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.

~~~~~

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 Marijuana – Cannabis for Pain


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These references include links to peer reviewed journal articles on cannabinoids. They are taken from the Reference Library of the outstanding RSD Association in Connecticut, whose mission is to help relieve pain. They have grouped the articles in helpful folders by subject, and this is one of many folders on the immense subject of pain. Please donate to them as their research helps everyone with pain, not just nerve pain or CRPS. May the references help enrich your lives and help support congress and regulators in legalizing cannabis across the country — the attorney general just now voted in by congress opposes medical marijuana.

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Be aware that states should monitor the plant for bacteria, fungus, pesticides, and heavy metals as discussed in this Smithsonian article:

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“Washington, the second state to legalize recreational marijuana, does require such testing for microbial agents like E. coli, salmonella and yeast mold, and officials there rejected about 13 percent of the marijuana products offered for sale in 2014.”

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Concentrates may be made with toxic butane or heptane. If you have cancer or are immunosuppressed – cancer and autoimmune diseases fall into that category – it is safer not to inhale. Cannabis can be used on the skin or swallowed but be aware when swallowed, it takes 60 to 90 minutes before you feel the effect. It is easy to overdose when swallowed. Check your blood pressure and pulse before use and again while you feel its effect.

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The article also points out that on testing, many of the plants have high THC but no longer have CBD, one of the 86 known cannabinoids, the one that blocks the psychoactive side effects of THC. On its own, CBD has many medical benefits.

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For those who have allodynia, the most intense form of nerve pain, pain that is triggered by a light touch or breath of air:

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Keep in mind that chronic pain is much harder to treat than cancer pain and acute pain. Chronic nerve pain is the hardest of all to treat. We need to be able to prescribe anything that helps. Pain can lead to suicide in these extreme pain conditions.

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Watch out for the munchies – do not get fat.

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O’Shaunessy’s today published articles that may be useful for your Senators, healthcare insurers and states:

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“some additional articles published by cannabis clinicians in O’Shaughnessy’s showing the strength of aggregated case reports. We hope the MBC Marijuana Task Force will give them serious consideration.”

 

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Cannabinoids

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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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Pain Much Better off Opioids


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Patient disabled with CRPS/RSD markedly better after off opioids. The intense nerve pain began in his left ring finger eight years ago, not the dominant hand. Now he has pain everywhere below the neck. He has been bed-ridden for years.  Now his “bones feel like ice, freezing from the inside out and shaking.”

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Had been on Fentanyl patch 100 mcg/hr for years. Dose was lowered to 75 mcg/hr, then his pain specialist did an involuntary taper off in two short weeks. Both of those doses are far higher than the new CDC guidelines from 2016. Fentanyl is 100 times stronger than morphine.
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He says his pain is feeling much better off the opiates. He is quite surprised. On Fentanyl 100 mcg/hr patch, he rates his pain then as 6 to 8 on scale of 10.
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Pain is now  2 to 4 off opioids the last 3 to 4 weeks. Even the hands are not hurting as much..

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Initially after the abrupt taper, he spent 7 days in bed, then says he “started getting out a little bit, now hands are not hurting as much. Neuropathy even isn’t hurting as much.”

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I have seen several patients who said opioids caused pain, all over the body in places they never had pain before or since.

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Yes, clearly many are helped by opioids. But many are simply afraid to taper off. I understand this. The question then is, what will we do to treat pain? Most doctors have nothing else. Patients rightfully fear stopping opioids.

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We need to understand there is outstanding science that demonstrated years ago that opioids cause inflammation in the CNS (brain and spinal cord). Inflammation causes pain.

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Treat pain with glial modulators that relieve inflammation in the brain, neuroinflammation. These are off label and most of them must be compounded. Compounded medications are not covered by your insurance — thanks to pharmaceutical donations to congress.

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Cannabis (medical marijuana) can help some with spasm, pain, insomnia. Also not covered by your insurance — thanks to pharmaceutical donations to congress. But patients in New Mexico were able to get insurers to reimburse them for the cost of their medical cannabis.  Congress should allow dispensaries free access to banking systems and allow insurers to directly pay the cost for medical use. We all know the emperor has no clothes. Lets be real. Pain leads to desperate measures.

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Let me say right now, to all those who will send in comments attacking science, attacking me, attacking my clinical experience (my patient reports) on opioids, I will not post your attacks on these pages. I do prescribe opioids to select patients. I strongly believe all pain should be treated initially by glial modulators that relieve neuroinflammation before we begin causing pain and inflammation by ultimately having nothing else to turn to and then prescribe opioids. There is no better solution because pharma wants you on a drug for life. That’s money in the bank, forever, every single month for decades. It’s awful.

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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.

~~
This site is not for email and not for appointments.

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

~~~~~

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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PEA Capsules & PEA Cream from Vitalitus – Soothamide


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Palmitoylethanolamide (Pea in the US, PeaPure in Netherlands) is a glial modulator, analgesic, anti-inflammatory, neuroprotective and anticonvulsant  with mechanisms involving the innate immune system and mast cells. It binds to a receptor in the cell nucleus. The major focus of hundreds of publications on it has been inflammation, neuropathic pain states and mast cell related disorders from University of Oxford,  Journal of Arthritis Research and Therapy, Journal of Pain Research, University of Bologna School of Dentistry (a study for TMJD pain), etc.

