Star-Tribune: Medtronic Touts Pump to Stop Pills

[drusso]

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Medtronic touts treatment to wean patients off pain pills

Medtronic's new patient workflow is designed to build on those results by identifying chronic pain patients best suited for the SynchroMed therapy. "The workflow is especially helpful for patients who may be on high doses or cannot tolerate systemic opioids, or for those who are not finding pain relief with systemic opioid therapy," said John A. Hatheway, a Spokane, Wash., pain physician and paid Medtronic consultant. "By placing the medication at the source of the pain, we can often provide better pain relief with fewer side effects at a fraction of the oral dose."

 

[kstarm]

"The workflow calls for people with chronic pain to slowly decrease their pain pill intake until they can take a complete "holiday" from the pills for up to 6 weeks. Once fully tapered, they start receiving smaller doses of liquid opioid drugs from the SynchroMed II."

Oye...Why go through all the work to taper a patient off opioids, have them be off opioids for 6 weeks, and then put them back on opioids through a pump? I still remember my interaction with the rep 5 years ago when she was shocked to find out that patients were on both a pump AND getting oral opioids. I had yet to see a patient that wasn't on both. I mean how do you treat fibromyalgia otherwise...

 

[Orin]

Oye...Why go through all the work to taper a patient off opioids, have them be off opioids for 6 weeks, and then put them back on opioids through a pump? I still remember my interaction with the rep 5 years ago when she was shocked to find out that patients were on both a pump AND getting oral opioids. I had yet to see a patient that wasn't on both. I mean how do you treat fibromyalgia otherwise...

Yeah, this is a failing of the clinician and not the therapy. You're prescribing both.

The taper gets 1) buy-in from the patient, 2) screens out crazy, 3) reduces DRG/peripherally mediated effects that trigger hyperalgesia.
It does work very well for patients that complete the process AND can stay opioid naive systemically.

The benefit is due to a lack of longterm iatrogenic risk of IT opioid as compared with systemic opioids. These patients can often still pee clean because they are getting 0.2 mg of Morphine per day and getting better relief than the crazy oral morphine equivalents/day they were on previously.

The challenge is getting them through the taper and then keeping them systemically naive in case they suffer trauma/surgery/etc that is distal to the region of the cord that is covered by the drugs.

The worst case scenario is they fail a trial and you have gotten a patient through a 6 week opioid holiday with the pump as a carrot.

Now, we all know for Fibromyalgia you need to use Abott's BurstDR

 

[Aether2000]

Studies show ultra low dose opioid patients increase their pump opioid infusion rate at the same % compared to high dose opioids. They continue to increase, only it takes longer for hyperalgesia. But the entire concept of putting in a pump for ultra low dose opioid use is flawed, absurdly expensive, and is not without significant (and sometimes life threatening) complications.

 

[Ducttape]

i personally fail to see how saying that someone is on only a tiny dose of morphine intrathecally is that much greater than getting a bigger numerical dose orally.


i mean, what is the purpose of an MED if not to equate the treatment so that we can determine efficacy? 0.2 mg morphine intrathecal is not 0.2 mg morphine orally and that is a complete fallacy to equate the 2, as you are doing.


i have had a lot of patients say "well, im only getting 25 mcg (fentanyl) instead of 75 mg (morphine), so its not a problem!"

 

[Orin]

Studies show ultra low dose opioid patients increase their pump opioid infusion rate at the same % compared to high dose opioids. They continue to increase, only it takes longer for hyperalgesia.

With regards to the studies about IT dose escalation, I have not seen this reported in the literature.
Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. - PubMed - NCBI
3 years out and stable in the 1.4 - 1.6 mg dose range for "high" dose. So I guess that's what you're worried about? I would remind you that you have control over this infusion and it doesn't care if the patient wants more, since you're dosing them, so it takes their compliance out of it unless they're abusing/diverting/etc.

