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Avian Flu scares again in 2005

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Deadly 1918 flu reborn for study

By M.A.J. McKENNA - The Atlanta Journal-Constitution - Published on: 10/06/05

Federal and private researchers, including scientists at the Centers for Disease Control and Prevention, have re-created the influenza virus that killed 50 million people in 1918 - in hopes of helping the world prepare for a long-expected next pandemic of flu.

The work, hailed as a stunning scientific achievement, confirms what some scientists have long suspected: The lost 1918 virus was a bird flu that jumped species to attack humans, much like the avian flu strain that has killed at least 60 people in Asia since late 2003. It was conducted in three cities and completed in a high-security Atlanta laboratory.

The marker for the grave of Pearl Smalley stands with more than 20 tiny headstones in a corner of the public cemetery in Decatur. All mark the graves of children who died in the 1918 flu pandemic.

Yet again we also see Professor John Oxford on the BBC webpages and on TV...giving dire warnings even though he has publicly stated his concerns at the political use of disease fear-mongering

The analysis reveals that the current avian flu strain, known as H5N1, has begun to acquire some of the mutations that apparently made the 1918 virus so lethal - though the researchers cannot say how long it might take for the current strain to accumulate them all.

The resurrection of the 1918 flu, which began with a sprinkle of molecules and ended with a living virus, is not without controversy. It is being questioned both for its inherent risks and for how useful its findings ultimately will be in devising antiviral drugs and vaccines.

The results, released Wednesday in simultaneous publications by the journals Nature and Science, "provide critical clues to the genesis of the 1918 pandemic and why it was so lethal," Drs. Julie Gerberding and Anthony Fauci, the directors of the CDC and the National Institute of Allergy and Infectious Diseases, said in a joint statement. "The findings reveal essential information to help us speed our preparation for - and potentially thwart - the next influenza pandemic."

In the Nature paper, Dr. Jeffery Taubenberger and colleagues from the Armed Forces Institute of Pathology in Washington reveal the complete genome of the 1918 virus, which they retrieved from tissues taken from flu victims: two young soldiers whose autopsy records were stored at their own institution, and a woman whose corpse was disinterred from Alaskan permafrost by a pathologist sympathetic to their efforts.

The group, who were originally outsiders to the tight-knit fraternity of flu virology, rocked the scientific world with a 1997 paper asserting that the long-lost 1918 virus -which vanished decades before the development of techniques that could have described it - could be retrieved.

Wednesday's paper made good on that boast. The group found that the virus was almost completely a bird-flu virus - not, as some had thought, a mixture of segments from both avian and human flus - and possessed a handful of mutations in each of its eight genes that probably occurred as the virus began to infect humans.

And in a second analysis, they compared the 1918 sequence with the genetic sequence of the avian flu now circulating in Asia, finding that the current bird flu shares some of those same mutations.

"In a sense, [the current bird flu] might be going down a similar path to what ultimately led to 1918," Taubenberger said. He suggested that with further research, virologists could provide an early-warning checklist of changes signalling what scientists fear most: bird flu's shift from a hard-to-acquire infection in people to one easily transmitted.

Mutation timeline unclear

It is not possible to say when those changes might emerge, he added. Scientists know the rate at which flu strains collect mutations as they circulate among humans - but they do not know how rapidly flu strains change when they move from one species to another as bird flu has done.

Since late 2003, bird flu has killed or caused the preventive slaughter of more than 100 million domestic fowl and wild birds in Asia. Almost all of the 116 people known to have been sickened by the virus are believed to have been infected by birds. The virus may have passed from person to person in a few cases but not in a sustained way.

The Taubenberger group's genome results were used to create the more controversial piece of research revealed Wednesday: the re-creation of a live virus containing almost all of the genetic components of the 1918 strain.

In a three-cornered collaboration using a process called "reverse genetics," a research group at Mount Sinai School of Medicine in New York used Taubenberger's sequence to re-create individual genes from the 1918 virus, and then passed them to Dr. Terrence Tumpey, a senior microbiologist at the CDC.

Tumpey and his colleagues worked under lab conditions designated "biosafety level 3+," a half-step below those used for the most dangerous organisms known, with additional precautions that are normally applied only to bioterror organisms. They inserted the genes in lab culture cells, where the components self-assembled into a living, reproducing virus.

The group then used the recovered virus in experiments on mice, chicken eggs and cultures of human lung tissue. It killed all the mice within days, as well as chicken embryos normally used to produce quantities of virus for vaccines. And it reproduced rapidly in lung cells, even in cell cultures made to mimic certain body tissues where flu cannot normally grow.

But analysis of the recovered virus did not reveal any single mutation that makes the 1918 flu virus - famous for killing young, healthy victims in days and sometimes in hours - so lethal.

"There is not a smoking gun," said Dr. John Treanor, of the University of Rochester School of Medicine, who studies pandemic vaccine development but was not involved in the research. "What we're seeing is that all the individual genes contribute, but there is no single gene in there that is sufficient to make that virus a killer."

The experiments pinpointed molecular terrain that drugs could be designed to attack, Tumpey said, adding: "I have already gotten messages from other scientists saying, 'I have an idea for targeting this.' "

Scientists hail findings

Scientists with no connection to the flu research hailed its results as a significant achievement in illuminating the historical record, but were divided on its usefulness for future pandemics.

"The studies do not add to ? what we need to do to develop a pandemic vaccine," said Dr. David Fedson, a longtime pharmaceutical researcher who now lives in France. The tasks ahead - formulating a vaccine, getting it licensed and distributing it as widely as possible - are not primarily scientific ones, he said.

Other scientists had mixed views on whether the research should have been undertaken at all. The Federation of American Scientists - which earlier this week criticized the CDC for withholding unrelated flu research data - supported the work, noting the CDC submitted the proposal to several research review committees, as well as the independent National Science Advisory Board for Biosecurity.

The CDC deserves praise for ascertaining in advance that currently available antiviral drugs would have protected researchers from becoming infected and spreading the virus, and also for inviting outside researchers to work at its Atlanta labs rather than distributing the re-created virus, said Dr. Michael Stebbins, the federation's director of biology policy.

But the nonprofit Sunshine Project, which opposes biological weapons research, disagreed. "We see no compelling scientific reason to re-create the virulent virus," said Edward Hammond, the project's director. - ajc.com

Possession, Use, and Transfer of Select Agents and Toxins--
Reconstructed Replication Competent Forms of the 1918 Pandemic 
Influenza Virus Containing Any Portion of the Coding Regions of All 
Eight Gene Segments

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Interim final rule.


SUMMARY: We are adding reconstructed replication competent forms of the 
1918 pandemic influenza virus containing any portion of the coding 
regions of all eight gene segments to the list of HHS select agents and 
toxins. We are taking this action for several reasons. First the 
pandemic influenza virus of 1918-19 killed up to 50 million people 
worldwide, including an estimated 675,000 deaths in the United States. 
Also, the complete coding sequence for the 1918 pandemic influenza A 
H1N1 virus was recently identified, which will make it possible for 
those with knowledge of reverse genetics to reconstruct this virus. In 
addition, the first published study on a reconstructed 1918 pandemic 
influenza virus demonstrated the high virulence of this virus in cell 
culture, embryonated eggs, and in mice relative to other human 
influenza viruses. Therefore, we have determined that the reconstructed 
replication competent forms of the 1918 pandemic influenza virus 
containing any portion of the coding regions of all eight gene segments 
have the potential to pose a severe threat to public health and safety.

DATES: The interim final rule is effective on October 20, 2005. Written 
comments must be submitted on or before December 19, 2005.

Centers for Disease Control and Prevention


Germany acts to prevent spread of bird flu

By Ralph Atkins in Frankfurt, Fiona Harvey in London and John Thornhill in Paris - August 19 2005 19:20

Highlighting German fears about the possible arrival of bird flu via the Urals, Berlin on Friday announced steps to impose emergency restrictions on poultry kept in the open.

Renate Kunast, consumer protection minister, said: "We are preparing for a worst-case scenario."

German farmers could be ordered to keep flocks of poultry in pens to prevent contact with wild migratory birds arriving from central Asia, expected in mid- September. The possible spread of bird flu has created considerable alarm in Germany, with the health service stepping up contingency planning.

Ms Kunast warned against panic, but called for preventive action across the European Union. The move follows the Dutch government's decision earlier in the week to order all poultry farmers to bring their birds indoors to prevent them coming into contact with wild birds that could be infected with the flu virus.

The fear is that birds migrating across Europe could carry the virus from east to west.

Russia discovered its first cases of the bird flu strain H5N1 - first identified in south-east Asian countries - in Siberia in July. Since then the disease has spread to the Urals. The disease is believed to have killed 11,000 birds in Russia and many more have been slaughtered as a precautionary measure.

On Friday Kazakhstan also reported an outbreak. It is thought that all forms of migratory wildfowl could potentially spread the disease.

In France, the authorities have not yet taken any specific action to guard against the latest threat of the disease but have put their network of 5,000 veterinary inspectors on high alert.

The UK's agriculture ministry said it had no plans for restrictions on poultry farmers at present, but that it was monitoring developments closely.

As revealed in the Financial Times on Friday, British doctors are to be schooled on how to handle an outbreak of bird flu if it spreads to humans, as experts fear is possible.

Doctors will be issued with a 50-page pamphlet detailing the steps they should take to contain any outbreak.

The H5N1 strain has killed at least 57 people in south-east Asia since 2003. Experts fear the virus could turn into a global flu pandemic, which could kill up to 50m people.

The Swiss pharmaceutical group Roche is close to agreeing a donation of up to 3m doses of Tamiflu, its antiviral drug, to the World Health Organisation in an effort to limit the effects of a bird flu pandemic.

But the WHO warned this week that the world's capacity to manufacture vaccines to counter bird flu might be insufficient to meet demand.

FT com

Migrating birds could bring deadly flu to UK this winter

By Severin Carrell And Andrew Osborn In Moscow - Published: 21 August 2005

Migratory ducks and waders could bring bird flu to Britain this winter, experts have warned, after the disease was found in wild flocks in Russia.

The potentially lethal avian flu virus, H5N1, is now spreading westwards after health experts in Siberia and Kazakhstan discovered outbreaks of the virus in birds that will soon enter Europe. Yesterday, as the total number of confirmed cases in Russia hit 40, the authorities revealed the first suspected case of the virus at a commercial chicken farm in the western Siberian region of Omsk. Another 78 villages have suspected cases.

The disclosure is likely to force European governments to step up control measures. The Dutch authorities have already ordered all poultry farmers to bring their chickens indoors from tomorrow, and the German government announced on Friday it would order all its poultry farmers to follow suit next month if the virus spread.

British bird experts have told The Independent on Sunday they believe there is a risk - although currently a small one - that migratory ducks and waders arriving in the UK this autumn will be carrying the disease. Health experts are increasingly alarmed about the dangers of its spread because nearly nine million water-birds and waders migrate from Siberia to Europe every autumn, with nearly 850,000 thought to make winter homes in Britain.

Some species, including the pochard duck, identified as one of the birds that brought the disease from elsewhere in Asia to Russia, breed in the affected areas. British ornithologists and the National Farmers Union (NFU) are now closely tracking the new outbreaks, and have drafted new measures to control an outbreak in bird sanctuaries and chicken farms.

The NFU admits it is also preparing plans to bring poultry indoors if the virus arrives in Britain, which could be quickly stepped up to include mass culls on infected farms. Bans on imports of all Russian poultry into the EU have already been imposed.

The risks of the virus being spread by wild birds will be high on the agenda of the Government's expert animal diseases advisory committee meeting this November. The Department of the Environment, Food and Rural Affairs is also planning a major national emergency exercise early next summer, to plan for a nationwide outbreak.

Andy Evans, of the Royal Society for the Protection of Birds, said conservationists were updating their plans as they tracked the outbreak in Russia. "It's evolving as rapidly as events unfold," he said.

Dr Ruth Cromie, a biologist with the Wildfowl and Wetlands Trust, said the spread of the virus to Europe could be slower than many fear because many birds with the disease would die en route. Most birds migrating from currently affected areas would fly southwards to the Mediterranean and north Africa, so the chances of it arriving in Britain this winter was "very slim indeed".

The fear was that the virus would spread within Russia to the northern Siberian regions where birds which flew to Britain nested. "There is a possibility of it spreading. It's important for us to be prudent with bio-security," she said.

Although the chances of the virus spreading from birds to humans within Britain is thought to be very low, the Cabinet's civil disasters committee, Cobra, is to stage its own emergency exercise next month.

Ministers and the World Health Organisation believe a global flu pandemic in the next few years is inevitable and fear it could potentially cause millions of deaths worldwide and hundreds of thousands in Britain.

Additional reporting by Gemma Collins


Why the continued scare stories?
It is done to scare you into getting a vaccine...
It is this which will cause a pandemic...
and the planets population and it's
money spinning diseases can be easily managed...

"Despite millions of birds having been infected in Asia and many thousands of people having been in close contact with those birds, the disease has only affected 119 people resulting in 60 deaths," said Freda Scott-Park, president of the British Veterinary Association.

- Times


Project Bioshield / Bioshield II

Senators Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah) introduced the "Project BioShield II Act of 2005" (S. 975) on April 29, 2005. The bill builds upon the first BioShield bill, which was signed into law on July 21, 2004, and authorized $5.6 billion over 10 years to encourage pharmaceutical and biotechnology companies to develop bioterrorism countermeasures. Bioshield II would provide additional liability protections for firms creating vaccines or drugs that could cause injuries. No action has been scheduled on the bill yet.

At a May 11 hearing, Senator Richard Burr (R-N.C.), chairman of the Health, Education, Labor and Pensions Subcommittee on Bioterrorism Public Health Preparedness, said he would take into consideration both S. 975 and S. 3 in crafting his version of BioShield II. S. 3, introduced by Senator Judd Gregg (R-N.H.), amends the Homeland Security Act of 2002 and includes provisions similar to those in S. 975 that encourage companies to develop bioterrorism countermeasures.

Project Bioshield

The President signed the Project Bioshield Act (P.L. 108-276) into law on July 21, following final approval by the House on July 14. The legislation authorizes funds to encourage pharmaceutical and biotechnology companies to develop bioterrorism countermeasures.

First proposed in the 2003 State of the Union address, Project Bioshield provides $5.6 billion over ten years. The final bill guarantees this funding cannot be diverted for other purposes, but Congress retains discretion over the program's annual appropriations, such as the $890 million approved for FY 2004.

Senators Judd Gregg (R-N.H.), Joe Lieberman (D-Conn.) and Orrin Hatch (R-Utah) are said to be working on "Bioshield II," a bill that will provide liability protections for firms creating vaccines or drugs that could cause injuries.

Provided under the proposed Department of Homeland Security FY 2005 budget is $2.5 billion for Project Bioshield, three times the $890 million provided by Congress in FY 2004. The conference report of the FY 2004 Homeland Security Appropriations bill was signed by the President October 1 (P.L. 108-90) and included $890 million for Project BioShield.

"Project BioShield," first announced in the President's State of the Union address in January, is designed to expand and speed up the availability of vaccines and treatments to combat potential bioterrorism agents. Under the plan, the federal government would provide $6 billion over 10 years to create and produce vaccines and treatments and would guarantee drug companies a buyer for these products. In addition, the Food and Drug Administration would have the authority to expedite the approval process for vaccines and treatments and approve their use, prior to formal approval, in the event of a bioterrorist attack.

- aamc.org

Bioshield II would provide additional liability protections
for firms creating vaccines or drugs that could cause injuries.

