if more than one child in 1000 has a febrile seizure, the vaccine is doing more harm than good

PUBLISHED research linking CSL’s influenza vaccine to high rates of fever in children was omitted from the product information for its 2010 Fluvax product, which caused serious adverse reactions in children.
The product information (PI) included data from the 2005 flu season showing that after receiving Fluvax, fever was experienced by 22.5% of children aged from 6 months to less than 3 years and 15.6% of children aged from 3 years to less than 9 years.

However, the PI omitted data from the 2006 season which showed that the rate of fever had increased considerably — to 39.5% in the younger age group and 27% in the older group. Of the 272 children who received the 2006 vaccine, one child in the older group experienced a febrile convulsion.

However, Professor Collignon said it was important to weigh the risks of the vaccine with the risks of influenza itself.

“By my calculations, if more than one child in 1000 has a febrile seizure, the vaccine is doing more harm than good”.

In 2010, Fluvax was found to be causally linked to a significantly increased rate of fevers and febrile convulsions among Australian children. One published estimate put the rate of paediatric febrile convulsions at 3.3 per 1000 doses, or more than 200 times the rate in the only other published population-based estimate. (3)
MJA InSight, 17 October 2011

CLINICAL practice guidelines are vulnerable to bias

CLINICAL practice guidelines are vulnerable to bias, with only 15% of NHMRC guidelines from Australia’s most prolific guideline developers including a declaration of conflicts of interest, new research has found.

Although a conflict of interest (COI) statement has long been required from authors of research papers, it is often lacking for developers of clinical practice guidelines, despite the influence of guidelines on clinical care.

The research, in the latest issue of the MJA, looked at more than 200 clinical guidelines that were listed on the NHMRC website. Its authors concluded that the NHMRC needed to “urgently promote a more ethically sound development process for guidelines”.

“Our review of the country’s most prolific guideline developers shows that only 15% of guidelines have COI statements”, they said.

“This raises questions about whether medical bodies are affected by unrecognised, and thus unaddressed, extraneous interests, and may erode the trust the community has in the profession to speak authoritatively about health problems.”
MJA InSight, 17 October 2011