Consumers Slow to Accept Their Doctors in a Kit : Do-It-Yourself Medical Tests Encounter Public Resistance and Doubts About Reliability
Until a few years ago, the only health-care diagnostic device in most home medicine cabinets was the lowly thermometer. For anything more complicated than confirming a fever, most Americans had to consult their doctor.
Thanks to advances in biotechnology, there are now simple at-home tests to detect pregnancy, monitor blood-sugar levels and detect signs of colon cancer--all without seeing a doctor.
And within a year, manufacturers expect to begin producing a second generation of tests that may be able to detect everything from strep throat and certain kinds of cancer to sexually transmitted diseases and allergies.
The tests are being hailed as an important advance for consumers, who have long been concerned about high medical costs. But as the $150-million-a-year home health diagnostic industry prepares to go into high gear, someanalysts wonder whether the Space Age technology can be made inexpensive and reliable enough for widespread consumer use.
Others doubt whether anybody besides a hypochondriac is really interested in routinely playing medical sleuth.
“There’s a mass segment of people out there that don’t care much about their health unless something goes wrong,” said Frederick H. Navarro, research operations manager for Peabody Marketing Group, a health-care market consulting firm in San Francisco. “Generally, people treat their health like they treat their cars.”
Only a year ago, the New York-based consulting firm Frost & Sullivan optimistically predicted in an exhaustive 235-page study that self-diagnostic products “are expected to achieve . . . dramatic sales growth.” The report cautioned, however, that it was uncertain how soon the fledgling diagnostic test market might take off.
At the time, Personal Diagnostics of Whippany, N.J., boldly predicted that its sales would top $7 million in 1985 for a line of tests for urinary tract infections, diabetic blood glucose imbalance and fertility, as well as tests for strep throat and pregnancy.
But the tests have yet to hit the market, according to Peter Meserol, executive vice president of Personal Diagnostics. And a year after the predictions of prosperity for home diagnostic kits, the market is still largely dominated by a handful of tests for pregnancy and ovulation.
Manufacturers have encountered a host of obstacles.
A skeptical medical community is worried about the effect of the tests on their business. A federal government agency says some tests are undesirable for consumer use. Meanwhile, there are still technical hurdles to overcome in order to make the tests reliable and easy to use. But even if tests are made 95% accurate, makers fear liability problems.
In addition, a major problem may be that Americans aren’t as concerned about their health as is widely assumed.
Health Strategies Group, a New York consulting firm, issued a report in 1983 that said that only 34.3 million Americans visited their doctors in 1982 to get a checkup and that just 13 million purchased any medical or surgical supplies for home use.
“As much as 70% of the adult (U.S.) population is relatively complacent about its health,” the report said.
Meanwhile, demand for colon cancer tests--actually a test for blood in the stool--has been lackluster, some manufacturers say. And the test is far from perfect. It tends to miss bleeding in about 25% of colon cancers and up to 50% of polyps, experts say.
The nation’s 7 million diabetics still rely largely on urine tests to measure glucose in the blood, said Miles Laboratories spokeswoman Deloris Cogan, despite the availability of more accurate home blood tests from Miles and other makers. The newest tests cost about $15 for 25 chemically coated plastic strips. When blood from a pricked finger is applied to a strip, the strip changes color to indicate the level of glucose in the blood. The sole over-the-counter venereal disease test--VD Alert for gonorrhea--can only be used by men and requires users to mail in samples and wait nearly one week for results.
Sales have been sluggish says the maker of the test, Bellbrook, Ohio-based Medical Frontiers.
Mary Guinan, associate director of sexually transmitted disease division of the federal Centers for Disease Control, said the agency is “against home testing for sexually transmitted diseases” and is studying whether other kinds of medical diagnostic tests are also undesirable for consumer use.
“One of the ways we rid ourselves of disease is by treating people appropriately,” said Guinan. “If a patient tests him- or herself and the test is negative, that doesn’t mean they don’t have a disease. The symptoms of gonorrhea and chlamydia are similar. These tests can give a false sense of security.”
That prospect worries some companies such as Quidel Inc. in San Diego.
