Swine Flu

This article is part of the Pharma_Portal project of Spinwatch.

Swine flu is a respiratory disease caused by a strain of the influenza type A virus known as H1N1 - the same strain which causes seasonal outbreaks of flu. A version of the strain emerged in Mexico in 2009, which became the first flu pandemic for forty years. Tamiflu and Relenza are used to treat swine flu.

Link with intensive pig farms?

The 2009 swine flu outbreak started near La Gloria, Mexico, with the first human case being found in a young boy. Some observers have identified the source of the outbreak as an intensive pig farm owned by Smithfield Foods, the world's largest pig processor. An article by Felicity Lawrence in The Guardian, "The pigs' revenge", summarises the story. Lawrence writes:

Smithfield's intensive factories of densely packed hogs, like those of the rest of the large-scale industry, produce vast lagoons of foul-smelling discharges. In many of the areas where it has sited its factory farms or slaughtering and processing complexes, activists and locals have campaigned against it, accusing it of environmental pollution, labour rights abuses and in some places operating without proper permits. The people of La Gloria have had long run-ins with the company's nearby subsidiary Granjas Carroll. When 60% of the town's population became ill in March with flu-like symptoms, they quickly blamed the pigs.

Smithfield denies the allegations.

Vaccination

As the outbreak reached pandemic proportions, drug companies began developing a vaccine for swine flu. Baxter International Inc. announced its vaccine would be available by July 2009 - just three months after the outbreak. GlaxoSmithKline (GSK), Sanofi-Aventis and Solvay SA (SOLB.BT) also started producing vaccines.

The first doses of GlaxoSmithKline's (GSK) vaccine were on track to be shipped by September 2009. The UK initially ordered 60 million doses of the vaccine, while the U.S. paid GSK '$250 million to supply it with "pandemic products" such as the individual ingredients used in the vaccine.' The drug company negotiated contracts with sixteen countries to start with and was in discussions with fifty more.

Note that "pandemic" is a word that refers to the wide spread of the virus. It does not say anything about the severity of the infection. In July 2009, even as vaccines were being rolled out for the entire population of the UK, the World Health Organization stated:

We are still seeing a largely reassuring clinical picture. The overwhelming majority of patients experience mild symptoms and make a full recovery within a week, often in the absence of any form of medical treatment... Most cases of severe and fatal infection continue to occur in people with underlying medical conditions.

Swine flu "gold rush"

In July 2009 The Guardian reported that GlaxoSmithKline was preparing to sell £3 billion worth of swine flu drugs in 2009. The UK government placed advance orders for 60m doses of GlaxoSmithKline's vaccine. GlaxoSmithKline made it clear that the vaccine will not have been through full clinical trials before it is used on the public. Instead, the vaccine will be tested after it has been used. The company told The Guardian:

clinical trials will be limited, due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.

The government announced 11 million people in the UK would get the vaccine starting October 2009 - people aged six months to 65 in at-risk groups including those with asthma, diabetes, heart disease, renal disease or with a compromised immune system were offered the vaccine first. The decision was made by the JCVI in August 2009 - before the vaccine was licensed and before negotiations with the British Medical Association on how the vaccine would be delivered.

Legal immunity for vaccine makers

In July 2009 the UK government's Department of Health said it would indemnify manufacturers if there were any serious side-effects from the vaccine, according to a report in the Sunday Times. This is a significant development in the light of the serious side-effects experienced from the swine flu vaccine implemented in the US after the 1976 outbreak (see "1976 outbreak").

A parallel move occurred in the United States, also in July 2009. A report on Google News stated:

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said ...

