During the past several months, a series of articles has appeared in RCR addressing the important question of potential health effects from the use of wireless phones. Included have been discussions of the type of research being conducted, particularly the efforts being undertaken by Wireless Technology Research, the propriety of funding mechanisms that are in place, the difficulties inherent to conducting research against the backdrop of litigation and the government’s oversight responsibility in meeting its goal of protecting the public health. Nevertheless, there remains confusion about many aspects of this problem, and from my seat as chairman of WTR, I would like to offer some important and clarifying perspective.
Phones and cancer
The questions raised in early 1993 about cellular phones and brain cancer presented unique challenges for government and industry. At the time, more than 15 million Americans had cellular phones, and the rapidly evolving technology was experiencing unprecedented popularity. Because historically there was no scientific reason to suspect that cellular phones would be a health threat, the government had not required the industry to put these phones through extensive pre-market safety testing prior to allowing the instruments to be sold to consumers. Questions raised involved not only the safety of phones but also the adequacy of the regulatory oversight structure that had exempted phones from the testing required for other radio frequency emitting devices. Both government and industry came under fire-were they doing enough to protect the public?
Critical to understanding the uniqueness of the cellular phone challenge is understanding the most common route by which consumer products such as medical devices and pharmaceuticals reach the marketplace. Traditional pre-market safety testing involves both in vitro, i.e., test tube studies and in vivo, i.e., live animal studies research done under the strictest guidelines for scientific rigor. These studies usually are done under a proprietary information umbrella (i.e., in secret), but with close regulatory agency oversight. The purpose of pre-market testing is to evaluate the potential for a device to harm users, keeping in mind, however, that the best any animal study can do is predict what might happen in humans who use the product. The true value of animal studies is in focusing the post-market surveillance, or the safety net of after-market screening and reporting that seeks out problems with the device that were not anticipated. Post-market surveillance is necessary to assure public health protection and is required in some measure for all registered medical devices, drugs and chemicals. An important part of post-market surveillance is the responsibility and ability to correct any problems that are found. The goal of the two-prong approach is to guarantee the protection of public health.
Because cellular phones already were on the market in 1993, the overall context for WTR in addressing the problem and achieving the goal of protecting public health was post-market surveillance. Indeed, the first meeting about this issue between the WTR precursor, the Scientific Advisory Group, and the Food and Drug Administration in May 1993 focused on post-market surveillance and risk management, i.e., the ability of the program to respond to and fix any problem found through research. The peer-reviewed Research Agenda, Potential Public Health Effects from Wireless Technology: Research Agenda for the Development of Data for Science Based Decisionmaking, published by WTR in 1994, carried forward the FDA’s suggestions and the post-market surveillance theme within a frank and straightforward public health protection framework.
In 1993, the government decided not to take regulatory action against the wireless industry and instead allowed the cellular phone industry itself to put in place what was necessary to meet the industry’s obligation of assuring that those who used cellular phones were protected from harm. The WTR program was the embodiment of this goal.
Popular distortions
In the ensuing years, several distortions of the appropriate context of the WTR program have become popular, precipitated by both vested interests and simple misunderstanding of the scientific and public health context in which this is being done.
“The no animal studies, no value” fallacy. The WTR program is comprehensive, and includes both experiments in animals and studies of phone users. However, animal studies only provide part of the picture, and expectations about the value of animal studies must be reasonable.
First, test tube and animal studies in the public health protection context of the WTR are being conducted only to fill data gaps that would have been filled if pre-market testing had been required for cellular phones. The value of these studies is in focusing whether the ongoing and future post-market surveillance efforts should be active, i.e., requiring sophisticated epidemiological studies of phone users, or passive, i.e., a mechanism to report adverse events among users of wireless phones. Animal studies are important steps along the way but are never determinative of risk in humans. Some people have erroneously interpreted these animal studies as being capable of proving or guaranteeing that cellular phones are safe-a scientific impossibility.
The only realistic expectation is that a comprehensive program such as that of WTR can be protective of public health if conscientiously implemented, and that any risks identified can be appropriately managed. That is what the WTR program is intended to do.
Second, the WTR template for these types of studies is based on what would be required in pre-market testing. The FDA pre-market testing requirements, which have evolved throughout 40 years of experience, include the use of an exposure system that both simulates as closely as possible the exposures of humans using the device, and allows for the assessment of dose-response (i.e., different exposure levels going from lower to higher). No existing exposure systems for cellular phones and RF exposure to brain tissue meet these criteria, and WTR has had to invent new exposure systems so that meaningful data could be gleaned from the studies prescribed in its research agenda.
This has proven to be a time-consuming and resource-intensive activity, but essential for the protection of public health. Studies done with inadequate exposure systems can either indicate risk of ill health when none is there, or more critically, give false assurances of safety. Neither would protect the public’s health. WTR has placed a premium on producing data that will enhance our ability to protect public health, and indeed the approach being followed does just that. Meaningful animal studies from WTR are forthcoming this year.
“The five years, $25 million and out” fallacy. In February 1993, the wireless industry committed to both the federal government and the public to fund research into the safety of cellular phones. The parameters of the commitment were $15 to $25 million over three to five years.
In May of 1993, the SAG (later WTR), the FDA and more than 100 scientists began to work together in defining the parameters of a program that would ensure protection of public health. The funding commitment of the industry was to be applied to this effort, with appropriate safeguards for independence, but the effort was not limited by the funding commitment. Further, the scientists of the SAG agreed to put the program in place with a five-year commitment.
While many, both in and out of industry, have defined the WTR program in terms of the monetary and time commitments of those involved in it, at no time has the program been defined by either the scientists or the government in those terms (i.e., as either a $25 million program or a five-year program). Indeed, the published and widely circulated WTR Research Agenda explains the nee
d for a long-term commitment to public health protection, and
defines the WTR’s ground breaking work as the foundation for the industry to meet its future responsibilities in that context.
What’s important?
WTR has met its goal of establishing a program that lays the foundation for appropriate protection of users of wireless instruments. The ongoing surveillance program of WTR, which includes an international database of research findings and studies in progress, a network of top scientists in the field, and daily evaluation of new findings, is regularly referenced as a reliable international resource on RF health effects. Specific research in the area of risk evaluation encompassed in the published Research Agenda is more than 80 percent completed, with a good portion of the remaining experiments and studies anticipated during the next 24 months. The first epidemiological analysis of mortality among cellular phone users anywhere in the world was published by WTR last year. WTR’s interim risk management report, Potential Public Health Risks from Wireless Technology: The Development of Data for Science-Based Risk Management Decisionmaking, was published in 1994. The most recent issue of the international peer-reviewed journal, Human and Ecological Risk Assessment, features 10 articles describing the WTR program and its findings.
While there is much that remains to be done through the coming years in the evaluation and management of any health risks from wireless phones, we have had a glimpse of the success of the WTR approach in its entirety-the identification and management of the risk of interference between wireless phones and implanted cardiac pacemakers. WTR surveillance identified the potential public health problem, WTR, the government, and the respective industries collaborated in researching and defining the solution, and the public was well served. And it all happened within two-and-a-half years. The results of this work will be published in an upcoming issue of The New England Journal of Medicine.
WTR is an innovation in public health protection that addresses four key public interest concerns: the ability to use industry funds to address an industry-related public health question without industry bias; the ability for the government to participate without exerting the bias that stems from government’s adversarial tendency regarding regulation; a demonstration that industry can be trusted to take steps to protect those who use their products; and a demonstration that the public is being well served by the approach.
Herein lies the real value of WTR. It is working.
Dr. George L. Carlo is chairman of Wireless Technology Research, L.L.C.
