Spinal cord stimulators: ~ 10% are good candidates. Pulling out more than putting in


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PainWeek 2018 has a series of conferences in different cities. This weekend 10/13-10/14, it was in San Diego teaching pain management. Thank those who funded this 2 day program for doctors and healthcare providers to bring us up to date in the field.

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Anesthesiology pain specialist Michael Bottros, MD, Associate Chief of the Division of Pain Medicine, Washington University St. Louis, made a comment on spinal cord stimulators:

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They are pulling out more than they are putting in. Only 10% are good candidates.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators, Advances? A Revolution? How about a lot more research first?


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The new issue of Practical Pain Management has a lead article on Spinal Cord Stimulators, stressing early treatment, a revolution using “new [and] different patterns of electric stimulation.” Advances?

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I don’t have the energy or time to compare these new claims with the information just posted on this site from the International Association for the Study of Pain that details existing evidence with the decades of claims by these companies and abysmal lack of research. Perhaps they could set aside some of the billions in profit they use for PR and give us good research data.

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Chronic pain would make any of us vulnerable to risk our lives for these devices. Research is desperately needed. Here are the new claims:

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Recent Advances

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Ivano Dones, MD, and Vincenzo Levi, MD, of the Functional Neurosurgery Department at the Carlo Besta Neurological Institute in Milan, Italy, highlight “an ongoing revolution” in the treatment of neuropathic pain using “new [and] different patterns of electric stimulation.”3

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Conventional SCS stimulation employs a tonic waveform in which electrical pulses are delivered at a constant frequency, pulse width, and amplitude. It has been found effective for approximately 50% of neuropathic pain patients.4 To help more sufferers, including those who develop a tolerance to conventional stimulation, the researchers say that new types and patterns of stimulation, such as burst and high frequency, should be considered.

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To date, only small studies have been performed on burst stimulation, but Drs. Dones and Levi say the results have been promising. “When compared to conventional SCS,” they state, “burst stimulation gave remarkable long-term pain higher suppression.” In addition to providing greater pain control than the traditional tonic pattern, it was also associated with a decreased incidence of paresthesia (a pins-and-needles sensation).

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Studies have also shown that burst stimulation may be more effective in reducing pain in the axial midline region, an area that conventional tonic stimulation often fails to treat effectively.5 Dr. Dones told PPM that this is because “burst stimulation can recruit more nerve fibers in the spinal cord, thus interfering with their transmission of pain to the brain.”

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The authors cite a small study using high-frequency stimulation that showed 70% of patients “experienced a significant and sustained low back pain and leg pain relief.”6 They note, however, that another study showed no significant difference between the high-frequency mode and a placebo. More studies need to be conducted, they say.

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Joshua Rosenow, MD, director of Functional Neurosurgery and Epilepsy Surgery at Northwestern Medicine in Chicago, IL, applauds these recent advances. New patterns of stimulation, including combinations, he says, “have allowed us to provide a wider population of patients with a significant amount of pain relief.” They have also enabled clinicians to “more precisely match the therapy to the patient,” both now and as pain changes over time.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators – Shortcomings of Evidence


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Shortcomings of Evidence for

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Spinal Cord Stimulators

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The journal Practical Pain Management has published a presentation of spinal cord stimulators, SCS’s, made at the International Association for Study of Pain, IASP, World Congress. This adds greatly to my concern that they not be trialed for those who have Complex Regional Pain Syndrome, CRPS. About 8,000 visits per year on my website, double any other topic on pain, are about the damage these devices have inflicted, and the comments are gruesome. See search function, top left above small photo.

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John Markman, MD, recounts what’s currently on the table for SCS and how much more is needed for adequate pain relief. A 2018 IASP World Congress on Pain highlight.”

