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SCIENCE AND CONFLICT OF INTEREST
IN BIOELECTROMAGNETICS
Dariusz Leszczynski, PhD, DSc
Adjunct Professor, University of Hel...
Content
• Who I am... My expert experiences
• Safety limits / Safety standards
• Scientific evidence for health risk
• Pre...
Who I am... My expert experience
• Two doctorates and docentship in biochemistry
• 22 years (1992-2013) at STUK - Radiatio...
“CELL PHONES REACH THE MARKET WITHOUT SAFETY TESTING
The cellular phone industry was born in the early 1980s, when communi...
5
Safety limits / Safety standards
Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
Problems associated with the safety standards
• No information whether/how cell phone radiation affects humans
• No certai...
Macro-scale dosimetry
7
Water
Salt
Sugar
+ =
The problem:
free movement of ions
Dariusz Leszczynski; GIGAHERZ Symposium, S...
8
Scientific evidence for health risk
Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
The problem of the funding ”firewalls”
“Firewalls” - set to assure independence of the scientific research from the
commer...
IARC evaluation in 2011
• 30 invited experts divided into four sub-groups
• Dosimetry
• Epidemiology
• Animal studies
• Me...
IARC 2011: Epidemiology
• Interphone & Hardell studies
• no reliable exposure data based
on person’s memory
• risk increas...
...after IARC: Epidemiology
• Trend-data - Little et al. 2012: slow rise of brain cancer cases in USA
• trend is similar t...
Epidemiological evidence supports cancer risk
• IARC classification was based on the results of Interphone and Hardell stu...
All epidemiology studies have completely
unreliable exposure data
• All epidemiology studies have completely unreliable ex...
IARC evaluation: Human studies
• The vast majority are “feelings” studies
• Subjects asked how they feel and do they feel ...
IARC evaluation: Animal studies
• No classical toxicology possible
• Not possible to overdose cell phone radiation because...
IARC evaluation: Mechanistic studies
•Laboratory evidence was considered, by voting (no
consensus) as insufficient to supp...
Mechanism of some of the biological effects:
Cellular stress response
18
Cell
proliferation
and
expression
of cancer
regul...
19
In my opinion, the currently available
scientific evidence is sufficient to upgrade
the carcinogenicity of cell phone r...
20
Precautionary Principle
Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
Invoking the Precautionary Principle
“Whether or not to invoke the Precautionary Principle is a
decision exercised where s...
Reasons for invoking the Precautionary Principle
Scientific information is insufficient, inconclusive, or uncertain
• IARC...
The impact of implementing the
Precautionary Principle
• Precaution does not equal Prevention
• Strong opposition from tel...
24
Conflict of Interest
Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
What is Conflict of Interest (CoI)
The Institute of Medicine of The US National Academies defines
Conflict of Interest (Co...
The goal of the CoI policies
Central goal of conflict of interest policies is to protect the
integrity of professional jud...
Sufficiency of the CoI disclosure
The disclosure of individual and institutional financial relationships
is a critical but...
Why CoI disclosure might be insufficient
• Person with the conflict of interest will be making decisions
• How reliable wi...
Criteria for evaluating CoI policies
Proportionality Is the policy most efficiently directed at the most important CoI?
Tr...
Specifics of the bioelectromagnetics
• Bioelectromagnetics is a narrow research area. Unavoidably, all
science is done, ev...
As if by default, all of the bioelectromagnetics’
“influential players” claim in their disclosures to
either have no CoI o...
Trustworthiness of the unchecked, self-made CoI
David Heath of the Center for Public Integrity, Washington, DC,
wrote in D...
Accountability in bioelectromagnetics committees
• Commonly, the disclosures of CoI, even in very influential
committees, ...
Examples of the committees
Committee Selections Disclosures Accountability Funding
ICNIRP ”private club” Yes, but... No Un...
ICNIRP members are asked to declare any personal interests in
relation to the activities of ICNIRP. Members' declaration o...
Examples of the scientific problems in the
bioelectromagnetics committees
• Selectiveness in collecting/admissing evidence...
Potential impact of the disclosed CoI
• Even in a situation when disclosure of the CoI is done in full,
what impact the di...
