Saturday, November 7, 2009
It is up to Week #42.
This is the chart for this past week. Week #43.
If you look at last weeks bar, it is different in both hospitalizations and deaths, than was reported last week. Notice the numbers along the left side, in the Hospitalizations chart, are different.....On week #42, the bar graph showed approx. 3,100 hospitalizations, and approx. 90 deaths. Now, this week, week #43, it shows week #42 as having 4,400 hospitalizations and 110 deaths. That is a 1,300 difference in hospitalizations, and 20 deaths, for Week #42.
The previous week's report is here:
Friday, November 6, 2009
NexBio(R) Publishes Two Articles Showing DAS181 (Fludase(R)*) Potently Inhibits Pandemic Influenza A(H1N1) and NAI-Resistant Influenza Viruses
SAN DIEGO, Nov. 6 /PRNewswire/ -- NexBio Inc., in collaboration with scientists at the Centers for Disease Control and Prevention (CDC), St. Louis University, and the University of Hong Kong, announced today the publication of two articles in the peer-reviewed journal PLoS ONE. These two published studies suggest that DAS181 (Fludase®) may play a potentially important role for the treatment and prevention of the Pandemic Influenza A(H1N1) and drug-resistant influenza.
DAS181 is a broad spectrum drug candidate being studied in human clinical trials for treatment and prevention of Influenza-Like Illness (ILI) caused by any strain of influenza and parainfluenza viruses. Unlike neuraminidase inhibitors (NAI), e.g. Tamiflu® (oseltamivir), as well as vaccines, which target the influenza virus ("pathogen target"), DAS181 works by inactivating the human receptors ("host target") for these viruses; thus, it may be less likely to cause drug resistance compared with currently-available antiviral drugs.
One published paper entitled "Novel Pandemic Influenza A(H1N1) Viruses are Potently Inhibited by DAS181, a Sialidase Fusion Protein" evaluated the antiviral activity of DAS181 against multiple Pandemic Influenza A(H1N1) viral clinical isolates in a number of preclinical models. DAS181 inhibited all of the pandemic viral strains in each study model. It demonstrates significant antiviral activity against the H1N1 viruses in primary human respiratory cells as well as in fresh human bronchial tissue. In studies performed at the CDC, DAS181 treatment given after infection by a Pandemic Influenza A(H1N1) virus completely prevented animal death. It also successfully prevented viral replication and weight loss in these animals.
In the second published paper entitled "Inhibition of Neuraminidase Inhibitor-Resistant Influenza Virus by DAS181, a Novel Sialidase Fusion Protein", the activity of DAS181 against clinical isolates of seasonal H1N1 influenza virus collected from influenza patients during 2004, 2007, and 2009 was studied. The isolates from 2007 and 2009 are all resistant to Tamiflu® as all contain the H274Y mutation known to cause such resistance. Notably, all isolates were strongly inhibited by DAS181. Additionally, NexBio has data to demonstrate that a laboratory strain of influenza which is resistant to all three NAIs (oseltamivir, zanamivir, peramivir) in vitro was inhibited by DAS181 in cell culture and in animals in the study.
"These results are particularly important because of the current H1N1 pandemic and the urgent need for new antiviral drugs with different approaches from currently available NAIs. Neuraminidase inhibitor drug resistance is already a significant problem for seasonal influenza. Tamiflu® drug resistance caused by the same mutation in Pandemic Influenza A(H1N1) is now being seen worldwide" commented Dr. Fang Fang, NexBio's President of Research & Development. "Unique among licensed influenza drugs and those in clinical development, DAS181 uses a Host-Oriented Therapeutic (HOT) strategy. Our goal for the continued advanced clinical development of DAS181 is to bring a potentially important new medicine to the treatment and prevention of this worldwide problem," Dr. Fang added
NexBio, Inc. is a privately held clinical-stage biopharmaceutical company located in San Diego. NexBio's mission is to save lives and to improve the quality of life by creating and commercializing novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening diseases. DAS181 (Fludase®), is an investigational drug that consists of an inhaled recombinant fusion protein. It inactivates viral receptors on the cells of the human respiratory tract, thereby preventing and treating infection by influenza, including potential pandemic strains, and by parainfluenza viruses (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic). The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under BAA Contract HHSN266200600015C and grant U01-AI070281. ViradinTM, invented and developed by NexBio, is a parenteral protein under development, currently at lead optimization stage, directed to the treatment of viral hemorrhagic fevers and bacterial biothreat sepsis. TOSAP® is a technology invented and developed by NexBio and is used to formulate DAS181 for inhalation, as well as to make nano/microparticles from virtually any type of molecule. TOSAP® is offered for the formulation of compounds of partners, under license.
