L
Separate Statement Robert S. Adler

Having listened to my fellow committee members' views and having carefully reviewed the drafts of the report as they have been circulated, I find myself reluctantly compelled to voice disagreement with several of the report's findings and recommendations. My disagreement stems from my belief that several of the committee's recommendations lack supporting evidence and constitute unwise public policy.

THE COMMITTEE'S CHARGE

As noted in the Preface to the committee report, several events prompted the Nuclear Regulatory Commission (NRC) to ask the Institute of Medicine (IOM) for an independent review and evaluation of the NRC's Medical Use Program. These events included a fatal radiation incident in Indiana, Pennsylvania, and a series of newspaper articles in the Cleveland Plain Dealer on the hazards of radiation medicine. In addition, during discussions between the NRC and the IOM, Senator John Glenn held a highly critical hearing on the NRC's regulation of nuclear medicine. These events combined to create doubts about the vigor and effectiveness of the NRC's Medical Use Program.

I think it important to keep the original concerns behind this study in mind when reviewing the committee's findings and recommendations. Among other things, we were asked to determine whether the NRC adequately protected public health with respect to medical radiation. In my judgment, our findings, which are critical of the NRC's efforts, fail to address this question directly. Nowhere do we state clearly and unequivocally, as we should, that the NRC does adequately protect the public's health. We owe the NRC and its critics a clear response



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Radiation in Medicine: A Need for Regulatory Reform L Separate Statement Robert S. Adler Having listened to my fellow committee members' views and having carefully reviewed the drafts of the report as they have been circulated, I find myself reluctantly compelled to voice disagreement with several of the report's findings and recommendations. My disagreement stems from my belief that several of the committee's recommendations lack supporting evidence and constitute unwise public policy. THE COMMITTEE'S CHARGE As noted in the Preface to the committee report, several events prompted the Nuclear Regulatory Commission (NRC) to ask the Institute of Medicine (IOM) for an independent review and evaluation of the NRC's Medical Use Program. These events included a fatal radiation incident in Indiana, Pennsylvania, and a series of newspaper articles in the Cleveland Plain Dealer on the hazards of radiation medicine. In addition, during discussions between the NRC and the IOM, Senator John Glenn held a highly critical hearing on the NRC's regulation of nuclear medicine. These events combined to create doubts about the vigor and effectiveness of the NRC's Medical Use Program. I think it important to keep the original concerns behind this study in mind when reviewing the committee's findings and recommendations. Among other things, we were asked to determine whether the NRC adequately protected public health with respect to medical radiation. In my judgment, our findings, which are critical of the NRC's efforts, fail to address this question directly. Nowhere do we state clearly and unequivocally, as we should, that the NRC does adequately protect the public's health. We owe the NRC and its critics a clear response

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Radiation in Medicine: A Need for Regulatory Reform indicating that with respect to the specific incidents that prompted the establishment of our committee, we found no deficiencies in NRC rules or procedures that led to these regrettable occurrences. Practitioner error and aberrational circumstances caused the problems. Short of the draconian step of stationing NRC inspectors in the facilities involved, however, there really was no way that the NRC could have prevented them from happening or could have resolved them more effectively once they occurred. As far as I can tell, I do not make this point in dissent. There seemed to be complete unanimity among committee members that the accusations of incompetence and timidity directed against the NRC are unfair and misplaced. To the contrary, my colleagues have concluded the exact opposite of these accusations. They insist that the NRC, if anything, is too aggressive and too intrusive in dealing with nuclear medicine. Not only do I disagree with this conclusion, I feel it important to emphasize how difficult it is for a regulatory agency like the NRC to calibrate its regulatory initiatives when it is simultaneously damned for doing too much and for doing too little.1 RISKS OF IONIZING RADIATION IN MEDICINE Ionizing radiation carries both risks and benefits. I have little doubt that ionizing radiation both in its diagnostic and therapeutic uses carries great benefits. Although I believe that the report describes the benefits associated with ionizing radiation, I remain concerned that the report does not detail the potential risks of radiation medicine as thoroughly as it might. I grant that we do not know with certainty the extent, if any, to which radiation medicine causes harm. However, I believe it critical not to dismiss the potential harm that inappropriate use or misuse of this technology presents. Not every concerned voice that is raised about radiation belongs to a cancerphobe, a Luddite, or an ideologue. Given the devastation that cancer causes in the United States—striking roughly 1 million persons and killing roughly 500,000 annually—it is critical that great care be taken with anything, such as radiation, that could potentially cause cancer. It may be that we overdo the regulation of medical radiation compared to other risks, but there are real concerns that need to be addressed.2 Moreover, the solution to 1   A number of committee members work in settings regulated by the NRC. They have shared their frustrations about the NRC with me and I have found a number of their comments helpful. As one of the few members who has worked for a regulatory agency, I have tried with equal concern to explain why agencies like the NRC act as they do. In particular, I have pointed out that agencies must enforce rules uniformly, that is, they must ask for the same compliance behavior from responsible actors as they do from irresponsible actors lest they be accused of ''selective and unequal" enforcement. To say the least, this can be annoying to those who feel hassled for what they consider minor infractions when they believe that they are operating in a safe and effective manner. 2   One might ask, "Where are the bodies?" associated with misuse of medical radiation. The response is that there are lots of bodies afflicted with cancer. Unfortunately, we lack the scientific means to discover which, if any, of them result from the misuse of medical radiation.

