Saturday, August 4, 2012

Rewriting the history of pandemic swine flu (to justify vaccine policies?)


Remember the 2009 Swine Flu Pandemic?  There were going to be a huge number of illnesses and deaths, but then it turned out the flu virus caused less severe disease than usual.  
  • We were in dire need of vaccines, so it was said.  Therefore a bizarre vaccine approval process was instituted.  
This process was crafted to mislead the public.  Vaccines were approved on the basis of prior testing of so-called "mock-up vaccines".  The mock up vaccines were actually old bird flu vaccines tested years earlier for a potential bird flu epidemic.  They contained the same adjuvants as swine flu vaccines, but the antigens were completely different.  According to WHO:
... some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.
Approval of the new vaccines rested on sleight of hand:  regulatory agencies made the claim that the two vaccines were substantially identical.  Therefore, data from tests of old bird flu vaccines provided the proof needed to demonstrate safety and effectiveness of new swine flu vaccines.  According to the Guardian:
The clinical trials on which approval was based involved more than 6,000 people for each vaccine, each of whom received a version which was basically the same as the one to be rolled out, but originally contained an avian flu (H5N1) strain – which had been expected to cause a pandemic – instead of H1N1.
And POOF! -- hundreds of millions of people received the new, untested vaccines.

Later came the bad news.  

The epidemic was actually mild, and most of those affected had few if any symptoms.

The vaccines had been given late, when most of the epidemic had passed, and many vaccinated people were already immune.  The vaccine probably had little impact on the pandemic.

The shot itself was dangerous.  Glaxo's version caused 13 times the expected number of cases of narcolepsy in children, and different versions increased the risk of Guillain-Barre syndrome.


The Council of Europe got into the act, investigating WHO and the provenance of the contracts to understand how billions of healthcare dollars were spent to buy and administer unnecessary vaccines.

WHO (the World Health Organization) didn't take the assault lying down.  It arranged for its own investigation, which unsurprisingly found no big mistakes.


Instead of acknowledging these findings and planning for better vaccine testing, the swine flu pandemic's history was rewritten. 

Although Bloomberg/Businessweek mentioned the study showing a doubling of the GBS rate, it concluded flu vaccine was safe in pregnancy:
Today’s research and a Canadian study looking at the vaccine’s effect on Guillain-Barre syndrome, a disorder in which the body attacks its nervous system, shows the shot is safe and should be used as a precaution to prevent infection, he said. 
More whitewashing of the data followed:  there were no problems with fertility in women vaccinated during any trimester of their pregnancy.  Here's a link to the Danish study published in JAMA.


Except CDC didn't find them; instead, it estimated them.  What was the authors' conclusion?  
Although no estimates of symptomatic case fatality ratios were available from Africa and southeast Asia, a disproportionate number of estimated pandemic deaths might have occurred in these regions. 
A different review published by CDC scientists in May 2012, honestly noted:
Human infection with H1N1 has generally resulted in low mortality, although certain subgroups... have significantly higher risk of severe disease.
Let's examine the claim of vaccine safety during pregnancy.    

In the US, the major birth defect rate is about 3%.  In the Danish study cited, the major birth defect rate in offspring of women vaccinated during their first trimester was 5.45%.  But in the Danish control group, the major birth defect rate was 4.54%.  


The authors were able to dismiss the high birth defect rate by selecting a control group with a higher than expected rate, and by using groups small enough that the 0.91% increased rate in the vaccinated cohort was not statistically significant.  

Anders Hviid, the last author on the study, was involved in an earlier study that was not sufficiently powered to detect a 2.7-fold increase in GBS following swine flu vaccinations.  He was then able to conclude that "The risk of occurrence of Guillain-Barr√© syndrome is not increased after pandemic influenza vaccine."

I imagine these are only the first volleys in CDC's attempt to rewrite the history of swine flu and its vaccine, and justify its vaccine policies despite evidence to the contrary.  Keep an eye out for what's next.

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