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Testing Testing: Sweat Patch Under Scrutiny

Sheryl Woodhall a California woman in her late 30s, first lost custody of her four children in 1995, when her youngest tested positive for methamphetamine at birth. The state's Child Protective Services intervened and sent her two older children to live with her parents and placed the younger two in foster care. Woodhall, who acknowledges that she struggled with drug addiction for years, went into a residential treatment center, then to an outpatient program. In October 1998, she got her kids back three days a week under the condition that she continue regular drug testing.

CPS suggested that Woodhall wear a sweat patch, a new drug-testing technology, to show Judge Lois Haight, who was presiding over the custody case, that she was staying clean. The judge believes in this patch," a social worker from CPS told her. Woodhall's first patch fell off, and she lost it. Her second patch came back positive for methamphetamine. So did her third one.

The sweat patch was supposed to solve the problems of urinalysis, but it created a host of its own problems.

Woodhall was ordered back to court. Although random urine tests performed by her outpatient program during the same period of time all came back negative, her three days a week with her kids were reduced to one a month. The judge ordered her to continue wearing the patch, and she repeatedly tested positive. In March 1999, the court held a hearing to determine whether to grant a request by the state that Woodhall's four children be placed in foster care because of her positive drug tests. At the proceedings, the prosecutor called Neil Fortner as an expert witness to testify on behalf of the patch's reliability. Fortner was an employee of PharmChem, the Texas-based commercial laboratory that markets the sweat patch.

Based on the positive tests and Fortner's testimony, Judge Haight granted the state's request and terminated Woodhall's parental rights. The patches were positive and that's what she was going with," Woodhall said recently. I could have taken a hundred urine tests and it wouldn't have mattered.
Drug tests have been a regular event in the lives of many Americans since the Reagan Administration launched its War on Drugs in 1986. All told, about 25 million people are tested in the United States each yearas a prerequisite for serving in the military, piloting a commercial airliner, operating a forklift, selling kitchenware at Wal-Mart, or playing on the high school football team.
Until the late 1990s, substance-abuse screening for people convicted of federal offenses had been done almost exclusively through urinalysis, considered the gold standard because of the refinement and standardization of its testing protocol after decades of scientific scrutiny and government oversight. In use since the Army began screening personnel with it in 1972, urinalysis is the only method used to test the millions of federal workers in safety-sensitive positionsmainly Department of Transportation employees, law enforcement agents, and officials involved in national security mattersfor whom substance-abuse screening is mandatory.

But urine testing isn't perfect. It's time consuming and invasive: In the federal justice system, a probation officer is often stationed in the bathroom when the sample is given to prevent tampering. Urine testing provides only a snapshot in time," detecting drug use during a period that may cover as few as 72 hours, depending on how quickly the drug moves through the offender's system; stimulants like cocaine and methamphetamine may disappear from the body in less than two days.

Urine samples are also highly susceptible to tampering and contamination. Anyone with access to the Internet can visit dozens of websites offering everything from dehydrated drug-free urine samples to advice on which over-the-counter and prescription medications are most likely to mask the effects of substance abuse.

PharmChem's sweat patch has undeniable advantages over urine testing. Worn on the upper arm, the patch looks like a big Band-Aid and works by trapping sweat excreted by the body in an absorbent pad. Once the patch is removed, the adhesive is thrown away and the pad is taken to a laboratory, where the collected sweat is analyzed for drug content. Wearing a patch is less embarrassing than peeing into a cup under supervision. Since the patch can stay on the skin for up to two weeks, it provides continuous monitoring by retaining all drugs used during the time it is worn, catching users who would beat" a urine test by getting high sporadically or by flushing the drugs out of their systems.

These advantages have made the sweat patch a popular alternative to urine testing. Since the mid-90s, state and federal governments have used the patch to test thousands of people, mainly criminal defendants and parents like Sheryl Woodhall who are battling a state for custody of their children.
Nowhere is drug screening more common, or the consequences more severe, than in the federal criminal justice system, where most offenders must submit to drug tests on a regular basis as part of their probation or supervised release (the equivalent of parole), with the understanding that they will face jail time if the results come back positive. The Administrative Office of the U.S. Courts, the agency that manages the federal judiciary and criminal justice system, authorized its probation departments to use the patch to test federal offenders in the fall of 1998. Two years later, the agency was still wholeheartedly endorsing the new drug-testing technology. Administrative Office director Leonidas Mecham stated in a September 2000 memo that the patch had been deemed superior" to urine testing for the detection of cocaine and amphetamines.

Federal probation offices were convinced that the sweat patch was more convenient and reliable than urinalysis. At the height of its popularity, more than 80 percent of federal probation offices used the patch in some capacity. Recently, however, the federal system's use of the patch has come under attack by defense attorneys who have challenged the patch's reliability. They have questioned whether PharmChem's financial stake in the patch's success may have led it to make claims about the product that have been contradicted by the company's own research.

Pharmchem's CEO, Joe Halligan, declined to answer questions about the sweat patch, referring all inquiries to the company's lawyer, who despite requests made over the course of several weeks, did not provide any answers. But PharmChem is a publicly traded company, and the battles over the sweat patch have taken place in courtrooms nationwide, so the story of the technology that was supposed to replace urinalysis can be traced through public documents and the experiences of lawyers on both sides of the sweat-patch cases.

PharmChem began marketing the sweat patch as a drug-testing device in 1992, funding studies to establish that it was capable of isolating five commonly abused drugscocaine, amphetamines, opiates, phencyclidine (PCP), and marijuana. The studies were submitted to the FDA, which cleared the patch as a screening device for all five drugs in July 1995. Before acquiring the rights to the patch, PharmChem had mainly provided urinalysis testing services; by 2000, it had grown into a company with more than 300 employees that generated nearly $40 million in annual revenue and maintained laboratories in Menlo Park, California and London.

Between 1992 and 1996, the company invested heavily in the sweat-patch technology, spending over $4 million on marketing, research, and development. Its expectation was that the sweat patch would become a popular tool in the company's drug-testing arsenal as its use spread from the criminal justice system to the federal workplace and the private sector, where the demand for drug-testing services was steadily increasing, along with the potential for profit.

Although PharmChem has long provided drug-testing services to the private sector, nearly half of its business comes from contracts with criminal justice agencies. Its most lucrative contract remains the one it struck with the Administrative Office. Criminal defendants in the federal system may be tested by urinalysis or any method of equivalent accuracy." Aaron Lucas, a probation administrator in the Administrative Office, noted that his office did not approve the sweat patch for testing on federal offenders until some three years after the FDA had cleared it for the market.

In the interim, the Administrative Office reviewed the documentation submitted to the FDA and the results of two separate clinical trials involving the sweat patch that were undertaken by the office's Federal Corrections and Supervision Department and its Office of Pretrial and Probation Services. While confirming that the sweat patch was highly effective at detecting drug usemore effective, in most cases, than traditional urine testingboth studies were field tests and therefore not subject to rigid scientific controls.

Still, the Administrative Office advised its probation officers that the sweat patch was a credible illicit drug detecting tool." Michael Severance, a drug-treatment supervisor for the federal probation office in Las Vegas, estimates that by 1999 he was purchasing approximately 800 patches annually at a cost of about $25 per patch (including the cost of testing services). We were told that the sweat patch was the Second Coming," he said. I pushed hard for it to be used in Nevada because I believed in it totally." Sales of the patch jumped by nearly 50 percent between 2000 and 2001.

But the patch's strengths were also its weaknesses. The amount of a drug that must be present in a sweat patch for that patch to be reliably judged positive (known as a cutoff level) was quite low. PharmChem's cut off levels, measured in billionths of a gram, were approximately one-thirtieth of those set by the federal government for urine testing. The patch's opponents believe that low threshold raised the risk of false positives.

Franny Forsman has been the head of the Federal Public Defender's Office in Las Vegas since 1989. Between 1998 and 2000, she litigated seven sweat-patch cases on behalf of clients accused of violating their supervised release by using drugs. In the process, she learned that the patch was perhaps too good at detecting drugs.

In 1999, Forsman began to notice similarities among her clients that led her to question the patch's reliability. Having run a drug-treatment program before becoming an attorney, she had extensive experience working with addicts. Her sweat-patch clients weren't fitting the addicts' profile.
Unlike clients who had positive urine tests, many sweat-patch clients steadfastly denied using drugs, even when those denials made them ineligible for treatment programs, resulted in the revocation of their supervised release, and exposed them to the possibility of going to jail. They had every incentive to admit they were users because there were benefits to them if they did and costs to them if they didn't.

There was also conflicting evidencemany had taken urine tests that had come back drug free, contradicting the results of the sweat patches they were wearing at the same time. Finally, many lived in homes that may have been contaminated with drug residue. Forsman began to suspect that the patch was so sensitive that its wearers didn't need to have taken drugs to test positive, they only needed to have been near them.

The environmental contamination theory that Forsman's work suggested anecdotally turned out to have scientific support as well. Dr. David Kidwell, a chemist at the Naval Research Laboratory in Washington, D.C., and Dr. Frederick Smith, the director of the Criminalistics Laboratory at the University of Alabama at Birmingham, decided to study the patch after reviewing PharmChem's FDA submissions and after listening to the complaints of Forsman and other criminal defense lawyers. There had really been no research to specifically address these questions," Smith said. He believed there were significant gaps in the work that had been done.

Kidwell and Smith thought that environmental contamination was very much a possibility, and they set out in the summer of 1999 to test the sweat patch's vulnerability to such contamination. In their experiment, they placed the equivalent of one-tenth of one percent of an average methamphetamine dose on their skin, showered, and then applied a sweat patch the following day, after cleaning the contaminated area with two alcohol wipes, as recommended by PharmChem in its sweat-patch application manual. During the rest of the week, they engaged in normal hygiene and activities, and added an additional patch each day.

In a proceeding in federal court in the fall of 1999, Smith testified that the patches he and Kidwell applied on the first day and wore throughout the week contained approximately 59 times the PharmChem cutoff level for methamphetamine. The patch applied on the final day and worn for 24 hours came back with seven times the cutoff.

