More swine flu vaccine recalled: FDA

Julie Steenhuysen
CHICAGO
Wed Dec 23, 2009 12:35pm EST


CHICAGO (Reuters) - The U.S. Food and Drug Administration said on Tuesday AstraZeneca's MedImmune unit is voluntarily recalling some of its H1N1 swine flu vaccine because it was not as potent as it should be. Norman Baylor, director of the office of vaccines research and review at the FDA, said the recall involves a total of 4.7 million doses of the company's nasal spray vaccine, but only about 3,000 of those doses are left in warehouses.

The rest of the doses were given out in October and November, when the vaccine was still at full potency, Baylor told reporters on a conference call. The FDA said people who had already received the vaccine do not need another dose. The company is the second to recall H1N1 swine flu vaccine in the past month. Sanofi-Aventis SA on December 15 recalled 800,000 doses of its pediatric H1N1 swine flu vaccine because it is not as potent as it should be. MedImmune said in a statement the recall involves unused doses of 13 specific lots of 2009 H1N1 nasal spray vaccine, because of a slight decrease in potency that was detected during regular checks.

"The doses were well within potency specifications at the time of distribution," said Tor Constantino, a spokesman for the unit of AstraZeneca. He said the recall was not for safety issues, but was intended to notify any healthcare providers who may still have some of the recalled vaccine in their refrigerators. "The cause of the loss of potency is being investigated," Constantino said by telephone, adding that this has not been an issue in the past with the company's seasonal flu vaccine.

MedImmune is recommending that all lots marked with an expiration date of between January 19 and January 26, 2010 not be used. Constantino said the company has delivered 23 million of the total 40 million doses on its contract with the U.S. government. He said the recalled doses were some of the earliest the company made, and most have already been given to people.

The U.S. Health and Human Services Department has contracts with five companies to make 251 million doses of H1N1 vaccine as well as seasonal flu vaccine -- Sanofi Aventis, CSL of Australia, AstraZeneca unit MedImmune and GlaxoSmithKline. The CDC's Dr. Anne Schuchat said on Tuesday 111 million doses of H1N1 vaccine have been made available so far.


Scientists discover natural flu-fighting proteins
Thu Dec 17, 2009 10:46pm GMT
By Julie Steenhuysen


CHICAGO (Reuters) - U.S. researchers have discovered antiviral proteins in cells that naturally fight off influenza infections, a finding that may lead to better ways to make vaccines and protect people against the flu. They said a family of genes act as cell sentries that guard cells from an invading influenza virus, the team reported on Thursday in the journal Cell. "This prevents the virus from even getting into the cell," said Stephen Elledge of Harvard Medical School and a Howard Hughes Investigator at Brigham & Women's Hospital. "It is out there fighting the flu all of the time," Elledge said in a telephone interview.Elledge and colleagues used a new research technique called RNA interference in which they systematically turned off individual genes and then exposed cells to the flu virus.

Using this method, they discovered a small family of flu-fighting proteins called interferon-indicible transmembrane proteins that boost the body's natural resistance to viral infection. "If you get rid of it (the protein), the virus can replicate 5 to 10 times faster. What that means is your cells have a mechanism that can block 80 to 90 percent of the virus that gets in," Elledge said. They also showed that if they make the cell overproduce the protein, they become more resistant to the flu. "If you crank it up, it really shuts down the flu," he said.

The team showed that a specific protein in the family -- IFITM3 -- protected against several viruses, including strains of influenza A now found in seasonal flu, the West Nile virus and dengue virus. The proteins did not offer any protection against HIV or the hepatitis C virus, but lab tests suggested they may defend against other viruses, including yellow fever virus.

The team showed that if the virus evades this first-line protein defense and makes it inside the cell, this activates an alarm system called the interferon immune response that gets pumped out of cells and alerts the rest of the body to make more of the natural antiviral proteins. The findings offer new insights into the body's natural defenses against influenza and other viruses, Elledge said. "We really did not know how our bodies were stopping the flu." They also may lead to better ways to protect people from influenza and other viral infections.

"By making this protein be expressed in poultry or pigs, we can make them resistant to the flu. That can help protect people by protecting animals from the flu," he said. It also may lead to more reliable vaccine production by creating a more friendly environment for the virus to grow in chicken eggs, he said. "If we take our gene away from the cells in which the virus is growing, it will grow much faster. You can actually produce vaccines much faster," he said.


© Thomson Reuters 2009. All rights reserved.


Kids' swine flu vaccines recalled due to fading potency
By Steve Sternberg, USA TODAY


Sanofi Aventis is voluntarily recalling 800,000 doses of pediatric swine flu vaccine in prefilled syringes because routine tests disclosed that its potency has diminished, federal officials said today. The Centers for Disease Control and Prevention issued an alert about the recall Tuesday morning, noting that the vaccine was fine when it was shipped, but its potency apparently faded during a month of storage. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, says there's no reason for parents to worry, because demand for the vaccine is so great that the doses were most likely administered before its potency faded. "There's no need for parents to call pediatricians. We think the doses given are protective and safe," Schuchat says. The manufacturer is now notifying health providers who received the affected lots to discard the syringes, meant for children from 6 to 35 months of age. The agency recommends that children in that age group get two doses, about a month apart. Injectable vaccine is licensed to be stable for 18 months, while the nasal spray should last for 18 weeks. Seasonal flu vaccine is typically dated to expire in June of the year after it was produced, but Shuchat says that "month to month" its potency may drop, but usually not enough to limit its effectiveness.


British Researchers: Little Evidence Tamiflu Works
British researchers say little evidence Tamiflu works, but WHO says the drug is useful
By MARIA CHENG
The Associated Press
LONDON




British researchers say there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the swine flu drug reduces flu hospitalizations and deaths.

Researchers at the Cochrane Review, an international nonprofit that reviews health information, looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The papers were published online Tuesday in the British journal, BMJ.

The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.

Fiona Godlee, BMJ's editor, said the papers cast doubt not only on how safe and effective Tamiflu is, but on the drug regulatory system that approved it. "Governments around the world have spent billions of pounds (dollars) on a drug that the scientific community now finds itself unable to judge," she said in a statement.

But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.

"This will not change our (Tamiflu) guidelines," said Charles Penn, a WHO antivirals expert. Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.

And Roche, the maker of Tamiflu, defended the drug, saying in a statement that they "firmly believe in the robustness of the data."

Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people — precisely the policy Britain has adopted to fight swine flu.

In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor's recommendation.

In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.


Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Copyright © 2009 ABC News Internet Ventures


CDC: Few Serious Reactions After Swine Flu Vaccine
Chances of Neurological Disorder Seen in 1976 "Vanishingly Remote"
By Cathryn Meurer
WebMD Health News
Reviewed by Louise Chang, MDDec. 4, 2009 -


Serious reactions after receiving the H1N1 swine flu vaccine are rare and not significantly higher than those seen from the seasonal flu vaccine, according to a briefing at the CDC today. Director Thomas Frieden, MD, MPH, presented preliminary safety data and confidence that the H1N1 vaccine will not be dogged by Guillain-Barre syndrome, the neurological disorder that was associated with the 1976 swine flu vaccine.

“The likelihood that we’ll have a 1976-like problem with this year’s H1N1 influenza vaccine is vanishingly remote,” said Frieden. H1N1 flu cases fell off somewhat during the Thanksgiving week, with widespread activity reported in 25 states, a drop from 32 states in the previous week. Still, 17 children died last week of laboratory-confirmed H1N1 flu, bringing the number of child deaths to 210. That’s three times the number of flu deaths expected in children at this point in a normal flu season. “This virus is a much worse virus for younger people. The number of people, not just children, but young adults under age 50 who will get severely ill or die from this virus is much higher than it is from seasonal flu," said Frieden.

