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Should the radiological community continue the present radiation dose-reduction campaign and efforts? Mohan Doss, PhD, MCCPM Medical Physicist, Diagnostic Imaging, Fox Chase Cancer Center, Philadelphia, PA, USA E-mail: [email protected] Revised and Updated version of the Presentation given at: The 74th Annual Meeting of the Japan Radiological Society, Yokohama, Japan, on April 17, 2015 Version 1.11 Copyright © 2015 by Mohan Doss. This presentation in its entirety may be copied, shared, and distributed freely without any restriction. If using individual slides or figures, please acknowledge this presentation as the source. Disclaimer: Opinions expressed in this presentation are my own professional opinion, and do not necessarily represent those of my employer. 1
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Page 1: Should the radiological community continue the present radiation dose reduction campaign and efforts - jrs talk 4-17-2015 - revised v1.03

Should the radiological community continue the

present radiation dose-reduction campaign and efforts?

Mohan Doss, PhD, MCCPM Medical Physicist, Diagnostic Imaging,

Fox Chase Cancer Center, Philadelphia, PA, USA

E-mail: [email protected]

Revised and Updated version of the Presentation given at:

The 74th Annual Meeting of the Japan Radiological Society,

Yokohama, Japan, on April 17, 2015

Version 1.11

Copyright © 2015 by Mohan Doss.

This presentation in its entirety may be copied, shared, and distributed freely without any restriction. If using

individual slides or figures, please acknowledge this presentation as the source.

Disclaimer: Opinions expressed in this presentation are my own professional opinion, and do not necessarily

represent those of my employer.

1

Page 2: Should the radiological community continue the present radiation dose reduction campaign and efforts - jrs talk 4-17-2015 - revised v1.03

☑ The author has no conflict of interest to

disclose with respect to this presentation.

2

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The presentation was given as part of the Joint Symposium of

Japan Radiology Congress, 2015, Yokohama, Japan http://www.j-rc.org/jrc/2015/jsmp_prog_taikai.pdf

Joint Symposium 1

April 17 (Fri) 15:10~17:10 (Main Hall)

Patient Dose in Radiology: Manage the Invisible

Moderator: Aichi Medical Univ. Tsuneo Ishiguchi

NIRS Keiichi Akahane

1. We Can And We Must Reduce Radiation Exposure. Perspective of

The American College of Radiology American College of Radiology, USA Paul H. Ellenbogen

2. Radiation Protection (EUROSAFE IMAGING) University of Crete, Greece John Damilakis

3. Activities for the Management of Medical Radiation Exposure in Japan

Asahi General Hosp. Takayuki Igarashi

4. Should the Radiological Community Continue the Present Radiation

Dose-reduction Campaign and Efforts? Fox Chase Cancer Center, USA Mohan Doss

3

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The answer depends on whether:

– Low-dose radiation is carcinogenic

– CT dose reduction efforts would result in

improved patient health.

Should the radiological community continue the present

radiation dose-reduction campaign and efforts?

4

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The traditional answer is YES based on

the linear no-threshold (LNT) Model

5

Is Low-dose Radiation Carcinogenic?

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Justification for the LNT Model

Radiation Free radicals DNA damage

Mutations Cancer

Linear relationships assumed.

Even a single ray of radiation DNA damage

Hence, No Threshold

Linear No-Threshold (LNT) Model

6

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7

The Linear No-Threshold (LNT) Model

For higher doses,

Observe a linear relationship between

ERR and Radiation Dose

For low doses,

Large errors in determining ERR

Hence a Model is used for low doses.

In LNT model, ERR is extrapolated

from high doses to low doses

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Does it make sense to extrapolate

the effect of radiation (or any other agent)

from high levels to low levels?

8

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Do these types of extrapolations make sense?

To determine the effect of Extrapolate from the effect of

1 sleeping pill 50,100,200… sleeping pills

Drinking a cup of water

Drinking 1,2,3,..buckets of

water

Jumping from a step

Jumping from 5th, 10th, 15th,

… Floors of a building

9

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No. Absolutely Not.

These types of extrapolations don’t make sense.

10

To determine the effect of Extrapolate from the effect of

1 sleeping pill 50,100,200… sleeping pills

Drinking a cup of water

Drinking 1,2,3,..buckets of

water

Jumping from a step

Jumping from 5th, 10th, 15th,

… Floors of a building

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In a similar manner, for radiation,

To determine the effect of Extrapolate from

1-10 mSv radiation dose

1 Sv radiation dose

this type of extrapolation does not make sense:

LNT model is senseless

However, we have been using it for

more than fifty years.

When, and why did we start using it?

What is the origin of the LNT Model? 11

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The first advisory body to adopt

the LNT Model

was the Genetics Panel of the

National Academy of Sciences (NAS)

Biological Effects of Atomic Radiation (BEAR) I

Committee in 1956.

