From Cindy Sage:
The FDA”s most recent dismissal of brain tumor risk from cell phone use is stunning in its timing. While other countries of the world are now advising consumers to take precautionary action, the FDA is issuing an “all clear”. Based on new evidence of risk from cell and cordless phone use, we should expect the FDA to step up and give us confidence they can handle this job of regulating pharmaceuticals and other potentially toxic exposures. Instead, they are reaching for another Vioxx moment. This is reminiscent of the National Academy of Sciences issuing an “all clear” press release at the conclusion of the study on electromagnetic fields in 1996, when the study itself pointed to public health risks. Contributing authors complained, but the damage was done. Get to the press early and confuse the message, and the public will be flim-flammed with contradictory messages.
In April of this year, I briefed the FDAs Center for Devices and Radiological Health in Rockville, MD. At their invitation, David Carpenter and I spent an hour discussing the BioInitiative Report findings and recommendations. I offered the advice below based on the in-depth review of relevant published scientific literature and prudent public health response to it.
Exactly the opposite happened. About two weeks after our meeting, the FDAs website content changed, but not in the direction warranted by the growing evidence of harm. FDA”s pronouncement that cell phones pose no risk to users appears to be a pre-emptive strike. Not only does it negate the findings of several recent scientific studies and reviews reporting brain tumor risks at 10 or more years of use, but will also counter the imminent release of the final Interphone Report. Several members of the Interphone study teams have openly discussed that the evidence is showing cell phone users with 10 or more years of exposure have higher rates of glioma, a malignant brain tumor.
“¢ Who told the FDAs Communications branch to issue an “all clear” on cell phone risks?
“¢ On what new evidence of safety of cell phones did the FDA Center for Devices and Radiological Health change its mind and decide it was time to tell the public that there is no risk?
That the Interphone research would find risk of brain tumors must not have been anticipated by FDA. Previously they used the on-going Interphone program work as a benchmark to stall reasonable precautionary responses to growing public concern and to urge us “to wait for the evidence”. Now that the evidence is pointing to big trouble, they”ve taken all references to the Interphone study off their website.
Issuing a positive assertion of safety and denying evidence to the contrary puts the FDA squarely in opposition to other countries whose health agencies are urging parents to reduce cell phone use for themselves and for their children. It puts the FDA at odds with some of the research team members of Interphone that have already broken ranks and given warnings that brain tumor risks are demonstrated.
The international response to FDAs dismissal of cell phone risks has been immediate and negative. Undermining the message of the final Interphone Report and other scientific studies and reviews that do show risks at 10 years and longer cell phone use is widely seen as a tactic to sow doubt, discredit the research, and undermine cooperative action among governments to develop new policies and regulations.
The FDA is reaching for another Vioxx moment with this bizarre move. With its credibility at an all-time low, the FDA should know from experience it cannot bury evidence of health risks for long.
July 7, 2009