Medical self-testing poses risks

Accurate tests don't mean the right diagnosis, prescription or prognosis

By: Lanny Boutin

  Although most medical self-testing products are reliable, health professionals worry about a growing trend that could produce real problems when these products are not correctly used.
  Between doctor shortages, busy lifestyles, heavy advertising, and people's desire to take control of their own health, home diagnostic tests have become quite popular. You can now measure your own cholesterol, check for diabetes, colon and prostate cancer, osteoporosis even AIDS.
  The US Federal Drug Administration's web site lists over 425 over-the-counter diagnostic devices, which have been cleared for use in the US. In Canada it is estimated that in-home pregnancy, ovulation and blood pressure testing alone bring in close to $125 million each year.

Accurate but...
  According the manufactures, most home diagnostic tests are as accurate as lab tests, most in the 90 to 99 percent range. And there's no question that over-the-counter diagnostic devices for blood glucose testing and in-home blood pressure screening have helped people live better and longer. But will this boom in self-testing fuel an increase in do-it-yourself medicine?
 

Does it make sense to receive the results of a life-altering test in the mail from a complete stranger - or machine?

  Some members of the Canadian Medical Association have voiced concerns over the safety and accuracy of the kits, the way they are marketed and whether patients are reporting the test results to their doctors, as the kits suggest.
  "Increasingly the physician is no longer the sole gatekeeper" notes Earl Berger the managing director of the Berger Population Health Monitor. His research shows that 75 percent of Canadians take one or more natural health products, about a quarter substitute natural health products for prescription medications, and the great majority do not tell their physicians.
  "These test kits available to the public are not regulated by the medical profession," notes Dr. Bryan Ward, Assistant Registrar at the College of Physicians and Surgeons of Alberta. "And from the perspective of our Laboratory Accreditation Program, testing which is not performed by or under the direction of an accredited laboratory in Alberta may be unreliable. Most test kits are not completely fool-proof."
  The colorectal screening test looks for the presence of blood in the stool, an early indicator of cancer, but a positive outcome could also be a sign of bleeding gums, stomach ulcers or the extra rare steak you had for supper.
  "Self-testing may raise questions best answered by a pharmacist, physician or other health care professional," notes Susan Winckler, Group Director of Policy and Advocacy for the American Pharmaceutical Association. "In many states, pharmacists help consumers navigate the use of these tests by either performing the test in the pharmacy, or helping consumers learn to use the equipment at home."
  Winckler notes that because prescription medications cannot legally be obtained without a valid prescription, there is little chance that people will self-diagnosing and then self-medicating. But legal or not, many Canadians are buying prescriptions over the Net. See Buyer Beware: prescription drugs on the Net.

The test's in the mail
  Doctors also question the common sense in sending the results of a life-altering test in the mail. "Communication of a diagnosis is a critical and high-level act," notes Dr. Sam Mikial Chair of Professional Affairs at the Canadian Psychological Association. Conveying a diagnosis is a controlled act in many Canadian jurisdictions. Only specific individuals with proper training are allowed by law to give a patient a diagnosis.
  "Any type of health diagnoses must occur in a context of the person as a whole," notes Mikial. You can not "simply communicate a diagnosis based on a laboratory procedure without a full understanding of the health history, the patient's preparedness, level of education, cogitative capacity and their ability to understand what's being conveyed."
  Mikial believes that "To send the results of a health test, to an individual, in the mail does them a significant disservice. When you send someone the results of a laboratory procedure, they may assume that it is a diagnosis, but that is not true, it is just one piece of information that you may use to build a larger understanding and arrive at a diagnosis."
  "Any lab procedure whether it's a blood test, X-ray, CT scan or personality inventory, only gives you a probability," notes Mikial. "To operate with and use only one piece of information in most instances is an irresponsible thing to do, it can be quite misleading and quite dangerous."

Lanny Boutin is a freelance writer living in Gibbons, Alberta.

Posted: June 18, 2001
Updated: June 20, 2001

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