Earlier this year we reported that nearly 800 children in Europe have developed narcolepsy, an incurable sleep disorder, after being immunised with the Pandemrix H1N1 swine flu vaccine, produced by the British drug firm, GlaxoSmithKline (GSK), in 2009 and 2010.

But according to a report in the Guardian newspaper:

“The Department for Work and Pensions (DWP) has contacted people turned down for compensation last year to explain that, after a review of fresh evidence, it now accepts the vaccine can cause the condition. The move leaves the government open to compensation claims from around 100 people in Britain, and substantial legal fees if a group action drawn up by solicitors is successful.”

The paper further reports that:

“The government U-turn follows a major study of four- to 18-year-olds by the Health Protection Agency which found that around one in every 55,000 jabs was associated with narcolepsy. A spokesman for [vaccine maker] GSK said it had details of around 900 people from 14 countries who had narcolepsy and were vaccinated.”

The study appeared in the British Medical Journal earlier this year.

Dangerous for children

After the global outbreak of swine flu – the H1N1 strain of the virus – in 2009, some 30million people across Europe were given the vaccine Pandemrix including 6m in Britain.

But its safety was questioned by health officials in Finland, where more than 300 cases of narcolepsy have now been reported in people vaccinated with Pandemrix.

In July 2011 the European Medicine Agency advised that, as a precautionary measure, the vaccine should only be given to the under-20s if they are at risk of contracting swine flu and alternative jabs are not available.

Its analysis found that for every 100,000 adolescents who are given the injection, up to seven are likely to develop narcolepsy.

That same year scientists at Stanford medicine school in California which claimed that it was the swine flu itself and not the vaccine that was responsible for a rise in cases of narcolepsy a claim which seems to hold very little water.

Accumulating evidence

There has since been a great deal of vacillating on an issue for which evidence is steadily accumulating.

Earlier this year, a comprehensive report from the Reuters news agency, revealed spikes in narcolepsy cases are also surfacing in Finland, Norway, Ireland, France and Sweden.

According to the Guardian a confidential letter, which the newspaper has seen, confirms that the UK’s welfare minister, Iain Duncan Smith, will announce the reversal in October.

“It has been accepted that, on the balance of probability, vaccination has contributed to … disablement,” the letter says.

Narcolepsy is the serious and incurable sleep disorder which causes nightmares, hallucinations, sleep paralysis and episodes of cataplexy, a condition which occurs when strong emotions trigger a sudden and dramatic loss of muscle strength.

Compensation claims could reach £1 million per person

In spite of this, the DWP denies that any disability caused by Pandemrix is severe enough to qualify for statutory compensation, a £120,000 tax-free lump sum. Those the DWP has contacted are invited to respond with their claims within three weeks.

Solicitors representing those affected by the vaccine disagree and say nearly all of the 100 people in the UK who have been harmed by the vaccine qualify for compensation and that damages could reach up to £1 million per person.

The group action will be brought against GSK, but say the solicitors, the drug company had an indemnity clause in its contract to provide the vaccine which means the UK government will ultimately foot the bill.

According to a report from the Reuters news agency, reports of spikes in narcolepsy cases are also surfacing in Finland, Norway, Ireland, France and Sweden.

During the 2009-2010 H1N1 swine flu pandemic, the vaccine was given to more than 30 million people in 47 countries. So far, a total of 795 people have reported developing the incurable sleep disorder after receiving the vaccine. Because it contains a booster, drug regulators have concerns about the vaccine and the shots have not been given here in the U.S.

Experts remain hesitant to blame the vaccine. Questions still remain regarding how the narcolepsy cases might be linked to Pandemrix, what the triggers and biological mechanisms might have been, and whether or not genetic susceptibility have anything to do with it.

“There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries – and probably in most countries,” says Emmanuel Mignot, a specialist in the sleep disorder at Stanford University in the US, who is being funded by GSK to investigate further.

And yet scientific reticence remains;“No-one wants to be the next Wakefield” Mignot adds.

Mingot is referring to British doctor Andrew Wakefield whose research sparked a bitter and decades-long debate about the safety of the measles, mumps and rubella (MMR) vaccine.

Many doctors still consider Wakefield’s claims to be false. Nevertheless, some of those false claims are now turning into compensation payments for vaccine damaged children.

The high cost of timidity

Goran Stiernstedt, a public health official in Stockholm, Sweden, questions the high cost of this scientific timidy and wonders if things should have turned out differently.

The World Health Organization estimates that more than 18,500 people were killed during the 2009-2010 swine flu pandemic. Stiernstedt estimates that approximately 5 million people in Sweden received the shot. He also estimates that between 30 and 60 people in his country were saved from swine flu death. Yet, more than 200 cases of narcolepsy have already been reported in Sweden.