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

1976 outbreak

A previous outbreak of swine flu occurred in the USA in 1976. In 1979, CBS television's 60 Minutes did a major expose of the swine flu vaccination programme of 1976. The expose revealed that:

• the swine flu vaccination programme was rolled out nationwide after a single soldier died following an episode in which he dragged himself out of his sick bed against medical advice to do a 5-mile march; he was later found to have the swine flu virus in his body
• 46 million Americans had the swine flu vaccination
• 4,000 people claimed damages totaling $3.5 billion from the US government for harm allegedly suffered from the vaccine
• Two-thirds of these 4,000 cases concerned neurological damage or death after the vaccine. The cases of neurological damage included Guillain-Barré syndrome such as that suffered by an interviewee on the CBS TV programme.
• The vaccine that was given to the public had not been tested. The approval for the public vaccination programme had been given on the basis of trials done on a previous strain of the vaccine. These trials had, however, revealed neurological side-effects. One of the researchers told the head of the Center for Disease Control, David Sencer, of his concerns about these but the programme went ahead anyway.

Baxter releases live bird flu virus

Governments lined up for Baxter's swine flu virus in the summer of 2009 in spite of the fact that shortly before, the company was responsible for releasing a contaminated seasonal flu vaccine product containing live bird (avian) flu virus from its plant in in Orth-Donau, Austria. Lab workers in the Czech Republic discovered the contamination and blew the whistle before the product was put into widespread use. A report in the Toronto Star stated:

The contaminated product, a mix of H3N2 seasonal flu viruses and unlabelled H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany.

The contamination incident, which is being investigated by the four European countries, came to light when the subcontractor in the Czech Republic inoculated ferrets with the product and they died. Ferrets shouldn’t die from exposure to human H3N2 flu viruses. ...

People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted.

In 2009 criminal charges were filed by Austrian investigative journalist Jane Burgermeister against Baxter for allegedly "manufacturing and releasing 72 kilos of vaccine material contaminated with live bird flu virus".

Burgermeister states that she objects to the Austrian government's proceeding with giving Baxter a swine flu vaccine contract while the company is undergoing investigation by the police:

In spite of the ongoing criminal investigation by the police in Austria into Baxter’s release of 72 kilos of pandemic vaccine material, of which the Health Minister is fully aware as is shown by his own correspondence, the Health Minister has rushed ahead with giving Baxter the authority to active the pre arranged contract to provide the “swine flu” vaccines.

Adjuvants

The US government has contracted several drug companies to develop and produce swine flu vaccines. At least two of those companies, Novartis and GlaxoSmithKline, are using the adjuvant squalene in their H1N1 vaccines. Adjuvants are substances added to vaccines to stimulate an immune response. Adjuvants such as the mercury compound thimerosal and aluminium have come under attack from vaccine safety critics.

Meryl Nass, MD has questioned the claims of safety of squalene as an adjuvant in the swine flu vaccines.

While squalene can be safely consumed in foods such as olive oil, injection is an abnormal route of entry for squalene into the body and appears to cause problems. Some researchers have linked squalene with Gulf War Syndrome found in soldiers who received experimental anthrax vaccines containing the ingredient.

A study carried out at Tulane Medical School and published in the February 2000 issue of Experimental Molecular Pathology found:

the substantial majority (95%) of overtly ill deployed GWS patients had antibodies to squalene. All (100%) GWS patients immunized for service in Desert Shield/Desert Storm who did not deploy, but had the same signs and symptoms as those who did deploy, had antibodies to squalene.

In contrast, none (0%) of the deployed Persian Gulf veterans not showing signs and symptoms of GWS have antibodies to squalene. Neither patients with idiopathic autoimmune disease nor healthy controls had detectable serum antibodies to squalene. The majority of symptomatic GWS patients had serum antibodies to squalene.

