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:
(2) Statistical review of the results reported in publications [1 – 4] was performed by external experts:
(3) Confirmation studies:
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]:
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 |
In vivo co-carcinogenicity |
WP5: exposure system, dosimetry, and QA |
FP5/MMF: ~€7.9mio |
|
In vitro cell endpoints, including gene toxicity |
WP10: exposure system, dosimetry, and QA |
EU FP5: ~€2.1mio |
|
Confirmation RF studies recommended by WHO |
WP10: exposure system, dosimetry, and QA |
MMF: ~€4.0mio |
|
Electroencephalography and performance |
WP8: exposure system, dosimetry, and QA WP5: dosimetry |
MMF: ~€2.0mio |
|
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 |
|
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 |
|
In vivo co-carcinogenicity |
Exposure system, dosimetry, and QA |
NIEHS: USD 25mio |
|
Non-Ionising Radiation - Health and Environment |
Exposure system, dosimetry, and QA, exposure evaluation |
SNSF: CHF 3mio |
Latest update, January 31, 2021:
Please note that in December 2020, the Hanseatic Higher Regional Court of Bremen ordered Professor Alexander Lerchl to withdraw his falsification claim against the REFLEX project without allowing for an appeal.