Author Archives: Zyp Czyk

About Zyp Czyk

Until I was disabled by the progressive pain and fatigue from Ehlers-Danlos Syndrome and Fibromyalgia, I was a high tech IT maven at Apple and Yahoo. I live in a rustic cabin in the redwood forests of the Santa Cruz Mountains just up the hill from Silicon Valley with my wonderfully supportive husband and two 4-legged kids. I use my remaining energy to run an informational blog about "Living with Chronic Pain from EDS & Fibromyalgia". I publish daily updates with selected excerpts of news, research, treatments, tips, support, and personal stories along with my own notes.

Pain patients: ‘Suicide is always an option for us’

Suicide is always an option for us’: Pain patients beg for more options – by Maggie Fox / Jul.10.2018

At this week’s Food and Drug Administration hearing on chronic pain, accommodations were at the forefront.

And the agency says it wants to be accommodating in other ways as it tackles the opioid crisis. Thus, a meeting was called simply to listen to people’s stories about their pain and how they may, or may not, handle it.

It was a room full of some very unhappy people.   Continue reading

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Cipro’s Safety Warnings Just Got Scarier

Cipro’s Safety Warnings Just Got Scarier – by Beth Skwarecki – July 2018

The “mental health effects” can be especially disturbing (who would think to blame an antibiotic for paralyzing anxiety?) and especially with EDS, this antibiotic can lead to tendon rupture.

fluoroquinolone antibiotics—a chemical family that includes ciprofloxacin, or Cipro—have been recognized as carrying several different kinds of serious risks, with the most recent warnings issued just yesterday.

Cipro and friends can cause blood sugar to dip low enough to put a person into a coma, and these antibiotics can also cause “mental health side effects” including agitation, memory and attention problems, and a type of serious mental disturbance called delirium.   Continue reading

Can meditation really make the world a better place?

Can meditation really make the world a better place? – Ute Kreplin | Aeon Essays – July 2018

Among the promised psychological and physical benefits of meditation are the elimination or reduction of

  • stress, anxiety and depression, as well as
  • bipolar disorder,
  • eating disorders,
  • diabetes,
  • substance abuse,
  • chronic pain,
  • blood pressure,
  • cancer,
  • autism and
  • schizophrenia.

Continue reading

Opioid Hysteria Leading to Patient Abandonment

Opioid Hysteria Leading to Patient Abandonment — Pain News Network – By Pat Anson, Editor – March 2018

As the overdose crisis has worsened, doctors are under increasing pressure from law enforcement, regulators and insurers to reduce or stop prescribing opioids.

A nurse practitioner in the Seattle area – who asked to remain anonymous — recently told us that she was closing her pain clinic because she was afraid of losing her license and going to prison.

And whether our doctor quits voluntary (it’s debatable how voluntary this is) or continues prescribing and loses their license, the result for patients is the same: no more pain relief.   Continue reading

Ethical Principles in Pain Management

Ethical Principles in Pain Management | Pain Medicine | Oxford Academic | Mark Sullivan, MD, PhD | September 2000

Introduction: The Role of Ethical Theory

The vast majority of the medical literature published concerning the ethics of pain management addresses pain relief at the end of life. This is a very important area, but does not address many of the most pressing concerns about pain management during other phases of life.

Readers are referred to the IASP Curriculum in Pain Management and Research, which lists many of the ethical issues with which practitioners should be familiar.   Continue reading

Tapentadol for Some Kinds of Severe Chronic Pain

Tapentadol Extended Release in the Treatment of Severe Chronic Low Back Pain and Osteoarthritis Pain – Pain Ther. Jun 2018 – free full-text /PMC5993688/

Tapentadol is a novel pain reliever with apparently synergistic dual mechanisms of action, capable of addressing both nociceptive and neuropathic components of chronic pain.

From Wikipedia: Tapentadol (brand names: Nucynta, Palexia and Tapal) is a centrally acting opioid analgesic of the benzenoid class with a dual mode of action as an agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor (NRI). Analgesia occurs within 32 minutes of oral administration, and lasts for 4–6 hours

As an effective analgesic with good tolerability, tapentadol may be appropriate for patients suffering from severe chronic pain associated with low back pain (LBP) or osteoarthritis (OA).   Continue reading

Opioid stigma keeps cancer patients from pain control

Opioid stigma is keeping cancer patients from proper pain control –  Stat News – By Sara Ray and Kathleen Hoffman – July 6, 2018

History is repeating itself. Twenty years ago, a pain management crisis existed. As many as 70 percent of cancer patients in treatment at that time, or in end-of-life care, experienced unalleviated pain.

