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26/03/2020

The REFLEX Project Controversy: The IT'IS Foundation’s Position

The EU FP7 REFLEX project – Risk Evaluation of Potential Environmental Hazards From Low Frequency Electromagnetic Field Exposure Using Sensitive In Vitro Methods – was a research program funded by the European Union under the program “Quality of Life and Management of Living Resources” from February 2000 to May 2004 (some activities of the REFLEX project continued until 2007). The aim of REFLEX was to apply advanced methods and procedures developed in toxicology and molecular biology to investigate the basic mechanisms in cellular and sub-cellular systems that are possibly triggered by exposure to electromagnetic (EM) radiation, e.g., from power lines and communication systems. The consortium was led by REFLEX coordinator Prof. Franz Adlkofer of the VERUM Foundation, and included eight biological laboratory partners plus the engineering partner, the IT'IS Foundation.

In line with its core competencies (see also Table 1 below for other major research programs similar to REFLEX), the IT'IS Foundation developed exposure systems for the REFLEX program and was responsible for ensuring that the experimental exposure levels were delivered at the target values with minimal standard deviations and uncertainties.

After completion of the experiments, the results of the REFLEX studies performed by the research laboratory of Prof. Hugo Rüdiger at the Medical University of Vienna and the corresponding publications [1 – 4] immediately received wide attention, as they indicated that exposures to both a simulated power supply signal at a frequency of 50 Hz and mobile GSM and UMTS signals could produce powerful genotoxic effects on human fibroblasts. The results were surprising to the scientific community, as the effects were more pronounced and more consistent than any effects that had been previously reported. The REFLEX UMTS study [4] received particular attention from industry, media, and political agencies, as it was published just at the time when novel UMTS systems were being deployed, and information about the potential health hazards of such signals was scarce.

Immediately following publications [1 – 4], several allegations questioning the validity of the results were made against Prof. Hugo Rüdiger's group of the Medical University of Vienna (e.g., [5, 6]). The assertions, which range from accusations of data falsification and/or fabrication to charges of general scientific misconduct, persist until today.

The exposure systems used in the REFLEX project were also criticized in that the blinding feature could be too easily manipulated [7]. As the provider of the exposure equipment for the REFLEX experiments [1 ‒ 4], and as a co-author on publication [4], Niels Kuster and the IT'IS Foundation has from the very beginning taken the allegations made against Prof. Rüdiger’s group very seriously. IT'IS, therefore, initiated the following steps:

(1) The exposure systems and the exposures delivered during the REFLEX experiments were re-evaluated:

  • All exposure systems were designed to quasi-continuously monitor the state of exposure plus environmental parameters such as humidity and temperature. These parameters were recorded every 10 sec and transmitted to the IT'IS Foundation for follow-up evaluations. The review of the data showed that all systems met the stipulated requirements [8, 9], and all exposures were correctly reported in the publications [1 – 4].
  • All exposure systems were designed to support the blinding function, i.e., to conceal the exposure conditions by randomizing active and sham exposure to the chambers. Blinding helps to eliminate non-intentional bias but cannot prevent outright fraud (for detailed discussions see also [7, 10]). The review of the data transmitted to IT’IS for decoding the sequence of the exposure conditions confirmed that the systems correctly met the design criteria in support of the blinding of the exposure conditions.

(2) Statistical review of the results reported in publications [1 – 4] was performed by external experts:

  • When the assertion was made that data falsification/fabrication could be proven solely via statistical analysis of the reported results, the IT'IS Foundation solicited review of the statistical arguments of publications [1 – 4] by a number of external experts. The editors of publications [3] and [4] were also approached with the assertion that data falsification/fabrication could be shown through statistical analysis and sought outside verification of the assertion. The external experts engaged by both the IT’IS Foundation and the publication journals [11, 12] concluded that falsification or fabrication of the results could not be statistically proven. The principle investigator also responded [13] to the criticism of [6].
  • Furthermore, none of the researchers or technicians involved in the studies at the Medical University of Vienna admitted to any wrong doing in any of the REFLEX experiments.

(3) Confirmation studies:

  • In accordance with good scientific practice, the IT'IS Foundation proactively developed and funded additional research programs to further investigate the controversial research findings reported in publications [1 – 4]. Some of the results of the REFLEX project were confirmed others were not (e.g., [14, 15, 16]).

In summary, several measures were implemented to address the scientific controversy regarding the REFLEX results reported in publications [1 – 4]. The current interpretation of the REFLEX and other findings is best described as follows [16]:

  • consistent increases of DNA damage levels due to EMF exposure to mobile communication signals including GSM, UMTS, WiFi, and RFID are not observed, even when DNA repair is inhibited
  • minor alterations to the DNA occasionally observed with certain experimental conditions are more likely caused by EMF-induced stress responses than by direct impact on DNA or DNA repair mechanisms
  • the nature of the interaction between EMF and cellular homeostasis remains unclear and needs to be investigated in future studies

References

[1] S. Ivancsits, E. Diem, A. Pilger, H.W. Rüdiger, O. Jahn, Induction of DNA strand breaks by intermittent exposure to extremely-low-frequency electromagnetic fields in human diploid fibroblasts, Mutat. Res. 519 (2002) 1–13.

