Canadian Province Adopts CDC Guidelines

By Pat Anson, Editor

Less than three months after their adoption in the United States, the CDC’s opioid prescribing guidelines are now being implemented in Canada.

The College of Physicians and Surgeons of British Columbia has released new professional standards and guidelines that are closely modeled after the CDC’s guidelines.

One key difference is that while the CDC’s guidelines are “voluntary” and intended only for primary care physicians, British Columbia’s standards of care are legally enforceable for all opioid prescribers because they set a “minimum standard of professional behaviour and ethical conduct.”

“The public health crisis of prescription drug misuse has developed in part due to the prescribing of physicians. The profession has a collective ethical responsibility to mitigate its contribution to the problem of prescription drug misuse, particularly the over-prescribing of opioids, sedatives and stimulants,” the college said.

"Every physician is professionally responsible for the prescription that they provide to a patient."

Like the CDC guidelines, the college discourages the prescribing of opioids for chronic pain, but goes even further by saying they should not be used to treat three specific health conditions: headaches, fibromyalgia and low back pain.

Opioids for acute pain should be limited to three to seven days’ supply, and when prescribed for chronic pain should be limited to only a month’s supply at a time. British Columbia physicians are also warned not to prescribe opioids concurrently with benzodiazepines and other anxiety medication.

Doctors are also cautioned to carefully document their reasons for increasing doses over 50 morphine milligram equivalents (MME) per day and to avoid increasing the dose to over 90 MME per day.

The British Columbia standards are more strict than Canada’s national guidelines, which have not been revised since 2010, “leaving them out of date with current research associated with taking painkillers,” according to The Globe and Mail.

“While Canada’s guidelines for opioid-prescription are expected to be updated in January, the death toll is mounting too quickly to wait,” said the Toronto Star in an editorial urging Ontario’s College of Physicians and Surgeons to adopt guidelines similar to British Columbia’s.

“B.C. has shown the way for other provincial regulatory bodies. Colleges across the country, including Ontario’s, should follow its example and set informed rules now. Injudicious prescriptions have already destroyed the lives of too many Canadians.”

Like the United States, Canada is one of the top opioid prescribing countries in the world and is struggling with an “epidemic” of addiction and overdoses. A growing number of deaths, however, can be attributed to illegal opioids such as fentanyl and heroin, and it remains in doubt whether restricting access to prescription opioids will lessen the problem or only make it worse by forcing legitimate patients to turn to the streets for pain relief.

As Pain News Network has reported, Canadian drug dealers are now selling counterfeit painkillers laced with fentanyl, an opioid that is more potent and dangerous than most pain medications.

The Star sees the problem differently, blaming doctors for Canada's opioid problem.

“It’s hard to believe that a large part of the blame for Canada’s latest drug-addiction crisis lies not with dealers, but with doctors. That is the conclusion of a growing number of health experts across the country who say our ballooning opioid problem can’t be solved until physicians stem the flow of prescriptions for the highly addictive painkillers,” the newspaper said in its editorial.

Pain Patients Sound Off on ‘Barbaric’ Treatment

By Pat Anson, Editor

We received a lot of feedback from this month’s PNN newsletter, which looked at the impact the CDC’s opioid prescribing guidelines are having on pain patients.

The guidelines – which discourage the use of opioids to treat chronic pain -- are voluntary and recommended only for primary care providers, yet pain patients say they are being widely implemented by physicians regardless of specialty. Many wrote to tell us they were being cutoff or weaned off opioids. Some were having trouble just finding a doctor willing to treat them.

I thought I’d share some of the comments with you, as well as some tips on what to do if your doctor drops you from their practice.

"My pain medications were reduced the very first appointment I had with my doctor after the CDC guidelines came down,” said Kathleen, who suffers from neck and shoulder pain.

“I have not had an increase in my pain medications in over 4 years and yet I was told that I may have hyperalgesia. I was told that the guidelines are going to cause insurance companies to reject payment for pain meds and that I was going to be weaned off, slowly, but weaned off.” 

“Do I believe suicide rates will increase due to these new guidelines? Absolutely.  ABSOLUTELY!”  wrote Karen, who suffers from Chronic Regional Pain Syndrome and other chronic conditions.

“For myself, I'd choose quality of life over quantity. And I think that's true for most people in chronic pain.  When the pain becomes too great, goes untreated and there's no hope in sight, I imagine death would be a welcome end.”

“All I know is they are trying to take my wife’s pain meds away because of a bunch of junkies is insane,” said one man. “They are forcing a lot of people in pain to turn to the streets. If we had an animal that we allowed to live in pain we would be fined or jailed for cruelty to an animal but according to our government it’s ok to do it to people. My wife said she won’t live like that. Wrong. So wrong.”

“I too have been told from my doctor that I'll no longer be receiving Rx narcotics from him. He said as a group they've decided not to prescribe to anyone but cancer patients,” wrote Peggy, who’s been taking opioids for almost 20 years. “There will come a time when I'm bed bound once again, not able to even cook, shower, care for myself because opioids are the only thing that work for me.”

Even some cancer patients are being weaned off opioids, as we learned from 64-year old Dan Hartsgrove, who was diagnosed with throat cancer last year.

“I suffer every day. Cannot eat or sleep due to the pain,” Dan wrote. “I have enough to deal with and no way in the world should be suffering in this manner. No one should. This whole opioid war is a failure and aimed at the wrong people.” 

Dan’s pain management doctor said he was taking “too much medication” and discharged him after Dan refused to have a pain pump installed. Even his chemotherapy doctor has lowered his dosage.

“It was fine for me to be allowed the poison of chemo and radiation, however I am allowed no relief from suffering daily,” said Dan.  “Where is the compassion? My wife had a friend who was 49 and had throat cancer, he was in so much pain he would put his head through his wall at night when he was trying to sleep. The doctors would not help control his pain and he committed suicide 2 years ago. This is barbaric.  I am slowly slipping away from this pain. I need to eat and just can't. Everybody thinks cancer patients are excluded from this war on opioids. NOT TRUE.”

A Florida woman who has been taking opioids for years for an autoimmune disease also says her doctor is trying to talk her into a pain pump.

“I currently have a kind and understanding pain management doctor who knows this is helping me but his office was raided last year by DEA agents and ever since then he has been afraid to prescribe,” she wrote.  “I feel I have been given a choice to get the pump or else. I shouldn't have to get something I don't want just to please the DEA and CDC. My doctor feels that by years end opioids will become less available at the pharmacy.”

“Now every snake oil salesman is pushing something to take the pain away. It’s all garbage. Opioids as a whole have been the gold standard for thousands of years when it comes to pain relief,” said Michael. “Take away the only thing that legitimately reduces our pain, then just kill us now, put us in jail or a psychiatric hospital. This is where we will ALL end up if this continues.”

