U.S. Response:  Biotechnology Companies Wary of Project Bioshield

Biotechnology companies are skeptical about U.S. President George W. Bush’s Project Bioshield plan, the San Jose Mercury News reported Sunday (see GSN, June 24).

The $6 billion, 10-year effort is designed to provide biotechnology companies with a guaranteed government buyer for vaccines and medicines to counter chemical and biological weapons.  The plan is still being considered in Congress.

Companies are concerned that the incentives and guarantees are not sufficient to spur research in bioterrorism defense.

“The government doesn’t have a good model there that would say why we should be putting our very valuable resources in this area,” said Robert Chess, chairman of California’s Nektar Therapeutics.  “They need to do a lot more work to make it lucrative,” he added.

Biotechnology executives are also concerned about the threat of lawsuits from product testing.  Many products cannot be tested on humans because of their potential side effects.

“Even the threat of a lawsuit can put us out of business,” said Una Ryan, chief executive of Avant Immunotherapeutics in Massachusetts (Heather Phillips, San Jose Mercury News, June 29).

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Threat Assessment:  Influenza Could Be Used as Bioterror Weapon, Scientists Say

A team of scientists says terrorists could turn influenza into a new type of weapon of mass destruction, the Reuters reported today (see GSN, April 18).

The scientists, who currently are close to completing the blueprint for the virus of the 1918 flu epidemic that killed millions globally, say rogue scientists could do the same and create new deadly potent flu strains, according to the Financial Times.

“Taken together with the fact that influenza virus is readily accessible and may be causing more deaths than previously suspected, the possibility for genetic engineering and aerosol transmission suggests an enormous potential for bioterrorism,” the University of Texas scientists wrote in the Journal of the Royal Society of Medicine.

Although the flu virus is usually transmitted via personal contact, it can also be delivered by way of tiny droplets in the air, the scientists noted.  A terrorist could easily pack the virus into an aerosol can and release it on a passenger airplane, leading to a rapidly spreading worldwide flu epidemic (Reuters, July 1).

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Smallpox:  CDC Says Smallpox Immunization Program Should Expand

The Centers for Disease Control and Prevention said Thursday the U.S. smallpox immunization program should expand despite an advisory panel recommendation to stop and evaluate the first few months of the effort (see GSN, June 24).

The CDC’s Advisory Committee on Immunization Practices recommended this month that U.S. officials delay plans to move past the initial stage of the program, in which emergency health care workers are immunized.  In the second stage, officials plan to expand the effort to include 10 million police officers, firefighters and other emergency workers.

“We respect the ACIP perspective, but we also recognize that we still have work to do, including ongoing immunization,” CDC Director Julie Gerberding said.

Almost 38,000 civilian health care workers have been immunized to date.  President George W. Bush initially laid out a plan to immunize 500,000 civilian health care workers by the end of February (David Wahlberg, Atlanta Journal-Constitution/Good Housekeeping, June 27).

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Anthrax:  Draining of Pond Yields No Additional Clues

The FBI has apparently found no additional clues to aid its investigation into the 2001 anthrax attacks after draining a Maryland pond, the Washington Post reported yesterday (see GSN, June 26).

FBI officials began draining the Frederick, Md., pond earlier this month in the hopes of finding clues in the anthrax investigation.  Agents had earlier recovered laboratory equipment. The items found following the pond’s draining, however, included a bicycle, logs, coins, a street sign, and a handgun, which was given to local authorities, according to the Post (Williamson/Snyder, Washington Post, June 29).

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Malaysian Response:  Officials Plan Research Lab to Combat Terrorism

Malaysian authorities plan to spend $58 million to establish a research facility to defend against potential bioterrorist attacks, Agence France-Presse reported today (see GSN, June 25).

“Are we ready to face a bioterrorism attack in this country?  The answer is ‘no,’” said Health Minister Chua Jui Meng.

The center, the National Institute of Natural Products and Vaccinology, is scheduled to open in 2005.  Chua said the government is obliged to protect its citizens from bioterrorism, but the country is currently forced to import vaccines.

