Courtney's Law

Abstract
Since the debut of Computerized Tomography in 1972, great improvements have transpired to create high resolution images coupled with a fast scan time, thus enhancing both the diagnostic capability of the technology and patient comfort. Despite these advancements, the quantity of ionizing radiation emitted from the CT procedure, while reduced per picture, has not been sufficiently mitigated. As a result, CT scans continue to confer an increased lifetime risk of cancer to the individual, frequently without their knowledge. Courtney’s Law establishes guidelines to better inform patients of the risks and benefits of CT scans, empowering the patient to play an active role in his or her own health.

Introduction
Today, CT scans expose patients to radiation comparable to the lower ranges in Hiroshima and Nagasaki survivors.1,2 Statistically, one in one thousand individuals will develop cancer as a direct consequence of CT radiation.3

The CT4 scan ushered in a new era of diagnostic medicine in 1972. Since its debut, medicine has seen great improvements in high-resolution images, fast scan time, diagnostic capability and patient comfort. Despite these advancements, the quantity of ionizing radiation emitted from the CT procedure, while reduced per picture, continues to pose a danger: CT scans confer an increased lifetime risk of cancer. Due to a lack of awareness on the part of the prescribing and administering doctors, patients frequently have no knowledge of the hazard. Patients should be aware of these radiogenic risks.

In spite of the known hazards, this scan is performed over 150,000 times each day, credited with the detection of maladies that would otherwise be invisible. Whether the benefits of CT scans outweigh the risks in all instances, however, is not always clear. Given their increasing popularity, growing segments of the U.S. population are experiencing radiation exposure, generally without their knowledge.5 Out of this fast growing, uncritical use of CT scans, a public health concern is born.

Thirty-Five Years of CT Technology
The Uses of Computed Tomography
Advancements in CT imagery have eliminated the need for exploratory surgery and refined surgical options due to the scans’ ability to detect life-threatening diseases and abnormalities previously indiscernible with a traditional two-dimensional x-ray. 6 Table 1 details the differences in technique and application of both diagnostic tools.

Table 1. X-Ray and CT Scan Compared: A Summary of Different Techniques and Applications. Source: The Mayo Clinic7

Each single CT procedure consists of the equivalent of multiple chest x-rays – from dozens to thousands – that are used to slice through the body generating three-dimensional images at resolutions of millimeters.

Proliferation of CT
A decade’s seven-fold increase in the use of pediatric and adult CT scans is a direct function of technology advancements that allow the diagnostic scanner to be applicable over multiple disciplines as well as increased procedure availability. Janet Sherman, M.D., a health activist, argues that as more machines arrive in medical offices, “those who own them want to maximize their investments by using…[the scanners] as much as possible.”8 Medical supply companies, such as Cardinal Health, have benefited from the growing demand for CTs, with annual revenues of more than $81 billion.9

The expansion of the CT, however, does not reflect the technology’s associated radiation health risks. CT scans release seventy percent of the collective medical radiation delivered to patients, yet the machines account for only thirteen percent of all radiographic procedures in U.S. hospitals.10,11

Radiation Risks Calculated as Lives Lost
There is no low-dose radiation “threshold” for inducing cancers, and no quantity of radiation should be considered benign. CT scan radiation exposure augments the normal one in four population risk of cancer. This incremental increase from the CT for a given procedure is small, but not trivial because the “effects of radiation are cumulative over a person’s lifetime.”12 The American Cancer Society estimates 559,650 individuals will lose their battle with cancer this year.13 In this same time period, 700 individuals will die from cancers associated with head CTs and 1,800 will lose their lives to radiation-induced cancer from abdominal examinations.14 Out of these radiogenic cancers, 170 and 310 respectively are deaths judged to be results of pediatric CT scans.

The numbers associated with CT-scan-induced-cancers appear small at this time, but, as the use of the CT grows, the population-wide risks will rise, as well.

Children and Amplified Risks
Children have special risks associated with radiation exposure. They are more vulnerable due to rapid cell division coupled with a longer life expectancy. This translates to greater opportunities for “expressing radiation damage,” and accumulating radiation throughout their lives.15 If children are given head CT scans that are not adjusted for their smaller size, they can receive sixty millisieverts16 of radiation; however, this dose can be halved to thirty millisieverts with proper calibration, an automatic feature on new CT models. 17,18 These dose amounts are equivalent to between 400 to 6,000 and 200 to 3,000 chest x-rays, respectively.19 Table 2 shows CT radiation risks and their corresponding equivalency in chest x-rays.

