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Controlled research? Legal maneuvering? The wireless industry is starting to sound like the next Big Tobacco
You resist the urge to make the comparisons. But the cellular industry invites them. So now it's public knowledge that the rumors swirling around the industry last week are true. Turns out the Cellular Telecommunications and Internet Association did hire Arthur Levine, a partner at Arnold & Porter, an established lobbying firm that has done work for Phillip Morris, to negotiate a contract with the Food and Drug Administration. The contract, known as CRADA — for Cooperative Research and Development Agreement — was enacted early last year with much fanfare by the two parties as a pact to research whether cell phones are dangerous to a users' health. This time, for real.
As a former bigwig with the FDA, Levine was the perfect candidate for such work. I called Michael Altschul, general counsel at the CTIA, about last week's rumors regarding the CTIA-Levine ties. While Altschul did confirm that the CTIA had hired Arnold & Porter in the past because of their expertise in contract negotiations, he would not say what those contracts were. He also vehemently denied any connection between the hiring of Levine and the fear of the tobacco-like lawsuits that are biting at the industry. Levine would not confirm the relationship.
"I don't discuss one way or the other who my clients are," said Levine.
CRADA has been a sore point with scientists and researchers. Under CRADA, the industry itself has final say over which research projects get the go-ahead. The industry is also footing the bill for CRADA. There are reported allegations that under the CRADA contract which Levine helped steer, the CTIA will own the rights to the research. That means the industry will control how that research is disseminated to the public. And even the industry says the crux of research will focus only on the findings brought out by WTR, the $27 million, 6-year industry-run research program that had been headed up by George Carlo. Since leaving that project, Carlo has written a book questioning the legitimacy of industry-sponsored research into health effects from wireless-phone usage.
The FDA will not answer questions regarding CRADA, referring queries to the agency's Web site. A press release on that site states that CRADA was enacted to "reflect the FDA's continued efforts to assure that thorough research is conducted on mobile phones."
The wireless industry is facing a dilemma that tobacco companies can identify with all too well.
The source of the dilemma, of course, is product safety. A growing number of researchers and consumer advocates are pointing to evidence that suggests a direct link between use of cell phones and health problems that include one of the scariest of all diseases: brain cancer. But there are just as many experts on the industry side that say their evidence shows no such links.
Here's the kicker: Neither side will be able to prove its case beyond a shadow of a doubt for at least a few years. That's how long it will take for long-term use of cell phones by the general public to yield meaningful data for epidemiological studies. Leif Salford, a professor of neurosurgery at the University of Lund in Sweden, has been quoted as calling cell phone usage "the world's largest biological experiment ever" — an experiment that now involves 450 million users worldwide, including more than 110 million in the United States. Revenues from those users now total more than $45 billion a year in the U.S. alone.
The multibillion-dollar question for the wireless industry is this: To what extent would manufacturers and service providers be held accountable and liable for damages IF (and that's a big IF on purpose) a link between cell phone usage and health damage is ever established? Is there anything that industry players can do now to minimize that potential liability?
The answers to both questions aren't exactly soothing — especially when the inevitable parallels to the tobacco industry are drawn.
The tobacco industry is facing hundreds of billions of dollars in liability claims stemming from lawsuits related to the adverse health effects from using their products. Tobacco companies are on the hook even though their products had been in use for decades before any link between smoking and health damage had been established by the scientific community, and even after the companies began printing warnings on their products, which they started doing back in 1965.
The wireless industry could start to market "safer" (as in lower power) phones and other equipment, such as headsets, that reduce users' exposure to radio frequency radiation (RF R). It could issue warnings about potential health effects caused by extensive and prolonged use of cell phones. It also could pony up for vast research efforts aimed at finally nailing down definitive answers to the cell phone safety question.
The problem is, doing any or all of these things won't necessarily limit liability. And the argument could be made that such steps would imply that the industry believes internally that a health risk exists — the smoking gun that eventually nailed the tobacco industry.
"Their worst-case scenario is if someone can prove that the cell phones are harmful and that the manufacturers have always known they were harmful," says Jim Speta, assistant professor of law at Northwestern University.
Proof of compliance with federal standards governing RF R emissions might not be enough to ward off liability, say some legal experts. "A jury would want to know if the industry did enough to educate itself about the possible risks," says a litigation attorney who requested anonymity. "In a case where there is elevated risk — as with brain tumors — there is an elevated duty on the part of the industry because the danger is that much higher."
