• 07 APR 06
    • 0

    FDA finds Hardell study “difficult to interpret”.

    From Louis Slesin:

    FDA press release April 6, 2006

    Use of Wireless Communication Devices and the Risk of Brain Cancer

    The FDA received numerous media inquires about a recently published paper (Pooled analysis of two case-control studies on use of cellular and cordless telephones and the risk for malignant brain tumors diagnosed in 1997-2003 by Hardell et al) reporting increased risk of malignant brain tumor associated long term use ( >10 years) of cell phones and cordless phones. This is not a new study but is a combined analysis of two studies published in 2005 and 2003. Both the 2005 and 2003 studies were population based case control studies. Cases were recruited based on histopathological diagnoses submitted to regional cancer registries in Uppsala/├ÔÇôrebro and Link├Âping regions of Sweden. Control subjects were taken from a population registry covering the whole population in Sweden.

    Exposure assessment was conducted using mailed questionnaires with a few follow up interviews having been conducted via telephone. The only statistical adjustment made was to avoid bias for year of diagnosis.

    A number of studies have recently been published looking at the risk of long term cell phone use (>10 years) and brain cancer1. The results reported by Hardell et al are inconsistent with results obtained in the other long term studies. Also the use of mailed questionnaires for exposure assessment and lack of adjustments for confounding factors other than time of diagnosis makes the Hardell et al study design significantly different from the other studies. These facts along with the lack of an established mechanism of action and supporting animal data makes the Hardell et al’s finding difficult to interpret.

    The FDA continues to monitor studies looking at possible heath effect resulting from exposure to radio frequency energy. The FDA also plans to convene a meeting in the near future to evaluate research conducted to date in this area and identify gaps in knowledge that warrant additional research.

    Footnote 1

    Results from the Danish component of INTERPHONE Study

    Results from the Swedish acoustic neurinoma component of INTERPHONE Study

    Results of the Danish brain tumor component of INTERPHONE Study

    Results from the Swedish brain tumor component of INTERPHONE Study

    Results combined analyses of acoustic neurinoma risk in the Northern European centres included in INTERPHONE

    Results from the UK brain tumor (glioma) component of the INTERPHONE Study

    Results from the German brain tumor (glioma and meningioma) component of the INTERPHONE Study

    Updated April 6, 2006

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