Much of the debate over prescription painkillers has focused on addiction, unnecessary prescribing and inappropriate promotions by drugmakers (back stories
here,
here,
here and
here). But another corner of this widespread marketplace is worth watching - the laboratories that run tests so physicians can monitor the use and abuse of these drugs.
How so? Well, a federal grand jury in Boston is investigating Millennium Laboratories, which sells urine drug testing services to pain clinics across the US, for health fraud, according to a nicely done piece by Reuters. And the lab is also being investigated by the US Department of Justice for intimidating former employees, including one who was portrayed in a slideshow at a company meeting as a corpse in a body bag, the news service writes.
Two former employees, who raised concerns about Millennium sales practices, also say they were followed for weeks by private investigators they believe were hired by the lab, Reuters writes. No criminal charges have been filed, however, and Millenium ceo Howard Appel tells Reuters that the privately held company did nothing wrong and is cooperating with a Justice Department subpoena. He also suggested the feds are probing his rivals.
At issue is the bruising competition among labs. In separate interviews, four witnesses described their grand jury testimony to Reuters, which reviewed copies of grand jury subpoenas seeking records on Millennium. All four testified that Millennium succeeded in getting doctors to order unnecessary urine tests and then charge excessive fees to Medicare and private insurers. Millennium has denied those accusations in civil lawsuits brought by rivals.
The witnesses said Millennium used aggressive pitches to pain clinics to order various urine tests even when they were not needed, at up to $1,600 a test. For instance, labs say urine tests can show whether someone is taking extra pain drugs, (although a loyal reader notes this is not so because drugs can be metabolized at different rates). One lawsuit, filed by a rival, alleged Millenium encouraged doctors to screen for as many drugs as possible, rather than conduct screening based on individual needs, and then bill payers for larger reimbursement.
Urine testing has rocketed as the number of prescriptions for pain drugs in the US rose from 30 million to 180 million a year over the last two decades, Reuters writes. This has also led to two previous prosecutions and numerous lawsuits by labs accusing each other of wrongdoing. In March, for instance, Calloway Laboratories paid $20 million to settle charges by Massachusetts state Medicaid that kickbacks were paid for unnecessary screening.
The story is lengthy, but there are some interesting details. For instance, the picture of a body bag was part of a PowerPoint presentation by Millenium general counsel Martin Price, according to the former employees. He showed that at a national sales meeting in January in which he described Millennium's success against its adversaries, Reuters writes, citing a grand jury witness and former Millennium employee named Jodie Strain.
She told Reuters that grand jurors gasped when the body-bag image was projected onto a wall during her testimony last month and the toe tag identified the corpse as Ed Zicari, a former regional manager Millennium was suing. Both Appel and the US Attorney in Boston declined to comment.
Other slides in the presentation showed the names of rival labs being riddled with bullet holes while gunfire sounded as if they were at a shooting range, according to her affidavit (which you can read here). Strain, a former senior sales rep, told Reuters the talk ended with an ominous warning: The company could not protect people who went "outside the Millennium family... I took it as a complete warning and threat to not only not go to the competition but don't even question Millennium once you were no longer under their protection," she told Reuters.
Shortly after the presentation, Strain said she told Zicari's girlfriend about the slide show because she feared for their safety and was fired the next week, Reuters writes. Zicari and his girlfriend, who is a former Millenium sales rep, were being sued by the lab at the time for allegedly taking confidential information when they left the company, according to Reuters. Both also accused the lab of misconduct and the suit was settled last summer, Reuters adds.
Zicari and Strain are currently pursuing suits against Millennium for wrongful termination and other claims, Reuters continues. Zicari, for instance, charges he was told by a supervisor to bribe doctors to obtain information about competitors, according to Courthouse News Service. Appel described them to Reuters as "disgruntled former employees" who were fired for cause, not for questioning company practices, the news services writes, adding that he described Zicari as "alive and well and living in Texas."
pic thx to cbc
60 Comments
http://www.thewhizzinator.com/
1: Cannot; there's very little look-back. Selling 29 and taking 1 works just as well.
2: You should read up on all the ploys used; these folks collect/save known urines for spiking - custom blending used to access the pills which are converted to $$$, used to feed an addiction, or both.
You can't tell if patients are taking the medications. These tests don't provide meaningful compliance data - never have - so please accept that you are writing blind.
The traffickers are so far ahead of the medical industry - they have a trick for every test.
For the time being, it is indeed a victory of marketing over science.
I would prefer to line up the friends that little Johnny sold his extra doses to, make them pee in a cup, then send them off to rehab.
You don't have to tell me about the manipulation around bup, I'm responsible for "managing" this for my health plan. The quotes here are to indicate that it is nearly impossible to do so.