The apparent game plan now for the wireless industry is to do very little, and to do it as a unified entity. The Cellular Telecommunications and Internet Association is the point organization for both service providers and manufacturers regarding cell phone safety issues. Which leads to this question: Is the CTIA doing enough to protect industry interests on the cell phone safety issue?
No smoking gun
In fact, no rigorous, definitive proof exists that cell phones cause tingling in the head, as some suspect, let alone brain cancer. But evidence pointing to a link has been emerging for the past few years. The UK's Department of Health said last year that it saw evidence that RF R emissions from cell phones can cause "subtle biological effects" that could lead to disease, and it advised limiting the use of cell phones by children. The French government also has warned against children using mobile phones. Also in 2000, researchers from Germany published a study claiming that cell phone users were three times more likely than others to develop eye cancer.
Everyone — including service providers and manufacturers — agrees more research is needed. But little of that research is being done in the U.S., and nearly all of that is financed by the wireless industry itself.
The research that does get done can get shrouded in doubt cast by those on either side of the debate. The most visible critic of the wireless industry regarding its safety research, George Carlo, has had his own credibility questioned by the industry, which portrays Carlo as an opportunist at best and a con artist at worst. Industry critics counter that at least one manufacturer — Motorola — has knowingly suppressed potentially damaging research. Others point to what they call a cozy relationship between the wireless industry and federal regulators as evidence that the industry is more interested in protecting itself than its customers.
There's enough dirt on both sides of the fence to suggest that the motives, if not the veracity, of at least some players on each side can be questioned.
The battle started in 1994, when University of Washington bioengineering professor Henry Lai and colleague Narendra Singh found DNA strands in rats' brains were broken by RF R exposure. Cell phones emit the same kind of radiation, although at different frequencies than those tested by Lai and Singh.
Research biologist Jerry Phillips was doing testing, paid for by Motorola, at Pettis Memorial Veterans Administration Hospital in Loma Linda, Calif., during the 1990s. Phillips says he duplicated the Lai and Singh results of DNA breakage in 1996 on human cells. He alleges that Motorola asked him not to publish the results, and that the company cut off its dealings with him when he refused that request.
Motorola's response to the Lai-Singh research, according to a memo leaked in late 1996 by a company insider, was to "war-game" spin control with the help of PR colossus Burson Marsteller. Motorola subsequently has said that it didn't discourage Phillips from publishing his results, but that it told him his findings needed clarification. The company continues to stand by its statement that no one has validated the Lai-Singh results to date.
"What do you expect from these folks?" Phillips counters. "There are a number of studies indicating changes in DNA structure as a result of exposure to RF R. They just want to ignore these studies."
Dr. Carlo, I
In setting up WTR, the CTIA said the program would operate independently of the wireless industry. It emerged, though, that WTR, CTIA and Motorola regularly communicated with one another. Critics say WTR produced little research before shutting down after six years.
Carlo now says that two WTR studies turned up links to cancers and brain tumors. Carlo also says he took findings from one study to CTIA's board in February 1999. Afterward, he claims, CTIA circumvented him and directly contacted the researcher responsible for that study, Joshua Muscat.
Carlo further alleges that some data in the study was altered, and that the altered data formed the basis for a report published in December 2000 by the Journal of the American Medical Association that concluded that cell phones are safe to use. Shortly after, the New England Journal of Medicine pushed up its publishing date of another study that also supported the safety of cell phones.
"The truth is, there have been seven epidemiological studies, and five of those show a significant increase in the risk of tumors," Carlo says. "Two of those seven do not show an increase in tumors and those two were not looking at rare tumors."
But while Carlo has been busy raising questions about the CTIA and its research efforts, others have been raising questions about Carlo. Louis Slesin, editor of Microwave News, points out that before his tenure at WTR, Carlo collected big bucks fronting for cancer-causing dioxin industries years back, in a role similar to the one he played with the cellular industry before the falling out.
"For the six years that he was an employee of the CTIA, Carlo got very little done," Slesin says. "And the two research items he is pointing to now are not on the top of lists of what should be studied."
Carlo contends that he was misused by the CTIA and now is being martyred. "I feel a deep sense of responsibility and regret that the good work done by the WTR has now been used as a basis to manipulate the consumer and the government and the media," he says. "They used the WTR to set up the consumer, and now they are using me as the guy they hang in the town square."
"Besides the FDA with its little bit of research, our little body of research and the National Institute of Cancer's little body of research, there is almost no funding for this type of research other than what is funded by the industry," says Gregory Lotz, a radiation research official at the National Institute for Occupational Safety and Health.