Thursday, November 5, 2009
"Pandemic influenza A(H1N1) emerged rapidly in California in April 2009," write Janice K. Louie, MD, MPH, from the California Department of Public Health, Richmond, and colleagues. "Preliminary comparisons with seasonal influenza suggest that pandemic 2009 influenza A(H1N1) disproportionately affects younger ages and causes generally mild disease."
However, data on the clinical features and populations at risk for complications from H1N1 influenza infection are still emerging, the authors add.
The aim of the study was to describe the clinical and epidemiologic features of H1N1 influenza cases that led to hospitalization or death.
The investigators studied all cases of California residents who were hospitalized or died with laboratory evidence of H1N1 infection that were reported to the California Department of Public Health between April 23 and August 11, 2009.
During that time, 1088 cases that led to hospitalization or death were reported in 41 of 61 local health departments, with most occurring in June and July. Of these, 344 (32%) were children younger than 18 years.
The median age of all cases was 27 years (range, <1>. The overall rate of hospitalization or fatality per 100,000 for all age groups was 2.8 and ranged from 11.9 in infants younger than 1 year to 1.5 in those aged 70 years or older.
The highest hospitalization rates per 100,000 were in infants 1 month old (35.8) and 2 months old (21.1). These rates were lower in infants aged between 3 and 12 months, ranging from 4.2 to 12.6 per 100,000.
The median length of stay in hospital was 4 days.
Although infants were hospitalized at greater rates than adults, individuals aged 50 years or older had the highest rate of death once hospitalized, the authors report.
The overall fatality rate was 11%. In children younger than 18 years, the death rate was 7%, and in persons older than 50 years, it was 18% to 20%. The median time from onset of symptoms to death was 12 days, and the most common causes of death were viral pneumonia and acute respiratory distress syndrome.
Sixty-eight percent (741/1088) of patients had risk factors for seasonal influenza complications.
Obesity a Risk Factor for Hospitalization
The study also found that a high number of hospitalized adult patients were obese. Of the 268 adults aged 20 years or older with a known body mass index (BMI), 156 (58%) were obese, as defined by a BMI 30 kg/m2 or higher. Of these, 67 patients (43%) were morbidly obese (BMI ≥ 40 kg/m2).
Sixty-three percent of obese patients had comorbidities associated with influenza complications such as diabetes, asthma, and renal disease.
"We found a surprising number of obese persons in this study," Dr. Louie commented to Medscape Infectious Diseases. "Our proportion of morbidly obese persons was much higher than in the general population. Others are reporting similar findings. We need to study further to find out if obese persons were also more likely to have other risk factors not yet diagnosed, like asthma or diabetes."
The study findings emphasize the importance of vaccinating children, as well as caregivers of infants younger than 6 months of age and pregnant women, she added.
"H1N1 has a reputation as a mild illness, but we found that almost one third of our hospitalized cases became severely ill and required mechanical ventilation. Over 10% died," she said. "Also, there is a perception that the elderly have some immunity. However, we found that if elderly persons were admitted to a hospital, they tended to be more likely to die from their H1N1 infection."
She emphasized that clinicians should be thinking about H1N1 infection, as well as seasonal influenza, when a person presents with fever and respiratory symptoms.
Rapid Influenza Tests Not Reliable
She added, "Clinicians should not rely on the rapid tests for influenza done in the clinic, because these can be unreliable, especially in adults. If a patient is not looking well or has risk factors like pregnancy, antiviral treatment should be started right away while awaiting test results with [polymerase chain reaction]. Many studies have shown that early treatment can make a big difference as far as hospitalization and death for influenza."
Commenting on the study for Medscape Infectious Diseases, John Bartlett, MD, professor of medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, said the authors did everybody a big favor by doing the study.
The big surprise here, he said, was the severity of H1N1 infection in older individuals.
"We've all emphasized the fact that this is a disease of young people and elderly people are relatively spared. A lot of people, including myself, have told older people not to worry about H1N1, that it's not their problem. I think we have to think twice about that now," he said.
This does not mean that all older people need to be vaccinated, he added. Rather, it means that clinicians need to be more cautious in advising them of their risk.
Dr. Bartlett also noted the finding that obesity appears to be a risk factor for hospitalization. "Everybody has been talking about this, but the CDC has never really recognized that as a risk per se. But it just keeps coming up. It came up in Canada, it came up in Mexico, and it came up in California. I think we are going to have to try to figure out why people who are morbidly obese tend to handle this flu less well. A lot of them in this series had comorbidities, but a lot of them did not."
Dr. Louie and Dr. Bartlett have disclosed no relevant financial relationships.
Pandemic H1N1 influenza is now in virtually every country in the world, and health officials are bracing for an upsurge in cases as winter sets in, World Health Organization officials said this morning.
"At WHO, we remain concerned about the pattern we are seeing, particularly because a sizable number of people do develop serious complications and death," Dr. Keiji Fukuda, a special advisor to the WHO director-general on pandemic influenza, said at a news conference. "We anticipate seeing continued or increased activity during the winter period in the Northern Hemisphere. This also means we expect to see continued reports of serious cases and deaths."
