It is now possible for some Americans go to the mall, stop in Banana Republic for a new shirt and then go next store and buy a full-body scan. Since it was first offered a decade ago, whole-body scanning offered directly to consumers by for-profit imaging centers has become increasingly popular. This is especially true in upper income areas filled with health-conscious consumers with deep pockets who have long heard that prevention is the best medicine. While periodic body imaging may sound like an unequivocally good thing to do for one's health—with the hopes of detecting a disease early enough to be cured—a recent study in the medical journal Radiology suggests that there is a need for guidelines to help clarify the risks and benefits of such scans for healthy individuals.
In healthcare settings, CT scans, which use a type of technology called X-ray computed tomography, are used to diagnose medical conditions in people who have signs or symptoms of disease. This technology is also used to monitor the progress of treatment for cancer, multiple sclerosis and other diseases. The new for-profit cancers, however, offer CT scans to people who do not have signs or symptoms of disease, or a doctor's referral, but wish to catch any medical problem at an early stage. But according to the Food and Drug Administration, there is no evidence at this point that indicates that whole-body scanning offers more benefit than harm to people without symptoms. Potential risks of CT scans include radiation exposure that might slightly increase risk of cancer later in life, and the possibility that one will have to undergo unnecessary invasive tests and procedures because of a false-positive result, or a finding that later proves harmless.
The Radiology study researchers analyzed 88 imaging centers, most of which were located on the two coasts. Below, lead study author Judy Illes, PhD, a senior research scholar at the Center for Biomedical Ethics and Department of Radiology at Stanford University, discusses the need for guidelines to help consumers make informed choices about self-referred CT scans.
When are CT scans usually recommended?
CT scans are typically ordered by a primary care physician upon a suspicious clinical finding. They are not typically ordered in the traditional healthcare setting for people who are free of symptoms.
What are some risks associated with self-referred CT scans?
CT scans are very sensitive. They'll pick up all kinds of things, both clinical findings that may reflect disease, and findings that are not representative of disease. The downstream effect is that somebody who may really be completely well has been turned them into a patient. We now have somebody who enters the professional healthcare system. They may even undergo a series of invasive tests, such as biopsies that are associated with some risks. CT scans may also introduce a whole host of psychological risks such as anxiety.
What kinds of scans do the imaging centers offer?
The study shows that these centers offer a wide variety of scans. This includes everything from full-body scans to single-organ scans such as the lungs, heart, breasts or abdomen. The types of scans may be purchased individually, but we are seeing offers of multiple scans and discounts for secondary scans. So you can have two-for-one offers and so forth. And again, these are completely at the discretion of the consumer without the advice of a doctor.
What marketing strategies are these centers using?
We currently have the results of an in-depth study of the marketing strategies that are used both in print and broadcast media. We're just analyzing the data now, but I will comment that the centers use a wide spectrum of strategies. They range from very positive advertisements that promise a benefit to advertisements that have what we would call a negative valence. That is, they really prey on people's fears about disease.
Who was the target of these marketing approaches?
We figured out the target population based on geography. The geographic distribution places these centers largely in areas of high socioeconomic wealth. These are primarily affluent communities populated by highly educated individuals, who are mostly European-American. It's likely that these people have a high level of health consciousness.
Is there a need for guidelines for the use of CT scans?
We have concluded that guidelines are needed to enable the industry to deliver the benefits that they promise. In the absence of scientific evidence of the benefit of CT scans, we really believe guidelines for the industry are needed. These will advise patients about how often they should come for these kinds of scans and help ensure that people don't get a false sense of reassurance. They will also assure quality and standards of practice.
The guidelines will also suggest a responsible means for reporting the results back to patients and to their physicians. Radiologists are not accustomed, and are not really even trained, to speak directly with patients. The appropriate route is really through an individual's primary care physician, who has hopefully had a long-standing relationship with that patient and understands the whole profile of that individual.
And of course, a very important consideration for us in the biomedical ethics community is that there is fair access for all people, not only the affluent sector of society.
What kinds of studies are needed?
The advertising study that we have now completed will enable us to understand the marketing strategies, and determine what advertising is fair and accurate, as well as what is effective for healthcare consumers. We're also very interested in understanding and conducting research on the impact that self-referral has on the patient-physician relationship.
And then of course, there are the basic outcomes and radiologic studies that need to be done to understand the true efficacy of early screening.
There is also a need to study the downstream costs on health care. What is the financial impact of having somebody without any symptoms, who would not previously have had to undergo a series of tests, introduced into that cycle? While the self-referred tests are paid for out-of-pocket, it's actually society and our third-party insurers who pick up the costs of further tests in the traditional healthcare system. So there's a profound impact on cost to our healthcare system.
How much are the tests?
The average price that we found in our study was about $800. They vary from $500 to $1500 and, as I mentioned, there are specials available that come with multiple tests. There are also specials available seasonally: Father's Day specials, spring specials. Those are also very interesting to us in terms of marketing strategies.
Based on your study, are there any recommendations for people who are considering these tests?
The advice that we give is to be an intelligent consumer. That is, people should understand what the possible benefits are, as well do their homework and understand what the possible risks are. People should definitely engage a primary care physician in dialogue about these types of scans before buying them for themselves.
How will this affect people's relationships with their physicians?
We're very interested in whether a physician will be pro or against having people purchase a CT scan for themselves. Those are very profound issues related to patient-physician trust and patient autonomy. For example, if there is a positive finding and if the physician was, in fact, negative about the CT scan at the outset and the patient decides to go anyway, does that patient go back to that primary care physician? So there are some fascinating and very profound ethical and health policy issues there that must be addressed.
Are there any other examples to model the guidelines on?
The direct-to-consumer marketing of prescription pharmaceuticals is the best example, and it's very heavily regulated now. There are very strict rules in place from the Federal Trade Commission about what can be marketed, how it can be marketed, and what types of information must be made available to a consumer at the time that a product is marketed. We would be very interested in seeing parallel guidelines for these types of medical imaging scans.
Who should put these guidelines together?
We would urge that a meeting of the minds of all stakeholders: radiologists, primary care physicians, biomedical ethicists, as well as representatives of the industry, and possibly interested consumers, who can bring some very valuable views to the table.
Federal regulations take a long time to put in place. What I would like to urge is prompt action from our professional community to develop even a preliminary set of recommendations.
Once there are guidelines, one can ask the question: Is this center following these guidelines? Or consumers can ascertain how many of the recommendations a center adhering to. That would provide a consumer with a valuable tool with which to make some choices.
We are not at all against self-referred body scanning. We are very pro-proactive health care and very pro-patient. One just needs to weigh all the benefits and risks, especially in light of the fact that all of those are not known at this time.