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Influenza

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containing two 1918 genes that proved to be very lethal in animal

experiments. This experiment is only one genetic step away fro m taking th e

1918 demon entirely out of the bottle.

A resuscitation of the Spanish flu is neither necessary nor warranted from a

public health point of view. Allegedly, the recent experiments sought to test the efficacy of existing antiviral drugs on the 1918 construct. But there is little need for antiviral drugs against the

1918 strain if the 1918 strain

had not been recreated in the firs t place " I t

simply does not make any scientific sense to create a new threa t jus t t o develop new countermeasures against it." says Jan van Aken, biologist with the Sunshine Project, "Genetic characterization of influenza strains has important biomedical applications. But it is not justifiable to recreate this particularly dangerous eradicated strain that could wreak havoc if released, deliberately or accidentally."

Construction of new maximum security (BSL-4) laboratories fo r biodefense

research has been justifie d in part by citing the potential of th e Spanish Flu

as a biological weapon. Influenza usually requires a low level o f containment;

but when scientists begin recombining virulence-related genes, the danger dramatically increases. The University of Texas Medical Branch's BSL-4 plans influenza 'gene reassortment' experiments in maximum containment. "This kind of research is creating a vicious circle, and could prompt a race by biodefense scientists to genetic engineer unthinkable diseases", says Edward Hammond of the Sunshine Project, "What disease comes after influenza? Biodefense laboratories must not become self-fulfilling prophesy centers. The world does not need biodefense programs to create a 'genetically engineered disease gap'."

>From an arms control perspective it appears to be particularly sensitive if a military research institution embarks on a project that aims at constructing more dangerous pathogens. "I f Jeffery Taubenberger worked

in a Chinese, Russian or Iranian laboratory, his work might well be seen as

the 'smoking gun' of an offensive biowarfare program," says van Aken.

On the label pdf, they say the vaccine can't be given to children under five, because it doesn't work, but take a look at the following label. I t states that

children younger than five, were contracting pneumonia, and developing asthma.

Flumist Regulatory Review

1. OVERVIEW 1.1. FluMist's Regulatory Review History Influenza virus vaccme live, intranasal (FluMist.) is an intranasally administered trivalent vaccine intended for active immunization for the prevention of influenza. I n a July 2001 meeting, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) considered safety and efficacy data accumulated fo r FluMist and concluded that: • Data were adequate to establish the efficacy and effectiveness of FluMist in the pediatric, adolescent, and adult population, specifically, from 15 months through 64 years of age. • Data were not adequate at that time to establish the safety of FluMist based on remaining concerns regarding asthma (possible signal observed in 18-35 month olds in one study), pneumonia, and lack of concurrent immunization

dat a fo r th e

Medlmmune Vaccines has interacted with CBER through responses to two Complete Response Letters (CRL) and discussions which have lead to the following outcomes: • Evaluation of integrated data across all studies and additional evaluation of Study AV019 suggest a possible increase in medically attended asthma/wheezing events after FluMist administration in children up to 59 months of age (Section 9 of this document). The magnitude of the apparent increase was small and clinical impact was generally mild. No evidence fo r an increase was observed in children over th e age of 59 months or in adolescents and adults. Until additional information regarding asthma/wheezing in children younger than 5 years is available, this population will not be included in the requested label. Medlmmune Vaccines will eventually seek an indication for healthy children 19 months through 59 months of age and plans to discuss a proposed clinical development plan fo r these children with CBER in the near future.

childre n <18 months o f age. Since th e 200 1 VRBPAC Meeting ,

Part of the package insert

(HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses that have been recommended by the USPHS for inclusion in the annual vaccine formulation. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses that are related to strains expected to circulate during the 2003-2004 influenza season. Viral harvests used in the

production of FluMist are produced by inoculating each of the three reassortant viruses into specific pathogen-free (SPF) eggs that are incubated to allow for vaccine virus replication. The allantoic fluid of these eggs is harvested, clarified by centrifugation, and stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate (0.47 mg/dose). Viral harvests from the three strains (H1N1, H3N2, and B) are subsequently blended and diluted to desired potency with allantoic fluid derived fro m uninfected SPF eggs t o produce trivalen t bulk vaccine. Each of viral harvest is tested for ca, ts , and at t and is also tested extensively

in vitro and in vivo methods to detect adventitious agents. The bulk vaccine is then filled directly into individual sprayers for nasal administration. These sprayers are labeled and stored at =-15oC. Gentamicin sulfate is added early in the manufacturing process during preparation of reassortant viruses at a calculated concentration of approximately 1 //g/mL. Later steps of the manufacturing process do not use gentamicin, resulting in a diluted residual concentration in the final product of <0.015 /jg/mL (limit of detection of the assay). FluMist does not contain any preservatives. Each pre-filled FluMist sprayer contains a single 0.5 mL dose. The teflon tip attached to the sprayer is equipped with a one-way valve that produces a fine mist that is primarily deposited in the nose and nasopharynx. When thawed fo r administration, FluMist is a colorless to pale yellow liquid and is clear to slightly cloudy (see

by

lot

DOSAGE AND ADMINISTRATION).

16 June 2003 Page 7 of 19

CONTRAINDICATIONS

Under no circumstances should FluMist. be administered parenteral ly. Individuals with a history of hypersensitivity, especially anaphylactic reactions, to any component of FluMist, including eggs or egg products, should not receive FluMist (see DESCRIPTION).

Prior to administration of FluMist, individuals or their parent/guardian should be asked about their current health status, their personal medical history and the medical history of household and close contacts, including immune status, to determine the existence of any contraindications (see CONTRAINDICATIONS and WARNINGS) to immunization with FluMist. FluMist recipients should avoid close contact (e.g., within the same household) with immunocompromised individuals for at least 21 days. EPINEPHRINE INJECTION (1:1000) OR COMPARABLE TREATMENT MUST BE READILY AVAILABLE I N THE EVENT OF AN ACUTE ANAPHYLACTIC REACTION FOLLOWING VACCINATION. The health care provider should ensure prevention of any allergic or other adverse reactions by reviewing the individual's history for possible sensitivity to influenza vaccine components, including eggs and egg products. Administration of FluMist should be postponed until after the acute phase

(at least 72 hours) of febrile and/or respiratory illnesses. Information for Vaccine Recipients or Parents/Guardians Vaccine recipients or their parents/guardians should be informed by the health care provider of the

potential benefits and firs t use of FluMist in

vaccine virus, vaccine recipients or their parents/guardians should be advised to avoid close contact (e.g., within the same household) with immunocompromised individuals for at least 21 days. The vaccine recipient or the parent/guardian accompanying the vaccine recipient should be told to report any suspected adverse events t o the physician or clinic where the vaccine was administered (see ADVERSE EVENT REPORTING).

risks of FluMist, and the need fo r 5-8 year olds. Due t o th e possible

two doses fo r the transmission of

Bell palsy following intranasal vaccination

Results from a case-control study and a case-series analysis indicate a significantly increased risk of Bell palsy developing following intranasal immunization wit h a new vaccine. This inactivated influenza vaccine,

composed of influenza antigens in a virosomal formulation with E. coli derived LT adjuvant, was licensed in Switzerland in October 2000.Following spontaneous reports of Bell palsy, the company decided not to market the

vaccine during the following

season. I n general, the etiology and

pathogenesis of Bell palsy remain inadequately understood. The greater risk of Bell palsy following immunization with thi s vaccine may be due t o specific vaccine components such as LT toxin, influenza antigens or virosomes, or simply t o use of the intranasal administration route.

I t is thus possible tha t such complications of vaccine administration may also apply to other nasal vaccines. GACVS therefore recommends tha t any novel vaccine for nasal administration should be tested on a sufficiently large number of subjects before licensing and submitted to active post-marketing surveillance studies. Since the average time to onset of Bell palsy following

intranasal immunization wit h thi s new vaccine was as much as GAC\/S recommends that the follow-up period in the context

trials should be routinely extended to 3 months following administration of a

new intranasal vaccine

60-9 0 days, of clinical

http://www.ncbi.nlrn.nih.g0v/entrez/query.fcgi?cmd=Retrieveddb=PubMed<&

list_uids=12763480Adopt=Abstract

Clin Immunol 2003 May;107(2):116-21 <A HREF="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMedÂcmd=Dis

playádopt=pubmed_pubmed_tfrom_uid=12763480">Related

Articles,</A»Links</A>

Influenza vaccination and Guillain Barre syndrome small star, filled.

Geier MR, Geier DA, Zahalsky AC.

The Genetic Centers of America, 14 Redgate Court, 20905, Silver Spring, MD, USA

Acute and severe Guillain Barre Syndrome (GBS) cases reported following influenza vaccine to the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1999 were examined. Endotoxin concentrations were measured using the Limulus amebocyte lysate assay in influenza vaccines. There were a tota l of 382 cases of GBS reported t o th e VAERS database following influenza vaccination (male/female ratio, 1.2). The median

onset of GBS following influenza vaccine was 12 days (interquartile range, 7 days t o 21 days). There was an increased risk of acute GBS (relative risk, 4.3; 95% confidence interval, 3.0 to

6.4) and severe GBS (relative risk, 8.5; 95% confidence interval, 3.7 t o 18.9) in comparison to an adult tetanus-diphtheria (Td) vaccine control group. There were maximums in th e incidence of GBS following influenza vaccine

that occurred approximately every statistically significant variation in

influenza manufacturers. Influenza vaccines contained from a 125- to a 1250-fold increase in endotoxin concentrations in comparison to an adult Td vaccine control and endotoxin concentrations varied up to 10-fold among different lots and manufacturers of influenza vaccine. The biologic mechanism fo r GBS following influenza vaccine may involve th e synergistic effect s of endotoxin and vaccine-induced autoimmunity. There were minimal potential reporting biases in the data reported to the VAERS database in this study. Patients should make an informed consent decision on whether to take this optional vaccine based upon its safety and efficacy and physicians should vigilantly repor t GBS following influenza vaccination t o th e VAERS in the United States so that continued evaluation of the safety of influenza vaccine may be undertaken.

thir d year (1993,1996, and 1998) and th e incidence of GBS among differen t

Message from Barbara Loe Fisher

NVIC Co-founder and President Barbara Loe Fisher, who ended her four years of service on the FDA yacanes and Related Biological Products Advisory Committee as the voting consumer member yesterday, made the statement below when she voted on whether Medlmmune had proven that th e live virus nasa\ fl u vaccine, FLUMIST, was safe t o use in children and adults. She was th e sole dissenting "No" vote tha t safety had not been proven for individuals aged five to 50.

The reference t o polio vaccine in her statement was in response t o an exchange she had earlier in the meeting with another Committee member,

Sam Katz, M.D., FLUMIST could

positive selling point for the vaccine rather than a negative consequence. He likened the effect to passive vaccination of close contacts of those recently

who had made th e argument tha t th e transmit vaccine strain fl u viruses to

fac t tha t recipients of close contacts was a

'/

vaccinated with live oral polio vaccine. Barbara reminded Dr. Katz that America no longer uses the live oral polio vaccine precisely because recipients and close contacts could come down with vaccine strain polio and be permanently crippled or die.

The transcripts of th e last four years of FDA Advisory Committee meetings in which Barbara participated are available on the FDA website. Here is what she said when she voted that the safety of FLUMIST had not been proven:

"The data are inadequate to support the safety of FLUMIST in individuals f ive to 64 years of age. The increased risk of asthma in young children and the increased risk for some children of URI's, musculoskeletal pain, otitis media and croup as well as URI symptoms in adults suggests that an unknown number of healthy but genetically vulnerable individuals across all age groups will not be able to handle this vaccine well.

This will, over the long term, lead to the public perception that when you get the flu vaccine, you get the flu. And this is an important consideration long term because when you make healthy people sick after they get a vaccination, whether it is with live virus polio vaccine or live virus flu vaccine even though you have inactivated vaccines that do not cause disease symptoms, then you are going to pay a price in terms of th e public perception

of the risks associated with vaccination. You were able t o

the argument to prevent polio but, as I

because most healthy children and adults are not permanently injured or die from the flu, I think careful thought needs to be given to this issue.

successfully make not polio and

said before, fl u is

The fact that live vaccine flu virus is shed in 80 percent of recipients poses an additional risk for our population at large, particularly for immune compromised individuals across all age groups. The outstanding questions about the true rate of transmission of vaccine strain viruses among children needs to be clarified as does the retention of the attenuation of the shed viruses and the high frequency of nucleotide changes. Because this live virus nasal vaccine is not indicated for high risk health groups, which have historically been the targeted population to receive the flu vaccine, it is a very serious step t o move t o use a live virus vaccine fo r the majority of healthy individuals and the standard for proof of safety must be very high. I

do not think tha t standard has been met by th e data which have been presented so far.

I would like to see a trial of a genetically diverse group of American children and adults which addresses safety and efficacy of simultaneous vaccination with FLUMIST and other vaccines; revaccination; vaccine shedding and rate of household transmission to unvaccinted individuals as well as genetic stability."

****************************************************************** *

************** *

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FROM THE NEW YORK TIMES December 18, 2002

Nasal - Spray Flu Vaccine Gets Initial OK

By THE ASSOCIATED PRESS

Filed at 9:14 a.m. ET

WASHINGTON (AP) ~ Government scientists gave a tentative endorsement to the firs t nasal-spray flu vaccine, while stressing that it's useful only for certain healthy people, not those most at risk of severe influenza.

Called FluMist, the long-awaited vaccine would be squirted up noses instead of injected into arms.

But advisers to the Food and Drug Administration cautioned Tuesday that if

it'

s allowed t o be sold, FluMist won't be fo r the people who need fl u

vaccination most: toddlers, the elderly and anyone with asthma or other

chronic diseases.

Indeed, FluMist initially was created with the hope of giving toddlers a needle-free vaccine. Then researchers discovered it seems to increase the risk of asthma attacks in children under age 5.

So in its second attempt

maker withdrew plans to sell FluMist for toddlers, saying it instead would

target healthy people ages 5 to 64.

at winning FDA approval in two years, th e vaccine's

But the FDA's advisers endorsed only part of that plan Tuesday, recommending that FluMist be approved for sale just for people ages 5 to

49. They concluded

ther e was too littl e evidence

tha t FluMist protects

people 50 and over, an age when the immune system begins to weaken.

As for people over 65, who are most at risk of dying from the flu, manufacturer Medlmmune Inc. hasn't yet studied the nasal spray in that age group.

Medlmmune, based in Gaithersburg, Md., wants to sell FluMist in time for next winter's flu season. But the question is whether the FDA, which isn't bound by ¡ts advisers' recommendations, will let a vaccine with so many restrictions be sold.

I f so, those curbs would severely limit how ofte n doctors would offe r FluMist instead of the flu shots that 70 million Americans get every year.

A big unanswered question is whether FluMist is as good as a standard flu shot. FluMist is made of a weakened but live flu virus, while flu shots are made of killed virus. Medlmmune hasn't compared the two vaccines.

Calling that question ч ч the elephant in the room,' ' FDA

Parsonnet of Stanford University complained that without such data, doctors won't know which product to offer which patient.

adviser Dr. Julie

They are issues that are going to be highly problematic,' ' agreed Dr. Dixie Snider of the federal Centers fo r Disease Control and Prevention.

Flu kills 20,000 Americans each year and hospitalizes 100,000. Those most at risk of fl u complications are people over age 65 and anyone with certain illnesses, including asthma and heart disease. Also, this year fo r the firs t time, pediatricians are being encouraged to vaccinate babies and toddlers,

who are hospitalized with fl u

of infection through day care and to elderly grandparents.

as ofte n as th e elderly and are key spreaders

Flu experts have longed fo r a needle-free alternative as a way t o persuade more people to get annual flu vaccinations.

The nasal vaccine works by stimulating the immune system through the same nose tissue where the flu virus attacks. But in July 2001, FDA's advisers blocked FluMist's sale, saying it wasn't yet proven safe for children.

Tuesday, Medlmmune argued ¡ts case again.

The vaccine proved 93 percent protective against flu in a study of 1,600 healthy children ages 15 months to 6 years. Side effects primarily included runny nose, muscle aches and fever.

But up t o 1.5 percen t o f childre n under age 5 who receive d

FluMis t suffere d

asthma attacks or asthma-like wheezing, rates almost four times higher than children who received a dummy vaccine, the FDA said.

The FDA's advisers agreed with Medlmmune's subsequent decision to targe t FluMist only t o children over 5, who didn' t seem t o have tha t asthma risk.

I n adults, FluMist didn't work as well. I n a study of 4,561 healthy, working adults ages 18 to 64, FluMist recipients were just as likely as people given a dummy vaccine to experience a flulike illness, although vaccination did cut severe illness by about 17 percent.

The FDA said FluMist didn' t protect people ages 50 t o 64 at all. Medlmmune argued that those people didn't get as sick as the unvaccinated, but FDA's advisers ultimately said the company hadn't proved its case.

Another key concern is that sneezing children occasionally spread the FluMist virus, raising questions about whether the spray vaccine would endanger grandparents or asthmatic playmates who aren't inoculated.

ml

guidance

ren.sht

Flu shot guidance renews old fears

An encouragement t o inoculate young children worries those who think the vaccine contributes to autism. By GRAHAM BRINK, Times Staff Writer © St. Petersburg Times published October 7, 2002

TAMPA — Last month, for the first time, the national Centers for Disease Control and Prevention encouraged parents to have their young children vaccinated against the flu.

To most, it seemed a sound idea for protecting youngsters. But a vocal minority of parents and doctors think such a move could be trouble.

The issue: Some flu vaccines still contain the mercury-based preservative thimerosal, which they think is linked to an explosion in the number of children diagnosed with autism and related disorders in the past two decades.

The many skeptics of this theory point out that the mercury used in thimerosal has not been definitively linked to autism.

But thos e who thin k ther e is a connection see th e CDC encouragement risk fo r children, especially those who already might have a buildup of mercury in their systems.

as a

"They continue to promote thimerosal as safe mercury and that there is no evidence of toxicity," said Dr. Jef f Bradstreet, an autism researcher in Palm Bay and th e fathe r of an autistic boy. "Eventually, they will be proven wrong.

But in th e meantime, one

wonders how many lives may be altered."

Unti l last month , th e CDC never had encouraged regula r fl u shot s fo r healthy children six months to 23 months old.

But about 20 children per 10,000 in that age group are hospitalized each year with the flu or its complications. That rate is at least five times higher than that of 5 to 15 year olds and 10 times higher than the rate fo r low-risk adults, according to the CDC.

Young children also are effective carriers of the influenza virus, often passing i t on t o relative s and friends . Th e CDC said vaccinating childre n would help improve the societal armor and cut down on the number of adults who get the flu.

The

recommending it. But a formal recommendation could come as early as next year.

CDC is only encouraging parents t o vaccinate thei r young children , no t

Dr. Scot t Harper , an infectiou s disease

specialist

wit h th e CDC in Atlanta ,

said the risks of complications from flu shots for young children are minimal,

especially when compared with the benefits.

"I n every decision tha t we make in life, there is a risk and a benefit," Harper

said. "This decision was based on facts, fact s tha t show tha t many children will avoid getting sick, not unproven theories."

Other health care giants ~ including the U.S. Food and Drug Administration, the National Institutes of Health, the American Academy of Pediatrics and the National Network for Immunization Information — also are skeptical of

a link between vaccines and autism. They say the theory is based more on coincidence and hope than hard data.

Even the Autism Society of America isn't convinced.

"(We) strongly support research to determine if, in fact, there is a correlation," the society says. "Until that research is performed and replicated, vaccines continue to be indicated."

* * * Thimerosal has been used as a preservative in vaccines since th e 1930s, but it became more common in the past 15 years as pharmaceutical companies began to produce more multidose vials to cut costs. Without the preservative, a multidose vial can become tainted once its seal is broken.

The increase in the use of thimerosal coincided with an increase in the number of vaccines administered to children. Children today can receive about 36 doses of 11 vaccines by age 5.

And those two trends corresponded with a surge in autism rates throughout the country, say supporters of the mercury/autism theory. They fear that some children can't flush all the mercury from their systems, so it builds up and triggers autism, a neurological disorder that affects communication and socialization.

Many doctors and scientists say such fears are unwarranted. But if the theory is so full of holes, the supporters ask, why did the government direct vaccine manufacturers in 1999 to remove thimerosal and other mercury from common childhood vaccinations, including hepatitis?

They say th e CDC encouragement means childre n migh t again be given vaccines containing mercury. Flu shots have not traditionally been childhood vaccines, so many multidose vials still contain thimerosal. I t is unclear

exactly how much of

th e fl u vaccine supply contains th e preservative.

"Promoting flu shots for healthy children concerns me a great deal," said Miami lawyer Roberto Villasante, co-chairman of the vaccine litigation group for the Association of Trial Lawyers of America. " I think the big question should be: Is this vaccine absolutely necessary?"

* * * Kim Dabney was shocked when she hear d th e news fro m th e month.

CDC last

Her son Drew had suffered from earaches and flulike symptoms. They weren't serious, but they were enough for her pediatrician to recommend

tha t Drew receive a fl u vaccination last year. He was 15

months old.

"Afte r that shot, that was the end of Drew as we knew

him," Dabney said.

Drew stopped making eye contact, stopped having fun, stopped making sense.

He had had some trouble after a round of shots administered a few months earlier, Dabney said, but the flu shot "put him over the edge."

Drew's pediatrician, like some other doctors, had never heard of thimerosal or theories about a link between vaccinations and autism, Dabney said.

But when Dabney researched Drew's vaccination record, she found it loaded with shots containing mercury.

The Dabneys, who moved from Miami

close t o $50,000 on therapy and other treatments fo r Drew, who is showing marked improvement.

t o Charlotte, N.C., last year, have spent

"No one wants the flu , but no one wants mercury poisoning either," she said. "Now that these links are showing up, I cannot believe they aren't screaming to get this stuff off the shelves."

Most members of the medical community think such a move is unnecessary. They note that many children with risk factors such as cystic fibrosis have received flu shots for years. I f there were a link, many more of those children would have autism, they say.

Some children don't show signs of autism until they are a few years old. The vaccinations don't cause it, the doctors argue, they just happen to be given around the same time.

* * * ß a r b a r a Fisher is co-founder and president of the National Vaccine Information Center, a nonprofit group that advocates reforming the mass vaccination system. She encourages parents of children in the 6- to 23- month age group t o arm themselves with as much information as possible before they decide whether to vaccinate their children against the flu.

Even if science never finds a definite link between thimerosal and autism, it's worth considering, Fisher said.

