Erik A. Wallace, MD; John H. Schumann, MD; Steven E. Weinberger, MD
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0927.
Requests for Single Reprints: Erik A. Wallace, MD, Department of Internal Medicine, University of Oklahoma School of Community Medicine, 4502 East 41st Street, Tulsa, OK 74135; e-mail, email@example.com.
Current Author Addresses: Drs. Wallace and Schumann: Department of Internal Medicine, University of Oklahoma School of Community Medicine, 4502 East 41st Street, Tulsa, OK 74135.
Dr. Weinberger: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Author Contributions: Conception and design: E.A. Wallace, J.H. Schumann, S.E. Weinberger.
Drafting of the article: E.A. Wallace, J.H. Schumann, S.E. Weinberger.
Critical revision of the article for important intellectual content: E.A. Wallace, J.H. Schumann, S.E. Weinberger.
Final approval of the article: E.A. Wallace, J.H. Schumann, S.E. Weinberger.
Wallace EA, Schumann JH, Weinberger SE. Ethics of Commercial Screening Tests. Ann Intern Med. 2012;157:747-748. doi: 10.7326/0003-4819-157-10-201211200-00536
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Published: Ann Intern Med. 2012;157(10):747-748.
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In this video, Erik A. Wallace, MD, offers additional insight into his original research article, "Ethics of Commercial Screening Tests"
David L. Keller, M.D.
Providence Medical Group
December 1, 2012
In Defense of Commercial Screening Tests
I disagree with the recent Annals opinion piece (1) which condemned the ethics of commercial screening tests, mainly ultrasounds, which are sold directly to individuals, relieving them of the need to spend the time and money to get these tests ordered by a personal physician. In my area, one such company offers a package for $129 which includes ultrasound screening for carotid stenosis and plaques and also abdominal aneurysms and peripheral artery disease (2). People can actually get screened for these atherosclerotic vascular diseases (ASVDs) for less money and time than they would spend on a primary-care office visit to simply get the tests ordered. If performed at a hospital radiology department, the total fees for these tests and having them read would cost substantially more in addition. The companies which market ultrasound screening tests directly to consumers provide a way to obtain valuable and actionable information about the presence of asymptomatic ASVD in a very economical and time-efficient manner. The expenditure of this $129 could produce enormous cost savings in the long run if it identifies asymptomatic ASVD before the first ischemic event, allowing for the initiation of aggressive preventative treatment with a statin. In my experience, the vast majority of patients with asymptomatic ASVD who are identified with ultrasound screening can be treated with aspirin and aggressive LDL-lowering, and do not require the invasive procedures, such as angiograms and endarterectomies, which account for many of the downstream costs and potential “harms” of screening.The authors cite the 2007 statement by the U.S. Preventative Services Task Force (USPSTF) which advised against screening asymptomatic persons for carotid stenosis (3). However, the USPSTF advice was narrowly focused on the identification of candidates for carotid endarterectomy, and did not evaluate the more widely applicable use of ultrasound screening to identify candidates for aggressive preventative lowering of LDL cholesterol. In addition, some of the harms of screening cited by the USPSTF have been rendered obsolete by the advance of technology since 2007. For instance, they factored in the harms of downstream use of digital subtraction angiography, with its exposure to IV contrast and to ionizing radiation, and stated that the safer MRI angiography was not accurate enough to rely upon at that time. However, the accuracy and resolution of MRI technology have improved considerably since then, and many clinicians do consider MRI angiography accurate enough to base decisions on at this time.Physicians should encourage patients to identify asymptomatic ASVD by safe and economical means such as commercial ultrasound screening, even if it means relinquishing some of the power and control we have exercised in the past. We should not allow the narrowly-formulated dictates of the USPSTF to cause us to confuse the lack of proof of benefit with the proof of lack of benefit.
(1) Erik A. Wallace, John H. Schumann, Steven E. Weinberger; Ethics of Commercial Screening Tests. Annals of Internal Medicine. 2012 Nov;157(10):747-748.
