Respiratory tularemia treatment created

U.S. researchers have developed a technique that has experimentally protected laboratory mice from developing respiratory tularemia.

The respiratory form of tularemia, a potentially serious bacterial disease, is a highly infectious disease with a high mortality rate if untreated. It is also considered a potential bioterrorism tool.

Although much research is focused on fighting the bacterium that causes tularemia -- Francisella tularensis -- little is known about the role that antibodies play in protecting against infection.

In the latest study, a research team led by Dennis Metzger at the Albany Medical College in New York has discovered treating laboratory mice with a serum containing tularemia-specific antibodies protects the mice against F. tularensis, not only if given before exposure to lethal doses of inhalational F. tularensis, but also up to 48 hours after exposure.

The researchers said their findings suggest a possible alternative treatment approach to traditional antibiotics, especially useful in the case of an intentional act of bioterrorism.

The research is reported in The Journal of Immunology.

source:www.sciencedaily.com

Risks of being risk-averse

Ben Stone meets Allison Scott at a bar. They get drunk and have sex, and Allison gets pregnant. In a somewhat surprising twist, Allison, young and unmarried, risks bringing a baby into her life. Now she must decide whether she wants to risk marrying Ben, a well-meaning, good-hearted man with a frat-house mentality. And Ben must decide whether he wants to risk marrying Allison, knowing that he will be forced to grow up.

The movie also involves Allison's sister, Debbie, who is skeptical of Ben as a husband and is herself consumed by daily risks, such as neighborhoods with sex offenders and vaccines with mercury.

Debbie reflects today's risk-averse culture. But like most of us, she's really not risk averse at all. Because we don't know where the real risks lie, we're actually risk takers.

For example, for four years we have been besieged by the notion that a bird flu pandemic is around the corner. Media stories focus on our lack of preparedness, who would be immunized first, and preliminary studies of a bird flu vaccine. Books such as John Barry's The Great Influenza underline just how devastating flu pandemics can be. But bird flu hasn't caused a pandemic.

Although two or three influenza pandemics will occur in this century, many more Americans will be killed by epidemic influenza - about 35,000 to 40,000 every year. Despite these grim statistics, elderly adults - those most likely to die of flu - are fairly casual about getting their yearly flu shot.

In March 2003, when the United States invaded Iraq, the Department of Defense feared a biological counterattack with smallpox. So it inoculated soldiers with smallpox vaccine; 40,000 health-care workers also were immunized. Since December 2002, about 1.2 million people have been immunized with a vaccine to prevent a disease that was eliminated from the Earth in 1979. Unlike the prevention of many infectious diseases, smallpox vaccine works even when it is given 48 hours after exposure to someone with smallpox, a disease whose symptoms aren't subtle. We could have distributed the vaccine, made sure that systems were in place to give it quickly and efficiently, and waited.

But we didn't. As a consequence, about 140 people were harmed when the vaccine virus caused inflammation of their heart muscle. In this case, getting vaccine was riskier than waiting.

As for the movie character Debbie's fear of mercury in vaccines, the only vaccine that might include a mercury-containing preservative is the influenza vaccine, now recommended for all children between 6 months and 5 years of age. The quantity of mercury in that vaccine, about 12 micrograms of ethylmercury, is dwarfed by the amount of mercury that one typically encounters in the environment.

Further, several studies have clearly demonstrated that vaccines containing mercury as a preservative don't cause neurological problems, including autism. (Since mercury as a preservative was removed from vaccines given to infants in 2001, the incidence of autism has actually increased.) Influenza virus, on the other hand, causes the hospitalization of more than 100,000 children every year and the deaths of about a hundred; most of these children were previously healthy. Debbie's choice to avoid mercury in vaccines wasn't risk-free; it was a choice to take a greater risk.

Media don't do a very good job of educating about risk. We're scared of anthrax, botulism, tsunamis, and serial killers when we should be scared of things like french fries (strokes and heart attacks are the most common causes of death). We're scared of pandemic flu when we should be scared of seasonal flu.

source:www.philly.com

Selling the threat of bioterrorism

WASHINGTON — In the fall of 1992, Kanatjan Alibekov defected from Russia to the United States, bringing detailed, and chilling, descriptions of his role in making biological weapons for the former Soviet Union.

As a doctor of microbiology, a physician and a colonel in the Red Army, he helped lead the Soviet effort. He told U.S. intelligence agencies that the Soviets had devoted at least 30,000 scientists, working at dozens of sites, to develop bioweapons, despite a 1972 international ban on such work.

He said that emigrating Russian scientists and others posed imminent threats. After the breakup of the Soviet Union, he said, several specialists went to Iraq and North Korea. Both countries, he said, may have obtained anthrax and smallpox. The transfer of smallpox would be especially ominous because the Russians, he said, had sought to genetically modify the virus, posing lethal risk even to those who had been vaccinated.

His expertise, combined with his dire pronouncements, solidified his cachet in Washington. He simplified his name to Ken Alibek, became a familiar figure on Capitol Hill, and emerged as one of the most important voices in U.S. decisions to spend billions of dollars to counter anthrax, smallpox and other potential bioterrorism agents.

"It was Alibek's revelations, when he defected, that really provided the first information about the scope" of both the Soviet program and the possible proliferation to Iran and Iraq, said Dr. Thomas Monath, who was a top biodefense specialist for the U.S. Army.

Monath, who later led a group of experts that advised the Central Intelligence Agency on ways to counter biological attacks, said Alibek's information resonated at high levels of the U.S. government and was "amplified by 9/11."

"I think he influenced many people who were in position to make some decisions about response," Monath said, adding, "Concern about smallpox, in particular, was driven by Alibek."

Dr. Kenneth W. Bernard, who served President Bush as a special assistant for biodefense, agreed, saying that Alibek "had a substantial and profound effect."

Having raised the prospect that Iraq had acquired the ability to wield smallpox or anthrax, Alibek also was outspoken as the U.S. went to war in early 2003, saying there was "no doubt" that Saddam Hussein had weapons of mass destruction.

Officials still value his seminal depictions of the Soviet program. But recent events have propelled questions about Alibek's reliability:

No biological weapon of mass destruction has been found in Iraq. His most sensational research findings, with U.S. colleagues, have not withstood peer review by scientific specialists. His promotion of nonprescription pills — sold in his name over the Internet and claiming to bolster the immune system — was ridiculed by some scientists. He resigned as executive director of a Virginia university's biodefense center 10 months ago while facing internal strife over his stewardship.

And, as Alibek raised fear of bioterrorism in the United States, he also has sought to profit from that fear.

By his count, Alibek has won about $28 million in federal grants or contracts for himself or entities that hired him.

He has had well-placed help. Some of the money has been allocated because of a Southern California congressman's "earmarks," controversial budget maneuvers that direct federal agencies' spending. Moreover, two senior aides to a New Jersey congressman who also provided crucial help to Alibek left government and promptly joined his commercial efforts.

Alibek now is seeking new government contracts related to countering biological terrorism that could be worth tens of millions of dollars.

He has followed an unconventional scientific approach, seeking a product that would protect against an array of deadly viruses and bacteria, not just a single germ.

He also is raising money to build a drug-manufacturing plant in the former Soviet republic of Ukraine. From there, his company will seek to sell its antiviral agents and antibiotics to the U.S. government's Strategic National Stockpile, he said.

Thickly built and with willing, if imperfect, English, Alibek said in an interview that his focus had been scientific, "in terms of raising awareness about biological weapons and biological terrorism." An attack, he said, could kill "hundreds of millions, if not billions" of people.

The Los Angeles Times explored Alibek's public pronouncements, research and business activities as part of a series that will examine companies and government officials central to the U.S. war on terrorism.

Uncertainty surrounds the threat of a biological attack. Authorities list no fewer than 30 fungi, bacteria and viruses as potential biological weapons. One agent, anthrax, already has been deployed in the U.S., killing five people in late 2001. Because anthrax spores can be dispersed in a variety of ways — perhaps even by bomb — some experts believe that a well-executed attack could kill millions of people over large areas. Others, citing the vagaries of weather, say that anthrax or other airborne agents are unlikely mass killers

source:www.latimes.com

National ag biosecurity institute opens at OSU

STILLWATER, Okla. – Call it, “Crime Scene Investigation with an agricultural focus,” courtesy of the new National Institute for Microbial Forensics and Food and Agricultural Biosecurity, headquartered at Oklahoma State University.

“Events such as Mad Cow disease, E. coli outbreaks and anthrax contamination of federal mail indicate the relevance of being able to quickly and accurately identify the source and, if applicable, the perpetrator(s) of contamination of agricultural products or disease outbreaks,” said Clarence E. Watson, associate director of OSU’s statewide Oklahoma Agricultural Experiment Station system.

Sarkeys Distinguished Professor Jacqueline Fletcher of OSU’s Division of Agricultural Sciences and Natural Resources will serve as director of the institute.

“OSU is in a position to make a real contribution to the nation,” Fletcher said. “The institute will support national and regional biosecurity and law enforcement communities, as well as the U.S. agricultural industry, by identifying, prioritizing and addressing issues of crop and food biosecurity.”

It is a tall order, for there are not many institutions with the expertise to deal with the fusion of the traditional plant pathology discipline with forensic science, including areas such as microbiology and epidemiology – the branch of science dealing with the detection of the source and cause of epidemics.

