New Test Identifies Poor Drug Metabolizers

By Pat Anson, Editor

We hear regularly from readers who say they were discharged by their doctor after failing a urine drug test. Often it’s a case of an opioid painkiller not being found, which leads the doctor to believe a patient is selling or diverting their medication.

“The doctor said after 12 years of never having a bad urinalysis or anything ever happening, such as lost medication, asking to receive more or an early prescription, they said no medication was in my system. No one would retest and I was cut off cold turkey!” a pain patient recently told us.

“I went through hell trying to clear my name, horrible withdrawal with no doctor supervision or help, was labeled and thought I would die. This is a terrible way to treat anyone, especially someone with an untreatable life-long pain condition.”

Why are patients being falsely accused? In many cases, it’s because they have genetic differences that make them a low or high metabolizer of certain opioids. A painkiller like hydrocodone, for example, can quickly be utilized or pass through their system -- with little or no trace of the drug left behind.

Urine drug tests that are typically done in a doctor’s office -- known as point-of-care (POC) tests – do not identify these poor drug metabolizers. And studies show that about 30 percent of POC tests have “false negative” findings about opioid medication.

“Just because it may not show up in their system may not mean that they’re not taking it. There are two rational justifications for that. One is a bad drug test and the other is a patient may be a poor or ultra-rapid metabolizer of the medication that is being prescribed to them,” said David McCrea, CEO of Insight Diagnostics.

“I think most (doctors) understand how faulty the point of care tests can be, especially pain physicians. But I’m not sure the average physician understands how much a person’s individual metabolism can affect their drug test.”

Insight Diagnostics recently began offering a new testing service – called Genetically Enhanced Medication Monitoring (GEMM) – that combines a saliva-based genetic test with a laboratory test that more precisely identifies drug molecules in a patient’s urine. When used together, the two tests can reassure a doctor that a patient is telling the truth about their drug use.

“This is a game changing test that will allow physicians to uncover why some patients say, ‘I am taking my medication, I am taking it as prescribed and it’s just not showing up.’ This is scientific information that can validate a patient’s assertion,” McCrea told PNN.

“Certainly there are going patients that are going to try and game the system. But for those patients that are in chronic pain and are doing what they signed their pain contracts to do, this allows for a deeper dive for the physician to determine whether the patient is actually taking their medication, or they can’t metabolize it or they over-metabolize it.”

McRae says GEMM costs "a couple hundred dollars at the most” and is covered by Medicare and most private insurers. It doesn’t offer immediate results, as POC tests do, but the findings are far more accurate. They can also help physicians identify medications that will be metabolized normally by a patient and will be more effective. 

Genetic tests cannot be used to explain “false positive” findings from a POC test – the detection of a drug that isn’t actually there. But laboratory testing can. Retesting a urine sample is more expensive, but it can help prevent patients from being falsely accused – something that happens far too often.   

A recent survey of doctors and health care providers by PNN and the International Pain Foundation found that 20 percent had discharged a patient for failing a drug test in the past year. About four percent of patients said they had been "fired" by a doctor over a failed test.

“I failed a drug test which said I was positive for 4 drugs I have never taken in my life and was negative for opiates when I was taking Norco. My doctor abruptly stopped treating me even after I demanded my sample be retested,” a patient told us. “These drug tests are not reliable and should not be used and pain contracts should be illegal since they are forced on the patient.”

Click here to see a short promotional video about GEMM.

New Saliva Drug Test for Pain Patients

By Pat Anson, Editor

A Denver-based drug testing company has developed a new saliva test to help doctors determine if their pain patients are taking opioid medications appropriately.

Cordant Health Solutions says its Comprehensive Oral fluid Rx Evaluation (CORE) test is more accurate than the point-of-care (POC) urine tests that are widely used by doctors to test patients for prescribed medications, as well as illegal drugs.

Urine tests only tell a doctor if a drug is present, not if the patient is taking the right amount of medication. As PNN has reported, studies have also shown the urine tests often give false results for drugs like marijuana, oxycodone and methadone.

