Spinal Cord Stimulators Can Cause Deaths & Injuries


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Washington Post Reports .

Injuries & Deaths from.

Spinal Cord Stimulators

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Excerpts below are from the November 25 report linked above on spinal cord stimulators. Use search function top left for prior several posts on this site:

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…one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.

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But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.

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Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.

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The FDA data contains more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.

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Medical device manufacturers insist spinal-cord stimulators are safe — some 60,000 are implanted annually — and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients.

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Most of these devices have been approved by the FDA with little clinical testing, however, and the agency’s data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.

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The AP reported on spinal stimulators as part of a nearly yearlong joint investigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.

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The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.

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The investigation also found that the FDA — considered by other countries to be the gold standard in medical device oversight — puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.

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Devices are rarely pulled from the market, even when major problems emerge. And the FDA does not disclose how many devices are implanted in the U.S. each year — critical information that could be used to calculate success and failure rates….

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…The four biggest makers of spinal-cord stimulators are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, with headquarters in Ireland and the U.S.; Nevro, in Redwood City, California; and Illinois-based Abbott, which entered the market after its $23.6 billion purchase of St Jude Medical Inc.

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St. Jude’s application to go to market with its first spinal stimulator contained no original patient data and was based on clinical results from other studies, while Boston Scientific’s application for its Precision spinal-cord stimulator was based largely on older data, though it did include a small, original study of 26 patients who were tracked for as little as two weeks.

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Once approved, medical device companies can use countless supplementary requests to alter their products, even when the changes are substantial.

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For example, there have been only six new spinal-cord stimulator devices approved since 1984, with 835 supplemental changes to those devices given the go-ahead through the middle of this year, the AP found. Medtronic alone has been granted 394 supplemental changes to its stimulator since 1984, covering everything from altering the sterilization process to updating the design.

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“It’s kind of the story of FDA’s regulation of devices, where they’re just putting stuff on the market,” said Diana Zuckerman, president of the National Center for Health Research, who has studied medical devices for nearly 30 years.

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….“These patients are guinea pigs,” she said.

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….Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, said trials for medical devices like spinal-cord stimulators are generally small and industry-sponsored, with a “substantial” placebo effect.

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“I don’t know of anyone who is happy with spinal-cord technology as it stands,” Koroshetz said. “I think everybody thinks it can be better.”

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….[Jim] Taft’s stimulator failed soon after it was surgically implanted. After an operation to repair it, he said, the device shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. Today, the 45-year-old Taft is virtually paralyzed, a prisoner in his own bed, barely able to get to the bathroom by himself…..

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Taft said his three-day trial helped reduce his pain so, a few days before his surgery, he began preparing for a new life. He ordered lumber to refurbish a patio and deck for his wife, Renee, as thanks for her years of support.

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In April 2014, Boston Scientific’s Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. A Boston Scientific sales representative was in the operating room — a common practice, the AP found.

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Highsmith would not comment on the payments. Other doctors have defended the practice, saying they do important work that helps the companies — and ultimately patients — and deserve to be compensated for their time.

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From the time Taft was cut open and the device placed inside his body, he had nothing but problems, according to hundreds of pages of medical records reviewed by the AP. The device began randomly shocking him, and the battery burned his skin.

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Taft and his wife complained repeatedly, but said his doctors and a Boston Scientific representative told them that spinal-cord stimulators don’t cause the kind of problems he had.

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That runs counter to Boston Scientific’s own literature, which acknowledges that spinal stimulators and the procedures to implant them carry risks, such as the leads moving, overstimulation, paralysis and infections.

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That also is not reflected in the AP’s analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal-cord stimulators. For Boston Scientific devices, infection was the most common complaint over the past decade, mentioned in more than 4,000 injury reports.

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In response to questions, the company called infection “unfortunately a risk in any surgical procedure” that the company works hard to avoid. It added that the FDA’s data “shouldn’t be interpreted as a causal sign of a challenge with our device. In fact, many examples of reportable infections include those that were caused by the surgical procedure or post-operative care.”

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“In our internal quality assessments, over 95 percent of the injury reports were temporary or reversible in nature,” the company added.