The United States has been keenly aware of establishing preparedness for bioterrorism since the anthrax attacks of 2001, said Robert Allen, chairman of the OSU Center for Health Sciences’ department of forensic science.

“In the last couple of years we have become more aware of the vulnerability of our systems to produce, process and deliver food, not only to our own population but to the populations of the world that we feed,” Allen said.

When plant pathologists do their jobs on an everyday basis, they generally work under the assumption that Mother Nature is responsible for an incident.

“Now, the first question we have to answer is whether or not a crime has been committed,” Fletcher said.

OSU officials and faculty envision the institute as having three components that are state and federally mandated functions of a land-grant university: teaching, research and extension.

“Initially, we’re going to focus primarily on research,” Fletcher said. “That could mean the development of new technologies or the application of technologies developed in other disciplines which are then used in plant pathogen forensics.”

Fletcher said the teaching element would include training for first responders, Cooperative Extension personnel or law enforcement agents. Outreach would be through a state’s Cooperative Extension Service, reaching out through county organizations to the population of farm communities.

“I have two graduate students, both of whom are working in a very traditional discipline of forensic science, namely the use of DNA testing to identify and attribute the source of biological material from crime scenes,” Allen said.

The students have changed their focus slightly from trying to identify and characterize human DNA. One student is applying similar technology to identifying bacterial DNA that affects plants in Oklahoma, while the other is working on a virus that attacks wheat.

“They’re developing laboratory methods that presumably and hopefully will be applicable to any kind of pathogenic agent, whether it is a virus or bacterium,” Allen said.

The vanguard of current students likely will become trainers for the next generation of forensic scientists as the field of microbial forensics and agricultural biosecurity expands into traditional crime lab settings.

“Food contamination outbreaks have long-lasting serious consequences, even when they occur naturally,” Allen said. “I don’t know how many farmers were driven out of business by spinach being contaminated by E. coli last year, but even large producers went through some serious, adverse financial times because spinach was removed from grocery store shelves.”

At this moment, the institute at OSU is the only center of its type in the nation.

“We’re linked with the FBI scientific working group on microbial forensics, as well as other law enforcement agencies at the national level,” Fletcher said. “Within the state, we have a number of excellent resources with whom we’ll partner, including OSU faculty, the University of Oklahoma’s Advanced Center for Genome Technology, the Oklahoma Mesonet weather-monitoring system, the Forensic Science Institute at the University of Central Oklahoma and the National Memorial Institute for the Prevention of Terrorism in Oklahoma City.”

Although the institute has only recently been created, Fletcher and Allen have been working in the area of microbial forensics and agricultural biosecurity for some time.

Following the terrorist attacks of Sept. 11, 2001, Fletcher was asked by the president of the American Phytopathological Society to take the lead in determining the society’s response to the U.S. government’s security needs. In that role, she spent significant time in Washington D.C. working with the U.S. Department of Agriculture, the Department of Homeland Security, Congress and various commodity groups. It did not take her long to begin collaborating with Allen, given their OSU connection.

“One of the major events we’ve already completed was a national-level workshop in Oklahoma City this past January, which brought together representatives from law enforcement agencies and scientific organizations to help shape the priorities and projects needed to enhance the nation’s capabilities in plant pathogen forensics,” Fletcher said.

Watson said the Oklahoma Agricultural Experiment Station has already provided more than $300,000 for salaries and start-up activities related to the institute.

“This is a great opportunity to strengthen our cooperative working relationship with the Center for Health Sciences at OSU-Tulsa,” Watson said. “We’ve got some of our best faculty at both campuses involved. This is certainly a program that has national relevance.”

source:www.cushingdaily.com

Leonard Cole wants to wake the world to what Israel has suffered — and learned — from terror attacks.

"It’s all one piece," said Cole, a bioterrorism expert from Ridgewood, in a wide-ranging interview just before leaving for his more-than-50th trip to Israel. Terror attacks have killed and wounded thousands of Israelis, and Israelis have created an entirely new branch of medicine — terror medicine — in response.
An adjunct professor of political science at Rutgers University in Newark, an adviser to government agencies, and a frequent commentator in print and on television, Cole said he "was stunned to see how many books about suicide bombers have appeared in the last few years. Some of them are empathetic, some critical, but the number of those about the true victims is quite sparse."

The author of "The Eleventh Plague: The Politics Of Biological And Chemical Warfare" (W.H Freeman and Co., 1998), which dealt, in part, with Israel’s Scud siege during the first Persian Gulf War, Cole wanted "to help fill the gap. There’s a fascination in reading about and understanding the rationale of suicide bombers, but much less attention is paid to the consequences of their actions on the victims, the families, emergency responders, and ultimately the whole country."

Through his latest book, said Cole, a past chair of the Jewish Council for Public Affairs and a past president of the UJA Federation of Northern New Jersey, "I wanted to reach the hearts of those who cry only for the misery of the Palestinians…. I want people to cry, not just for the Palestinians, genuine as their suffering may be, but no less for the anguish they’ve caused to the Israelis."

To that end — evoking empathy and comprehension, not always the same thing — he wrote a book that is often hard to read, because your eyes fill with tears.

He tells, among other horrific accounts, of the devastating loss, in June of 2001, of young and vibrant life at Tel Aviv’s Dolphi Disco, popularly called the Dolphinarium.

A suicide bomber there killed 21 people and wounded some 120, mostly immigrant teens from the former Soviet Union, but the story of 16-year-old Yuli and 18-year-old Yelena Nelimov — and their mother, Ella, waiting at home for them to return from the disco — is particularly poignant.

Cole, who interviewed Ella Nelimov at length, outlines the girls’ day — how it began, as well as how it ended. "Both sisters loved to dance," he writes, "and going to the Dolphi at the end of a school week had become a joyful routine. In fact, that day their fun had begun at home, when they posed for photographs in their mother’s dresses."

But, Cole adds, earlier in the day that "Yuli and Yelena were draping themselves in their mother’s attire, Sa’id Hutari was preparing to wrap himself in something less seemly….

"Under the guidance of Hamas’s Qassam Brigades, that June evening in 2001, Sa’id Hutari donned a garment variously described as a harness or belt. It was packed with explosives and inch-long nails, screws, washers, and ball bearings. Hamas and other terrorist groups," Cole writes, "including Islamic Jihad and the Al Aqsa Martyrs Brigades, were prompting young people like Sa’id toward actions incompatible with civilized society."

What Hutari then did was certainly "incompatible with civilized society."

"Scarcely older than the Israeli teenagers gathered near the [disco’s] entrance," Cole notes, "he wedged his way among them. His bulky jacket drew no particular attention as he moved within feet of Yuli and Yelena….

"In an instant, bodies were thrown into the air. Limbs were sundered, and pieces of arms, legs, and hands flew in every direction. A burgeoning fireball engulfed an area 50 feet across as strips of human membrane were catapulted far beyond the edge of the fire."

Cole’s description of how the "suicide bomb" does its deadly work may be the best ever written — and is almost viscerally painful to read: "The metal pieces that had been packed with the explosives sprayed outward as fast as bullets. In less than a second, a nail could puncture a victim as cleanly as a hypodermic needle. Drilling farther inward, it could slice through an artery and end up lodged in the heart. A screw might take a different trajectory. Turned into a propeller, its rotary force could tear open a wad of skin and grind into the underlying muscle and nerve tissue, converting them into a mushy mass. A second screw might spin through the spinal cord, severing the motor connections between brain and limbs and leaving the victim permanently paralyzed."

What of the parents like Ella Nelimov, waiting at home, unable to reach their children, rushing into the night from hospital to hospital, desperate for news and terrified to get it? How does a suicide bomb damage them, and their country?

But here Cole has a surprise for us. Israelis mourn their dead like anyone else, but they have developed ways, he says, to cope with terror and grief, ways that can be models.

There is "a simple memorial several feet from the entrance to the former dancehall," Cole writes. "A life-size iron silhouette depicts a boy and girl holding hands. Not far away are the names of the victims and a simple inscription: ‘We will not stop dancing.’"

Just three months later, Cole notes, "on September 11, 2001, dancing … in the New York area came to a halt. In the following days the slogan, ‘We are all Israelis now,’ became a commonplace for many, at least for a while."

Cole uses "dancing" almost like a code. How to keep on living without giving in to terror, how to keep "dancing," is fast becoming a universal quandary in these troubling times when "we are all Israelis now." Israel, he says, which has become a master dancer, has lessons for the rest of the modern world.

Ella Nelimov, for example, is not left alone to deal with her grief as best she can. Her society has devised ways to help her — and others who are, unfortunately, in a similar situation. In her case, she told Cole, volunteers from Selah, an organization that provides counseling and retreats for immigrants whose bodies and lives have been shattered by terror attacks, "understood. They would hold my hand, and just by doing that, sometimes without words, they helped me to feel better."

"The support system in Israel has evolved into a remarkable network for recovery," Cole writes. "With the help of family, friends, and counselors, many survivors have embraced new lives, some with gusto. But even those who have successfully dealt with their trauma," he acknowledges, "may never feel fully repaired. The memory of physical wholeness and life experiences in their pre-terror years cannot be erased. Still," he adds, in a passage that a weary world may find hard to credit, "with personal determination and support from others, many have not only come to terms with their condition, but have gained a greater appreciation for life."

source:www.jstandard.com

Bushmeat Passed Off As Beef in Kenya

James Akedi's plate is piled with fragrant strips of nyama choma, the entree of choice in much of East Africa whose name means, quite simply, "roasted meat."