Tamiflu Shortage Coming to an End

Liquid forms of the antiviral drug Tamiflu should be easily available now, according to CDC. The agency distributed the drug from the strategic national stockpile until manufacturers could catch up with demand. Frieden says the agency is seeing a dramatic improvement in the treatment of children who are severely ill with influenza, due to the use antivirals like Tamiflu. In most years, only one in five sick children arriving at a hospital have been started on an antiviral. This year, 80% are getting early treatment, which helps prevent severe illness. The vaccine supply is increasing as well, with 73 million doses of the H1N1 swine flu vaccine available this week and another 10 million coming next week. Top priority for getting the shot should still go to people in the high-risk groups. “Vaccination is the single best thing you can do to protect yourself and your family against the flu,” Frieden said.







Insurers to expand flu vaccine funding
Tuesday, December 1, 2009, 5:35pm EST
Boston Business Journal - by Julie M. Donnelly

A group of private health insurers has agreed to foot the bill for the H1N1 vaccination clinics that are going on at public health clinics around the state. It’s expected to cost $25 million and will alleviate some pressure on cities and towns, which have sustained multiple budget cuts.

The H1N1 vaccine is free and is distributed by the federal government to local health departments and physicians’ offices around the country. But it’s not free to staff the clinics, and to pay for the needles and other consumables.

The Patrick Administration held a news conference Tuesday to announce the deal.

Mary Lou Buyse of the Massachusetts Association of Health Plans said it was the right thing to do. “This is a really bad pandemic - millions of people need to be immunized and if we don’t do it, it will get worse,” Buyse said in a interview. She agreed that a failure to provide widespread immunizations would also cost insurers more since more people would get sick.

Blue Cross Blue Shield cited higher costs from the flu as a reason for worsened financial performance in the third quarter. Other insurers said it was one of many factors that has caused their costs to rise over the past year.

Commonwealth Medicine, a non-profit health care consulting organization affiliated with UMass Medical Center, will act as the third party administrator to bill insurers so they can reimburse the municipalities.

The Massachusetts Department of Public Health has also issued a separate RFP asking organizations to step forward who might be able to come up with a pilot program to help arrange reimbursements for vaccinations that take place in school-based clinics. Proposals were due Nov 30 and the winning organization stands to gin $100,000 in federal stimulus money





All contents of this site © American City Business Journals Inc. All rights reserved.


Measures to fight H1N1 swine flu in Europe
Tue Nov 10, 2009 9:39am EST

Nov 10 (Reuters) - Here are some details about measures taken to fight the new H1N1 swine flu, a mixture of swine, bird and human viruses and which has killed 6,500 people globally, according to the latest European Centre for Disease prevention and Control (ECDC) tallies. The World Health Organisation (WHO) declared an H1N1 pandemic on June 11, indicating the first influenza pandemic since 1968 was under way. The H1N1 pandemic flu virus could kill up to 40,000 people across Europe and be followed by seasonal flu waves that could kill the same number, European health experts said last week. The WHO has advised governments to prepare for a long-term battle against the virus. Here are some details about those measures taken around Europe.

* LATEST MEASURES BY GOVERNMENTS:

BRITAIN - Britain started a vaccination programme from Oct. 21 for high-risk patient groups including hospitalised patients, frontline healthcare workers and young children with health
problems like asthma or other respiratory conditions.

BULGARIA - Bulgaria declared national epidemics on Nov. 6 due to the quickly rising numbers of the infected people. The health ministry has recommended organising public events be limited. All Schools across the country have been shut down for a week (to Nov. 13) to prevent further spread of the virus.

CROATIA - Says 50,000 additional doses of antiviral drugs will be distributed to doctors. Vaccination started on Nov. 5 and the health authorities are urging all citizens to take part.

FRANCE - France's mass vaccination campaign against H1N1 flu got off to a shaky start, with low take-up among hospital staff who were first in line and allegations that government advisers
received funding from pharmaceutical firms. Vaccinations began on Oct. 20 for front-line hospital workers. A general vaccination programme is to start on Nov. 12. -- France has ordered 94 million doses of anti-H1N1 vaccines, at a cost of 808 million euros ($1.2 billion), to cover its population of 64 million.

GERMANY - Germany began a campaign to vaccinate against H1N1 two weeks ago, but has been held back by a lack of doses. The federal states have ordered 50 million doses which are gradually being delivered.

HUNGARY - Hungary has started a school vaccination campaign and public officials, including the health minister and the prime minister, were vaccinated on TV. -- The country would be protected from a full-fledged epidemic if 60 percent of the population was vaccinated, authorities have said. The vaccine is produced locally by the Hungarian pharmaceutical company Omninvest.

IRELAND - Ireland launched a national vaccination campaign from Nov. 2, with priority given to people considered at risk of developing complications, including patients with a chronic disease and pregnant women.

NETHERLANDS - Health authorities started vaccinations of risk groups on Nov. 9, widening initial plans to also include children aged from 6 months up to and including four-year-olds. -- The government bought 34 million vaccine doses, enough to supply the population twice over, but now expects to only use 11 million doses. It plans to sell the excess to other nations.

ROMANIA - Romania's Supreme Defence Council has 1.3 million doses of vaccine that could be used starting at the end of this month. The interior ministry has intensified monitoring of
cross-border transit to identify potential cases of infections.

SERBIA - A government work group is discussing whether to recommend health minister Tomica Milosavljevic declare an epidemic throughout Serbia or in individual regions. The health
and education ministries extended a school holiday that started on Nov. 5 until Nov 16. -- Media has said the government is likely to purchase a total of 3 million vaccines from Novartis. If the deal happens, the first batch of 500,000 doses should be delivered in December and administered to priority groups (children, elderly, patients with chronic diseases and health workers).

SLOVENIA - Vaccination started Nov 2. Slovenia recorded its first death from swine flu on November 3.

SWITZERLAND - Expects vaccination campaigns against H1N1 flu to start in mid-November. It has ordered 13 million doses from GlaxoSmithKline and Novartis.

UKRAINE - Parliament has approved an additional $1 billion for medicinal supplies. Extra supplies of swine flu medicine have begun to arrive. -- The government has imposed measures such as a ban on public meetings, including political rallies ahead of a January presidential election, and closing schools for three weeks.


TX withholds details of flu vaccine distribution
© 2009 The Associated Press
Nov. 7, 2009, 7:21PM


AUSTIN, Texas — Texas health officials are defending a decision not to disclose the names of doctors in Dallas County who received large swine flu vaccine doses.

The state recently ordered a shipment of H1N1 vaccine doses as large as 22,600 to be sent to a doctor in Dallas County. But officials won't provide any details.

State health department spokeswoman Carrie Williams says it's not a good idea to disclose the names because officials don't want to create more confusion among the general public.

Dallas County health director Zachary Thompson disagrees, saying the process needs to be as transparent as possible. He says people are anxious because the vaccine is scarce and the public doesn't know where it can find it once the supply increases.

___

Information from: The Dallas Morning News, http://www.dallasnews.com


Another reason to cover your cough- pets at risk

Fri Nov 6, 2009 4:39pm EST

* Cat infection shows other species can get swine flu

* Owners urged to take care with sick animals

By Maggie Fox, Health and Science Editor

WASHINGTON, Nov 6 (Reuters) - People who think they may have H1N1 flu need to stay away from work, avoid sneezing on their spouses and children and now, they have someone else to worry about infecting too -- their pets. U.S. vets reported this week that a pet cat had been infected with the pandemic swine flu virus, apparently by its owners, who had reported flu-like illness in the days before. Two pet ferrets also caught flu, again apparently from their owners, and several herds of pigs around the world have been reported infected.

Animals have long been known to be a source of new infections. Influenza itself originates in birds, possibly domestic ducks. AIDS appears to have come from chimpanzees and possibly gorillas. Ebola virus comes from bats while rabies is spread by many different species. And this strain of H1N1 very likely originated in pigs although it is now infecting almost exclusively humans. But with flu, at least, it can go the other way, too.