But the entire concept of putting in a pump for ultra low dose opioid use is flawed, absurdly expensive, and is not without significant (and sometimes life threatening) complications.

The concept of delivering medication to an effective site of action is really not that complicated. Do you also think insulin pumps are also flawed, absurdly expensive, and not without significant complications, or is this just about morphine and things that might reflect on your license?

i personally fail to see how saying that someone is on only a tiny dose of morphine intrathecally is that much greater than getting a bigger numerical dose orally.

i mean, what is the purpose of an MED if not to equate the treatment so that we can determine efficacy? 0.2 mg morphine intrathecal is not 0.2 mg morphine orally and that is a complete fallacy to equate the 2, as you are doing.

MED makes sense most of the time when comparing between opioid types when discussing analgesia and/or risk of iatrogenic injury.
- Are you more worried about the patient on Buprenorphine 8 mg or the Oxycodone 30 mg?

MED makes sense when comparing between a single opioid for routes of administration when discussing analgesia but we could argue about the risk of iatrogenic injury.
- If not, do you mind if your patient takes 1 mg IV Dilaudid q2h rather than 4 mg PO q2h PRN?

MED makes little sense when comparing between IT administration and systemic administration because the BBB is a barrier to outward exodus as well as inward transport. Studies show significant decreases in the risk of peripherally mediated side effects like nausea, constipation, etc. MED between a chronic infusion, a bolus IT dose, and systemic IV/PO equivalent dosing is also more complicated. You would be dumb to use that IT to PO MED in either direction due to the lack of data and the risk for massive over/underdosage depending on the way you're going.

So again, the concept makes little sense for this discussion, other than to say the total risk to the individual/society is less with 20 mg per 90 days in an intrathecal pump reservoir and 600 mg per 90 days in pills. Some hacks might say that a plain language reading of the CDC guidelines would mandate you to consider the therapy for patients with focal pain requiring opioid analgesia, as it can provide the lowest effective dosage of opioid.

Pumps are difficult to use effectively, but it's not because they're a problem or they don't work. Most patients are just looking for more than just the analgesia IT therapy provides, and most of us are not very good surgeons, especially when lateral.

 

[Aether2000]

The studies I cite were not published- they were internal studies accidentally released to me via email. The complication rate for intrathecal infusion pumps is not insignificant- much higher than an insulin pump. Physicians have the same degree of control over oral or transdermal medication quantities as they do an intrathecal pump therefore the pump is placed for ???? what purpose? I have had a couple of patients accessing their pumps with needles to draw out the concentrated solution, then injecting IV so they do not prevent abuse. Most patients I have seen in the community are also taking oral opioids with their pump, prescribed by the physician filling the pump or by their PCP- this is ridiculous and points to the lack of understanding of the purpose of the IT pump. The reasons patients should have intrathecal pumps being implanted in 2018 in my estimation should not include an alternative opioid delivery system to oral or transdermal opioids. There are other medications such as baclofen for spasticity that are useful but it is uncommon that pain physicians implant pumps without filling them with opioids.

 

[Orin]

Great, unpublished studies and anecdotal data. That's c/w the state of our field.

Physicians don't have the same degree of control of what happens with the medications once they are prescribed. For the rare drug addicted patient that you made the poor decision to implant or to not explant, they rarely use a non-coring needle to get IT drug and the device is kaput, in addition to them having a likely infection in the near future. The risk of diversion to the community is also lessened as well

I agree there are other medications. The PACC guidelines are full of them, but the only 3 on label are Baclofen, Morphine, and Ziconotide. Baclofen is easy to assay the effect for. Ziconotide is a niche medication but it does work well for some patients.

Bypassing the systemic effects of opioids is a great reason to use an ITDD. I obviously wouldn't do that for patients with end-of-life cancer pain, but for non-end-of-life pain, you shouldn't do both. My favorite cases are the little old ladies who can't stand a whiff of an opioid due to the nausea, vomiting, fatigue, but run circles around your clinic after a 20 mcg Fentanyl bolus IT!