And we’re heading back to that situation as fast as we can, with one rule after another being rushed to implementation to prove its sponsors are “doing something about the opioid crisis”.

But now that even cancer patients are being affected, I hope the rest of the country can see that withholding pain relief is simply torture and has no place in a modern-day healthcare system.  Continue reading

CDC Opioid Guideline: Unintentional Consequences?

CDC Opioid Prescribing Guideline: Unintentional Consequences? – July 2018 – By Angelika Byczkowski

I’m sick of reading how all the horrible and entirely predictable consequences of the CDC Opioid Prescribing Guideline were “unintentional” and “unforeseeable”.

The broad misinterpretation of the CDC’s Opioid Prescribing Guideline as establishing fixed limits on opioid prescribing has stranded hundreds of thousands of pain patients in agony without the effective relief they had achieved with opioids.

Yet we are expected to believe that these consequences were “unintentional” and “unforeseeable” by the guideline authors. Most pain patients realized right away that these “suggestions” would become codified rules, no matter how little evidence supported them–and we were even more right than we ever imagined.  …Continue reading article on National Pain Report

 

Trackable Pill Technology and Smart Bottles

The good news: the tech boom has not overlooked us. The bad news: we can look forward to even closer scrutiny and deeper intrusions into our privacy when technology is used to invade and monitor our bodies from the inside.

The Emergence of Trackable Pill Technology: Hype or Hope?– By Mark A. Young, MD, MBA, FACP and Lauren DiMartino – June 8, 2018

Technological advances in the domain of wearable medical technology have optimized delivery and efficiency of healthcare throughout the medical spectrum.

This is such typical MBA jargon, the kind found in every cliché about finance nerds, that I find it jarring here.

This isn’t a medical article, it’s a marketing brochure to attract financial investors to profitable businesses. All the businesses that have sprung up to monitor pain patients have been very profitable (like drug-testing labs and PDMP database software).

The combination of wearable technology with a Digital Ingestion Tracking Program (DITP) embedded within a pill has further enhanced functionality. Within the field of pain management, there is an emerging application for the use of this dynamic combination.

So now we’re supposed to swallow a tiny computer in every pill to make sure when and how it actually traveled through our bodies. This is a whole new level of intrusive monitoring developed for us.

They claim it’s for diseases like high blood pressure that require regular medication. Top many patients forget to take, don’t take, or don’t even purchase their expensive meds these days and then they end up in the emergency room with a stroke.

However, by now I’ve learned how much effort is being directed at arbitrarily limiting opioid use that I’m certain this technology will be used on us. Isn’t high tech amazing?

(Of course, any additional cost incurred by putting a tiny computer in every single capsule will be borne by the patient, just like we’ve had to absorb the higher cost of abuse-deterrent opioids)

Heralding a new era in pharmacotherapeutics, the US Food and Drug Administration (FDA) has recently approved the first-ever medication equipped with DITP.

This revolutionary advance has created huge potential for further expansion of the technology to other pharmacological agents, including pain medication.

It’ looks like this company will try to position itself as another cure for “opioid use disorder” and only use its applicability in other health conditions as window dressing to seem more equitable (see, you ALL benefit!).

How it Works

Digital Ingestion Tracking Program functions through a closed loop program in which the patient has full control.

Yes, the patient can decide not to use the data gathered, but good luck getting more medication if you refuse to go along with this invasive monitoring.

As with our “opioid contracts,” we are being coerced at every turn. They have us over a barrel and they know it so they can ask us to do pretty much anything. Is this really a choice?

What other medical scenario involves telling a patient: you can either give me total control over every dose of this medication you take (and when and how) and not deviate the slightest bit from the “as prescribed” schedule or I won’t give you this quality-of-life-saving medication (and make sure no other doctors do either by writing about your “non-compliance” in your medical chart).

Embedded within each pill is an ingestible event marker (IEM), which is a unique sensor designed to track drug ingestion. The IEM is made of a copper, magnesium, and silicon assembly that allows the patient’s stomach acid to function as an organic battery.

