In February 2020 US Food and Drug Administration (FDA) published Report analyzing studies examining the possible causal link between RF-EMF and cancer.
The anti-5G activists in their reading of the FDA Report have narrowly focused on Report’s dismissal of the carcinogenicity evidence/claim by the FDA and they demand withdrawal of the FDA Report as biased and scientifically flawed. This might be a mistake, like ‘throwing out baby with a bath water’, because FDA Report, when read carefully, contradicts some of the opinions of ICNIRP that are the pillars of the ICNIRP’s claim of RF-EMF safety.
In 1980’s, it was US FDA opinion, referred as ‘low-power exclusion’, that permitted deployment of cellular communication technology without pre-market testing for health effects.
Some 30 years later, in 2011 the International Agency for Research on Cancer (IARC) has classified this ‘low-power exclusion’ agent, the RF-EMF emitted by cell phones, as possible human carcinogen (category 2B in the IARC scale). It means that in 2011 it was determined that there is limited evidence in human (epidemiology) studies to support the possibility of carcinogenic effect of RF-EMF but the supporting evidence from animal in vivo studies was considered as insufficient (only the 6 co-exposure animal in vivo studies supported the notion of carcinogenicity).
After the 2011 IARC classification was published, many organizations expressed criticism of it, e.g.: ICNIRP, SCENIHR, SSI, IEEE/ICES, MMF (currently MWF), GSMA and many others, for going too far with the classification. The activists, on the other hand, were complaining that the IARC classification didn’t go far enough.
Numerous reviews of science, published after 2011, by various scientists as well as various organizations, have presented different interpretations of the same scientific data, arriving at different than IARC’s conclusions. The most recent addition to these post-2011 reports is the review of science published in February 2020 by the US FDA.
Publication of the US FDA Report “Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer” was meet, on the one hand, with enthusiasm by the telecom industry but, on the other hand, with calls to retract the report as scientifically biased by the so-called anti-5G activists.
In this brief blog post I will not analyze every and each of the reviewed studies. It might be found in other website sources, e.g. Environmental Health Trust (EHT).
The FDA Report has several important problems and limitations:
- First, it is not known who wrote the FDA Report. The only information given is that it was written by the employees of the FDA. This is, however, not enough for the reader to determine the professional expertise of the writers, as well as the potential for biases and potential for conflict-of-interest that might be involved.
- Second, the report reviews studies published between 2008 and 2018. This is only fragment of the to-date published research. The authors of the FDA Report should have presented the conclusions from the 2008-2018 studies in the context of the whole to-date (pre-2008) published research. As the research is presented now, the readers do not get any idea whether the findings from the earlier research studies have been enhanced or dismissed by the newer studies and what is the opinion of the FDA on the totality of the to-date published scientific studies.
- Third, the FDA Report analyzes only studies performed in vivo and epidemiology. It does not look at the in vitro evidence that provides clues as to the possible mechanism of non-thermal effects. It would be of importance that the FDA Report, claiming that only thermal effects have established scientific evidence, would critically analyze studies suggesting non-thermal mechanisms.
- Fourth, the FDA Report does not address the current controversy over the possibility of health effects of the 5G technology that is being developed and deployed without any pre-market human health testing and which safety guidelines are based on assumptions because the necessary adequate scientific research has not been sufficiently performed.
All of the scientific studies listed in the FDA Report were published following peer-review. However, all and each of them have a longer or a shorter list of limitations, and weaknesses.
Of course, there is no perfect study, not in RF-EMF subject and in no other scientific subject. Every published peer-reviewed study could be made better and many of the published peer-review studies are of poor quality or simply rubbish. No doubt here.
The FDA Report, while rightly points out to the very well-known general weaknesses of in vitro and epidemiological studies, unfortunately trivializes the health policy usefulness of the to-date executed studies.
In vitro studies performed in animals are done where it is not possible to, ethically, experiment with human volunteers. It is generally accepted that the results of the in vivo animal studies cannot be directly applied to humans. However, it is also generally accepted that when the in vivo animal studies indicate that given agent causes negative health effect, the use of this agent for humans needs to be very carefully assessed because indication of it causing health effect in animals is an indication (not proof) that it might also have negative impact on human health.
