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March 31st, 2006 posted by Paul Rega, MD, FACEP March 31, 2006 @ 7:37 am

New England Journal of Medicine study about a new H5N1 vaccine

Safety and Immunogenicity of an
Inactivated Subvirion Influenza A (H5N1)
Vaccine

John J. Treanor, M.D., James D. Campbell, M.D., Kenneth M. Zangwill, M.D., Thomas Rowe, M.S., and Mark Wolff, Ph.D.

   

[ClinicalTrials.gov] .)

Comment:  Despite receiving twelve times the standard vac`cine dose for flu, slightly more than 1/2 the recipients achieved adequate antibody response.    An accompanying editorial stated that if it required these high doses to achieve some immunogenicity, the vaccine companies could only produce enough vaccine to vaccinate 75 million people around the world (1.25%) and just about 1/2 of them would be protected.  Anyway, it’s a good first step according to experts and no serious side effects were reported.



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March 31st, 2006 posted by Paul Rega, MD, FACEP @ 7:37 am

New England Journal of Medicine study about a new H5N1 vaccine

Safety and Immunogenicity of an
Inactivated Subvirion Influenza A (H5N1)
Vaccine

John J. Treanor, M.D., James D. Campbell, M.D., Kenneth M. Zangwill, M.D., Thomas Rowe, M.S., and Mark Wolff, Ph.D.

   

[ClinicalTrials.gov] .)

Comment:  Despite receiving twelve times the standard vac`cine dose for flu, slightly more than 1/2 the recipients achieved adequate antibody response.    An accompanying editorial stated that if it required these high doses to achieve some immunogenicity, the vaccine companies could only produce enough vaccine to vaccinate 75 million people around the world (1.25%) and just about 1/2 of them would be protected.  Anyway, it’s a good first step according to experts and no serious side effects were reported.



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March 31st, 2006 posted by Paul Rega, MD, FACEP @ 7:11 am

Earthquake in Iran

Iranian news reports an early morning earthquake in Iran.  Right now the numbers are 38 dead and about 700 injured.

Keep tuned.  These numbers are preliminary.



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March 30th, 2006 posted by Paul Rega, MD, FACEP March 30, 2006 @ 6:49 am

FDA Approves a Second Drug for the Prevention of Influenza A and B in Adults and Children

FDA News

FOR IMMEDIATE RELEASE
P06-43
March 29, 2006

Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

The Food and Drug Administration (FDA) today approved the use of Relenza (zanamivir for inhalation) for prevention (prophylaxis) of influenza (flu) in adults and children 5 years of age and older. Relenza, an antiviral medication, was previously approved for the treatment of influenza A and B virus infections in adults and children. Tamiflu (oseltamivir phosphate) previously was approved for both prevention and treatment of flu; today’s approval of Relenza for prevention provides Americans with another option for the prevention of influenza A and B infections.

“This approval is a welcome addition to the available defenses against the flu,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “This new use offers the medical community another option to prevent and control influenza A and B.”

The effectiveness of Relenza in preventing seasonal influenza has been demonstrated in four large-scale studies comparing the drug with placebo. In two of these trials, the use of the drug substantially reduced the spread of influenza in the participating households where participants were five years of age or greater. In both of these trials, the proportion of households that developed symptoms confirmed to be flu was 19.0% for the placebo group and 4.1% for the Relenza group.

In the other two trials, which were conducted in communities experiencing an influenza outbreak, Relenza reduced the incidence of the disease in both young and older populations. In the first study, with participants 18 years of age or older, the proportion of people who developed symptoms confirmed to be flu was 6.1% for the placebo group and 2.0% for the Relenza group. The second community study enrolled people 12 to 94 years of age (56% of whom were older than 65 years). In this trial, the percent of people who developed symptoms confirmed to be flu were reduced from 1.4% of the participants on placebo to 0.2% for those who used Relenza.

In all of these studies, the most common events during treatment with Relenza in adults and adolescents were headaches; diarrhea; nausea; vomiting; nasal irritation; bronchitis; cough; sinus infections; ear, nose, and throat infections; and dizziness. In children, the most common side effects were ear, nose, and throat infections; vomiting; and diarrhea. Less common reported events included rashes and allergic reactions, some of which were severe.

Breathing problems (bronchospasm), including deaths, were reported in some patients after the initial approval of Relenza. Most of these patients had asthma or chronic obstructive pulmonary disease. Relenza therefore is not recommended for treatment or prophylaxis of seasonal influenza in individuals with underlying airways disease such as asthma or chronic obstructive pulmonary disease.

Relenza has not been proven effective for treatment of influenza in people with underlying airways disease, or for prevention of influenza in nursing homes. The drug is also not a substitute for the flu vaccine, which is the primary means for preventing influenza. Consumers should continue receiving an annual flu vaccination according to guidelines on immunization practices.