The Dark Side of Project BioShield

Project BioShield, a national security measure proposed by President Bush in 2003 to stockpile drugs and treatments against terrorist threats, was approved by Congress and signed by the president on July 21, 2004. Despite taking 560 days to receive congressional approval, Project BioShield passed the House (421-2) and the Senate (99-0-1) with near unanimous support. The measure will provide $5.6 billion over the next 10 years for the purchase of vaccines and therapeutics against chemical, biological, and radiological attacks. Currently, Project BioShield has $0.9 billion (FY 2004) in available funds that will increase to $2.5 billion in 2005. The procurement process will likely involve the submission of requests for application (RFAs) under the guidance of the Department of Homeland Security. Reportedly, the purchase of next-generation vaccines for smallpox and anthrax is high on the government's list.

But before the government purchases any "anti-terror" products, the items must pass safety and immunogenicity testing in humans, as well as challenge in two animal models. These criteria, although essential for safety and efficacy, raise a number of major issues and concerns for any company interested in participating in Project BioShield. For example, why invest large amounts of resources and capital toward the development of a product that has little commercial value and essentially one potential customer - the U.S. government? The development of a vaccine is an expensive endeavor, costing millions of dollars and years of development. And the market upside is relatively limited. Furthermore, some companies already have a head start on the development of drugs and vaccines via federal funds from the NIH, the DoD, and the Defense Advanced Research Projects Agency (DARPA), for example, potentially giving them an unfair advantage.

Despite the fiscal challenges of developing a new drug, many biopharmaceutical companies are eager to obtain biodefense funding for anti-terror product development for two reasons: patriotism and dual-purpose research. The former is laudable, but patriotism does not produce profits, leading some bottom-line-focused companies to use federal funds for the development of highly related, or dual-purpose, research projects. Some companies may use federal funds to develop both a "patriotic" but less profitable product and, at the same time, a commercially viable product.

Lingering Questions

BioShield funding is unique since it awards money to companies after the product has been developed. Thus, companies must fund their own R&D efforts, including preclinical and clinical tests. Interestingly, the required testing in humans and animals raises another concern: What if the BioShield product doesn't protect the animal model from disease or is found to be immunogenic in humans? Negative data may disappoint the company, but how will the company's investors react? Negative results will affect the stock price or investors' attitudes toward the company. Is it, therefore, worth the risk to develop a "patriotic" drug or vaccine that may adversely affect the stock price? And if so, should companies developing BioShield products be granted indemnity for those specific programs?

Another concern over Project BioShield is raised by Una Ryan, CEO of AVANT Immunotherapeutics, which is developing a next-generation anthrax vaccine. "What if a company develops an improved anthrax vaccine before ours, but it does not possess all of the advantages as AVANT's? What happens to ours?" AVANT is developing a single, oral-dose "sip-and-go" combination anthrax-plague vaccine that is temperature stable and provides immunity in days instead of the current multiple-dose anthrax vaccine that may take months. The advantages of AVANT's vaccine may be clear, but others will find themselves in a similar position. Will more than one company be awarded contracts for similar products, or is the first one to the finish line the only winner?

Several other key questions remain. Since many companies already receive funds from federal sources for various biodefense projects and have close ties with government agencies, how fair will the RFA process be? And what guarantees exist that anti-terror products developed will be purchased?

Despite the uncertainties, an estimated 100 biopharma companies are developing anti-terror technologies. The passage of Project BioShield is an important development for the safety of American citizens that provides a significant impetus for drug and vaccine research. That said, Project BioShield might have adverse effects on struggling companies. Given the magnitude of this program and the lingering questions concerning its implementation, it is no surprise that researchers and legislators are refining the program and hope to create a BioShield II in the near future.

Zachary Zimmerman

who's in charge? yet another lawyer

This story may sound very familiar.

The National Response Plan (NRP), whose formulation was headed by the Department of Homeland Security, is intended to serve as the blueprint to the response to a host of possible disasters and terrorist attacks. The NRP contains several annexes which serve as situation-based response plans called Emergency Support Functions. "Function #8 is the Public Health and Medical Services Annex and it tasks the Secretary of the Department of Health and Human Services (HHS) leadership in responding to a health crisis, such as a flu pandemic, through the Assistant Scretary for Public Health Emergency Preparedness (ASPHEP).

The former Assistant Secretary, Jerome Hauer, was also the director of the Response to Emergencies and Disasters Institute at The George Washington University. Prior to being appointed as assistant secretary, Hauer served as Director of Emergency Management for New York City. Hauer is a gradaute of the Johns Hopkins University School of Public Health and has served on the National Academy of Sciences Institute of Medicine's Committee to Evaluate R&D Needs for Improved Civilian Medical Response to Chemical and Biological Terrorism.

His succesor, appointed in 2003 as ASPHEP, is Stewart Simonson. Like Michael Brown at FEMA, Simonson is a lawyer who was close to a political benefactor. Simonson graduated from the University of Wisconsin law school in 1994 and served as legal counsel to Tommy Thompson while he was governor of Wisconsin from 1995 to 1999. Simonson then followed Thompson to Washington when the governor was appointed as head of HHS. Simonson's bio at HHS states that "from 2001-2003, he was the HHS Deputy General Counsel and provided legal advice and counsel to the Secretary on public health preparedness matters. Prior to joining HHS, Simonson served as corporate secretary and counsel for the National Railroad Passenger Corporation (AMTRAK)."

Congressman Henry Waxman has recently pointed to Simonson as an example where Bush has "repeatedly appointed inexperienced individuals with political connections to important government posts, including positions with key responsibilities for public health and safety."

In addition to being very close to Thompson, Simonson has given generously to the Bush political machine. The website, Political Money Line's contribution database shows that he contributed $3,000 to various Bush-Cheney committees in the 2004 election cycle and gave $250 to the RNC. (Which for a $134,000 a year job is more than chump change.)

The Washington Drug Letter published an article in its December 2004 issue in which Hauer was harshly critical of Simonson:

Speaking as part of a biodefense panel in Washington, D.C. Dec. 15, Jerome Hauer, formerly the Assistant Secretary for Public Health Emergency Preparedness (ASPHEP) at HHS, said the $877 million contract awarded to VaxGen to produce a new anthrax vaccine was insufficient. He also insinuated poor policymaking has left the country vulnerable to terrorist attacks using weapons of mass destruction.

Hauer faulted the current management at the ASPHEP Office, including acting secretary Stewart Simonson, for not being better prepared to handle its duties. He called for the creation of a new federal office to coordinate U.S. biodefense activities. . . .

"The decisions being made do not appear to have a sound basis," said Hauer, currently senior vice president of government relations for consulting firm Fleishman-Hillard.

Last spring, Simonson came under fire from several Republican senators as well. Idaho Senator Larry Craig, during a Homeland Security Subcommittee hearing in April questioned the acquisition process for influenza vaccine:

Noting that the flu can be lethal to some populations such as the elderly, Sen. Larry Craig, R-Idaho, said the country was unprepared to deal with a possible flu pandemic.

Simonson . . . stopped short of agreeing with Craig's assessment, but said "it would pose an enormous challenge."

Sen. Ted Stevens, R-Alaska, and Gregg also questioned if the process used by Simonson's office to award vaccine development contracts ensured open competition and delivery to prevent a vaccine shortfall.

"Are we creating the same situation with anthrax?" Gregg asked, referring to the flu vaccine shortfall last winter.

Although Simonson said the different agreements show that they are "seeking not to put all our eggs in one basket," he added that he remains unsure if the contract award process is being done right. "We're learning as we go," he said.

The bottom line is that there is a risk of a flu pandemic that could kill millions of people worldwide if it is able to jump from human to human. Hurricane Katrina amply demonstrated what happens when underqualified yet well-connected lawyers are in charge.

- transparentgrid.com

Bush proposes using military in bird flu pandemic

WASHINGTON, Oct 4 (Reuters) - President George W. Bush suggested using the military to contain any epidemic of avian influenza on Tuesday, saying Congress needs to consider the possibility. He said the military, perhaps the National Guard, might be needed to enforce quarantines if the feared H5N1 bird flu virus changes enough to cause widespread human infection.

"If we had an outbreak somewhere in the United States, do we not then quarantine that part of the country? And how do you, then, enforce a quarantine?" Bush asked at a news conference. "It's one thing to shut down airplanes. It's another thing to prevent people from coming in to get exposed to the avian flu. And who best to be able to effect a quarantine?" Bush added. "One option is the use of a military that's able to plan and move. So that's why I put it on the table. I think it's an important debate for Congress to have."

Bird flu has killed more than 60 people in four Asian nations since late 2003 and has been found in birds in Russia and Europe.

Experts fear that the H5N1 bird flu virus, which appears to be highly fatal when it infects people, will develop the ability to pass easily from person to person and would cause a pandemic that would kill millions.

He noted that some governors may object to the federal government commandeering the National Guard, which is under state command in most circumstances.

"But Congress needs to take a look at circumstances that may need to vest the capacity of the president to move beyond that debate. And one such catastrophe or one such challenge could be an avian flu outbreak," Bush said.

Health experts are working to develop vaccines that would protect against the H5N1 strain of flu, because current influenza vaccines will not.

And countries are also developing stockpiles of drugs that can reduce the risk of serious disease or even sometimes prevent infection -- but supplies and manufacturing capacity are both limited.

Bush said he was concerned and involved in planning for an influenza pandemic, which experts say will definitely come, although they cannot predict when or whether it wil be H5N1 or some other virus.

"And I think the president ought to have all options on the table to understand what the consequences are -- all assets on the table, not options -- assets on the table to be able to deal with something this significant," he said. - alertnet.org

hmmm this seems like another mandate for martial law

Hospitals to treat avian flu epidemic same as terrorist attack

Thursday, October 13, 2005 - By Patrick Ferrell, The Star

If the avian flu breaks out in the United States, area hospital officials say they will handle the matter much the same as they would a terrorist attack.

"We've all made some type of provisions for how we would handle it. We're correlating it to a weapon of mass destruction type thing," said Bernie Heilicser, an Ingalls Memorial Hospital doctor and medical director of South Cook County Emergency Medical Services. Heilicser said hospitals have been practicing and preparing for bio-terrorism attacks for many years, so things should run smoothly if the deadly avian flu virus impacts the United States.

Since 2003, a strain of avian - or bird - flu has infected poultry throughout Southeast Asia. So far, human infections from poultry have been limited, with an estimated 110 cases and 65 deaths, most of them in Vietnam, according to international media. But the virus is now moving to Eastern Europe, where this week in Turkey and Romania officials slaughtered thousands of fowl to prevent the spread of the disease. Health officials worry the virus may mutate, making a human-to-human infection possible. Since there is yet no vaccine for the avian virus, a mutation could cause a worldwide flu pandemic, health officials say.

The likelihood of a human flu pandemic similar to one that struck in 1918 is very high, U.S. Health and Human Services Secretary Michael Leavitt said this week as he coordinated plans in Asia to deal with the disease. The 1918 pandemic killed an estimated 40 million to 50 million people worldwide; it killed 500,000 in the United States, according to the national Center for Disease Control and Prevention.

"A lot of people look at not will (a mutation and pandemic) happen, but when it will happen," said Karen Martin, manager of infection control at Advocate Christ Medical Center in Oak Lawn. Martin is a member of the Region 7 Bio-Terrorism Task Force. The avian flu does not have a vaccine; the creation of one could take months, if not years, after the first human-to-human case is identified. So the key to stopping the virus' spread will be to quarantine the infected while they are treated. Area hospitals are beginning to look at where they may have "surge capacity," or an area to house infected patients.

Christ, for instance, is looking at the possibility of using its adjacent Hope Children's Hospital as a flu ward if necessary. Other area hospitals are looking at the possibility of creating mobile hospitals in tents. Christ also is stockpiling respirators, masks and individual transport units that will allow doctors to transport avian flu patients without infecting others.

The national Center for Disease Control and Prevention is expected in coming days to release a report dictating how hospitals should respond to an avian flu crisis. President George Bush last week hinted that should an outbreak of human-to-human avian flu occur in the United States, he would use the military to force a quarantine of the infected area. While some envisioned a police state representative of communist countries, such a quarantine could mean the difference between a minor outbreak or a major pandemic.

"That's been the plan for many, many years for any communicable disease," Heilicser said. "The big question is how our government can effectively quarantine the area." Heilicser said such a quarantine is not likely to be enforced by the military, but people will voluntarily comply. "If there is a problem, people would need to pay attention and cooperate," he said. "If we panic, then bad things are going to happen."

A quarantine also could mean that area schools and businesses close for some time to prevent the public spread of the disease. Limiting travel to and from an infected area will be key to limiting the spread of an outbreak, Martin said. "We have so much travel going on in our society that it is going to be very difficult to control a virus," Martin said. Such traveling restrictions along with voluntary and forced quarantines at hospitals were effective at stopping the deadly SARS outbreak in Toronto in 2003. As far as the avian flu is concerned, common sense will always prevail, Martin and Heilicser said.

They suggest people make sure to get a regular flu shot. While the shot won't prevent the spread of the avian flu, it will prevent the typical flu strain. That could make identifying any symptoms and illnesses easier.

"Preventive medicine really has a big plus here," Heilicser said. Such prevention includes washing your hands frequently, covering your mouth and nose when you sneeze or cough and avoiding close contact with those that may be infected. Also, don't be afraid to take a day off.

"They key in a lot of this is people staying home from work," Martin said. "You don't want to be out in public if you're sick."

Patrick Ferrell

news headlines reveal why Avian flu
is a useful political economic tool

France calls for EU minister meeting on bird flu
11 Oct 2005 09:12:12 GMT
Source: Reuters
PARIS, Oct 11 (Reuters) - The European Union's health and foreign ministers should meet soon to coordinate their reaction to the spreading bird flu virus, France's Foreign Minister Philippe Douste- ... Full Article...
UAE bans bird imports from Turkey, Romania
11 Oct 2005 08:54:09 GMT
Source: Reuters
DUBAI, Oct 11 (Reuters) - The United Arab Emirates banned on Monday all imports of live birds and feathers from Turkey and Romania due to the presence of cases of bird flu. The decision by the ... Full Article...
On alert, Bulgaria tests dead birds for flu
11 Oct 2005 07:19:12 GMT
Source: Reuters
(adds details, quotes, background) SOFIA, Oct 11 (Reuters) - Bulgarian authorities said on Tuesday they were testing three birds found dead in the northern part of the country for avian flu but ... Full Article...
Indonesia seeks Vietnam advice on fighting bird flu
11 Oct 2005 06:58:03 GMT
Source: Reuters
(Recasts with comments by health minister) JAKARTA, Oct 11 (Reuters) - Indonesia will study how Vietnam managed to contain an outbreak of bird flu in humans, Jakarta's health minister said on ... Full Article...
Australia cracks down on illegal fishing
11 Oct 2005 05:18:04 GMT
Source: Reuters
By Michelle Nichols CANBERRA, Oct 11 (Reuters) - Australia will deploy extra patrol boats and armed officials in remote northern waters to crack down on illegal fishing and strengthen border ... Full Article...
Indonesian man is latest positive bird flu case
11 Oct 2005 03:28:47 GMT
Source: Reuters
JAKARTA, Oct 11 (Reuters) - A 21-year-old man from the Indonesian island of Sumatra is being treated for bird flu, the Health Ministry said on Tuesday, bringing the number of positive cases of the ... Full Article...
WRAPUP 5-EU bans Turkish bird imports after avian flu outbreak
10 Oct 2005 17:45:05 GMT
Source: Reuters
(Recasts with confirmation of EU import ban on Turkish poultry, adds EU detail and reaction in paragraphs 5-7) By Gamze Alarslan MANYAS, Turkey, Oct 10 (Reuters) - The European Commission banned ... Full Article...
Balkan states ban poultry from Turkey, Romania
10 Oct 2005 15:51:24 GMT
Source: Reuters
(Updates with import bans in Macedonia, Montenegro) By Zoran Radosavljevic ZAGREB, Oct 10 (Reuters) - All Balkan countries announced on Monday a ban on poultry imports from Turkey and Romania and ... Full Article...


