Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Unregulated Direct-to-Consumer Marketing and Self-referral for Screening Imaging Services: A Call to Action

Unregulated Direct-to-Consumer Marketing and Self-referral for Screening Imaging Services: A Call... Advertising may be described as the science of arresting human intelligence long enough to get money from it. Stephen Leacock (1869-1944), humorist and political economist In this issue of Archives, Illes et al1 present a descriptive study of the content of a sample of direct-to-consumer (DTC) marketing publications, and the findings are disturbing. Their study of 40 newspaper advertisements and 20 brochures from a variety of national and regional sources found that the DTC marketing for the industry of screening computed tomography (CT) and magnetic resonance imaging (MRI) frequently contains misinformation, unsubstantiated scientific claims, and fear-provoking threats and that it lacks information on uncertainties and risks associated with such imaging. In fairness, the small sample of advertisements and brochures should not be assumed to be representative of all screening CT and MRI centers. Similar analyses from impartial scientific panels comparing advertisements with published clinical practice guidelines would be preferable to the ratings of 2 reviewers who may have been privy to the a priori hypotheses and therefore biased. These analyses should also measure the direct impact of the advertisements on consumer knowledge and behavior. However, until such data are available, the study presented by Illes et al “rings true,” and most health care providers have likely encountered similar advertisements in their localities. We propose a call to action by the medical community to halt DTC marketing and self-referral for screening imaging and advocate for regulatory control comparable to what is in place for pharmaceutical advertising. The only basis upon which DTC marketing and self-referral would be justified is if they actually expanded the use of effective but underused medical interventions. Despite the lack of such evidence, DTC and self-referral for screening imaging have become widely accepted practices: How could this have happened? In this age of shared decision making, DTC advertising is appealing in theory. It allows the persuasive power of “Madison Avenue” to educate the public in ways the medical community cannot, and better educated patients would play a more vital role in their own health care. However, in the arena of screening imaging, this places the cart before the horse, as the ethical principle of beneficence (ie, primum non nocere) should override the ethic of patient autonomy. Before implementing a health communication strategy, it seems rational to prove that what it promotes is effective, safe, worthwhile, and meets the standard of medical professional ethics. Whether imaging serves as an adjunct in carefully selected patients deserves further study; but how effective is screening imaging and how does the general public feel about it? Although there is substantial evidence that imaging detects some subclinical diseases, most imaging devices are, as yet, insufficiently studied to ascertain their overall effectiveness in improving clinical outcomes. Among health care providers, an attractive rationale for screening imaging is that, by providing evidence of subclinical disease, it may motivate patients to implement healthy behaviors—despite little supportive evidence from prospective clinical trials that this is the case.2 As for patients, they find the idea of screening imaging extremely appealing despite a lack of evidence for its effectiveness. In a national telephone survey on public enthusiasm for cancer screening, including total body imaging, 86% of 500 adults responded that they wished to have free screening imaging, if offered; and 85% preferred screening imaging to receiving $1000 in cash.3 Since insurance does not currently pay for such procedures, they are being marketed to relatively healthy, asymptomatic individuals who have the financial resources to afford the direct costs of the tests. What are the risks of screening tests? This is an area that also needs better study, but some justifiable concerns are disease labeling, false-positive test results, incidental scan findings, psychological effects (including worry and anxiety), radiation exposure, wasteful costs, and lower likelihood of insurability. Although our randomized study of coronary CT imaging did not show increased psychological morbidity,2 one systematic review of the effects of screening tests on mental health indicates that it is likely to have some adverse effects.4 In another study, the cost-effectiveness analysis of coronary CT screening was highly sensitive to the disutility (defined as the decrement in the quality of life of patients who have been diagnosed “at risk”) of a finding of subclinical atherosclerosis.5 Thus, screening imaging may cause net harm if the diagnosing of pseudodiseases or subclinical diseases decreases quality of life. Economic implications are another “risk” to the health care system, as neither CT nor MRI screening have been shown to be cost-effective. Most important to health care payers, most of the costs associated with screening imaging might eventually be incurred, directly and indirectly, by health systems and employers, with the imaging industry promulgating the need for screening reaping the profits. The most disturbing aspect of DTC marketing of diagnostic devices is that it frequently preys on the vulnerabilities of our patients. Illes et al1 found that 45% of the advertisements contained “negatively valent statements,” ie, negative, emotion-evoking statements about one’s health that create an incentive-by-guilt to obtain the advertised test. This is clearly unethical. The medical community wants to inculcate a healthy concern about preventing disease; the stratagem of invoking fear of disease, however, can lead to irrational decisions, especially when presented outside of the relationship with a caring regular health care provider. If screening technology gets advertised on a self-referral basis, thereby bypassing the provider-patient relationship, the benefits of rational, informed, shared decision making cannot be realized, and unreasonable, medically unnecessary testing will likely result. As noted by Illes et al, most self-referral programs for screening imaging do not truly seek informed consent since screening is not a Food and Drug Administration (FDA)–approved use of imaging devices.6 Given the concerns, uncertainties, and lack of evidence, how has DTC marketing of imaging become so widely practiced? Clearly, this marketing is driven by the need of medical entrepreneurs to recoup the large investment costs of CT and MRI scanners. At