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“In a presentation titled “Yes, We Now Have the Evidence, But..,.” John Markman, MD, professor of neurosurgery at the University of Rochester, outlined some shortcomings of the existing evidence for spinal cord stimulation (SCS) including heterogeneous populations studies.Dr. Markman’s main concern with SCS is the level of uncertainty he has with the procedure—how it works, whom it works for, and the non-specific treatment effects of the procedure. To rectify this, he has begun to conduct crossover studies in his practice to get a better grasp of these questions. “Imagine if, in 2018, the indication for putting in a spinal cord stimulation system were as matched to mechanism as a cardiac pacemaker,” Dr. Markman posed the audience, noting that SCS implementation remains heavily dependent on self-reporting.”

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…snip…

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“Existing Evidence”

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“SCS technology is still evolving, Dr. Markman said. While self-reporting is still prevalent, what has changed in the past five decades is the upgrade from a single case report to prospective, multinational, randomized clinical trials. One landmark trial, for instance, randomized 100 failed back surgery syndrome (FBSS) patients with predominant leg pain of neuropathic radicular origin to receive SCS plus conventional medical management (the SCS group) or conventional medical management alone (the CMM group) for at least 6 months.Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction. Between 6 and 12 months, five SCS patients switched to CMM, and 32 CMM patients switched to SCS. At 12 months, 27 SCS patients (32%) had experienced device-related complications. In selected patients with FBSS, SCS provided better pain relief and improved health-related quality of life and functional capacity compared with CMM alone.”

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“Other significant trials for SCS include North, et al, from 2005,3 and Kemler, et al, from 2008.4 “This is an era marked by open-label studies,” Dr. Markman said. Enormous technical innovation, improvement of clinical trial designs, and larger study populations (prospective, head-to-head), are just some of the factors leading these recent advancements.”

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“Evidence Still Needed”

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“Despite the success in recent years of more trials being applied to SCS, many questions have yet to be addressed. For instance, the totality of study participants to date is only 973, a study population that is “poorly characterized,” according to Dr. Markman. “Chronic pain after spine surgery, that’s an iatrogenic injury, and it’s a very heterogeneous group of patients, some of who have axial-predominant neuropathic pain.” In one study,5 of 97 subjects who completed a trial of HF10 therapy, 90 (92.8%) had significant back pain relief and were eligible for an implant of an SCS system. In comparison, 81 of 92 subjects (88.0%) were successfully trialed with traditional SCS (P = 0.33). “Which is incredibly high in my opinion. Think about in your own practice how many times you’ve tried someone on a therapy for a heterogeneous pain problem, some of which is nociceptive, some of which is neuropathic…and 92% of them get relief? It just doesn’t reflect anything in my practice,” Dr. Markman said.”

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“In addition to this, the lack of blinding in trials, as well as the lack of controls, makes the results weaker by design. External challenges include the regulatory framework for devices being much less rigorous for analgesic drugs, for example. Study sponsorship has also been an issue, as many current studies that are industry-sponsored have a clear publication bias compared to payor studies that are normally negative in nature, Dr. Markman suggested.”

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“Devices are also constantly changing. “It’s a moving target,” he said. “It’s like comparing your phone in 1967 to your phone today. It’s not really a great comparison.” A generation of studies now has emerged that has made comparisons to figure out what the on-target analgesic actions are and what non-specific treatment effects have been seen. “The disruption in technology is changing the stakeholders and how they engage,” Dr. Markman said. He concluded by noting that, due to an impact-style meeting having an enormous accelerant effect on deciding the “rules of the road” for oral analgesic trials, a group is now meeting with representatives from the International Neuromodulation Society and the North American Neuromodulation Society to develop consensus guidelines for spinal cord stimulation.”

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulation, Current Status 2017


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One of the top read articles in 2017 from the journal Pain (free pdf).