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Taft said had he known the devices hurt so many people, he would have reconsidered getting one. A Boston Scientific sales representative tried reprogramming the device, he said, but nothing worked.

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“I told them that it feels like the lead is moving up and down my spine,” Taft said. “They said, ‘It can’t move.’” But in July 2014, X-rays revealed the lead indeed had moved — two inches on one side.

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Highsmith told the AP the electrode broke from “vigorous activity,” though Taft said that would not have been possible due to his condition. Taft said he was in such bad shape after his surgery that he was never able to redo the patio and deck for his wife or do anything else vigorous.

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That October, Highsmith said, he operated on Taft to install a new lead, tested the battery and reinserted it.

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Still, Taft’s medical records show that he continued to report numbness, tingling and pain. During a January 2015 appointment, a physician assistant wrote that the device “seemed to make his pain worse.”

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The stimulator was surgically removed in August 2015. The following June, Taft got a second opinion from a clinic that specializes in spinal injuries, which said he had “significant axial and low back pain due to implantation and explantation” of the stimulator.

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Highsmith said other doctors have documented severe arthritis in Taft and that, while he has not examined Taft in more than three years, it’s “likely his current condition is the result of disease progression and other factors.”

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He did not answer questions about whether he informed Taft of the risks associated with stimulators.

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The doctor said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief.

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“Unfortunately, in spite of the major medical breakthroughs with devices like these, some patients still suffer from intractable pain,” he said.

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Renee Taft, a paralegal, reached out to Boston Scientific in 2017, but said the company refused to help because her husband’s stimulator had been removed and blamed Taft for his problems, also saying he had engaged in “rigorous physical activity” after surgery.

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In the letter from the company’s legal department, Boston Scientific also noted that federal law shielded manufacturers from personal liability claims involving medical devices approved by the FDA.

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In response to questions from the AP, Boston Scientific again blamed Taft’s “activity level” but didn’t elaborate. The company also said other factors could contribute to his problems such as “hyperalgesia, a phenomenon associated with long-term opioid use which results in patients becoming increasingly sensitive to some stimuli.”

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Brenda Simpson-Davis of Milton, Florida, said Boston Scientific also disregarded her complaints after her husband suffered a life-threatening infection following implant surgery.

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George Davis, 57, had three Medtronic spinal-cord implants between 2003 and 2007 after a car accident mangled his back. They temporarily reduced some of his pain, but he said the non-rechargeable batteries that were supposed to last for years never did and he tired of multiple surgical removals.

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In 2015, his pain management doctor urged him to try Boston Scientific’s Precision Spectra, which he called the best on the market. Unlike Davis’s old models, it had a rechargeable battery.

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Within weeks of his surgery, Davis said, he started feeling pain shooting down his back and legs and a burning sensation at the implant site. After his skin started turning black, the doctor performed emergency surgery to remove the device.

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Months later, Davis reluctantly agreed when his doctor urged him to try another Boston Scientific model but found that device even worse.

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Over the next year, he spent more than 100 days in and out of hospitals battling a life-threatening infection. Today, Davis says he has trouble getting out of bed.

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Boston Scientific said it never received the stimulators that were implanted in Taft and Davis so could not “conclusively identify” the causes of their problems. “Numerous factors can contribute to a patient’s ongoing symptoms, from increased physical activity to the onset of pain in other areas,” the company said.

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Simpson-Davis said she spoke with attorneys around the country, who warned her about the high bar set for a lawsuit . Finally, she found a Texas lawyer who said he will consider taking the case if she can find another two dozen potential plaintiffs.

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“To me, it’s not about the money, It’s about the people. It’s about them knowing what they’re getting themselves into,” she said.

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For years, Valerie McJunkin had been seeking relief from a rare neurological disorder that made her legs and feet feel like they were on fire. So when a medical device company sales representative and her West Virginia pain management doctor recommended what sounded to her like a “miracle device,” she was all in.

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They said a new kind of stimulator — one that targeted a bundle of sensory nerve cells in the lower back — was better than a spinal-cord device. She just needed to undergo a weeklong trial.

