WASHINGTON-The Food and Drug Administration, citing industry funding limitations, recommended the struggling wireless industry-funded bioeffects research program be redirected to give lifetime animal exposure studies highest priority and to expand scientific investigation beyond brain cancer to other diseases.
But WTR head Dr. George Carlo said last week he will not be able to conduct lifetime rat exposure studies under the remaining $10 million of the total $25 million committed by the wireless industry.
Instead, as a questionable substitute for lifetime rat studies, Carlo said he is examining the possibility of conducting a six-month RF exposure experiment with cancer-prone rodents called “transgenic mice.”
However, the RF mice exposure procedure is not scientifically validated yet or widely accepted as a tool that can be substituted for standard lifetime rat exposure studies. Lifetime rat exposure studies, the state-of-the-art standard in RF bioeffects research, can take several years and cost up to $10 million or more.
“It’s a risky thing,” said Carlo, referring to the transgenic mice experiment.
In addition, because the $23 billion wireless industry has not committed research dollars beyond the original $25 million, WTR likely will not be able to do another key study recommended by the FDA that replicates rat studies that the FDA said show positive bioeffects.
“A careful replication of the (C.K.) Chou and (William) Guy study, which suggests that chronic exposure of rats to microwaves is associated with an increase in tumors, would contribute a great deal to the risk identification process for wireless communication products,” said Elizabeth Jacobson, deputy director for the Science Center for Devices and Radiological Health at FDA.
Carlo, however, said replicating the Chou-Guy study would be redundant if mice RF exposure studies are conducted.
The failure of the wireless industry to fund key research recommended by the FDA could invite government intervention at a future date, a prospect the wireless industry has tried to avoid since the cellular cancer question was raised in early 1993.
Indeed, Jacobson in her March 13 letter to Carlo, and copied to Cellular Telecommunications Industry Association President Tom Wheeler, cited “limited” and “lack” resources as preventing the pursuit of a comprehensive program as originally envisioned by Carlo.
WTR, having produced one epidemiology study in four years, is under pressure from the industry to produce multiple epidemiology, cell culture and animal exposure studies in the fifth but not necessarily the final year of a program that was supposed to end in May 1998.
“We think it is very productive that we’re working with FDA and WTR,” said Tim Ayers, spokesman for CTIA.
But because of ongoing legal and funding problems between WTR and CTIA, it is unclear how much scientific work can be accomplished over the next 12 months. Key WTR researchers have not been paid for months and morale is waning. WTR receives money from a blind trust into which CTIA carriers and manufacturers pay. But some CTIA members are unhappy with the association’s funding structure, believing the financial burden is not spread evenly.
As of late last week, Carlo and CTIA had not signed an agreement indemnifying WTR scientists as indications surfaced of new disagreement between the parties over the terms of accord.
Several health-related lawsuits are pending against the wireless industry and WTR.
It is far from certain whether the government will endorse non-validated, short-term mice studies as a surrogate for lifetime rat studies. Exposure systems developed by WTR over the last four years are for rats and might not be readily modified for mice RF exposure. If WTR proceeds with mice studies instead of lifetime rat studies, the results and success of the entire program may be questioned.
Jacobson also recommended WTR replicate work by Dr. Henry Lai and Dr. Narendra Singh at the University of Washington that found single- and double-strand DNA breaks in rats exposed to low-power microwave energy for two hours.
In addition, Jacobson said that given “the latency of the health effects that have been suggested to be associated with exposure to non-ionizing radiation, long-term study is essential to test associations,” and therefore FDA believes “that continuing postmarketing surveillance is important in ensuring the safety of wireless technologies.”
