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February 09, 2005

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Publication Date: Wednesday, February 09, 2005

Health & Fitness: Examing the body scan: Stanford researchers advise people considering body scans to proceed with caution -- and with eyes wide open Health & Fitness: Examing the body scan: Stanford researchers advise people considering body scans to proceed with caution -- and with eyes wide open (February 09, 2005)

By Monique Johnson

Special to the Almanac

"Early Detection...It May Save Your Life" "Add years to your life in just a few minutes." "Every day ... our medical staff saves the lives of ordinary people."

Sound promising? These attention-grabbing advertising slogans from Bay Area "body scan" centers offer a medical test many would find hard to resist.

There is no need for a doctor's referral to undergo the 10-minute, non-invasive CT (computed tomography) scan, which allows the consumer to take a look at the intricate workings of the body's organs and tissues from the neck to the pelvis.

Claiming that such scans can detect heart disease, lung disease, cancer, aortic aneurysms, kidney stones, and other problems before outward symptoms occur, these centers have sprung up during the last four or five years around the country.

As the fear of a silent disease lurking inside our bodies increases with age, these offers seem more and more attractive.

But a recent study by a team of Stanford researchers and doctors cautions that advertisements and claims like these are not telling us the whole story.

Dr. Judy Illes, lead author of the study and senior researcher and director of the program in neuroethics at the Stanford Center for Biomedical Ethics, advises, "Be cautious of the emotional content of alluring advertising."
Misleading ads

Dr. Illes' study team found the direct-to-consumer advertising of scan centers to be misleading, often conveying a false sense of the benefits of body scans without providing balanced information on the limitations and risks of the technology.

Dr. Illes and the study team evaluated newspaper advertisements and informational brochures from body scan centers against a standard set by the American Medical Association: "The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice." The researchers concluded that the centers' marketing messages do not measure up.

Almost none of the ads and brochures referred consumers to outside sources of information, such as a primary care physician, and the risks of having a scan were seldom mentioned.

"Many contained messages conveying a false sense of reassurance, and some conveyed fear," the authors write.

The marketing pieces fail to mention that the benefits of screening healthy individuals have not yet been established by clinical trials, and 25 percent of ads stated the technology was FDA-approved. In fact, the FDA states clearly that it "has never approved CT for screening any part of the body for any specific disease, let alone for screening the whole body when there are no specific symptoms of disease at all."

The Stanford researchers are not alone in their concerns. In a development independent of the work of Dr. Illes and her team, one of the leading scan companies closed its doors in 2003 after a lawsuit was filed against it by the state of California and the California Medical Board, charging it with false advertising practices.

Dr. Illes says her main concern is that the current standard of direct-to-consumer marketing "does not provide prospective consumers with the information that allows them to be truly autonomous, informed decision makers."

She suggests that advertising for self-referred scans be held to the same standard as that for pharmaceutical drugs: The FDA requires advertising for prescription drugs to refer patients to secondary sources of information, to encourage them to seek the advice of a health-care provider, and to provide balanced information on the associated benefits and risks.

Currently, no such requirement applies to the scanning industry; it has "fallen through regulatory cracks," according to the study.
Consult your doctor

Dr. Illes and other experts consulted for this article recommend that individuals consult with their personal physician before signing up for a body scan.

A body scan "should not replace going to see your doctor," advises Dr. Scott Atlas, a Hoover Institution senior fellow by courtesy, professor of radiology and chief of neuroradiology at Stanford University Medical School, and a member of Dr. Illes' research team. Your personal doctor can help you understand the potential risks and benefits in the context of your overall health picture, and be a helpful guide if you choose to go ahead with the scanning procedure, he says.

Dr. Michael Modic, chairman of the Division of Radiology at the Cleveland Clinic Foundation, has established a framework for self-referred CT scans at the Cleveland Clinic that Dr. Illes calls "a model pathway for the industry."