5he recommends tha t parents who want their children vaccinated against the flu read the manufacturer's insert that comes with the vaccine to

determine whether i t contains

thimerosal or any other mercury.

"Parents should not rely solely on their doctors, who don't always have all the information themselves," she said. "Whatever decision is made, it should be made from a position of knowledge, not a position of ignorance."

!*•

• Graham Brink can be reached at (813) 226 3365 or brink@sptimes.com.

NO SHOTS ON JOB

Date: 10/4/02; Publication: The Toronto Sun; Author: CHRISTL DABU

Ontario's paramedics will no longer be forced to get a flu shot to stay on the job.

The province announced yesterday that the shots were no longer mandatory fo r paramedics, the only health care workers in Ontario who had t o get vaccinated to keep working.

" I was very pleased that the (health) ministry and (union) were able

to sit

down and work this out. I t ' s far preferable than having t o go to courts and beat each other over the head," said CUPE president Sid Ryan at yesterday's press conference. " I t was a classic win win case."

"We became convinced with our discussions with Sid Ryan, among others, that we can have a higher rate of compliance if we went to a voluntary system," said Health Minister Tony Clement.

Up t o 96% of workers will voluntarily comply t o vaccinations now tha t it' s not mandatory, Ryan said.

Clin Nephrol 2002 Sep;58(3):220 3

Influenza vaccination induced leukocytoclastic vasculitis and pauci immune crescentic glomerulonephritis.

Уапаі Berar

N, Ben Itzhak O, Gree J , Nakhoul F.

Department of Nephrology, Rambam Medical Center, Haifa,

Israel.

Influenza vaccination is a widely accepted practice, particularly among the

elderly and high-risk individuals.

the vaccination are common, while systemic complications are infrequently reported. We describe here a case of a patient who presented to the emergency room with arthralgia, myalgias and purpura, following influenza vaccination. Necrotizing vasculitis associated with pauci-immune glomerulonephritis was observed on kidney biopsy. Wit h increasing use of influenza vaccination, attention should be drawn to the possible expression

of systemic adverse effects such as vasculitis and glomerulonephritis.

Minor and transitory side effect s following

2002 Drugs vs. the Bug of 1918 Virus' deadly code

is unlocked to test strategies to fight it

By Robert Cooke STAFF WRITER

Wit h extreme care under tigh t conditions, scientists in New York City and Georgia have constructed a bug that resembles the deadly virus that caused the disastrous 1918 worldwide influenza pandemic.

Hoping to find ways to protect people if the natural virus returns, microbiologist Christopher Basier and his colleagues recently made new copies of several genes that rendered the 1918 flu so dangerous. These few genes were engineered into infectious viruses for testing at a U.S. Department of Agriculture laboratory in Athens, Ga.

The results showed, fortunately, that existing drugs such as amantadine, zanamivir and oseltavir seem to work, protecting mice against big doses of engineered virus.

"These data suggest that current anti-viral strategies would be effective in curbing the dangers of a re-emergent 1918 or 1918-like virus," Basier and his colleagues announced Sept. 23 in the Proceedings of the National Academy of Sciences.

The lead author, Terrence Tumpey, works for the U.S. Department of Agriculture's Southeast Poultry Research Laboratory, in Athens. Ga. Basler's team works at the Mount Sinai School of Medicine in Manhattan.

The researchers said the drugs that are already available could be used as a stopgap measure while work began on creating protective vaccines against 1918 flu. Their tests in animals show that the drugs can be used to protect against infection or to treat infections that are already under way.

Biochemist Eckard Wimmer, at SUNY Stony Brook, said, " I believe

this kind

of work is extremely important, because we would like to know why these viruses caused such an enormous rate of death. This in turn would allow us to protect ourselves against outbreaks of similar strains."

Wimmer, who recently announced construction of whole polio virus "from scratch" using off-the-shelf materials and publicly available information, added tha t the 1918 bug is especially important. "We're all afraid tha t the influenza virus may come up again wit h a new mixtur e o f genes, against which we are not protected, and we might have a disaster."

The Mount Sinai researchers emphasized tha t thei r new experiments were done using extreme care not t o let any engineered viruses escape the laboratory. And th e laboratory itsel f was a high- security facilit y maintained by the USD A near the University of Georgia. I t is specifically designed to keep dangerous microbes from getting out.

The reconstructed flu viruses were made by stringing together chunks of DNA to create the specific "virulence" genes that apparently made the 1918 pandemic so lethal. These special genes were engineered into infectious flu viruses, which were then tested in mice and shown to be surprisingly lethal.

The special genes are of great interest because the original flu virus that

came armed wit h such genes was fa r more deadly than "ordinary" various types of which strike year afte r year. The complete 1918

fl u viruses, fl u bug has

never been isolated, but chunks of its DNA have been found in old tissue

samples and are being studied.

As a result, researchers have deciphered the chemical "spelling" of several

virulence

genes from the 1918 virus. This allowed Basler's team t o make new

copies of

the genes, plug them into viruses and tr y to re-create the 1918

bug. I t ' s not

clear they've succeeded, but perhaps they're close.

Such work is important because infectious disease experts fear that the 1918 bug might return to again wreak havoc. Or, the Mount Sinai team suggested, a similar virus might be used as a bioterrorism weapon, with large impact.

"The influenza pandemic of 1918-19 resulted in the deaths of millions of people worldwide," the researchers said, "and an estimated 550,000 excess deaths in the United States."

Worse, unlike most fl u outbreaks, the 1918 pandemic was especially hard on the healthiest people, striking and killing many young adults. This might be explained, in part, by the pandemic emerging during World War I , when many young men were gathered in barracks and aboard military ships.

Doctors say don't rush for kids' flu shots

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Dr. Donna Woodson has spent years urging her elderly patients to get fl u shots, but she's a little perplexed at a recent federal suggestion that young children get the shots as well.

The Centers fo r Disease Control and

time this year that healthy children ages 6 months to 2 years get a flu shot. I f it' s th e firs t time a child has gotten a fl u shot, two shots one month apart would be needed.

Prevention is suggesting for the firs t

The CDC has always recommended tha t high-ris k childre n ge t a fl u shot , bu t never specifically urged healthy children to do so.

"Thi s message fro m th e CDC is confusing," said Dr. Woodson, a famil y physician in Maumee and member of the Toledo-Lucas County Board of Health.

Dr. Woodson, president of the Academy of Medicine of Toledo and Lucas County, a professional organization representing doctors, said physicians and parents have never been told to focus on giving healthy children flu shots.

She wondered if a rush of parents looking to vaccinate their children will deplete supplies for known high-risk groups, such as those 65 and older. The new information, she points out, was issued afte r many physician office s ordered flu vaccine supplies.

CDC official s stres s th e new informatio n is only a suggestion and they'v e no t formall y recommended it . However, th e CDC says recen t informatio n shows young children are at a higher risk for complications, including hospitalization, because of the flu.

Dr . Francis Rogalski, a Sylvania pediatrician , called th e CDC suggestion "a great idea."

"We have been recommending flu shots for kids for years," he said of his practice. "We look fo r any excuse to give vaccines. I tell parents I've always given i t t o my own children."

Dr. Christopher Rizzo, a Cleveland pediatrician who's president of the Ohio chapter of the Academy of Pediatrics, said physicians have long reminded parents tha t sick children can pass the flu on to grandparents and others at high risk.

"Influenza spreads very easily, easier than a cold," Dr. Rizzo said.

Dr. Rizzo and Dr. Rogalski cautioned that parents should not feel they need to rush out and get a flu shot for their healthy children. For example, even with Dr. Rogalski pushing flu shots for children, only about 20 percent of his young patients get them.

Dr. Rizzo said, "No one expects we'll immunize every child under 2", and

instead it' s jus t something parents and physicians need to about.

begin thinking

Kristopher Weiss, spokesman for the Ohio Department of Health, said the department bought 280,000 flu vaccine doses this year, which are used by health departments and some physicians to vaccinate low-income people at high risk for the flu.

The department isn't recommending health departments vaccinate healthy children, he said, although it's not discouraging private physician offices from doing so.

Dr. David Grossman, health commissioner for the Toledo-Lucas County Health Department, said his department will focus on those 65 and older and other high-risk individuals, not healthy children. Vaccine supplies are expecte d t o be a t normal levels thi s year . Th e CDC urges tha t thos e a t high risk fo r the flu get the flu shot firs t - in October - and everyone else in November.

Th e CDC says thos e a t high ris k include

those 65 and older are at highest risk); anyone with chronic medical conditions like asthma, diabetes, or kidney or heart disease; residents of long-term care facilities; women who will be more than thre e months pregnant during fl u season, and children on long-term aspirin therapy.

thos e over 5 0 (many doctor s say

Late flu outbreak strikes nursing home

A

late flu outbreak appears to be hitting Nebraska's urban areas, according

to

state epidemiologist Tom Saf ranek.

Safranek made th e call afte r a Blair nursing home was quarantined when 42

of the 83 residents developed symptoms in the last two weeks.

One of those residents died when his respiratory infection led to pneumonia.

Nearly all of the Blair residents received flu shots before the outbreak there, Safranek said

No visitors were being allowed at the nursing home, and all residents were taking anti-vial drugs and eating meals in their rooms in an attempt to stop the spread of the virus.

The quarantine comes two weeks after an outbreak of the flu led the Grand Island Veterans Home to take similar measures.

The Grand Island home was quarantined in February afte r seven cases were diagnosed at the home of 340 residents. The outbreak came even though 98% of residents were given flu shots.

Source:

Midwest Nurse Week, Vol.3, No. 2; March/April 2002, p27 www.nurseweek.com

Aviari Influenza Get the Facts!

Fear of Flu, Questionable Medical Treatment, and One Reasonable Homeopathic Alternative

By Dana Ullman, МРИ

The media, doctors, and drug companies have been impressively effective in instilling great fear into the hearts and minds of the public about the potential "bird flu epidemic." And they add fuel to the fear by "warning' 1 the public that there are inadequate amounts of the flu vaccine for people. Some experts assert that this is particularly a problem for the elderly and children who are most vulnerable to complications from the flu. However, according to the LANCET (October 1,2005), a systematic review of all previous studies testing vaccines for influenza to elderly populations has not shown that they are effective in preventing this disease. Another important study in the LANCET (February 26, 2005) analyzed every study published in any language, and they could not find a single study that showed a flu vaccine led to tiie reduction in mortality or serious complications from the flu in children.

Tom Jefferson, MD, the author of the above two LANCET articles, asserts, "What you see every year as the flu is caused by 200 or 300 different agents with a vaccine against two of them. That is simply nonsense."

As for conventional medical treatment for the flu, this is similarly problematic. Rick Bright of the CDC analyzed 7,000 blood samples of flu viruses that were collectedfrom people in various countries, and yet, many of these viruses have already developed resistance to Tamiflu and similar antiviral drugs. It should also be noted that there is no clinical evidence that Tamiflu is effective in treating the "bird flu," and further, it primarily seems useful in only reducing flu symptoms for around one day.

These important therapeutic problems have not stopped the Bush administration from proposing that we stockpile over $1 billion worth of these questionably effective drugs. What may be even more

problematic is that the media's fear mongering about this year's flu may lead many people to take Tamiflu or other antiviral drugs for even minor flu symptoms which will inevitably increase the

chances o f

creating more problematic super flu viruses.

It may not surprising for many people to learn that Donald Rumsfeld, Bush's Secretary of Defense, was the Chairman of the Board of Gilead Sciences, the company that developed Tamiflu, The New York Times (October 28,2005) reported that Rumsfeld still hold significantly shares of stock in Gilead Sciences and hasrecusedhimself from decisions around this issue, though it is hard to wonder how this minor action will reduce the conflict of interestfrom decisions made by bis close associates. (See CNN Report)

The Homeopathic Alternative

There are, however, good reasons that homeopaths and their patients are not afraid of the flu, either this year or for years in the past Homeopathy is a leading _alternative_ therapy in Europe (even Englands Royal Family has used homeopathic treatment as their primary medical care since the 1830s).

The premise behind homeopathy is that symptoms represent defenses of the body, and rather than use drugs that inhibit or suppress symptoms, they use very small _nanodoses_ of medicinal agents that are prescribed based on theirtoxicology.That is, whatever a substance causes in overdose, it will elicit a healing response when given in specially prepared nanodoses. The logic of the homeopathic approach is that because symptoms are adaptations and defenses o f the body to infection and/or stress, it make sense to mimic the body s wisdom rather than suppress it As for treatment of the flu, homeopaths have

proven treatments for people with i t The Cochrane Collaboration (an mternationally respected group of scientists) have concluded that ahomeopathic medicine called "Oscillococcinum" has undergone four treatment trials with "promising" results for people with the flu or influenza like syndrome.

To get the best results with Oscillococcinum, one should to take it within 48 hours of onset of the flu. After thistime,a more individually chosenremedybased on the sick person_s specific symptoms is necessary (using a homeopathic self care book or going to a professional homeopath is recommended), though there is not yet formal research on the use of other homeopathic medicines for the flu. One of the reasons that Oscillococcinum may be so effective is because it is made from the heart and liver of a duck. It is now widely known that the vast majority of ducks carry various flu viruses in their digestive tracts, and epidemiologists have determined that ducks are one of the prime carriers of the flu from one part of the world to another. It seems that homeopathic doses of the flu virus and of the duck's antibodies to these viruses provide special therapeutic benefit

Oscillococcinum was first used in 1925, but other homeopathic medicines were so effective during the

1918 flu epidemic that only 1 2%

of patients admitted to a homeopathic hospital died, while the death

ratefrom influenza in the conventional medical hospitals was approximately 30% (Dewey, 1921). Oscillococcinum has not yet been proven to prevent the flu, and as yet, no homeopathic medicine has beentestedin the treatment of the new bird flu, but Oscillococcinum and other individually chosen homeopathic medicines may provide a safe and often effective treatment for people with the flu.

Dana Ullman, MPH, has authored 9 books on homeopathic medicine and has served in teaching or

advisory capacity to alternative medicine institutes at Harvard, Columbia, and the University of

Arizona.

homeopathy as well as access to homeopathic books, tapes, medicines, software, and courses.

His website (www.homeopathic.com) is arich source

of up to date information on

REFERENCES:

Jefferson T, Rivetti D, Rivetti A, Rudin M, Di Pietrantoni С» Demicheli V. Efficacy and Effectiveness of Influenza Vaccines in Elderly People: A Systematic Review. The Lancet, October 1,2005, 366(9492):1165 74. (NOTE: The author of this article has acknowledged that the abstract of his article may provide some confusing information. For more accurate information about the study, please read the study itself, and/orreadthis article in which Dr. Jefferson was interviewed:

htto://medicalconsimierc.org/page^

Jefferson T, Smith S, Demicheli V, Harnden A, Rivetti A Di Pietrantoni С. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet 2005 Feb 26 Mar4;365(9461):773 80. Review.

Dewey, WA

Institute of Homeopathy, 1921,1038 1043.

Homeopathy in Influenza: A Chorus of Fifty in Harmony, Journal of the American

The Cochrane Collaboration, Homoeopathic Oscillococcinum for Preventing and Treating Influenza and Influenza Like Syndromes (Review), The Cochrane Library, 4,2005.

Casanova, P, Gerard R. Bilan de 3 asnees d'estudes randomisées multicentriques Oscillococcinum/placebo. Oscillococcinum-rassegna della letterature internationale. Milan :

Laboratoires Boiron; 1992:11-16.

Ferley, JP, Zmirou, D. D'Admehar, D, et al., "A Controlled Evaluation of a Homoeopathic Preparation in the Treatment of Influenza-like Syndrome," British Journal of Clinical Pharmacology, March,

1989,27:329-35.

Papp, R. Schuback, G. Beck, E., et al, "ОвсШососсіпшп in Patients with Influenza like Syndromes: A Placebo Controlled Double blind Evaluation," British Homeopathic Journal, April, 1998,87:69 76.

Reference to Rick Bright: httoV/msnbc.mm<x3m/id/9428919/

Rumsfeld to Avoid Bird-Flu Drug Issues, New York Times, October 28,2005 CNN Report (October 31,2005) This report highlights many Mgh-ranking political people who are connected to Gilead Sciences. "I don't know of any biotech company that's so politically well-connected," says analyst Andrew McDonald of Think Equity Partners in San Francisco.

Dana Ullman, MPH 2124 Kittredge St Berkeley, C A 94704 (510)649-0294 (510)649-1955 (fax) dullman@igc.org

Bird Flu or Cash Cow?- The Pandemic Some Want to Have WHO'S Behind Designer Germs?

by Eve Hillary -©2005

Released November 15,2005 - Sydney Australia

I'd finally lost my taste for TV. Its gaudy ads. Its manufactured news, mind numbing sitcoms and titty- tainment I'd successfully avoided TV for the entire year, until one night my finger strayed onto the button and flicked around the channels. Graphic footage of dead birds and masked "health" workers spraying people with chemicals triggered a bad case of deja' vu.

I recalled the time I'd flown to South America to give a presentation at an international Human Rights conference. A few months previously, on March 4* 2003 the first person had been diagnosed with SARS, a brand new disease. It was Professor Liu Jianlun, a microbiologist working in a laboratory involved in secret, government-sponsored work in China's Guangdong province. (1) Incredibly, he had also been "researching" the H5N1 virus, now known as the "Bird Flu". This was closely followed by two other deaths; a Singaporean researcher working in a laboratory of the Singapore Environmental Health Institute and a post doctoral student working on West Nile virus. Singaporean Health Minister Mr. Balaji Sadasivan, stated that theresearcher'sexposure to the SARS virus "is most likely linked to

that laboratory

hazard labs were in operation and what other new germs they were engineering.

where the SARS virus is [also] cultured," (2) It made me wonder just how many bio-

I'd barely made my flight My husband and I had been very busy in our Integrative (wholistic) medical clime which offered patients a variety of orthodox as well as complementary and reliable alternative medical treatments. People traveled long distances to get treatment for cancer and other serious diseases. For most it was the first time they had been able to make lifestyle changes and receive physical, emotional and spiritual healing. They literally got a new lease of life. They felt better and looked better. Lately, since the media had whipped up fear of a world wide epidemic, dozens of patients visited the clinic because they were worried about SARS. The health department had issued a SARS bulletin to all doctors, which listed only 3 criteria for making the diagnosis of SARS; cough, fever and a recent trip overseas. That could include almost anyone, and I immediately became suspicious. It troubled me that authorities did not list a specific disease profile for a brand new illness that seemed to one minute reside exclusively inside biohazard laboratories and the next minute allegedly spread into human populations. I'd also noticed drug company shares rise from the sale of drags forrespiratoryillness. In our practice we found very few drugs were in fact necessary for healing and disease prevention. Our patients who had taken regular doses of vitamins, minerals, omega oils, antioxidants and other natural supplements had rarely come down with colds, flu, and other infections. I hadn't had a cold or flu for over ten years since I had started takingregularsupplements. After much illness and many attempts at personal healing, I finally realised the fact that the only thing that would keep me healthy was a functional immune system.

The day I boarded the aircraft two passengers were plucked from Sydney airport and quarantined in a Sydney Hospital. Media reports showed masked Asian airport personnel prowling around tenninals with fever detector gadgets, hauling hot and bothered travelers off into quarantine areas. Having finally made it on board I had a chance to think again about the emergence of diseases for profit, an issue which I had just published in my second book "Health Betrayal". I thought about AIDS - a previously unheard of disease entity which emerged in the early 1980's. A few years earlier Merck pharmaceutical

company had developed an experimental hepatitis vaccine which was given to gay men and Africans. By 1980 (he AIDS epidemic started in those populations which had received the experimental vaccine.

(3)

Since then the WHO (World Health Organization) with its close ties to pharmaceutical companies,

has strictly mandated billions of doses of various types of vaccines to Africans and other third world

residents where AIDS has spread like wild fire. Governments have vaccinated unwilling populations at gunpoint. One African activist, Kihura Nkuba writes; "The enthusiasm of government to give vaccines

to a people that it normally gives nothing [to] was seen as very suspicious. Theforcing of them to take

a vaccine against a disease they know to be harmless and which they know how to cure in its harmful

state was seen as government hell bent on killing its own population for the benefit of

All village people know that once you have recoveredfrom measles you will never catch it again, but

white world.

here they were telling people to vaccinate even those who have recovered from measles. In other villages police armed to the teeth moved from house to house searchingfor children to immunize. In

was one mother who hadfour children, and

2002 Nkuba writes after a vaccination campaign; "

she hid one and took three other children for vaccination, and three children died and that one

survived. "

there

It is noteworthy that of over 45 million people afflicted with HIV/AIDS worldwide, 39 million of them

are in third world countries. In 2003 the average AIDS patient, who could afford it, paid US $15,000 per year for AIDS drugs which have not been shown to be effective in the treatment of the disease. (4)

In late 2001 someone mailed anthrax bacillus to several key individuals and news organizations in the US. Two people subsequently died of anthrax. The strain was identified as originating from Fort Detrick - a military bio-weapons facility. The anthrax had been weaponised, its potency increased for use in biological warfare. There are few facilities known in the world to have that capacity. They include US military laboratories and a government contractor. (5) While the mainstream media whipped up anti Muslim sentiment, drag company cashregistersstarted ringing. Almost immediately, sales for Cipro, an antibiotic made by Bayer hit the roof as 30,000 Americans started taking the drag, just in case. Terrified Americans thought nothing of paying US $700 for a two mondi supply of Cipro despite its potentially serious side effects. Other generic versions of the drug were available but not widely publicized. The anthrax scareresultedin lucrative new drag company contracts to manufacture both anthrax and smallpox vaccinations for the military and general population. It also gave rise to the Model State Emergency Health Powers Act, giving the government wide powers to quarantine, drag and inject vaccinations into persons at gunpoint in the event of a "public health emergency" being declared Many US states passed this Bill after September 11, which included an exemption to drag companies and vaccine makers for any vaccine deaths or injuries that would occur. (16) Public advocacy groups have already started work on having the Bill repealed, on the grounds that it is unconstitutional.

