Thursday, June 14, 2012

UDT Cannot Assess Rx-Dose Compliance, Court Rules

UDTUrine drug testing, or UDT, can be an important component of effective clinical pain management. However, a recent court decision has labeled claims by a major diagnostic testing laboratory — that their approach to UDT could help clinicians identify potential abuse, misuse, or diversion of patient medication — as false and deceptive advertising. This latest judgment reinforces the principle that UDT must be carefully and properly used as a tool for helping to gauge patient compliance with medication regimens.

Ameritox Ltd, a diagnostic testing laboratory headquartered in Baltimore, Maryland, has long claimed that its proprietary Rx Guardian℠ and Rx Guardian CD℠ monitoring systems based on UDT results allow practitioners to determine how patients have been taking their pain medications, both in terms of the dosage and frequency of drug use. Now, a unanimous Federal jury verdict and a confirming order by United States District Court Judge Benson Everett Legg has determined that Ameritox's advertising claims about its Guardian systems are literally false and potentially deceptive.

According to a news release appearing in the San Francisco Business Times [here], the court found that “monetary damages would be insufficient to correct the harm imposed by Ameritox's ad campaign and that the public interest would best be served by a permanent injunction prohibiting the dissemination of any advertisements promoting the ability of Ameritox's Urine Drug Tests (UDT) to determine dosage compliance or adherence.” Additionally, the Court ordered Ameritox's CEO, Ancelmo Lopes, to promptly send a “corrective advertising” letter to all current Ameritox customers, and post to its website, conceding the company’s false advertising campaign from 2008 through 2012.

According to James Slattery, CEO of Millennium Laboratories — a San Diego-based diagnostic testing firm [website here], which brought the lawsuit against Ameritox — “This case has always been about putting patient care first by dispelling the myth perpetrated by Ameritox about Rx Guardian and Rx Guardian CD. The jury's verdict should put an end to Ameritox's nearly decade-long practice of using false claims and advertising practices to mislead physicians into believing they could use the Rx Guardian service to determine whether their patients were taking the proper dosage of their prescribed medications, leading to damaging outcomes for patients and their physicians.”

Essentially, the two Rx Guardian systems did not do what Ameritox claimed and, consequently, patients could have been wrongfully labeled as adherent or nonadherent based on quantitative Rx Guardian ranges. In some cases, patient test results could have been erroneously recorded in physicians' records as reflecting aberrant behaviors, when in fact the patient was taking medications exactly as prescribed.

The news release further reports that Judge Legg established at the outset of the trial that UDT, including the Rx Guardian and Rx Guardian CD systems, cannot determine whether or not a patient is taking the prescribed dosages of a pain management medication. It was the testimony of Ameritox's own executives that doomed its efforts to defend the ads. For example, during rigorous cross-examination, the firm’s Chief Medical Officer, Harry Leider, MD, admitted to Rx Guardian's failings in the following exchange:

He was asked, “Dr. Leider, you would agree with me that Rx Guardian cannot determine the dosage of a medication that a patient has taken; isn't that correct?” He answered, “Yes.” 
Leider was then asked, “And you would agree with me that Rx Guardian cannot determine the frequency with which a patient actually is taking a prescribed medication; isn't that correct?” he answered, “Yes.”
Moreover, Dr. Leider conceded that patients who were excluded from Ameritox's “Compliance Database” could in fact be compliant with their regimens, while those abusing or misusing their medications could actually be included.

The case against Ameritox was further bolstered by Howard A. Heit, MD, FACP, FASAM, a widely-respected expert in the pain field who provided testimony on the adverse consequences that may occur when clinicians rely on Rx Guardian to determine how a patient has been taking prescribed medications, both in terms of overall dosage and frequency of medication use. According to Heit:

“The decision to alter a patient's medication regimen based on false scientific data can easily lead to patient harm through dose reduction, and a worsening of the patient's complaints of pain. Worse still, we know that some clinicians discharge their patients based on urine drug test results. Any clinical decision based on unsound laboratory testing can expose the patient as well as the prescriber to significant risk and potentially devastating adverse outcomes. It is only a matter of time before an injured patient holds his prescriber legally accountable for actions taken against him based on UDT results that claim more than they can deliver.”

COMMENTARY: Whether or not future lawsuits will arise from patients who were wronged by practitioners following the guidance of Ameritox UDT programs remains to be seen. However, we have previously asserted that urine drug testing, or UDT, can have significant value as a clinical tool for improving patient care — if it is “done right.”

Although sophisticated laboratory testing methodologies can accurately detect even minute quantities of substances in urine, those results cannot reliably ascertain for individual patients the dose of a particular drug or medication that was taken at a particular time or frequency. There are simply too many variations of individual metabolism and other confounding factors that can come into play and affect such determinations.

Most appropriately, UDT laboratory assays are extremely good at indicating the presence of specific drugs/medications and/or their metabolites. It tells whether or not a patient took a particular prescribed medication, or other substance, within a broad time period or window of drug detection. This information, when properly interpreted and used, can be of vital importance for monitoring therapeutic compliance and patient response to treatment.

We have cautioned in the past about claims and research studies that have misused the enormous reservoirs of data collected on millions of patients who have had UDT ordered as a part of their pain management regimens. Such data-mining studies often reflect biases in data collection and the potential for many unknown or unrecorded factors that can skew results and invalidate study outcomes. For example, in prior UPDATES [here] and [here] we critiqued studies sponsored by Ameritox that reported questionably high rates of medication noncompliance and abuse among pain patients.

Using such a database, and proprietary algorithms — never fully revealed and explained to the public — Ameritox had developed what has now been adjudicated in the courts as a deceptive program and false advertising campaign. This has hurt patients, their healthcare providers, the public, and the diagnostic-testing industry overall. We also wonder whether the medical journals that published the many studies sponsored by Ameritox, based on invalidated evidence, will now retract those articles.

Hopefully, this closes a controversial chapter surrounding the use UDT in pain care. However, at the time of this writing, Ameritox has not issued a response to the court verdict and the Rx Guardian programs are still prominently promoted at the company’s public website [here].

ADDENDUM: In fair balance we must note that on June 15, 2010, Ameritox issued a rebuttal press release [available here] disclaiming some of the issues noted above. It states in part, “NO NEED exists for Ameritox to change its current products or services. NO financial damages of any nature were awarded. NO adverse ruling was made by the Court as to the science behind Ameritox's industry-leading Rx Guardian CD, despite Millennium's misleading claims to the contrary. Rx Guardian CD will continue to be offered WITHOUT CHANGE.”

DISCLOSURE: Pain Treatment Topics is supported in part by an educational grant from Millennium Laboratories. In accordance with the strictest standards, Millennium had absolutely no role in the initiation, development, or review of this Pain-Topics UPDATE.

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