Leading Pathologists: Clear Evidence of Cell Phone Cancer Risk! $25 Million National Toxicology Program

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Leading Pathologists: Clear Evidence of Cell Phone Cancer Risk!

Why Peer Review Panel and NTP Interpreted the Same Animal Data Differently

“You had it right the first time.” That was the implicit message to the National Toxicology Program (NTP) from an expert panel after a point-by-point review of NTP’s draft reports on its $25 million study of cancer risks of cell phone radiation in mice and rats.

Two years ago, with the results in hand, the NTP had rushed to warn the public about the dangers of cell phones. It issued an interim report pointing to higher rates of tumors in the hearts and brains of male rats exposed to two different kinds of phone radiation. Then early this February with the release of the formal draft reports, the NTP made a U-turn, saying that using a cell phone “is not a high-risk situation.”

Now a peer review panel —11 pathologists and toxicologists from academia and industry and one statistician— has concluded that there is “clear evidence of carcinogenic activity” in those male rats. The panel, which met* March 26-28 in Research Triangle Park, NC, determined that both GSM and CDMA signals had led to the development of a rare tumor in the hearts of rats, malignant schwannoma. The NTP, on the other hand, had concluded there was only “some evidence” for this association.

The panel saw some evidence of that same schwannoma risk among female rats, where the NTP had found only equivocal evidence.

The NTP uses five categories to classify evidence of carcinogenicity. The strongest is “clear evidence.” In decreasing order of severity, the others are: “some,” “equivocal,” “no” and “inadequate” evidence. For more details, go here.

Beyond the schwannomas in the heart, the panel members saw more evidence of a cancer risk than the NTP for tumors in two other organs of the male rats: the brain and in the adrenal gland. In both cases, the panel again raised the finding a notch, from equivocal to some evidence.

All in all, the panel upgraded seven different NTP findings, an unprecedented number. “It is highly unusual for a peer review panel to recommend so many upgrades to NTP’s conclusions,” Ron Melnick told us after the meeting. “As far as I recall, no panel has ever recommended so many, in fact, I don’t remember any at all.” Melnick led the team that designed the animal study. He retired in early 2009 after close to 30 years as a staff scientist at NTP.

In February, after NTP’s about-face, we speculated about the political forces that might have led NTP to change its outlook. The NTP presentations at the peer review meeting followed by the comments of the panelists shed light on how the two groups could look at the same tumor data and reach very different conclusions.

The panelists unanimously praised the design and execution of the NTP project. But when it came to interpreting the results, they diverged. Two factors that kept coming up over the course of the three-day meeting help explain the dynamics of their disagreement: (1) The role of the unexposed comparison animals, known as the “controls,” and (2) How RF radiation interacts with living systems. In the end, the peer reviewers were willing to accept the idea that RF radiation does not necessarily behave in the same way as the toxic chemicals that the NTP has been testing for decades.

Concurrent vs. Historical Controls

In a standard cancer bioassay, animals are exposed to the agent under study while a second set of similar animals, the controls, is treated exactly the same way without receiving the agent. At the end of the experiment, the tumor counts in the two groups are compared and inferences drawn.

To understand how the controls became an issue, we must first describe the NTP’s RF–exposure system. From the outset, Melnick was convinced that the animals should not be restrained and be able to run free while being exposed to the radiation. Restraint could put the animals under stress and would likely confound the experiment. A set of six animal studies in the 1990s used restrained animals. Even though RF exposures were limited to only a few hours a day (NTP’s were over nine hours a day), the animals showed signs of stress. The entire $10 million project was a washout.

The NTP commissioned 21 large, sealed rooms —called reverberation chambers— to house the exposed and control animals. There were 14 for the rats and 7 for the mice to allow for three levels of exposure (1.5, 3 & 6 W/Kg) to the two different signals (GSM & CDMA) under study. (Rats are larger than mice and required twice as many chambers). Every aspect of what went on in those closed spaces was controlled and monitored. The chambers were expensive: they cost on the order of $100,000 each.