The FDA Report seems to trivialize the usefulness of the results of the reviewed in vivo studies, including the recently published NTP study.
However, in 1999 the FDA had a dramatically different opinion on the usefulness of the in vivo animal toxicology studies when it requested the US National Toxicology Program (NTP) to examine effects of RF-EMF on rats and mice that resulted in spending of $ 30 million.
Here is the quote from the 1999 FDA letter to NTP requesting study on RF-EMF; letter is not mentioned in the FDA Report; (emphasis added DL):
“…Currently cellular phones and other wireless communication devices are required to meet the radio frequency radiation (RFR) exposure guidelines of the Federal Communications Commission (FCC), which were most recently revised in August 1996. The existing exposure guidelines are based on protection from acute injury from thermal effects of RFR exposure, and may not be protective against any non-thermal effects of chronic exposures. Animal exposure research reported in the literature suggests that low level exposures may increase the risk of cancer by mechanisms yet to be elucidated, but the data is conflicting and most of this research was not conducted with actual cellular phone radiation. In one study transgenic mice exposed to a digital phone signal developed more than twice as many non-lymphoblastic lymphomas as the unexposed control group, a statistically significant increase. These results suggest a potential carcinogenic effect from the digital phone signal using this animal model. There is wide agreement within the international scientific community regarding the types of research needed to assess whether RFR from wireless communications poses a health risk to users. Research needs have been articulated by a number of groups, including the European Commission and the World Health Organization International EMF Project. Animal experiments are crucial because meaningful data will not be available from epidemiological studies for many years due to the long latency period between exposure to a carcinogen and the diagnosis of a tumor…”
In 1999 FDA certainly knew what are the difficulties and limitations of performing animal toxicology study on RF-EMF. However, the FDA requested the NTP to perform animal study. The starting point for the NTP study was to prove that RF-EMF does not cause cancer in animals. The result, however, showed something opposite and now, the evidence of possible carcinogenicity provided by the NTP study is being trivialized using standard arguments about limitations of the animal studies.
There seems to be a big discrepancy between what FDA thought about animal studies in 1999 and what it thinks now, in 2020, when unexpected carcinogenicity-indicating result is in.
Epidemiological studies are also being criticized, and rightly, for many of their scientific problems. The major problem, pointed out in the FDA Report is the same that I have been mentioning numerous times in my blogs and lectures. Namely, in all epidemiological studies is relatively good knowledge about the cancer cases. However, the RF-EMF real radiation exposure is unknown. Various surrogates used to estimate radiation exposure are of poor quality and lead to underestimation of the brain cancer risk. Other problems listed in the FDA Report are variety of biases as well as often insufficient number of cases to get reliable statistical analysis.
It is embarrassing that FDA Report continues to cite as evidence epidemiological studies of proven low quality that, in practice, should be retracted because they overstate results using insufficient and unreliable evidence:
“…the two available cohort studies, the million women study of Benson et al (2013) and the Danish cohort study of Schuz et al (2011) both failed to find an association between cell phone use and glioma or meningioma…”
Following the analysis, for better or for worse, of epidemiology studies, the FDA Report has arrived at conclusion that is very cleverly written. Namely, FDA Report uses word ‘quantifiable’. Without this word the conclusion would be incorrect or biased at the least (emphasis added DL):
“…In summary, the epidemiological data published between January 1, 2008 to May 8, 2018, continue to support the FDA’s findings that there is no quantifiable causal link between RFR exposure and tumor formation…”
Insertion of the word ‘quantifiable’ makes conclusion correct. Indeed, based on the results of the epidemiology studies we cannot reliably quantify the cancer risk in human population. This doesn’t automatically mean that there is no risk.
Based on the analysis of the in vivo and epidemiology studies presented in the FDA Report, the problem is rather: what to do with the imperfect scientific evidence on RF-EMF carcinogenicity at hand?