Are there irreplaceable experts ?
As the society at large and as the scientific community, should we
be solely dependent o...
In dealings with experts, as a society and as
scientists, should we exercise a full trust or a
limited trust, and make sur...
ICNIRP hijacked the WHO EMF Project #1
• WHO EMF Project is working as “front” for implementing
ICNIRP opinions
• Head of ...
WHO EMF Project = ICNIRP
41
• ICNIRP members play a lead role in preparation of the Environmental Health
Criteria on RF-EMF (e.g. cell phone radiation...
• The World Health Organization Director General Dr. Margaret Chan does
not care what the WHO EMF Project does with the sc...
Conclusions
• IARC classification of cell phone radiation as a possible carcinogen is a sufficient
reason for invoking Pre...
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Science and conflict of interest in bioelectromagnetics

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Swiss association Gigaherz will celebrate the 15th anniversary of its existence. On this occasion Gigaherz is organizing Jubiläums-Generalversammlung taking place in Thalvil (near Zurich) on March 7, 2015. These are slides of presentation by Dariusz Leszczynski, the keynote speaker at this meeting, discussing the validity of the currently available science on cell phone radiation and health, in context of the currently ongoing WHO and ICNIRP preparation of the Environmental Health Criteria (presentation will be available afterwards on BRHP).

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Science and conflict of interest in bioelectromagnetics

  1. 1. SCIENCE AND CONFLICT OF INTEREST IN BIOELECTROMAGNETICS Dariusz Leszczynski, PhD, DSc Adjunct Professor, University of Helsinki, Finland Editor-in-Chief of Frontiers in Radiation and Health, Switzerland Member of the Advisory Board, Cellraid, Ltd, Oulu, Finland Science blogger @ BRHP – Between a Rock and a Hard Place Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  2. 2. Content • Who I am... My expert experiences • Safety limits / Safety standards • Scientific evidence for health risk • Precautionary Principle • Conflict of Interest • WHO EMF Project = ICNIRP • Conclusions 2
  3. 3. Who I am... My expert experience • Two doctorates and docentship in biochemistry • 22 years (1992-2013) at STUK - Radiation and Nuclear Safety Authority in Finland • 2003-2007 as Head of Radiation Biology Laboratory • 2000-2013 as Research Professor • Assistant Professor at Harvard Medical School 1997-1999 • Guangbiao Professor at Zhejiang University, Hangzhou, China 2006-2009 • Visiting Professor at Swinburne University of Technology, Melbourne, Australia 2012/2013 • Testified in US Senate hearing on cell phones and health, in 2009 • Participated in IARC 2011 classification of carcinogenicity of cell phone radiation • Advised e.g. Parliament of Finland, US National Academies, WHO, IARC, BfS, ICNIRP, Swiss National Foundation 3 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  4. 4. “CELL PHONES REACH THE MARKET WITHOUT SAFETY TESTING The cellular phone industry was born in the early 1980s, when communications technology that had been developed for the Department of Defense was put into commerce by companies focusing on profits. This group, with big ideas but limited resources, pressured government regulatory agencies - particularly the Food and Drug Administration (FDA) - to allow cell phones to be sold without pre-market testing. The rationale, known as the “low power exclusion,” distinguished cell phones from dangerous microwave ovens based on the amount of power used to push the microwaves. At that time, the only health effect seen from microwaves involved high power strong enough to heat human tissue.” 4 Quote from the LifeExtension Magazine August 2007 The Hidden Dangers of Cell Phone Radiation George Carlo interviewed by Sue Kovach Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  5. 5. 5 Safety limits / Safety standards Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  6. 6. Problems associated with the safety standards • No information whether/how cell phone radiation affects humans • No certainty that safety standards protect all users from anything besides thermal effects • Any equipment radiating below safety standards is considered safe, which might be misleading • Compliance with the safety standards is currently used as an excuse to stop research funding and to continue untamed deployment of new wireless technologies, without any testing • Non-thermal effects exist but are refused to be acknowledged and studied in depth because of the “excuse” of safety standards 6 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  7. 7. Macro-scale dosimetry 7 Water Salt Sugar + = The problem: free movement of ions Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  8. 8. 8 Scientific evidence for health risk Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  9. 9. The problem of the funding ”firewalls” “Firewalls” - set to assure independence of the scientific research from the commercial interests Current system of the “firewalls” does not work: • the industry knows whom they are funding • the scientists know who is funding them • the “firewall” keeper is profiting from providing the “firewall” (administrating the industry’s money for the scientists) This situation resembles the proverbial ‘public secret’ – everyone knows about it but no one publicly admits to knowing… Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 9
