A Swine Flu Windfall for GlaxoSmithKline?

British drugmaker GlaxoSmithKline has orders for its swine flu vaccine from 16 countries and is in talks with 50 more.

Work on the swine flu vaccination could reap huge profits for pharmaceutical company GlaxoSmithKline.

British pharmaceutical giant GlaxoSmithKline (GSK) is set to reap billions as fear of the swine flu pandemic grows. The world's second-largest drug company has secured orders from 16 countries for 195 million doses of the vaccine it is developing against the H1N1 virus, which has killed more than 740 people worldwide.

The Brentford (England)-based drugmaker began production of its new flu vaccine in June and is on track to begin shipping the first doses in September. At a July 22 briefing to announce the company's second-quarter results, CEO Andrew Witty confirmed the number of orders is expected to be "substantially more" as the company currently is in discussions with 50 countries. While Britain has ordered 60 million doses of the vaccine, according to Witty, the US has paid GSK $250 million (€175.6 million) to supply it with "pandemic products" such as the individual ingredients used in the vaccine. These include the antigen that prompts an individual's immune response and GSK's adjuvent technology, a sort of booster used to increase the vaccine's yield and potency.

GSK also announced it expects to increase annual production of its inhalable anti-viral flu treatment Relenza threefold, to 190 million doses, by yearend. Relenza sales for the three months ended June 30 were $99 million, up from just $5 million in the second quarter of 2008. Since the beginning of 2006, GSK has invested $2.5 billion to put in place the technology and capacity needed to meet demand. "Short of putting beds in the labs, we are throwing just about every resource we have into this,"

http://www.spiegel.de/international/business/0,1518,637748,00.html

Should Germany Gamble Millions on More Vaccine?

Swine flu hasn't caused nearly as many problems as some had predicted. Still, some worry that the next wave of the epidemic is going to be much, much worse. A debate is raging in Germany over whether to steer millions more to pharmaceutical companies for additional vaccine for the entire population.

Matthias Orth is fighting on the frontlines against the epidemic. He works as a medical manager at the Marienhospital in the southwestern German city of Stuttgart. This is where the city's emergency health facilities are, and this is where the ill gather at night and on the weekends.

http://www.spiegel.de/international/world/0,1518,647666,00.html

Germans Unhappy with Alternative Swine Flu Vaccine for Politicians

Damage control is the name of the game in Berlin on Monday as politicians rush to deny that they are receiving a better, safer swine flu vaccine than ordinary Germans. The first of 50 million doses arrived in Germany on Monday.

One might think that the arrival in Germany of the first of 50 million doses of swine flu vaccine on Monday might be cause for celebration. But with news breaking over the weekend that top government officials in Berlin will be injected with an alternative vaccine -- one widely seen as safer -- a debate about an alleged two-class medical system has erupted.

http://www.spiegel.de/international/germany/0,1518,656028,00.html

The Weekend Australian sets the vaccination agenda

Don't confuse us with information - that's not our department. We simply report what the drug companies and medical community tell us and don't want to hear or report any dissenting views.

This is what the Weekend Australian's health section seems to be saying. Please read and forward the information below:

Below is an article that ran in this weekend's Australian newspaper. It is by Dr Sue Page who is a local GP on the Far North Coast of NSW where the AVN is located. One of our members alerted me to this article (thank you!) which is great because I never saw it this weekend. I contacted the editor of this section, a woman named Leigh Dayton, who admitted that she has no sympathy for our viewpoint and believed that we really don't have any scientific reason to question vaccination.

I asked her for the right of reply and she asked me to send her my piece and she would see. She just wrote back and said that she would not be running my article because Sue Page never mentioned either myself or the AVN by name.

I think that those of you who think this is not good enough should take the time to write a quick letter into the newspaper. Direct your letters to daytonl@theaustralian.com.au. Please send a copy to David King who is the Chief of Staff at kingd@theaustralian.com.au - just put his email address in the cc field.