EU shenanigans - bird flu psyops related???

EU to hold emergency meeting on Turkey

ISN SECURITY WATCH (Thursday, 29 September: 14.11 CET) - The EU will hold an emergency meeting on 2 October in an attempt to break the deadlock over Turkey's membership talks, EU sources said on Thursday.

The deadlock has stalled Turkey's bid to become the European bloc's first predominately Muslim, albeit largely secular member.

EU foreign ministers will seek agreement on a negotiating plan for Turkish membership talks, which are scheduled to begin on 3 October.

Some EU countries – notably Austria and some political forces in Germany – are calling on the bloc to offer Turkey a partnership deal rather than full membership. Negotiations over Turkey's accession could last up to ten years.

All 25 EU nations have to agree on a negotiating mandate before talks can begin with Ankara. If EU foreign ministers fail to reach consensus on Sunday, the planned Monday talks would be delayed. - isn.ethz.ch

Turkey for bird flu shocker

Turkish health minister urges calm over bird flu outbreak

13/10/2005 - 13:58:39 - The bird flu outbreak in western Turkey has been contained, the health minister said today, urging the public to remain calm amid panic over news that Turkish birds were infected with the virulent H5N1 virus.

"Bird flu is totally under control," Health Minister Recep Akdag said. "The outbreak in winged animals occurred in one area and has been contained." "Of course, we need to be careful; we need to do our homework well," he said, reassuring Turks that the government was ready to deal with bird flu.

The European Union announced earlier that it found the H5N1 bird flu virus in Turkish poultry - the first confirmation of H5N1 in Europe. The virus has killed 60 people in Asia since 2003. Experts have been tracking the disease in birds because they worry the strain might mutate into a human virus and spark a pandemic. Public health authorities want the poultry outbreaks wiped out as rapidly as possible to prevent those opportunities for mutations.

The village outside Balikesir in western Turkey where 1,800 turkeys died has been under a two mile quarantine for the past week. Authorities culled 7,600 domestic birds and disinfected five hectares of land in the area to contain the highly contagious virus, officials said.

Turkey asked the Swiss pharmaceutical company Roche Holding AG for one million boxes of a standard flu medicine as a precaution against a possible pandemic, a health official said.

The Anatolia news agency reported that Turkey wanted to stockpile 500,000 boxes of the anti-viral oseltamivir, known commercially as Tamiflu, and had requested that 300,000 be sent as soon as possible.

"A letter of intent … has been sent so that a fixed amount of the anti-viral drug is kept in Turkey," Anatolia quoted ministry official Turan Buzgan as saying.

But a Health Ministry official said later that the government asked Roche for one million boxes. Each box contains 10 capsules. - IOL

Vaccinations recommended after deadly bird flu found in Turkey

13/10/2005 - 12:01:02 - EU Health Commissioner Markos Kyprianou today said he advocated "the increase of vaccination among the risk population" to deal with a potential or possible pandemic.

The European Union said the bird flu virus found in Turkish poultry was the H5N1 strain that scientists worry might mutate into a human virus and spark a pandemic.

"We have received confirmation that the virus found in Turkey is an avian flu H5N1 virus," said Kyprianou. "There is a direct relationship with viruses found in Russia, Mongolia and China."

Kyprianou said precautionary measures being assessed were to warn people travelling to countries where the disease has been diagnosed to avoid "going to farms, coming in contact with wild birds and so on."

The H5N1 bird flu strain does not easily infect humans, but 117 people, mostly poultry workers, have caught it over the past two years and 60 of them had died.

Scientists were tracking the spread of the virus in birds because it could mutate into a dangerous human pandemic strain. - IOL

Turk PM eats chicken to help avert bird flu panic

ANKARA, Oct 14 (Reuters) - Anybody for chicken salad? Prime Minister Tayyip Erdogan has joined a campaign to reassure his public that poultry is still safe to eat despite the outbreak of a deadly strain of bird flu on a farm in western Turkey.

Friday's newspapers showed Erdogan breaking his Ramadan fast on Thursday evening by tucking into a chicken salad and even offering some to a photographer recording the scene.

"(I hope) you will now change your headlines," the Sabah newspaper quoted Erdogan saying as other officials, including the speaker of Turkey's parliament, Bulent Arinc, also ate chicken. - alertnet.org

First Turkey, then Greece...

Greece confirms first case of bird flu in EU

By Philippe Naughton October 17, 2005 -The Agriculture Ministry said the H5 virus had been detected on a turkey on the island of Chios. It was not yet clear whether the bird was infected by the H5N1 sub-strain, which has claimed at least 60 human lives in Asia.

Chios is in the eastern Aegean, only a couple of miles at its closest point from western Turkey, where an outbreak of bird flu at a turkey farm, confirmed as H5N1, has brought a major cull. The virus has also been found in wildfowl in Romania's Danube delta.

News of the outbreak in Greece came as Patricia Hewitt, the Health Secretary, told the Commons that the Government was taking the prospect of a bird flu pandemic - if it crosses across into humans - "very seriously" and its latest contingency plans would be published.... Times Online

Monitoring a VIRUS or monitoring you?

World body looks to boost bird flu vaccines

By Martin Nesirky - SEOUL, Oct 13 (Reuters) - The International Vaccine Institute has set up a consortium to help monitor deadly bird flu, boost regional vaccine production and develop a new vaccine in South Korea, the director-general of the world body said on Thursday.

John Clemens, a U.S. doctor who is an adjunct professor at Johns Hopkins University, also told Reuters the institute had proposed working with impoverished North Korea to try to prevent diseases such as bacterial meningitis among children there.

The Seoul-based International Vaccine Institute is the only international research organisation focused on developing new vaccines for the world's poorest people, notably children.

In response to the march of bird flu across Asia and into Europe and the risk of a pandemic, Clemens said his organisation had put together a consortium of public health experts as well as experts in vaccine production from the public and private sectors in South Korea. It was seeking funds for its plans.

"I think there is very good reason to believe that something will happen in the coming years. We don't know whether it will be this year, next year, 3 years from now," he said by telephone. "But the H5N1 epidemic in birds shows no sign of subsiding. In fact quite the reverse." He said if the mortality rate in such a pandemic matched that of the 1918 influenza outbreak it could mean up to 100 million deaths in a space of 1 to 3 years. "Hard to imagine a health threat in that space of time that would be greater," he said.


Clemens said the consortium was just organising itself.

"But the work we have proposed with this consortium falls into several categories," he said.

Avian influenza -- commonly know as bird flu -- is a highly contagious virus which has killed millions of birds and more than 60 people in Asia since 2003.

Clemens said the consortium wanted to help neighbouring countries monitor for the virus in animals and humans.

"We are very concerned about the fate of developing countries in the setting of a pandemic. There is the feeling that certainly they will be extraordinarily vulnerable to a pandemic," he said. "But also it would be of value to Korea and other industrialised countries by nipping the outbreak in the bud," he said of the surveillance.

Another idea would be to exploit strong links with regional producers to get one or more of them to help increase vaccine output, Clemens said. He noted capacity was woefully inadequate at 300 million doses for the world's 6 billion people.

The institute could also help with clinical trials if South Korean firms develop new avian flu vaccines and help look at better ways to produce more and potent vaccines. The only international organisation based in South Korea, the vaccine institute has 100 members of staff from 16 countries. The World Health Organisation and 36 countries are members of the institute, which was set up in 1997.

Clemens said he hoped any bird flu vaccine developed in the South would be made available to North Korea. He said he had written to the North's health minister about joint efforts on other illness -- including Japanese encephalitis and diarrhoeal diseases as well as bacterial meningitis -- but had not heard anything definitive from Pyongyang.

"Follow-on discussions presumably will occur in the future," he said. "But we are a little bit in limbo at the moment." - alertnet


drug-resistant VIRUS

Scientists warn of possibility of drug-resistant avian flu

By Justin Teo, RSI First published 11 October 2005

US scientists warn that a drug-resistant Avian flu strain could arise with unrestrained and improper use of available drugs. The warning came as governments around the world are stockpiling antiviral drugs and the H5N1 avian flu strain threatens to break out into a flu pandemic.

The virus has killed 65 people in Asia since late 2003 and recent reports of an outbreak amongst poultry in Turkey are unnerving European states. How could improper or unrestrained use of antiviral drugs affect the battle against Avian flu?

Justin Teo spoke to Dr. Jeffrey Staples, Senior Medical Advisor at International SOS, for more.

JS: Well, there are actually two ways that it could affect that I can see. Firstly, the anti-viral drugs are already in limited supply, so improper or unrestrained use of them could already reduce the supply significantly. Also there's the issue of drug resistance to develop and as proven with other anti-viral medication and bacteria, the unrestrained use of anti-viral drugs can lead to drug resistance. If the avian flu does become pandemic, then these two anti-viral drugs will be effective against avian flu to an extent. The concern is that people will be using the medication improperly, maybe when they don't have the virus or maybe they'll be using it improperly when they do and some resistance could develop. I think that it's safe to say that the anti-viral drugs will continue to be effective but if resistance develops, that resistance is likely to decrease.

JT: If resistance against the virus does decrease, and in the case of Vietnam where a patient did not respond to the drug Tamiflu, would a higher dosage work?

JS: It's certainly possible although I've not seen any studies out there with conclusive evidence but it's certainly possible that a higher dosage or a longer treatment course could be effective. Now unfortunately if this is the case, it'll put a further strain on the supplies of the medication.

JT: Michael Osterholm, an infectious disease expert advising the US government, mentioned that if the H5N1 bird flu virus infects humans, it will move too quickly for drugs and vaccines to be of much use. How true is this?

JS: I think he is absolutely correct in a lot of ways. First and foremost, on the vaccine front, there is no vaccine against the avian flu virus. The US has developed one in experimental stages, but that's just a vaccine out there currently in birds. If this virus mutates into a human pandemic form, we'll not have a vaccine for that virus probably for six to nine months because we don't know what the virus looks like yet and so we can't make a vaccine for it. In terms of the medication, again, the supplies of the medication are limited and the distribution of the medication is probably going to lag behind the spread of the virus, even in our best efforts. In the current phase, where the virus seems to be having great difficulty infecting humans, we are probably well able to catch up and contain it. But if it mutates into a full pandemic form, it will probably spread beyond our capabilities to contain it with medication.

JT: All this reflects the world's reliance on vaccines and drugs to combat the avian flu. What alternatives are there to fight the virus?

JS: I think the world in general is looking for a sure thing, quick-easy fix, in terms of vaccine and medication. Where there certainly is a reasonable component of a preparedness pandemic plan, they are not going to be in of itself be able to stop the pandemic should the pandemic occur. So alternatives are really good, comprehensive planning for infrastructure, communications, transportation, logistics and supplies, and planning alternative sources and alternative means of getting critical operations done. We basically have to figure out how we can operate our society should a pandemic occur and we shouldn't just rely on vaccines and drugs. - channel news asia


Top U.S. health experts urge nations to step up surveillance

U.S. says bird flu in Europe a "troubling sign"

HANOI, Oct 14 (Reuters) - The spread of Asia's deadly bird flu to Europe is a "troubling sign" and migratory birds will inevitably carry the virus farther, U.S. Health Secretary Mike Leavitt said on Friday.

Speaking to reporters in Hanoi on a tour of bird flu-hit Southeast Asia, Leavitt said outbreaks in Turkey and Romania underscored the need for urgent action against the virus to prevent a possible human pandemic.

"What is the probability that it will occur? No one knows, but signs that have occured in Turkey and Romania and other countries along the natural flyways are certainly troubling signs," Leavitt said.

European countries tightened border controls on poultry and poultry products on Thursday after tests confirmed a bird flu outbreak in Turkey was H5N1, the same virus which has killed more than 60 people in Asia since 2003.

Test results to determine the strain of virus infecting three ducks in Romania were due sometime on Friday.

Experts suspect migratory birds, usually wildfowl which are silent carriers of the virus, may have carried the disease to Europe along their natural migratory routes.

"We can expect for it to continue. There is no reason to expect it will not continue along the flyways that are well-documented," Leavitt said.

"It will require a measured response on all of our parts if this continues to occur, as it inevitably will," he added.

The World Health Organization has said that bird flu, which swept through parts of Asia in late 2003 and has spread since to Russia and Europe, is moving towards a form that could pass between humans.

Leavitt, accompanied by top U.S. health experts on the fact-finding mission to Thailand, Cambodia, Laos and Vietnam -- the worst hit country with 41 deaths since 2003 -- has urged nations to step up surveillance so any potential human pandemic is snuffed out early.

The United States has pledged $25 million for a raft of measures -- everything from new lab equipment to training rapid-response teams -- to the region where bird flu is now endemic. - alertnet.org

French PM cautions against bird flu panic

14/10/2005 - 08:30:38 - French prime minister Dominique de Villepin today cautioned against panic over bird flu before presiding over a meeting of key ministers on the potentially devastating virus.

De Villepin, speaking on Europe-1 radio, said that chicken was still on the menu at Matignon, the prime minister's office, and "I ate some yesterday."

De Villepin was heading a meeting of French ministers whose work is critical to virus prevention.

"This virus is approaching," he said, referring to the confirmed case of the virulent H5N1 strain detected in Turkey.

Tests were to confirm whether the same strain had indeed been found in Romania.

However, de Villepin said the European Union "is totally mobilised" and that France has "a large number of anti-viruses and vaccines".

Asked whether all poultry raised naturally, and therefore risking contact with sick birds, should be closed up, the prime minister said,

"We're not at that stage."



Invasion from the east...

Anxious Europeans scan eastern skies as bird flu looms

By Ralph Boulton LONDON, Oct 14 (Reuters) - Hungarian butchers throw up their arms in despair as customers shun their poultry, anxious citizens across Europe buy up anti-flu vaccine, and Bulgarian newspapers, prematurely perhaps, proclaim outright panic.

The arrival of the deadly H5N1 strain of avian flu on Europe's doorstep is viewed with varying degrees of alarm and puzzlement from Dublin to Athens. A Cypriot daily invoked historic parallels of invasion, announcing a "feathered Atilla".

Greece, sitting on one of the main paths for birds migrating to Africa, has reacted calmly to the news. However, as in other countries, such as Germany and Britain, doctors' surgeries have seen a rise in inquiries about vaccines.

Bulgaria, bordering Turkey, which has confirmed cases of H5N1, and Romania, which is investigating possible cases, awoke to alarming headlines. "Panic! Dead Birds At Home, Too!" runs a huge headline in red letters in the daily 24 Chasa.

While Bulgaria has seen no cases of bird flu, over-anxious citizens, it says, have been picking up dead birds found in fields and streets and offering them for testing. Another daily spoke of "bird flu hysteria besieging Bulgaria".

Businesses clearly look to the skies with concern.

So far there have been about 120 cases of the virus passing from birds to humans in Asia, with about 65 people dying. Scientists fear any larger spread among humans could lead to a mutation allowing it to move rapidly between humans.


Hungarian butchers said sales of poultry had fallen sharply over the past week.

"We keep saying that these chickens haven't caught the flu, we spend all day doing that," Iren Kirilla, a 55-year-old butcher at Budapest's main Fovam Ter market said.

"But even if people turn up, they just complain and don't buy."

In Turkey, Prime Minister Tayyip Erdogan, seeking to soothe fears in his country, was pictured in Friday's newspapers savouring a chicken salad. But Vatan newspaper said Turks had bought up 100,000 boxes of the flu vaccine Tamiflu in 15 days, compared with just 20,000 boxes in the whole of 2004.

In Serbia, people were reported to have bought 20,000 face-masks in 2 days. Belgrade pharmacies sold out of Tamiflu.

