Dr. C.J. Peters warns of bioterror threat
by Ashton Daigle on May 27, 2010
According to Dr. C.J. Peters, former chief of special pathogens for the Centers for Disease Control and former head of the U.S. Army's Medical Research Institute of Infectious Diseases disease assessment division, bioterrorism is a very real threat.
Peters, in an interview with WebMD, noted that, first and foremost, bioterrorism is a very complex issue and that biological attacks could come in a variety of different ways. Tularemia, plague, smallpox, anthrax, and viral hemorrhagic fevers, like Ebola, all pose potential threats.
"Those bugs can all be grown in large quantities at a special state-sponsored factory or some other factory such as the Japanese terrorist cult in Tokyo," Peters told WebMD. "They could be spread around in an airborne fashion so as to infect many people.
"The only one of these that can spread from person to person is smallpox. The others only have limited ability to spread from one person to another."
There is a concern that smallpox has or could fall into terrorist hands, Peters said.
"That is why the government has 7.5 million doses of smallpox vaccine stored away and why they are contracting to make 300 million more doses," Peters told WebMD. "The other bugs can make you very sick and have a mortality rate of up to 100 percent if not treated, but they won't spread and cause an epidemic."
Peters stressed it's a fool's game to try to outguess terrorists because they all have different motives, capabilities and abilities. The answer, he said, lies in strengthening our public health infrastructure.
"There are some things that we must guard against more specifically, and those are anthrax, smallpox, plague, tularemia and the viral hemorrhagic fevers," Peters told WebMD. "These are capable of causing so many deaths and such disruption that we are obliged to make specific plans for them. That's why the U.S. is purchasing additional smallpox vaccine and has been stockpiling antibiotics."
As far as the threat posed by bioterrorist attack, Peters said the threat is real.
"Three months ago you could mention the idea of bioterrorism at any level and someone would quickly give you 10 reasons why it could not possibly happen," Peters said. "Nevertheless, government reports based on very bright and well-informed persons who had no ax to grind, said that we should be worried about terrorism in general, including explosives, nuclear devices, biological agents, and chemical agents. There warnings were unequivocal."
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Cat Gets Rare Tick Disease
Lynchburg, VA - Pet owners listen up. A rare and deadly disease is popping up in the area. The symptoms are that of the flu -- but without aggressive supportive intensive care, it's fatal. Only cats can get this disease... but it is a silent killer. It's called Cytauxzoonosis and once the symptoms pop up -- most cats have about 24 hours until their bodies start to completely shut down. Rick McMullen, Owner -- "Oscar is always first at our front door to get outside and he wasn't there. That was the first time in his life he has not been at the front door." Rick McMullen knew something was wrong with his normally very active four-year-old cat. Instead of bounding around, Oscar was sleeping... his body warm. A day later -- things got worse. McMullen -- "He was just like a limp dish rag." The next day - he couldn't get up. McMullen -- "He just didn't move all day." McMullen took Oscar to the vet. McMullen -- "He said I have some very bad news." Oscar had cytauzoonosis. Dr. Scott Miller, Addison Animal Hospital -- "It's a blood parasite that they get from ticks that have actually been in contact with bobcats." There is no treatment. McMullen had one choice. McMullen -- "You have to euthanize Oscar. You have to do it within 24 hours, he said." ... or watch Oscar die right in front of him. But he wouldn't give up... taking Oscar to the college of veterinary medicine at North Carolina state - for intensive care. McMullen -- "It's horrific. The treatment itself is terrible. It involved force feeding. They've got to put the cat on a 24 hour a day EKG." McMullen -- "It's got to have lines inserted to give it drugs, it's got to have blood thinners, it's got to have antimalarial drugs." McMullen -- This whole process has cost us many, many, thousands of dollars." McMullen -- "It's worth every penny." There are no guarantees with the treatment -- cats that undergo it only have about a 60-80 percent chance of surviving. There is no practical way to prevent this other than good tick control. Veterinarians recommend using some type of monthly tick preventative.
http://www.wset.com/news/stories/0510/740460.html
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Emergent's Shofe advocates Strategic National Stockpile
by Nick Rees on May 27, 2010
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Allen Shofe
Anthrax is heavily pursued by potential terrorists for its ease of manufacture, ease of delivery and longevity, Allen Shofe, senior vice president of public affairs at Emergent BioSolutions, Inc., said.