“The last thing chronic pain patients need is to take less medication than they should because they're afraid of either being labelled addicts or even worse, having their medicine taken away without any notice,” said Doreen, who suffers from fibromyalgia and autoimmune diseases.

“My rheumatologist has told me I cannot ever stop taking the pain patches I'm on. I don't enjoy taking them, but it scares the hell out of me wondering what will happen when I get to that point! Please consider chronic pain patients when talking about cancelling the prescribing of opioids!! Where does this leave us?”

Tips for Dealing with Patient Abandonment

Patient advocate and fibromyalgia sufferer Celeste Cooper says she’s been “deluged” with complaints from patients who have been abandoned by their doctors.

It’s important to understand what is happening. Physicians are caught in a quagmire of discontent. They are put in harm’s way by the DEA and other government agencies if they do prescribe opioids, and yet they run the risk of losing their license if they don’t treat their patient’s pain and it causes harm,” Celeste wrote on her website.

“When a patient is fired, the physician has an ethical obligation to ensure a patient’s care is uninterrupted or they are subject to the repercussions of patient abandonment. If a patient is harmed because they are abandoned, there may be grounds for a lawsuit.”

Celeste says it’s important to gather factual evidence to protect your legal rights, such as getting a written letter from the doctor stating their reasons for stopping your pain care. The physician is also obligated to provide copies of all relevant medical records.

If you have been harmed due to patient abandonment or changes in pain care, you could file a complaint against your doctor under the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, which was signed into law in April.

Flood Congress with Phone Calls

Connie Raterink suggests another way pain patients can get their voices heard. In 1994 she was homeschooling her children when Congress was considering legislation that would have basically made home schools illegal. When attempts to amend the bill failed, home school advocates flooded their congressional representatives with phone calls.

“We literally shut down Congress that day. They couldn't make outgoing calls, and the only ones getting through were home schoolers. They couldn't even call their own staff within Congress!” Connie said. “They got the message, and immediately amended the bill. Over the few days involved with this, there were over one million phone calls made.”

Connie, who suffers from a severe form of osteoporosis, thinks the same approach could be used by pain patients.

“So, pick a date... get the message out.... there are 600 people in my Church alone that would call just on MY behalf,” she wrote. “Congress again needs to hear from us individually, but en masse. We need to tell them to get their noses out of our medical records, and let our doctors make the decisions for their patients, not Congress.”

To learn more about the home schoolers’ campaign, click here.

To sign up for our free monthly newsletter, click here.

Belbuca Effective in Treating Pain Long Term

By Pat Anson, Editor

A new opioid film designed to be taken orally twice a day significantly reduces pain and the need for breakthrough pain medication in patients with moderate to severe pain, according to a new clinical study by Endo International (NASDAQ: ENDP). The results of the Phase III study were released this weekend at the International Conference on Opioids in Boston.

Belbuca is the only analgesic formulation of buprenorphine in a sublingual film that is dissolved in the mouth and absorbed through the inner lining of the cheek.

Buprenorphine is an opioid classified as a Schedule III controlled substance, which means it has lower abuse potential than Schedule II drugs, a category that includes opioids such as hydrocodone. Buprenorphine is also used to treat addiction when combined with naloxone.

Over 400 patients with moderate to severe pain took Belbuca for 48 weeks after being titrated to find the most effective dose. During long term treatment, the average daily pain score was about 3 on a scale of 0 (no pain) to 10 (worst pain imaginable).

The need for daily rescue medication to relieve breakthrough pain decreased from an average of 3 tablets to 1.1 tablets.

"Many patients living with chronic pain require long-term treatment to control their suffering, so it is important that patients have options to manage their pain," said Martin Hale, MD, Medical Director of Gold Coast Research, one of the study's investigators. "These new findings support the safety and tolerability of treatment with Belbuca across a broad range of dosage strengths.”

About half of the patients (54%) experienced some type of side effect, including nausea, constipation, headache, vomiting and upper respiratory tract infection.

Belbuca was approved by the U.S. Food and Drug Administration in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.

Belbuca utilizes a drug delivery system developed by BioDelivery Sciences (NASDAQ: BDSI). Because the oral film delivers buprenorphine into the bloodstream faster than pills or skin patches, lower doses are needed to treat pain. The film contains one-tenth to one-twentieth the amount of buprenorphine as Suboxone and other products that are used to treat opioid addiction.

Belbuca is available in seven different dosages, allowing physicians to titrate Belbuca to a tolerable dose that provides pain relief with fewer side effects. According to the Healthcare Bluebook, a 75mcg, 60-day supply of Belbuca should cost about $265.

5 Tips on Leaving Your Career Due to Health Issues

By Ellen Lenox Smith, Columnist

Leaving your career due to chronic pain and illness can be heartbreaking, but for some of us it’s a necessary step.

There was never a day in my life as a teacher that I didn’t love getting up and going to work, yet that career had to end due to the progression of Ehlers Danlos syndrome and sarcoidosis. I felt so lost and not sure who I would be without the career I had.

So, one day before retiring, I went for a walk at the Scituate Reservoir in Rhode Island with my dogs at the time, Corey and Carmel. I made the decision to not think about all the emotions entering my mind -- trying to push those negative thoughts away so I could de-stress. I only allowed myself to look and listen to nature.

Within minutes, I started to have words and thoughts come into my head. Before I knew it, I had to come home, sit at the computer and start writing. The first of what turned out to be over a hundred poems poured out of me. I always laugh when I share this experience, for I am not particularly into poetry.

This was the first of my eventual one hundred poems, which helped cleanse my emotions and prepare for announcing my need for retirement and a life with two progressive conditions:    

ELLEN LENOX SMITH

I Attended a Concert This Morning

It was that time to escape, to go for an adventure. We were attending a concert. All ten of our legs got into the car to begin the trip. No clues had been provided to us to prepare for what an impact this performance would have on the rest of our day.

We arrived, opened the door and got out, some of us more easily than others, and then shut the door off from life as we knew it…

It seems that we were late for the concert. It was already in progression. We knew when we arrived that we would have to follow the rules. We had to turn off everything from our lives; the cell, the TV, the radio, computer and most importantly, “the mind”.

We began to walk and quickly heard the concert. It felt loud and overwhelming at first. It felt crowded listening to it despite a lot of space provided. It was too much to hear, too much to absorb. And “the mind”, it wanted to come on, even though it knew it wasn’t invited. But it seemed to finally learn how to respect the rule.

As it cooperated, the concert began to take on a new dimension of sounds and feelings. It became soft, clearer, calmer and incredibly comforting. This concert became exceptional, being absorbed in every space of the mind and body.

And all that was needed to feel this was to just turn off everything else.

The concert never came to a close, but it was time we return to the car and journey back to home as we know and love it. But, we knew we had had an experience that gave us strength and renewal to our lives.