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Click title below:

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Current status and future perspectives of spinal cord stimulation in treatment of chronic pain

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Geurts, José W.a,*; Joosten, Elbert A.a,b; van Kleef, Maartena

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3. Complications and side effects

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“Complications and side effects (adverse events) acquiring reinterventions often occur during treatment with SCS.6,8,16,20,37 Complications include deep and superficial infections or equipment-related side effects like hardware malfunction, lead migration, fractured electrode, pulse generator discomfort, and battery replacements. Localized pain over the implanted hardware occurs regularly, on average in 6% of cases.6 This pain, for instance, can present as pain around the implanted pulse generator or over the lead. Such pain typically leads to replacement of the lead and therefore an additional surgery. Removal of the SCS system may be necessary in cases of deep infection or treatment failure. A prospective study performed over 12 years8 showed adverse events in 61% of patients. However, the complication rate was significantly reduced during the last 4 years of the study from an annual mean of 30% to 22%. The authors concluded that this was likely due to technological developments and improvements in the SCS hardware. Another explanation for this reduction is that the physicians treating patients gradually gain experience in a particular implant technique.22 New implantation techniques like DRG-STIM have been reported to cause more complications and it has been concluded that refinement and optimization of the technique are needed to minimize adverse events.22

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5. Future perspectives of spinal cord stimulation

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….”A point of concern is that, at present, cost-effectiveness of SCS is impeded by the high cost of the device and the high incidence of complications and side effects requiring reintervention and surgery. Consequently, SCS treatment is not accessible for everyone in the world and up to now is only available for selected indications.”….

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Among problems from spinal cord stimulators that I have seen in those with CRPS, the procedure has created a new pain that is now #1 most severe, often at the battery pack that is placed at the low back. Several patients reported units were explanted with difficulty due to severe scar formation.   

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Reference

[8]: Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M.

Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up.

Neuromodulation 2013;16:523–9; discussion 529.

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Objectives: Spinal cord stimulation (SCS) is an effective treatment for intractable complex regional pain syndrome type I pain. Long-term data are scarce on effectiveness, degree of pain relief, predictors, and complications.

Materials and methods: From 1997 to 2008, 84 consecutive patients who received an implanted SCS system after positive test stimulation were included in the prospective study. Treatment effectiveness was assessed annually as measured by mean visual analog scale pain scores and with the Patients Global Impression of Change scale. Treatment success was defined as at least 30% mean pain relief at end point and treatment failure as explantation of the system. A Cox regression determined if baseline factors were associated with both these outcomes.

Results: During 11 years, 41% (95% CI: 27-55) of the patients experience at least 30% pain relief at assessment end point. During 12 years of follow-up 63% (95%CI: 41-85) of the implanted patients still use their SCS device at measured end point. Pain relief of at least 50% one week following test stimulation is associated with a higher probability of long-term treatment success. In 51 patients, 122 reinterventions were performed over 12 years; 13 were due to complications, 44 to battery changes, and 65 reinterventions were equipment related.

Conclusion: SCS provides an effective long-term pain treatment for 63% (95%CI: 41-85) of implanted patients. Forty-one percent (95%CI: 27-55) of SCS treated patients have at least 30% pain reduction at measurement end point. The number of reinterventions after implantation due to equipment-related problems, battery changes, and complications is 122 over 12 years of follow-up. Sixty-one percent (N = 51) of the patients had at least one reintervention. Mean pain relief of at least 50% (visual analog scale) one week after the test stimulation is associated with long-term treatment success.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators – Not Allowed to Sue Medtronic – Supreme Court Ruling 2008


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More than any other topic  readers seem to read and comment more about serious problems with the Medtronic spinal cord stimulator than anything else on this site, yet they overlook this post last week: 

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Supreme Court ruling 2008

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Riegel v Medtronic

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Patients Who are Implanted with High-Risk Devices

 

Not Allowed to Sue

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And the problems never get addressed. There is no accountability for the damage to spinal cord that so many experience—the spinal cord for Pete’s sake —and no research on the incidence of the many different problems. If complications were not severe, thousands would not care to search the subject.

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Perhaps a person with a legal background would discuss how that case was won.