Please read below. I will put Sue Page's article first, followed by my covering letter and my article last. Feel free to use any of this information to draft your own response and as always, please send a blind copy (BCC) to me at meryl@avn.org.au. (and I note with interest that the paper is soliciting comment from health professionals - as if they are the only ones with any interest in this issue - or perhaps - the only ones with any common sense?)

Kind regards,
Meryl

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A Dose of Commonsense won't hurt: Vaccination
http://www.theaustralian.news.com.au/story/0,,26214447-23289,00.html

I UNDERSTAND the media loves controversy, but as a GP in a region with one of the lowest vaccination rates in Australia I am sick of having local kids injured or killed by illnesses that could have been prevented.

It is time to stop giving media attention (otherwise known as free advertising) to the crackpot claims of the anti-vaccination lobby. Unfortunately, through the years the group in question has found little trouble finding journalists willing to give it a platform.

The arguments this group presents, with fancy websites and titled authors, do not stand up to even the most rudimentary investigative journalism. Arguing vaccines are not effective, they have been using the same graphs for more than 20 years.

Yes, death rates fell before the introduction of vaccination campaigns, but death is surely the most crude measure of health outcome. I would rather children did not need to test the improvements we have made in intensive care, including life support machines.

Far more dramatic have been the reductions in children exposed to harm through the falling incidence of vaccine-preventable diseases. For instance, for every 3000 children who contract measles (listed by this group as a ``harmless'' childhood illness), just one will die, but one in 25 will contract a severe form of pneumonia that cannot be treated by antibiotics and can cause permanent lung scarring and bronchiectasis.

Before the mass vaccination program, in NSW in 1981 and 1984 there were 200,000 cases with 2850 recorded hospital admissions. In 2007 just three cases were reported.

In promoting vaccines as dangerous, some of the agitators' claims become ludicrous. Nobody is arguing vaccines are 100 per cent safe. But if you are going to quote the anti-vaccination lobby, at least check their information or give the full context so people can judge its reliability for themselves.

The same group recently sent a newsletter saying flu vaccines can cause pregnant women to lose their unborn child and become sterile, and this was part of a campaign to reduce the world's population. The newsletter included photographs of a microdot contraceptive said to be inserted in the vaccine. Puh-leeze! Nobody in media thinks it is OK to falsely shout ``fire'' in the airport, and we never see articles promoting the use of alcohol to reduce stress while driving. The interests of free speech have never been served by publicising rubbish.

Sue Page is a GP in northern NSW and vaccination spokeswoman for the Northern Rivers GP Network.

Health professionals, send your 350-word comment or concern to healthissues@theaustralian.com.au

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Dear Leigh,

Thank you for your time on the phone earlier today. Attached to this email is my response to Sue Page's piece from this weekend's Health Section in the Weekend Australian. I do hope that this will be printed since right of reply is one of the most important features of journalistic fairness. If I could ask you to let me know one way or the other, I would really appreciate that.

I did want to pass one thing by you because it's something that has been going through my mind since we spoke. When I told you that we had received a report of a woman who was pregnant losing her baby within 24 hours of getting the swine flu vaccine, your first reaction was to say that there was no evidence that the vaccine was linked with this spontaneous abortion.

That is perfectly true. But think about this.

If there were a new medication which had never been tested for its safety in pregnancy and it had been administered to a woman who was 4 months pregnant and she began to feel ill within 3-4 hours and before 24 hours had elapsed, had lost her baby, would your first response still be that there must be no connection?

Well, no vaccine has ever been tested for safety in pregnancy and all vaccines carry a warning in the manufacturer's information stating that they should only be used in pregnancy if the risk of the disease is considered to outweigh the unknown risk of the shot. So every pregnant woman is a guinea pig and yet, the media tells them that the vaccine is perfectly safe in pregnancy. Is this right or fair? Is that the media's role?