“Malaysia must have its own capability to do research,” he added (Agence France-Presse/Straits Times, June 27).

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Anthrax I:  Attacks Illustrated U.S. Public Health System Weaknesses, Study Says

By Mike Nartker
Global Security Newswire

WASHINGTON — The fall 2001 anthrax attacks illustrated a number of weaknesses in the U.S. public health system that could limit the system’s effectiveness in responding to a future bioterrorist attack, according to a study by researchers at the ANSER Institute for Homeland Security and the Johns Hopkins Center for Civilian Biodefense Strategies (see GSN, April 22).

The anthrax attacks — which resulted in 22 infections and five deaths — revealed “an unacceptable level of fragility in systems now properly recognized as vital to national defense,” says the study, which was submitted earlier this month for publication in Biosecurity and Bioterrorism: Biodefense Strategy, Practice and Science.  “Too many citizens, elected leaders and national security officials still have a limited understanding of the degree to which 22 cases of anthrax rocked the public health agencies and hospitals involved in the response to this small bioterrorist attack,” the study says.

According to the study, no comprehensive analysis of the response to the anthrax attacks has been made public to date.  Interviews with doctors, public health officials, government officials, journalists and others, however, revealed several issues raised by the anthrax attacks, including challenges in public health decision-making processes, miscommunication and inefficient resources, the study says. 

Decision-Making

The anthrax attacks challenged the decision-making processes of public health officials from the U.S. Centers of Disease Control and Prevention all the way down to those at the local level, the study says.  Recommendations often differed between those issued by the CDC and those issued by state and local public health officials, as well as between states themselves. 

In some instances, states refused to take certain actions without prior CDC guidance, while other states chose to make decisions without such guidance — decisions that later conflicted with CDC recommendations, the study says.

For example, New Jersey public health officials wanted to provide preventive antibiotics to state postal employees after three postal workers contracted cutaneous — or skin — anthrax, according to the study.  CDC officials, however, did not agree with the recommendation, resulting in a delayed release of resources from the National Pharmaceutical Stockpile, the study says, adding that state public health officials therefore told postal workers to seek antibiotics from private physicians.

CDC personnel added to the confusion by not having extensive experience dealing with anthrax, the study says.  It also says that the organization’s usual epidemiological investigative procedure — “a careful step-by-step gathering of evidence followed by deliberate scientific analysis” — could not be conducted during a biological attack occurring in several locations and causing massive public disruption.

Over the course of the anthrax attacks and the immediate aftermath, some public health officials began to question the advice they were receiving from the CDC, the report says.  It quotes one interviewed government official as saying,  “We would ask CDC a question [about antibiotic treatment] and they would tell us ‘It’s not warranted.’  We would ask why and they would answer, ‘Not sure.’”

The study recommends that a “national discussion” be conducted on the future role of the CDC during large-scale public health events, such as a future bioterrorist attack.  The levels of assistance to be provided by the CDC and other U.S agencies to local health officials and providers, as well as the timeframe for the provision of such assistance, should also be clarified, the study says.

Communications

Another weakness in the U.S. response to the anthrax attacks was poor communication between public health officials and doctors, the media, and the general public, the study says.  Such poor communication began at the top, with the CDC, it says.

“The lack of a consistent, credible message emanating from CDC in the early days after the anthrax attacks has yet to be fully explained,” the study says.

According to the study, doctors initially believed that they were going to receive guidance from public health officials on recognizing and treating anthrax victims.  They soon learned, however, that such guidance would not be issued fast enough to play a role in important clinical decisions, resulting in increased self-reliance, the study says.  Many doctors also said they had difficulty in getting information on the number and locations of anthrax cases, CDC treatment and diagnosis recommendations and risk factors associated with anthrax exposures, it says.

The study says that many doctors reported relying on the media as a constant source of information.  It found, however, that public health officials often had difficulties in meeting the media’s demands during the anthrax attacks, in part because they often did not see media requests for information as a high priority.  As a result, many health departments did not have prepared materials or communications plans to provide to the media, the report says.