On the long flight I had a chance to think about the West Nile virus (WNV) which first broke out in a poor, predominately black section of New York City in August 1999, when it had never been known to

exist in the US. The virus had only ever been known in East Africa where it resulted in a mild disease that did not affect other animal and bird populations to any significant degree. However, the new NY strain of the WNV is able to jump the species barrier. Since the year 2000 over 10,000 wild birds have died, countless horses, primates and the human death toll exceeds 146 Americans. Only the most vulnerable people die however. As many as 200,000 people are infected and are clinically well, posing

a good argument for keeping the immune system functioning well. The new strain has spread over

most eastern US states. While health officials claim the WNV virus jumped into the U.S. from Africa,

the new virulent NY strain had been cultured and engineered in Biohazard facilities for years and sold

to labs around the world

Meanwhile, pharmaceutical companies including Ora Vax have made millions in WNV vaccine research and products. Thomas Monath, Vice President of Research and Medical Affairs at OraVax, is one of die world's leading arbovirologists. He became an advisor to NY Mayor Giuliani when the

WNV problem first emerged in the city. Monath had previously developed genetically engineered vaccines against WNV type organisms in his capacity as the Chief of the Virology Division, U.S. Army

at Fort Detrick, Maryland. Since the 1950s die U.S. military began developing bio-warfare weapons at

Fort Detrick by cooking up germs from exotic animal diseases intended to cripple die Soviet or other enemy economies by killing horses, cattle, birds and swine with crippling new epidemics. By the 1970s new advances in genetic engineering allowed the creation of new designer viruses that jump species

barriers and even cause cancer. Since then many analysts have claimed these germs have been used for population control as well as commercial purposes with the assistance of high level US government agencies.

In fact plagues of animal diseases had badly affected the UK which had slaughtered almost 4 million animals after an outbreak of foot and mouth disease (FMD). Wikipedia defines the disease as a highly contagious but Non Fatal viral disease, meaning it is similar to the common cold in humans. If left to their own devices animals recover from the disease with permanent immunity to it. However laboratories licensed to manipulate or engineer the FMD virus can create forms that differ from the wild virus strain. The UK animals were infected with type О pan Asia strain, which is not normally found in the UK. Foot and mouth virus "research" was carried out by Merial Animal Health. This facility, owned by Merck and Avenus, is also a vaccme production laboratory located near Pirbright, Surrey, not far from Britain's own government Institute for Animal Health. According to the Sunday Express, a routine audit into the government's bio warfare research laboratory Porton Down revealed that a container of foot and mouth virus went missing two months before the outbreak in early 2001. (7) While it is still unknown who was responsible for the outbreak, there were certainly many who profited from i t Merck's Merial is the leading supplier of foot and mouth disease vaccme. (8) After the UK beef market collapsed overnight, Tyson Foods, the US based largest meat and poultry producer and packer in the world expanded its international market into the UK. The outbreak proved to be catastrophic to UK agriculture and rural families but a lucrative cash cow to multinational slaughter houses, food processors and pharmaceutical companies.

My flight arrived at midnight in Panama City, where I disembarked and waited for another flight to

Columbia. I was tired and wanted nothing more than to get on board and catch a few hours sleep, but I was about to learn a lesson about the political benefits of unleashing fear. Unbeknownst to me, a flight from Tokyo had arrived at San Jose International airport on red alert after the cabin crew informed US ground officials of five people aboard suspected of having SARS. The reason for the alert, as it later turned out, was that the passengers had simply coughed. Official fear mongering included few actual facts about SARS, an atypical pneumonia vims, which had only ever lived in a bio lab before it appeared in several Asian countries simultaneously. Of the alleged 2960 cases of SARS worldwide,

from the virus. In comparison, 3 5 million people are affected by

119 people died, a death rate of 4 %

seasonal influenza virus, having identical symptoms, resulting in between 250 000 and 500 000 deaths every year around the world, mainly affecting high risk groups such as the elderly, poorly mourished or chronically ill. (10)

Dr. Loraine Day MD, a distinguished US physician states; "The supposed disorder of "SARS": A CANNOT be distinguished, by its symptoms, from virtually ANY other mild or severe respiratory disorder! And B. CANNOT be distinguished by any specific microorganism! If I, a highly trained physician, CANNOT distinguish SARSfrom ANY OTHER type of routine pneumonia based on ANY of the government's published information, how are lay people going to do it? ". (12) The atmosphere seemed unusually tense around the Panama terminal during the early hours of the morning. I drank from my bottle of water, and cleared my throat after the dry air on the plane had irritated it. This caught the eye of several uniformed health department personnel scanning the crowd in the transit lounge. I looked away as I felt two sets of dark eyes scanning me suspiciously. When a passing crowd of travelers obscured the officials' view of me I hastily moved away to another lounge. Why? Because, new public health legislation around the world modeled on the US Model State Emergency Health Powers Act means to allow force in detaining and quarantining anyone, using the latest disease as a reason, whether it actually exists or not That means fasten your seatbelts travelers, because now flight attendants, cleaners,teachers,general informants and bureaucrats will be practicing medicine without a license. Personally, I'drathertake my chances with a real doctor than an airport employee.

Bird Flu Pandemic of Greed

Since my trip I wondered why the first SARS deaths involved Asian scientists working in a biohazard lab with west Nile virus and bird flu. The bird flu has made its rounds yearly, severely affecting Asian countries where 117 people have allegedly been infected and 60 have allegedly died since 1997. Most deaths occurred in Vietnam, where scientific facilities are barely adequate to make a definitive diagnosis.

Prior to 1997, the wild bird flu was a rare andrelativelymild virus affecting only birds. The first case of bird flu affecting a human appeared in Asia in 1997. Apparently the wild virus had mysteriously changed to H5N1 strain, a variety that could very rarely affect humans when ingesting infected meat or in very close contact with birds. The "high path" H5N1 strain appeared suddenly and has been known to be located in many bio-hazard labs around the world. When the Associated Press reported the death of a 60-year-old woman allegedly of bird flu, the U.S. Government halted "all chicken imports from China in a move to curb the spread of the virus." Shortly after, the first wave of slaughter began with 1.2 million Asian chickens. By 2003, 40 million birds had been slaughtered and Tyson foods, the Arkansas based largest meat producer and packer in the world has been making steady inroads into the previously closed Asian poultry market, filling the gap in production. The "high path" H5N1 strain hit the Asian countries hardest, such as Thailand, Japan, Vietnam and China who rely on poultry products for export and pose a real competition to giant US based meant processing corporations. These countries have had strong independent markets catering to domestic poultry needs, traditionally impenetrable to western imports. Meanwhile the US reported a "low path" H5N2 outbreak of bird flu in Texas in 2004, which has not disrupted US exports. Tyson Foods chief administrative officer, Greg Lee, isreportedby Reuters to have said: "We are seeing and do expect to see some positive benefit as a result of disruptions in some of the Asian production," (11) Meanwhile, since May 2005, new outbreaks of high path H5N1 bird flu strain has cut a swathe across poultry in Russia, Greece, Holland, Kazakhstan, Turkey, Romania, Mongolia and Croatia, where massive poultry exterminations have begun. The poultry infection near the eastern block has caused widespread suspicion, A member of the Liberal Democratic faction of the Russian State Duma, Aleksei Mitrofanov, has said in a parliamentary speech that bird flu was invented by Americans who wanted to dominate the world's poultry markets.

(13)

Dr. Len Horowitz, US independent public health expert writes; 'According to USA Today (October 9,

2005), "European health officials are working to contain the [avian flu] virus, which so far has not infected anyone in the region. " Although, allegedly "more than 140 million birds have died or been

destroyed,

actually admits, "the current virus, known as H5N1, has not yet mutated to the point at which it can easily spread from person to person. " In fact, it is likely to have never spread from person to person

other than during laboratory handling!' He further states: "In not a single case has human-to-human communicability been confirmed. So long as that remains the case, there is no bird flu threat to the human population of places such as Vietnam, much less the United States. "

and financial losses to the poultry sector have topped $10 billion. " This propaganda

DR. Nancy Cox, Chief, Influenza Branch, CDC (Centers for Disease Control) has said during a

February 2004 news conference, "

As

you've already heard, avian influenza viruses usually do not

infect humans. " Meanwhile, the prestigious British Medical Journal editorial October 2005 Quotes; "The lack of sustained human-to-human transmission suggests that this H5NI avian virus does not currently have the capacity to cause a human pandemic". Despite the scientific evidence to the contrary, US and global health officials insist on calling the bird flu a human pandemic. A UN spokesman David Nabarro said in late 2005; "5 million to 150 million people "could" be killed "if the virus mutated and jumped to humans. " While Health and Human Services Secretary Mike Leavitt, said in the US Senate; 'Ifit isn't the current H5N1 virus that leads to an influenza pandemic, at some point in our nation 'sfuture, another virus will."

Meanwhile panic is being spread globally. An October 31, 2005 article in the Australian Age newspaper states; "DISASTER experts from the Asia-Pacific region will meet in Brisbane today to discuss how to cope with a global outbreak of deadly birdflu, amid warnings that international travel would be virtually wiped out in a pandemic." While the Canberra Times reported: "Health Minister Tony Abbott yesterday said overseas travel would almost cease for a "significant period" if avian flu broke out in the region. " (18) Australia, regarded by some as the Asia Pacific regional policeman for implementing global policies, has not had a case of bird flu to date.

Without a sign of a human epidemic, on October 28, 2005 the US Senate passed an $8 billion emergency bill to fund research, drugs and vaccines, based on no scientific evidence that bird flu constitutes a significant human threat and overwhelming evidence to the contrary. The administration is seeking an additional $6 billion to $10 billion from US taxpayers, according to a current Business Week report "President Bush this week asked the leaders of the world's top vaccine manufacturers - Chiron, Sanofi-Aventis, Wyeth, GlaxoSmithKline and Merck - to come to the White House on Friday to discuss preparationsfor pandemicflu,"reportsthe New York Times in October. Meanwhile taxpayer

billions will also flow into the coffers of selected pharmaceutical giants such as Roche, which holds the sole license to manufacture Tamiflu, an anti viral drag that is meant only for reducing the symptoms of the seasonal influenza and has never been tested for use for the bird flu. Thousands of Americans are lining up for their dose when there has not been a single case of H5Nlbird flu in the US. Without a single human case of H5N1, Tamiflu is in such demand that a new US factory is being planned to ensure there is more of the drag available by the 2006 flu season.

Meanwhile President Bush is discussing the use of the military to enforce quarantine of suspected bird flu carriers. The US plans to install a new quarantine station at Logan International Airport to diagnose travelers. Preliminary discussions include plans to impose 10 year jail terms on people who breach orders to stay at home, in hospital or within their city during an influenza outbreak. This has resulted

in heavy opposition among independent thinkers. The Boston Globe quotes on October 8,2005, "On

Tuesday, the president suggested that the United States should confront the risk of a bird flu pandemic by giving him the power to use the US military to quarantine "part[s] of the country" experiencing an "outbreak " So we have moved quickly in the past month, at least metaphorically, from the global war on terror to aproposed war on hurricanes, to aproposed war on the bird flu. " (14) Quotes an editorial on Freemarketnews.com: "President Bush's recent remarks about mandating vaccinationsfor avian flu isfurther evidence of the militarization ofpublic health care and would abo

seem to reflect a dangerous misunderstanding about disease and palliative methodologies." Many qualified doctors would agree, including Dr. Lorraine Day MD who states; "It is virtually IMPOSSIBLE to get sick ifyour immune system isfunctioningproperly ".

SOLUTIONS - Are Already Here

A Culture Change is spreading around the world, albeit largely unreported by mainstream media.

However, more people now source their news, and health information from the internet and alternative new publications than from tbe mainstream media which is funded by corporate advertisers and reflects corporateratherpublic interest. Fresh knowledge and truth is blowing a wind of change through every country, profession, corporation and corridor of power on the planet The truth in fact is astonishingly powerful. It empowers people to act, to challenge wrongs, to make informed choices, to create authentic lives, to have better options, to resist deception, to have; more power, confidence, better communication, more faith, hope, and love. In contrast to creating wars, the truth makes for better families, better communities and more freedom.

For example, it is increasingly known that main stream medicine is becoming the leading cause of death because it is dominated by improper drag company and bio-tech influences. Health professionals and ethical scientists are now reporting truth in medicine and science from independent websites and alternative news publications, and millions are clicking on to get important health and scientific mformation. Lawyers are now tracking legal and Constitutional abuses. Activists and independent consumer advocates are now reaching millions of people, spawning a host of mformation and support organizations, ethical companies and investment opportunities. Scores of former main stream journalists are becoming independent, reporting news on alternative news sites, with some creating their own popular identities as ethical broadcasters, investigative writers and filmmakers. This alternative media is attracting millions of readers each day who have abandoned mainstream media sources. This has caused a massive resurgence of 'grass roots health care, activism, literature, democracy, family values, morality and spmtuality, which is tj-ieatening to rattle the cages of those in power.

"Things have changed. " Writes Ignacio Ramonet in La Monde, "

even

the "masters of the world"

are not free of trouble

are not impressed. Democratic election does not justify presidents when they

Nor

does it entitle them to move heaven and earth to service the demands of the companies that financed their electoral campaigns. "

demonstrators

the G8 leaders were besieged and publicly upstaged by upwards of 200,000

people

betray their electoral promises and the public interest, or embark on wholesale privatization

Some Independent Sources

1. Seek a balance of information from independent media sources. hito://www.michaelmoore.com/, http://www.fintandunne.com/. hlto://www.mdvmedia.org/eii/mdex.shtml.

hlto://www.mdeoendent mem'a.lv/index.cfm and many orner alternative media sources.

2. Public health information and healthfreedom sites; try www.mercola.com, or

hl^://www.drdav.com/ or htto://www.mercola.com/2005/oct/25/avian flu epidemic is a hoax.htm or www.evehillarv.orp or htto://www.shirlevs wel1ne&s cafe.coin/v l^ser.ht~. htto://www.credence.org/ or many others include information on how to stay healthy naturally, despite increased manufactured illness and official mismfonnatioa

3. Before consenting to any vaccine, check the information from National Vaccine information Centre

4. Information on vaccine exemptions; htto://thiijktwice.com/ Also everyone has the right to make

contracts or agreements with others. You may hold your health care provider legally accountable in any jurisdiction for any administered vaccination or invasive medication or treatment by requiring them to sign a private agreement to accept full legal liability for any damages that may occur as a result of the vaccination/medication/treatment. See http://www.vaclib.org/legal/acceptl .htm or

or

www.vaclib.org/exempt/australia.htm for a sample agreement. Vaccine exemptions are also possible in Africa. Or enroll your child into the newly forming vaccmefreepreschools.

5. Support The Institute of Science in Society who want Independent science supported " to establish

broad funding criteria that put public interest ahead of Ч еаі ш creation', and to include ethical and safety considerations before the research is funded" http://www.i sis.org.uk/ISPF7.php. Sign up for

their excellent newsletter.

References

1.

Original story appeared on April 4th only on the Italian newspaper "La Repubblica" under the tide: "Da super scienziato a grande untore il paziente zero del virus killer"., written by Marco Lupis

2.

Channelnewsasia report April 2003.

3.

Death in the Air Globalism Terrorism and Toxic Warfare by Dr. Leonard Horowitz. Tetrahedron Publishing Group. 2001

4.

FindLaw.com. November 26,2003

5.

Anthrax Attacks Pushed Open an Ominous Door 22 September, 2002 By Barbara Hatch Rosenberg Chair, Federation of American Scientists Working Group on Biological Weapons, Professor, SUNY Purchase

6.

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8.

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htto://vvvm.freemarketnevvs.com/WoridNevvs.asp?nld=1320

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http://www.mastemewmedia.org/2003/04/24/sars separating fact from ficlion.htm

11.

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13.

MosNews, Moscow, 21 October, 2005.

14.

Published on Saturday, October 8, 2005 by the Boston Globe. Bush's Risky Flu Pandemic Plan by George J. Annas.

15.

Presidents under pressure By Ignacio Ramone t in La Monde. August 2001

16.

htto://en.wuripedia.org/wiki/Model State Emergency Health Powers Act

17.

"The Rise of Global Activism" A feature article by Eve Hillary 2004. www.evehillarv.org

18.

Canberra Times 30 October 2005

About Eve Hillary

Eve Hillary is based in Sydney, Australia.

over ten years and the author of Health Betrayaland Children ofa Toxic Harvest

She has been as a free lance Investigative writer for

As an internationally published writer and speaker, Eve specializes in documenting the human impact of multinational medical and btotech corporations, emerging epidemics, gene pollution, chemical pollution, government regulators, CODEX and their implications to human

health.

Eve has spent 25 years in health care as a health practitioner where she has

observed the medical industry at first hand from the inside.

Eve has mainly reported on material that the mainstream media ignores. She is convinced there is a global grass roots Health Freedom and Social Justice movement emerging that will bring about a phenomenal renaissance in the years to come.

In 2005, Eve conducted a Health Freedom campaign in Australia to preserve natural health supplements from the influence of CODEX Alimenta rius.

Knowledge is power, and Eve's primary objective is to return this power to the individuals whose lives depend on it. She uncompromisingly believes that knowing the truth is a right

that belongs to the public.

Flu shot ineffective ; "marketing rules the response to influenza"

September 22,2005 2 Studies Find Flu Treatments Fall Far Short By ELISABETH ROSENTHAL

International Herald Tribune

ROME, Sept. 21 - Just as governments around the world are stockpiling millions of doses of flu vaccine and antiviral drags in anticipation of a potential influenza pandemic, two new surprising research papers to be published Thursday have found that such treatments are far less effective than previously thought.

"The studies published today reinforce the shortcomings of our efforts to control influenza," wrote Dr. Guan Yi, a virologist at the University of Hong Kong, in an editorial that accompanied the papers. The two studies were published early online by The Lancet, the London-based medical publication, because of their important implications for the corning flu season.

In one paper, internationalresearchersanalyzed all the datafrompatient studies on the flu vaccine performed worldwide in the last 37 years and discovered that vaccines showed at best a "modest" ability to prevent influenza or its complications in elderly people.

"The runaway 100 percent effectiveness that's touted by proponents was nowhere to be seen," said Tom Jefferson, aresearcherin Rome with the Cochrane Vaccine Fields project, an international consortium of scientists who perform systematic reviews of research data.

"There is a wild overestimation of the impact o f these vaccines in the community," he said. "In the case of a pandemic, we are unsurefrom the data whether these vaccines would work on the elderly."

In the second paper,researchersfrom the Centers for Disease Control and Prevention in Adanta found that influenza viruses, particularly those from the dreaded bird flu strain, had developed high rates of resistancetothe only class of cheap antiviral drugs available - drugs mainly used to treat flu once patients have caught it Theseresistancerates have increased rapidly since 2003, particularly in Asia.

"We were alarmed to find such a dramatic increase in drag resistance in circulating human influenza viruses in recent years," said Dr. Rick Bright of the disease control centers. "Our report has broad implications for agencies and governments planning to stockpile these drugs for epidemic and pandemic strains of influenza."

Before 2000, almost no virus wasresistantto the drag Amantadine. By 2004,15 percent of influenza A viruses collected in South Korea, 70 percent in Hong Kong and 74 percent in China were impervious. During the first six months of 2005,15 percent of the influenza A viruses in the United States were

resistant, upfrom 2 percent the year before. All human cases of the bird flu A(H5N1) strain - which is still extremely rare in humans • have been resistant, theresearcherssaid.

The immediate implications of thesefindingare most ominous for the developing world, because wealthier nations have been stockpiling newer and vasdy more expensive antiviral medicines, like Tamiflu, which are effective against the disease but still under patent

Even so, the research is alarming because it demonstrates how quickly and unexpectedly flu viruses can become impervious to medicines once they are put into common use, as they would be in the case of a pandemic. Also, at their best, antiviral medicines do not cure influenza. Theyreducetransmission of the disease and lessen somewhat the symptoms and complications in people already infected, including the highrateof associated pneumonias.

Called for comment, Dick Thompson, a spokesman for the World Health Organization, said that the group could neither support nor deny the findings of the analysis of vaccine studies at this point, noting only that some specialists criticized theresearchersfor "not including some important past studies" in their sample.

But the problem of resistance "is afindingthat is being discussed widely within the flu world and will bear careful monitoring," he said, noting that he was not aware of any country in the developing world that had been able to stockpile the newer drugs.

Anticipating a possible flu pandemic caused by a variant of the bird flu virus - which belongs to the influenza A group - countries have been aggressively buying antiviral medicines and contracting to purchase a flu vaccine against that strain, even though it is still under development The United States has ordered $100 million worth of vaccme, and Italy $43 million worth, for example.

The current bird flu virus does not spread easily - if at all - from human to human, and so has little potential to become a worldwide human scourge. But the World Health Organization has warned that it could acquire that potential through a couple of common biological processes, and that countries should prepare for a possible wave of serious influenza.

The fact that the vaccine study showed that inoculations have had only a modest effect in the elderly is particularly worrisome, because this is a group thattendsto suffer highratesof complications and deathsfrom the disease and vaccination is the standard practice. In people over 65, the vaccines "are apparently ineffective" in the prevention of influenza, pneumonia and hospital admissions, although they didreduce deathsfrom pneumonia a bit, by "up to 30 percent," the study says.

"What you see is that marketing rules the response to influenza, and scientific evidence comes fourth or fifth," Dr. Jefferson said. "Vaccines may have arole,but they appear to have a modest effect The best strategy to prevent the illness is to wash your hands."

Intermsof antiviral drags, 30 countries have placed huge orders for Tamiflu, the most popular newer more expensive antiviral medicine, said Martina Rupp, a spokesman for Roche, the Swiss company that makes it The Dutch Health Ministry has ordered five million doses, enough to treat one-third of the population. Britain has ordered supplies to treat 15 million.

Researchers speculate that onereason resistancerates to the older, cheaper antiviral drags jumped so much starting in 2000 - and skyrocketed after 2002 - is that doctors in Asia started prescribing the drags far more widely after the advent of bird flu in 1997 and sudden acute respiratory syndrome, or SARS, in 2002.

No Mutation Seen In Fatal Virus

The New York Times

HONG KONG, Sept 21 - A woman's deathfromavian influenza in Jakarta, the capital of Indonesia, has caused alarm there, but genetictestshere on virus samplesfromthe woman showed on Wednesday that the virus had not mutated in ways likely to make it more of a threat to people.

The virus in the woman, who died early this month, "seems like a virus that has gone directly from birds," rather thanfromperson to person, said Dr. Georg Petersen, the World Health Organization representative in Jakarta. The deaths of two girls withflulikesymptoms this week in Jakarta have fed public concern there. But Dr. Petersen said that laboratory tests would be needed to conclude whether the girls had been infected with the A(H5N1) virus.

Suicides raise fears over Tamiflu

Medicines regulators are monitoring the antiviral Tamiflu after reportsfromJapan that two teenagers who had taken the drug committed suicide. The European Medicines Evaluation Agency said it was aware of the cases. But it said there was no evidence there was a direct link between Tamiflu and the teenagers' suicides, and said flu itself could lead to delusions.

