The
Committee
for Nuclear Responsibility . . . submits the following comments
upon the Draft Recommendations of the International Commission
for Radiological Protection (ICRP) concerning maximum annual
radiation doses for workers and members of the public, and
concerning release of radioactive contaminants into commerce
(including foodstuffs) and into the environment.
CNRs
conclusion is that the health damage from ICRPs
recommendations is seriously underestimated with respect to radiation
doses accumulated year after year in the annual range from 10 cSv (10
rems) down to zero, and that the recommendation for putting little or
no constraint on small individual releases of radioactive material may
cause irreversible harm many-fold greater than assumed. One of our
chief concerns is the unevaluated risk in the ICRP Recommendations of
radiation-induced coronary artery disease. . . .
We
recommend that the ICRP and other such groups carefully consider
the RMP study
before issuing any radiation guidelines in 2005. The consequences of
effective doses of radiation up to a few cSv (rems) each year, upon
causation of such an important disease, should certainly not be
excluded from the estimated detriment. The proposed
exclusion in the ICRP 2005 Recommendations (p.34) is unacceptable
and will surely end up creating a false sense of safety. . . .
There
is no doubt that the menace of dose-cohorts, unmatched for
accumulated x-ray organ-doses in the ABSS [A-Bomb Survivor Study],
should warn everyone to reduce the trust commonly placed in
quantitative risk-estimates derived from the ABSS --- as are most
of the ICRP guidelines.
And
this menace is not limited to the ABSS or to other
dose-response studies of the effects from just ionizing radiation. For
instance, it is a hazard in dose-response studies of any suspected
causal co-actor (e.g., any mutagen, or diet, smoking, non-ionizing
radiation) in mortality from coronary artery disease or cancer.
This communication, with its three attachments, is
offered in complete support of the U.S. Food and Drug
Administration's (FDA) proposed performance standards for
new x-ray fluoroscopic systems . . . Our
purpose here is to contribute scientifcally strong
evidence that the FDA has greatly underestimated the health
benefits of its own proposals . . .
The
FDA asks an important question (FR, p.76072):
With such a favorable ratio of benefits over costs, why must a
federal mandate be invoked? The FDA's answer: The "market"
does not respond to the ratio because the costs accrue to the
profession, but the benefits accrue to the patients.
We
believe that the above dynamic does operate, but
that it operates only because the medical profession has been
taught for decades that the cancer hazard from medical x-rays is
negligible. That same message continues to be repeated today,
not only by the FDA (Part 2, above),
but elsewhere with greater vigor (Part 6, below).
In
great contrast to claims of very low hazards from
customary medical x-ray practices (and thus, negligible health
benefits from dose-reduction), we have uncovered powerful
evidence that customary x-ray practices became and remain one
of the necessary causal co-actors in over half of the fatal cases
of cancer and over half of the fatal cases of ischemic heart
disease (coronary artery disease) in the USA
(Gofman 1999).
The study's method and findings are most succinctly summarized
in Attachment-1
(i.e., Parts 4
and 5 of
Gofman 2002). . . .
"If
you care, you measure." This axiom reflects the
well-known fact in business and education that, if you are
serious about achieving a goal, you establish a system to
measure progress or its absence. "What you measure
improves." Without seeing the improvement, or knowing of its
absence, people lack guidance and motivation, and are robbed of
their pride in achievement.
It
is impossible to believe that doses during
fluoroscopy will be cut in half (and much more) unless the
measurement of fluoroscopic x-ray dose becomes easy and
automatic.
The study's two principal conclusions are 1) Medical radiation,
introduced into medicine in 1896, became and remains a necessary causal
co-actor in over half of the fatal cases of cancer in the USA, and 2)
became and remains a necessary causal co-actor also in over half of the
fatal cases of ischemic heart disease (coronary artery disease) in the USA. . .
.
The
conclusions above are obviously so important for human
health that they demand thoughtful, independent scrutiny, i.e.,
peer-review.
How
have our conclusions held up under peer-review? Has
someone shown a reason to discard them, to ignore them, or to modify
them? Not so far. . . .
Why,
then, are the findings not yet treated as one of the major
medical breakthroughs of the past decade? Experience shows that it always
takes time for humans to discard mistaken beliefs, especially when the
beliefs are so comforting (e.g., "The harm from medical x-rays is trivial").
Still, patience may be no virtue when very many premature deaths could be
prevented by a little speed (Gofman 1999pp.17-20). We agree with the
author, Kenneth Graham, who has observed:
"The
strongest human instinct is to impart information, and the
second strongest is to resist it."
The fact that some people do benefit from various x-ray screening
tests certainly does not guarantee that individuals who consent to (or insist
upon) getting screened are likely to receive more personal benefit than
personal harm.