The most recent figures available show that at least 5,700 people worldwide have died from swine flu, with 4,175 of those in the Americas.
Fukuda said that vaccinations against swine flu have started in 20 countries and that millions of doses have been delivered safely, with no adverse events. He complained, however, that the agency has yet to receive most of the 200 million doses of vaccine that were to be donated by 11 countries. Delays in production of the vaccine have led to shortages, and most countries, like the United States, have chosen to vaccinate their high-priority groups before making good on their pledges.
In other flu news:
-- Swine flu has struck the remote Yanomami tribe in Venezuela, showing that no one is safe from the virus. Seven people have died from the flu, out of a population of only 28,000. Several of the victims were babies, and one was a pregnant woman. Fukuda said the virus has also struck aboriginal populations in Australia severely, and it is not clear yet whether the high rate of infection is related to a genetic susceptibility or to poor healthcare.
-- Cold weather has brought an outbreak of swine flu in Mongolia, and the country has been requesting additonal doses of the antiviral drug Tamiflu to combat its spread. The country has confirmed 859 cases of swine flu and six deaths, but healthcare facilities have been struggling to cope with the surge in unconfirmed cases. Mongolia previously had a stockpile of 11,000 doses of Tamiflu, half provided by the WHO in May. The agency is now sending an additional 45,000 doses.
-- In an effort to ease the burden on its healthcare system caused by swine flu, Norway has decided to allow sale of Tamiflu without a prescription. Health officials have feared that such sales would lead to indiscriminate use of the drug, increasing the risk of the virus developing resistance to what is currently the most valuable tool to fight infections. Fukuda, however, called the decision to allow over-the-counter sales "innovative and prudent."
-- An intense outbreak is occurring in Ukraine, with 500,000 cases of acute respiratory distress and 85 deaths, according to the European Centre for Disease Prevention and Control. Both the WHO and European officials have been sending in teams to help out.
-- As if Wall Street weren't already hated enough, recent news reports have said that at least 13 major companies, including Citigroup, Goldman Sachs and JP Morgan Chase, have received allocations of swine flu vaccine. Such allocations are approved by state health officials, in this case New York, who generally approve shipments for use in high-risk groups. Critics charge that the companies are getting favorable treatment. "It seems safe to assume the vast majority of their employees are not pregnant women, infants and children, young adults up to 24 years old, and healthcare workers," said Melanie Sloan, executive director of Citizens for Responsibility and Ethics in Washington.
-- A new McClatchy-Ipsos poll found that almost half of Americans are rejecting the swine flu vaccine. Only 52% said they were likely to get it, and only 33% said they are very likely to get it. The poll apparently did not ask why they were rejecting it, but many people have been concerned about the safety of the vaccine, despite repeated assurances that it is made exactly like the seasonal flu vaccine, which has proved safe in hundreds of millions of people.-- Thomas H. Maugh II
TORONTO — The World Health Organization's top flu scientist often describes the virus he's studied for years as "humbling."
And Dr. Keiji Fukuda isn't alone in marvelling at the mercurial nature of influenza. Flu scientists repeat almost as a mantra that the only thing predictable about flu is its unpredictability.
Yet despite decades of evidence that influenza will repeatedly rewrite the rules, flu dogma emerges and takes hold. Scientists keen to sift patterns from chaos agree X is true about Y - until the virus sets them straight yet again.
In the late '60s it was held that pandemic viruses emerged in 11-year cycles, after the closely spaced 1957 Asian flu and 1968 Hong Kong flu outbreaks.
It used to be accepted that only H1, H2 and H3 viruses could infect humans. And then viruses from the H5, H7 and H9 subtypes jumped from birds to infect people. Wrong again.
Though the world is not quite seven months into this pandemic, a number of widely held assumptions about flu and pandemics seem destined for the redrawing board when the dust from this outbreak settles.
Here are some:
-Pandemic viruses emerge from Asia, the cradle of flu viruses.
Years of focus on H5N1 avian influenza viruses left experts convinced Asia was the birthplace of new flu viruses and would be the source of the next pandemic. Despite the fact that there's good evidence the 1918 Spanish flu virus may have emerged in Kansas, no one was looking to North America as ground zero for the first pandemic of the 21st century.
It's a valuable lesson, says Dr. Nancy Cox, who has been pushing for a number of years for more flu surveillance in Latin America.
"You can't take your eye off the other possible threats. You can't focus too much on one area of the world because influenza - a new virus - can emerge from anywhere," says Cox, head of the influenza division at the U.S. Centers for Disease Control.
-Pandemics are triggered by "antigenic shift."