Children represent a population of individuals extremely susceptible to radiation risk. However, if CT scans are used appropriately and adjusted for patient size this diagnostic machine can prove important in making diagnoses.

Communication Failure
A typical chest CT scan is equivalent to four hundred chest x-rays.21 Are doctors aware? A Yale University study of CT scan knowledge found that most Emergency Department physicians and radiologists were unable to accurately estimate the dose of a CT scan compared to a chest radiograph.22 While the risks of x-ray radiation are relatively well known and the subject of major public relations campaigns worldwide, those of CT remain unknown to patients, as shown below:

1. Seven percent of patients reported that they were told about risks and benefits of their CT scan;
2. Twenty-two percent of Emergency Department physicians reported that they had provided such information;
3. Three percent of patients believed that there is an increased risk of cancer compared to fortyseven percent of radiologists and nine percent of Emergency Department physicians who associated an increased cancer risk with CT scans.23

Table 2. Radiation Risks of CT Scans. Source: National Cancer Institute20
*Chest-x-ray equivalency based on NCI estimates per single film
** Not provided by NCI, numbers calculated by author

Instigating Communication
In spite of the lack of awareness masking the carcinogenic hazards of CT radiation, the risks of the scan are beginning to be more broadly recognized. Doctors and hospitals are beginning to discuss the advantages as well as disadvantages of CT scans with their patients. Furthermore, grassroots organizations, forwardthinking insurance companies, and leaders in managed care are working at the forefront to break the silence. Each communication method ameliorates the knowledge gap regarding the costs and benefits of the CT, in addition to mitigating the number of individuals exposed.

Consent Forms
Consent forms are one method of patient education promoting discussions concerning the risks of CT scans. Currently, two-thirds of hospitals in the United States have guidelines for informed consent.24 A survey published in the American Journal of Roentgenology investigated various institutions’ nonemergent CT scan protocol: the information delivered to patients regarding the scan’s purpose, specific risks, and alternative imaging procedures. The study found:

1. Two thirds (60/90) of hospitals surveyed currently have guidelines for informed consent;
2. Fifty-two percent (30/58) of sites provided verbal information and 5% (3/58) provided information in written form.
3. Radiology technologists were most likely to inform patients about possible CT risks (52/91, 57%), whereas ordering physicians were most likely to inform patients about purpose of the CT scan (37/66, 56%).
4. Nine percent (8/88) of sites informed patients of alternatives to CT. 25

Mothers Unite to Take Action
Another form of patient education is derived from the efforts of Mothers Against Silence About CT Radiation Risks (MASACRR). The objective of this grassroots organization is to heighten public awareness of CT scan radiation risk via informed consent, while at the same time acknowledging the power of the CT when used appropriately.26 Members are motivated to fight for their cause by stories of loved ones subjected to unnecessary radiation. An account of a MASACRR mother captures the emotions of the entire community, as her memories take her back to the winter of 2005, when her 4-year-old son was suffering from a severe cold virus and vomiting.

Should I worry for the rest of my life that my only child may develop cancer or leukemia as a result of [4 uncalibrated] CT scans? I lose so much sleep over this issue; it has been a huge burden. I kick myself for not knowing what CT scans were when we brought him to the hospital. I cry every time I think about this. I hope no other kids and their parents will have to go through this in the future.27

MASACRR strives to ensure every pediatric CT scan is properly adjusted for body size and that every family receives informed consent. The organization praises the work and success of Dr. Steven Birnbaum, a radiologist practicing in southern New Hampshire. He “has been able to jaw bone his way into the medical staff consciousness in both of the hospitals in which he works such that profligate CT utilization is beginning to decline.”28

An Insurance Company Mitigating CT Scan Exposure
Dr. Birnbaum’s influence and activism prompted Anthem Blue Cross and Blue Shield, a New England health insurance company, to implement “one of its top patient-safety initiatives” mitigating repetitive scanning for patients under 40 years of age.29 Birnbaum designed Anthem’s three-phase program to educate doctors, identify multiple screened patients, and discuss alternative diagnostic techniques for these identified patients. 30 These policies are congruent with those of Adriane Fugh-Berman, M.D., a public health activist at Georgetown University, who believes tracking total medical radiation exposure is an excellent step towards ensuring patient well-being.31

Private Sector
One private organization is modeling another form of CT awareness. National Imaging Associates (NIA), a managed care company, enacted “a new procedure with thirty of its clients to flag excessively scanned patients.”32NIA notifies doctors and opens discussions exploring alternative diagnostic procedures.