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When McJunkin showed up at the pain clinic this January for the trial, the Abbott sales representative was there, along with her doctor and his staff. They explained every detail. This device wasn’t for everyone, but she was the perfect candidate, she recalled them saying.

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Over the next week, they called or texted her nearly every day to see if the stimulator was easing her torment. And since the trial did seem to help, she went ahead with the implant.

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Within days, though, the device began randomly shocking her — a sharp pain that felt like a lightning bolt.

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When McJunkin called her doctor and the Abbott representative, she said they suggested that she was at fault because “stimulators don’t do that.” It wasn’t until she received a certified letter from Abbott in March that she learned it wasn’t all in her head: The company said her device was being recalled due to a glitch that could cause patients some “discomfort.”

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Since 2005, there have been 50 recalls involving spinal stimulators, averaging about four per year in the last five years. Roughly half the recalls involved stimulators made by Medtronic, the world’s largest device manufacturer, though none warned of a risk of serious injury or death.

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In early September, McJunkin invited an AP reporter to accompany her when she met with her doctor and the company sales representative to request the device be removed.

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The Abbott salesman and her doctor both suggested she get another stimulator, saying she had run out of options, especially since her doctor couldn’t write prescriptions for opioids because of a government crackdown. If she didn’t get another stimulator, he said, she faced a lifetime of pain. He did not suggest other options, such as steroid shots or continued physical therapy.

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“I’m not trying to force your mind,” the doctor said. “But for me, would I want to live my life like this?… If I get that new battery and it totally helps, that changes my life 180 degrees, right? But if I don’t I already know what’s going to happen to me: I’ll be suffering for the rest of my life.”

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On the drive home to Martinsburg, West Virginia, McJunkin gripped the steering wheel of her car, her tattoo reading “persevere” visible on her forearm.

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“You trust your doctor. You think he’s going to do the right thing,” she said. She paused, fighting back tears. “I just wanted to live without pain. But now that hope is gone.”

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In late October, her doctor removed the device.

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The experience of nearly all the 40 patients interviewed by the AP mirrored McJunkin’s: Their pain was reduced during the trial but returned once their stimulators were implanted.

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Experts say the answer may be a placebo effect created when expectations are built up during the trial that only the stimulator can offer relief from pain, exacerbated by patients not wanting to disappoint family members, who often have been serving as their caregivers.

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“If patients know this is a last resort, a last hope, of course they will respond well,” said Dr. Michael Gofeld, a Toronto-based anesthesiologist and pain management specialist who has studied and implanted spinal-cord stimulators in both the U.S. and Canada.

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By the time the trial ends, the patient is “flying high, the endorphin levels are high,” Gofeld said.

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Manufacturer representatives are heavily involved during the entire process. Along with often being in the operating room during surgery in case the physician has questions, they meet with patients to program the devices in the weeks following surgery.

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Most of the patients interviewed by the AP said the adjustments to their devices were performed by sales representatives, often with no doctor or nurse present. That includes one patient who was billed for programming as if the doctor was in the room, though he was not.

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“People who are selling the device should not be in charge of maintenance,” Gofeld said. “It’s totally unethical.”

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In a 2015 Texas case, a former Medtronic sales representative filed suit contending she was fired after complaining that the company trained employees to program neurostimulators without physicians present. She also claimed that a Medtronic supervisor snatched surgical gloves away from her when she refused to bandage a patient during a procedure, pushed her aside and then cleaned and dressed the patient’s wound. Medtronic denied the allegations, and the case was settled on undisclosed terms.

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In the Justice Department case involving Medtronic, a salesman who said he earned as much as $600,000 a year selling spinal-cord stimulators claimed sales representatives encouraged physicians to perform unnecessary procedures that drove up the costs for Medicare and other federal health programs.

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“While there have been a few instances where individuals or affiliates did not comply with Medtronic’s policies, we acted to remedy the situation in each case once discovered and to correct any misconduct,” the company said.

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Gofeld said he believes stimulators do work, but that many of the problems usually arise when doctors don’t choose appropriate candidates. And he thinks the stimulators are used too often in the U.S.

