U.S. Response:  Washington Unprepared for Infectious Diseases, Report Says

The United States is unprepared to deal with many infectious diseases, members of a U.S. Institute of Medicine panel said yesterday.

“The United States has taken important steps,” said panel leader Margaret Hamburg.  The group released a report yesterday on microbial threats.

“The present reality is that we are unprepared … We still have not done enough in our defense and in the defense of others,” she said.

Influenza could kill hundreds of thousands and damage the U.S. economy but health officials are unprepared to track or treat an outbreak, according to the panel.

“This experience with severe acute respiratory syndrome is just the most recent wake-up call,” said James Hughes, chief of the infectious diseases unit at the Centers for Disease Control and Prevention, referring to a mysterious pneumonia that might have killed nine people and has been reported in seven countries.  The panel recommended that Washington work with other countries to coordinate efforts to detect and treat outbreaks.  The report also called for the United States to fight the use of antibiotics on farm animals if they are also used on humans, which allows diseases to become more potent.

The panel, however, said U.S. efforts to prepare for a biological terrorist attack could help public health systems prepare for infectious disease outbreaks.

“We think we have an unprecedented opportunity in this country to continue to rebuild the systems required to deal with infectious diseases.  We see this report as a call to action,” Hughes said (Maggie Fox, Reuters, March 18).

RAND Report

Infectious diseases can weaken national security and the nation’s military capacity, according to a RAND report.

The report cited South Africa, where one-quarter of the population is HIV positive, as a country that has a weakened security system due to infectious diseases.  RAND called on U.S. intelligence to focus more closely on public health threats, particularly from countries with poorly developed medical systems.

“Considerable policy attention and resources are flowing to build defenses against the relatively unlikely scenario of a large-scale bioterrorist attack.  Responses to more commonly occurring and currently more taxing natural outbreaks remain relatively overlooked and underfunded.  Serious assessments of the threat posed by infectious diseases suggest that this imbalance needs to be addressed, as a matter of both fiscal responsibility and judicious public policy,” the report said.  “Security, conflict, and the definition of general threat have become more diffuse and opaque,” it added (RAND report, March 2003).

Almost 80 percent of attendees at the recent Pediatric Preparedness for Disasters and Terrorism conference in Washington said the United States is not prepared to treat children after a terrorist attack.

Pediatric doses of medicine and specialized training for medical personnel are required, according to experts.

“It’s a matter of national urgency that we move as quickly as possible to protect our children,” said Irwin Redlener, a member of the American Academy of Pediatrics task force on terrorism (Donald McNeil, New York Times, March 19).

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Anthrax I:  Preattack Antibiotic Distribution System Needed, Experts Say

By Mike Nartker
Global Security Newswire

WASHINGTON — Distributing anthrax antibiotics, such as Cipro, prior to or shortly after an attack could dramatically reduce casualties, according to a study to be published this week in the online version of the Proceedings of the National Academies of Sciences (see GSN, March 14).

Yale University, Stanford University and Massachusetts Institute of Technology researchers have determined that distribution of antibiotics before a large-scale anthrax attack could cut anticipated casualties by half by reducing delays in administering such treatments, the study says.  It also says some other biological terrorism countermeasures being developed, such as advanced sensors, could be less effective without a rapid-response plan in place.

The researchers developed a mathematical model to simulate the effects of an anthrax release in a major city.  In the study’s base scenario, 1.5 million people out of a population of 11.5 million are infected with anthrax through a release of billions of spores.  If the entire infected population received antibiotics after 48 hours — the time needed to become aware that an attack had occurred — more than 123,000 casualties would be expected, the study says.

The number of anticipated casualties could be reduced by almost half, however, if anthrax antibiotics were distributed before an attack to reduce waits at medical facilities to receive such supplies, the study says.  “The hospital queue is the system bottleneck,” it says.