Flu viruses evolve constantly via small mutations, a process called antigenic drift. But once in a blue moon an entirely new virus bursts out of nature, an event known as antigenic shift. Because most people are vulnerable to the new virus, it ignites a pandemic.
It used to be thought pandemics could only be started by a virus with a new hemagglutinin - the H number in the virus's name - or a virus with a hemagglutinin that hadn't spread recently among people, such as the H2N2 viruses that circulated from 1957 to 1968.
The current pandemic is caused by an H1N1 virus, which is startling because almost everyone alive has antibodies to H1 viruses. They've been circulating among people since 1918, except for a 20-year gap between 1957 and 1977.
So few scientists would have predicted a new H1 virus could cause a pandemic at this point in history.
Some, in fact, still question whether this outbreak is a pandemic, at least by the definition science currently applies. The retired head of virology for the U.S. Centers for Disease Control is one of the doubters.
"There's no precedence for this," says Dr. Walter Dowdle, who now works for the non-profit Task Force on Global Health, based at Emory University in Atlanta. "Nobody had really thought that . . . the virus would re-emerge with this much background immunity."
But Dowdle cautions about dismissing the potential of this virus just because it defies our assumptions.
"We're the ones that make the definitions. And if the virus doesn't behave according to the definitions, well, it's our fault, not the virus's fault. So I think we have to be very careful about forcing the viruses into our definition, which can only be made based on what we've seen in the past.
Now we've seen something different. And so therefore we've got to go back and rethink this."
-Emerging pandemics can be extinguished with quick use of antiviral drugs.
Landmark modelling studies published in August 2005 suggested that with good surveillance, rapid response capacity and enough Tamiflu, a flu virus that was just starting to spread person-to-person could be snuffed out.
The late Dr. J.W. Lee, then director general of the WHO, committed the agency to try. Experts at the agency and elsewhere spent untold person-hours honing a plan for trying to stop a pandemic at source.
And while flu experts were watching the spread of H5N1 avian flu viruses from Asia, pigs got infected with some viruses that swapped genes and created the H1N1 virus we call swine flu. By the time we knew it was spreading, containment was out of the question.
"This cat was not only out of the bag, but this cat had nine litters before we realized what had happened," says Dr. Michael Osterholm, director of the University of Minnesota's Center for Infectious Diseases Research and Policy.
-We'd know it when we saw it.
Pandemics are rare. And before this one, only two had occurred in the era of virology. So what would a pandemic look like? Experts insisted it was a bit like pornography - we'd know it when we saw it.
And then a new virus of swine-avian-and-human genes started to spread.
It wasn't from a new subtype (see above). And but for the fact it was spreading in the off season and causing severe illness in younger people, it might have been mistaken for plain old flu.
-There would be little time between the spotting of an emerging pandemic virus and the declaration of a pandemic.
The WHO's pandemic alert scale goes from Phase 1 (no threat) to Phase 6 (pandemic). For years the world had been at Phase 3, which means a non-human virus (H5N1) posed a pandemic threat and was triggering occasional cases, but person-to-person transmission was rare and limited.
Most experts assumed when a pandemic virus started to take off, the world would race through Phases 4 and 5 to 6.
Within 10 days of the first announcement that human swine flu infections had been found, the WHO raised the alert level from 3 to 4 and then to 5.
And then the world waited.
The virus spread as expected. What wasn't anticipated was political resistance to the declaration of a pandemic caused by such a mild strain.
The gap between Phase 5 and Phase 6 stretched for six weeks - not because of the virus, but because of political wrangling and perceived need to ease the world into the first pandemic in 41 years.
-A mutation at position 627 on the PB2 gene means trouble.
After years of study, flu scientists believe they've found a number of signature motifs in viruses that can predict characteristics like disease severity or transmissibility. One is a mutation at the 627 position on a gene called PB2.
For as far back as molecular biology can see, all flu viruses known to have spread among humans had the mutation. That has led flu scientists to peg it as essential to transmission in humans. But this virus doesn't have that mutation.
Flu virologists have been on the lookout for pandemic H1N1 viruses with this change, believing it would confer greater transmissibility and maybe greater severity of disease. But when it was found in a few cases in the Netherlands, there were no nightmare changes in the illness pattern.
-People would clamour for pandemic vaccine.
Much of the recent pandemic planning was done with H5N1 flu in mind.
The virus is a monster in humans, killing around 60 per cent of those infected. Planners assumed people would be desperate for pandemic vaccine.
But until recently, it seemed H1N1 wouldn't scare many people into vaccine queues. Instead, polls showed a surprising number were more nervous about the vaccine than the virus.
And even after the recent death of 13-year-old Evan Frustaglio of Toronto received widespread attention, a Canadian Press Harris-Decima poll showed only 55 per cent of Canadians want this vaccine.
Meanwhile in Europe, response to vaccination efforts has been indifferent.