Akedi can only hope he's getting what he paid for: two pounds of government-inspected, disease-free beef. Kenyan authorities say wild animals such as zebra and wildebeest are illegally slaughtered and passed off as beef _ posing grave threats from diseases such as Ebola and anthrax linked to eating the flesh of infected animals.
"I have always been cautious when going out to buy meat," Akedi said. "But you never know."

Over the weekend, police recovered more than 450 pounds of "bushmeat" in an unrefrigerated minibus traveling from a wildlife dispersal area outside Nairobi National Park, Kenya Wildlife Service spokesman Paul Udoto said.

The driver said he was going to pass off the meat as beef at Nairobi markets, Udoto said.

Similar shipments have been entering Nairobi nearly every day for the past two months, the wildlife service said. Three people have been arrested and are charged with poaching and illegal trade in wildlife meat.

"This is a big threat to human consumption," Udoto said. "It has not been inspected by veterinary officials."

Human outbreaks of Ebola, a deadly virus that causes massive hemorrhaging, have been linked to handling carcasses and eating the flesh of primates infected with the disease. Anthrax and the hemorrhagic disease Rift Valley fever are also risks to people who are exposed to dead infected animals or eat tissue from infected animals.

The problem isn't limited to Africa, either: In southern China, authorities have cracked down on a burgeoning illegal civet cat trade to prevent an outbreak of SARS. Civet cats, mongoose-like animals, are considered a delicacy in China and are suspected of spreading severe acute respiratory syndrome to humans.

In many West and Central African countries, bushmeat _ particularly from primates and elephants _ is considered a delicacy. But in Kenya, the main reason for eating it is the lower cost. While beef sells for around $1 per pound, a pound of bush meat may cost 20 cents.

The problem of bushmeat making its way onto Kenyans' dinner plates is not new. In 2004, a conservation group analyzed the meat from 202 butchers in Nairobi, finding that 25 percent of the products surveyed were bushmeat and 19 percent a mixture of game and meat from domestic animals

source:www.washingtonpost.com

Livermore lab doesn't make cut

A federal agency has dropped a Lawrence Livermore Laboratory testing site from its list of locations to research on deadly disease organisms.

The Department of Homeland Security selected sites in Mississippi, Kansas, Texas, North Carolina and Georgia as finalists for the National Bio and Agro-Defense Facility lab. The apparent deletion of the local site delighted area residents who opposed using the lab's Site 300 in the hills between Tracy and Livermore.

The new list is "a major victory for the community," said Marylia Kelley, executive director of Tri-Valley Communities Against a Radioactive Environment.

"This facility is going to be one of the most dangerous bio-warfare agent research facilities in the world, not just the country. It's going to be bigger than five Wal-Marts."

The facility, funded by the U.S. Department of Homeland Security, would research and develop cures for life-threatening diseases affecting humans and animals.

Lawrence Livermore Laboratory had suggested using Site 300 and spokeswoman Susan Houghton said officials were extremely disappointed.

"We felt our proposal was extremely strong," she said. "We felt more importantly that it was vital that a facility like this be located in the state of California because there was a lot the state had to offer. We don't know any of the specifics why our facility was not selected."

The facility will replace an aging lab in Plum Island, N.Y., where security lapses after the 2001
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terrorist attacks drew scrutiny from Congress and government investigators.

The site should be announced next year, and the lab should be operating by 2014.

The Plum Island lab conducts research on foot-and-mouth disease and other germs to protect agriculture and livestock from foreign diseases.

The new lab will do that and research diseases, possibly including anthrax, smallpox and Marburg and Lassa, rare hemorrhagic fevers that attack the vascular system.

The sites were chosen by a team from Homeland Security, along with the departments of Agriculture and Health and Human Services.

Community acceptance was one criteria examined by the panelists selecting the final sites.

In January, the Tracy City Council voted 3-1 to send a letter opposing the Site 300 proposal. Tri-Valley Cares collected thousands of signatures from people opposed to the plan.

"We don't want to see any unnatural hazards happen in any community," Kelley said.

"Even as we're celebrating our victory today, and it's a huge victory, I'm going to sleep better tonight knowing the Ebola virus, foot-and-mouth disease and anthrax are not coming to Site 300, but they are still planned from some community."

The university remains committed to working with DHS, said Chris Harrington, a spokesman for UC Berkeley, which operates the Livermore lab and Site 300.

"UC is hopeful that the DHS will not rule out options to locate a bio and agro-defense facility in California in the future," Harrington said in a prepared statement.

"California is the nation's largest food producer - which includes the largest dairy industry - and the state which has the largest volume of agricultural imports and exports through seaports and borders."

In a separate matter, the lab is awaiting word on paperwork resubmitted to the San Joaquin Valley Air Pollution Control District seeking an increase in the amount of explosives allowed for Site 300's outdoor tests.

The April 6 permit application said the lab anticipates using up to 350 pounds per day and up to 8,000 pounds of explosives per year.

Among the dangerous materials expected to be found in the explosions are thallium and depleted uranium, according to the application.

source:www.contracostatimes.com

CDC Lab Breakdown Could Have Exposed Workers to Deadly Diseases

Richard Ebright, a Rutgers University microbiologist and biodefense critic said today the power loss last month at the CDC's new high-security research lab in Atlanta could have exposed researchers to dangerous diseases.

The $214 million Building 18, opened two years ago, houses labs for Biosafety Level 2, 3 and 4 research. Among the pathogens studied in BSL-3 are anthrax and the SARS virus. BSL-4 labs are designed to handle the most lethal organisms known to man, including the Ebola and Marburg viruses. No cure exists for BSL-4 diseases; fortunately, the BSL-4 space at Building 18 isn't yet operational. The others, however, are. Ebright said:

In BSL-2, one works in an air-filtered biocontaiment cabinet. If the power goes out, the filter fails. In BSL-3, one works inside a cabinet inside a room with negative air pressure. Both cease when power fails. If there had been BSL-4 in effect, they would have lost the negative air pressure in that as well.

The CDC isn't saying what they're working with, it but probably includes the 1918 influenza virus, H5N1 avian influenza, and certainly anthrax and plague. It would have gotten more play anywhere else, but the agency responsible for investigating was CDC itself.

It's too early to know if there were infections. This would count as exposure.... This wouldn't be acceptable at a small company or university lab, and was astonishing for lab working with 1918 influenza.



In this in this Atlanta Journal Constitution story, CDC officials downplayed the importance of the outage , caused by a lightning strike that overloaded a circuit breaker in the lab. The building wasn't equipped with its own backup generator, instead relying on what is now an obviously imperfect connection to backups on the CDC's research campus.

source:blog.wired.com

Malaria vaccine produced in mouse model

Malaria vaccine produced in mouse model
British scientists say they have made a significant breakthrough in the search for an effective and safe malaria vaccine.

Richard Pleass and colleagues at the University of Nottingham's Institute of Genetics report developing the first reliable animal model for human malaria, as well as developing a novel therapeutic entity.

Using blood from a group of people with natural immunity to the disease, the scientists refined and strengthened the antibodies using a new animal testing system that, for the first time, mimics in mice the way malaria infects humans.

When injected into mice, the antibodies protected them against the disease.

Pleass and his collaborators in London, Australia and the Netherlands took a closely related mouse parasite and genetically modified it to produce an antigen that the human immune system recognizes.

Next, they genetically altered the mouse's immune system to produce a "human molecule" on its white blood cells that recognizes the parasite and, together with antibodies, destroys it. In trials the team showed that human antibodies given to the mice protected them from the parasite.
source:www.sciencedaily.com

Mice Cured of Bird Flu Using Human Antibodies - Strides made in fight against bird flu

As time passes, the reality (or possibility) of the threat posed by a mutation of H5N1 making the jump to humans has increased the attention being paid to the progress being made. It was recently announced that a collaborative international team of scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the Institute for Research in Biomedicine, Bellinzona, Switzerland and the Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, had used antibodies derived from immune cells from recent human survivors of H5N1 avian influenza to successfully treat H5N1-infected mice as well as protect them from an otherwise lethal dose of the virus.

“The possibility of an influenza pandemic, whether sparked by H5N1 or another influenza virus to which humans have no natural immunity, is of serious concern to the global health community,” says NIAID Director Anthony S. Fauci, M.D. “If the success of this initial study is confirmed through further laboratory and clinical trials, human monoclonal antibodies could prove to be valuable therapeutic and prophylactic public health interventions for pandemic influenza.”

While this is not a new approach since it was used in treating victims during the 1918-1919 influenza outbreak, scientists had been struggling to do the same with bird flu. The process is known as passive immunotherapy, the new approach relies on two distinct steps: the extraction and culturing of antibody-producing white blood cells known as Memory B cells, and the purification of the B cells to isolate four distinct monoclonal antibodies (mAbs) that secrete bird flu neutralizing antibodies. Tests showed that mice receiving either of the two protective mAbs had levels of virus in their lungs that were 10 to 100 times lower than those in control mice, and little or no virus moved beyond the lungs. The mouse study is ”a very lovely, elegant proof of principle,” said Dr. William Schaffner, a flu expert at Vanderbilt University.