Journalists also reported having had difficulty in obtaining information during the attacks from public health officials, saying they “frequently” ignored or did not return telephone calls.

“Finding out what was being done was incredibly difficult.  Finding out what was happening at the national level was next to impossible,” the study quotes one newspaper journalist as saying.  “We couldn’t get through, or no calls were returned.  This went on for weeks,” the journalist said.

The lack of information from public health officials often led journalists to seek information during the anthrax attacks from other sources with varying levels of credibility, such as Web sites and other experts, according to the study.  “You don’t want reporters making scientific judgments,” it quotes a reporter as saying.

In the study, researchers recommended the creation of “near real-time” communications networks to assist doctors treating bioterrorism victims to communicate amongst themselves and with other noninvolved physicians.  In addition, procedures should be considered to establish a network of medical experts to offer advice and to monitor any clinical issues that might arise during the response to a biological attack, the study says.  While the CDC could aid in the creation of such a network, the network arguably should not be the centers’ responsibility, it says.

The study also recommends that officials begin to familiarize both the general public and the media with the concept that, in the event of a future biological incident, reliable information cannot be immediately provided.  Government spokesmen must do more to highlight uncertainties in information and to explicitly state what facts are known and unknown.  Failure to adequately express information, the study says, could lead to a public unwillingness to follow recommendations.

Insufficient Resources

The anthrax attacks also placed increased demands on a public health system long-suspected of lacking adequate resources, according to the study.  During the response to the anthrax attacks, public health officials often lacked communications equipment and rapid procurement systems.  The study also found that the attacks placed an increased strain on public health laboratories due to the large number of potentially contaminated items brought in for anthrax testing.  One state public health laboratory director told the study’s researchers that the laboratory he managed handled more than 2,000 suspect anthrax samples in two months, when the laboratory previously conducted one anthrax test per year.

State and local public health systems often lacked necessary personnel to handle both anthrax- and nonanthrax-related functions, the study says.  In addition, states did not have the capability to credential public health professionals from other states to help cope with personnel demands, it says.

“If we had another simultaneous health problem we would have been in trouble,” the study quotes a senior local public health official as saying.

While the report praises efforts at the federal level to increase bioterrorism preparedness funding to the states, it also found that states themselves are facing limited revenues.  In addition, public health preparedness is often not a high priority of state and local leaders, the study says.

“It will take considerable vision and leadership — and sustained funding — to build the medical and public health systems needed to appreciably improve the nation’s capacity to mitigate the consequences of bioterrorist attacks,” the study says.

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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Anthrax II:  FBI Expects to Complete Pond Search Soon

The FBI’s search of a pond near Frederick, Md., part of the bureau’s investigation into the 2001 anthrax attacks, is in its third — and possibly final — week, the Frederick News-Post reported yesterday (see GSN, June 13).

At the pond, which was drained earlier this month, a power shovel has been dumping mud taken from the pond bottom into a box-like structure that acts as large strainer, according to the News-Post.  Workers then spray the mud with water and comb through it using rake-like tools to search for evidence.  Previous searches of the pond, employing divers, recovered what appeared to be pieces of laboratory equipment, prompting the expanded search effort (Liz Babiarz, Frederick News-Post, June 25).

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Smallpox:  Study Says Immunizations Safer Than Expected

Military immunization results have shown that it is safe to speed up the U.S. national effort to vaccinate health and emergency workers against the smallpox virus, according to a study published yesterday by the Journal of the American Medical Association (see GSN, June 24).

The Defense Department immunized almost 500,000 military personnel without any deaths and with fewer complications than were expected, the report said.

Some health care worker groups were still skeptical about President George W. Bush’s plan to immunize up to 10 million emergency workers by the end of this summer.  The plan began in February, but fewer than 38,000 civilians have received the vaccine.

The immunization effort is failing partly because there is no clear threat, according to Charles Idelson, a spokesman for the 50,000-member California Nurses Association.

The immunizations are a “massive diversion of public resources for badly needed health care toward a program that has, to this date, been demonstrated to be totally unnecessary.  Any of the adverse reactions that have occurred as a result of this immunization program have been too many,” he said.