"This is just another illustration of why influenza viruses are so tricky and frustrating and interesting at the same time, is this ability to occasionally jump species," said Dr. Carolyn Bridges of the U.S. Centers for Disease Control and Prevention. Bridges said it is impossible to know how many pets may have been infected -- this particular cat lived near a sophisticated animal laboratory in Iowa where vets ran an influenza test out of curiosity. The good news is that the cat survived. Even for people, it is difficult to find out if a fever, cough and stuffy nose was the swine flu or something else because ordinary flu tests can miss H1N1 and doctors do not have easy access to the more sophisticated test needed to diagnose it.

NO KISSING

So no one knows how often pets might get infected. But if there is a season for it to happen, this would be it, says Bridges. "We have a great deal more disease now than we have in a typical flu season," she said in a telephone interview. "With the higher numbers of infected people, that increases the possibility of seeing these transmissions." Cats were known to get H5N1 avian influenza, which is still circulating and which has killed snow leopards and tigers that were fed infected chickens. A strain called H3N8 can sicken and kill pet dogs, Bridges added. "It is hypothesized that dogs got it from horses. There is potential, certainly, for cross-species infection," she said.

This is bad news for sick pet lovers.

"Even though I think when I am sick in bed the best thing I can have is my cats piling in with me, we realize that is no longer a risk-free activity," said Dr. Julie Levy of the University of Florida, a specialist in pet diseases. "When a pet is sick we should use common sense -- wash hands, not let them kiss us in the face," Levy added. According to the World Health Organization, H1N1 has killed at least 6,071 people worldwide and likely far more. The Sweden-based European Centre for Disease Prevention and Control projects the virus could kill up to 40,000 people across Europe and be followed by seasonal flu waves that could kill the same number. The international veterinary disease agency, the OIE, says it is compiling reports of H1N1 in animals. "It is very likely that there will be additional findings of other influenza strains," OIE Director Dr. Bernard Vallat said in a statement.

(Editing by Sandra Maler)


© Thomson Reuters 2009 All rights reserved



-nytimes.com-

The federal health official in charge of immunization and respiratory diseases said Friday that swine flu vaccine should be distributed through many outlets, including workplace clinics, to get it to high-risk people as quickly and efficiently as possible. The official, Dr. Anne Schuchat of the Centers for Disease Control and Prevention, was responding to a furor caused by the revelation that the employee health departments of some big Wall Street banks, including Goldman Sachs and Citigroup, had received small shipments of vaccine — while pediatricians, clinics and major hospitals waited for their full allotments.

“There’s nothing wrong with an employer-based clinic,” Dr. Schuchat said. “When you look at adults and where they get vaccinated, it’s a common place. It’s convenient.” Workplaces often have employees who are pregnant, have newborns at home, or have asthma or diabetes, she said, adding, “Our goal is put vaccine in the path of people who are in those priority groups to make it as easy as possible for them to be vaccinated.”

Goldman Sachs got 200 doses for its 8,700 New York employees, a spokeswoman said, and had signed an agreement saying they would all go to people in the high-risk groups specified by the disease control centers. Local health departments decide who gets each vaccine lot, and the centers sent a letter to all state, county and city health officers on Thursday reminding them to make sure it was going only to people at risk.

The agency itself had “no evidence that providers were giving vaccine outside the recommended priority populations,” Dr. Schuchat said. Independent flu experts noted that workplace clinics could control who got vaccine, while public vaccination campaigns have been plagued by reports of people begging vaccinators for shots or admitting having lied about being pregnant or asthmatic. Dr. Schuchat also praised the Champaign-Urbana Public Health District in Illinois for its program for disabled children. Nurses give shots in the parking lot “so when parents bring the kids in with special needs, they don’t have to get out of the car,” she said. Children with muscular dystrophy, cerebral palsy and other neuromuscular diseases appear to be at the highest risk of dying from swine flu, she said, followed by children with severe asthma.

Flu is widespread in 48 states, and virtually every sample taken is swine flu rather than seasonal flu, Dr. Schuchat said. More than half of all hospitalizations are of people under 25. As of Friday, 129 children had died of swine flu since April, and others who were not tested have died from flulike symptoms. Almost one-third had been healthy, with no underlying problems. About 38 million doses of vaccine are available now, Dr. Schuchat said. Canada had its own swine flu vaccine distribution brouhaha this week, and on Friday, a second member of the Alberta provincial health administration lost his job over it, according to The Edmonton Journal. Members of the Calgary Flames hockey team and their families had been allowed to avoid long public lines and get vaccinated at their arena on Oct. 30, one day before the province canceled mass immunizations after demand created a shortage.

The flu is taking a toll on the National Hockey League. Members of the Boston Bruins, the New York Islanders, the Edmonton Oilers, the Colorado Avalanche, the Washington Capitals and the Detroit Red Wings have all been out sick recently, The Boston Globe reported. In Milwaukee, a truck containing 900 doses of swine flu vaccine was stolen as it idled outside a flu clinic Thursday night, The Associated Press reported. The police said it was found abandoned less than an hour later with the vaccine intact. But officials decided to throw the doses away; because the vaccine must be kept refrigerated and its sterility must be assured, it was considered compromised in that time outside the city’s custody.


Poll: One-third can find, get swine flu vaccine
By MIKE STOBBE (AP) – 2 hours ago


ATLANTA — Only about a third of adults who have tried to get a swine flu vaccine have been able to get it, according to a new national poll.

That's true even for people are at extra risk for severe complications and should be at the front of the line. The numbers are about the same for parents who tried to get the vaccine for their higher-risk children, the Harvard School of Public Health poll found.

Swine flu vaccine has been available in the United States for about a month. But supplies have been limited because of manufacturing delays. The shots are only supposed to be go to those at high risk of complications.

The Harvard School of Public Health telephone poll also found that half of those who tried couldn't find information about where to get the vaccine. The survey of 1,000 adults was conducted last weekend and the results released Friday. The margin of error was plus or minus 3.8 percentage points.

Swine flu is widespread in 48 states, officials with the Centers for Disease Control and Prevention said Friday.

CDC officials said 129 children have died from swine flu complications since the virus was first identified in April. The government does not keep a close count of all swine flu deaths, but estimates the number is above 1,000. Many millions of Americans have been infected with the virus, though most suffered only mild illness, health officials say.

On the Net:
CDC swine flu web site: http://www.cdc.gov/h1n1flu/
Harvard School of Public Health: http://www.hsph.harvard.edu
Copyright © 2009 The Associated Press. All rights reserved.





US declares swine flu 'emergency'

bbc.co.uk


US officials say swine flu activity is widespread in 46 states
US President Barack Obama has declared swine flu a national emergency.
The White House said the president signed the proclamation concerning the 2009 H1N1 outbreak on Friday evening.
It increases the ability of treatment facilities to handle a surge in H1N1 patients by easing the implementation of emergency plans.
Last week US officials said swine flu activity was widespread in 46 states. More than 1,000 US deaths have been linked to the virus.
Health officials say the infections are already comparable to peak season flu levels.
Vaccine warning
US officials said the president's declaration was similar to ones issued before hurricanes make landfall.