  10. 10. IARC evaluation in 2011 • 30 invited experts divided into four sub-groups • Dosimetry • Epidemiology • Animal studies • Mechanistic laboratory in vitro studies • Decisions by a consensus or by a simple majority • The vast majority of 30 experts voted for the classification of cell phone radiation as a possible carcinogen (Group 2B) 10 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  11. 11. IARC 2011: Epidemiology • Interphone & Hardell studies • no reliable exposure data based on person’s memory • risk increase in long-term avid users • Children – only CEFALO • exposures for 2-4 years • has no statistical power to detect small risk • Bruce Armstrong, Australia • Maria Blettner, Germany • Elisabeth Cardis, Spain • Lennart Hardell, Sweden • Peter Inskip, USA • David Richardson, USA • Martin Roosli, Switzerland • Jonathan Sammet, USA • Malcolm Sim, Australia • Jack Siemiatycki, Canada 11 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  12. 12. ...after IARC: Epidemiology • Trend-data - Little et al. 2012: slow rise of brain cancer cases in USA • trend is similar to Interphone “prediction” but not Hardell “prediction” • Danish Cohort update study 2011 – no effect • no exposure data but just the length of phone subscription with service provider • Million Women study 2014 - no effect but exposure data inadequate • use of cell phone: ‘never’, ‘less than once a day’, ‘every day’ • CERENAT study from France 2014 – effect as in Inerphone and Hardell • no reliable exposure data based on person’s memory 12 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  13. 13. Epidemiological evidence supports cancer risk • IARC classification was based on the results of Interphone and Hardell studies • In 2014, a new epidemiological study was published - the French CERENAT • The French study reached similar conclusions as Interphone and Hardell previously – long term avid use of cell phone increases a risk of developing brain cancer • Now, there are three replications of the same epidemiological type of study, the case-control study, that all suggest the cell phone radiation might increase risk of developing brain cancer 13 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  14. 14. All epidemiology studies have completely unreliable exposure data • All epidemiology studies have completely unreliable exposure data • Length of calls or length of phone subscription with service provider or saying whether you ever or never used cell phone, does not inform about the real exposure of the cell phone user. • Using the above ”exposure data”, persons with very different radiation exposures are placed in the same exposed group for statistical evaluation. This dilutes results! • Ongoing cohort study COSMOS collects exposure data as length of calls! • There is a way to collect real exposure data by using apps installed on currently used smart phones 14 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  15. 15. IARC evaluation: Human studies • The vast majority are “feelings” studies • Subjects asked how they feel and do they feel when radiation is on/off • EHS must exist – question is only what is radiation cut-off level • Otherwise EMF would be the only factor not causing individual sensitivity • Problem of EHS – studied by psychologists not physiologists – wrong methods • WHO definition of health – how to consider it? IARC classification justifies reasoning for “mental and social well-being” • Lack of studies examining biochemical responses of human tissues (!) • Single skin proteomics study • Two studies examined glucose metabolism in the brain 15 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  16. 16. IARC evaluation: Animal studies • No classical toxicology possible • Not possible to overdose cell phone radiation because of heating effect • By classical toxicology standards RF would be judged as harmful to humans • Life-time exposures to radiation at doses similar to those emitted by cell phones show no effect – result is useless for human health risk estimation • Misleading claims that because animal studies, performed with cell phone radiation levels, do not show effects means that people are safe • Co-carcinogen studies show some effects – cell phone radiation might potentiate effects of carcinogenic chemicals or radiation • Just now published: Tillmann 2010 confirmed by Lerchl 2015! 16 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  17. 17. IARC evaluation: Mechanistic studies •Laboratory evidence was considered, by voting (no consensus) as insufficient to support/show mechanism of cell phone radiation effects 17 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  18. 18. Mechanism of some of the biological effects: Cellular stress response 18 Cell proliferation and expression of cancer regularory genes Leszczynski et al. 2002 Caraglia et al. 2005 Friedman et al. 2007 Buttiglione et al. 2007 Yu et al. 2008 Lee et al. 2008 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  19. 19. 19 In my opinion, the currently available scientific evidence is sufficient to upgrade the carcinogenicity of cell phone radiation from the possible carcinogen (Group 2B) to the probable carcinogen (Group 2A) Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  20. 