Kidwell and Smith believed that some of the methamphetamine they used as a contaminant formed a chemical bond with their skin that survived normal hygiene and alcohol swabbing. That portion remained fixed on the skin until loosened by sweat, at which point it soaked into the absorbent pad and created a positive test result. They asserted that there was a distinct possibility of drugs settling on the bodies of non-drug users as they went about their normal business. They cited experiments in which items like money, furniture, and even the foreheads of children had been shown to retain trace amounts of drugs. According to Kidwell and Smith, because many patch wearers lived in drug-contaminated environmentsfor example, houses or apartments that had previously been inhabited by drug usersthe very people most likely to be tested by the sweat patch are also the most likely to be externally contaminated.

Challenges To The Sweat Patch

Relying on Smith and Kidwell's research first arose in federal court in November 1999. PharmChem insisted the claims were baseless. The company emphasized that the FDA had cleared the patch for drug testing after the agency had reviewed numerous studies. Experts for the government (often employed by PharmChem), which was using the patch as a basis to revoke the supervised release of federal offenders, pointed out that the FDA studies didn't consider the possibility that drugs in the environment could bond to the skin and cause a positive test result.

But PharmChem gave no ground, continuing to insist that thoroughly and aggressively" scrubbing the skin with two alcohol wipes was adequate to cleanse it of contaminants.

In the opinion of PharmChem toxicologist James Meeker, the amount of drug contaminant used in the Kidwell and Smith study was far greater than the amount likely to be found in the environment. He also criticized Kidwell and Smith for mixing the drug contaminant in an alcohol-based solution to facilitate its application to their skin, arguing that this type of drug transfer would never happen in real-world conditions.

The company's response in these legal proceedings was consistent with its practice of aggressively defending its testing methods. According to company documents, PharmChem representatives testify as experts in an average of 100 adversarial proceedings each year. In the first six months of 1999, PharmChem representatives testified to the reliability of the sweat patch in court proceedings in Cleveland, Las Vegas, Los Angeles, and Cedar Rapids, Iowa. In each of the cases, judges found the sweat patch reliable.

But while Pharmchem's defense of the patch was vehement, the company also relied on questionable tactics and testimony. In United States v. Stumpf, USDC Case No. 95-023-PMP, a sweat-patch case that went to a hearing in January 1999, Joseph Sullivan, an assistant U.S. attorney, called Neil Fortner, the PharmChem toxicologist who would later appear in the Woodhall case, as an expert witness. Fortner's performance, Sullivan said recently, was a nightmare.

During cross-examination, under questioning by civil rights attorney Julian Gross, Fortner acknowledged that his description of his Ph.D. as nearly completed and based on doctorate work in the area of neurochemistry at Cleveland State and San Francisco State," was not a correct statement." Fortner admitted that he had testified falsely in several earlier sweat-patch cases about his academic credentials and had misrepresented the results of several FDA studies as well.

Fortner's concessions came after Gross produced two letters, one from an administrator at San Francisco State confirming that Fortner had never been a student in any of its graduate programs, and the other from a Cleveland State vice provost who noted that Cleveland State University does not offer, nor has it ever offered, a Ph.D. program in neurochemistry." According to the second letter, Fortner had enrolled in Cleveland State's master's program in biology in 1987, but he never completed his degree and is no longer considered to be an active student." Technically, Fortner is not even a scientist," Gross said recently, and yet in a lot of cases he was the only expert who testified.

Still, Sullivan believed at the time that Fortner's statements were more of a personal failing than an indictment of PharmChem or the sweat patch. Sullivan based his assessment in part on the results of the Stumpf case itself: Although Fortner's credibility was badly damaged, the judge concluded that the patch was a reliable drug-testing tool based on the opinion of Sullivan's second expert, Dr. Edward Cone, the former chief of clinical pharmacology at the National Institute on Drug Abuse, who had impeccable credentials and no ties to PharmChem.

Cone believed the Kidwell and Smith study was seriously flawed. He testified that scientists doubling as subjects in their own experiment is not a good way to do science" because you cannot divorce your own bias from the outcome of the study," and he characterized their findings of environmental contamination as based on unrealistic conditions.

Cone argued that the amount of drug contaminant used by Smith and Kidwell was extreme" when viewed in the context of the relatively small area of skin to which it was applied. The sweat patch, in Cone's opinion, was essentially reliable. The judge agreed and found that Stumpf and his codefendant had violated the terms of their supervised release.

PharmChem's winning streak was relatively short-lived, however, thanks in large part to a case called United States v. McLemore, Case No. 95-157-LDG.

No one disputed that Marsha McLemore, a single mother in her late 30's, had made impressive strides in the 18 months since her release from prison on federal drug-trafficking charges. Even as her probation officer asked a judge to send McLemore to jail in the fall of 2000, he described her as a woman with lots of good things going for her" and ticked off a list of her achievements: holding down a job as an aide in a nursing home, caring for her 9-year-old son, and saving enough money to move into a one-bedroom apartment in Las Vegas. Michael Severance didn't want to see McLemore go back to prison but felt that he had no choice but to recommend it. She had 19 positive drug tests," he said. We had to do something.

McLemore had submitted to regular drug testing as a requirement of her supervised release. Although she was also submitting to urinalysis during the same nearly two-year period, sometimes as often as every other day, all but one of her 19 positive tests came from sweat patches; the exception was a urine sample taken over a year before the government requested that her parole be revoked. Between late February 1999 and early October 2000when the positive sweat-patch tests occurredMcLemore had submitted 109 negative urine samples at 48-hour intervals. For part of that time, she lived in an apartment that had previously been occupied by a drug user.

Sullivan nevertheless expected the McLemore case to go much as the Stumpf case had. Based on the witness list, it looked like it was going to be the same thing all over again," he said. But undeterred by Stumpf, federal defender's offices around the country had continued to press the environmental contamination issue, and a few sweat-patch cases had been dismissed.

The successful challenges buoyed Forsman, who was representing McLemore. She was convinced that PharmChem must have done studies to put the environmental contamination issue to rest once and for all; she believed that the company couldn't afford to do nothing about it, particularly when the necessary experiments were inexpensive. Several times, she asked Sullivan to retrieve any in-house studies that PharmChem had conducted prior to the McLemore hearing and turn them over to the defense as required by law.

Shortly before the hearing, Sullivan and Severance sat down with James Meeker, the PharmChem representative whom Sullivan planned to call as a witness, to prepare him to testify. Severance recalls that Meeker seemed very nervous." Severance was unsettled enough that he recalls saying to Meeker at one point, You are acting like there's a problem." But Meeker denied there was anything wrong.
Following up on Forsman's request, Sullivan asked Meeker if PharmChem had done its own studies to come up with ammunition to counter" the Kidwell and Smith article. Meeker mentioned that PharmChem had funded a study at the Center for Human Toxicology at the University of Utah, but it was not yet complete and no reports about it were available.

Meeker also told Sullivan that PharmChem had done two minor experiments of its own, one involving sweat patches whose surfaces were wetted with drugs and fixed to glass plates. The purpose of this experiment, he explained, was to determine whether drugs could penetrate the patch membrane from the outside and seep into the pad. In the second experiment he described, several PharmChem employees had worn the sweat patch under drug-contaminated T-shirts, again to test the vulnerability of the patch to outside contamination. None of the patches in either study had tested positive for drugs. Sullivan relayed this information to Forsman.

When Meeker testified at the McLemore hearing, Sullivan asked him to discuss PharmChem's internal studies once again. Meeker described the glass plate experiment and then made a passing reference to the T-shirt study. Sullivan said, Okay. So you're talking about there were two separate tests done?" Meeker responded, We've done numerous tests. OneI described one test just now, and we've done two additional types of tests, as well.

Forsman's ears immediately pricked up at the reference to a third test that she had never heard about. On cross-examination, she challenged Meeker's opinion that alcohol wipes can effectively remove all drug residue from the skin. Meeker replied that he had done studies at the lab" on that issue. You've done studies in the lab on placing drugs on the skin?" Forsman asked.

Meeker described an experiment that mimicked the study performed by Kidwell and Smith. At the highest concentration of drug applied to the skin of the subjects in the PharmChem studya fraction of the dose applied by Kidwell and Smithtwo of the five sweat patches tested positive for drug amounts above the cutoff level.

It was like bombs going off," Sullivan said. [The study] totally undermined the reliability of the sweat patch." Shortly after Meeker's testimony, there was a break in the proceedings, and Sullivan huddled with Severance and McLemore's probation officer. Neither of them knew anything about the third study. I was furious," Severance said. Meeker had every opportunity to tell us about those tests and he didn't.

Sullivan says that had he known about the study, he would not have brought the case. Unlike Fortner's statements in Stumpf, which did more to damage his personal credibility than bolster substantive claims of environmental contamination, Meeker's surprise disclosure about PharmChem's internal study went to the heart of the case against the sweat patch. Looking back on the meeting with Meeker before the hearing and Meeker's failure to give him the information he asked for, Sullivan said, My perception was that he was willing to omit the truth, but not to commit perjury.

Sullivan asked that the case be dismissed, and the judge granted his request. PharmChem made no public statement in response to subsequent coverage of the case in the Nevada press at the time. Meeker left the company shortly after the case and now works as a toxicologist at a drug-testing laboratory in northern California.

After McLemore, Severance's office no longer relied on positive sweat-patch tests in court unless there was substantial evidence corroborating a defendant's drug use. The outcome in McLemore and in United States v. Snyder, 187 F. Supp.2d 52 (ND NY 2002), a subsequent case in which the results of PharmChem's internal studies were introduced, seemed like very bad news for PharmChem and its shareholders.

In the Snyder case, the presiding judge ruled that the company's internal tests support the conclusion that the sweat patch is susceptible to outside contamination." The court's decision in Snyder is frequently cited in other sweat-patch cases as evidence that the patch is not a reliable indicator of drug use, particularly when the defendant's living conditions suggest the possibility that his body picked up traces of drugs from his environment. United States v. Alfonso, 284 F.Supp.2d 193 (D Mass. 2003) revoked a defendant's supervised release for cocaine use based on PharmChem's sweat patch, but the court indicated great unease about the reliability of the sweat patch.

It's difficult to say how much of PharmChem's financial woes have come as a result of the legal battles over the sweat patch, but in 2001, the year the Snyder case was argued, sales of the sweat patch dropped by almost 35 percent. Many factors may be at work, including the struggling economy and competition from other testing providers, but McLemore and Snyder, and the negative press coverage of those cases, suggest that PharmChem, in its zeal to promote the sweat patch and defend its reputation, served the interests of neither.