“This is a medical tragedy,” he said. “Hundreds of young people have had their lives almost destroyed.”

It’s estimated that between 200 and 500 people out of every million suffer from narcolepsy, an incurable, life-long condition which causes nightmares, hallucinations, sleep paralysis and episodes of cataplexy, a condition which occurs when strong emotions trigger a sudden and dramatic loss of muscle strength.

Saeid and Parivash Mojabi, from San Jose, California, claimed that son Ryan suffered a ‘severe and debilitating injury to his brain’ after being administered with two measles-mumps-rubella vaccinations in December, 2003 and in May the following year.

They claimed in court papers that Ryan was diagnosed with Autism Spectrum Disorder.

The ruling comes less than a year after a judge in Italy awarded £140,000 to an Italian couple who said their son had autism after his routine childhood MMR vaccination. At the same time another US family was awarded compensation for MMR damage to their baby girl.

In August 2012 a young Sottish girl was awarded compensation after it was determined that the MMR left her partially deaf.

This latest judgement – although it doesn’t lay fault for the child’s disability with the drug – fuels anti-MMR campaigners challenging the view of the majority of the medical profession that holds the vaccinations are safe.

No blame for drug companies

The Mojabi’s claim was against the US government which set up a Vaccine Programme. Although a judgement rules whether or not each case is eligible for compensation and the amount – in this case against the US Health Department – it does not, perhaps conveniently, apportion blame.

The family first took their case to the US Court of Federal Claims in 2006.

Under the National Vaccine Injury Compensation Programme, parents can petition the US government for compensation for injuries or deaths allegedly caused by compulsory childhood vaccines.

Lifelong damage

A judgement in Ryan’s case was finally made on December 13 2012, by the Office of Special Masters set up by US Congress to decide on compensation claims. The defendant in the case was the US Secretary of Health and Human Services.

The damages payment takes into account the boy’s future loss of earnings because it’s unlikely he will be able to work.

In statements to the court, Ryan’s grandmother Paravaneh Shah-Mohammadi and his aunt Pooran Vahabi told how the boy appeared ‘lethargic’, ‘hardly responsive to noises and people around him,’and ‘unable to hold himself upright’ after having the first MMR vaccination.

• See also related articles (left) and: The autism and allergy overlap

The survey, which currently includes data on around 8,000 unvaccinated children, aged newborn to 19 years, shows vaccinated children have at least 2 to 5 times more diseases and disorders than unvaccinated children.

The data for unvaccinated children is compared to the national German KIGGS health study of the children in the general population. The complete data and study results are here.

The data (see chart right), first released in 2011, was collected from parents with vaccine-free children via an internet questionnaire hosted by the group Vaccine Injury and Andreas Bachmair, a German classical homoeopathic practitioner.

Do-it-yourself research

Click for larger image

The independent study is self-funded and is not sponsored by any NGO or government health organisation with political and financial conflicts of interest. Bachmair relies on Google ads and donations for revenue.

The comparisons of the health of vaccine-free children with the health statistics of the general population are considered to be the same as comparing unvaccinated with vaccinated because vaccination is so ubiquitous.

However,  in response to requests from parents Vaccine Injury have started to collect data on vaccinated children in order to make a more exact comparison with unvaccinated children.

According to Bachmair and his supporters, parents of unvaccinated children are obviously concerned about the health risks of vaccines, and are more likely to make other healthier choices such as feeding their children a much better diet and using more natural remedies and using fewer pharmaceuticals. This may introduce some bias into the results. Nevertheless the numbers are astonishing

No money for studies

Most of the respondents to the survey have been from the US where half the US children suffer from chronic diseases and disorders and 15% are developmentally disabled. You’d think it would be to everyone’s advantage to find out what’s going on. Certainly what most children have in common today is a massive load on vaccinations – anywhere from 15-26 doses before their first birthdays

It seems amazing that no study has ever been done, but vaccine manufacturers have been steadfast in their refusal to fund such work. The only suggestion of a study in this area, that we could find, is a US study at Jackson State University, Alabama – and this study is also soliciting funds from the public to keep going. In the absence of official studies, the ongoing German survey provides valuable information to inform parents’ choices.

• The German survey is ongoing and you if you have UNVACCINATED children and wish to take part use this link

• If you have VACCINATED children and you wish to take part please use this link

Let’s shame the public health system and Big Pharma into doing the right thing by our children. Instead of simply parroting the brainless mantra of  “vaccines for preventable diseases” it may turn out that we should be having a conversation about how to avoid preventable vaccine-induced diseases.

After the jab she developed a fever and irreparable damage to the nerve between her brain and ear, and is now permanently deaf on her left side.

According to a report in the UK’s Daily Mail, Stephen alleged the adverse reaction was similar to the brain disease encephalitis.