 

[Ducttape]

a few issues, particularly with the study you quoted....

first, bypassing the systemic effects is only valid if there are valid reasons for prescribing continuous opioid therapy. I don't suppose you feel that IT therapy is valid for fibro, IBS, etc? if you are discussing IT therapy for palliative care, end of life care, then I agree with use of therapy for those "conditions". I would argue that there are not a lot of indications - outside of Legacy Patients - of using chronic continuous opioid therapy for chronic nonmalignant pain

second your defense against not using MED is ludicrous. MED is supposed to "equate" doses with respect to medication and route, which would take into account BBB. (a stable dose of 1.6 mg of morphine IT at the most optimistic calculation now would be at least 100 MED, but that is a digression)

your study is interesting. prospective, maybe. not blinded. no control. all of the patients got PT - who is to say that the mandated emphasis on PT after implantation did not provide some of the long term benefit?

also interesting, 3 years out. they tout reduction in oral dose, but this was essentially self imposed by the implanters, so difficult to state that this is a benefit, which the researchers did.
second, they tout only 11% increase in dose over 3 years. however, that is a troubling trend, as the dose was "stable" for the first 18 mo then the 11% started to increase primarily from 18 to 24 months. the question is - how much would it increase over a course of 5+ years?

finally, there is no propublica prior to 2012, when the data was first started, and no sunshine act for before, but he got at least $50,000 from "Drug Infusion Systems" from 2012-2015 (and over $100K from Neuromodulation...)

 

[Aether2000]

Low dose IT opioid therapy makes no financial sense. The cost for IT therapy for non cancer pain was $208,000 for 5 years in one study (2007 dollars) whereas the cost of an office visit monthly plus the cost of 40mg hydrocodone per day is $7,560 for 5 years. There is no credible evidence low dose IT therapy is any more effective than hydrocodone. The differences are so stark that it is impossible to conclude anything else other than for most situations, low dose IT opioid therapy is simply a willful ignorance and insouciance of health system (and patient) finances. Regarding IT being less "addictive", there is no evidence of this, and in fact, given the tendency of these patients to continue acquiring opioids from other sources (if not from their pain docs who continue to supply them with "breakthrough" oral medications. Many pain docs administering IT opioids via pump and no other opioids only rarely test their patients with urine drug screens (unless required by state law or medical board guidelines/regulations). The pain docs believe the patients are being compliant. However they frequently are not, relying on the sappy compassion of the PCP or their friends or family to supplement them with oral opioids. They also continue drinking alcohol and using illicit drugs, but many pain docs only occasionally (if ever) test for these in IT patients. The cumulative effect of these drugs when combined with the periaquaductal grey effect of morphine that exists in high concentration in the 3rd and 4th ventricle and the cisterns can be just as deadly as oral opioids. Of course the more lipophilic (but not FDA approved) intrathecal hydromorphone still has some penetration into the periaquaductal grey, but not as much as morphine.

And this is not even considering the complication rate of reimplantation/explantation of 22% in the first year or the cost of medication related complications.

So no, I really cannot fathom how low dose IT opioids could possibly be a good idea. The only thing worse is high dose IT opioids.

 

[Orin]

Who hurt you?

Honestly, I understand the fears after having handled mangled cases by unscrupulous and poorly trained folks. You're waving your hands though based on bad personal experiences and lack of any published evidence. Realize your concerns are based primarily on a clinician's failings and not the therapy.

There are few things as logically and scientifically sound as intrathecal therapy.

 

[Ducttape]

you know the quote that is commonly attributed to Einstein, right?

to wit: "Stupidity is doing the same thing over and over and expecting different results."