The
older you are, the more abnormalities you have accumulated.
When they are detected by x-ray screening, you are very likely to face a
host of additional procedures which are not risk-free (e.g., more x-rays,
biopsies, surgeries, etc.) --- quite possibly to care for abnormalities which
would never have caused you any trouble.
Responsible
health professionals are finally asking: Do some sorts
of screening policies cause more harm than good? Because the potential
benefits have been so widely promoted, this document concentrates on
providing more information about the likelihood of harms.
In this document, the X-rays and Health Project (XaHP) offers links
and addresses to six professional societies whose leaders and members
have either the authority or expertise to reduce x-ray dose per x-ray
imaging procedure.
Short
messages of encouragement from non-members can intensify
professional attention to dose-reduction . . . When you contact
the leaders of these societies, you could express
your confidence that they have the skills to achieve a
better benefit-risk ratio for patients by reducing
x-ray doses . . .
The
societies fall into three categories: (1) Radiologists, (2) Radiologic
Technologists, (3) Health Physicists. In addition, we have listed a
route of easy access to the radiation divisions of Health Departments
in every state.
To help educate health professionals and the public about x-ray
dose-levels, the X-Rays and Health Project has assembled some
excerpts from the peer-reviewed radiology journal American
Journal of Roentgenology. (Roentgen ray is another name for
x-ray.) The AJR is edited by Lee F. Rogers, M.D. and
published by the American Roentgen Ray Society
(www.arrs.org),
which was founded in 1900 -- the nation's first radiology
society.
These comments apply primarily to x-ray exposure received during medical
imaging procedures (during diagnosis, during surgery, during placement of
catheters, needles). These comments do not address x-rays and gamma rays
used at very high doses for cancer therapy because the
Report on Carcinogens (RoC) lists causes of cancer, not
potential treatments. . . .
The
mistaken assumption, that x-ray exposure from medical imaging is negligible, has been very widely embraced. Although the NTP Reports on Carcinogens explicitly exclude any risk-assessments, the NTP has the responsibility to evaluate whether or not exposure to a nominated carcinogen is literally negligible. . . .
There
is a vast literature on human cell-studies which demonstrates that x-rays
and gamma rays are a potent cause of structural chromosomal mutations of every sort, including re-arrangements, acentric fragments, and deletions
ranging in size from multiple genes probably down to single nucleotides. (The deletion of a single nucleotide is no small matter, since it can scramble the genetic code by causing a frame-shift.)
CT doses below are merely "ballpark" values. Entrance
doses during CT scans are almost never measured. Actual doses
--- even from the same equipment for the same patient --- can vary
many-fold according to the settings selected for kVp, mAs, pitch,
filtration, slice-width, and some other variables.
Real
doses in centi-Gray units (cGy) are distinctly different
entities from "effective" doses in centi-Sievert units
(cSv). Real doses quantify energy per gram of tissue delivered by
an x-ray exam to the irradiated sections of the body, whereas
"effective" doses are artificial values based on
assumptions about risk ("detriment").
A guaranteed way to reduce future breast cancer is to reduce x-ray dose per
x-ray imaging procedure. And if we are serious about achieving good
images with the least possible x-ray doses, x-ray measurements are
the key. If we care, we measure -- because otherwise we do not know if
we are succeeding or failing. "What you measure improves," is an
appropriate motto here.
I am
unaware of any other aspect of medicine where we use a potentially
lethal agent without measuring the dose and making every effort to
reduce the risk. It is not good enough, morally, that the benefit
exceeds the risk. The moral imperative includes making the risk
as small as possible.
Naysayers
will deny that patients commonly receive much higher x-ray
doses than necessary. Such denials would be wrong according to recent
articles right in the medical literature.
Techniques to reduce x-ray doses are already known and demonstrated,
and await application. . . .
Where
will we find the "Heroes for Breast Health?" There are three
professional groups, present in large hospitals, who are outstanding
candidates for this honor: The radiologists, radiologic technologists, and
health physicists. Together they have the expertise to do what is needed to
reduce x-ray dose per x-ray imaging procedure. Links to their main
professional societies are provided
here.
When
these three groups decide to accept this responsibility, they will
change the entire landscape in the breast-cancer field. Local chapters could
contribute successful models which other localities could duplicate. By
leading a relentless program to reduce doses during x-ray imaging, these
professionals can say "NO!" to permitting a great many preventable
cases of future breast cancer, and they would deserve every honor of the
realm, absolutely! Will they rise to the occasion? How soon?
The key point is that peacetime nuclear activities (military
and civilian) expose the general public to low doses of ionizing
radiation.
