  “As the investigation moves along, the agents will take it wherever it leads.  No exact date has been set,” he said.

The FBI is “not close” to filing any charges in the “Amerithrax” investigation into the anthrax attacks, Maddox said (Kate Leckie, Frederick Post-News, Dec. 16).

Brentwood Cleanup

The U.S. Postal Service announced yesterday that it successfully filled the anthrax-tainted Brentwood Road postal facility in Washington with chlorine dioxide gas to decontaminate the facility (see GSN, Dec. 12).

“We are extremely pleased with the results of this process.  It represents a tremendous effort between all parties involved,” Thomas Day, Postal Service vice president of engineering, said in a press statement.

Technicians began removing the gas from the facility yesterday, using a scrubber system to neutralize the chlorine in a saltwater solution.  That process is expected to be completed today.  Officials then plan to dehumidify the facility, the Postal Service said in a press release (U.S. Postal Service release, Dec. 15).

Technicians plan to remove thousands of test strips from the facility over the next several weeks to evaluate whether it has been fully decontaminated, a Postal Service spokesman said.  The U.S. Centers for Disease Control and Prevention plans to test the samples, according to the Washington Post.  An independent committee of scientists has been chosen to review those results.  If the committee determines that the decontamination has been a success, the facility might be reopened in April, the Post reported.

To date, it has cost more than $100 million to decontaminate Brentwood and another anthrax-contaminated postal facility in New Jersey, according to the Post (Debbi Wilgoren, Washington Post, Dec. 16).

Some postal employees have expressed doubts regarding the effectiveness of the Brentwood decontamination process.

“I’m confident they will kill a large amount of the spores, but it’s the negligible-risk amount of spores that may be left that I’m uncomfortable with,” said Dena Briscoe, a postal worker and president of Brentwood Exposed, an employee support group (H.J. Brier, Washington Times, Dec. 15).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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Smallpox II:  Australia and New Zealand Stockpile Vaccine

Australia has received 50,000 doses of smallpox vaccine in the past few days and officials plan to receive up to 100,000 more early next year, the New Zealand Herald reported today (see GSN, Oct. 2).  Officials do not plan to administer immunizations in the absence of any outbreak, according to the Herald.

Similarly, New Zealand health officials announced recently that they plan to place an order for 10,000 doses of smallpox vaccine that would be stockpiled.  New Zealand will most likely buy the vaccine from France, although officials are still debating which brand of vaccine to buy and how much to secure, Deputy Director General of Public Health Don Matheson said.  The vaccine, which is expected by March, would be used to treat health care workers and anyone exposed to smallpox (Angela Gregory, New Zealand Herald, Dec. 16).

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Smallpox I:  Bush Formally Introduces U.S. Vaccination Plan

By Greg Webb
Global Security Newswire

WASHINGTON — Formally announcing the U.S. smallpox vaccination policy today, U.S. President George W. Bush said he was ordering certain members of the U.S. military to receive the vaccine and, in a move to demonstrate solidarity, said he too would receive the vaccination (see GSN, Dec. 12).

In addition, the U.S. Health and Human Services Department will encourage state and local governments to form volunteer civilian teams to respond to any smallpox attack, Bush said, and team members would be asked to voluntarily receive the vaccination.

In the military, vaccinations will be administered to smallpox response teams, hospital and clinic workers, and “other designated forces having critical mission capabilities,” according to a Pentagon release issued today

The U.S. military has relatively recent experience with vaccine, which the general U.S. population stopped receiving in 1972.  Although the World Health Organization declared smallpox eradicated from the world in 1980, U.S. military recruits continued to receive the vaccine until 1990, according to the Pentagon release.

Explaining his decision, Bush said the Sept. 11 terrorist attacks were forcing the United States to evaluate “old threats in a new light.  Our government has no information that a smallpox attack is imminent.  Yet it is prudent to prepare for the possibility that terrorists who kill indiscriminately would use diseases as a weapon.”