In preparation for a potential pandemic, FDA has assembled an agency-wide Pandemic Influenza Preparedness Task Force to provide policy leadership and strategic planning on pandemic influenza. The Task Force is charged with developing a comprehensive plan to accelerate the development, production, and regulatory review of antivirals and other pandemic countermeasures.

FDA also is working with the pharmaceutical industry to make available appropriate products and ensure that mechanisms are in place to collect the necessary efficacy and safety information. Both Relenza and Tamiflu have been identified for stockpiling.

Relenza is manufactured and distributed by GlaxoSmithKline Inc., based in Research Triangle Park, N.C.



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March 28th, 2006 posted by Paul Rega, MD, FACEP March 28, 2006 @ 6:23 pm

Hurricane Katrina and the BIg Easy’s Health Infrastructure

Hurricane Katrina: Status of the Health Care System in New Orleans and Difficult Decisions Related to Efforts to Rebuild It Approximately 6 Months After Hurricane Katrina. GAO-06-576R, March 28
http://www.gao.gov/cgi-bin/getrpt?GAO-06-576R



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March 28th, 2006 posted by Paul Rega, MD, FACEP @ 6:53 am

This day in history

On March 28, 1979, America’s worst commercial nuclear accident occurred inside the Unit Two reactor at the Three Mile Island plant near Middletown, Pa.



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March 28th, 2006 posted by Paul Rega, MD, FACEP @ 6:48 am

Testers Slip Radioactive Materials Over US Borders

March 28, 2006

WASHINGTON, March 27 — Undercover Congressional investigators successfully smuggled into the United States enough radioactive material to make two dirty bombs, even after it set off alarms on radiation detectors installed at border checkpoints, a new report says.

The test, conducted in December by the Government Accountability Office, demonstrated the mixed progress by the Department of Homeland Security, among other federal agencies, in trying to prevent terrorists from smuggling radioactive material into the United States.

Many border crossing points, including many seaports, still have no detection equipment, the report says.

In the test case, undercover investigators bought a small amount of radioactive material, most likely cesium. Then on Dec. 15, they drove across the border at undisclosed locations from Canada and Mexico, intentionally picking spots where the detection equipment had been installed.

The alarms went off in both locations, and the investigators were pulled aside for questioning. In both cases, they showed the agents from the Customs and Border Protection agency forged import licenses from the Nuclear Regulatory Commission, based on an image of the real document they found on the Internet.

The problem, the report says, is that the border agents have no routine way to confirm the validity of import licenses.

Also, so far, about 670 of the planned 3,034 primary radiation detection monitors are in place, and at the rate they are being installed — 22 a month on average last year — the Homeland Security Department will not meet its September 2009 goal, the report said.



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March 28th, 2006 posted by Paul Rega, MD, FACEP @ 6:39 am

The Inside Scoop on the Anthrax Survivor: Vado Diomede

This is from last week’s NY Post:

By this time vado should be released from the hospital.  A phot in the Post shows him looking drawn, but happy.  He’s lost nearly 50 lbs. during his sickness.

His was the first naturally-occurring case of inhalational anthrax in the US since 1976.

The doctors were optimistic about a full recovery, but he will be maintained on an antibiotic regimen after his release.  His pulmonary function is still abnormal according to one of the doctors, and the hope is that the entertainer will dance again, probably in terms of months, not days.

Vado speculated that he acquired the disease from cutting a large cow skin to make drums.  He said it was very dirty and full of dark powder. 

 

Way to go, Vado!!



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March 28th, 2006 posted by Paul Rega, MD, FACEP @ 6:29 am

Mild H5N1 cases weren’t missed in Cambodian outbreak

Mar 27, 2006 (CIDRAP News) – Researchers who looked for mild or asymptomatic human cases of H5N1 avian influenza following an outbreak in Cambodia last year didn’t find any, challenging the view that human cases have gone undetected, according to findings presented last week.

The research described Mar 20 at the International Conference on Emerging Infectious Diseases in Atlanta implies that the findings imply that the case-fatality rate for avian flu is higher than some experts thought.

Dr. Philippe Buchy and his colleagues at the Institut Pasteur in Phnom Penh last spring tested blood samples from 351 residents of a Cambodian village where poultry and one person had died of avian flu, the CP reported. No signs of antibodies to H5N1 were found in the samples, indicating the residents had not suffered even mild cases of avian flu.

Some of the people tested had “significant” exposure to poultry or infected peopleA doctor who inserted a tube down an H5N1 patient’s windpipe without wearing any protective gear did not show any antibodies indicating infection. The same was true for other healthcare workers, including two veterinarians who had autopsied H5N1-infected birds. The healthcare workers did not know at the time they were dealing with avian flu cases.