"It's funny because I would not have predicted us to be in this situation a year ago. Because it's a no-brainer that you'll get the vaccine out and you'll want to vaccinate as many people as possible," says Dr. Michael Gardam, of the Ontario Agency for Health Protection and Promotion.
-People would need two shots of vaccine to be protected against a pandemic virus.
The assumption was that a pandemic virus would be so new our immune systems wouldn't be able to protect us against it with just one shot. One jab would be needed to "prime" our immune systems and a second to "boost."
Those assumptions were based on the idea a pandemic virus would be a new virus subtype, foreign to our immune systems.
Clinical trials of H1N1 vaccine show most people respond to a single shot of vaccine as if it's a booster, not a primer.
-Vaccine would be ready in time to combat the second wave of infections.
Planners expected more time between the emergence of the virus and a proper first wave of activity. And they thought there would be enough time before the second wave to make and deploy vaccine.
This virus has followed a different timetable, with a rapid and heavy first wave in the spring, continued activity over the summer and an early start to the flu season in the fall.
In Canada, the first supplies of vaccine have arrived as activity is really taking off in many parts of the country. Public health officials are in a race with the virus, trying to get vaccine into people before they can catch the bug. But it takes about 10 days for an immune response to develop after vaccination and in some cases, the virus is winning the race.
"I think most of us were hoping that there was going to be a longer gap between the initial identification and even a first wave," says Dr. Allison McGeer, head of infection control at Toronto's Mount Sinai Hospital.
The head of the CDC has been surprisingly blunt in his assessment of the existing system's capacity to make pandemic vaccine in a timely way.
"The technology we are using, although tried and true, is not well suited for pandemics," Dr. Tom Frieden has said.
-Hospitals would be crippled.
Pandemic planners thought hospitals would be overwhelmed. Emergency departments would be swamped. Overflow facilities might be needed. Surgeries would be cancelled.
No one knows what this winter has in store and that scenario could still materialize. Certainly after high profile cases like the Frustaglio death, emergency departments have reported heavy use.
But so far, hospitals haven't been overwhelmed - except intensive care units.
Severe cases of H1N1 are rare, but people who develop bad disease are profoundly ill. ICU staff have to take extraordinary measures to oxygenate the blood of these people because their embattled lungs cannot do the work for them.
ICUs in a number of hard hit places during the spring wave reported nearing the point of overflow. If they reach that point, experts say, death rates will rise and other hospital services will need to be rationed. But that hasn't been the case to date.
Follow Canadian Press Medical Writer Helen Branswell's flu updates on Twitter at CP-Branswell
Copyright © 2009 The Canadian Press. All rights reserved.
Wednesday, November 4, 2009
Inactivated Vaccine: Dosage, Administration, and Storage
The composition of the influenza A (H1N1) 2009 monvalent inactivated influenza vaccine varies according to manufacturer, and package inserts should be consulted. Inactivated vaccine formulations in multidose vials contain the vaccine preservative thimerosal; preservative-free, single-dose preparations also are available. Inactivated vaccine should be stored at 35°F to 46°F (2°C to 8°C) and should not be frozen. Inactivated vaccine that has been frozen should be discarded. Dosage recommendations and schedules vary according to age group (Table 1).
Live Attenuated Influenza Vaccine (LAIV): Dosage, Administration, and Storage
Each dose of 2009 monovalent LAIV contains the same vaccine antigen used in the inactivated vaccine. However, the antigen is constituted as a live, attenuated, cold-adapted, temperature-sensitive vaccine virus. Providers should refer to the package insert, which contains additional information about the formulation of this vaccine and other vaccine components. LAIV does not contain thimerosal. LAIV is made from an attenuated virus that is able to replicate efficiently only at temperatures present in the nasal mucosa. LAIV does not cause systemic symptoms of influenza in vaccine recipients, although a minority of recipients experience nasal congestion or fever, which is probably a result of the effects of intranasal vaccine administration or local viral replication or fever.
LAIV is intended for intranasal administration only and should not be administered by the intramuscular, intradermal, or intravenous route. LAIV is not licensed for vaccination of children younger than 2 years or adults older than 49 years of age. LAIV is supplied in a prefilled, single-use sprayer containing 0.2 mL of vaccine. Approximately 0.1 mL (i.e., half of the total sprayer contents) is sprayed into the first nostril while the recipient is in the upright position. An attached dose-divider clip is removed from the sprayer to administer the second half of the dose into the other nostril while the recipient is in the upright position. LAIV is shipped at 35°F to 46°F (2°C to 8°C). LAIV should be stored at 35°F to 46°F (2°C to 8°C) on receipt and can remain at that temperature until the expiration date is reached.
[See site for Chart, click on title]
Tuesday, November 3, 2009
It’s cold and flu season and the news is filled with just how deadly influenza can be. A figure that is frequently repeated in most news outlets when talking about the flu is that 36,000 people die each year from the flu.