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How can this possibly be right? 

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Medical Devices: Supreme Court ruling 2008, Riegel v. Medtronic, Patients Who are Implanted with High-Risk Devices Not Allowed to Sue


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Supreme Court ruling 2008, Riegel v. Medtronic

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Patients Who are Implanted with High-Risk Devices

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Not Allowed to Sue

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If you are not certain you are willing to take on risk, more medical problems, grave risk, even death, do not get a device implant. Keep in mind what some orthopedic surgeons teach: Do not get an joint replacement until you absolutely cannot walk anymore.

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Let me take this opportunity to demand a 5 year followup study of spinal cord stimulators to include every death and every problem regardless of cause. It will never happen. The swamp is impervious to us.

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NPR interview today on risk of implanted medical devices.

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“…40 percent of conditional approvals haven’t had a post-approval study five years after it’s on the market. So people are being subjected to devices that scientists may have had serious concerns about, and yet, they don’t even know if they’re safe or not.

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…DAVIES: This is FRESH AIR. I’m Dave Davies in for Terry Gross….We’re speaking with medical journalist Jeanne Lenzer, who’s written a new book about the risks and implanted medical devices such as artificial joints, cardiac stents and pacemakers. She says they’re approved with far less scrutiny than new drugs, and some can cause serious harm. Her book is called “The Danger Within Us.”

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…Dennis Fegan, this firefighter and paramedic who suffered from epileptic seizures, and out of some desperation, got this vagus nerve stimulator planted in him, this little box with wires that would stimulate the vagus nerve that runs down his body and hopefully ease his epileptic seizures. He ended up in a life-threatening situation in [2006].

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LENZER: So one night, he was awakened about a – with a pain in his throat. About 2 in the morning, he woke up. And he knew that the pain in his throat was associated with a seizure, so he got up, and he put a vertical mark on his calendar on that date….And when his parents found him the next morning, they saw him stumble out of his room and fall unconscious onto the floor. And when he came to, he got up, sat down on a dining room chair and immediately fell face-first into the floor again. This time, you know, he’s afraid of falling again, so he wiggles across the room with his back against the wall. His legs are splayed in front of him. His jeans are soaked with urine. He looks half dead. His parents frantically call for an ambulance. By the time the ambulance gets there, he’s already passed out eight more times.

The paramedics, figuring he’s having seizures – as Dennis thought he was having seizures – gave him seizure medication that they injected in his arm. But it didn’t stop the seizures. So they rush him to the hospital, where the ER doctor also gives him more seizure medicine seeing his seizures. And again, he can’t stop the seizures. And the ER doctor is frantic. He, you know, thumps Fegan on the chest trying to bring him back to life. And that’s when he notices something very curious.

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Fegan’s heart is stopping at precisely three-minute intervals. This makes no sense to the ER doctor. He calls in a cardiologist. The cardiologist rushes downstairs, looks at him. They both see the same thing. And it’s only when the neurologist arrives – Fegan’s neurologist – who says, oh, Fegan has a VNS device, and it’s set to fire at exactly three-minute intervals. So the device, instead of stopping his seizures, was stopping his heart. So they rushed to turn off the device. And when they finally get it turned off, the seizures stop immediately and Fegan doesn’t have anymore. They send him up to the ICU to recover. And the next day, Fegan learns that his heart has been stopped by the device. And that launches him into a decade-long battle with FDA, regulatory authorities and the device manufacturer….

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LENZER: Right. And Fegan gets concerned about other people implanted with the device and wants to know whether it’s happening to other people, so he finds out about the FDA’s MAUDE database. It’s a database where all device adverse events are kept. And when he looks into the database, he sees that many people have actually had very similar experiences to his own, but also, many have died. And he’s wondering, you know, if I’d been found dead, he told me, everybody would have said I died of epilepsy rather than the device. And it’s only because he lived and there’s a recording in the ER of what happened to him that anyone knows it wasn’t because of epilepsy. It was because of the device.

