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CARLO: INDEPENDENT OR INSTRUMENT?

When confronted with the question of why there is no radio frequency radiation bioeffects research after four years and $15 million, embattled Wireless Technology Research L.L.C. head Dr. George Carlo passionately replies that his critics-those in the wireless industry and in the scientific community-just don’t understand.

They don’t understand the research agenda and the complexities of the novel program. They don’t understand the implications of lawsuits by folks who claim wireless phones cause brain cancer-including one former cellular subscriber with a benign brain tumor who believes WTR is in bed with the industry to cover up possible health risks from pocket phones. They don’t understand funding problems with the Cellular Telecommunications Industry Association. And they don’t understand about industry interference with the science.

“My commitment is to do the job right,” said Carlo, in a lengthy interview with RCR recently.

Carlo was picked by Thomas Wheeler, president of the Cellular Telecommunications Industry Association, to run the WTR program after the media frenzy in early 1993 surrounding a Florida man’s lawsuit that claimed his wife’s brain tumor was caused by using a portable cellular phone. The judge dismissed the case for lack of scientific research. Other lawsuits are pending.

Congress’ General Accounting Office in November 1994 said existing research was insufficient to determine whether pocket phones cause brain cancer or other diseases, a finding at odds with the cellular industry’s claim that numerous studies prove pocket phones are safe.

That was then. Today, there are 45 million wireless phones in use, most are the handheld style. Car phones and tote phones are not believed to pose health risks because their antennas are separate from handsets that users place against their heads to make and receive calls.

Still, no RF bioeffects research results from WTR. Little, if any actual bioeffects work has begun. Carlo might differ with that view. He puts a premium on WTR’s development of RF exposure systems for cell culture and rodent studies and on scientific peer review.

“We developed this (exposure system) because I’m looking at value for 20 years,” said Carlo. “I’m not looking at studies that the industry can say, `Alright we’ve done a five-year program, we’re done.’ Again, that was one of the philosophical differences I think people didn’t pick up on. We’re talking about things that are going to be valuable to public health people, the industry, the [Food and Drug Administration] … for 20 years down the line. And that’s why we spent so much of our effort doing it.”

Yet the animal exposure system was roundly criticized by prominent RF scientists at the Bioelectromagnetics Society’s annual meeting in Victoria, British Columbia, Canada, last June. And, while a high priority, only $900,000 of the $1.5 million contracted to C.K. Chou, director of City of Hope National Medical Center’s Department of Radiation Research in Duarte, Calif., to develop exposure systems has been spent.

That still leaves $14 million spent elsewhere so far. And on what? A WTR audit has been completed, but WTR’s auditor has refused to release it. Only one general epidemiology study has been conducted to date and that study is mired in litigation.

Ronald Petersen, manager of Radiation Protection and Product Safety for Lucent Technologies Inc. and a sharp critic of Carlo early on, has suggested on occasion that the wireless industry is going to be viewed in the same light as the tobacco industry if the WTR bioeffects research program fails even if research shows no connection between cellular phone use and cancer.

Some scientists who helped Carlo get the program off the ground never heard back after contracts were set. They got angry. Carlo writes that off to sour grapes.

But the blame for WTR’s quandary is not limited to Carlo. CTIA’s Wheeler is the target of criticism for funding problems and for aggressively publicizing the safety of phones while research is ongoing.

Carriers and manufacturers contribute to RF bioeffects research through CTIA, which in turn deposits money in a blind trust.

Today, CTIA is telling carriers and manufacturers the remaining $10 million they’ve committed to spending will cover the remainder of research, except for post-market surveillance costing an estimated $1 million a year.

Carlo is saying something different. He says the remaining $10 million might cover multiple epidemiology and cell culture studies and replication of earlier research at the University of Washington that showed DNA breaks.

But chronic (multiyear, lifetime) rodent RF exposure studies could run $8 million to $10 million alone “over what we have left,” Carlo said.

“The program is more expensive than what the industry thought,” said Carlo, noting the outline of studies recommended March 13 by the FDA that puts the highest priority on lifetime rat RF exposure studies.

CTIA officials said Carlo told them all epidemiology, cell culture and lifetime rat exposure studies would be covered by the remaining $10 million. CTIA said it expects the research to answer questions about whether pocket phones cause cancer.

“I think CTIA knows it’s going to be more expensive,” said John Madrid, a Washington, D.C., representative of Toshiba Corp. and the most outspoken critic of CTIA’s funding structure. Madrid said CTIA has ignored suggestions that the financial burden for supporting RF bioeffects research be spread among a larger group of manufacturers.

Other wireless manufacturers share that view.

“Yes, we’re frustrated we’re paying so much” and haven’t seen results, said John Malloy, a government relations representative for Nokia Corp. “The rift between Carlo and Wheeler doesn’t help,” added Malloy.

Malloy and Kevin Kelly, a lobbyist for Qualcomm Inc., said they believe RF research will have to continue into the future beyond five years and $25 million. Who will pay for further research and who will manage it remains unclear. Kelly gives Carlo credit for attempting to put a solid research program in place.

As for the arms-length distance relationship that is supposed to exist between WTR and the wireless industry, Carlo did his best to dispel any notion that the relationship is anything but that. “The mindset among industry in general is that those who pay get something back-that those who pay get control,” Carlo said.

As for industry browbeating, CTIA a year ago ended a dosimetry program under Carlo’s purview that was to be the basis for certifying that pocket phones meet RF safety exposure limits.

“They were exerting (influence) and in the midst of all that is when the conflict began,” said Carlo. “We didn’t take kindly to that.”

Wheeler initially wanted to take research funds to pay for litigation. Carlo balked, and Wheeler relented. But the litigation problem didn’t go away. WTR’s scientists refused to continue work until they were indemnified. Wheeler didn’t want carriers vulnerable to unlimited liability costs. Though the indemnification snafu appears resolved, Carlo laments that a year was lost fighting Wheeler.

But some question whether Carlo himself has contributed to delays.

Meanwhile, there is no love lost between Carlo and Wheeler.

There is a belief within WTR that CTIA flirted with the idea of taking the RF bioeffects research away from Carlo and putting it into a different venue.

CTIA denies that the idea was ever broached.

Next week: Government oversight

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