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Radiation in Medicine: A Need for Regulatory Reform overregulation need not be the repeal of a substantial portion of federal authority with respect to the medical uses of ionizing radiation. Rather, a measured approach that mixes adequate regulatory authority with a more moderate enforcement philosophy strikes me as preferable to the one advanced in our report. COMPARING MISADMINISTRATION RATES AMONG MEDICAL MODALITIES Our report includes a lengthy discussion of misadministration rates and comparison of those in nuclear medicine to other medical modalities. Although I am open to the possibility that misadministration rates in nuclear medicine are lower than in other areas of medicine, I find the attempts to quantify the relative rates among medical modalities not to be helpful.3 Although our report acknowledges that in "statistical, clinical, and epidemiological terms, comparisons of the risks inherent in very different health care interventions can be problematic," it fails to emphasize the dramatically different methodologies used to collect data related to medical mistakes.4 One simply cannot draw meaningful quantitative conclusions from data drawn from such disparate sources.5 Moreover, in making the case that misadministration rates in radiation medicine are lower than in other areas of medicine, the report recognizes that one of the essential reasons for these rates has been the existence of NRC regulations. Yet, it then declares that the NRC's medical use regulations can be repealed without significant consequence because the standard of safety can now be maintained through nonregulatory mechanisms such as "improving technology, professional guidelines, training requirements, and institutional quality assurance programs." I remain skeptical. These nonregulatory mechanisms operate 3   I realize that we were asked specifically by the NRC to assess the "error rates and consequences of the use of byproduct materials in comparison to other medical interventions." One reasonable response to this request that could, and should, have been given is that these data do not permit useful quantitative comparisons. 4   The data regarding different modalities are derived from a mix of voluntary and mandatory systems. Some involve self-reporting, others involve reviews of medical records, and others involve direct observations. One can readily see how these different approaches would confound meaningful quantitative comparisons. 5   For example, the NRC data come primarily, if not exclusively, from reporting under its misadministration rule. This is a recent rule, which is unpopular among licensees and which is likely not widely complied with. On this point, our report states that even "if it is assumed that the numbers are underreported by a factor of 10 … this level of 'misadministration' is remarkably low." Based on my experience with underreporting at another agency, the Consumer Product Safety Commission, I think it quite conceivable that the rate of underreporting could be much greater than a factor of 10.