Why use something that the courts and the vendors agree cannot establish compliance? Note the signatories to the Order (link at the first comment above). Of course, the Order was based on the consensus from the medical literature.
If this were a cheap test (you are using tests that cost hundreds of dollars per patient sample), then perhaps we could afford to collect poor CYA data. Our health care system cannot pay for expensive & discredited data, however.
One certainly would not want to over-interpret the data given that there are individual differences in metabolism and distribution. But that range of variability is clearly not infinite, as otherwise a third of patients taking a standard dose would die of respiratory depression and another third would experience no relief of symptoms.
Data that is less precise than one would like is still data, nonetheless.
Also, you don't seem to have addressed his points. He stated that he mainly uses the data to look for what is present and not what is missing. If an LCMS trace shows benzos, then the patient has ingested benzos. There's really not much of anyway you can get it wrong using appropriate internal standards and two orthogonal measures of identity.
If this were a cheap test (Dr. Ricky Bobby is using LCMS testing that cost hundreds of dollars per patient sample), then perhaps we could afford to collect poor CYA data. Our health care system cannot pay for expensive & discredited data, however.
You might be aware that we have brewed a fiscal crisis in these parts. The court decision is supported fully by the medical literature.
I recognize that you have an issue with drug testing. I'm not a big fan of it either. But wishing it were so doesn't invalidate the science. I've worked as an LCMS operator, and if God himself tested positive for an illicit drug, I'd cut off His supply of painkillers until he finished rehab and His urine came back clean for 6 weeks running.
This has nothing to do with LCMS (except the expense). No urine test - regardless of technology used - has meaningful look-back capability. Additionally, the traffickers and addicts are very good at spoofing the samples.
Too expensive. No utility for compliance. Plague on our medical system. The public should not be asked to pay $$$$ for window dressing, although it might be OK if it were only $.
If you want to take the judges word on this issue, I'm certainly not offended and will be happy to offer you my opinion on some issues of constitutional law instead.
You might be qualified to find contrary evidence from the medical literature, but you will not find said evidence and you will not report back with appropriate references.
People need to know how much is in there before you put more in.
Don't you use a dipstick to check your oil or do you just go get a gallon and start throwing it in and once it spills over, then you get out your calculator to take the measurement of how much was in there in the first place?
Logic 101 - it may be logic, but it still serves no purpose in solving the problem.
-BAC at time of arrest; -person's age -male or female -body weight -time of last drink -time of last meal
Although not 100% accurate you can come close to the peak BAC by back extrapolating the blood alcohol concentration. You can get even closer with actual blood sample Even if the BAC is below 0.08 at time of arrest with these data you can prove the person was legally drunk at the time he or she left the bar and make a DUI hold up in court.
dz since you didn't specify urine in this quote I assumed you were speaking in general.
On the other hand, if you are prescribed a low dose of codeine and your urinary metabolite levels are above the 99th percentile for a patient prescribed that dose (or worse yet, indicate the ingestion of unrelated opioids), that information indicates a high likelihood of a problem.
Ditto if you come in to your doctors office to get your Oxy prescription refilled, show no signs of being in pain, and your urine test shows you havent taken the drug in at least 3 days.
I don't know if I can provide a supporting reference for these statements any more than I can find one stating that the sun will come up in the East tomorrow morning, its just common sense to anyone who isnt up to their eyeballs in ideology. You might take a look at the treatment guidelines for chronic pain from the American Pain Society and other professional groups, all of which recommend urinary metabolite monitoring in high risk patients.
But I'm done here, having recognized that I'm using reason to try to convince folks whose beliefs are based in other criteria.
Because John cannot provide any references to the medical literature, he has reached the same conclusion as the federal court. Using his "sun will come up in the East tomorrow" framework, the data do not exist if they cannot be found in the medical literature.
We cannot afford hundreds of dollars per test per patient encounter for something that 1) has no look-back utility and 2) is readily gamed.
As it happens, the majority of the pain groups are astroturf organizations for the pharma companies. (References readily available.)
But ditto for urine tests...
Without a baseline test(s) - which I do not believe is current SOP, although good clinicians are doing it if they consistently manage the patient, which you would think IS happening for chronic pain - get a pre-dose, and timed post-dose like 1 hour, 6 hour, etc. (metabolism is unique to the patient) and then getting a sample that is *clear* so that you can plot the whole cycle FOR THE PATIENT is the only way the tests can be CLINICALLY relevant. After all that, you can use the single test and see where it falls on the timeline...
Reminds me of the "Seinfeld" episode where she ate a poppy seed muffin :-) before peeing in the cup...
Bottom line - it's not the test that's the problem. Like, duh.