Vaccines hold a privileged place in society but is this status warranted? There are many top doctors who question both the safety and effectiveness of this medical procedure - it is not just the AVN. Tom Jefferson an epidemiologist with The Cochrane Collaboration, the largest database of medical information in the English language, has just completed a 40-year retrospective study on the safety and effectiveness of flu vaccines. His results may surprise you. He demonstrated that the vast majority of studies indicate that in the target age groups, flu vaccines are completely ineffective. In children who are now targeted, there has only been one scientific study and the results of that study were mixed.

And safety has never been studied at all since any study which claimed to look at safety was so flawed in its design as to be completely useless. This is what Dr Jefferson said - not me.

So, is it really wrong to question this shot and to ask for more science since it is now aimed at billions of people worldwide?

I hope that you will look at this information and will take the time to consider that, though you may not agree with what the AVN is saying, our message is scientifically valid and we do have a right to say it.

Kind regards,
Meryl Dorey

Studies Fail To Demonstrate Safety Or Effectiveness Of Influenza Vaccine In Children And Adults - http://www.medicalnewstoday.com/articles/55507.php

Cochrane Influenza Resources - http://www.cochrane.org/influenza/press.html

Does the vaccine matter? Atlantic Monthly - http://www.theatlantic.com/doc/200911/brownlee-h1n1

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Trust me, I'm a doctor - not good enough any more

It is dangerous to represent a viewpoint that opposes what the mainstream considers to be self-evident. Dr Semmelweis discovered this when he was discredited for claiming that women and babies were dying from Puerperal fever due to surgeons going straight from the morgue to the maternity ward without washing their hands. It was decades before he was exonerated and decades more before hand washing became routine.

It took decades for doctors to admit that smoking cigarettes did not reduce the symptoms of asthma; that thalidomide did in fact cause catastrophic birth defects; that Vioxx increased the risk of heart attacks and stroke and that antibiotics were most-often counterproductive in the treatment of otitis media.

In each of these instances, those who pushed for increased attention to safety and scientific principles in opposition to ingrained beliefs were called anti-science, ignorant or crackpots. They were ridiculed, ignored or denigrated by those who could not accept that something they believed in could possibly be wrong.

No other area exemplifies this resistance to open debate more than the issue of vaccination where, instead of examining the opposing viewpoints, the pro-choice side is accused of misinformation even though their evidence is scientifically based.

Dr Page criticises those who ask questions about vaccination, but who benefits when questions are suppressed? Where would we be now if Semmelweis had been stopped or if McBride hadn't questioned Thalidomide?

In her article, Dr Page accuses the Australian Vaccination Network (AVN) of spreading absurd conspiracy theories. Check our web site - we don't. Our information is referenced from primary, peer-reviewed medical sources.

Dr Page says that death rate is a crude measure of vaccine effectiveness, but many studies have shown that between 95-97.5% of doctor-diagnosed measles diagnoses are wrong. Other diseases such as whooping cough are also incorrectly diagnosed more often than not. Crude though it may be, death rate is the most accurate measure of infection we have. And as Dr Page says, these diseases declined long before vaccinations were introduced.

An investigative journalist would be good; a Royal Commission would be better. How about a study examining the health of the vaccinated compared with the unvaccinated, using the Medicare database which is linked with the ACIR? Simple - and Australia is possibly the only country in the world that can do it.

Does the Vaccine Matter?

Drive too fast along Red Lion Road, beside Philadelphia’s Northeast Airport, and you will miss the low-rise cement building where the biotech company MedImmune has been quietly pumping out swine flu vaccine at about a million doses a week. Through the summer and fall, workers wearing protective gear that covered them from head to toe brewed up batches of live, genetically modified flu virus. Robots then injected tiny doses of virus-laden fluid into glass vials, which were mounted into nasal spritzers, labeled, and readied for shipment at the direction of the Centers for Disease Control and Prevention, in Atlanta, which is helping to coordinate the nation’s pandemic-preparedness plan. In the most ambitious vaccination program the nation has mounted since the anti-polio campaign in the 1950s, the federal government has commissioned MedImmune and four other companies to produce enough vaccine to cover the entire U.S. population.