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Radiation in Medicine: A Need for Regulatory Reform in other branches of medicine—such as anesthesia or blood transfusions—yet none of them produce the same low error rates claimed for radiation medicine, the one highly regulated branch. FINDINGS AND CONCLUSIONS I disagree with several findings and conclusions: The Level of Regulation Compared to the Level of Risk of Reactor-Generated Byproduct Material Perhaps the key finding of the report is that the level of federal regulation of reactor-generated byproduct material is not commensurate with the risks associated with its medical and biomedical research uses. In making this case, my colleagues make several valid points. First, ionizing radiation is not regulated uniformly—the NRC addresses only reactor-generated byproduct material, not naturally occurring and accelerator-produced radioactive materials (so-called NARM) or machine-produced ionizing radiation, such as x-rays.6 Second, byproduct materials are regulated in a more stringent fashion than are other forms of ionizing radiation. As noted elsewhere in this report, the NRC's primary focus is nuclear power in large reactors, and its enforcement approach with respect to nuclear medicine evidently borrows heavily from its comprehensive approach to regulating reactors. Based on these findings and others, my colleagues urge a consistent approach to the regulation of ionizing radiation. I agree. Unfortunately, the "consistency" my colleagues endorse would end all federal regulation of the medical uses of ionizing radiation. On this, I disagree. I find the case for abandoning all federal regulation of the medical uses of ionizing radiation unpersuasive. As I discuss below, reform, not abolition, makes more sense. NRC as an Overly Stringent Regulator Based on numerous discussions with my fellow committee members and on my site visits to regulated facilities, I accept the concern that NRC enforcement of its regulations seems inappropriately rigid with respect to the practice of nuclear medicine. Although medicine, like other professions, clearly requires guidelines and standards, it also demands a substantial degree of judgment and flexibility if it is to deal effectively with a variety of circumstances. Unfortunately, given its primary mission of regulating large reactors and given the public's insistence on stringent regulation of these reactors, the NRC may not be well suited for the job. Does this suggest, however, that all federal regulation of the medical uses of ionizing radiation should end? I think not. What is needed is 6   To the extent that these other forms of ionizing radiation are regulated, it is through state regulation.

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Radiation in Medicine: A Need for Regulatory Reform a more flexible regulatory approach such as that of the Food and Drug Administration (FDA).7 In making this point, I take strong issue with the portions of our report that refer to the NRC's overall regulatory approach as "burdensome, costly, and unduly prescriptive." Describing the NRC's approach in such an accusatory manner implies that the agency somehow has abused or mistreated those whom it regulates. To say the least, I have seen no such evidence nor do I believe that any exists. Demonizing an agency for adopting a regulatory approach that to many is quite reasonable serves no useful purpose. One needs to remember that the NRC has been accused of timidity as often, if not more so, as it has been charged with excessive zeal. Propriety of the NRC's Quality Management and Misadministration Reporting Rules The report takes sharp issue with two rules issued simultaneously in 1992 by the NRC. The first is the so-called quality management rule (10 CFR 35.32) and the second is the so-called misadministration reporting rule (10 CFR 35.33). To the committee's majority, these rules intrude excessively into the patient-physician relationship and represent a barrier to reasonable interaction between the NRC and its regulated community. Although I recognize the sincerity and intensity of my colleagues' views, I find neither rule substantively objectionable. First, the objections voiced by my colleagues essentially revisit points extensively debated within the NRC when it promulgated the two rules. As far as I can tell, the agency responded to the concerns raised in a reasonable and sensitive manner. In particular, it stressed that the rules did not mean that the agency approached misadministration issues in an absolutist or intrusive manner.8 To the contrary, the NRC indicated that it had adopted an approach to "minimizing the occurrence of misadministrations"9 and noted that the agency "realizes that it is impossible to prevent all mistakes. …"10 Second, despite my colleagues' objections to rules that affect the physician-patient relationship, I note that the NRC's Medical Policy Statement has never barred the agency from regulating the practice of medicine. Instead, it declares that the agency "will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of 7   To say the least, numerous observers of the FDA would vigorously disagree with my assessment of the agency. Although the FDA, like other agencies, occasionally acts with excessive enthusiasm, I consider it to be highly sophisticated about the practice of medicine and to be generally flexible in dealing with medical practitioners. 8   The NRC indicated that it promulgated the rules reluctantly in response to a doubling in the rate of reported misadministrations in the previous year. See 56 Fed. Reg. 34104 (July 25, 1991) at pp. 34109-10. 9   Ibid. at p. 34110. 10   Ibid.