Pain Medicine has done IT pump therapy. it lead to horrible results. pretending to reinvent the wheel and thinking that one can just put a hard cap on that wheel in no way makes IT therapy logical and sound.



in fact, if chronic opioid therapy is not safe nor appropriate for chronic nonmalignant pain in the working disabled, using it IT is a worse sin...

 

[Aether2000]

Orin I totally understand the cavalier, inexperienced attitude of one who can only zip their pants if they have a double blind study to show them how it is done. I recognize the callousness towards your colleagues and your supercilious nature. I was just like you once.

 

[DODOCSS]

you know the quote that is commonly attributed to Einstein, right?

to wit: "Stupidity is doing the same thing over and over and expecting different results."

Pain Medicine has done IT pump therapy. it lead to horrible results. pretending to reinvent the wheel and thinking that one can just put a hard cap on that wheel in no way makes IT therapy logical and sound.



in fact, if chronic opioid therapy is not safe nor appropriate for chronic nonmalignant pain in the working disabled, using it IT is a worse sin...

do no harm...

 

[Orin]

Orin I totally understand the cavalier, inexperienced attitude of one who can only zip their pants if they have a double blind study to show them how it is done. I recognize the callousness towards your colleagues and your supercilious nature. I was just like you once.

I'm going to have to break out a dictionary here, but it's the callousness toward the patients that bothers me. What I am hearing is I'm happy to help if you'll die soon so I don't have to put up with the stress/liability/risk. I don't think that makes me inferior or superior to others, but I do think we have to balance our comfort with the patient's well being and function, and I like to have options to pursue since everyone else does the easy stuff.

We all find our own balance with things. I personally see no reason to limit this therapy for end of life pain if you can implement it safely and appropriately. I don't think people did that in the past. Based on the outside devices I see, I don't know if anyone reads or follows any of the PACC/NACC guidelines, and I am left thinking there is fear due to lack of understanding.

The mechanistic data and clinical outcomes are marginal for pain medicine, but I can rationalize targeted drug delivery far easier than I can magic stem cells or chakra adjustments, and I know how to mitigate and control for risks. It isn't like everyone in my clinical cohort has a pump, but for the 5 - 20% of severe non-malignant pain patients that respond well to oral opioids but are high dose/unsafe for them, it's good to have options. I do love offering trials as a carrot for patients that are willing to wean from 300 - 500 OMEs to try low dose morphine monotherapy.

So since I can rationally understand it and point to "expert" guidelines that counsel the use of it for non-malignant pain, I generally sleep as well as my partners that don't offer it, albeit I keep my pager on in case there's a pump emergency since they don't want to handle it.

I'm sure I'll burn out eventually but the relevant portion of the oath I remember reciting and signing my name under was: I will apply, for the benefit of the sick, all measures that are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

 

[Ducttape]

what you in your inexperience has failed to see is that most people, in the past, who had IT therapy have failed utterly in almost all aspects.

continuing to offer such drastic therapy feeds in to the thought process that "we have a way of curing your chronic pain" paradigm. and I would argue that those patients on 300-500 MED are better not because you got them on to IT morphine monotherapy but you reduced their OIH.


fwiw, please review the financial remuneration your "experts" have received from advocating pumps. it is not dissimilar to the financial renumeration provided to the "founding fathers" of the opioid crisis....



finally, those of us who have taken care of post pump patients can educate you of the last line of your own statement - trap of overtreatment.



"the road to Hell is paved with good intentions..."

 

[Orin]

what you in your inexperience has failed to see is that most people, in the past, who had IT therapy have failed utterly in almost all aspects.
continuing to offer such drastic therapy feeds in to the thought process that "we have a way of curing your chronic pain" paradigm. and I would argue that those patients on 300-500 MED are better not because you got them on to IT morphine monotherapy but you reduced their OIH.
fwiw, please review the financial remuneration your "experts" have received from advocating pumps. it is not dissimilar to the financial renumeration provided to the "founding fathers" of the opioid crisis....
finally, those of us who have taken care of post pump patients can educate you of the last line of your own statement - trap of overtreatment.
"the road to Hell is paved with good intentions..."