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Nevro, one of the four big manufacturers, has cited estimates that there are as many as 4,400 facilities in the U.S where spinal-stimulation devices are implanted by a variety of physicians, including neurosurgeons, psychiatrists and pain specialists.

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It’s a lucrative business . Analysts say stimulators and the surgery to implant them costs between $32,000 and $50,000, with the device itself constituting $20,000 to $25,000 of that amount. If surgery is performed in a hospital, the patient usually stays overnight, and the hospital charges a facility fee for obtaining the device. Costs are typically covered by insurance.

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The AP found that doctors can make more money if they perform the surgery at physician-owned outpatient surgery centers, since the doctor buys the device, marks it up and adds on the facility fee.

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In Canada, where Gofeld now works, he said the surgeries are done only by those who specialize in the procedures. He said spinal-cord stimulators should be used when pain starts and not after failed back surgeries.

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“By then,” he said, “it’s too late.”

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While manufacturers and top FDA officials tout stimulators as a weapon in the battle against opioids, neurosurgeons like Steven Falowski are the front-line evangelists.

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“Chronic pain is one of the largest health-care burdens we have in the U.S. It’s more than heart disease, cancer and diabetes combined,” Falowski said in an interview.

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He referred AP to Corby, as one of his surgical patients who was helped by a spinal-cord stimulator.

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Corby got the device more than two years ago and says that, after some initial adjustments, he hasn’t had any further problems. He says he wouldn’t trade the stimulator for opioids.

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“I was actually buying them on the street … a little like a druggie because I couldn’t get them anymore” from his pain doctor, Corby said.

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Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that’s where spinal-cord stimulators come in.

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If they’re used early enough for pain, they can prevent people from going on opium-based pain killers, said Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.

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Since 2013, device manufacturers have paid Falowski — or St. Luke’s University Health Network in Fountain Hill, Pennsylvania, where he works — nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.

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.….Another of Falowski’s patients was Lisa Snyder of Kempton, Pennsylvania, who was searching for relief from a painful nerve disorder. By the time she came to Falowski, she had cycled through three spinal-cord stimulators, which were removed for reasons ranging from infection to rejection.

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“Not everybody could do it, but he was confident he could,” she said.

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After her fourth implant this March, “I complained about this battery right away. I knew it was positioned funny. It burned,” Snyder said.

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AP’s analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words “heat” or “burn.”

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Abbott said that many of the “adverse events” reports in the FDA’s data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site “is often a reality for rechargeable spinal-cord stimulation systems,” which is why the company is now concentrating on devices that do not need to be recharged.

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….Snyder said she felt like Falowski’s nurse and physician assistant downplayed the problems and that the reprogramming of her device was conducted by the Abbott sales representative, with no medical staff present. On at least one occasion, she was charged as if the medical staff was there, when she said they weren’t, according to insurance bills reviewed by the AP.

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.Despite insisting nothing was wrong with the unit, Snyder said, Falowski called her one day out of the blue. “He said ‘Under no circumstances are you to turn it on.’ I asked him why and he wouldn’t say,” Snyder recalled..Falowski then scheduled immediate surgery to remove the stimulator, she said..Falowski called Snyder a difficult patient and said she was receiving “100 percent pain relief” when she had the stimulator removed, adding that she “remained very appreciative of her care.” He added that programming is “performed under the direction of a physician.”.“The physician is not present during the entire programming session, but provides oversight and direction..

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…The only time programming sessions are billed is when the physician is actively seeing the patient during a visit which was the case with this patient,” he said..

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.All Snyder ever wanted was to feel better. Today, she often is immobilized by pain..Before the latest stimulator, she could walk, stand and cook meals. Now, she finds it hard to get out of bed and rarely leaves her house. She says the device has ruined her life....

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“My fear is I’ll be like this forever,” she said...

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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 – 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.

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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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Have You Been a Victim of Felony Fraud Criminal Charges by Workers Compensation Insurer Because of Disabling Pain?


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No one can see pain and neuropathic pain is especially difficult to treat. It may be even more difficult because there may be no visible abnormality on X-ray or any test, e.g. Complex Regional Pain Syndrome (CRPS). CRPS  is further unusual as it may flare profoundly for a time and may even go into remission then flare some time later.

