Pubdate: Thu, 25 May 2000 Source: Metro (CA) Copyright: 2000 Metro Publishing Inc. Contact: http://www.metroactive.com/metro/ Author: Dara Colwell STICKER SHOCK A Popular New Drug-Testing Technology Hits The Streets--Or In This Case, The Arms--Of People Being Tested For Illicit Substance Abuse. But While Santa Clara County Is Sold On The Patch, Others Feel The Results Are Shaky At Best. Sandra, a robust and handsome Latina with long tinted hair and a mouth carefully outlined in black, touches her right shoulder with a scratching motion. "Here's where they put it," she says, separating her fingers two inches apart to measure the space. "It left me with circular rashes. I'd poke it with a pen because it irritated me." Sandra is talking about "the patch," a relatively new drug-testing device resembling a giant Band-Aid, which collects sweat that is then screened for illicit drugs. Sandra wore the patch on alternating shoulders week in and week out for almost a year in hopes of regaining custody of her son. Sometimes it visibly stuck out of her T-shirt. Sometimes Sandra just wore long sleeves to avoid explanations. When the patch results were delivered to the court, Sandra was aghast to discover that five of 20 patches in a six-month period had read positive for methamphetamine, a drug she swears she hadn't used for more than four years. Only when she lost the right to have her child returned to her did Sandra question the patch's validity as a drug test. While there were other factors involved in her case, Sandra feels the patch results damaged her chances for reunification with her son in court. "I felt that I lost against the county for that," she says. "I would have done urine [testing], knowing it was more accurate." SANTA CLARA COUNTY started using the device three years ago to monitor drug use by parents of children who have been removed by Child Protective Services. And while the use of the patch is voluntary, most parents who opt to use it have no idea of the growing controversy surrounding it and particularly of its rate of false positives that may be damaging to their cases. Gary Proctor, supervising manager of the Department of Legal Services, which represents families in juvenile dependency court, believes the patch's reliability lacks a solid scientific foundation. "Legitimate research has created some significant doubts," Proctor says. "The [Santa Clara County Superior] court has seen fit not to use it as an exclusive method." While the federal court system has approved of its use, the state appellate courts have yet to determine the patch's broader application. In California, each court must decide independently whether or not to use the patch. DEVELOPED BY Menlo Park-based PharmChem Laboratories, the device looks like a nicotine patch--only with serial numbers printed across it. Developed as an alternative to the urine test, the patch was tested on a trial basis by California probation officers in 1992. "Urine tests have been the basic standard throughout the industry," says Gary Evans, Santa Clara County Social Services drug testing coordinator, "but there are certain problems in its use." Such problems include what Evans refers to as "substitution"--when a person substitutes pure or drug-free urine for his or her own, usually by hiding it on the body. "It happens quite frequently," he says, noting that workers at Combined Addicts and Professional Services (CAPS), one of the agency's main drug testing services, have observed hidden balloons or condoms falling out of female clients as they urinated. Other major obstacles in testing urine accurately are the common practices of adulterating urine by taking something orally to interfere with or taint the test results, and "flushing," when a person drinks a large amount of liquid beforehand, which dilutes the sample. "I've talked to people who have told me--and they're proud of it--that they could cheat," Evans says. "You can cheat urinalysis, but you can't cheat the patch." PharmChem president Joseph Halligan believes the patch is more effective because of its long test period. "A urine test takes a picture in time--in other words, when you go in for a urine test, you're only looking at that urine sample," he says. "When you wear the patch, it's monitoring you seven days a week. What you've got is a monitoring device replacing the equivalent of eight drug tests a day." PREPARATION FOR the patch starts with cleaning the skin to remove excess oils, sweat and possible drug residue from its surface. As I watched the technician apply it to my arm, I felt slightly ill at ease. The serial number, reminiscent of a Nazi tattoo, made the otherwise innocuous-looking device seem rather sinister. I forgot about the patch until hours later, when a friend pointed to a sliver that had edged out from under my sleeve. The patch, which PharmChem began marketing in 1992, consists of an adhesive plastic membrane that holds an absorption pad in place. The membrane allows moisture molecules to travel through and let the skin breathe, while trapping larger drug molecules inside. It is usually worn from seven days to two weeks. Once removed, according to PharmChem, the adhesive film can't be reapplied. A "tampered" patch is automatically considered a "dirty" or positive drug test. The patch is then sent to PharmChem and the results are delivered in a week. Whenever there is a positive result, the specimen is tested again. The second confirmation method, called GC/MS (for gas chromatography/mass spectrometry), is the same process used in regular urine testing. Unlike urinalysis, which can test thousands of different substances, the patch screens for the five federally mandated drug classes in workplace drug testing: cocaine, opiates, amphetamines, marijuana and PCP. According to Neil