In February 2003, the company received a letter from NASDAQ stating that the value of its publicly traded stock had fallen below $1 million, the minimum amount necessary for its shares to be traded on that exchange. Unless the company's finances improved, the exchange warned, PharmChem would be delisted at the end of May.

While the market has punished PharmChem, the federal system has been slow to let it go. With the blessing of the Administrative Office, most probation offices continue to use the sweat patch as an independent basis for prosecuting offenders for suspected violations of their supervised release. The office has not changed its position regarding the sweat patch's validity, and the patch is still relied on in criminal prosecutions in 40 federal districts, including probation offices in Boston, San Francisco, Los Angeles, and Kansas City, Missouri.

PharmChem's contract with the Administrative Office expired at the end of 2002 but was extended through August 2003 while the agency goes through its usual practice of soliciting contract proposals for drug testing from interested companies. Kimberly Golder, a probation administrator at the Administrative Office, declined to comment directly on whether PharmChem's finances and the ongoing controversy surrounding the sweat patch would affect the company's chances of securing a new contract with her office. They have the right to bid," she said, just like everyone else." g

Lara A. Bazelon is a federal public defender in Los Angeles. This article originally appeared in Legal Affairs. Reprinted with permission.

[Editor's Note: In the meantime, PharmChem has potentially lost its federal office of the court's contract. The following statement was issued by PharmChem in a press release on its website,, concerning the restructuring of its bank debt: The Company believes that the Bank required these modifications because of the possible loss of all or a significant portion of the Administrative Office of U.S. Courts (AOUSC) drug testing contract which was previously announced on October 16, 2003. The Company has filed a protest with GAO seeking recovery of at least one-third of the AOUSC contract. On December 31, 2003, the Company agreed to yet another extension of the original contract whereby testing, by the Company on a national basis, may continue until April 30, 2004. The Company has granted numerous contract extensions to AOUSC since the expiration of the current contract late in 2002. Estimated sales from the AOUSC drug testing work for 2003 will be $7.4 million or 26% of the Company's total sales." The company's financial troubles appear to be continuing as in December, 2003, its stock was delisted by the NASDAQ securities exchange.

It does not appear that any prison system uses sweat patches. A pilot project in the Washington prison system in 2001-02 revealed the sweat patches caused allergic reactions to some prisoners and were readily subject to tampering, with some of the patches being removed as soon as the prisoner returned to his cell, and were affixed to wall lockers for the duration of the test.]

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Related legal cases

United States v. Alfonso




284 F. Supp. 2d 193; 2003 U.S. Dist.

August 13, 2003, Decided

DISPOSITION: [**1] Magistrate Judge's order revoking Alfonso's supervised release was affirmed.

COUNSEL: For USA, Plaintiff: Bruce C. Judge, United States Attorney's Office, Boston, MA, LEAD ATTORNEY.

For USA, Plaintiff: Peter K. Levitt, United States Attorney's Office, Boston, MA, LEAD ATTORNEY.

For Pretrial Services, Notice: Pretrial Services, US Pretrial Services, Boston, MA.




August 13, 2003

The United States Courts operate the largest drug testing program in America. Its Administrative Office has entered into a lucrative, nationwide, sole-source contract with PharmChem Laboratories, Inc. to provide sweat patches for drug testing. This motion raised important questions about the accuracy of this sweat patch method for drug testing -- questions that warrant searching scientific review.
On December 19, 2001, the grand jury returned a four-count indictment against Henry Alfonso III ("Alfonso"), charging him with (1) possession with the intent to distribute oxycodone; (2) unlawful use of a communication facility on November 8 and 9, 2001; (3) unlawful [**2] use of a communication facility on November 27, 2001; and (4) attempt to possess with intent to distribute oxycodone. Indictment [Docket No. 2]. Alfonso was subsequently released on bail with conditions by Magistrate Judge Joyce London Alexander. Order Setting Conditions of Release [Docket No. 4].
On June 12, 2002, the Government moved to revoke Alfonso's order of release due to his alleged failure to comply with certain of his conditions of his release -- namely, his failure to undergo drug treatment as well as the fact that he had tested positive (via a sweat patch) for cocaine use. Mot. for Revocation of Order of Release [Docket No. 17]. Magistrate Judge Alexander held a hearing on this motion on June 19, 2002. At the conclusion of that hearing, Magistrate Judge Alexander denied the Government's motion and instead amended the conditions of Alfonso's release, ordering him to undergo additional intensive drug treatment, to surrender his driving license, and to refrain from driving. June 19, 2002 Order on Motion to Revoke Bail [Docket No. 19].
On July 24, 2002, after more alleged violations, Alfonso appeared before Magistrate Judge Alexander for an appearance and preliminary [**3] hearing pursuant to a warrant for violation of the conditions of his supervised release. July 25, 2002 Order on Preliminary Revocation and Detention [Docket No. 23] at 1. At that hearing, the Government contended that Alfonso had violated the conditions of his release in three different ways: (1) Additional [*195] positive drug test results, taken from Alfonso via a sweat patch, indicated that Alfonso had used cocaine; (2) Alfonso had failed properly to notify the government of a change in his residence; and (3) Alfonso had intimidated witnesses by posting information about those witnesses on an internet website. Id. Based on the Government's evidence of those offenses, Magistrate Judge Alexander ordered Alfonso to be detained pending a final hearing on revocation before this Court. Id. at 2. Alfonso subsequently sought review of that order in this Court [Docket No. 26].
On October 9, 2002, this Court held a hearing to review Magistrate Judge Alexander's detention order regarding Alfonso. At that hearing, Alfonso raised concerns about the accuracy of the sweat patch drug tests that had indicated his usage of cocaine. Recognizing the gravity of Alfonso's challenge, the Court subsequently [**4] conducted hearings on October 24, October 25, and November 1 to evaluate its merits. At the close of evidence on November 1, the Court affirmed Magistrate Judge Alexander's detention order. The following memorandum serves to discuss more fully the reasoning behind the Court's decision.

A. Standard for Revocation of Pretrial Release
A person found to have violated a condition of his pretrial release is "subject to a revocation of release, an order of detention, and a prosecution for contempt of court." 18 U.S.C. § 3148(a) (2000). Where a person is charged with violating a condition of his release, the judicial officer hearing the charge shall enter an order of revocation and detention if, after a hearing, the judicial officer:

(1) finds that there is--

(A) probable cause to believe that the person has committed a Federal, State or local crime while on release; or
(B) clear and convincing evidence that the person has violated any other condition of release; and

(2) finds that--

(A) based on the factors set forth in section 3142(g) of this title, there is no condition or combination of conditions of release [**5] that will assure that the person will not flee or pose a danger to the safety of any other person or the community; or
(B) the person is unlikely to abide by any condition or combination of conditions of release.

18 U.S.C. § 3148(b) (emphasis added).
As noted above, Magistrate Judge Alexander revoked Alfonso's release on July 24, 2002, finding that Alfonso had violated the conditions of his release by, among other things, using a controlled substance (cocaine). July 25, 2002 Order on Preliminary Revocation and Detention at 2. Magistrate Judge Alexander further found that the evidence "strongly supported the conclusion that the defendant cannot conform his conduct to that required by the conditions of his release and that he poses a danger to the community." Id.
This Court's review of Magistrate Judge Alexander's order is de novo. See, e.g., United States v. Rivera, 104 F. Supp. 2d 159, 159 (D. Mass. 2000) (Gorton, J.) ("A district judge is to engage in a de novo review of a contested release order issued by a magistrate judge.").
B. The Sweat Patch: An Overview
In 1998 -- after an initial pilot program in 1996 and [**6] a 40-district-wide pilot program in 1997 -- the Administrative Office of the United Courts (the "Administrative Office") authorized United States Probation and Pretrial Services officers to use the [*196] sweat patch drug testing device as an alternative to urinalysis. See U.S. Probation & Pretrial Services, Court & Community -- An Information Series About U.S. Probation & Pretrial Services: A Brief History, at (last visited August 12, 2003); Office of National Drug Control Policy, Agency Budget Summaries, The Federal Judiciary, part V ("Program Accomplishments"), at (last visited August 12, 2003); Office of National Drug Control Policy, Agency Budget Summary, The Federal Judiciary, part V ("Program Accomplishments"), at (last visited August 12, 2003); Lara Bazelon, Testing Testing, Legal Affairs, July/August 2003, at 46.
There is a nationwide contract between the Administrative Office and PharmChem Laboratories, Inc. ("PharmChem"), pursuant to which the United States probation [**7] departments use sweat patches manufactured by PharmChem. n1 10/24/02 Tr. at 17-18; see also Bazelon, Testing Testing, at 46, 49. Since 1997, the Probation Office of the United States District Court for the District of Massachusetts (the "Probation Office") has used the sweat patch drug test. 10/24/02 Tr. at 17.

n1 PharmChem has named its sweat patch the "PharmChek Drugs of Abuse Patch."

The sweat patch essentially operates like a large bandage that absorbs sweat from its wearer. It features an "absorbent pad sandwiched between the skin and an outer non-occlusive membrane that allows water vapor to pass through." United States v. Snyder, 187 F. Supp. 2d 52, 58 (N.D.N.Y. 2002). After the sweat patch is affixed to a person's skin, it adheres by forming a bond with the skin. Id. It then becomes a collection device: "the offender's sweat wets the pad, the water in the sweat eventually evaporates through the non-occlusive membrane, and any drugs remain in the absorbent pad." Id. Once [**8] removed from the skin, the sweat patch cannot be re-attached. Id.
The sweat patch presents two main advantages over the urine tests that have traditionally been employed to detect drug use. First, the sweat patch poses fewer intrusions on the offender's privacy and schedule. An offender wearing a sweat patch need not be monitored as he urinates, nor must he face random urine tests that may interfere with his work schedule. n2 Instead, he can simply come into the Probation Office on a scheduled basis for removal of his patch and application of a new one. Second, the sweat patch has the potential to provide a more accurate picture of an offender's drug use. Whereas a urinalysis is essentially a snapshot that provides a picture of drug use over a 72-hour period, the sweat patch is worn continuously. Snyder, 187 F. Supp. 2d at 58. In addition, because of the widespread usage of the urine tests, techniques and products have been developed to "beat" them through dilution, adulteration, and substitution, thus further undermining the accuracy of urine tests. Dennis Crouch, et. al., An Assessment of the Effectiveness of the PharmChek Sweat Patch Skin Cleansing Procedures [**9] , 32 Bulletin of the [*197] International Association of Forensic Toxicologists 5, 5 (2002).

n2 In fact, Alfonso requested to switch from urinalysis to the sweat patch for precisely this reason according to the testimony of Pretrial Services Officer Judith Oxford ("Oxford"), who supervised Alfonso. See 10/24/02 Tr. at 25 ("Mr. Alfonso had indicated that it was difficult for him to come in for random urines because of his work situation and had asked at one point if he could have the sweat patch placed on him. So it would make it a little easier to come in once a week and he would be able to have a set day.").