Corey, Carmel and Mom all took a moment to enjoy nature and listen to the truth of life. It was a concert that will never be forgotten. A lesson was learned, “turn it all off”, attend the concert of nature. It’s there for us all and is open at all times.

Looking back, I learned that writing about my emotions helped me face the changes that were happening to my life. It was a very cleansing process that I entered and I continue to do it.

Here are some tips if you are also dealing with the loss of your career:

  1. Try writing down emotions that are swirling in your head. You will gain more than you might realize with this process. Many write to the US Pain Foundation for help and I respond to them, but often I do not hear back from them. I believe this is because they’ve cleansed their emotions by just writing down their story and frustrations.
  2. Accept that you will have to redefine who you are. I was a teacher by profession, but have discovered I am still teaching, just in a different way.
  3. Remember you are not alone for many have also had to face the loss of their career. Try to find comfort in knowing this. I talk to myself and say that if they can do this, so can I!
  4. Mourn your losses. You are human and allowed to do this, but remember to move on from this loss too. You are more than your career. There are others things in life that will make you feel worthwhile and productive. It will take work to figure out what you will do next, but it is a worthwhile effort.
  5. Try to not get stuck on “Why me?” Instead, try to find a way to move on with acceptance and grace for others to learn from. I always remind myself that although my four sons are now adults, they are still observing how I handle my life, including this process of letting go and redefining. I want to be remembered by them for trying, fighting and not giving up.

I know it is heartbreaking to have to step away from a career, especially if it is one you love. But you also have to remind yourself that you have one life to live, and you need to redefine yourself and find things that will bring meaning, joy and happiness back, despite the loss.

I know this is hard to do, but the effort will pay off in the end. Despite illness, you can discover new things about yourself and have a positive impact in life. Be strong, reach out for support and may you, too, discover there is life despite your huge loss.

Ellen Lenox Smith and her husband Stuart live in Rhode Island. They 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.

Ellen recently published her new book, It Hurts Like Hell!: I live with pain -- and have a good life, anyway.”

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 Blamed in Prince Overdose

By Pat Anson, Editor

A medical examiner has confirmed widespread speculation that opioids were involved in the accidental death of pop star Prince. The surprise was the type of opioid that was found in the singer's system.

“The decedent self-administered fentanyl,” Dr. A. Quinn Strobl, chief medical examiner for the Midwest Medical Examiner’s Office, wrote in his widely awaited report, which you can see by clicking here.

The report was released six weeks after Prince's death and only covered the manner and cause of death. All other information is considered private under Minnesota law.

The medical examiner’s report is likely to focus new attention on the so-called opioid abuse epidemic, which is routinely blamed on prescription opioids. Fentanyl is a potent opioid more powerful than morphine, and when prescribed the drug is generally only given to people in severe pain.

However, the report does not state whether the fentanyl that killed Prince was from a prescription or if it was illicit fentanyl obtained through other means.

Illicit fentanyl is an odorless white powder that is typically combined with heroin or cocaine to boost their potency. In recent months it has increasingly been found in counterfeit pain medication sold on the streets.  

Thousands of people have died from fentanyl overdoses in the U.S. and Canada, but because of the nature of the drug it’s impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and sold as a street drug.

“Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl. Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl,” said a recent report from the Centers for Disease Control and Prevention, which nevertheless still classifies all fentanyl overdoses as prescription drug deaths.

Massachusetts and Rhode Island recently reported a “significant increase” in fentanyl-related overdoses, with nearly 60% of the fatal overdoses in those states now attributed to fentanyl. Rhode Island health officials say the shift to fentanyl worsened when “more focused efforts were undertaken nationally to reduce the supply of prescription drugs.”  

Prince’s body was found in an elevator at his Paisley Park estate near Minneapolis on April 21. There was immediate speculation the singer was addicted to pain medication that he took for hip pain, but the only opioid ever mentioned was Percocet.  In the days before his death, Prince reportedly sought help from an addiction specialist in California.

The singer’s use of painkillers and how he obtained them are now the focus of a criminal investigation. No charges have been filed and a judge has sealed all records in the case.

According to search warrant that was accidentally released and obtained by the Los Angeles Times, Dr. Michael Todd Schulenberg, a family medicine practitioner, treated Prince on April 7 and 20, the day before his death.

Senators Propose Tax on Opioid Pain Meds

By Pat Anson, Editor

A group of U.S. Senators has introduced legislation that would establish a federal tax on all opioid pain medication. If approved, it would be the first federal tax on a prescription drug levied directly on consumers.

The bill, called the Budgeting for Opioid Addiction Treatment Act, would create a one cent fee on each milligram of an active opioid ingredient in pain medication. Money from this “permanent funding stream” would be used to provide and expand access to addiction treatment.  

“A major barrier that those suffering from opioid addiction face is insufficient access to substance abuse treatment,” said Sen. Joe Manchin (D) of West Virginia. “This legislation will bridge that gap and make sure that we can provide treatment to everyone who makes the decision to get help. I look forward to working with my colleagues to get this bill passed so we can take another step forward in the fight against opioid abuse.”

Sens. Amy Klobuchar (D-MN), Jeanne Shaheen (D-NH), Angus King (I-ME), Heidi Heitkamp (D-ND), Tammy Baldwin (D-WI) and Bill Nelson (D-FL) are co-sponsoring the bill, which has been dubbed the “LifeBOAT” Act.

“By establishing a reliable stream of funding, this bill will bolster treatment facilities across the country, increase the amount of services available, and support people as they fight back against addiction – all while doing so in a cost-effective way,” said Sen. King.

The opioid tax would raise an estimated $1.5 billion to $2 billion per year. In an interview with the Portland Press Herald, King said the fee would range between 75 cents and $3 for a 30-day prescription, depending on the dose. He claimed many patients wouldn’t have to pay the additional cost because their insurance would cover it.

King said treatment programs need funding, and tacking the cost onto the price of the drug is a fair way to do it, much like automakers are required to install seat belts and air bags in vehicles.

“The obvious way to fund this is to build it into the price of the drug,” said King. “The cost of the drug should reflect the danger of the drug.”

Although most of the press releases and public statements from the senators avoid using the word “tax” and refer to it as a fee, the bill itself doesn’t hide behind semantics. The legislation would apply to the sale of “any taxable active opioid” and would amend the Internal Revenue (IRS) Code to make it possible.

The federal government and the vast majority of states do not levy a sales tax on prescription drugs. Only two states, Illinois and Georgia, currently have a sales tax on prescription medication.

"I don't understand how, in a world where we are getting upset about the 'tampon tax' we find it perfectly socially acceptable to tax chronic pain patients to pay for addiction treatment," said Amanda Siebe, who suffers from Chronic Regional Pain Syndrome (CRPS) and is a founder of the advocacy group #PatientsNotAddicts.