(Calabrese, 2009)

12

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Summary Report of BEAR I Genetics Committee

Published in Science, in 1956

Some of the statements in the summary report:

“The genetic harm is proportional to the total dose”

“there is no such figure other than zero” (for the amount of radiation

that is genetically harmless)

“our society should hold additional radiation exposure as low as it

possibly can”

The essence of the LNT model and ALARA principle are embodied in

these statements of the report.

The Report was also published in New York Times, received high

publicity, and resulted in public fear of low-dose radiation.

However, statements by the Committee Members in letters exchanged

between themselves next year expressed quite a different viewpoint 13

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Statements in letters between Committee members in 1957

“I, myself, have a hard time keeping a straight face when there is talk

about genetic deaths and the tremendous dangers of irradiation. I

know that a number of very prominent geneticists, and people whose

opinions you value highly, agree with me.”

“Let us be honest with ourselves—we are both interested in genetics

research, and for the sake of it, we are willing to stretch a point

when necessary”, and

“Now, the business of genetic effects of atomic energy has produced

a public scare, and a consequent interest in and recognition of

importance of genetics. This is to the good, since it will make some

people read up on genetics who would not have done so otherwise,

and it may lead to the powers-that-be giving money for genetic

research which they would not give otherwise.”

See: (Calabrese, 2014) (Seltzer, 2007)

(Note: Keep a straight face = say it without laughing, or say it seriously.

Stretch a point = Exaggerate) 14

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Excerpts from: Dobzhansky letter to Demerec (1957b) August 13 Letter, Milislav Demerec papers.

Reproduced with permission from American Philosophical Society Library. 15

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BEAR I/II Committee Members:

•did not consider low levels of radiation to be dangerous

•were willing to exaggerate risk from low levels of radiation

to improve funding for genetics research

•were pleased that there was a public scare about the

genetics effects of radiation (after the publication of the

Genetics Panel Report), as it may lead to increased funding

for research

Such considerations among the Committee Members

indicate self-interest may have led the BEAR I

committee members to exaggerate the risk of low-dose

radiation by their adoption of the LNT model.

(Calabrese, 2014) 16

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What are the consequences

of using the LNT Model?

17

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18

The grey band covers the normal variation of baseline cancer rates (average

of male and female rates normalized to 100) during an extended period (1960-

1994) in which the cancer rates were relatively stable in Japan. See Table 9

on Page 80 of the report: Cancer Statistics in Japan, 2013 by Foundation for

Promotion of Cancer Research.

Cancer Mortality Rate vs. Radiation Dose

According to the LNT Model

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19

Dose reduction efforts

10 mSv down to 1 mSv (e.g.)

- cancer rate stays within grey area

- 0.15% reduction of cancer

mortality rate while the range of

natural variation is ±2%

- no health benefit.

- a total waste of resources

Of course, wasted resource for the

public are BIG $$$$$ for the LNT

model proponents and the resulting

enterprises.

Impact of Dose Reduction Efforts in Diagnostic Imaging

on Cancer Mortality Rate, according to the LNT Model

Financial motivation that apparently initiated the LNT model appears to be the reason

for its persistence and expansion into radiology, since there is no health benefit to the

patients from its use but huge financial benefit to the resulting enterprises including

research.

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Is the LNT Model valid?

Let us examine the evidence.

20

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22

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How can we explain the observed reduced

cancers or no increase in cancers following low-

dose radiation exposures in so many instances?

Didn’t the LNT model arguments

(Radiation DNA damage Mutations Cancer)

show the smallest radiation dose should

increase cancers?

Explanation:

There are major defects in

the LNT Model arguments.

24

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Major Defects of the LNT Model arguments

25

DNA damage occurs even in the absence of low-dose radiation due to

endogenous causes. Low-dose radiation results in increased defenses known

as adaptive protection (Feinendegen, 2013) consisting of antioxidants, DNA

repair enzymes, apoptosis, etc. which would reduce the endogenous damage

that would have occurred in the absence of the low-dose radiation. Thus, there

would be less overall DNA damage following low-dose radiation exposure, as

seen in the above data.

DNA damage does not increase linearly with dose at low doses.

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LNT Model argument assumes increased mutations mean increased cancers.

However mutations do not imply cancer.

Almost everyone has cancerous mutations, see (Greaves, 2014),

but everyone does not have cancer. 26

Percentage of patients with cancerous mutations is unchanged

But Cancer mortality rate increases drastically with age.

Major Defects of the LNT Model arguments

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The LNT model completely ignores the immune system which plays a

major role in preventing covert cancers from becoming clinical cancers.

Low-dose radiation boosts the immune system response, and so would

reduce cancers. 27

Major Defects of the LNT Model arguments

Suppression of the immune system increases cancer risk by a factor of ~3,

demonstrating how important immune system is for keeping covert cancers in

check. Immune system response declines rapidly with age, qualitatively

explaining the age-related increase in cancers. Low-dose radiation boosts the

immune system.