Questions, however, have arisen over the sweat patch's potential to be contaminated by drugs other than those recently ingested by the sweat patch wearer. Although an early challenge to that effect was rejected by a district court in 1999, United States v. Stumpf, 54 F. Supp. 2d 972 (D. Nev. 1999), a similar challenge brought in 2000 -- buttressed with more evidentiary support, including the [**10] results of certain experiments performed internally by PharmChem -- prompted the United States Attorney's Office for the District of Nevada to withdraw its motion to revoke the supervised release of an alleged offender. United States v. McLemore, Docket No. CR-S-95-157 (transcript of hearing on file with Court); see also Bazelon, Testing Testing, at 48-49. On January 30, 2001, the Administrative Office sent a memorandum to probation officers and pretrial services officers advising them of the challenge, informing them that independent testing of the sweat patch was being conducted, and stating that in the meantime, PharmChem would report test results as positive only where the sweat patch result met a threshold level. Memorandum from the Administrative Office to Chief Probation Officers and Chief Pretrial Officers (January 30, 2001).
The Administrative Office sent a subsequent memorandum on the topic on May 3, 2001, in which it stated that the independent study, conducted by Duo Research had concluded that contamination -- if at all possible -- "would occur only under the most extreme exposures." Memorandum from the Administrative Office to Chief Probation Officers and [**11] Chief Pretrial Officers (May 3, 2001); see also Leo J. Kadejian & Robert E. Willette, Duo Research, Sweat Patch Testing For Cocaine: A Review of Issues and Studies, Prepared for the Administrative Office of the U.S. Courts, February 26, 2001, available at (last visited August 12, 2003). In its May 3, 2001 memorandum, the Administrative Office further noted that the Duo Research study "supported the current approach of reporting a positive cocaine test result that requires either cocaine or its metabolite, benzolecognine ["BE"], to be present at the 10 ng/ml cutoff." One of the authors of the Duo Research study -- Dr. Leo J. Kadehjian -- has apparently become a prominent expert witness on the subject of the sweat patch, see, e.g., United States v. Zubeck, 248 F. Supp. 2d 895, 898 (W.D. Mo. 2002), and, in fact, submitted an expert report in the instant motion on the Government's behalf.
Other studies have reached less benign conclusions about the accuracy of the sweat patch. In one 1999 study, researchers described evidence that among chronic drug users, drugs are sometimes stored in the adipose [**12] tissue beneath the skin before ultimately being transported to the skin surface itself. Joseph A. Levisky, et. al., Drug Deposition in Adipose Tissue and Skin: Evidence for an Alternative Source of Positive Sweat Patch Tests, 110 Forensic Science International, 35-46. The researchers suggested that it was therefore "possible to envision a situation where a sweat patch, used as a detection device, might falsely indicate that new drug use had occurred." Id. at 45.
More recently, two research reports submitted to the United States Department of Justice on September 20, 2002, specifically distinguished between two types of sweat patch contamination: (1) external contamination from without, that is, "drugs permeate the skin in areas not covered by the patch, enter the blood stream, and are re-excreted in sweat into the patch"; and (2) external contamination [*198] from within or under the patch, that is, "drugs on the exterior skin, not removed by the cleaning process[,]" get caught under the patch. David A. Kidwell & Frederick P. Smith, Susceptibility of PharmChek Drugs of Abuse Patch to Environmental Contamination, available at (last [**13] visited August 12, 2003), at 2; Melissa Long & David A. Kidwell, Improving the Pharmcheck Sweat Patch: Reducing False Positives from Environmental Contamination and Increasing Drug Detection, available at (last visited August 12, 2003), at 3. The researchers concluded that "except in extreme cases of external contamination," contamination from without "is unlikely to occur, because, generally speaking, drugs do not enter the bloodstream through skin in high concentrations." Kidwell & Smith, Susceptibility of PharmChek Drugs of Abuse Patch to Environmental Contamination, at 2. They further concluded, however, that contamination from within presented a more likely scenario because less drug must be present to cause a false positive: "only a source of drugs, a plausible transfer mechanism to the skin, and binding of the drugs to the skin need occur." Id. A co-author of one of these studies -- Dr. Frederick Smith -- also has apparently become a prominent expert witness on the subject of sweat patches, see, e.g., Snyder, 187 F. Supp. 2d at 57; Zubeck, 248 F. Supp. 2d at 897-899, and submitted an [**14] expert report on Alfonso's behalf in the instant motion.
In the past year, challenges to the sweat patch have continued to be brought in the courts and have met with a range of results. In Zubeck, the court rejected the defendant's claims of contamination and revoked her supervised release. 248 F. Supp. 2d at 899. By contrast, in Snyder, the court ruled that "although the sweat patch is generally reliable, it cannot be relied upon in situations where it is shown that the possibility of exterior contamination exists due to exposure to a basic solution containing drugs." 187 F. Supp. 2d at 60. The Snyder court further ruled that the defendant's testimony that he resided with a crack cocaine user who used drugs in the home rendered his positive sweat patch results unreliable. Id.
At present, numerous probation offices continue to use the sweat patch. The United States Attorney's Office for the Northern District of New York -- the district that brought the Snyder case noted above -- has, however, discontinued the usage of the sweat patch as an institutional matter, according to the Government. 11/1/02 Tr. at 29-30. Moreover, the United States [**15] Attorney's Office for the District of Nevada -- in which the McLemore case was brought -- no longer relies in court on positive sweat patch results unless there is substantial corroborating evidence of a defendant's drug use. Bazelon, Testing Testing, at 49; see also 11/1/02 Tr. at 30. PharmChem's contract with the Administrative Office expires in August of 2003; it is not yet clear whether it will be renewed. Bazelon, Testing Testing, at 49.
C. Alfonso's Sweat Patch Results
In January 2002, Alfonso switched from random urinalysis to the sweat patch mode of drug testing. 10/25/02 Tr. at 40-41; see also Memorandum from Judith Oxford to Magistrate Judge Alexander (April 29, 2002) (marked as Exhibit C). At that time, Oxford instructed him to report to Pretrial Services on a weekly basis to have his patch removed and to have a new patch applied. 10/24/02 Tr. at 25-26. According to Oxford's reports to Magistrate Judge Alexander, however, Alfonso often failed to report on a weekly basis for removal of his patch, resulting in patches that were partially [*199] detached by the time they were removed and therefore compromised. For example, Alfonso wore one patch from February 11, 2002 to [**16] February 26, 2002; by the time he had it removed, it was being secured with scotch tape. Memorandum from Judith Oxford to Magistrate Judge Alexander (June 19, 2002) (marked as Exhibit O).
On April 29, 2002, Oxford sent a memorandum to Magistrate Judge Alexander, describing Alfonso's non-compliance and stating that Alfonso had worn the patch placed on his arm on April 8, 2002 until April 25, 2002, at which point the "patch was almost completely off his arm and exposed to the air . . . and [could not] be tested." Memorandum from Judith Oxford to Magistrate Judge Alexander (April 29, 2002). Oxford further reported that Alfonso was given a urine test on April 25, 2002, which was negative. Id. On May 31, 2002, Oxford advised Magistrate Judge Alexander that this patch had, in fact, tested positive for the cocaine metabolite BE. Memorandum from Judith Oxford to Magistrate Judge Alexander (May 31, 2002).
On June 12, 2002, the Government moved -- based upon this evidence -- to revoke Alfonso's supervised pretrial release. At the June 19, 2002 hearing on this motion, Magistrate Judge Alexander had before her two positive sweat patch results for Alfonso. The first result -- which this [**17] Court marked as Exhibit F -- came from the above-described sweat patch that Alfonso had worn from April 8, 2002 to April 25, 2002. This patch yielded a positive result for the metabolite BE in the amount of 24 nanograms, but did not yield a result for cocaine because the quantity was insufficient for testing. 11/1/02 Tr. at 18. In addition, at the time of the hearing Magistrate Judge Alexander also had before her a new positive sweat patch result that this Court marked as Exhibit G. This patch was worn by Alfonso from May 17, 2002 to May 28, 2002; it yielded a positive result for cocaine in an amount higher than 100 nanograms, but was below the cut-off level for the metabolite BE (that is, below 10 nanograms). Id. at 20; see also Memorandum from Judith Oxford to Magistrate Judge Alexander (June 19, 2002). At the conclusion of that hearing, Magistrate Judge Alexander did not revoke Alfonso's bail but instead imposed additional conditions upon him.
The Government subsequently moved again to revoke Alfonso's pretrial release, based, among other things, on two additional positive sweat patch results, which this Court has marked as Exhibits H and I. The sweat patch marked as Exhibit [**18] H was worn by Alfonso from May 28, 2002 to June 10, 2002; it yielded positive results for both cocaine and the metabolite BE in excess of the threshold level, that is, in excess of 10 nanograms. 11/01/02 Tr. at 24. The sweat patch marked as Exhibit I was worn by Alfonso from June 17, 2002 to June 24, 2002; it yielded a positive result for cocaine, but a result for BE that was below the threshold level. Id. at 25. Thus, at Magistrate Judge Alexander's hearing on this motion on July 24, 2002, she had a total of four positive sweat patch results: tests F, G, H, and I. At the conclusion of the hearing, as noted above, Magistrate Judge Alexander revoked Alfonso's release and detained him.
At the time of Magistrate Judge Alexander's hearing, two additional sweat patch results were pending from patches that Alfonso had worn between June 17 and June 24, and between July 9 and July 16. Id. at 25. Those results subsequently both came back positive for cocaine, but below the threshold level for the metabolite BE; at the hearing before this Court, they were marked as Exhibits J and K. Id. at 25, 51. Thus, in total, this Court had six positive sweat patch results for Alfonso -- Exhibits [**19] [*200] F, G, H, I, J, and K -- before it at the time of its hearing.
D. Alfonso's Claims of Contamination
Alfonso consistently asserted that the six positive sweat patch results are not due to his own recent use of cocaine; indeed, he testified on the stand that the last time he had used cocaine was approximately three-and-a-half years prior to July 2002. 11/1/02 Tr. at 4. In support of this assertion, Alfonso points out that he underwent a urine drug test on April 25, 2002 at Oxford's direction, and that the test was negative (although the sweat patch worn from April 8, 2002 to April 25, 2002 subsequently yielded a positive result); he subsequently asked to return to urinalysis, a request that Oxford denied. 10/25/02 Tr. at 44. Alfonso further testified that after learning in July of the additional positive sweat patch results, he voluntarily went to a laboratory for a blood test. Id. at 45. The laboratory report, dated July 23, 2002, states that no drugs were detected in Alfonso's blood; it was marked by this Court as Exhibit S.
Alfonso identified two potential sources that may have led to contamination of his patch: (1) his residence in a house formerly occupied by a drug [**20] user; and (2) his contact with his wife, an exotic dancer. Alfonso further asserted that the inconsistent protocol followed by the various pretrial service officers who applied his patches resulted in a failure to clean sufficiently the area on his arm where the patches were placed, thus permitting the patches to become contaminated.
1. Sources of Contamination
Alfonso posited that his patch might have become contaminated with drug residue as a result of his residence at 31 Russell Street in Fall River, Massachusetts. Alfonso testified before this Court that he moved with his family into this house in approximately the first week in May, 2002, and that he spent significant time during April cleaning the house. Id. at 47. Alfonso further testified that the person who had previously lived in the house was a drug user, claiming that he became aware of this once he began cleaning. In support of this claim, Alfonso produced a letter from his landlord, Geraldine Kempf, which was marked as Exhibit A at the Court's hearing. In this letter, Kempf stated that the prior resident of the house "had druggies living with her, [and] also did many drug [sic] herself. This is why I had [**21] to evict her. Because I live in Pennsylvania Mr. Alfonso got rid of a lots [sic] of junk that was left behind. When they were cleaning they came across many needles and the [sic] such."
Alfonso also asserted that his sweat patch may have become contaminated as a result of his contact with his wife, who works as an exotic dancer. In fact, Oxford testified that Alfonso told her that he "had sex with his wife and he believed that his wife used cocaine," and asked her whether "if he was having sex with somebody and they were using cocaine that would possibly trigger a positive test for him." 10/24/02 Tr. at 28-29. Alfonso, however, has disputed that he ever told Oxford that his wife actually used cocaine. He testified that he simply asked Ms. Oxford whether he could "have gotten a positive test from sex," explaining that because his wife works as a dancer, he believed that her skin might have become contaminated with money that contained cocaine residue, perhaps by "sitting on somebody's lap [that] might have had coke money on it." 11/1/02 Tr. at 5-7.
2. Administration of the Patch
Alfonso further argues that the Pretrial Services officers in this District who were involved [**22] in the application of his patch followed an inconsistent protocol that [*201] failed to prevent contamination of the patch from drug residue. Indeed, the testimony adduced at trial indicated not only that the officers within this District did not uniformly follow the same protocol, but also that there is a troubling lack of clarity as to the optimal protocol for application of the patch.
At the hearing before this Court, Oxford -- who trains the Pretrial Services officers in this District as to the application of the sweat patches -- described the procedure that she teaches as follows:
What we would do is we would take an alcohol swab -- actually, you would put on, in the video the PharmChem suggests or recommends that you wear rubber gloves, latex gloves. So, you would put your latex gloves on, you would clean a surface area on the person's arm, and you would scrub rigorously so that you could take off the first layer of skin cells so that it would make a nice seal. Then they ask you to do it a second time as well. So there's two alcohol pads that you use and you clean it again. In fact, if it still appears that there's skin cells there or dirt, then they continue to ask you to clean [**23] with that alcohol pad until the surface is clean.
After that you let it dry for 60 to 90 seconds. . . .
And then you make sure that the patch is completely dry. You unseal the patch, and you, there's a sticky layer, you take that off and you put it, you ask the person to make a muscle so that the skin will be taut, and you place the patch on the arm and then go around with your finger several times around the clear face to help the adhesive stick. Then after that is stuck you peel of the outer layer of the patch, throw that away and then the patch is secured.