In Switzerland, calmer counsels prevailed. Poultry dealers said plans had long been in place to deal with any problems.

"Our strength in Switzerland is hygiene and cleanliness," Nicolas Vincent, a poultry farmer, told Swiss Television. - alertnet.org


TamiFlu a Roche patent - is this for real???

Board of Directors: John Irving Bell, Rolf Hänggi, Peter Brabeck-Letmathe, Bruno Gehrig, André Hoffmann, Franz B. Humer, Lodewijk J.R. de Vink, DeAnne Julius, Walter Frey, Andreas Oeri, Horst Teltschik (from left).

The founder of Roche, Fritz Hoffmann-La Roche, was a pioneering entrepreneur who was convinced that the future belonged to branded pharmaceutical products. He was among the first to recognise that the industrial manufacture of standardised medicines would be a major advance in the fight against disease.

This led him to found F. Hoffmann-La Roche & Co. on October 1st 1896. From the very beginning, Fritz Hoffmann attached great importance to product information as the link between the pharmaceutical manufacturer and doctors, pharmacists and patients. Shortly after the foundation of the company, affiliates were opened in Germany, Italy, France, the US, Great Britain and Russia.

Since then, Roche has grown into one of the world's leading healthcare companies and one of the most important in Europe.

Further expansion of Tamiflu manufacturing capacity

Roche reiterates willingness to enter discussions with governments and other manufacturers on the production of Tamiflu for emergency pandemic use.

Roche announced today that the Food and Drug Administration (FDA) has granted approval of an additional capsule manufacturing site in the US for the supply of the influenza antiviral Tamiflu (oseltamivir), expanding its already significantly increased worldwide production capacity. This facility is part of a network of more than a dozen production sites for Tamiflu worldwide, more than half of which are with third party manufacturers.

William M. Burns, CEO Roche Pharma Division, commented: "For Tamiflu, the key need today is the rapid expansion of production capacity. Patients' needs in case of a pandemic remain our top priority. We have already significantly expanded production capacity internally and by working in close collaboration with other companies, and we will continue to do so. In addition, we are prepared to discuss all available options, including granting sub-licenses, with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing. In support of the global effort to fight a potential pandemic, we would be prepared to discuss such sub-licenses to increase the manufacturing of Tamiflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications, safety and regulatory guidelines".

Tamiflu is designed to be active against all clinically relevant influenza viruses and key international research groups have demonstrated, using animal models of influenza that Tamiflu is effective against the avian H5N1 strain circulating in the Far East. As a result, more governments are stockpiling Tamiflu therefore Roche is expanding a collaborative production network to meet the increasing demand. The manufacturing process for Tamiflu is complex and lengthy.

Roche has been working with many governments over the last few months to determine their needs for stockpiling of Tamiflu and has received and/or fulfilled orders from around 40 countries.

About Tamiflu (oseltamivir)

Tamiflu is designed to be active against all clinically relevant influenza viruses.3 It works by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.

Tamiflu delivers:

* 38 percent reduction in the severity of symptoms1
* 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals2
* 37 percent reduction in the duration of influenza illness5,3
* Tamiflu was shown to provide up to 89 percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients4

In children, Tamiflu delivers:

* 36 percent reduction in the severity and duration of influenza symptoms5
* 44 percent reduced incidence of associated otitis media as compared to standard care6

As with any antiviral, a theoretical potential exists for an influenza virus to emerge with decreased sensitivity to a drug. Extensive monitoring, by Roche and the independently established Neuraminidase Inhibitor Susceptibility Network (NISN) measured the incidence of resistance to NAIs. From around 4000 patients treated with Tamiflu resistance was encountered in 0.4 per cent in adults and 4 per cent in children aged one to 12. This resistant virus was found to be less virulent than the wild type virus and did not affect the course of the illness.

The greatest use of Tamiflu today is in Japan. To illustrate this, there were an estimated 16 million influenza infections in Japan over the 2004/2005 influenza season. Roche estimates that around 6 million of those individuals infected with the influenza virus received Tamiflu. Even with this degree of usage, resistance appears very infrequent.

Avian Influenza and Pandemics

Most avian influenza viruses are not infectious to humans, but, should an avian and a human influenza virus co-infect a human or a pig, the virus strains can join, mutate and create a completely new virus, which may be transmissible from animals to humans, and from humans to humans. Such a strain would be entirely new in composition, so vaccines developed and administered to date to protect humans during seasonal epidemics, would be ineffective against this new strain, leaving the population vulnerable to infection. Experts believe the next influenza pandemic could result from such a mutation of virus strains.

World Health Organisation

The WHO has recommended as part of its Pandemic Preparedness Plan that countries establish stockpiles of antiviral treatments such as Tamiflu, which are effective against all strains of the influenza virus. The Pandemic Preparedness Plan, along with details of the 15 countries that have implemented national plans, can be viewed on the Internet.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. - roche.com


is this for real?

Indian Co. Eyes Generic Tamiflu for 2006

BOMBAY, India (AP) - A major Indian pharmaceutical company said Friday it plans to bring a generic version of the anti-influenza drug Tamiflu into the market early next year, filling any potential shortages in event of a bird flu epidemic. The drug is already in short supply following fears of a possible epidemic. But the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, has refused to license generic versions of the drug despite pressure from several countries and United Nations Secretary General Kofi Annan.

Dr. Yusuf K. Hamied, chairman of Cipla Ltd., said that his company has already developed the generic version, oseltamivir, which would be much cheaper than Tamiflu -- the only available drug that is effective in treatment of people infected with bird flu. "We have been able to synthesize it. Once the lab work is done things don't take too long," Hamied said in a telephone interview. "We are in the process of scaling up and commercialization. That should be completed next month."

Hamied did not disclose how his company would price the generic brand, but said the company will make it available at "a humanitarian price." "I have always said there should be access to medicine at affordable prices," he said.

A strip of 10 Tamiflu tablets cost about $60, a lot of money for people in Asia where millions earn less than a dollar a day. Patients are advised to take a tablet daily for at least a week and the dosage could extend up to six weeks for people living in epidemic infested areas.

The H5N1 strain of avian flu has been sweeping through poultry populations in Asia since 2003, infecting humans and killing at least 65 people, mostly poultry workers. The virus does not pass from person to person easily, but experts fear the virus could mutate. The 1918 influenza pandemic killed more than 40 million people. Subsequent pandemics in 1957 and 1968 had lower death rates, but caused extreme disruption.

World Health Organization spokesman Dick Thompson declined to comment specifically on Cipla's plans, but said WHO supported the line taken by Annan at a visit to the Geneva-based agency two weeks ago. "We will take the measures to make sure poor and rich have access to the medications and the vaccines required," Annan said at the time.

Scientists in Taiwan have recently said they, too, can produce generic Tamiflu, if patent issues are resolved.

Generic manufacturers cannot legally sell the patented drug in the West and in many countries in Asia, including India, which recently tightened its patent laws. But the laws in many of these countries allow governments to invalidate patents during emergencies and permit sale of generics.

Hamied didn't say how and where he plans to sell his product, but insisted he won't "break the law."

"Anyone who wants the drug can purchase it from us," he said. "May be people in America and Europe would want to buy it from us, but they are governed by their own patents."

Roche declined a direct comment on Cipla's announcement. "We fully intend to remain the sole manufacturer of Tamiflu, together with our partners," said Daniel Piller, a Roche spokesman, in Geneva.

The company had previously said it is increasing Tamiflu's production. The company also insists that making the drug is a very complex process and if any other company was given a license to make generic copy, it would take at least two to three years for the firm to ramp up production.

But Hamied said that was not the case with his company, which has copied dozens of Western drugs, including Pfizer's Lipitor and Viagra, as well as AIDS drugs, approved by the World Health Organization, that are used by hundreds of thousands of HIV-infected people worldwide.

"We have learned a lot in the past 30 years of flexible patent laws in India," he said.

Until January this year, India's patent laws allowed Indian pharmaceutical firms to make cheap versions of expensive Western drugs using a technique different than that of the patented product. But under the new law, Roche could possibly go to an Indian court, challenging any attempt by Cipla -- India's third largest drug manufacturer -- to market generic copies of Tamiflu. - money central.msn


Vaccine TamiFlu hoarded by Roche Useless?

Girl 'showed drug-resistant case of bird flu'

14/10/2005 - 19:44:47 - The bird flu virus that infected a Vietnamese girl was resistant to the main drug that's being stockpiled in case of a pandemic, a sign that it's important to keep a second drug on hand as well, a researcher said tonight.

He said the finding was no reason to panic.

The drug in question, Tamiflu, still attacks "the vast majority of the viruses out there," said Yoshihiro Kawaoka of the University of Tokyo and the University of Wisconsin-Madison in the US.

The drug, produced by Swiss-based Roche Holding AG, is in short supply as nations around the world try to stock up on it in case of a global flu pandemic.

Kawaoka said the case of resistance in the 14-year-old girl is "only one case, and whether that condition was something unique we don't know." He also said it's not surprising to see some resistance to Tamiflu, because that had also happened with human flu.

The girl's Tamiflu-resistant virus was susceptible to another drug, Relenza, Kawaoka said. He and colleagues report the case in the October 20 issue of the US journal Nature, which released the study today. The researchers conclude that it might be useful to stockpile Relenza as well as Tamiflu.

Both drugs are being stockpiled by the US government.

The girl, who had been caring for an older brother with the disease, had been receiving low doses of Tamiflu as a preventive measure when the virus was isolated in late February. She later fell ill and was given higher doses. She recovered and left the hospital in March.

Kawaoka said it's not clear whether the low preventive dose had encouraged the emergence of drug resistance.

Dr William Schaffner of Vanderbilt University in Tennessee called the report important and said it shows the importance of watching for drug resistance.

"It is not unusual to find the occasional resistant virus," he said. "It could be just a biological oddity, or we could see this more frequently.

"This is a blip on the radar screen, and it surely does mean that we have to keep the radar operative," Schaffner said. "We have to keep testing more viruses." - IOL

Bird flu's tendency to mistakes makes it dangerous

Oct 15 (Reuters) - Lab tests detected the deadly H5N1 strain of bird flu in samples from Romanian ducks on Saturday, confirming the virus had arrived for the first time in mainland Europe. The World Health Organization believes it is only a matter of time before the virus develops the ability to pass easily from human to human, possibly causing a catastrophic pandemic.

It is the virus's tendency to make mistakes when replicating itself that makes it so dangerous and unpredictable. Here are some facts about H5N1 avian influenza:

-- The H5N1 strain first emerged in Hong Kong in 1997, causing the death or destruction of 1.5 million birds and sickening 18 people, killing six.

-- It re-emerged in 2003 in South Korea, and has now spread to China, Vietnam, Thailand, possibly Laos, Indonesia, Turkey and perhaps Romania. Japan, Malaysia and South Korea are considered free of H5N1 avian flu after having outbreaks. H5N1 has also been seen in wild birds in Mongolia, Kazakhstan and Russia's Siberia.

-- The outbreaks have led to the death or destruction of an estimated 150 million birds.

-- H5N1 has infected 117 people in four countries and killed 60, according to the World Health Organization. Experts say more people may have been infected but were not ill enough to seek medical attention, so it is not known what the fatality rate is.

-- Avian flu exists almost everywhere. There are 15 subtypes of influenza virus known to infect birds, but the so-called highly pathogenic forms tend to be caused by influenza A viruses of subtypes H5 and H7.

-- Influenza type A viruses are named according to two proteins they carry call hemagglutinin (H) and neuraminidase (N). There are 16 possible "H" variations and nine "N."

-- Influenza viruses are RNA viruses, meaning they lack mechanisms for proofreading and repairing genetic errors. This makes them especially prone to mutation. This is why there is a new strain of seasonal flu almost every year and why the annual vaccine must be reformulated every year.

-- Some years this means the flu is not especially deadly but it usually kills 250,000 people at a minimum globally, in an average season. About every 20 years or so the virus changes enough to cause a pandemic that infects and kills many more people than usual.

-- Three pandemics occurred in the 20th century -- the 1918 pandemic that killed anywhere between 20 million and 100 million people globally, the 1957 "Spanish influenza" which killed an estimated 2 million people globally and the 1968 "swine flu" which killed 1 million. Experts agree another pandemic could occur at any time.

-- The seasonal flu vaccine provides no protection against H5N1 avian flu. There is an experimental H5N1 avian flu vaccine but there are only a few thousand doses and it is unlikely to provide perfect protection.

-- H5N1 mutates rapidly and is beginning to show some of the changes that made the 1918 H1N1 flu pandemic so deadly.

-- Four drugs work against influenza. But two older drugs, amantadine and rimantadine, already have minimal activity against H5N1. Two newer drugs work better. Tamiflu, known generically as oseltamivir, was invented by Gilead Sciences and is made and marketed by Swiss drug giant Roche Holdings. Relenza, known generically as zanamivir, was developed by Australia's Biota Holdings and is marketed by GlaxoSmithKline.

Relenza is a powder given via the nose and is considered less desirable than a pill like Tamiflu.

-- Just as bacteria develop resistance to antibiotics, viruses develop resistance to antivirals and H5N1 has become resistant to amantadine. It has also begun to show signs of mutating into a form resistant to Tamiflu.

-- Tamiflu and Relenza, in a class known as neuraminidase inhibitors, do not cure influenza infection but can reduce the severity of illness if given within 48 hours after symptoms begin. They may also help prevent infection if given early.

-- WHO has urged countries to develop preparedness plans, but only around 40 have done so. WHO predicts that most developing countries will have no access to vaccines or antiviral drugs throughout the duration of a pandemic, and experts say developed nations will not have enough to cope well.

- alertnet.org

Vaccines are useless...er...does this flu even exist?

Vaccines are useless against this virus

By Jeremy Laurance, Health Editor Published: 14 October 2005

There is no vaccine available against bird flu. Existing vaccines are unlikely to be effective against the new strain.

Researchers are working to develop a vaccine targeted at the H5N1 strain but even if it is successful, to manufacture sufficient quantities to protect the world's population from a pandemic will take years. A generic H5N1 vaccine would not prevent infection but it might lessen its severity and save lives. Countries including the UK are relying on the anti-viral drug Tamiflu.

Anti-flu drugs work in a different way from vaccines and can be used against any strain of flu. But they have a limited effect, shortening the course of the illness by a day or two, provided they are taken within 48 hours of infection. In outbreaks of ordinary human flu, they can prevent secondary complications such as pneumonia and reduce infectivity, cutting the rate of spread.

It is hoped that they would be similarly effective against bird flu in humans, saving lives by reducing the severity of the illness. But it is not certain.

The Government has ordered 14.6 million courses of Tamiflu, enough for a quarter of the population, at a cost of £200m, from the manufacturers, the Swiss pharmaceutical company Roche. About 900,000 doses have been delivered.

There is a worldwide shortage of Tamiflu because the raw materials from which it is made are scarce and the manufacturing process is slow and complex. If a human pandemic were to arrive in the UK this winter, the shortage could provoke panic, with hospitals under siege. - independent

Roche to donate bird flu drug to Romania,Turkey-WSJ

LONDON, Oct 17 (Reuters) - Swiss pharmaceuticals company Roche is donating packs of its anti-influenza drug Tamiflu to Turkey and Romania, the Wall Street Journal newspaper reported on Monday in its online edition.

The news comes as governments in short supply of drugs to combat avian influenza stock up ahead of a possible epidemic after laboratory tests confirmed that the deadly H5N1 strain of the virus has been found in birds from Turkey and Romania.

A Roche spokesman said the pharmaceuticals company is donating 20,000 packs of Tamiflu to Turkey to protect workers who may come into contact with infected poultry, and has given 2,400 packs to Romania, the Journal reported.

Roche, which has said it is increasing production of Tamiflu as quickly as possible, has also given three million packs to the World Health Organization, the paper said.