The decision was made by the Vaccine Damage Payment Unit, which is administered by the Department of Work and Pensions.

Amazingly, the panel had the power to award compensation of a one-off tax-free lump sum of £120,000 in this case, but refused to do so because, in it’s view, she was only 20% disabled.

Compensation is only awarded if a vaccine caused ‘severe disablement’, which means a person has be 60% disabled. Being completely deaf, for example, would constitute a 100% disablement score. Stephen argues that her disability has had a profound affect on her life.

Stephen was originally part of a 1,000 strong class action for compensation, which was focused on the adverse effects of the MMR jab, such as autism. However, in 2003 as a result of the the media circus that followed the original Lancet article linking MMR with autism, the class action was dropped when legal aid was withdrawn on the basis of the ‘official’ view that no link between the MMR vaccine and autism could be found.

Wakefield’s original Lancet articles have long been withdrawn but you can find links to other peer reviewed papers supporting their conclusions here.

Mounting evidence

This is not the first case to rule that MMR jab can cause neurological damage. Earlier in the year, as reported on this site, families in Italy and the US were awarded payouts when courts ruled that the MMR jab did cause autism.

In 2010, a severely disabled boy from Warrington, Robert Fletcher, was awarded the lump-sum compensation of £90,000 by a medical assessment appeal panel, after his mother battled for 13 years to prove his epileptic condition was due to the MMR jab he received at just over one year old.

At the time the panel accepted that MMR had caused Fletcher’s brain damage but added: “We would stress that this decision is fact-specific and it should not be seen as a precedent for any other case… In particular, it has no relevance to the issue… as to whether there is a link between the MMR vaccine and autism.”

This view misses the point. It is now accepted that some types of brain damage can result from an MMR jab. Autism may well be part of a spectrum of neurological damage linked to the vaccine. This latest ruling – although disappointing for Katie Stephen and her family – may cause around 2,000 families, who still believe their children’s autism is due to the vaccine, to have renewed hope.

• See also: The autism and allergy overlap

Two of former Merck employees have filed a lawsuit against the company claiming that it falsified test results for its mumps vaccine making the vaccine appear much more effective than it actually is.

On the basis of this information, they say, the company convinced the federal government to purchase hundreds of millions of dollars worth of potentially worthless vaccines.

The lawsuit was filed in 2010 under the False Claims Act by virologists Stephen Krahling and Joan Wlochowski, who say that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings“.

The details of the case have been sealed from the public for two years whilst the US government considered whether to participate in the lawsuit. The government has now declined be involved (but has reserved the right to become involved later).

The case was finally unsealed in late June and the former employees to now move forward with their claims against Merck.

It should be noted that the UK’s National Health Service also uses Merck’s MMR vaccine –which contains the allegedly ineffective mumps vaccine.

Second lawsuit filed

In a second lawsuit, filed at the same time as the unsealing of the first, a federal anti-trust class action was filed against Merck by Alabama-based Chatom Primary Care.

Chatom allege that Merck falsely claims its mumps vaccine is 95% effective and that Merck has known for a decade that its mumps vaccine is ‘far less effective’ than it tells the government, and that it falsified test results and sold millions of doses of ‘questionable efficacy’, flooding and monopolising the market.

By falsifying claims about the effectiveness of the vaccine Merck “deterred and excluded competing manufacturers,” who would enter the risky and expensive vaccine market only if they believed they could craft a better product, Chatom says in its complaint.

Putting profit before people

Merck is the only manufacturer licensed by the FDA to sell the mumps vaccine in United States, and if it could not show that the vaccine was 95% effective, it risked losing its lucrative monopoly, according to the complaint.

Chatom claims that’s why Merck went to great lengths, including “manipulating its test procedures and falsifying the test results,” to prop up the bogus figure, though it knew that the attenuated virus from which it created the vaccine had been altered over the years during the manufacturing process, and that the quality of the vaccine had degraded as a result.

Sham testing

Starting in the late 1990s, Merck set out on a sham testing program with the objective of “report[ing] efficacy of 95 percent or higher regardless of the vaccine’s true efficacy,” the complaint states.

Chatom says Merck initially called its testing program Protocol 007.

Under this Protocol Merck did not test the vaccine’s ability to protect children against a “wild-type” mumps virus, which is “the type of real-life virus against which vaccines are generally tested,” the complaint states.

Instead, according to the complaint, Merck tested the blood of children who had been vaccinated with its products – which meant their blood contained  Merck’s own attenuated strain of the virus.

That “subverted” the purpose of the testing regime, “which was to measure the vaccine’s ability to provide protection against a disease-causing mumps virus that a child would actually face in real life. The end result of this deviation … was that Merck’s test overstated the vaccine’s effectiveness,” Chatom claims.