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DAVIES: This raises one of the interesting issues about these devices and their regulation. The FDA has this database at which physicians and hospitals are expected to report problems – adverse events with medical devices. Sounds like it would be a smart way – and the FDA says it is the way – we look for red flags. Why doesn’t it work better?

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LENZER: Well, first of all, there’s a study showing that only about 1 percent of all serious adverse events make it into the FDA’s adverse event database. And something that really surprised me was, it turns out that the more serious the event was, the less likely it was to be reported. Manufacturers are supposed to report these adverse events. And there is some leeway granted to them about determining whether the device event was related or not to the device.

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So, you know, sometimes people cough and sneeze when they have a device. It doesn’t mean the device caused it. The problem is is that there’s no independent party assessing whether these problems are related to the device or not. So leaving that decision to the company presents a real conflict of interest.

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DAVIES: Yeah. So, for example, if someone died because this stimulator had actually stopped his heart, it could appear to be epilepsy and therefore would not appear as an adverse event associated with the device….

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…LENZER: That’s a big problem. And that’s something that I refer to as cure as cause, where – doctors assume that when a patient dies – and I did too when I was in practice – that a patient has a heart attack, they died of a heart attack and the bad heart rhythm that went with it. We don’t assume that it’s the drug or the device that we prescribed for the patient. And that’s a real problem because it turns out that the kind of studies we need – there really shouldn’t even be a decision about whether a side effect is due to the device or not.

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We should just count up all the adverse events, all the deaths that occur in the patients who are implanted and in the control group. And that would give us a far better picture because it turns out that the kind of studies we need – there really shouldn’t even be a decision about whether a side effect is due to the device or not….

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LENZER: Well, he was told that he could have the generator taken out but not the lead wires, the lead wires that tunneled up to his neck and were wrapped around the vagus nerve because many surgeons have found that the wires become enmeshed in scar tissue. And it just becomes too dangerous to try to tease those wires out of the scar tissue. They can tear and destroy the very nerves that are next to them and even the jugular vein and the carotid artery that are right adjacent to the vagus nerve. So it’s too dangerous a surgery, and they left the lead wires in but took the generator out.

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DAVIES: Dennis Fegan was frustrated by what happened to him, and one of the things he considers is a lawsuit. It turns out he is unable to sue and he learns why….

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LENZER: Well, it turns out there was a Supreme Court ruling in 2008 called Riegel v. Medtronic, and it’s also called the pre-emption ruling. And what it means is that patients who are implanted with high-risk devices that went through the premarket approval process called PMA are not allowed to sue. And the basis for that is – is that supposedly they underwent rigorous testing proving the device was safe.

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DAVIES: So patients can sue in the case of a drug that they think has harmed them but not in devices that have gone through this process.

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LENZER: Not in certain devices – that’s right – certain high-risk devices…

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DAVIES: You argue in this book that the FDA does a bad job of regulating these devices because they’ve become heavily influenced, maybe even captured by the industries they regulate….

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LENZER:That’s no longer the case. We’ve had a number of instances now, including an episode dubbed Devicegate in which all of the scientists agreed that certain devices should not be approved because they were unsafe and ineffective. And yet the devices were put on the market over the unanimous opinion of their own scientists when politicians made phone calls to FDA superiors. This is really stunning that politics is trumping science. And it’s getting worse now with 21st Century Cures Act that was passed in late 2016, which essentially is deregulating even further.

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…. Even if we read the studies that are released, we don’t know that we can trust them.

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Other Devices That Are Particularly Problematic

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And I’ll give you two examples of just how difficult the situation is. One of the people I talk about in the book is a man who was harmed by a hip implant. Well, it turns out that man is also an orthopedic surgeon who specializes in hip replacements, and yet he landed up being poisoned by his hip implant from cobalt that leaked out of the hip and destroyed his muscles and tissues and even caused some degree of heart damage.