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But many forms of pain including chronic spine pain can flare hours later or the next day. Your walking may appear normal, but you know that limit beyond which you dare not step a foot more or revenge of the body will occur and you will be unable to function possibly for days. No doubt you’ve learned that limit may vary with the weather, or you may have good days and bad, able to walk longer or function better on good days.

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Sub rosa films are important to prevent insurance fraud. Some who claim total disability have been filmed  playing soccer, water skiing, etc. Others with legitimate total disability claims have been filmed during brief periods showing their gait appears normal. They can walk. But only for minutes.

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Abuse may exist on both sides. But it took 43 years for me to discover that pain is not an accepted medical condition for Social Security Disability even when completely disabling.

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Your comments of your personal experience would be invaluable for others. Did you experience fraud and abuse by insurers who deny medical care based on brief sub rosa films, then become victimized by criminal felony charges that produced years of extremely costly litigation?

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As long as felony criminal charges are pending, neither Medicare nor Tricare nor Social Security Disability payments can be made. No insurance, no care and litigation expenses that go on for 5 to 10 years or more in a person unable to work.

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It is important to expose fraud on all levels. If you have been a victim of Worker’s Compensation insurance fraud accused of felony misrepresentation, please comment below.  Name names of the companies.

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Perhaps there is a pattern.

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Would you be able to pay for adequate legal representation if you were unable to work or receive medical care?