SWINE FLU SYMPTOMS

Typical symptoms: sudden fever (38C or above) and sudden cough
1. Other symptoms include: Tiredness and chills
2. Headache, sore throat, runny nose and sneezing
3. Stomach upset, loss of appetite, diarrhoea
4. Aching muscles, limb or joint pain
Source: UK NHS
It allows authorities to bypass certain federal requirements in order to deal more effectively with emergencies.
The aim of the directive is to remove bureaucratic hurdles, allowing sick patients to receive treatment more quickly and giving health-care providers more flexibility in providing it.
Paperwork on patients can be reduced and additional health centres set up outside hospitals to care for the sick.
In his proclamation statement, Mr Obama says the 2009 H1N1 pandemic "continues to evolve".
"The rates of illness continue to rise rapidly within many communities across the nation, and the potential exists for the pandemic to overburden health care resources in some localities."
He said the US had already taken "proactive steps" by implementing public health measures and developing an effective swine flu vaccine.
However, the government has admitted there are delays in the delivery of vaccines.
It had hoped to roll out 120 million doses by mid-October.
It now hopes for about 50 million by mid-November and 150 million in December.
Dr Thomas Frieden, of the US Centers for Disease Control and Prevention (CDC), said on Friday: "We are nowhere near where we thought we'd be by now."
Given the shortfall, New York State on Friday stayed a directive ordering health care staff to be inoculated or risk losing their jobs.
The CDC says widespread influenza activity in 46 states is "unprecedented during seasonal flu".
It said the hospitalisation rates for laboratory-confirmed swine flu were still climbing.
Although figures are hard to verify, it is thought H1N1 has hospitalised about 20,000 people in the US.
Visits to the doctor for influenza-like illnesses were also much higher than expected for the time of year, the CDC said.
The seasonal flu peak is usually between late November and early March.
Children and young adults have been among the hardest hit by H1N1. Almost 100 of the deaths have been children.






WHO Recommends Antivirals For Patients With Symptoms Of Both H1N1, Pneumonia

Monday, October 19, 2009

The WHO concluded a three-day meeting on H1N1 (swine flu) in Washington, D.C., on Friday, where health experts issued recommendations that patients with symptoms of H1N1 and pneumonia be treated quickly with antivirals, even before the results of H1N1 tests are complete, the San Francisco Chronicle blog, "ChronRX" reports (Allday, 10/16).

"Experts stress that most people who get the H1N1 virus either never get sick or recover easily. But some young adults, possibly especially women, are falling seriously ill at an unexpectedly rapid pace and are showing up in intensive care units and dying in unusually high numbers, they say," the Washington Post reports. "Although why a minority of patients become so sick remains a mystery, new research indicates that H1N1 is different from typical seasonal flu viruses in crucial ways -- most notably in its ability to penetrate deep into the lungs and cause viral pneumonia" (Stein, 10/17).

H1N1 Vaccines Shortages In U.S., Mexico

Also on Friday, the CDC announced the number of H1N1 vaccine doses to arrive in the U.S. by the end of October would be about 10 million short – "about 25% fewer than expected" – due to slower than anticipated vaccine production, the Los Angeles Times reports. "Despite the current low production, however, there are no plans to use adjuvants -- chemicals added to increase the immune response to the antigen -- to extend the supply of the pandemic H1N1 vaccine, said Dr. Jesse Goodman of the U.S. Food and Drug Administration" (Maugh/Ellingwood, 10/17).

"Yields for vaccine are lower than would be hoped," Anne Schuchat, of the CDC, said during a telephone press conference, Reuters reports" (Fox, 10/16). According to the Associated Press, "[W]hat CDC calls the 2009 H1N1 flu is causing widespread disease in 41 states, and about 6 percent of all doctor visits are for flu-like illness — levels not normally seen until much later in the fall" (Neergaard, 10/17).

The Los Angeles Times reports that Mexico is also facing H1N1 vaccine shortages, where "[o]fficials had promised 30 million doses, but now say they don't expect the first batch of 5 million to 8 million doses until late December," due to "the huge demand for vaccines around the world." Even so, the newspaper notes, "reaction to the H1N1 pandemic in Mexico has been more muted than it was in the spring, when the country was the first to be hit hard by the outbreak."

"Nearly 20,000 new cases of swine flu infection have been confirmed in that country since early September, with at least 61 fatalities, according to health authorities there. That contrasts with the nearly 42,000 cases and 260 deaths reported since the outbreak began in the spring -- though authorities cautioned that the winter flu season has just begun," the newspaper writes. "This time, health officials are stressing good hygiene and prompt medical treatment for flu-type symptoms, but say there is no need for widespread precautionary closures" (10/17).

In related news, Rwanda could receive the country's first batches of H1N1 vaccine from the WHO as early as next month, according to the Minister of Health, Richard Sezibera, New Times/allAfrica.com reports (Nambi, 10/17).

The Hill Examines Congressional Positions On H1N1 Vaccine

Meanwhile, the Hill examines discussion over whether Americans should receive the H1N1 vaccine. "In the Senate, the topic has accomplished the rare feat of uniting Democrats and Republicans — members of both parties are promoting vaccinations regardless of the rhetoric," the newspaper writes (Rushing, 10/18).

The Kaiser Daily Global Health Policy Report is published by the Kaiser Family Foundation. © 2009 Henry J. Kaiser Family Foundation. All rights reserved.





US swine flu vaccines 'delayed'

01:22 GMT, Saturday, 17 October 2009 02:22 UK


Some 11.4 million vaccines have been made available in the US
US officials have warned of delays in the delivery of swine flu vaccines just as deaths from the H1N1 virus climb above epidemic level in some states. Only 28-30 million doses would be available by the end of the month, said Anne Schuchat of the US Centers for Disease Control and Prevention (CDC). That was down from an earlier estimate of 40 million. Swine flu has had an especially strong impact on children, 86 of whom have died this year, Ms Schuchat said. The number of children who have died so far this year from the H1N1 virus was greater than the number that normally die in an entire flu season, Ms Schuchat said.

Forty-three children are reported to have died from flu since 30 August, with 38 of those confirmed to have been caused by the H1N1 virus. Half of those deaths were in children aged between 12 and 17. "These are very sobering statistics," Ms Schuchat said. "Some of these children have been totally healthy."

'Rapid deterioration'

Ms Schuchat said swine flu activity was widespread in 41 states, and deaths had reached the epidemic threshold in some states and cities. "Influenza is widespread in the country and illnesses, hospitalisations and deaths continue to increase," she said. "It's unprecedented for this time of year to have the whole country seeing such high levels of activity." Testing the vaccines for strength and purity was cited as one reason for a delay in their delivery. "We are not cutting any corners in the safety of the production of this vaccine or the testing and oversight of the vaccine," Ms Schuchat said.

Some 11.4 million vaccines have so far been made available in the US.

At a meeting on swine flu in Washington, officials from the World Health Organisation said the H1N1 strain was killing unusually quickly. "In severe cases, patients generally begin to deteriorate around three to five days after symptom onset," said the WHO's Nikki Shindo. "Deterioration is rapid, with many patients progressing to respiratory failure within 24 hours, requiring immediate admission to an intensive care unit."


Billionaires in Duel Over a Hog Farm
By KEITH SCHNEIDER, Special to The New York Times
Published: Tuesday, November 28, 1989


A battle among billionaires has broken out along the South Platte River here at the western edge of the Great Plains, where the nation's largest hog farm is being built.

The $50 million complex of gleaming metal buildings, being erected by National Hog Farms Inc., is to produce 300,000 hogs a year when it is completed in 1992.

Opposing the hog farm, which is owned by the Bass brothers of Fort Worth, Tex., is Philip Anschutz, owner of the Southern Pacific Transportation Company, and Peter H. Coors of the brewing family. Both men own ranches in the area and they say the urine and feces from the farm will pollute underground water and foul the South Platte River. Company Facing Suits

The two men are suing National Hog Farms in State District Court, running full-page advertisements in The Greeley Tribune and have financed two small citizen's groups. Both men have declined, through spokesmen, to discuss the fight.

Nearly obscured by the people involved are a number of other issues. Many groups fear that as technology allows more animals to be kept on immense farms, competition will decrease and the quality of beef, pork and chicken will decline even as prices rise.

