Controversy surrounds home monitoring and diagnosis

BMJ 1996; 313 doi: (Published 30 November 1996) Cite this as: BMJ 1996;313:1354

Over the past 20 years home monitoring of medical conditions has proliferated in the United States, but the growth now is creating criticism from both patient groups and doctors. Home monitoring began with the support of doctors. They believed that when patients monitor their own health progress they have goals to aim at, thus increasing compliance with medical regimens.

The first monitoring was innocuous—thermometers to gauge the effects of antibiotics and bathroom scales to monitor the effects of treatment for congestive heart failure. Then came home glucose monitors, relatively inexpensive kits (less than $100; £70) that help diabetic patients to adjust their own insulin. Home pregnancy kits have become a staple item for many Americans seeking to become pregnant, and kits that detect ovulation are critical to successful conception for couples with infertility problems.

Despite the undoubted benefit of these tests, newer home health monitoring devices have raised questions. Many Americans now monitor their cholesterol concentration and blood pressure at home, and some doctors report that patients check their levels much too often causing undue anxiety.

But true public debate over home monitoring opened this year with the introduction of two new home tests.

The first of these was home testing for HIV infection. This spring the US Food and Drug Administration allowed the marketing of two such tests, one by the pharmaceutical company Johnson and Johnson and another by Home Access Health Corporation. The kits cost about $40, and they are not so far truly home test kits. They are bought at pharmacies and include a blood lancet and a paper blotter to collect the sample. The blotter is sent to a central laboratory, along with an anonymous identification number, and the results are available on a telephone recording within three business days.

Many HIV activists have opposed this method of testing. They say that people should receive the test results in person from a health professional, not a telephone recording. Furthermore, even though the recordings given to those with a negative result describe the need to use caution in sexual practices and explain the window between infection and antibody production, the critics claim that most people, on hearing that their result is negative, will simply hang up before the six minute recording has run.

But public health leaders say that at least 60% of Americans at risk of HIV infection, an estimated 30 million people, have not been tested. Officials from Johnson and Johnson say that the $40 price tag is not too high for poorer Americans, who are at highest risk of infection. During early marketing tests in Florida and Texas, both Afro-American and Hispanic people bought tests far out of proportion to their numbers in the population. And 85% of those whose result was negative did listen to the entire educational recording.

The second home test to receive widespread criticism is the home drug test that is marketed to parents of adolescents. American parents are extremely concerned with drug use among their children—some have even taken their children to hospital emergency departments for mandatory drug tests, at a cost of up to $1000. One such parent, high school teacher Sunny Cloud of Atlanta, began to sell a home drug test costing about $40 that detects marijuana, barbiturates, cocaine, amphetamines, phencyclidine, opiates, and benzodiazepines. As with the HIV home test, the specimen (in this case, urine) is sent to an approved laboratory, and confidentiality is maintained through coded identification numbers.

The Food and Drug Administration has objected to the test, saying that it has not met the agency's approval for home medical tests. Supporters maintain, however, that the test is identical to those already approved for and in use by employers, sports organisations, and even the federal government. And leaders in Congress are apparently lobbying the administration to allow use of home tests.

But the administration does have the support of the medical community. Richard Heyman, chairman of the American Academy of Pediatrics' committee on substance abuse, told the American Medical Association that the test “is an inappropriate way to do detection work.”

The results may be inaccurate because the child may give a false urine sample if unobserved and parents may have a false sense of security. Perhaps more dangerous are the problems with false positive results, which could result in unfair punishment, perhaps even child abuse. Moreover, the test only detects drug use. It does not diagnose the cause, which may include depression, anxiety disorders, or attention deficit disorder.—JOHN ROBERTS, Washington

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