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WTR TO SKIP RAT EXPOSURE STUDIES

WASHINGTON-In a surprisingly candid admission, the head of the cellular industry’s cancer research project said he will leave the six-year, $28 million program in mid-1999 without conducting either short-term or long-term animal exposure studies.

Last week’s revelation, which Wireless Technology Research L.L.C. head Dr. George Carlo made in a telephone interview with RCR, follows a Sept. 25 meeting he had with officials from the Food and Drug Administration, the Environmental Protection Agency and other federal agencies. Officials discussed the use of transgenic (cancer-prone) mice in future experiments at the meeting.

An expert workshop on transgenic mice, whose novel and little understood use supposedly saves money and time, is planned here in the next month or so.

The omission of short- and long-term radio-frequency radiation animal studies from WTR research is bound to cause embarrassment to the cellular industry, and could trigger further congressional investigation into the matter.

Rep. Edward Markey (D-Mass.), who held hearings in early 1993 when cellular cancer allegations first surfaced, was told by FDA earlier this year that the federal government has neither conducted nor sponsored major research on possible health risks from pocket phones since 1993.

That prompted Markey to call for the federal government “to engage in an aggressive research strategy, designed to get specific answers to the potential health risk to wireless phone users.”

Most of the 50 million mobile phone subscribers in the United States use pocket phones, which unlike car phones, have built-in antennas that are placed flush against the human head when in use.

Scientific data on possible public health risks from cellular phones are limited and conflicting. A handful of cell phone subscribers that contracted brain cancer (including two people who died) alleged in lawsuits that the phones caused their illnesses. Yet no suits have succeeded to date.

At the same time, litigation has cut into WTR’s research budget and even brought research to a halt for several months last year. Most recently, a Chicago lawsuit was dropped by the plaintiff’s lawyers because they could not identify any experts to testify on their behalf.

Carlo, for his part, has been criticized for mismanaging WTR and appearing too close to the cellular industry at times. Carlo said he believes his independence makes the industry nervous.

Carlo and the Cellular Telecommunications Industry Association, the powerful wireless trade group that hired Carlo four years ago to oversee cancer research and whose members underwrite it, had contemplated WTR performing sub-chronic, 90-day rat exposure experiments in the remaining year-and-a-half of the program.

But sub-chronic studies are viewed to have only limited value in the scientific community. Indeed, federal health and safety regulators have consistently pushed for lifetime animal exposure studies as the highest priority in RF bioeffects research and reiterated that point with Carlo in the Sept. 25 meeting.

“Obviously, we want chronic studies to be done,” said Dr. Elizabeth Jacobson, deputy directory for science at FDA’s Center for Devices and Radiological Health in Bethesda, Md.

Jacobson said she also emphasized the importance of continued epidemiology in last month’s meeting with Carlo.

Despite the fact he will not conduct lifetime (two years) or sub-chronic (90 days) animal exposure experiments, Carlo vigorously defended WTR’s work and said the foundation has been laid for further research.

“The best exposure system is the one we have,” said Carlo.

Jacobson said that while WTR may have not produced much in the way of scientific data, its work could be useful here and abroad in the future.

“I hope people would not walk away. Everyone would lose then,” said Jacobson.

Carlo said he may seek funding from alternative sources if CTIA members balk at further funding. Some CTIA manufacturer members have held back WTR payments in the past to protest the association’s allocation of resources and WTR’s oversight of the cancer research program.

“Our opinion is that we’re relying on the scientists to sign off on the science,” said Tim Ayers, a spokesperson for CTIA. “It would be inappropriate for us to second guess the science. We think what has been accomplished has been important.”

Originally, the program was supposed to end after five years and $25 million next June. But Carlo said the deadline was extended and a little more money committed so WTR can complete work on new, state-of-the-art RF exposure systems and can perform cell culture, acute animal exposure and epidemiology studies.

Cell culture exposure experiments will be begin in North Carolina under Don McRee, head of WTR extramural research, and continue through next spring.

Following that work, WTR will try to duplicate the research of University of Washington scientist Dr. Henry Lai, who several years ago found single- and double-strand DNA breaks in rats exposed to low-level microwave radiation after a couple hours. Some in the cellular industry have questioned the validity of that research.

In a Canadian Broadcasting Corp. TV program last month on WTR’s and CTIA’s handling of the cellular cancer question during the past four years, Carlo insisted WTR was moving “at the speed of light.”

Carlo said WTR has been diligently following the 1994 research agenda, which had the blessing of Dr. John Graham, director of the Harvard Center for Risk Assessment.

That research agenda contemplated multiple long-term animal exposure tests as well as cell culture work and epidemiology studies.

WTR and CTIA have refused to make public an audit of WTR’s work over the past two years, saying only that accountants found WTR’s books in order.

The decision to keep the audit under wraps is at odds with Carlo’s commitment to federal policy makers two years ago.

“The WTR’s principles governing the management of the escrow account provides for full and public disclosure of the financial structure and will ensure the integrity of the program and the resulting research,” Carlo said in an April 10, 1995, letter to Keith O. Fultz, assistant comptroller of U.S. General Accounting Office.

The letter was copied to President Clinton, Federal Communications Commission members, Markey and other key members of Congress.

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