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Are Low-dose Radiation exposures

of concern for children?

Data generally shown to raise the concerns However, excess cancers

are observed for high-dose

radiation exposures only in

atomic bomb survivors.

Only by LNT model

extrapolation, these

graphs are extended to

low-doses.

But since there is no

evidence/justification for

the LNT model, extension

of the graph to low doses

is not valid. 28

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Other arguments used to raise concerns:

Children

- have higher proportion of dividing cells,

- more susceptible to mutations due to radiation.

This argument ignores adaptive protection.

Low-dose radiation adaptive protection

- reduces overall mutations

- enhances the immune system

- would reduce cancers

NO CONCERNS REGARDING LOW-DOSE RADIATION

EXPOSURES TO CHILDREN, e.g. from CT scans 29

Are children at risk from low-dose radiation?

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The most important data for determining

the health effects of radiation are

the atomic bomb survivor data.

30

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Importance of the Atomic Bomb Survivor data

31

BEIR VII Report, 2006

Page 141

Hall and Brenner, Cancer risks from diagnostic radiology, BJR, 81, 2008, p362-378

Page 323

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Linearity in the Atomic Bomb Survivor Data

(after the latest update in 2012)

Atomic bomb survivor data no longer have a linear dose-response.

Excess relative risks for low doses near zero would be lower due to adaptive

protection, as seen in data in earlier slides. Since these ERRs extrapolated to zero

dose were used as baseline cancer rates in the fitting process for determining the

ERRs by Ozasa et al, the baseline cancer rates would have a negative bias.

Ozasa et al. state:

(Ozasa et al, 2012) Page 234

Page 238

32

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33

The shape of dose-response curve, with the correction for the negative bias in

the baseline cancer rate, is consistent with the concept of radiation hormesis.

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Threshold Dose in Atomic Bomb Survivor Data

Dose-Threshold Analysis (Ozasa, 2012)

- used linear dose-response model shape

(this shape did not cover the full range of

observed ERR values, i.e. negative values)

- concluded zero dose is the best estimate of threshold dose

Analysis using a more general functional form

- Comments in Radiation Research by

(Doss, Egleston, Litwin, 2012)

- conclusion: finite threshold dose is possible.

Ozasa et al. had no response/rebuttal to these Comments.

34

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Opening Statement of Counterpoint by Dr. Little:

Did not use atomic bomb survivor data (the most important

data according to LNT model supporters) to claim cancer risk

from low-dose radiation

In earlier debates,

The atomic bomb survivor data played a major role.

Conclusion: The atomic bomb survivor data no longer

provide evidence for the LNT model, even according to the

LNT model supporters.

Recent debate in Medical Physics, 41, 070601 (2014)

Low-dose Radiation is Beneficial, Not Harmful,

Authors: Doss, Little, Orton.

35

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Major Consequences from the Change in the

Nature of Atomic Bomb Survivor Data in 2012

In the past, Atomic Bomb Survivor Data have been utilized in

most publications, reports, research funding applications, etc.

as the key data to claim support for carcinogenicity of low-

dose radiation or for the LNT model.

Such publications and reports (and any consequential

publications that claim low-dose radiation cancer risk) should

not be used any longer since the atomic bomb survivor data

no longer support the LNT Model. Such publications will be

tagged with the label:

Also, any funding applications for research dated 2013 and

later that justify low-dose radiation cancer risk based on the

LNT model or atomic bomb survivor data should be rejected

retroactively since they should never have been approved.

36

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Are there any evidences to support the

LNT model or the concept that low-dose

radiation causes cancer?

Many publications have made such claims, they get

huge publicity, are cited by many other publications, but

are later found to be faulty, with their conclusions being

reversed.

The damage – misleading the professionals and the

public about the carcinogenicity of low-dose radiation -

has already been done, and continues for a long time.

37

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What to do with such faulty publications?

The faulty publications should be tagged

and they should not be used. Any

publications that utilize the faulty

publications to justify low-dose radiation

concerns should also be tagged

and should not be used.

Two such recent publications will be

discussed now.

38

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Studies Claiming Increased Cancers Following

Childhood CT Scans

(Pearce, et al, 2012) UK Study:

Claimed increased leukemias and brain cancers

770 citations in Google Scholar

(Mathews, 2013) Australian Study:

Claimed increased cancers of many types

309 citations in Google Scholar

Created a lot of buzz in popular media, and concerns among the

public regarding children’s CT scans.

Study was criticized and its conclusions questioned by many, with

no rebuttal from the authors.