 The data indicate the virus still finds it difficult to jump from poultry to man.  On the other side of the coin, it means that the case-fatality rate is still very high.

Experts have suggested that the current case fatality rate for avian flu, about 56%, could be inaccurate because milder or asymptomatic cases have not been identified.

“The work in Cambodia is extremely important because it shows that we really aren’t missing that much,” Cox told the CP. However, she added that it is important to conduct research on a larger scale to determine whether mild or asymptomatic cases are occurring, and said such studies are planned.



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March 27th, 2006 posted by Paul Rega, MD, FACEP March 27, 2006 @ 11:10 am

Despite 9/11 Effect, Railyards Are Still Vulnerable

NEWARK — Two signs just inside the entrance of the Oak Island rail depot here hint at dangers inside. “Our Employees’ Safety Is in Your Hands.” one reads. “You Are Accountable for Your Safety,” reads another.

Beyond those two placards, however, there are few visible signs that security is a high priority at the railyard, just three miles from downtown Newark and seven miles from Manhattan, where 90-ton tanker cars full of deadly chemical gases are routinely stored and shipped.

Gates to the depot are unlocked and unguarded, allowing unimpeded access to tracks where cars loaded with deadly chlorine, ammonia or oleum gases are stored.

Along the track bed, many switching devices are unlocked, so unauthorized passers-by could redirect, and possibly derail, a train by simply pulling a lever. Security is so lax that a reporter and photographer recently spent 10 minutes driving along a rail bed beside cars holding toxic chemicals without being challenged, or even approached, by railroad employees.

In the years since the 9/11 attacks, public concern about a potential terrorist strike at one of the nation’s chemical plants has caused federal and local officials to inch toward tighter safeguards at manufacturing and processing plants. On Tuesday, in a speech before the American Chemistry Council, Michael Chertoff, secretary of homeland security, said he would ask Congress to adopt a series of chemical plant security measures that have largely been endorsed by the industry.

Even if the chemical plants are secure, the public could be left vulnerable by the railways running in and out of many of them. The railways transport more than 1.7 million shipments of hazardous materials every year, including 100,000 tank cars filled with toxic gases like chlorine and anhydrous ammonia.

According to a recent study by the Navy, an accident or terrorist attack involving a single car of chlorine near a densely populated area could kill as many as 100,000 people.

In New Jersey, where so many chemical factories and refineries are crowded near major population centers, including a stretch near Newark Liberty International Airport that has been called “the most dangerous two miles in America,” the difficulty of managing that potentially deadly cargo is particularly complex.

Since 9/11, railroads have spent millions to install fences and security cameras and add additional officers around the state, but industry officials concede that their facilities are far too large to be completely sealed. Leaders of railroad workers’ unions say it is not uncommon for tanker cars to be left unattended for days, and that security along the rails is frighteningly inadequate. And the sight of graffiti-covered tank cars filled with deadly gases is a reminder of the holes in the security system.

State and local officials say they are limited in what they can do to regulate the thousands of tank cars of deadly gases hauled around New Jersey each year. In other cities and states, proposals to reroute dangerous chemicals away from major population centers, most notably in Washington, D.C., have faced fierce opposition and legal challenges from both the railroads and local communities where the chemicals would be rerouted. The courts have also upheld the railroads’ assertion that only the federal government can regulate rail traffic.

The Homeland Security Department has been reluctant to tighten regulations regarding the transportation of deadly chemicals by rail. In his speech last week, Mr. Chertoff made only passing reference to the risks of transporting the deadly cargo, and there is no indication that the department will require the kind of changes in equipment and procedures that security experts say will reduce the risk of a terrorist attack or catastrophic accident.

“Chemical transport is clearly the greatest vulnerability in the country today, and for some reason — and I’m not sure what it is — the federal government has not acted,” said Richard A. Falkenrath, President Bush’s former deputy homeland security adviser. “There’s no legislation necessary, the government already has the authority to require stronger containers, reroute shipments, and allow the kind of tracking that would allow local police agencies to know what they have to contend with in their communities. But to date it hasn’t been done.”

The risks involved in moving toxic rail cargo are a particular concern in New Jersey. Last fall, it became the first state to enact regulations intended to deter terror attacks on chemical plants by requiring companies to explore the feasibility of switching to safer technologies.

Because many of the railyards in New Jersey are near petroleum storage tanks, natural-gas depots, or propane tanks, the effect of an attack on a rail car is likely to be magnified, said Paul DeMatteis, a security analyst at Global Security Risk Management, a corporate security company.

When Gov. Jon S. Corzine was still in the United States Senate, he helped write federal legislation to tighten safety standards for both chemical plants and the railroads that supply them.