After taking blood samples from Vietnamese adults who were confirmed to have an H5N1 infection, researchers extracted white blood cells (called memory B cells) and treated them to cause them to produce large amounts of antibody. The samples of antibody materials were then tested to identify those that could neutralize the H5N1 influenza virus, and then the B cells were purified to create four monoclonal antibodies (mAbs) that secrete H5N1-specific neutralizing antibodies. Skipping through most of the technical biomedical discussion that I don’t understand, the test mice were given one of two different H5N1 mAbs at one of three dosages or a human mAbs for diphtheria or anthrax. All of the test mice were then exposed to lethal doses of H5N1 influenza virus. The mice that were given the non-H5N1 mAbs died within a week. Comparatively, the survival rate of mice receiving one of the H5N1 antibodies was remarkable.

What does all of this mean? The implications are:

► researchers say, that human mAbs may provide broad protection against variant H5N1 viruses—a desirable quality in any therapeutic aimed at the constantly evolving flu virus.

► the findings from this international collaboration are encouraging

► the neutralizing ability of fully human mAbs with potent H5N1 influenza virus…can be rapidly generated from the blood of convalescent patients

Big Pharma Donates Vaccines
GlaxoSmithKline to make unprecedented vaccine donation to WHO pandemic flu stockpile
GlaxoSmithKline (GSK) today announced its intention to donate 50 million doses of H5N1 adjuvanted pre-pandemic influenza vaccine to the World Health Organization (WHO) in support of its stockpile initiative.

Sanofi Pasteur Supports WHO Initiative for the Establishment of an H5N1Vaccine Stockpile.
Sanofi said it, too, was ready to supply a significant number of doses of H5N1 vaccine for an international stockpile through a WHO partnership. Part of this supply could be made available immediately, in bulk form.

Baxter, Glaxo to donate flu vaccine
GlaxoSmithKline PLC will donate enough prepandemic influenza vaccine to the World Health Organization to inoculate 25 million people in poor countries, and Deerfield-based Baxter International Inc. said it also will donate vaccine.

The United Nations agency said on its Web site Wednesday that it will get 50 million doses to distribute in the event of a pandemic caused by the deadly H5N1 flu virus. WHO said Sanofi-Aventis SA and Hungary’s Omnivest also might make some vaccine available.

The question remains if having this stockpile of pre-pandemic flu vaccine will do much if the H5N1 morphs as expected before it jumps to humans. For that reason, keeping an eye on research like that done on the mice by the NIAID/International consortium. I continue to follow this subject because of the implications on preparedness and response, and the concerns in some circles that an outbreak could be quite devastating.
source:rapidrecon.threatswatch.org

Human antibodies protect mice from H5N1 virus

Antibodies gleaned from four Vietnamese patients who survived H5N1 avian influenza were used successfully to prevent and treat H5N1 infection in mice, suggesting that the same approach might be useful in humans, according to a recent report by an international team of researchers.

The authors, reporting in the journal Public Library of Science (PLoS) Medicine, said the human antibodies, when used to treat sick mice, were effective not only against the H5N1 strain that infected the Vietnamese patients, but also against a later strain that came from Indonesia.

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said the study suggests that antibody treatment could be a valuable weapon against pandemic influenza.

"If the success of this initial study is confirmed through further laboratory and clinical trials, human monoclonal antibodies could prove to be valuable therapeutic and prophylactic public health interventions for pandemic influenza," Fauci commented in a news release. The NIAID was a sponsor of the study.

Antibody treatment, also known as passive immunotherapy, has been used to prevent chickenpox, hepatitis A and B, rabies, and respiratory syncytial virus infections. A crude form of it was used during the "Spanish flu" pandemic of 1918-19, when blood products from recovering patients were sometimes given to sick patients. A recent analysis of studies conducted at the time indicated that the treatment reduced mortality by about half (see link below).

The new study was conducted by a team from Vietnam, Switzerland, and the United States, with Kanta Subbarao of the NIAID in Bethesda, Md., as the senior author.

The antibodies used in the study were gleaned from four Vietnamese who were infected with a "clade 1" strain of H5N1 between January 2004 and February 2005 and donated blood after their recovery. Swiss researchers on the team extracted antibody-producing white blood cells, called memory B cells, from the samples and used Epstein-Barr virus to induce them to continuously produce large amounts of antibody, according to the NIAID release and the PLoS Medicine report.

Team members at the NIAID lab then screened 11,000 antibody-containing samples and found a few that, in the lab, neutralized H5N1 virus strains from 2004 and later. The researchers purified the B cells from these and created four monoclonal antibodies (mABs) that secreted H5N1-specific neutralizing antibodies, the NIAID said.

To find out if the antibodies could prevent H5N1 infection, the researchers treated groups of five mice with either of two H5N1 antibodies at one of three doses. Two other groups of mice were treated with human antibodies against diphtheria or anthrax to serve as controls. A day later, all the mice were given lethal intranasal doses of H5N1 virus.

All the control mice died within a week, while all the mice that received an H5N1 antibody called FLA5.10 survived, regardless of dose. The effectiveness of the second antibody, called FLA3.14, depended on the dose; 80% of mice that received the highest dose survived, but with the two lower doses, fewer survived.

The control mice were found to have high levels of H5N1 virus in the lungs and evidence of the virus in the brain and spleen as well, according to the report. The treated mice, in contrast, had 10- to 100-fold lower levels of virus in the lungs and no detectable virus in brain tissue.

To test the antibody method as a treatment for already-sick mice, the researchers exposed mice to a lethal dose of the 2004 strain of H5N1 from Vietnam. A total of 60 mice were given one of the four antibody preparations 24, 48, or 72 hours after infection, and control mice were treated with human diphtheria antibodies. All the control mice died within 10 days, while 58 of the 60 treated mice survived.

Encouraged by these findings, the team went on to try the antibodies as treatment for mice infected with an H5N1 strain collected from Indonesia in 2005 (a clade 2 strain). The mice were treated 24 hours after infection. Mice treated with a control antibody and with one of the H5N1 antibodies died, but those treated with the other three H5N1 antibody preparations survived.

"These data provide proof of concept that mAb therapy for at least 72 h[ours] postinfection in the mouse model can markedly improve survival from highly virulent H5N1 infection," the authors write. "Importantly, these data also imply it is possible to obtain significant cross-protection against a Clade II H5N1 virus using a mAb elicited by a Clade I virus."

They add, "Potentially, a cocktail of these cross-reactive antibodies mAbs could represent an adjunctive treatment option against [human] H5N1 infection."

They caution that it is not certain that the antibodies used in this study would be effective against an emerging H5N1 pandemic virus. But they say they are encouraged by the antibodies' broad neutralizing activity and the "moderate doses" required to confer protection in mice.

The NIAID said the researchers now plan to scale up the protection of H5N1 antibodies, test them in other animal species, and, if those studies are successful, test them in humans.

Other experts hail the findings as promising, but there are reservations about how much of a practical impact passive immunotherapy could have in a flu pandemic.

Gregory Poland, MD, a flu vaccine expert at the Mayo Clinic in Rochester, Minn., called the report "a very promising development." If further studies support the approach, it could be used along with antiviral drugs to treat human patients with severe H5N1 disease, and also to protect people who might be exposed to H5N1 and have not been vaccinated, he said.

"If [H5N1] cases were going to be admitted to the University of Minnesota Hospital and healthcare workers had to go in and take care of them, this might be a useful interim measure," said Poland, who is a professor of medicine in infectious diseases at the Mayo College of Medicine and directs the Mayo Vaccine Research Group and Program in Translational Immunovirology.

"One can think of it a bit like how we used to use immunoglobulin to protect against hepatitis A before we had vaccine," Poland added. "But something like this could not and would not supplant vaccines as the cornerstone of prevention of disease."

He listed other caveats as well. One big if is whether the findings in mice will be duplicated in humans. Though the researchers demonstrated "cross-clade protection," "that may or may not be true in a human model," he said. Another question is whether the antibody preparations could be produced in large amounts.

Assuming the treatment turns out to be effective, the timing of its use will be important, Poland said. "If you give it too far in advance of exposure, there won't be any circulating in the bloodstream. If you give it too long after exposure, it won't help. . . . And we don't know what the effect would be of giving this and a vaccine in close proximity."

Michael T. Osterholm, PhD, MPH, an infectious disease expert and pandemic preparedness advocate, agreed that the findings are promising from the scientific standpoint but expressed doubts about the practical potential to exploit them in the face of a pandemic.

"In theory it makes obvious sense—it's an extension of the immunization process," said Osterholm, director of the University of Minnesota Center for Infectious Disease Research and Policy, which publishes CIDRAP News.

The main question on the scientific side is whether the antibody treatment would have broad enough activity to be effective against an emerging pandemic strain of H5N1, which could differ from the strain used in producing the antibodies, he said.

But on a practical level, Osterholm said, "Once a pandemic hits, there won't be time or materials to obtain and stockpile large volumes of this. What in theory is ideal, is in practice maybe a nightmare. I don't see how the plasmapharesis community is going to be able to quickly gear up to actually make lots of this antibody and then move it into the clinical setting in a timely way to have much impact. . . . The idea of trying to create millions of immunotherapy treatments is a stretch."

Concerning Poland's idea of using passive immunotherapy to protect healthcare workers who could be exposed to H5N1 patients, Osterholm commented, "Now there's a more targeted application. But that's going to be a hell of an ethical dilemma. Are you going to get a consensus in the community to actually allow giving it to healthcare workers and not others?"