20. 20 Precautionary Principle Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  21. 21. Invoking the Precautionary Principle “Whether or not to invoke the Precautionary Principle is a decision exercised where scientific information is insufficient, inconclusive, or uncertain and where there are indications that the possible effects on environment, or human, animal or plant health may be potentially dangerous and inconsistent with the chosen level of protection.” 21 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  22. 22. Reasons for invoking the Precautionary Principle Scientific information is insufficient, inconclusive, or uncertain • IARC classification as possible carcinogen (Group 2B) There are indications that the possible effects on human health may be potentially dangerous • epidemiological studies from Interphone, Hardell and CERENAT show an increased risk of brain cancer in long-term avid users Inconsistent with the chosen level of protection • epidemiological studies, showing increased risk in long-term avid users, were generated in populations using regular cell phones, meeting current safety standards = current safety standards are insufficient to protect users 22 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  23. 23. The impact of implementing the Precautionary Principle • Precaution does not equal Prevention • Strong opposition from telecom industry • Technology providers can be made responsible to prove their product is safe • Requirement of making more efficient (less radiation emissions) technology • Limiting current rampant and uncontrolled deployment of wireless networks • Will create new knowledge through research • Will create new jobs in research and technology 23 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  24. 24. 24 Conflict of Interest Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  25. 25. What is Conflict of Interest (CoI) The Institute of Medicine of The US National Academies defines Conflict of Interest (CoI) as: “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”. Quotes selected/modified from Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine of the National Academies 2009 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 25
  26. 26. The goal of the CoI policies Central goal of conflict of interest policies is to protect the integrity of professional judgment and to preserve public trust rather than to remeditate bias or mistrust after it occurs Quote modified from Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine of the National Academies 2009 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 26
  27. 27. Sufficiency of the CoI disclosure The disclosure of individual and institutional financial relationships is a critical but limited first step in the process of identifying and responding to conflict of interest Quote modified from Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine of the National Academies 2009 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 27
  28. 28. Why CoI disclosure might be insufficient • Person with the conflict of interest will be making decisions • How reliable will be decisions made by the person with the conflict of interest? • How reliable are the past decisions of persons who left the advisory expert committee to work for the industry? Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 28
  29. 29. Criteria for evaluating CoI policies Proportionality Is the policy most efficiently directed at the most important CoI? Transparency Is the policy comprehensible and accessible to the individuals and institutions that may be affected by the CoI policy? Accountability Does the CoI policy indicate who is responsible for enforcing and revising it? Fairness Does the CoI policy apply equally to all relevant groups within an institution and in different institutions? Quoted after Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine of the National Academies 2009 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 29
  30. 30. Specifics of the bioelectromagnetics • Bioelectromagnetics is a narrow research area. Unavoidably, all science is done, evaluated and presented to the general public and decision-makers by a small group of “influential players”. • Large research consortia, appointed committees and self-appointed committees consist of the same “influential players”. The same applies to the narrow field of “influential” peer-reviewers of new research projects and of articles published in peer-reviewed journals. Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 30
  31. 31. As if by default, all of the bioelectromagnetics’ “influential players” claim in their disclosures to either have no CoI or, if they have it, they claim to be absolutely unaffected in their scientific decisions by their CoI. Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 31
  32. 32. Trustworthiness of the unchecked, self-made CoI David Heath of the Center for Public Integrity, Washington, DC, wrote in December 2013 about Patricia Buffler, Dean of the School of Public Health at the University of California, Berkeley, CA, USA • Buffler’s own research found strong evidence suggesting that preschoolers should stay away from wet paint • Yet, in the past three years, Buffler was paid more than $360,000 to work as an expert witness on behalf of companies that used to sell lead- based paint Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 32