the same time, there is no effective regulation to hold the industry accountable for proof of efficacy and responsibility in advertising. There is a constant tension between the potential of exciting new devices and the need for clinical evidence to prove their true value. Once approved, “the cat is out of the bag.” Rapid deployment of new devices through aggressive marketing (often for indications not approved by the FDA) may promote a false sense of efficacy, thereby further encouraging their use and leading to inappropriate expectations in “standard of care.” In the United States, although by law all medical devices must be assessed for safety and effectiveness, the burden of device applications to the FDA (roughly 4000 per year) has led to a more rapid approval process using the claim of “substantial equivalence.” The challenges to keep the product-to-market time short have influenced the FDA to rely on postmarketing surveillance and evaluation to determine the balance of risks and benefits.7 However, this process is not sensitive to all adverse events. When accumulated over large, healthy populations, even a very small decrement in quality of life for brief periods can have a substantial net negative effect. Such “minor effects” on individual patient-centered outcomes are typically not incorporated into diagnostic device assessment and are therefore underestimated. The reliance on postmarketing data to determine the bare minimum of safety and effectiveness leaves the clinician with inadequate information about the value of a given screening test. Health care providers should take guidance from credible resources such as the US Preventive Services Task Force and from scientific statements from medical societies that have a credible history of critical appraisal of medical interventions and diagnostic devices. All of these recommend against screening imaging. However, with self-referral, physicians are faced with interpreting results after the test has been done without their knowledge. Although most imaging centers are now associated with postscan counseling by an ancillary health care provider (usually a nurse educator), the screened individuals receive information outside of an established relationship with a regular provider. Therefore, they often lack the context of a valid baseline risk and do not benefit from a legitimate concern for their overall health. Regular providers who have not ordered or discussed the test with the patient before it was done, and who have no clear evidence that the test results are relevant to the patient’s well-being, are expected to provide management and education on the basis of these results. This situation can breed anxiety, mistrust, even anger between patients and their physicians. The medical community is partly to blame for encouraging the current state. Ironically, our response to control health care costs and medical error focuses on areas that are largely immutable in the current US health care system; and yet, we allow the problem of DTC marketing and self-referral to continue when it can so easily be regulated through simple measures. Although the regulating agency’s resources would need to increase, this would be a cost-saving investment from a societal perspective. Greater efforts are also needed in acculturating physicians-in-training about the critical appraisal of scientific evidence so that they are not vulnerable to misinformation. Individual physicians and medical societies should vigorously resist inappropriate advertisements and look beyond the remunerative aspects of their enterprise or the evangelical passion of their beliefs. However, the ability of the medical community and the screening imaging industry to police themselves is likely to be limited. This is where regulation can help, first by limiting the availability of imaging devices to those who pass a threshold of clinical efficacy. The current model of new device approval by the FDA is broken; as a result, a wave of new diagnostic tools of uncertain value has flooded the medical community, with little to no incentive to assess their true value. Inappropriate DTC marketing continues despite FDA guidance that clearly states that imaging companies cannot make any claims of efficacy in improving health outcomes. This guidance is insufficient, however, without enforcement. An oversight system comparable to FDA regulation of pharmaceutical advertising is sorely needed. The findings of Illes et al1 are alarming, and they should bring all parties involved in the promotion of health to reconsider the current use of DTC advertising for CT scan and MRI services. It is time for all state medical boards, medical societies, and relevant governmental health agencies to play a more active role in overseeing responsible advertising of health information—which should be based on sound evidence and with the public’s interest as the first and foremost priority. Passive inaction in this area will seriously affect our professional credibility, if it has not already. Correspondence: Dr O’Malley, Division of General Internal Medicine, Walter Reed Army Medical Center, 6900 Georgia Ave, Washington, DC 20307-5001 (patrick.omalley@amedd.army.mil). Disclaimer: The views expressed herein are those of the authors only and are not to be construed as those of the Department of the Army or Department of Defense. References 1. Illes JKann DKaretsky K et al. Advertising, patient decision making, and self-referral for computed tomographic and magnetic resonance imaging. Arch Intern Med 2004;1642415- 2419Google ScholarCrossref 2. O’Malley PGFeuerstein IMTaylor AJ The impact of electron beam tomography, with or without case management, on motivation to change, behaviors, and the cardiovascular risk profile: a randomized controlled trial. JAMA 2003;2892215- 2223PubMedGoogle ScholarCrossref 3. Schwartz LMWoloshin SFowler FJ JrWelch HG Enthusiasm for cancer screening in the United States. JAMA 2004;29171- 78PubMedGoogle ScholarCrossref 4. Shaw CAbrams KMarteau TM The psychological impact of predicting individuals’ risk of illness: a systematic review. Soc Sci Med 1999;491571- 1598PubMedGoogle ScholarCrossref 5. Smith JJBerlin L Informed consent when using medical devices for indications not approved by the Food and Drug Administration. AJR Am J Roentgenol 1999;173879- 882PubMedGoogle ScholarCrossref 6. O’Malley PGGreenberg BATaylor AJ Cost effectiveness of using electron beam computed tomography to identify patients at risk for clinical coronary artery disease. Am Heart J 2004;148106- 113PubMedGoogle ScholarCrossref 7. Postmarket surveillance: final rule 67 Federal Register. 38878 2002; http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Unregulated Direct-to-Consumer Marketing and Self-referral for Screening Imaging Services: A Call to Action