Tamiflu, the main weapon against a flu pandemic, is being stockpiled by governments including the UK's. One of the things that has to be determined in these cases is if there was a causal link between the drug and theteenagers'actions EMEA spokesman. The incidents in Japan took place in February 2004 and February 2005. Bothteenagersdisplayed abnormal behaviour before their deaths.

In thefirstcase, a 17-year-old ran out of his house and jumped over arailing,falling into the path of a track In the second, ateenagerfell to his deathfromthe ninthfloorof his apartment building. An estimated 33m people around the world havereceivedTamiflu. During the 2004-05 flu season in Japan, six million took the drug.

Safety review

Japanese authorities have amended the patient information which comes with the drag to list psychiatric effects, such as delusions, in the list of side effects. However, a spokesman for the EMEA said it had not been felt necessary to put similar warnings on the medication labelling in Europe. He stressed flu itself could lead to such conditions, particularly in the elderly and the young. He added:

"Psychiatric side effects are one of the things that is most closely monitored in relation to all drags.

The spokesman said it was known one of the teenagers had taken Tamiflu before without any ill effects, but would not reveal which for reasons of patient confidentiality. And he said ute EMEA had evaluated 48 reports ofpsychiatric side effects from Tamiflu as part of a regular safetyreviewof the drug in July this year. Most - 28 - of those reports had comefrom Japan, with 10 comingfrom the US, fivefromCanada, threefrom Germany and twofrom France. Theyrelatedto serious abnormal psychiatric behaviour, such as delirium and hallucinations.

Evidence review

A spokeswoman for Roche, the manufacturers of Tamiflu, said the company was aware of the two Japanese cases involving instances of "abnormal behaviour". She added: "The information on these two cases has been shared with otherregulatoryauthorities around the world, who have taken them into consideration and made the decision that no change to the summary of product characteristics was warranted. "These conditions are known complications of influenza and its associated high fever. "A number of studies have clearly shown that use of Tamiflu does not increase the likelihood of such events occurring in patients with influenza."

Story from BBCNEWS: httD://news.bbc.co.uk/eo/pr/fr/-/2/hi/health/4438342.stm Published:

2005/11/1513:10:43 GMT

FDA probes deaths of Tamiflu patients

B y Lis a RIChWineThu Nov 17, 1:15 PM

ET

U.S. regulators are studying the deaths of 12 children in Japan who took Roche AG's flu- fighting drug Tamiflu, officials said on Thursday, but they said it was difficult to tell whether the drug played a role in any of the cases.

The U.S. Food and Drug Administration said it was "concerning" that 32 psychiatric events, such as hallucinations and abnormal behavior, also had been reported in children who took Tamiflu, which is in high demand because it is considered to be one of the best defenses against avian flu in people. All but one of the psychiatric problems also were reported in Japan, the FDA said.

The agency will ask for input on the cases from an advisory panel of outside experts at a public meeting on Friday. Officials said the review was part of the routine monitoring of the safety of medicines used by children.

In a separate summary posted on the FDA Web site, Roche said: 'There is no increase in deaths and neuropsychiatrie events in patients on Tamiflu versus influenza patients in general."

Roche shares fell 2.7 percent in Swiss trading. Shares of Gilead Sciences Inc., which invented the drug and receives royalties on Tamiflu sales, were down 1.6 percent in afternoon Nasdaq trade.

Interest in Tamiflu has risen as experts around the world warn of the possibility for an H5N1 bird flu pandemic in people. Several countries are stockpiling Tamiflu, which may be able to lessen symptoms.

Earlier this week Roche reported two possible suicides of Japanese youth who took Tamiflu but said there was no clear evidence the drug contributed.

Tamiflu is recognized as causing psychological disturbance, and therefore the apparent suicidal behavior of these two teenagers has been linked to taking Tamiflu," analysts at Morgan Stanley Equity Research said in a statement.

The FDA said the 12 deaths it was reviewing included one suicide, four cases of sudden death and four cases of cardiac arrest. There also were single cases of pneumonia, asphyxiation and acute pancreatitis.

'The level of detail in these reports was highly variable and determining the contribution of Tamiflu to the deaths was difficult," the FDA summary said.

"At this point in time, we cannot make an association between Tamiflu and the deaths of these children," said Dr. Murray Lumpkin, FDA deputy commissioner for international and special programs. He said no similar cases have been seen in the United States. "But we thought it was very important to talk about these publicly with our advisory committee," Lumpkin said.

The "most alarming" psychiatric events included two cases in which a 12-year-old and a 13- year-old jumped out of the second-floor windows of their homes after receiving two doses of Tamiflu, the FDA summary said.

Warnings about possible skin reactions may need to updated on the Tamiflu label, the FDA said. Twelve cases have been reported, including one of a severe skin problem known as Steven-Johnsons syndrome that was reported in a 3-year-old. The agency said it had requested more information from Roche and Japanese regulatory authorities and had received preliminary responses.

"We

to the labeling of Tamiflu as a result of these observations," the Morgan Stanley team said. Roche will present data from three drug databases and a study of Tamiflu use in young children at the advisory panel meeting, company spokesman Al Wasilewski said. "Over the past six years, Tamiflu has been used widely and has set a consistent safety record in both the United States and Japan," he said.

conclude that there is virtually no chance of the FDA making any significant changes

The Flu Vaccine

Pat Thomas 18/02/2009

A Shot in the Dark?

If we truly knew about flu, and the lack of effectiveness of the vaccme being offered as protection, would we really be so obedient about getting the jab?

It's flu season again. The posters are up in the clinics, your GP has a stack of NHS information leaflets and advertisements and articles are appearing in the media carrying the health authority message that it's time to get vaccinated.

Stirring up fear and apprehension through association is not a new tactic, but among the more troubling aspects of this message is the way that promoting a vaccine for flu places influenza on a par with more devastating diseases such as smallpox and diphtheria. Nevertheless the scare tactics have worked. Flu vaccine uptake among the over 65s, for example, has risen for each of the last three years from 65, to 68 and now 69 per cent against the government target of 70 per cent set three years ago.

The catch phrase on this year's NHS information leaflet is: 'If you knew about the flu you'd get the jab'. But if people truly knew about flu, and the lack of effectiveness of the vaccine being offered as protection, would they really be so obedient about getting the jab?

How deadly is the flu? According to the UK Department of Health (DOH), 3,000 to 4,000 excess deaths are attributable to flu in non-epidemic years. During epidemics this figure rises; in 1989-90 there were apparently 30,000 excess deaths in Great Britain attributable to flu. The new DOH 'factsheet' Influenza: The Disease and The Vaccine goes further, estimating that an additional 12,500 people die each year during the flu season in England and Wales. In the US, the Centers for Disease Control and Prevention (CDC) website notes that, on average, 36,000 people die each year from flu in the US.

Contrast these figures with those from the Office for National Statistics, which show that in 2004 only 33 people died of influenza in England and Wales, and the CDC's own data showing that in 2002 just 753 people died from flu and in 2001 only 257.

The discrepancy between actual deaths and those reported in 'factsheets' arises from the practice of combining flu deaths with a percentage of those from pneumonia and other respiratory diseases, making flu appear more deadly than it is.

The most recent CDC National Vital Statistics Report, for example, lists influenza and pneumonia as the seventh leading cause of death in 2002. Break down the figures and you find that only 753 of those deaths were flu-associated, while 65,321 were pneumonia-associated. Ifall flu-associated deaths are removed, pneumonia-associated deaths would still rank number 7, but influenza would barely register on the medical radar.

Tbe whole truth?

In the UK, the DOH's

paint its dramatic picture offlu related mortality. In small print

to establish how many people are seriously affected byflu each year as hospital admissions and

totalflu deaths are also the result of combining influenza and pneumonia deaths, but influenza factsheet goes further combining data onflu, pneumonia and bronchitis, to

it acknowledges: 'It is difficult

deaths may be due to complications or the infection making other illnesses worse.'

In other words they are guessing and it is the laziest kind of guesswork since the winter season can bring about a whole range of health complications, including higher cholesterol levels and worsening glucose control, which have nothing at all to do with viruses. In fact, according to a 2002 report published in the British Medical Journal in which British scientists tracked the causes of excess winter deaths over the preceding 10 years,flu accounted for less than three per cent of all excess winter deaths in the UK (a higherfigurethan in other developed countries). In this country 'cold stress' lack of adequate heating indoors and lack of appropriate winter clothing when outdoors was the bigger killer.

Health professionals justify combiningfludeaths with pneumonia deaths by insisting that 'influenza leads to pneumonia', but the facts don't generally support this. The American Lung Association, for instance, acknowledges over 30 different causes of pneumonia (one of which is influenza). A single bacterium Streptococcus pneumoniae is responsible for up to 50 per cent of all cases of pneumonia. Pneumonia is also caused by other bacteria such as Staphylococcus aureus, Pertussis (whooping cough), Streptococci, and Mycoplasma pneumoniae (a common cause of walking pneumonia). There are also many noninfectious causes of pneumonia such as asthma, aspiration offluids,toxic exposures and immunodeficiency.

Neither the CDC nor the DOH track the specific causes of the pneumonias that result in death. What is clear, however is that influenza is not the major cause of pneumonia and not a major cause of death. What has also become clear is that theflu vaccination does not prevent death.

Earlier this year a report in the medical journal Archives ofInternal Medicine dropped a bombshell: although immunization rates in the elderly (people over 65) have increased 50 per cent in the past 20 years, there has not been a concurrent decline influ relateddeaths.

Another year, another vaccme Vaccines are the sacred cows of medicine, you can't question their effectiveness or publicise their adverse effects without sustaining a volley of criticismfromthe medical orthodoxy. Nevertheless we should be sceptical of their necessity and effectiveness, especially for seasonal, selflimiting illnesses like the flu.

There are three types offlu virus types А, В and С Influenza A occurs morefrequently,is the most virulent and is responsible for most major epidemics and pandemics. Influenza В often cocirculates with influenza A during the yearly outbreaks, but generally causes less severe illness. Influenza С usually only causes a mild or asymptomatic infection similar to the common cold.

Within each of these types there are many different strains of influenza virus. While some are more common than others, there are literally hundreds of flu viruses that can be circulating at any one time. Nevertheless, every February the scientists at the World Health Organization meet tó try and divine the three that are likely to cause the most misery the following winter. The viruses they choose - two type As and one type B, say - are then included in that year's vaccine.

Problematically, in the several months between formulating the vaccine and administering it, the viruses - which are naturally constantly evolving and mutating - may have changed, or new ones may have emerged.

Maybe you will be infected with the virus that matches the vaccine, but then again maybe you won't; flu 'experts' often get it wrong. For example, in 1994 they predicted that Shangdong, Texas, and Panama strains would be prevalent that year, thus millions of people were vaccinated against these viruses. However, when winter arrived, it was the Johannesburg and Beijing strains that circulated through society. It was a similar story in 1996,1997 and most recently, in 2003 when the vaccine was made from flu strains that were uncommon that season.

No Protection While the flu vaccine is vigorously promoted by health agencies as the 'best' protection against flu, proclamations of how many people didn't get flu thanks to vaccination are little more than fantasy; there is no truly reliable way to tell who would or would not have contracted the disease. What is more, studies into the efficacy of the vaccine continually show mixed results.

Health authorities justify the yearly vaccine campaign with data showing that when the match between the vaccine and circulating viruses is close, the flu vaccine provides a 70-90 per cent chance of temporary immunity in healthy persons under 65 years of age - a bizarre justification for the effectiveness of the jab given that healthy people don't need the vaccine and are not among those targeted by government campaigns.

At any rate, reviews of the benefits of the flu vaccine in otherwise healthy adults show these figures to be overstated. While vaccinating healthy individuals temporarily reduces the number of people carrying the virus, it does not reduce the number people who ultimately go on to develop flu.

Recently doctors at the prestigious Cochrane Collaboration, a respected international organisation that conducts and publishes systematic reviews into the effectiveness of medical treatments, set out to find the answer to a simple question: how effective are flu vaccines for healthy people under the age of 60? They reviewed 25 good quality clinical trials, published in medical journals between 1969 and 2002, in which healthy people between the ages of 14 and 60 years had been randomly given either an actual or placebo vaccine. Their conclusion? Only six per cent fewer vaccinated people got flu, compared to the unvaccinated people. In addition, the influenza vaccine did not reduce the number of working days lost, nor did it reduce the incidence of flu-related complications, deaths or hospitalisations.

In at-risk groups, such as those aged over 65, officialfigurestell us that the effectiveness rate is dramatically lower than for healthy individuals, around 30-40 per cent. To put this into context most placebos, if enthusiastically promoted by a physician, will work 30-70 per cent of the time. And even if the vaccine containstiie 'right' strains, not everyone responds to it by producing antibodies (see below). As many as 40 per cent of people over age 65, for example, do not respond to the vaccination.

Declarations of how many vulnerable people didn't getflu thanks to vaccination are also little more than fantasy, based on 'after the event' data collection. The only reliable way to tell who would or would not have contracted the disease is to track illness rates among vulnerable people during theflu season. Last year, for thefirsttime ever, that is what the US federal government did. The CDC-funded study followed health care workers in Colorado, where the 2003-04 flu season started with a vengeance. Results showed that virtually the same percentage of people suffered from influenza-like illness whether they were vaccinated or not, and that the vaccine 'was not effective or had very low effectiveness' againstflu-likeillness.

The results of these and other recent studies have dealt a serious blow to vaccine proponents.

Hidden ingredients Apartfromits low effectiveness against constantly evolving viruses, there is also concern over the various ingredients of thefluvaccine. Most vaccines are grown on animaltissues.The flu vaccine is grown in chicken eggs, which makes it unacceptable for vegans and those with egg allergies.

Flu vaccines can also contain some alarming 'inert', or inactive ingredients. The formulation varies between manufacturers but can include preservatives such as aluminium hydroxide, associated with Alzheimer's disease and seizures, thimerosal - a mercury-based neurotoxin, and phenol, which is a human carcinogen. Antibiotics such as neomycin, streptomycin and gentamycin sulphate are also sometimes included as preservatives.

Vaccines can contain traces of the chemicals used to inactivate the viruses including

formaldehyde - a known

including the neurotoxin monosodium glutamate (MSG), potassium phosphate, sucrose and sorbitol.

carcinogen. Theflu vaccine can

also contain a range of stabilisers

For this reason opponents of lhe vaccine say that, for most people, theflu shot does not protect, but instead weakens the immune system making the recipient more vulnerable to illness. The same people who are being targeted for the jab, the elderly, the very young and the immune compromised, are those least able to withstand such a systemic chemical assault.

For some people the adverse effects of the jab - fever, fatigue, painful joints and headache - can be more intense than suffering through a week or so offlu.In some patients theflu vaccine can be a trigger for asthma attacks. Optic neuritis and permanent blindness, vasculitis and joint problems are other rare, but welldocumented adverse effects.

However it is Guillain-Barre Syndrome - a devastating immune-mediated nerve disorder characterised by muscle weakness, numbness, pain and paralysis - that remains the most serious reported reaction to a flu vaccine, and this usually occurs within two weeks of vaccination. The risk appears to vary from year to year, though globally the vaccine accounts for hundreds of cases each year. One possible cause is that flu vaccine contains the disease trigger Campylobacter jejuni, a bacterium found in 40-50 per cent of chickens eggs.

Cultural cure-all The shortsighted health authority strategy for winter wellness involves improving 'herd immunity' - vaccinate the majority to lower the risk for a minority. US health authorities are currently considering implementing universal flu immunization for all Americans, and the UK can't be far behind in this thinking. But widening flu vaccination programmes to include healthy people will not protect the most vulnerable because exposure to a virus is only a small part of why we succumb to flu.

Logically if exposure was the only factor, each of us would get sick every time we were exposed to a flu virus, yet this is not the case. To understand why some people are more vulnerable to flu than others we need to address the bigger picture of what makes us ill and stop relying on crude calculations of who is most at risk.

While health authorities tend to classify the very young and very old as being the most vulnerable to flu, age per se is not a reliable indication of risk. Social status is much more influential.

In a supposedly classless society this is a contentious assertion. But medical research consistently shows that adults and children of lower socioeconomic status are at higher risk for a wide range of communicable infectious diseases, especially respiratory infections, and their complications.

With regard to flu, this concept has a certain amount of historical precedence. While many authorities promote the idea that the 1918 flu pandemic, which killed around 30 million people worldwide, was an egalitarian disease, a closer look at the data says otherwise.

According to a summary published in the British Medical Journal in 2000, data from the 1918 pandemic showed a striking impact in areas such as sub-Saharan Africa and India, where the death rate was 30 per 100,000 population, compared with five per 100,000 in Europe and North America. The estimated 20 million deaths in India were among those living in poor, crowded and starving conditions. In Europe, the epidemic was more devastating than usual because of the poverty, the run-down immune systems and poor nutritional health of both military and civilian populations following the deprivations of the First World War.

This year the UK Government has tacitly acknowledged the special vulnerability of disadvantaged individuals through its special efforts to target people from black and minority ethnic communities - statistically those most likely to be living in poverty.

People living in poverty face many unique health challenges. Often they live in substandard or crowded housing, with inadequate heating, damp and mould. They arefrequentlyignorant of basic hygiene measures - such as regular and thorough washing of hands - that can stop the spread of viruses. They may be stressed physically and emotionally, their bodies overloaded with environmental toxins such as heavy metals (ie leadfromold paint) and subsisting on a nutritionally poor diet. Childrenfromlow-income families are also less likely to have been breastfed, and thus are denied an essential foundation for a healthy immune system.

Wanting to protect the vulnerable is commendable. But in the absence of education, improved living standards and better hygiene, employing a vaccine as protection is like spitting on a raging fire. Yet in a recent consultation document entitled Making Markets for Vaccines - A Practical Plan, produced by the Center for Global Development (CGD), an independent think tank that conducts research and analysis into global poverty and inequality, the veryfirstline says:

'Vaccines are a very effective way to tackle poverty'. It goes on to say: 'As well as preventing death and illness, immunization also contributes to greater attendance in school, increased productivity, enhanced lifetime earnings and economic growth.'

Read that again and ask yourself if you still believe that vaccines aren't being aggressively marketed as cures for social problems. The vaccine as a panacea remains the unshakeable mindset of the medical community. While the CGD report focuses on spreading the vaccine gospel to the developing world, its ethos can be seen in the developed world as well where vaccines are a endorsed as a remedy for so many things that are too complicated (better hygiene, encouragement to breastfeed) or too expensive (winter-proof housing, higher benefit rates) for the government to fix.

Throwing pharmaceutical solutions at social problems never works and is ultimately more damaging to human health and well-being. Nevertheless, encouragement from government and publicityfrom an acquiescent media means that Big Pharma is currently rubbing its hands with glee. As drugs like Vioxx take big bits in the court and the adverse effects of popular magic bullets such as HRT, Prozac and Ritalin shake people's faith in drug solutions to common health problems,revenuesfrom vaccines and other panacea drugs are helping to keep drug companies in the black.

Flu vaccines generated about one billion dollars in worldwide sales last year, and the market is expected to double by 2007. In the future, for companies like Avenus Pasteur, Chiron and GlaxoSimthKline, Christmas will come in October and last well into April.

We are currently in the grip of an organised attempt to keep us fearful of even the most innocuous illnesses and, as aresult,keep us consuming drugs that do no good whatsoever. The government misinformation campaign and the yearly media circus that surrounds the influenza vaccine is a good illustration of this.

Thankfully theflu vaccine is not (yet) compulsory. People have the choice to either choose or refuse it. The question is: Now that you know more aboutflu,and theflu vaccine - will you be getting ajab?

COMMON SENSING THE FLU

If you do succumb toflu, two antiviral drugs zanamivir (Relenza) and oseltamivir (Tamiflu) are

currently being promoted as the best way tofightback. Taken within a day or two of the onset of symptoms these drugs are supposed to lessen the duration of the flu and reduce debilitating symptoms. In addition, Tamiflu is currently being touted as effective prevention for all types of flu including bird flu (though given that bird flu is exceptionally rare in humans, it's tempting to ask where the supportive data for this claim comes from).

Unfortunately medical research

in influenza symptom duration. What is more, there will be pressure for high risk individuals to take drugs like Tamiflu for weeks on end to the exclusion of simpler methods of prevention, and the safety and efficacy of these remedies in individuals at high risk of pulmonary disease, such as pneumonia, has not been established. Fortunately other methods of protection may be just as effective without the risk of adverse effects.

shows that at best, both drugs provide about a one day reduction

In a perfect world healthy people would recognise that the best protection against a new virus is

a successful, managed encounter with the real thing. Rather than trying to avoid flu, consider simple common sense measures to keep virus populations to a minimum while boosting your own immunity:

• Wash your hands. Hands are the main vehicles for transmitting virusesfrom person to person.

Wash thoroughly and frequently during the day, especially after going to the toilet or before preparing food.

• Eat well. Winter diets can be low in essential nutrients like Vitamins С and A. Go out of your

way to includefresh,deeply coloured vegetables in your daily diet such as spinach, broccoli, tomatoes and peppers. Avoid foods that destroy these nutrients such as sugar, caffeine, and trans fats.

• Exercise. Regular moderate exercise improves immune function and reduces susceptibility to

cold andflu. If you can take exercise in the open air, rather than in enclosed potentially germ

ridden environments, so much the better.

• Watch your stress levels. The ability of stress to depress immune function and

to precipitate and aggravate infectious diseases is widely recognised in medicine and some

physicians believe that stress may be the single biggest risk factor for flu. Research shows that it

is not just the stress of work and family that are influential the stress of being lonely and

disconnectedfromyour social group is equally devastating to immunity.

FLU VACCINE ROULETTE This year's vaccine contains two virusesfrom last year's vaccine: type A/New Caledonia/20/99 (HlNl) like strain and type B/Shanghai/361/2002 like strain.

It also contains one new

virus: type A/California/7/2004 (H3N2) like strain.

Like all flu vaccines it is madefrom inactivated parts of these viruses. These virus parts correspond to parts of proteinsfloatingaround in your body. When the virus latches onto a matching protein, it stimulates the body to produce antibodies that help to destroy the

corresponding virus. The catch is that a flu vaccine can only stimulate your immune system to protect you against the viruses in the vaccine, with some lesser protection against very similar viruses. If you are exposed to a different virus or to a mutated form of the same virus, the vaccine won't keep you from getting sick.