There are several risks in the preattack distribution of antibiotics, such as the still-unknown costs of such a plan and the side effects of the drug, the study says.  There are also concerns among scientists that if people take such antibiotics needlessly, it could increase the number of drug-resistant bacteria. 

If a preattack distribution plan is determined to be too risky, then it is “imperative” that nonmedical personnel and volunteers be used to distribute antibiotics in the event of an attack to reduce delays, the study says.  Antibiotic distribution delays could also be reduced by increasing the amount of available medical personnel by expanding inhalational anthrax training and through the development of mobile medical teams, it says.

The anticipated casualty rate could also be further reduced by promoting adherence to antibiotic regimens, the study says.  This was a concern during the autumn 2001 anthrax attacks, when many people who were potentially exposed to anthrax spores either declined preventive antibiotics or discontinued their use too early.

“It’s one thing to simply worry about what anthrax can do to us, but quite another to determine how we can best respond to an anthrax attack.  The United States must act quickly to put a rapid response plan in place,” Edward Kaplan of Yale University’s School of Management, one of the researchers involved in the study, said in a statement.

“To not prepare for the possibility of such an attack puts many more lives at risk,” he said.

The study was not as supportive of development of biological weapons detection systems.  Such detectors, if used without a preattack antibiotic distribution system in place, would provide a “false sense of security,” the study says, because even if the delay in antibiotic distribution were reduced from 48 hours to six hours, 70,000 casualties would still be suffered. 

The Bush administration has placed a high emphasis on the development of biological detectors.  In January, the U.S. Defense Department launched a program to develop new high-speed sensors capable of detecting an aerosolized release of biological agents in less than 60 seconds (see GSN, Jan. 8).  The New York Times also reported in January the administration’s plans to modify the Environmental Protection Agency’s national network of air quality monitors to detect biological agents (see GSN, Jan. 22).

In addition to calling for development of a rapid-response plan, the study also urged officials to begin a “serious consideration” of mass anthrax vaccination if the threat of a large-scale anthrax attack became significant enough.  This approach should be considered because of the potentially huge numbers of casualties that could be suffered in such an attack, the possibility of panic and flight, the potential economic consequences and the “general societal dysfunction in the aftermath of an attack,” the study says.

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax   

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Smallpox:  Revised Guidelines Open Door to Local Mass Vaccinations

By David McGlinchey
Global Security Newswire

WASHINGTON — U.S. health officials last month revised their smallpox attack response plan, creating the option of widespread smallpox vaccinations after an attack.  Previously, the Centers for Disease Control and Prevention had pushed solely for a “ring vaccination” strategy which seeks to prevent an epidemic by first vaccinating those who have been in contact with known victims.

Some experts have cautioned that the ring vaccination would not work in the event of a terrorist attack.

Following the revisions, health officials will still act first to identify and isolate an outbreak with targeted vaccinations, but will also consider large-scale vaccinations as a more viable option.  The change was made possible by the growing availability of smallpox vaccine, said Raymond Strikas, director of smallpox preparedness and response activity at the CDC’s national immunization program.

The former guidelines for state and local health officials were “written in large part over a year ago, in late 2001.  At that point we were talking about a small amount of vaccine available,” Strikas said.  Those guidelines were removed from the CDC Web site in late January and replaced Feb. 27.

The Vaccination Guidelines for State and Local Health Agencies says “vaccination of close contacts to smallpox cases played the most important role in stopping transmission of disease.  Public health authorities may supplement this strategy with broader vaccination campaigns to increase the level of community immunity to smallpox.”

This language represents an opening to allow for local mass vaccinations, according to William Bicknell, a Boston University professor and an authority on immunization planning.

“They are clearly moving toward much more comfort with going to local and national mass vaccination early after an attack.  It is not explicit, but it is a distinct shift in tone and balance,” Bicknell said.

In November, White House biological terrorism chief D.A. Henderson said health officials should offer to immunize the local population if an attack spreads smallpox.

“There’s nothing else that one can really do at that point, other than make the vaccine available,” he said.

