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.

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 programme

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

Resources

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