National Hog Farms, a subsidiary of the Kansas City-based swine and cattle company, National Farms Inc., insists there is no evidence to support such concerns. William J. O'Hare, the manager of the hog farm at issue, said he was taking advantage of its isolation to raise hogs without feeding them grain laced with antibiotics and other drugs, a common practice on Middle Western family hog farms.

''This is a brand new, modern facility that could set new trends in the industry,'' Mr. O'Hare said of the farm, situated on 25,500 acres and 20 miles east of Greeley, near Kersey. ''We fully intend not to use drugs in these animals if we don't have to.''

Nonetheless, opponents are suspicious of Mr. O'Hare and National Farms. The company has run into problems throughout the 1980's in controlling livestock waste in Holt County, Neb., where National Farms owns three operations that together produce as many pigs as the new Colorado farm will. Complaints on Odors and Animals

Holt County residents also complained about the number of animals that died and the manner used to dispose of the carcasses.

Similar concerns have now arisen in Colorado. Over the weekend, the environmental group Protect Our Water, formed in Greeley in October and financed by Mr. Anschutz, made public photographs of dead pigs beside an irrigation canal parallel to the South Platte River along the hog farm's southern boundary. The group asserted that the bloated carcasses were from the hog farm.

''This is exactly the thing that we are worried about,'' said James A. Monaghan, a Denver-based public relations expert hired by Mr. Anschutz to advise Protect Our Water. ''It's the exact opposite of what they're portraying.''

Mr. O'Hare confirmed that carcasses had been left by the canal. ''We've asked the removal company to pick them up daily and we've had troubled getting this scheduled,'' he said.

The heat and acerbity of the fight have suprised most residents of Weld County, where some of the country's largest cattle-feed yards and a beef slaughterhouse are situated. The annual income from agriculture, nearly $900 million, is greater than all but a handful of counties in California, Texas and Florida. Opposition Developed Quickly

When it arrived in Weld County in June 1988, National Farms believed the farm would easily slip into a landscape where American agriculture had already attained a level of technical sophistication, size and profitability matched in few other regions.

But in six months opposition developed among several Weld County residents who formed the Platte River Environmental Conservation Organization, another opposition group financed by Mr. Anschutz.

''We'd love to shut it down,'' said Tim Erickson, a 38-year-old farmer from Fort Lupton, 20 miles south of Greeley, who is the group's spokesman. ''These huge operations, helped by tax breaks and loopholes, will drive the family farmer out of business.''

The recent history of the hog industry reflects what is occurring in American agriculture, said Mr. Erickson. About 300,000 farms, half the number of hog farms that existed in 1965, raise the 90 million hogs consumed in the United States each year. At least 15 percent of the $9 billion annual market for hogs is controlled by about 25 corporate producers, studies by Iowa State University and the University of Missouri show.

Mr. Erickson's group was joined by Mr. Coors in a lawsuit in April that questioned the hog farm's ability to dispose of its wastes safely. The suit, against Weld County, National Hog Farms and the state, sought to halt construction and overturn the county's decision to grant the company a building permit. National Farms has argued that neither Weld County nor the state required the hog farm to gain a disposal permit because farms are exempted from water quality control laws in Colorado.

In July, a State District Court judge ruled that the procedures followed by the county were proper and the building permit was valid. Other sections of the suit are still to be heard. Seeking New Treatment Plant

''If the water is polluted it will affect the cattle and it will affect the river from a wildlife standpoint,'' said J. Robert Stovell, the manager of Eagle's Nest Ranch, a 32,000-acre cattle ranch and hunting preserve downstream from Mr. Anschutz's hog farm.

Mr. Stovell, a founding member of Protect Our Water, wants National Farms to apply the same treatments to its waste water that a city would use for municipal wastes. The group's attorneys wrote a detailed petition urging the passage of an ordinance requiring secondary treatment of wastes from ''swine production facilities in the county designed to hold more than 25,000 animals.''

More than 2,000 county voters have signed the petition; 2,511 confirmed signatures are needed for the county commissioners either to pass the ordinance or put it on the ballot.

Mr. O'Hare said during a tour of the farm earlier this month that the petition should not alter the company's plans. Mr. O'Hare said the hog farm has the most elaborate and effective waste-water treatment system of any livestock farm in the country. Waste water, he said, would be treated by one system that removes the solids and another that aerates the effluent to reduce the smell. Slightly more than two million gallons of effluent will then be sprayed every day through circular sprinklers to irrigate and fertilize thousands of acres of pasture.

''Our engineers tell us this system is as effective or more effective than secondary treatment,'' said Mr. O'Hare. ''The amount of effluent we apply through the sprinklers will have no effect on the groundwater or the river.''

Photo of William J. O'Hare, manager of the hog-rasing complex (NYT/Bruce McAllister); map of Colorado showing location of the site of the hog farm (NYT)

Correction: November 30, 1989, Thursday, Late Edition - Final Because of an editing error, an article on Tuesday about a dispute over a huge hog farm being built in Colorado misstated the holdings of Philip Anschutz, an opponent of the development. He owns the Eagle's Nest ranch; he does not own a hog farm.

A version of this article appeared in print on Tuesday, November 28, 1989, on section A page 16 of the New York edition.


Hog lawsuits raising stink in Missouri
Wednesday, September 23, 2009 7:59:55 AM
Central Florida Channel 13 News
BERLIN, Mo.(AP)

A faint rotten-egg smell drifts off a covered lagoon a hundred yards from a well-traveled Missouri gravel road. It's not an overpowering odor, but it's there.

Aside from a few dirt-speckled pickup trucks kicking up dust as they pass by, this battleground _ ground zero in what some see as a high-stakes fight for the future of Missouri agriculture _ is calm.

But in Kansas City law offices 80 miles away, combatants prepare for another showdown over the smells drifting from this 80,000-head hog operation. Is the aroma an obnoxious affront to neighbors or simply the "odor of agriculture" that comes with life in the country?

It's a fight Charlie Speer has waged for nearly 15 years. The Kansas City attorney has won almost $10 million from Premium Standard Farms and its affiliates in trials since 1999, and this summer praised a $1.2 million settlement with an unrelated southwest Missouri operation as having "set the bar" for future settlements.

Hog odor lawsuits are nothing new. The issue of what constitutes an agricultural nuisance has been argued anywhere hogs are raised.

The debate has new traction in Missouri, where some say flawed right-to-farm legislation encourages multimillion-dollar lawsuits like the ones against Premium Standard and its Virginia-based owner, Smithfield Foods.

In an internal memo accidentally e-mailed to The Kansas City Star last year, Smithfield attorneys estimated the company's exposure to litigation against Premium Standard at $150 million to $200 million. Smithfield, the world's largest pork producer, purchased Premium Standard in 2007.

Speer says he has at least 350 cases pending in Missouri against large hog operations. In contrast, only three were on file in Iowa, the nation's biggest pork-producing state with more than six times the number of hogs Missouri produces. Unlike Iowa's hog farms, which Speer says are traditionally family-run, Speer's targets in Missouri _ the seventh-largest hog state _ are corporate mega-farms.

"In Missouri, there is no limit to the amount a plaintiff can recover for an alleged nuisance, no matter how slight," Smithfield said in a statement to The Associated Press. "The potential for an unlimited recovery for a minor injury makes Missouri extremely attractive to out-of-state plaintiffs' lawyers looking for big paydays."

Speer contends Smithfield is sucking millions of dollars from the state and sending it to wealthy East Coast executives.

"They've got billionaires running billion-dollar operations worldwide," he said. "They don't live on the farms anymore. They never even visit the farms."

Members of seven families, many of whom have lived in Gentry County most of their lives, are suing the Premium Standard operation known as the Homan farm. Of the 15 plaintiffs, 13 received $100,000 apiece in a 1999 lawsuit against the same property.

Their argument is the same as it was 10 years ago: Stifling odors from the northwest Missouri hog confinements and lagoons are making their lives unpleasant.

