May 24, 2010 Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Attention

: Subject: Dr. Margaret Hamburg, MD, Director, FDA FDA Center for Devices and Radiological Health “All-clear” Wrongly Issued on Brain Tumor/Cell Phone Use

Dear Dr. Hamburg, The newly released INTERPHONE study has reported a clear increase in risk of glioma on the same side of the head where a cell phone was used for more than 10 years. The INTERPHONE report now confirms what many experts have warned – that regular use of a cell phone by adults can significantly increase the risk of glioma by 40% with 1640 hours or more of use (and 96% with ipsilateral use). Tumors were more likely to occur on the side of the head most used for calling. And yet, the FDA consumer advisory posted this week has issued what amounts to an “all clear” with the headline “No Evidence Linking Cell Phone Use to Risk of Brain Tumors”. FDAs dismissal of cell phone risks is unwarranted and counter to the evidence within the INTERPHONE study, its two appendices, and with opinions from the principal author, Dr. Elizabeth Cardis of CREAL (and formerly of IARC). To make the situation even more serious, there is emerging evidence that the risks of cell phone use by children is significantly greater than for adults. It is irresponsible for the FDA to ignore this evidence. The credibility of the FDA is certainly at stake as the evidence of risk from cell phones grows with each new study. The FDAs role is protect consumers from risks of disease even when some questions remain as to the magnitude of that risk. We ask the following questions. • 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?

Dr. Margaret Hamburg May 24, 2010 Page 2 We were greatly encouraged by your views in the New England Journal of Medicine (June 11, 2009) on the mission of the FDA to provide reliable consumer advice, transparency in process and to actively work on improving FDA’s credibility with the public. “The FDA's job is to minimize risks through education, regulation, and enforcement.” “For these communications to have credibility, the public must trust the agency to base its decisions on science.” “Transparency is a potent element of a successful strategy to enhance the work of the FDA and its credibility with the public. Whenever possible, the FDA should provide the data on which it bases its regulatory decisions and other guidance and explain its decision-making process to the public.” Governments around the world have been waiting for release of this information from IARC, and hanging their hats on the outcome. This is exactly the right time for FDA to look comprehensively at all the evidence, including the INTERPHONE results, and issue consumer advice that is precautionary and prudent. What FDA has done this week on consumer advice on cell phones does not meet this standard. We urge you to take another look with your staff at the FDAs new consumer advice page on cell phones, and modify it in accord with the factual findings of the INTERPHONE report with particular attention to Table 1 of Appendix 2. Thank you for your attention to this very important public health matter. Cindy Sage, MA Co-Editor BioInitiative Report Sage Associates
cc: Linda Birnbaum, NIEHS, NTP Norb Hankin, EPA Joe Bowman, NIOSH Rep. Dennis Kucinich Rep. Edward Markey Rep. Nancy Pelosi Sen. Barbara Boxer Rep. Lois Capps

David Carpenter, MD Co-Editor BioInitiative Report Director, Center for Health and the Environment University at Albany, Rensselaer, New York
Ed Mantiply, FCC Carl Blackman, EPA Greg Lotz, NIOSH Rep. Henry Waxman Rep. Tom Harkin Sen. Diane Feinstein Rep. Jackie Speier Rep. George Miller

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