Tamiflu is the most effective anti-viral drug available for avian flu, and governments are rushing to build up stocks amid fears a virus that has claimed more than 60 lives in Asia since 2003 could mutate into a more deadly form for humans.

Roche said on Wednesday it would outsource some stages of production as it comes under pressure to boost supplies, but added it would not relinquish its patents.

"Roche and its partners fully intend to remain the only manufacturer of Tamiflu and are best qualified to scale up production," spokesman Daniel Piller said on Friday. - alertnet.org

WHO remind everyone who is the real 'danger' - The East

WHO says SE Asia remains biggest bird flu danger

MANILA, Oct 17 (Reuters) - The World Health Organisation said on Monday it was concerned that European countries facing the spread of bird flu would divert funding and attention away from Southeast Asia, the most likely epicentre of a human pandemic.

Officials in Europe are braced for an outbreak of the deadly H5N1 strain of bird flu, which has killed more than 60 people in Asia since 2003, after tests confirmed the disease in poultry in Romania and Turkey.

No human cases have been reported in Europe.

"There's a lot of anxiety (in Europe)," said Peter Cordingley, spokesman for the WHO in Manila.

"Quite clearly, the result of this could be that governments might focus on domestic preparedness and forget the fact that ground zero is Southeast Asia."

Cordingley said the feared mutation of the virus into a form that is easily transmitted between humans was most likely to take place in Southeast Asia, where millions of birds have been culled in an attempt to limit the disease's spread.

"(U.S. President) George Bush has said it and he got it right. He said you can't fight bird flu within the boundaries of the United States. You have to go to its genesis, and that's out here."

Experts say the fight against bird flu in Asia is being hampered by huge differences in wealth between countries.

Some countries still have no stockpiles of the expensive anti-viral drugs that could help limit a human pandemic and have poor public health infrastructure.

The WHO said on Friday it needed $260 million from the international community to fight the spread of bird flu in Asia.

To date, about $20 million had been committed to help fight the disease in Cambodia, Indonesia, Laos and Vietnam, where most of the deaths caused by the H5N1 strain have been reported. The WHO hopes to generate more pledges for Asia from wealthier states during meetings on bird flu in coming weeks in Canada, Australia and Switzerland.

"So far, there have been good indications but we don't have the money in the bank yet," Cordingley said.

"While we are concerned that money shouldn't get diverted into Europe, we're pretty confident we're going to get the money we want." - alertnet.org

UK prepares for martial law?

UK: Schools to close and sport banned if bird flu hits

By Geoffrey Lean, Environment Editor Published: 16 October 2005

The Government believes that a pandemic could kill some 700,000 people in Britain

Emergency plans in the event of a British bird flu pandemic - including closing schools, banning sporting events and dealing with disorder on the streets - are to be announced by ministers this week, The Independent on Sunday can reveal.

They will also disclose a contract to buy two and a half million doses of flu vaccine to enable essential workers to operate during the pandemic, and publish a booklet to be sent to every GP on how to combat it.

The move follows yesterday's discovery that the deadly virus has reached Europe for the first time. Tests at the Veterinary Laboratories Agency in Weybridge, Surrey, revealed that wild birds in the Danube delta in Romania had died of the H5N1 strain of the disease, which scientists fear will mutate to spread rapidly among people, killing tens of millions worldwide.

The Government believes that a pandemic could kill some 700,000 people in Britain, and that it would be impossible to stop it once it reached the country. The new plans are designed merely to mitigate its worst effects and to try to stop a total breakdown of services and public order.

The plans allow for: closing schools, theatres and public buildings; cancelling mass gatherings such as sporting fixtures; suspending international flights from infected countries; deploying police to deal with public disorder; setting up special centres to dispense the anti-viral drug Tamiflu; and encouraging people to observe basic hygiene.

Ministers accept that some of these measures could involve making hard choices. Closing schools, for example, could result in nurses who are mothers staying at home to look after their children. Suspending flights would lead to massive disruption, and would probably delay the virus's arrival by only a few weeks.

And the plans allow for Tamiflu to be given only to people who have had symptoms of the flu for less than 24 hours. There are medical grounds for this, as this is the period during which it is effective.

Ministers will also announce they have finalised a contract to supply a vaccine to essential workers that they hope would blunt the effects of the disease, although it would not provide complete protection. - independent

British Lab tests confirm what exactly????

BUCHAREST, Oct 15 (Reuters) - Lab tests in Britain have confirmed that an outbreak of bird flu in Romania is that of the highly pathogenic H5N1 strain, Romania's state veterinarian authority said on Saturday.

"We have received telephone confirmation from London that it is the H5N1 virus," Alina Monea, spokeswoman at Romania's veterinary and animal health authority told Reuters. - alertnet.org

Officials announced yesterday that samples of Romanian bird flu being tested this weekend in a British laboratory did contain the deadly H5N1 virus. However further results are needed to find out whether it is similar to the particularly lethal strain which has been found in Turkey and Asia. Scientists fear that H5N1 could genetically mutate into a form which is easily passed from human to human, sparking a global pandemic. - 'Bird flu outbreak is inevitable'

UK Culling plan:

The Department of Health will also announce its revised pandemic flu contingency plan this week. At the moment, planning is based on 54,000 Britons dying but in June the civil contingency secretariat advised the plan should be able to cope with a death toll of 700,000 - just over 1% of the population.

The new plan is understood to take account of the Civil Contingencies Act which allows the government to introduce emergency powers to safeguard human life. This means people could be confined to their homes and the army used to enforce quarantines.

Defra is to seek powers to cull every flock within two miles of an avian flu outbreak. At the moment, it only has the authority to kill infected flocks.

The move is likely to anger the farming industry, which saw millions of animals culled during the foot and mouth disease outbreak of 2001. But experts believe "pre-emptive" culls are the only way to ensure the virus does not spread. - timesonline

EU - We will not hesitate ... to propose more drastic measures

EU to propose 'drastic measures' against bird flu

17/10/2005 - 07:22:59 - The European Union will not hesitate to propose "drastic measures" to fight the spread of bird flu if current safeguards prove insufficient, EU Commission President Jose Manuel Barroso said yesterday.

Bird flu has been found in Romania and Turkey, and the EU has banned all poultry imports from those countries. It also recommended that member states increase biosecurity measures on farms, and implement early detection systems in risk areas, such as wetlands.

"We should avoid alarmism, but at the same time I think we should ... use very serious precaution on this situation and monitor it constantly," Barroso told reporters during a visit to Stockholm, Sweden. "We will not hesitate ... to propose more drastic measures if at technical and expert level this is recommended," Barroso said, but did not give details.

EU experts on Friday urged poultry farmers to check on their birds more frequently and to report deaths and illnesses quickly. They did not require EU farmers to bring their flocks indoors, nor did they recommend vaccinations among flocks or bans on the hunting of wild fowl.

The Commission has called another emergency meeting of EU veterinary experts for Thursday to assess developments.

Although the H5N1 virus strain is highly contagious among birds, it is difficult for humans to contract. Still, it has killed about 60 people in Asia, mostly poultry farmers infected directly by birds.

The strain has already appeared in Turkey, and the European Union has banned all poultry imports from Turkey and Romania. The EU's top public health official, Health Commissioner Markos Kyprianou, said no further measures to prevent the disease spreading from Romania and Turkey were immediately needed.

Turkish authorities said today that the outbreak in the western village of Kiziksa had been contained, while initial lab tests conducted after about 1,000 chickens died in eastern Turkey showed no signs of bird flu.

Romanian officials said all domestic birds in Ceamurlia de Jos were killed and the village was being disinfected, but the area would remain under quarantine for 21 days before it could be declared free of the virus.

"We finished (killing domestic fowl) in Ceamurlia de Jos," said Gabriel Predoi, who heads the national Agency for Animal Health. They hoped to complete the cull in Maliuc by tonight.

Both Ceamurlia de Jos and Maliuc are in the quarantined eastern province of Dobrogea. All cars, trucks and trains travelling between Dobrogea and the rest of the country are being disinfected, while authorities have increased the surveillance of domestic birds in neighbouring areas, Agriculture Minister Gheorghe Flutur said.

The two villages are under even stricter regulations, with police restricting access to them. Authorities have also banned farmers in surrounding areas from leaving birds and animals outside, for fear they could come in contact with wild migratory birds carrying the virus.

In Italy, poultry for sale as of Monday will carry labels indicating its origin, in a bid to reassure consumers worried about bird flu.

An Italian lobby for the farm industry, Confagricoltura, said the labels would indicate where the poultry had come from, as well as a number indicating the poultry farm had clearance from health authorities.

The label will also contain information about the butchering of the poultry. - IOL

But...er...not this winter...

A bird flu pandemic will hit Britain - but not necessarily this winter, the chief medical officer has said. - BBC

Why haven't countries such as Macedonia got their own labs???

Macedonia seeks UK tests on suspect bird death

SKOPJE, Oct 18 (Reuters) - Macedonian authorities said on Tuesday that one dead chicken found among hundreds in a village north of the Greek border had raised suspicions and samples were being sent to Britain for tests for possible bird flu.

"We had one sample which was suspicious. It could be any kind of flu, not only bird flu. But to be sure we decided to send the sample to the U.K. for tests," said Sloboden Cokrevski, Macedonia's chief veterinarian official.

Greece confirmed its first case of bird flu on Monday and was conducting tests to determine if it was the deadly strain of the virus, which some scientists say is likely to mutate, causing a pandemic among humans.

The virus, called H5N1, has been found in Romania and Turkey where thousands of fowl have been culled in an effort to prevent its spread.

The suspect sample comes from a village called Mogila, near Bitola, about 130 kms (70 miles) north of the border with Greece. This is a rural area of some 500 households which keep some 10,000 chickens.

Hundreds of chickens have died recently in the area, but of 40 samples taken, all but one showed they died of what Cokrevski said was a "well-known plague" among poultry, known as Newcastle disease and endemic in many countries.

Macedonian authorities said they would monitor a 3-km zone around the site but did not seal the area off.

Macedonia is also awaiting the results of tests by local authorities on chickens that died near Kumanovo, on the country's northern border with Serbia. - alertnet.org

Coming soon: Global lockdown?

Report: Israel, Syria to discuss bird flu,
Representatives of Israel, Syria, Iraq, to meet

Arabic-language papers report Roee Nahmias

Joining forces to confront the danger? Israeli, Syrian, Iraqi, Jordanian, and Palestinian officials are set to meet Thursday on the Sheikh Hussein bridge connecting Israel and Jordan, in order to discuss efforts to curb a bird flu epidemic.

Global Threat

World Health Organization says efforts to contain deadly virus in Southeast Asia have failed; experts say 7 million could die. Israel prepares for worst-case scenario that would see thousands hospitalized, 3,000 die

A word of the planned meeting was leaked after Jordan's agriculture minister met with his country's parliament speaker and other parliament members, Arabic-language newspapers al-Sharq al-Awsat and al-Bayan reported Wednesday morning.

Meanwhile, the Agriculture Ministry confirmed a meeting on the matter will take place in Jordan on Thursday. The Health Ministry, however, said it was unaware of the meeting.

Later, Agriculture Ministry spokeswoman Daphna Yurista said Israeli officials will meet with their Jordanian counterparts - but not with representatives from other countries such as Syria and Iraq.

"The representatives may be briefed about the preparations of neighboring countries that Jordan maintains contacts with and Israeli doesn't," the spokeswoman said

According to the newspaper report, Jordan views the meeting as a "technical coordination session" in order to deal with the disease, and called to avoid politicization of the issue. The Jordanian minister refused to provide further details and said it will be attended by neighboring countries in order to learn about preventive steps that could help curb the spread of the disease.

On Tuesday, European Union foreign ministers characterized the spread of bird flu as a global threat in a session convened several hours after new cases of the disease were discovered in Romani.

The bird flu virus does not exist in Israel for the time being, head of the chicken branch in the Agriculture Ministry, Dr. Shimon Pokamonski, said Saturday, in wake of fears that the deadly virus spread to Israel.

"We are examining all reports in the chicken industry for fear of the disease or any problem," he said. "Several reports were received over the weekend and we took samples in for laboratory testing. It revealed that there is no reason for concern." - ynetnews

Brazil readies emergency plan to fight bird flu

By Inae Riveras - SAO PAULO, Brazil, Oct 18 (Reuters) - Brazil, the world's No.1 poultry exporter, is preparing an emergency plan to combat bird flu, Brazil's Agriculture Ministry said on Tuesday. Brazil shipped 2.47 million tonnes of poultry worth $2.6 billion in 2004, overtaking the United States as the top poultry exporter.

"We are updating emergency sanitary measures with greater emphasis on bird flu," Inacio Afonso Kroetz, acting secretary of animal and plant protection, told Reuters.

In Luxembourg, EU foreign ministers on Tuesday urged global cooperation to tackle the threat of avian flu as Greece probed what could be the first appearance of a deadly strain in an EU member country.

The H5N1 strain, which has killed more than 60 people since it first appeared in 1997, was recently discovered in Turkey and Romania. Scientists fear that if the virus passes from birds to humans it could kill millions worldwide.

Brazil's contingency plan, due to be finalized by this weekend, would reinforce airport controls. Brazilian poultry production would be regionalized so that if bird flu was found, eradication measures, such as slaughter of birds, could be more easily restricted to the infected area. A similar measure exists for foot-and-mouth disease. The aim is to allow importing countries to ban poultry purchases only from the infected area, not from all Brazil.

Brazil's Poultry Producers' Union (UBA) said that regionalization would be implemented in three stages, starting in January 2006, covering the country's southern states and Sao Paulo and Minas Gerais.

The plan, involving the creation of checkpoints and transit corridors, would cost 50 million reais ($22 million) and take three years to implement, according to the producers' union.

Ariel Mendes, UBA's technical vice president, said emergency veterinary teams would be trained in Brazilian states to fight bird flu. Such teams are equipped only for foot-and-mouth disease now.

After a case of bird flu in Colombia, Brazil's producers also urged the government to strengthen border controls to stop poultry being smuggled in from neighboring countries. - alertnet.org

China reports new outbreak of bird flu

Oct 19 6:58 AM US/Eastern - China announced its first reported outbreak of bird flu in more than two months, saying 2,600 birds had died from the disease on a farm in its northern Inner Mongolia region. China's national bird flu laboratory confirmed that an epidemic on a farm near the Inner Mongolian capital of Hohhot was the H5N1 strain which is potentially lethal to humans, the Xinhua news agency reported.

The most recent confirmed case before this one was near the Tibetan capital of Lhasa in August, in which 133 birds died and another 2,475 were slaughtered.

The brief Xinhua report did not provide any detail on when the outbreak happened.

It said the ministry of agriculture had immediately dispatched teams to ensure necessary quarantine and disinfection measures were undertaken.

"Currently, the outbreak has been brought efficiently under control," the agency said. "No new outbreaks have been discovered."

A Chinese doctor who became famous for his efforts to curb the SARS virus warned last month that a global outbreak of bird flu could happen at any time.

A global flu epidemic strikes every 20 to 50 years, and it is now more than 20 years since the last outbreak, Zhong Nanshan, director of the Guangzhou Institute of Respiratory Diseases, said according to Xinhua in September.

Asia has been battling bird flu since late 2003, with vaccination campaigns and massive culls of tens of millions of chickens and ducks that have devastated poultry industries, particularly in Thailand and Vietnam.

So far, it appears that all the human victims of bird flu contracted the disease from poultry, and not from other people. - breitbart.com

Economic pressure = Poultry Farmers are panicking

Stuffing, not flu, killed Albanian turkeys

TIRANA, Oct 19 (Reuters) - The death of 200 turkeys raised fears of a bird flu outbreak in southern Albania but a post-mortem exam by the country's Veterinary Institute showed the birds died of eating too much.