Should the imperfect evidence be dismissed because it is imperfect and every listed study has weaknesses or even flaws or should it be, in some responsible precautionary way, used in our public health policies because the same ‘imperfect’ results pop-up continuously in different studies, having often differing limitations?
The authors of the FDA Report were faced with a dilemma: what to do with the rest of the scientific evidence suggesting that RF-EMF causes cancer? Disregard this evidence, as if it would be non-existent or useless garbage or use it in responsible way?
The authors of the FDA Report have chosen to disregard the evidence as if it would be non-existent or useless garbage.
It is clearly unscientific approach, simply ‘cherry picking’ that presents FDA and its science review in a very dubious spot-light.
The unexpected twist in the FDA Report
Two of the pillars of the ICNIRP’s safety guidelines are:
- the claim that the ICNIRP safety limits protect every user, no matter what is the users age or health status, and
- the claim that persons claiming sensitivity to RF-EMF are mistaken and the cause of the sensitivity symptoms is something else, no RF-EMF.
Doubting, or invalidation, of these to claims by ICNIRP might, and scientifically should, open a ‘Pandora’s box’ for the telecom industry.
Invalidation of the above mentioned ICNIRP claims would indicate that some of the users of the wireless technology can be expected to develop health problems from the exposures that are below the current safety guidelines recommended by ICNIRP and propagated by the WHO.
This is the collateral damage that can be expected and should be acted upon.
Opening this ‘Pandora’s box’ should lead to new, very needed and urgent, research to find out what is the scale of the ‘collateral damage’ problem. How sizable is the ‘collateral damage’ group of the RF-EMF vulnerable persons and what variety of vulnerabilities (health problems) they might develop.
This ‘Pandora’s box’ effect would be a big problem to explain, and to take responsibility for (anyone ready?) for the WHO, for the ICNIRP, for the governments, for the telecoms, all that are claiming the RF-EMF to be safe for anyone and forever.
Here is the ‘earthquake’ conclusion of the FDA Report that clearly disagrees with ICNIRP (emphasis added DL):
- “…The [epidemiology] data suggest the need for shifting the focus from the general population with undetectable overall risk to a very small subset of people who might be inherently predisposed to the risk for tumorigenesis and who therefore might be more susceptible to putative risk modification by the intense RF-EMF exposure…”
Furthermore, another conclusion of the FDA Report indicates the need for research on co-effects of RF-EMF and other external factors because, since RF-EMF alone is unable to cause cancer then, since cancer is possible in some part of population, co-factors must play a role in cancer associated with the RF-EMF exposures:
- “…existing epidemiologic evidence is insufficient to suggest that use of cell phones can be considered as an independent etiological factor capable of influencing the incidence of intracranial and some other tumors in the general population…”
Summa summarum, the conclusion of the FDA Report clearly indicates that ICNIRP’s claims that their safety guidelines protect everyone, no matter what age and health status, as well as that there is no RF-EMF sensitive subgroup in human population, are false.
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For a start there are only 68 individual references instead of 69 as stated in the FDA report. 11 Reference studies were not in the ORSAA database so this leaves 58 for comparison with the ORSAA database. Some of these references are obscure. There are 6 what we call Non-Experimental Scientific Studies (NESS) or Review Studies, There is a problem with review studies they can be biased and should not be used in an experimental assessment. So there are now 52 experimental studies.
20 “Effect” studies
23 “No Effect” studies
9 “Uncertain Effect” studies.
Compare this with the number of studies in the ORSAA database. https://n432.fmphost.com/fmi/webd#Research_Review_V4
154 “Effect” studies
84 “No Effect” studies
54 “Uncertain Effect” studies.
This FDA report takes ‘Cherry Picking” to a new level called “Hyper Cherry Picking” and is a political report. We had a famous Australian Politician “Don Chipp” https://en.wikipedia.org/wiki/Don_Chipp
who’s favorite saying was “we have to keep the bastards honest”, I think that applies here.
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First, thank you Dr.Leszczynski for a good analysis, as always.
This says it all.