"With less than 5% of chronic pain patients becoming addicted to opiates, this leave the other 95%, who are often some of the poorest in America and have nothing to do with addiction or addiction treatment, to pick up the tab for addiction treatment. I find myself truly disappointed and ashamed of our government. This tax is discriminatory and we are going to fight it."

The LifeBOAT Act would exempt buprenorphine, an opioid used to treat addiction, from taxation, as well as all over-the-counter pain relievers such as acetaminophen. Cancer and hospice patients would be exempted from the opioid tax, although they would have to apply for a rebate to get their money back.

The discount or rebate mechanism shall be determined by the Secretary of Health and Human Services with input from relevant stakeholders, including patient advocacy groups. The discount or rebate shall be designed to ensure that the patient or family does not face an economic burden from the tax,” a fact sheet on the bill states.

Sen. Manchin told to his colleagues that there would be little or no opposition to the bill.

“There’s not one person who will lose a vote over this. Not one person. You won’t be accused of voting for a tax,” Sen. Manchin said during a news conference announcing the bill.  He noted that no Republican senators have signed on as co-sponsors.   

“This is something that’s much needed, overdue and they all recognize it, but they’re scared to death. They’ve taken the (no tax) pledge. They’re scared to death somebody will use it against them. I’ll be standing beside my Republican colleagues if any Democrat tried to attack them and said they tried to vote for a tax,” Manchin said.

To read the full text of the bill, click here.

To watch a video of the press conference, click here.

Canada Fights Wave of Fake Pain Pills

By Pat Anson, Editor

Canada’s Healthy Ministry today added a dangerous synthetic opioid – known as W-18 -- to a list of illegal controlled substances after the drug was found in counterfeit pain medication sold on the street.

W-18 has been used recreationally in Europe and Canada over the past two years. Recently, Canadian law enforcement have found W-18 disguised to look like legitimate prescription pain medication, such as oxycodone. W-18 is believed to be manufactured in China. It is blamed for one overdose death in Calgary.

"Substances like W-18 are dangerous and have a significant negative impact on some of the most vulnerable people in our society,” said Jane Philpott, Canada’s Minister of Health.

Classifying W-18 as a Schedule I controlled substance – the same class as heroin and cocaine -- makes its production, possession, importation and trafficking illegal in Canada. W-18 was originally developed in the 1980’s as a pain reliever at the University of Alberta, but was never marketed commercially. It is 100 times stronger than fentanyl, another synthetic opioid that is also increasingly being disguised as pain medication and sold on the street.

A Health Canada analysis of counterfeit oxycodone and Percocet pills confirmed the presence of W-18 last month, according to The Globe and Mail.

“Of particular concern is a green coloured oxycodone tablet marked CDN80,” said Corporal Eric Boechler of the Royal Canadian Mounted Police. "It was discontinued as a prescription tablet in 2012, so virtually any encountered on the street today are counterfeit and will contain fentanyl and/or other potent synthetic opioids such as W-18.”

Last week police in North Bay, Ontario seized hundreds of fake fentanyl pills that were disguised to look like 30 mg oxycodone prescription pills. The pills are blue and imprinted with “A 215.”

Counterfeit fentanyl pills have previously been found in western Canada, where they are blamed for dozens of overdose deaths. This was the first time they were found in North Bay, according to BayToday.

“I don’t think these illicit pills coming in from China are aimed at pain patients," said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.

NORTH BAY POLICE PHOTO

"They appear to be aimed at those who are willing to try ‘new’ things and the usual addiction population. I don’t know what possesses the younger groups to try this stuff from the street as they know full well what could happen.”

As Pain News Network has reported, fake fentanyl pills have also been appearing in the United States, where they are blamed for at least 14 deaths in California and 9 in Florida.  Some pills were purchased off the street by pain patients who were unable to get prescription medication through a doctor.

Massachusetts and Rhode Island have both reported an “alarming” rise in fentanyl overdoses. Over half the opioid overdose deaths in those states are now blamed on illicit fentanyl, not prescription pain medication.

Lasers Work for Fibromyalgia, But Why So Pricey?

By Ryan Baker, Guest Columnist

I’ve had severe fibromyalgia for 14 years, and I’ve been disabled as long. Without a doubt, the pain is certainly a central issue, along with the severe fatigue, flare ups, and crashes.

It’s an absolutely miserable disease that’s intrusive and destructive. I broke commitments that really shouldn’t be broken, which put a strain on personal relationships. The pain is a level of suffering that can easily push one to insanity or worse.

I found laser therapy last October at my chiropractor’s office, where they have a $25,000 K-Laser. While it worked great, I could not get enough coverage all over my body as often as I needed, and it was just too expensive for office visits.

I was getting good results, so I dove into trying to find a laser I could use at home, and settled on a very effective unit for $2,500. Pricey, but worth the convenience of having one I could use whenever I wanted.

Since receiving the TQ Solo laser in late January, I have not taken any prescription pain pills. My hydrocodone, methocarbamol, and Klonopin, which I had whittled down long before the laser to “emergency use only” (once every 3-7 days), have gone untouched since I’ve had the laser.

I have taken 2 ibuprofens for a dehydration headache, but no other OTC meds, aside from vitamins. I take a sleep aide and blood pressure medication, that’s it.  

TQ SOLO LASER

It still astonishes me how well laser therapy works. I still suffer from fibro fog, low energy, and all of the other problems associated with fibromyalgia, but my pain levels have dropped from a constant 7-9 out of 10, to a much more tolerable 2-4. I use the laser between 20 minutes to an hour or more a day, and rather than become resistant, my body seems to respond better after getting used to treatment.

Some areas are completely free of pain at times, which hasn’t happened in 14 years, but if I stop treatment the pain returns. It’s not a cure, my fibro is still terribly limiting, but it’s an amazing treatment for the pain. The decrease in my personal suffering has been outstanding.

The laser is like an alarm clock for under active mitochondria, only stimulating the cells in need. Properly functioning tissue (not in pain) have little to no response, while damaged or inflamed tissue “wake up” and begin healing. Some areas need daily treatment, like my calves and back, while other areas can go days between treatments.

If you’re a fan of science fiction, this is the coolest thing since the smartphone made Captain Kirk’s communicator look silly.

I find the 5 hertz setting, the deepest setting, to be the most beneficial. It’s like a massage, but deeper, and there’s no pain from working tender tissue. In fact, there is very little sensation during treatment. If I can feel the treatment at all, it’s usually a mild tingle or twitch, which I consider a signal to treat more intensely.

The laser does not hurt or burn. It’s very comfortable and soothing, and treating before bed is fantastic for sleep. I don’t wake up with that stiff, poisonous feeling ache anymore.  