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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.

~~~~~

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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Soothamide (PEA) Cream Helps Psoriasis & Seborrheic Dermatitis


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I have posted on PEA (palmitoylethanolamide) for several years on this site – use the search function top left above photo and type in PEA. No prescription is needed. Before it was available in the US, patients ordered it from the Netherlands where it is sold as PeaPure. One whose neuropathic pain was finally relieved by it, ran out, flew to the Netherlands just to pick up an emergency supply and flew back immediately. Thankfully Vitalitus began offering PEA capsules in the US a few years ago, and then made the 2% cream called Soothamide, which I have also posted on this site. It may even relieve the neuropathic pain of Complex Regional Pain  Syndrome (CRPS).

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Palmitoylethanolamide (PEA, or PeaPure in Netherlands) is nontoxic, anti-inflammatory, analgesic, and has no side effects. Your body makes it; plants make it. Years ago the publications on it were extensive. A Nobel Prize winner published on it in the early 90’s. When taken in capsule form for CRPS, I have seen it take 6 or 8 weeks to be effective, but when it relieved pain, it lowered pain from very severe to mild in a patient bedridden for 6 years. I have seen the cream relieve neuropathic pain instantly in a couple minutes in some with CRPS. I have seen the cream fail to relieve CRPS pain in one patient, who then wiped the remainder of the cream along the lumbar spine of her dad who had been groaning with pain, who had instant relief. And I have published on its use for vulvodynia, discussing its autocoid mechanism.

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Skin conditions can be their own constant day and night torment. A patient reports almost complete immediate relief from the itch of psoriasis and seborrhea (around eyes and all over scalp). Itch can be a form of neuropathic pain besides more common causes such as allergy. The rash, the bleeding crusted itchy skin of those two conditions is treated by prescription steroid creams that can thin the skin, and thin skin itself can predispose to bleeding, further discomfort, and frankly did not help this patient. If you use steroid creams, it must be applied 3 or 4 times a day and use gloves or caution where you rub your fingers — risk thinning the delicate skin near eyes and nether regions as weeks and weeks drag on. Soothamide worked quickly, not needing 3 or 4 applications per day.

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Instantly the itch was markedly better. And overnight! the rash was markedly improved. The patient had had some mild relief from the bleeding itchy scabs on scalp with T/Sal shampoo but not great, for weeks and weeks. Before that, DHS Zinc shampoo helped only mild “dandruff”, did not touch the crusts and itch. Aloe Vera helped the itch for a few hours. Steroid creams were no help for itch, for 4 months scratching the delicate skin around eyes with hard scratchy cloth almost like a dry loofah sponge. Soothamide 2% took away the itch around eyes immediately though it can easily get into eyes when washed or when rubbing the eyes, it does not burn. It is truly very soothing.

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It’s also a remarkable moisturizer, absorbs very quickly, is not greasy, and for those whose other skin conditions are unusually thickened, it would likely be worth a try.

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I see Vitalitus now also sells CBD, that is cannabidiol, the cannabinoid from the marijuana plant that has no psychotomimetic properties – does not make you “high”. GW Pharmaceuticals’s “Epidiolex”, their CBD, recently received FDA approved for epilepsy. Imagine! a Schedule I drug received FDA approval! hmmm, must not be deadly after all. Wait til the DEA kills that idea. Does congress make sense when they dictate medicine?

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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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Memantine for Neuropathic Pain & Complex Regional Pain Syndrome, CRPS


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Neuropathic pain syndromes show an over-expression of NMDA receptors in the brain in animal models. Ketamine blocks the NMDA receptor. Another medication with the same mechanism, but in pill form is memantine. This report on six patients of the use of memantine for Complex Regional Pain Syndrome (CRPS) from 2007 in the Clinical Journal of Pain, six months after treatment with memantine, showed significant decrease in pain, improved motor symptoms and autonomic changes, and fMRI changes on the affected side improving, comparable to the unaffected side of the brain.

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It was approved for Alzheimer’s dementia gradually titrating to a dose of 28 mg/day, but for decades has been very useful off label for neuropathic pain including but not limited to CRPS, at a dose of 55 mg/day, and in recent years often prescribed for migraine.

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Ketamine is highly successful also for treatment resistant depression, and one patient, a psychiatrist disabled from the unfortunate triad of intractable neuropathic pain, migraine and treatment resistant depression, while slowly titrating to a dose of 55 mg/day, a process that takes almost 3 months, found depression relieved for the first time in decades at the dose of 35 mg. It was highly effective as one component of the multi-pronged approach for all three conditions.

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This life is a hard fact. We all need all the help, encouragement and positive attitudes we can get. Complex intractable pain and/or depression requires rational polypharmacy, selectively chosen based upon well known mechanisms, neurotransmitters, receptors, hormones, stress reduction, cognitive behavioral therapy, physical therapy, occupational therapy, nerve blocks, and spiritual understanding, etc. Several choices were summarized almost two years ago here.

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In my experience, memantine is very well tolerated with few if any side effects but covered by insurance only for mild to moderate dementia. Thus, not only is it highly challenging to treat neuropathic pain, but important to creatively meet the challenges of our backwards medical system that barely recognizes the needs of those with chronic pain.

