Full-body scans—or scams?

Your patients are being bombarded with hype about full body CT scans. What should you tell them about these controversial tests?

By Dorothy L. Pennachio
Senior Editor

Turn on your radio, tune in Oprah, or flip through an issue of virtually any consumer magazine, and chances are you'll come across what The Wall Street Journal calls the biggest craze in preventive medicine since vitamin C. Full-body CT scans promise peace of mind to the worried well, and you don't even need a physician's referral.

The scans are nothing if not controversial. Proponents say the tests can pick up cancers and heart disease long before symptoms appear. "A Body Scan (neck to pelvis) can detect health problems at very early stages when cure rates are highest," claims one newspaper ad. "The procedure is fast, noninvasive, and affordable."

More than 100 clinics across the country offer neck-to-pelvis screens, and that number is growing quickly. Patients pay $800 to $1,500 out of pocket, since insurers generally don't cover the test if there's no strong clinical indication or referral from a physician. Patients get their results within 30 minutes. So what's the controversy?

Opponents say the scans expose patients to excessive levels of radiation and can engender either needless worry or a false sense of security. "It's impossible to find a doctor in favor of these scans who doesn't have a financial interest in a scanning facility," says Thomas H. Lee Jr., a Boston cardiologist and associate professor of medicine at Harvard Medical School.

What should you tell your patients about these much-debated screening tests?

No endorsement from the Feds or organized medicine

Neither the FDA nor the American College of Radiology endorses the full-body tests. "Full-body scans are an off-label use of CT," says Thomas B. Shope, a physicist in the Office of Science and Technology in the FDA's Center for Devices and Radiological Health. He says the FDA's concerns center on the lack of data showing the technology's effectiveness, the risk for patients when follow-up exams chase false-positives, the radiation exposure, and the questionable use of health care dollars.

"Radiation can be a significant issue especially if the procedure is done incorrectly," says radiologist James P. Borgstede, a member of the ACR's Board of Chancellors. "Dosages vary from machine to machine and operator to operator. There is no set standard on how scans are performed, or how thick or thin the slices are."

The radiation from one body scan alone is equal to about 150 chest X-rays, says Michelle S. Ginsberg, director of general radiology at Memorial Sloan-Kettering Cancer Center in New York City. "Imagine a hypochondriac getting scans every couple of months," she says. Individual labs typically make sure patients don't come back for five years for a repeat scan, but there's nothing to keep a determined person from going lab to lab.

The risk of false positives and false negatives

"One problem with the scans is that they can generate unnecessary concern over abnormalities with little medical significance, leading to expensive and anxiety-provoking follow-up testing," says cardiologist Thomas Lee.

Timothy Johnson, a physician and medical expert for ABC's 20/20 television show, signed up for a scan for a news report that aired in January. CT revealed calcified plaque in a coronary artery. As a result, Johnson underwent a battery of tests only to find that his heart was fine. The follow-up testing, he reported on the show, hit him with more radiation and cost his insurance company nearly $4,000.

Mark R. Needham, a family physician in Santa Monica, CA, whose medical group is opening a CT/MRI clinic that may also do total scans, saw a similar false-positive case. This one involved a radiologist's report of liver and lung lesions. "Chances are low that these are true positives," says Needham, "but if you don't chase them down, then you're negligent."

Full-body scans can also give false assurance to patients. "Because no contrast dye is used," says Lee, "there's no guarantee that suspicious lesions are being picked up."

Why no contrast dye? "For mass screening purposes, you don't want any associated morbidity, and the dye can cause allergic reactions ranging from hives to anaphylactic shock and death," says Memorial Sloan-Kettering's Ginsberg. Dye is used only when symptomatic, high-risk patients are scanned, because, in these cases, the benefit outweighs the risk, she explains. "But without dye, you can't see most of the lesions you're looking for—liver or pancreatic tumors, for example. The result is, the patient may get a clean bill of health when, in fact, a potential tumor just hasn't been picked up."

Ginsberg says she knows of a man who had a full-body scan as part of his company's executive wellness package. The scan showed no abnormalities, but a couple of weeks later, he had a heart attack. Because he had been given the clean bill of health, he doubted his symptoms and delayed going for emergency treatment.

The ethics of scanning asymptomatic patients

"As trustees of the health care system, physicians should not encourage the expenditure of resources on a procedure with no evidence of efficacy," says cardiologist Lee. "Physicians have an obligation to be more than snake oil salesmen."