See:

(Cohen, 2013), (Walsh, 2013), (Boice, 2013), (Walsh, 2014), (Socol, 2015)

39

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(Pearce, et al, 2012) UK Study:

Brain Cancers:

• ERR/Gy for glioma increased with

age at exam – this is reverse of

prior studies. The risk is expected

to decrease for higher ages when

brain development nears

completion (UNSCEAR 2013)

• ERR/Gy =23 much higher than

0.88, observed in A-Bomb

survivors <10 y

Leukemias and MDS:

• ERR/Gy Leukemia and

Myelodysplastic Disease (MDS) –

36, much higher than 6.5 in A-

Bomb Survivors <20y

(Mathews, 2013) Australian Study:

All cancers:

Risk estimate for All cancers (excluding brain

cancers) was 27 vs 3 for A-bomb survivors

Latency period:

Study of cancers one year after CT scans

increased the likelihood of reverse causation

Implausible tumors associated with CTs:

Excesses seen for melanoma and Hodgkin’s

lymphoma, not known to be associated with

radiation, and not for breast cancer, a

radiosensitive site

Inconsistent Age at exposure effect:

Excess leukemias observed for later age

exposure but not for early age, contrary to

other earlier studies.

Both studies were subject to reverse causation because of study design. Considering

the large inconsistencies with previous studies, the conclusions of these studies are in

doubt, and so these studies do not provide evidence for causal link between CT scans

and cancers (Boice, 2013). The conclusions of these publications are not credible.

Discussion of Recent Publications Claiming Increased Cancers

following Childhood CT scans as described in (Boice, 2013)

40

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In the following slides, several publications

that raise low-dose radiation concerns are

examined to determine if they have referred

to older atomic bomb survivor data or faulty

publications to claim cancer risk from low-

dose radiation. If they have, then they

would be tagged .

41

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42

Author(s)/Journal/

Title

Arguments or articles cited to

justify low-dose radiation cancer

concerns

Reason Why Arguments or Articles Cited

are Not a cause for concern Disposition of

Publication

BEIR VII Report

(NRC, 2006) Health risks from

exposure to low

levels of ionizing radiation

Atomic Bomb Survivor Data

(from 2006 and earlier)

Superseded by newer data (Ozasa et al.,

2012) which no longer support the LNT

model; see (Doss, 2012, Doss, 2013);

BEIR VII

radiation

cancer risk

model no

longer valid

(Cardis et al., 2005) Study Conclusion no longer valid due to

faults identified in Canadian Data. See

(CNSC, 2011, Zablotska et al., 2014)

(Brenner and Hall,

2007)/NEJM

Computed

tomography--an

increasing source of

radiation exposure

Concerns raised about DNA

double strand breaks due to

radiation exposure

Completely ignores adaptive protection in

the body which would reduce the naturally

occurring damage in the subsequent

period, resulting in less overall DNA

damage. See e.g. (Koana, 2010, Osipov,

2013) Conclusion of

Publication no

longer valid Atomic Bomb Survivor Data

(Preston et al., 2007)

Superseded by newer data (Ozasa et al.,

2012) which no longer support the LNT

model; see (Doss, 2012, Doss, 2013);

15 Country Study of Radiation

Workers (Cardis et al., 2005)

Study Conclusion no longer valid due to

faults identified in Canadian Data. See

(CNSC, 2011, Zablotska et al., 2014)

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Author(s)/Journal/Title Arguments or articles cited to

justify low-dose radiation cancer

concerns

Reason Why Arguments or

Articles Cited are Not a cause for

concern

Disposition of

Publication

(Berrington de

González, 2009) /Arch.

Int. Med./ Projected cancer risks from

computed tomographic scans

BEIR VII report radiation cancer

risk model BEIR VII Report conclusions no

longer valid

Conclusion of

Publication no longer

valid

(Smith-Bindman,

2009) / Arch. Int. Med/ Radiation dose associated

with common computed tomography examinations

BEIR VII Report radiation cancer

risk estimates BEIR VII Report conclusions no

longer valid

Conclusion of

Publication no longer

valid

(FDA, 2010) White Paper - Initiative

to Reduce Unnecessary

Radiation Exposure from

Medical Imaging

(Brenner and Hall, 2007,

Berrington de Gonzalez et al.,

2009, Smith-Bindman et al.,

2009)

Cited publications' conclusions no

longer valid.

Conclusion of

Publication no longer

valid

(Pearce, 2012) /

Lancet/ Radiation exposure from

CT scans in childhood

and subsequent risk of

leukaemia and brain tumours

ERR/Gy for glioma increased

with age at exam; This is reverse of prior studies

Because of large

inconsistencies with

previous data, and

because the study

design that allowed

reverse causation,

Conclusion of

Publication not

credible.

see (Boice, 2013)

ERR/Gy =23 ; ERR/Gy much higher than 0.88,

observed in A-Bomb survivors less

than 10 y old.