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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 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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Cannabis That Can Stop the Munchies? What is THCV?


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MEDICAL MARIJUANA

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Cannabis is legal in California for adult use as of January 1, 2018. This may be helpful to someone you know. It is a most important drug. Below you can find a few pointers that are basic to understanding what strains to try. Distributors are swamped with ten times as many buyers as last week, prices are doubled, taxes are very high, it is very expensive and you will need to test many strains before you find what works for you without making you stupid with euphoria that lasts 12 hours. Do be warned of turning the body into sofa-size obesity overnight. Munchies occur with high THC strains. To discuss below how to avoid that torture and still relieve pain or muscle spasm.

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Horvath et al at Yale in 2015 found cannabis stimulates hunger and arousal in hypothalamic neurons. Here’s the YaleNews on the multi-authored work.

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Horvath is the Jean and David W. Wallace Professor of Neurobiology and of Obstetrics, Gynecology, and Reproductive Sciences, director of the Yale Program in Cell Signaling and Neurobiology of Metabolism, and chair of the Section of Comparative Medicine.

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To orient you in the quote below, cannabinoid receptor 1 (CB1R) is one of the two known cannabinoid receptors in the brain. Others are located outside brain, throughout the body.

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“The Pomc gene encodes both the anorexigenic peptide α-melanocyte-stimulating hormone, and the opioid peptide β-endorphin. Hypothalamic pro-opiomelanocortin (POMC) neurons promote satiety. Cannabinoid receptor 1 (CB1R) is critical for the central regulation of food intake. CB1R activation selectively increases β-endorphin but not α-melanocyte-stimulating hormone release in the hypothalamus, and systemic or hypothalamic administration of the opioid receptor antagonist naloxone blocks acute CB1R-induced feeding.

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Interesting. Low dose naltrexone, which is essentially long acting naloxone, may block munchies in humans? At what dose? Please comment if you take naltrexone 4.5 mg or 15 mg (anti-inflammatory doses) or 28 mg (weight loss dose) or 50 mg and above doses of naltrexone (high doses for addiction).

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One strain that is better at stopping or reducing the munchies, and that is believed due to a cannabinoid in the strain called THCV. You can always do a search for THCV.

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Cannabis is one of the few medications that can relieve some of the worst side effects of opioid withdrawal. Many patients find they need to use fewer opioid pills for pain or can stop them altogether; they need to use fewer muscle relaxants; and they can eat or sleep better if they use cannabis. Once cannabis became legal, many alcoholics were able to give up alcohol because their first preference is cannabis.

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Get a low cost recommendation for medical marijuana in minutes at home from your mobile phone. The best source for recommendation is : HelloMD.

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Cannabis may be legal in all states once tobacco companies toss some money at Congress. Could cannabis be related to the vow of Phillip Morris and a wave of big tobacco companies to stop selling cigarettes this year?

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It is dreadfully expensive and heavily taxed. All states should adopt New Mexico’s law that allows healthcare insurers to reimburse patients who have paid for medicinal cannabis. Voters…

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Cannabis is made by the body and the brain makes two of the endogenous cannabinoids. If is highly anti-inflammatory, and profoundly important mainly in the immune system but also in bone turnover. You have more cannabinoid receptors in your body than any other kind. It is as old as sponges, an ancient medicine.

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A WORTHY READ

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Mr. X – by Carl Sagan who describes his experience with marijuana at length and used it creatively for decades opening his brain to experiences he was otherwise not oriented to at all.

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MUNCHIES

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Fear the munchies. Cannabis, medical marijuana, can cause the munchies, an overwhelming desire to eat nonstop, usually all the most high calorie things your desperately fevered brain can dream of cramming in.

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Certain strains of cannabis can be life saving for those who have loss of appetite from conditions such as cancer, HIV/AIDS, depression, inflammatory conditions, etc. But the munchies can be disastrous when you cannot afford to gain weight due to pain or disability or simply wish to develop an important standard to maintain best health which means good lean body weight. The best way to reduce inflammation is to avoid obesity, avoid sugar, avoid diabetes, heart attacks, strokes. Remember inflammation is the root cause of 90% of the conditions we die of: diabetes, cancers, Alzheimer’s, Parkinson’s, autoimmune disease, atherosclerosis, etc.

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Those with an eating disorder should scrupulously avoid those strains that are highly rated for helping anorexia, loss of appetite.

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CHOOSE STRAINS THAT STOP THE MUNCHIES

STRAINS WITH HIGH THCV  OR HIGH CBD 

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If needing high THC for pain or appetite, for example, then a strain with high THC and high THCV is Durban Poison. Read in detail about strains on leafy.com using the search function and it will find dispensaries in your area.

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If low THC is all you need, then Leafly discusses high CBD strains with low THC currently available. Google it or ask the dispensary.

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I am not going to do more than mention these three cannabinoids: THC, CBD, THCV. You can google them but do glance at my outdated 2009 cannabis website – CBD has vastly changed since then, available even at farmer’s markets and nutrition departments of groceries.