Last June, another CTIA-funded program was announced, called the Cooperative Research and Development Agreement (CRADA). The Food and Drug Administration is offering recommendations and oversight for work under CRADA, but the CTIA has the last word on which projects go forward. Experiments for CRADA will follow up only on the health risks that Carlo has said were suggested by two studies in the WTR research that are being publicized. That will leave many other questions unanswered, he says.
The relationship between the FDA and the CTIA is drawing criticism from some outside the wireless industry. Those critics assert that one reason the industry has been able to avoid directly addressing the cell phone safety issue is that it has some deep connections within the federal government's power structure.
Those connections have their roots in wireless technology itself. Much of the radio frequency technology underpinning wireless communications was developed by various arms of the U.S. military.
"The wireless industry is extremely influential," says Libby Kelley, executive director of the Council on Technology Wireless Impact, a nonprofit advocacy group that is involved in cell phone safety issues. "That's why we've been unable to address this as an issue. The government, through political leadership, is cooperating with the telecom industry."
The fact that the CTIA is funding the research casts CRADA in a dubious light, say other critics. "It's the ultimate conflict of interest," says Ross Adey, a professor at the University of California at Riverside who specializes in RF R research.
Business as usual
The FDA's role in determining the safety of cell phones remains less than fully defined. Regulation of the wireless industry typically falls under the purview of the Federal Communications Commission. The FCC mandates that wireless phones comply with standards — like the 1.6 watts per kilogram specific absorption rate (SAR) standard. The agency, which reviews and records the paperwork submitted by the manufacturers on their testing procedures, will soon be spot-checking phones to make sure they comply with this standard. But at the end of the day, the FCC is only an enforcer of the standards, looking to other agencies — especially the FDA — to determine if such levels are safe, says Kwok Chan, a scientist in the FCC's office of engineering and technology.
The federal government is still trying to sort the jurisdictions out. The General Accounting Office is now auditing the state and cost of research at the request of Sen. Joe Lieberman, D.-Conn. The roles and responsibilities of federal agencies including the FDA, the FCC, the National Cancer Institute and the Environmental Protection Agency are being studied, along with CRADA, says John Findore, assistant director of the GAO. That agency was originally requested to look at the validity of research on the issue, but instead will confine its investigation to cost issues surrounding research projects involving federal agencies. A report is due in May.
Waiting in the
That last point is critical, and it highlights one of the more troubling aspects of the current state of U.S. research in cell phone product safety. "If you are a lawyer representing the industry, the last thing you want to say is that you haven't done any studies in two years," says one legal expert who requested anonymity. "That would be a nightmare."
For service providers looking to protect themselves against possible liability, being up-front about potential problems is the best course of action, says John Halebian, who practices consumer-protection law in New York. "If I was their attorney, I'd say, 'We are not aware of any dangers, but there has been some anecdotal evidence that cell phone usage may be dangerous.' The better the disclosure, the more likely the limit on their liability."
A likely problem
But it's clear that litigators are starting to line up for a chance at taking on the wireless industry on product safety. Michael Allweiss, an attorney based in New Orleans, is handling a case charging companies with selling mobile phones they knew were dangerous and seeking reimbursement to users who have bought head sets for protection from radiation. The case not only survived a January dismissal challenge but also gained momentum, when the judge overseeing the case ruled that the FDA has taken little action on mandating cell phone safety rules. That ruling is now being appealed by the wireless industry.
Allweiss also represents Michael Murray, who claims his work in the 1990s testing cell phones for Motorola gave him two brain tumors. Although the Murray case is being litigated under workman's compensation law, a victory would boost pending and future lawsuits on the product safety front, say attorneys.
Previous similar cases against Motorola either have been withdrawn, usually for lack of funding, or thrown out of court. Allweiss says that track record won't deter him. "Tobacco won many cases for many years," he says. "It doesn't mean the plaintiffs should have lost. It means that what they were doing to win wasn't accepted."
The legal stakes in the cell phone safety battle rose considerably in December, when high-profile attorney Peter Angelos jumped into the fray. Angelos brings the analogy to the tobacco industry full circle: He has successfully litigated suits against the tobacco and asbestos industries, winning a reported $4.3 billion in settlements for the state of Maryland against the tobacco industry. Angelos, who owns the Baltimore Orioles baseball team, had said he wouldn't get involved in litigation against the wireless industry unless he felt he had a 90% chance of winning.