The reality is that if you are speaking about an addict, they are masters at faking pain. That's how they got the drug in the first place. Doctors don't do drug screens, in fact many narcotics can be renewed in limited quantitites over the phone. What seems excessive to me is that in one state a 72 hour renewal per phone gets you up to 30 Percocets, no questions asked.
Dz, as you recall, although Elaine got cleared on the poppy seed deal, she wound up being diagnosed as postmenopausal when she substituted Jerry's mother's urine for the test.
Are you sure that "Ricky Bobby is an actual Clinician who knows WTF he is talking about," as I only see parroting of a marketing pitch. As you know, these testing companies use every shenanigan around, including "ownership" and outright bribery.
Read it, Jim.
Mind telling us how many patients you see? And what tests you use?
"...Millennium was founded in 2007 by Edward Slattery. His bio says he previously worked in real estate and broadcast and served eight years as Massachusetts commissioner of aeronautics. Last year, he won an Ernst & Young Entrepreneur of the Year award in San Diego. He declined to comment....".
real estate, broadcast, and MA commissioner of aeronautics..?
very original...
These big labs have really slacked off of taking care of their equipment and doing calibrations, btw. Kind of a tip off when all the labs done on the same day all came out to be the exact same value. They don't print the report that way for the sponsor anymore - go figure. Have to do the cross check yourself and CROs don't teach anyone how to do THAT....
I regret this development. When we studied an imidazopyridine anxiolytic back in the 1980's I monitored the labs from the printer in my office. After the first 50 patients I picked up a trend in elevated LFT'S that would have been detected probably later nowadsys with everything electronic. We eventually killed the drug for that reason.
Screw all that fancy noise about "early safety signals". The best early safety signals are the medical monitor's eye's and ears.
http://www.nbc.com/saturday-night-live/video/alec-baldwin-monologue/1358179/
Indeed, MUCH later, like 2 years after the drug has been on the market is where *safety signals* are being picked up since up to 2 years they are *theoretical* - the ACCEPTABLE death rate in the risk/benefit ratio...
Well, any unfortunate addict trolling this discussion board for ways around their upcoming urine test only got sent back to a Seinfeld episode :-)
Please note at page 6 of the Order that all the parties (the judge and two of the largest laboratories in this market) agreed to this statement: “Urine Drug Testing cannot determine the timing or quantity of the drug taken by the patient.” Hence, the companies selling the tests agree that there is no medical basis to support their use for assessing compliance to a prescribed regimen. Said another way, there is no look-back capability.
Oncologists are not going to stop ordering the test(s) that THEY need to determine the next therapeutic dose based on this ruling for the urine test. So don't even think about applying this ruling across all practices for all disease management uses.
You completely MISS the science here.
Why are you bringing up TDM? These tests cannot be used to set or modify controlled substance dosage.
Why are you bringing up baseline? These tests are flogged for repetitive testing. Since they are not medically credible, why do a baseline?
Why can't you understand that a $6 test is sufficient for presence or absence purposes? A test that costs several hundred dollars is not justified for presence/absence.
Six dollars good; six hundred dollars bad.
If you really do not know what is wrong with that, then there's no hope for science ever righting the pharma ship or the practice of medicine.
This is not a precedent against lab tests. This is a precedent against lab tests that make utility claims that are not substantiated by data. We cannot allow marketing to trump science.
yup, don't figure out how much they've already got in their system...
You've got to let this go. Please accept that unsubstantiated claims should not generate sales in the $billions.
You've got to let this go. Your huffpost link describes a criminal enterprise. Criminals do not modify dose even if the test had this utility.
You've got to let this go.
Fine with me to *let go* of a legal precedent that can be trotted out to litigate that ALL lab tests are not "medically credible" because they ARE only credible when compared to a baseline, per patient, and to ranges of normal set by thousands of experiments based on hard sciences (chem, biochem, engineering, etc.)
Just for the record, I agree that a childhood friend who got hooked on street heroin and who ended up beaten into unconsciousness and then to make sure she was dead, drove over forward and backward by the *trick* she picked up to pay for her habit -
that she was in a *criminal* world that does not get helped by any legal precedents that serve to protect upper economic strata addicts.
Carry on...
I suggest you save your hard earned money by ditching the lawyerrs, contracts and your malingering pain patients and send them all to a pain management specialist, that is if such specialists exist south of the Chatahoochee River.
That's why your contract is meaningless, since any one of your patients with true drug seeking behavior knows the masking agents probably better than me.
So again, trf these GOMERS to a pain specialist.
These enterprises are prepared because of the street value of the prescriptions. Heavily marketed lab tests without a clinical basis may be reimbursed, but only for a short period; the payors do catch on eventually.
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