WASHINGTON-The mobile-phone research pact between the Food and Drug Administration and the Cellular Telecommunications Industry Association has come under attack by the former chairman of the leading Canadian wireless association, adding fuel to a controversy that could become mired in litigation soon.
In a June 13 e-mail to wireless executives that was obtained by RCR, John Phillips, executive vice president of carrier relations for Clearnet Communications Inc. and immediate past chairman of the Canadian Wireless Telecommunications Association, stated: “CTIA’s close treatment of this issue will justifiably generate increased and huge cynicism within each stakeholder community. That cynicism will spill over to Canada. We should consider aggressively separating ourselves from the U.S. industry on this issue. I wonder how some CWTA members can continue to support the CTIA as members, and I ask them to re-evaluate their continuing membership.”
Mark Langton, a spokesman for Clearnet, confirmed that Phillips was the author of the e-mail. Clearnet is a nationwide personal communications services and dispatch radio operator in Canada.
Phillips could not be reached for comment. As to whether Canada would emulate the FDA-CTIA model, Langton replied: “There could never be an equivalent approach because of the differences [between the two countries] …,” said Langton. “There’s always an ongoing debate on approaches.”
Roger Poirier, executive vice president of CWTA, declined to say whether other CWTA members share Phillips’ views.
“This is his (Phillips) opinion and we don’t have any comment or opinion on this right now,” said Poirier. Poirier said CTIA is going to brief CWTA on the Cooperative Research and Development Agreement (CRADA) in the next two weeks.
Christina Martin, a CTIA spokeswoman, echoed Poirier’s remarks. “This is simply one man’s opinion. CTIA will continue to do what is right and good.”
On a separate front, Baltimore lawyer Peter Angelos is considering filing suit to block the FDA-CTIA research agreement, according to a source close to Angelos.
The source said the lawsuit, which could be filed within weeks, would seek not only to void the FDA-CTIA pact but would direct FDA to take greater steps to determine whether mobile phones cause cancer or other health risks to the nation’s 93 million subscribers.
Angelos, who has successfully litigated product liability lawsuits against asbestos and tobacco manufacturers, is nearing a decision on whether to file a class-action suit against the wireless industry. He did not return calls for comment.
The FTC-CTIA accord, announced June 8, calls for a handful of studies as a follow-up to research conducted by the industry-funded Wireless Technology Research L.L.C. Several WTR studies had results suggesting possible health hazards from mobile-phone RF radiation.
Under the CRADA, government scientists will make recommendations for studies. But CTIA will have final say on which scientists will be chosen to conduct the research and CTIA will determine the funding of individual studies.
Indeed, the research studies themselves are not even be covered by the CRADA.
“The parties agree the third-party research studies will not be conducted pursuant to this CRADA, but rather under separate agreements with the relevant parties,” states the FDA-CTIA pact. That means CTIA directly controls contracts with scientists, including any confidentiality agreements.
The FDA-CTIA agreement also allows CTIA to “provide travel expenses and honoraria for scientific and technical experts to participate in review meetings and to review research progress.”
That the FDA agreed to closely cooperate with CTIA on only a limited number of studies (mainly a genotoxicity study and a epidemiology study conducted by WTR that had positive results) is at odds with recommendations for large-scale mobile-phone health research that FDA has made to Congress and others.
“Little is known about the possible health effects of repeated or long-term exposure to low levels of radio-frequency radiation of the types emitted by wireless communications devices,” stated FDA in a May 5, 1997, letter to Rep. Edward Markey (D-Mass.), an influential member of the House telecommunications subcommittee.
“A significant research effort, involving exposures of large numbers of animals to the various types of cellular phone modulation in current or expected use, coupled with epidemiologic surveillance of exposed populations, is needed to provide a further basis for risk assessment of these devices,” stated FDA in the same letter.
In a Jan. 14, 1998, letter to Markey, FDA said it advised WTR that “due to the latency of some of the health effects that have been suggested to be associated with exposure to non-ionizing radiation, long-term study is essential to test such associations.”
In a March 13, 1997, letter to WTR head George Carlo, Elizabeth Jacobson-then-deputy director of the FDA’s Center for Devices and Radiological Health-said chronic (lifetime) animal exposures should be given highest priority.
No lifetime animal studies will be conducted under the FDA-CTIA research agreement.
Neither Jacobson nor an FDA spokesman were available for comment.
Carlo criticized the FDA-CTIA CRADA, saying industry has too much control over the research process.
Norman Sandler, director of global strategic issues for Motorola Inc. and a recipient of the Phillips e-mail, said lifetime animal studies are being conducted by Motorola in the United States and in other countries.
“I think there was a misunderstanding about what the CRADA is all about,” said Sandler, explaining that it is narrowly constructed follow-up research and not a brand new project.