“H1N1 has been getting top line publicity and it’s important to know that seasonal flu takes a toll year in and year out,” Sebelius said. “But each year, 36,000 Americans die from the seasonal flu.”
New York Times
“… seasonal flu, which kills about 36,000 people annually.”
Wall Street Journal
“The seasonal flu sends an average of 200,000 Americans to the hospital each year, and 36,000 of them die, according to the CDC”
“According to the Centers for Disease Control and Prevention, 5 percent to 20 percent of the U.S. population is infected with seasonal flu each year… about 36,000 people die — mostly elderly.”
All these news reports leave the reader with a very specific and definitive figure of 36,000 people dying each year directly from the flu. But where did this figure come from? Most people would probably assume that careful statistics are kept to arrive at this figure. However, this 36,000 number that is repeated so authoritatively is actually based on a single study published in 2003. A mathematical model was applied to estimate flu-related deaths by using death certificates where the cause of death was listed as respiratory or circulatory disease.
“CDC estimated that about 36,000 people died of seasonal flu-related causes each year, on average, during the 1990s in the United States. This figure includes people dying from complications of seasonal flu. This estimate came from a 2003 study published in the Journal of the American Medical Association (JAMA), which looked at the 1990-91 through the 1998-99 flu seasons. Statistical modeling was used to estimate how many flu-related deaths occurred among people whose underlying cause of death on their death certificate was listed as a respiratory or circulatory disease. During these years, the number of estimated deaths ranged from 17,000 to 52,000.”
The fact is the 36,000 number of deaths is really an estimate and not an exact number as often it is represented. More importantly it is a mathematical estimate based on an assumption that if a death certificate had “respiratory or circulatory disease” listed as a cause of death that it should be counted as a “flu-related” death.
Just how many deaths are directly associated with the flu? According to Peter Doshi in the British Medical Journal:
‘… according to the CDC's National Center for Health Statistics (NCHS), “influenza and pneumonia” took 62,034 lives in 2001 - 61,777 of which were attributed to pneumonia and 257 to flu, and in only 18 cases was flu virus positively identified. Between 1979 and 2002, NCHS data show an average 1348 flu deaths per year (range 257 to 3006).’
So the real statistics show a far lower number of people dying from the flu with only a handful of cases being definitely identified as even having the influenza virus. 257 deaths from the flu in 2001 is only a fraction of the often cited 36,000. The CDC directly admits to using this model because most cases aren’t even tested to see if the flu virus was even involved.
‘In a written statement, CDC media relations responded to the diverse statistics: “Typically, influenza causes death when the infection leads to severe medical complications.” And as most such cases “are never tested for virus infection ... CDC considers these [NCHS] figures to be a very substantial undercounting of the true number of deaths from influenza. Therefore, the CDC uses indirect modeling methods to estimate the number of deaths associated with influenza.”’
An article published in Journal of American Physicians and Surgeons in 2006 is highly critical of the CDC methods.
“The CDC and news media frequently proclaim that there are about 36,000 influenza-associated deaths annually. Review of the mortality data from the CDC’s National Vital Statistics System(NVSS) reveals these estimates are grossly exaggerated. The NVSS reports preliminary mortality statistics and distinguishes between influenza-related deaths and pneumonia-related mortality. When the final report is issued, influenza mortalities are combined with the far more frequent pneumonia deaths, yielding an exaggerated representation of influenza deaths. Pneumonia related mortality due to immunosuppression, AIDS, malnutrition, and a variety of other predisposing medical conditions is therefore combined with seasonal influenza deaths. The actual influenza related deaths for the years 1997 to 2002 ranged from 257 to 1,765 annually. These values are further overestimated by combining deaths from laboratory-confirmed influenza infections with cases lacking laboratory confirmation.”
Looking at how the CDC website has changed over the years and how they report on the flu shows that there was a shift in 2002 from “influenza associated” to an absolute “die from the flu” statement. In 2003, the number of 20,000 was adjusted based on the discussed mathematical model to 36,000 “die from influenza”. The CDC website now currently and slightly more correctly notes that the deaths are “flu-related”.
- Dec 16, 2001 - "In an average year, influenza is associated with more than 20,000 deaths nationwide"
- Jan 24, 2002 - "An average of about 20,000 people per year in the United States die from the flu"
- Feb 9, 2003 - "An average of about 36,000 people per year in the United States die from influenza"
- Nov 02, 2009 - "about 36,000 people die from flu-related causes."
Peter Doshi concludes in his paper that, “If flu is in fact not a major cause of death, this public relations approach is surely exaggerated. Moreover, by arbitrarily linking flu with pneumonia, current data are statistically biased. Until corrected and until unbiased statistics are developed, the chances for sound discussion and public health policy are limited.”