10/24/02 Tr. at 40-41.
Because Alfonso is male, and because Pretrial Services officers of the same sex apply sweat patches to defendants in this District, Oxford herself did not apply the sweat patch to Alfonso. Id. at 20. Thus, this Court also heard the testimony of the two Pretrial Services officers who actually applied the sweat patch to Alfonso: Thomas O'Brien ("O'Brien") and Joshua Ulrich ("Ulrich"). This testimony revealed deviations from the procedure described by Oxford. For example, in contrast to Oxford's testimony that she instructs Pretrial Services officers to clean defendants' arms with alcohol pads [**24] before applying the patch, O'Brien testified that he typically asks the defendant himself to clean his own arm with an alcohol swab. 10/25/02 Tr. at 10. Ulrich similarly testified that although he sometimes wipes the defendant's arm with the alcohol pad himself, "if the defendant does it right there in front of me, I'm satisfied that it's done in a manner that's going to, you know, achieve that objective then generally I let the defendant do it." Id. at 33. Moreover, Ulrich testified that -- in direct contrast to Oxford's testimony that the recommended procedure is for the Pretrial Services officer to wear rubber or latex gloves -- he does not wear rubber gloves at any point during the application of the patch. Id. at 32.
Alfonso's description of the cleaning procedure is consistent with that described by O'Brien and Ulrich. He testified that although "a few people would use gloves . . . for the most part they wouldn't use gloves." Id. at 42. In addition, he testified that he was always asked to clean his arm himself, with little instruction: "As the officer was putting the pad inside of the plastic bag, I would, he would slide the box over of alcohol swabs and say clean [**25] your arm. I would take out an alcohol swab and I would, I would try to get the outline of the dirt or the glue, what would be around the patch, I would try to just take that off." Id. at 41. He further [*202] testified that no one ever instructed him to clean his entire forearm, stating that "all I would do is just clean the glue mark off of it . . . [and then] blow on my arm until it would be dry enough." Id. at 41-42.
Interestingly enough, the procedure that Oxford herself described for application of the sweat patch is inconsistent with the procedure advocated by the Administrative Office. Although Oxford described the cleaning procedure as simply involving alcohol pads, the Administrative Office's May 3, 2001 memorandum to all Chief Pretrial Services and Probation Officers explicitly stated that "the best approach when applying a sweat patch is to have the offender wash the area where the patch is to be applied with soap and water before the officer wipes the skin with an isopropanol (alcohol swab)" (emphasis added). Memorandum from the Administrative Office to Chief Probation Officers and Chief Pretrial Officers (May 3, 2001). Further compounding the confusion is that [**26] the PharmChem patch itself (marked as Exhibit L) explicitly states on its face: "Use isopropyl alchol skin preparation to clean skin and allow skin to dry completely prior to patch application (DO NOT USE SOAP)." As such, it is entirely unclear to this Court -- and, presumably, to those charged with applying the sweat patch -- whether soap and water should in fact be used to reduce further any risk of contamination. One thing that is clear is that neither O'Brien nor Ulrich used soap or water in the process of cleaning Alfonso's skin prior to the application of his sweat patch; both of them testified that they never do so, and Alfonso similarly testified that soap and water was never used. 10/25/02 Tr. at 20, 33, 42.
E. Analysis
As an initial matter, it is important to identify the standard for revoking Alfonso's pretrial release. At the hearing before this Court, both the Government and Alfonso stated that the standard was whether Alfonso's drug use could be proved by a fair preponderance of the evidence. 10/24/02 Tr. at 4. In fact, the applicable standard is even lower. Although a preponderance of the evidence standard was indeed applied in the above-noted cases involving [**27] sweat patch results -- namely, Stumpf, Zubeck, and Snyder -- those cases all arose in the context of the revocation of supervised release after imprisonment. See 18 U.S.C. § 3583(e) (3) (stating that the court may "revoke a term of supervised release . . . if the court . . . finds by a preponderance of the evidence that the defendant violated a condition of supervised release"); Stumpf, 54 F. Supp. 2d at 973; Zubeck, 248 F. Supp. 2d at 897; Snyder, 187 F. Supp. 2d at 57.
The instant motion with respect to Alfonso, however, arises in the context of the revocation of pretrial release. The applicable standard is even more favorable to the Government when, as here, the allegation is that the defendant committed a crime while on pretrial release. The standard, in relevant part, n3 is simply whether there is "probable cause to believe that the person has committed a Federal, State, or local crime while on release" and whether "there is no condition or combination of conditions of release that will assure that the person will not flee or pose a danger to the safety of any other person or the community. [**28] " An affirmative finding on the first prong helps lead to an affirmative finding on the second prong: once there is probable cause to believe that the person "committed a Federal, State, or local felony, a rebuttable presumption arises that no condition or combination of conditions will assure that the person will not pose a danger to the safety of any other person or the community." 18 U.S.C. § 3148(b). See also United States v. Rivera, 104 F. Supp. 2d 159 [*203] (D. Mass. 2000) (Gorton, J.) (holding that blood test of defendant, who was out on pretrial release, indicated that he had been smoking marijuana; as such, "probable cause existed to believe that [the defendant] violated state law by possessing marijuana when he used it," there was reason to believe that the defendant was "unlikely to abide by any condition or combination of conditions of release," and the defendant's release should therefore be revoked).

n3 The complete standard is set forth supra page 3.