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The cannabis plant has 400 chemicals of which about 86 are known cannabinoids but we focus on just a few and hybrids have been bred to display many qualities and various percentages of cannabinoids.

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THC

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THC, tetrahydrocannabinol, can cause euphoria and is the principal psychoactive ingredient useful for pain, depression, appetite, multiple sclerosis, fatigue, stress, and many conditions including just to have fun, be giggly or creative. For the California Medical Board, a strain with 18% THC is considered high, but some strains such as Holy Grail have 27% or more THC. Some strains are noted for causing more anxiety or paranoia due to THC content. It is widely said THC is necessary for pain relief but… see CBD below.

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CBD

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CBD, cannabidiol, a non-psychoactive cannabidiol that blocks the psychoactive component of THC so that you may be able to mix with THC in order to use a stronger dose of THC for the underlying condition —  find your best ratio of CBD to THC. Or use 100% CBD. Among strains of flower sold at dispensary, I’m not sure what % CBD

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Some people are highly sensitive to THC (paranoia, panic attacks, anxiety) and cannot use any THC or only very tiny amounts of THC with higher percentage CBD.

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Some use pure 100% CBD which is said to be useful for Crohn’s Disease, PTSD, multiple sclerosis and certain seizure disorders, the severe childhood Dravet Syndrome. There is a recent single report of an adult who failed all anticonvulsants and responded to CBD alone. I have seen a patient with depression after 2 years of severe disability from 4 major chronic pain conditions, surprisingly all pain 100% relieved by CBD. It is widely said that THC is essential for pain relief but for this case not needed.

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Some dispensaries will mix liquid CBD:THC in ratios of 15mg/mL CBD to 0.1 mg/mL CBD all the way up to ratio of 15:15 or more. Use topically, under tongue or swallow. One patient dilutes and uses topically. Very expensive!!! It is the only thing helping his extremely painful autoimmune neuropathy.

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THCV

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Leafly discusses ten strains that will not make you (as) hungry

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After discussing high CBD strains, then turn to high THCV:

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High THCV Sativa Strains

“By now you know what THC and CBD is, but you may not be familiar with the less ubiquitous THCV, a related chemical that suppresses appetite. While most strains on the market today tend to test anywhere between 10-20% THC, what’s considered a high THCV content might only hit a high-water mark of 5%. THCV tends to be more abundant in sativa strains, and it’s possible you’ve noticed that sativas tend to provoke hunger less than indica strains. The unique metabolic effects of THCV even have researchers considering its utility in treating obesity and diabetes.”

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Durban Poison is the name of the strain with highest THC and THCV, and a good profile detailed on Leafly: Maximal effect is Energetic > happy > uplifted >> focused >> euphoric. Not everyone may have all these effects.

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Always check Leafly’s negatives for each strain and look at the bar graphs — how severe are the side effects? Note that always worst is dry mouth. Half as bad are dry eyes for this strain – at least not as bad as dry mouth; and much lower in incidence is dizzy, anxious, paranoid. Overall a very good profile for a high THC strain.

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RISKS

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Note, those with Sjogren’s Syndrome who have dry eyes are at risk for corneal transplants and who have dry mouth are at risk for all teeth crumbling, so choose and treat accordingly.

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Cannabis can increase pulse and blood pressure which can be a risk of heart attack and stroke for any age. It is especially likely if you are naive to the drug, i.e. have never used it or have not introduced it to your system for decades. Check blood pressure and pulse before use and after you feel the peak effect.

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The youngest person I found on the internet who died of heart attack caused by cannabis was a healthy 17 year old male, possibly a false report, but cardiac arrhythmias can be fatal and there are undiagnosed cardiac conditions in young athletes who may be likely to use cannabis.

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Cannabis can interfere with memory.

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The adolescent developing brain may be vulnerable to harmful effects.

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HOW TO USE IT

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Vaporize it. Avoid 4 toxins. Rapid onset, short duration of effect.

If smoking, you will inhale 4 major toxins.

Use under tongue or topically on skin.

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If you swallow cannabis, you will not feel effect for 90 to 120 minutes so allow 2 hours before you add more or you may seriously overdose. Duration of effect may be 4 to 12 hours or more – overdosing can last days.

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5 mg oral THC may be too much for a starter dose for some people, but may be average for many, and some may need 10 mg. But heavy users need far, far more: TOLERANCE DEVELOPS!!! Money down the drain. Use only as much as you need or you will develop tolerance and require more frequent and higher and higher doses to reach same effect. That can be unaffordable for the average middle class person. 

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And yes, it may appear in urine for 30 to 60 days, possibly more.

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Cannabis is still a schedule I drug. The Emperor has no clothes. Do not take it onto planes or attempt to mail it.

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Do read more about it on my cannabis website linked above. It is a drug. You will benefit from learning how to use it.

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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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