“Urine screening methods are subject to false positive and false negatives. If somebody for instance is taking a cold medication, they could very easily test positive for amphetamines,” said Richard Stripp, PhD, Chief Scientific Officer for Cordant. “The CORE test is specific for the drug that’s in the blood at the time the oral fluid (saliva) is collected.

“And not only will it tell you whether the drug is there or not, it will tell you whether it’s there at a level that consistent with what was prescribed.”

If a prescribed drug is found in saliva, the CORE test will tell whether it’s within an expected range, or at a level that’s above or below it – an indication the patient is taking too much or too little medication. Stripp admits the test is not foolproof. About 25 percent of the time, he says drug levels detected in saliva don’t match what is found in the patient’s blood.

“There are always things that you have to consider when you are interpreting results. I often say this does not replace the clinical judgement of the physician. This is a tool to help them make better decisions,” Stripp told PNN.

“If a doctor says (a patient is) out of range, I’m kicking them out of my practice, we would never, ever suggest that should be the case. Basically, it’s time to have a conversation with a patient and maybe it requires further monitoring.”

Unlike urine samples, which are usually collected privately in a bathroom and can be swapped or altered with “clean” urine from someone else, a saliva sample for the CORE test can be collected directly from a patient’s mouth with a simple swab.  

One disadvantage of the CORE test is that the results are not immediately available, as they are with POC tests that utilize color-coded “dipsticks” that quickly change color when a drug is detected.

The saliva samples need to be shipped to a Cordant laboratory for testing and the results generally won’t be available for 48 to 72 hours. Currently the CORE test can be used to detect levels of oxycodone, hydrocodone, morphine, oxymorphone, hydromorphone, tramadol and fentanyl.

Patients Penalized After Failed Test

Laboratory testing is far more accurate than POC tests, but some doctors don’t bother ordering confirmatory lab tests if something suspicious is found in a patient’s urine. We hear regularly from readers who say their doctor became suspicious or even “fired” them after a POC test turned up something unexpected.

“Last week they had me come in to take a urine sample. A week later they called and said I failed because they found no drugs in my sample,” said one man who has been taking hydrocodone for nearly 30 years.

“The doctor now tells me they can't approve any more refills. I thought they were joking. They also told me that no one in the area could either. It's crazy and I don't know what to do. I tried not taking pain meds and nearly went insane from the sleepless nights.”

A woman who takes Percocet for her fibromyalgia pain wrote to us saying two urine tests failed to detect any opiates in her system.

“My physician of 14 years immediately interrogated me about compliance and asked if I was giving it away,” she said. “Based on the negative findings, he said he could not prescribe me any further narcotic pain relief.

“I have no idea how I will manage my pain now. This has turned into an insane circus. I feel betrayed by my physician, and the doctor-patient relationship has had its trust destroyed.”

Stripp says he cautions doctors not to jump to conclusions after a failed test.

“If you don’t do the laboratory confirmation test, from a legal perspective you can’t say with reasonable certainty that the test actually contains or doesn’t contain the material it was tested for,” he said.

“You never want to accuse a patient of aberrant behavior if you have an inconsistent result, because there are other reasons why you could have inconsistent results. It could be there are differences in metabolism or they could have a health issue that may be causing the problem. Or there may be a drug interaction.”

Another reader who is on probation was given a urine test that showed he was positive for fentanyl.

"After a nightmare trying to keep myself out of jail, they allowed me to go to a hospital for another urine and blood tests. Both came back 100% negative! The second tests were taken an hour after the first," he wrote. "The judge accepted the hospitals tests and I am free, but this should not be happening."

The CDC’s opioid prescribing guidelines encourage doctors to conduct urine tests on patients before starting opioid therapy and at least once a year afterward. But they explicitly warn against dropping a patient after a failed test.

 "Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources," the guidelines state.

How common is patient abandonment? In a recent survey by Pain News Network and the International Pain Foundation, 20 percent of doctors and healthcare providers said they had discharged a patient who failed a drug test in the past year.  And about 4 percent of the patients surveyed said they had been fired by a doctor over a failed test.

Doctor Defends Use of Urine Drug Tests

By Pat Anson, Editor

A prominent pain doctor is disputing reports that a widely used urine drug test often gives faulty results.

