Sunday, January 10, 2016

UK govt trying to stop compensation it already granted for Narcolepsy cases linked to GSK's Pandemrix swine flu vaccine/ Guardian

Over 1,300 people who received the Pandemrix swine flu vaccine in 2009-10 developed narcolepsy.  Demographically,  adolescents were hardest hit. The vaccination caused profound neurologic disability and frequent personality changes in those affected.   

All governments that gave out swine flu vaccines were required (by manufacturers, the World Health Organization and pre-existing contracts that had been inked years earlier in the expectation they would be used for a deadly bird flu pandemic) to assume all liability for any injuries the vaccines might cause. Poland was the only country that publicly balked, and did not offer vaccine to its citizens.

After the swine flu pandemic ended, Finland noticed a spike in narcolepsy cases.  Since then, many studies have been done in about a dozen countries, and it has been established that Glaxo's Pandemrix swine flu vaccine caused a 10-16 fold increase in new narcolepsy cases. After years of debate, this part of the science is settled.

Although initially claiming the vaccine was not implicated in narcolepsy,  in 2013 the UK government admitted that the Pandemrix vaccine had in fact caused narcolepsy.  Some injured parties who were refused initially, were compensated with government funds.

However, in 2015 the UK government requested the right to appeal its earlier granting of compensation.  Most of those affected were adolescents, and the UK is now suggesting that they are less disabled than a working adult might have been. From the Guardian:

... Government lawyers are seeking to block compensation payments to people who developed the devastating sleep disorder, narcolepsy, as a result of a faulty swine flu vaccine. The Pandemrix vaccine made by GlaxoSmithKline (GSK) was given to 6 million people in Britain and millions more across Europe during the 2009-10 swine flu pandemic, but was withdrawn when doctors noticed a rise in narcolepsy cases among those who received the jab. 
Government lawyers are seeking to block compensation payments to people who developed the devastating sleep disorder, narcolepsy, as a result of a faulty swine flu vaccine.
In June 2015, a 12-year-old boy was awarded £120,000 by a court that ruled he had been left severely disabled by narcolepsy caused by Pandemrix. The win ended a three-year battle with the government that argued his illness was not serious enough to warrant compensation. 
The government has paid out to the boy’s family, but has nonetheless asked the court of appeal for permission to challenge the decision. A successful appeal would effectively deny compensation to 100 more families awaiting damages and could rule out any prospect of damages for other children who are injured by different vaccines in the future.
The government argues that vaccine damages should be decided on the immediate, rather than the future, impact of the vaccine-related injury. In this case, that would mean comparing the life of a 12-year-old boy with narcolepsy with a healthy boy the same age. Any effect on his future sex life, his ability to drive, his ability to work or go to university would be completely disregarded. 
“That is a radical interpretation of the law. It is very hard to show that you are disabled enough [to qualify for compensation] if the vast majority of your disability had to be ignored,” said the boy's attorney. “If their interpretation was accepted by the court of appeal, it would virtually abolish the prospects of anybody ever getting any vaccine injury compensation in the UK, because vaccines are mainly given to children and usually very young children.”
In the US, a new industry-friendly FDA Commissioner (Robert Califf, MD) is likely to be confirmed by the Senate this month. The 21st Century Cures Act, a bill that makes approval of drugs and devices easier, and promises to expedite the addition of new vaccines onto CDC-ACIPs list of recommended/required school vaccinations, was passed by 83% of the House and will soon be voted on by the Senate.  Other efforts are underway to weaken FDA regulation of drug safety and rush products to market.  Three hundred plus vaccines are in development. The head of FDA's vaccine center, Karen Midthun, MD, has announced her imminent retirement.

One might suspect that a cabal of industry and government insiders are working feverishly to deny any possibility of industry-provided compensation for injuries caused by drugs, medical devices and vaccines, before a slew of new, hurriedly approved products hits the market.  [In fact, since the 2011 Supreme Court Brucewitz decision, US vaccine manufacturers have had no liability for vaccine injuries in both federal and state courts. The goal of the UK government may be to reduce the definition of compensable injuries over there, before the wave of new vaccines appears.]

UPDATE: Feb 4, 2016 TechTimes
"A 10-year-old boy who developed narcolepsy from swine flu vaccine won £120,000 (nearly $175,000) in damages after a six-year legal bout. In 2010, Josh Hadfield received a Pandemrix vaccine and in three weeks developed narcolepsy, a condition that made him fall asleep almost every five minutes regardless of activity..."

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