ERR/Gy Leukemia and MDS ~

36 Much higher than 6.5 in

A-Bomb Survivors <20y

Reason for CT scans not

specified. Likelihood of Reverse Causation 43

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Author(s)/Journal/

Title

Arguments or articles cited to

justify low-dose radiation cancer

concerns

Reason Why Arguments or

Articles Cited are Not a cause for

concern

Disposition of

Publication

(Mathews, 2013) / BMJ/ Cancer risk in 680,000

people exposed to

computed tomography

scans in childhood or adolescence

Risk estimate for All cancers

(excluding brain cancers) was 27 Was 3 for A-bomb survivors

Because of so

many

inconsistencies

with previous data,

and because of the

deficiencies in the

study design that

allow reverse

causation,

Conclusion of

Publication not

credible.

see (Boice, 2013)

Excesses seen for melanoma and

Hodgkin’s lymphoma, and not for

breast cancer

Melanoma and Hodgkin’s

lymphoma are not known to be

associated with radiation. Breast

cancer known to be associated

with radiation.

Excess leukemias observed for

later age exposure but not for

early age

This is contrary to other earlier

studies.

Cancers just one year after CT

scans were included in the study Increased the likelihood of

reverse causation

THE FOLLOWING PUBLICATIONS USED REFERENCES WHOSE CONCLUSIONS WERE ALREADY NEGATED BECAUSE OF UPDATED DATA OR IDENTIFICATION OF FAULTS.

(Brenner, 2014) / BJR/ What we know and what we

don't know about cancer

risks associated with

radiation doses from radiological imaging.

(Cardis et al., 2005,

Preston et al., 2007,

Pearce et al., 2012,

Mathews et al., 2013)

(Preston, 2007) was superseded

by newer data (Ozasa et al.,

2012) which no longer support

the LNT model; see (Doss, 2012,

Doss, 2013); Conclusions of

other publications no longer valid

or not credible.

Conclusion of

Publication invalid

44

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Author(s)/Journal/

Title

Arguments or articles cited to

justify low-dose radiation cancer

concerns

Reason Why Arguments or Articles

Cited are Not a cause for concern Disposition of

Publication

(Redberg and Smith-

Bindman, 2014) /

New York Times/ We are Giving

Ourselves Cancer

(Berrington de Gonzalez et al.,

2009, Pearce et al., 2012,

Mathews et al., 2013)

Conclusions of Publications are not

credible or are no longer valid.

Conclusion of

Publication invalid

(Smith-Bindman and

Boone, 2014)/ JACR/ Introduction to the

special issue:

radiation dose

optimization

(Preston et al., 2007, Pearce et

al., 2012, Mathews et al., 2013),

BEIR VII Report

(Preston et al., 2007) was

superseded by newer data (Ozasa

et al., 2012) which no longer

support the LNT model. see (Doss,

2012, Doss, 2013); Conclusions of

other publications are not credible

or are no longer valid.

Conclusion and

recommendations of

Publication invalid

(EPA, 2014)/ FEDERAL GUIDANCE

REPORT NO. 14

Berrington de González et al.

2009; Brenner 2007; Smith-

Bindman et al. 2009; Pearce et

al. 2012; Mathews et al. 2013.

Conclusion of Publications no

longer valid or not credible.

Recommendations of

Publication not

justified.

(Consumer Reports,

2015)/ The Surprising

Dangers of CT Scans and X-rays

(Berrington de Gonzalez et al.,

2009, Pearce et al., 2012,

Mathews et al., 2013)

Conclusions of Publications are not

credible or are no longer valid.

Conclusion and

recommendations of

Publication invalid.

45

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References:

Berrington de Gonzalez, A., et al. 2009. Projected cancer risks from computed tomographic scans performed in the

United States in 2007. Arch Intern Med, 169, 2071-7. http://www.ncbi.nlm.nih.gov/pubmed/20008689

Boice, J. D. 2013. Paediatric CT and Recent Epidemiological Studies.

http://www.icrp.org/docs/John%20Boice%20Paediatric%20CT%20and%20Recent%20Epidemiological%20Studies.pdf

Brenner, D. J. 2014. What we know and what we don't know about cancer risks associated with radiation doses from

radiological imaging. Br J Radiol, 87, 20130629. http://www.ncbi.nlm.nih.gov/pubmed/24198200

Brenner, D. J. & Hall, E. J. 2007. Computed tomography--an increasing source of radiation exposure. N Engl J Med,

357, 2277-84. http://www.ncbi.nlm.nih.gov/pubmed/18046031

Cardis, E., et al. 2005. Risk of cancer after low doses of ionising radiation: retrospective cohort study in 15 countries.

BMJ, 331, 77. http://www.ncbi.nlm.nih.gov/pubmed/15987704

CNSC. 2011. INFO-0811. Verifying Canadian Nuclear Energy Worker Radiation Risk: A Reanalysis of Cancer Mortality

in Canadian Nuclear Energy Workers (1957-1994) Summary Report, Canadian Nuclear Safety Commission. [Online].

http://nuclearsafety.gc.ca/pubs_catalogue/uploads/INFO0811_e.pdf Published June 2011.