[2] S. Ivancsits, A. Pilger, E. Diem, O. Jahn, H.W. Rüdiger, Cell type-specific genotoxic effects of intermittent extremely low-frequency electromagnetic fields, Mutat. Res. 583 (2005) 184–188.

[3] E. Diem, C. Schwarz, F. Adlkofer, O. Jahn, H. Rüdiger, Non-thermal DNA breakage by mobile-phone radiation (1800 MHz) in human fibroblasts and in transformed GFSH-R17 rat granulosa cells in vitro, Mutat. Res. 583 (2005) 178–183.

[4] C. Schwarz, E. Kratochvil, A. Pilger, N. Kuster, F. Adlkofer, H.W. Rüdiger, Radiofrequency electromagnetic fields (UMTS,1,950 MHz) induce genotoxic effects in vitro in human fibroblasts but not in lymphocytes, Int. Arch. Occup. Environ. Health 81 (2008) 755–767.

[5] A. Lerchl. Fälscher im Labor und ihre Helfer, Books on Demand (2009), ISBN 10: 3837063410; ISBN 13: 978-3837063417.

[6] A. Lerchl, A.F. Wilhelm, Critical comments on DNA breakage by mobile-phone electromagnetic fields [Diem et al., Mutat. Res. 583 (2005) 178–183], Mutat. Res. 697 (2010), 60–65.

[7] C. Wolf, Security considerations in blinded exposure experiments using electromagnetic waves, Biolectromagnetics 29 (2008) 658–659.

[8] N. Kuster, F. Schönborn, Recommended minimal requirements and development guidelines for exposure setups of bio–experiments addressing the health risk concern of wireless communications, Bioelectromagnetics 21 (2000) 508–514.

[9] N. Kuster, J. Schuderer, A. Christ, P. Futter, S. Ebert, Guidance for exposure design of human studies addressing health risk evaluations of mobile phones, Bioelectromagnetics 25 (2004) 524–529.

[10] N. Kuster, Comments on the Brief Communication ‘‘Security considerations in blinded exposure experiments using electromagnetic waves’’ by Christian Wolf, Bioelectromagnetics 29 (2008) 660–661.

[11] H. Drexler, K.H. Schaller, Expression of concern, Int. Arch. Occup. Environ. Health 82 (2009) 143–144.

[12] R.A. Baan, Letter of Concern, Mutat. Res. 695 (2010) 1.

[13] H. Rüdiger, F. Adlkofer, Letter to Editor, Mutat. Res. 697 (2010) 66–67.

[14] F. Focke, D. Schuermann, N. Kuster, P. Schär, DNA fragmentation in human fibroblasts under extremely low frequency electromagnetic field exposure, Mutat. Res. 683 (2010) 74–83.

[15] M. Manser, M.R. Sater, C.D. Schmid, F. Noreen, M. Murbach, N. Kuster, D. Schuermann, P. Schär, ELF-MF exposure affects the robustness of epigenetic programming during granulopoiesis, Sci. Rep. 7 (2017) 43345.

[16] D. Schuermann, C. Ziemann, Z. Barekati, M. Capstick, A. Oertel, F. Focke, M. Murbach, N. Kuster, C. Dasenbrock, P. Schär, Assessment of genotoxicity in human cells exposed to modulated electromagnetic fields of wireless communication devices, Genes 11 (2020), 347-366.


Table 1: Major research programs for which IT'IS was responsible for the development of the exposure systems, including dosimetry and quality assurance (QA) of the exposure between 2000 – 2010 (all akin to REFLEX); abbreviations: RF: Radiofrequency; WP: Work Package; FP: Framework Program of the EU; MMF: Mobile Manufacturer Forum; NIEHS: US National Institute of Environmental Health Sciences; SNSF: Swiss National Science Foundation

Research Programs on EMF Health Risks

2000 – 2012

Topic

IT'IS Responsibility

Program Funding

PERFORM A

In vivo co-carcinogenicity

WP5: exposure system, dosimetry, and QA

FP5/MMF: ~€7.9mio

REFLEX

In vitro cell endpoints, including gene toxicity

WP10: exposure system, dosimetry, and QA

EU FP5: ~€2.1mio

PERFORM B

Confirmation RF studies recommended by WHO

WP10: exposure system, dosimetry, and QA

MMF: ~€4.0mio

PERFORM C

Electroencephalography and performance

WP8: exposure system, dosimetry, and QA

WP5: dosimetry

MMF: ~€2.0mio

SEAWIND

Sound Exposure and Risk Assessment of Wireless Network Devices, including confirmation of REFLEX RF results

WP1: coordination, management

WP10: exposure system, dosimetry, and QA

FP7: ~€3.0mio

ARIMMORA

Advanced Research on Interaction Mechanisms of electroMagnetic exposures with Organisms for Risk Assessment, including confirmation of REFLEX ELF results

WP1: coordination, management

WP6: exposure system, dosimetry, and QA in collaboration with SPEAG

FP7: ~€3.2mio

NIEHS RFR

In vivo co-carcinogenicity

Exposure system, dosimetry, and QA

NIEHS: USD 25mio

NRP 57

Non-Ionising Radiation - Health and Environment

Exposure system, dosimetry, and QA, exposure evaluation

SNSF: CHF 3mio

 

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