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Sustiva Seems to Cause Prisoners to Wrongly Test Positive for Marijuana Use

By Enid Vázquez

November/December 2001

Inmate Efrain Campbell was eagerly looking forward to finishing his six months in solitary confinement following a fight at Illinois' Pontiac Correction Center (PCC). But then his drug tests kept coming back positive. He was accused of smoking marijuana and it was determined that he should be held another six months in solitary. At the same time, prisoner advocates learned that more than a dozen other prisoners at three different Illinois prisons were found to have "dirty drops" for marijuana, and were being punished by being put in solitary confinement or losing months of good time (which would have reduced their prison sentence). One inmate lost six months of good time and six months of contact visits. Like Campbell, each prisoner was HIV-positive, and each was taking the anti-HIV drug Sustiva (efavirenz).

Sustiva is known to make people wrongly test positive for marijuana use (called "false positive" results). But here the story gets tricky, and the crisis for the prisoners builds. (Remember when you see the word "assay" that it means a test.)

The Sustiva package insert is ambiguous: "False positive test results have only been observed with the CEDIA DAU Multi-Level THC assay, which is used for screening, and have not been observed with other cannabinoid assays tested, including tests used for confirmation of results." That makes it sound like Sustiva manufacturer DuPont Pharmaceuticals tested the med against all marijuana tests. In fact, the company did not do so, and it did not look at the test used in Illinois prisons, DrugCheck 5. DuPont only looked at three marijuana assays. The other two tests measured were Cannabinoid Enzyme Immunoassay from Diagnostic Reagents and AxSYM Cannabinoid assay from Abbott Laboratories.

This helps get the Illinois Department of Corrections (IDOC) off the hook for civil rights violations. In a letter to a prisoner advocate group, IDOC Deputy Chief of Institution Operations Larry Sims wrote that, "The Department is currently unaware of any scientific evidence to suggest that the DrugCheck 5 reacts to Sustiva by rendering a false positive. Research conducted by DuPont reflects that only the [CEDIA DAU] assay has been identified as creating false positives. Other assays do not cause false positives. The Department will continue to monitor this situation in an attempt to determine if a further investigation is warranted." But advocates say IDOC has done nothing.

In the midst of the Illinois crisis, the purchase of DuPont by Bristol-Myers Squibb was finalized on September 26. That left DuPont staff scrabbling, and allegedly unable to run lab tests to see how the Illinois marijuana test functions with Sustiva. But David Rosen, associate director of public affairs for DuPont Pharmaceuticals, said that the DrugCheck 5 package insert clearly states that a confirmatory test must be used and that it is up to IDOC to run those tests. He notes that even the CEDIA DAU test states that a confirmatory test must be given following positive results. The package insert for both tests states that, "The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical consideration and professional judgment should be applied to any drug abuse test result particularly when preliminary positive results are used." Rosen also said it is up to the DrugCheck 5 manufacturer to test Sustiva for interactions. He said DuPont will look into changing the wording of its package insert, which requires approval by the Food and Drug Administration (FDA), and that such a change might be able to go into effect immediately.

In memos, prison healthcare providers reported simply that, "We have been directed from Office of Health Services that positive drug screens are a security issue, and we are not to get involved" and "Per the Office of Health Services, we can confirm for security you are on the medication but whether it causes false positive is not a medical issue." [Emphasis in the original.]

In a letter to IDOC director Donald N. Snyder, Jr., Charles A. Fasano, staff associate at the John Howard Association (a prison reform organization located in Chicago), explained that, "If use of a prescribed medication such as Sustiva, which is essential in AIDS treatment [as they are all], caused any false positive test results, inmates will be placed in a position of having to choose between punishment in segregation and prolonging their lives with a medication that leads to their placement in segregation." He adds that prisoners refuse to continue taking their Sustiva, "for fear that they will fail further random urine tests."

Prisoner advocate Dick Helms, also at the John Howard Association, says, "How can all of these people be flunking the test? That's too much of a coincidence." Prisoners taking Sustiva can contact Helms at the association, 300 W. Adams, Chicago, IL 60606; or Jackie Walker, National Prison Project, American Civil Liberties Union (ACLU), 733 15th St. NW, Suite 620, Washington, DC 20005. In the meantime, it is obvious that prisoners and others, such as people on methadone, need to reconsider going on Sustiva.

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