"This lawsuit is on the theory that they haven't done anything to abate the nuisance, and we want the jury to send the message to stop it or we're going to keep coming back," Speer said.

None of the plaintiffs is alleging health issues beyond those associated with bad smells.

A lot has changed since 1999, said Premium Standard President Bill Homann, whose family lives 8 miles from a 140,000-head hog operation near Princeton, an hour north.

"Folks that manage these farms, including myself, are rural people who are no different than anybody else that lives in this community," said Homann, an Iowa State University graduate with a degree in agricultural education. "We are this community."

He said Premium Standard has pumped millions of dollars into measures _ mostly in response to complaints from the farm's neighbors _ to neutralize much of the odor.

"You can't raise hogs without there being a smell," said Jean Paul Bradshaw, an attorney for Smithfield Foods. "Hogs smell. There is the odor of agriculture, and we think we probably do more than anyone else to reduce odor."

Homann acknowledges mistakes made in the 1990s, including spills and effluent releases, probably warranted the legal judgments against the company in 1999. But he defends Premium Standard's environmental performance since then.

Stanley and Jean Berry, who received $100,000 apiece in the 1999 lawsuit and are plaintiffs in the current one, insist the odors are as bad as ever.

"At night when you think it's really still and there's no air movement, there really is" a smell, said Stanley Berry, 70, a farmer who was born in a farmhouse up the road. "And if it happens to be creeping your way, that is the very worst time, because it's so intense."

Bradshaw contends the lawsuits are driven by money, and suggested Missouri farmers pay the ultimate price while Speer and his colleagues line their pockets.

"They've made an industry out of filing nuisance cases, the effects of which cripple the biggest industry in Missouri," Bradshaw said, referring to agriculture. "It's no secret now is a bad time in the hog industry."

In June, Smithfield reported a fourth-quarter net loss of $78.8 million and a $190 million loss for the fiscal year. Industrywide, the National Pork Producers Council says hog producers have lost nearly $4.4 billion since September 2007.

The big operations will get no sympathy from Speer, who in April helped form The Center to Expose and Close Animal Factories. The center's stated mission: "to expose the dangers of concentrated animal feeding operations."

___

On the Net:

Center to Expose and Close Animal Factories: http://www.closeanimalfactories.org/

Premium Standard Farms: http://www.psfarms.com/index.html

Missouri Pork Association: http://www.mopork.com/default.asp

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


HIV vaccine regimen demonstrates modest preventive effect in Thailand clinical study
EUREKALERT

Sep 24 2009, 9:40 AM EST

Contact: Kathy Stover
stoverk@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases

In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.

"These new findings represent an important step forward in HIV vaccine research," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, which provided major funding and other support for the study. "For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.

"We thank the trial staff in Thailand and the United States for their years of effort in successfully conducting this study and the study participants and the people of Thailand for their long-standing support of HIV vaccine research," Dr. Fauci adds.

The Thai Phase III HIV vaccine study, also known as RV144, opened in October 2003. The placebo-controlled trial tested the safety and effectiveness of a prime-boost regimen of two vaccines: ALVAC-HIV vaccine (the primer dose), a modified canarypox vaccine developed by Sanofi Pasteur, based in Lyon, France, and AIDSVAX B/E vaccine (the booster dose), a glycoprotein 120 vaccine developed by Vaxgen Inc., and now licensed to Global Solutions for Infectious Diseases (GSID), based in South San Francisco, Calif. The vaccines are based on the subtype B and E HIV strains that commonly circulate in Thailand. The subtype B HIV strain is the one most commonly found in the United States.

Led by principal investigator Supachai Rerks-Ngarm, M.D., of the Thai Ministry of Public Health's Department of Disease Control, the study was sponsored by the U.S. Army in collaboration with NIAID, Sanofi Pasteur and GSID. The trial, conducted in the Rayong and Chon Buri provinces of Thailand, enrolled 16,402 men and women ages 18 to 30 years old at various levels of risk for HIV infection. Study participants received the ALVAC HIV vaccine or placebo at enrollment and again after 1 month, 3 months, and 6 months. The AIDSVAX B/E vaccine or placebo was given to participants at 3 and 6 months. Participants were tested for HIV infection every 6 months for 3 years. During each clinic visit, they were counseled on how to avoid becoming infected with HIV.

In the final analysis, 74 of 8,198 placebo recipients became infected with HIV compared with 51 of 8,197 participants who received the vaccine regimen. This level of effectiveness in preventing HIV infection was found to be statistically significant. The vaccine regimen had no effect, however, on the amount of virus in the blood of volunteers who acquired HIV infection during the study.

"The Thai study demonstrates why the HIV vaccine field must take a balanced approach to conducting both the basic research needed to discover and design new HIV vaccines and, when appropriate, testing candidate vaccines in people," says Margaret I. Johnston, Ph.D., director of NIAID's Vaccine Research Program within the Division of AIDS. "Both avenues provide critical information that will continue to help us better understand what is needed to develop a fully protective HIV vaccine."

NIAID and the collaborating partners are working with other scientific experts to determine next steps, including additional research of the RV144 vaccine regimen and the need to consider the impact of these new findings on other HIV vaccine candidates.

Individuals who acquired HIV infection while participating in the Thai trial have been provided access to HIV care and treatment, including highly active antiretroviral therapy based on the guidelines of the Thai Ministry of Public Health.


###

For more information about the Thai Phase III HIV vaccine trial, please see: www.hivresearch.org.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH)The Nation's Medical Research Agencyincludes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.





Young children need 2 doses of H1N1 vaccine: U.S.

Mon Sep 21, 2009 11:43am EDT

WASHINGTON (Reuters) - Younger children will need two doses of the vaccine against the new pandemic of H1N1 influenza, U.S. officials said on Monday. They said tests of Sanofi-Pasteur's swine flu vaccine showed that children respond to it just as they do with seasonal flu vaccines, with children over 10 needing just a single dose.

Dr. Anthony Fauci, director of the U.S. Institute of Allergy and Infectious Diseases, said young children will likely need to have their doses 21 days apart, but he said they could receive seasonal flu shots and H1N1 shots on the same day -- something that could ease the logistics of vaccinating children multiple times.

"Immunologically this is acting like seasonal flu and we are very pleased with that," Fauci told reporters in a telephone briefing. "The response in younger children is less robust but that is not unexpected." The children up to age 17 all mounted an immune response that should protect them from H1N1 within 8 to 10 days, Fauci said. The U.S. Centers for Disease Control and Prevention said 46 U.S. children have died from swine flu.

(Reporting by Maggie Fox, Editing by Sandra Maler)


1 Swine Flu Shot Enough?
Single Swine Flu Shot Gives Immunity in Early Tests

By Daniel J. DeNoon
WebMD Health News Reviewed by Louise Chang, MDSept. 10, 2009 -


Adults are immune to swine flu after just one shot of vaccine, early test results suggest. It's a surprise finding. Most experts expected that two shots of the vaccine -- given three weeks apart -- would be needed.

Now vaccine supplies may go twice as far, and may start working twice as fast as expected, suggests University of Washington researcher Kathleen M. Neuzil, MD, MPH, chairwoman of the flu vaccine working group of the Advisory Committee on Immunization Practices (ACIP), the independent panel that recommends vaccine policy to the CDC.

"On the basis of these data, it would be appropriate to begin vaccination with the use of one dose," Neuzil writes in an editorial accompanying a report of the study rushed into online publication by The New England Journal of Medicine. Neuzil, a pediatrician, notes that children may still need two doses of the vaccine. But she says vaccine supplies "should not be held in reserve to be used for a second dose."