Anthrax spores, which are found in nature, can be produced by dual-use technology, or technology that can be used for both peaceful and military.
Once produced, anthrax spores are easily spread by missiles, rockets, artillery, aerial bombs and sprayers. The resulting release can travel downwind for hundreds of miles, Shofe said.
The spores are also incredibly long lived and able to remain dormant in soil for decades. An island used by the British for anthrax experiments in World War II had to be decontaminated 40 years later.
In addition, Shofe says, anthrax bacteria are odorless, colorless and tasteless and, therefore, there is limited detection capability available to combat such an attack.
An anthrax attack would also cause more carnage than a traditional weapon.
"The devastating effect of a small amount of anthrax spores used as a biological weapon is equivalent to the effect of a major chemical or nuclear attack," Shofe said.
To combat a potential bioterror attack, Shofe has advocated for the Strategic National Stockpile, which he says serves to protect the civilian population while supplying materials to both state and local governments for distribtution to affected areas.
The stockpile also provides a centralized maintenance and replenishment of desperately needed products and complements the conventional defenses currently being stockpiled.
There is a renewed international focus on preparedness and response measures for a biological attack, Shofe said, with the European Commission taking action to develop a comprehensive action plan to address CBRN threats. The commission has placed a significant focus on the biological subgroup of weapons to create appropriate strategies for countermeasure acquisition and stockpiling.
China, Malasyia and Singapore have recently recognized the international nature of a biological attack and have expressed a desire to improve their countermeasures and strategies.
In the Middle East, India has begun approving more products to combat CBRN attacks and held multiple symposia on countermeasures.
"Terrorism, biological or otherwise, has truly become a global problem," Shofe said.
Shofe says that the steps needed for bioterror-related preparedness on both a national and international scale include ensuring the availability of adequate numbers of immunized military and critical response personnel and the development of military, first responder and civilian immunization plans.
Additionally, adequate stockpiles of antibiotics and vaccine are needed as well as the development of clear-cut distribution logistics.
http://www.bioprepwatch.com/news/213221-emergents-shofe-advocates-strategic-national-stockpile
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Safety Rules Can't Keep Up With Biotech Industry
By ANDREW POLLACK and DUFF WILSON
They are the highly trained, generally well-paid employees in the vanguard of American innovation: people who work in biotechnology labs. But the cutting edge can be a risky place to work.
The casualties include an Agriculture Department scientist who spent a month in a coma after being infected by the E. coli bacteria her colleagues were experimenting with.
Another scientist, working in a New Zealand lab while on leave from an American biotechnology company, lost both legs and an arm after being infected by meningococcal bacteria, the subject of her vaccine research.
Last September, a University of Chicago scientist died after apparently being infected by the focus of his research: the bacterium that causes plague.
Whether handling deadly pathogens for biowarfare research, harnessing viruses to do humankind's bidding or genetically transforming cells to give them powers not found in nature, the estimated 232,000 employees in the nation's most sophisticated biotechnology labs work amid imponderable hazards. And some critics say the modern biolab often has fewer federal safety regulations than a typical blue-collar factory.
Even the head of the federal Occupational Safety and Health Administration acknowledges that his agency's 20th-century rules have not yet caught up with the 21st-century biotech industry.
"Worker safety cannot be sacrificed on the altar of innovation," said David Michaels, OSHA's new director. "We have inadequate standards for workers exposed to infectious materials."
The current OSHA rules governing laboratories, for example, were not written with genetic manipulation of viruses and bacteria in mind. "The OSHA laboratory standard deals with chemicals," Mr. Michaels said. "It doesn't deal with infectious agents."
Earlier this month, as a first step toward possible new regulations, the agency issued a sweeping request for information on occupational risks from infectious agents, and for suggestions on how best to reduce them. The focus is mainly on hospital and other health care workers, but any rules are expected to also cover industry laboratory workers.
Some safety experts in the biotechnology industry argue that there is no big safety problem, and that workers are adequately protected by various voluntary guidelines on safe laboratory practices and by OSHA's general rule that employers provide a safe workplace.
"The OSHA requirement applies to all industries, including the pharmaceutical industry," said John H. Keene, a biosafety consultant to industry and former president of the American Biological Safety Association, a professional society for those involved in biolab safety.
