Drug Tests Scare Off Some Chronic Pain Patients

By Pat Anson, Editor

Urine drug testing has become standard protocol for many patients who are prescribed opioid pain medication. But a new study suggests the practice may be counterproductive, because it increases the odds a patient won’t come back for further treatment.

In a study involving 723 chronic pain patients being treated at a pain clinic, researchers at the University of Houston and the University of Texas Medical Branch at Galveston found that nearly a quarter (23.75%) who were given a urine drug screen on their first visit failed to show up for the next appointment. 

The odds were even higher for those who tested positive for an illicit drug, but the “no show” trend also applied to patients whose drug tests were negative.

“Even those who tested negative for illicit substances in the UDS (urine drug screen) were more likely to be no-shows compared to those who did not get tested. This raises concerns that the UDS administered early in the doctor-patient relationship might have an inadvertent impact on injuring patient expectations of trust,” the researchers reported in the journal Pain Physician.

Only about 10% of those who weren’t tested skipped their follow-up appointment.

“It is a balancing act,” said Partha Krishnamurthy, director of the Institute for Health Care Marketing at the University of Houston’s Bauer College of Business. “On one hand, concerns about patient safety and public health necessitate the monitoring of patients on opioid medications. On the other hand, aggressive monitoring may interfere with the therapeutic alliance.”

Routine use of urine drug tests is one of the main recommendations in the CDC’s draft guidance for opioid prescribing, which calls for primary care physicians to “use urine drug testing before starting opioid therapy and consider urine drug testing at least annually.”

The scientific research behind that recommendation is considered weak, as is much of the evidence that standard “point of care” urine drug tests are reliable or accurate.

I've only been saying that UDT (urine drug tests) harms patients and the patient/provider relationship for the past seven years and not a single physician, researcher, or healthcare provider of any kind supported my position.  I guess common sense wasn't enough but now we have evidence,” said Mark Collen, an independent scholar and patient advocate. 

“As I've stated previously in regards to UDT, the entire pain community will end up on the wrong side of history and it looks like that's beginning to occur.”     

Researchers say one possible solution to the high-rate of patient “no shows” is for doctors to delay drug screening of new patients until they’ve had a chance to develop rapport and trust with them.

“Not testing is not an option,” the researchers said, while at the same time warning that routine testing may only make prescription drug abuse worse.

If the patients are disengaging from the clinic, where are they going? Is the illicit market place their next stop? Thus, while UDS may induce the problematic patients to go away from the clinic, the problem of opioid misuse may continue to persist.”

The CDC and Profit Driven Drug Testing

(Editor’s Note: As part of its draft opioid prescribing guidelines, the Centers for Disease Control and Prevention (CDC) recommends that physicians “use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.”  Mark Collen is an expert in this field and has submitted the following to the CDC.)

By Mark Collen, Guest Columnist

There are a number of conflating factors which have led to the CDC‘s recommendation for urine drug testing (UDT) in pain management -- none of which have to do with quality patient care. These include the federal government‘s complicity in the overprescribing of drugs, the unethical marketing of OxyContin by Purdue Pharma, the profit motive which drove drug testing patients in pain, and physicians‘ fears and inability to effectively treat pain.

We live in a drug addled society with Americans consuming record amounts of prescription drugs, including opioids. In other words, American healthcare providers are exceptional at writing prescriptions. Someone needs to tell them to, “Just say no.”

The pharmaceutical industry‘s direct-to-consumer advertising (DTCA) has driven demand for drugs and has contributed to the escalating cost of prescription medications. Both Congress and the FDA are largely responsible for this overprescribing public health issue since they have allowed DTCA to exist and spread.

What has not been investigated is the influence the incessant drug ads have had on the American culture and more importantly, the American psyche in terms of one‘s views on drug use, prescription or otherwise. Almasi and colleagues write, “DTCA pushes a ‘Brave New World‘  where if anything unpleasant should somehow happen, why, there‘s always [the sedative] soma to give you a holiday from the facts.” DTCA may influence the abuse of opioids and other drugs.

The pharmaceutical company Purdue Pharma was responsible for one of the most deceptive marketing campaigns in history with their medication OxyContin, a timed-release oxycodone. Art Van Zee writes, “A consistent feature in the promotion and marketing of OxyContin was a systematic effort to minimize the risk of addiction in the use of opioids for the treatment of chronic non–cancer-related pain.” As a result, OxyContin became the poster boy for prescription drug abuse and Purdue was fined $600 million to settle criminal complaints. That has had little impact on the Sackler family, Purdue‘s owners, with Forbes estimating their worth at $14 billion.

Although Purdue is not completely responsible for the current opioid abuse epidemic, they certainly have played a meaningful role. In addition, a congressional investigation suggested that the pharmaceutical industry has promoted opioid sales through a number of organizations including the American Pain Society and the American Academy of Pain Medicine, both of which write treatment guidelines. 