The finding comes from a clinical trial of the CSL H1N1 swine flu vaccine in Australia. Some 40% of the 195 million doses of swine flu vaccine purchased by the U.S. will be made by CSL, although other makers' swine flu vaccine is expected to be equally effective. In the Australian study, Michael E. Greenberg, MD, MPH, and colleagues gave the vaccine to two groups of adults, one group age 18 to 50 and the other age 50 to 64. Half of the subjects in each group got a 15-microgram doses of the vaccine -- the same dosage being prepared for U.S. vaccines. The other half got a double 30-microgram dose. Of the 120 volunteers who got the lower dose, 116 -- 96.7% -- developed at least the minimum level of anti-flu antibodies considered to be protective.

"The robust immune response to the H1N1 vaccine after a single dose was unanticipated," Greenberg and colleagues note. "Much of the current global pandemic planning is predicated on previous experience that two doses of vaccine are required to elicit a protective immune response in populations that are immunologically naive to a new influenza strain." U.S. trials of swine flu vaccine are underway. It remains to be seen whether these studies will support the Australian findings. Even then, larger studies will be needed to know exactly how different people, at different ages and with different health status, will react to the vaccine. But Neuzil says that in the face of an ongoing pandemic, it's urgent to deploy the vaccine as soon as possible. "The desire to see all the available data must be balanced with the needed to deploy vaccine quickly to reduce morbidity associated with the pandemic," Neuzil writes.


Report Finds Swine Flu Has Killed 36 Children
Published: September 3, 2009


Federal health officials reported Thursday that at least 36 children in the United States had died of swine flu as of Aug. 8, including many who had underlying disorders of the nervous system. Some also had chronic lung disease, and one had leukemia.

Swine Flu (AH1N1 Virus)But some of the children had been perfectly healthy, and died of bacterial infections with staph or strep that set in after the flu. A report on the deaths was published online Thursday by the Centers for Disease Control and Prevention and discussed at a news conference by Dr. Thomas R. Frieden, the centers’ director. The report said the confirmed death count among people of all ages was 477 as of Aug. 8, but it focused on the toll on children. The 36 who died ranged in age from 2 months to 17 years, with a median age of 9 years. Nearly two-thirds had nervous system disorders like cerebral palsy, muscular dystrophy or developmental delays. Children with nerve and muscle problems may be at especially high risk for complications from the flu because they cannot cough hard enough to clear their airways.

It is too soon to tell whether the H1N1 swine flu will turn out to be more deadly in children than other types of influenza, Dr. Frieden said, adding that in most years 50 to 100 children die of seasonal flu. But so far the swine flu seems to be taking a heavier toll among chronically ill children than the seasonal flu usually does. The deaths mean that children with neurological conditions need to be seen quickly by a doctor if they run a fever, Dr. Frieden said. “Treatment in the first 48 hours can make a big difference in hastening your recovery,” he said. In children without chronic health problems, it is a warning sign if they seem to recover from the flu but then relapse with a high fever, Dr. Frieden said. The relapse may be bacterial pneumonia, which must be treated with antibiotics.

Dr. Frieden urged that children be vaccinated as soon as swine flu vaccine becomes available, probably next month. Health officials have recommended that children be among those given first priority for the vaccine, because they seem more vulnerable than adults to the H1N1 virus and to complications from it. Pregnant women will also receive top priority for the vaccine, because they have a high risk of infection and complications from the flu. Glen Nowak, a spokesman for the disease centers, said health officials worried that pregnant women who were vaccinated and then had miscarriages would blame the vaccine. But he said there was no evidence that flu vaccine increased the risk of miscarriages, which generally occur in 15 percent of pregnancies. Even so, Dr. Frieden said the disease centers would carefully monitor miscarriage rates to determine whether the new vaccine had any such effect.

Another report issued Thursday, by the Institute of Medicine, recommended that health care workers treating people with swine flu protect themselves from infection by wearing a type of specially fitted mask called an N95 respirator, which is tighter and better able to seal out viruses than the more common types of surgical masks. Dr. Frieden said the disease centers had not yet had time to evaluate the new report about masks. A spokesman for the centers said the nation had 79.7 million N95s in the “strategic national stockpile” controlled by the government. To put the H1N1 flu in perspective, Dr. Frieden emphasized that so far, most stricken people had had a relatively mild illness and that the virus had not become any more virulent over time in the United States or any other country.

Health » A version of this article appeared in print on September 4, 2009, on page A13 of th

Gnarls Barkley Mystery Man


UNCLASSIFIED
Worldwide: New 2009-H1N1 Influenza Virus Poses Potential
Threat to U.S. Forces
Defense Intelligence Agency
Defense Intelligence Assessment


excerpt from wikileaks.org.....

(U) Key Judgments

(U) NCMI assesses with high confidence a new H1N1 influenza virus (referred to by the media as "swine flu") poses a potential threat to U.S. forces overseas and within the United States. The virus can be acquired relatively easily through casual contact with infected persons. The full worldwide extent of the H1N1 outbreak, including the extent of the virus spread, the number of cases, and the number of related deaths, remains unknown because of the lack of specialized diagnostic capabilitiesin many countries.

(U) Based on clinical and epidemiological data from current cases, NCMI judges the 2009-H1N1 influenza virus may cause attack rates exceeding 10 percent per month in U.S. forces. Most cases will likely debilitate personnel for approximately 1 week, possibly longer. Military populations living in crowded or austere conditions where handwashing and personal hygiene are suboptimal are particularly vulnerable to person-to-person spread of H1N1 influenza virus if introduced. Attack rates in such populations may exceed 50 percent per month.

(U) NCMI judges a small percentage of healthy military-age adults may develop severe and potentially fatal illness, requiring hospitalization, intensive care, and weeks of recovery. If large outbreaks occur among deployed U.S. military personnel, they will likely strain and possibly overwhelm military medical capabilities, particularly at the intensive care level.

(U) NCMI further assesses with high confidence that detection of H1N1 outbreaks in local populations, including those near concentrations of U.S. forces, will be limited in developing countries with poor surveillance capabilities.


THE WHITE HOUSE

Office of the Press Secretary
____________________________________________________________________________
For Immediate Release August 24, 2009

President’s Council of Advisors on Science and Technology (PCAST)
releases report assessing H1N1 preparations

Administration’s H1N1 efforts to date praised
Additional recommendations made to improve monitoring and strengthen medical response

WASHINGTON – A Presidential advisory group of the nation’s leading scientists and engineers today released a new report assessing the Obama Administration’s preparations for this fall’s expected resurgence of 2009-H1N1 flu and outlining key steps officials can take in the coming weeks and months to minimize the disease’s impact on the nation.

The Federal Government’s preparations for 2009-H1N1 flu have been well-organized and are scientifically grounded, according to the report by the President’s Council of Advisors on Science and Technology (PCAST), which assembled a subcommittee of experts on influenza and public health for the purpose. (PCAST is an independent group of leading scientists from academia and industry administered by the Office of Science and Technology Policy in the Executive Office of the President.) But some aspects of those preparations could and should be improved or accelerated, the group concluded.

"As the nation prepares for what could be a challenging fall, it is crucial that our public health decisions are informed by the very best scientific and technological information," said John P. Holdren, Assistant to the President for Science and Technology and a co-chair of PCAST.

The report concludes that the 2009-H1N1 flu is unlikely to resemble the deadly flu pandemic of 1918-19. But in contrast to the benign version of swine flu that emerged in 1976, the report says the current strain "poses a serious health threat" to the nation. The issue is not that the virus is more deadly than other flu strains, but rather that it is likely to infect more people than usual because it is a new strain against which few people have immunity. This could mean that doctors’ offices and hospitals may get filled to capacity.