Fortner, vice president of lab operations, the patch is something "cheaters" can't buck. "Most drugs are excreted out of the body within a few days. The patch retains the drug," he says. The federal government has used the patch since 1998 on pre-trial defendants, individuals under supervisory release and parolees. Although the patch is not FDA-approved as a medical device, PharmChem can legally market it. The FDA doesn't regulate drug tests for forensic purposes. While I intended to keep the patch on for a week and have it tested, by the second day, the skin under the patch felt tight. As I showered and rubbed at it distractedly, I tugged a small section of the adhesive off. When it wouldn't reseal, I decided to pull it off completely. My skin looked blotchy and aggravated. The rash remained for a few days. SANTA CLARA COUNTY'S adult probation unit, which has been exploring its potential use, has decided against the patch--for the time being. "It hasn't been proven as reliable [as urine tests]," says Kathy Cordova, management analyst for the San Jose Police Department's public information office. Until the Superior Court determines that its use is appropriate, Cordova says, the county's law and justice agencies are considering other available options. They will release a report to the Public Safety and Justice Committee in August, she says. John Michael Schlim, general manager of Schlim, McCabe & Associates in Fremont, has been in the urinalysis business since 1985. He says he still lacks confidence in the patch's accuracy over urine testing. "Everything is compared to the urine test," he points out. "That tells you how accurate it is. I'm not comfortable with the patch yet." PharmChem is currently the only lab in the United States that is authorized to conduct testing on the patch. It tests over 3 million specimens a year, according to the company's website. This makes Schlim uncomfortable. "Even if it's 99 percent accurate compared to urine--as they say--we cannot afford to be inaccurate in this industry," he says. "If we are, someone could lose their child, their job, or go to jail." A 1 percent error rate in the patch translates into 30,000 errors per year. The mounting concern over false positives attracted lawyer Daniel Abrahamson's attention. Abrahamson, head attorney at San Francisco's Lindesmith Center, a research institute focused on drug-policy issues, has followed the patch's use for years. He says the technology hit the market long before evidence proved its efficiency. "There is no government oversight and no independent testing on the patch," he says. "There's only one producer and marketer. It's a monopoly. [PharmChem] runs the show." Abrahamson says he has met more than 80 individuals who either lost their children or whose probation was revoked when they didn't test drug-free on the patch. The results to their lives, he says, have been "devastating." Fred Smith, professor of forensic science at the University of Alabama at Birmingham, conducted several studies on the patch to determine how easily the device could be contaminated. In a report presented to the American Academy of Forensic Sciences in February, Smith concluded that the patch could be adulterated externally by drugs in the wearer's immediate environment. "Virtually every currency bill circulated in the U.S. has a trace of cocaine on it," he says. "It's well-known that drugs are pervasive in our environment." Add to that the presence of alkaline products, such as Windex or certain types of soap (which can alter the patch's pH), and external drugs, all of which can diffuse into the patch's membrane and cause positive results, he says. "Insufficient testing has been done to justify its [the patch's] introduction as a method for drug testing that produces punitive results," Smith says. AS A SOCIAL WORKER, Gary Evans emphasizes that Child Protective Services uses the patch in hopes of keeping families together. "I like to show the court that the person is not using [drugs]," he says. "The majority of people who wear the patch never come up dirty, never." Child Protective Services' priority, he says, is using a method that is less intrusive and more convenient. "We don't have to observe clients urinating and they only have to come in once a week." That's why Sandra decided to follow her social worker's suggestion. "I thought it would be more convenient [instead of] coming in for random urine tests," she says. Worried that the county equated both "tampered" patches and no-shows with positive results, Sandra insisted on taking urine tests along with the patch. On at least one occasion, her urine test came up negative at the same time the patch tested positive. But Sandra only learned of this in court. "My social worker assumed I was in denial," she says. "She told me, 'You can get help.' I thought, 'What does she know that I don't?' " While PharmChem will not release a list of its clients, Danna Fabella at Contra Costa County's Children and Family Services tells Metro that her agency still uses the patch in some cases. "We still use the drug patch for working families that can't get to the urine site," she says. Fabella explains that Contra Costa County used the patch more broadly two years ago. But a number of clients contested the results in court, claiming they received false positives. "Rather than spending all our fiscal resources and energy refuting [their claims]," Fabella says "our policy now is to offer the patch as an option." In the meantime, Santa Clara County Child Protective Services continues to conduct drug testing with the patch. Evans feels the patch ultimately allows his agency to keep children safe. "We understand that these tests may affect someone's life," he says. "So we are extremely careful." - --- MAP posted-by: Doc-Hawk