Criticism of swine flu vaccination

Micropathologist warns of inadequate safety trials for vaccine

On 20 August 2009 Colin G. Fink, a micropathologist at the University of Warwick, published a letter in The Times criticising the swine flu vaccine programme:

Vaccine caution: Swine flu vaccine could be a recipe for disaster

Sir, Dr David Salisbury does NHS nurses an injustice by saying that they have a duty to their patients to be vaccinated against swine flu (report, Aug 18). Their caution is based on the experience in the US where an influenza vaccine was withdrawn during a previous influenza outbreak when the vaccine was found to cause many cases of Guillain-Barré syndrome (an ascending paralysis that may also affect sensory nerves). Adequate safety trials are a prerequisite for any new vaccine and require volunteers who are not morally blackmailed.

The new vaccine for the pandemic strain is being trialled on nursing staff. Completion of adequate safety trials before winter now seem unlikely. The Chief Medical Officer, Sir Liam Donaldson, feels that giving the vaccine to pregnant women is essential because high temperature with flu may cause abortion.

These pronouncements seem to be muddled thinking and a recipe for disaster. The same may be said for the widespread distribution of the antivirals Relenza and Tamiflu. Nothing will more rapidly aid a resistant flu strain to be widespread this winter. In most cases so far, this influenza is characterised by its mild nature. Many are infected but remain unaware. At present doing nothing except avoiding crowded places and observing good hand hygiene has much to recommend it.

Colin G. Fink

Micropathology Ltd, University of Warwick

UK government agency warns of link between vaccine and nerve disease

On 15 August 2009, the Daily Mail reported that the UK government's Health Protection Agency had sent a letter to senior neurologists warning of the link between the swine flu vaccine and Guillain-Barré syndrome. The Daily Mail report states:

It [the letter] tells the neurologists that they must be alert for an increase in a brain disorder called Guillain-Barre Syndrome (GBS), which could be triggered by the vaccine.

GBS attacks the lining of the nerves, causing paralysis and inability to breathe, and can be fatal.

The letter, sent to about 600 neurologists on July 29, is the first sign that there is concern at the highest levels that the vaccine itself could cause serious complications.

The letter refers to the 1976 swine flu vaccine disaster in the United States when:

• More people died from the vaccination than from swine flu.
• 500 cases of GBS were detected.
• The vaccine may have increased the risk of contracting GBS by eight times.
• The vaccine was withdrawn after just ten weeks when the link with GBS became clear.
• The US Government was forced to pay out millions of dollars to those affected.

More than half of health workers polled would not accept the vaccine

Research published in the August 25 issue of the British Medical Journal reveals that more than half of doctors and nurses in public hospitals would refuse the H1N1 (swine flu) and H5N1 (bird flu) influenza vaccine, due to concerns about side effects and doubts about its efficacy. This was true even when the World Health Organization alert level was at phase 5 (phase 6 is the highest level of alert).

Vaccine hit by new cancer fears

In August 2009, German lung specialist and epidemiologist Dr Wolfgang Wodarg told Bild.com that there are many risks associated with the vaccine for the H1N1 virus.

Dr Wodarg is a specialist in lungs, hygiene and environmental medicine. He is the chairman of the health committee in the German parliament and European Council.

He said he has grave reservations about the firm Novartis which is developing the vaccine and testing it in Germany. The vaccination is injected “with a very hot needle," Wodarg said.

The nutrient solution for the vaccine consists of cancerous cells from animals and "we do not know if there could be an allergic reaction".

More importantly, some people fear that the risk of cancer could be increased by injecting the cells.

The vaccine - as Johannes Löwer, president of the Paul Ehrlich Institute, has pointed out, can cause worse side effects than the actual swine flu virus.

Wodarg also described people’s fear of the pandemic as an "orchestration": “It is great business for the pharmaceutical industry,” he told the Neuen Presse.

Swine flu is not very different from normal flu. “On the contrary if you look at the number of cases it is nothing compared to a normal flu outbreak,” he added.