As opioid abuse and overdose deaths began to rise, so did the drug testing industry within pain management. Drug testing labs used a similar strategy as the pharmaceutical industry in promoting their wares and money was used as an incentive to drug test. 

In my 2012 article entitled, “Profit-Driven Drug Testing,” I presented Medicare data which showed a meteoric rise in drug testing:

“A deeper examination finds that between 2000 and 2009, the total number of CLIA-waived drug tests paid for by Medicare and conducted at physicians‘ offices increased approximately 3,172,910%; with 101 tests conducted in 2000 and 3,204,740 in 2009. Furthermore, during that same time period and within the specialty of anesthesiology, CLIA-waived drug tests increased 63,687,900%.”

The annual cost of drug testing in pain management is estimated at $2 billion per year. Unfortunately, that may be a gross underestimate since no study has ever evaluated the indirect costs of patient harm or harming the therapeutic patient-provider relationship—likely the most important aspect of pain management. A November, 2014 article in the Wall Street Journal reported that some physicians are making more money from drug testing patients than treating them.

Not unlike big pharma, there appears to be a dearth of integrity in the drug testing industry. Millennium Health, the largest drug tester in pain management, was recently fined $256 million by the U.S. Department of Justice and then filed for bankruptcy. This led to the discovery that the founders took $1.3 billion out of the business in 2014.

Ameritox, the second largest drug tester, actually paid physicians to drug test their patients, and as a result was fined $16.3 million by the Justice Department. Calloway Laboratories is yet another drug testing lab that was prosecuted and it is going out of business.

This author asked Debra Maul, a whistleblower in the laboratory industry, for her comment on UDT in pain management for this paper. Debra wrote, “Personally, I believe it‘s all about the money. When I entered the laboratory business in 2003, it was very difficult to get physicians to test their patients. In 2007, when Millennium entered the industry with the POCT (point of care tests) business model, pain doctors significantly increased their patient testing, I believe, because they could make money on in-office testing. New labs were popping up everywhere promoting this business model.”

She continued, “If you look at the information the WSJ obtained from CMS regarding Medicare reimbursements for UDT, reimbursements for simple UDTs grew significantly from 2007 until reimbursements were cut in 2010. Then in 2011 and 2012, high tech drug testing took a big jump, I believe, due to laboratories promoting in-office analyzers and other high-tech testing equipment to doctors, so they could continue billing for UDTs. It will be interesting to see what happens with in-office testing and the entire UDT market, with the significantly reduced reimbursements this year.”

What follows is a list of drug testing labs and the amount they were reimbursed by Medicare for urine drug testing in 2012. These numbers come from Medicare‘s website and were provided by Debra Maul:

  • Millennium: $109,031,768
  • Ameritox: $99,553,258
  • Aegis: $36,140,368
  • Alere: $16,937,116
  • AIT: $13,845,880
  • Dominion: $12,551,313
  • Calloway: $6,918,972

To complicate matters, healthcare providers do a poor job at treating chronic pain and opioids may not be the best choice for the long-term treatment of chronic, non-acute, non-malignant pain. Moreover, insurers have been known to reimburse for pain medication and not physical therapy. It is likely that a number of clinicians prescribe opioids because they don‘t know what else to do, and then perform random drug tests in hopes of mitigating any damage they may cause, but it does not work. There is a great need to develop and test cost effective, alternative interventions to pharmacotherapy for the treatment of chronic pain and illness in the primary care setting.

The overriding factor in this historical perspective is the consistent and negative impact industry has on medicine and in this case, pain medicine. A good example of how close the drug testing industry gets to individuals who write guidelines, please go to this link and note the presenter is the lead author of the CDC guideline (Dr. Deborah Dowell) and a conference sponsor is a drug testing lab (Ameritox). 

There is no question that industry has a negative influence on medicine. Stamatakis and colleagues write, “The industry has created means to intervene in all steps of the processes that influence healthcare research, strategy, expenditure and practice. These include evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluation, clinical guidelines formation, healthcare professional education and direct influences on healthcare professional decisions.”

Urine drug testing in pain management costs an estimated $2 billion per year and there is no proof of efficacy. Moreover, it may cause patient harm and harm to the patient-provider relationship and thus increase healthcare costs even further. 

The desire for profits likely started and maintains UDT in pain management along with fear. Fear of prosecution has been attributed to the proliferation of drug testing by doctors treating chronic pain. Goldberg and Rich write, “This singular focus strongly suggests purposes beyond ensuring quality patient care, such as fear of regulatory scrutiny and potential legal liability.”