Furthermore, “we believe that regimes hostile to the United States may possess this dangerous virus,” Bush said.

Bush said he would also be vaccinated.  “As commander in chief, I do not believe I can ask others to accept this risk unless I am willing to do the same.  Therefore, I will receive the vaccine along with our military,” Bush said.

His family, however, will not.  “Neither my family nor my staff will be receiving the vaccine, because our health and national security experts do not believe vaccination is necessary for the general public,” Bush said.

Though not recommended, the vaccine will be made available to the U.S. public.  “HHS is in the process of establishing an orderly process to make unlicensed vaccine available to those adult members of the general public without medical contraindications who insist on being vaccinated either in 2003, with an unlicensed vaccine, or in 2004, with a licensed vaccine,” according to a White House fact sheet.

Under the White House plan, about 1 million people will probably receive the vaccination, including 500,000 civilian emergency responders and health care workers and 500,000 military personnel.

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Anthrax:  FBI Searches Forest for Clues to 2001 Attacks

FBI investigators began searching a section of forest near Frederick, Md., yesterday in an apparent attempt to obtain more clues in the investigation into the last year’s anthrax attacks (see GSN, Nov. 11).

FBI agents told local police officials that they would be conducting a search of the City of Frederick Municipal Forest, 10 miles south of Camp David, over the weekend, according to the Baltimore Sun.  So far, investigators have excavated part of a clearing in the area and have searched several small ponds, the Sun reported.

An FBI press statement suggested that investigators have begun sampling for anthrax in the area.

“It is important to note that based on water, soil and sediment testing already conducted, there is no indication of any risk to the public health or safety,” the statement said.

FBI agents are apparently searching the area because of a tip that former U.S. Army biologist Steven Hatfill, who has been the public focus of the bureau’s investigation into last fall’s attacks, was seen there, said Patrick Clawson, Hatfill’s spokesman.  Clawson said Hatfill told him yesterday that he had been in the area only as a volunteer with a Boy Scout troop.

This latest search will find nothing to connect Hatfill to the anthrax attacks, Clawson said.

“The FBI can search the planet until hell freezes over, but it will find that Steve Hatfill was never involved in the anthrax attacks,” Clawson said.  “We’d just like to know how many searches it takes to get his reputation and employment restored,” he added (Scott Shane, Baltimore Sun, Dec. 13).

Hatfill’s attorney Victor Glasberg yesterday refused to comment on the search.  “I know nothing about it, zero about it,” he said (Kate Leckie, Frederick News-Post, Dec. 13).

Meanwhile, the U.S. Justice Department has said that it did not intend for Hatfill to come under such intense media scrutiny by describing him has a “person of interest” in the anthrax investigation, according to department letters sent to Senator Charles Grassley (R-Iowa), which were released yesterday.

The department sent the letters in reply to inquiries that Grassley made after Hatfill was fired from his position at Louisiana State University and after the FBI searched Hatfill’s apartment three times (see GSN, Sept. 19).  Grassley had asked Attorney General John Ashcroft to explain the dismissal from the university and to define the term “person of interest.”

The department did not intend to cause any harm to Hatfill when it described him as a person of interest, Assistant Attorney General Daniel Bryant said in one of the letters.  Instead, the department meant “to deflect media scrutiny” and “explain that he (Hatfill) was just one of many scientists” who had cooperated with the FBI investigation, Bryant said.

In another letter, Bryant said that, as the main source of funding for the university’s National Center for Biomedical Research where Hatfill was employed, the department was entitled to “substantial involvement” in “the selection of key personnel” (see GSN, Sept. 5).  Bryant provided no further details on the reasons for Hatfill’s dismissal, according to the Washington Post.

Grassley said yesterday that he appreciates the department’s replies to his inquiries.