Loading next page...
 
/lp/american-medical-association/unregulated-direct-to-consumer-marketing-and-self-referral-for-X6k7fYzfWP

References (10)

Publisher
American Medical Association
Copyright
Copyright © 2004 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinte.164.22.2406
Publisher site
See Article on Publisher Site

Abstract

Advertising may be described as the science of arresting human intelligence long enough to get money from it. Stephen Leacock (1869-1944), humorist and political economist In this issue of Archives, Illes et al1 present a descriptive study of the content of a sample of direct-to-consumer (DTC) marketing publications, and the findings are disturbing. Their study of 40 newspaper advertisements and 20 brochures from a variety of national and regional sources found that the DTC marketing for the industry of screening computed tomography (CT) and magnetic resonance imaging (MRI) frequently contains misinformation, unsubstantiated scientific claims, and fear-provoking threats and that it lacks information on uncertainties and risks associated with such imaging. In fairness, the small sample of advertisements and brochures should not be assumed to be representative of all screening CT and MRI centers. Similar analyses from impartial scientific panels comparing advertisements with published clinical practice guidelines would be preferable to the ratings of 2 reviewers who may have been privy to the a priori hypotheses and therefore biased. These analyses should also measure the direct impact of the advertisements on consumer knowledge and behavior. However, until such data are available, the study presented by Illes et al “rings true,” and most health care providers have likely encountered similar advertisements in their localities. We propose a call to action by the medical community to halt DTC marketing and self-referral for screening imaging and advocate for regulatory control comparable to what is in place for pharmaceutical advertising. The only basis upon which DTC marketing and self-referral would be justified is if they actually expanded the use of effective but underused medical interventions. Despite the lack of such evidence, DTC and self-referral for screening imaging have become widely accepted practices: How could this have happened? In this age of shared decision making, DTC advertising is appealing in theory. It allows the persuasive power of “Madison Avenue” to educate the public in ways the medical community cannot, and better educated patients would play a more vital role in their own health care. However, in the arena of screening imaging, this places the cart before the horse, as the ethical principle of beneficence (ie, primum non nocere) should override the ethic of patient autonomy. Before implementing a health communication strategy, it seems rational to prove that what it promotes is effective, safe, worthwhile, and meets the standard of medical professional ethics. Whether imaging serves as an adjunct in carefully selected patients deserves further study; but how effective is screening imaging and how does the general public feel about it? Although there is substantial evidence that imaging detects some subclinical diseases, most imaging devices are, as yet, insufficiently studied to ascertain their overall effectiveness in improving clinical outcomes. Among health care providers, an attractive rationale for screening imaging is that, by providing evidence of subclinical disease, it may motivate patients to implement healthy behaviors—despite little supportive evidence from prospective clinical trials that this is the case.2 As for patients, they find the idea of screening imaging extremely appealing despite a lack of evidence for its effectiveness. In a national telephone survey on public enthusiasm for cancer screening, including total body imaging, 86% of 500 adults responded that they wished to have free screening imaging, if offered; and 85% preferred screening imaging to receiving $1000 in cash.3 Since insurance does not currently pay for such procedures, they are being marketed to relatively healthy, asymptomatic individuals who have the financial resources to afford the direct costs of the tests. What are the risks of screening tests? This is an area that also needs better study, but some justifiable concerns are disease labeling, false-positive test results, incidental scan findings, psychological effects (including worry and anxiety), radiation exposure, wasteful costs, and lower likelihood of insurability. Although our randomized study of coronary CT