6. Defectos Interphone
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L. Lloyd Morgan [[email protected]] 1
Interphone Studies To Date
An Examination of Poor Study Design
Resulting in an UNDER-ESTIMATIONof the Risk of Brain Tumors
L. Lloyd MorganBEMS, San Diego, 12 June 2008
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L. Lloyd Morgan [[email protected]] 2
MethodologyWhat If There Is No Risk of Brain Tumors?
ORs 1.0
Think coin tossing
OR=1.0 are excluded
~5% of ORs would be significant ORs 1.0
Calculate ratio: OR1.0
13 Interphone brain tumor studies to date
Exclude 2 overlapping studies and recent (Schlehofer) study
Analysis restricted to 10 Interphone brain tumor studies
Calculate binomial p-values
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L. Lloyd Morgan [[email protected]] 3
MethodologyCalculate Ratio by Categories by Studies
How to have statistically independent categories? Compare between studies, not within studies
Categories
Brain Tumors
All
Acoustic Neuroma Glioma
Meningioma
Years of use (Years)
Cumulative hours of use (Hours)
Cumulative number of calls (Call #) Regular cellphone use (Regular)
Years of ipsilateral cellphone use (Years Ipsi)
Years of contralateral cellphone use (Yrs Contra)
Minutes of cellphone use per day (Min/Day)
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L. Lloyd Morgan [[email protected]] 4
ResultsPercent Significant Findings By Category
Expectation: ~5%
0%
5%
10%
15%
20%
25%
All Years Hours Call # "Regular" Years Ipsi Years
Contra
Min per
Day
Categories
~ expected
Based
on 7
Findings
0%
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L. Lloyd Morgan [[email protected]] 6
Results
Ratio by Category
0
1
2
3
4
5
6
7
8
All Call # Hours Years "Regular" Years
Contra
Min per
Day
Years
Ipsi
Categories
Ratio
p=1.2x10-20
p=6.0x10-07
p=6.1x10-06
p=1.1x10-07
p=0.0011 p=0.0097p=0.16
p=0.097
Highest
Exposure
LowestRatio
Non-significant
Near-significant
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L. Lloyd Morgan [[email protected]] 7
ResultsRatio by Brain Tumor Type
0
1
2
3
4
5
6
All Acoustic
Neuroma
Glioma Meningioma
Ratio
p=1.2x10-20
p=2.9x10-5
p=6.0x10-10
p=8.2x10-9
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L. Lloyd Morgan [[email protected]] 8
Interphone Protocol Design Flaws
Flaw 1: Selection Bias Participating controls use cellphones more than non-
participating controls
Weighted average control participation rate: 59%
Lon 2004: 20% control refused; 34% used, 59% did not use Underestimates risk
Flaw 2: Tumors outside the radiation plume areunexposed
Unexposed tumors treated as exposed
Plume volume small relative to brain volume Well know since 1994 (4 previous papers)
Underestimates risk
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L. Lloyd Morgan [[email protected]] 9
Flaw 2
Tumors Outside Radiation Plume Are Unexposed
Radiation plumes volume is small % of brains volume
Ipsilateral: exposed Contralateral: unexposed Absorbed radiation decreases rapidly with plume penetration depth
Half-way to the brains mid-line, >90% of energy is absorbed
Percentage of absorbed cellphone radiation Ipsilateral temporal lobe: 50-60% (wt. av.=53%)
~15% of brains volume
Ipsilateral cerebellum: 12-25% (wt. av.=19%)
~5% of brains volume
62-85% of absorbed radiation is in ~20% of thebrains volume
Plume decreases rapid with depth (actual exposedbrains volume:
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L. Lloyd Morgan [[email protected]] 10
Flaw 2
Absorbed Radiation Decreases Rapidly w Depth
Relative Absorbed Radation and Penetration
Depth in Temporal Lobe
0%
10%
20%
30%
40%
50%
60%
15-24 25-34 35-44 45-54 55-64 65-74 75-84
Depth (mm)
% Absorbed Radiation
Relative to Max
Absorbed Radiation
900 MHz European Phones (worst case)
800-900 MHz Japanese Phones
Source: Cardis et al 2008
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L. Lloyd Morgan [[email protected]] 11
Interphone Protocol Design Flaws
Flaw 3: Latency time Known latency times
Ionizing radiation & brain tumor: 20-40 years
Smoking & lung cancer: ~30 years
Asbestos & mesothelioma: 20-40+ years
Short latency times underestimates risk
Flaw 4:Definition of regular user
Regular user: At least once a week for 6 months ormore
If definition of regular smoker were used, would a risk oflung cancer be found?