 

Reverberation Chambers
NTP reverberation chambers in Chicago. They were built by the IT’IS Foundation in Zurich. Details here.
Photo: Myles Capstick and Niels Kuster

To save money and space, NTP used the same control animals for both GSM and CDMA exposure groups. This meant that NTP did not need to build and install three additional reverberation chambers (two for rats and one for mice). While this seemed to be a good idea at the time, it would later blunt the power of the statistical analyses. It became more difficult to show that an outcome was statistically significant, a key measure for judging the reliability of an experimental finding. “If we could do this over, we would have had a second control group,” said John Bucher, who led the NTP RF study team and helped preside over the meeting.

A common workaround is to compare the exposed animals to historical controls —data from control groups used in past studies. But this option was limited in this case because of the small number of available historical controls. About ten years ago, the NTP began using a new breed of rats (Sprague-Dawley) in its chronic studies and, since then, has completed only a few two-year bioassays.

Another important difference between the RF control animals and the historical controls has to do with the nature of the reverberation chambers. In the RF study, the rats and mice lived in completely shielded rooms with air and white noise piped in —a more artificial environment than the open cages that housed the controls in NTP studies on toxic chemicals. The reverberation chambers also featured incandescent lighting instead of the fluorescent bulbs that were used in the past.

For all these reasons, the control animals from past studies may not be a suitable comparison group for those in the RF study. “The historical controls are an important issue,” said David Eaton, the dean of the graduate school at the University of Washington, Seattle, who served as the non-voting chairman of the peer review panel.

The NTP presentations often referred to the historical controls to question the reliability of some of the findings. The panel tended to rely on the concurrent controls.

One example of their different approaches was the evaluation of the pheochromocytomas (“pheos” for short), tumors of the adrenal gland. Here is NTP’s table of tumor incidences and related data for rats exposed to GSM radiation:

NTP Rats GSM Pheos
Source: Michael Wyde, Presentation at March 28, 2018, NTP Peer Review Meeting

The number of pheos was statistically significantly higher at 1.5 W/Kg and 3 W/Kg, relative to the concurrent controls. Importantly, the number of control animals with tumors (12.5%) was well below the average (20.1%) of the historical controls. In addition, the range (16-31%) in the three exposure groups was within or just above that seen in the historical controls (13-28%).

The NTP decided that the pheos were an equivocal finding. The peer review panel disagreed and voted to upgrade it to some evidence of carcinogenic activity. “If you have [concurrent] controls, you have to believe the controls,” commented Mark Cline, a pathology professor at Wake Forest School of Medicine and the member of the panel who made the motion to raise the classification. It passed by a vote of six-to-four, with one abstention.

Linear vs Nonlinear Responses

Another one of the critera used by the NTP to determine whether an agent is carcinogenic is whether more animals develop a tumor as the dose is increased. This is called a linear dose-response relationship. Without it, there is often a lingering suspicion that the tumors were random events rather than causal.

Take, for instance, the results for glioma (brain tumors) and glial cell hyperplasia (abnormal growth, seen as an early indicator of a developing tumor) among male rats exposed to GSM radiation in the NTP table below.

Glioma among male rats exposed to GSM
Source: Michael Wyde, Presentation at March 28, 2018, NTP Peer Review Meeting

There were tumors in all the RF–exposed groups and none in the controls. But there were more tumors at the two lower doses than at the highest dose. This is a “nonlinear” response. The same mixed trend was seen for glial hyperplasia. (As well as in the pheos example above.)

The NTP was ambivalent about this finding and decided that it represented only equivocal evidence of carcinogenicity. This stands in contrast to its view in 2016, when senior managers at the NTP, including Bucher, expressed concern not only about the schwannomas in the heart but also over the gliomas in the brain. (For more on the similarities of these two tumors, see “More Than a Coincidence.”)

Here again, the panel upgraded the risk to some evidence, this time by a vote of seven-to-four. A majority of the panel believed that the absence of a linear response did not preclude cause and effect.

Some panel members were likely swayed by a presentation by Melnick during the public comment period. He opened his talk by saying he was there “representing the American people.” Melnick showed a slide (below) in which he had combined the incidences of glioma and glial cell hyperplasia and showed that, while the trend was still nonlinear, the increases at the two lower doses were now statistically significant.

Melnick: glioma and hyperplasia GSM rats
Source: Ron Melnick, Presentation at March 27, 2018, NTP Peer Review Meeting

“The brain is obviously a target organ and should not be ignored,” Melnick advised.