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Radiation in Medicine: A Need for Regulatory Reform medicine."11 Clearly, the agency contemplated that some intrusion might be necessary from time to time to protect patients. Third, with respect to the agency's quality management rule, I find little objectionable in its provisions. In essence, it simply directs licensees of the NRC to develop and maintain written quality management programs. Rather than tell any institution the precise program it must adopt, the rule, in one page, outlines a small number of general guidelines and asks licensees to submit copies of their written programs to the agency. I find it hard to imagine anyone objecting to the substantive guidelines set forth in the rule. They represent modest and minimal quality assurance approaches that any responsible licensee would undertake as far as I can tell. I stress this point because I remain convinced that what disturbs licensees is the way that the NRC has enforced the rule, not the rule per se. According to my colleagues, the agency has nitpicked the documents submitted by licensees in response to the quality management rule. That may or may not be, but the solution to this concern is to improve the NRC's review process, not to abolish the rule. Fourth, with respect to the misadministration reporting rule, with one exception, I strongly disagree with my colleagues' objections to this rule. The NRC rule requires licensees to notify the agency when misadministrations occur and to explain how they occurred and what actions the licensee has taken to prevent recurrence. This rule is similar to rules at numerous agencies like the FDA, the Consumer Product Safety Commission, the Environmental Protection Agency, the National Highway Traffic Safety Administration, and others that require individuals and companies to share safety problems with bodies entrusted with the public's health. With all due respect, I find the rule to be a reasonable, minimal intrusion into the practice of medicine. It is triggered only when a mistake has occurred and asks only that an explanation of the event be proffered. It is true that the rule requires reports of events that arguably present little meaningful risk to patients. This, in my view, is commendable and as it should be. As I have argued to my colleagues—obviously in a quite unsuccessful manner—health and safety agencies need to require reporting of marginal safety concerns to ensure that no events of consequence are missed. The one valid point raised by the majority relates to notifying patients of misadministrations. Although it is a very close call, I agree that a rule that automatically requires notification of patients12 probably produces more harm than benefit, especially with respect to trivial misadministrations. Given that a physician cannot generally undo a misadministration, it probably causes excessive anxiety in patients to be told that a minor misadministration occurred. Instead of 11   This statement is reaffirmed in the agency's Federal Register notice promulgating the two rules. Ibid. at p. 34109. 12   The only exception to the rule arises when, based on the physician's medical judgment, telling the patient would be harmful. See 10 CFR 35.33(a)(3).

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Radiation in Medicine: A Need for Regulatory Reform this rule, I would be comfortable with a requirement that the physician or licensee indicate in its report to the NRC whether or not the patient was notified and explain the reasons for doing so or not doing so. The NRC should retain the authority to require patient notification in particularly serious misadministrations but should not insist on it in routine circumstances. One hopes that such a modification would stimulate a greater willingness among licensees to report misadministrations. Finally, having found little substantive objection to the rules, as previously noted, I reach a different conclusion with respect to the NRC's enforcement of the rules. Again, I accept my colleagues' observation that the NRC's general enforcement philosophy, derived from regulating large reactors, may operate with excessive rigidity and formalism when it comes to the practice of medicine. I repeat my general support for transferring the medical use program to an agency like the FDA that is more experienced in dealing with the medical profession. I, however, disagree that the solution is simply to repeal all federal regulatory authority in this area. RECOMMENDATIONS The report's recommendations call for the abolition of the NRC's Medical Use Program. Instead of federal regulation, the report urges the establishment of a federal agency that would work with and coordinate efforts among the states and professional societies with respect to radiation safety. Among other things, such an agency would assist states in developing safety programs; investigate radiation accidents and issue reports about them; and help educate the public about the risks of radiation. As the committee put it, the agency would act as a "bully pulpit."13 I find aspects of this proposal appealing and sensible. I favor voluntary action when possible, I strongly support education efforts, and I endorse collaborative approaches between government and those whom it regulates. I even agree that it might make sense to transfer the NRC's authority to another agency. I part company, however, with respect to two aspects of the proposal. Abolition of All Federal Regulatory Authority I strongly disagree that the case has been made to repeal federal authority over the medical uses of ionizing radiation. Ionizing radiation, in my view, presents serious risks to the public health if not properly regulated. Without dwelling on the point, I am quite uncomfortable relying on state authorities and professional 13   One new twist to the majority's proposal calls for the NRC to continue its regulatory authority to the extent that it would prohibit reactor-generated byproduct material from being shipped to any state that failed to establish a regulatory program over such material. This approach does not solve the problems that I see with the report. See footnote 15.

