January 23, 2013
On January 22, 2013, Reuters reported that nearly 800 children in Europe have developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine produced by the British drugmaker, GlaxoSmithKline in 2009. 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.
According to the Reuters article, experts are 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.
“’No-one wants to be the next Wakefield,’ said Mignot, a specialist in the sleep disorder at Stanford University in the United States, referring to the now discredited British doctor Andrew Wakefield who sparked a decades-long backlash against the measles, mumps and rubella (MMR) shot with false claims of links to autism.”
Goran Stiernstedt, a public health official in Stockholm, Sweden, questions the wisdom 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.
In the case of Emelie Olsson, a 14-year-old honors student who “loved playing the piano, taking tennis lessons, creating art and having fun with friends,” having fun is the emotional trigger that causes her to collapse.
“I can’t laugh or joke about with my friends any more, because when I do I get cataplexies and collapse,” she said in an interview at her home in the Swedish capital.
In January 2011, a Puerto Rico subsidiary of GlaxoSmithKline pleaded guilty to distributing adulterated drugs after whistleblower Cheryl Eckard went public on a “60 Minutes” report, detailing incidents of bacteria-tainted water being used to manufacture tablets, employees contaminating products in an attempt to save money, and mix-ups in medications due to production line failures.
In July of 2012, the U.S. Department of Justice and GlaxoSmithKline came to a $3 billion settlement agreement to resolve allegations that GSK broke U.S. laws in marketing several of their products. GSK pleaded guilty to misdemeanor criminal charges for illegally marketing antidepressants Paxil and Wellbutrin, and for failing to report the safety data on the diabetes drub, Avandia.
According to the Reuters report, “GSK is funding a study in Canada, where its adjuvanted vaccine Arepanrix, similar to Pandemrix, was used during the 2009-2010 pandemic. The study won’t be completed until 2014, and some experts fear it may not shed much light since the vaccines were similar but not precisely the same.”