"Our analysis shows they died of over-eating. There is no virus," chief vet Dashamir Xhaxhiu told the Panorama newspaper as concern grew in Europe that the deadly bird flu virus was spreading.

Turkeys are traditionally fattened for the New Year's dinner table in Albania. Some farmers who think rich feed makes them tastier force-feed them with olives and nuts. - alertnet.org

protect the entire population...after an outbreak - eh?

Update: UK plans mass vaccination against pandemic flu

By Patricia Reaney LONDON, Oct 19 (Reuters) - Britain plans to buy enough vaccine to protect the entire population in case a deadly bird flu virus develops into a pandemic strain capable of killing millions of people, the government said on Wednesday.

Chief Medical Officer Liam Donaldson said vaccine manufacturers are being invited to tender contracts to supply 120 million doses, enough for two shots per person, once the pandemic strain is known. "A vaccine to protect against pandemic flu cannot be made until the new virus is known," Donaldson said. "We're asking vaccine companies to gear up to supply us with pandemic flu vaccine even though at this stage we can't give them the strain, nobody can," he told a news conference.

The move would put Britain at the front of the line in getting a vaccine if a pandemic emerged. Scientists believe a human flu pandemic is already overdue. They are worried that the H5N1 bird flu virus that has been circulating in Asia since 1997, and has been reported in birds in Russia, Turkey and Romania, could evolve into a highly infectious strain in humans similar to the 1918 Spanish flu pandemic that killed as many as 50 million people worldwide.

Samples of a bird flu virus from a turkey in Greece are also being tested to see if it is lethal bird flu. The H5N1 bird flu virus has jumped to humans and killed 60 people in Asia. Twice as many have been infected but so far it is not easily transmissible from person-to-person -- a prerequisite for a pandemic strain. To become a pandemic strain the H5N1 bird flu would have to mutate on its own or mix its genetic material with a human influenza virus to become highly infectious in humans who would have little or no immunity against it.


An effective vaccine is the only measure that will defeat a human flu pandemic but it could take 4-6 months if a pandemic strain emerged to identify it and develop a vaccine. Donaldson said the so-called sleeping contracts would be incentive for vaccine manufacturers to gear up to supply a vaccine because they would know they had the contract if a pandemic emerges. "We regard pandemic flu as public health enemy number one and we are on the march against it," he said.

Several companies are working to develop a pandemic flu vaccine, including Sanofi-Aventis SA , GlaxoSmithKline Plc and Chiron Corp . The move is the latest in Britain's contingency plans for dealing with a possible influenza pandemic. In March it announced that it was buying 14.6 million courses of the antiviral drug Tamiflu made by Swiss pharmaceutical giant Roche The stockpile, which will cost about 200 million pounds ($350.6 million), will be completed by September 2006. The drug reduces the severity of flu and is considered a first line of defence until scientists can develop a vaccine.

The European Commission has advised member states to stockpile antiviral drugs. Officials also plan to hold talks with the vaccine manufacturers. (BIRDFLU-BRITAIN-VACCINE, editing by Steve Addison, Reuters Messaging: patricia.reaney.reuters.com@reuters.net)) - alertnet.org

Tamiflu is by Roche right? Wrong

Rumsfeld To Profit From Avian Flu Hoax

Finally, the pieces of the puzzle start to add up. Last week, President Bush sought to instill panic in this country by telling us a minimum of 200,000 people will die from the avian flu pandemic but it could be as bad as 2 million deaths in this country alone.

This hoax is then used to justify the immediate purchase of 80 million doses of Tamiflu, a worthless drug that in no way shape or form treats the avian flu, but only decreases the amount of days one is sick and can actually contribute to the virus having more lethal mutations.

So the U.S. placed an order for 20 million doses of this worthless drug at a price of $100 per dose. That comes to a staggering $2 billion.

We are being told that Roche manufactures Tamiflu and, in yesterday's New York Times, they were battling whether or not they would allow generic drug companies to help increase their production.

But if you dig further you will find that a drug was actually developed by a company called Gilead that 10 years ago gave Roche the exclusive rights to market and sell Tamiflu.

Ahh, The Plot Thickens...

If you read the link below from Gilead, you'll discover Defense Secretary Donald Rumsfeld was made the chairman of Gilead in 1997.

Since Rumsfeld holds major portions of stock in Gilead, he will handsomely profit from the scare tactics of the government that is being used to justify the purchase of $2 billion of Tamiflu.

For more on the nonsense of the avian flu hoax, you'll want to review my post from yesterday.

Gilead Sciences Inc.

from mercola

and there's more:

US Defense Secretary Donald Rumsfeld, former chairman of Gilead, the manufacturer of Tamiflu, will also make big profits, since he is a major shareholder.

Better yet, Bilderberger spokesman Etienne F. Davignon (Vice-Chairman, Suez-Tractebel)and Reagan-Bush Cabal insider former Secretary of State George P. Shultz, PhD (Distinguished Fellow, Hoover Institution, Stanford University) are also on the board of directors of Gilead. (http://www.gilead.com/wt/sec/bod)

Another Bilderberger regular is Lodewijk J.R. de Vink, who sits on the board of Hoffman-La Roche, Gilead's partner. http://www.roche.com/home/company/com_gov/com_gov_dir/com_gov_dir_vink.htm

In other words, the "Bird Flu" scam will generate outrageous profits for globalist-insiders like Shultz, Rumsfeld, Davignon, and de Vink.

- globalnewsmatrix

Roche may license its bird flu vaccine

Thursday 20th October, 2005 (UPI) Switzerland's Roche Holding AG, maker of an in-demand bird flu vaccine, will meet with at least four drug companies about licensing Tamiflu.

Roche, which holds the exclusive rights to the anti-viral agent, has also agreed not to increase the price of sublicenses, CNN reported Thursday. Tamiflu is one of two drugs known to reduce the severity and length of sickness caused by influenza.

The four companies with which Roche officials will meet are Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories and Ranbaxy Laboratories.

The World Health Organization, which has documented 118 cases of human infection by bird flu -- 61 of them fatal -- is urging governments to prepare for a possible pandemic by stockpiling anti-viral treatments such as Tamiflu.

Roche says it has gotten orders from about 40 countries and cannot meet the demand for the product, which requires a lengthy, complex manufacturing process. - BNN

Psyops backstory?

Scientists discover deadly bird flu began in Scotland


Scientists tracing the history of the H5N1 virus have traced its first recorded episode to an Aberdeen farm. The dead bird was taken to Surrey for medical examination, after infecting two flocks of chickens.

But while British medical authorities are preparing to cope with a pandemic of a new H5N1 outbreak from South-east Asia, the case notes of the original Scottish case have not been consulted, on the grounds that the virus has grown far heartier and deadlier over the past 46 years. The reams of research papers tracing the history of H5N1, which resurfaced in South Korea two years ago, show academics are unanimous in identifying the virus as being effectively made in Scotland. A scientist identified only as Dr JE Wilson, of the Veterinary Laboratory in Lasswade, outside Edinburgh, is recorded as having worked on the case - sending the chicken to Addlestone, where the strain was medically isolated so it could be used in experiments. The Scottish H5N1 has been used in experiments, named "chicken/Scotland/1959".

It was the first of 21 avian flu outbreaks that have affected the world - including English turkeys in 1963, 1979 and 1991. But none showed the powers of contagion seen by the eight Asian countries to have confirmed H5N1, which has killed 69 people and 100 million birds.

Tom Pennycott, an avian veterinary specialist at the Scottish Agricultural College at Auchincruive, Ayrshire, said the virus may have the same title, but other characteristics will have changed over 46 years.

"The H5N1 that was found back in 1959 would have been quite different to the one that's around now," he said. "Similarly, there was an H5N1 down in Norfolk in December 1991 and it will be different to the H5N1 that's about just now."

He added that the only additional information he has been able to find about the H5N1 in Scotland was that two flocks of chickens were infected. The total number of birds affected, however, was not reported. No medical agency in Scotland or England was able to give many details - except to say that the disease has become heartier and deadlier since it was found in Scotland. There is also no sign of Dr Wilson. The Moredun Research Institute at Penicuik said that it had no record of him and that he was likely to have passed away. Flu strains are named after the various H and N protein codes recognised by the immune system. No H5 flu had ever spread to humans before 1997, when Hong Kong reported six casualties.

The 1959 Scottish H5N1 was - like all its successors - incapable of moving from species to species. But this changed last year, when the South Korean version showed itself capable of infecting pigs, rodents and humans.

Scientists have been most alarmed at the fast rate of H5N1's mutation. For the first time, the virus can survive in chicken faeces and in dead meat, without requiring the flow of fresh blood. This has made it stealthier, claiming victims who had no obvious connection with the agricultural industry. But its low human death toll suggests that the disease has yet to pass from human to human.

Meanwhile, Tony Blair, the Prime Minister, met British farmers yesterday and said he agreed with the National Farmers Union that chicken remained safe to eat. - scotsman

Year Country/area Domestic birds affected Strain
1959 Scotland chicken H5N1
1963 England turkey H7N3
1966 Ontario (Canada) turkey H5N9
1976 Victoria (Australia) chicken H7N7
1979 Germany chicken H7N7
1979 England turkey H7N7
1983–1985 Pennsylvania (USA)* chicken, turkey H5N2
1983 Ireland turkey H5N8
1985 Victoria (Australia) chicken H7N7
1991 England turkey H5N1
1992 Victoria (Australia) chicken H7N3
1994 Queensland (Australia) chicken H7N3
1994–1995 Mexico* chicken H5N2
1994 Pakistan* chicken H7N3
1997 New South Wales (Australia) chicken H7N4
1997 Hong Kong (China)* chicken H5N1
1997 Italy chicken H5N2
1999–2000 Italy* turkey H7N1
2002 Hong Kong (China) chicken H5N1
2002 Chile chicken H7N3
2003 Netherlands* chicken H7N7

CHINA caused the global bird flu crisis???

China's blunder led to flu crisis

From: Sunday Herald Sun By Lincoln Wright and Paul Dyer October 23, 2005

CHINA caused the global bird flu crisis by feeding an antiviral drug meant for humans to its chickens, experts say.

The move rendered most anti-viral defences useless because the virus mutated into a more virulent strain.

As a result, the avian influenza virus, H5N1, is now largely resistant to amantadine - a low cost drug once effective in protecting humans.

The world must now rely more on the two less effective and more expensive anti-virals, Tamiflu and Relenza.

The revelation came as Australia planned to impose one of the world's toughest quarantine regimes at airports in the event of an avian flu pandemic, government sources said. The quarantine plan would result in overseas passengers being thermally scanned to check their body temperature. If they showed signs of flu, they would be put in converted aircraft hangars for up to six days.

Meanwhile, Agriculture Minister Peter McGauran is considering banning live bird imports to Australia after several racing pigeons from Canada tested positive to bird flu antibodies.

"The minister has sought advice on that," a spokesman for Mr McGauran said yesterday.

Fear of a pandemic has also led Australian doctors and pharmacists to stock up on hard-to-find anti-viral medicine to protect their families. And some doctors and medical workers have devised "exit strategies" to flee their homes if human-to-human bird flu takes hold.

Brisbane GP Dr Tom Lyons said he had bought stocks of Tamiflu in March. "I know pharmacists who are, some doctors who are as well," he said. "It is like an insurance policy. You don't get one expecting a cyclone or a car accident."

The World Health Organisation's Beijing spokesman, Henk Bekedam, confirmed China's blunder this week. "We are more and more concerned that this antiviral (amantadine) might not be that useful any longer," he said.

Amantadine was put in the drinking water of millions of China's estimated chicken population of 13 billion in the late 1990s. That broke international livestock guidelines on health. China's Ministry of Agriculture denied the practice, but in June said it was sending inspectors to make sure the antiviral use on chickens ended.

The mutated avian influenza virus that is now resistant to amantadine has spread to Vietnam, Thailand and even Europe. The H5N1 virus can cross the species barrier into humans, leading to viral pneumonia and organ failure. The biggest fear among health experts is the virus will mutate so that it can spread easily between humans, causing a pandemic that could kill millions of people. - news.com.au

Sheeple buy anti-viral drugs like hotcakes

Bird flu drugs fly off shelves in flu-fearing HK

By Tan Ee Lyn HONG KONG, Oct 26 (Reuters) - Worried residents and companies in Hong Kong are sweeping bird flu drugs off pharmacy shelves as the deadly virus spreads in poultry and wild birds in mainland China and parts of Europe. The worry in Hong Kong is understandable. The H5N1 virus made its first known jump to humans in the city in 1997, when it killed six people. SARS, which killed nearly 300 people here in 2003, is also fresh in people's minds.

Health experts have warned for months that the bird flu virus, which has killed more than 60 people in four Southeast Asian countries since 2003, could soon mutate into a strain that is easily passed among people. Millions could die.

At some pharmacies, store managers said they had run out of Tamiflu and Relenza, which are known by their generic names oseltamivir and zanamivir, about two weeks ago. Both anti-viral drugs are considered by many doctors as an effective way to reduce the severity of avian influenza and its complications, if taken correctly.

Although both are prescribed drugs in Hong Kong, they had been freely available over the counter in pharmacies until very recently. The government began enforcing the restrictions since it warned against indiscriminate use of the drugs.

"We sold out a few weeks ago. You need a doctor's prescription now or we won't be able to get them for you," said one store manager at a pharmacy. "And even with a prescription, I don't know when you can get yours. Supply is very tight because companies have been buying in bulk for their own staff. I've got four orders before yours." "But if you can't wait, you can get them from shops in Mongkok. They are going for between HK$600 and HK$1,000 ($77 and $128)."

Each course of Tamiflu and Relenza had fetched about HK$200 (US$25) a few weeks ago. A course of Tamiflu is 10 tablets.

Some scientists believe migratory birds escaping the harsh northern winter are helping spread H5N1 to the eastern edge of Europe. Mainland China reported outbreaks of birdflu in poultry in central Hunan province and eastern Anhui province this week alone. Hong Kong's government plans to amass a large stockpile of anti-viral medicine by 2007. But some residents want their own supplies now.

"I want to get two courses for my own family, because there may not be enough when the pandemic happens," said bank employee Olga Lo. "But I will not take it without doctor's advice, because that may lead to resistance," Lo said.

Professor Yuen Kwok-yung, a scientist at the University of Hong Kong and one of the city's top health experts who helped fight against bird flu and SARS in recent years, warned against indiscriminate use of the anti-virals on Tuesday. "We strongly advise the public against self medication with anti-viral agents. One of the most important reasons is because of the development of anti-viral resistance," Yuen said. "If you are infected by a H5N1 virus at the same time, there may be gene reshuffling which will allow the resistant gene from the human influenza virus to go into the bird flu virus. That may make the whole pandemic preparedness plan useless because you can increase the amount of resistance in the virus, leading to prophylactic or treatment failure," Yuen said.

- alertnet.org

The Ministry of silly diseases? This Parrot is no more...

Parrot enthusiasts have voiced concerns: apparantly there was 2 shipments of exotic birds from South America & an entire shipment of birds may have be culled needlessly. Which begs the question...how many thousands / millions of birds have been needlessly destroyed...

Bird flu found in parrot in UK quarantine-ministry

LONDON, Oct 21 (Reuters) - A parrot that died in quarantine in Britain has been diagnosed with bird flu, the agriculture ministry said on Friday.

"A highly pathogenic H5 avian flu virus has been isolated in the parrot imported from Suriname, South America," the ministry said in a statement.

The statement did not specifically say whether it was a case of the H5N1 strain which has caused alarm in Europe in recent weeks as it can transfer to humans in limited circumstances.

The parrot was part of a mixed consignment of birds that arrived on Sept. 16, the ministry said. Those birds were held with another consignment from Taiwan.