I began researching all sorts of red light therapy. I’ve tried several, along with some LED only therapies. I even tried a heat lamp. While the heat lamp and LED therapies felt okay, they were no match for the laser.

While searching for other light therapy devices, I found the Handy Cure. It has a striking resemblance to the TQ Solo I had purchased, but it was selling for under $600. Same frequency settings, same power, same everything. Only the handle was different, as far as I could tell.

I looked it up, and it was made by the same company that makes the TQ Solo. But why so much cheaper? Was it a knock off? Was it less potent, or somehow lower quality? I put an order in.

After using the Handy Cure side by side for weeks with the TQ Solo laser, I can’t tell any difference. It’s just as effective. I’d overpaid by $2,000. I’m not wealthy, and I assume most fibro patients aren’t either, so that hurt.

I started looking into other lasers and found the Game Day laser. It looks exactly like the Handy Cure, no doubt about it, only the labels were different. Instead of variable, 50 hertz, and 5 hertz, the menu is a simple 1, 2, and 3. It appears to me that the Game Day is simply a rebadged Handy Cure.

handy cure laser (left) and TQ solo laser(right)

You’d think the Game Day would be priced more like the Handy Cure, but it’s listed for $2,995! My jaw dropped when I saw that, but the picture became crystal clear. All of these lasers had the same manufacturer and, except for subtle differences, appear to be essentially the same products.

But one sells for under $600 and the other is marked up to nearly $3,000. Why?

I’m not against the profit motive, but I am when people are suffering and treatment is unnecessarily kept out of reach.   

One month later, I have become a distributor for the Handy Cure, making YouTube videos to bring laser therapy to the attention of fellow fibromyalgia patients. It’s been a big adjustment, but a meaningful one. I have no idea what I’m doing, I just know lasers work, and they take some of the “crazy” out of fibromyalgia.

Fibromyalgia pain is real and physical, not some form of hypochondria or mental illness. If it was, the laser would have no physical effect. But it works reliably for my pain, even when I’m particularly depressed.  

I feel vindicated, because something finally works for the pain when powerful opiates barely made a dent. It’s not in my head. 

(Editor's note: Since this article was first published, Pain News Network has been contacted by Max Kanarsky, President and CEO of Multi Radiance Medical, the maker of the Handy Cure laser. Mr. Kanarsky maintains that the "Handy Cure" featured in this article is a counterfeit reproduction of his product, is not FDA cleared, and "might present a hazard to users.")

Ryan Baker lives near Sacramento, California. You can learn more about laser therapy by visiting his website, Chronic Pain Laser.

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Teenage Marijuana Problems Declining

By Pat Anson, Editor

A large survey of nearly a quarter of a million adolescents indicates the number of American teenagers with marijuana related problems is declining – despite the fact that nearly half the states have legalized medical marijuana or decriminalized it.

Researchers at Washington University School of Medicine in St. Louis studied a national database on drug use by over 216,000 young people, ages 12 to 17, and found that the number dependent on marijuana or having trouble in school and in relationships declined by 24 percent from 2002 to 2013.

During the same period, the number of kids who said they used marijuana in the previous 12 months fell by 10 percent. The drops were accompanied by reductions in behavioral problems, such as fighting, shoplifting and selling drugs.

Researchers believe the two trends are connected -- as kids became less likely to engage in problem behavior, they are also less likely to have problems with marijuana.

"We were surprised to see substantial declines in marijuana use and abuse," said lead author Richard Grucza, PhD, an associate professor of psychiatry at Washington University School of Medicine

"We don't know how legalization is affecting young marijuana users, but it could be that many kids with behavioral problems are more likely to get treatment earlier in childhood, making them less likely to turn to pot during adolescence. But whatever is happening with these behavioral issues, it seems to be outweighing any effects of marijuana decriminalization."

The new study is published in the Journal of the American Academy of Child & Adolescent Psychiatry. The data was gathered as part on ongoing study called the National Survey on Drug Use and Health, which surveys young people in all 50 states about their drug use, abuse and dependence.

In 2002, just over 16% reported using marijuana during the previous year. That number fell to below 14% by 2013. Meanwhile, the percentage of young people with marijuana-use disorders declined from around 4% to about 3%.

"Other research shows that psychiatric disorders earlier in childhood are strong predictors of marijuana use later on," Grucza said. "So it's likely that if these disruptive behaviors are recognized earlier in life, we may be able to deliver therapies that will help prevent marijuana problems -- and possibly problems with alcohol and other drugs, too."

A similar survey, the University of Michigan's Monitoring the Future Study, found that marijuana use by teens has leveled off since 2010, but was still at stubbornly high rates. In 2015, about 35% of 12th­ graders reported using marijuana at least once in the past year.

The same survey found that teenage abuse of prescription opioids declined for the fifth year in a row. Only about 5% of 12th graders reported using an opioid pain medication in the last year, and the number reporting that prescription opioids were “fairly easy” or “very easy” to get also continues to drop.

Medical marijuana is legal or decriminalized in 24 states and the District of Columbia, and several states are considering legalization. Opponents have long maintained that legalization would have harmful effects on young people.

“Perhaps the biggest public health concern around medical marijuana liberalization and legalization concerns the potential impact on teenagers, who could have greater access to it as a drug of abuse and who may increasingly see marijuana as a ‘safe, natural’ medicine rather than a harmful intoxicant,” wrote Nora Volkow, MD, director of the National Institute on Drug Abuse, in Alcoholism & Drug Abuse Weekly.

“Although there is still much to learn about marijuana’s impact on the developing brain, the existing science paints a picture of lasting adverse consequences when the drug is used heavily prior to the completion of brain maturation in young adulthood. In teens, marijuana appears to impair cognitive development, may lower IQ and may precipitate psychosis in individuals with a genetic vulnerability.”

According to a recent report from the Colorado Department of Public Safety, where marijuana has been fully legalized since 2013, nearly a third (31%) of young adults, ages 18 to 25, have used in marijuana in the last 30 days, up from 21% in 2006. The number of juveniles on probation testing positive for THC has also increased since legalization.  

Painkillers Cause Chronic Pain? Rats!!!

By Pat Anson, Editor

A provocative new study is likely to stir fresh debate about the risks associated with opioid pain medication. It’s not another study about addiction or overdose, but whether opioids actually increase chronic pain, a condition known as hyperalgesia. 

An international team of researchers found that even just a few days of morphine can make chronic pain last for several months by intensifying the release of pain signals in the spinal cord.

But there’s a catch. The research was conducted on laboratory rats.

"We are showing for the first time that even a brief exposure to opioids can have long-term negative effects on pain," said Peter Grace, PhD, an assistant research professor at the University of Colorado-Boulder's Department of Psychology and Neuroscience. "We found the treatment was contributing to the problem."