Laws
The American public can also be protected from and informed about CT scan risks by laws and government press statements. The Federal Drug Administration oversees The Radiation Control Health and Safety Act and Medical Devise Amendment. Combined these regulations establish equipment performance standards assuring “the safety and effectiveness” of the CT scanners.33 However, principles to mitigate patient radiation risks are absent. At the state level, the Illinois Radiation Act of 1990 constructs a platform acknowledging CT radiation as a threat to health stating the need for “effective” regulation of radiation sources for the protection of human health, welfare and safety. However, this document suffers from a large degree of ambiguity regarding the monetary funding for such a program “to promote an orderly regulatory pattern within the State.”34 In 2002 the Commonwealth of Pennsylvania released a press statement from the Office of the Governor affirming the harms of radiation exposure and emphasizing the need for “medically sound reason for… [all] radiation exposure.” 35 This statement lacks a policy plan to implement its recommendations. Current government action falls short of protecting patients.

A Solution to the Knowledge Gap
In a democratic society, any potential public policy solution must respect the individual human being, noting the circumstances and conditions of each personal case. The need for standardized state level regulation overseen by each state’s respective medical boards and Medical Practice Acts represents another obligatory policy consideration due to the entrenched tradition of medical laws implemented at the state level.36 Adhering to this philosophical and theoretical framework will build a foundation for patients to become active participants in their own healthcare.

A solution must ameliorate the lack of radiation risk awareness among doctors and patients. The policy should implement measures to prevent unchecked expansion of the technology and ensuing widespread population hazards. In addition it must further medicines’ understanding of radiation and its affects on the human body. Courtney’s Law37 fulfills these goals by providing the stimulus and strategy to facilitate and support doctor-patient discussions about the appropriate use of CT scans and alternative procedures.

Courtney’s law

1. Institute compulsory Continued Medical Education (CME) on the risks and benefits of CT scans for all practicing medical doctors.
a. A recommended 1-2 hours of CME per year for all medical practitioners and an additional 3 hours per year for all radiologists.
2. Create standardized consent forms detailing the individual patient’s CT scan information.
a. Written and oral consent will establish a doctorpatient relationship in order to discuss the risks and benefits of the CT scan, in addition to alternative evaluations.
b. Legally binding document including the signatures of both the medical doctor and patient, stating that both parties understand the potential risks and benefits of performing or not performing a CT scan.
c. Will strongly advise patients to keep track of their personal lifetime radiation.
3. Implement New CT Protocol
a. Requires CT machines to be calibrated to the size and weight of the child.38
b. Requires all patients to wear bismuth radiation protection gear.
4. Establish accountability via unannounced audits of medical facilities, which may result in fines and closure of facility by State Medical Board if facilities are not compliant with Courtney’s Law acts: 1, 2, or 3.
5. Fund research and development through the accountability fining process. Research will determine the relationships between CT quality and dose, and CT radiation and cancer risk.
6. Does not set limits to patient radiation exposure, which naturally varies on a case-bycase basis.39

We need a strategy to educate physicians, other health professionals, and patients about the risk-benefit ratio of improved diagnostic accuracy and increased lifetime risks of cancer associated with CT scans. Courtney’s Law provides a strategy that will increase doctor-patient awareness of CT scans. For the better health and safety of all, each state should implement this law. paJ

About Courtney Wilson
Courtney Wilson, William Smith Class of 2008 and resident of San Carlos, California, is a double major in Public Policy and Environmental Studies with minors in French and Economics. As an active member of the Hobart and William Smith community, she is a Big Sisters mentor and a member of both Habitat for Humanity and Campus Greens. Over the past two summers, she has conducted Environmental Economics summer research at the Colleges and served on the staff of the Environmental Studies Summer Youth Institute. In her free time she can be found road biking, hiking and kayaking.