The first criteria is that a one-on-one consultation with a Cleveland Clinic radiologist is a prerequisite to any self-referred CT scan. The radiologist is thus actively involved in the decision process, educating the patient about the test, evaluating the patient's background, and discussing the ways in which a CT screen may or may not help -- much as a primary care physician would do. The clinic reports that an estimated 15 percent of those going through its consultation process decide against proceeding with a scan.

"The general population is not the right target for CT screening," Dr. Modic states. For example, the Cleveland Clinic strongly discourages CT screening for individuals under the age of 45, because, in general, "there is a very low probability that the test will help them at all," he explains.

But CT screening is potentially worthwhile for segments of the population with certain risk factors, such as a history of smoking or of heart disease, Dr. Modic notes, although he stresses that this question should be evaluated on a case-by-case basis with the input of a health-care professional.

Dr. Illes emphasizes that there is a lack of definitive, scientific data from rigorous clinical studies on the value of self-referral CT screening for people who show no symptoms of illness.

Such studies, she says, might track the incidence of false-positive and false-negative test results, and seek to correlate scan findings with clinically confirmed disease.

Dr. Modic agrees, adding that "Good research takes time." There are studies under way and more in the planning stages, he says, and he is hopeful that the results of these studies will identify target populations for whom CT screening will have an impact -- helping to diagnose disease early enough to apply effective treatment.
Ambiguous results

It is important to be aware of the possibility of false-positives and false-negatives, says Dr. Illes. Because the quality of the images is so highly defined, a CT scan can detect many "abnormalities" in the body.

Literature from one scan center claims that "a full body scan can detect any masses or abnormalities the size of an eraser head or larger." When detected on a scan, the radiologist would report such findings to the patient.

According to Dr. Illes and Dr. Atlas, further investigation of these potentially ambiguous findings -- sometimes turning out to be false-positives, meaning essentially unimportant or even normal variations -- often involves repeat scans and/or invasive procedures that have their own risks and complications, causing anxiety for the patient and imposing costs on the health-care system.

On the other hand, Dr. Atlas cautions patients about the significance of a "normal" scan reading, meaning nothing noteworthy has been detected.

"It simply means that certain things are not there," says Dr. Atlas, "and should not be equated with a clean bill of health." In other words, disease could be present, but not at a stage that is detectable yet by the scan. A "normal" scan result should not keep anyone from continuing routine medical check-ups, he says.
Radiation exposure

Self-referring patients should also be aware of radiation exposure from full-body CT scans.

According to the patient information Web site of the Radiological Society of North America (RSNA), the radiation dose from a conventional chest X-ray is comparable to 10 days of "normal background radiation" we are exposed to from natural sources in our everyday lives. A mammogram is comparable to three months' worth.

A CT body scan, on the other hand, exposes an individual to radiation comparable to three years of the same natural radiation.

Dr. Modic says the risk of an individual scan is not really an issue.

The radiation exposure, however, becomes more significant if patients seek repeated elective scans over time, says Dr. Atlas. He cautions that one must always balance the risks of a procedure with the potential benefits. If a scan is needed to diagnose illness, he says, the benefits clearly outweigh the issue of radiation exposure. But for a healthy person, the risks of accumulated exposure to radiation from repeat scans may not be acceptable given the questionable benefits, he adds.

Dr. Atlas also points out that "it matters who your radiologist is." Reading CT scans is not an exact science with black and white conclusions. Be sure to ask how the scan is being done and what the qualifications are of the radiologist who will interpret the results.
Guidelines, standards needed

Overall, the Illes research team conclude that it's important that a proper framework for self-referred CT scans be developed by bringing together members of the medical community, professional associations, industry, and patient advocates to ensure that benefits of these services outweigh the risks to individuals and the health-care system.

This framework should include guidelines for the frequency of repeat scans, quality control, studies on patient-physician trust and populations more or less likely to benefit, guidelines on the reporting of information to patients, and standards for direct-to-consumer advertising.

"Patients getting involved in self-directing their health care is a positive step," Dr. Atlas says. "The more educated and involved they are, the better the health care they will receive."

"Be good decision makers," advises Dr. Illes, "taking into account scientific fact, as well as your personal needs and values."

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