But at least three trends are stoking concern among safety advocates. In the wake of the 2001 anthrax attacks, the federal government stepped up research involving biowarfare threats, like anthrax, Ebola and many other of the world's deadliest pathogens. Another factor is that the new techniques of so-called synthetic biology allow scientists to make wholesale genetic changes in organisms rather than just changing one or two genes, potentially creating new hazards. Just this month, the genome pioneer J. Craig Venter announced the creation of a bacterial cell containing totally synthetic DNA, which Dr. Venter described as the first species "whose parent is a computer."
The third trend involves the shifting focus of the pharmaceuticals industry — potentially the largest source of new biotechnology jobs. Drug makers, responding to competition from cheap generic medications, are moving beyond the traditional business of making pills in chemical factories to focus instead on vaccines and biologic drugs that are made in vats of living cells.
There are currently few good statistics on biolab accidents. One study, reviewing incidents discussed in scientific journals from 1979 to 2004, counted 1,448 symptom-causing infections in biolabs, resulting in 36 deaths. About half the infections were in diagnostic laboratories, where patient blood or tissue samples are analyzed, and half in research laboratories.
But that may be a "substantial underestimation," the study's authors wrote, because many incidents are never made public. The study was done by two biosafety experts and published in the book "Biological Safety: Principles and Practices."
A survey done by the Bureau of Labor Statistics in 2006 found that the rate of workplace injury and illness in corporate scientific research laboratories was well below the average for all industries. The survey included labs in industries like information technology as well as biotechnology, and excluded labs handling the most dangerous pathogens.
Allegations about a more recent case came to light only through a lawsuit. It was filed against the drug giant Pfizer by Becky McClain, a former molecular biologist at the company's largest research center, which employs 3,500 people in Groton, Conn.
Ms. McClain, now 52, says she has suffered bouts of temporary paralysis after being infected by a genetically engineered virus at the Groton lab. A jury last month awarded Ms. McClain $1.37 million, saying Pfizer had fired her for raising questions about laboratory safety.
Pfizer said it went to considerable effort to accommodate Ms. McClain and dismissed her for refusing to return to a safe workplace. The company also pointed out that OSHA had found that Ms. McClain was not fired for raising safety concerns. But the jury ruled otherwise, saying Ms. McClain was indeed fired for raising safety concerns of public interest.
The jury never actually addressed whether a workplace virus had made Ms. McClain ill, because the judge threw out that claim, in part for lack of evidence. Mr. Michaels, the OSHA director, declined to comment on the McClain verdict, but said the issues under dispute in her case underscored the gaps in regulatory protection for lab workers.
For almost all private businesses, OSHA requires employers to report workplace deaths and serious accidents. But the information is usually kept in-house by employers and given to OSHA only if requested during an annual spot check of 80,000 companies — a small fraction of the approximately seven million employers bound by OSHA regulations.
Moreover, OSHA does not have jurisdiction over many academic and government biolabs, where there have been dozens of known cases of worker illness or at least exposure to harmful agents.
Many laboratories in both the public and private sectors adhere to practices in a safety manual published jointly by the Centers for Disease Control and Prevention and the National Institutes of Health. Employees of government biolabs and others that receive federal research grants for genetic engineering are covered in part by stricter guidelines from the National Institutes of Health, and some companies voluntarily follow those guidelines. But other private industry workers are dependent on OSHA.
Mr. Michaels said that rather than trying to establish new rules for each infectious agent or for any specific hazards, he expected OSHA to eventually require employers, in consultation with their employees, to identify all potential hazards in their workplaces and to take steps to reduce them. OSHA would then have the power to cite employers for failure to adequately implement this process.
"OSHA has 2,000 inspectors for 130 million-plus workers in seven million workplaces," Mr. Michaels said. "We can't take them on one at a time."
Despite the fact that some worker advocates are pointing to Ms. McClain's case as representative of broader problems, they are hard pressed to cite other examples of workers in biotechnology companies being harmed.
But these advocates contend that the reason more cases in private industry are not coming to light is that current rules do not put enough pressure on companies to report them. And OSHA's general safety requirement is notoriously difficult to enforce.
"We don't know how many Becky McClains there are," said Adam M. Finkel, who worked for OSHA both as a regional administrator and a director of health standards. "Everybody knows there's new stuff being made every day that's incredibly dangerous, but nobody knows how to get their arms around it."
http://www.nytimes.com/2010/05/28/business/28hazard.html?src=busln
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