Indeed, Bucher had offered a similar argument at the NTP press briefing in May 2016. The increases in hyperplasias, which are fairly rare,” he said on releasing the interim report, “add to our conclusion that, in fact, these tumors are related.”

Nonlinear Responses Are To Be Expected

Over the course of the three days of discussions, Frank Barnes, a distinguished professor emeritus of electrical engineering at the University of Colorado in Boulder, noted repeatedly that he has often observed nonlinear effects in RF experiments carried out in his own laboratory. “I would not expect a linear dose-response based on our data,” he said. “Nonlinearity is important,” he stressed.

Barnes was a member of a second panel that was invited to offer technical advice to the pathologists and toxicologists. The three members of this engineering panel did not have a vote on the cancer classifications.

Some members of the pathology panel were sympathetic. “Nonlinearity is a hot topic today in radiation biology,” pointed out George Corcoran, the chairman of the Department of Pharmaceutical Sciences at Wayne State University.

In fact, nonlinear interactions are nothing new in the electromagnetic radiation community. Thirty-five years ago, Ross Adey organized a conference on nonlinear effects of electromagnetic radiation in biological systems. (We covered that meeting.) “There is [now] impressive and growing evidence consistent with nonlinear, nonequilibrium interactions … in widely diverse tissues that include brain, bone, pancreas and leucocytes,” Adey said at the time.

Will NTP Revert to Its Earlier Outlook?

In general, members of the peer review panel took a more holistic approach to the NTP results. “I have more questions than answers, but the heart is clearly sending a signal in the rat studies, between the levels of cardiomyopathy [heart disease] and malignant tumors,” saidRick Adler, a panel member and the head of pathology for the U.S. arm of GlaxoSmithKline, a large pharmaceutical company.

A week after the NTP meeting, we wrote to Melnick and asked him why he thought the peer reviewers had upgraded so many of NTP’s evaluations of the tumor risks. Here’s what he told us:

“NTP relied more heavily on dose-response relationships, historical control data, the magnitude of the responses and p-values for trends and pairwise comparisons. In contrast, the panel did not require linear dose-responses, was not influenced by historical control data and believed that the increased incidences of rare tumors represented true effects.”

At the close of the meeting, Bucher said that, “It is very rare for NTP to reject the advice of its advisory panels.” If so, the NTP will have come full circle and be back where it was two years ago.

The NTP expects to release the final reports on the project in the fall.

___________________________
* The agenda of the meeting is here. Only the rat study is discussed in this article. The mice experiment showed equivocal evidence for a number of different tumors in males, including in the lung and the skin, as well as lymphoma among females.

Source Article (with no added videos!).

“Clear Evidence of Cancer” Concludes U.S. National Toxicology Program Expert Panel on Cell Phone Radiation

Scientific panel advises there is evidence for an association between both heart and brain cancers and cell phone radiation in large-scale animal study.

Expanded Press Release (with radio/TV/print news at bottom of page)

(Triangle Park, NC) March 28, 2018

Scientific panel advises there is evidence for an association between both heart and brain cancers and cell phone radiation in large-scale animal study.

(Triangle Park, NC) Scientists concluded there is “clear evidence” linking cell phone radiation to the development of cancers in rats. The U.S. government invited an expert panel to make a majority-rules declaration in response to the $25 million U.S. government National Toxicology Program (NTP) study of cell phone radiation in animals. After a three-day review of the study data, they voted to strengthen the conclusions that cell phone radiation caused health effects in the cell phone radiation exposed rats and mice.

Scientific American and The Nation both ran stories on the issue along with The News and Observer entitling their piece, “Can your cellphone cause cancer? Scientists find definitive link in study of rats.” Ira Flatow of Science Friday also featured the scientific conference findings in a radio interview “Is There A Cell Phone Link To Cancer? A Definite Maybe” on March 30, 2018.

The National Institute of Environmental Health Sciences, National Toxicology Program released a statement about the conclusions of the panel for each endpoint, found here.