Grace and his colleagues found that damaged nerve cells in rats send a message to spinal cord immune cells known as glial cells, which normally act as "housekeepers" to clear out unwanted debris and microorganisms. The first signal of nerve pain sends glial cells into alert mode, priming them for further action.

"I look at it like turning up a dimmer switch on the spinal cord," said Grace.

Nerve pain was induced in the rats by slicing open their thighs. A fine thread was then tied around a major nerve. Over the next three months, researchers poked the rats' paws with stiff nylon hairs to see how sensitive they were to pain.

Injured rats that were not treated with morphine eventually recovered and did not show pain, but those that were treated with morphine for five days remained sensitive to pain. Researchers believe the morphine stimulated their glial cells and sent them into overdrive. They liken the effect to being slapped in the face twice.

"You might get away with the first slap, but not the second," said co-author Linda Watkins, a Distinguished Professor at CU Boulder. "This one-two hit causes the glial cells to explode into action, making pain neurons go wild."

"The implications for people taking opioids like morphine, oxycodone and methadone are great, since we show the short-term decision to take such opioids can have devastating consequences of making pain worse and longer lasting," said Watkins. "This is a very ugly side to opioids that had not been recognized before."

Patient advocates had a mixed reaction to the study.

“Linda Watkins is doing some awesome work. We know that glial cells are the key to pain generation. Exactly how is still poorly understood,” said Terri Lewis, PhD, a rehabilitation specialist who teaches in the field of Allied Health. We know that 'something' triggers inflammation and maintains it. When that trigger is turned up high, glial cells are activated."

“Generalizing from rats to humans is not okay. But if the same results are found in pigs, there is probably something to talk about,” added Lewis.

“There is enough evidence in humans that opioids work and do not make pain worse,” said Janice Reynolds, a retired nurse and patient advocate.  “Even the work in hyperalgesia has not, contrary to claims by opiophobics, translated well from rats to humans. The write up is extremely negative and tends to lead one to believe the results may be slanted or even poorly interpreted. The fact they are singling ‘chronic pain’ out is a warning sign.”

The CU-Boulder study, which is published online in the Proceedings of the National Academy of Sciences, does have an impressive pedigree, including researchers at the University of Adelaide in Australia, the University of North Carolina, the Chinese Academy of Sciences, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Tsinghua University in Beijing.

The study was funded in part by the American Pain Society, Australia's National Health and Medical Research Council, the National Natural Science Foundation in China, the National Institute on Drug Abuse, the National Institute of Dental and Craniofacial Research and the National Institute of Alcohol Abuse and Alcoholism.

Let’s Go Crazy: Lessons Learned From Prince

By Emily Ullrich, Columnist

As many call for Prince’s death to be a “wake up call” to America about the dangers of prescription drugs, I propose a different wake up call.

If the allegations are true, and Prince did die of an overdose, I propose that we use the messages that Prince preached and lived: messages of understanding and compassion. America needs to “wake up” to the oppression and depression that keep many chronic pain patients quiet about their conditions, and the reprehensible stigma with which this country punishes pain patients.

By now, many of us have read Lorraine Berry’s insightful piece, “Prince did not die from pain pills -- he died from chronic pain.” Perhaps the most poignant statement Berry made was, “Chronic pain kills. It killed Prince. It’s time to talk about it.”

We love to find flaws in celebrities, particularly those of a scandalous nature. Instead of finding compassion for a beloved icon, we are quick to turn our backs and make the pain of loss easier by falling prey to the judgmental “celebrity druggie” stereotype.

I propose that we pay tribute to Prince in a way I think he would have appreciated, by using this tragedy to start a conversation about the differences between addiction and dependence, about the commonality of chronic pain, and the deeply rooted prejudice associated with the disease of chronic pain.

But, I also propose we take it one step further, and affect change. We need not complain to each other endlessly about “us” (those who suffer chronic pain) and “them” (the healthy), and the great rift between. We have been doing that for years, and although it’s nice to know that someone else “gets it,” it is not other chronic pain sufferers who we need to understand our plight.

As much as we may not like to admit it, there are some similarities between addicts and chronic pain patients -- neither of us get the treatment or respect we need and deserve. We tend to be equally as judgmental of addicts, deeming them lower on the social hierarchy than us, in the same way as healthy people think of us to them.

I am not suggesting we continue to blur the lines between addiction and dependence, but I am suggesting we consider fighting this battle together.

There was a time when white people who sympathized with black civil rights activists were considered “almost as bad” as the “uppity blacks,” who demanded their well-deserved, long overdue rights to equality. Eventually, most people began to understand that treating people differently, as though they were not entitled to the same liberties, was intrinsically wrong. Many didn’t like it, but they had to abide by it. Understanding would only came later.

The same can be said about the lesbian, gay, bisexual and transgender community, and other groups that differ from what society considers “normal.” On many levels, these groups still struggle with inequities, just as we do, but they are making strides. And we must, too.

As it stands, the current political and social climate surrounding pain medication and chronic pain itself, not to mention addiction, have become civil rights issues. We no longer need to worry about gaining understanding, as much as we do defending our basic human rights. Although understanding is a part of the answer and a desirable outcome, sometimes people must be pressed to follow rules against discrimination. 

I was an outsider long before I was a chronic pain patient. I am a long–time artist, activist, outspoken woman, and all-around “weirdo” in many circles. But, I’ve never been ashamed of that. In fact, I’ve always taken pride in my one-of-a-kindness, having been voted “Most Unique” in my class of ‘93 at a conservative, rural high school.

To me, Prince always seemed a kindred spirit—emotional, passionate, creative, misunderstood. Now that I know he suffered chronic pain, and that he may have had double hip replacement, I find myself even more drawn to his spirit of individuality and strength. I find myself respecting him and relating to him on an entirely different level now.

His elusive, gentle, humane, kind, pained soul was not merely the cliché tortured soul of an artist, but also the tortured soul of a human being who must present a strong face, while holding back the physical and emotional pain, loneliness, and often hopelessness that all chronic pain patients can relate to.

In the name of Prince, I propose a revolution. The play on words is not accidental. Prince revolutionized music, fashion, art, gender and sexual perceptions, and more. He was for many of us the embodiment of our coming of age and understanding. Let us memorialize him in a way he would appreciate—by standing up for who we are, and by not being afraid or embarrassed of what people will think or say.

And like his band, The Revolution, let us stand with him, and make the world see that we will not be shamed, shunned, or disenfranchised, and that we will stand up for our rights and be prepared to explain and defend our cause -- life.

“Dearly beloved: We are gathered here today to get through this thing called life. Electric word, life. It means forever and that's a mighty long time.”

In Prince’s honor, let’s go crazy and do something unheard of. Understand each other and learn from this.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, endometriosis,  Interstitial Cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, bursitis, depression, multiple chemical sensitivity, and chronic pancreatitis

Emily is a writer, artist, filmmaker, and has even been an occasional stand-up comedian. She now focuses on patient advocacy for the International Pain Foundation, as she is able.