Guidelines Provide More Detail

Strikas said the new guidelines address concerns of local and state health officials who have requested more specific direction.  The revised guidelines provide “a clear statement about what to do in the first period of time [after an attack] … dividing responsibilities, some more detail on the when,” he said.

Officials involved in the program — which has been plagued by low turnout and volunteer fears of adverse reactions to the vaccine — have often pointed to the CDC’s education efforts as examples of success.

Two weeks ago, CDC Director Julie Gerberding said the CDC’s programs had reached “hundreds of thousands” of medical workers through several media, including the Web site guidelines.

Bicknell corresponded with CDC officials in the weeks leading up to the change, and he said the revision is a step in the right direction.  He faulted the new guidelines, however, for several omissions that he said were glaring.

Specifically, he criticized the advertisement of a post-exposure “window,” which federal health officials say allows patients to protect themselves with vaccinations even several days after coming in contact with the virus.

Bicknell said the window does not give an accurate picture of a post-exposure scenario because people most likely would not know when they were exposed.

When a person realizes that they have been exposed to the smallpox virus, they could mistakenly believe they have several days from that point to become immunized, Bicknell said.  By the time they are vaccinated, “this rather imaginary window is long since shut, and you have suggested to planners that somehow people can be found in that time,” he added.

Bicknell also doubted the medical benefit of vaccinations several days after exposure.

“Vaccination after exposure may decrease the severity of the disease.  There is, I think, no credible evidence that allows anyone to state that it will prevent disease.  That is an extraordinary conclusion to make based on the data,” he said.

Strikas conceded that a time lag between the attack and the onset of vaccinations would allow some transmission of the disease.  Current plans, however, are designed to stop the infections soon after the initial cases, called the first generation, are discovered.

“We will recognize the first generation as it is happening.  Modify the second generation and prevent the third,” he said.

The CDC cannot stop the smallpox virus immediately after an attack.  “We know that won’t happen, some cases will slip through, some of those second generations,” Strikas said.

Pushing the idea of widespread vaccinations, Bicknell criticized what he called an “excessive reliance” on ring vaccination and the tracing of an infected patient’s personal contacts.

“Although contact tracing is a beloved concept in public health, it doesn’t work” after a biological terrorist attack, Bicknell said.

“A narrow medical approach would say, ‘let’s go individual-by-individual.’  A public health approach, a keeping-the-nation-functioning approach, would say, ‘let’s stop this thing in its tracks,’” he added.

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Anthrax II:  U.S. Biotechnology Firm Develops New Treatment

The U.S. biotechnology company Human Genome Sciences, Inc. announced today the development of a new drug capable of both preventing and treating anthrax infection (see GSN, March 14).

The new drug, ABthrax, is a genetically engineered human antibody drug that treats inhalational anthrax by countering protective antigen — one of the three toxins produced by the anthrax bacterium.  When a person is infected with anthrax, the protective antigen binds to a cell and acts as a syringe to inject the cell with the other two toxins produced by the bacterium.  ABthrax prevents the protective antigen from binding with a cell, and in turn, preventing the other toxins from entering and killing the cell, according to a company press release.

When administered pre-exposure, ABthrax was found to significantly increase the survivability rate of rabbits and primates exposed to inhalational anthrax, the company release said.  As opposed to the current anthrax vaccine, which requires a series of injections administered over an 18-month period to provide protection against infection, a single dose of ABthrax may be able to do the same once the appropriate level of the antibody is reached in the blood, the release said.

Human Genome Sciences now plans to file an Investigational New Drug application with the U.S. Food and Drug Administration to begin human clinical testing of the drug’s safety and tolerability, according to the company release.  Under the FDA’s “animal efficacy rule,” animal data can be used to demonstrate a drug’s effectiveness when it cannot be ethically or feasibly tested on humans.