Definition of regular user underestimates risk
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L. Lloyd Morgan [[email protected]] 12
Flaws 3 and 4
Latency Time and the Definition of Regular Users
UK Subscribers by Year
0
10
20
30
40
50
60
1 2 3 4 5 6 7 8 9 10 1 1 1 2 13 1 4 1 5 16
Years from Eligibility Date
(Latency Time)
Millions
0Wt. Ave.
Eligibility
Date
2002.5
123456789101112131415
5 year latency
15% User-years
>10 year latency
2% User-years
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L. Lloyd Morgan [[email protected]] 13
Interphone Protocol Design Flaws
Flaw 5: Young adults and children
excluded
Children and young adults at greater risk thanadults
Interphone Protocol: 30-59 years
Some studies reduce minimum age to 20 years
Underestimates risk
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L. Lloyd Morgan [[email protected]] 14
Flaw 5
Young AdultsandChildrenExcluded
0
1
2
3
4
20-29 years 30-39 years 40-49 years 50-59 years
Age Range
OR
P
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L. Lloyd Morgan [[email protected]] 15
Interphone Protocol Design Flaws
Flaw 6: Comparison cellphone radiated
power: higher vs lower
Analog Vs Digital phones No longer possible
Rural Vs Urban users
Underestimates risk
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L. Lloyd Morgan [[email protected]] 16
Interphone Protocol Design Flaws
Flaw 7: Cordless phone, walkie-talkie, Ham, andproximity to TV & radio transmitters
Treated as unexposed
Underestimation of risk
Flaw 8: Exclusion of brain tumor types
Includes only acoustic neuroma, glioma & meningioma
Other brain tumor types are excluded
For example lymphoma and neuroepithelial brain tumors
Underestimates risk
Flaw 9: Exclusion of brain tumor cases becauseof death
Underestimates risk of most deadly brain tumors
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L. Lloyd Morgan [[email protected]] 17
Interphone Protocol Design
Flaws Flaw 10: Recall bias
Light users underestimate use
Heavy users overestimate use
Result: Large underestimation of risk
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L. Lloyd Morgan [[email protected]] 18
How to Resolve Flaws
Increase diagnosis eligibility time
Nine Interphone studies: weighted-average 2.6 years
Hardell et al. eligibility time: 6 years
Lower age range to
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L. Lloyd Morgan [[email protected]] 19
Conflict-of-Interest Cellphone Industry
Interphone funding is inadequate to resolve flaws More funding, greater potential of substantial revenue
loss
Researchers conflict-of-interest
(unconscious?)
Source of funds is known in spite of Firewall
Honest, but
Dont bite the hand that feeds you
90 significant protectiveresults
Ignored by authors (no commentary in the text)
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L. Lloyd Morgan [[email protected]] 20
Potential Brain Tumor Risk
30-year Latency
Poisson Distribution Calculation
0%
20%
40%
60%
80%
100%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
Years Since First Exposure
Risk
1985
1st Use
1995
10 Yrs2005
20 Yrs
2015
30 Yrs
0.002%
4%
55%
97%
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L. Lloyd Morgan [[email protected]] 21
Potential Public Health Risk
Potential Brain Tumor Cases From Use of a Cellphone
Assuming a 30-Year Latency Time and 10% of Users1
Diagnosed with a Brain Tumor
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
1,600,000
1,800,000
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
Potential Cases
of Brain Tumors
per Year
0
50
100
150
200
250
300
350
400
450
Cellphone
Subscribers
millions
Year 2004
44,447 Dx
~3,600 from
cellphone use
Year 2019
1,590,5131Based on 10% of long-term smokers are diagnosed with lung cancer
Source Cellphone Subscribers: CTIA
Source brain tumor diagnosed in 2004: CBTRUS
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L. Lloyd Morgan [[email protected]] 22
Conclusions Interphone resultssubstantiallyunderestimate the risk of
brain tumors Great majority of results have OR10 yearsof use
Significant risk found for >10 years andipsilateral use
Without design flaws Odds Ratios would increasesubstantially
Cellphone industrys conflict-of-interest is obvious
Government: ignores potential epidemic (see no evil)
Public health impact is enormous
Industry independent studies are required
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L. Lloyd Morgan [[email protected]] 23
I Pray Im Wrong!