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.

Most Patients Don’t Think Opioids Are Risky

By Pat Anson, Editor

A small survey of chronic pain sufferers may give physicians a better understanding  of why many patients are reluctant to reduce or discontinue their use of opioids. Most patients simply don’t see themselves at risk of abuse and addiction, and think they can manage their opioid use safely.

Researchers at the University of Colorado School of Medicine and the VA Eastern Colorado Health Care System conducted in-depth interviews with 24 patients who were on long-term opioid therapy for chronic non-cancer pain. Six of the patients were still taking their regular opioid dose, 12 were tapering, and 6 had discontinued the use of opioids.

When asked about specific concerns related to opioid medications, patients were generally aware of opioid overdose as a potential complication but did not perceive themselves to be at risk,” said lead author Joseph Frank, MD, assistant professor of medicine and a primary care physician at the VA Medical Center in Denver.

The majority of patients described a long history of opioid medication use without prior overdose and cited this as evidence of their ability to safely take opioid medications. Patients attributed overdoses to others using opioids in risky ways or overdosing intentionally rather than accidentally.”

The survey findings, published in the journal Pain Medicine, include comments from some of the patients.

“Overdose? No. I’m very mature, very conscious, very intelligent as far as adhering,” said a 52-year old man who was still taking his regular opioid dose.

“The concern is that if they increase my opioid dosage, I could stop breathing. It’s ridiculous,” said another patient who was also taking his normal dose.

Even patients who were tapering or had discontinued opioids said that overdose risk was not their primary motive for cutting back. Others said they were so focused on pain relief they were willing to overlook the side effects of opioids.

“I like to research everything, but the pain was so severe I didn’t care about anything else... I don’t think that people actually consider the side effects and what not when it comes to something like that. I think that they just want the pain to go away,” said a 46-year old woman who was tapering.

“I don’t think people in chronic pain think about long term. We are basically, how do I get through today? I just gotta get through today,” said another woman who was still taking her regular dose.

Many patients said they had extensive experience with non-opioid therapies and found they weren’t effective. That led to pessimism about their ability to manage pain without opioids.

“I needed help desperately by the time [hydrocodone] was prescribed for me... I had taken ibuprofen, Aleve, everything over the counter, and it did nothing to help me at all. So I knew I needed more help, stronger help,” said a 73-year old woman who was tapering.

"Throughout my life, the doctors have done everything, trying to get me to exercise, to stretch, things that shocked my muscles,” said a 58-year old man. “In the ‘70s, they put some kind of body cast on me that I wore for months... Gosh, I’ve had everything. I’ve went through all the minor ones like Tylenols and aspirins and stuff, you know... I’ve went through a few years on Morphine. I’ve went to a time on Oxycodone and OxyContin, Vicodin, Tramadol. Now I’m on Fentanyl patches.”

Several patients said they eventually decided to taper when they realized that opioids weren’t helping as much or reduced their quality of life.

“The pills turned out horribly for me... I wasn’t caring for myself. I wasn’t bathing. I was sleeping all the time... Everything in my life was such a mess, and my husband was, you know, really worried about me... My husband [told me] that this is bad. This is really bad. You’re not doing well,” said a woman who was tapering.

“I didn’t stop under doctor’s orders or discussion or anything. I just got up one day and I’m done,” said a 60-year old male patient. “Instead of taking four, I took three and I did that for a couple of weeks and then I took two and then I took one. I never felt any discomfort or anxiety or anything so... it worked for me.”

Patients who tapered successfully emphasized the support they received from family, friends and healthcare providers in helping them make the transition.

“My doctor is very conscientious, and I respect her very much... It wasn’t her idea to take me off OxyContin,” said a 73-year old woman. “I just quit cold turkey, which was difficult... She was overjoyed. She thought it was just great that I didn’t need it anymore."

“It’s not much worse without the medication as it is with it. After you’ve taken it for a while, it doesn’t do any good. That’s what I’ve found,” said a 61-year old woman. “But that’s hard to convince people of it. They look at me like I’m nuts, but it’s true... I mean my pain is not any more severe than it was when I was taking all that stuff.”

“I am more alert since I stopped taking [OxyContin], and I need less sleep, which is a blessing. So I’m able to do more things with my life,” said a 72-year-old female patient.

The researchers admit their study was small and may not be representative of the pain community. But they think there are important lessons to learn from it, because tapering “may become an increasingly common patient experience.”

"To achieve goals of improving quality of life and preventing opioid-related harms, we need better evidence and more resources to support patients both during and after this challenging transition," Frank said.  It will be important to ensure that patients' voices are heard in the national conversation about these medications."

Are CDC Opioid Guidelines Causing More Suicides?

By Pat Anson, Editor

A recent report by the Centers for Disease Control and Prevention documented a disturbing trend in suicides in the United States. Suicides increased by 24 percent from 1999 to 2014, and are now the 10th leading cause of death in the country.   

In 2014, nearly 43,000 Americans committed suicide, over twice the number of deaths that have been linked to opioid overdoses. Most often suicides are blamed on depression, mental illness, financial problems, or drug and alcohol abuse. Untreated chronic pain is rarely even mentioned.

But in recent months there have been a growing number of anecdotal reports of pain patients killing themselves because they can no longer get pain medication or find doctors willing to treat them.

Donald Alan Beyer of Bovill, Idaho was one of them.

After years of suffering from chronic back pain, the disabled logger went into his backyard on May 8 – his 47th birthday --- and shot himself in the head.

“He was in so much pain he could barely get out of bed to go to the bathroom. I guess he felt suicide was his only chance for relief,” says Beyer’s son, Garrett.

“I have witnessed my Dad in more pain than any one person should deal with every day of his adult life due to degenerative disc disease that was made so much worse by an accident on the job that broke his back. This and the eventual hole in the healthcare system focused on ignoring people with chronic pain led to his suicide this month.”

That hole in the healthcare system turned into an abyss when Beyer’s doctor retired last year. Beyer searched frantically for a new doctor, according to his son, but was unable to find anyone willing to take a new patient with chronic pain.

After months without pain medication, Beyer reached his breaking point.

DONALD BEYER

My dad was a great man and worked through the pain every day as a logger to support his family,” says his son. “Even in his suicide all he thought about was his family. He worked up the strength to go outside before he shot himself in the head specifically so he could leave his house to my little brother. If that isn't the model of what we should all be then I don't know what is.”

Garrett Beyer is sharing the painful memory of his father’s death because he wants government officials, politicians and anti-opioid activists to recognize that efforts to discourage opioid prescribing are having devastating consequences for pain patients and their families across the country. 

