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MARKEY PRESSURES FDA ON RF RESEARCH AND FUNDING STATUS

WASHINGTON-Rep. Edward Markey (D-Mass.) has resumed his probe of the Food and Drug Administration’s oversight of mobile phone safety, requesting the agency respond by Dec. 19 to a new series of questions on the status of government and non-government research on radio-frequency radiation from wireless devices and on the outlook for future funding of such research.

“I recognize that the lengthy time line necessary to conduct sound scientific inquiry into these issues may mean that the ability of the agency to make determinations as to the safety of handheld wireless phones is likely to be years away,” Markey told lead FDA Commissioner Michael A. Friedman in a Nov. 21 letter.

“I do feel strongly, however,” said Markey, “that it is incumbent upon the government to assure consumers that germane investigations are being conducted, either by the government or non-governmental entities, both within the United States and abroad, that are designed to fill the gaps in scientific knowledge that have so far prevented a more precise assessment of any health risk.”

In response to a query from Markey earlier this year, the FDA reported the federal government was neither conducting nor supporting major RF health-effects research.

Markey, top ranking Democrat on the House telecom subcommittee, grabbed the national spotlight five years ago when he hauled in cellular industry officials and federal policy makers to testify whether pocket phones cause health problems as a Florida man alleged in a lawsuit after his wife, a cell phone user, died of brain cancer.

H. David Reynard lost his legal challenge in the Florida case and no lawsuit making the same or similar allegations has succeeded since then.

Nevertheless, the issue-both in terms of public health policy and telecom policy-remains controversial and is being played out today in the courts, in Congress and in public hearings on antenna siting around the country.

The U.S. wireless industry, despite having a research program in place for the past four years and spending $17 million of a total $28 million, cannot speak of any RF bioeffects research to date.

An epidemiology study performed during that span by Wireless Technology Research L.L.C., the entity directing industry-financed RF research, found little difference in the mortality rate among subscribers who used pocket phones and those who used car phones with detached antennas.

Susan O’Donnell, a spokeswoman for WTR, said she knew of the latest Markey-FDA letter but had not read it. She said WTR Chairman Dr. George Carlo would not be available for comment until after results are in from cell culture exposure research next March.

“We will be responding as quickly and as completely as possible,” said Dr. Elizabeth Jacobson, who oversees mobile phone safety at the FDA.

Meanwhile, Motorola Inc., the world’s largest mobile communications equipment supplier, says its studies have found no evidence that wireless products are dangerous to consumers.

However, some RF research overseas has suggested a linkage between RF radiation and health problems.

Given the lingering questions about possible health risks and what research might do to shed more light on the issue, Markey posed the following questions to the FDA:

1) Is the FDA monitoring biological health effects other than cancer, for example, headaches or ocular problems? If so, please describe such research and any available resulting data.

2) Has the FDA received any information that digital wireless phone technology poses a greater, or qualitatively different, potential risk to certain users than analog wireless phone technology? If so, please describe such research and any available resulting data.

3) Has the FDA received any information indicating that current or future base stations pose a health risk? If so, please describe such research and any available resulting data.

4) In its May 5 response, the FDA indicated that its Center for Devices and Radiological Health has performed experimental and computational investigations of energy deposition in the body from cellular phones. Please describe such research and resulting data. Also in its May 5 response, the FDA stated the Department of Defense conducts research on basic bioeffects of RF exposure. Please describe such research and resulting data and provide a list of all such experiments conducted by the Department of Defense.

5) What provisions have been made to ensure that there are long-term monitoring studies of users of wireless telephones? Are specific studies in place? Who is conducting such research?

6) As you may know, WTR’s peer review board, coordinated by the Harvard University School of Public Health Center for Risk Analysis, wrote to WTR on July 15. In that letter, the peer review board lauded WTR for its work in addressing unanticipated health risks associated with interference with pacemakers in some patients who used cellular phones. Does the FDA believe that such creative and decisive action by WTR to address this discrete risk in a timely fashion can serve as a model when other discrete risks are identified? Please explain and reference which distinct potential health risks might be addressed by WTR, or other research entities, in this manner.

7) Also in its July 15 letter, the WTR’s peer review board identified significant areas for improvement in WTR’s activities, including asserting that WTR’s “decision making appears to be less independent of industry and government than it was several years ago.” The board articulated a series of recommendations to WTR including, but not limited to, revisiting and revising its research agenda, not relying wholly upon industry to fund certain studies, articulating a plan to support a continued program of health research and fully documenting its spending for its first three years. For each of the peer review board’s recommendations, please respond as to whether the FDA concurs with the peer review board’s critique and supports its recommendations. In addition, please provide any additional recommendations that the FDA believes that WTR should implement to further improve its efforts.

8) Does the FDA believe that additional government funding is needed to perform scientific investigations of RF exposure in order to more adequately assess potential risks to the public? If so, does the administration plan to request such funding?

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