This piece first appeared in the Ecologist October 2005

Calculating U.S. Influenza Deaths By F. Edward Yazbak, MD, FAAP

Posted on Justice Awareness and Basic Support on 09/24/2006 18:10:22

http:/AvMm'.jabs.org.iik/fonim/topic.asp?TOPIC_ID=293

For years, the Centers for Disease Control and Prevention (CDC) has been telling anyone who would listen: "Every year in the United States, on average:

5 percent to 20 percent of the population gets theflu,more than 200,000 people are hospitalizedfromflu complications, and about 36,000 people die from flu." (1)

It is not clear how the specific statistic - 36,000 American deaths a year "on average" - was formulated orfromwhat sources it was derived. It seems to have just suddenly appeared, like a rabbitfroma top hat. It certainly could have been any other number of thousands of cases. After all, what are a few thousand deaths up or down?

No one knows when the next number change will come but, when it does, it is guaranteed to be an increase. Scaring people, especially old people, out of their wits always sells vaccine and that seems to have become the CDC's main purpose.

Another well-kept secret is over how many years the influenza deaths were "averaged." Did the CDC calculate "average deaths"from 2000 to 2004 or from 1980 to 2004?

To have 36,000 deaths "on average," there must be years with 26,000 deaths and about the same number of years with 46,000 deaths and, not to belabor the point, as many years with 16,000 deaths as with 56,000. At least, this is what most people would think averaging and "on average" mean.

The past influenza season came and went very quietly because the CDC was busy with dying birds in the Far East and Turkey. We will neverfindout where exactly the most recent "deathsfromflu"will fit on the curve, but it is a good bet that 2005-2006 will not be, propaganda-wise, a "real good year."

Testifying before the committee on government reform of the U.S. House of Representatives on Feb. 12,2004, CDC Director Julie L. Geiterding, MD, carefully stated that "CDC scientists estimate that an average of 36,000 people diefrominfluenza-related complications each year in the United States." (2)

It is not clear why the director made the distinction, while under oath, between deaths from the flu and deaths from complications of theflu.A few people, including this writer, think there is a distinct difference between the two; many others do not think so.

To place the CDC influenza deaths in perspective, the U.S. lost 33,741 officers and enlisted men and women in Korean War battles from 1950 to 1953. (3) And a special communication published by the Journal of the American Medical Association listed 43,000 deaths due to motor vehicle crashes and 29,000 involvingfirearmsin the U.S. in 2000. (4)

The National Vital Statistics Report for 2001, published on Sept. 18,2003 [Vol. 52, No. 3], was the last official U.S. government report on influenza mortality before the CDC director's appearance at the February 2004 Congressional hearing. Certifiedfiguresabout Influenza mortality [J10-J11] were listed on page 31 of thereport.(5)

There were, in all, 257 influenza deaths recorded in 2001.

Of those, 13 deaths were under the age of 5; 50 were between 5 and 54; 21 from 55 to 64; 21 between 65 and 74; 56from 75 to 84; and 96 were 85 years old or older.

Also in 2001, there were 61,777 official deaths due to pneumonia (J12-J18) of which 48,686 (79 percent) were 75 years old or older.

The same document (table 11, page 35) lists the reciprocal number of deaths per 100.000 population. In 2001, influenza-pneumonia deaths (J10-J18) amounted to 21.8 per 100.000 with influenza at 0.1 and pneumonia at 21.7.

With the U.S. population being around 284 million in 2001, it would seem that the calculated number of 284 (0.1/100.000) deathsfrominfluenza would be close enough to the actual listed number of 257.

The following should be kept in mind:

"Pneumonia" is caused by bacteria, viruses and fungi. Elderly patients (75 years and over) who have laboratory confirmed influenza disease may develop pneumonia but diefromother underlying serious conditions, such as heart or kidney failure to name just two. It is not known how many of the 48,686 elderly individuals who died in 2001 had received the influenza vaccine that year. People ofthat age are usually vaccinated early in the season and certainly more frequently than others. In the U.S., influenza/influenza-like illnesses only occur during theflu season, a period of three months on average and rarely four months. Pulmonary complications and specifically deaths due to influenza will only occur during that short period, while other causes of pneumonia deaths exist year-round.

Most people who have influenza-like illness, as the condition is fondly referred to by the CDC, do not have influenza; only a small percentage of them

are ever confirmed by culture or other accurate laboratory means. For the period 2000-2005, influenza virus positive cultures were 11 to 18.9 percent of the obtained cultures with a mean of 12.5 percent It is well known that the virus strains in the community may be different from those in the available vaccine. Because immunity is strain-specific, vaccination in such cases is essentially ineffective in preventing disease. The percent of antigenic match between 2000 and 2005 varied from 11 to 63.2 percent with a mean of 54.2 percent. The maximum effectiveness of the vaccination effort, therefore, ranged between 2.1 percent in 2003-2004 and 11.5 percent in 2002-2003 with a mean of 7.2 percent. (6)

Taking all these facts into consideration, it is safe to say that only a small percentage of the 61,777 individuals who died of pneumonia in 2001 actually had influenza. Clearly, therefore, a large majority of individuals who died that year of pneumonia did not die of influenza or influenza-related complications.

In addition, the CDCfiguresclearly show that a large percentage of those who died were elderly and, historically, the elderly, as a group, have always been better vaccinated. As to the 257 individuals who were actually listed as influenza deaths in the 2001 statistical report, the influenza virus was actually identified in only 18 of them, the 18 classified as J10. (6)

Apparently in 2001, not even 257 people died of influenza or influenza- related complications.

The Monthly Vital Statistics Report of Sept. 17, 1981 sheds additional light on the issue. Under pneumonia and influenza, the report states: "An estimated 52,720 deaths in 1980 were attributed to pneumonia and influenza. The age- adjusted death rate for this cause increased about 14 percent from 11.1 per 100,000 population in 1979 to 12.6 in 1980,reflectingthe influenza epidemics in 1980 and the absence of one in the previous year. For pneumonia and influenza, death rates increased for the age groups 35 years and over." (7)

The above statement by none other than the CDC suggests that around 1.5 deaths per 100,000 were or could have been attributed to influenza or influenza complications in 1980, an epidemic year, when one would have expected a very large number of cases and more severe illness and certainly in a period when influenza vaccination was not as popular as it is now.

Considering that the U.S. population was around 226.5 million in 1980,1.5

deaths per 100.000 would translate to around 4,000 deaths that year. So here we have official CDC statistics listing around 4,000 deaths, unconfirmed by viral

cultures,from influenza and influenza-related complications in 1980,

year, and maybe 18 or 257 in 2001 and the propaganda machine is still talking about "an average of 36,000 deaths" a year.

a banner

How preposterous!

References

1. Key Facts about Influenza and the Influenza Vaccine, CDC. Available at http://www.cdc.gov/flu/keyfacts.htm

2. J.L. Gerberding. Protecting the Public's Health: CDC Influenza

Preparedness Efforts. Testimony before the Committee on Government Reform U.S.

House of Representatives, Feb. 12,

2004.

Available at

3. America's Wars: U.S. Casualties and Veterans.

4. A.H. Mokdad et al. Actual Causes of Death in the United States, 2000. JAMA. 2004; 291 :

5. E. Arias et al. Deaths: Final Data For 2001. National Vital Statistics

Reports. Volume 52, Number 3. Sept. 18,2003. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr52/nvsr52_03.pdf

6. D.M Ayoub, F.E. Yazbak. Influenza Vaccination During Pregnancy: A Critical Assessment

of the recommendations of the Advisory Committee on Immunization Practices. J. Am Phys Surg. 2006; 11(2): 41-47. Available at http://www.jpands.org/voll lno2/ayoub.pdf

7. Annual Report of Births, Deaths, Marriages and Divorces: United States

1980. Monthly Vital Statistics Report: Vol. 29, No.13. Sept. 17,1981. Available at http://www.cdc.gov/nchs/data/mvsr/supp/mv29 13

Why the Fiu Vaccine Doesn't Work

By Dr Joseph Mercóla

Each year enormous effort goes into producing that year's vaccine and delivering it to appropriate sections of the population. And yet, year after year there are studies showing that flu vaccines DO NOT provide any benefit.

Two years ago a study in the British Medical Journal concluded that the effectiveness of annual flu shots has been exaggerated, and that in reality they have little or no effect on influenza campaign objectives, including reducing the number of hospital stays, time off work, and deathfrom influenza and its complications. Other studies, done prior and subsequently, also confirm these findings.

However, preventing flu-related deaths in the elderly has been, and still is, the primary argument for recommending flu shots each year. And, according to the theory of "herd immunity," a majority of the population must be vaccinated in order to protect the lives of the elderly and other categories of people susceptible toflu-relatedcomplications.

However, the flu prevention strategy set by the Centres for Disease Control and Prevention

(CDC) has been

published in the Archives of Internal Medicine also could not find support for the use of flu vaccine to prevent deaths in the elderly. The report highlights that=2 Oalthough immunization rates in people over 65 have increased dramatically in the past 20 years, there has not been a consequent decline in flu-related deaths.

called into serious question time and again. Another studyfrom 2005,

Do You Know What the Risks are?

Instead, there is emerging evidence that flu shots cause Alzheimer's disease, most likely as a result of combining mercury with aluminium and formaldehyde. Mercury in vaccines has also been shown to be a contributing factor in autism. Other serious, and potentially deadly, adverse reactions to the flu vaccine include joint inflammation and arthritis, anaphylactic shock (and other life-threatening allergic reactions), and Guillain-Barré syndrome, a paralytic autoimmune disease.

And, in the case of Tamiflu, thousands of cases of abnormal behaviour, neuropsychiatrie problems like convulsions, delirium or delusions, and brain infections, have been reported. (Tamiflu is approved for treatment of uncomplicated influenza A and В in children 1 year of age or older. It is also approved for prevention of influenza in people 13 years or older.)

More Scientific Research Backing Up Recommendation to Avoid Fiu Vaccines Like the Plague

For those of you who are still unconvinced, there s plenty of scientific evidence available to back up the recommendation to avoid flu vaccines if not for their potentially serious or deadly side effects, then for the simple reason that they don't work, and don't offer any real benefit to offset their potential health risks.

A sampling of these studies include:

• A recent study published in the October 2008 issue of the Archives of Pediatric & Adolescent Medicine found that vaccinating young children against the flu had no impact onflu-relatedhospitalizations or doctor visits during two recent flu seasons. The researchers concluded that "significant influenza vaccine effectiveness could not be demonstrated for any season, age, or setting" examined.

• A study published in the Lancet just two montiis ago found that influenza vaccination was NOT associated with a reduced risk of pneumonia in older people. Vaccination coverage among the elderly increased from 15 percent in 1980 to 65 percent now, yet there has been no decrease in deaths from influenza or pneumonia.

• That Lancet study supports a similar study donefiveyears ago, published in The New England Journal of Medicine, which concluded that vaccination against pneumonia does not reduce your risk of contracting the disease.

• Research published intiieAmerican Journal of Respiratory and Critical Care Medicine last month also confirms that there has been no decrease in deaths from influenza and pneumonia, despite the fact that vaccination coverage among the elderly has increased from 15 percent in 1980 to 65 percent now.

• Last year, researchers with the National Institute of Allergy and Infectious Diseases, and the National Institutes of Health published this conclusion in the Lancet Infectious Diseases: "We conclude that frailty selection bias and use of non-specific endpoints such as all-cause mortality have led cohort studies to greatly exaggerate vaccine benefits."

• A large-scale, systematic review of 51 studies, published in the Cochrane Database of Systematic Reviews in 2006, found no ev idence that theflu vaccine is any more effective than a placebo in children. The studies involved 260,000 children, age 6 to 23 months.

For most people, the flu shot does not prevent illness, but actually does the polar opposite-it weakens your immune system and makes you more predisposed to the illness. The people who actually die after contracting theflu do so because they are already sick and have compromised immune systems, and that certainly doesn't have to include you.

In addition to making sure your vitamin D levels are in the optimal range, the following tips are sure-fire ways to improve the function of your immune system and greatly reduce your chances of getting theflu this winter:

Avoid sugar.

• Get plenty of sleep.

• Exercise regularly.

• Eat a whole foods diet

• 0A

Eat garlic regularly.

• Support yourself during stressful times.

Source: htrn://articles.mercola.com/sites/articles/archive/2008/l 1 /18/do-flu-shots-work-ask-a- vaccine-manufacturer.aspx

COMMENTS:

Mercury in Flu Shots

SHOULD YOU GET THE FLU SHOT?

By RFD Columnist, Dr. Sherri Tenpenny

News reports have been flooding us with articles warning that the impending flu season may be the worst in years. Even though it is difficult to separate the facts from the hype, a close evaluation of the flu vaccine will reveal that serious questions must be raised about the recommendations that are routinely touted, namely high efficacy with little risk. Anyone considering a flu shot should become informed about the substances coming through that needle, and should be determined to investigate the safety and efficacy issues that are still unresolved.

The Vaccine Virus Each year, a new vaccine is developed that contains three different viruses (one influenza В and two influenza A strains) . CDC officials select th e new viruses based on which viruses were prevalent during the flu season in China and Australia the previous year. The CDC admits tha t the viruses selected for the new vaccine are chosen on the basis of an "educated guess." [i]

What' s in a Flu Shot?

The influenza virus is grown in "specific pathogen free" (SPF) eggs. Eggs are tested for a variety of agents—usually between 23 and 31—to confirm the absence of those specific pathogens. Laboratories limit the number of agents that are screened due to the shear abundance of potential viruses and/or bacteria to choose from. In addition, screening for every potential agent would be cost prohibitive.[ii] If none of the tested agents are detected, the vaccine is reported as "pathogen free."

However, it should be understood that there is a distinct difference between "pathogen free" and "specific pathogen free." In its July 1996 report, the Institute of Medicine acknowledged that E2although it is not possible to produce a completely uncontaminated animal, it is possible to produce an animal [or egg] certified to be free of specific pathogens."[iii] Viruses that are harmless to their animal host, however, may be potentially harmful to humans.

During the manufacturing process, antibiotics (neomycin, polymyxin В and gentamicin) are added to eliminate stray bacteria found in the mixture. The final solution can contain the following additives in any combination: Triton X 100 (a detergent); polysorbate 80 (a potential carcinogen); gelatin; formaldehyde; and residual egg proteins. In addition, many of the influenza vaccines still contain thimerosal as a preservative. Thimerosal (mercury) is being investigated for its link to brain injury and autoimmune disease.

Does the Flu Shot Protect? There are no guarantees that the influenza viruses selected for the vaccine will be the identical strains circulating during a given flu season. In fact, it has recently been announced that this year's flu vaccine does not include the strain that is being reported by doctors in the community called the "A Fujian" strain. Outbreaks have been reported in Texas, Colorado and elsewhere [iv] that involve strains that do not match the current flu vaccine. CDC test s have confirmed tha t more tha n 80 per cent of th e 55 strains of influenza virus isolated thus far are the A Fujian strain. Even so, the CDC still maintains that the current vaccine could provide cross protection against the new variant, but the fact is, no one knows for sure.

Moreover, the majority of illnesses characterized by fever, fatigue, cough and aching muscles are not caused by the influenza virus. Non-influenza viruses (e.g., rhinoviruses respiratory syncytial virus [RSV], adenoviruses, and parainfluenza viruses) can cause symptoms referred to influenza-like illnesses (ILI). Certain bacteria, such as Legionella spp., Chlamydia pneumoniae, Mycoplasma pneumoniae, and Streptococcus pneumoniae, have been documented as the causes of ILL[v]

Notably, these microbes are not part of the flu vaccine. Unless an organism's antigen is contained within the vaccine, there is no protection conferred by the vaccine. It is

estimated that most

average 3-6 episodes. The CDC also admits

vaccinated against influenza can still get the flu"[vi]

adults will average 1-3

episodes of ILI , and most children will tha t "man y persons who have been

Targeting the Elderly The flu vaccine is generally recommended for persons aged 65 and older, and those with medical conditions who could experience serious complications from the flu. Medical journals report broad differences in effectiveness for the elderly, ranging from 0 to 85%.

The CDC states tha t 90 % of deaths from influenza occur among the elderly. Considering that nearly 65% of all deaths (from any cause) occur in this age group, it is nearly impossible to prove that flu shots significantly increase life expectancy in this group. The truth is that most people—young and old—will weather a bout of the flu without hospitalization or complications.

A Serious Concern: Alzheimer's Disease Hugh Fudenberg, MD, an immunogeneticist and biologist with nearly 850 papers published in peer review journals, has 20 reported that if an individual had five consecutive flu shots between 1970 and 1980 (the years studied), his/her chances of getting Alzheimer's Disease is ten times higher than if they had zero, one, or two shots, [vii]

Dr. Boyd Haley, Professor and Chair of the Department of Chemistry at the University of Kentucky, Lexington has done extensive research in the area of mercury toxicity and the brain. Haley's research has established a likely connection between mercury toxicity and Alzheimer's disease, [viii] In a paper published in collaboration with researchers at University of Calgary, Haley stated that "seven of the characteristic markers that we look for to distinguish Alzheimer's disease can be produced in normal brain tissues, or cultures of neurons, by the addition of extremely low levels of mercury."[ix]

Does this prove that the mercury contained in the influenza shot can be directly linked to Alzheimer's? No, absolutely not. But further research in this area is critically needed because the absence of proof is not the "proof of absence."[x]

Flu Vaccine Now for Children The Advisory Committee on Immunization Practices (ACIP) adopted a resolution effective March 1 , 2003 that expanded the use of the influenza vaccine to include children aged 6- 23 months. The recommendations also included vaccinating those aged 2 to 18 years who live in households containing children younger than 2 years of age.[xi]

The flu vaccine most commonly given to children is Fluzone, a trivalent vaccine grown in chicken eggs. Harvested with formaldehyde and containing the recommended ratio of 15 ug of each of the three prototype viral strains, each dose of Fluzone also contains 25 ug of mercury.[xii ] The new CDC recommendations include giving the influenza vaccine to children beginning at six months of age and then annually, for the rest of their lives. Children less than age 9 receiving their first flu shot, two doses of vaccine are recommended, with a minimum interval of one month between the two doses. However,

the CDC does not provide ь direct reference t o substantiat e thi s = 0 A recommendation.[xiii]

On June 17, 2003, the FDA approved a n intranasal influenza vaccine for use i n healthy persons aged 5 49 years. Flumist is a live virus vaccine that can cause a litany of problems.

Alternatives? If you choose not to receive the flu shot, have a discussion with your doctor regarding other options. However, some simple and possibly quite effective things you can do for yourself to prevent the flu include: 1) avoid white sugar;[xiv] 2) exercise regularly; 3) get adequate sleep; 4) eat a healthy diet, omitting trans fats; 5) drink plenty of purified water daily and 6) wash your hands. A common way people contract viral illnesses is by rubbing their nose or their eyes after their hands have been contaminated with a virus. The CDC states , "th e mos t important thing you can do t o keep fro m gettin g sick is t o wash your hands."[xv]

We are so used to taking medications—for prevention and treatment—that it is difficult to comprehend that these modest recommendations are really the most powerful ways to minimize the likelihood of getting the flu.

Making the Decision You may decide to consult a physician who is schooled in alternative medicine to assess a variety of options for you and your family. What is most important, in the end, is to become as informed as possible regarding your options for keeping healthy and avoiding the flu.

REFERENCES [i ] Sabin, Russel and Reynolds. Breakdowns Mar Flu Shot Program Production, distribution delays raise fears of nation vulnerable to epidemic. San Francisco Chronicle. Feb. 25, 2001

0A

[ii]

Charles River Laboratories, A Laboratory Animal Health Monitoring Program:

Rationale and Development,' (Winter 1990); Source: Internet address

[iii] Institute of Medicine Press Release: Federal Guidelines Needed to Ensure Safety in

Animal to Huma n Organ

Transplants. July 17, 1996.

[iv]CBS: The Associated Press. CDC Says Flu Season I s Going Strong i n Parts of U.S.,

Vaccine Doesn't Match Strain Doctors See.

[v]

MMWR. November 9, 2001 / 50(44);984 6

[vi]

MMWR Nov. 9, 2001/50(44); 984 6

[vii]

Hugh Fudenberg, MD, is Founder and Director of Research, Neurolmmuno

Therapeutic Research Foundation. Information from Dr. Hugh Fudenberg came from

transcribed notes of Dr. Fudenberg's speech at the NVIC International Vaccine Conference, Arlington, VA September, 1997. Quoted with permission.

[viii] The Relationship of Toxic Effects of Mercury to Exacerbation of the Medical

Condition Classified as Alzheimer's Disease by Boyd E. Haley, PhD.

20

[ix]

NeuroReport, 12(4):733 737, 2001

[x]

[xi]

MMWR. 2002;51[RR 3]:1 31

[xii]

Package insert. Influenza Virus VaccineFluzone® 2003 2004 Formula

[xiii] MMWR. 2002: 51 [RR 3], pg. 19

[xiv] All forms of refined sugar depress white blood cells' ability to destroy bacteria. See

Sanchez A, et al. Role of sugars in human neutrophilic phagocytosis. Am J Clin Nutr

1973;26:1180.

[xv]CDC—Handwashing: An ounce of prevention keeps the germs away.

Why the Flu Vaccine Doesn't Work

By Dr Joseph Mercóla

Each year enormous effort goes into producing that year's vaccine and delivering it to appropriate sections of the population. And yet, year after year there are studies showing that flu vaccines DO NOT provide any benefit.

Two years ago a study in the British Medical Journal concluded that the effectiveness of annual flu shots has been exaggerated, and that in reality they have little or no effect on influenza campaign objectives, including reducing the number of hospital stays, time off work, and death from influenza and its complications. Other studies, done prior and subsequently, also confirm these findings.

However, preventingflu-relateddeaths in the elderly has been, and still is, the primary argument for recommending flu shots each year. And, according to the theory of "herd immunity," a majority of the population must be vaccinated in order to protect the lives of the elderly and other categories of people susceptible to flu-related complications.

However, the flu prevention strategy set by the Centres for Disease Control and Prevention (CDC) has been called into serious question time and again. Another study from 2005, published in the Archives of Internal Medicine also could not find support for the use of flu vaccine to prevent deaths in the elderly. The report highlights that=2 Oalthough immunization rates in people over 65 have increased dramatically in the past 20 years, there has not been a consequent decline influ-relateddeaths.

Do You Know What the Risks are?

Instead, there is emerging evidence that flu shots cause Alzheimer's disease, most likely as a result of combining mercury with aluminium and formaldehyde. Mercury in vaccines has also been shown to be a contributing factor in autism. Other serious, and potentially deadly, adverse reactions to the flu vaccine include joint inflammation and arthritis, anaphylactic shock (and other life-threatening allergic reactions), and Guillain-Barre syndrome, a paralytic autoimmune disease.