As such, [**29] the Government's motion to revoke Alfonso's pretrial release fundamentally presented the question of whether there was probable cause to believe that Alfonso had used cocaine while out on release. In applying a preponderance of the evidence standard on the basis of the parties' representations, therefore, this Court employed an analysis that was even more favorable to Alfonso than was warranted. See, e.g., United States v. Kin-Hong, 110 F.3d 103, 120-21 (1st Cir. 1997) ("The probable cause standard does not even require that the government make its showing by a preponderance of the evidence.").
That established, the Court now proceeds to discuss why it concluded that there was probable cause to believe that Alfonso used cocaine while on pretrial release -- indeed, why it ruled that a fair preponderance of the evidence supported that charge.
As noted above, at the Court's hearing on this motion, it received expert reports from both Dr. Leo Kadehjian (on behalf of the Government), marked as Exhibit P, and from Dr. Frederick Smith (on behalf of Alfonso), marked as Exhibit U. Dr. Smith opined that Alfonso's patch may well have become compromised as a result of his residence [**30] and his contact with his wife and further opined that the "sweat patch application and removal procedures, both as recommended and as applied in this case," were not adequate to prevent contamination of the patch. Smith Expert Report P5. Dr. Kadehjian, on the other hand, asserted that there is not adequate scientific support for the notion that a sweat patch could become contaminated through any of the means described by Alfonso and further stated that Alfonso's negative urine and blood tests were not inconsistent with the positive sweat patch results, in that urine and blood tests provide information about a much narrower period of time. Kadehjian Expert Report PP7-8.
The Court, after reviewing Dr. Smith's studies, concluded that although they do raise questions that warrant further research, they do not undermine the reliability of sweat patches to such a degree that the Court should reject them as a general matter, particularly because those studies are limited to laboratory contexts in which solutions containing drugs were applied directly to subjects' skin. As such, the Court did not give dispositive effect to Dr. Smith's studies but instead took them into account when considering [**31] Alfonso's specific sweat patch test results: namely, positive results F, G, H, I, J, and K.
An examination of each of these results indicated that some are more probative than others. Specifically, test result F lacks reliability because -- due either to the length of time the patch was worn, actual tampering with the patch, or some combination of the two -- the patch was almost completely detached from Alfonso's arm by the time it was removed and tested. In fact, Oxford herself wrote in her memorandum to Magistrate Judge Alexander that the patch was so significantly compromised that it could not be tested. The Court therefore concluded that test F could not be considered in determining whether Alfonso had used cocaine. On the other hand, test H is the result that most strongly [*204] indicates that Alfonso did use cocaine, in that it was positive for both cocaine and the metabolite BE in amounts exceeding the cut-off level. It is true that this sweat patch was worn by Alfonso for thirteen days, but given that it was Alfonso himself who failed to report to have it removed as scheduled, the Court has declined to disregard it on that basis. The remaining test results -- I, J, and K -- can [**32] be grouped together in that all of them yielded positive results in excess of the threshold level solely for cocaine.
At the close of the Court's hearing, the Court found that the aggregate of tests G, H, and I -- namely, the tests (other than F, which the Court found unreliable) before Magistrate Judge Alexander at the July 24, 2002 hearing -- provided an adequate basis for Magistrate Judge Alexander's conclusion that Alfonso was using cocaine and should therefore be detained. Test results J and K -- which were not before Magistrate Judge Alexander, but were before this Court -- further supported that conclusion. The Court therefore affirmed Magistrate Judge Alexander's revocation of Alfonso's supervised release.
The Court deems it important to note that it was the aggregate of positive results that provided probable cause to believe that Alfonso used cocaine while on supervised release. The Court reserves judgment as to whether test result H alone would have been sufficient. The Court further notes its concern with the general lack of clarity regarding the appropriate protocol for application of the sweat patch, particularly in light of the conflicting scientific findings as [**33] to the potential for sweat patch contamination. At a minimum, the Pretrial Services officers in this District should be following a uniform protocol in their application of the patch. In this particular instance, there were enough positive results, taken over a span of several months, to convince this Court that there was probable cause that Alfonso was using cocaine -- indeed, that it was more likely than not that this had occurred. That this degree of repetition was necessary to convince the Court, however, presents a real concern in terms of the general use of the sweat patch test -- a concern that, in this Court's view, need be addressed if the sweat patch is to remain in use. The costs of inaccuracy in testing are measured not only in the $ 25,000 taxpayer cost per day to hold hearings in the United States district courts, n4 but also in the intangible but far more important costs in human liberty, should a mistake be made.

n4 See Chappee v. Massachusetts, 659 F. Supp. 1220, 1227 n.9 (D. Mass. 1987), rev'd on other grounds, 843 F.2d 25 (1st Cir. 1988) for the method of calculation. This figure was adjusted for inflation to 2003.


For the foregoing reasons, the Court affirmed Magistrate Judge Alexander's order revoking Alfonso's supervised release [Docket No. 23].

United States v. Snyder


5:99-CR-528 (HGM/GJD)


187 F. Supp. 2d 52; 2002 U.S. Dist.

February 20, 2002, Decided

DISPOSITION: [**1] April 25, 2001 Order imposing confidentiality provisions upon all documents submitted by non-party PharmChem in compliance with subpoena duces tecum VACATED.





OPINION: [*55]
Currently before the court is a Petition for Warrant of Summons for Offender Under Supervision (Probation Form 12C) recommending revocation of the term of supervision for defendant Jamie M. Snyder. n1

n1 The U.S. Probation Office initially filed a Petition on February 20, 2001. An Amended Petition was filed on June 6, 2001, containing additional probation violations. A Second Amended Petition was filed on August 28, 2001, containing additional probation violations occurring subsequent to the original Amended Petition. For purposes of evaluating the Probation Office's recommendation of revocation of the term of supervision, the court will examine the alleged probation violations contained in the Second Amended Petition.

On July 6, 2000, defendant was sentenced by this court to three years of probation after pleading guilty to a charge of Possession of an Unregistered Firearm in violation of 26 U.S.C. § 5861(d). In addition to the standard conditions of probation, the court imposed the following additional special conditions: (1) defendant shall serve six months of home detention; and (2) defendant shall submit to drug/alcohol testing and treatment as directed by the Probation Office of the United States District Court for the Northern District of New York ("Probation Office").
On July 12, 2000, defendant reviewed the conditions of his probation with Mark Walker, Senior United States Probation Officer ("P.O. Walker"). Defendant acknowledged that he fully understood and [*56] would comply with the conditions. P.O. Walker also provided defendant with a copy of the conditions for his records.
On July 17, 2000, defendant commenced his term of home detention and he remained under monitoring until January 17, 2001. During this period of home detention, defendant's compliance with the electronic monitoring program was marginal. On several occasions, defendant failed [**3] to answer his telephone during the time that he was required to be at home. Additionally, defendant cut off his electronic transmitter at 12:02 a.m. on January 17, 2001 without permission.
As another special condition to his probation, defendant was required to submit to drug/alcohol testing as directed by the Probation Office. Defendant failed to report for required drug testing on several occasions. As a sanction for these violations and in addition to continued urinalysis testing, the Probation Office began testing defendant using the PharmChek sweat patch ("sweat patch") on October 20, 2000. The Probation Office uses sweat patch testing as either a sanction or as an alternative to urinalysis in situations where an offender fails to provide a urine specimen.
On November 3, 2000, the Probation Office received notification of a positive test result for cocaine on a sweat patch. On November 8, 2000, P.O. Walker and Timothy Keohane, Supervising United States Probation Officer ("Supervising P.O. Keohane"), questioned defendant about his drug use during an Administrative Conference. Defendant denied using cocaine or any other illegal drug and admitted only to occasional alcohol use. [**4] During the Administrative Conference, the Probation Office referred defendant to Syracuse Behavioral Healthcare ("SBH") for a substance abuse evaluation.
On November 20, 2000, defendant commenced outpatient substance abuse treatment at SBH. Defendant failed to report for treatment sessions on November 28, 2000 and December 22, 2000. As a result, his treatment level was increased to intensive outpatient, resulting in daily treatment sessions.
On January 3, 2001, defendant and his father, Darren Francisco, met with P.O. Walker and members of the SBH staff for a second Administrative Conference. During the discussion, defendant refused to admit that he had used cocaine during the course of his probation.
On January 8, 2001, defendant met with P.O. Walker and members of the SBH staff for a treatment meeting. SBH counselors advised defendant that if he admitted using drugs, they would refer him to an inpatient facility. Defendant refused to do so, and SBH terminated defendant's treatment because they were unable to treat him without an admission of drug use.
On July 28, 2001, defendant failed to report for a drug test in a timely manner and was subsequently unable to provide a urine [**5] specimen. On August 2, 2001, defendant produced a urine specimen to make up for the previous failure. On August 15, 2001, the Probation Office received word that the results of the urinalysis were positive for marijuana. On August 17, 2001, defendant was confronted with the results of the test and he admitted using marijuana at a rock concert during the end of July.
In addition to the specific instances discussed above, defendant has violated the terms of his probation on numerous other occasions. Since defendant was sentenced by this court on July 6, 2000, he has failed to report for a drug test on five different occasions, in violation of Special Condition [*57] No. 2. n2 Additionally, defendant submitted a positive sweat patch to the Probation Office on a total of eight different occasions, in violation of Standard Condition No. 7. n3

n2 Special Condition No. 2 states "[defendant] shall submit to alcohol and drug testing as directed by the probation officer."
Defendant failed to report for a drug test on:

July 15, 2000
September 6, 2000
October 15, 2000
November 14, 2000
November 11, 2001


n3 Standard Condition No. 7 states "[defendant] shall not use any narcotic or controlled substance ..."
Defendant submitted a positive sweat patch on:

October 20, 2000 - October 25, 2000
October 25, 2000 - November 3, 2000
November 3, 2000 - November 8, 2000
November 8, 2000 - November 15, 2000
November 17, 2000 - November 22, 2000
November 22, 2000 - November 30, 2000
November 30, 2000 - December 7, 2000
December 11, 2000 - December 18, 2000
NOTE: date ranges represent the date that the patch was applied and the date that the patch was removed


I. Standard for Revocation of a Term of Supervised Release
Under Title 18 of the United States Code, Section 3583(e)(3), the court may revoke a term of supervised release if it finds by a preponderance of the evidence that the defendant violated a condition of the supervised release.

II Violations

A. Number 1 - Submission of a Positive Sweat Patch
As previously stated, defendant submitted eight sweat patches that were positive for cocaine, in violation of Standard Condition No. 7. Prior [**7] to a Violation Hearing scheduled for April 9, 2001, defendant challenged the use of sweat patches for drug testing purposes. Defendant based his challenge on a similar issue raised in United States v. Stumpf, 54 F. Supp. 2d 972 (D. Nevada 1999).
In Stumpf, defendants filed a motion in limine to exclude the admissibility of sweat patch test results from proceedings to revoke their supervised release. Judge Pro held that drug testing by means of the sweat patch utilized by the United States Department of Probation was a reliable scientific method of testing for the presence of controlled substances.
On June 11, 2001 through June 13, 2001, this court held an evidentiary hearing to examine the sweat patch and its use in the present case. The court heard testimony from defendant, P.O. Walker, Supervising P.O. Keohane, Edward Cone, Ph.D., and Frederick Smith, Ph.D. During the course of the hearing, documents obtained by defendant pursuant to a subpoena duces tecum served on non-party PharmChem Laboratories Inc. ("PharmChem") n4 were discussed by the witnesses and admitted into evidence. Initially, PharmChem resisted complying with the subpoena without promises from [**8] counsel that all of its responses would be kept strictly confidential. In order to avoid unnecessary delay in preparing for the hearing, counsel agreed to an Order requiring that the dissemination of the documents would be restricted until such time as the court could determine whether or not the documents should remain confidential. At the close of the hearing, defendant requested a determination from the court that none of the subpoenaed documents should be kept [*58] confidential. The court will address this issue at the conclusion of its analysis of the violations.

n4 PharmChem is represented in this matter by Timothy J. Cappuccilli, Esq. of Menter, Rudin & Trivelpiece, P.C., Syracuse, New York.

