Employers Adding Stem Cell Options to Insurance Plans

By Liz Szabo, Kaiser Health News

A Midwestern grocery chain, Hy-Vee, is taking an unusual approach to reducing health care costs. Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider.

Hy-Vee has contracted with one of the United States’ leading stem cell companies — Regenexx, based in Des Moines, Iowa — that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.

Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery.

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A single knee replacement ranges from $19,000 to $30,000 in the U.S.

Health insurance typically doesn’t cover stem cell injections, with the exception of certain accepted treatments, such as bone-marrow transplants for cancer and aplastic anemia.

Aetna, the United States’ third-largest health insurer, dismisses stem cells and platelet injections as experimental; Anthem, the country’s second-biggest health insurance provider, classifies the injections as “not medically necessary.” Without insurance coverage, patients are forced to pay out-of-pocket or forgo treatment.

So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren’t part of a standard insurance package.

In a statement, Regenexx said its goal is to “replace more invasive surgical orthopedics” with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures “repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments.”

In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient’s hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a “platelet-rich plasma” treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.

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Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors.

Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, who has published a series of articles describing the stem cell market.

At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures.

Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.

Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than “minimal manipulation.”

On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy.

Other research suggests stem cells and platelets may work no better than placebos. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections.

There’s also no definitive evidence stem cells and platelets can regrow lost cartilage. A 2018 review concluded platelets have “marginal effectiveness,” and experts note that most published studies are so small or poorly designed that their results aren’t reliable.

Corporate Boosters

Corporate executives have become some of Regenexx’s biggest boosters. Hy-Vee’s former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, “I knew that giving our employees the chance to explore options besides surgery was in their best interest.”

Hy-Vee did not make Jurgens or other employees available to interview.

Perhaps Regenexx’s best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens.

Steve Lacy, Meredith’s former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try.

The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. “The rehab and recovery is far less onerous” with the Regenexx procedure than with surgery, Lacy said. “If the procedure doesn’t work for an individual, there’s no harm.”

Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That’s a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.

At its headquarters, Meredith has promoted Regenexx procedures through email, posters and “lunch-and-learn” sessions in the office, said Jenny McCoy, Meredith’s corporate communications director.

McCoy herself has become a poster child for Regenexx’s benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site:

Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.

“I thought, ‘If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,’” said McCoy, 52. Given the price tag, she said, “I would not have done it otherwise. I wouldn’t have even known about it.”

‘Very Pushy’ Marketing

Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn’t sold.

“My experience with them has not been great, in terms of marketing and sales. They’re very, very pushy,” McKay said. “They claim they can get people back to work earlier” than surgery. “But if I still need knee surgery a year down the road, that doesn’t cut my costs.”

The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers’ compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn’t included Regenexx in its health plan.

McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another “went through a couple procedures and ended up needing surgery anyway.” 

In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Is Tramadol Just as Addictive as Other Opioids?

By Pat Anson, PNN Editor

Patients recovering from surgery who take the opioid tramadol have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids, according to a large Mayo Clinic study.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have been increasing because it is widely perceived as a “safer” opioid with less rick of addiction. The new study, published in The BMJ, appears to debunk that claim, at least for surgery patients.

Mayo Clinic researchers looked at health data for over 350,000 patients who were prescribed opioids after undergoing 20 common surgeries in the U.S. between 2009 and 2018. A little over 7% of the patients were still refilling opioid prescriptions 90-180 days later. When the researchers dug a little deeper into the data, they found that patients taking tramadol had a 6 percent higher risk of prolonged use compared to other opioids.  

"This data will force us to reevaluate our postsurgical prescribing guidelines," says lead author Cornelius Thiels, DO, a general surgery resident in Mayo Clinic School of Graduate Medical Education. "While tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids."

Tramadol is a synthetic opioid that was classified as a Schedule IV controlled substance by the Drug Enforcement Administration in 2014, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse.

Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

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Over half (53%) of the patients in the Mayo Clinic study were prescribed hydrocodone, about a third (37.5%) received oxycodone (also a Schedule II drug) , and only 4% received tramadol.

"We found that people who got tramadol were just as likely as people who got hydrocodone or oxycodone to continue using opioids past the point where their surgery pain would have been expected to be resolved," said senior author Molly Jeffery, PhD, the scientific director of research for the Mayo Clinic Division of Emergency Medicine. "This doesn't tie to the idea that tramadol is less habit forming than other opioids."