And, in the case of Tamiflu, thousands of cases of abnormal behaviour, neuropsychiatrie problems like convulsions, delirium or delusions, and brain infections, have been reported. (Tamiflu is approved for treatment of uncomplicated influenza A and В in children 1 year of age or older. It is also approved for prevention of influenza in people 13 years or older.)

More Scientific Research Backing Up Recommendation to Avoid Fiu Vaccines Like the Plague

For those of you who are still unconvinced, there s plenty of scientific evidence available to back up the recommendation to avoid flu vaccines if not for their potentially serious or deadly side effects, then for the simple reason that they don't work, and don't offer any real benefit to offset their potential health risks.

A sampling of these studies include:

• A recent study published in the October 2008 issue of the Archives of Pediatric & Adolescent Medicine found that vaccinating young children against the flu had no impact onflu-relatedhospitalizations or doctor visits during two recent flu seasons. The researchers concluded that "significant influenza vaccme effectiveness could not be demonstrated for any season, age, or setting" examined.

• A study published in the Lancet just two months ago found that influenza vaccination was NOT associated with a reduced risk of pneumonia in older people. Vaccination coverage among the elderly increased from 15 percent in 1980 to 65 percent now, yet there has been no decrease in deaths from influenza or pneumonia.

• That Lancet study supports a similar

study donefive years ago, published in The

New England Journal of Medicine, which concluded that vaccination against pneumonia does not reduce yourriskof contracting the disease.

• Research published intiieAmerican Journal of Respiratory and Critical Care Medicine last month also confirms that there has been no decrease in deaths from influenza and pneumonia, despite the fact that vaccination coverage among the elderly has increased from 15 percent in 1980to 65 percent now.

• Last year, researchers with the National Institute of Allergy and Infectious Diseases, and the National Institutes of Health published this conclusion in the Lancet Infectious Diseases: "We conclude that frailty selection bias and use of non-specific endpoints such as all-cause mortality have led cohort studies to greatly exaggerate vaccine benefits."

• A large-scale, systematic review of 51 studies, published in the Cochrane Database of Systematic Reviews in 2006, found no ev idence that theflu vaccine is any more effective than a. placebo in children. The studies involved 260,000 children, age 6 to 23 months.

For most people, theflu shot does not prevent illness, but actually does the polar opposite-it weakens your immune system and makes you more predisposed to the illness. The people who actually die after contracting the flu do so because they are already sick and have compromised immune systems, and that certainly doesn't have to include you.

In addition to making sure your vitamin D levels are in the optimal range, the following tips are sure-fire ways to improve the function of your immune system and greatly reduce your chances of getting theflu this winter:

Avoid sugar.

• Get plenty of sleep.

• Exercise regularly.

• Eat a whole foods diet

• 0A

Eat garlic regularly.

• Support yourself during stressful times.

Source: http://articles.mercola.eom/sites/articles/archive/2008/l 1/18/do-flu-shots-work-ask-a- vaccine-manufacturer.aspx

COMMENTS:

Mercury in Flu Shots

SHOULD YOU GET THE FLU SHOT?

By RFD Columnist , Dr. Sherri Tenpenny

News reports have been flooding us with articles warning that the impending flu season may be the worst in years. Even though it is difficult to separate the facts from the hype, a close evaluation of the flu vaccine will reveal that serious questions must be raised about the recommendations that are routinely touted, namely high efficacy with little risk. Anyone considering a flu shot should become informed about the substances coming through that needle, and should be determined to investigate the safety and efficacy issues that are still unresolved.

The Vaccine Virus Each year, a new vaccine is developed that contains three different viruses (one influenza В and two influenza A strains). CDC officials select the new viruses based on which viruses were prevalent during the flu season in China and Australia the previous year. The CDC admits that the viruses selected for the new vaccine are chosen on the basis of an "educated guess." [i]

What's in a Flu Shot? The influenza virus is grown in "specific pathogen free" (SPF) eggs. Eggs are tested for a variety of agents—usually between 23 and 31—to confirm the absence of those specific pathogens. Laboratories limit the number of agents that are screened due to the shear abundance of potential viruses and/or bacteria to choose from. In addition, screening for every potential agent would be cost prohibitive.[ii] If none of the tested agents are detected, the vaccine is reported as "pathogen free."

However, it should be understood that there is a distinct difference between "pathogen free" and "specific pathogen free." In its July 1996 report, the Institute of Medicine acknowledged that E2although it is not possible to produce a completely uncontaminated animal, it is possible to produce an animal {or egg] certified to be free of specific pathogens."[iii] Viruses that are harmless to their animal host, however, may be potentially harmful to humans.

During the manufacturing process, antibiotics (neomycin, polymyxin В and gentamicin) are added to eliminate stray bacteria found in the mixture. The final solution can contain the following additives in any combination: Triton X 100 (a detergent); polysorbate 80 (a potential carcinogen); gelatin; formaldehyde; and residual egg proteins. In addition, many of the influenza vaccines still contain thimerosal as a preservative. Thimerosal (mercury) is being investigated for its link to brain injury and autoimmune disease.

Does the Flu Shot Protect? There are no guarantees that the influenza viruses selected for the vaccine will be the identical strains circulating during a given flu season. In fact, it has recently been announced that this year's flu vaccine does not include the strain that is being reported by doctors in the community called the "A Fujian" strain. Outbreaks have been reported in Texas, Colorado and elsewhere [iv] that involve strains that do not match the current flu vaccine. CDC tests have confirmed tha t more than 80 per cent of the 55 strains of influenza virus isolated thus far are the A Fujian strain. Even so, the CDC stil l maintains that the current vaccine could provide cross protection against the new variant, but the fact is, no one knows for sure.

Moreover, the majority of illnesses characterized by fever, fatigue, cough and aching muscles are not caused by the influenza virus. Non-influenza viruses (e.g., rhinoviruses respiratory syncytial virus [RSV], adenoviruses, and parainfluenza viruses) can cause symptoms referred to influenza-like illnesses (ILI). Certain bacteria, such as Legionella spp., Chlamydia pneumoniae, Mycoplasma pneumoniae, and Streptococcus pneumoniae, have been documented as the causes of ILI.[v]

Notably, these microbes are not part of the flu vaccine. Unless an organism's antigen is contained within the vaccine, there is no protection conferred by the vaccine. It Is estimated that most adults will average 1-3 episodes of ILI, and most children will average 3-6 episodes. The CDC also admits that "many persons who have been vaccinated against influenza can still get the flu"[vi]

Targeting the Eiderlv The flu vaccine is generally recommended for persons aged 65 and older, and those with medical conditions who could experience serious complications from the flu. Medical journals report broad differences in effectiveness for the elderly, ranging from 0 to 85%.

The CDC states that 90 % of deaths from influenza occur among the elderly. Considering that nearly 65% of all deaths (from any cause) occur in this age group, it is nearly impossible to prove that flu shots significantly increase life expectancy In this group. The truth is that most people—young and old—will weather a bout of the flu without hospitalization or complications.

A Serious Concern: Alzheimer's Disease Hugh Fudenberg, MD, an immunogenetlcist and biologist with nearly 850 papers published in peer review journals, has 20 reported that if an individual had five consecutive flu shots between 1970 and 1980 (the years studied), his/her chances of getting Alzheimer's Disease is ten times higher than if they had zero, one, or two shots, [vii]

Dr. Boyd Haley, Professor and Chair of the Department of Chemistry at the University of Kentucky, Lexington has done extensive research in the area of mercury toxicity and the brain. Haley's research has established a likely connection between mercury toxicity and Alzheimer's disease, [viii] In a paper published in collaboration with researchers at University of Calgary, Haley stated that "seven of the characteristic markers that we look for to distinguish Alzheimer's disease can be produced in normal brain tissues, or cultures of neurons, by the addition of extremely low levels of mercury."[ix]

Does this prove that the mercury contained in the influenza shot can be directly linked to Alzheimer's? No, absolutely not. But further research in this area is critically needed because the absence of proof is not the "proof of absence."[x]

Flu Vaccine Now for Children The Advisory Committee on Immunization Practices (ACIP) adopted a resolution effective March 1 , 2003 that expanded the use of the influenza vaccine to include children aged 6- 23 months. The recommendations also included vaccinating those aged 2 to 18 years who live in households containing children younger than 2 years of age.[xi] -

The flu vaccine most commonly given to children is Fluzone, a trivalent vaccine grown in chicken eggs. Harvested with formaldehyde and containing the recommended ratio of 15 ug of each of the three prototype viral strains, each dose of Fluzone also contains 25 ug of mercury.[xli] The new CDC recommendations include giving the influenza vaccine to children beginning at six months of age and then annually, for the rest of their lives. Children less than age 9 receiving their first flu shot, two doses of vaccine are recommended, with a minimum interval of one month between the two doses. However,

the CDC does not provide a direct reference t o substantiat e thi s = 0 A recommendation.[xiii]

On June 17, 2003, the FDA approved an intranasal influenza vaccine for use in healthy persons aged 5 49 years. Flumist is a live virus vaccine that can cause a litany of problems.

Alternatives? If you choose not to receive the flu shot, have a discussion with your doctor regarding other options. However, some simple and possibly quite effective things you can do for

yourself to prevent the flu include: 1) avoid white sugar;[xiv] 2) exercise regularly; 3) get adequate sleep; 4) eat a healthy diet, omitting trans fats; 5) drink plenty of purified water daily and 6) wash your hands. A common way people contract viral illnesses is by rubbing their nose or their eyes after their hands have been contaminated with a virus.

The CDC states, "the wash your hands."[xv]

most important thing you can do

t o keep from getting sick is t o

We are so used to taking medications—for prevention and treatment—that it is difficult to comprehend that these modest recommendations are really the most powerful ways to minimize the likelihood of getting the flu.

Making the Decision You may decide t o consult a physician who is schooled in alternative medicine to assess a variety of options for you and your family. What is most important, in the end, is to become as informed as possible regarding your options for keeping healthy and avoiding the flu.

REFERENCES [i] Sabin, Russel and Reynolds. Breakdowns Mar Flu Shot Program Production, distribution delays raise fears of nation vulnerable to epidemic. San Francisco Chronicle. Feb. 25, 2001

0A

[ii]

Charles River Laboratories, A Laboratory Animal Health Monitoring Program:

Rationale and Development,' (Winter 1990); Source: Internet address

[iii] Institute of Medicine Press Release: Federal Guidelines Needed to Ensure Safety in

Animal to Huma n Organ

Transplants. July 17, 1996.

[iv]CBS: The Associated Press. CDC Says Flu Season I s Going Strong i n Parts of U.S.,

Vaccine Doesn't Match Strain Doctors See.

[v]

MMWR. November 9, 2001 / 50(44);984 6

[vi]

MMWR Nov. 9, 2001/50(44); 984 6

[vii]

Hugh Fudenberg, MD, is Founder and Director of Research, Neurolmmuno

Therapeutic Research Foundation. Information from Dr. Hugh Fudenberg came from

transcribed notes of Dr. Fudenberg's speech at the NVIC International Vaccine Conference, Arlington, VA September, 1997. Quoted with permission.

[viii] The Relationship of Toxic Effects of Mercury to Exacerbation of the Medical

Condition Classified as Alzheimer's Disease by Boyd E. Haley, PhD.

20

[ix]

NeuroReport, 12(4):733 737, 2001

[xi]

MMWR. 2002;51[RR 3]:1 31

[xii]

Package insert. Influenza Virus VaccineFluzone® 2003 2004 Formula

[xiii]

MMWR. 2002: 51 [RR 3], pg. 19

[xiv]

All forms of refined sugar depress white blood cells' ability to destroy bacteria. See

Sanchez A, et al. Role of sugars in human neutrophilic phagocytosis. Am J Clin Nutr

1973;26:1180.

[xv]CDC—Handwashing: An ounce of prevention keeps the germs away.

800,000 Doses Of Kids' Flu Vaccine Recalled

Tests Show Vaccine May Not Be Strong Enough To Protect Against Virus

MIKE STOBBE, AP Medical Writer

ATLANTA — Health officials are recalling hundreds of thousands of doses of swine flu vaccine after tests indicated they may not be potent enough to protect against the virus.

The Centres for Disease Control and Prevention notified doctors about the recall Tuesday. The recall involves about 800,000 doses made by Sanofi Pasteur. The doses are pre-filled syringes intended for young children, ages 6 months to almost three years.

Health officials recommend children those ages get two doses, spaced about a month apart.

Health officials say it's not clear how many doses have already been given, but they don't think children need to be re-vaccinated. The lots passed potency tests when they were first shipped, but tests indicate the potency waned after.

70% of FRENCH REFUSE SWINE FLU VACCINEDD

10 November, 2009D

Online poll draws invective comments against H1N1 vaccination of childrenD

Many French remain hostile to H1N1 vaccination, which begins this Thursday for three priority groups: families of babies 6-month old and younger, health personnel and people weakened by other health conditions.

An online poll carried in today's issue of French daily Le Figaro, which tends to draw an

informed,

educated readership,

asks "H1N1: Should we get (our) children vaccinated? 0

Currently running 70 percent "non" (no) the non-scientific poll has drawn not only comments negative toward the vaccine, but often virulent attacks against the vaccination policy.

Below is a representative selection of comments for and against. The author has translated the comments into English.

"No-one really knows the risks that this quickly-thrown-together vaccine poses to test subjects. If, as many doctors say, this vaccine handicaps children for life, whose fault will it be ?"

"Mortal danger! No-one should get vaccinated because that will lead to a catastrophe in 20 "

years. Everyone knows

the sequels that this vaccine leads to

"Dear doctors, scientists and immunologists. According to what I read here, you all seem to have studied one or the other to be able to give us all formal lessons on the subject. Well both my wife and I work in the health sector and we are going to get vaccinated, as are our two children."

"There is no H1N1 flu, there are just 94 million vaccine doses to sell."

"This is political. The French are making a political issue of it. The comments here are lamentable. Moreover, if, god forbid, H1N1 turned out to be more serious than was thought and that there were deaths, the French would do the opposite to what they are saying today."

"Fear, skeptical doctors, no one is satisfied with the efficiency of (his ineffective vaccine) against H1 N1. During the Gulf War the Americans invented a vaccine for soldiers with a lot of ingredients. The results and secondary effects were catastrophic."

"I have spared my children from all vaccinations, including obligatory ones

doing very well."

my children are

"It's precisely the fact that our children are obliged to be vaccinated against certain illnesses that those illnesses no longer exist! If everyone did things like you do, your children would already be seriously ill. Your behavior is egocentric, it lacks civility, and you should be put in front of a judge."

"Crazy! They're talking about vaccinating as many people as possible but we don't even know "

the secondary effects of the vaccine

"France = 65 million doctors!!! It's very fashionable, but (criticizing the vaccine) is at the origin of an enormous wave of disinformation in this country!"

"It's just a way of getting rid of the stockpile. Maybe we will know the truth when a heroic

journalist somewhere is ready to let us know the truth

be patient."

"It's a political conspiracy

weaker people will be those who die the easiest!"

to

kill part of the population. And it just happens that children and

"NO! Not with adjuvants. The German government and the army get vaccines without adjuvants, so why should the French be injected with adjuvants?"

Children to get just half dose of swine flu vaccine | Mail Online

By Mail On Sunday Reporter

Children receiving the swine flu vaccination will now be given only half the original dosage in

a single shot after fears it could cause a high fever.

The Government had previously recommended two separate 0.25ml doses of the Pandemrix vaccine, given three weeks apart.

But after warnings from the European medicines watchdog that the second dose could cause fevers of up to 38C (100F), the Government now recommends one 0.25ml dose for children under ten.

A patient is given a swine flu vaccination: Children are to be given half the previous level of

the vaccine after warnings from the European medicine watchdog

A patient is given a swine flu vaccination: Children are to be given half the previous level of

the vaccine after warnings from the European medicine watchdog It is half the amount given

to adults and older children but still enough to provide immunity.

Children with weakened immune systems will continue to get two doses of 0.25ml each.

The updated safety advice was disclosed days after the start of the second wave of the Government's swine flu vaccination programme.

It aims to inoculate three million children aged between six months and five years - the group deemed most at risk of needing hospital treatment.

Meanwhile, the medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), reported four people had died after receiving the Pandemrix vaccine, although all had serious underlying health conditions and the deaths are not being linked to the jab.

One baby died in the womb three weeks after its mother was given the jab and five women miscarried, although the incidents are being described as 'coincidental'.

One person developed the paralysis condition Guillain-Barre Syndrome which was linked to a swine flu jab given in America in the Seventies.

The MHRA had received 1,506 reports of minor adverse reactions to Pandemrix such as swelling at the site of injection, nausea or 'flu-like' illness.

The Joint Committee on Vaccination and immunisation, which recommended the dosage change, said that children could be given paracetamol if they developed a fever after vaccination. The Department of Health said that the vaccine remained safe.

GSK says still no answer on whether H1N1 vaccine batch triggers more reaction

By Helen Branswell Medical Reporter (CP) - Nov 24, 2009

TORONTO —The investigation into whether a batch of H1N1 vaccine may have triggered a higher-than-normal rate of allergic reactions hasn't yet come up with answers, vaccine manufacturer GlaxoSmithKline said Tuesday.

And health officials in Quebec said they are still trying to determine if the death of an elderly man who died of anaphylaxis after receiving a pandemic flu shot was triggered or hastened by the vaccination.

"Investigations being undertaken by GSK, Health Canada and the Public Health Agency of Canada (PHAC) have not yet been completed," GSK spokesperson Megan Spoore said in an email about the pulled batch of vaccine.

The lot, No. A80CA007A, comprised 172,000 doses of vaccine that were shipped last month to British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and Prince Edward Island.

Quebec did not receive vaccine from the batch under investigation.

After discussions with Health Canada, which regulates vaccines, GSK told provinces last week not to use any more doses from this lot after it came to light that six cases of anaphylaxis had been reported in people who had H1N1 shots from the batch.

The event is raising a lot of questions. Here are some answers:

Q: What is anaphylaxis?

A: Anaphylaxis is a severe allergic reaction that in extreme cases can lead to death. Marked by sudden onset, the reaction can produce hives, cardiovascular problems and swelling of the tissues in the mouth and airways that can compromise breathing.

True anaphylaxis has to meet an internationally accepted diagnostic criterion called the Brighton collaboration case definition. It must involve at least two organ symptoms - in other words, some combination of reactions involving the skin, heart and respiratory systems.

Q: What causes anaphylaxis?

A: Anaphylaxis is an allergic response to exposure to an allergen, a non-pathogenic (i.e. not a germ or a fungus) substance that's capable of triggering a response from the immune system. For some people, pollen is an allergen. For others, peanut protein is.

Why some people are allergic to some things and others are not isn't clear. But when a person with an allergy encounters the specific allergen, his or her immune system generates

a type of antibodies that trigger the release of histamines into their system, says Dr. Scott Halperin, a vaccine expert at Dalhousie University. Histamines induce the response.

Q: How is anaphylaxis treated?

A: True anaphylaxis is treated with epinephrine (adrenaline). That's the stuff in EpiPens carried by people with life-threatening allergies.

Q: Are there any doses of this suspect batch of vaccine left?

A: By the time GSK issued the halt-use order last week, all but about 20,000 doses of the batch had been used, a spokesperson for the Public Health Agency of Canada says.

Q: So that's about six cases of anaphylaxis out of about 152,000 shots given. Is that unduly

high?

A: GSK said in a statement Tuesday that the expected rate of anaphylactic reactions to flu shots is in about one in 100,000.

Q: Is anaphylaxis a reaction seen with other vaccines or just flu shots.

A: "Any time you immunize somebody with something, there's always a chance of an allergic reaction," says Dr. John Treanor, an influenza vaccine expert at the University of Rochester in New York.

And if you vaccinate millions? "Some people are going to have anaphylaxis, absolutely," Treanor says.

Halperin says the rate of anaphylactic reactions will vary depending on the type of vaccine used and the age of the people the vaccine is being given to.

It can even vary by location. Australia saw higher than expected rates of anaphylaxis when it roiled out its HPV vaccine campaign - about 2.6 cases per 100,000 shots, according to one study. But those elevated rates weren't seen in North America.

Q: Why do some people have allergic reactions to vaccines?

A: "For most times people have anaphylaxis, you don't know exactly what it is. And vaccine is

a complex mixture," Halperin says.

Most flu vaccine - and all the flu vaccine used in Canada - is produced in eggs. If there was residual egg protein in the vaccine it could trigger an allergic response in people with egg allergies, he says.

With the combined measles, mumps and rubella vaccine, reactions have occurred that are believed to be due to an antibiotic that is used in the production process, Halperin says.

Q: Why would one batch of vaccine produce more reactions than others?

A: Treanor says that's a difficult question to answer.

"It's hard for me to think of what the mechanism would be for a lot-specific increase in anaphylactic reactions," he says.

Th e only thing that would make sense if it was really true that you were seeing with a specific batch that there were more anaphylactic reactions that there's something in that batch that's

not in the other batches

. that people tend to be allergic to."

H1N1 less lethal than feared: U.K. study

By CBC News

The strain of swine flu virus currently circulating around the world is less deadly than previously thought, say British scientists who compared its effect to that of other pandemic viruses.

The strain of swine flu virus currently circulating around the world is less deadly than previously thought, say British scientists who compared its effect to that of other pandemic viruses.

The 2009 flu pandemic is about 100 times less lethal than the 1918 Spanish flu and nearly 10 times less fatal than the flu pandemics of 1957 and 1968.

Thosefindingswere reported in Thursday's online issue of British Medical Journal, BMJ.

After analyzing British health department data on all reported swine flu patients who were hospitalized between July and Nov. 8 , the researchers estimated that about 26 of every 100,000 people infected with the H1N1 influenza A virus that causes swine flu died. That is a death rate of 0.026 per cent.

Thefindingsare similar to a U.S. study published on Monday that estimated the death rate in the current swine flu pandemic is 0.048 per cent, or one death per every 2,000 cases.

'The first influenza pandemic of the 21st century is considerably less lethal than was feared in advance," England's chief medical officer, Liam Donaldson, and his co-authors from Britain's Health Protection Agency wrote in the study.

In comparison, the fatality rate for the 1918 Spanish flu pandemic was two to three per cent,

compared with around 0.2 per cent for the pandemics in 1957-1958 and 1967-1968. Fatality estimates for previous pandemics were probably less reliable since they were based on statistical methods and death certificates, with few ? if any ? lab confirmations.