Another flu expert, Dr. William Schaffner of Vanderbilt University, called the study by Subbarao's team "a very lovely, elegant proof of principle," according to a recent Associated Press (AP) report.

Schaffner suggested that the possible applications of this principle include not just H5N1 influenza, but also ordinary seasonal flu, which kills thousands of people each year.

"This has the dual potential of being useful potentially in a pandemic, but perhaps more so on an annual basis," he told the AP. "That's where I think the real excitement is."

source:www.cidrap.umn.edu

The Threat of Bioweapons

Immediately following 9-11, an anthrax attack originating from letters containing anthrax spores infected 22 people, killing five. After almost six years, the case has not been solved.

Intelligence analysts and academics report that North Korea has developed anthrax, plague, and botulism toxin and conducted extensive research on smallpox, typhoid and cholera.

A world-renowned bioweapons expert has confirmed that Syria has weapons grade smallpox resistant to all current vaccines developed under the cover of legitimate veterinary research on camelpox, a very closely related virus. The researcher further reports that Syria is suspected of testing the pathogen on prison populations and possibly in the Sudan.

Although there are close to 50 organisms that could be used offensively, rogue nations have concentrated their bioweapons development efforts on smallpox, anthrax, plague, botulinum, tularemia and viral hemorrhagic fevers. With the exception of smallpox, which is exclusively a human host disease, all of the other pathogens lend themselves to animal testing as they are zoonotic, or can be transmitted to humans by other species.

Biological weapons are among the most dangerous in the world today and can be engineered and disseminated to achieve a more deadly result than a nuclear attack. Whereas the explosion of a nuclear bomb would cause massive death in a specific location, a biological attack with smallpox could infect multitudes of people across the globe. With incubation periods of up to 17 days, human disseminators could unwittingly cause widespread exposure before diagnosable symptoms indicate an infection and appropriate quarantine procedures are in place.

Unlike any other type of weapon, bioweapons such as smallpox can replicate and infect a chain of people over an indeterminate amount of time from a single undetectable point of release. According to science writer and author of The Hot Zone, Richard Preston, "If you took a gram of smallpox, which is highly contagious and lethal, and for which there's no vaccine available globally now, and released it in the air and created about a hundred cases, the chances are excellent that the virus would go global in six weeks as people moved from city to city......the death toll could easily hit the hundreds of millions.....in scale, that's like a nuclear war."[1]

More so than chemical and nuclear research, bioweapons development programs lend themselves to stealth development. They are difficult to detect, can be conducted alongside legimate research on countermeasures, sheltered in animal research facilities within sophisticated pharmaceutical corporations, disguised as part of routine medical university studies, or be a component of dual use technology development. Detection is primarily through available intelligence information and location-specific biosensors that test for the presence of pathogens.

Biological weapons have many appealing qualities for warfare and their effects can be engineered and customized from a boutique of possibilities. Offensive pathogens are inexpensive compared to conventional weapons and small quantities can produce disproportionate damage. They have unlimited lethal potential as carriers and can continue to infect more people over time. Bioweapons are easy to dispense through a variety of delivery systems from a missile, an aerosol or a food product. They can be placed into a state of dormancy to be activated at a later stage allowing for ease of storage. Pathogens are not immediately detectable or identifiable due to varying incubation periods and can be rapidly deployed, activated and impossible to trace. The technology to develop biological agents is widely available for legitimate purposes and large quantities can be developed within days.

Bioweapons can be tailored for specific situations from a variety of desired characteristics, including pathogenicity or disease-producing capacity, incubation period, virulence and transmissibility. Pathogenicity is relative to the quantity of a particular agent that is necessary to cause disease. The incubation period is critical for determining the timing of the desired period between exposure and the onset of illness. Virulence determines how debilitating and lethal the disease will manifest in the target population. Transmissibility defines the ease in which the disease is able to spread.

The ultimate goal of bioterrorism is to induce fear, panic and chaos by high morbidity and mortality rates to breakdown the existing political, economic and social structure. For bioweapons to be successful, "The biological agent should consistently produce the desire effect of death or disease. It should be highly contagious with short and predictable incubation period and infective in low doses. The disease should be difficult to identify and be suspected as an act of bioterrorism. The agents should be suitable for mass production, storage, weaponization, and stable during dissemination. The target population should have little or no herd immunity and little or no access to treatment. The terrorist should have means to protect or treat their own forces and population against the infectious agents or the toxins."[2]

Due to their virulence, ease of dissemination and detection difficulties, bioweapons experts and the Department of Homeland Security assert that smallpox and anthrax are the most worrisome biothreats to national security. Both have been weaponized which means they can be produced in a particle size that is releasable in the air and can be easily inhaled into the respiratory system. Both smallpox and anthrax are extremely deadly and present unique forensic, environmental, logistical and public health care delivery challenges.

Smallpox

Although smallpox was officially eradicated in 1980, there is evidence of the virus beyond the two World Health Organization-designated repositories. There is little immunity in the U.S. population as the smallpox vaccination program ended in 1963 and the vaccinations are believed to be effective for a ten year period.

Following 9-11 and heightened fears of a bioattack, the U.S. government, under the direction of Health and Human Services, revitalized the smallpox program and by 2003 acquired sufficient live-virus vaccines in the Strategic National Stockpile for the entire population. Approximately 50-60 million Americans are identified either as high risk for developing post-vaccination complications or unable to be vaccinated. These include individuals who are allergic to vaccine components, are HIV-positive, have immune system disorders, are undergoing chemotherapy, have certain dermatologic conditions and pregnant and breast-feeding women.

The FDA just recommended for approval a new smallpox vaccine that is grown in a cell culture in a laboratory and has less of a risk of complications. It can be used for populations who can't receive the conventional smallpox vaccination and will most likely be added to the stockpile within the next year. An anti-viral drug that effectively treats adverse vaccine reactions will be purchased for the stockpile as well.

The challenges presented by a smallpox outbreak are numerous for diagnosis, surveillance and containment. Although easily diagnosed, the majority of practicing physicians has never seen a case of smallpox and may not accurately identify symptoms at first. Due to the long incubation period, infected individuals may remain undetected for extended periods leading to misjudgments in the trajectory of the epidemic and delayed implementation of quarantine procedures. Potential contacts of cases may be too great to effectively trace and monitor. Also, the vaccine is ineffective beyond the first few days of exposure when people are asymptomatic and few health care workers have been immunized. During the 20th century, with greater immunity, smallpox killed 300 million people.

Anthrax

Anthrax is a serious disease that is caused by spore-producing bacteria that releases toxins in the body. It cannot be spread through direct human contact but can be transported on inanimate objects and disseminated through the air. Anthrax infections can occur through the skin, by inhalation and by ingesting contaminated food.

Anthrax presents difficult challenges for clean-up and decontamination. The spores tend to be widely dispersed in the environment and can survive for long periods of time after release. Decontamination procedures are costly and extremely time-consuming as the bacteria is highly stable and maintains its potency.

A number of treatments exist for anthrax infections and several are in the national stockpile or in the process of being acquired. Vaccinations provide pre-exposure protection for individuals at high risk for anthrax contact. For post-exposure, a combination of vaccination and oral antibiotics is used. For those who are symptomatic, intravenous antibiotics are the treatment of choice. HHS is in the process of acquiring the next generation of anthrax vaccine that can be produced more rapidly than what is currently available. Also, drugs that clean up the toxins excreted by anthrax bacteria are being developed and will be added to the stockpile.

September 11th and the anthrax attack that followed were watershed events that spawned programs to fight bioterrorism. The newly established DHS was charged with the responsibility of performing threat assessments and communicating the need for countermeasures to Health and Human Services to procure countermeasures for the national stockpile. In 2002, several programs were enacted by the Bush administration to create the necessary infrastructure for the detection and necessary interventions for a bioterrorist attack against the United States. The programs include Project BioWatch, Project BioSense and Project BioShield.

Project BioWatch

Project BioWatch is an early biothreat detection system coordinated through the Department of Homeland Security (DHS), the Environmental Protection Agency (EPA) and the Center for Disease Control (CDC) with the goal of minimizing casualties, assisting law enforcement efforts and identifying exposed populations and contamination patterns. BioWatch monitors a network of biosensors or filters in 30 U.S. cities that detect the presence of biological materials, capture samples and analyze them in a field laboratory. The current system tests for the existence of up to eight toxins, bacteria and viruses. If bioagents are detected, BioWatch has a series of protocols to follow to initiate an appropriate course of action and affect public health policy. The acquisition and implementation of next generation technology biosensors that will perform insitu sample collection, analysis and wirelessly report biothreats is being explored by DHS and should be ready for pilot testing shortly. The new technology, which can test for around 20 pathogens, will provide cost savings that could possibly result in greater coverage or increased density within currently monitored locations.

Project Biosense

Project BioSense was established to reduce the time between the detection of a potential biothreat and the initiation of an appropriate response. It's primary function is to analyze multiple data streams from hospitals, pharmacies, Project BioWatch and other relevant sources, for the purpose of expediting a coordinated comprehensive response. The goal is to have a single center collect and evaluate available data and transmit critical threat information to health care providers. It aims to strengthens the working relationship between the CDC and the caregivers on the frontlines in a biothreat emergency.