1. Sweat Patch Procedures
During mid-1999, the Probation Office began using the sweat patch, produced by PharmChem, for drug testing purposes. The decision to use the sweat patch was made because of inherent flaws in urinalysis testing. When testing for cocaine, urinalysis is only able to detect cocaine during [**9] the 72-hour time period that it will normally remain in an offender's system. Utilizing the sweat patch allows the Probation Office to expand its testing window to beyond the 72 hours that urinalysis offers.
The sweat patch features an absorbent pad sandwiched between the skin and an outer non-occlusive membrane that allows water vapor to pass through. The sweat patch is affixed to an offender's skin using a tamper-evident adhesive backing on the membrane. Once the sweat patch is affixed, the outer layer of the absorbent pad adheres to the skin in an unusual way, forming a bond with the skin so it stays on and will not come off. If the absorbent patch is removed from the skin, it cannot be reattached. After the absorbent pad bonds with the skin, it becomes a collection device. The offender's sweat wets the pad, the water in the sweat eventually evaporates through the non-occlusive membrane, and any drugs remain in the absorbent pad. Once the sweat patch is removed from the offender, it is returned to PharmChem for analysis.
Members of the Probation Office, including P.O. Walker, were taught about the sweat patch and the applicable drug testing procedures by Senior Probation Officer [**10] Matthew Brown. The training consisted of watching a video produced by PharmChem and a discussion of the Probation Office's procedures for applying the sweat patch.
The Probation Office has a specific drug testing room that is used to apply and remove sweat patches. The room remains off limits to any unauthorized personnel, ensuring the offender's privacy. Additionally, controlled substances are prohibited from entering the controlled environment.
Prior to affixing a sweat patch to an individual, a probation officer reviews a notice stating the testing procedures with the offender and makes recommendations on how to successfully wear the sweat patch. After reviewing the notice, the offender signs and dates it, and the probation officer subsequently does the same.
Next, the probation officer completes the form for the sweat patch. Each sweat patch has a unique bar code identification number that is specific to each test. This identification number is written on the form, along with the probation officer's name, the offender's name, and the date on which the sweat patch is applied. Once the probation officer completes the form, the offender initials it.
Once the paperwork is completed, [**11] the probation officer puts on a pair of single-use latex gloves and instructs the offender to expose the area where the sweat patch is going to be applied. Typically, the sweat patch is applied to the upper arm. Prior to application of the sweat patch, the entire area is wiped down with alcohol wipes. The recommended minimum number of wipes is two, but P.O. Walker testified that he would typically use between four and five wipes, doubling that number if the wipes were small.
After the entire area has been wiped and allowed to dry for approximately four or five seconds, the probation officer removes the sweat patch from its packaging and places it on the offender's area of skin [*59] previously wiped. If any of the corners of the patch are not completely adhered to the offender's skin, the probation officer uses his hand, still wearing the latex gloves, to make sure that the entire area is completely sealed.
When the offender returns to the Probation Office so that the sweat patch can be removed, there is a second part of the form that the probation officer fills out. The removal date is filled in and it is initialed by both the probation officer and offender. An additional section of the [**12] form allows the probation officer to include use information, such as whether the offender completed the testing period, whether the sweat patch fell off, whether there are any indications that the sweat patch was tampered with, or whether the pad itself was exposed to air or moisture. The final section allows the probation officer to describe any medications that the offender is taking. Once the second part of the form is completed, the offender signs the certification and consent, and the probation officer signs the certification. The offender and probation officer also initial the chain of custody strip, which is located under the security seal.
Following the completion of the removal paperwork, the probation officer puts on a pair of single-use latex gloves and proceeds to remove the sweat patch from the offender. First, the probation officer removes the adhesion strip and exposes the absorbent pad, not allowing the offender to touch the strip or pad with their bare hands. Then, the probation officer uses a pair of single-use tweezers to remove the testing pad from the adhesion strip and places it into a small sealable bag.
The sweat patch form includes two bar code labels. One [**13] of the bar code labels is placed across the seal of the small bag. The small bag is then placed inside a larger sealable bag along with the completed sweat patch form. The larger bag is sealed and a bar code label is placed across the seal, as well as a security seal that maintains the integrity of the test. The larger bag is then placed in a pre-stamped manilla envelope and it is mailed to the PharmChem testing facility for analysis.

2. Sweat Patch Reliability
After reviewing the testimony of the June 2001 evidentiary hearing and the admitted exhibits, the court has determined that the sweat patch is generally reliable for drug testing purposes. However, the sweat patch is not perfect and the potential for erroneous results clearly exists.
The testimony of Drs. Cone and Smith supports the court's conclusion that the sweat patch is susceptible to outside environmental contamination in limited situations. In order for outside environmental contamination to occur, the offender must be exposed to a source of drugs for contamination. Potential sources of drugs for contamination are plentiful. Several types of drugs, including cocaine, are found on paper currency. Although drugs [**14] on currency are difficult to transfer to the skin, they can be transferred if the skin is moist. Once the drugs are transferred to an offender's skin, such as a hand, they are easily transferred to the exterior of the sweat patch because touching the patch with one's hand is a natural reaction to the presence of a foreign material on the body. Transfer can also occur if an offender intentionally presses on the sweat patch to keep it adhered to the skin.
There is also the possibility of contamination from the clothing of an offender exposed to drugs. Reports indicate that clothing retains drugs, such as cocaine metabolite. If an offender wears contaminated clothing over the area above the sweat [*60] patch, the drugs could be transferred to the exterior of a patch moistened by sweat.
If the offender is exposed to a source of the drugs for contamination, the drugs may penetrate the sweat patch from the outside through the non-occlusive membrane. In order for this to occur, the drugs must be part of a basic solution (i.e., a solution with a pH greater than 7) that penetrates the membrane. A combination of drugs, an additional chemical and water can create such a solution. If the additional [**15] chemical is basic, the resulting basic solution could penetrate the exterior of the sweat patch and wet the absorbent pad. Once the water evaporates through the non-occlusive membrane, the drugs will remain in the absorbent pad, despite the fact that they originated from outside of the sweat patch and not from within the offender's body.
A potential source of the water required to create a basic solution is profuse sweating. When an offender sweats profusely, the absorbent pad on the inside of the sweat patch may become saturated, allowing the outside of the patch to also become moistened with sweat. This moisture, combined with drugs and an additional chemical present on the exterior of the patch, can create a basic solution that can penetrate the non-occlusive membrane.
There are several ways that an additional basic chemical can be introduced onto the exterior of the patch. Common cleaning products such as Dial soap or Windex are basic. They could be placed on the sweat patch by a variety of means, including showering or contact with contaminated hands. Additionally, crack cocaine is made with sodium bicarbonate. During production, some of the bicarbonate can remain with the crack [**16] cocaine, making it basic. Once the crack cocaine is combined with water, the solution becomes basic without the introduction of an additional chemical because the crack cocaine is already basic.
In addition to the testimony of the experts, PharmChem's documents detailing its internal testing support the conclusion that the sweat patch is susceptible to outside environmental contamination in limited situations. Exhibit I describes an experiment performed by PharmChem where it affixed sweat patches to glass plates and then applied basic, neutral and acidic cocaine solutions to the exterior of the patches. The results of the experiment showed that cocaine was found in the absorbent pads of the sweat patches treated with the basic solution.
On the basis of the testimony of Drs. Cone and Smith, as well as the PharmChem documents admitted into evidence, the court concludes that the sweat patch is susceptible to outside contamination in situations where the exterior of the patch is exposed to a basic solution containing drugs. Therefore, although the sweat patch is generally reliable, it cannot be relied upon in situations where it is shown that the possibility of exterior contamination [**17] exists due to exposure to a basic solution containing drugs.

3. Sweat Patch Contamination in the Present Case
For the past three years, defendant resided in a house on West Ellis Street in East Syracuse, New York owned by his mother. In June of 2000, defendant's mother moved back into the house to live with defendant and remained there until the middle of December 2000, when she primarily stayed with a boyfriend in Oswego, New York. Defendant's mother is a crack cocaine user. Although she never smoked the crack cocaine in front of defendant, defendant often returned home from work to find his mother high and in the company of friends. When defendant confronted [*61] his mother about her drug use, she admitted smoking crack cocaine, but told him that she can do what she would like and it is none of his business.
During the relevant time period of July through December of 2000, defendant worked at McLane's Northeast, a distribution company. Defendant worked ten to twelve-hour days manually loading trucks. Defendant described the workload as heavy, leading to continuous sweating while on the job. During the summertime, defendant would wear the least amount of clothing as possible, [**18] usually shorts and a t-shirt. During the colder months, defendant would arrive to work wearing sweatpants and a sleeveless undershirt. Once he began working, defendant would remove the sweatpants and wear the mesh shorts that he had on underneath.
The profuse sweating lead to problems for defendant and his sweat patches. On a couple of occasions, the sweat patches started peeling back. On other occasions, the area where the sweat patch was affixed would become uncomfortable and itchy. Defendant would rub the patch while at work and at home in an attempt to relieve the itchy sensation.
On the basis of defendant's testimony, the court concludes that defendant's positive sweat patch results fall within the limited exception to the general reliability of the sweat patch. During the time period of his positive test results, defendant resided with his mother, an admitted crack cocaine user that smoked with her friends in her house. Defendant also worked in an occupation where he sweated profusely on a daily basis and often rubbed his sweat patch in order to relieve the discomfort. Recognizing these facts, the court concludes that defendant's exposure to drugs in his environment and profuse [**19] sweating is a sufficient basis for rejecting the reliability of the sweat patch in this specific instance. A preponderance of the evidence does not demonstrate that defendant violated Standard Condition No. 7 by submitting a positive sweat patch.