Since the past pandemics, there have been advances in medicine such as ventilators to help patients with breathing problems, as well as better housing, health care and nutrition, Donaldson said.

When the World Health Organization declared swine flu had reached a pandemic stage in June, the agency described it as "moderate," with most people infected showing mild symptoms and recovering without medical treatment.

A pandemic designation reflects how widely a virus has spread, not the severity of illness.

Findings not a reason for inaction

Donaldson's study suggested two-thirds of those who died from H1N1 would be eligible for

the H1N1 vaccine under the British government's plan, which prioritizes those at highest risk

of developing complications from the flu.

This includes patients sick in hospital, pregnant women, people with asthma or other underlying health problems and health care workers.

"Viewed statistically, mortality in this pandemic compares favourably with 20th century influenza pandemics. A lower population impact than previous pandemics, however, is not a

justification for public health inaction," the study's authors concluded. "Our data support the priority vaccination of high-risk groups."

Some of the deaths, 38 per cent, occurred in people not considered at high risk.

The findings also reinforced calls to prescribe antiviral medications for people at highrisk or those showing severe symptoms.

Most of the people who died of swineflu in Britain, 78 per cent, had been prescribed antiviral drugs. But of these, 76 per cent did not received them within the first 48 hours of illness as recommended.

Infection rate higher among native populations

Also on Thursday, U.S. health officials said an estimated 15 per cent of Americans had been infected with the H1N1 virus by mid November.

In its weekly report on death and disease, the U.S. Centers for Disease Control and Prevention (CDC) suggested the death rate among the aboriginal population in the U.S. is about four times higher than that of all other racial and ethnic groups combined.

Similarly, indigenous populations in Australia, Canada and New Zealand have been found to have a three to eight times higher rate of hospitalization and death associated with swine flu.

There is a lot of debate about why the rates are higher among aboriginal populations, but it likely reflects environmental conditions such as nutrition in early childhood, access to health care and the a higher likelihood of underlying disease such as diabetes and asthma, said CDC director Dr. Thomas Frieden.

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In early December 2009, it wasjust over 6,000 who had died worldwide from H1N1. One week later, it Is over 10,000 in the US alone and over 50,000,000 who have had it? Since Americans are not being tested for H1N1; since anyone who says ah-choo at any point in their day is told they have'it;and since the government has lied before about these things, they have GOT to think we are all really, really stupid to believe this crap! These are all made up figures (the use of the word estimates is another way of saying - we are making up these numbers to prove our point) and are not worth the e-paper they are printed on.

CDC: About 1 in 6 Americans have had swine flu

December 10, 2009

By MIKE STOBBE AP Medical Writer

Swine flu has sickened about 50 million Americans, and killed about 10,000, according to new estimates released by federal health officials on Thursday.

That means about 1 in 6 Americans have had the illness, said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.

The estimates are for the first seven months of the pandemic, from April through mid- November. The new numbers are a big jump from previous estimates, which said swine flu had sickened 22 million Americans and killed about 4,000 through mid-October.

Most of the increase is due to cases that occurred after early October, when the nation saw the peak of a second wave of illness, CDC officials said.

The CDC also estimates that nearly 200,000 people were hospitalized through mid-November — about the same amount that occurs normally in an entire winter flu season.

While the elderly account for most of the hospitalizations and deaths from seasonal flu, the largest proportion of reported swine flu hospitalizations and deaths are in non-elderly adults, CDC officials said.

More than three-quarters of the deaths were people ages 18 to 64, according to the CDC.

The new estimates seem to echo an unpublished, in-depth CDC analysis of 100 U.S. swine flu deaths. About 80 percent of those deaths were in people ages 20 through 59, and 45 percent were obese, that research found.

Flu estimates are tricky and inexact because many illnesses are relatively mild and go unreported, and hospitalizations and deaths often involve maladies beyond the flu. The CDC actually thinks that between 34 million and 67 million Americans have gotten sick from swine flu, but Frieden gave 50 million as a midpoint estimate.

Flu estimates are also difficult to compare. Seasonal flu kills about 36,000 Americans each year, according to a long-standing estimate. But that number includes many elderly people who had not only seasonal flu and related pneumonia but also heart attacks and strokes. The new CDC swine flu estimates do not include heart attacks and strokes, mainly because there hasn't been time to collect that kind of data.

So it's likely the new estimate is conservative, and undercounts elderly deaths, CDC officials acknowledged.

Even so, the number of hospitalizations and deaths of younger people from swine flu far exceed what normally occurs in the same ages from the winter flu.

This flu is much harder on younger people," Frieden said at a press conference in Atlanta.

The swine flu pandemic has so far hit in two waves in the United States: First in the spring when it was first identified, then a larger wave that started in the late summer.

In late October, 48 states reported widespread flu activity. Increasingly, that appears to have been the peak of the second wave. Since then, fewer states have been reporting widespread cases, and the number of school closings due to swine flu has at times dropped to zero.

But there are still plenty of ill people — as many as during the worst days of many regular flu seasons. And CDC officials have said the signs of declining cases do not necessarily mean the worst is over.

About 15 percent of Americans have had swine swine flu, Frieden said. Between 5 percent and 20 percent of Americans get seasonal flu each year, experts believe.

Even though tens of million of Americans have had swine flu, the majority haven't, so it's still important to get a vaccination, Frieden added. Swine flu vaccine first came out in early October in very limited supplies. But deliveries are increasing dramatically, and now about 85 million doses are available.

Also on Thursday, the CDC released a study that found American Indians and Alaska Natives have died from swine flu at a rate four times greater than other Americans.

The study looked at swine flu deaths in 12 states that are home to about half of the nation's American Indians and Alaska Natives, and counted 42 people in those groups who died of swine flu or its complications by mid-November.

That was a rate of nearly 4 out of every 100,000 people for that group, compared to a rate of about 1 per 100,000 for everyone else.

The finding was not surprising. American Indians and Alaska Natives have higher rates of diabetes, asthma and other conditions that make them more vulnerable. The two groups also have higher poverty rates, and were hit harder than other people during past flu pandemics.

The study is being published in the CDC's Morbidity and Mortality Weekly Report.

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Interview with Epidemiologist Tom Jefferson

07/21/2009 12:19 PM

'A Whole Industry Is Waiting For A Pandemic'

The world has been gripped with fears of swine flu in recent weeks. In an interview with SPIEGEL, epidemiologist Tom Jefferson speaks about dangerous fear-mongering, misguided, money-driven research and why we should all be washing our hands a lot more often.

SPIEGEL: Mr. Jefferson, the world is living in fear of swine flu. And some predict that, by next winter, one-third of the world's population might be infected. Are you personally worried? Are you and your family taking any precautions?

Tom Jefferson: I wash my hands very often - and it's not all because of swineflu.That's probably the most effective precaution there is against all respiratory viruses, and the majority of gastrointestinal viruses and germs as weil.

SPIEGEL: Do you consider the swine flu to be particularly worrisome?

Jefferson : It's true that influenza viruses are unpredictable, so it does call for a certain degree of caution. But one of the extraordinary features of this influenza - and the whole influenza saga - is that there are some people who make predictions year after year, and they get worse and worse. None of them so far have come about, and these people are still there making these predictions. For example, what happened with the birdflu, which was supposed to kill us all? Nothing. But that doesn't stop these people from always making their predictions. Sometimes you get the feeling that there is a whole industry almost waiting for a pandemic to occur.

SPIEGEL: Who do you mean? The World Health Organization (WHO)?

Jefferson: The WHO and public health officials, virologists and the pharmaceutical companies. They've built this machine around the impending pandemic. And there's a lot of money involved, and influence, and careers, and entire institutions! And all it took was one of these influenza viruses to mutate to start the machine grinding.

SPIEGEL: On your Italian homepage, there is a "pandemic countdown" that expires on April 1. Don't you think the situation calls for just a bit more seriousness?

Jefferson: I'm just using it ironically to expose the false certainty that we are fed. Will one-third of the world's population get swine flu? Nobody can say for sure right now. For now, at least, I don't really see any fundamental difference, no difference in the definition between this and a normal flu epidemic. Swine flu could have even stayed unnoticed if it had been caused by some unknown virus rather than an influenza virus.

SPIEGEL: Do you think the WHO declared a pandemic prematurely?

Jefferson: Don't you think there's something noteworthy about the fact that the WHO has changed its definition of pandemic? The old definition was a new virus, which went around quickly, for which you didn't have immunity, and which created a high morbidity and mortality

rate. Now the last two have been dropped, and that's how swine flu has been categorized as a pandemic.

SPIEGEL: But, year after year, 10,000 30,000 people in Germany alone die from influenza. In the Western world, influenza is the most deadly infectious disease there is.

Jefferson: Hold on! These figures are nothing more than estimates. More than anything, you

have to distinguish

Both of them have the same symptoms: a sudden high fever, a sore throat, coughing,

rheumatic pain in the back and legs, possible bronchitis and pneumonia. But realflues,real influenzas are only caused by influenza viruses, while there are more than 200 different

between an influenza like illness and

a genuine flu, the real influenza.

viruses that

deaths, you always get other causes of death caused by other viruses mixed in. Now, in the

case of elderly people who die of pneumonia, nobody would do a postmortem tofigureout if it

was really

cases are caused by influenza viruses. It's a very small percentage. What I know is that real

cause influenza like illness. When it comes to figures related to so called flu

an influenza virus that killed them. Approximately 7 percent of influenza like illness

influenza is systematically overestimated.

SPIEGEL: And what about the 200 other kinds of viruses?

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Jefferson: They're not as popular as influenza. Researchers are just not as interested in that. Take rhinovirus, a horse derived virus. It's the most commonly isolated agent in common colds. There are a hundred different types of these rhinoviruses. They usually only cause a normal runny nose, but they can be deadly, too. Or so called RSV, the human respiratory syncytial virus, that is highly dangerous to infants and small children.

SPIEGEL: So why aren't researchers interested in it?

Jefferson: It's easy: They can't make money with it. With rhinoviruses, RSV and the majority of the other viruses, it's hard to make a lot of money or a career out of it. Against influenza, though, there are vaccines, and there are drugs you can sell. And that's where the big money from the pharmaceuticals industry is. It makes sure that research on influenza is published in the good journals. And that's why you have more attention being paid there, and the entire research field becomes interesting for ambitious scientists.

SPIEGEL: But is there any scientific reason to be interested in influenza viruses?

Jefferson: The strict focus on influenza is not only misguided; it's also dangerous. Do you remember something called SARS? That was a truly dangerous epidemic. It was like a meteor: It came and it went quickly, and it killed a lot of people. SARS took us by surprise because it was caused by a completely unknown Coronavirus. Where did it come from? Where did it go? Or is it still here? We still don't know. There are lots of other strange things like that coming out. Every year, a new agent is identified. For example, there's something

called bocavirus, which can cause bronchitis and pneumonia in small children. And there's something called metapneumovirus, which studies say is responsible for more than 5 percent of allflu-relatedillnesses. So, we should keep our eyes open in all directions!

SPIEGEL: But the great pandemic of 1918/1919 was caused by an influenza virus, and it killed up to 50 million people around the world. Or do scientists contest that?

Jefferson : It's very well possible that it was, but there are many aspects about the 1918/1919 pandemic that still puzzle us. It was only 12 years ago that we learned that the H1N1 virus caused it. But there was also a lot of bacterial activity going on at the time. And it's particuiaríy unclear why the mortality rate for the flu dropped so dramatically after World War II. Today, you only get a fraction of what was standard before the war. When it comes to the later pandemics, such as the "Asianflu"of 1957 or the "Hong Kongflu"of 1968/69, you can barely detect them as exceptional figures when it comes to death statistics as a whole.

Contradictions between Scientific Findings and Practice

SPIEGEL: So why should we even speak of pandemics at all?

Jefferson: That's something you should ask the World Health Organization!

SPIEGEL: In your opinion, what do you think it takes to make a virus like the swine flu a global threat?

Jefferson: Unfortunately, we can only say that we don't know. I suspect that the whole issue is much more complex than we are even able to imagine it today. Given all the viruses that produceflu-likesymptoms, perhaps Robert Koch's postulate that one particular pathogen causes one particular disease doesn't go far enough. Why, for example, do we not get influenza in the summertime? In the end, the pathogen is there all year long! Already in the 19th century, the German chemist and hygienist Max von Pettenkofer had developed a theory about how the pathogen's contact with the environment can alter the disease. I think that research in this direction would be worthwhile. Perhaps it would allow us to understand the pandemic of 1918/1919 better or to be able to assess the dangers of swine flu.

SPIEGEL: Humans have better defenses today than they did in 1918, and it probably won't be long before we have a swine flu vaccine. Last week, Germany's federal government announced that it wanted to buy enough for 30 percent of the population. How much do you think that will protect us?

Jefferson: When it comes to pandemic vaccination, as we say in English, the proof is in the pudding. The proof is in using it. We'll see. It does generate an antibody response, but will it really guard against the disease?

SPIEGEL: Are you pessimistic about that?

Jefferson: No, I'm just saying I think we're about to find out (laughter). Let's have this conversation again in about a year's time, shall we?

SPIEGEL: For a number of years, as part of the Cochrane Collaboration, you have been systematically evaluating all the studies on immunization against seasonal influenza. How good does it work?

Jefferson: Not particularly good. An influenza vaccine is not working for the majority of influenza-like illnesses because it is only designed to combat influenza viruses. For that reason, the vaccine changes nothing when it comes to the heightened mortality rate during the winter months. And, even in the best of cases, the vaccine only works against influenza viruses to a limited degree. Among other things, there is always the danger that theflu virus in circulation will have changed by the time that the vaccine product isfinishedwith the result that, in the worst case, the vaccine will be totally ineffectual. In the best of cases, the few

decent studies that exist show that the vaccine mainly works with healthy young adults. With children and the elderly, it only helps a little, if at all.

SPIEGEL: But aren't those the exact groups that influenza immunization is recommended for?

Jefferson: Indeed. That's one of the contradictions between scientific findings and practice, between evidence and policy.

SPIEGEL: So, what's behind this contradiction?

Jefferson: Of course, that has something to do with the influence of the pharmaceutical industry. But it also has to do with the fact that the importance of influenza is completely overestimated. It has to do with research funds, power, influence and scientific reputations!

SPIEGEL: So, at the moment is it reasonable to keep vaccinating against seasonal influenza?

Jefferson: I can't see any reason for it, but I'm not a decision maker.

SPIEGEL: And what about Tamiflu and Relenza, two of the anti-flu medications that are being deployed against swine flu? How well do they really work?

Jefferson : If taken at the right time, on average, Tamiflu reduces the duration of a real influenza by one day. One study also found that it diminishes the risk of pneumonia.

SPIEGEL: Could these medications lower mortality rates associated with the flu?

Jefferson : That's possible, but it has yet to be scientifically proven.

SPIEGEL: And what about side effects?

Jefferson: Tamiflu can cause nausea. And there are things that point toward psychiatric side effects. There are reports coming out of Japan that young people who have taken Tamiflu have had acute psychotic reactions similar to those found in schizophrenics.

SPIEGEL: So, is it sensible to use such medications at all?

Jefferson : When it comes to severe disease, yes. But under no circumstances should Tamiflu be handed out to whole schools, as is currently sometimes being done. With that being the case, it doesn't surprise me at all that we're already hearing reports about resistant strains of swine flu.

SPIEGEL: In Germany, the government is supposed to stockpile flu medications for 20 percent of the population. Do you see that as being sensible?

Jefferson: Well, at least there are much cheaper ways to accomplish a lot more. For example, school children should be taught to wash their hands regularly — preferrably after every class! And every airport should install a couple hundred wash basins. Whoever gets off a plane and doesn't wash their hands should be stopped by the border police. You could tell for example by putting an invisible, neutral dye in the water. And wearing masks can be sensible, as well.

SPIEGEL: Has it really been shown that these measures work?

Jefferson : There are several good studies on this that were done during the SARS epidemic. They are so-called case-control studies that examined individuals that had had close contact with the SARS virus. They compared the characteristics of those who had been infected with the virus through this contact with those of people who had not been infected. These studies resulted in very clear results.

SPIEGEL: You sound pretty impressed.

Jefferson: I am. What's great about these measures is not only that they are inexpensive, but also that they can help against more than just influenza viruses. This method can fight against

the 200 pathogens that bring aboutflu symptoms as well as against gastrointestinal viruses and completely unknown germs. One study done in Pakistan has shown that hand washing can even save children's lives. Someone should get a Nobel Prize for that!

SPIEGEL: Mr. Jefferson, we thank you for this interview.

Interview conducted by Johann Grolle and Veronika Hackenbroch.

Australian Scientist Repeats - Swine Flu Lab-Escape Claim in Published Study

By Simeon Benne

Nov. 24 (Bloomberg) - Adrian Gibbs, the virologist who said in May that swine flu may have escaped from a laboratory, published hisfindingstoday, renewing discussion about the origins of the pandemic virus.

The new H1N1 strain, which was discovered in Mexico and the U.S. in April, may be the product of three strains from three continents that swapped genes in a lab or a vaccine- making plant, Gibbs, and fellow Australian scientists wrote in Virology Journal. The authors analyzed the genetic makeup of the virus and found its origin could be more simply explained by human involvement than a coincidence of nature.

Their study, published in a free, online journal reviewed by other scientists, follows debate among researchers six months ago, when Gibbs asked the World Health Organization to consider the hypothesis. After reviewing Gibbs' initial three-page paper, WHO and other organizations concluded the pandemic strain was a naturally occurring virus and not laboratory-derived.

"It is important that the source of the new virus be found if we wish to avoid future pandemics rather than just trying to minimize the consequences after they have emerged," Gibbs and colleagues John Armstrong and Jean Downie said in today's eight- page study.

Gibbs and Armstrong are on the emeritus faculty at the Australian National University in Canberra and Downie is affiliated with the Centre for Infectious Diseases and Microbiology Laboratory Services at Sydney's Westmead Hospital, according to the study.

While the exact source of the new H1 N1 strain is a mystery, their research has "raised many new questions," they said. The authors compared the genetic blueprints of flu strains stored in the free database Genbank and found the pandemic virus's nearest ancestors circulate in pigs.

'Simplest Explanation'

While migratory birds may have acted as conduit for their convergence, human involvement in bringing them together is "by far the simplest explanation," Gibbs said in a telephone interview today.

Gibbs wrote or coauthored more than 250 scientific publications on viruses, mostly pertaining to the plant world, during his 39-year career at the Australian National University, according to biographical information on the university's Web site.

"Knowing Adrian Gibbs, he will have thought through it pretty logically and come to that conclusion," Lance Jennings, a clinical virologist with Canterbury Health Laboratories in Christchurch, New Zealand, said in a telephone interview, "it's up to someone else to try and prove it or disprove it."

Just one in five diagnosed with swine flu on hotline actually had the disease | Mail Online

By Daniel Martin

Last updated at 8:09 AM on 09th December 2009

Hundreds of thousands of people were wrongly diagnosed with swine flu after calling the Government's emergency helpline, it was revealed yesterday.

Around 800,000 people were incorrectly told to stop work and take the Tamiflu drug, costing employers hundreds of millions of pounds and adding to the NHS drug bill.

In fact just one in every five people diagnosed by the controversial call centres actually had the illness.

Research published today has revealed that just one in five people diagnosed with swine flu by the National Pandemic Flu Service actually had the illness

And at the height of the scare during the summer the rate fell to as low as one in 20, the Health Protection Agency disclosed.

The revelation came as a survey concluded there was no clear evidence that Tamiflu reduced the risk of life-threatening complications.

The Government's pledge to vaccinate all under-fives against swine flu this month was also mired in chaos as GPs pulled out of the scheme in a row over cash.

Just 20 per cent of ail cases diagnosed by the National Pandemic Flu Service were actually cases of swine flu, HPA scientists found. Everyone diagnosed by the service was given vouchers to get Tamiflu.

It means that more than 800,000 of the 1 million packets of Tamiflu - which cost around £15 each - were given out needlessly.

In the busiest week 40,000 doses of Tamiflu were dished out - yet now it would appear that 95 per cent - 36,000 packets - should not have been.

It could also mean that millions of working days were lost by people taking time off claiming to have been hit by the pandemic.

Businesses say the mistakes have lost them more than £500million after thousands took the opportunity to take swine flu 'sickies'.

This will also raise concerns that the system could have encouraged the virus to become resistant to Tamiflu.

Critics have attacked ministers for handing out the drug in such huge quantities at the beginning of the outbreak, when it was feared that up to 65,000 may die.

Now the expected death toll has been revised to less than 1,000 - with 270 having died so far, of whom 80 per cent had other illnesses or underlying conditions.

Scientists warned in the summer that handing out the antiviral to healthy people could be a bad move, because a more resistant form of the virus could be dangerous in those with underlying health problems which makes them more likely to die from the disease.

Two weeks ago it emerged that thefirstcase of Tamiflu-resistant swine flu being passed from person to person had occurred in Wales.

The Government's swine flu call centres, staffed by unqualified students and temps, were set up to take the strain off GPs' surgeries.

More than 800,000 of the one million packets of £15 Tamiflu were prescribed needlessly. Millions of working days were lost by people taking 'swineflu sickies'

People with suspected swineflu were told to ring the helpline or a related internet site to get the antiviral rather than visit their doctors. The requirement to get a sick note from the GP was waived.

Similar tests of patients diagnosed by GPs found half of their patients were also misdiagnosed.

Liberal Democrat health spokesman Norman Lamb said the potential danger to misdiagnosed patients is 'seriously concerning'.

'Ministers had years to prepare for such an outbreak but completely failed to put in place an effective flu-line service,' he added.

And Mark Wallace, of the Taxpayers' Alliance, said: 'If call centres were so inaccurate, then it suggests this was more about PR than medical treatment. In effect, this was a very expensive press release.'

A Department of Health spokesman insisted the 'best scientific advice' states Tamiflu should still be taken as soon as possible. To suggest otherwise is potentially dangerous,' he added.

The Truth About Tamiflu

- The Atlantic (December 10, 2009)

Two months ago, we pointed out ¡n our story on flu in The Atlantic that the antiviral drug Tamiflu might not be as effective or safe as many patients, doctors, and governments think. The drug has been widely prescribed since the first cases of H1N1 flu surfaced last spring, and the U.S. government has spent more than $1.5 billion stockpiling it since 2005 as part of the nation's pandemic preparedness plan.