The CDC has turned a blind eye to a number of important issues regarding UDT in pain management, including its constitutionality and the fact that it was likely driven by profits. Group think can negatively influence treatment guidelines and that is likely to blame for the CDC urine drug test recommendation. Giving a person with pain a “choice” to either submit to a drug test or not receive pain medication is really the option to either submit to a search or suffer, and that is coercion. It exemplifies patriarchal medicine at its worst and is the antithesis of patient-centered care. 

James L. Madara, MD, CEO of the American Medical Association, was quoted as saying about the CDC guideline, "The guidelines and supporting discussion are devoid of a patient-centered view and any real acknowledgment or empathy of the problems chronic pain patients may face."

The CDC should not recommend UDT as part of the current guideline since there is no proof of efficacy, it may be unconstitutional, and was likely driven by profits and nurtured through fear. Furthermore, it is very expensive and may cause harm to the patient and patient-provider.

Mark Collen is an independent scholar and patient advocate. He serves on the editorial board of the Journal of Pain & Palliative Care Pharmacotherapy, and has peer reviewed manuscripts for journals including The Patient: Patient-Centered Outcomes Research, The American Journal of Pharmacy Benefits, and The Clinical Journal of Pain. 

Mark is also the founder of PainExhibit.org, an online art exhibit from artists with chronic pain, which seeks to educate healthcare providers and the public about chronic pain through art, and to give a voice to the many who suffer in silence.

This column is an abbreviated version of the comment Mark has submitted to the CDC. The full version of Mark’s comment can be read here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Reader Calls for Pain Patient 'Bill of Rights'

By Pat Anson, Editor

A North Carolina woman who suffers from Reflex Sympathetic Dystrophy and several other chronic pain issues wrote to us recently about a serious problem she had with a urine drug test (UDT) performed in her doctor’s office.

Her urine tested positive for oxycodone and hydrocodone, two opioid pain medications she did not have prescriptions for. So the doctor dropped Paulette Waters from his practice, informing her by registered letter that she would no longer be his patient after 12 years without any other issues.

“This is where my horror story starts and has as of yet to end. The letter stated that I had broken the pain agreement and my doctor would not be seeing me anymore. The letter being generic and not including any details or UDT results,” wrote Paulette, who asked that Pain News Network not use her real name because she’s afraid of being blackballed by more doctors.

We’ve written before about these “point of care” (POC) urine tests. The immunoassay tests are often used by doctors to screen pain patients for the misuse or abuse of drugs – but they’re wrong about half the time. One study, for example, found that POC tests give false positives 41% of the time for oxycodone. Sometimes even a simple over-the-counter medication like ibuprofen can trigger a false positive for marijuana.

A more complex laboratory test that uses chromatography-mass-spectrometry to identify individual molecules is far more accurate than POC tests, but they cost thousands of dollars -- something many insurers and patients are unwilling or unable to pay for.

Instead of conducting additional tests or giving a patient the benefit of the doubt, some doctors take the easy way out by dropping patients like Paulette.

The problem now has become that since this test, no pain clinic will see me, let alone let me tell my side of the story,” says Paulette, who has been struggling for the past year to clear her name and get the pain medication she needs.

“Knowing I have a legitimate chronic disease there is no cure for, why would I jeopardize myself by doing something that would put me in a position to not have the medicine I needed to help me live somewhat of a normal life?” she asks.

Paulette has called different lawyers and even the ACLU, but no one has taken her case. She’s also written to the state medical board, believing her doctor didn’t follow proper protocol before dismissing her.

“As of now a patient who legitimately suffers from chronic pain has no voice, recourse or method to keep them from being falsely accused of failing a urinary drug test,” she adds.

Patient Bill of Rights

Paulette thinks it’s long past time for a “Patient Bill of Rights” – one that spells out exactly what’s expected of doctors andpatients before, during and after a drug test, including:

  1. Make patients aware that UDT’s can have false positives and false negatives.
  2. Inform patients what kind of test they are taking.
  3. Make sure the patient and doctor have a list of all prescription drugs the patient is taking, including over-the-counter meds, vitamins and supplements that could affect the test results.
  4. Make patients aware what consequences they could face if a test result is abnormal.
  5. Make sure the patient has a signed copy of their pain contract or drug agreement.
  6. Allow the patient to observe the urine sample being sealed in front of them.
  7. Make patients aware that insurance companies do not always pay for drug tests.
  8. Make doctors follow guidelines if there is an abnormal test result. Have them tell the patient in person, instead of a generic letter dismissing them.
  9. Allow at least one more reliable drug screen to be sure false positives or negatives did not occur.

Paulette says pain patients have paid a price for too long in the “War on Drugs” – becoming casualties of misguided policies they have no voice in. 

“All of these battles are between the DEA, insurance companies and doctors,” she says. “The one person that is left out is the patient who is the one suffering. that only has the option of seeing a doctor for their chronic pain. This leads them to such things as buying street drugs, depression, committing suicide, and other health problems because their legitimate chronic pain is not under control.”