imaging did not show increased psychological morbidity,2 one systematic review of the effects of screening tests on mental health indicates that it is likely to have some adverse effects.4 In another study, the cost-effectiveness analysis of coronary CT screening was highly sensitive to the disutility (defined as the decrement in the quality of life of patients who have been diagnosed “at risk”) of a finding of subclinical atherosclerosis.5 Thus, screening imaging may cause net harm if the diagnosing of pseudodiseases or subclinical diseases decreases quality of life. Economic implications are another “risk” to the health care system, as neither CT nor MRI screening have been shown to be cost-effective. Most important to health care payers, most of the costs associated with screening imaging might eventually be incurred, directly and indirectly, by health systems and employers, with the imaging industry promulgating the need for screening reaping the profits. The most disturbing aspect of DTC marketing of diagnostic devices is that it frequently preys on the vulnerabilities of our patients. Illes et al1 found that 45% of the advertisements contained “negatively valent statements,” ie, negative, emotion-evoking statements about one’s health that create an incentive-by-guilt to obtain the advertised test. This is clearly unethical. The medical community wants to inculcate a healthy concern about preventing disease; the stratagem of invoking fear of disease, however, can lead to irrational decisions, especially when presented outside of the relationship with a caring regular health care provider. If screening technology gets advertised on a self-referral basis, thereby bypassing the provider-patient relationship, the benefits of rational, informed, shared decision making cannot be realized, and unreasonable, medically unnecessary testing will likely result. As noted by Illes et al, most self-referral programs for screening imaging do not truly seek informed consent since screening is not a Food and Drug Administration (FDA)–approved use of imaging devices.6 Given the concerns, uncertainties, and lack of evidence, how has DTC marketing of imaging become so widely practiced? Clearly, this marketing is driven by the need of medical entrepreneurs to recoup the large investment costs of CT and MRI scanners. At the same time, there is no effective regulation to hold the industry accountable for proof of efficacy and responsibility in advertising. There is a constant tension between the potential of exciting new devices and the need for clinical evidence to prove their true value. Once approved, “the cat is out of the bag.” Rapid deployment of new devices through aggressive marketing (often for indications not approved by the FDA) may promote a false sense of efficacy, thereby further encouraging their use and leading to inappropriate expectations in “standard of care.” In the United States, although by law all medical devices must be assessed for safety and effectiveness, the burden of device applications to the FDA (roughly 4000 per year) has led to a more rapid approval process using the claim of “substantial equivalence.” The challenges to keep the product-to-market time short have influenced the FDA to rely on postmarketing surveillance and evaluation to determine the balance of risks and benefits.7 However, this process is not sensitive to all adverse events. When accumulated over large, healthy populations, even a very small decrement in quality of life for brief periods can have a substantial net negative effect. Such “minor effects” on individual patient-centered outcomes are typically not incorporated into diagnostic device assessment and are therefore underestimated. The reliance on postmarketing data to determine the bare minimum of safety and effectiveness leaves the clinician with inadequate information about the value of a given screening test. Health care providers should take guidance from credible resources such as the US Preventive Services Task Force and from scientific statements from medical societies that have a credible history of critical appraisal of medical interventions and diagnostic devices. All of these recommend against screening imaging. However, with self-referral, physicians are faced with interpreting results after the test has been done without their knowledge. Although most imaging centers are now associated with postscan counseling by an ancillary health care provider (usually a nurse educator), the screened individuals receive information outside of an established relationship with a