Contents
- Comments upon the “Draft Recommendations
of the International Commission on Radiological Protection.”,
December 26, 2004
Submitted to the ICRP by John Gofman and Egan O'Connor
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.
CNR’s conclusion is that the health damage from ICRP’s 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.
- FDA Proposes New X-Ray Regulations: Immense Health Benefits Possible
--- Unless Naysayers Prevail.
X-Ray-Induced Diseases, Hormesis, and Medical Ethics.
March 31, 2003. Testimony submitted to the FDA, by John Gofman and Egan O'Connor
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.
- What Are the Main Critiques of the 1999 Study by Gofman,
after Three Years of Peer-Review?
Six Critiques of Radiation from Medical Procedures
in the Causation of Cancer and Ischemic Heart Disease (IHD), November 2002
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 1999 pp.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."
- Making Personal Decisions about X-ray Screening Tests,
Such as Mammography and CT of the Lung,
Colon, Heart, or the Entire Body, May 2002
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.
- Links to Professional Societies, Current to 12 Oct 2001
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.
- Who Says that Usual X-Ray Doses Can Be Much Lower?, October 2001
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.
- X-Radiation and Gamma Radiation:
Comments on Their Nomination as Known Human Carcinogens
for the Eleventh Report on Carcinogens (RoC), September 11, 2001
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.)
- COMPUTED TOMOGRAPHY (CT) X-RAY EXAMS:
Estimated Doses to Patients, September 2001
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").
- Breast Cancer: Why Do We Permit So Many Preventable Cases?, June 2001
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 (links and references at www.x-raysandhealth.org). 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 at www.x-raysandhealth.org.
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?
- How the Cold War Caused Millions of American Deaths
Through Medical Practice:
A Story of Intended and Unintended Consequences, April 2001
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?
- On the Web:
Medical X-Rays As an Environmental Toxin:Proposal for Professional Action ,
by John W. Gofman, MD, PhD, San Francisco Medicine, March 2001A 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.
- X-Ray Dose-Measuring Service for Physicians and Dentists, January 2001
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.
- Eight Key Points:
Your Stake in the Patients' Right-to-Know about X-Rays, December 7, 2000
3My 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
- Mammography and XaHP (the X-Rays and Health Project):
Is There Any Conflict?
Four Brief Comments, October 2000
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.
- A Proposal for Radiologists:
How a Specific Consultation Can Become a Major
Asset for the Practice and for the Community, October 2000
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.
- Do X-Ray Practitioners Give Enough Attention
to Minimizing the Patients' X-Ray Dosage?
Some Opinions, Some Facts, September 2000
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.
- How X-Ray Doses Vary
From One X-Ray Practitioner to Another:
Nationwide Surveys, September 2000
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.
- Fear, and the Patients' Right-to-Know:
The Viewpoint of an Influential Radiologist,
Deserving a Public Response, September 2000
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.
- A Patient's Guide, When X-Rays Are Proposed, September 2000
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.
- Making the Bay Area a Model
for California and the Nation:
A Guaranteed Way to Reduce Future Cancer-Rates, Fall 2000
A dose-reduction program requires no one to give up any of the benefits of x-ray images. The fact is that the benefits of x-ray images can be obtained from lower doses. Only 25% of x-ray practitioners are using the lowest doses technically possible. The other 75% are giving patients higher doses than the doses needed for high-quality images --- in some cases, 5-times, 10-times, 15-times more dose than needed. . . .
We suggest that the goal in the Bay Area, and in every county of the nation, should be that all x-ray practitioners give patients the lowest x-ray doses technically possible, consistent with obtaining good images. No patient deserves to receive an unnecessary x-ray-induced death later on, due to uselessly high x-ray exposure. . . .
If the two goals of the Policy Statement had been adopted 30 years ago, when it was first clear that x-rays are a cause of Cancer in adults, countless cases of misery would have been prevented. It is a moral imperative to do now what could have been done ago. The Bay Area can lead the way, as a model for the rest of California and the nation.
- X-Rays: The Fallacy of the "Day in the Sun" Comparison, February 28, 2000
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.
- See Also:
- Radiation from Medical Procedures in the Pathogenesis of Cancer and Ischemic Heart Disease: Dose-Response Studies with Physicians per 100,000 Population, John W. Gofman, M.D., Ph. D., 1999, 699 pages. San Francisco: Committee for Nuclear Responsibility Books. ISBN 0-932682-97-9.