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FDA RECOMMENDS MORE RF STUDIES

WASHINGTON-The Food and Drug Administration has recommended to Rep. Edward Markey (D-Mass.) that more research be conducted on possible health risks from mobile telephones, but the agency left unclear whether it believes the issue is important enough to warrant funding by the Clinton administration.

“The FDA believes additional research in the area of RF exposure is needed,” the agency stated in response to a Nov. 21 questionnaire from Markey. At the same time, the FDA noted, “there is no new information indicating that use of cellular phones is a human health risk.”

Replying to his initial probe last year, the FDA told Markey there is not a major radio-frequency research project either being conducted by or funded by the federal government.

Vague responses by the FDA in its latest report to Markey have raised questions about whether there is internal debate within the agency on how to deal with the controversial issue.

One government scientist said the cellular phone health issue is so politicized that FDA officials may simply want to stay out of the crossfire and concentrate instead on regulating other radiation-emitting consumer and medical devices.

“We need to see how industry-funded research plays out,” said Dr. Elizabeth Jacobson, deputy director for science in the FDA’s Center for Devices and Radiological Health.

Indecisiveness by the FDA on how to proceed with lingering questions over whether mobile phones cause or promote brain cancer could, in turn, affect how aggressive or tentative Markey is in monitoring the issue.

“We’re going to be looking for additional clarity and see what the president says in his State of the Union address (on Jan. 27),” said Colin Crowell, an aide to Markey.

Markey, who held hearings in 1993 after claims of an alleged link between cell phone use and health dangers surfaced, appears less willing to lobby for federal funding for RF bioeffects research so long as the FDA declines to press the White House for support.

With a stalemate on what role, if any, government should play in RF research and the lack of scientific data to date from the six-year, $25 million industry-funded cell phone-cancer research project set to end next year, the United States-either by default or design-appears to be ceding the prickly issue to the World Health Organization.

The WHO, based in Geneva, is moving forward with a plan to track mobile phone users in eight countries during the next decade to determine whether the popular communicators pose a public health risk.

The project will be headed by Dr. Elisabeth Cardis, a Canadian epidemiologist. Cardis is affiliated with the International Agency for Cancer Research, a WHO unit located in Lyon, France.

Ben Greenebaum, a consultant to the IACR, said the eight countries first need to develop a common protocol to monitor mobile phone users.

Plans call for a pilot study in the next six months, followed by an epidemiology survey that could last at least 10 years.

The eight countries that Greenebaum identified as participating are Australia, Canada, Denmark, Italy, Israel, France, the United Kingdom and Sweden.

Greenebaum said the WHO also supports animal experiments and subjective studies. Greenebaum said that funding required for the research is an issue that has not been settled.

Dr. Kjell Mild is due out with a subjective study this year on whether cell phones cause headaches. The FDA, which reiterated its support for long-term RF animal studies, said it is aware of such complaints here and overseas.

Greenebaum noted that while there is no evidence that long-term exposure to low-level RF radiation is dangerous, there are still questions that additional scientific research could answer.

“People can get scared about small things,” said Greenebaum.

Motorola Inc., the largest U.S. mobile communications supplier, says none of the RF research it has conducted or sponsored has found wireless devices a risk to users.

But other research here and abroad has found single- and double-strand DNA breaks and increased cancer in rats exposed to low-intensity RF energy.

“Mobile telephones are arguably the most radiative appliance we have ever invented apart from the mircrowave oven and people are putting them by their heads – arguably the most sensitive part of the body,” said Roger Coghill, an RF bioeffects scientist in Wales.

Coghill, according to Reuters, intends to bring a test case lawsuit against a local cellular phone distributor for breach of consumer protection.

Coghill wants mobile phones to carry health warning labels.

Likewise, Neil Cherry, a biophysicist in New Zealand, told Reuters that “very low, non-thermal microwave radiation alters the basic biochemistry of cells, which have a potential to cause altered brain function, carcinogensis and impaired immune system functioning.”

None of the lawsuits in the United States that tried to link cell phones to brain cancer have succeeded.

Responding to Markey’s question about the Harvard Peer Review Board’s recommendation that Wireless Technology Research L.L.C. – the entity performing the RF research for the cellular industry – provide a more open accounting of its spending for the first three years, the FDA said only that “we have asked WTR on several occasions…for a listing of grants funded, amounts of the grants, principal investigators and institution and beginning and end dates of the grants.”

WTR and the Cellular Telecommunications Industry Association, the trade group that hired Dr. George Carlo to direct RF research, have not released the WTR audit.

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