In a statement to the hearing on the handling of the H1N1 pandemic, Strasbourg, 26 January 2010, Wodarg blamed the WHO for manipulating the definition of a pandemic to whip up fear of "a relatively mild flu" and transform it into "a worldwide pandemic". The outcome, said Wodarg, was to

implement relevant plans, which allowed pharmaceutical companies to transform their contracts with many governments all over the world into cash. Therefore millions of people were vaccinated for no good reason, and children were vaccinated whereas it was not even clear, if the vaccine had a positive effect on them because this was never clinically tested and proven.

Wodarg concludes his statement:

So we can see that the WHO undertook an incomprehensible action, which up to now was never justified by any scientific evidence. WHO ‘gambled away’ public confidence. It does therefore seem right that we investigate this matter within the Council of Europe to find out how the WHO could undertake such risky action in spite of lots of warning and protesting voices from scientists and national Governments. It did so in the case of the avian flu and again for the swine flu. The main questions to investigate are: Why has this been done, who is behind this, what is the core of this public-private-partnership which was introduced ten years ago, what is the role of the enterprises, who participates in relevant decision-making processes and who takes the overall responsibility?

Genetic engineering link?

Dr Russell Blaylock, MD, a former board certified neurosurgeon and health newsletter editor commented in his blog on the swine flu virus:

This virus continues to be an enigma for virologists. In the April 30, 2009 issue of Nature, a virologist [Robert Webster, a flu virologist at St Jude Children's Research Hospital in Memphis, Tennessee] was quoted as saying, “Where the hell it got all these genes from we don’t know.” Extensive analysis of the virus found that it contained the original 1918 H1N1 flu virus, the avian flu virus (bird flu), and two new H3N2 virus genes from Eurasia. Debate continues over the possibility that swine flu is a genetically engineered virus.

Others dispute the GM connection. The science writer David Bradley replied to a question about whether the swine flu virus may have been genetically engineered as follows:

These flu viruses have a segmented genome containing eight pieces of RNA. If two strains infect a single cell their progeny undergo reassortment so that new strains emerge. Pigs are a particularly good biological mixing bowl for flu viruses, it takes just one lucky reassortment that can infect humans to then make the species leap. This has happened several times in the past.

Scaremongering exposed

In September 2009 the UK chief medical officer Liam Donaldson was forced to admit that the worst case scenario for swine flu had been slashed from 65,000 deaths to 19,000. The Daily Mail reported:

After millions were spent on antiviral drugs and telephone hotlines, he revealed the toll could be as low as 3,000 - less than half the number who die in an average flu season.

Even a total of 19,000 deaths would be 2,000 lower than the number who died in the last major seasonal flu epidemic of 1999-2000.

According to a report for Fox News in January 2010:

Wolfgang Wodarg, head of health at the Council of Europe, claimed major firms organized a "campaign of panic" to put pressure on the World Health Organization (WHO) to declare a pandemic.

He believes it is "one of the greatest medicine scandals of the century," and he has called for an inquiry. ...

Wodarg said, "It's just a normal kind of flu. It does not cause a tenth of deaths caused by the classic seasonal flu.

"The great campaign of panic we have seen provided a golden opportunity for representatives from labs who knew they would hit the jackpot in the case of a pandemic being declared."

"We want to clarify everything that brought about this massive operation of disinformation. We want to know who made decisions, on the basis of what evidence, and precisely how the influence of the pharmaceutical industry came to bear on the decision-making."

He added: "A group of people in the WHO is associated very closely with the pharmaceutical industry."

The Fox News article continued by reporting Wodarg's concerns about health risks from swine flu vaccines:

"The vaccines were developed too quickly. Some ingredients were insufficiently tested," he [Wodarg] said.

"But there is worse to come. The vaccine developed by Novartis was produced in a bioreactor from cancerous cells, a technique that had never been used until now.

"This was not necessary. It has also led to a considerable mismanagement of public money.

"The time has come at last for us to make demands on governments. The purpose of the inquiry is to prevent more false alarms of this type in the future."

"We must make sure people can rely on the analysis and the expertise of national and international public institutions. The latter are now discredited, because millions of people have been vaccinated with products with inherent possible health risks."