Among the group’s prime recommendations: accelerate the preparation of flu vaccine for distribution to high-risk individuals; clarify guidelines for the use of antiviral medicines; upgrade the current system for tracking the pandemic’s progress and making resource allocation decisions; accelerate the development of communication strategies—including Web-based social networking tools—to broadcast public health messages that can help mitigate the pandemic’s impact; and identify a White House point person with primary authority to coordinate key decisions across the government as the pandemic evolves. An overarching message of the new report is that through their behavior, individuals can have a potentially big impact on the flu season’s severity. Frequent hand-washing and staying home from school or work when sick will be crucial. The report recommends intensive public education campaigns to reinforce those key behaviors, and also calls for policy adjustments that can reduce economic and other incentives that might encourage people to risk infecting others. For example, workplaces could liberalize rules for absenteeism so employees don’t feel pressured to come to work when sick and school districts could arrange alternative means of distributing lunches to children who are sick but who normally depend on school meals for adequate nourishment.

Overall, the PCAST subcommittee concluded that it was "deeply impressed" by the H1N1-related efforts underway across the Federal Government, including the breadth of issues being anticipated and addressed, the depth of thinking, the overall level of energy being devoted, and the awareness of potential pitfalls.

"The Federal Government’s response has been truly impressive and we’ve all been pleased to see the high level of cooperation among the many departments and agencies that are gearing up for the expected fall resurgence of H1N1 flu," said Harold Varmus, a PCAST co-chair and President of Memorial Sloan-Kettering Cancer Center.

"This virus has pulled us all together in common cause," said PCAST co-chair Eric Lander, who is also President and Director of the Broad Institute of Harvard and MIT. "The preparations are the best ever for an influenza pandemic."

"As the Council of Advisors on Science and Technology notes, influenza brings many challenges and agencies across the government will need to make many key decisions in the face of uncertainty about when and how the virus will play out. As we did in the spring, we can hope for the best, but we must prepare for the worst."

Administration officials leading the flu response efforts praised the report and welcomed the recommendations from the PCAST subcommittee.

"The PCAST H1N1 subcommittee report recommendations will enhance National preparedness and response to 2009-H1N1 flu, and be valuable for longer term, systematic pandemic policy coordination and planning. The President discussed this report at length with PCAST members and expressed sincere thanks for their expert contributions," said John Brennan, White House Homeland Security Advisor.

"The President has been clear from day one that he wants our H1N1 flu response to be guided by science. He also has made it clear that he believes that responding to the flu is a shared responsibility, one that requires the efforts of every American and cooperation between the private and public sectors," said Health and Human Services Secretary Kathleen Sebelius. "The Department of Health and Human Services, including the Centers for Disease Control and Prevention, National Institutes of Health, and Food and Drug Administration, has already made some important progress on the recommendations found in the PCAST subcommittee report and we plan to adopt others to ensure we are doing everything we can to keep Americans healthy and safe."

"As this PCAST report notes, it is not possible to predict how the 2009-H1N1 influenza virus or the upcoming influenza season will play out, but it is best that we plan and prepare for a resurgence of H1N1 flu," said Homeland Security Secretary Janet Napolitano. "HIN1 influenza has the potential to affect virtually every aspect of our lives, from our economy and national security to our education system. It may not be possible to stop influenza, but we can reduce the number of people who become severely ill by preparing well and acting effectively."

"Schools, child care facilities and institutions of higher learning will not only play a key role in helping to mitigate the transmission of the flu this fall but will also play a significant role in promoting critical public health information," said Secretary of Education Arne Duncan. "I am happy to report that we are well on our way to implementing many of the recommendations for schools found in this comprehensive report and have joined with our partners across government to roll out guidance for K-12 and Institutions of Higher Learning over the past two weeks."

"The President’s Council of Advisors on Science and Technology did an excellent job, working on a short timeline, of summarizing and assessing the U.S. preparations for 2009-H1N1 influenza," said CDC Director Tom Frieden. "Their subcommittee, which included individuals from across the public and private sectors, has provided valuable insights and recommendations, including strategies for strengthening our nation's ability to monitor the presence and impact of 2009-H1N1 influenza and strengthen our medical and non-medical response."

To see the PCAST Recommendations and Administration Progress, click here (pdf).

To see the full report, click here (pdf).

For more about PCAST, visit: http://www.ostp.gov/cs/pcast.


Special interests' on both sides in health fight
By DAVID ESPO (AP) -8/19/09 – 1 hour ago


WASHINGTON — As public pitchman, President Barack Obama accuses special interests of fighting to block his health care overhaul. "They run their ads. And let's face it, they scare people," he told one weekend audience. Yet Obama has spent months assembling a formidable lineup of special interests of his own, an essential element of a plan to remake the health care system and succeed where President Bill Clinton memorably failed. "We have the American Nurses Association, we have the American Medical Association on board," Obama told the weekend crowd in Grand Junction, Colo. "We have an agreement from drug companies to make prescription drugs more affordable for seniors. ... The AARP supports this policy." In the parlance of Washington, the organizations on both sides are special interests — the insurance industry and business groups strongly opposed to the direction health care legislation is taking in Congress, as well as the groups of doctors, nurses, drug makers and labor unions working to pass an overhaul despite any misgivings they may have. Part of the permanent landscape in the capital, they all lobby Congress and federal agencies on the issues they care most about. Many purchase political ads in campaign season or try to turn out their own memberships to vote for preferred candidates. They have enormous sums at stakes in the outcome of the struggle over Obama's proposed remaking of the health care system.

Take just two:

_ America's Health Insurance Plans has emerged as a leading opponent of the portion of Obama's plan that calls for the government to sell insurance in competition with private companies.

_ The Pharmaceutical Research and Manufacturers Association is unhappy about the same provision but has pledged to spend a staggering $150 million on television commercials in support of the administration's quest for legislation.

What's the difference?

"They're stakeholders when they're with you, and they're interest groups when they're against you," Mary Matalin, a Republican, said recently, a tongue-in-cheek explanation that hints at the unappealing aroma associated with the label "special interests." White House spokesman Robert Gibbs seemed to understand as much when he said the administration is benefiting from the help of "interest groups," avoiding the more unsavory term "special interests." "It'd be sort of odd to go to a town hall meeting and rail against interest groups that are supporting reform ... who have acknowledged that it's time for health care reform," he said. The president's criticism is aimed at "interest groups that are aligned to keep the status quo either because it benefits them or they have a vested interest."

Far more than semantics is involved.

Eager to succeed where Clinton failed, Obama nailed down agreements with deep-pocketed drug makers and others. The effect was not only to secure allies who could pay for grass-roots and advertising campaigns but also to drive a wedge between Republicans and organizations that have supported them in the past. Despite the obvious turbulence surrounding Obama's proposals, there is evidence the strategy is working. GOP discomfort was obvious when Rep. John Boehner, the House Republican leader, accused the drug industry of trying to protect its own profits by "cutting a deal with the bully" on health care. It marked a turnabout from the days when congressional Republicans received two-thirds of the political contributions handed out by the pharmaceutical industry. Ken Johnson, a senior vice president at PhRMA, sought the high ground in response. "We have been working diligently for more than a year to advance bipartisan health care reform. We're proud of those efforts, and they are completely consistent with our core principles." The drug makers went first in making a deal with the White House, agreeing to pick up $80 billion in additional costs over the next decade to help defray the expenses of the legislation.

The American Hospital Association agreed to shoulder an additional $155 billion.

In exchange, both won assurances the White House would protect them against attempts in Congress to seek additional cuts in their projected Medicare and Medicaid payments. The American Medical Association's key issue was different. Doctors hope the legislation will allow them to avoid a looming 21 percent cut in payments under Medicare. The cost to the government for that would be about $230 billion over a decade. Obama also agreed to require individuals to purchase insurance, reversing a position he held during his campaign. "My thinking on the issue of mandates has evolved. And I think that that is typical of most people who study this problem deeper," he said. It was a bow to the special interests — some now with Obama, others not — that suddenly opened up the possibility of millions of new customers with insurance to help pay for their health care.

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