The IEM offers a safe option for transmitting secure information to a wearable patch worn by the patient. The signal is transmitted from the wearable patch to a mobile application on the patient’s smartphone. An additional signal is sent from the smartphone application through the cloud to a secured web portal that the physician is able to access.

This process allows patients, caregivers, and healthcare providers [and law enforcement, like with PDMPs -zyp]  to conveniently monitor ingestion of medications.

Potential Benefits

The advantages of DITP are multiple, including improved patient compliance and enhanced adherence.

By equipping a patient with DITP, physicians are able to corroborate whether the patient has taken the prescribed pill and at precisely what time.

For patients on pain medication, this information is immensely important as compliance is a cornerstone of proper pain management.

The word “compliance” bothers me more and more. Only prisoners are expected to be “compliant”, versus other groups we belong to, like students, co-workers, and neighbors, are expected to be “cooperative”.

“Compliant” implies absolute control over a submissive victim, and it’s often not benevolent.

Parents and teachers have roles of benevolent control, while dictators and tyrants (and jailers) exercise demeaning and destructive control, demanding complete submission from their subjects, compliance at any cost.

That’s what is demanded of us: submissive compliance.

The anti-opioid activists don’t give a hoot about the outcomes of their edicts: pain, depression, suicide. But if we don’t “comply” with their exact instructions for whatever minuscule amounts of opioid they might deign to prescribe us, we face losing access to all opioid pain relief now and in the future.

As a pain patient who takes opioids, this is an endless nightmare. My life depends on a healthcare industry, specifically pain management, to approve my continued use of opioids. I need that medication to survive this life.

Knowing that a patient has consumed his or her prescribed medication, as directed, may enforce and support statutory safeguards and prevent improper diversion of pills or overdose.

Why in the world would they describe “safeguards” as “statutory”?

I looked it up and statutory means: “(Law) prescribed or authorized by statute – subject to a punishment or penalty prescribed by statute”.

I thought “safeguards” were there to reduce medical errors and assure good outcomes for the patients, but this shows that their aim is to “enforce and support” legislated (unscientific and arbitrary) dose limits.

In the event that a patient chooses to deviate from his or her original dosing schedule, the DITP updates the portal, allowing the physician virtual access to patient information.

This is almost funny, it’s so obnoxious.

So, this pill you’re taking at the “wrong time”, while it’s slithering through your intestines, is going to “rat you out” (update) to your doctor/cop (the portal) who’s monitoring your digestion via tiny sensors in the pill you took.

Potential Drawbacks

Despite the benefits, there are several salient limitations of the DITP including:

  • potential for a “false-negative” response,
  • increased cost,
  • passive notifications to providers, and
  • possible[?] privacy concerns.

Well, if it’s either that or not get any opioids anymore, possibly be branded with OUD (Opioid Use Disorder) and never again being prescribed opioids…

As they say, BOHICA – bend over, here it comes again.

While DITP helps to positively identify whether a patient has ingested a prescribed narcotic embedded with an IEM sensor, it does not necessarily ensure that the patient has not simultaneously ingested a non-IEM pill in an effort to overmedicate.

The wording here sounds like it’s coming straight from the DEA: they still refer to opioids as “narcotics” to stigmatize them as much as possible.

The current era of opioid hypervigilance and public focus on the ill effects of narcotic medications (ie, opioids) has led to a heightened realization of the importance of optimized tracking methods.

…and this is the service they are selling. Now they’re not even pretending to talk about anything other than opioids anymore.

Technological solutions such as DITP offer a novel opportunity in this arena.

This same boilerplate text could appear in glossy marketing materials for just about any industry. These are the usual generic statements from financial companies, focused on the money-making opportunity and with little interest in the specific product.

The Research

One recent study explored the clinical utility of DITP in emergency room pain patients. The Harvard findings demonstrated that a digital pill is a reasonable method to measure opioid consumption patterns in patients with acute pain.

“Reasonable method?” Reasonable for who? Now the opioid-police are not only in the examining room with your doctor or over the counter at the pharmacy, but in your own guts too…

Use of DITP further allowed intervention when opioid abuse was detected. This study revealed a 90% medication adherence to ingestion of prescribed opioids.