“I also appreciate the department’s candidness that the action regarding Mr. Hatfill and his employment is unprecedented,” Grassley said in a statement, and that “there is no ... formal definition for the term ‘person of interest’” (Gugliotta/Lengel, Washington Post, Dec. 13).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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Smallpox II:  Terrorist Attacks Involving Disease Unlikely to Succeed, Experts Say

Experts have said that a smallpox attack on the United States, either conducted through a suicidal self-infected terrorist or the use of a smallpox bomb, is not likely because such attacks would be too prone to failure, the Los Angeles Times reported today (see GSN, Dec. 12).

One fear is that terrorists would attempt to launch a smallpox outbreak by infecting themselves with the disease and moving through a crowded public place such as an airport, according to the Times.  Smallpox, however, is contagious for no more than a day before the onset of the disease’s telltale rash, which would identify an infected person, said Clarence Peters, director of the Center of Biodefense at the University of Texas medical center in Galveston.

Before a terrorist could infect others with smallpox, the disease’s painful flu-like symptoms would have begun, making it difficult to move easily, Peters said.  After an incubation period of up to 17 days, a smallpox-infected person experiences symptoms such as body aches, fever, severe abdominal pain and delirium, according to the Times.  The person would not be contagious, however, until the onset of a rapidly spreading rash, according to experts.

“The guy is going to feel terrible; he is going to be walking around, not shedding virus until maybe the day before, or the day of the rash,” Peters said.  “He may be obviously ill, a fever, a flushed face and bumps on his face,” he added.

There have been a few cases of single-source outbreaks such as one that started in Yugoslavia in 1972 after a single infected individual caused 150 smallpox cases before the outbreak was stopped.  Such outbreaks are rare, however, because smallpox is harder to spread than other infectious diseases, according to the Times.  To contract the disease, a person must be exposed directly to viral particles shed from pustules on the skin, or from the mouth and throat, the Times reported.  The smallpox virus cannot survive in an open environment for extended periods of time except in cool, dry conditions, experts said.

A lone infected terrorist or a small group “could certainly do some damage,” Peters said.  “But he’s not going to cruise through (John F.) Kennedy (International) Airport and leave hundreds of people infected behind him.  This whole scenario that there’s going to be massive spread by people that nobody notices is not realistic,” he added.

Smallpox Bomb

Scientific and technical challenges would also prevent terrorists from creating a smallpox bomb, said Jonathan Tucker, the author of Scourge: The Once and Future Threat of Smallpox.

The virus must be grown in living cells, Peters said.  Technicians must make the resultant protein into a liquid or fine powder and package it into a bomb or other dissemination device that could release viral particles without destroying them, he said.  Even if a terrorist group could develop a workable weapon, it would have to contend with the fear accidentally releasing the disease, according to the Times.

“It’s still quite unlikely that smallpox would be used as a weapon,” Tucker said (Charles Piller, Los Angeles Times, Dec. 13).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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U.S. Response:  New Science Regulations Receive Mixed Reviews

By David Ruppe
Global Security Newswire

WASHINGTON — New federal regulations announced Tuesday to tighten controls on biological agents and toxins have received mixed reviews from microbiologists (see GSN, Dec. 4).

Experts said the regulations, intended to keep dangerous biological materials out of terrorists’ hands and mandated by a law passed this year, go too far in some areas and not far enough elsewhere.  The regulations affect the possession and transfer of “select agents” and toxins such as the anthrax bacteria and the smallpox and Ebola viruses, as well as lesser-known pathogens.

The new regulations, consisting of two sets of rules issued in tandem by Health and Human Services and Agriculture departments, are to take effect Feb. 7, pending public comments.

Richard Ebright, laboratory director at Rutgers University’s Waksman Institute of Microbiology, faults the regulations, for instance, for not requiring specific access-control and monitoring measures at facilities.

Ronald Atlas, president of the American Society for Microbiology, however, believes the new security requirements could dampen enthusiasm for work with select agents.