“They are reasonably reliable and highly cost effective for use in a pain management practice. I would strongly recommend the practitioners use this,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Dr. LAXMAIAH MANCHIKANTI

Dr. Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, was the lead author of a study published in the journal Pain Physician in 2011, which looked at the reliability of immunoassay “point-of-care” (POC) tests. The urine tests are inexpensive and give immediate results, and doctors often use them to monitor their patients for opioid or illicit drug use.

“The UDT (urine drug test) with immunoassay in an office setting is appropriate, convenient and cost effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay office testing had high specificity and agreement,” Manchikanti's study found.

Pain News Network recently reported on the results of a second study conducted by Millennium Health, a San Diego-based drug testing laboratory, which found that POC tests were wrong about half the time – frequently giving false positive and false negatives results for drugs like marijuana and oxycodone. The Millennium study advocates the use of chromatography-mass-spectrometry – a more complex laboratory test that costs thousands of dollars – to confirm POC test results.

“Following the advice from companies in reference to numerous expensive tests and also income generating avenues will only lead to time in the slammer and will not improve patient care at all,” said Manchikanti.

“(The) Millennium study is performed by the company which makes a living by testing. The more samples that are sent to them, the better off they are. Further, they are not even a practical setting. From our practice we send approximately only 2% of the samples for confirmation testing. Even then, the patients can’t pay their bills.”

Manchikanti’s study found false negative and false positive rates for POC tests that were far below the rates reported by Millennium.

For example, Millennium’s false positive rate for oxycodone was 41.3 percent. For Manchikanti, it was only 7.7 percent.

Millennium’s false positive rate for marijuana was 21.3 percent. For Manchikanti, it was just 2 percent.

There were discrepancies between the two studies for several other drugs, including methadone, cocaine and methamphetamine.

Millennium Sponsored Both Studies

How could two studies come to such different conclusions?

There were some differences in their design. Urine samples in the Millennium study came from nearly 4,300 patients in addiction treatment clinics, while the urine samples in Manchikanti’s study came from 1,000 patients in pain management programs. Millennium maintains the patients in its study were younger and more likely to be drug users.

Ironically, the laboratory tests for both studies were conducted by Millennium – which collected samples and provided chromatography-mass-spectrometry testing at no cost to Manchikanti. Millennium is identified as the “sponsor” of Manchikanti’s study, but he says the company had “no influence or interference” in his and his three co-authors’ findings.

“We had our agreement in the beginning itself that they will not be involved in any way in writing the manuscript or publishing the results. Consequently, they really did not have much input into the publication. The publication was as it is and without any bias from the industry,” Manchikanti wrote in an email to Pain News Network.

Millennium’s study, which was published last year in the Journal of Opioid Management, had six co-authors. All but one were employees of the company. The lone exception is a pain management doctor who frequently testifies as a legal expert for Millennium in court cases.

A source with broad experience in the drug testing industry told Pain News Network the data in Millennium’s study was “skewed toward exaggeration.”

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test. Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company,” the source said.

Millennium bristles at the notion that its study was biased.

“Millennium Health strongly disagrees with the characterization… that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.

“Millennium is committed to providing data that helps clinicians evaluate the best course of treatment for patients with pain and addiction issues. Millennium Health performs only the tests ordered by clinicians.”

In recent years a growing number of doctors who treat addicts and pain patients have required them to submit to drug tests. The competition between Millennium and other laboratories for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry.

But Manchikanti maintains that a single inexpensive urine test that costs about $20 is often the only one that’s needed.

“If a proper (patient) history is provided which matches with the test, there is no need for further testing,” he said.

Urine Drug Test Often Gives False Results

By Pat Anson, Editor

A urine drug test widely used by pain management and addiction treatment doctors to screen patients for illicit drug use is wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The “point-of-care” or POC tests come with immunoassay testing strips that use antibodies to detect signs of recent drug use. Physicians like the urine tests because they can be performed in their offices, are inexpensive, and give immediate results. But experts say the tests are wrong so often that no doctor should base a treatment decision solely on the results of one test. 

