WASHINGTON-The Food and Drug Administration-which recently agreed with the cellular industry to replicate two studies by Wireless Technology Research L.L.C. that showed positive findings-may have rejected cooperating with industry on research when mobile-phone cancer allegations first surfaced in 1993 because of a potential conflict of interest.
Dr. George Carlo, who headed the five-year, $27 million cancer research program for the cellular industry, said former FDA official Mays Swicord in 1993 raised the idea of using a Cooperative Research and Development Agreement (CRADA) to determine whether mobile phones pose a health risk. But the idea was shot down, according to Carlo.
“I remember a correspondence specifically that involved the FDA where Dr. Jacobson said something along the lines of, `We can’t be both collaborator and a regulator at the same time,’ ” said Carlo.
Carlo’s version of the events is supported by Motorola Inc.
“Yes, there was consideration of a CRADA,” said Norm Sandler, a Motorola spokesman. “Dr. Swicord and others at FDA were involved in those discussions and, in the end, the CRADA option was not selected.” Swicord now works for Motorola.
Dr. Elizabeth Jacobson, director of FDA’s Center for Devices and Radiological Health, could not be reached for comment. But an agency spokeswoman denied that FDA considered, and later rejected, a plan to cooperate on cancer research with the Cellular Telecommunications Industry Association in the early 1990s.
Today, FDA and CTIA have agreed on a CRADA. The go-between in the cooperative pact between FDA and the cellular industry is Jeff Nesbit. Nesbit is a former FDA staffer who was Carlo’s right-hand man at WTR. He did not respond to a request for comment.
Nesbit, who joined the Porter Novelli public-relations firm after leaving WTR, is now a paid consultant to CTIA.
Carlo, who has angered industry by going public with research findings that he claims suggest a possible health risk from mobile phones, calls the cooperative accord between FDA and CTIA “a blatant conflict of interest.”
Carlo said CRADAs are designed to help firms develop drugs and other products of potential public benefit where a market-driven incentive is lacking.
In a interview with RCR, Carlo said his relationship with CTIA began to sour long before last month’s ABC “20/20” broadcast on mobile phone health questions.
“The industry is now concerned about Carlo and about his intentions,” said Andrew Sukawaty, chief executive officer of Sprint PCS and vice chairman of CTIA’s board. Sukawaty said Sprint is satisfied with CTIA and has no plans to fund cancer research itself.
Other CTIA board members contacted for this article were unavailable for comment.
There has been speculation Carlo might become an expert witness in any future health-related lawsuits against the wireless industry. To date, no lawsuits against industry have succeeded.
“If anybody wants me for an expert witness, they’ll have to subpoena me,” Carlo angrily replied. “I won’t be an expert witness voluntarily. This is not what this is about.”
Carlo said his falling-out with CTIA actually began three years ago when WTR reported findings (and recommendations) on mobile-phone interference with cardiac pacemakers. Getting CTIA to cover WTR’s legal fees, after WTR and industry were hit with lawsuits, was another sore spot in CTIA-WTR relations that put research on hold for months until researchers were indemnified.
“That was an eye-opening experience for me because (CTIA) tried to hammer me,” said Carlo. “They came after me. They cut off our funding. In private, they did everything they could to cut the legs out from under us. And then in public, they tried to take the credit for the entire (electromagnetic compatibility) process. I looked at that and said, `It’s dishonest,’ and knew I was going to now have to take steps that I never had to take before to cover my own behind.”
Not long afterward, Carlo said CTIA prevented him from interacting with industry officials as he had done previously. He said CTIA President Thomas Wheeler and Jo-Anne Basile, vice president for external and industry relations, became the conduit for information about WTR.
As a result, Carlo handed off communications duties to Nesbit. Carlo now says he feels betrayed by Nesbit.
Earlier this year, when Carlo discovered positive results in several of his studies, he said he called Wheeler. Carlo said Wheeler asked him to speak to CTIA’s board of directors at the annual meeting in New Orleans in February.
“I gave an overview (to CTIA’s board) that the sky isn’t falling because I was assured by Tom that I didn’t need to get into all that stuff,” said Carlo. “But then what happens is this vote, and I heard it, I was sitting there, about continuing on with tracking, monitoring and the work that WTR had done. They voted unanimously to continue on the foundation of what had been done by the WTR.”
A couple weeks later, Carlo said he met with Basile to discuss a budget for monitoring the nation’s 80 million mobile-phone users in order to detect any adverse health trends. Carlo said Basile replied there would be no post-market surveillance.
CTIA differs on what additional research it agreed to fund.
“I was at the board meeting, and the board voted to support the necessary research to answer the scientific questions raised by the WTR studies,” said Basile. “And one form post-market surveillance can take is epidemiology studies, and that certainly is one of the research area items under consideration with the FDA.”
But last week, the FDA’s Russell Owen said post-market surveillance is not included in the CRADA.
Carlo now says he believes Wheeler misled him.
CTIA claims research to date proves mobile phones are safe. The FDA, on the other hand, says there is insufficient data to conclusively determine whether a potential health risk exists, but the agency sees no need for government intervention at this time. A Government Accounting Office investigation in 1994 came to the same conclusion. Sen. Joe Lieberman (D-Conn.) has asked for a new GAO probe.
Sen. Patrick Leahy (D-Vt.) has introduced legislation that would earmark $10 million for mobile-phone cancer research and return all antenna-siting jurisdiction to local authorities.
Carlo, who has written to wireless executives to enlist their support in clarifying health questions for consumers, said the limited number of responses he has received are mixed. As such, Carlo said he believes the wireless industry is not of one mind on how to address wireless health issues.
“Writing the letters was a real good thing and it gave me more reassurance that this industry is not really a bunch of Neanderthals trying to follow the tobacco industry. I don’t believe that about the industry right now. I think they’re trying to think it through.”
If he were to do it all over again, Carlo said he would not work with a trade association. “CTIA is a political organization. I should have known that when the going got rough they would go back to what they do best, which is politics,” Carlo stated.
CTIA said Wheeler, who picked Carlo in 1993 to oversee industry-funded research, was not available for comment.