The study was completed by John Grabenstein of the Army Medical Command’s Military Vaccine Agency and William Winkenwerder, the assistant defense secretary for health (Susannah Rosenblatt, Los Angeles Times, June 25).

“Our experience suggests that broad smallpox vaccination programs may be implemented with fewer serious adverse events than previously believed,” the report says (Reuters/New York Times, June 25).

Military researchers did determine, however, that cardiac inflammation should be added to a list of potential side effects of the vaccine.  The inflammation, also known as myopericarditis, occurred at a rate of 78 cases for every million vaccine recipients.  That rate is triple the occurrence in the unimmunized population (Associated Press/Baltimore Sun, June 25).

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Anthrax:  U.S. Biotechnology Company Receives FDA Approval to Begin Human Testing of New Treatment

A U.S. biotechnology company announced today that it has received Food and Drug Administration approval to begin human testing of a new drug that has been found to both prevent and treat anthrax (see GSN, March 18).

Human Genome Sciences is now set to begin enrolling adult volunteers into a Phase 1 placebo-controlled clinical trial to evaluate the safety and tolerability of its new drug, ABthrax.  Adults enrolled into the study will be administered different dose levels of intramuscularly and intravenously administered ABthrax, the company said in a press release.  Under the Bioterrorism Act of 2002, the company can use the results of animal testing to demonstrate the drug efficacy for the purposes of licensing and marketing approval, the company said.

“We are pleased to be able to proceed with a clinical trial to evaluate the safety, tolerability and pharmacology of ABthrax in healthy adults,” Human Genome Sciences Senior Vice President David Stump said in a statement.  “Positive results from such a human study, along with our preclinical proof of efficacy data, would support the further development of ABthrax as a new means to prevent and treat anthrax infections,” Stump said.

ABthrax is a human monoclonal antibody that works by countering protective antigen — a toxin released by the anthrax bacterium.  Animal testing has found that a single dose of the drug can protect against anthrax infection once an appropriate level of the antibody is built up in the blood, the company said.  The drug also works against the toxins produced by anthrax bacterium, making it suitable as a treatment.

Large-scale production of ABthrax is dependent on government funding, which could be provided through the pending “Project Bioshield” legislation, the company said (see GSN, June 24; Human Genome Sciences release, June 25).

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U.S. Response:  Area Residents Oppose New Biosafety Level 4 Laboratories

U.S. plans to build at least six new Biosafety Level 4 research facilities, able to work with the most dangerous pathogens to help prevent against biological terrorism, are facing opposition from residents near the proposed laboratory sites, the Los Angeles Times reported today (see GSN, Feb. 24).

The United States has four Biosafety Level 4 facilities, located at the Centers for Disease Control and Prevention in Atlanta, the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., the Southwest Foundation for Biomedical Research in San Antonio, Texas, and the National Institutes of Health in Bethesda, Md.  The NIH facility, however, currently only works with Biosafety Level 3 organisms, according to the Times.

Several new Biosafety Level 4 laboratories are set to be open, with one to be installed at the CDC and another at the University of Texas in Galveston.  In addition, the National Institute of Allergy and Infectious Diseases plans to open large-scale facilities at the Rocky Mountain Laboratories near Hamilton, Mont., and at Fort Detrick.  Several other academic institutions and the New York state Health Department are competing to construct two additional facilities.

The plans to construct the new laboratories, however, have raised concerns and opposition among area residents worried about possible consequences of an accident.  Area residents have been able to block a Homeland Security Department plan to upgrade the Plum Island Animal Disease Center off the coast of Long Island, N.Y., and have also sued to block a laboratory proposed by the University of California at Davis, the Times reported.

“The risk is low, but the outcome is total devastation,” said Linda Perry, a Hamilton veterinarian.  “If there is an accident, people here are going to lose everything,” she said.

NIAID Deputy Director John La Montagne denied that the new laboratories pose increased risks to the public.

“Safety is a nonissue,” La Montagne said.  “These are highly safe facilities,” he added (Charles Piller, Los Angeles Times, June 25).

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