The figure of 36,000 deaths each year from the flu as reported is clearly not based on careful analysis of actual cases that are tested for the influenza virus. Instead, the number is a mathematical model estimate based on a single 2003 study that links death certificates that list “respiratory or circulatory disease” as a cause of death as proof of influenza as causing the death.
Orlando Sentinel, “Flu 101: What you need to know about seasonal and swine strains”, November 2009
Fox News, “Health Officials: Get Your Seasonal Flu Vaccine Today”, September 10, 2009
New York Times, “As Flu Vaccine Arrives for the Season, Some Questions and Answers”, October 9, 2009
“Two Flu Vaccines, Lots of Questions”, Wall Street Journal, October 18, 2009
Questions and Answers Regarding Estimating Deaths from Seasonal Influenza in the United States, http://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm
Peter Doshi , Are US flu death figures more PR than science? BMJ, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1309667
Influenza Vaccination During Pregnancy: A Critical Assessment of the Recommendations of the Advisory Committee on Immunization Practices (ACIP), Journal of American Physicians and Surgeons, Volume 11,Number 2,Summer 2006, http://www.jpands.org/vol11no2/ayoub.pdf
Monday, November 2, 2009
U.S. Dept. Health & Human Svcs.: Initial Results Show Pregnant Women Mount Strong Immune Response to One Dose of 2009 H1N1 Flu Vaccine
FOR IMMEDIATE RELEASE
Contact: NIAID Office of Communications
Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.
“For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring,” says NIAID Director Anthony S. Fauci, M.D. “The immune responses seen in these healthy pregnant women are comparable to those seen in healthy adults at the same time point after a single vaccination, and the vaccine has been well tolerated.”
According to the Centers for Disease Control and Prevention, since the outbreak began last spring, at least 100 pregnant women have been hospitalized in intensive care units in the United States and at the last official count, 28 pregnant women have died.
A preliminary analysis of blood samples taken 21 days post-vaccination from a subgroup of 50 pregnant women participating in the trial shows the following:
- In 25 women who received a single 15-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 92 percent, or 23 of 25, of these women.
- In 25 women who received a single 30-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 96 percent, or 24 of 25, of these women.
The trial began on Sept. 9 and reached its target enrollment of 120 volunteers in mid-October. All participants are between 18 to 39 years old and began the study in their second or third trimester (14 to 34 weeks) of pregnancy.
At entry into the study, the participants were divided at random into two groups: half are receiving two doses of a 15-microgram vaccine and the other half are receiving two doses of a 30-microgram vaccine. The two injections of vaccine are spaced three weeks apart.
Safety is being monitored closely in the trial, by the study investigators and by an independent panel of experts known as a safety monitoring committee. To date, the vaccine appears to be well-tolerated, and no safety concerns related to the vaccine have arisen.
The vaccine used in this clinical trial was manufactured by Sanofi Pasteur in its plant in Swiftwater, Pa., in the same manner as the company’s injectable seasonal influenza vaccine. Like the seasonal flu vaccine, the 2009 H1N1 flu vaccine contains a purified portion of the killed virus and therefore cannot cause infection. The vaccine does not contain the preservative thimerosal or an immune boosting substance known as an adjuvant.
NIAID is conducting this trial through five clinical sites affiliated with its longstanding clinical trials network known as the Vaccine and Treatment Evaluation Units. For additional information about the NIAID trial in healthy pregnant women, see the Sept. 9 NIAID news release http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pregnanttrials.htm and related Q&A http://www3.niaid.nih.gov/news/QA/H1N1pregnanttrials.htm .
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to 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 Agency—includes 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.
Here is an updated chart comparing pediatric for the past several flu seasons. The seasonal flu information (in green) was derived from the CDC FluView chart of reported pediatric deaths. The H1N1 deaths (in red) were taken from this thread, U.S. Pediatric Deaths: [http://www.flutrackers.com/forum/showthread.php?p=313159&posted=1#post313159], the dead children thread: [http://www.flutrackers.com/forum/showthread.php?t=124781], and the US child death thread on the Pandemic Flu Information Forum. Note that the last green row and the first red row cover the same time period (the 2008-2009 flu season), just separating the seasonal flu deaths and the H1N1 flu deaths.
Sunday, November 1, 2009
(CP) – 1 day ago
The World Health Organization says relatively few cases of Tamiflu resistance have been found among pandemic H1N1 viruses, but there are some concerns that bear watching.
The agency says there have been 39 cases of Tamiflu resistance reported so far, seven of which are still being investigated.
Of the 32 for which details are known, 13 occurred in people taking the drug to prevent infection, a procedure called prophylaxis.
The WHO says while the numbers are low, resistance hasn't previously been seen in people taking the drug prophylatically and the fact it is now being seen is a concern.
And there have been three cases of drug resistance in people who hadn't taken Tamiflu, which is the brand name for oseltamivir.
The WHO says there's no evidence of ongoing spread of resistant viruses, but there is a strong suspicion that limited spread has occurred among close contacts in some cases.