Vaccination is central to the government’s plan for preventing deaths from swine flu. The CDC has recommended that some 159 million adults and children receive either a swine flu shot or a dose of MedImmune’s nasal vaccine this year. Shots are offered in doctors’ offices, hospitals, airports, pharmacies, schools, polling places, shopping malls, and big-box stores like Wal-Mart. In August, New York state required all health-care workers to get both seasonal and swine flu shots. To further protect the populace, the federal government has spent upwards of $3billion stockpiling millions of doses of antiviral drugs like Tamiflu—which are being used both to prevent swine flu and to treat those who fall ill.

But what if everything we think we know about fighting influenza is wrong? What if flu vaccines do not protect people from dying—particularly the elderly, who account for 90 percent of deaths from seasonal flu? And what if the expensive antiviral drugs that the government has stockpiled over the past few years also have little, if any, power to reduce the number of people who die or are hospitalized? The U.S. government—with the support of leaders in the public-health and medical communities—has put its faith in the power of vaccines and antiviral drugs to limit the spread and lethality of swine flu. Other plans to contain the pandemic seem anemic by comparison. Yet some top flu researchers are deeply skeptical of both flu vaccines and antivirals. Like the engineers who warned for years about the levees of New Orleans, these experts caution that our defenses may be flawed, and quite possibly useless against a truly lethal flu. And that unless we are willing to ask fundamental questions about the science behind flu vaccines and antiviral drugs, we could find ourselves, in a bad epidemic, as helpless as the citizens of New Orleans during Hurricane Katrina.

http://www.theatlantic.com/doc/200911/brownlee-h1n1

Three Cape teens believe HPV vaccine made them sick

It's been months since dancer and former gymnast Nicole Goodman of Pocasset has been able to do a forward jazz slide or a kick ball change move.

The 18-year-old fell ill weeks after receiving her third Gardasil shot, and she blames the vaccine for the human papillomavirus for putting her in a wheelchair.

http://www.capecodonline.com/apps/pbcs.dll/article?AID=/20091015/LIFE/910150301

Army first in line to get cutting-edge swine flu shot

The German Military is getting a thiomersal-free - squalene-free flu shot. Good for them! But while vaccine apologists like Paul Offit in today's NY Times continue to insist that these products are perfectly safe (roll up your sleeve, Paul!), one has to wonder why the German government would say they are too dangerous for troops but safe enough for pregnant women, children, the elderly and the sick? This page calls for your comments (see link below) so please do send them in.

http://www.thelocal.de/national/20091012-22523.html
The German army has ordered a stock of special swine flu vaccine that does not contain controversial additives that will be given to the general public, the Defence Ministry confirmed on Monday.
The announcement came in response to a report in daily Westfalen-Blatt, which said that Bundeswehr soldiers and their families on foreign deployments or preparing for missions overseas would receive the inoculations.

The A/H1N1 flu shots given to soldiers will contain neither a controversial strengthening additive, nor the preservative agent mercury, both of which are contained in the shots for the general public.

Additive-free Celvapan, manufactured by the US pharmaceutical company Baxter, was approved on October 6 for use in the European Union.

Defence Ministry spokesman Thomas Raabe said the Bundeswehr needs to be able to quickly and impartially inoculate soldiers and their dependants on foreign missions to ensure they were protected.

Raabe said that not all of the Bundeswehr‘s 250,000 soldiers could be vaccinated at once, but added it is important that the 7,200 troops on foreign missions receive the first shots, he said.

Some doctors have warned of unforeseeable side effects to the other EU-approved vaccines Pandemrix, made by British firm GlaxoSmithKline, and Focetria, manufactured by Swiss company Novartis.

However, there are no studies comparing the side effects, according to the Paul Ehrlich Institute, which oversees drug registration and safety in Germany.

The president of Germany's Association of Children’s and Young People’s Physicians (BVKJ), Wolfram Hartmann, told the Westfalen-Blatt that the vaccines committee of the Robert Koch Institute in Berlin had reacted with surprise to the Bundeswehr’s “solo approach.”

He called for children aged six months to six years to also be given the additive-free shots