“We believe that ABthrax demonstrates significant potential as a new prophylactic and therapeutic option in fighting anthrax infection,” William Haseltine, chairman and chief executive officer of Human Genome Sciences, said in a statement.  “We hope, by applying our expertise in protein and antibody discovery and development, that Human Genome Sciences will be able to make an important contribution to our nation’s biodefense initiative,” he added (Human Genome Sciences release, March 18).

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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Smallpox:  Smallpox Immunizations Continue, but Advance Slowly

Authorities are perplexed that few health workers have been inoculated with the smallpox vaccine, the Los Angeles Times reported today.

“We’ve been putting a lot of eggs in the vaccination basket and it hasn’t gotten us a lot,” said Joseph Henderson, associate director of terrorism preparedness and response for the Centers for Disease Control and Prevention (Vicki Kemper, Los Angeles Times, March 14).

Health officials had vaccinated 16,919 people as of March 7, according to numbers released by the CDC.

Concerns about the vaccine’s side effects, compensation for those adverse effects and the small likelihood of a smallpox terrorist attack caused participation to stay far below expectations for the first month of the program.  To date, 14 people have suffered moderate to severe reactions and one person has been treated with vaccinia immune globulin, which treats adverse effects from the vaccine.  In recent weeks participation has increased and the following chart details progress in each state and major cities through March 7 (CDC release, March 13).

State / City	Number of Immunizations
Alabama	310
Alaska	87
Arizona	5
Arkansas	407
California	366
Chicago	18
Colorado	193
Connecticut	332
Delaware	63
District of Columbia	4
Florida	2015
Georgia	73
Hawaii	23
Idaho	125
Illinois	5
Indiana	544
Iowa	231
Kansas	256
Kentucky	142
Los Angeles County	115
Louisiana	499
Maine	177
Maryland	177
Massachusetts	41
Michigan	151
Minnesota	1349
Mississippi	149
Missouri	651
Nebraska	1388
New Hampshire	90
New Jersey	619
New Mexico	13
New York City	41
New York State	115
North Carolina	282
North Dakota	100
Ohio	738
Oklahoma	78
Pennsylvania	57
South Carolina	217
South Dakota	618
Tennessee	2280
Texas	810
Utah	64
Vermont	20
Virginia	292
Washington State	178
West Virginia	257
Wisconsin	79
Wyoming	213
TOTAL	16,919

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From March 14, 2003 issue.

Anthrax:  Antibiotic-Antitoxin Combination Could Be Effective Post-Exposure Treatment

By Mike Nartker
Global Security Newswire

WASHINGTON — Researchers at Advanced Biosystems Inc. in Virginia have found that a combination of antibiotics and antitoxin substances is an effective post-exposure treatment for anthrax, Serguei Popov, a researcher at Advanced Biosystems, told Global Security Newswire yesterday (see GSN, Jan. 30).

During the autumn 2001 anthrax attacks, the antibiotic Cipro was administered to thousands of people suspected of being exposed to anthrax.  Preliminary efficacy testing has found that the combination approach — using both antibiotics and antitoxins — was effective in treating anthrax, Popov said.  Antitoxin substances, such as bestatin, which is also used as a cancer treatment, prevents anthrax bacteria-produced toxin from killing body cells, he said (see GSN, Jan. 14).  While antitoxins prevent cell death by themselves, they do not stop bacteria from replicating inside the body, so antibiotics are also necessary.

Advanced Biosystems researchers infected mice with between 10 to 30 times the lethal dose of anthrax, Popov said.  The mice were then administered the combination therapy, which consisted of low doses of antibiotics for 10 days along with the antitoxin substances.

The test found that the combination therapy resulted in almost full survival of the infected mice, Popov said.  In comparison, the use of antibiotics alone resulted in only about a 45 percent survival rate, while the use of antitoxin substance alone resulted in a survival rate of up to only 20 percent, he said.

