People like Neil Koun have the $40 billion clinical-lab industry in a flutter. Weary of having to go through primary-care physicians and other medical gatekeepers to get the tests they want performed, a small but growing number of patients are ordering their own. Scores of chemical analyses are available direct to the consumer, covering everything from testosterone deficiency to HIV.
Part of the appeal to consumers is convenience. Quest Diagnostics, the world's largest reference lab firm, sells tests at CVS drugstores in Ohio and Florida through color-coded cards that resemble prepaid phone cards and cost anywhere from $40 to $115. All you have to do is register through the toll-free number printed on the card and drop by a Quest lab. You'll get your results by mail five days later or online in 48 hours. The company also runs walk-in facilities in strip malls in Denver and Kansas City, Kans., and, in collaboration with US Wellness, a company based in Gaithersberg, Md., at Giant Food stores in Virginia and Maryland. Perhaps half a dozen Internet brokers offer similar services on the Web.
Can the results be trusted? In most cases, yes. Labs offering the tests are the same ones doctors use to do their patients' blood work. That doesn't mean doctors welcome the trend. "We think it's a bad idea for patients to try to direct their own care by getting tests they may not know how to interpret," says Dr. J. Edward Hill, chairman of the American Medical Association. For one thing, clinical tests are never 100% dependable. There's a 60% chance that at least one result in a standard work-up which assesses 20 or more variables of your physiological chemistry will be a false positive. There are also a lot of false negatives; 1 in 5 men with prostate cancer have normal psa levels cases doctors often catch during physical examination. While false positives can cause unnecessary anxiety, patients may take false negatives as an excuse to skip regular checkups. Aware of this, many labs urge clients to take test results to their physicians.
But there are other, more intractable problems. "The seemingly innocuous blood test," notes Dr. Steven Woolf, a professor of medicine at Virginia Commonwealth University, "can set in motion a cascade of follow-up tests, some of which are not innocuous at all." Take, for example, the CA-125 test, pitched by some entrepreneurs as a possible way to detect ovarian cancer. Studies have shown that the vast majority of positive CA-125 results are false, which is why few physicians recommend it. Yet InterFit Health in Houston still offers the CA-125 test albeit with caveats. "We get a lot of requests," says president Laurie Lee. "People want to take charge of their health, and they don't trust their doctors to do all the health screenings they need."
Giving people what they want, however, is not always a good idea in medicine. A significant number of women with a positive CA-125, explains Woolf, will need to have those results verified surgically or by the insertion of a fiber-optic scope into the abdomen. Any surgical procedure carries a risk of serious complications, so offering the CA-125 screen to consumers is likely to increase the incidence of useless operations and associated complications.
If they are aware of such risks, most consumers don't seem to care. They want more control not less over their medical care. They like the privacy of home pregnancy tests, for example, and the convenience and pleasure of sonograms taken at the shopping mall (see box). At the vanguard of the self-testing trend, says Lee Hargraves of the Center for Studying Health System Change in Washington, are the country's 76 million baby boomers, who as they grow older become more interested in the state of their health.
Not every state allows do-it-yourself medical testing, but that may be changing. Matthew Schulze of the American Society for Clinical Pathology says 32 states, as well as Puerto Rico and the District of Columbia, permitted some form of direct-access testing last year up from 27 in 1999. In states that bar the practice, labs often get around the restrictions by retaining physicians to order the tests.