The peer review panel voted that the malignant schwannoma tumors found in the heart of male rats be scientifically categorized as “clear evidence of carcinogenicity” and that the malignant gliomas found in the brain of male rats be categorized as “some evidence of carcinogenicity.” In addition, they voted that the increased tumors of the adrenal medulla in male rats exposed to the GSM type of cell phone radiation be categorized as “some evidence of carcinogenicity,” adding a new type of tumor thought to be caused by the exposure. The expert panel advised strengthening the conclusions regarding seven different health effects. The panel called attention to statistically significant increases in an unusual pattern of cardiomyopathy, or damage to heart tissue, in exposed male and female rats. The panel highlighted that in Italy a recent animal study on radiofrequency radiation at much lower radiation levels than the NTP study found the same types of rare malignancies.

In addition to the heart and brain cancers, statistically significant increased numbers of tumors were found in other organs at one or more of the exposure levels studied, including the prostate gland, pituitary gland, adrenal gland, liver, and pancreas.

“What should happen now is the FDA should be immediately working on developing a quantitative risk assessment from this data and in the meantime the FDA, FCC, and other agencies should promote precautionary measures for the population—especially for children,” said Ronald Melnick PhD, who led the design of the NTP study in his 28-year career as a scientist at the National Toxicology Program. Melnick is currently senior advisor to Environmental Health Trust (EHT).

“Enough is enough, how many more deaths would be needed before serious action is taken? Evidence just continues to accumulate. On March 28, 2018, the external peer reviewers of the National Toxicology Program voted to increase the level of evidence for the causal role of radiofrequency radiation for several tumors and other negative health effects. It’s time for action,” commented Annie Sasco MD, DrPH, former Chief of Research Unit of Epidemiology for Cancer Prevention at the International Agency for Research on Cancer of the World Health Organization and medical advisor to EHT.

“The NTP study found far more than evidence of cancer. Animals exposed in their lifetimes to the same amount of radiation that a human can receive in theirs gave birth to smaller babies with more defects in their hearts. What also makes these results especially compelling is the fact that all well-designed studies of people with 10 or more years of exposures to cell phones find higher risks for comparable tumors—gliomas and acoustic neuromas. Yet exposures continue to increase every day in schools and homes throughout this nation as children are handed two-way microwave radiating devices to use next to their young developing bodies,” stated Devra Davis PhD, MPH, Visiting Professor of Medicine at Hebrew University and President of Environmental Health Trust, who added, “the Ramazzini Study published this week in Environmental Research found statistically significant increases of the same rare cancers as found in the National Toxicology Program study, but at radiation levels significantly lower than those of the NTP. Combined, these two studies strengthen the case that this radiation is a carcinogen. Cautionary action is urgently needed to reduce exposures for children and the rest of us. The chairman of our Business Advisory Group Frank Clegg, former President of Microsoft Canada, has advised: ‘I come from a smart industry. Tell us what we need to do and we will get it done.’”

This animal evidence, together with the extensive human evidence showing increased risk of gliomas of the brain and vestibular schwannomas in humans exposed to prolonged radiofrequency radiation, largely from cell phones, especially if the exposure begins at a young age, coupled with a rising incidence of brain cancers in young people in the U.S., conclusively confirms that radiofrequency radiation is a Category 1 human carcinogen,” explains Anthony Miller MD, Professor Emeritus, Dalla Lana School of Public Health, University of Toronto, medical advisor to EHT, who has served as an advisor to the World Health Organization.

“The peer reviewers reviewed the tumor data in a transparent scientific process. This landmark U.S. government study, in addition to the recently released Italian Ramazzini study, provides the scientific evidence governments need to take swift action to protect the public,” said Theodora Scarato, Executive Director of EHT who added, “The rollout of 5G small cells must be halted. Schools need to install wired internet networks. Communities should have maintained landlines. Solutions exist such as Ethernet and fiber optic networks. Public Health Departments need to initiate public awareness campaigns to educate the public on how to reduce exposure. People need to understand just how easy it is to use wired connections, instead of wireless radiation, especially at home. Employers need to prioritize this issue and make changes in the workplace to limit and minimize workplace exposures. We have a responsibility to take action on this issue now.”