The
government's solution to quelling public fear of
"radiation" was to have its agents assert --- for decades after it
was no longer true --- that evidence of human harm from
ionizing radiation comes exclusively from exposure to high
doses, and that evidence of human harm from low doses
does not exist. . . . What
the government and its agents failed to point out in
the 1950s and early 1960s was that no studies capable of
producing evidence about low doses had ever been completed. . . .
Fifty
years of ridiculing the fear of low-dose ionizing
radiation ("radio-phobia") have had a tragic unintended
consequence: Two
or three generations of practicing physicians and
their professors at medical schools have mistakenly believed
that danger from x-ray imaging procedures was either absent or
trivial. . . .
The
evidence in my 1999 monograph (Ref.4), which no
one has refuted, indicates that about 250,000 persons each year
in the USA are dying prematurely from cancer and coronary
heart disease due to the unnecessary half of the x-ray
doses which they accumulated earlier in life, during x-ray
imaging procedures. This has been going on for 50 years, and
continues. . . .
The
Cold War propaganda has left the medical professions
unaware of the premature, preventable, x-ray-induced deaths
which they have been causing, by using higher x-ray doses than
needed during imaging.
The
era of unawareness should end --- forever. Ethical
responsibility for current and future x-ray practice rests now
with the medical professions, and especially with the gatekeepers
to their education: The medical school professors, the medical
journal editors, and the members of the radiological professional
societies. How will they respond?
A short presentation (with references) to physicians, about the need
and feasibility of reducing x-ray doses during imaging procedures,
and about the ethics of giving patients a potential lethal agent
without measuring the dosage and without making every effort to
reduce the dose per procedure to the lowest level at which good
images can be obtained.
The entrance dose of x-rays is the dose
received at the body's surface, where the x-ray beam
enters. The exit dose, which is what results in an
image, is very much lower. The body absorbs the
difference between the entrance and exit doses.
TLDs
(ThermoLuminescent Dosimeters) can measure the x-ray entrance
dose received by any patient during an x-ray imaging procedure. . . .
X-ray practitioners can obtain TLDs the instructions, and the
reading service by mail from an accredited laboratory at the
University of Wisconsin.
3 My
recent study (Radiation from Medical Procedures, 699 pages)
provides the first powerful evidence that the U.S. population's accumulated
exposure to medical x-rays is a necessary co-actor in causing over half the
deaths from cancer, and over half the deaths also from ischemic (coronary) heart
disease. Since the study's publication in November 1999, no one has shown that
it overestimates the impact of x-rays in causing cancer and coronary heart
disease. Some people say "it must be an overestimate," but they have never
shown how. Some of the critics have never even looked at the study.
8 The
right time to start action on the "Doses Down Now" policy is
today, because achievements in your locality can benefit your family and
your
community within 18-24 months, without waiting for statewide or nationwide
success. Any locality can get its x-ray doses down, regardless of how slowly
other regions might make progress. The "Doses Down Now" policy is a proven way
to prevent some of the cancer problem, not a "maybe." So please invite people
on your E-mail address book to join the "Patients' Right-to-Know" effort.
If there is a war on cancer, but no group or agency is
devoted to reducing exposure to a PROVEN cause of every major
type of cancer --- namely, x-rays --- then the decision to
neglect x-rays really CAUSES the future xray-induced cancers
(and heart attacks) which could have been prevented. This
logic creates the moral obligation to succeed at what is
demonstrably feasible: Obtaining all the benefits of medical
and dental x-rays, at lower doses per procedure. An imaginary
conflict, between this goal and mammography, would be tragic
for nearly everyone.
Radiologists in Toronto invited a team of medical
physicists to observe their actual x-ray imaging practices, to
measure doses, to teach low-dose techniques, to tune-up
existing equipment, and to ensure proper processing of exposed
films. . . . The consultation demonstrated
that --- without loss of image-quality --- average dose could
be reduced "by a factor of at least 3 with little work and by
a factor of 10 or more if all conditions are optimized"
(Taylor 1983, p.557). These achievements
were obtained without purchases of major new equipment.
The personal comments of the radiologist's wife seem
to be consistent with the published comments of Joel E. Gray,
Ph.D., professor and medical physicist at the Mayo Clinic
until his recent retirement to become a consultant. Dr. Gray
is a world-class expert in obtaining high-quality x-ray images
while minimizing x-ray dosage to patients and staff. . . .
"If
your exposures have not been measured recently,
you cannot be sure what exposures you are using. And if you
don't know what your exposures are, you don't know if you are
doing a good job" (Gray 1998a, p.61). Dr. Gray stresses that
dose-reduction techniques not only reduce the risk of causing
cancer, but they can sometimes produce better images.
An assumption, widely held among physicians and
patients alike, is that x-ray practitioners in general already
give x-ray doses which are as low as technically possible,
consistent with obtaining good images.