Project Bioshield

Project Bioshield's charter is to procure vaccinations and drugs for potential biothreats for the national stockpile. In 2004, $5.6 billion was allocated over ten years to fund research and purchase countermeasures against threats from private companies. Bioshield was established to simplify the procurement process and enable the FDA and the NIH to partner with research communities and the biopharma industry in the fight against bioterrorism. In its initial stages, it was difficult for Project Bioshield to incentivize biotechnology companies to develop countermeasures for bioweapons. More lucrative drug development projects for cancer and HIV had greater market potential and promised better returns on investment. Also, Project Bioshield contracts included extensive regulations, offered no liability protection, and lacked purchase guarantees. Private companies were incurring all of the risk of doing business with the government and received no payments until the actual delivery of products to the stockpile. Once a product was developed, companies were saddled with costs for extensive testing that could span a five year period and be difficult to recover.

In 2005, BARDA, the Biomedical Advanced Research and Development Authority, was established to facilitate the development of medical countermeasures against national security threats. BARDA simplified the procurement process, provided liability protection for private companies and advanced development money for testing promising products.

Two new bills have been proposed to improve the national response to biological threats. The Material Threats Act, H.R. 1089, aims to improve the ability of DHS to assess chemical, biological, radiological and nuclear threats and the availability and effectiveness of countermeasures that may be grouped together to address multiple threats. The second bill, H.R. 1290, establishes a National Biosurveillance Integration Center to monitor, review and consolidate data from multiple sources in the event of a biological incident.

Conclusion

The testimony before Congress in April of 2006 of Tara O'Toole, M.D., M.P.H., Director and CEO of the Center for Biosecurity at the University of Pittsburgh Medical Center sums up the current situation vis a vis biothreats. "The U.S. does not yet have a coherent biodefense strategy, nor do we have a strategy for countermeasure research, development, and production that takes account of the full spectrum of possible bioweapons agents, including engineered threats."[3] Dr. O'Toole went on to explain the urgency for national security of developing and stockpiling countermeasures against high-priority threats such as anthrax, smallpox, plague and others. In the long term, she criticized the futility of chasing countermeasures for specific pathogens due to the multitude of pathogens that are potentially weaponizable. What is needed according to Dr. O'Toole is the "ability to rapidly design, develop and produce new countermeasures from a standing start - in weeks, if not days."[4] This will occur with technological improvements, wider sharing and accessibility of data, streamlined clinical testing and regulatory review and through public-private partnerships.

Even with the BioWatch, BioSense and BioShield projects, still in their infancy, current measures fall far short of this broad, well thought out approach. The two proposed Congressional bills are a step forward. But the United States remains almost as ill prepared today to cope with a bioweapons attack as it proved itself to be shortly after 9/11. We must begin to remedy this now.
sourcE:www.americanthinker.com

Selling the threat of bioterrorism

n the fall of 1992, Kanatjan Alibekov defected from Russia to the United States, bringing detailed, and chilling, descriptions of his role in making biological weapons for the former Soviet Union.

As a doctor of microbiology, a physician and a colonel in the Red Army, he helped lead the Soviet effort. He told U.S. intelligence agencies that the Soviets had devoted at least 30,000 scientists, working at dozens of sites, to develop bioweapons, despite a 1972 international ban on such work.

He said that emigrating Russian scientists and others posed imminent threats. After the breakup of the Soviet Union, he said, several specialists went to Iraq and North Korea. Both countries, he said, may have obtained anthrax and smallpox. The transfer of smallpox would be especially ominous because the Russians, he said, had sought to genetically modify the virus, posing lethal risk even to those who had been vaccinated.

His expertise, combined with his dire pronouncements, solidified his cachet in Washington. He simplified his name to Ken Alibek, became a familiar figure on Capitol Hill, and emerged as one of the most important voices in U.S. decisions to spend billions of dollars to counter anthrax, smallpox and other potential bioterrorism agents.

"It was Alibek's revelations, when he defected, that really provided the first information about the scope" of both the Soviet program and the possible proliferation to Iran and Iraq, said Dr. Thomas Monath, who was a top biodefense specialist for the U.S. Army.

Monath, who later led a group of experts that advised the Central Intelligence Agency on ways to counter biological attacks, said Alibek's information resonated at high levels of the U.S. government and was "amplified by 9/11."

"I think he influenced many people who were in position to make some decisions about response," Monath said, adding, "Concern about smallpox, in particular, was driven by Alibek."

Dr. Kenneth W. Bernard, who served President Bush as a special assistant for biodefense, agreed, saying that Alibek "had a substantial and profound effect."

Having raised the prospect that Iraq had acquired the ability to wield smallpox or anthrax, Alibek also was outspoken as the U.S. went to war in early 2003, saying there was "no doubt" that Saddam Hussein had weapons of mass destruction.

Officials still value his seminal depictions of the Soviet program. But recent events have propelled questions about Alibek's reliability:

No biological weapon of mass destruction has been found in Iraq. His most sensational research findings, with U.S. colleagues, have not withstood peer review by scientific specialists. His promotion of nonprescription pills — sold in his name over the Internet and claiming to bolster the immune system — was ridiculed by some scientists. He resigned as executive director of a Virginia university's biodefense center 10 months ago while facing internal strife over his stewardship.

And, as Alibek raised fear of bioterrorism in the United States, he also has sought to profit from that fear.

By his count, Alibek has won about $28 million in federal grants or contracts for himself or entities that hired him.

He has had well-placed help. Some of the money has been allocated because of a Southern California congressman's "earmarks," controversial budget maneuvers that direct federal agencies' spending. Moreover, two senior aides to a New Jersey congressman who also provided crucial help to Alibek left government and promptly joined his commercial efforts.

Alibek now is seeking new government contracts related to countering biological terrorism that could be worth tens of millions of dollars.

He has followed an unconventional scientific approach, seeking a product that would protect against an array of deadly viruses and bacteria, not just a single germ.

He also is raising money to build a drug-manufacturing plant in the former Soviet republic of Ukraine. From there, his company will seek to sell its antiviral agents and antibiotics to the U.S. government's Strategic National Stockpile, he said.

Thickly built and with willing, if imperfect, English, Alibek said in an interview that his focus had been scientific, "in terms of raising awareness about biological weapons and biological terrorism." An attack, he said, could kill "hundreds of millions, if not billions" of people.

The Los Angeles Times explored Alibek's public pronouncements, research and business activities as part of a series that will examine companies and government officials central to the U.S. war on terrorism.

Uncertainty surrounds the threat of a biological attack. Authorities list no fewer than 30 fungi, bacteria and viruses as potential biological weapons. One agent, anthrax, already has been deployed in the U.S., killing five people in late 2001. Because anthrax spores can be dispersed in a variety of ways — perhaps even by bomb — some experts believe that a well-executed attack could kill millions of people over large areas. Others, citing the vagaries of weather, say that anthrax or other airborne agents are unlikely mass killers
source:www.latimes.com

Respiratory tularemia treatment created

U.S. researchers have developed a technique that has experimentally protected laboratory mice from developing respiratory tularemia.

The respiratory form of tularemia, a potentially serious bacterial disease, is a highly infectious disease with a high mortality rate if untreated. It is also considered a potential bioterrorism tool.

Although much research is focused on fighting the bacterium that causes tularemia -- Francisella tularensis -- little is known about the role that antibodies play in protecting against infection.

In the latest study, a research team led by Dennis Metzger at the Albany Medical College in New York has discovered treating laboratory mice with a serum containing tularemia-specific antibodies protects the mice against F. tularensis, not only if given before exposure to lethal doses of inhalational F. tularensis, but also up to 48 hours after exposure.

The researchers said their findings suggest a possible alternative treatment approach to traditional antibiotics, especially useful in the case of an intentional act of bioterrorism.

The research is reported in The Journal of Immunology.
source:www.sciencedaily.com

Selling The Threat Of Bioterrorism

In the fall of 1992, Kanatjan Alibekov defected from Russia to the United States, bringing detailed, and chilling, descriptions of his role in making biological weapons for the former Soviet Union.

As a doctor of microbiology, a physician and a colonel in the Red Army, he helped lead the Soviet effort. He told U.S. intelligence agencies that the Soviets had devoted at least 30,000 scientists, working at dozens of sites, to develop bioweapons, despite a 1972 international ban on such work.

He said that emigrating Russian scientists and others posed imminent threats. After the breakup of the Soviet Union, he said, several specialists went to Iraq and North Korea. Both countries, he said, may have obtained anthrax and smallpox. The transfer of smallpox would be especially ominous because the Russians, he said, had sought to genetically modify the virus, posing lethal risk even to those who had been vaccinated.

His expertise, combined with his dire pronouncements, solidified his cachet in Washington. He simplified his name to Ken Alibek, became a familiar figure on Capitol Hill, and emerged as one of the most important voices in U.S. decisions to spend billions of dollars to counter anthrax, smallpox and other potential bioterrorism agents.
It was Alibek's revelations, when he defected, that really provided the first information about the scope" of both the Soviet program and the possible proliferation to Iran and Iraq, said Dr. Thomas Monath, who was a top biodefense specialist for the U.S. Army.

Monath, who later led a group of experts that advised the Central Intelligence Agency on ways to counter biological attacks, said Alibek's information resonated at high levels of the U.S. government and was "amplified by 9/11."

"I think he influenced many people who were in position to make some decisions about response," Monath said, adding, "Concern about smallpox, in particular, was driven by Alibek."