DITP may provide an innovative strategy for enforcing the proper use of opioid drugs.

Medicolegally, there are distinct advantages for pain practitioners to vigilantly monitor opioid use, adherence, and compliance among patients.

Medico-legally? What has happened to the “medical visit”? Now we have not only the DEA with our doctor in the “private” exam room, but lawyers as well.

With non-compliance or non-adherence to physician-prescribed regimens growing, and estimated at 100 billion dollars per year[?], the use of DITP may help ameliorate the issue.

The sentence above doesn’t even make sense. And how can non-compliance and non-adherence be growing when opioids are prescribed so much less? This is clearly a fabricated statement of convenience – the truth hardly matters anymore.

It sounds like a garbled text from some standard marketing/sales materials used for all the other companies this company might be promoting to investors.

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~

And another article about insidious monitoring of pain patients:

Sampling of Available Smart Bottles – by Michael Crowe, PharmD, MBA, CSP, FMPA – July 2018

There are many smart bottle companies competing today. In a prior article, the most common features of smart bottles were covered. In this article, a glimpse into 4 specific products (GlowCap, AdhereTech, CleverCap, and SMRxT) is given.

These 4 aren’t the only ones available, but they do represent the varied means by which smart bottles record medication adherence and are some of the most well-known products in the space.

GlowCap

Glowcap is probably better defined as a smart cap than a smart bottle. The cap provides visual and auditory reminders when it is time for the patient to take his or her dose. The action of removing the cap at the dosing time is equated to a taken dose.

GlowCap has a companion mobile app, as well as an adherence portal. The patient can decide with whom to share their adherence record, whether it be prescribers, pharmacies, or caregivers.

AdhereTech

Compared to GlowCap, the Adheretech bottle moves the technology from the cap to the actual container. Cellular functionality is incorporated into each of its bottles, meaning patients don’t have to pair the bottle with a wifi hub, or app on a mobile device. However, there is a portal where healthcare providers can view their patients’ adherence levels.

Like GlowCap, Adheretech equates a dose to removal of the cap at dose time; however, it also incorporates something called capacitance, which is similar to how your smartphone’s screen registers touch. In the same way that your phone can detect two fingers on the screen, the AdhereTech bottle can sense an approximate number of doses remaining based on the capacitance at the floor of the bottle’s interior.

CleverCap

With CleverCap, the technology is all in the cap, as it was with GlowCap. However, rather than cap removal equating to a dose, the CleverCapdevice has a door on the device, and internal mechanics that can be calibrated to track precisely how many dosage units were removed and when. This is helpful as we know that patients don’t solely open their bottles to take a dose; they might remove the cap to determine if they need a refill or to confirm the color or imprint on the dosage unit.

SMRxT

Like AdhereTech and CleverCap, SMRxT incorporates cellular connectivity into its bottles so patients are not required to connect the bottle with wifi or pair the bottle with a hub or device. It can also communicate with the patient, caregivers, or healthcare providers.

What is unique about the SMRxT system is the ‘way’—no pun intended—in which it measures a dose taken. Each bottle sent to a patient is precalibrated with the weight of each unit (tablet or capsule) and the patient’s dosing schedule. Each time the patient sets the bottle down on a level surface, the bottle weighs the contents. If it detects a weight reduction, it will record that as a dose

Depending on the time and amount, it may be categorized as an on time dose, a partial dose, an extra dose, or a late dose. Missed doses are also recorded. These dosing trends can be monitored over time and, if helpful to the patient, the dosing window can be adjusted remotely by the pharmacy.

The smart bottle space is certainly one with many potential benefits and choices.

Again, who are the intended beneficiaries of all these “many potential benefits and choices”? 

Perhaps these tools might be useful in the relatively rare circumstances when people who are addicted to opioids must also take them for pain or for patients with the beginnings of dementia.

But for the average pain patient, these are just a reminder that we are simply not trustworthy, a judgment based solely on the fact that we use this type of medication for our chronic pain.

Michael Crowe earned his Doctor of Pharmacy from Ferris State University and completed a PGY-1 community pharmacy residency.
He founded the Genesee County Pharmacists Association in 2011 and earned an MBA from The University of Michigan in 2013. He has served on the Michigan Pharmacists Association Executive Board for over four years, currently serving as Speaker of the House of Delegates.