FDA – failing to warn (obstructing actually) re. dangers of cell phones

Dr. Weeks’ Comment:   FDA continues to serve corporations at the expense of citizens’ health.

Original Press Release available at:
July 13, 2009
FDA Guts Web Site Cell Phone Safety Pages

The EMR Policy Institute
Advancing Sound Public Policy on the Use of Electromagnetic Radiation (EMR)
P. O. Box 117 Marshfield VT 05658 Tel. and FAX : 802-426-3035 E-mail: info@emrpolicy.org

Press Release

FDA Guts Web Site Cell Phone Safety Pages

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, the American public should expect the FDA to step up and give us confidence that it can handle this job of regulating pharmaceuticals and other potentially toxic exposures. Instead, it is reaching for another Vioxx moment. This is reminiscent of the National Academies of Science 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 2009, FDA’s Center for Devices and Radiological Health in Rockville, MD invited BioInitiative Report (The Report) (www.bioinitiative.org ) co-editors David O. Carpenter MD and Cindy Sage MA to brief then on The Report’s findings and recommendations. Dr. Carpenter is the Director of The Institute for Health and the Environment, University at Albany, SUNY. Ms. Sage is an environmental consultant specializing in evaluation of electromagnetic fields. Both are widely published in scientific journals on the biological effects of electromagnetic fields.

In the hour-long meeting Sage and Carpenter offered a technical presentation of The BioInitiative Report findings and recommendations. Ms. Sage also gave her views to the FDA panel based on the in-depth review of relevant published scientific literature and prudent public health response to it. Ms. Sage’s power-point presentation on the BioInitiative Report findings and recommendations, and her briefing notes for this meeting are available at:
http://www.healthandenvironment.org/working_groups/emf

Ms. Sage has reacted strongly to the FDA’s subsequent actions:
Exactly the opposite has happened. About two weeks after our meeting, the FDA’s 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 preemptive 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 it 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.

FDA’s action begs these questions:

• Who told the FDA’s 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 it 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, FDA has taken all references to the Interphone study off its website.

Ms. Sage emphasizes:
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.

See FDA web pages:
Research – Results to Date www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/Cel lPhones/ucm116335.htm

Children and Cell Phones www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/Cel lPhones/ucm116335.htm

Other governmental agencies around the world have already issued various cautions and precautionary advice to the public on wireless exposures. The governments of Belgium, France, Germany, Finland, Liechtenstein, Austria, Switzerland, Greece and Sweden have already taken public positions encouraging precautionary action. Medical associations in many countries have issued resolutions that warn the public of risks from cell phone use and other wireless technologies like WI-FI and wireless internet. The FDA will have to explain to Congress and the public why it continues to adhere to outdated policies and ignores mounting evidence of health risks.

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 that it cannot bury evidence of health risks for long.

FDA’s actions on cell phone safety recommendations must be viewed in light of the FDA commentary published in the June 2009 issue of The New England Journal of Medicine by FDA’s new commissioner Margaret Hamburg, and Joshua Sharfstein, her principal deputy commissioner, under the title, “The FDA as a Public Health Agency.”

Here is a short excerpt:

“[O]ne of the greatest challenges facing any public health agency is that of risk communication. … The FDA’s job is to minimize risks through education, regulation, and enforcement. To be credible in all these tasks, the agency must communicate frequently and clearly about risks and benefits —and about what organizations and individuals can do to minimize risk. When, like the FDA, Americans must make choices about medication, devices, foods, or nutrition in the absence of perfect information, the FDA cannot delay in providing reasonable guidance —guidance that informs rather than causes unnecessary anxiety. For these communications to have credibility, the public must trust the agency to base its decisions on science.”

The complete article is found at: http://content.nejm.org/cgi/content/full/360/24/2493

The EMR Policy Institute
Advancing Sound Public Policy on the Use of Electromagnetic Radiation (EMR)
P. O. Box 117 Marshfield VT 05658

Tel. and FAX : 802-426-3035   E-mail: info@emrpolicy.org

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