"The confirmed case does not affect the UK's official disease-free status because the disease has been identified in imported birds during quarantine," chief veterinary officer Debby Reynolds said.

The bird had been held in a secure quarantine unit and all the birds there were being culled humanely, the ministry said. The small number of people who had been in contact with the birds were receiving antiviral treatment as a precautionary measure, the statement added. - alertnet.org

Update: Parrot did not die of bird flu - tests are a farce

Doubts over bird flu tests raised

Doubts over testing in quarantine for bird flu have been raised after it emerged Taiwanese finches, not a parrot, brought the disease to the UK. A government report said the mixing of tissue samples led officials to wrongly assume a South American blue-headed pionus was the source of the virus.

Opposition politicians said the report exposed confusion in the system and raised more questions than it answered. But ministers argued it showed quarantine procedures were working.

The probe for the Department of Environment, Food and Rural Affairs (Defra) said it was more likely the virus was brought to an unnamed quarantine centre in Essex by 50 finches from Taiwan rather than by the parrot as previously thought.

Because the tissue samples of the first birds to die were mixed, it was unclear which birds had the H5N1 virus strain.

Later tests showed the Taiwanese birds were the "most likely" virus source, as H5N1 was not found in other species.

Shadow environment secretary Oliver Letwin said the report had exposed confusion in the handling of the issue and that quarantine procedures should be tightened immediately. Testing pooled samples for diseases may have been appropriate in the past but not now when the country was on a state of alert for bird flu, he said. He added: "Defra informs us that it will be another three weeks before they will announce what they will do to strengthen the quarantine system. This delay is quite unacceptable."

His comments were backed by the former president of the British Veterinary Society Bob McCracken who said although pooling samples was standard practice in some cases, it should not have been done with two separate consignments. But he said this was a minor issue compared with the fact that the disease had been successfully contained in the quarantine centre.

Liberal Democrat environment spokesman Norman Baker said it was more important than ever the quarantine review produced recommendations that inspired public confidence. He added: "This is turning into even more of a shambles than could have been imagined. This revelation raises more questions than it answers."

The report said the birds were grouped according to species and location in the quarantine facility and tested in line with accepted epidemiological sampling practice. But chairman of the environment, food and rural affairs committee Michael Jack said if officials wanted to know where a disease had come from it would be sensible for tissue samples to be tested separately.


Environment minister Ben Bradshaw admitted the procedures for detecting the disease may have to be strengthened and said Environment Secretary Margaret Beckett had already set up a review. But he said there was no cause for alarm as all the birds had been accounted for and none had been released into the country.

The report found the highly pathogenic strain of bird flu was initially identified when tissues from two birds that had died in the centre were analysed together. These were a blue-headed pionus from Surinam and a mesia from Taiwan, which were found dead on 14 October. The report concludes "on the balance of probabilities" the H5N1 was brought to the facility by the mesias. This was because later tests showed that 53 Taiwanese mesias died from the disease, but that none of the birds from Surinam had.

Responding to the report, the Taiwanese government said: "There is a good possibility that profit-driven traders smuggled mesias from China to Taiwan, using our avian flu-free country as a front from which they laundered these birds to the UK and other countries."

A separate investigation is being undertaken by Essex County Council's trading standards department into the circumstances surrounding the quarantine of infected birds. -

what next? are we to see the slaughter of domestic cats
as their tests are mixed to serve no useful purpose???

Our findings in tigers and leopards extend the host range of this virus and, together with the findings in domestic cats, suggest that this H5N1 virus is more pathogenic for felids than other influenza viruses. This finding has important implications for wildlife conservation and influenza virus epidemiology. First, H5N1 virus infection may threaten the survival of endangered felids, as has been shown recently for other emerging viruses in susceptible wildlife (19,20) . The severity of this threat is increased because H5N1 virus may be transmitted horizontally between domestic cats (18). Second, if the higher pathogenicity of H5N1 virus for felids also means longer excretion of more virus, the role of felids in avian influenza epidemiology, both in humans and in poultry, needs to be reevaluated. Finally, the confirmation of H5N1 virus infection as the probable cause of death in two other mammalian hosts besides humans implies that more species of mammals may be at risk for infection with this virus.

Avian Influenza H5N1 in Tigers and Leopards

Vietnams Martial law Bird flu plans

Vietnam to send army, police to fight bird flu

By Ho Binh Minh HANOI, Nov 10 (Reuters) - Vietnam, the country worst hit by bird flu, will send soldiers and police to help contain the spread of the virus as more outbreaks erupt and the sudden death of ducks in two provinces hints at a more virulent strain.

Deputy Prime Minister Nguyen Tan Dung said Vietnam's death toll from a human pandemic, which experts fear could occur if bird flu mutates to pass easily between people, would be higher than the 800,000 forecast by the World Health Organisation.

"No matter how much it costs, and even if we have to readjust the growth rate, the entire nation should try to fight the epidemic," Dung was quoted on Thursday as saying by Thanh Nien newspaper.

The agriculture ministry's emergency plan, seen by Reuters, said police, paramilitary and health workers should join forces to disinfect farms, destroy sick poultry and man checkpoints around it. Provincial authorities in Vietnam were not showing enough urgency in fighting the fast-spreading virus, Agriculture Minister Cao Duc Phat said.

"We must launch a campaign to build each hamlet, each commune into a stronghold for fighting the epidemic," Phat was quoted as saying in Nong Nghiep Vietnam, a newspaper run by his ministry. "In an emergency, the army will be deployed to isolate the infected area."

The United States also pledged around $6.5 million to Vietnam this year for vaccine development, drug stockpiling, surveillance and the needs of health officials, a U.S. embassy statement said.


The urgency was reinforced by Veterinary Institute head Truong Van Dung, who told a government meeting that bird flu may have become more virulent. He cited the death within three to four hours of a flock of ducks in Bac Giang province. Even though none showed symptoms of the virus while alive, all 15 samples taken after their deaths were positive for the H5N1 strain of bird flu.

Dung could not be reached for further comment and there was no proof that H5N1 had become more virulent, but many ducks also died quickly in a field in Hai Duong province, the Nong Nghiep Vietnam newspaper said. Since bird flu arrived in December 2003, 92 people in Vietnam are known to have caught the virus and 42 have died. The latest victim was a 35-year-old man in Hanoi who died in late October.

The World Health Organisation's forecast of 800,000 Vietnamese deaths should bird flu become a human pandemic is based on the 10 percent infection rate of the 1918 influenza pandemic. Of about 8 million Vietnamese who would be infected, 10 percent would die, according to the WHO projection.

Outbreaks since October have killed or resulted in the slaughter of more than 140,000 poultry in Hanoi and 10 other provinces, while animal health officials said 93 million birds had been vaccinated in 50 of Vietnam's 64 provinces.


The Agriculture Ministry said two outbreaks this week killed more than 1,300 fowl in Bac Giang and Quang Nam and Thursday's state media reported 2,100 ducks and chickens died or were slaughtered in the provinces of Hai Duong and Quang Ngai. They said 80 fighting cocks were slaughtered in the northern province of Hung Yen after 20 cocks died on a farm last week. About 300 ducks died in the central province of Quang Nam and animal health workers slaughtered another 1,000 while tests for bird flu were still under way, the Animal Health Department said.

Agriculture Minister Phat urged local authorities to provide more information to farmers to help detect outbreaks quickly. "Poultry slaughter should be centralised so the animal health work can be done better," Phat said on state-run Voice of Vietnam radio.

On Monday, Vietnam's three deputy prime ministers and six ministers started touring different areas in a two-week campaign to shake up prevention plans and preparations for a pandemic. alertnet.org

Experts dismiss scare over bird flu

Gainesville Sun/DIANE CHUN | November 3 2005

At a time when headlines trumpet the potential dangers of "bird flu," Gary Butcher is the man of the hour. Butcher has been an extension veterinarian at the University of Florida's College of Veterinary Medicine since 1988. He was trained as a veterinarian specializing in avian diseases, and has a Ph.D. in poultry virology. As the only poultry veterinarian in the state, Butcher fields phone calls and e-mails about avian flu every day. Lately, he's been traveling the world, speaking to alarmed government officials and industry groups dispelling the myths and reinforcing the realities of avian influenza or so-called "bird flu."

Gary Butcher begins his presentation with a slide that shows a "news flash" from the British press agency Reuters reporting that avian flu "poses the single biggest threat to the world right now."

The H5N1 avian flu virus has led to the death of 150 million birds, either through infection or culling to prevent the virus from spreading. So far, however, the number of people who have become infected remains small, with 121 confirmed illnesses and 62 reported fatalities as of Monday. No one has yet been proven to have given avian influenza to someone else.

The World Health Organization continues to warn that a human pandemic may occur and has advised national governments to make contingency plans. President Bush is expected to announce today the White House strategy for handling a potential pandemic during a visit to the National Institutes of Health.

"The emphasis of all my work has changed to dealing with this madness," Butcher said Friday, while briefly back at his office on the UF campus in Gainesville. "Realistically, avian influenza is not a threat to people, but everywhere you go, it has turned into a circus."

He's been to Indonesia and Thailand, Hong Kong and Mexico, and a few days from now, he will be in Russia.

The poultry industries in those countries have been greatly disrupted because of the public's flu fear. In countries where poultry consumption has dropped by 75 percent, it's a real crisis, Butcher said. So from an economic perspective, bird flu is a big issue.

Millions of chickens and waterfowl have been slaughtered in Asia in an attempt to halt the spread of the bird virus known as H5N1, but Butcher said that of the billions of people who have probably been exposed, only about 120 have been reported to have fallen ill with avian flu. They were people who worked closely with chickens and came into contact with the birds' blood and feces.

Butcher also said that there has yet to be a proven case in which one person is known to have passed the illness on to another.

Bird flu viruses have been around throughout history, he said. What is unique about the H5N1 strain is that, on rare occasions, it has shown the ability to infect humans.

"It is very inefficient, but it does manage," Butcher said.

That same inefficiency makes it much more likely that the virus can't replicate itself rapidly enough to spread from that first infected human to another, he said. Could happen, but not likely. That's his view. But the virus can go from poultry to the wild bird population, which will carry it to other locales along their migration routes. If and when it comes to this part of the world, Butcher predicts, it will get here via migratory shorebirds or waterfowl coming from Russia, through Siberia, across the Bering Strait, down through Alaska and Canada.

"That's how it is probably going to come in, and it is of very little relevance," he said, because the poultry industry in this part of the world is so different than in the parts of the world that have been affected so far.

Not all health officials are sounding a warning about avian influenza, either. Dr. Marc Siegel, a practicing internist and associate professor of medicine at the New York University School of Medicine, is one physician who isn't buying into the scare scenario.

"If anything is contagious right now, it's judgment clouded by fear," Siegel said. And if Americans are scared of avian flu now, Siegel continues, "imagine what will happen if a single scrawny, flu-ridden migratory bird somehow manages to reach our shores."

That, he maintains, is how the fear epidemic - as opposed to a flu pandemic - spreads.

Back to the unlikely scenario of those migratory birds carrying avian flu to a poultry house somewhere in Kansas.

"Only once in every blue moon do you get infection in a poultry house, and the government has a system of monitoring and eradication that means it is quickly wiped out," Butcher said. "So it can happen, but it is rare and it is not allowed to spread."

Because the United States exports about one-third of the 9 billion poultry produced, if potentially dangerous disease turns up, there is a policy of zero tolerance.

"Other countries would not accept poultry from anywhere in the United States if there was any question of infection," Butcher said.

He said that although there is a potential that the virus could mutate, as it exists, it could not become an important disease in humans.

"For it to become dangerous to humans, it has to go through a pretty significant genetic change. If you put this in perspective, it's not going to happen. For a person to be infected now, it appears that the exposure level has to be astronomical," Butcher said.

"While we are putting all our attention on this avian influenza, another virus is going to come up and bite us in the bottom," he said.


Japan to cull 180,000 chickens exposed to avian flu

TOKYO, Nov 4 (Reuters) - Authorities in eastern Japan ordered the culling of 180,000 chickens at a poultry farm after avian flu antibodies were found in the birds on Friday, a local official said.

Tests showed that chickens at a farm in the town of Ibaraki, north of Tokyo, had been exposed to the H5 strain of avian flu, although the virus itself was not detected, an official at Ibaraki prefecture said.

"It is not the case that there were abnormalities, that there was a rise in the death rate among chickens (at the farm)," the official said, adding that although antibodies were found, the chickens apparently did not develop symptoms.

Due to the lack of a virus, it may be hard to pin down the exact strain of avian flu the chickens were exposed to, he added.

A total of 1.48 million chickens have been culled in Ibaraki prefecture between June -- when a bird flu outbreak was first detected there -- and mid-October.

The World Health Organisation has said the H5N1 strain of the virus is endemic in most poultry flocks in Asia and experts say migratory birds, which act as hosts for the virus, could be spreading it.

The virus has already surfaced in eastern Europe in birds, though no human infections have been detected there.

In Asia, though, it has killed 62 people and infected 122 since late 2003. It remains hard for people to catch and is spread almost exclusively through human contact with birds.

But scientists say it is steadily mutating and could acquire changes that make it easy to spread from human to human, triggering a pandemic in which millions could die. - alertnet


Brooks laboratory aids in avian flu detection

Blackanthem.com, BROOKS CITY-BASE, Texas, November 11, 2005

A Brooks City-Base epidemiology laboratory is working to develop more effective and timely methods for detecting avian flu to support a worldwide Air Force surveillance program designed to safeguard American military personnel from a potential outbreak.

The Air Force Institute for Operational Health's Epidemiology Division is at the forefront of an Air Force initiative to create more reliable and faster testing procedures for H5N1, the influenza virus that scientists believe has spread from birds to humans across three continents.

"We're developing assays (DNA testing) to rapidly screen for avian flu," said Maj. David Eddington, a molecular biologist who is the AFIOH Epidemiology Division's microbiology chief. He said Air Force scientists began the process this year of developing new technology to detect avian flu. The new assay uses polymerase chain reaction, or PCR, technology. Additionally, the organization is capable of performing molecular sequencing of the viral genome which helps detect mutations.

Since first appearing in Asian poultry in 1997, the Highly Pathogenic Avian Influenza, as it is scientifically known, mostly has killed people who have been in direct contact with domesticated fowl. The deadly respiratory strain has become zoonotic (jumping from non-human host to people), leading to the first reported human death in 1997 in Hong Kong. Scientists fear that its transmission between humans could trigger a pandemic.

To do that, it would have to mutate. During the last century, mutations in influenza viruses caused pandemics that killed millions of people in 1918, 1957 and 1968. For avian flu to become pandemic, it would have to mix its genes with those from the naturally circulating flu 'A' strain to transform so that it becomes easily transmissible from human to human, said Linda Canas, chief, AFIOH Virology section.

Influenza viruses are known to transform with some frequency. This is why surveillance exists to determine which strain is best for the current vaccine, said Major Eddington.

"With the influenza virus, two different mutations called 'shift' and 'drift' exist," said Major Eddington. He said the drift mutation process involves a small nucleic acid variation that occurs after the virus invades a cell and during replication of its nucleic acid genome. Shift mutations, however, involve larger genetic segments and can occur in naturally circulating flu 'A' strains.

"The problem (leading to potential pandemics) is someone infected with a normal circulating flu 'A' strain is (also) co-infected with avian flu," Major Eddington said. The co-mingling of virus strains creates conditions for gene sharing. This occurs after an infected cell produces gene segments from both strains and they mix together during the process called self assembly. During this process, the virus mutates into a new variation in which humans have no immunity.

"The Air Force has stepped up worldwide avian flu surveillance that includes research sites in South America and Thailand," Ms. Canas said. Since 1997, the Air Force has been executive agent for the laboratory-based Global Emerging Infections System.