Notes
(Endnotes)
¹ D. R. Martin and R.C. Semelka, “Health Effects of Ionizing Radiation from Diagnostic Ct.,” The Lancet.
² Adriane Fugh-Berman, “Carcinogenic Diagnosis,” The Hastings Center Report.
³ National Academy of Sciences, “BEIR VII: Health Risks from Exposure to Low Levels of Ionizing Radiation,” Washington, D,C,: The National Academies Press, 2006; Food and Drug Administration, “What are the Radiation Risks from CT?” accessed 30 November 2006, available from http://www.fda.gov/ cdrh/ct/risks. html.
⁴ Computed Tomography.
⁵ National Cancer Institute, “Radiation Risks and Pediatric Computed Tomography (CT): A guide for Health Care Providers,” accessed 24 November 2006, available from http://cancer.gov/canertopics/causes/radiation-risks-pediatric-CT.
⁶ Jay Klein, E-mail to author, 19 April 2007.
⁷ MayoClinic.com, “CT Scan,” accessed 24 November 2006, available from http:// mayoclinic.com/health/ct-scan/FL000065.
⁸ Janette Sherman, Personal interview, 11 December 2006.
⁹ D. R. Martin and R. C. Semelka, “Health Effects of Ionizing Radiation from Diagnostic Ct.,” The Lancet (2006).
¹⁰ A. K. Dixon and KE Goldstone, “Abdominal CT and the Euratom Directive,” European Radiology (2002).
¹¹ FA Mettler Jr, et al., “CT scanning: patterns of use and dose,” Journal of Radiology Protocol (2000).
¹² Jay Klein, E-mail to author, 19 April 2007.
¹³ American Cancer Society, “Estimated Cancer Deaths for Selected Cancer Sites by State, US, 2007,” accessed 3 May 2007, available from http://www.cancer.org/ docroot/ MED/content/downloads/MED_1_1x_CFF2007_Estimated_Deaths_ Sites_by_State.asp.
¹⁴ David J. Brenner et al., “Estimated Risks of Radiation Induced Fatal Cancer from Pediatric CT, American Journal of Roentgenology (2001).
¹⁵ RadiologyInfo: The Radiology Information Resource for Patients, “Pediatric CT (Computed Tomography),” accessed 30 November 2006, available from http:// www.radiologyinfo.org/en/info.cfm?pg=pedia-ct&bhcp=1.
¹⁶ A chest x-ray results in radiation ranges from 0.01 - 0.15 mSv depending on the view taken.
¹⁷ National Cancer Institute, “Radiation Risks and Pediatric Computed Tomography (CT),” accessed 24 November 2006.
¹⁸ Jay Klein, E-mail to author, 19 April 2007.
¹⁹ National Cancer Institute, “Radiation Risks and Pediatric Computed Tomography (CT),” accessed 24 November 2006.
²⁰ Ibid.
²¹Eugenio Picano, “Informed Consent And Communication of Risk From Radiological And Nuclear Medicine Examinations: How To Escape From A Communication Inferno,” British Medical Journal (2004).
²² C. I. Lee et al., “Diagnostic CT Scans: Assessment of Patient, Physician, and Radiologist Awareness of radiation Dose and Possible Risks,” Radiology, (2004).
²³ Ibid.
²⁴ Brenner et al., “Estimated Risks of Radiation Induced Fatal Cancer from Pediatric CT. American Journal of Roentgenology (2001).
²⁵ ibid.
²⁶ “Cathy,” E-mail to author, 17 April 2007.
²⁷ MASSCRR Mother, “June 2006: Mothers Against Silence About CT Radiation Risks (MASSACRR),” Medscape Radiology. Accessed 21 June 2006.
²⁸ “Cathy,” E-mail, 17 April 2007.
²⁹ Heather Tesoriero, “Worries Mount Over Excessive CAT Scans,” Wall Street Journal, 2 November 2006.
30 Ibid.
31 Adriane Fugh-Berman, E-mail to author, 2 January 2007.
32 Tesoriero. “Worries Mount Over Excessive CAT Scans,” Wall Street Journal, 2 November 2006.
33 Federal Drug Administration, “How Does the FDA Regulate CT Systems?” accessed 24 November 2006, available from http://www.fda.gov/cdrh/ct/regulatory. html.
34 Radiation Protection Act, accessed 29 November 2006 www.state.il.us/iema/ legal/ statutes/radprotect/radpro.htm.
35 “PA Health Officials Warn Against ‘Ct Screening’ Without Physician Recommendation,” Daily News Release from the Commonwealth of Pennsylvania, accessed 29 November 2006, available from http://www.ahs.dep.state.pa.us / newsreleases/default.asp?ID=1731.
36 California State Medical Board, “Continuing Medical Education. Frequently Asked Questions,” accessed 10 December 2006, available from http://www.mbc. ca.gov/ laws.htm.
37 Fictional law designed by author.
38 National Cancer Institute, “Radiation Risks and Pediatric Computed Tomography (CT),” accessed 24 November 2006.
39 Eugenio Picano, “Informed Consent And Communication of Risk,” British Medical Journal (2004).

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