In September 2009 the UK chief medical officer Liam Donaldson was forced to admit that the worst case scenario for swine flu had been slashed from 65,000 deaths to 19,000. The Daily Mail reported:

After millions were spent on antiviral drugs and telephone hotlines, he revealed the toll could be as low as 3,000 - less than half the number who die in an average flu season.

Even a total of 19,000 deaths would be 2,000 lower than the number who died in the last major seasonal flu epidemic of 1999-2000.

In March 2010 a draft report by Labour MP Paul Flynn, vice chair of the Council of Europe's health committee, said:

In the United Kingdom, the Department of Health initially announced that around 65,000 deaths were to be expected. In the meantime, by the start of 2010, this estimate was downgraded to only 1,000 fatalities. By January 2010, fewer than 5,000 persons had been registered as having caught the disease and about 360 deaths had been noted.

It was noted that some advisory groups members are flu experts who've received funding from pharmaceutical companies manufacturing drugs and vaccines against flu:

"The neutrality of their advice could be contested...To date, WHO has failed to provide convincing evidence to counter these allegations and the organisation has not published the relevant declarations of interest. Taking such a reserved position, the organisation has joined other bodies, such as the European Medicines Agency EMEA, which likewise, have still not published such documents."

German government flu expert advising pharma lobby group

In October 2009 a story by Gerald Traufetter in the German news outlet Der Spiegel reported that a German government flu expert was advising a group funded by the pharma industry:

The European Working Group on Influenza [ESWI] says it wants to raise awareness of the dangers of a pandemic. But epidemiologist Luc Bonneaux says ESWI is a lobby group "that has as much to do with science as McDonald's with healthy nutrition."

Traufetter noted that Germany's swine flu vaccination campaign would cost about €600 million ($890 million), and the German government had already built up stocks of Tamiflu and Relenza worth €90 million. Traufetter wrote: "These high costs beg the question -- how closely should scientists and government authorities be allowed to work together with the pharmaceutical industry?"

The European Working Group on Influenza, Traufetter wrote, says it brings together scientific "key opinion leaders in influenza." But the sole financial backers are 10 pharmaceutical companies, including GlaxoSmithKline -- manufacturer of the German swine flu vaccine -- and Roche -- producer of the antiviral drug Tamiflu. Traufetter wrote:

The group [European Working Group on Influenza] also enlisted Walter Haas as one of its scientific advisors. Haas coordinates Germany's flu pandemic preparedness measures at the Robert Koch-Institut (RKI), the federal institute for disease research.

ESWI portrays itself as an independent group of scientists. But even the organization's own statute tells a different story, describing its role as advising politicians and health authorities on "the benefits and safety of influenza vaccines and antivirals" and initiating "a policy for antiviral provisions."

Traufetter continued:

According to ESWI spokesman Derek Smith, an epidemiologist at the University of Cambridge, the organization orients itself "strictly according to the current state of scientific knowledge." The reality, however, is that the ESWI Web site includes, among other things, an advertising video from Tamiflu producer Roche.

The Web site also features a film recorded before the swine flu outbreak that shows British virologist John Oxford, founder of a company offering flu research services, declaring that he would be surprised if there was no pandemic within the next 10 years.

And ESWI member Thomas Szucs wrote last October in the medical journal Lancet Infectious Diseases that "conservative estimates suggest that up to 350 million people could die" in a future flu pandemic.

Epidemiologist Luc Bonneux, based in The Hague, took a closer look at ESWI's statements and concludes that the group is a "crystal clear lobbying group for the pharmaceutical industry." The information on its Web site, he says, has "as much to do with science as McDonald's does with healthy nutrition."

Resources

• The Flawed 1976 National “Swine Flu” Influenza Immunization Program, Biot Report #177: February 22, 2005, accessed 16 July 2009
• Pandemics