B. Number 2 - Association with Persons Engaged in Criminal Activity or Felons
The court finds by a preponderance of the evidence that defendant violated Standard Condition No. 7 by associating with persons engaged in criminal activity and associating with persons convicted of a felony, without permission of a probation officer. As previously discussed, defendant resided with his mother, an admitted crack cocaine user. Additionally, on February 6, 2001, defendant associated with his co-defendant and felon, Joseph Gilkey. On that day, defendant and Mr. Gilkey shared a ride to the Probation Office without receiving permission from a probation officer. On March 1, 2001, when directly questioned by this court about his association with Mr. Gilkey, defendant denied the allegation. However, during the June 2001 evidentiary hearing, defendant admitted to the court that he had lied and that he had associated with Mr. Gilkey in violation of [**20] Standard Condition No. 7.

C. Number 3 - Submission to Alcohol and Drug Testing
The court finds by a preponderance of the evidence that defendant violated Standard Condition No. 2 by failing to submit to alcohol and drug testing as directed by his probation officer. As previously discussed, defendant has failed to report for drug testing on five different occasions.

D. Number 4 - Submission to Substance Abuse Evaluation and Complete Treatment
The court finds by a preponderance of the evidence that defendant violated Special [*62] Condition No. 3 by failing to submit to a substance abuse evaluation and complete treatment as directed by his probation officer. As previously discussed, on January 8, 2001, SBH terminated defendant's substance abuse treatment prior to completion because of his failure to admit drug use.

E. Number 5 - Submission of a Positive Urine Test
The court finds by a preponderance of the evidence that defendant violated Standard Condition No. 7, prohibiting use of any narcotic or controlled substance. As previously discussed, on August 2, 2001, defendant submitted a positive urine test for marijuana. When confronted with the results of the test, [**21] defendant admitted to using marijuana at a rock concert.

III. Confidentiality of the Subpoenaed Documents
As previously mentioned, on April 25, 2001, this court issued an Order prohibiting, with certain exceptions, disclosure of documents produced by PharmChem pursuant to a subpoena duces tecum. At the close of the June 2001 evidentiary hearing, defendant requested a determination that none of the subpoenaed documents should be kept confidential and PharmChem requested that this court prohibit further dissemination of the subpoenaed documents. The government did not have a position on this issue.

A. Public Access to Judicial Documents Analysis
The common law right of public access to judicial documents is said to predate the Constitution. See United States v. Amodeo, 44 F.3d 141, 145 (2d Cir. 1995) ("Amodeo I"). Recognizing this long-standing right, the Supreme Court has stated:

It is clear that the courts of this country recognize a general right to inspect and copy public records and documents, including judicial records and documents. In contrast to the English practice, ... American decisions generally do not condition enforcement [**22] of this right on a proprietary interest in the document or upon a need for it as evidence in a lawsuit.

Nixon v. Warner Communications, Inc., 435 U.S. 589, 597-98, 98 S. Ct. 1306, 1312, 55 L. Ed. 2d 570 (1978). In fact, not only is there a common law right to public access, there is a presumption in favor of public access to judicial documents. See Securities and Exch. Comm'n v., 273 F.3d 222, 231 (2d Cir. 2001). However, despite this presumption, the fact that a document is a judicial record does not mean that access to it cannot be restricted. The Supreme Court has said that:

it is uncontested ... that the right to inspect and copy judicial records is not absolute. Every court has supervisory power over its own records and files, and access has been denied where court files might have become a vehicle for improper purposes.

435 U.S. at 598, 98 S. Ct. at 1312. In order to determine whether or not public access is appropriate, the task of the courts is to "weigh the interests advanced by the parties in light of the public interest and the duty of the courts." 435 U.S. at 602, 98 S. Ct. at 1314.
The first step [**23] to determining whether or not public access is appropriate requires the court to face the issue of whether a document may be classified as a "judicial document," and is therefore accessible to the public. The Second Circuit has stated that:

The mere filing of a paper or document with the court is insufficient to render that paper a judicial document subject to [*63] the right of public access. The item filed must be relevant to the performance of the judicial function and useful in the judicial process in order for it to be designated a judicial document.

Amodeo I, 44 F.3d at 145.
Once the court deems a document to be a judicial document, the weight of the presumption of public access must be determined by evaluating "the role of the material at issue in the exercise of Article III judicial power and the resultant value of such information to those monitoring the federal courts." United States v. Amodeo, 71 F.3d 1044, 1049 (2d Cir. 1995) ("Amodeo II"). Typically, a judicial document will "fall somewhere on a continuum from matters that directly affect an adjudication to matters that come within a court's purview solely to insure their [**24] irrelevance." Id. As one moves along the continuum, the weight of the presumption declines. Therefore, the presumption is strong where a judicial document directly affects an adjudication, but where a document only plays a negligible role in the performance of Article III duties, "the weight of the presumption is low and amounts only to a little more than a prediction of public access absent a countervailing reason." Id. at 1049-50.
After the weight of the presumption of public access has been determined, the court must balance competing considerations against it. Id. at 1050. The Second Circuit has identified two countervailing factors: (1) the danger of impairing law enforcement or judicial efficiency, and (2) the privacy interests of those resisting disclosure. Id. The first factor recognizes that unlimited access, while perhaps aiding the monitoring of the courts, might adversely affect law enforcement or judicial performance. Id. Individuals with law enforcement responsibilities may be reliant upon the cooperation of persons that may want or need confidentiality. Id. If confidentiality cannot be assured, the necessary cooperation [**25] may not be forthcoming. Id. Additionally, if public access to the documents at issue is likely to materially impair a court's performance of Article III functions, this must be considered as a danger of impairing judicial efficiency. Id.
The second factor pertains to the privacy interest of the party resisting disclosure. "The privacy interests of innocent third parties ... should weigh heavily in a court's balancing equation." Gardner v. Newsday, Inc. (In re Newsday, Inc.), 895 F.2d 74, 79-80 (2d Cir. 1990) (quoting In re New York Times, 828 F.2d 110, 116 (2d Cir. 1987)). In determining the weight given to an assertion of privacy, a court should first consider the degree to which the subject matter is traditionally considered private rather than public. Amodeo II, 71 F.3d at 1051. Subsequently, the nature and degree of potential injury to the party must also be weighed, requiring consideration not only of the subject and sensitivity of the information, but also of the intended use of the information by the person seeking access. Id.

B. Application of the Analysis to the Present Case
In the present case, the [**26] subpoenaed documents pertain to tests performed or commissioned by PharmChem to determine the susceptibility of the sweat patch to false positive results. The documents were provided to Drs. Cone and Smith for their review. During testimony made during the June 2001 evidentiary hearing, each of the doctors discussed the specific experiments detailed in the documents and their opinions on the scientific conclusions. Additionally, Defense Exhibits C, F, G, H, I, J and K were all admitted into evidence during the hearing. [*64]
The court relied heavily upon the testimony of the doctors and admitted exhibits during its analysis of the reliability of the sweat patch. As such, the subpoenaed documents were relevant to the performance of the judicial function and useful to the court in its review of the evidence presented. Therefore, the court finds that the subpoenaed documents are judicial documents for public accessibility purposes.
A presumption in favor of public access to the subpoenaed documents now exists. The court must now evaluate the role that the documents played in the present case and the resultant value of the documents to those monitoring the federal courts. As previously noted, [**27] the court relied heavily upon the subpoenaed documents admitted into evidence and the testimony of the doctors based, in part, on their review of the documents. Therefore, the contents of the subpoenaed documents directly affected the findings of this court in the present matter and access to these documents would be important to those monitoring the courts for a greater understanding of the court's findings. Recognizing these facts, the presumption in favor of public access can be described as strong.
The court must now balance the strong presumption of disclosure with the competing considerations. There is little likelihood of danger of impairing law enforcement or judicial efficiency in the present case. It is unlikely that access to the subpoenaed documents will prevent cooperation of others with law enforcement officials in the future. Additionally, public access to the documents is unlikely to materially impair a court's performance of subsequent Article III functions. Therefore, the court finds that the strong presumption of disclosure is not outweighed by the first countervailing factor.
The second competing consideration of third-party privacy is more applicable in the present [**28] case. PharmChem claims that the subpoenaed documents are confidential and proprietary, and were disclosed solely for the purpose of the June 2001 evidentiary hearing. PharmChem further states that it has ongoing research and development projects to test and enhance its existing products and services in order to better serve its clients, remain competitive, continue to be an industry leader, and try to develop new products and services. In order to preserve the confidential nature of these research and development efforts, PharmChem claims to have limited the number of persons having knowledge of these efforts and securely maintained any related documents. PharmChem's concern is that its competitors will seize the information contained in the documents and utilize it against PharmChem by developing competing products, thereby causing significant harm and prejudice.
In order to evaluate the effect of disclosure upon PharmChem's privacy interest, the nature and degree of potential injury must be examined. As previously stated, PharmChem claims that it will be significantly harmed by public access to the confidential and proprietary information contained in the subpoenaed documents because [**29] it would assist a competitor with the development of a competing product. However, Dr. Smith's testimony rejects such a claim. After reviewing the documents, Dr. Smith found that they did not contain any design information and did not discuss any experiments unique to PharmChem's testing program. Additionally, Dr. Smith explained that the findings that have been published in the general literature includes the scope of PharmChem's experimentation, as well as additional testing. After considering the likelihood of potential injury to PharmChem's [*65] privacy interest, the court finds that the strong presumption of disclosure is not outweighed by the second countervailing factor.
PharmChem has failed to satisfy its burden of overcoming the strong presumption in favor of public access to the judicial documents. Therefore, the court finds that any confidentiality provision previously imposed on the subpoenaed documents is no longer appropriate and that public access to the documents may exist.
WHEREFORE, for the foregoing reasons, it is hereby
ORDERED, that the term of supervision is REVOKED. It is further
ORDERED, that the April 25, 2001 Order [**30] imposing confidentiality provisions upon all documents submitted by non-party PharmChem in compliance with the subpoena duces tecum is VACATED. It is further
ORDERED, that parties are directed to appear before the court for sentencing on February 22, 2002 at 2 p.m. in Syracuse, New York.

Dated: February 20, 2002
Syracuse, New York