Medicine is an evolutionary thing. There are many examples in evolution where mistakes happened, but that doesn't mean they aren't still useful in some settings or with new twists. Some things do need to go extinct though sometimes as evolution to happen.

In this case though, you're describing a therapy as drastic and invasive because of what? Is a pump as dangerous as extending a fusion or a high dose systemic opioids? Yeah the risk is higher than a single TFESI for an individual, but when you do 1000x more TFESIs, the actual risk is probably higher for those as a whole.

The fear of surgery, lack of understanding of the therapy, prior experience with poorly placed/managed implants, and the worry about constant liability is driving this. To me, the bomb pumps are no different than the patient fused from top to bottom with rods and high dose opioids, except in that case it is our fault as a field, and we owe them a greater debt to fix our colleagues mistakes.

All the experts get financial remuneration, whether from industry, insurance, or NIH/AHRQ/PCORI or whatever. Quit hiding behind the the sunshine act as if you just figured out the experts get more money from the things they support. Pick your favorite expert; I'll be happy to examine their secondary gain and biases.

My intentions are to help the patient, and I'd rather do it with an opioid pump than high dose systemics for focal pain problems.
For diffuse issues, like multilevel chronic VCFs, a ziconotide pump may work well.

Like anything we do in pain medicine, it's generally easily trial-able in a variety of ways and then it's a matter of you and the patient's judgement, married to hopefully objective PT and subjective patient/family evaluations before moving to the more expensive implant.

 

[Ducttape]

Multiple fallacies in your statement. Most experts agree that trials are rather biased - yes, still do them, but not as predictive as one would really want for such an invasive procedure. There are as many trial varieties as there are physicians who do them...
Other problems with your statement - that it not only ignores the realities of the prior experiences with pumps, it can be used to justify any treatment. You are still trying to justify the core premise that opioids improve qol and functioning.

Using opioid ITP is NOT different to any significant degree from high dose systemic opioid. Do not delude yourself. It’s the same drug whether oral, iv, topical, IT, or skin popped...

This is not evolutionary- it is the opposite. Revisiting past demons, trying to dress them up as new and fancy. Last years Halloween...

 

[Orin]

Using opioid ITP is NOT different to any significant degree from high dose systemic opioid. Do not delude yourself. It’s the same drug whether oral, iv, topical, IT, or skin popped...

I'm very confused as maybe my understanding of basic pharmacokinetics is incorrect.

Drugs have effect sites correct? Let take another class of medications: local anesthetic.
Do orally vs topically vs perineurally vs intravascular LA have different effects, risks, or benefits?

Why are opioids different here?
Are you arguing that neuraxial opioids have no benefit as compared to systemic opioids? Should be scrap all the epidurals for ERAS protocols around surgery because an opioid is an opioid no matter how it is given?
Do they have some magical property where they diffuse throughout the whole body evenly and cause the same effects no matter where they given?

 

[Ducttape]

Here is a refresher as to where opioids have target effect. It’s not in the periphery that the complications from COT occur, it’s the CNS. It’s also the CNS where we get beneficial effects too, such as pain relief.

Bypassing the periphery may reduce some unwanted side effects, but it doesn’t change the humoral or immunologic or opioinergic or CNS depressant side effects related to chronic exposure of the CNS to opioids. Going IT this does not change these long term complications.

 

[drusso]

Here is a refresher as to where opioids have target effect. It’s not in the periphery that the complications from COT occur, it’s the CNS. It’s also the CNS where we get beneficial effects too, such as pain relief.

Bypassing the periphery may reduce some unwanted side effects, but it doesn’t change the humoral or immunologic or opioinergic or CNS depressant side effects related to chronic exposure of the CNS to opioids. Going IT this does not change these long term complications.

I think you need to go back and check your facts.