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Another example is a Medtronic executive that I report on who had a Medtronic device implanted in her spine and suffered just terribly disabling and painful effects from that device. So even people who are insiders and who should know don’t really know….

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The Sprint Fidelis leads that go to defibrillators pacemakers were found to have fractured and cause serious injury and death. And these were implanted in hundreds of thousands of people. And this is one of the problems with devices – is that, you know, what do you do once you’re implanted with something that may be dangerous? Having them removed in 15 to 18 percent of people, nearly 1 in 5 people suffered serious adverse events or death when they tried to remove the leads.

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Hip implants have leaked chromium and cobalt, and there are other problems. Pelvic mesh – again, a seemingly simple device. It’s just mesh after all – surgical mesh. And yet it has grated through tissues like a cheese grater through cheese and caused what’s called fistulas – holes between the rectum and the vagina and causing serious pain, infections, hemorrhage. There are all kinds of problems with medical devices that people might want to think about first.

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And one of the common things I hear from patients is, you know, now that I think of it, my problem wasn’t that serious. So a woman who has a little bit of urinary dribbling when she sneezes or gets excited goes and gets this pelvic mesh put in because a doctor recommends it and then has a lifetime of pain, infections and suffering. So I guess my best advice would be, if you’re not certain you really need something, it might be best to wait….

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LENZER: And ask if your ER doctors know how to take care of you. I mean, there was one tragic case of a woman with a vagus nerve stimulator who called her sister saying, oh, my God, my VNS is shocking me. I can feel it. It’s so painful. I dropped to my knees. And her sister told her, go. Go straight to the ER.

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And the young woman who was about 39 years old, a young mother, said, I can’t because they don’t have the tools to turn this off. I have to wait until my doctor comes in on Monday morning. She didn’t get to see her doctor on Monday morning because her 9-year-old daughter found her dead in the bathroom on Sunday night….

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 Risk of Devices  – New York Times Opinion

by medical journalist Jeanne Lenzer

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When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was talking about: As an orthopedic surgeon, Dr. Tower specializes in complex hip replacements. But what he knew wasn’t enough to protect him from a defect in the device.

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Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.

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Despite Dr. Tower’s repeated efforts to warn his colleagues and the company that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.

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More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdictfor serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.

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About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices….

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Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

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Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.

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The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

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How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

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With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

..In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. they made a minor change to a previously approved device. The use of these loopholes is widespread: A study published in The Journal of the American Medical Association in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.

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Metal hips are far from the only devices with catastrophic consequences. In October 2007, Medtronic, a leading medical device manufacturer, recalled the lead wires in its Sprint Fidelis defibrillator after they were found to fracture and misfire, harming or even killing patients. The devices had not been clinically tested and were approved for sale by the F.D.A. through the supplement pathway. But in this case, the “minor change” was a fatal one; the new wire was thinner and prone to fracture.

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By the time of the recall, 268,000 leads had been implanted in patients worldwide, the majority in the United States. After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.

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Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.

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The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.

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How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.

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With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Spinal Cord Stimulators – comment on RSD


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Spinal Cord Stimulators 

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 Craig’s comment

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By no means do I mean to say that I or anyone else has better insight into how to treat pain, but I am against spinal cord stimulators [SCS’s] for treatment of pain due to CRPS, and possibly against use in other situations. I demand that the billions in profit they made be put into a retrospective and prospective study of damage caused by them in order for them to give full informed consent.

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I have 3 goals writing this.

  1. SCS’s

  2. Craig’s experience

  3. The Only Real Answer for severe pain, not damaging the system with opioids

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Informed consent is never given for spinal cord stimulators because it requires truth telling, something our corporations have been reluctant to do. Business ethics are not medical ethics, as we keep being reminded daily in the headlines.