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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Anthrax:  Researchers Investigate Use of Spinach in Vaccine Production

By Mike Nartker
Global Security Newswire

WASHINGTON — Researchers at Thomas Jefferson University in Philadelphia are testing a process that utilizes spinach in the production of anthrax vaccine, Alexander Karasev, a lead researcher on the study, told Global Security Newswire today.

The process involves genetically engineering the tobacco mosaic virus, a plant virus, to produce anthrax protective antigen, a component of anthrax toxin that is used as a vaccine against the disease.  The modified virus is then implanted into spinach plants, where it replicates to produce significant quantities of the antigen, Karasev said.  The antigen is then extracted from the spinach and purified using traditional vaccine-production methods, he said.

“We are trying to use the nature of [the] virus replication cycle for our own benefits,” Karasev said.

Karasev said he and his research team are trying to promote the use of plants as an alternative vaccine-production method because it is cheaper and safer than the current method, which involves extracting the antigen from a nonpathogenic version of the anthrax bacterium itself.  The modified tobacco mosaic virus poses no direct risks to humans or animals because it is only pathogenic in plants, he said. 

University researchers are planning animal tests of the extracted antigen, which will likely involve testing on guinea pigs, mice and rabbits, Karasev said.  He expects the tests to be completed this year.  The U.S. Navy has expressed interest in this new vaccine-production method and will likely also participate in the animal testing, he said.  If the extracted antigen is deemed both safe and effective, the next step “ideally” would be to format spinach itself as a delivery method, Karasev said.

For all those who dislike spinach, Karasev said his research team was also testing the process in other leafy vegetables and that some progress has been made using lettuce.  Still, “our workhorse is spinach,” he said.

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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Cuba:  Scientists Deny Biological Weapons Development

In an effort to refute U.S. charges that it is conducting biological weapons research, Cuba recently invited science journalists to visit Havana’s Center for Genetic Engineering and Biotechnology, Public Radio International’s The World reported yesterday (see GSN, June 6, 2002).

U.S. Undersecretary of State for Arms Control and International Security John Bolton last year charged Cuba with having “at least a limited offensive biological warfare research and development effort” (see GSN, May 7, 2002).

During the recent visit of journalists, however, Cuban officials denied the charge again.

“It would be nonsense on our side to produce biological weapons,” said Cuban researcher Sergio Pastrana.  “What for?  Will we attack Miami?  That’s nonsense, nonsense. ... If we can produce vaccines and people are going to pay the same amount and even more, why produce biological weapons?  We can do the vaccines, we’re very good at that.  Why lose time producing bioweapons and having this type of hassle within your country?  It’s absurd, makes no sense,” he said.

The latest Cuban tour followed an earlier one in October, when Bruce Blair from the Center for Defense Information in Washington led a delegation to Havana.  Blair said Cuba allowed him to select the facilities he wanted to visit and, after consulting with U.S. officials, Blair chose nine facilities and his team of security, tropical disease and other experts was granted access to all of them.  They were able to “look into every nook and cranny,” Blair said, adding, “Our impressions clearly were that the United States at least doesn’t really have a very good idea of what’s going on first of all, that we’re operating pretty much in the dark about many of these facilities, which struck us as doing legitimate research and production of pharmaceuticals.”

Former U.N. Iraqi weapons inspector Terence Taylor from the International Institute for Strategic Studies said Cuba’s biotechnology industry is international in character.  “It does have a commercial aspect to it, it does have an academic aspect.  It’s probably one of the healthiest industries in Cuba,” he said.  “But that doesn’t help you determine whether or not the Cubans have a biological weapons program.  I don’t think any of us could express anything like a complete opinion on that issue one way or the other.” 

Taylor said any biotechnology is at risk of being abused and that the issue is to learn how to live with that risk and make biotech companies accountable.

A Bolton aide said Bolton stands by his earlier comments on Cuba, saying credible intelligence information indicates that Cuba is at least researching biological weapons (Carol Hills, The World, March 12; Note:  Readers may need to download free software to access this audio link).

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