Science and conflict of interest in bioelectromagnetics

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

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

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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

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“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.”

4Quote from the LifeExtension Magazine August 2007

The Hidden Dangers of Cell Phone Radiation

George Carlo interviewed by Sue Kovach


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Safety limits / Safety standards


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

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Macro-scale dosimetry

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Water

Salt

Sugar+ =

The problem:

free movement of ions


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Scientific evidence for health risk


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…


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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)

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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

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...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

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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

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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

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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

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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!

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IARC evaluation: Mechanistic studies

• Laboratory evidence was considered, by voting (noconsensus) as insufficient to support/show mechanism ofcell phone radiation effects

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Mechanism of some of the biological effects: Cellular stress response

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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


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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)


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Precautionary Principle


Invoking the Precautionary Principle

“Whether or not to invoke the Precautionary Principle is adecision exercised where scientific information isinsufficient, inconclusive, or uncertain and where there areindications that the possible effects on environment, orhuman, animal or plant health may be potentiallydangerous and inconsistent with the chosen level ofprotection.”

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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 bepotentially dangerous

• epidemiological studies from Interphone, Hardell and CERENAT showan 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 avidusers, were generated in populations using regular cell phones,meeting current safety standards = current safety standards areinsufficient to protect users

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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

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Conflict of Interest


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


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The goal of the CoI policies

Central goal of conflict of interest policies is to protect theintegrity of professional judgment and to preserve public trustrather than to remeditate bias or mistrust after it occurs

Quote modified from




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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




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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?


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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




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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.


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As if by default, all of the bioelectromagnetics’“influential players” claim in their disclosures toeither have no CoI or, if they have it, they claimto be absolutely unaffected in their scientificdecisions by their CoI.


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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


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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


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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


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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.


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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


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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?

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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?

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In dealings with experts, as a society and asscientists, should we exercise a full trust or alimited trust, and make sure that the ”skeletons”do not remain hidden?

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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

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WHO EMF Project = ICNIRP

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• 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?

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• The World Health Organization Director General Dr. Margaret Chan doesnot care what the WHO EMF Project does with the science

• The complaint about the WHO EMF Project’s handling of the writing processof the Environmental Health Criteria, was sent for response to... Dr. Emilie vanDeventer, Head of the WHO EMF Project – clear problem of Conflict ofInterest

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Conclusions

• IARC classification of cell phone radiation as a possible carcinogen is a sufficientreason for invoking Precautionary Principle

• Claims that the current safety standards protect all users are not supported bythe scientific evidence

• Users should be informed about the current scientific uncertainty and advised tolimit exposures whenever possible and feasible and strongly discouraged fromkeeping 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 shouldbe overhauled... and clear accountability rules should be set

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Science and conflict of interest in bioelectromagnetics

Presentations & Public Speaking

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