Dr. Kenneth W. Bernard, who served President Bush as a special assistant for biodefense, agreed, saying that Alibek "had a substantial and profound effect."

Having raised the prospect that Iraq had acquired the ability to wield smallpox or anthrax, Alibek also was outspoken as the U.S. went to war in early 2003, saying there was "no doubt" that Saddam Hussein had weapons of mass destruction.

Officials still value his seminal depictions of the Soviet program. But recent events have propelled questions about Alibek's reliability:

No biological weapon of mass destruction has been found in Iraq. His most sensational research findings, with U.S. colleagues, have not withstood peer review by scientific specialists. His promotion of nonprescription pills �” sold in his name over the Internet and claiming to bolster the immune system �” was ridiculed by some scientists. He resigned as executive director of a Virginia university's biodefense center 10 months ago while facing internal strife over his stewardship.

And, as Alibek raised fear of bioterrorism in the United States, he also has sought to profit from that fear.

By his count, Alibek has won about $28 million in federal grants or contracts for himself or entities that hired him.

He has had well-placed help. Some of the money has been allocated because of a Southern California congressman's "earmarks," controversial budget maneuvers that direct federal agencies' spending. Moreover, two senior aides to a New Jersey congressman who also provided crucial help to Alibek left government and promptly joined his commercial efforts.

Alibek now is seeking new government contracts related to countering biological terrorism that could be worth tens of millions of dollars.

He has followed an unconventional scientific approach, seeking a product that would protect against an array of deadly viruses and bacteria, not just a single germ.

He also is raising money to build a drug-manufacturing plant in the former Soviet republic of Ukraine. From there, his company will seek to sell its antiviral agents and antibiotics to the U.S. government's Strategic National Stockpile, he said.

Thickly built and with willing, if imperfect, English, Alibek said in an interview that his focus had been scientific, "in terms of raising awareness about biological weapons and biological terrorism." An attack, he said, could kill "hundreds of millions, if not billions" of people.

The Los Angeles Times explored Alibek's public pronouncements, research and business activities as part of a series that will examine companies and government officials central to the U.S. war on terrorism.

Uncertainty surrounds the threat of a biological attack. Authorities list no fewer than 30 fungi, bacteria and viruses as potential biological weapons. One agent, anthrax, already has been deployed in the U.S., killing five people in late 2001. Because anthrax spores can be dispersed in a variety of ways - perhaps even by bomb - some experts believe that a well-executed attack could kill millions of people over large areas. Others, citing the vagaries of weather, say that anthrax or other airborne agents are unlikely mass killers.

Some experts question Alibek's characterizations of the threats.

Dr. Philip K. Russell, a retired Army major general and physician who joined the Bush administration from 2001 to 2004 to confront the perceived threat of smallpox, said he was convinced that Alibek had solid firsthand information about the former Soviet Union's production of anthrax. But regarding other threats, such as genetically engineered smallpox, Russell said he "began to think that Ken was more fanciful than precise in some of his recollections."

"He would claim that certain things had been done, and then when you came right down to it, he didn't have direct knowledge of it - he'd heard it from somebody. For example, the issue of putting Ebola genes into smallpox virus. That was viewed, at least in many of our minds, as somewhat fanciful. And probably not true."

Alibek told The Times that the comments in question were based on articles he read in Russia's "scientific literature."

Big Transition

Alibek, 56, is now a player in the multibillion-dollar business that has sprouted around the U.S. war on terrorism.

It's been a stark transformation for the former Communist military man.

Alibek grew up in Almaty, the capital of the then-Kazakh Soviet Socialist Republic. After entering the Tomsk Medical Institute in Siberia, he studied the 1942-43 battle of Stalingrad.

As he described in a 1999 memoir, "Biohazard," Alibek concluded that the Soviets had waged biological warfare against the Germans and that "large numbers" of the invaders fell ill with tularemia, a deadly infectious disease also known as rabbit fever.

Alibek also described a lesson he learned about the risk of waging germ warfare: Because of a wind shift, the Soviets had inadvertently infected their own troops and civilians, causing perhaps thousands of casualties.

When Alibek emerged with a medical degree, he was recruited by the Soviet government and climbed in military rank while earning a doctorate in microbiology. In 1987, he was promoted to a top position in Biopreparat, the civilian agency that ran the Soviets' secret biological-weapons program.

Alibek has said he worked with numerous lethal agents - including Marburg virus, plague, smallpox and a virulent "battle strain" of anthrax. The Soviets assumed that the U.S., which began developing germ weapons during World War II, maintained its program despite the 1972 international ban.

By the late 1980s, with the Cold War ending, teams of U.S. and Soviet biological warfare experts prepared to visit each other's laboratories to see for themselves.

On Dec. 11, 1991, Alibek and his Soviet colleagues traveled to Ft. Detrick, Maryland, home to the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), where researchers studied how to protect troops from germ warfare, work that was allowed under the 1972 agreement. And Alibek began making personal connections that would soon ease his transition to American life.

None would prove more important to him than his rapport with USAMRIID director Charles L. Bailey, an entomologist and U.S. Army colonel.

Within a year, Alibek resigned from Biopreparat and fled to the U.S. with his wife and three children. Bailey retired from the Army but stayed at Ft. Detrick as an analyst with the U.S. Defense Intelligence Agency.

Bailey's job was to assess what the Russians were up to.

This gave him a close view of Alibek's confidential debriefings with U.S. intelligence agents. The debriefings, Bailey said, provided "very valuable" information about the Russian program. Alibek described threats beyond the Russian borders.

"Alibek thought that every country that had anthrax" also had smallpox, including Iraq, Iran and North Korea, Bailey said.

In the mid-1990s, when Bailey went to work for a Huntsville, Alabama, company with defense and intelligence contracts, Alibek visited frequently. They shared meals, attended horse shows. Alibek seemed to enjoy learning about American life.

"He was easy to like," Bailey recalled. "We became friends."

They also became a commercially sought-after team.

"I helped to build Alibek's reputation with the military," said Bailey. "A lot of people were impressed with Alibek. I was impressed."

The Alabama company also hired Alibek as a consultant, and asked him to compose a history of the Soviet program that could be used by the intelligence community.

In 1997, the two worked together for Battelle, a large nonprofit research and development organization. Next, they moved to Virginia-based Hadron Inc., another firm that had ties to U.S. intelligence agencies. Alibek also circulated among government officials. He privately briefed Gen. Joseph W. Ralston, then vice chairman of the Joints Chiefs of Staff, the nation's second-highest military officer.

Alibek made his first network-television news appearance in February 1998, and three months later testified at a congressional committee hearing on terrorism and intelligence. A news release said Alibek would "provide new information on Russia's offensive biological weapons program."

The only contact listed was a committee staffer named Vaughn Forrest, a onetime candidate for Congress. Forrest in the 1980s had traveled to Afghanistan to support the Muslims who ultimately drove out the invading Soviet Union. In helping Afghanistan's mujahedin, Forrest had developed a productive relationship with the CIA. Forrest introduced Alibek to the chairman of the Senate-House Joint Economic Committee. Forrest took the lead in arranging the hearing.

He and Alibek formed a lasting bond.

In his 1999 memoir, Alibek said that Forrest "was among the first to perceive the potential" for developing a product that would guard against not one, but an array of biological agents.

Forrest introduced Alibek to others who could help, including Florida Republican Bill McCollum, then-chairman of the House Intelligence Committee. Forrest had once been McCollum's chief of staff. McCollum, now Florida attorney general, said Alibek "was worried about what the Soviets had made and what somebody else could get a hold of."

The list of identified suspects, McCollum said, included Libya, Iran and Iraq.

"I thought we had a real threat from this," McCollum said, adding that he distributed Alibek's book to "people in the administration and also members of Congress."

When Forrest left the congressional payroll, he became a consultant to Hadron Inc., where Alibek and Bailey worked. Forrest later became a director with Alibek in a successor company. Forrest declined to be interviewed for this report.

Alibek's public profile rose after the Sept. 11 attacks and the mailings of anthrax a month later that killed five people.

Appearing before a House subcommittee on national security in October 2001, Alibek said that earlier "attempts to wipe out Iraq's biological weapons capability were probably not successful." He also told the subcommittee that Russian biological weapons experts had "emigrated to rogue nations such as Iraq." As the U.S.-led war got underway in March 2003, Alibek said during an online discussion hosted by the Washington Post: "There is no doubt in my mind that [Saddam] Hussein has WMD."

Fear that Iraq possessed smallpox was emphasized by the Bush administration leading up to the war. As Congress prepared to vote on whether to authorize war, then-Defense Secretary Donald H. Rumsfeld told the House Armed Services Committee on Sept. 18, 2002, that a smallpox attack by Iraq could kill as many as 1 million Americans and infect an additional 2 million.

Alibek has not retreated from his statements regarding Iraq's possession of smallpox or other biological weapons. He said in an interview that he had "talked to people who actually visited the Iraqi sites. And they said they had no doubt [there] was an offensive biological weapons program…. We need to look for the traces."

It is a lonely position today.

"There's been a lot of people thrashing around there for the last five years," said Russell, the retired general. "I don't think anybody could have hid it."

Alibek's most reliable benefactor in Washington, D.C., has been Rep. H. James Saxton (R-New Jersey), a gravelly voiced former elementary school teacher and state legislator. Saxton says that for two decades, he has focused on the threat posed by Islamic terrorism.