Consumer_Reports. 2015. The Surprising Dangers of CT Scans and X-rays. Consumer Reports, March, 2015.

http://www.consumerreports.org/cro/magazine/2015/01/the-surprising-dangers-of-ct-sans-and-x-rays/index.htm

Doss, M. 2012. Evidence supporting radiation hormesis in atomic bomb survivor cancer mortality data. Dose

Response, 10, 584-92. http://www.ncbi.nlm.nih.gov/pubmed/23304106

Doss, M. 2013. Linear No-Threshold Model vs. Radiation Hormesis. Dose Response, 11, 480-497.

http://www.ncbi.nlm.nih.gov/pubmed/24298226

EPA. 2014. FEDERAL GUIDANCE REPORT NO. 14 - Radiation Protection Guidance for Diagnostic and

Interventional X-Ray Procedures . http://www.epa.gov/radiation/federal/fgr-14.html

FDA. 2010. White Paper - Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, 2010, Center

for Devices and Radiological Health, FDA.

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm

Koana, T. & Tsujimura, H. 2010. A U-shaped dose-response relationship between x radiation and sex-linked

recessive lethal mutation in male germ cells of Drosophila. Radiat Res, 174, 46-51.

http://www.ncbi.nlm.nih.gov/pubmed/20681798

46

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References (continued):

Mathews, J. D., et al. 2013. Cancer risk in 680,000 people exposed to computed tomography scans in

childhood or adolescence: data linkage study of 11 million Australians. BMJ, 346, f2360.

http://www.ncbi.nlm.nih.gov/pubmed/23694687

NRC 2006. Health risks from exposure to low levels of ionizing radiation : BEIR VII Phase 2, National

Research Council (U.S.). Committee to Assess Health Risks from Exposure to Low Level of Ionizing

Radiation., Washington, D.C., National Academies Press. http://www.nap.edu/catalog.php?record_id=11340

Osipov, A. N., et al. 2013. In vivo gamma-irradiation low dose threshold for suppression of DNA double strand

breaks below the spontaneous level in mouse blood and spleen cells. Mutat Res, 756, 141-5.

http://www.ncbi.nlm.nih.gov/pubmed/23664857

Ozasa, K., et al. 2012. Studies of the mortality of atomic bomb survivors, Report 14, 1950-2003: an overview

of cancer and noncancer diseases. Radiat Res, 177, 229-43. http://www.ncbi.nlm.nih.gov/pubmed/22171960

Pearce, M. S., et al. 2012. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia

and brain tumours: a retrospective cohort study. Lancet, 380, 499-505.

http://www.ncbi.nlm.nih.gov/pubmed/22681860

Preston, D. L., et al. 2007. Solid cancer incidence in atomic bomb survivors: 1958-1998. Radiation Research,

168, 1-64. http://www.ncbi.nlm.nih.gov/pubmed/17722996

Redberg, R. F. & Smith-Bindman, R. 2014. We are Giving Ourselves Cancer. New York Times, Jan 30, 2014.

http://www.nytimes.com/2014/01/31/opinion/we-are-giving-ourselves-cancer.html?_r=0

Smith-Bindman, R. & Boone, J. M. 2014. Introduction to the special issue: radiation dose optimization--

improving the safety of CT. J Am Coll Radiol, 11, 229-30. http://www.ncbi.nlm.nih.gov/pubmed/24589393

Smith-Bindman, R., et al. 2009. Radiation dose associated with common computed tomography

examinations and the associated lifetime attributable risk of cancer. Arch Intern Med, 169, 2078-86.

http://www.ncbi.nlm.nih.gov/pubmed/20008690

Zablotska, L. B., et al. 2014. A reanalysis of cancer mortality in Canadian nuclear workers (1956-1994) based

on revised exposure and cohort data. Br J Cancer, 110, 214-23.

http://www.ncbi.nlm.nih.gov/pubmed/24231946

47

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Manuscripts submitted after 2012 with the

claim of low-dose radiation cancer risk

based on the LNT model or using older

atomic bomb survivor data should not have

been approved for publication, since the

(Ozasa, 2012) update to the atomic bomb

survivor data do not support the LNT model.

48

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As seen in the Table in the previous slides, a

large number of influential publications continue

to use the old atomic bomb survivor data (or

publications based on such data) to justify the

LNT model or low-dose radiation cancer concerns

when the updated atomic bomb survivor data do

not support the LNT model. Such publications

generate a tremendous amount of economic

activity (research, dose reduction and monitoring

efforts, etc.) which do not benefit the public but

financially benefit the resulting enterprises. Public

funding of such work is not justifiable, and should

be terminated. 49

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Recent Research Funding Should be Reviewed

Any research projects publicly funded since 2013

should be reviewed to determine if they were

justified by low-dose radiation concerns based on

the LNT model. If so, the research funding for the

projects should be terminated, since they should

not have been approved in the first place, because

the newer atomic bomb survivor data, which are

recognized to be the most important data and gold

standard data, do not support the LNT model any

longer.