Angelos apparently believes that Christopher Newman gives him that chance. Newman, a neurologist who has a brain tumor, blames his disease on his use of cell phones and has filed an $800 million lawsuit against Verizon Wireless, Motorola, Cellular One, the CTIA and the Telecommunications Industry Association. Angelos has filed to be co-counsel in the Newman suit. More than 100 people with brain tumors have called attorneys in the case about participating in such a suit.
The rumor mill operated by wireless industry opponents is grinding at full tilt. According to one unsubstantiated story, one unnamed law firm has what it believes to be a memo showing that a cell phone manufacturer sliced 30% off the radiation levels its phones registered before releasing its results.
The industry so far remains steadfast in discounting such rumors. "We have confidence in the safety of our products, which are backed up by science," says Norman Sandler, director of global strategies at Motorola. "The claim of [the Newman] lawsuit and others like it are groundless."
Despite all the smoke emanating from both sides of the cell phone safety issue, one thing is certain: Litigators eyeing a huge potential payday will spend the next few years looking for the smoking gun that could send the wireless industry on an unwanted trip down Tobacco Road.
The Fuzzy Side of Radiation
There is a standard for measuring RF R emissions. It is called the specific absorption rate, or SAR. SAR gauges how much RF R is absorbed by human tissue given the amount of RF R emitted by a device. SAR is expressed as a ratio of energy (in watts) to body weight (in kilograms).
The Federal Communications Commission has established an SAR of 1.6 W/kg as the acceptable threshold for wireless handsets. That threshold is based on recommendations made by the Institute of Electrical and Electronics Engineers, which developed the SAR standard along with other standards groups.
The SAR adopted by the FCC is fairly stringent compared with other countries. That's the good news. The bad news is that the practical value of SAR as a product safety measurement is dubious at best.
The first problem involves how SAR is measured. Actual SAR readings depend on the phone's power setting and the position in which the user holds the phone. SAR also can be affected by the slightest variation in product manufacturing. Readings for one phone on an assembly line could vary widely from those for another.
To measure SAR, researchers typically use a model plastic head filled with a gooey substance. The model is based on the size of a man's head, with no accounting for variations in women and children.
While some testing is done independently, some manufacturers do their own testing and then submit data to the FCC. Dissatisfaction with the amount and quality of reported data has spurred the FCC to buy equipment to spot-check phones, a government source says.
Phone makers are not required to put their SAR results in their phone packages, although they are urged to do so under a voluntary policy set up by the Cellular Telecommunications and Internet Association. But it is not clear the disclosure has any value, say critics of the practice.
"It's very similar to when the tobacco companies came out with packages that said that each packet contained something like 10 milligrams of tar," says Henry Lai, a University of Washington bioengineer who authored a 1994 study linking RF R to tissue damage. "What does that mean to the consumer? Should I smoke that, or not smoke that or just smoke half a pack a day before I get cancer?"
Even those on the industry side of the fence acknowledge that SAR is a less-than-ironclad measurement. "It's a fuzzy number kind of thing," says Megan Matthews, a spokeswoman for Nokia, the world's leading maker of handsets.
But even fuzziness isn't the main reason why SAR is suspect. The standard was established by engineers to measure the threshold at which animals exposed to RF R exhibited a behavioral disruption, such as the inability to perform a learned task when exposed to a certain level of radiation. In this context, SAR basically measures the immediate thermal effects of using a device. It has nothing to do with assessing nonthermal effects, such as damage to cell tissue.
The Cast of Characters
George Carlo: Industry-paid researcher turned renegade. Headed up the CTIA-funded WTR program, then wrote an expose alleging a wireless industry cover-up of cell phone health hazards.
Kwok Chan: Physical scientist in the FCC's Office of Engineering and Technology. Oversees filing process of cell phone manufacturers in complying with the SAR standard.
C.K. Chou: Director of Motorola's Corporate RF Dosimetry Laboratory. Brother-in-law of Kwok Chan. Also an editorial board member of the Bioelectromagnetic Society Journal.
Henry Lai: Research professor at University of Washington who, with Narendra Singh, authored a federally funded 1994 study showing a link between microwave exposure and DNA strand breaks in the brain tissue of rats.
Joshua Muscat: A WTR researcher who found a statistical link between cell phone use and a rare form of brain tumor. Presented findings to the FDA in 1999. A subsequent version of the report is published in December 2000 in the Journal of the American Medical Association that refutes a link between short-term (three years or less) use of cell phones and brain cancer.
