Friday, August 16, 2013

Ethical Questions Raised About UDT

In attempting to ensure that patients do not abuse prescribed drugs, healthcare providers are increasingly relying on sophisticated urine drug testing, or UDT, to learn which drugs patients are taking, and, often just as important, which drugs they are not taking. The result of this, as described in a recent New York Times article by Barry Meier [access here], has been mushrooming profits for diagnostic laboratories that offer the urine tests. At the same time, questions as to whether these business interests benefit or hinder patient care raise some ethical concerns.

Meier notes that sales this year, 2013, at diagnostic testing labs are expected to reach $2 billion, up from only $800 million in 1990. The growing use of UDT in recent years has paralleled the rise in prescriptions for opioid analgesics; yet, there are vexing concerns about what practitioners should do with the information from UDT results, about the accuracy of the tests, and about whether some companies and healthcare providers are financially exploiting the urine-testing boom.

For one thing, Meier asserts, research using UDT reveals that large numbers of patients with pain allegedly are not taking medications as prescribed or are taking substances not given to them by a healthcare provider. For example, a study of 800 pain patients treated at a Veterans Affairs facility in North Carolina — reported in Pain Medicine, June 2013 [abstract here] — found that 25% tested negatively for a drug they had been prescribed, while 20% tested positively for an illicit drug or a non-prescribed opioid analgesic.

Such findings are consistent with data in a study by a large UDT laboratory, Ameritox [here]. In a review of 500,000 urine tests, the company said that about one-third (35.9%) failed to detect a physician-prescribed drug and in most cases, 75%, the drugs at issue were opioid analgesics. However, Meier stresses, “the fact that a patient tests negatively for a prescribed drug does not necessarily mean they are selling it; it could simply mean they decided to stop taking it.”

Still, practitioners face tough choices about what to do with patients when UDT shows they are not taking prescribed drugs or are mixing them with unapproved or illicit substances. For example, Meier writes that Dr. Roger Chou — who helped develop urine-screening guidelines for the American Pain Society — said that, while UDT can be a valuable tool, he was concerned that to protecting themselves practitioners would use the tests as an excuse to drop, or “fire,” patients. “I think that it is problematic from an ethical perspective for doctors to fire patients,” Chou is quoted as saying.

Although other approaches have been used to monitor how patients are using and/or misusing their prescription medications, practitioners still rely heavily on UDT, either qualitative and/or quantitative testing. The most basic testing is a qualitative screen to detect various classes of drugs like opioids, amphetamines, barbiturates and cocaine.

Meier observes that such screens have high rates of false positives — finding that a drug is present when it is not — and false negatives, which fail to detect a drug that is present. Still, the use of qualitative screening has increased in recent years as a growing number of states have passed laws requiring recipients of welfare and other types of public assistance to undergo UDT. The American Civil Liberties Union has challenged such laws, saying they violate Constitutional protections against unreasonable search.

In the case of patients with pain, urine samples are most commonly sent for more sophisticated and costly quantitative testing that use precise assay techniques like mass spectrometry. The annual costs of conducting regular quantitative UDT to monitor a patient with pain can run into the thousands of dollars, Meier writes. “And with big money at stake, the growth of the urine screening industry has also opened the door to charges of illegal profiteering and other questionable activities.” For example, Meier writes…

  • In 2010, Ameritox agreed to pay $16.4 million to settle charges that it had paid kickbacks to physicians who sent tests to its laboratories.

  • Last year, another testing company, Calloway Laboratories, paid $20 million to resolve claims brought by the State of Massachusetts that it funneled cash to operators of drug treatment facilities in exchange for UDT business.

  • In 2012 there was a report that Millennium Laboratories was under federal investigation for various charges and the company stated it was cooperating with the inquiry [Reuters article here].

Meanwhile, other UDT companies aggressively market their services to healthcare providers by touting the big profits to be gained by testing patients. For example, Meier observes, a brochure distributed by Liberty Diagnostics of Pasadena, California, declared that doctors could “Average $400 Profit per Screen” with “No Additional Overhead” like added staff or equipment.

The brochure, obtained by the New York Times, also had a chart titled “Potential Profit Payout to Doctor” that stated practitioners ordering 10 UDTs a week could make $155,000 annually from the tests plus an additional $133,000 for reviewing the results and discussing them with patients. Meier states that, “In a telephone interview, an executive of Liberty Diagnostics, Timothy P. O’Brien, declined to discuss the brochure and would not confirm its authenticity. A former sales representative for the company, after hearing a reporter’s description of the brochure, said it was genuine.”

In many ways, the above article by Barry Meier is both sensational and disappointing, although he is certainly well-qualified to write on the topic. He is an award-winning reporter concentrating on the intersection of business, medicine, and the public’s health, and is author of the books, A World of Hurt: Fixing Pain Medicine’s Biggest Mistake (New York Times, 2013), and Pain Killer: A “Wonder” Drug’s Trail of Addiction and Death (Rodale, 2003).

Perhaps, Meier attempted to cover too much content in an overly brief space, but one gets the impression that he is largely equating profit-making with a lapse in medical ethics when it comes to the UDT monitoring of patients with pain. Certainly, profit exploitation may be driving some unscrupulous practitioners and there also are egregious examples (provided by Meier) of companies in the diagnostic laboratory field misbehaving. However, a most critical question in terms of medical ethics would address whether or not UDT truly fosters better care for patients with acute or chronic pain of any type.

In general, a sizeable and convincing body of high-quality evidence to support the benefits of UDT for better pain care is lacking. And, much of the existing evidence has come from industry-sponsored studies portraying biased perspectives — usually stressing allegedly aberrant drug-using behaviors by patients who need close and frequent monitoring via UDT — without accounting for alternative explanations for study outcomes.

Yet, as we have previously noted in a short series of articles on “Understanding UDT” [here], urine drug testing can be a worthwhile component of effective pain management and pharmacovigilance. However, when UDT is motivated by fear and coercion — or profiteering, as noted by Meier — rather than diagnostic and therapeutic objectives, it can be offensive or intimidating to patients and misunderstood or misused by practitioners. As we suggested, “UDT is becoming an increasingly accepted and emerging standard of practice that, if done at all, should be done properly.”

UDT provides a relatively convenient and objective means of monitoring patients’ adherence to prescribed pharmacotherapies for pain — if used and interpreted correctly. However, results can be burdened by error or misinterpretation, and high costs of UDT assays may not be covered by insurance reimbursement.

In some cases, it might be prudent for practitioners and patients to ask, would it be better to spend $1,000 on a UDT assay or should that same money be invested in several sessions of pain counseling? For example, a qualified pain psychotherapist or other counselor should be able to thoroughly assess a patient’s medication (and other drug) using behaviors and help to guide the patient in proper use of analgesics as well as nondrug modalities. Perhaps, however, this is overly idealistic, since in many settings the availability of or access to such counseling may be unrealistic.

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