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L. Lloyd Morgan [[email protected]] 24
Now What?Based on CBTRUS Incidence Data
Window closed for case-control studies
No unexposed cases remain
Cohort studies
Unable to know users of company owed cellphones
Unable to interview cellphone users
Requires enormous numbers
1,000,000 user-years will find (assuming cellphones do not increase
risk)
~6 acoustic neuromas
~54 gliomas
~45 meningiomas
Requires ~1 billion user-years to analyze by
Gender, SES, Years of use ,Exposed tumors only
Requires 30 year cohort study
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L. Lloyd Morgan [[email protected]] 25
Interphone Protocol Design Flaws
Flaw 11: Recall bias Interview cases immediately after diagnosis and 6 months
after surgery Improved memory and cognition 6 months after surgery
Flaw 12: Observational bias
Interviewer not blinded with face-to-face interviews
Mailed questionnaires provide blindness
Supplement by phone as necessary
Flaw 13: Too few cases for statistical power
Nine Interphone Brain Tumor Studies: Use for >10 years Average 18 cases per study
At minimum requires 2-fold more cases and controls forsufficient statistical power
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L. Lloyd Morgan [[email protected]] 26
Design Changes to Resolve Flaws
Treat unexposed tumors as unexposed Tumors outside radiation plume
Data was available, but to date not used, or even discussed
Too few cases?
Treat RF/MW exposures and exposed Cordless phone, walkie-talkie radios, Ham transmitters
Overweight rural users or increase eligibility time
Compare risk of brain tumor with rural and urban users Requires sufficient number of cases and controls
Use questionnaires not face-to-face interviews
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L. Lloyd Morgan [[email protected]] 27
Design Changes to Resolve Flaws
Reporting regular use
Do not publish regular use data
At minimum report regular use for >5 years,
or >10 years
Assumes >3-fold increase in case eligibility range Latency time: initiation or promotion?
Some researchers assume cellphone can only be
promoters
What is evidence for initiation vs promotion?
Follow cases & controls for a longer period
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L. Lloyd Morgan [[email protected]] 28
Design Changes to Resolve Flaws
Increase eligibility time to 9 years (for
sufficient statistical power)
>3-fold increase in cases and controls Publish results every 3 years
Provides longer latency time
Resolves whether cellphones use initiates or
promotes tumors
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L. Lloyd Morgan [[email protected]] 29
Flaw 2
Tumors Outside Radiation Plume Are Unexposed
900 MHz European Phone: Depth by Structure
0%
10%
20%
30%
40%
50%
60%
15-24 25-34 35-44 45-54 55-64 65-74 75-84Depth (mm)
Relative
SAR
Temporal Frontal Parietal Occipital Cerebellum
50% 19%Total Raditaion Absobed by Structure
9% 5% 12%
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L. Lloyd Morgan [[email protected]] 30
Flaw 5
Children Excluded
Ionizing Radiation ExampleExcess Relative Risk (ERR) per Gray (Gy)
Malignant Brain Tumors
by Age from Ionizing Radiation Exposure
47%
224%
356%
0%
100%
200%
300%
400%
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L. Lloyd Morgan [[email protected]] 31
Flaw 5Young Adults Excluded
Korean Cellphone Study
0
1
2
3
4
20-29 years 30-39 years 40-49 years 50-59 years
Age Range
OR
P
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L. Lloyd Morgan [[email protected]] 32
Flaw 5Young Adults Excluded
Swedish Cellphone Study
Increased Risk of Brain Tumor
0
1
2
3
4
5
6
7
8
20-80 years 20-29 years 20-80 years 20-29 years
Analog cellphone Cordless phone
OR
Source: Hardell et al.Arch Environ Health. 2004 Mar;59(3):132-7.
Fl 2
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L Lloyd Morgan [bilovsky@aol com] 33
Flaw 2
Tumors Outside Radiation Plume Are Unexposed
Source: http://serendip.brynmawr.edu/bb/kinser/Glossary.html
~10.4
~5.6 cm
Surface area ~162 cm2
Ipsilateral temporal lobesvolume to
total brains volume ~15%
Worst case: ~62% of ipsilateral radiation
is absorbed in ~20% of brain
Ipsilateral cerebellums volume to total
volume ~5%