Christopher Newman: Baltimore-based neurologist who claims wireless phone use caused him to develop a brain tumor. The lead plaintiff in an $800 million suit filed in August 2000.
Russell Owen: Chief of the radiation biology branch of the FDA's Center for Devices and Radiological Health and FDA point person for the CRADA project. Contends there is no evidence linking cell phone use with adverse health effects.
Norm Sandler: Director of global strategic issues at Motorola. Is that manufacturer's leading voice on cell phone safety.
Mays Swicord: Former chief of radiation biology at the Center for Device and Radiological Health at FDA. Now director of biological research at Motorola Research Lab. Also editor-in-chief of the Bioelectromagnetic Society Newsletter.
Tom Wheeler: Head of the CTIA.
CRADA: Cooperative Research and Development Agreement. Latest CTIA-funded project into cell phone health concerns.
CTIA: The Cellular Telecommunications and Internet Association. The trade group that represents the wireless industry.
FDA: The U.S. Food and Drug Administration. Federal agency that is involved in determining health effects of cell phone use.
WTR: Wireless Technology Research. A six-year, $27 million project (1994-99) funded by the CTIA to investigate health effects of cell phone use. After the project was terminated, WTR director George Carlo broke with the wireless industry.
1. The CTIA and Motorola are squarely on the same page – nothing wrong with that.
2. The CTIA is funding the CRADA project, which by default has become the main research effort involving cell phone health effects.
3. The FDA is working with the CTIA on CRADA. Russell Owen, an FDA researcher, is overseeing the project for the agency, but the CTIA has final say over CRADA's scope and direction.
4. The FDA and the FCC are each responsible for some aspect of monitoring cell phone safety issues, but the lines of responsibility are undefined and unclear.
5. Mays Swicord, who used to work as a researcher at the FDA, now works as a researcher for Motorola, focusing on cell phone safety issues.
6. Kwok Chan, a scientist at the FCC, is the brother-in-law of C.K. Chou, who works for Motorola.
7. Chou also is a member of the review board of the Bioelectromagnetic Society Journal, one of only two journals that publish peer reviews of RF R research.
8. Swicord is editor-in-chief of the Bioelectromagnetic Society Newsletter.
4 Reasons To Be Afraid
1. The Peter Principal. So maybe Peter Angelos doesn't know how to run a baseball franchise. But he knows what money smells like, and his decision to get involved in a cell phone safety lawsuit means he's caught a whiff of something.
2. The British Are Coming. And the French, and the Germans and the Swedes. Even if meaningful and impartial research doesn't get done in the U.S., it will get done somewhere.
3. Ignorance Isn't Bliss. Just because the FCC and the FDA aren't pushing the cell phone safety issue now doesn't mean they won't come hard after the wireless industry if evidence of a health effect link starts showing up.
4. Proof Negative. The wireless industry is caught in the bind of proving a negative regarding product safety. That means as long as there's a researcher or a trial lawyer out there with an ax to grind, there's a threat.
Testing 1, 2, 3…
1994 Henry Lai and Narendra Singh at the University of Washington report increases in DNA breaks in rats' brain tissue following exposures to microwaves.
The CTIA launches the WTR project to study potential health effects of wireless phone use.
1996 Jerry Phillips, a biochemist, says he replicated the Lai/Singh study in a project funded by Motorola, but that Motorola discouraged him from publishing.
1997 Studies funded by Telstra in Australia reveal a doubling of cancer rates in mice exposed to RF R.
1999 Industry-sponsored researchers in Germany found that mice exposed to GSM mobile phone signals took longer to develop tumors after being injected with a cancer-causing chemical. Reports of research don't come out until January 2001.
Joshua Muscat completes a CTIA-funded study under the WTR program showing a statistical link between cell phone use and incidence of a rare form of brain tumor.
George Carlo is dismissed as director of the WTR project.
2000 The CTIA announces the CRADA project, its second long-term research effort. The FDA is announced as a project participant, although CTIA will fund and direct all research.
The U.K. Department of Health orders new research into potential harmful effects from using mobile phones and advises against use of cell phones by children.
2001 A statistical study by Peter Inskip and Martha Linet and published in the New England Journal of Medicine concludes that there is a statistically insignificant risk that cell phone usage causes tumors.
Researchers from University of Essen in Germany report that people who regularly use cell phones are three times more likely to develop cancer of the eye.