(2) https://secure.lifelinescreening.com/ecom/package.aspx , Life Line Screening of America, company website accessed on 12/1/2012.
(3) Screening for Carotid Artery Stenosis: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2007 Dec;147(12):854-859.
Erik A. Wallace, John H. Schumann, Steven E. Weinberger
University of Oklahoma School of Community Medicine (Wallace and Schumann), and American College of Physicians (Weinberger)
January 2, 2013
The letter by Dr. Keller correctly states that some of the tests offered by commercial screening companies can be obtained for less time and money than if they were ordered by their primary care physician during an office visit. In some cases, he is correct. However, through the Affordable Care Act (ACA), some recommended preventive services (such as abdominal aortic ultrasonography in men aged 65 to 75 years who previously smoked) are required to be covered by health insurance plans with no cost sharing by beneficiaries (1).
Additionally, it is important to note that our focus in the article was not primarily on the costs or the quality of the imaging, but rather on the ethical responsibility of the company or organization offering the screening tests to inform consumers about whether or not the advertised testing is recommended by clinical guidelines and/or reputable medical organizations, and if so, for which patient populations. The arguments offered by Dr. Keller do not negate the need for “truth in advertising.” It is fine for testing to be offered to consumers, as long as there are disclosures about whether and for whom each of the advertised screening tests is formally recommended by reputable sources.
We can all agree that the tests we have to offer, and the evidence and guidelines that support these tests, will change over time. We can also agree that more research needs to be done about the benefit of specific screening tests. However, as physicians, we need to embrace the responsibility to provide accurate information to patients and to engage them in shared-decision making about what, if any, testing should be ordered. We believe that encouraging patients to obtain “safe and economical” commercial screening tests that are currently not supported by scientific evidence, without providing appropriate and objective background information about accepted indications, cannot be justified.
1. Koh HK, Sebelius KG. Promoting prevention through the Affordable Care Act. N Engl J Med. 2010;363:1296-9.
David L Keller, MD
January 9, 2013
Commercial Testing Final Comments
Organizations such as the USPSTF issue guidelines which are based on the results of large clinical trials and therefore apply on average to entire populations, but may not apply to atypical individuals. We have all seen "outliers" who suffered a heart attack despite having few or no Framingham risk factors. Tests which are not justified on a population-wide basis can yield valuable information for atypical individuals. Since risk scores are not perfect at predicting who will have an adverse outcome, individuals should be allowed to decide for themselves how much risk they are willing to take, and how much of their own money they are willing to spend to assess their risk.
Consider the Affordable Care Act's mandate of free aneurysm screening for men aged 65 to 75 who have ever smoked: a man aged 65 who quit smoking 30 years ago gets a free ultrasound, but a 64 year old man who has been smoking 2 packs per day for the past 40 years does not. This makes no clinical sense, but is a perfect example of what Mark Twain meant when he said "the law is an ass [donkey]". Clinical decisions should be left to patients and their physicians, not written into law. Furthermore, these "free" ultrasounds will cost taxpayers a lot more if ordered by physicians and performed in hospital radiology departments than if patients can self-refer to commercial test companies which offer abdominal ultrasounds for $129, with carotid and peripheral artery screens included for no additional fee. The cost of hospital-based imaging is inflated in part due to excessive regulation. Commercial imaging companies can provide ultrasound at such a low cost partly because they are not yet burdened with providing mandatory counseling sessions which their customers may not even want.
Here is the crux of our disagreement. I believe that individuals in a free society should be allowed to purchase tests such as ultrasound and genetic testing, which pose no risk of direct harm. Stigmatizing commercial vendors of such tests as unethical for not providing counseling is the first step toward laws mandating counseling, which will increase the cost of the tests. To me, that outcome would be unethical.
David L. Keller, M.D.
21311 Madrona Avenue
Torrance, CA 90503
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