Since being sworn in as governor two months ago, Mr. Corzine has earmarked $20 million to strengthen security around New Jersey’s critical highways, rail links and bridges against possible terror attacks, and vowed to strengthen safeguards at railway chemical depots and plants around the state.

The vulnerability of the rail lines has even undercut some of New Jersey officials’ progress in making chemical plants safer. Last fall, owners of the Keene Chemical plant in Kearney agreed to reduce their stockpiles of chlorine by keeping no more than one tanker car of chlorine on the premises at a time. That policy means that tanker cars that were once stored in the moderately guarded chemical plant will spend more time waiting on less secure railway sidings.

“It’s this shell game,” said Rick Engler, director of the New Jersey Work Environment Council, a union group that has lobbied for an assortment of restrictions on toxic chemicals. “But shifting around the problem doesn’t solve the problem.”

Railroad officials say their self-imposed security measures have provided a web of security far more effective and sophisticated than that in virtually any other industry. Peggy Wilhide, spokeswoman for the Association of American Railroads, said that major rail carriers have spent more than $200 million since 9/11 on security measures, including fences and motion detectors, training, high-tech scanning devices, and tracking to monitor the shipment of some dangerous cargo.

After two accidental derailments in 2004 and 2005 caused toxic chemical releases that killed 12 people and injured hundreds, the railroads have also been considering a requirement that chemical companies replace their aging tankers with a newer, more highly reinforced generation of cars, Ms. Wilhide said.

Ms. Wilhide said that the industry opposed the plan to reroute shipments because it would actually increase the chance of an accident by forcing trains to haul the tankers full of toxic chemicals for longer distances, over older, less well-maintained rails.

Homeland Security Department officials have praised the rail carriers’ cooperation, saying the railroads have moved responsibly to bolster the security of their facilities and to give law enforcement officials the information needed to develop a real-time tracking system for the most dangerous toxic rail cars. Homeland Security officials are also working with the railroads and the federal Department of Transportation to devise buffer zone protection plans to provide security near the most perilous rail sites.

But the Homeland Security Department has not embraced calls to reroute trains carrying toxics or require that chemical companies update their fleet of tank cars.

Brian Doyle, a Homeland Security Department spokesman, said it wanted to complete a thorough assessment of the system before imposing any restrictions on the railways. “It’s one thing to just throw money at something and say it is fixed,” he said. “But you want to do it right.” In his speech on Tuesday, Mr. Chertoff said the department supported the one policy that local communities, environmental advocates and the railroads all agree on — that chemical plants and manufacturers should be urged to adopt processes that reduce, or eliminate, the need for toxic chemicals like chlorine and ammonia.

But the department will not require any shift to safer technology, Mr. Chertoff said, and the chemical security bill he is now advocating is likely to prevent states from adopting any such requirement.

In Spotswood, N.J., about 17 miles northeast of Princeton, many residents were startled to learn in the months after 9/11 that their community was home to a plant that had enough chlorine on hand kill as many as 960,000 people if an accident or terrorist attack caused it to be released and carried on the wind. Local officials worked with the company, Schweitzer-Mauduit, which makes cigarette papers, to tighten its security procedures and adopt more sophisticated plans for evacuation, detection and cleanup.

Bill Foust, a spokesman for the company, said switching to new technology that would eliminate the need for chlorine would be too expensive.

Barry H. Zagnit, mayor of Spotswood, said that despite the continuing risks, he could understand why company officials did not feel the investment was warranted.

“You have a mill that’s our largest employer, our largest taxpayer,” he said. “It’s essential to the economy of the borough. “We certainly would never want to see Schweitzer move the plant,” he said. “That would have a devastating effect on the borough, where people are already saddled with high property taxes.”

A similar political struggle has been simmering in Paulsboro in South Jersey, where the Valero refinery has enough toxic hydrofluoric acid on hand at one time to create an airborne plume 19 miles long that could affect as many as three million people, according to a study by the Work Environmental Council based on federal Environmental Protection Agency data.

The company has spent more than $5 million on bolstering security since 9/11, according to its spokeswoman, and has several systems designed to dissipate toxic gases in the event of a discharge. But Valero officials have resisted demands that they move to a process that would not use hydrofluoric acid, saying that it would be unworkable.

Steven M. Sweeney, the state senator whose district includes the Valero plant and at least three others that use large amounts of toxic gases, said that unless the state and federal governments intercede, little will be done to make communities like his safer.

“In Fieldsboro, there are a few trains a week that roll through town, 125 cars long; at least 80 of them are the kind of toxic chemicals that could cause a catastrophe, just devastate a community,” he said. “Anyone who feels safe is living in a dream world.”



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