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Radiation in Medicine: A Need for Regulatory Reform societies to safeguard the public health with respect to a technically challenging and potentially hazardous arena such as nuclear medicine. It is commendable for all concerned parties to work cooperatively if at all possible. However, one must take careful note of the following point: under the majority's approach, if and when the federal "bully pulpit" agency is confronted by the failure of a state regulatory system or state licensing authorities to address a crisis involving the medical use of ionizing radiation, the federal agency will be without any power to act to protect the public. So objectionable is federal authority to the committee members that they specifically eschew even a minuscule dollop of residual federal regulatory authority. 14 I find this unacceptable.15 Regrettably, my experience with state authorities and professional medical societies does not leave me sanguine about their ability to deal with radiation hazards in a completely acceptable fashion. Not only do state authorities often have limited resources and expertise, they sometimes find it more difficult than would federal authorities to resist political pressure from those they regulate. The likely result of abandoning a federal regulatory presence is not a flowering of harmonious, effective relations among states, physicians, and hospitals. Rather, we are likely to see a patchwork quilt of approaches—some states will do an outstanding job of regulating, some will do an abysmal job, and others will likely approach regulation with a heavy hand that makes the NRC look benign by comparison. The essential difficulty with repealing NRC authority, in my judgment, is that at some point in the not-too-distant future, we will encounter a serious safety concern that is unaddressed, or incompetently addressed, that will result in unnecessary 14   This is made clear in the committee's Recommendation B2, which calls for the repeal of the NRC's Medical Use Program in its entirety even if Congress fails to establish a "bully pulpit" federal presence. Despite language in committee Recommendation A1 stating that elimination of the NRC's Medical Use Program should take place only upon the creation of the federal "bully pulpit" program, Recommendation B2 demonstrates that the committee clearly intends the abolition of the Medical Use Program come what may. 15   Again, I note the addition of language in the final version of the report indicating that the NRC might retain the authority to deny licenses to facilities in states that fail to establish programs to regulate reactor-generated byproduct materials. I see several problems with this approach. First, the proposal establishes no criteria for the NRC to apply in order to determine whether a state's regulatory program meets minimal safety needs. Without such criteria, states would be free to establish wholly inadequate regulatory schemes. Second, to the extent that the proposal might be amended to add criteria for NRC approval of state programs, this alternative would become, in effect, a watered-down "Agreement State" approach, requiring NRC monitoring of state regulatory programs—a far cry from the committee's stated goal of removing federal regulation of medical uses of ionizing radiation. Third, the proposal fails to indicate whether states would be obligated to upgrade their regulatory programs as technology changes or as new levels of risk are determined. Finally, the proposal provides no details regarding implementation. Whether or how the NRC would have such authority if all of the agency's Medical Use Program were abolished is unexplained.

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Radiation in Medicine: A Need for Regulatory Reform deaths or illnesses. Should that occur, and I have little doubt that it will, the result might well be the reimposition of a federal regulatory system, but one that is more draconian and less effective than the one in place today. Second, although I salute the conclusion in this report that the medical uses of ionizing radiation should be treated in uniform fashion, I object to the uniformity envisioned in the report, to wit, a repeal of all federal authority over its medical uses. Instead, I favor a reexamination of ionizing radiation risks as a whole and an appropriate restructuring of regulatory approaches. It may be that the regulation of reactor-generated byproducts can be minimized in a way that substantially reduces costs (and annoyance) without significantly increasing risks. If so, I favor such an approach. It may also be—and I strongly suspect it to be so—that we would find that other medical uses of ionizing radiation have been inadequately addressed under state regulation. I particularly worry about the widespread use of x-rays by medical technicians and marginal "medical" professionals such as chiropractors who may have little insight into the risks associated with these products. Let's consolidate the control of ionizing radiation but not simply end it. CONCLUSION I believe that the IOM report raises many important issues. As a number of my colleagues have noted, no one in the group agrees totally with all of the report's recommendations. In this spirit, I have tried to see the merits of the majority—and, indeed, there is merit in some of its views. In the end, however, I find that the case for abolishing federal regulatory authority over the medical use of ionizing radiation has not been made.