regular provider. Therefore, they often lack the context of a valid baseline risk and do not benefit from a legitimate concern for their overall health. Regular providers who have not ordered or discussed the test with the patient before it was done, and who have no clear evidence that the test results are relevant to the patient’s well-being, are expected to provide management and education on the basis of these results. This situation can breed anxiety, mistrust, even anger between patients and their physicians. The medical community is partly to blame for encouraging the current state. Ironically, our response to control health care costs and medical error focuses on areas that are largely immutable in the current US health care system; and yet, we allow the problem of DTC marketing and self-referral to continue when it can so easily be regulated through simple measures. Although the regulating agency’s resources would need to increase, this would be a cost-saving investment from a societal perspective. Greater efforts are also needed in acculturating physicians-in-training about the critical appraisal of scientific evidence so that they are not vulnerable to misinformation. Individual physicians and medical societies should vigorously resist inappropriate advertisements and look beyond the remunerative aspects of their enterprise or the evangelical passion of their beliefs. However, the ability of the medical community and the screening imaging industry to police themselves is likely to be limited. This is where regulation can help, first by limiting the availability of imaging devices to those who pass a threshold of clinical efficacy. The current model of new device approval by the FDA is broken; as a result, a wave of new diagnostic tools of uncertain value has flooded the medical community, with little to no incentive to assess their true value. Inappropriate DTC marketing continues despite FDA guidance that clearly states that imaging companies cannot make any claims of efficacy in improving health outcomes. This guidance is insufficient, however, without enforcement. An oversight system comparable to FDA regulation of pharmaceutical advertising is sorely needed. The findings of Illes et al1 are alarming, and they should bring all parties involved in the promotion of health to reconsider the current use of DTC advertising for CT scan and MRI services. It is time for all state medical boards, medical societies, and relevant governmental health agencies to play a more active role in overseeing responsible advertising of health information—which should be based on sound evidence and with the public’s interest as the first and foremost priority. Passive inaction in this area will seriously affect our professional credibility, if it has not already. Correspondence: Dr O’Malley, Division of General Internal Medicine, Walter Reed Army Medical Center, 6900 Georgia Ave, Washington, DC 20307-5001 (patrick.omalley@amedd.army.mil). Disclaimer: The views expressed herein are those of the authors only and are not to be construed as those of the Department of the Army or Department of Defense. References 1. Illes JKann DKaretsky K et al. Advertising, patient decision making, and self-referral for computed tomographic and magnetic resonance imaging. Arch Intern Med 2004;1642415- 2419Google ScholarCrossref 2. O’Malley PGFeuerstein IMTaylor AJ The impact of electron beam tomography, with or without case management, on motivation to change, behaviors, and the cardiovascular risk profile: a randomized controlled trial. JAMA 2003;2892215- 2223PubMedGoogle ScholarCrossref 3. Schwartz LMWoloshin SFowler FJ JrWelch HG Enthusiasm for cancer screening in the United States. JAMA 2004;29171- 78PubMedGoogle ScholarCrossref 4. Shaw CAbrams KMarteau TM The psychological impact of predicting individuals’ risk of illness: a systematic review. Soc Sci Med 1999;491571- 1598PubMedGoogle ScholarCrossref 5. Smith JJBerlin L Informed consent when using medical devices for indications not approved by the Food and Drug Administration. AJR Am J Roentgenol 1999;173879- 882PubMedGoogle ScholarCrossref 6. O’Malley PGGreenberg BATaylor AJ Cost effectiveness of using electron beam computed tomography to identify patients at risk for clinical coronary artery disease. Am Heart J 2004;148106- 113PubMedGoogle ScholarCrossref 7. Postmarket surveillance: final rule 67 Federal Register. 38878 2002;

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Dec 13, 2004

Keywords: patient referral,diagnostic imaging,screening

There are no references for this article.