  33. 33. Accountability in bioelectromagnetics committees • Commonly, the disclosures of CoI, even in very influential committees, are not standardized and seemingly not checked for their accuracy • The CoI disclosures rely entirely on the willingness of the discloser to make the full disclosure • There seems to be no accountability for any false, erroneous or incomplete disclosures Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 33
  34. 34. Examples of the committees Committee Selections Disclosures Accountability Funding ICNIRP ”private club” Yes, but... No Unclear sources SCENIHR ”buddies system” Yes, but... Yes* EU BioInitiative ”private club” No? No Members’ own * Potential exclusion from the SCENIHR Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 34
  35. 35. ICNIRP members are asked to declare any personal interests in relation to the activities of ICNIRP. Members' declaration of personal interests are available on ICNIRP’s website. Accuracy checks are missing. Avoidance of “straight” answers? • Q: Do you have research support from the industry? • A: I have no personal support from the industry. Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 35
  36. 36. Examples of the scientific problems in the bioelectromagnetics committees • Selectiveness in collecting/admissing evidence • All evidence listed but not considered in practice (ICNIRP) • Selection of predominantly supportive evidence (BioInitiative) • Single scientist making judgement/writing opinion paper • BioInitiative • SCENIHR • Committees do not want to talk to each other • Call for the round-table to resolve differences was flatly rejected by ICNIRP, BioInitiative and MMF/GSMA Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015 36
  37. 37. Potential impact of the disclosed CoI • Even in a situation when disclosure of the CoI is done in full, what impact the disclosed CoI has on the decisions made by the discloser? • Even after the full disclosure of the CoI, person having the CoI might be making decisions. • Are these decisions influenced, or not influenced, by the CoI, also when it was disclosed? 37 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  38. 38. Are there irreplaceable experts ? As the society at large and as the scientific community, should we be solely dependent on the ethics and the consciousness of persons having Conflict of Interest, or should we intervene and exclude persons with significant CoI from the advisory and decision-making role? 38 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  39. 39. In dealings with experts, as a society and as scientists, should we exercise a full trust or a limited trust, and make sure that the ”skeletons” do not remain hidden? 39 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  40. 40. ICNIRP hijacked the WHO EMF Project #1 • WHO EMF Project is working as “front” for implementing ICNIRP opinions • Head of the WHO EMF Project is Dr. Emilie van Deventer, an engineer, without expertise in evaluating bio-medical research • WHO EMF Project relies completely on bio-medical expertise from the ICNIRP 40 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  41. 41. WHO EMF Project = ICNIRP 41
  42. 42. • ICNIRP members play a lead role in preparation of the Environmental Health Criteria on RF-EMF (e.g. cell phone radiation) that will determine the future of the wireless technologies • ICNIRP, the self-appointing NGO, has no accountability at all – nobody controls its activites (not for CoI disclosures, not for errorenous decisions) • Can ”private club”, ICNIRP, be fully trusted with the EHC task that is certainly lobbied by the telecom? 42 ICNIRP hijacked the WHO EMF Project #2 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  43. 43. • The World Health Organization Director General Dr. Margaret Chan does not care what the WHO EMF Project does with the science • The complaint about the WHO EMF Project’s handling of the writing process of the Environmental Health Criteria, was sent for response to... Dr. Emilie van Deventer, Head of the WHO EMF Project – clear problem of Conflict of Interest 43 ICNIRP hijacked the WHO EMF Project #3 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015
  44. 44. Conclusions • IARC classification of cell phone radiation as a possible carcinogen is a sufficient reason for invoking Precautionary Principle • Claims that the current safety standards protect all users are not supported by the scientific evidence • Users should be informed about the current scientific uncertainty and advised to limit exposures whenever possible and feasible and strongly discouraged from keeping cell phones close to body (in pockets) • Real radiation exposure data should be used in epidemiological studies • ALARA principle should be implemented for cell phone radiation exposures • Activity of WHO EMF Project and membersips of ICNIRP and SCENIHR should be overhauled... and clear accountability rules should be set 44 Dariusz Leszczynski; GIGAHERZ Symposium, Switzerland, March 7, 2015

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