No relation to real life exposures

Merck also added animal antibodies to blood samples to achieve more favourable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that “did not in any way correspond to, correlate with, or represent real life … virus neutralization in vaccinated people,” according to the complaint.

Chatom claims that the falsification of test results occurred “with the knowledge, authority and approval of Merck’s senior management.”

While parents who choose not to vaccinate their children are derided – for endangering their own children and others around them, Merck’s alleged actions raise a question mark about all childhood vaccines. All vaccines must go through the same approval process and all pharmaceutical companies face the same temptation to fudge results in order to gain lucrative contracts. It may well be that these cases are just the tip of the iceberg.

As we recently reported, judges in Italy and the US have found that the MMR vaccine did cause autism in two children.

Bribery and corruption are commonplace

At the same time another global drug company, Roche  is under investigation by the European Medicines Agency for ignoring 80,000 adverse reactions, including 15,161 deaths to its Tamiflu vaccine.

And, of course, GlaxoSmsithKline has recently been fined $3 billion ( £1.9 bn) for bribing doctors – which took the form of lavished hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to resorts in Bermuda, Jamaica and California – and encouraging the prescription of unsuitable antidepressants to children. In particular Paxil – which is only approved for use by adults – was being pushed as an ‘off-label’ prescription for children and teenagers in spite of trials proving it was ineffective.

The original court documents filed  in the US District Court of Massachusetts, by disgruntled former employees Gregory Thorpe and Blair Hamrick make hair-raising reading.

Although shocking bribery, kickbacks, paying ‘independent’ spokespeople to hawk their products around, and ‘rewards’ for doctors who push drugs on the public is hardly new in the world of Big Pharma. Pfizer and Johnson & Johnson have both recently settled bribery cases. Others like AstraZeneca, Bristol-Myers Squibb, Merck and Eli Lily have likewise been investigated for bribery, untruthful marketing and pushing off-label prescribing. In 2004 Merck’s anti-inflammatory drug Vioxx, was famously withdrawn after it was shown the company misled the public about the associated risk of  cardiovascular problems.

If these are examples of ‘business as usual’ in the pharmaceutical industry, then the veil has been lifted on a disturbing pattern:  lie about product efficacy and then ignore adverse reactions, and rake in as much money as possible before anyone finds out.

Given that, consumers of healthcare have every reason to question why they should put their trust (and potentially the health of their children) in this process.

In what may be a ground-breaking decision, the Italian Court of Rimini has ruled that causation between an MMR vaccine and the resulting autism in a young child “has been established.”

The unnamed child received the vaccine in March of 2004 and on returning home immediately developed adverse symptoms. During the next year the child regressed, receiving the autism diagnosis one year later and is now 100% disabled by the disease.

The Italian court ruled that the child “has been damaged by irreversible complications due to vaccination (prophylaxis trivalent MMR)” and ordered the Ministry of Health to compensate the child with a 15 year annuity and to reimburse the parents of their court cost.

The judgement can be found in full  here and the original news report in Italian appears here. A rough Google translation appears here.

The case is expected to go to appeal as authorities are concerned it may set a legal precedent.

Not the first judgement against the vaccine

This, however, is the second recent judgement to come to this conclusion. Earlier this year a US court also ruled that the MMR (measles, mumps, rubella) vaccine can cause autism.

In a ruling that was kept very quiet in the press, the US Court of Federal Claims has conceded that the mercury-based preservative thimerosal, which was in vaccines until 2002, caused autism in the case of one child.

The ruling was just one of 4,900 cases currently being considered for compensation payments. Health officials are concerned that it could open the floodgates for even more claims.

The ruling, made by US Assistant Attorney General Peter Keisler, was made last November, and was one of three test cases into the MMR-autism link that was being considered by a three-member panel, which Keisler chaired.

The case involved a child who received nine vaccinations in July 2000, when she was 18 months old. Two of these contained thimerosal.  Within days, the girl, who had previously been healthy, began to exhibit loss of language skills, no eye contact, loss of response to verbal direction, insomnia, incessant screaming, and arching.

A diagnosis of autism was confirmed seven months later.

In its defence, the US government claimed the girl had a pre-existing mitochondrial disorder that was aggravated by the vaccine. However in his conclusion, Keisler said that “compensation is appropriate”.

Too much heat, not enough light

Both findings would appear to support the controversial findings of Dr Andrew Wakefield who, in 1998 published an article in the Lancet suggesting a link between the vaccine and autism.  Official reaction to the paper was of such force and such outrage that the Lancet withdrew the paper on the grounds that it was scientifically unsound.

Wakefield has been in a battle for his professional reputation ever since and the question of the proposed link between the MMR vaccine and autism has been largely sidelined (though not solved) by bitter and very public professional rows that have done little to bring clarity to concerned parents.

Read more here.

See also: Survey shows unvaccinated children get sick less often and The autism and allergy overlap