“We reviewed articles on RF exposure in general and did not limit the analysis to any specific power levels or modulations used by cell phones”
I am just an old retired former accountant. But how many of the 256 reviewed studies were actually performed using actual cell phone frequencies Americans are exposed to gaily and their correct modulations? How many? Can anyone answer that question?
And why should I care about the studies performed on frequencies I am not exposed to? Are all frequencies created equal? Are continuous waves just the same as pulsed modulated?
As you point out and quote from the FDA nomination letter to the NTP – “but the data is conflicting and most of this research was not conducted with actual cellular phone radiation.” Actual cell phone radiation is what matters to the public and why the NTP study was so important and relevant.
So pardon me for being a little pissed off when my US officials tells me cell phones are safe because we have thousands of studies, most of them done on other frequencies and modulations, and that they don’t indicate harmful effects.
Hundreds of billions of dollars have poured into the US Treasury from selling the public’s airspace at spectrum actions. Not ONE CENT was requested by the FCC or the FDA for research into the known controversies that have persisted for decades (non-thermal effects, accumulated long term chronic exposures, vulnerable populations). Not ONE CENT. America also refuses to participate in international projects such as Interphone and COSMOS. Apparently the great and powerful OZ is waiting for the research fairies to do the work.
Bottom line – The FCC was told in 2012 by the GAO to do a formal reassessment. All they did was issue a NOI and play Delay and Deflect. Then when pushed, 7 years later, they closed the Docket without ONE substantive comment letter from the “health agencies” they claim to rely on (FDA, EPA) posted to that Docket – not one. They blew the GAO off, saying the guidelines didn’t need updating. Then they circumvented controls by opening up a limited procedure to adjust the guidelines for the things they wanted (wireless power transfers).
If I were to do a performance evaluation on the FCC for its role as the fiduciary of the public health as it pertains to RF exposure, well they would be graded a big fat Gross Negligent.
You can’t find what you don’t look for and you can’t resolve issues that you don’t work on.
There is a special place in hell for people that operate under those methods. May God have mercy on their souls.
Thank you Dariuz for a good review of the FDA report….. putative – seen that used before by Ken Karipidis.
In 2016, well after the IARC meeting, but before the NTP results were announced, attorney for the CTIA, Ted Olsen, stated clearly in court, reading from a paper with emphasis, that “There are no links between cell phones and any known health problems.”
I’d like to know how science defines a “link;” does a link indicate certainty? does it have to describe the mechanism?
The way the industry uses language, there seems to be a wide expanse of interpretation in their carefully chosen individual words, that reliably do two things: provide industry lawyers wiggle room to defend the industry in court, while leaving the impression with the public that there is nothing to worry about.–words like “conclusive” (to whom?), “established” (by whom?) and “link” (defined by whom?). I’m also curious as to what role the word “known” might have in the sentence I quoted above.
It appears that there is a new addition to the vocabulary: “quantifiable”. When that gets covered, I’m sure there will be a new limiting word to replace it.
I am sensitive to microwave radiation and have been since I was born. The technology is not safe for everyone. The approval of it in the first place is pure evil. I hope everyone who approves it, sells it and lies about it, burns in everlasting hell fires.
I don’t agree that you have uncovered a contradiction between the FDA Report conclusions and the ICNIRP conclusions.
Firstly, the guidelines refer to exposures below permitted limits. While the FDA Report refers to power levels with no limits. (“We reviewed articles on RF exposure in general and did not limit the analysis to any specific power levels or modulations used by cell phones”. Pg 9 and “As has been noted before, these extremely large whole-body RFR exposures (6 W/kg is 75 times higher than the limit for the public which is 0.08 W/kg) in rodents cannot be directly compared to real world partial body exposures to people using mobile phones”. Pg 18 )
This argues against the first pillar of your critique.
With regard to the second pillar, I think you overlooked the words “…who might be” and “…might be more” in the FDA conclusions on the possibility of a sensitive subgroup. (“Some Evidence Pointing at Possible Subgroup Effects” Pg 46). ‘Might’ is not an affirmative word.
The inclusion of these words argues against the second pillar of your critique.