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I enclose, below, a generously expressed and detailed comment by a man who had the patience to sit down and  write the painfully gory details so you can weigh-in on your decision whether to follow your pain specialist’s opinion to give you one. I don’t want anyone to feel suckered into choosing them and if I had pain I’ll admit I’d crave relief too. Anything. I’d be in line before the doors open.

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But if you have CRPS, spinal cord stimulators will create more pain. CRPS evolves unpredictably, by a will of its own. I know some very desperate patients with CRPS everywhere including face, mouth, gums, tongue, organs, trunk, limbs. Spinal cord stimulators will create more pain. Keep in mind, I don’t see the 5 year success stories even for lumbar disc pain. They don’t need me if they are pain free.

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But if you have CRPS and desperate need for pain relief because all else has failed — every known drug in highest possible doses of ketamine, propofol, opioids for weeks in ICU fail to even touch pain— there is one thing, and only one thing to do and I will set it out below. I just sent my recommendation to a patient with CRPS in extreme pain.

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My recommendation, below, is for patients who have nowhere else to turn.

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First I’ll mention the problems Craig encountered with SCS’s. He sent his comment to the opening page of this blog, so I will reproduce below. 

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I am currently undergoing a trial Medtronic SCS. I have had to have it reprogrammed 3 times since it was installed 5 days ago. I have had sensations and issues that I have addressed with my rep and my neurosurgeon. I get a severe headache when the unit is turned on. I get the constant feeling of having to urinate. I have current running through my testicles which they can not seem to program out and I am getting little pain relief. I have had to failed back surgeries, many failed injections and I have CRPS. The leads that were inserted when I was in the table covered my mid back and both legs. After I got to my feet and waited while they programmed the unit in another room. They came in and plugged it in and I no longer had coverage on the right side. My crps is in both legs, my hands, arms and face. The lyrica helped to tamp down some of the burning but I am in pain 24/7 and this was my last resort. I have scar tissue completely surrounding my S1 nerve. By the grace of God, I am on my feet, on crutches. I seem to get a look of disbelief when I tell them the unit is causing these issues or it’s not giving me the relief I was counting on. Relief, only to cause greater issues and pain. Is not relief to me. I can not wait to get this trial out of my back. I believe the leads slipped and that is why I am not getting the full coverage I had on the table. The issues I have had are as follows: severe headache, constant feeling of having to urinate, extreme joint pain, abdominal pain, sleeplessness, involuntary jerking, surges in current even when sitting still. Intense pain around the lead insertion site. Current uncomfortably running through my testicles, regardless of setting. It is my opinion there is still not a lot known about crps and I have read evidence of people have great success with these units. Everyone reacts differently. My body obviously creates a lot of scar tissue and my orthopedic surgeon created a fair amount herself. I can’t imagine even more or being forced into a chair for yet another unlucky decision. The medication helps and I have lived this far without the optimism that it would end soon. I had high hoed for this device but I don’t think it is right for me.

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One of my patients with CRPS was hospitalized for weeks with recurring unusual abscesses and required repeated surgery of hand and forearm. Even before surgery, she had failed opioids, failed ketamine, and was in ICU for weeks and weeks while the same medications were still given along with Propofol and IV Tylenol. Nothing helps her extreme pain.

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Anesthesiologists on staff in ICU threw everything they had at the pain for weeks. Most anesthesia pain doctors would have probably done what they did because that is the limit of tools we have.

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When you have hit the limit of benefit from opioids, ketamine, propofol, we have nothing else that treats pain with one exception: drug holiday.

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Stop all analgesics including Tylenol that destroys the liver as severely as cancer, the severity of which was newly discovered and published yesterday.

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The receptors for these analgesic drugs have up-regulated to such an extent they have caused the situation. Again, I stress, everything that was done during the ICU admissions would be done by any anesthesiology pain specialist. Those are the only tools. They cause the problem. The same for opioid induced hyperalgesia. We used to do it with Parkinson’s drugs in the 80’s.

