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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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It’s not just in the United States that Direct-to-Consumer (DTC) medical laboratory tests are coming under criticism, as reported in recent weeks by Dark Daily. Two prominent organizations in the United Kingdom (UK) have issued reports with serious criticisms of what are known as “Do-It-Yourself” (DIY) clinical laboratory tests in that country.

Researchers identified the several ways that DIY test in the UK, often bought over-the-counter in pharmacies, could mislead or harm consumers. In our earlier Dark Daily e-briefing titled “Medical Laboratory Tests for Consumers Under Investigation on Two Continents,” we presented pathologists and clinical laboratory managers with the results of a General Accountability Office (GAO) study that was critical of DTC medical laboratory tests.

This e-briefing also reported on the findings of a public hearing conducted by the Food and Drug Administration (FDA) about Direct-to-Consumer (DTC) testing that included a special focus on genetic tests sold to consumers by Internet-based clinical laboratory testing companies.

(After the FDA sent a letter to San Diego, California-based Pathway Genomics, the manufacturer of this DTC test kit, Walgreens removed it from their store shelves. Image sourced from The Los Angeles Times online.)

(After the FDA sent a letter to San Diego, California-based Pathway Genomics, the manufacturer of this DTC test kit, Walgreens removed it from their store shelves. Image sourced from The Los Angeles Times online.)

Even as the GAO and the FDA were investigating the DTC laboratory testing industry in this country, across the Atlantic Ocean, the United Kingdom’s (UK) National Health Service (NHS) commented on a report from Which?, an independent consumer group similar to U.S.-based Consumer Reports that determined Do-It-Yourself (DIY) health tests “could do more harm than good.”

Is Patient Self-testing Safe?

Which? investigated six DIY test kits that were designed for a variety of medical conditions. They included:

  • Prostate and bowel cancers,
  • Stomach ulcers,
  • Urinary tract infections,
  • Diabetes,
  • Heart disease, and,
  • Monitoring blood glucose and cholesterol levels.

According to Chris Mathews, a Principal Home Researcher for the Home Research Group at Which?, the results of this study were disappointing.

“We uncovered instructions [with the medical tests] that were either unclear, or didn’t give enough detail on taking samples,” reported Mathews in an article posted on the Which? website. “Plus, our experts found that there wasn’t always enough information on the box, making it difficult to decide whether it was the right product [medical test] for you.”

In “Are Self-Test Health Kits a Waste of Money?Which? researchers stated their trepidations that consumers might overly rely on DIY test results versus visiting a doctor for confirmation.

“I’m no doctor, so I’d be relying on crystal clear directions to make sure I used the test properly and didn’t do anything that would affect the final result. But even the medical professionals assessing these kits found some of them difficult to use.”

UK’s National Health Service Comments on DTC Medical Laboratory Tests

The findings of the Which? study generated a corresponding report that the National Health Service (NHS) posted on its website. Titled “Warning About Self-Test Health Kits,” the NHS article reported that the tests contained:

  • “Gaps in information,
  • “Difficulty of use,
  • “Baffling language,
  • “Risk of false alarms or false reassurance, and,
  • “Misleading naming.”

The NHS report goes into great detail on specific findings of the Which? researchers for each DIY kit tested. Pathologists and clinical laboratory managers here in the United States will find the report to be useful reading. The authors of the NHS report stated that “Although the report was limited to only six kits, and they were assessed by only two experts, the findings are worth noting. The current lack of legislation for these home testing kits may mean that these problems are common among testing kits in general.”

Danielle Freedman, M.D., Specialty Advisor for The Royal College of Pathologists, was one of two medical experts who evaluated the DIY tests for Which?. They studied the packaging, websites and marketing materials of the six DIY test kits. They also questioned 64 people who were asked to review the test kit materials and comment.

Dr. Freedman was involved in a previous study of DIY tests for Sense About Science, an independent charitable trust that “promotes good science and evidence in pubic debates.” That study, titled “Making Sense of Testing” endeavored to alert the public and policy makers in the UK to “the potential damage caused by health tests and scans for well people and the need for a national system to evaluate laboratory tests.”

In a guide published post-study, the researchers warned that:

  • “Most tests weren’t designed for well people,
  • “Many tests are not researched or adequately regulated,
  • “Tests are only one part of diagnosis,
  • “Testing can cause harm, especially in well people.”

The Royal College of Pathologists published a related report titled “The Evaluation of Diagnostic Laboratory Tests and Complex Biomarkers” that called for:

  • “A national system to evaluate diagnostic tests,
  • “A publicly accessible database to provide evidence of performance and usefulness, and,
  • “Policy makers to decide who is responsible for gathering evidence and meeting the costs.”

“The public buy ‘testing kits’ over the counter and via the Internet without knowing the limitations of their results,” commented Dr. Freedman on the results of the study. “There are ‘cowboys in vans’ on the high street offering for a price a wide range of tests. Does the public know whether tests are performed to the same quality standards as laboratories routinely providing this service to both the NHS and private sector?”

“NHS and independent laboratories have to perform to high standards and must go through a formal accreditation process,” said Dr. Freedman in a related article in The Telegraph.

“Patients who buy over-the-counter or Internet kits do not know whether what they are getting is of the same standard,” she continued. “They could be wasting their money, but more importantly they could be given inaccurate results leading to either false re-assurance or unnecessary worry.”

Tell Us Something We don’t Already Know!

Astute readers will recall that Dark Daily reported on the GAO report in “Many Genetic Tests Offered to Consumers Over the Internet are Misleading and of No Practical Use.”

That researchers in the UK are arriving at similar conclusions should come as no surprise to clinical laboratory managers and pathologists who are keenly aware that DTC or DIY tests—genetic or otherwise—can be misleading and have the potential to negatively affect patient outcomes. Given the continued demand for low-cost tests that patients can take at home without a prescription, it’s not a stretch to believe that the FDA will arrive at similar conclusions as officials in the UK’s NHS concerning DTC test kits manufactured in this country.

—Michael McBride

Related Information:

FDA Weighs Pros, Cons of Home Genetic Testing (Business Week)

DIRECT-TO-CONSUMER GENETIC TESTS: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices (GAO Report)

Warning About Self-Test Health Kits

Do-it-Yourself Test Kits “Could Put Health at Risk” (The Telegraph)

Making Sense of Testing

The Evaluation of Diagnostic Laboratory Tests and Complex Biomarkers

FDA has Questions about DNA Testing Kit, so Walgreens Backs Off on Selling It