That
assumption is demonstrably false, as illustrated
by the table below, which is based on nationwide surveys of
about 300 facilities (CRCPD 1989 + CRCPD 1994). . . .
Joel
E. Gray, Ph.D. --- using the CRCPD data plus his
own vast experience as a professor and medical physicist at
the Mayo Clinic (and currently as a private consultant) ---
has published two articles which further demolish the
assumption that doses received during x-ray imaging are
already as low as technically possible (Gray 1998a+b).
Helpfully,
Dr. Gray's articles also describe
"relatively simple, inexpensive, and easily applied"
techniques which, combined, can reduce dose in various
circumstances to one-fifth the amount given if such measures
are not used. Unfortunately, the two articles are very hard
to obtain, and they probably have been seen by almost no one
in medicine and certainly not by the public.
The goal of the X-Rays and Health Project (XaHP) is to reduce
the x-ray dose per x-ray procedure, to the minimum level
consistent with obtaining the medical and dental benefits. The
reason for dose-reduction is that x-rays increase the risk of
consequential mutations, even when each x-ray exposure occurs
at low doses. . . .
In
our opinion, a medical degree confers an especially strong
duty to examine evidence bearing on life and death very
carefully, before urging anyone to ignore it.
Imagine
that persons with such a degree hear about a new
study whose conclusion is that millions of future cases of
cancer and coronary heart disease could be prevented by
reducing x-ray dosage per x-ray procedure. Such a benefit would
hardly be trivial! Without examining and refuting the new
evidence, can physicians ethically urge anyone to ignore it?
What about the very great harm that such advice may cause?
Our
viewpoint is that the best outcome for health, with
respect to x-rays, will occur only if both patients and
physicians are aware of the full range of informed medical
opinion. Our informed opinion is that reducing x-ray dosage per
x-ray procedure will prevent significant shares of future cases
of cancer and coronary heart disease. That would be an immense
health benefit. The evidence is so strong that we would feel
ashamed if we did nothing about it.
The U.S. Food and Drug Administration makes this
estimate on its website, March 2000: Seven out of 10
Americans will get a medical or dental x-ray "picture" this year. . . . Sooner
or later, you or a family member is very likely
to contemplate an x-ray, due to a medical or dental problem or
due to an accident.
Two
types of x-ray imaging procedures which generally
(not always) deliver the highest x-ray doses are fluoroscopy
and CT exams (XaHP Doc.102). The American Cancer Society has
stated, "Fluoroscopy delivers larger doses of x-ray than that
used in standard films. If there is an alternative means of
making a diagnosis, fluoroscopy should be avoided". . . .
There
is no mystery about how to reduce doses,
technically. What is lacking is leadership. If just a few
thousand American radiologists would openly endorse the goal,
their leadership (in our opinion) could reduce the average
dose-level administered by other radiologists virtually
overnight. Other kinds of x-ray practitioners would follow
suit.
Usually, when exposure to x-rays is compared with "a day in the sun" or "a day
at the beach," the mistaken assumption is that the ultraviolet light from the
sun is comparable to the penetrating photons of x-rays and gamma rays. . . .
When the "day in the sun" analogy is meant to compare x-ray exposure to
exposure by one day of natural background radiation, the comparison is still
mistaken, even though natural background radiation has access to the body's
internal organs.
Part 1. Orientation: What Is Old, and What Is New.
Part 2. Some Key Facts about X-Rays and Ionizing Radiation in General.
Part 3. No Doubt about Benefits from Medical Radiation.
Part 4. Role of Medical Radiation in Causing Cancer and IHD, Past and Present.
Part 5. Our Method for Calculating Fractional Causation.
Part 6. Eight Features Which Confer High Credibility on the Findings.
Part 7. Our Unified Model of Atherogenesis, and NonXray Co-Actors in IHD.
Part 8. A Personal Word: The X-Ray Deserves Its Honored Place in Health.
Part 9. Every Benefit of Medical Radiation: Same Procedures, Lower Dose-Levels.
Part 10. An Immense Opportunity: All Benefit, No Risk.
Part 2. 1896-1960: Rapid and Widespread Embrace of X-Rays in Medicine.
Part 3. 1960 to Present: Some Changes in Usage of Medical Radiation.
Part 4. Ionizing Radiation: A Proven Carcinogen with Some Unique Properties.
Part 5. Is the Carcinogenic Power, per Rad of Radiation, the Same at All Dose-Levels?
Part 6. Absence of Any Threshold Dose: "Risk" vs. Rate.
Part 7. X-rays: More Carcinogenic than Gamma Rays at Equal Doses.
Part 8. Variable Latency-Periods for Radiation-Induced Cancer.