50

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Update to BEIR VII Report being considered by NAS

At the recent scoping meeting for BEIR VIII Report

Speakers referred to studies that are not credible or whose

conclusions have been negated due to identification of faults

– Cancers following pediatric CT scans (Pearce, 2012; Mathews, 2013)

– 15-Country Study of Radiation Workers (Cardis, 2005)

to claim increased low-dose radiation cancer risk

But ignored evidences:

– Deviation from linearity of atomic bomb survivor data (Doss 2012,2013)

– Nuclear Shipyard Worker Study (Sponsler and Cameron, 2005)

– Study of second cancers in radiation therapy patients (Tubiana, 2011)

showing decreased cancer risk from low-dose radiation

51

BEIR VIII should not be funded in view of such bias.

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In summary, dose reduction

campaign and efforts in diagnostic

imaging do not benefit patients by

reducing cancer risk but financially

benefit the resulting enterprises by

increasing economic activity,

research, etc.

52

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Now let us discuss the impact of the fear

and concerns that have been raised about

CT scans by articles incorrectly claiming

they cause cancers, and the efforts to

reduce the radiation dose from CT scans.

53

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Caution about harm caused to patients by

cancer concerns from diagnostic imaging

(Brody, 2014) in Thorax

54

This article describes many ways in which

actions taken due to the current radiation dose

concerns about CT scans can harm patients.

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Consequences of Misinforming Patients/Parents

About Cancer Risk from CT scans

55

When patients or parents are misinformed that there is

increased risk from CT scans, some fraction of them

would refuse the CT scans. What they gain by refusing

the scan is nothing, even if LNT model projection is true,

since the change in cancer risk is within the range of

normal variation from year to year (see figure on right),

but they have lost the diagnostic information that could

potentially be lifesaving.

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Stress in patients/parents following CT scans

Example of text in emails from concerned parent:

• At the moment I am googling like mad as concerned

about my 1 year old daughter having CT scan after

falling and fracturing her skull. Thankfully all is well.

• It is tantamount to mental cruelty what is being written

and reported about radiation effects from CT scans, I

saw many other mothers had made entries on web

sites regarding the CT scan their child had and their

concerns for future cancers.

56

See comment on next page.

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Stress in patients/parents following CT scans

Example of text in email from concerned patient

I am familiar with the controversy and debate concerning

<100 mSv exposures, hormesis, and the “consensus” on the

LNT. Still, I am having a difficult time moving on with my life

despite it all. I see constant reminders of the risks of CT

everywhere in the media, and those stories often warn against

the risks of a SINGLE scan. It is absolutely terrifying to think that

I have had 5 scans, and that consequently a latent cancer is

waiting to manifest.

This matter has caused me such paralyzing anxiety….

57

We should not be causing this type of concerns in

patients/parents by misinforming them about the risks of

diagnostic imaging. The increased risks claimed are

phantom risks because they are based on the invalid LNT

model, and even if the LNT model is believed to be valid,

the increased risk is within the normal variation in cancer

rates from year to year (see figure on right).

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Physicians influenced in imaging decisions

by radiation dose concerns

58

When physicians are misinformed that there is increased

cancer risk from CT scans, some fraction of them would

refuse to order the appropriate CT scans. What they gain by

refusing to order the CT scans is nothing, even if LNT model

projection is true, since the change in cancer risk is within

the range of normal variation from year to year (see figure on

right). But they would lose the diagnostic information that

could potentially be lifesaving for the patient.

Page 59: Should the radiological community continue the present radiation dose reduction campaign and efforts - jrs talk 4-17-2015 - revised v1.03

CT Dose Reduction efforts Non-diagnostic CT scans

Figures from: Goske MJ,

Strauss KJ, Coombs LP, B,

Diagnostic reference ranges for

pediatric abdominal CT.

Radiology. 2013;268:208-18.

Reproduced with permission

from RSNA (Copyright holder).

59

It is unethical to perform non-diagnostic CT scans like the one

shown (Fig. 6b) with the claim that the lower dose is reducing

cancer risk, when the claim is based on the invalid LNT model,

and even if the model is believed to be valid, the reduction in

cancer risk would be within the normal variation of cancer risk of

population from year to year (see figure on right), and so the claim

has no merit.

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Non-diagnostic CT scans Quote from (Brody, 2014)

“Five percent of the CT scans using standard clinical protocols

and radiation doses below the 25th percentile were judged to be

non-diagnostic,15 suggesting that 1 in 20 paediatric abdominal CT

scans performed at some of the top institutions in the USA were

inadequate for diagnostic purposes due to excessive radiation

dose reduction efforts. This is wasted radiation exposure and,

even worse, may negatively influence care when it results in

misguided treatment based on inadequate or erroneous

information.”