For most of the last decade, Saxton chaired the House Armed Services Committee's terrorism subcommittee and also headed the Joint Economic Committee, where Forrest landed as a senior aide.

On May 21, 2002, Saxton called a news conference to announce "a potential new defense against bioterrorism," based on Alibek's tests with mice. After being treated with an experimental product, the mice had survived doses of smallpox and anthrax.

Saxton at the time said that the results held hope for "lifting some of the burden of fear that haunts Americans."

And, while fighting for an earmark of federal grant money for Alibek at a March 2004 hearing, Saxton upbraided Anthony Tether, the Bush administration's director of the Defense Advanced Research Projects Agency (DARPA).

"You need to be more on his side," Saxton said of Alibek, adding: "I find it hard to believe that I have to fight as hard as I can to get a few measly bucks to keep him going."

Tether assured Saxton that he would accede to his wishes. Tether did so - and fresh grant money was sent for Alibek's research.

Tether said that he had resisted spending more on Alibek's research because his "cocktail approach" - mixing more than one drug with other ingredients in search of a product that might protect against smallpox, anthrax and plague - made it "very hard to determine what is working and what is not."

The research could have dragged on for years with the ambiguous results, Tether told The Times.

"After the [March 2004] hearing, I basically said, 'OK, this is it, Alibek. You're either going to get over here and listen … or you're not going to get a nickel from us'," said Tether.

He preserved the funding, said Tether, after Alibek agreed privately to change his approach and perform experiments outlined by Tether's staff. Some of Alibek's subsequent work with mice has shown promise, said Tether.

Alibek also has been helped by Mark A. O'Connell, a lobbyist and Republican fundraiser who for a decade served as Saxton's congressional chief of staff. (Campaign contributions in recent years to Saxton from Alibek, Alibek's wife and one of their business partners have totaled $14,450, public records show.)

O'Connell said he began lobbying Congress for Alibek's company in mid-2003, two months after he left Saxton's staff. His congressional salary, O'Connell said, was slightly below a revolving-door threshold that would have barred him from lobbying Saxton or his staff for one year. He confirmed that he had lobbied for the congressional earmarks benefiting Alibek's company.

Saxton acknowledged in an interview that he had done much for Alibek since Forrest brought them together about a decade ago:

He said he introduced Alibek to then-Speaker of the House Newt Gingrich and to other congressional and executive-branch leaders. Among them was Rep. Jerry Lewis (R-Redlands), who from 1999 to 2005 was chairman of the subcommittee that controlled spending for national security projects. Lewis headed the full House Appropriations Committee from 2005 to 2006.

Lewis, Saxton said, began providing the annual earmarks of federal money for Alibek's projects.

"We were able to convince Jerry Lewis to begin an appropriations stream for him," said Saxton.

Lewis' spokesman, Jim Specht, did not return telephone calls seeking an interview with the congressman. Earmarks generate controversy because they enable some projects to win federal funding based more on political influence than competitive merit. And earmarks can be carried out discreetly, obscuring the identity of the originator.

This year, Saxton said, he has guided Alibek as he seeks an additional $10 million in research funds - from the U.S. Defense Threat Reduction Agency.

Saxton said that he had helped Alibek solely to bolster national security.

"I was committed to do whatever I could do to help develop an answer to problems posed by bioterrorism," he said.

"And if they had worked for Alibek or not, I would have been just as committed," he added, referring to Forrest and O'Connell.

Alibek's federal research money also has come from the Army Medical Research and Materiel Command, the National Institutes of Health, the Department of Energy and the State Department, according to company and government documents.

The company that Alibek formed and for which Forrest serves as general manager and as a director, AFG Biosolutions Inc., has said that it is developing "a new generation of vaccines" and medicines for anthrax, smallpox, plague and tularemia.

Claims In Question

Some of the projects Alibek has helped lead were promoted heavily but faltered.

One sensational claim came in a Sept. 11, 2003, news release from Virginia's George Mason University, where Alibek two years earlier arrived on the faculty.

Findings from laboratory research led by Alibek and another professor, the news release said, suggested that smallpox vaccination might increase a person's immunity to HIV, the virus that causes AIDS. The release quoted Alibek saying, "Our outcomes are very encouraging."

University President Alan Merten weighed in, saying the research might "produce dramatic, practical benefits for future generations."

Scientists elsewhere were less enthused.

They pointed out that George Mason had announced the results even though the Journal of the American Medical Association had declined to publish them. Alibek and his colleagues also submitted a paper summarizing the research to another prominent medical journal, the Lancet.

The paper "was rejected after peer review," said Dr. Sabine Kleinert, senior executive editor of the Lancet, in an e-mailed comment.

More than three years later, no published study has replicated the provocative results touted by Alibek and his colleagues at George Mason. Neither Alibek nor his principal collaborator, who had worked at another university, is still pursuing the project.

"This is a theory that, I must say, does not hold up at all, and it does not make any sense from a biologic point of view," said Dr. Donald A. Henderson, a former White House science advisor whose work with the World Health Organization is credited with eradicating smallpox outbreaks globally. "This idea … was straight off the wall. I would put no credence in it at all."

Alibek said that it was not his decision alone to issue the September 2003 news release. He ascribed others' criticisms to professional jealousies.

Apart from the university or his company, Alibek has used his ties with the government to promote "Dr. Ken Alibek's Immune System Support Formula," nonprescription pills sold over the Internet. Advertisements for the product described Alibek as a biological and medical expert who had "testified before Congressional committees and is a frequent consultant to the U.S. government."

Alibek acknowledged that he did "consulting work" for a dietary supplement company that distributed the product in his name, but said that he was not paid for subsequent sales. However, an aide to the chief executive of the company, Vital Basics Inc., said that Alibek was paid.

More recently, Alibek's warnings of bioterrorist threats echoed in the debate surrounding "Project Bioshield," signed into law by Bush in July 2004. The program, with an initial budget of about $5.6 billion, aims to encourage companies to develop vaccines or other products that could counter a biological or chemical attack.

And, as Alibek has warned Congress that enemies of the U.S. have sought genetically altered biological agents to resist antibiotics or vaccines, he has promoted products that would address those very threats:

In 2004, a San Diego, California, company, Aethlon Medical Inc., signed Alibek to its advisory board and issued a report, co-written by Alibek, which said its product for filtering toxins from blood "could be rapidly deployed even against genetically altered biowarfare agents."

Alibek's report emphasized the availability of federal funds, including from Project Bioshield. Aethlon said that Alibek served without pay on the advisory board but "may be compensated for future consulting work."

Alibek also hopes to tap into Project Bioshield with his own company.

He said that he expected to submit a proposal to sell what could be millions of dollars of medicines to the government for use in the event of a terrorist attack or other emergency. As envisioned by Alibek, his drug facility in the Ukraine would produce generic versions of antiviral agents or antibiotics at a cost "three, four, five times lower" than if they were made in the U.S.

Meanwhile, within the last year an internal controversy flared regarding Alibek's leadership of the National Center for Biodefense and Infectious Diseases, a fledgling graduate program at George Mason. Alibek resigned as a tenured and distinguished professor there last Aug. 31.

University spokeswoman Christine LaPaille confirmed the resignation and said that George Mason was no longer collaborating with Alibek's company on research backed by any of the recent federal grants or contracts. LaPaille declined to comment on the circumstances surrounding Alibek's departure.

Alibek said the college administration had grown displeased with his company's role in sharing grant-funded research. The university, he said, requested that he dismantle or leave AFG Biosolutions. He chose to resign from George Mason.

This spring, Alibek traveled to the Ukrainian city of Kiev to push his plans for the drug-manufacturing plant and for a center for cancer and cardiac care. He did so after making comments, reported by the Russian news agency Interfax, which struck some officials in Washington as inconsistent with his previous dramatic claims:

Since 1992, Alibek has told U.S. intelligence agencies, and later general audiences, that Russia had persisted in developing biological weapons. For instance, in his memoir, "Biohazard," subtitled, "The Chilling True Story of the Largest Covert Biological Weapons Program in the World - Told From Inside by the Man Who Ran It," Alibek wrote in 1999:

"I am convinced that a large portion of the Soviet Union's offensive program remains viable despite [then-President Boris N.] Yeltsin's ban on research and testing."

And in a September 2000 interview with an online publication sponsored by the U.S. Department of Homeland Security, Alibek said:

"Russia is still retaining its biological weapons capability, specifically at the Ministry of Defense. The Ministry of Defense is maintaining four major research and production sites, which are still active."

But as reported by Interfax, Alibek in November 2005 told a different story in his ancestral hometown of Almaty: As of the early 1990s, Alibek said, the Russians had stopped "all work to develop biological weapons."

The arc of Alibek's statements has not been lost on Bailey, the former USAMRIID chief who remains at George Mason after having been recruited there six years ago by his former friend. Does the inconsistency cause him to reassess Alibek's earlier statements regarding global biological threats?

Bailey answered quietly.

"Definitely, it does."

After helping to lead the Soviet Union's germ-weapons program, Dr. Ken Alibek defected to the U.S. and began warning about the threat of a mass-casualty biological attack. Alibek also has sought to profit from the fear of such weapons of mass destruction, landing federal contracts or grants for himself or entities that hired him totaling about $28 million, including several listed below.
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