This tri-service system relies on a network of global sentinel (early warning) sites, Ms. Canas noted. "Our surveillance data is shared with the Food & Drug Administration's Vaccine and Related Biological Products Advisory Committee," she said.

This information is compared with other surveillance information and used to develop North American flu vaccines. Typically, flu vaccines are composed of two 'A' strains and one 'B' strain. All flu vaccines and anti-flu prescription drugs, such as the FDA-approved prophylactic Tamiflu, are made overseas.

Air Force scientists know that current flu vaccines offer no protection against avian flu. Ms. Canas said, "We have very little information on the use of Tamiflu. The only thing that it seems to help is morbidity (onset of illness). We don't know how it will affect mortality."

By Rudy Purificato 311th Human Systems Wing

Gilead Royalties

Roche settles dispute with Tamiflu inventor

By Tom Armitage ZURICH, Nov 16 (Reuters) - The main producer of Tamiflu, the drug thought to be the best defence against a possible flu pandemic caused by bird flu, has settled a dispute with the drug's inventor over production and royalties, the companies said on Wednesday.

Governments have been seeking to stockpile the drug as a precaution against the possible outbreak of a human variant of avian flu but drug maker Roche Holding AG has come under pressure over concerns production could fall short.

Under Wednesday's deal the drug's inventor Gilead Sciences Inc will get a greater say in plans to increase production of the drug by farming out parts of the process to third-party producers such as generic drug makers.

Gilead's share of the royalties from Tamiflu sales, which are expected to reach over $1 billion due to government orders, will remain unchanged, although it will no longer have to shoulder the burden of certain manufacturing costs.

"The money is not a great deal," said Claude Zehnder, market analyst at Swiss bank ZKB said. "But it is certainly a good thing that they have agreed this amicably."

The settlement also involves Roche paying the U.S. firm around $62.5 million in reimbursements for so-called cost of goods adjustments backdated to the start of 2004.

Investors in the Swiss drugmaker had feared that the dispute, which broke out in June, could weigh on the firm's shares or scupper Tamiflu sales. Roche's participation certificates were 0.4 percent higher at 194.40 Swiss francs by 0806 GMT, in a flat Swiss market. Gilead threatened in June to end a deal signed in 1996 under which Roche got an exclusive licence to manufacture and sell the antiviral drug worldwide. The U.S. firm claimed Roche had failed to market the drug properly, particularly in the United States, and had not launched the drug as a treatment for seasonal flu in other countries. If Gilead had won, all rights to the drug would have reverted back to the U.S. firm.

Roche has come under pressure from governments around the world to increase its production capacity for the treatment and said last month that it would consider allowing other parties, such as generic drugmakers, to produce the remedy. Gilead will also have a greater say in selling Tamiflu as a seasonal flu treatment and will have the option to co-promote the drug in specialised areas in the United States. However, it will not co-promote the drug in 2006, it said. Roche said that Gilead's royalties would remain unchanged, with the U.S. firm receiving a cut of between 14 and 22 percent based on Roche's annual net sales of the drug. This would work out at 18 to 19 percent for 2005, the firms said. Roche has already sold 859 million Swiss francs ($649.8 million) worth of Tamiflu in the first nine months of 2005.

Roche will pay Gilead the $62.5 million in royalty reimbursements and has said that the U.S. firm could keep $18.2 million which Roche had paid in protest over a dispute on royalty calculations for sales in 2001 to 2003. - alertnet.org

Tamiflu dangerous?

Chugai says two deaths have possible Tamiflu link

(Reuters) Updated: 2005-11-14 - Japan's Chugai Pharmaceutical Co said on Monday it has reported to the government that two teenage boys exhibited abnormal behaviour that led to their deaths after taking the anti-flu drug Tamiflu, made by Chugai's Swiss parent Roche Holding AG.

The comments come in response to weekend news reports that Japan's health ministry is investigating the deaths of two teenage boys who died in accidents linked to odd behaviour shortly after taking the drug. Health ministry officials were not available for comment.

Shares in Chugai were down 3.1 percent at 2,630 yen on Monday afternoon, compared with a 1.3 percent fall in the Tokyo Stock Exchange's pharmaceutical sector subindex.

Tamiflu, considered one of the best defences against bird flu in humans, might help slow the spread of a much-feared pandemic should the H5N1 flu virus become able to spread from person to person. The Mainichi newspaper and Kyodo News agency reported on Saturday that a 17-year-old high school student jumped in front of a truck in February last year shortly after taking the medicine, while a junior high school student is believed to have fallen from the ninth floor of his apartment building this February.

"We reported these cases to the health ministry as a link between the deaths and the drug could not be ruled out," a Chugai spokesman said. The reports were made separately after each incident, he said.

He said Chugai has included in the literature accompanying the drug a list of side effects such as impaired consciousness, abnormal behaviour and hallucinations and has called doctors' attention to the possible side effects. Kyodo said the ministry is considering issuing a fresh warning about the side effects, following its decision to increase stockpiles of the drug amid growing fears about a possible pandemic.

The Pharmaceuticals and Medical Devices Agency said there were 64 cases of psychological disorders linked to the drug between fiscal 2000 and 2004, according to Kyodo.

Chugai launched Tamiflu in Japan in 2001. During the last flu season it shipped the drug to more than 10 million people.

The Japanese government is planning to boost its target stockpile of Tamiflu to 250 million capsules, up 70 percent from its previous target, to cover treatment for 25 million people. - chinadaily.com

Health officials probe Tamiflu deaths

Thursday 17th November, 2005 (UPI)

Health experts in the United States and Japan are investigating the deaths of 12 Japanese children who took Roche's anti-viral Tamiflu.

Food and Drug Administration officials have not yet commented publicly on a possible link between Tamiflu and the fatalities, but the FDA said four of the fatalities were due to sudden death, which the agency said is unusual in otherwise healthy young people.

Tamiflu is viewed as the best medicine currently available to combat a potential bird-flu pandemic. Governments and corporations worldwide are currently stockpiling the drug as pandemic fears mount.

Tamiflu's Swiss sponsor Roche says the medication has been used to treat more than 33 million patients in 80 countries worldwide. The anti-viral was launched in the United States, Canada and Switzerland between 1999 and 2000.

Tamiflu's developer, Gilead Sciences, said earlier this week it had resolved its dispute with Roche over the marketing of the drug. Under a revised deal, Gilead has the option to co-promote the flu treatment starting next year. - Big News Network.com

Tamiflu Neuropsychiatric Events, Death, Serious Skin Reactions To Be Focus Of Pediatric Committee Meeting

Neuropsychiatric events and deaths with Roche's Tamiflu, as well as serious skin reactions, will be discussed by FDA's Pediatric Advisory Committee meeting for Nov. 18.

FDA has reviewed 75 case reports of adverse events from patients receiving Tamiflu (oseltamivir) for influenza treatment. The reports included eight deaths, 32 neuropsychiatric events and 12 skin/hypersensitivity events. The remaining events were categorized as gastrointestinal, musculoskeletal, abnormal test values, vascular, infectious, and hypothermia. There was also and one cardiac adverse event and an overdose.

The 32 neuropsychiatric adverse events included delirium, hallucinations, convulsions, encephalitis and abnormal behavior, which FDA termed the "most alarming" events in its briefing materials for the meeting.

The abnormal behavior involved two adolescents who "jumped out of the second floor window of their homes after receiving two doses" of Tamiflu, and a third eight-year old boy who ran into the street three hours after receiving his first dose of Tamiflu, FDA said.

The vast majority of the 75 case reports, 92%, originated from Japan where Tamiflu usage is more common. According to IMS Health, approximately 24.4 mil. prescriptions for oseltamivir in Japan were dispensed between 2001 and 2005 while approximately 5.5 mil. prescriptions were filled in the U.S. in the same period. Pediatric prescriptions accounted for 11.6 mil. in Japan vs. 872, 386 in the U.S.

FDA said that there is "insufficient evidence to establish that deaths and neuropsychiatric AEs represent a safety signal associated with Tamiflu." The agency suggested that the "pattern of neuropsychiatric AEs [is] more suggestive of increased AE reporting from Japan, increased use of the drug in Japan, and previously described manifestations of influenza."

There is an increased awareness of influenza in Japan facilitated by public health authorities and an active surveillance of flu-associated encephalitis and encephalopathy that began in the late 1990s.

Roche pointed other differences between Japan and the U.S. In Japan, oseltamivir is often dispensed as a powder in Japan, and mixed at the pharmacy, possibly contributing to higher dosing. The length of dosing may also be different, with Japanese patients possibly stopping administration before the recommended period, contributing to recrudescence (symptom reoccurrence), Roche's briefing documents for the meeting state.

Roche commissioned Ingenix to conduct an analysis from U.S. healthcare insurance claims databases. The study investigated the safety of Tamiflu in 63,000 children (1-12 years old) and concluded that there "was no indication of an increased risk of neuropsychiatric events for children aged 1-12 over that already posed by influenza illness alone," Roche said.

Roche also maintains "that there is no association between Tamiflu use and the deaths or neuropsychiatric events reported. Roche sees no scientific or medical basis for any changes in how Tamiflu is used."

While FDA said that updated labeling for neuropsychiatric events and death is not warranted for Tamiflu, the agency plans to closely monitor the adverse events with the antiviral and report back to the Pediatric Advisory Committee in two years.

The agency is, however, recommending the addition of information to labeling in serious skin reactions with Tamiflu.

"Hypersensitivity and serious skin reactions were identified as a potential safety signal that may need to be strengthened in the current oseltamivir product labeling," FDA said.

"As compared to the neuropsychiatric AE reports that may be related, in part, to an increased recognition of influenza-associated neurologic events in Japan, the cases of skin/hypersensitivity reactions do not appear to be related to a manifestation of influenza illness or increased in a specific population," the agency explained.

FDA will ask the committee to comment on its plans to further monitor Tamiflu adverse events and its proposed relabeling for serious skin reactions.

Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use requested at its Nov. 14-17 meeting that Roche provide a "cumulative safety review of all available data on serious psychiatric disorders, including all case reports with a fatal outcome where Tamiflu was involved," according to a Nov. 17 press release.

The request resulted from two cases of alleged suicides in adolescents reported to the EMEA. The agency stresses that the events could have been from concomitant therapies or the result of high fever.

- fdaadvisorycommittee.com

- Roches briefing document pdf

EU Health Regulator Asks Roche For Tamiflu Safety Data

ZURICH (MarketWatch) -- The European health regulator late Thursday said it asked Roche Holding AG (RHHBY) for safety data on its flu drug Tamiflu.

The Committee for Medicinal Products for Human Use decided at its most recent meeting to ask Roche to provide a cumulative safety review of all available data on serious psychiatric disorders, including all case reports with a fatal outcome where Tamiflu was involved.

The Committee for Medicinal Products for Human Use is the scientific committee of the European Medicines Agency, or EMEA. The EMEA is the European equivalent of the U.S. Food and Drug Administration.

The agency's request follows a posting by the FDA Thursday on its Web site ahead of a panel meeting to discuss the safety of Tamiflu and other drugs used to treat children.

Two cases of alleged suicide, associated with the treatment of influenza, were reported to the EMEA. In both cases the adolescents exhibited abnormal or disturbed behavior, which led to their deaths. So far, no causal relationship has been identified between the use of Tamiflu and psychiatric symptoms,such as hallucination and abnormal behaviour, the agency said.

"The EMEA stresses that the assessment of psychiatric events during Tamiflu treatment is difficult, because other medicines are often taken at the same time as Tamiflu and because patients with influenza and a high fever can show psychiatric symptoms."

The agency also said this is particularly relevant for children and elderly patients.

Roche moved to defend its Tamiflu anti-viral drug Thursday, saying only one out of a million children who had taken it had died, and the drug reduced mortality rates among flu sufferers.

Worldwide, Roche said 32 million people have taken Tamiflu, 89 of whom have died and 130 have had so-called neuropsychiatric events. No children have died in the U.S., said Dr. David Reddy, who heads the company's influenza task force.

Most of the deaths and severe side-effects were observed in Japan, where use of the drug is much more widespread than in Europe or the U.S.

Reddy said in past clinical studies, fewer flu patients who had taken Tamiflu died than those in a comparison group who didn't take the drug. He added "We mustn't forget that influenza itself can be a fatal illness." - marketwatch Company Web site: http://www.roche.com

FluWrap: Tamiflu gets safety nod

By KATE WALKER UPI Correspondent WASHINGTON, Nov. 18 (UPI) -- An FDA advisory panel Friday said that Tamiflu is safe and apparently unrelated to the deaths of 12 Japanese children who took the drug.

The Food and Drug Administration panel did suggest adding warnings about possible serious skin conditions, and said the FDA should review the drug safety profile again in a year. But by a unanimous vote, they said there was no evidence to link the drug to the deaths or to serious psychiatric events in children.

The 12 deaths in the past 13 months included one suicide, four cases of sudden death and four heart attacks. Other deaths involved asphyxiation, pneumonia and acute pancreatitis.

There have also been 32 cases of psychiatric abnormalities, including delusions, hallucinations and delirium, reported in children who had taken Tamiflu. Thirty-one of the cases involving psychiatric episodes occurred in Japan.

Two of the psychiatric cases involved teenagers who jumped from second-floor windows after taking two doses of the drug.

"In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail. The level of detail in these reports was highly variable and determining the contribution of Tamiflu to the deaths was difficult," an FDA summary said. - upi.com

1/2 of all Tamiflu users die in Vietnam

Deaths cast doubts over Tamiflu

By Andrew Jack in London Published: December 21 2005 18:45

Fresh doubts were cast on the efficacy of Tamiflu as a treatment for bird flu on Wednesday night when one of the world’s most prestigious medical journals published new reports of resistance to the drug and deaths in patients in Vietnam.

Menno de Jong and colleagues from the hospital for tropical diseases in Ho Chi Minh City recorded in the New England Journal of Medicine that four out of eight patients suffering from the H5N1 flu strain and treated with Tamiflu had died, including two who developed resistance.

The reports increase suggested levels of resistance to nearly 10 per cent, or three out of the 31 known human cases of H5N1 treated with Tamiflu, which is marketed by Roche of Switzerland.

The study raises new questions about the drug, which more than 50 governments have ordered in significant quantities in recent months to stockpile as a potential prophylactic and treatment in the case of a flu pandemic.

An accompanying article in the Journal reinforced calls for alternative approaches to treatment for a pandemic, including the stockpiling of the rival drug zanamivir, or Relenza.

Dr Anne Moscona wrote that individuals’ stockpiling of Tamiflu was “potentially dangerous” because it could lead to insufficient doses and inadequate courses of therapy, in turn accelerating the development of resistance.

Roche said it took the reports seriously, and was stepping up its own clinical research on Tamiflu’s use in humans and animals, including work on dosages of twice the current levels for longer periods. It said findings should be ready early next year.

The UK health department said on Wednesday night: “Tamiflu was chosen on the basis of independent expert advice that reflected its efficacy and ease of administration. Internationally, this is agreed as the product of choice. Our antiviral strategy is kept under constant review and we are looking carefully at Relenza as a possible back-up to Tamiflu.”

However, David Reddy, who is responsible for Tamiflu at the company, stressed that any findings on resistance or deaths should be set against the fact that an eventual pandemic strain of H5N1 would be different from the current bird flu virus which has so far infected 139 people and killed 71.

Separately, Roche said on Thursday that the US Food and Drug Administration had approved Tamiflu for preventing influenza in children - a vulnerable group during an outbreak. The company said that when the drug was administered within 48 hours of exposure, the incidence of flu fell from 17 per cent in the group not receiving the drug, to 3 per cent in the group that did.

Roche shares fell 0.8 per cent to Sfr197.2 in early trade. - ft.com




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