“Immunoassay testing has an extraordinarily high rate of false positives and false negatives as compared to laboratory testing,” said Steve Passik, PhD, Vice President of Research and Advocacy for Millennium Health, which analyzed urine samples from nearly 4,300 POC tests obtained at addiction treatment clinics.The Millennium study was published in The Journal of Opioid Management.

A false positive reading means a drug was detected that isn’t actually there, while a false negative means the POC test missed finding a drug that was present in a urine sample.

The Millennium study found plenty of both.

False positive readings for marijuana, for example, were given over 21% of the time, while false negative results for marijuana also appeared about 21% of the time.

The POC tests had an even worse track record for oxycodone, a widely prescribed opioid pain reliever. False positive results were detected over 41% of the time and false negatives over 31% of the time for oxycodone.

“We always knew it wasn’t as sensitive and we always knew that it didn’t look for specific drugs within a class. But this was revealing in regard to how much it misses, with false negative and false positives rates in 40 to 50 percent in some instances,” said Passik.

“If we were in another area of medicine, let’s say oncology, and you had a tumor marker or a test that you were going to base important treatment decisions on, and it was as inaccurate as immunoassay is, the oncologists would never stand for it.”

Passik says “the word is starting to get out” how inaccurate the immunoassay tests are. But few patients are aware of it and some doctors are still dropping patients from pain management programs after POC tests found illicit or unprescribed drugs in their urine. 

Passik told Pain News Network that patients should insist on a second test if they feel the first one is wrong.

“If they think it’s a false positive, they need to ask the doctor to be re-tested. And particularly they should ask what method was used. And if they find out they were tested with immunoassay, they should say they want the same specimen either re-tested at the lab or they want to provide another specimen tested at the lab,” Passik said.

A laboratory test that uses chromatography-mass-spectrometry to break down and identify individual molecules is far more accurate than an immunoassay POC test, but it could cost thousands of dollars -- something many insurers and patients are unwilling to pay for.

And critics say Millennium – one of the largest drug screening companies in the nation – has produced a self-serving study designed to drum up more business for itself.

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test,” said a source with broad experience in the drug testing industry. “Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company.”

The source told Pain News Network the data in Millennium’s study was “skewed toward exaggeration” and questioned the need for further testing.

“In addiction centers, there is not really a large demand for confirmation testing. I understand Millennium wants to increase that business because that’s what they do.  However, medical necessity does play into all laboratory testing.  The great majority of the time, when a patient in a treatment center is confronted with the results of a POC test that shows a drug in their system that shouldn’t be there, they will confess to taking the drug.  So, what would be the medical necessity of confirming that test?

“I believe many of the urine drug testing labs are promoting confirmation testing when it is not medically necessary.”

Millennium took offense that the validity of its study was being questioned.

“Millennium Health strongly disagrees with the characterization in the story that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.”

"Liquid Gold"

A growing number of doctors who treat addicts and chronic pain patients require them to submit to random drug screens. And some companies and government agencies also require employees and job applicants to submit to POC tests as a condition of employment.

The competition between drug screening companies for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019.

But addiction experts say more reliable and expensive testing is needed, simply to be fair to patients.

“Heavy reliance on immunoassays in addiction treatment can be detrimental to the patient due to their higher risk for false positives and false negatives in comparison with more reliable technology, such as chromatography-mass-spectrometry,” said Michael Barnes, executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a non-profit that gets some of its funding from Millennium.

“A false positive can be detrimental to a patient by subjecting her to unjust suspicion or accusations, unnecessary adjustments to the treatment plan, or the deterioration of the practitioner-patient relationship. A false negative may result in delayed diagnosis or misdiagnosis, false confidence that a patient has not relapsed, and failure to catch behavior that could eventual result in a preventable overdose death. Therefore, chromatography-mass-spectrometry is often more appropriate.”

Millennium’s Passik says most doctors recognize that both tests may be needed.

“These two different methods yield very different kinds of results,” Passik said. “If I was still practicing, I wouldn’t feel that immunoassay is accurate enough to be the only test that you use.”

Ironically, a federal court last year found Millennium guilty of giving illegal kickbacks to doctors by providing them with free POC test cups – the very tests the company says have an “extraordinarily high rate” of false results.