Dr. Marc Arazi stated that he traveled from France 4000 miles to tell the National Toxicology Program scientists that the way cell phones are radiation tested do not reflect real human exposure and that the exposure levels they used are comparable and in fact lower than radiation exposures people can be experiencing from cell phone use. “In terms of actual use, almost all of our mobile phones expose us to levels 2 to 10 times higher than the limits allowed by the regulations to protect our health. I say this based on government radiation tests conducted between 2012 and 2016 by the French National Frequencies Agency on nearly 400 of the best-selling mobile phones in Europe. This issue is at the origin of the international health and industrial scandal called Phonegate. The radiation measurements found in the French tests far exceed the exposure levels used in the NTP study. I presented these revelations publicly during the Peer Review session in front of the authors of the study and the scientists of the pane. I was pleased to hear Dr. John Bucher of the NTP explain to reporters how to reduce radiation exposure by keeping the phone at a distance from the body.

“This is an important step forward in our understanding. But the NTP study, in my judgement substantially underestimates the risk. That is because they used a reverberation exposure chamber which lowers the polarization of the electromagnetic field and can also produce substantial amounts of destructive interference. Both of these changes decrease biological effects,” stated Martin Pall, PhD, Professor Emeritus of Biochemistry and Basic Medical Sciences, Washington State University.

“RFR from wireless devices appears to act as a common toxic exposure similar to other chemical toxins and metals. In this increasingly wireless environment, more people will be developing chronic diseases. It will take decades (if it is even possible) to sort out the additive contribution of harm from wireless technology. Your research indicates that guidelines need to be based on biological cellular effects and not thermal effects. Precaution is warranted. Reduction of exposure to RFR is a preventative public health measure,” stated Cindy Russell, MD of Physicians For Safe Technology and author of “Wi-Fi in Schools” and “A 5G Wireless Future: Will It Give Us a Smart Nation or Contribute to An Unhealthy One?”.

The National Institute of Environmental Health Sciences webcast of the three-day review will be online within days. The NIEHS meeting webpage with powerpoint slide presentations is here.

Click here to download and share an infographic about cell phone radiation and cancer.

Environmental Health Trust has compiled key documents and resources so you get the information you need about the National Toxicology Program Study findings.

NIEHS Webpage with peer review meeting information, registration and details on registering comments.

Video of the peer review meeting that includes all presentations and comments.

UPDATE: The Peer Review panel for the NTP technical Report review has been released. See it here

Draft Technical Reports

NTP Rat Report: Studies of Cell Phone Radiofrequency Radiation (Rats)

NTP Mice Report: Studies of Cell Phone Radiofrequency Radiation (Mice)

Full report/presentation by NIEHS on DNA damage found in rats and mice. Note: This information was presented in 2017.

National Institute of Health Press Materials

2/1/2018 NIEHS Press Release “High Exposure to Radiofrequency Radiation Linked to Tumor Activity in Male Rats”

***Statement on conclusions of the peer review meeting by NIEHS, released after external peer review meeting.

NEWS STORIES

New Studies Link Cell Phone Radiation with Cancer, Scientific American March 29, 2018

Can cellphones really cause cancer?, Pittsburgh (KDKA) –

Findings of cancer in rodents exposed to cell-phone-like radiation draws crowd to RTP, CBS News

Can your cellphone cause cancer? Scientists find definitive link in study of rats” The News and Observer March 28, 2018

“Researchers find the cellphone-cancer risk is higher than originally thought” The Blaze March 30, 2018

The Nation: How Big Wireless Made Us Think That Cell Phones Are Safe: A Special Investigation: The disinformation campaign—and massive radiation increase—behind the 5G rollout. By Mark Hertsgaard and Mark Dowie, The Nation, March 29, 2018

On Point WBUR NPR Interview “Big Tobacco lied about cigarettes. Is Big Wireless lying about cell phones? We’ll look at the cancer-cell phone connection.”

New Study Links Cancer to Cell Phone Use, NBC DFW March 28, 2018

Advocates for Tougher RFR Standards Welcome Expert Views, Paul Kirby, Senior Editor, TRDaily

“We now have the first clear evidence cell phone radiation can cause cancer in rats” Quartz, March 30, 2018

“Is There A Cell Phone Link To Cancer? A Definite Maybe” Science Friday Radio 7:56 Minute Radio, March 30, 2018

Cell Phone Radiation Linked to Cancer in New Studies, Interesting Engineering, April 1, 2018

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