Most of the viruses have been found in North America and in the Western Pacific region, though a few have been spotted in Europe.
Asthma is more common in children than in adults, and swine flu seems to strike younger people more often than older ones. This is completely different than the seasonal flu, which affects less children and more adults.
In the study, 45 percent of the hospitalized patients were under age 18, and only 5 percent were 65 or older. "If you are a young adult and you have asthma, you are in double jeopardy," stated Richard Gower, M.D., the president of the American College of Allergy, Asthma and Immunology.
Asthma causes 4,000 deaths a year in the United States. This is without the added problem of the H1N1 swine flu. Asthma can occur in anyone at any time of life from infancy to adulthood. In some children with asthma, the disease goes away as they enter adolescence or adulthood. However, there is no cure for asthma, though symptoms sometimes decrease over time. Asthma is not contagious and poses no risk to others.
Many people experience similar symptoms when they get the H1N1 swine flu. This includes fever, congestion, and possibly nausea, diarrhea, and vomiting. Most of the time, swine flu symptoms can be successfully battled with bed rest and liquids. However, those who have asthma are at a higher risk of complications when they get the H1N1 swine flu.
People with asthma are at risk for breathing trouble with infections in general, not just the H1N1 swine flu. The best course of action for people with asthma during the H1N1 swine flu pandemic is to:
*Take asthma medication daily, even when not ill. It can help protect the lungs from triggers such as infections.
*Get vaccinated for the H1N1 swine flu. The CDC recommends the shot, not nasal spray, which is safer for asthmatics.
*Get treatment quickly if you get the H1N1 flu or symptoms and have asthma. Prevention is better than waiting.
The H1N1 swine flu is spreading rapidly across the United States. Those with chronic conditions such as asthma should be preventative and although patients do not always have to go into see their necessarily physician, they need to contact them if they have high risk conditions.
sources: AAFA, Health.com, Wikipedia
The good part ...
Although the distribution of the H1N1 vaccination has been delayed, it is expected to be more available for the general public in the month of November. According to the H1N1 in PA Web site, the state is awaiting more vaccines from the suppliers. The site has been updated in the past week and it says they will post information identifying vaccination sites here http://www.h1n1inpa.com/vaccines/h1n1-vaccine-locations-in-pa/ when it is available. In the meantime they suggest talking to your doctor if you are in a high risk group to find out what local places will distribute the shot. If you are unable to find the vaccine in your area, the site said to call the Pennsylvania Department of Health at 1-877-PA-HEALTH (1-877-724-3258).
While nearly all the influenza cases identified are the 2009 H1N1 influenza A virus, the virus remains similar to the virus used to develop the H1N1 vaccine. Additionally, the virus remains highly susceptible to two of the antiviral drugs.
IV antiviral drug Peramivir was approved by the FDA this week for use in pediatric and adult patients admitted to the hospital for H1N1. The drug was issued an emergency approval and is currently the only antiviral drug administered intravenously.
Now the rest of the facts ...
The proportion of deaths attributed to pneumonia and influenza far exceeds what is normal at this time of the year. Twenty-two pediatric flu deaths were reported this week. Nineteen were confirmed H1N1 and the additional three are considered likely H1N1. The CDC said the H1N1 virus is the only flu virus circulating at the moment. Since April 2009, 114 laboratory-confirmed H1N1 cases have resulted in death of a child younger than 18 and another 12 more children died from suspected H1N1 virus.
The vaccine is still in short supply so health care officials are reminding people to seek treatment with any concerning symptoms. CDC officials said those with underlying health concerns or in high risk groups need to seek immediate medical treatment if they suspect the have the H1N1 flu. They stated a only half of the high-risk population is heading that advice and consequently, officials said the lack of medical attention is leading to more hospitalizations and complications. Emergency rooms are reporting high volumes however, so it is advised to seek care from your primary doctor or child's pediatrician unless severe symptoms are suspected.
The high risk groups are: pregnant women, persons six months to 24 years old, Health care providers and EMS personnel, parents, household members or caregivers of children less than six months and those under 65 with certain underlying medical conditions (including respiratory conditions like asthma).
Pediatric deaths from H1N1
Current influenza season (data from August 30)
75 suspected pediatric deaths (65 confirmed H1N1)
Since April 2009
114 confirmed H1N1 pediatric deaths
October 31, 2009
The biggest rise was recorded in the Americas region, where 4,175 deaths have now been reported to the WHO, up 636 from data published last week.
"In the temperate zone of the northern hemisphere, influenza transmission continues to intensify, marking an unusually early start to winter influenza season in some countries," said the WHO.
Fatal cases in Europe rose to at least 281, while those in Asia-Pacific rose to 1,070.
Amid the mounting death toll, the WHO said a single dose of vaccine would provide sufficient immunity.