60

See the comment on previous slide.

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Decreased diagnostic accuracy

(Goenka, 2014)

25% dose reduction – diagnostic accuracy

maintained

50% dose reduction – unacceptable loss of

diagnostic accuracy

61

Having a 25% margin to ensure diagnostic quality is

certainly justified, when there is no validity to the claims

of increased risk of cancer from CT scans, even if the

LNT model is believed to be valid (see figure on right).

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There is NO benefit to patients from

dose reduction campaign and efforts

but potential harm to patients. There

is benefit to the organizations and

individuals that perform the

campaign and efforts because of the

financial gain for performing these

potentially harmful tasks.

62

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Why ACR’s Dose Reduction Campaign Must be Ended In his presentation at Japan Radiology Congress 2015 entitled “We Can And We Must

Reduce Radiation Exposure: Perspective of The American College of Radiology”,

Dr. Paul Ellenbogen, ACR President, stated that

- he believes the dose-response shape for radiation-induced cancers is somewhere

between threshold response and radiation hormesis.

- there is demand for dose reduction from patients, physicians, payors, legislators, etc.

Hence ACR has ongoing dose reduction efforts in diagnostic imaging.

In view of the above shape of dose-response acknowledged by ACR President, which is

consistent with evidence discussed earlier in this presentation, there would be zero benefit

to patients from the dose-reduction efforts and there would be potential harm from the

efforts as seen in previous slides. On the other hand, there are considerable costs for the

dose-reduction and dose-monitoring efforts, which would ultimately get passed on to the

patients or the public. In view of no benefit to patients but costs and potential harm, how

can ACR justify these efforts?

The demands for dose reduction from patients, physicians, payors, legislators, etc. are

based on their misunderstanding that small doses of radiation increase cancer risk. If their

misunderstanding is corrected by providing them correct information, there would no longer

be such demands. Thus, using their demands to undertake wasteful and potentially harmful

dose-reduction efforts is not justified. These dose-reduction campaigns and efforts should

be stopped immediately. 63

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• There is neither valid reason nor evidence for cancers caused by the low

radiation doses from diagnostic imaging; on the other hand, there is plenty of

evidence for reduction of cancers from low-dose radiation. Hence, dose

reduction efforts in diagnostic imaging would not benefit patients.

• Dose-reduction campaigns perpetuate the misguided cancer concerns among

patients, parents, and physicians regarding the low radiation doses from

diagnostic imaging, resulting in some physicians not ordering appropriate

studies and some patients not undergoing needed studies, delaying

diagnoses, potentially harming patients. Many patients/parents also undergo

unnecessary emotional stress due to the misguided cancer concerns

regarding scheduled or past diagnostic studies.

• Dose-reduction efforts can harm patients by misdiagnoses due to poorer

quality images.

• Dose-reduction campaigns and efforts benefit the resulting enterprises

including research while not benefiting patients and potentially harming

patients.

Hence, the definitive answer to the above question is:

No

64

Should the radiological community continue the

present radiation dose-reduction campaign and efforts?

Page 65: Should the radiological community continue the present radiation dose reduction campaign and efforts - jrs talk 4-17-2015 - revised v1.03

Summary and Conclusions • LNT model is senseless, and its use results in no improvement of public health but causes

large public expenditures which provide income to LNT model proponents and resulting

enterprises including research.

• Self-interest motivated committee members to adopt the LNT model in the 1950s.

• There is plenty of evidence against the LNT model and for radiation hormesis.

• Major defects of the LNT model – ignoring adaptive response and the immune system.

• Atomic bomb survivor data – key data – no longer support the LNT model.

• Evidences quoted for low-dose radiation (LDR) carcinogenicity have dissipated.

• Children do not face increased cancer risk from low-dose radiation.

• Many publications need to be discarded and marked “Do Not Use” as they utilized older

atomic-bomb survivor data or faulty publications to justify LDR concerns.

• Research work based on the LNT model cannot be justified any longer. All the research

projects publicly funded since 2013 should be reviewed, and if any work was justified based

on low-dose radiation concerns due to the LNT model or older atomic bomb survivor data, the

project funding should be terminated, as it should not have been approved at all.

• Radiation dose concerns and dose reduction can harm patients in multiple ways:

– Patients/parents are likely refusing imaging studies and physicians not ordering proper

studies due to radiation dose concerns, placing patients’ health potentially at risk.

Patients/parents have emotional stress regarding scheduled or past diagnostic studies.

– Non-diagnostic scans are likely being performed, with one estimate of 1 in 20 pediatric

exams not being of diagnostic quality. Dose reduction efforts can harm patients from

misdiagnoses.

• Dose reduction campaigns and efforts benefit the resulting enterprises including research

while not benefiting patients and potentially harming patients.

Dose-reduction campaigns and efforts should be ended. 65


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