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It is a food supplement. It is a naturally occurring lipid amide, i.e. the body makes it, plants make it. It is available as a capsule and a cream without prescription. It may take days to weeks to work, but I’ve seen the cream work in two minutes – shock!  The relief is amazing for someone who has failed everything for intractable pain.

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Soothamide Cream is 2% palmitoylethanolamide from Vitalitus in the US.

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It’s been fascinating to see the cream work for so many pain syndromes including severe CRPS/RSD nerve pain! arthritis, muscle and severe ligamentous strain – often in less than two minutes! Not everyone, not every pain benefits but it is well worth trying and very affordable for large amount.

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One senior whose osteoarthritis in finger joints has been painful, very stiff, and prevents him from only very slightly being able to bend four fingers on his right hand. It’s been years since he’s been able to touch tips of the fingers to his palm because of stiffness and pain. They just would not go.

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After applying Soothamide cream, in less than 20 minutes he was able to fully, easily and painlessly bend all four fingers to the palm without any trace of stifness – quite astonishing. And the next day, three of the four fingers still had complete 100% relief 20 hours later, but it did not last for the index finger, even applying it later to that finger over those 20 hours. Twenty hours relief is amazing for three fingers after years of severe stiffness and pain. Relief may have been hours longer, but he took off for the day and data like this is difficult to pay attention to, and then to make a memory note of how long.

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Another with knee pain and significant joint effusion (fluid that creates pressure inside the joint), had relief for 3 hours after one application in the office.

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I have seen the cream relieve low back pain completely in less than two minutes. This was the father of a patient who had tried it in the office and it failed to help that patient, but she had a little left on her hand and schmeared it across her dad’s back. All pain gone in less than two minutes!  I am assuming this was muscle strain, not deep mechanical structures in the spine.

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Another patient with RSD pain on the foot had no benefit, but she then applied the Soothamide to a very severe pain from torn ligament in the arm that was more painful than her RSD. It was gone in less than two minutes, to her shock and delight.

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The cream has only recently been available in the US, and I have seen it help so many patients including those with CRPS/ RSD nerve pain. Most relief from creams is short lived, but if you see 4 hours of relief, or 20 plus hours as the patient above, it is very special.

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The cream has been such fun! Having seen even the severe nerve pain of CRPS/RSD improve or be astonishingly gone -!- in less than two minutes -!- it helps doctors forget the pain of being unable to offer anything more. Here we have capsules and cream that do not require prescription. And even in the most extreme pain syndromes is worthy of a try.

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PEA capsules – open and place powder under tongue for instant relief of breakthrough pain.

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That was a blessing in the middle of last night for one of my patients with RSD who was having a severe flare of pain. In August, she had started PEA capsules 3 twice daily – always take with something fatty (milk, peanut butter, etc) to aid absorption. In 3 weeks it had reduced her lower limb pain from severe to mild-moderate while in bed. Now months later, after reducing another medication briefly due to side effects, pain flared severely. What to do?

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I instructed her to open the PEA capsule and place the powder under tongue to absorb there. She had relief. I don’t have data to relate more as yet but hope to post as I learn from her and hopefully other patients who write in their comments. How much is safe? I will try to find more information. We know the body makes it, plants make it and at doses of 6 capsules daily it causes no side effects.

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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.

~~
This site is not for email and not for appointments.

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

~~~~~

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 Marijuana Proven to Save Lives, Science Issue on Pain, November 4, 2016


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The entire issue is devoted to Pain 

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From “Pot and Pain” page 566:

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Analyzing Medicare drug prescription data from 2010 to 2015 in states where medical marijuana is legal, David and Ashley Bradford at University of Georgia in Athens found significant differences in prescription of medications for anxiety and nausea. “But one condition stood out from the rest: ‘The effect for pain was 3 to 4 times larger than all of the others.'”

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“In medical marijuana states, each physician prescribed 1826 fewer doses of conventional pain medicines each year.” The reduction in pain prescriptions is even more dramatic in the younger Medicare Group.  [presumably disabled by pain]

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Marcus Buchhuber, previously at the Veterans Affairs Medical Center in Philadelphia, examined death certificates in all 50 states between 1999 and 2010. In states that permitted marijuana, there were nearly 25% fewer deaths from opioid drug overdose.

In 2010 alone, “that translated into 1729 fewer deaths” from overdose. And the effects grew stronger in the 5 to 6 years after medical marijuana was approved.

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Further information on Marijuana here.

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

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

~~
This site is not for email and not for appointments.

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

~~~~~

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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