“If I had select agents in my lab, I think I’d have to give serious consideration in the morning as to whether I really want to do this or not,” he said in an interview yesterday.

“Which is not to say they [the new regulations] are wrong.  They might represent the right, essential steps,” Atlas added.  “But, they represent a significant culture change to at least how some of us in academia run laboratories,” he said.

Some of the paperwork requirements are “nothing short of draconian,” said Steven Block, a Stanford University biophysicist.  According to one key requirement, nongovernmental facilities are required to obtain a risk assessment from the Justice Department before they can receive, possess, use, or transfer any select agent.

“All these regulations in the end will be an enormous burden for those people trying to implement them,” said Block, who argued such restrictions on select agents ultimately “won’t stop the bad guys.”

With the exception of the smallpox virus, most agents and toxins are widely available around the world as is the information to weaponize them, he said.

Promoting the new rules in an announcement this week, HHS Secretary Tommy Thompson said, “Protecting the health of Americans is paramount, and this new rule strengthens our ability to ensure that essential research on these agents continues while making certain they don’t fall into the wrong hands.”

The regulations require laboratories handling select agents to be registered with the Centers for Disease Control and Prevention or the Agriculture Department, depending on the agent.

Previously, facilities had only to report transfers of such materials to federal authorities.  So far, 817 of an estimated 1,167 academic, commercial and government facilities have registered, according to the CDC.

The regulations also restrict access to such agents by certain groups of people.  To accomplish that requirement, laboratories must first submit names of people chosen to handle select agents to the Justice Department for screening using numerous databases.

The CDC anticipates an estimated 20,000 staff will be subjected to such “risk assessment” screening.

As required by the law, select agents, toxins or delivery systems can be possessed only if possession can be “reasonably justified” for specific “bona fide” research or other peaceful purposes, which has raised concerns biologists can no longer preserve specimens unspecific future use.

Security Risk Assessment

The classes of restricted people include aliens from a country on the State Department’s list of terrorism sponsors, admitted or convicted users of a controlled substance, persons indicted or convicted of a crime punishable by imprisonment for more than one year, dishonorably discharged veterans, fugitives from justice, illegal aliens, and persons adjudicated as mentally defective or committed to a mental institution.

HHS also may bar people suspected of involvement or association with organizations suspected of involvement in terrorism.

Violations can be punished with up to a $10,000 fine, 10 years imprisonment or both.  The regulations were published independently by the Health and Human Services and Agriculture departments, to implement requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 signed into law last June and the USA Patriot Act signed October 2001 in the wake of the Sept. 11 attacks and anthrax mail attacks (see GSN, June 12 and Oct. 26, 2001).

“The [bioterrorism preparedness] act bolstered the authority to protect against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts,” HHS said in a statement on the regulations.

Areas for Tightening Suggested

Ebright said the regulations represent an “important first step” in securing research laboratories with pathogens relevant to bioterrorism.

In a letter sent to the CDC yesterday, however, he called for strengthening the new rules in a number of areas.  He said the regulations should be more specific in describing how to control access to biological facilities and how to monitor security.  The new regulations leave those decisions to individual facilities, but Ebright said video surveillance and, in some cases, security personnel should be required.

Atlas said there was some merit to that idea, that the lack of specified measures “creates a certain angst for me and the community to know, ‘how do we know we did the right thing?’”

Ebright also recommended restricting additional types of research, such as efforts to make select agents resistant to vaccines, to make them more environmentally stable or to powderize or aerosolize them.

Atlas said such restrictions would need to be carefully scrutinized to prevent unnecessary limits on research into new vaccine delivery methods, or even something as common as deodorants.

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Smallpox:  Bush Prepares to Announce Vaccination Plan

U.S. President George W. Bush plans to announce tomorrow that military personnel and emergency workers will soon begin receiving smallpox immunizations, the New York Times reported today.  The vaccine will be available in 2004 to all U.S. residents who want it, administration officials said (see GSN, Nov. 25).