“What if you give your child a strep throat test and you get a negative result and you don’t go to the doctor; then the child comes down with serious complications?” John Stewart, the company’s chief executive officer, asked rhetorically. He said Quidel wants to sell home tests but is worried about potential lawsuits.
Physicians have also expressed concern about having their business diverted to the drugstore. But their anxiety has been tempered so far because there doesn’t seem to have been any big cutback in testing in physicians’ offices and labs.
Laboratory and office testing for pregnancy has actually increased despite the availability of home pregnancy tests, according to many commercial labs and a survey conducted by the New York-based health-care consulting firm Channing, Weinberg & Co. Some experts, however, link the increase to a rise in defensive medicine and doctors ordering more tests to avoid lawsuits.
Proceeding Cautiously
Still, because of these obstacles, manufacturers appear to be proceeding cautiously on introducing tests for cancer, strep throat and sexually transmitted diseases, such as chlamydia, syphilis and herpes.
“This is a damn tough business, putting all of this technology into the hand of consumers for less than 10 bucks,” said Peter Meserol, executive vice president of Personal Diagnostics.
Added George B. Rathmann, president of Amgen in Thousand Oaks: “The home testing market was a little scary because of the questionable demand, so we decided to focus more strongly on” developing better tests for use by physicians in their offices.
What triggered the initial optimism over home diagnostic testing was the discovery of monoclonal antibodies. These molecules can be biologically coded to latch onto certain substances in the body or onto disease-causing agents--much like a programmed missile can hone in on a specific target.
But the clever antibodies are not enough by themselves. Once they seek out, say, an infection, there’s still the problem of communicating to the person being tested a simple yes-or-no indication of whether an infection is present.
One of the new pregnancy tests uses a color change to indicate a positive result. A day after a woman has missed a menstrual period, she can mix her urine with a solution of the monoclonal antibodies which react to a hormone produced during pregnancy. If the hormone is present, the antibodies bind to it and trigger a chemical reaction in the solution. If the fluid changes from red to clear, pregnancy is confirmed.
Tests can put off the squeamish, however.
C. B. Fleet Co., a Lynchburg, Va.-based maker of a home test for hidden blood in the stool, was flooded with inquiries about their test after President Reagan underwent surgery last July for the removal of a polyp from his colon. But a surge in sales never developed.
Uncomfortable Subject
“The telephone inquiries are still high,” said Fred Wickis, new-products manager. “But for a lot of people it’s an uncomfortable subject.”
Carol V. Hall, an analyst for Sutro & Co. in San Francisco, said she still has hopes for the industry. She said new-generation tests using monoclonal antibody technology should begin hitting stores late this year when the first over-the-counter strep throat becomes available.
“The market is still developing,” she said.
Abbott Laboratories and Tambrands Inc. have indicated that they are still interested in developing over-the-counter tests for sexually transmitted diseases. Abbott, which is rumored to be close to introducing an at-home strep throat test, made such a test available for physicians’ use in April, said a spokesman.
Personal Diagnostics thinks some of the accuracy problems encountered by the first-generation tests can be overcome by using inexpensive watch-size electronics to read results, rather than leaving interpretation of test results to human judgment.
Since the Food and Drug Administration approved the first home test--for pregnancy--in March, 1977, there have been about 69 diagnostic chemistry tests approved for home use. The most popular and accurate have been the six pregnancy tests and the two ovulation tests that rely on monoclonal-antibody technology.
Marcia A. Kean, a vice president at one of the nation’s largest testing labs, Damon Corp. in Needham Heights, Mass., is one of thousands of women who have purchased a pregnancy test. She purchased one two years ago after becoming impatient that she couldn’t get tested right away at her doctor’s office.
Tests Are Faster
“I just couldn’t wait,” explained Kean, who is married, has one child and is expecting another. Using the test “was just faster than going to my doctor.”
But an official of one of the nation’s big commercial medical testing labs is not concerned about the potential threat from home diagnostic tests.
“I don’t think they (home tests) will have a huge impact,” said Joseph C. Isola, group vice president and general manager of Damon Corp.’s clinical labs division. “If a patient takes a home test a lot of times, he’s going to have trouble getting a good sample and he’s still has to go to a physician. Once the physician gets involved, he’s got to make sure that the (home) test was done accurately and appropriately. That generates another test.”
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