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MARKEY PROBES FDA ON CELLULAR RESEARCH

WASHINGTON-Rep. Edward Markey (D-Mass.) last week launched a congressional investigation into the Food and Drug Administration’s oversight of the struggling cancer research program funded by the cellular telephone industry, a move that signals renewed congressional interest in the controversial issue.

The probe by Markey, top ranking Democrat on the House telecommunications subcommittee, follows recent news accounts by RCR and The Washington Post on the lack of bioeffects studies under Wireless Technology Research L.L.C. after four years and $17 million.

The articles also raised questions about the independence of the industry-backed research effort in light of, among other things, a 1994 Motorola Inc. internal memo that identified WTR and the Cellular Telecommunications Industry Association as part of a media strategy to downplay University of Washington research on single- and double-strand DNA in rats exposed for two hours to low-level microwave radiation at 2.45 GHz.

“Today, there are 45 million users of wireless phones, yet we are still unable to certify the safety of this product for American consumers because adequate research apparently has not been performed,” said Markey in a April 7 letter to the FDA in which he asked for answers to a series of questions by next Monday.

Markey chaired a House telecommunications subcommittee oversight briefing in February 1993 to assess the state of scientific research on the potential public health risks from portable cellular phones.

A Florida man’s claim on prime time national cable TV that his wife’s fatal brain cancer was caused by cellular phone use sent wireless stocks into a short-lived tailspin. H. David Reynard’s lawsuit was subsequently dismissed for lack of scientific evidence.

Other lawsuits that make similar claims and accuse the cellular industry of conspiring with WTR to cover up cellular health risks are pending, though no lawsuit has succeeded to date. WTR research was halted for months after scientists refused to work until they were indemnified from similar litigation.

WTR and CTIA said they’re close to signing an agreement that indemnifies RF scientists and that guarantees WTR $10 million at regular intervals for the duration of the program, which is scheduled to end a year or so from now.

Markey in 1993 ordered the General Accounting Office to report back on the status of the safety of cellular telephones. GAO, the investigative arm of Congress, found in November 1994-more than a decade after cell phones first hit the market-that no long-term studies on human exposure to low-level radiation from cellular phones had been conducted and concluded that existing data was insufficient to ascertain health risks, if any, from portable phones.

Last August, the Federal Communications Commission adopted stricter RF exposure limits for wireless products. That standard has came under attack from industry and consumer advocates.

“This is a plan suggested by GAO and we have put fire walls up to protect independence and, the fact is, no one else stepped up to the plate to the funding and we did,” said Tim Ayers, CTIA spokesman.

Four years into the five- year, $25 million industry-funded research program, WTR has produced no long-term animal RF exposure studies or any cell culture work. WTR, organized in early 1993 under a different name and led by CTIA-appointed Dr. George Carlo, has produced one epidemiology study that found little difference in the mortality rates of pocket phone users, who place handsets directly against their heads, and car phone users, who are exposed to less RF energy because antennas are mounted separately on vehicles.

“For whatever reason, there’s a renewed interest in WTR,” said Carlo, an epidemiologist and a lawyer. “I welcome that.”

Thomas Wheeler, president of CTIA, characterized as “aspersions” references in Markey’s FDA letter regarding the issue of WTR’s freedom from industry influence.

“The industry has lived up to its commitments and obligations … and will continue to do so,” said Wheeler in a terse, April 9 letter to Markey.

WTR has refused to release an audit of how the $17 million has been spent, though about $2 million is said to have gone toward research on interference to pacemakers from wireless phones.

The FDA last week, perhaps reflecting on lackluster WTR research, told a government advisory panel it might take another five years to assess the relative health risks of pocket telephones.

Markey wants answers to the following questions from FDA:

1) What type of scientific research is needed to fully assess whether RF exposure from wireless phones poses a health risk to consumers? What research is WTR conducting? Is this the type of research that is necessary to fully assess whether RF exposure from wireless phones poses a health risk to consumers?

2) To your knowledge, is WTR conducting any biomedical research to assess whether the frequencies and power levels used by portable wireless cellular phones produce RF exposure that is unsafe to consumers? If so, please provide a description of such research.

3) Is the FDA fully confident that the research being conducted by WTR has the independence and scientific integrity to assess adequately portable wireless phone safety? In your opinion, can the federal government, and American consumers, rely on the results of this industry-sponsored research?

4) What research has been conducted at any federal agency since 1993 to assess whether the frequencies and power levels used by portable wireless phones produce RF exposure that is unsafe to consumers? Please list the agencies, types of research and expected dates for completion of such research. If no such research has been, or is being conducted, please explain why not.

5) Has the federal government sponsored or funded any outside research since 1993 that specifically analyzes whether the frequencies and power levels used by portable wireless phones produce RF exposure that is unsafe to consumers? Please list the organization conducting such research, the amount of federal support and the expected dates for completion of such research. If no such research has been, or is being conducted or funded, please explain why not.

6) Since 1993, has the federal government conducted any research itself, received any research data from WTR, or received any outside research results, that serve to reassure the public that portable wireless phones are safe? If so, please describe such research.

7) Since 1993, has the federal government conducted any research itself, received any research data from WTR, or received any outside research results, that serve to diminish confidence that portable wireless phones are safe? If so, please describe such research.

8) When does the FDA expect to be able to make any conclusory statements about health risks associated with RF exposure from the portable wireless phone use?

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