“I think it ought to be a voluntary plan,” Bush said in an ABC News interview broadcast yesterday.  “In other words, I don’t think people ought to be compelled to make the decision which they think is best for their family.  And what’s going to be very important is for us to make sure that there’s ample information for people to make a wise decision,” he added.

The United States plans to immunize up to 1 million military and emergency personnel in the first wave of vaccinations, which might begin in the next few weeks, administration officials said following the broadcast.

The television report seemed to surprise at least some top government health officials.

“We have no confirmation of the policy decision yet,” said Julie Gerberding, the director of the Centers for Disease Control and Prevention.  The CDC is currently evaluating smallpox immunization plans that states and large cities have submitted, she said (see GSN, Dec. 10).

“We have almost all the states’ plans and we are very pleased with the preliminary evaluation of them,” Gerberding said.

The administration has not decided, however, what to do about public demand for smallpox vaccine before sufficient stocks are licensed.  Officials can simply withhold the vaccine until 2004 — when sufficient amounts are expected to be available — or they can label the vaccine as an “investigational new drug” and make it available only to those who have a compelling need, according to the Times.

“The question is what do you do about John Q. Public between now and when licensed vaccine is widely available,” said a source familiar with the administration’s smallpox policy debate.  “That’s what the president hasn’t decided,” the source added (Stevenson/Altman, New York Times, Dec. 12).

“Preparing the emergency response teams is the highest priority,” an administration official said.  “Americans who feel they would like to be vaccinated will have access to it,” the official added.

Bush and his wife, Laura Bush, briefly addressed concerns about the vaccine’s side effects and said they would be comfortable having their 21-year-old twin daughters inoculated.

“If the vaccine were available, which I think it will be, I would feel like that was certainly safe for them to do,” Laura Bush said.  “I know there’s a slight risk.  That’s what people weigh when they make the decision whether or not to have their children vaccinated,” she added.

Meanwhile, the administration has come under fire for signing the Homeland Security Bill, which protects vaccine producers from lawsuits, without creating a compensation fund for those who suffer side effects from immunization, according to the Washington Post.

“Forcing people who are trying to do the right thing for the country to take care of themselves is wrong,” said Vermont Governor Howard Dean, a doctor and a Democratic presidential contender (Ceci Connolly, Washington Post, Dec. 12).

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Anthrax:  Brentwood Fumigation to Begin This Weekend

After preparing for almost a year, U.S. officials are expected to begin fully decontaminating the anthrax-tainted Brentwood Road postal facility in Washington this weekend (see GSN, Nov. 25).

During a community meeting yestereday, U.S. Postal Service officials provided details on the plan to sanitize the facility using chlorine dioxide gas.  Technicians plan to pump 2,000 pounds of gas into the facility starting Saturday, the Washington Post reported.  Scrubbers will then operate for 20 hours Monday to neutralize the gas, officials said.

Technicians are scheduled to enter Brentwood later in the week to collect thousands of spore strips and samples to determine whether the decontamination effort was a success.  A committee of Washington Health Department and U.S. Environmental Protection Agency specialists are expected to meet 30 days later to determine what, if any, further action is needed.

During yesterday’s meeting, postal officials told Brentwood-area residents and postal employees that the chlorine dioxide gas poses little risk.  Several safety measures have been established, including the installation of 26 air monitors around the facility and the establishment of a safety perimeter of 282 yards, officials said.  Additionally, technicians from the U.S. Environmental Protection Agency plan to patrol the area in a specially equipped bus and monitor air quality during the decontamination, the Post reported.

Several area residents and postal employees expressed concerns over the plan and criticized postal officials, the Post reported.

“Last year, they were ignorant (about how to respond to an anthrax attack), but this year, they’re experts,” said James Harper, a Brentwood worker and member of Brentwood Exposed, an employee support group (see GSN, Dec. 9; Manny Fernandez, Washington Post, Dec. 12).

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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