But California FP Mark Needham sees the issue differently. Patients no longer blindly accept a doctor's judgment, he says. They wonder if it's really just a headache, or whether there should be a higher degree of diagnostic certainty. "And the demand is also coming from doctors who are worried about overlooking something."

Many ethicists don't buy that argument, however. One of them, George Annas, a bioethicist and professor of health law at Boston University School of Public Health, says that pitches for full-body scans remind him of the old joke: "A well patient is someone who hasn't been sufficiently worked up."

His colleague, Michael Grodin, a pediatrician and Director of the Law, Medicine and Ethics Program at BU, agrees. "Scanning an asymptomatic person is a fishing expedition. For every abnormal entity found, there may be 100 more. It does no more than make patients anxious. The bottom line: It's a bad idea to reassure patients inappropriately, and it's a bad idea to give information that's not helpful. Scans should only be done for clinical indications."

Supporters defend the controversial tests

Kenneth H. Cooper, a preventive medicine specialist who has overseen more than 35,000 full-body scans, disagrees with the naysayers. "Scans are valuable for picking up heart disease long before symptoms develop," says the director of the Cooper Aerobics Center in Dallas. "Even in patients with no risk factors, we're finding calcification buildup in coronary arteries, which may be a predictor for future coronary events."

But couldn't that result in a false positive? To avoid that, says Cooper, technicians at his center administer a stress test when a calcification score is high. "We add a functional test to the anatomical test," he explains. "That way, we can see if the calcified plaque is obstructing the lumen." In addition, technicians sometimes measure lipid, homocysteine, and CRP levels, as well.

"These scans provide a whole new way of deciding how to prescribe cholesterol-lowering drugs," Cooper says. Needham agrees. "Knowing who might be a candidate for cholesterol-lowering drugs is especially important in younger patients who might be taking the therapy for years and years," he says. If the scan demonstrates the beginnings of calcification, that can be a motivation to diet and exercise.

In addition, Cooper is adamant that the scans can pick up cancer long before it causes symptoms, especially lung cancer. Cooper does issue some caveats about full-body scans, however. He says quality will vary depending on where the scan is done, who does the interpretation, and what type CT is used. Needham emphasizes that the scans' efficacy varies with the part of the body it covers. "The test may be worthwhile for cardiac problems," he says, "but chest scans, for example, may reveal suspicious lung nodules that turn out to be benign, and then those nodules have to be followed for up to two years."

The bottom line: Scan shops are multiplying around the country, enticing your patients to "act now for special savings." Sober, informed words of advice from you may be their best defense.

The liability risks of full-body CT scans

What if you advise a patient against a full-body scan, then he dies a few weeks later of a heart attack? His estate claims that if only he'd had a scan, he might have been saved. Are you liable?

Probably not, says health care attorney Steven I. Kern of Bridgewater, NJ. "No one can demonstrate the full-body scan to be a recognized standard of care," he says. "There must be deviation from the accepted standard of care for a malpractice suit to succeed."

Actually, the greater liability risk may lie in recommending the scans, due to the high level of radiation, says James L. Griffith Sr., a malpractice attorney in Philadelphia. "I'm concerned that physicians are going to run into the same problem they did when quarterly chest X-rays were popular. The hope was to find cancer at an early, treatable stage, but they found out the frequent radiation was causing cancers to form."

Inform patients about the level of radiation involved in full-body scans, advises Griffith. Talk to your lawyer about the malpractice risks in your jurisdiction before referring for one. "If there is any doubt, have the patient sign an informed consent form that spells out the risks and benefits of the procedure," he says.

Is this test a cash cow?

Mark Needham, a family physician in Santa Monica, CA, is a member of a large group that's in the process of assembling a wellness facility that will offer full-body scans as well as traditional imaging.

"As a primary care physician," he says, "I incur the liability of following up the results of these full-body scans. I'm going to feel a little better about that if I've collected some of the scanning revenue myself. If we bring the business in-house, at least we'll be able to keep costs down. We'll be paying our own facility." He expects it will take several years to break even.

Full-body CT scanners typically cost $2 million apiece. The Cooper Aerobics Center in Dallas has two, and they charge $649 for a total scan and $315 for a chest scan. Other facilities charge up to $1,500 for a total scan.

"Running these scanners has been financially successful for us," says chairman and CEO Kenneth H. Cooper, "but the big benefit is to the patient—picking up disease at a stage when lives can be saved."

 

Dorothy Pennachio. Full-body scans--or scams?. Medical Economics 2002;15:62.