WASHINGTON (AP) — An ever-increasing number of Americans are using medical kits that let them check for high cholesterol, colon cancer and even the AIDS virus without having to leave the privacy of their homes.
Yet the government has no policy to guide decisions on when these increasingly sophisticated tests — with their sometimes emotionally charged results — go beyond the routine and demand a doctor’s interpretation.
“It becomes a matter of social policy — what is an appropriate test for an individual to engage in themselves?” said Wayne Pines, a former Food and Drug Administration official who is a consultant to the medical device industry.
Now, an Atlanta housewife who wants to sell worried parents a test to check their children for drug use is again forcing the FDA to grapple with that policy question.
The home drug test has “got a lot of people thinking,” Pines said.
Amid sweeping changes in the U.S. health care system, Americans are growing more aggressive about making their own medical decisions. They spent more than $1 billion on home tests last year, a 13 percent jump from 1994.
The FDA regulates the effectiveness of home tests and makes sure laymen can use them and understand the results. Some decisions about some tests are straightforward, like pregnancy tests where chemically treated strips simply change color in urine samples.
Others pose more complicated challenges. The FDA wrangled for almost six years over whether Americans should be allowed to mail their blood samples to a laboratory and learn over the telephone if they had the AIDS virus. The FDA approved a home HIV test this year only after phone counseling was added.
Even after that experience, the FDA failed to set a policy on how to balance rapidly evolving tests with the social concerns of how and when to sell them directly to laymen.
Will patients be hurt if tests are wrong? When do they see a doctor? Could they force a test on a family member? More basic, are there some tests — like those that detect genetic flaws that might cause incurable diseases — that laymen should never use?
The agency again faces these unresolved questions because of the Atlanta woman’s home drug test.
After Sunny Cloud caught her son smoking marijuana, she created kits to help other mothers diagnose teen drug use. The $40 “Parents Alert” kits contain a cup to collect urine, a package to mail it to a federally certified laboratory and a toll-free telephone number where Cloud provides the lab’s test results.
The FDA says Cloud violated federal law by selling more than 1,000 of the kits without its knowledge. But after congressional complaints that the FDA was being paternalistic, the agency let Parents Alert stay on the market until the government re-evaluates how strictly to regulate it.
Scientific experts are expected to meet within two months to debate whether the FDA should simply check that Cloud uses reliable test methods and explains them to parents — or whether it should consider broader social questions, including whether false results create family strife.
Twice before, the FDA has opposed home drug tests for fear of “potential adverse consequences in parent-child or spousal relationships” if the test falsely detected drug use. Each time, top agency officials were divided over whether they should even consider such social concerns, but never settled the issue.
The impasse shows the FDA can’t “meet the needs of the … market of the 21st century,” said Rep. Richard Burr, R-N.C. He was outraged that the FDA suggested parents couldn’t handle the tests as capably as doctors.
Cloud says her test doesn’t need FDA scrutiny because it is identical to ones employers already give workers. Those tests are unregulated because they’re used only for employment decisions, not medical diagnoses.