Laboratory News

Today's WSJ Takes Pathology Labs to Task for "Bad Cancer Tests"

Thousands of breast cancer patients may be getting the wrong treatment because of errors in two laboratory tests, according to an article in today's The Wall Street Journal ,  "Bad Cancer Tests Drawing Scrutiny." Pathologists and laboratory managers will want to grab today's issue of the WSJ and read the article. It is significant for two specific reasons.

First, it demonstrates that the public and the media do not understand the complex issues involving the sensitivity and specificity rates of laboratory tests. This is a knowledge gap that has plagued laboratory testing for decades and is likely to become more of a problem as growing numbers of consumers start to pay more attention to the quality of their healthcare provider and the amount of money they pay for health services, including laboratory testing.

But, second, and perhaps the more immediate issue about The Wall Street Journal's article today, is that it shows clinical laboratory testing is not a commodity item that can be bought and sold as traders do with wheat, soybeans, and iron ore. Just the opposite! Clinical lab testing is a complex discipline in which highly-trained medical professionals must supervise complex laboratory testing procedures to ensure that the final results reported to the patient and physician are accurate, to the degree allowed by the sensitivity and specificity of the various assays and methodologies. Lab testing is a precise science in which the top practitioners are among the best trained and most educated physicians and Ph.D.s in medicine.

Not coincidentally, the fact that laboratory testing is not a commodity is the reason why the Medicare Clinical Laboratory Competitive Bidding Demonstration about to unfold in the San Diego area is a recipe for disruption and a decline in access to high-quality laboratory testing services in that region. The bidding demo is likely to prove that, when Medicare wants to select based on cheapest price, it won't get the best combination of quality and value for its dollar.

The Wall Street Journal article today discusses why not all tests are equal. It quotes experts who explain why. Reporter Anna Wilde Mathews (at anna.mathews@wsj.com), writing about breast cancer testing, noted that, "The tests relating to Herceptin and the antihomone drugs are less straightforward than many traditional lab procedures. They require pathologists to make judgment calls after looking at tissue through a microscope, rather than giving simple yes-or-no answers as in a pregnancy test. One test examines whether a patient's tumor cells have too much of a protein called Her-2. If they do, Herceptin can help by targeting and destroying those cells. The other test checks for the presence of cell proteins that serve as receptors for the hormones estrogen or progesterone. These hormones can help tumors grow, so if the test is positive, doctors often prescribe drugs such as tamoxifen to suppress or block the hormones."

The article also quotes Soonmyung Paik, director of the pathology division at the National Surgical Adjuvant Breast and Bowel Project , a nonprofit clinical research group in Pittsburgh, Pennsylvania, who says, hormone-testing methods are "a chaos," because "every lab uses a different method and different criteria to call a case positive."

Pathologist Allen Gown, M.D., Medical Director of PhenoPath Laboratories  in Seattle, Washington, is quoted as saying, "If we tried to market pregnancy tests with this rate of inaccuracy, they would be taken off the market." He was referencing the false positive and false negative rates that are the subject of The Wall Street Journal article. Obviously the reporter edited down his full comments on the limits of different tests to deliver results with extremely high rates of sensitivity and specificity.

Given the importance of these issues, it's no surprise that the article also said, "such concerns could add momentum to efforts by Congress and consumer groups to push for increased oversight over the lab-testing business." Thus, by those who don't understand the complexity of laboratory medicine and laboratory testing, there is the inevitable call to the government to pass laws to solve the problem. Dark Daily doesn't need to comment on how that would complicate progress toward resolving these issues of variability in the quality of lab test results-which are rooted in both the recognized limitations of diagnostic technology, as well as how variability in the way individual laboratories perform the assay can affect the final result that is reported to patients and physicians.

Expect to see some letters to the editor as a result of this story. With the headline "Bad Cancer Tests Drawing Scrutiny," there are more than a few pathologists and trained laboratory experts who will want to respond to how this reporter covered a technically complex subject.

Related Information

• Bad Cancer Tests Drawing Scrutiny 
• Breast Cancer Test Errors Cause Faulty Treatment