Jeffery and his colleagues say the DEA and FDA should consider reclassifying tramadol to a level that better reflects the risk of prolonged use.

"Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention," said Thiels.

In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.

Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is an unscheduled drug in Canada, but Health Canada is currently reviewing its status.

A Pained Life: Accepting the Unacceptable

By Carol Levy, PNN Columnist

I was recently talking with a friend who has chronic pain and, like me, has had to deal with many bad side effects on top of the pain.

Helene has a facial pain disorder. Unfortunately, as a consequence of her last surgery, she developed problems speaking and swallowing. She has repeated injections to help with her voice, but the swallowing problem Helene says “is permanent." 

I can't believe that. “Have you had a third or fourth opinion?” I asked.

“Yes, and a fifth and sixth opinion. There is nothing more to be done,” Helene explained. “But I have adjusted to it and accept it.”

Her last statement felt almost like a punch to my gut. I am happy for her. But truth is, even after 40 years, I do not accept the pain, disabilities and disfigurement the many procedures and surgery have wrought in my life.

It is hard to adjust to change, especially when it affects our natural abilities and body functions. Even harder still when it is the result of medical or surgical mistakes. Or a surgery or treatment that went fine but caused more damage.

Acceptance certainly makes life more bearable. And yet, I have never been able to reach that state.

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My pain started in 1976. By now I should be well over having to accept and adjust, but instead I am still angry, frustrated and upset when the pain strikes. When I try to read or write, it exacerbates my eye and facial pain and becomes more then I can bear. The facial paralysis, a side effect of a surgery in 1979, is a hateful reminder of the terrible surgery that caused it.

Children sometimes look at me strangely and stare. I get it. I look different. If I was a child I would also probably look and wonder, “What happened to that lady?”

But It is the adults who feel a need to point me out or comment about me, within earshot, that hurt the most.

My cervical spine was severely injured during one operation. As a result, I have 12 screws and 2 clamps placed in my neck to literally hold it up. When I saw a man look at me, tap his companion's shoulder, point me out and make a slashing motion across his neck -- appearing to indicate to his buddy that I tried to slash my throat -- I wanted to crawl under a table.

Then the question becomes, “How do you adjust?” Or for people like me, “Why haven't you adjusted and accepted?”

As I think about the people I know who have chronic pain, I realize the difference between those who have accepted, adjusted and accommodated versus those of us who have not is a simple one: They have been accepted, and their pain and disabilities have been incorporated not only into their lives, but the lives of those around them. They are believed.

What do those of us who do not have that kind of outside affirmation do? We need to find a way to self-solace, whether it’s by therapy, a support group or meditation. It may seem simplistic, but we are our own best healers. By self-healing we can throw off the hurt and disbelief heaped upon us by others and instead nurture ourselves.

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Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Patients at Ohio Hospital Have Surgery Without Opioids

By Pat Anson, PNN Editor

Would you want to go through a major surgery without the use of opioid pain medication?

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

“Over 75 percent of our elective colorectal patients underwent surgery without requiring narcotic analgesics postoperatively, including after discharge,” says Sophia Horattas, MD, of Cleveland Clinic Akron General Hospital.  “During this time period our patient satisfaction scores improved as well as patients' perceptions of pain control.”

All eight general surgeons at Akron General adopted the non-opioid treatment protocol in 2016, applying it to patients who had elective colon operations. Prior to surgery, the patients were all educated about pain management, non-opioid analgesics, and the risks associated with opioids.

Researchers evaluated 155 of the patients and presented their findings this week at the American College of Surgeons Clinical Congress in Boston.

Overall, 83 percent (128) of the patients did not need opioid medication after their operations. Among those who did, use of opioids before surgery was often an indicator that they would want them again. Nine of the 15 patients who had prior experience with opioids used them again after surgery.

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Among the remaining 140 patients who did not use opioids before surgery, 85 percent (119) did not need opioid medication for pain relief.

The researchers found that patients who used opioid painkillers typically spent more time in the hospital; an average of 2.7 days vs. 2.3 days for the non-narcotic group.

“Patient education played a large role in protocol compliance, and patient satisfaction improved as they were able to avoid prolonged fasting, achieve improved pain control without the side effects of narcotic analgesia, and be discharged home earlier,” said Horrattas.

For pre-emptive analgesia before surgery, patients received one dose of acetaminophen, gabapentin, and the NSAID celecoxib (Celebrex).  In the operating room, patients received a nerve block and underwent anesthesia with the non-opioid pain relievers ketamine and lidocaine.   

Surgeons at Akron General have since adopted the non-opioid protocol for other major abdominal operations, such as bariatric procedures, gynecological and genital/urinary tract procedures, and liver and gall bladder operations.

“One of the great things about our protocol is its reproducibility.  Once we developed our program, we found that it could be standardized across departments with consistently reproducible results,” said Horattas.

Akron General’s protocol is similar to guidelines adopted by the American Pain Society (APS) for postoperative pain care. The APS also encourages the use of non-opioid medications such as acetaminophen, NSAIDs, gabapentin (Neurotin) and pregabalin (Lyrica).  

Akron General gets below average ratings for patient satisifaction from Hospital Compare, a Medicare survey that asks patients about their experiences during a recent hospital stay. The hospital received only two of a possible five stars, which places it in the bottom third of hospitals nationwide. Only 68% of Akron General’s patients said they would definitely recommend the hospital.

According to Healthgrades, 3 percent of the patients died after a colorectal surgery at Akron General, which is slightly below the national average for that procedure.

Opioid Addiction Rare After Surgery

In recent years, many hospitals have shifted away from routinely giving patients opioids during and after major surgeries -- even though it is rare for patients to become chronic opioid users.

A large Canadian study found that only 0.4% of elderly patients that were prescribed opioids while recovering from a heart, lung, colon, prostate or hysterectomy operation were still using them a year after their surgeries.

Another large study published this year in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Long-term opioid use after dental surgeries is also rare. A recent study published in JAMA found that only 1.3% of teens and young adults who were given opioids after wisdom teeth removal were still being prescribed opioids months after their initial prescription.

The vast majority of patients still prefer opioids and perceive them as the most effective form of pain relief after surgery. In a recent survey of over 500 adults who were scheduled to have surgery, researchers at Thomas Jefferson University Hospital in Philadelphia found that 77% expected opioids, 37% expected acetaminophen, and 18% expected a NSAID for pain relief.

"Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery," said lead author Nirmal Shah, DO, an anesthesia resident at Thomas Jefferson University Hospital.

"But research shows opioids often aren't necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen."

Many Invasive Surgeries No Better Than Placebo

By Pat Anson, PNN Editor

In an age when doctors are urged not to prescribe opioids, many patients are being told to have surgery or other invasive procedures to treat their chronic pain.

But a systematic review of 25 clinical trials found little evidence that invasive surgeries are more effective than placebo or sham procedures in reducing low back and knee pain. The study was published in the journal Pain Medicine.

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"Our findings raise several questions for clinicians, researchers, and policy-makers. First, can we justify widespread use of these procedures without rigorous testing?" said lead author Wayne Jonas, MD, a Professor of Family Medicine at Georgetown University School of Medicine.

“Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.”

The invasive procedures that were analyzed include arthroscopic, endoscopic and laparoscopic surgeries, as well as radiofrequency ablations, laser treatments and other interventions.

In each study, researchers also performed sham or placebo procedures on a control group where they faked the invasive procedure. Patients did not know which intervention (real or sham) they received. Researchers then compared the patients’ pain intensity, disability, health-related quality of life, use of medication, adverse events, and other factors.

They found that reduction in disability did not differ between the two groups three months after the procedures or at six months. Seven of the studies on low back pain and three on knee osteoarthritis showed no difference in pain intensity at six months compared with the sham procedures.

“There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain,” said Jonas.

Invasive treatments are being increasingly used as an alternative to opioids. Americans spent an estimated $45 billion on surgery for chronic low back pain and $41 billion on arthroplasty for knee pain in 2014.

Several previous studies have also questioned the value of arthroplasty. Over 850,000 arthroscopic surgeries are performed every year to relieve knee pain in the UK and the United States. But a 2015 study published in the BMJ questioned the evidence behind the surgery and said it provides only “small inconsequential benefit.”

I Thank God for Opioid Medication

By Carmen Littizzio, Guest Columnist

I was born with a rare genetic defect called Arnold Chiari Syndrome, which blocks the flow of cerebral fluid and causes pressure to build in my brain. I had brain surgery to treat it in 1999, when I was 44 years old.  

During this surgery they cut off a portion of the skull in the back of my head to make more space for cerebral fluid to flow. Lack of fluid in the brain and spinal cord causes intense pain for me from the waist down.  At times I’m not able to walk and have painful electrical sensations that are torturous.

Nineteen years after the surgery, I still suffer from high pressure headaches, chronic leg pain, thigh and buttock pain, and other symptoms. The high cerebral pressure has also caused other problems, such as retinal detachment in both eyes, vomiting, vertigo and vision issues. 

In 2008, when I was 53, I developed a crowding in my spinal cord the same as I had in the brain and had to have a spinal cord decompression. They put a titanium plate with four screws into my back to hold it all together.

This operation was so intense that for days after the surgery, I just wanted to die. It was a living hell.

I survived with the help of morphine, but eventually went back to my old pain medication, which consisted of Neurontin, Topamax, Elavil and Diamox -- all in very high doses.

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In 2009, my body started shutting down because of those meds and I was unable to urinate. I had a permanent catheter put in and all those medications were stopped. I started taking Percocet for pain. After 4 months, I began urinating again and never wanted to go back to those other meds. 

I was told of the dangers of long term opioid use, but decided to risk it for some quality of life. My other choice was to sit in a wheelchair for the rest of my life, be able to do nothing, and still die young because of being so sedentary. 

I am now 63 and next year it will be 20 years since the brain surgery. I take a time released OxyContin in the morning and evening, and oxycodone for breakthrough pain and the headaches. 

I am entering my senior years, but still walking on my own and enjoying my children and 5 grandchildren. I don't know how much longer I will live, but I feel like I’ve won the war. What war? The war for quality of life. I thank God for opioid medication. I have never been high or abused my medications. 

I feel very bad for those that abuse narcotics or overdose.  But why should I pay the price for their inability to use self-control? We don't take alcohol off the market because we have alcoholics and drunk driving.

There are many people like me that have chronic pain and illness, and we are paying the price for those who abuse. It’s not right and not fair that we should be made to stop living because of their issues.  Nobody has the right to choose for me. 

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Carmen Littizzio lives in Maine.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

A Nightmare Experience With Surgery

By Rochelle Odell, Columnist

I have been warning my “healthy” family and friends that the opioid epidemic and the backlash against prescription opioids would affect them at some point. My recent nightmare of a surgery may prove that the time may now be at hand. 

On February 2, I underwent what normally would be minor surgery to remove a catheter -- called a portacath -- that had become dislodged. For patients with Complex Regional Pain Syndrome (CRPS), there is no such thing as a minor procedure and my experience became a prime example of what could go wrong.

My friend Debbie drove me to the hospital where the surgery was performed. I have undergone over 40 procedures for CRPS and I always become apprehensive, as any patient facing surgery should be. I told Debbie I did not have a warm toasty feeling about the surgery. I was frightened, a feeling I don't usually experience. But this time I did.

Before I was taken back to pre-op, Debbie asked me if I would like to pray. Thankful for the thought, I responded yes. It did not alleviate the feeling of dread nagging at me, but I hoped God would protect me.

Once in pre-op, the nurse went over my extensive allergy list. Believe me, it's long. I am allergic to almost all antibiotics, including penicillin, along with some opioids like Demerol and methadone, as well as aspirin and NSAID's. Betadine causes blisters and a horrible rash. I’m also allergic to most medical tape, including cloth, plastic, silk and paper tapes. The only one I can tolerate is Hypafix. It's a soft adhesive that allows the skin to breathe. I was very vocal about that.

The nurse asked what kind of surgery I was about to undergo and why. I told her it was because I don't have any good veins, never have, and that a catheter was a necessary evil. Without one, if I were to pass out or become very ill, dying could be a real possibility.

I told her she would only got two tries for the IV line I would need for surgery. I am not a pin cushion and multiple needle pricks could cause a major pain flare. She started the IV on the second try.

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The surgeon and anesthesiologist then came to see me. I explained how nervous I was and that I honestly was very close to walking out. I should have done that. I could tell the surgeon had no clue what CRPS was or how to treat me post-op. That is not unusual, a lot of doctors have no clue what it is, and that extra steps are needed to keep a major pain flare from happening.

Even the anesthesiologist seemed clueless about CRPS. I thought that odd, since anesthesiologists are often pain management physicians. He kept telling me don't worry, once in the operating room I would be out soon.

Four hours later I was taken to the operating room. I told the anesthesiologist that I forgot to add fentanyl to my allergy list. It gives me a smothering feeling and can't breathe. I also told him I wanted an LMA mask, because being intubated causes my asthma to flare. He told me he would use the mask, but he wanted to use fentanyl and that if I stopped breathing he would intubate me.

What is wrong with this explanation? Use something other than fentanyl and you won't have to intubate me. I also asked the surgeon to place me on IV antibiotics, as I have a long history of staph and MRSA infections.

Upon coming out of anesthesia, my throat was killing me. I knew he must have intubated me and used a drug I didn't want. The pain was excruciating. I was given small doses of Dilaudid and oxycodone, which did absolutely zip for me.

They also gave me IV Tylenol. Really, Tylenol post-op in a CRPS patient? The recovery room nurse was trying to console me as I was in tears.  Any nurse I dealt with said they were trying to make sure I didn't die of an opioid overdose. That took the cake, the minuscule doses I received were obviously not working, so an opioid overdose certainly would not happen.

One nurse told me my pain was emotional pain. I should have screamed at her to get away from me, but I was in so much pain I couldn't think clearly. I was kept for observation overnight, which brought more problems and the realization that the very thing I warned my healthy family and friends about was indeed at hand.

What kind of pain control do patients get now after surgery?  My surgeon was responsible for ordering all my meds, but how is a man who has no clue what CRPS is going to manage my pain? A man I had only seen one time before the surgery.

My RN was very sweet, but she too was stating what I think must be the hospital's policy. They do not want to provide opioid pain management.  Everyone is so convinced the opioid epidemic was and is caused by prescription opioid medication. It dawned on me, ignorance is alive and well and it must be contagious.

My ordeal continued to worsen. I looked at my surgery sites. Not only were my upper chest and right arm covered in the tell-tale orange color from Betadine, but there was medical tape. A big painful and very itchy rash had developed.

My skin was driving me nuts. I asked the nurse to remove the tape and use non-stick pads and Hypafix, but she refused. Didn't anyone read my allergy list? Why ask for one if you are going to ignore it? The surgeon ordered Benadryl cream for my arm. It helped a little and I did get one injection of IV Benadryl, but that was it. I received less medication in the hospital than I was taking at home.

After a long painful night, I told the nurse I would refuse to see the surgeon. Anyone who causes a patient as much pain as he did is one I will not see again. The nurse said he had to see me in order to release me. I told her to tell him to have a different doctor release me, as I did not want to see him. I was livid. The morning I was released I removed the tape, as I could no longer tolerate it. She helped me cover the area with sterile gauze.

As soon as I got home I cleaned the surgery area thoroughly and made an occlusive dressing over the two surgical sites. The next morning my whole upper right chest was covered with tiny blisters and a nasty looking rash. My friend took pictures for me.  The asthma flare I was afraid of was in full swing and I was running a temperature of 102.  I could barely breath and my pain was completely out of control.

I had a temperature for three weeks, and six weeks later I am still coughing up yellow gunk. That could have easily been prevented, but what do I know, I am just the patient.  Because I refused to see the surgeon for a post-op checkup, my primary care provider sent me a letter informing me I was trying to direct my care and was argumentative. He would only treat me for 30 more days and I needed to find a new primary care physician.

In the past I might have been upset with a letter like that, but since this opioid epidemic has affected me so negatively, I simply do not want to be seen by any physician who doesn't try to understand how sick I am. I was in so much pain.  Wouldn't you try to direct your care at that point?

My ordeal has not ended. As of this writing, the whole port area and catheter tubing are swollen and look infected. Have I gotten it checked yet? Nope. I have literally been frozen in place by fear, a fear I have never experienced before. I know this will require more surgery to remove and replace the portacath. Just thinking about it scares me.

All of this could have been avoided if my allergy list had been read, if there had been adequate pain management, and if IV antibiotics had been started. If this is the future of medical care, I may reconsider seeing any doctor. It just isn't worth the stress and pain.

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Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Surgery Patients Rarely Misuse Opioid Meds

By Pat Anson, Editor

A large new study published in the British Medical Journal is debunking some popular myths about the causes of opioid addiction.

One such myth is that many hospital patients abuse and become addicted to opioid pain medication while recovering from surgery.

But in a data analysis of over 568,000 patients who were prescribed opioids for post-surgical pain, researchers at Harvard Medical School identified only 5,906 patients (0.6%) who were later diagnosed with opioid dependence, abuse or a non-fatal overdose -- collectively known as opioid misuse.

Of those, only 1,857 patients (0.2%) showed signs of misuse in the first year after surgery – suggesting that the dependence or abuse that others later developed may have had little or nothing to do with the surgery itself.

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But the remarkably low rate of opioid misuse by surgery patients was not the primary focus of the study. What researchers really wanted to know is whether the dose and duration of an opioid prescription influences future chances of abuse and addiction.

And here another myth was dispelled.

Researchers found that high doses of opioids after surgery appear to have little impact on misuse rates. Their findings show that how long a patient takes opioids is a more reliable predictor of misuse than how much medication they took. Dosage only emerged as a risk indicator for those who took opioids for extended periods.

"Our results indicate that each additional week of medication use, every refill is an important maker of risk for abuse or dependence," said study co-author Denis Agniel, a statistician at the RAND Corporation and a part-time lecturer in the Department of Biomedical Informatics at Harvard Medical School.

Researchers found that each additional week of opioid use increased the risk for dependence, abuse or overdose by 20 percent. And each refill boosted the risk by 44 percent.

But the risk of misuse still remains small. For those who had a single prescription with no refills – the vast majority of patients -- misuse occurred at a rate of only 145 cases per 100,000 patient years. The rate was still minuscule for those who refilled a prescription -- 293 cases per 100,000 patients years.

And for patients who took high doses for short periods -- two weeks or less -- the risk of misuse was no greater than those who took an average dose.

Agniel and his colleagues say their research indicates that opioids -- even at high doses -- can be safely prescribed to patients with post-surgical pain.

“These findings suggest a more nuanced understanding of the relationship between duration and dosage with a focus on early appropriate treatment of pain (including higher doses) for a limited time,” researchers concluded.

“Such findings suggest that optimal post-operative prescribing, which maximizes analgesia and minimizes the risk of misuse, may be achieved with moderate to high opioid dosages at shorter durations, a combination that merits further investigation in population-based and clinical studies.”

Anti-opioid activists and government regulators have long made sensational claims that even just a few painkillers can lead to addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” former CDC Director Thomas Frieden told the Washington Post in 2016. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Harvard Medical School study was not the first to find that long term opioid use after surgery is rare. A 2016 Canadian study found that less than one percent of older adults were still taking opioid medication a year after major elective surgery.  

Many patients are dissatisfied with the quality of their pain care in hospitals. In a survey of over 1,200 patients by PNN and the International Pain Foundation, 60 percent said their pain was not adequately controlled in a hospital after surgery or treatment. And over half rated the quality of their hospital pain care as either poor or very poor.

Tylenol for Postoperative Pain?

By Margaret Aranda, MD, Columnist

I saw them do it to our veterans. Now they were going to do it to me.

I heard the veterans scream decades ago, when I was president of a pre-med club at a VA hospital in Los Angeles. There was a little local anesthetic, no oxygen, no vital signs and no anesthesiologist. The hematologist-oncologist did the bone marrow extraction herself.

Now I was about to have the same procedure myself, to get an early diagnosis of mastocytosis, an orphan disease.  No one was going to tell me that I won’t hurt. The veterans fought in a war, yet they screamed.

After taking my vital signs, the intake nurse interrogated me, eyes peering over her bifocals.

“When was the last time you took OxyContin?” she asked.

(My thoughts: We never asked such a scrutinizing question. They could draw an opioid blood level, to “check” and see if I was telling the truth. Sure, my blood levels would be low, because it’s been a week. I’m not a drug addict. Big breath. Don’t let your thoughts get negative. Just get through this day.)

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Postoperative pain was a big concern for me.

“What will I get for post-op pain?” I asked the anesthesiologist.

(My thoughts: I don't want to cry. I don't want to hurt. I've had a lifetime of pain, and I live with it daily. Sores pervade me. They are all over my head, itchy ones that feel like cold sores mixed with chicken pox. If I scratch one, they all itch, including the sores on my arms and back. How much worse is my life about to get?)

"Tylenol. No post-op opioids for pain," was his reply.

You bet my world crashed.

"I can't do Tylenol. I need to save my liver. Everyone knows the smallest dose of Tylenol can hurt the liver. Besides, I don’t want to lose my empathy. Studies show acetaminophen causes a lack of empathy,” I said.

“Ibuprofen,” was his answer.

(My thoughts: How much lower can my world crash? What the heck? Do you really know I’m a doctor, too? Do you know how many patients I’ve personally intubated through a GI bleed so they could breathe?)

“I can’t do ibuprofen,” I told him. “I can’t have a GI bleed. Or a heart attack. Or a stroke.”

“Oh, okay! Morphine and fentanyl, a mixture. Morphine lasts longer," the anesthesiologist said.

(My thoughts: I can breathe again. Now I have to be the perfect patient.)

The pathologist was cheery, polite and smiled a lot. We went over the pathology of mastocytosis, WHO classifications, the systemic vs. cutaneous forms, early diagnosis, and the bone marrow procedure I was about to have. He asked if I had enough opioids for post-op pain. I did. I concluded that he does not write his own pain prescriptions.

Once on the operating table, the surgeon caressed my head, patting it before I fell asleep. I inwardly smiled as I laid straight on my right side. Cold prep solution dripped down my lower back as I sunk into sleep.

The surgeon bore into the ileum, then sucked out the bone marrow with a syringe.

When I woke up, my butt was numb and I did not need any more pain medication. But I was not given a prescription for postoperative pain for when I went home. I was told to use my existing opioid prescription for pain, which is reasonable, as long as my doctor doesn't "count" them against me.

(My thoughts: How do patients defend themselves to get opioids for during and after surgery? I mean, I’m a doctor and I had to stick up for myself. What if the patient does not even know to ask about postoperative pain at all? They must wake up screaming, an insult to any anesthesiologist. What has happened to patient care?

They profession of anesthesiology has changed.

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Dr. Margaret Aranda is a Stanford and Keck USC alumni in anesthesiology and critical care. She has dysautonomia and postural orthostatic tachycardia syndrome (POTS) after a car accident left her with traumatic brain injuries that changed her path in life to patient advocacy.

Margaret is a board member of the Invisible Disabilities Association. She has authored six books, the most recent is The Rebel Patient: Fight for Your Diagnosis. You can follow Margaret’s expert social media advice on Twitter, Google +, Blogspot, Wordpress. and LinkedIn.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Genetics Play Significant Role in Post-Surgical Pain

By Pat Anson, Editor

An important new study has confirmed that a patient’s genes really do play a role in determining whether they develop chronic pain after surgery.

Researchers in China collected blood samples from 1,152 surgical patients to look for genetic variations in 54 "pain-related" genes which have been associated with pain sensation. Patients were then contacted a year later to see if they had chronic post-surgical pain.

A surprising number – one out of five patients – still experienced pain at the wound site, and 33 percent of them said their pain was severe.  Patients with pain also reported problems with their overall health, as well as daily activities such as mood, walking, relations with others, sleep, and quality of life.

Aside from genetic factors, the study also found patients younger than 65, males, and those with a prior history of chronic pain were at increased risk. The study is published online in the journal Anesthesiology.

"Our study not only shows there are common genetic variations among people that may help to identify whether they are at high-risk for developing chronic pain after surgery, but it also helps explain why only a fraction of patients ever even experience persistent pain," said lead researcher Matthew T.V. Chan, MD, at the Chinese University of Hong Kong.

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"Until now, the genetic variations associated with chronic post-surgical pain have not been well identified."

One genetic variation in particular - a gene found in the nervous-system called brain-derived neurotrophic factor (BDNF) - was found to be most frequently associated with chronic post-surgical pain. Researchers confirmed the finding in a study on laboratory mice.

The researchers also found that genetic variations account for a higher percentage of chronic post-surgical pain (between 7 percent and 12 percent) than other risk factors such as age, sex, smoking history or anesthesia technique (between 3 percent and 6 percent).

Chronic post-surgical pain is one of the most common and serious complications after surgery. Previous studies have found that chronic pain was common after abdominal hysterectomies (25.1%) and heart or lung surgery (37.6%).

“Considering that more than 230 million surgeries are performed each year worldwide, the data would imply that millions of patients will continue to suffer wound pain, months to years after their surgery,” researchers said.

The study comes at a time when many U.S. states have adopted or are enacting laws that would limit the supply of opioid medication to just a few days for acute short-term pain. Minnesota, for example, is close to adopting strict guidelines that would limit the dose and supply of opioids to three days for acute pain and seven days after a major surgery.