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The only way to rehabilitate the up-regulation of all those receptors that have now exploded in numbers, immune to anything you throw at them, is stop the drugs.  Stop all of them for weeks, maybe months, years, no one knows, you are all the human guinea pig waiting to happen. But if we restart them, how long do we wait, how quickly will it again lead to this massive hyper-excitable state of pro-inflammatory cytokines that we know have gone wild, flooding the CNS. A flooded engine will not restart.

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Ketamine at least is known to reduce pro-inflammatory cytokines, but the system is too busy exploding, birthing new receptors that take over, and you’ve got a 55 car pile up. Well, more like millions I’d guess. No scientist here. Clnically, when can we resume something after a drug holiday, how soon and which drug? I’d avoid opioids because they create more pro-inflammatory cytokines. Choose ketamine, because they reduce pro-inflammatory cytokines, but if it works at all, stop it at first sign of tolerance, which is the need for increased dose. It becomes less effective. Walk a fine line, endure more pain because unless you do, it will no longer help. Opioids, analgesics of many kinds. 

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How do we get you through a drug holiday because we know withdrawing these drugs will trigger even more pain for possibly weeks until the system settles down?

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Pain storms, hurricanes

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This is complex regional pain syndrome where we see this insanity of pain storms. There is no other condition, unless several neuropathic pains in people with cancer, nowhere I have seen this type of pain in decades except CRPS – comparable to pain of subarrachnoid hemorrhage, blinding pain.

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No one has answers. None. One university does outpatient infusions of ketamine six hours daily for 8 to 12 weeks. Does it help? A small percentage. Outpatient, 6 hours daily, 5 days a week, staying at a hotel, 8 weeks.

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This is CRPS/RSD. No one has answers. It is futile to throw more of the drug in the system. That is my opinion. You have a choice and may choose otherwise. It is your body. You may stay on monthly opioids for decades, until you finally admit how poorly they work. A drug holiday is what we did in the 70s during my ancient training with Parkinson’s patients. They needed full 24-hour support. The American medical system has changed since then and those are not options currently available—cost.

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You need full psychological and psychiatric support.

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The Only Real Answer

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The country needs to invest $10 million to complete the clinical trials needed for an injectable, long-lasting interleukin 10 [IL-10], the anti-inflammatory cytokine. It already has full scientific and animal studies performed by and with the world’s foremost glial scientist at University of Colorado Boulder. Professor Linda Watkins has won awards from many countries. She has been the keynote speaker at the annual academy pain meetings for years. IL-10 can relieve pain for three months in animals that have intractable chronic neuropathic pain. This is not new —–NIH I’m looking at you to fund clinical trials. And those of you who care, do a Kickstarter to fund the clinical trials.

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This is the power of the innate immune system. NIH would rather fund research on the unknowns like stem cells rather than the known. It’s known for decades, NIH does not like to fund pain research. Glia are not all about pain. They are the innate immune system, the key to Alzheimer’s, neurodegenerative diseases, almost all known disease including atherosclerosis. It’s all about inflammation. We need the trials to stop giving drugs that cause inflammation, opioids —–CDC fiats are not as good as a drug that relieves pain, a drug that really works on mechanism. Where will the addicts go if the ER only has IL-10 for pain? That is one way to overspend on ER visits.  And NIH, please get us some real clinical research funding on how to use glia for our benefit. Get us some research on the entourage effect, combining medications to achieve relief especially for neuropathic pain.

Then bring on some crack negotiating teams from insurers to do some negotiation about pharmaceutical prices. Our new president has mentioned that.

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Please bring this to everyone’s attention. One way to get a grip on pain and/or depression is to build hope, help others, and energize behind a goal.

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Kickstarters work to raise tens of millions overnight. 

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IL-10 – animals have been shown to be pain free for three months, already proven in animal studies, by one of the world’s most widely acknowledged pain specialists Professor Linda Watkins, PhD. We need the final steps to fund the clinical trials in humans.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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