Now it looks as if our concerns were correct, and the nation may have put more than a billion dollars into the medical equivalent of a mirage. This week, the British medical journal BMJ published a multi-part investigation that confirms that the scientific evidence just isn't there to show that Tamiflu prevents serious complications, hospitalization, or death in people that have the flu. The BMJ goes further to suggest that Roche, the Swiss company that manufactures and markets Tamiflu, may have misled governments and physicians. In its defense, Roche stated that the company "has never concealed (or had the intention to conceal) any pertinent data."

The BMJ's investigation began innocently enough, with an update of a review by the Cochrane Collaboration, a widely-respected international consortium of researchers who periodically examine the medical literature to assess the safety and effectiveness of various treatments. Roche has claimed that its drug reduces hospital admissions by 61% in patients who were otherwise healthy before they got the flu. It has also said that Tamiflu reduces such complications as bronchitis, pneumonia, and sinusitis by 67%, and lower respiratory tract infections requiring antibiotics by 55%. A 2006 Cochrane review of Tamiflu came to similar conclusions—based largely on a paper that looked at ten studies, all of them funded by the company.

The dog ate my homework

But when the Cochrane team, led by Chris Del Mar, from Bond University in Australia, re-examined the studies they had previously used in 2006, they found some discrepancies. It turned

out that only two of the ten studies had ever been published in medical journals, and those two showed the drug had very little effect on complications compared to a dummy pill, or placebo. So the Cochrane reviewers decided to look at the data for themselves.

First they went to the lead authors of the published studiets—the researchers who were supposed to have access to all of the data. One author said he had lost track of the data when he moved offices and the files appeared to have been discarded. The other said he'd never actually seen the data himself, and directed the Cochrane team to go directly to the company.

Four months and multiple requests later, the Cochrane researchers had a hodgepodge of data from the company, including two studies that showed the drug was ineffective, but which the company had never published. Roche also provided data from a third study, which involved 1,447 adults and adolescents aged 13-80, the largest study of the drug ever conducted. Yet the company never published that one either. (A summary of this and other studies is available at www.roche- trials.com). But with only partial data, the Cochrane team couldn't even figure out what the study had been intended to measure.

In the meantime, two former employees of Adis International, a large communications company, came forward with documents showing they had ghostwritten some of the published studies of Tamiflu. One of the ghostwriters told the BMJ, "The Tamiflu

accounts had a list of key messages that you had to get in. It was run by the [Roche] marketing department and you were

answerable to them. In the introduction

problem influenza is. I'd also have to come to the conclusion that Tamiflu was the answer."

I had to say what a big

Stockpiling

The Cochrane team eventually concluded that the evidence that Tamiflu reduces complications, hospitalizations, or deaths is weak at best, and if the drug does offer any benefit, it is slight indeed. This is precisely the conclusion of the U.S. Food and Drug Administration (FDA), and the UK's National Institute for Health and Clinical Excellence (NICE). As we reported in our story in The Atlantic, the FDA directed Roche to state on the drug's label the following caveat: "Tamiflu has not been proven to have a positive

impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza." An FDA spokesperson told the BMJ, 'The clinical trials . failed to demonstrate any significant difference in rates of hospitalization, complications, or mortality in patients receiving either Tamiflu or placebo." Yet in the wake of the H1N1 pandemic, the FDA gave temporary approval for the drug to be given to hospitalized flu patients, who are at risk of dying.

Another big unknown is just how safe—or dangerous—Tamiflu may be. According to an FDA spokesperson, side efTects may include potentially fatal heart problems. If the drug is going to be used to prevent death, it seems reasonable to ask whether or not its potentially deadly side effects are outweighed by potential benefits. We asked the FDA whether it had required Roche to conduct an additional trial or trials looking at whether or not, on balance, the drug reduces more serious complications than it causes. This week, a spokesperson reported back that there has been no such request made to Roche.

All of which leaves open the question of why governments around the world have invested so much—on the order of $3 billion since the emergence of H1N1 last spring, according to investment bank, JP Morgan—in a drug that appears to do so little.

The answer may lie in the politics of disease. Far from a commercial success when it was initially approved by the FDA in 1999, Tamiflu's fortunes began to look up in 2003, after the SARS outbreak and the emergence of bird flu. Then Hurricane Katrina hit. In the wake of criticism over ¡ts handling of the disaster in New Orleans, the Bush Administration announced a multi-billion-dollar pandemic and bioterrorism preparedness strategy, which included stockpiling millions of doses of Tamiflu.

As the nation's lead public health agency, the Centers for Disease Control and Prevention appears to be operating in some alternative universe, where valid science no longer matters to public policy. The agency's flu recommendations are in lockstep with Roche's claims that the drug can be life-saving—despite the FDA's findings and despite the lack of studies to prove such a claim. What's more, neither the CDC nor the FDA has demanded the types of scientific studies that could definitively determine whether or not the company's claims are true: that Tamiflu reduces

the risk of serious complications and saves lives. Nancy Cox, who heads the CDC's flu program, told us earlier this year she opposes a placebo-controlled study (in which one half of patients would be given Tamiflu and the other half would be given placebo), because the drug's benefits are already proven.

There are a couple of take-home messages here. One is pretty obvious: Tamiflu may not be doing much good for patients with the flu who take it, and it might be causing harm. The more important issue, however, involves the need for trust in science and medicine. Governments, public health agencies, and international bodies such as the World Health Organization, have all based their decisions to recommend and stockpile Tamiflu on studies that had seemed independent, but had in fact been funded by the company and were authored almost entirely by Roche employees or paid academic consultants. So did the Cochrane Collaboration, at least in its earlier assessments of Tamiflu. Millions of flu patients have taken the drug as a result.

That trust appears to have been misplaced, and a drug touted as beneficial on the basis offlimsyevidence has by now become so entrenched that no one appears willing to conduct the sort of study needed to prove whether or not it can, in fact, save lives.

Reports probe Tamiflu benefits, call for clinical data transparency

Lisa Schnirring Staff Writer

Dec 9,2009 (CIDRAP News) - In an update of a review on the role of neuraminidase inhibitors in seasonal flu prevention and treatment, the authors reversed a previous conclusion that oseltamivir (Tamiflu) prevents complications like pneumonia in healthy patients because they were unable to reconstruct the data in one of the key studies that found a benefit.

The review was published today in the British Medical Journal (BMJ), along with an investigation that the journal conducted with England's Channel 4 News on the authors' attempts to obtain the raw data from Roche, which supported the earlier studies and is the maker of Tamiflu.

The BMJ's investigative report and an accompanying editorial say difficulties the review authors had in verifying the data cloud government stockpiling policies and point to other problems with drug company transparency in the drug approval process and medical journal pubHshing practices. They also wrote that an earlier Cochrane Library review, published in 2006, should have been more rigorous.

Though today's BMJ articles focus on seasonal flu and healthy patients, they may have implications for pandemic flu, because Tamiflu is the drag of choice for managing H1N1 infections, especially in those with severe illness and those at high risk for complications.

Analysis includes 20 studies The research team, which included experts from Australia and a doctoral student from the Massachusetts Institute of Technology, analyzed 20 published trials on neuraminidase inhibitor use in seasonal flu that focused on prevention, treatment, and adverse reactions. However, they dropped eight trials that were included in the 2006 review, because they were never published and the researchers weren't able to verify the results. According to the BMJ investigative report, Roche wouldn't send the authors the raw data without a signed confidentiality agreement.

They concluded that neuraminidase inhibitors have a modest effect against seasonal flu symptoms in healthy adults, but a scarcity of good data undermines the previousfindingthat Tamiflu is useful in preventing flu complications. The investigators wrote that independent randomized trials are needed to resolve uncertainties.

During negotiations with the authors over the raw data, Roche sent them a group of observational studies. An analysis of those studies in the same issue of BMJ found that oseltamivir may reduce the risk of pneumonia in healthy patients who haveflu,but the benefit is small and side effects and safety should be considered. The authors of the analysis also said interpreting the observational studies was difficult, because some patients were included in more than one study.

In an editorial in the same issue oí BMJ, the journal's editor-in-chief, Dr Fiona Godlee, and Mike Clarke, director of the Cochrane Centre in Oxford, England, wrote that Roche hasn't done anything wrong by current pharmaceutical standards, but they said the current system isn't working and "gives a false sense of security."

They wrote that drag company studies are often shrouded in secrecy and aren't always subject to full independent review. They call for more publicly funded trials and said governments should pass laws requiring access to raw data on licensed drugs.

Data access limited Fred Hayden, MD, a virologist at the University of Virginia and coordinator of influenza activities at the Wellcome Trust, an independent medical research funding charity based in London, was the corresponding author of an analysis that included raw data from some of the Roche-supported studies that Australian researchers couldn't obtain from Roche. That report, published in a 2003 issue ofArchives of Internal Medicine, has been widely use to support Tamiflu use for preventingflu-relatedpneumonia and hospitalizations. Hayden said that after several moves he was unable to track down the raw data and advised them to request itfromRoche.

Hayden told CIDRAP News that the 2003findingsare still valid and that he supports the researchers' access to the primary data. Roche said in a response to BMJlhat it would provide the raw data to researchers who have a legitimate need for it on a password-protected Web portal. "There's no question that this is the right thing to do," Hayden said.

The new BMJ review might send a confusing message to clinicians who are in the midst of treating pandemic H1N1 patients, Hayden said. He

said the review focuses on uncomplicated seasonal influenza, and he cautioned physicians not to generalize too broadly from it in their management of pandemic HiNi cases.

Studies on patients with H5N1 avian influenza infections from different countries have shown that early oseltamivir treatment can reduce mortahty, and clinicians are seeing the same pattern for patients with pandemic H1N1 flu.

Hayden is part of a World Health Organization (WHO) panel of antiviral experts that met in June to update WHO guidance for pandemic H1N1 management. He said the group meets again in January to review the most recent data, and he doesn't think the BMJ review will have much of an impact on the discussions.

WHO evaluating reports Charles Perm, PhD, a scientist with the WHO's global influenza program, told CIDRAP News that the WHO is still evaluating all of the BMJ reports to see how they might affect its antiviral guidelines. However, he said the review isn't based on any new evidence and that its conclusions contain findings about neuraminidase inhibitor use that are already well known, such as a modest benefit in otherwise healthy patients.

He pointed out that the pandemic H1N1 virus is affecting a different age range than seasonal flu, with a small number of very severe cases, including some involving viral pneumonitis. Researchers are building up a body of evidence from 6 months of clinicians' experience in managing pandemic H1N1 patients, and the data suggest oseltamivir is having an impact on severity and hospitalizations.

When queried about a response from the Centers for Disease Control and Prevention (CDC) to the BMJ review, CDC spokesman Tom Skinner referred CIDRAP News to a recent perspective article by Tim Uyeki, MD, MPH.

Uyeki, a medical epidemiologist in the CDC's Influenza Division, wrote in a Nov 18 article in the New England Journal ofMedicine that evidence "supports the benefit of neuraminidase inhibitors (oseltamivir or zanamivir) in reducing complications, including deaths, among hospitalized patients with 2009 pandemic influenza A (H1N1)."

Uyeki cited three observational studies of oseltamivir in seasonal flu that showed reduced mortality in hospitalized patients.

"Taken together," Uyeki concluded, "although data are limited, findings

of observational studies all point in the same direction, suggesting benefit of early neuraminidase inhibitor treatment for hospitalized influenza patients as well as for patients presenting >48 hours after illness onset."

Some conclusions already accepted Vincent Racaniello, PhD, professor of microbiology at Columbia University and author of Virology Blog, told CIDRAP News that the BMJ studies are well done and the conclusions are valid, but he said

scientists have known for a long time that neuraminidase inhibitors are marginally effective. "They were approved because there are no other

antivirale available,"

they work about 70% of the time in reducing symptoms by a day. That's been known for years and these meta analyses confirm that."

he said. "In people with lab confirmed influenza,

He said the new BMJ review's conclusion that there is no benefit from postexposure prophylaxis for influenza like illness contradicts earlier studies, but he said some of the illnesses might not have been flu and may not have been affected by neuraminidase inhibitors. "That's one reason why the authors of this study call for more trials," Racaniello said. The other reason they support more study is because they're not sure that the drugs don't prevent complications, he added.

The issue the BMJ articles raise about the release of clinical trial data is "terrific," Racaniello said. "This is immediately relevant because, for example, many people would Uke t o see th e results of H1N1 clinical trials before deciding to take the vaccine. They aren't widely available, yet the vaccine is in use," he added.

Racaniello predicted that the new review won't have much affect on policies regarding the use of neuraminidase inhibitors. The drags help, even if experts aren't sure if they help with complicated influenza, he said. "The study emphasizes the fact that we don't have very good drags against influenza and we need to have more. Some are in development, but it's not enough."

Jefferson T, Jones M, Doshi P. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta analysis. BMJ 2009 Dec 85339 (Early online pubHcation).

г / Ъяю б

Cohen D. Complications: tracking down the data on oseltamivir. BMJ 2009 Dec 8; web extra Abstract:

я/Ь.«*а87

Freemantle N, Calvert M. What can we learn from observational studies of oseltamivir to treat influenza in healthy adults? BMJ 2009 Dec 8;339 Full text: http://www.bmj.com/cgi/content/full/33Q/dec07 2/b5248

Godlee F, Clarke M. Why don't we have all the evidence on oseltamivir? BMJ 2009 Dec 85339 (Editorial) Full text: http://www.Dmvcom/cgi/content/full/.4.4Q/deco8 a/bfiasi

See also:

Uyeki T. Antiviral treatment for patients hospitalized with 2009 influenza A (H1N1). N Engl J Med 2009 Nov 18 Full text: http://hini.nejm.org/?p=ii88

Swine flu: £500million spent on Tamiflu but British Medical Journal says it doesn't work

An investigation by the British Medical Journal has found no robust data to prove that Tamiflu prevents swine flu from becoming a serious condition.

In what could prove an acute embarrassment to the Government, analysis by two teams of academics suggests that the benefits of Tamiflu were vastly over-estimated. And it could call into question the Government's decision to spend £50omillion stockpiling the drag.

The research, published in the BMJ online, reviewed a number of studies looking at how well Tamiflu works in otherwise healthy patients. Some of the data was provided by the drug's manufacturer Roche. But after some research was thrown out of the analysis, experts said they could only find evidence to prove Tamiflu reduces the length of illness by a day.

Although they admitted it was of great use in reducing the severity of swine flu in people with underlying health conditions, they said this was not the case in "healthy" swine flu victims.

Dr Fiona Godlee, editor-in-chief of the BMJ, said there was not enough good research on Tamiflu to prove it works on healthy patients. "Governments around the world have spent billions of pounds on a drag that the scientific community now finds itself unable to judge," she said.

The news came as another area of the Government's pandemic flu campaign also descended into chaos. Health Secretary Andy Burnham announced that under-fives will be offered the swineflujab in the next three weeks.

But it quickly emerged that GP leaders were not on-board with the plan, following a row over how much they would be paid. While the Government wants to pay £5.25 for each jab given, the British Medical Association said this was not enough.

The impasse means local health bosses will have to step into the breach and negotiate a pay deal with family doctors or ask pharmacists and district nurses to provide the jabs instead.

Last night the Government stood by its decision to offer Tamiflu to all patients. A spokesman said: "On November 30 the Scientific Advisory Group for Emergencies reviewed the most up-to-date available evidence on anti-viral use and concluded that it clearly continues to point towards a benefit in those with severe illness."

A

spokesman for Roche said that they "firmly believe in the robustaess

of

the data".

Girlfightsfor life as Tamiflu Ъш is face' | The Sun |News

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Helpline staff told 18 year old Samantha Millard she probably had the killer bug and to take the antiviral drug. But after popping just three pills Samantha developed blisters on her body.

Doctors now fear the drug triggered life threatening Stevens Johnson syndrome, which causes chunks of skin to fall off.

The horror condition affects just three in a million people. If it doesn't kill a victim they are left covered in scars.

Samantha's shocked mum Deborah took a photograph of her at home on Friday two days after taking Tamiflu. But hours later the teen who hopes to become an air hostess was in intensive care unable to breathe on her own. Last night her condition had deteriorated and she was transferred to a specialist burns unit at Chelsea and Westminster Hospital, West London.

Deborah and Samantha's sister Charley, 23, were keeping vigil at her hospital bedside. Samantha had called her GP in Bicester, Oxon, after suffering flu-like symptoms. But she was told to call the helpline.

An operator said her headache and runny nose was probably swine flu and to take Tamiflu. Last night angry Deborah, 41, blasted the helpline staff. She said: "It shouldn't be the case that people with no medical background can make these decisions. "These people are just Joe Bloggs off the street. My daughter could die because of this. Her condition is getting worse."

She added: "The doctor said because the rash appeared after she took Tamiflu it was probably caused by Tamiflu." Tamiflu maker Roche is investigating the case.

A spokesman said it was "difficult to determine the role" Tamiflu played

but it could not be ruled out that it played a part in triggering the

syndrome. The Department for Health defended the helpline.

A spokesman added: "Serious reactions to Tamiflu are extremely rare

and it should still be taken as soon as possible, especially for very serious swineflucases."

Meningitis

Meningitis

meningitis vaccine cause or cure?

This article by Meryl Dorey is the first in a series of 4 on the new

vaccines

that the government

proposes

to introduce

into the

Australian

Childhood

Vaccination Schedule.

Next issue will cover Prevenar, the vaccine against

Pnuemococcal

disease,

followed

by an article on the Chicken Pox

Vaccines, finishing up with an in depth look at both Oral and Injected

Polio

vaccination.

The Parting Shot in our last issue showed a terribly poignant picture of a happy, smiling baby with arrows pointing to different parts of his anatomy demonstrating how 7

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shots (many of them

polyvalent vaccines' such as DPT and MMR) can be administered in one office visit. The number of vaccines our children are being challenged (some may say assaulted) with is increasing exponentially.

Fifteen years ago, children received 4 DPT's (Diphtheria, Tetanus, and Pertussis), 4 OPV's (Oral Polio) and one MMR or MR (Measles. Mumps and Rubella or Measles, Rubella), a total of 1S or 19 vaccines depending upon the child's sex. This was still a lot more than they received 15 years before that, but it is less than half of the number of vaccines in today's proposed schedule.

Today, children receive Hib (Haemophilus Influenzae type B) and Hep В (Hepatitis B) vaccines, and MMR is recommended for boys as well as for girls with an initial shot at 12 montiis and at least one booster before school.

page 10

Recently, the government has begun to consider adding yet more vaccines to the childhood vaccination schedule. These include Varicella (Chicken Pox), Meningitec (Meningococcal),

Prevenar (Pneumococcal) and IPV (Injected Polio) to replace the OPV (Oral Polio Vaccine) and hopefully do away with vaccine associated paralytic

poliomyelitis (VAPP).

recommendations for children to receive the Influenza vaccine.

All of these shots are already licensed and available to Australian parents. If they are added to the schedule however, the government will subsidise their use and parents must either vaccinate according to schedule or register as conscientious objectors in order to receive certain financial entitlements.

Prevenar is given in a 4 dose schedule for infants (the schedule varies depending upon the age at which vaccination is started for more details on this or any other Australian vaccine, check the AVN's website http://www.avn.org.au for package

In addition, there are now

inserts). Meningitec is given as 3 doscs to infants. Varicella vaccine is given as a single dose to infants or 2 doses to adults and adolescents. Injected Polio is a 4 dose schedule.

If infants are vaccinated according to this proposed schedule, they will receive 40 vaccines by the time they start kindergarten.

Some of these vaccines are so new (both Prevenar and Meningitec were only approved in in February and October 2000 respectively) that their package inserts state there is no long term safety or effectiveness data.

There is scope for an in depth article on all 4 of these new proposed vaccines, but for this issue, I have decided to focus my attention on the one meant to prevent Meningitis Meningitec. Prevenar is being touted as an ear infection vaccine though Pneumococcal infections arc also associated with Bacterial Meningitis. A future article will investigate this vaccine more

thoroughly.

Basically, meningitis is an infection of the

Meninges the membranes that surround the central nervous system (the brain and the spinal cord). The Meninges is the prime defender of this sensitive and vital area of the human anatomy and what is meant when someone talks about the

blood brai n

without our brains, the body has devoted a lot of resources towards ensuring that infections cannot enter this most sensitive area. The blood brain barrier usually does a very good job in protecting us from these sorts of dangerous illnesses. There are times, however, when for one reason or another, our defences are not enough and we can develop either Meningitis or Encephalitis (literally an inflammation of the brain).

barrier. Because we cannot function

Viral Meningitis is generally milder than Bacterial Meningitis. It is also most often self limiting with only a small chance of any long term problems.

Bacterial Meningitis, however, can be a dreadful disease. It has a very rapid onset and can kill within hours of the first symptoms appearing. The classic symptoms of Meningitis (particularly of Bacterial Meningitis) include fever, headache, vomiting, sensitivity to light (photophobia), irritability, severe fatigue (lethargy), stiff neck, and a reddish purple rash on the skin. Untreated, the disease can progress to seizures, confusion, and eventually coma and death.

There arc many bacteria and viruses that can cause

informed choice

Meningitis. Vaccines currently address only 3 of the bacteria Haemophilus Influenzae, Meningococcal and Pneumococcal. Of these 3, the vaccines only cover a very limited number of strains. For instance, the most common cause of Meningococcal Meningitis in Australia is the type В strain associated with approximately 70% of the disease. The Meningitec vaccine, however, is only intended to prevent type С There are at least 11 other strains of Meningococcal bacteria none of which are addressed by this vaccine. Therefore, the government is proposing that we administer a vaccine which, even if it were effective, would only prevent a very small fraction of the total number of cases of this already very rare illness.

In addition, these bacteria are associated with Meningitis, but also with a host of milder illnesses causing symptoms as common as sore throats and ear infections to more serious conditions such as epiglottitis.

The Hib vaccine was introduced to the Australian vaccination schedule in the early 1990's and its use has been credited with a huge decline in the incidence of Hib associated Meningitis.

This however, is only part of the story. Tv en in an epidemic situation, only a small

vaccination rate of close to 100%. It shows that in general, bacteria are a lot smarter (and more adaptable) than the average vaccine manufacturer.

Our susceptibility to infections seems to be governed by much more than exposure to an illness. Even in an epidemic situation, only a small percentage of the overall susceptible population will usually succumb to infection. Why this is and what protects those who don't contract the illness is a question that medical science has been unable to answer and in many cases, has neglected to even ask!

It seems that there is much more to immunity than the simple development of antibodies after infection. As touched on briefly in the last issue of the AVN's Journal, the production of antibodies does not necessarily correlate with immunity just as the absence of antibodies does not necessarily indicate susceptibility. What we know about the immune system is vastly outweighed by what we don't know.

While it seems evident that the incidence of