The Associated Press - Monday, October 14, 1996.
Lauran Neergaard, Associated Press Writer

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.

And Cloud insists she wouldn't sell an untrustworthy service. "I'm a mom. I don't want to confront my child" with an incorrect drug test, she said.

But Georgetown University testing expert Sorrel Schwartz says every laboratory makes mistakes. The test also can falsely detect drugs if someone ingests something as innocent as a poppy-seed bagel.

"It's not oversight for paternalism, it's oversight to make sure people understand," Schwartz said.

Still, Cloud's case may be easy compared with other tests headed for the home. Now in development are kits to track cancer growth and make on-the-spot diagnoses of cocaine use.

"People are developing tests that are faster, easier and lend themselves to being used in less and less sophisticated environments," acknowledged Dr. Susan Alpert, FDA's chief of medical device evaluation. "We know it's coming."

961014
AP961017

Copyright © 1996 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, Pacific Life Foundation, and donations from users like you.

Always watch for outdated information. This article first appeared in 1996. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1996. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .