A Pained Life: An Unexpected Gift

By Carol Levy, Columnist

This past Christmas I started thinking about a Christmas long past.

I lived in New York City at the time, but was spending the holidays at my mother's house outside Philadelphia. My family had been estranged for many years (especially from me), and for some reason one of my two sisters came to the house to spend Christmas with my mother and I.

The presents were opened, gifts from my mother to us and from us to our mother. I had nothing for my sister and expected nothing from her.

There were a few more boxes under the tree, but I assumed they were gifts for other people for later that day. To my amazement and consternation, my sister picked up one of them and handed it to me. “This is for you,” she said.

I took it with trepidation. “Why is she giving me a gift?” I asked myself while slowly removing the wrapping. I worked hard to keep my expression neutral as I pulled off the tissue paper and looked at the gift.

It was a blouse, bilious green decorated with farm animals, silos, barns and ribbons. It was probably the ugliest thing I had ever seen.

I smiled nicely, thinking what is her point? Why waste money to tell me via a blouse how much she dislikes me?

“Oh, thank you. This is.... really... nice,” I said.

My sister’s only reply was, “You're welcome.” There was nothing to indicate she meant it as the insult it sure as heck seemed to be.

Later on I walked into the kitchen. My mother was crying, “I can't believe she would give you something like that!”

It was awful. How mean, childish, and cruel. Such a waste of money merely to hurt someone, and for reasons never explained.

I returned home to New York. I hate the idea of wasting anything, so instead of throwing out the blouse, I decided I would use it as junk clothing, for painting or using solvents, etc. Nothing I could do to it would make it worse than it already was.

I had not taken it out of the box. I did so now and put it on. I looked in the mirror. To my amazement, it was adorable. In the box it was a horror, but somehow once I put it on, the ugly worked its way into cute.

I wore it until it wore out. I can't count the number of compliments I got, like “Boy, is that adorable.”

So what is the take away?

I didn't give the shirt a chance. I jumped on the meaning of it – horrid, mean and nasty. I didn't say anything to my sister or ask why she would give me something so ugly. I knew what it meant. I didn't need any help with the translation.

I think of this story sometimes, when someone I thought I had a good relationship with says to me, “Your pain can't be that bad” or “I've seen you climb the stairs, so I know you can.”

That’s like waving a red flag before a bull. Or a ringing bell to a boxer. How dare they! What does it take to get them to accept my pain and disability? My anger rises with my blood pressure. I am ready for a fight. 

But maybe I am jumping to a conclusion that never was.  Could they have meant something else? Maybe even an awkward kindness like, “I don't want you to have pain that bad. I don't want you to be so disabled.”

Maybe Ogden Nash said it best in his poem, “I Never Even Suggested It.” It was written about men and women quarreling, but I think the last line is what counts: 

In real life it takes only one to make a quarrel.

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.

Lyrica and Neurontin Use Triples

By Pat Anson, Editor

The use of gabapentin (Neurontin) and pregabalin (Lyrica) has soared in the United States, with little attention paid to their safety and effectiveness, according to a research letter published in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids, which are increasingly prescribed as alternatives to opioids in treating neuropathy, fibromyalgia and other types of chronic pain.

In an analysis of health data for nearly 350,000 patients, researchers found that the use of gabapentinoids more than tripled in the past decade, from 1.2% of patients in 2002 to 3.9% in 2015.

Use of the drugs was concentrated in older patients with numerous other health problems, who were often co-prescribed opioids or benzodiazepines, a class of anti-anxiety medication.

“The combination of a dearth of long-term safety data, small effect sizes, concern for increased risk of overdose in combination with opioid use, and high rates of off-label prescribing, which are associated with high rates of adverse effects, raises concern about the levels of gabapentinoid use,” wrote lead researcher Michael Johansen, MD, of OhioHealth, a large non-profit health system based in Ohio.

“While individual clinical scenarios can be challenging, caution should be advised in the use of gabapentinoids, particularly for those individuals who are long-term opioid users, given the lack of proven long-term efficacy and the known and unknown risks of gabapentinoid use.”

JAMA INTERNAL MEDICINE

Johansen’s research adds to a growing body of evidence that pregabalin and gabapentin are overprescribed and being abused. A recent study by Canadian researchers found that there was “no clear rationale” for the off-label use of the drugs and warned that they have a “significant risk of adverse effects” such as dizziness, fatigue and diminished mental activity.

Lyrica (pregabalin) and Neurontin (gabapentin) are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in annual sales. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while Neurontin is approved to treat epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off label to treat back pain, depression, migraine and other conditions.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. in 20l6, a 49% increase in just five years.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. Lyrica and Neurontin have been linked to heroin overdoses in the United Kingdom, where prescriptions for both drugs have soared in recent years. 

Lawmakers Ask FDA to Lift Kratom Warning

By Pat Anson, Editor

A bipartisan group of 17 congressmen is asking the Food and Drug Administration to lift a public health warning about kratom, an herbal supplement used by millions of Americans to treat chronic pain, addiction, depression and anxiety.

In a joint letter to FDA commissioner Scott Gottlieb, MD, the lawmakers said kratom was “a natural alternative to opioids” and was “found to be as safe as coffee.”  The letter was drafted by Rep. Jared Polis (D-CO) and Rep. Dave Brat (R-VA).

“We have heard from many constituents who have used kratom to successfully end their dependence on dangerous opioids, and maintaining legal access to kratom is important to many Americans to maintain sobriety,” the letter states. “We believe that if legal access to professionally-manufactured kratom were made difficult or illegal, instances of kratom laced with opioids or other dangerous compounds would likely become more common.”

The FDA issued a public health advisory in November, warning that there were “increasing harms associated with kratom” and that the herb was involved in 36 deaths. The agency did not say when or where the deaths occurred.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs,” Gottlieb said in a statement.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect.

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry by kratom supporters and a lobbying campaign that enlisted the help of dozens of senators and congressmen.

“We need to improve access to alternative pain relief options beyond addictive opioids.  For some, kratom, a cousin of the coffee plant, can be that alternative.  Like cannabis, it should be legal and available,” Rep. Polis said in a statement. “The FDA must end its bogus ‘public health warning’ that has already led to several cities banning kratom.  Patients need and deserve options.”

Kratom Pioneer Calls for Government Regulation

One of the dilemmas faced by the FDA is that kratom products are considered dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims.

“I know that regulation is needed and I think that is something we conscientiously have to work towards,” says Duncan Macrae, the founder of Kratom.com and one of the first commercial suppliers to bring kratom products into the United States, Canada and Europe.

“I think that direct government regulation will eventually come about. But while everybody’s waiting for that to happen, I think that vendors in the industry that are making money from this should get together and start their own internal regulation to try to be more transparent,” Macrae told PNN.

“I can tell you for sure that there are a lot of adulterated products on the market, and vendors going in and out of business the whole time, changing names and companies. There’s no central body checking or controlling anything.”

Macrae says kratom vendors should certify their products and list their ingredients – or risk the government stepping in and banning kratom altogether.

“Right now the problem is that every vendor is labeling their product ‘not for consumption.’ And there’s no information about the product or what’s inside it,” he said. “This is the regulation we need to do from inside and hopefully the government won’t (ban kratom) because it is an extremely valuable medicinal herb and they will embrace some kind of regulation that makes sense, so that kratom can be administered safely and distributed safely and people will know exactly what they’re getting.”

Macrae is working to ensure the quality of his own products by growing kratom on farms in Indonesia, as opposed to just harvesting the leaves from trees growing wild in remote jungles. He’s planted hundreds of thousands of kratom trees, with hopes of somebody mass producing kratom tea, pills and extracts.

“I think this is the future for the industry and that is the product that we need to develop, and that’s what I’ve been working on,” he said.

Legal Battles Brew Over High Cost of Arthritis Drugs

By Julie Appleby, Kaiser Health News

Early last winter, Pfizer launched its new rheumatoid arthritis treatment, Inflectra, pricing it 15 percent below the $4,000-a-dose wholesale price of Remicade, the drug for which it is a close copy.

Pfizer figured its lower price would attract cost-conscious insurers.

A year later, though, its drug has barely scratched the market and Pfizer has filed an antitrust suit against its rivals, alleging they are thwarting lower-priced competition through “exclusionary contracts” and rebates.

The outcome of the case — filed in September in U.S. District Court against Johnson & Johnson, the maker of Remicade, and Janssen Biotech — could affect the future of biosimilars, a new class of drugs. Some policy experts say these near-copies of biologics are key to slowing spending on complex and expensive specialty medications like those used to treat rheumatoid arthritis.

At the heart of the case are rebates, which are discounts off the wholesale price of drugs.

Manufacturers offer them to help keep their products on insurers’ lists of covered drugs. The money mainly goes back to insurers and pharmacy benefit managers, who say the rebates help reduce health care spending.

But Pfizer alleges that those rebates are being used to thwart biosimilars’ entry into the marketplace.

“This is the first antitrust case we’ve seen like this around biosimilars,” said Michael Carrier, a Rutgers Law School professor “Pfizer is claiming that one form of anti-competitive behavior involves withholding rebates from insurers.”

Biosimilars are costly to produce, so they are not likely to trigger the same sharp pricing drop triggered by generics. Still, their manufacturers say they could bring consumers some relief to rival biologics’ high price tags.

Pfizer’s Inflectra is one of the first biosimilars to hit the market since Congress passed legislation in 2010 to pave the way.

According to Pfizer, weeks after Inflectra gained Food and Drug Admininstration approval, J&J moved to stake out its biologic turf.

J&J began requiring insurers and PBMs to sign “exclusionary contracts … designed to block both insurers from reimbursing and hospitals and clinics from purchasing Inflectra or other biosimilars of Remicade despite their lower pricing,” alleges the case filed in federal district court in Philadelphia.

If insurers don’t agree to the J&J contracts, the loss of rebates could “for some insurers, run into the tens of millions of dollars annually,” the Pfizer case alleges.

Even with its lower price, Pfizer faced an uphill battle to win market share.

Remicade is the fifth-biggest-selling drug by revenue in the U.S., reaping more than $4.8 billion in 2016 for makers J&J and Janssen, the suit said. Often, patients are reluctant to switch once they are established on an RA drug that is working for them.

Still, Pfizer thought it would pick up newly diagnosed patients and gain ground that way. But its lawsuit says the drug accounted for only about 4 percent of total sales, with Remicade getting the rest, by early September.

“We stand by our contracts,” said J&J and Janssen Biotech in a written statement. The firms also defend rebates as “competition that is doing what competition is meant to do: driving deeper discounts that will lead to overall lower costs.”

Yet the price of Remicade has not fallen, the Pfizer case says.

Since approval of Inflectra, J&J has raised the list price of Remicade by close to 9 percent, the lawsuit alleges. As of September, Remicade’s average sales price –after discounts and rebates — is more than 10 percent higher than Inflectra.

“This case is a big deal, because it has the potential to bring to light some of the anti-competitive contracting practices at work to keep … prices extremely high,” said Jaime King, a professor at University of California-Hastings College of the Law.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

How to Prepare for a Scheduled Hospitalization

By Ellen Lenox Smith, Columnist

No one enjoys the experience of being admitted to the hospital. Indeed, hospitalization can provoke extreme anxiety, which does not contribute to successful outcomes in any medical procedure.

Proper preparation before you go to the hospital not only reduces stress, but enhances the probability of a successful medical experience and helps promote a smoother healing process – all of which lead to considerable benefits to the patient.

For example, while recently preparing for a revised neck fusion, I realized that eating would become an immediate issue because nutrition is so important for healing. I don’t want to rely solely on hospital food, so I am preparing meals that I puree and freeze for my husband to bring to the hospital that I can sip through a straw.

Here is a list of other things I plan on doing:

• I plan to arrive with all of my compounded medications in their labeled containers, along with my regular pharmaceutical drugs, so I will not miss any scheduled doses.
• I will bring my entire medical folder, which includes my name, address, insurance coverage, contact information for my primary care doctor, pharmacy and nurse case manager, a list of medications and dosages, a list of medications I am sensitive to, previous surgeries, and my diagnoses.
• I will also include a list of Do’s and Don’ts to help keep the staff educated about Ehlers Danlos Syndrome and keep me safe when I might not be able to advocate for myself.
• I will pack my supplements that I will take after the surgery, so my body is allowed to quickly return to the routine it is used to.
• I will bring a special pillow that I sleep with that keeps my head in the correct position all night long (I use the Therapeutica Sleeping Pillow).
• I will give to the staff my list of food sensitivities and request to meet with the hospital dietician in hopes of getting food delivered that I can metabolize.
• I will pack t-shirts, loose flannel pants and warm socks so I can walk around the halls comfortably, instead of having to wear those lovely gowns you wake up from surgery in!
• I will bring a small bag of toiletries I prefer to use, along with a comb, brush and a toothbrush since what they provide always seems to be so skimpy.
• I will prepare a list of friends and family phone numbers for my husband/caregiver to contact after the surgery is completed.
• I will bring my Living Will and any needed directives.
• I will wear my medical alert bracelet and will ask that they please read what is on it!
• I will bring my own BiPAP breathing machine, so I know I am sleeping with the correct readings. I’ll also have the doctor write down the exact setting in case the hospital decides to use their own machine.
• I’ll bring things to do that are simple and peaceful that will help calm me, as well as items that will help re-stimulate the mind, such as Sudoku puzzles, adult coloring books and quiet music to listen to.
• I will pack enough food for my service dog to cover a few weeks, in case we stay longer than expected. I will also make sure I have her list of shots and credentials proving she is a legal service dog.
• With serious food sensitivities, I always pack snacks.
• I will bring paper and pen to jot down things I want to remember to ask the doctor when he arrives in the room. It is not a time to count on one’s memory!
• I will bring my cellphone and charger to keep connected to the world when back in a room.
• I will bring a list of my passwords in case I need to use the internet.
• I will contact my case manager nurse to alert her of the upcoming surgery, so she is able to help assist with in any snags that might come up and arrange for home healthcare when I’m discharged from the hospital.
• Many of my surgeries are out-of-state, so I make sure my primary care provider clears me for surgery in writing and sends a copy to the hospital. I’ll also bring a hard copy with me, in case they don’t get it or it is misplaced.

Anything a patient can do to simplify the hospitalization is worthwhile! For those of us with complicated and rare medical conditions, we must be prepared to advocate for ourselves. I have found that, for the most part, hospital staff does appreciate enlightened input from patients on best practices and how to keep us safe from harm.

As effective patient advocates, we need to educate others not only for our own safety, but to benefit future patients with our condition.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

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.

Tennant Patients Live in Fear of DEA

By Pat Anson, Editor

Deborah Vallier is living proof that high doses of opioid medication can safely relieve pain and improve quality of life. The 42-year old Michigan woman says her chronic back pain was so bad before she started getting high dose opioids that she contemplated suicide.  

“I was so bad that I spent most of my time in bed. I didn’t leave my house for almost two years, except for doctor’s appointments,” Vallier says.

After seeing over a dozen doctors in her home state and getting little pain relief, Vallier flew to California last April to see Dr. Forest Tennant, a prominent pain specialist. 

“Now, because of Dr. Tennant, I’m able to go to (my son’s) high school football games. I’m able to go to his wrestling matches. I actually have some of my life back, where I’m not stuck in bed and thinking about suicide.”

It was Tennant who diagnosed Vallier with adhesive arachnoiditis, a disabling, incurable and painful inflammation of nerves in her spine. Tennant put Vallier on a regimen of hormones and opioid  medication – a dose more than double the highest amount recommended by the Centers for Disease Control and Prevention, which is 90mg morphine equivalent dose (MED).

dr. forest tennant

“I would say I’m close to close to 200mg,” Vallier says.

That kind of high dose would be inappropriate – even dangerous – for most pain patients. But for Vallier and about 100 other intractable pain patients that Tennant sees, it’s not unusual at all. Tennant puts many on multiple medications that include opioids, anti-depressants, hormones, muscle relaxants and benzodiazepines, a class of anti-anxiety medication. Patients from 25 different states see Tennant and most consider him a life saver.

“I credit him with saving my life. Absolutely, no doubt,” says Dale Rice.

But to the Drug Enforcement Administration, those high doses of pain medication and multiple prescriptions to out-of-state patients are signs of criminal activity and drug diversion.  

In November, DEA agents raided Tennant’s home and pain clinic in West Covina, CA, using a search warrant that alleged Tennant was part of a drug trafficking organization and insinuated that his patients were selling their drugs on the black market. In early December, the DEA used another search warrant to raid Sunny Hills Pharmacy in Fullerton, CA, where 19 of Tennant’s patients get their prescriptions filled.

“I know based on my training and experience that patients traveling long distances to obtain controlled substance prescriptions is another ‘red flag’ of drug abuse and addiction. The out-of-state patients also received multiple opiate and benzodiazepine drug cocktails,” wrote lead DEA investigator Stephanie Kolb, who according to her LinkedIn profile was self-employed as a dog walker and pet groomer before she started working for the DEA in 2012.

“Either they’re extremely ignorant that patients have to travel out of state to find the top specialists, because no one in their area knows how to treat them, or they’re just trying to go after doctors and eliminate the ones that they see as a problem, the ones that are helping patients who  need high doses,” says Vallier. “We have failed all other treatments and there’s nowhere else to go. Why are they going after him?”

Judging by the search warrants, the medical experts hired by the DEA as consultants in the Tennant case seemed unfamiliar with the nature of his practice. In the Sunny Hills search warrant, Kolb quoted Dr. Timothy Munzing, a family practice physician who reviewed Tennant’s prescribing records.

dr. timothy munzing

Munzing noted that “many patients are traveling long distances to see Dr. Tennant” and thought it unusual that many were prescribed “extremely high numbers of pills/tablets.”

“I find to a high level of certainty that after review of the medical records… that Dr. Tennant failed to meet the requirements in prescribing these dangerous medications. These prescribing patterns are highly suspicious for medication abuse/and or diversion. If the patients are actually using all the medications prescribed, they are at high risk for addiction, overdose, and death,” Munzing wrote.

Munzing is an experienced family practice physician who has worked as a consultant for the DEA and the Medical Board of California for several years.

According to GovTribe, a website that tracks payments to federal contractors, Munzing is paid $300 an hour by the DEA to work as an expert witness and to review patient records. Munzing was paid about $45,000 by the DEA during the period Tennant's prescribing records were under review.   

Vallier says Munzing is not qualified to critique Tennant’s medical practice.

“This is almost like having a proctologist be the advisor for the American Dental Association. Just because he’s an MD does not mean he is trained for intractable pain,” she said.

‘I’m Afraid I’m Going to Die’

Tennant denies any wrongdoing, has not been charged with a crime and – after three years of investigation -- the DEA has not publicly produced evidence that any of his patients have overdosed, been harmed by his treatments, or that they are selling their drugs. Tennant’s clinic also remains open.

But the fallout from the DEA raids has frightened many of Tennant’s patients and left some without adequate medication. 53-year old Dale Rice used to get his prescriptions filled at Sunny Hills, but after the pharmacy was raided he was told to go elsewhere. Rice found another pharmacy in Rancho Cucamonga, but the pharmacist there is only willing to fill some of his high dose opioid prescriptions. Rice estimates he’s now only taking about half of his regular dose of opioids.

“I thought the hardest part was dealing with the insurance company, and now I can’t get a prescription filled,” says Rice, who suffers intractable pain from arachnoiditis, scoliosis, arthritis and failed back surgery. Like many of Tennant’s patients, Rice is also a rapid metabolizer of opioids and gets only a fraction of the pain relief other patients get from them.

“You pull the rug out from under me with all these medications and it’s hard on the body. Dr. Tennant told me I could die from adrenal failure, a stroke, a massive heart attack, anything like that,” Rice told PNN. “I’m afraid I’m going to die. I’m afraid I could drop dead right now.

“I predict by the end of the year I’ll be probably bedridden again, unless something changes.”

Another Tennant patient worried about her future is Trini Yeager, a 59-year old California woman who developed arachnoiditis after a failed back surgery and a misplaced epidural steroid injection into her spine. Once very fit and active, Yeager now has trouble walking and spends most of her day in bed.

“What’s going on is absolutely outlandish and just very corrupt in my opinion,” Yeager says. “I’m just shocked beyond belief that they would do this to Dr. Tennant.

“He is being crucified for cleaning up other doctor’s messes. That’s really what’s happening.”

Yeager takes multiple opioid medications at the highest doses available, and even then gets only limited pain relief. Asked what would happen if her dosage was brought within the CDC opioid guidelines, she spoke bluntly and without hesitation.

“I would commit suicide and I would post it publicly. And I would tell people that the DEA was responsible,” Yeager said. “The pain is so tremendous, I can’t even tell you. If they took my medications away or took them down, they would have a public suicide on their hands.”

Sunny Hills was one of 26 pharmacies recently targeted by the DEA in in “Operation Faux Pharmacy,” an investigation that focused on so-called rogue pharmacies in California, Nevada and Hawaii that the agency alleges “may have operated outside the bounds of legitimate medicine.”

The agency made a public show out of the pharmacy raids, inviting television cameras to record DEA agents hauling medical records out of one Southern California pharmacy.

"I don't prescribe medication, doctors prescribe medication," pharmacy owner David Rubin told KNBC-TV. "I'm not like one of those pharmacies you read about on TV. Everything is documented everything is crosschecked with the doctors."

"We only went after the pharmacies that we thought were prescribing or putting drugs on the street that had no obvious medical reason to do so," said David Downing, the special agent in charge of the investigation.

The DEA may just be getting started. Attorney General Jeff Sessions recently ordered all U.S. Attorneys to appoint “opioid coordinators” in their districts to monitor opioid prescriptions and to convene local law enforcement task forces to identify more doctors and pharmacies for prosecution.

Ironically, a few days after the raid on Sunny Hills, a teenage drug courier was caught in San Ysidro, CA at the Mexican border attempting to smuggle illicit fentanyl into the U.S. Nearly 78 pounds of fentanyl -- a synthetic opioid up to 100 times more potent than morphine -- were found hidden inside a 2010 Ford Focus. Experts say that is enough fentanyl to kill 17 million people --- or half the state of California. 

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

4 N’s That Can Help Lower Pain Levels

By Barby Ingle, Columnist

I have covered 28 treatments so far in my alphabet series on alternative therapies that can be used in the management of chronic pain. I am now moving on to the N’s of pain management -- two of which I have tried and two that I learned about while researching this article.

Nerve Blocks

A nerve block is the injection of an anesthetic or anti-inflammatory drug into a nerve or group of nerves to relieve pain. I had this procedure 37 times over a 3-year period, starting in 2005. In my case, the injections were made in my neck into a group of nerves called the stellate ganglion. The injections did not take away my pain, but they lowered the intensity of it and helped me function better for a limited time.

As with most therapies for pain, nerve blocks are not a lasting treatment or cure. They are only a tool to manage pain and can help diagnose where the pain is coming from. Diagnostic nerve blocks are typical done to determine if a longer lasting treatment or procedure could be more successful in treating pain.

My first nerve block gave me pain relief for only about 3 hours, but it also showed my doctors that I had sympathetically maintained pain -- a form of Reflex Sympathetic Dystrophy (RSD).

Some people receive a few nerve blocks and experience months to years of extended pain relief. For me, it was only a few hours, but when the blocks were later combined with radio frequency ablations, I would get up to 20 days of pain relief. The nerve blocks also helped me avoid additional surgery and having to take daily medications.

There are many types of nerve blocks that can be performed on different body areas. Injections can be made in the face, eyelids, scalp, forehead, upper jaw, nose and palate, neck, shoulder, elbow and wrist, as well as the abdomen and pelvis. The procedure can be painful, so many providers sedate patients or give them a local anesthetic. I was sedated for all of my nerve blocks except one, where the IV failed. 

Nitric Oxide

Another treatment I am hearing some alternative providers suggesting is nitric oxide, a gas that relaxes muscles and improves blood flow, especially in the lungs. Some intractable chronic pain conditions, such as chronic orofacial pain, can be helped by taking nitrous oxide supplements. These supplements don’t actually contain nitric oxide, but provide amino acids and other ingredients that increase nitric oxide production in the body.

Nitric oxide helps lower blood pressure, increases circulation, and improves cardiovascular and heart health. Athletes have used nitric oxide supplements for years to build muscle, and increase speed and endurance. The closest thing I have tried to a nitric oxide supplement is creatine, back in the day when I was a college athlete and coach. I was using it in a totally different setting and was monitored by trainers and team doctors, but I wonder now if creatine helped me more than I understood at the time. 

It is important to note that taking too much creatine or nitric oxide supplements can be harmful. But if you can find the correct dose and are closely monitored, they can be useful tools to help with some of the secondary effects of living with chronic pain, such as chronic fatigue. Some of the most common side effects from nitric oxide supplements are an increased urge to urinate, reduced dopamine levels (which we need for sleep), zinc deficiencies, nausea and stomach cramps. If you are a diabetic type 2, this is probably not a good option for you because blood sugar levels tend to go up as nitric oxide levels increase.

Neurotransmitter Regulation

A treatment I have used over the years is neurotransmitter regulation, which is the use of antidepressants and anti-anxiety medication to help manage depression, anxiety and other mood disorders. I no longer need these types of drugs, as I was able to learn through psychological counseling new coping skills to better manage my moods.

Mood disorders can be caused by chronic pain, which disrupts the production of neurotransmitters, the chemical messengers that our bodies produce to regulate our nervous systems. The four major neurotransmitters that regulate mood are Serotonin, Dopamine, GABA and Norepinephrine.

Medications can be used treat mood disorders. For example, anti-anxiety drugs that are receptor agonists – such as Valium, Xanax, Klonopin and other benzodiazepines -- bind to receptors and mimic the way a natural neurotransmitter decreases anxiety.

I can’t stress enough how common it is for people in pain to develop depression and anxiety, due to the challenging situations we face with our physical, emotional and mental health. Don’t be shy about discussing these needs with your provider. We must address all aspects of living with chronic pain and our mental stability is important to maintain.

Nabilone

The final option I looked at in the N’s is nabilone, a medication that is approved for treating or preventing nausea and vomiting caused by chemotherapy. A few studies have shown that low doses of nabilone can also be effective in managing chronic pain from fibromyalgia and multiple sclerosis, although that would be considered an “off label” use in the United States.

Nabilone is a synthetic cannabinoid that mimics tetrahydrocannabinol (THC), the primary psychoactive compound in marijuana. According to the studies I’ve read, researchers believe that nabilone can benefit patients not only by reducing pain, but in improving quality of life. In a head-to-head trial of nabilone and a weak opioid medication, nabilone had similar pain relieving effects in patients with chronic neuropathic pain.   

Once again, I hope that I was able to share something new with you. I encourage you to be open-minded when it comes to using alternative therapies. Always talk with your provider to make sure you are on the same page and that everyone involved in your care understands the treatment plan and the options you are choosing.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

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.

Rising Cost of Arthritis Drugs Defies Economics

By Julie Appleby, Kaiser Health News

Renda Bower knows well the cost of drugs to treat rheumatoid arthritis – her husband, son and daughter all have the painful, disabling autoimmune disease. And the family’s finances revolve around paying for them.

Even with insurance, Bower’s family last year faced $600 a month in copayments for the drug, plus additional payments on another $16,000 in medical bills racked up in 2016 when a former insurer refused to cover all the doses her 9-year-old daughter needed.

Bowers, of Warsaw, Ind., said her family tries to keep up with prices by cutting back on her children’s sports and extracurriculars and skipping family vacations. She also works as a part-time teacher.

But financially, it’s hard. “The cost should not be this high,” she said.

Wholesale prices for Humira and Enbrel, the two most commonly used treatments for rheumatoid arthritis, known as RA, increased more than 70 percent in the past three years.

Since the first RA drug came to market a decade ago, nearly a dozen have been added. If basic economics prevailed, RA treatments and patients would have benefited from competition.

But, because of industry price-setting practices, legal challenges and marketing tactics, they haven’t. The first RA drug cost $10,000 a year. It now lists for more than $40,000 — even as alternatives have entered the U.S. market.

“Competition generally doesn’t work to lower prices in branded specialty drugs,” said Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes.

Humira is the world’s No. 1 prescription drug by revenue. AbbVie manufactures and markets the drug and is on track to reach revenue from the product of $17 billion this year.

Other RA treatments are also among the top 10 drugs by revenue sold in the U.S. Enbrel, made by Amgen, ranks as No. 3. Remicade, by Janssen Biotech, is fifth. Some RA medications are approved for other conditions, including psoriatic arthritis, Crohn’s disease and psoriasis.

About 1.5 million Americans have rheumatoid arthritis. The Bowers found some relief this year but not because prices dropped. Rather, Renda’s husband left his job at an engineering firm to work as a machinist at a medical device company that has an insurance plan with lower copayments. Her daughter was accepted into a clinical trial at Cincinnati Children’s Hospital. The trial covers the drug’s cost but not the associated expense of weekly travel, among other things.

Middlemen Benefit As Wholesale Price Rises

The complicated pharmaceutical supply chain in the United States means middlemen — such as pharmacy benefit managers (PBM) and, in some cases, hospitals and doctors’ offices — can gain financially by choosing more expensive drugs. That’s because PBMs usually get a rebate from the drugmakers on top of whatever profit they get from selling or administering the drug.

Those rebates often are based on a percentage of the list, or wholesale, price. So, the middlemen who get the rebates take in more money when drugmakers raise those sticker prices.

But who pockets the rebates? PBM firms, which oversee drug benefits for millions of Americans, say they share all or part of them with the insurers or employers who hire them. In some cases, the rebates go directly to specialty pharmacies, medical clinics or physicians dispensing the treatments.

The rebates rarely end up directly in patients’ pockets.

Those rebates affect the market in another way: They can make it harder for some companies to offer new treatments or they can thwart less costly rival products.

“We could give [our new drug] away for free and … it would still be more economically advantageous” for insurers and PBMs to send patients to Humira first, said Andreas Kuznik, a senior director at Regeneron Pharmaceuticals, at a conference examining the cost and value of RA treatments.

Thomas Amoroso, medical director for medical policy at Tufts Health Plan, said at the same March conference that he has found drug industry sales representatives to be persistent in tracking how their drugs are positioned on plan formularies.

If insurers decide to add a new, lower-cost drug as the preferred alternative, “our Humira rep would be knocking on our door next week and saying, ‘Hey, that rebate we gave you? We’re taking it back,’” Amoroso said.

The roundtable at which they spoke was part of an assessment of RA drug pricing convened by the Institute for Clinical and Economic Review, a nonprofit that evaluates the value of medical tests and treatments for insurers and other clients.

PBMs won’t disclose the rebates they provide to clients, but studies provide a clue. It’s a huge amount of money.

The Berkeley Research Group, a consulting firm that advises major employers, said that rebates and other discounts paid to insurers, PBMs and the U.S. government for brand-name drugs grew from $67 billion in 2013 to $106 billion in 2015.

Most RA drugs are a complex type of medication, called biologics, which are made in living organisms. Nearly identical copies of biologics are called biosimilars. They hold the promise of lower prices, just as generic drugs did for less complex medications.

While several biosimilar RA treatments have won Food and Drug Administration approval, including replicas of Humira, Enbrel and Remicade, most are tied up in court battles over patents. And those biosimilars that have made it to market are now the subject of new areas of legal challenge.

In mid-September, Pfizer filed what will be a closely watched antitrust lawsuit against Johnson & Johnson. The case alleges that J&J is using exclusionary contracts and the threat of withdrawing rebates to protect Remicade from Pfizer’s lower-priced biosimilar, Inflectra, which hit the market last winter.

J&J defends its contracts, saying they are “driving deeper discounts that will lead to overall lower costs.”

Arguments For And Against Rebates

Rebates are under increasing scrutiny, amid growing alarm about soaring prescription drug prices in the United States. But the Pharmaceutical Care Management Association, the PBM industry’s trade lobby, said that complaints that rebates help fuel higher prices are unfounded.

These rebates, the lobby says, help save the health system millions of dollars by shifting dollars back to insurers or other clients, who can then use them to lower future premium increases. This year, it commissioned a study that found no correlation between rebates and the rising list prices of the top 200 brand-name drugs, suggesting higher rebates didn’t necessarily drive higher prices.

“The rebate system exists because [insurers, employers and other clients] want discounts,” said Steve Miller, chief medical officer for Express Scripts, one of the nation’s three largest PBMs.

Express Scripts offers clients an option to give patients the discount directly, but most choose not to, he said.

“While individual patients would get the benefit, everyone else’s premiums would go up [because the rebate savings would not flow back to the insurer],” Miller said. “Changing where the rebate goes doesn’t lower the price of the drug.”

But rebates play a role in what some patients pay at the pharmacy counter.

It stems from a simple calculation: whether a patient’s insurance copayment is based on a percentage of the drug’s wholesale price or the drug’s price after rebates are given to the middlemen.

Heidi Barrett , a mother of five from Everett, Wash., faces a 10 percent copay whenever she or one of her four children who have RA, all of whom have been on medication for years, go for their monthly infusion of Remicade.

Although Barrett is shielded from much of the cost because she has good employer-based insurance through her husband’s job, the question of whether her monthly copayments are based on the wholesale price or the after-rebate price rankles her.

“I have asked that question of the insurance company. I’ve asked that of our union,” said Barrett, 47, a paralegal who isn’t working because she spends so much time on her children’s treatments. “I never got any answers back.”

Based on data analyzed by Bach’s group at Sloan Kettering to determine the cost of 100 milligrams of Remicade, it appears she is paying based on the pre-rebate price.

Here’s how that works: Barrett’s 18-year-old son recently received a 600 mg dose that required a copay of $655. That is close to 10 percent of Remicade’s average U.S. wholesale price for that dose of $6,450, the Bach analysis showed.

Barrett is not benefiting from the rebate that middlemen receive.

Rebates and discounts, however, drive down the price for pharmacy benefit managers, hospitals or doctors.

According to the analysis, the average net cost of a 600 mg dose is $4,140, once all discounts are calculated. If Barrett could use that base price as her copay, she would save more than $240. For her entire family — all her children and Barrett take similar doses — that equals a savings of $1,000 a month.

With her current insurance, Barrett quickly meets a yearly $12,900 deductible. She considers herself lucky that her insurer then picks up the drug’s full cost. But the experience has changed her motherly advice to her children, who are 10, 18, 19 and 25, about what to hope for in life.

“I tell them, you can be anything you want when you go grow up. But you need to go to a company with good health insurance, even before you look at the salary or whether you’ll be happy there, your first priority is health insurance,” Barrett said. “It’s an insane world we live in.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

10 Myths About the Opioid Crisis

By Roger Chriss, Columnist

There is no shortage of false statements being made about opioids. As the overdose crisis worsens, old and debunked claims reappear, while new claims rise up alongside them. Pundits, politicians and even physicians are perpetuating them, despite all evidence to the contrary.

So let’s set the record straight in order to promote an informed dialog about opioid medication, chronic pain, and the opioid crisis.

Myth 1: America has 5% of the world’s population but uses 80% of the world’s opioids.

Numerous politicians, such as Missouri Sen. Claire McCaskill and former New Jersey Gov. Chris Christie, as well as many journalists, have made this statement. It is demonstrably false.

In fact, the U.S. only uses about 30% of the world’s opioid supply. That estimate includes the addiction treatment drugs methadone and buprenorphine, both of which are opioids.

Myth 2: 80% of heroin addicts began by abusing prescription opioids.

This myth is pernicious because it is based on a kernel of truth. The number is correct but the implication is wrong. Only 4 to 6% of people who misuse prescription opioids go on to use heroin. And the number of people who start heroin without taking prescription opioids first has been rising in the past year.

Myth 3: Addiction starts with a prescription.

This claim persists despite decades of data to the contrary. A 2010 study found that only one-third of 1% of chronic pain patients without a history of substance abuse became addicted to opioids during treatment. Most abuse begins when people take medication that was not prescribed to them, using pills that were stolen, purchased illegally, or obtained from friends and family members.  

Myth 4: Opioid use leads to pain sensitization or ‘opioid induced hyperalgesia.’

Addiction treatment specialists like to repeat the claim that long-term opioid use makes patients hypersensitive to pain. But hyperalgesia is poorly understood and often confused with opioid tolerance. One study found that chronic pain patients on opioids had no difference in pain sensitivity when compared to patients on non-opioid treatments.    

Myth 5: Opioid overdoses are killing 64,000 people per year.

Nearly 64,000 Americans died from drug overdoses last year, according to the CDC, so that part is true. But opioids were involved in only about two-thirds of those deaths – and most of those overdoses involved heroin and illicit fentanyl.

Myth 6: Reduced opioid prescribing will end the overdose crisis.

Reduced prescribing is clearly not working.The number of opioid prescriptions has been in steady decline since 2010, yet fatal overdoses have risen sharply ever since.

Myth 7: Medical cannabis will cure the opioid crisis.

This is a recurring myth, made popular again in 2017. Unfortunately, not only does the recent data show that medical cannabis is not helping in states where it is legal, the underlying assumption of this myth is that chronic pain care is driving the opioid crisis. This is not the case.

Myth 8: Banning opioid medication will fix the opioid crisis.

This was put forth again early in 2017 by New Hampshire attorney Cecie Hartigan. Setting aside the problem of banning illegal drugs like heroin and fentanyl analogues (they are already banned), opioids are simply too medically useful to give up. Moreover, prior experience with drug bans, from Prohibition to the current overdose crisis, shows that bans do not stop misuse or addiction.

Myth 9: There are lots of ways to treat chronic pain

This myth has become increasingly popular as states, medical facilities, and health insurers pursue policies to reduce opioid prescribing. Although some of these methods, from physical therapy to spinal cord stimulators, may prove helpful, that misses the fundamental point. Chronic pain disorders are so horrible that all effective options, including opioid therapy, need to be on the table.

Myth 10: Opioids are ineffective for chronic pain.

This is the biggest myth of all. There is an abundance of high-quality research showing that opioids can be effective for some forms of chronic pain. Here’s a partial list of recent studies:

• Benefits and Risks of Opioids in Arthritis Management

• Opioids for chronic pain: new evidence, new strategies, safe prescribing

• The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain

• Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects

Adding to these studies is a recent review in Medscape, in which Charles Argoff, MD, a professor of neurology at Albany Medical College, said that “in multiple guidelines and in multiple communications, we have a sense that chronic opioid therapy can be effective."

New myths appear regularly, but these persist despite all efforts to counter them. Like an ear-worm or viral meme, they cannot be eliminated. The only defense is knowledge.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

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.)

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.

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.

Fentanyl & Heroin Deaths Lead Soaring Overdose Rate

By Pat Anson, Editor

Deaths from drug overdoses soared by 21 percent last year in the United States, with fentanyl and heroin now playing a bigger role in the overdose crisis than prescription pain medication, according to a new report from the Centers for Disease Control and Prevention.

The report estimates that 63,600 Americans died from drug overdoses last year, up from 52,400 in 2015. The soaring overdose rate helped lower U.S. life expectancy for the second consecutive year. A baby born last year is expected to live 78 years and 7 months, about two months less than a child born in 2014.

"If we don't get a handle on this, we could very well see a third year in a row. With no end in sight," CDC researcher Robert Anderson told the Associated Press.

About two-thirds of the drug deaths in 2016 involved opioids, a broad category that includes not only pain medication, but heroin and synthetic opioids such as fentanyl that are increasingly available on the black market. Fentanyl is up to 100 times more potent than morphine.

Fentanyl and its chemical cousins were blamed for over 19,000 deaths last year, followed by heroin (15,500 deaths) and prescription painkillers (14,500 deaths).

In the chart below, fentanyl is included in the category of "synthetic opioids other than methadone," while "natural and semisynthetic opioids" includes pain medications such as oxycodone and hydrocodone.

SOURCE: CDC

The CDC’s new report may actually underestimate the number of people dying from fentanyl and heroin. CDC researchers relied on data from International Classification of Disease (ICD) codes on death certificates, which merely list the drugs that are present at the time of death -- not the actual cause of death.

A more reliable way to list the cause of death is through toxicology blood tests, which often find that multiple drugs are involved in overdoses. Florida, Massachusetts, Pennsylvania and several other states that conduct their own toxicology reports have found that fentanyl, heroin and anti-anxiety medications are responsible for far more overdoses than prescription opioids. A recent study found that fentanyl or fentanyl analogues were involved in over half of the overdoses in 10 states.

Another recent study of emergency room admissions found that heroin overdoses exceeded those from prescription opioids by almost a 2 to 1 margin.

President Trump's opioid commission recognized the need to improve the CDC’s drug overdose data when it released its final report last month.

"The Commission recommends the Federal Government work with the states to develop and implement standardized rigorous drug testing procedures, forensic methods, and use of appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the commission found.

Although its own research shows that fentanyl and heroin are causing more overdoses than opioid medication, the CDC continues to focus on painkillers as the root cause of the overdose crisis.  As PNN has reported,  a public awareness campaign recently launched by the CDC only warns about the risks of prescription opioids, while completely ignoring the growing scourge of heroin and fentanyl.

But there is little evidence that awareness campaigns or prescription guidelines are reducing opioid addiction and overdoses, according to a recent op-ed in The New England Journal of Medicine.

"National trends show that we do not yet understand how to stem the tide of opioid overdoses by changing physicians’ prescribing practices. Although the volume of opioid prescriptions has fallen by 12% since its peak in 2012, the rate of overdose deaths continues to increase faster than ever, driven by an influx of potent synthetic opioids such as fentanyl. How and when decreased prescribing will translate into fewer deaths is unclear," wrote lead author Michael Barnett, MD, assistant professor of health policy management at the Harvard T.C. Chan School of Public Health.

"In the meantime, there is a real danger that aggressive opioid-prescribing policies could drive more people to use more dangerous injection opioids or force patients to live with inadequately treated pain. We simply do not know which policies will strike the right balance between promoting safe opioid use and avoiding unintended consequences."

No, I Don’t Want a Spinal Cord Stimulator

By Crystal Lindell, Columnist

There’s a word that my best friend came up with that we now use when someone is being obscenely awful: J-hole.

It’s a mix between a jack [redacted] and an [redacted] hole. Get it? J-hole. You’d be surprised how useful it is. Especially around kids.

And can I just tell you something? The pain specialist I saw yesterday? He was a real J-hole.

I used to think I just had a string of bad luck when it came to doctors and it was some weird coincidence that most of the ones I met were J-holes.

But now I’m starting to wonder if there’s something about the medical profession that has a way of attracting an above average number of J-holes.

Yes, there are good ones. I think I’ve met two of them — in six years with chronic pain. But most of the doctors I see? Well, they’re J-holes. And this guy was one of the ones that prove the rule.

He is obsessed with me getting a spinal cord stimulator. But I do not want to get a spinal cord stimulator. It’s created some friction.

This was only my second time meeting with him. He oversees a local pain clinic where I now get my weekly lidocaine infusions. It’s been great, because before I found this place, I had to drive two hours each way to the closest university hospital for the infusions. And I am too sick to drive afterward, so I was always begging people for rides. This place is about a half hour from my house, and right by my mom’s work, so it’s super convenient.

But every single time I go in, they try to sell me on this spinal cord stimulator thing. And I’m just not interested.

I usually see another doctor, a woman. Technically, I think she’s a nurse practitioner. And she at least has the ability to read a room. She presents the spinal cord stimulator every week like one of those cashiers at Kohl’s who is required by corporate law to ask if you want to sign up for a credit card, but who knows just as well as you do that you’re never going to be interested. And then we both move on. 

She’s in Mexico for Christmas though, so yesterday I had to see the J-hole guy. And he’s not someone who likes to hear the word no.

He asked me if I was interested in the stimulator, and I told him I wasn’t. Then he asked why not, so I told him I talked to my primary care doctor and he didn’t recommend it, which was true.

My PCP, who is an internal specialist at a university hospital — so you know, qualified — said I probably wouldn’t get much more relief than I get from the infusions, and that I would probably still need to take hydrocodone.

He also told me that a fair number of the patients he knows who got a stimulator ended up getting infections from it. And so for now, he recommends that I stick with the lidocaine infusions.

I trust this guy. He’s been my PCP for like five years and he has always taken my pain seriously. He’s one of the two doctors I’ve met who is not a J-hole.

And you know what this pain specialist said when I told him what my PCP said?

“Well that guy doesn’t know what he’s talking about.”

Ok. Cool.

So then I told him that I write for a pain site online and I’m pretty connected to the pain community and I have heard nothing but bad things about these stimulators. They’re hard to remove. The batteries die. They don’t work that well.

His response to that was, “You can’t believe everything you read online.”

Always a good thing to say to someone who just told you they write for an online publication, am I right? My sister was in the room and told me later she wanted to laugh in his face when he said that.

Then he tried to lecture me about getting weekly infusions and said insurance wasn’t going to be willing to cover those forever, and in my head I was like, OK, did my insurance tell you that? Or are you just annoyed that I come in here every single week and give you hundreds of dollars in revenue for what is basically a simple IV, and you would prefer that I stop? Because I can always go back to the hospital for infusions, where they at least offered me graham crackers every week.

His main selling point was that the stimulator would free up my life, so that I wouldn’t have to deal with the weekly infusions. It’s an argument that makes sense to healthy people, but what he doesn’t understand is that the infusions are what have freed up my life.

Before the lidocaine, I was lucky to get one good day a year. Now I spend one day each week dealing with an IV drug that makes me nauseous and tired and then I get the whole rest of the week to live my best life. It’s amazing! Plus, I get the added benefit of not having to have surgery on my spine.

Look, at the end of the day, the idea of getting something implanted into my spine just doesn’t sit well with me, even if complications are rare. Especially since I have a bad habit of having rare medical issues.

And it’s hard to take a doctor seriously when you know he stands to make thousands of dollars if I get the stimulator. But for now, I’m stuck going to this pain clinic for my infusions because everyone else in town says they are too risky to do.

But no, I’m not going to be getting a spinal cord stimulator. Maybe I’ll change my mind though. After all, you can’t believe everything you read online.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

One Million Australians Abuse Rx Drugs

By Pat Anson, Editor

Like the United States, Australia is struggling to find answers to a growing addiction and overdose crisis – and restricting access to opioid pain medication is the favored solution.

A new report by the Australian Institute of Health and Welfare (AIHW) found that a million Australians -- about 4.7% of the population – abused a prescription drug in 2016. That’s up from 3.7% in 2007.   

‘Over the past decade, there has been a substantial rise in the number of deaths involving a prescription drug, with   drug-induced deaths more likely to be due to prescription drugs than illegal drugs,’ said AIHW spokesperson Matthew James.

In 2016, there were 1,808 drug overdose deaths in Australia, but the leading cause was not pain medication. Benzodiazepines, a class of anti-anxiety medication that includes Xanax and Valium,  were involved in 663 overdoses -- compared to 550 deaths linked to opioid medications such as oxycodone and codeine.

Recent reports from Florida and Pennsylvania also show that overdoses linked to "benzos" outnumber those from pain medication, although you rarely hear about that in today’s anti-opioid climate.

Unlike the United States, where prescriptions for opioid medication have been in decline for several years, in Australia they rose by 24% from 2010 to 2015 – driven largely by a 60% increase in the rate of prescriptions for oxycodone.

Like their American counterparts, Australian regulators and health officials are responding to the overdose crisis by reducing access to opioid medication. Starting in February 2018, Australians will need a prescription for codeine, which is now widely available in over-the-counter analgesic and flu medications.  Australia is also introducing a national prescription drug monitoring system.

Economic despair and social isolation appear to be playing major roles in Australia's overdose crisis, just as they are in the United States. Earlier this year, a nationwide survey found that people living in remote, rural areas of Australia were almost twice as likely as those living in major cities to use pharmaceutical drugs for non-medical purposes.

“This finding also held true for Australians living in the most disadvantaged socio-economic areas, with 6 percent having recently misused pharmaceuticals compared with 4.2 percent of those in the most advantaged areas,” James said.

Australians who misused prescription drugs were also more likely to experience mental illness, chronic pain and psychological distress compared with those who did not misuse them. 

What’s the Difference Between Opiates and Opioids?

Rochelle Odell, Columnist

Like many of you, I use the words opioids and opiates interchangeably. I incorrectly thought one was singular and the other plural. It pays to look up definitions before using a word!

Merriam Webster defines opiate as “a drug containing or derived from opium and tending to induce sleep and alleviate pain.”  The first known use of the word “opiate” was in the 15th century. Natural forms of opiates include morphine, codeine, heroin and opium.  

Merriam Webster defines opioid as “possessing some properties characteristic of opiate narcotics but not derived from opium.”  Interestingly, the first known use of the word “opioid” was not until the 1950’s. Two of the most widely prescribed pain medications, oxycodone and hydrocodone, are opioids.

Just Believe Recovery, an addiction treatment center in Florida, has a straightforward explanation of the difference between opiates and opioids on its website:

“Opiates are alkaloids derived from the opium poppy. Opium is a strong pain relieving medication, and a number of drugs are also made from this source.”

“Opioids are synthetic or partly-synthetic drugs that are manufactured to work in a similar way to opiates. Their active ingredients are made via chemical synthesis. Opioids may act like opiates when taken for pain because they have similar molecules.”

But neither opiates or opioids make pain go away – what they do is temporarily block pain signals.  

"Both of these types of drugs alter the way that pain is perceived, as opposed to making the pain go away. They attach onto molecules that protrude from certain nerve cells in the brain called opioid receptors. Once they are attached, the nerve cells send messages to the brain that are not accurate measures of the severity of the pain that the body is experiencing. Thus the person who has taken the drug experiences less pain," is how Just Believe Recovery explains it.

The problem with this definition is that it fails to address why an addict uses heroin and other narcotics. It's not to relieve physical pain, it's for the euphoric effect or high. Big difference.

I can attest to that feeling. Years before I developed Complex Regional Pain Syndrome (CRPS), I was hit by a beginner snow skier, who caused a nasty spiral leg fracture. I screamed in pain for what seemed like hours, until a Demerol shot was given. It still hurt, a lot, I just didn't care that it hurt.

A week after the accident, I received a call from my orthopedist (who ultimately saved my left leg) informing me I must get to the hospital for immediate surgery. It turned out that my broken leg had not been reset and cast properly. A rod was inserted to correct the problem, but the post-op pain was excruciating.

I was on strong opioids for the next three weeks, until I had to go back to work and stopped cold turkey. I needed to work with a clear mind, and it was going to hurt whether I was at home or work. I had no cravings for pain medication and no addiction developed. Simply didn't need them.

However, after I developed CRPS and slowly titrated up on Dilaudid, the pain was different than it was from the broken leg. The relief obtained was not the "I don't care" reaction, but one of the pain is less, now I can do what needs to be done at work or at home. That’s the classic difference between acute, short term pain and chronic pain.

"When people use these medications only to treat pain as directed and for a short time, they are less likely to become addicted. Prescription drug addiction occurs when patients develop a tolerance for the level of medication they have been described and no longer get the same level of relief," is how Just Believe Recovery explains it.

"They may not have the same expectations for relief as their physicians and may equate the term ‘painkillers’ with the medication being able to take away all of their pain, while their doctor may be thinking in terms of pain management, which means bringing the pain to a level where they can function at a reasonable manner. When expectations do not match, patients may take more of the pain medication than prescribed to get a higher level of relief and in turn develop a drug addiction issue."

The CDC and several states have now decided to establish what acute pain is and how long it should be treated with opioids, be it three or five or seven days.

But if you suffer from a chronic pain disease or condition, a few days’ supply won’t cut it. You require the medication long term in order to function. Not addicted mind you, you just want the pain at bay. We all know pain medication does not “kill” the pain. It just becomes tolerable. Most pain patients do not increase their pain medication and many, including me, have been on stable doses of opioids for many years.

We also know pain patients are not the driving force in today's misguided opioid crisis or public health emergency or whatever you wish to call it. Illicit drug users are, and they are primarily young adults who snort, smoke or inject heroin and illicit fentanyl. Many are addicts who are in methadone clinics, and they still abuse not only the methadone but other drugs as well.

It's like everyone in power or who is affiliated with rehab has blinders on. Pain patients have become the issue, yet statistics clearly show we are not the problem. The rate for opioid abuse in pain patients is at or less than 5 percent.  Why are patients singled out in this battle?  Even the CDC admits opioid prescriptions are no longer the driving force in the overdose crisis. I believe they never were.

Opiates and opioids are not the same, and should be addressed separately. Instead, they have become interchangeable. We don’t have a heroin or opiate epidemic; we have an “opioid epidemic.”  The government usually lumps them together as one. And, as we all know, what the government decides somehow becomes set in stone.

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.

Medicare Paid Millions for Bogus Lab Tests

By Fred Schulte, Kaiser Health News

Five years ago, Companion DX Reference Lab hoped to cash in on cutting-edge genetic tests paid for by Medicare.

The Houston lab marketed a test to assess how a person’s genes affect tolerance for drugs such as opiates used to treat chronic pain. It also ran DNA tests to help treat cancer and urine screens to monitor drug abuse.

But the lab went bust last year after Medicare ordered it to repay more than $16 million for genetic tests health officials said were not needed.

Companion Dx is one of at least six clinical labs mired in bankruptcy court after Medicare alleged they improperly billed the government for unnecessary urine, genetic or heart disease tests expected to cause hundreds of millions dollars in losses to taxpayers, an investigation by Kaiser Health News found.

As the nation’s bill for drug and genetic tests has climbed to an estimated $8.5 billion a year, there’s mounting suspicion among health insurers that some testing may do more to boost profit margins than help treat patients.

Medicare has slashed fees for urine tests and tightened coverage of some genetic screens, which can cost Medicare $1,000 or more per person. Private insurers, who mostly have paid these bills without question, also are taking a more penetrating look at spending on the controversial lab work.

Yet, getting these firms to repay Medicare and private insurers remains a formidable challenge. While some doctor-owned labs have dodged collection efforts for years, several testing firms deeply in debt to Medicare appear to have few assets to repay overcharges dating back years, court records show.

COURTESY PAIN EXHIBIT

“Medicare shouldn’t be paying for dubious tests, but the time to catch that is in the very beginning when [labs] are asking for payment,” said Steve Ellis, vice-president of Taxpayers for Common Sense, a budget watchdog group. “They need to increase oversight so the dollars don’t go out the door in the first place.”

A spokesman for the federal Centers for Medicare & Medicaid Services (CMS) had no comment. Neither did the Department of Justice, which represents the government’s interests in court.

Labs can run a range of genetic and drug tests using a saliva sample, blood or urine specimen. The price tag to Medicare can mount quickly, especially when doctors order highly specialized tests for large numbers of patients. Two bankrupt labs that federal officials say routinely overused tests to detect rare heart ailments in the elderly, for instance, could end up owing the government a total of more than $200 million, court records show.

Some labs have kept operating in bankruptcy while others liquidated equipment and sold off assets. Several bankruptcy trustees, whose duty is to ferret out assets, are suing suppliers, insurers and some doctors to recover funds.

Whether they can raise the pile of cash needed to repay Medicare is doubtful.

Companion Dx, according to bankruptcy records, had $117,497 cash on hand at the end of September. Medicare is seeking the return of $16.2 million paid to the company for services “not considered medically necessary,” according to a January court filing.

The Texas lab had no comment, but in court filings has blamed its collapse on disagreements with Medicare over the merits of its tests and government audits that retroactively disallowed claims. Medicare pays only for services it deems “medically necessary,” and audits typically take many years to complete.

Companion Dx opened in January 2012 expecting to “capture favorable profit margins that existed in connection with this cutting edge technology,” the company wrote in its bankruptcy filing.

However, starting in 2013, Medicare began having second thoughts about the validity of some tests and ultimately decided to cover them on just 1 percent of patients, according to the company. The lab declared bankruptcy in July 2016. The case is pending.

Iverson Genetic Diagnostics Inc. is another lab that turned to bankruptcy court as Medicare tried to reclaim $19.7 million, court records show. The case is pending.

Medicare took aim at the Seattle firm in November 2013 after reviewing “numerous” complaints of billings for genetic tests that patients “had not actually received,” federal officials wrote in a court filing.

A later federal audit concluded that Iverson had charged Medicare for tests that were “not reasonable and necessary.” In September 2015, about two months after Medicare called for the refund, the lab filed for bankruptcy.

Iverson denied overbilling Medicare and is appealing the Medicare decision, which it said in a court filing “was not based upon sufficient or proper evidence.” And Iverson denied wrongdoing in court filings.

Neither the lab, now located in Charleston, S.C., nor its lawyers would comment.

‘No Cash Left’

In another case, Pharmacogenetics Diagnostic Laboratory LLC in Louisville exited bankruptcy in late October without repaying Medicare $26.3 million for disallowed genetic tests. The lab, set up in 2004 by two University of Louisville professors, strongly disputed Medicare’s findings but said they were the “primary reason” for the bankruptcy, court records show.

Charity Neukomm, a lawyer for the lab, said another medical group agreed to purchase all its assets “free and clear of liens.” That left nothing for the government.

There’s also little chance that Natural Molecular Testing Corp., a defunct genetic testing lab, will repay the $71 million it owes Medicare, according to John Kaplan, an attorney for the bankruptcy trustee.

Kaplan said the lab near Seattle, which opened in 2010, was “printing money from billing Medicare” until the government suspended payments in April 2013. The company filed for bankruptcy in 2013 in the face of a Medicare audit of its billing and concern over its business practices, such as paying some doctors who ordered its tests as much as $10,000 a month in consulting fees, according to court records.

Five years in, the bankruptcy case is expected to settle next year, but there’s likely to be “no cash left” to repay Medicare, Kaplan said.

Critics argue that Medicare has been slow to assess the benefits of new and controversial tests and technologies — even when soaring costs signaled a warning of possible overuse.

Spending on genetic testing, for example, shot up from about $167 million in 2013 to more than $466 million a year later, according to Medicare billing data. In 2015, the program spent about $317 million on the tests and some $165 million last year. Government auditors credit tighter oversight for the sharp decline in billing.

Ellis, the budget watchdog, said the “huge jump” in these bills should have “sent out a red flag.”

Medicare officials don’t routinely verify that the sales claims labs make to doctors are rooted in scientific evidence. Some labs have hawked genetic tests as a tool for making pain management safer. The labs contend the tests can pinpoint the proper drugs and dosage for each patient based on their genetic makeup, thus reducing the threat of overdose or other injury.

However, many experts argue that the science hasn’t caught up to the sales pitch — and that some high-priced tests may do little to diagnose or treat illness.

Genetic tests “are not ready for prime time,” said Charles Argoff, professor of neurology at Albany Medical College in New York. He said their impact on medical care “hasn’t been measured.”

Court records show that the legal battles to recover assets from failed labs often plod on for years, especially when trustees believe labs paid illegal fees or other kickbacks to persuade doctors to order dubious tests.

“Some of these cases never go away,” said David Schumacher, a Boston health care lawyer who has defended doctors against these claims. Still, he said that even after years of legal wrangling Medicare often is unlikely to “be made whole and fully repaid.”

The trustee for Heart Diagnostic Laboratory, which marketed a panel of blood tests to detect heart disease and other illnesses before its June 2015 bankruptcy, has filed more than three dozen lawsuits to recover money paid to doctors and medical offices, including suspect consulting fees.

“Our analysis is that all of these payments were tainted and therefore we’re entitled to go after them,” said Richard Kanowitz. He added: “It’s an uphill battle.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.