Docs see danger in direct-to-consumer screening tests

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Physicians, hospitals and medical organizations should refrain from sponsoring direct-to-consumer screening tests such as ultrasonography of carotid arteries, according to the authors of an opinion piece published online Aug. 28 in the Annals of Internal Medicine. Such screening may lead to unnecessary downstream testing and additional costs with no benefit for patients.

Erik A. Wallace, MD, of the University of Oklahoma School of Community Medicine in Tulsa, and colleagues credited the use of low-cost screening for hypertension, diabetes and dyslipidemia for lowering the rate of heart attacks and stroke in the U.S., because they allowed physicians to assess and treat patients medically or through lifestyle changes. But screening tests such as ultrasonography may be misapplied in the direct-to-consumer market with promotions that fail to fully disclose the risks to patients.

“When screenings are provided in a church and sponsored by a trusted medical organization, consumers may have a false sense of trust in the quality and appropriateness of services provided,” Wallace and colleagues wrote. “Consumers are generally unaware of the potential harms of screening.”

The writers took aim at direct-to-consumer ultrasonography of carotid arteries, which can be used to assess carotid stenosis. Companies that perform these tests inform patients that they will be provided any “abnormal” test results but they may not give the preliminary counseling that should occur in a physician’s office. Patients may then seek additional testing and referrals.

“That most of these tests are not medically indicated in the first place is left undisclosed to the consumer, nor is there a discussion of potential adverse consequences or additional costs,” they wrote.

Research has shown that mere awareness is unlikely to alter patient behavior. A recent randomized trial on the impact of carotid plaque screening found that patients who smoke were no more likely to stop the habit than nonsmokers, although carotid stenosis is prevalent among smokers (Arch Intern Med 2012;172:344-352).

Guidelines reflect this reality. “Most commercial screening companies offer carotid ultrasonography, but the U.S. Preventive Services Task Force recommends against screening the general adult population for carotid artery stenosis because there is a moderate or high certainty that there is no net benefit or that the harms outweigh the benefits,” they pointed out.

Promoting and selling tests that hold no benefit for patients is unethical, they argued. Marketing of these services with the pitch that “ultrasound screening may save your life” is deceptive if it fails to disclose the appropriate indications or fully explain the consequences of testing.

“In direct-to-consumer advertising of pharmaceuticals, companies are required to disclose the potential risks of taking a medication. We believe that commercial screening companies should also be obligated to disclose from published guidelines the recommended indications and benefits of testing, as well as the potential risks and harms,” they argued.

Given the drawbacks of direct-to-consumer screening tests, Wallace et al advised physicians, hospitals and medical organizations to disassociate themselves from “the unethical business of promoting unproven and potentially harmful screening tests.”