“I use such painfully vivid expressions in hopes that the people in the CDC and DEA and everywhere can maybe experience for a second what a person with chronic pain and their families live with every day,” said Garrett, who suffers from many of the same back problems his father did.

“I have inherited his genetic spine problems, and after a car accident when I was 19 crushed 2 of my already flawed lumbar discs leading to my first spine surgery, I suddenly plummeted quite literally into my Dad's painful shoes. I am now terrified that I will also follow in his devastating footsteps.”

Garrett is 27, married and has two children, but says he is “constantly plagued” by the feeling that his wife and kids deserve better.

“I have now had 2 spine surgeries in the past 5 years, which included 3 discectomies and laminectomies, leaving me completely disabled and preparing for yet more surgeries in hopes that one day I can be normal,” Garrett said. “But until the day that medical technology can simply cure chronic pain, we could use all the compassion we can get, rather than the exact opposite that we are getting now.”

Impact of CDC Guidelines

In mid-March, the CDC released controversial guidelines that discourage doctors from prescribing opioids for chronic pain. The guidelines are voluntary and were only meant for primary care physicians, but many other doctors appear to be adopting them, even pain management specialists. Two pain clinics in Tennessee recently said they would stop prescribing opioids to patients “in response to changing regulations.”

Pain News Network has been contacted by dozens of pain patients in recent months who say their physicians are weaning them off opioids or abruptly cutting them off completely.

Others say they are being dismissed by their longtime doctors – often with the excuse of a failed urine drug test. Still others say they are contemplating suicide, rather than face a life of intractable pain.

A 67-year old Florida woman who has suffered from migraines since the age of five wrote to us, saying she was having trouble finding a doctor.

“I finally have an appointment with a doctor in two months who will then refer me to a pain clinic which no doubt will take another two months. At this point I have to live in pain. I may become one of the suicide statistics,” said Lana.

“I was told by several people including a cousin that I should just check into a nursing home. All I need is medicine for pain. I'm not ready to be written off. A cab driver told me that a lot of retirees with pain issues are resorting to buying heroin on the street because it's easier to get and cheaper! Is that what we want for people who led productive lives and are now in pain?”

Another woman, who suffers from chronic back and abdominal pain, is worried that her physician will stop prescribing pain medication.

“My pain management doctor constantly makes comments that he's going to stop all meds. No reason or plan.  If this happens I will be forced to go on disability, I will lose my job, insurance benefits, and means of caring for myself and family,” she wrote. “I rarely speak to avoid upsetting him. This doctor has full control of my life with a swipe of his pen.”

“I’ve been on Percocet and Vicodin for 15 years passed every test,” said a 51- year old Massachusetts woman with chronic back pain who failed a drug test last month and was dismissed by her doctor.

“I was discharged. Told me I was positive for morphine, methadone, cocaine, Klonopin and no Percocet in my system. I have never ever done those drugs ever. I told doctors wouldn't all that kill me? Oh and positive too for Suboxone. I'm in shock. What went wrong?”

What went wrong is that her doctor is not following the CDC’s guidelines, which urge physicians not to dismiss patients for a failed drug test because it “could constitute patient abandonment and could have adverse consequences for patient safety.”

Unintended Consequences

“I'm a chronic pain sufferer affected by the new law to curb addiction,” Jeannette Poulson wrote to us. “I suffer severe pain disorders and no longer have access to my previously working medications. I've never had a history of abusing my medications, and the quality of my life has been greatly diminished.”

Poulson has a question for CDC director Tom Frieden, who said the guidelines couldn’t wait because “so many people are dying” from overdoses.

“Then I ask you, are you willing to deal with a new epidemic of increased suicide rates, as many are dying of a result of unintended suffering?” said Poulson.

We'll never know just how many patients kill themselves because their pain was untreated or under-treated. Experts believe many suicides go unreported or are misclassified as accidental, often covered up by grieving family members or accommodating medical examiners.

In some cases, as we learned with Sherri Little (see “Sherri’s Story: A Final Plea for Help”), it takes months or even years for someone to acknowledge that a loved one died at their own hands.

The fallout from the CDC’s guidelines – which were released a little over two months ago – was in many ways predictable. In our survey of over 2,200 pain patients last fall, many predicted there would be unintended consequences if the guidelines were adopted.

  • 90% thought more people will suffer than be helped by the guidelines
  • 78% thought there would be more suicides
  • 76% thought doctors would prescribe opioids less often or not at all
  • 60% thought pain patients would get opioids through other sources or off the street
  • 70% thought use of heroin and other illegal drugs would increase

It didn’t take long for drug dealers to begin targeting pain patients as potential customers. Counterfeit pain medication made with illicit fentanyl -- disguised as Norco, oxycodone and other medications -- have recently appeared in several states. The so-called “death pills” are blamed for at least 14 deaths in California and 9 in Florida.

Rhode Island has reported a “significant increase” in fentanyl-related overdoses since March, with a whopping 60% of the fatal overdoses in that state now attributed to fentanyl. Rhode Island health officials say the shift began when “more focused efforts were undertaken nationally to reduce the supply of prescription drugs.”  

We’re still in just the early stages. How have the CDC guidelines affected you and your family?

Leave a comment below or send me an email at editor@painnewsnetwork.org.

FDA Approves New Drug Implant

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved the use of a new drug implant for the treatment of opioid addiction.  Probuphine is the first implant of its kind approved by the agency and could potentially be a game changer for other medical conditions such as chronic pain that require steady doses of medication around-the-clock.

Probuphine is designed to be inserted into the arm beneath the skin, where it delivers a low dose of burprenorphine directly into the bloodstream for up to six months.  

Buprenorphine is an opioid itself, but when combined with naloxone, the medication reduces cravings for opioids. Until now the drug has only been available as a pill or film strips placed under the tongue.

For many years buprenorphine was sold exclusively under the brand name Suboxone, but several pharmaceutical companies have entered the lucrative addiction treatment market and now make versions of their own. As many as 2.3 million people who are dependent on opioid pain medication or heroin could benefit from buprenorphine treatment,

FDA approval was a major win Braeburn Pharmaceuticals and its partner, Titan Pharmaceuticals (OTC: TTNP), which holds the rights to the implant technology. Titan and Braeburn were stunned in 2013 when the FDA denied approval of the implant and asked for new clinical studies proving Probuphine’s effectiveness.  

Results from a recent Phase III study showed that over 85% of the patients who had the implant abstained from using illicit opioids for six months, compared to about 72% of patients who used buprenorphine film strips that were taken daily.

"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Robert Califf, MD. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Expanding the availability of addiction treatment is a major goal of the Obama administration. The White House has asked Congress for an additional $1.1 billion to fight opioid abuse, with much of the money earmarked for addiction treatment. The administration has also proposed doubling the number of patients that doctors can treat with buprenorphine from 100 to 200.

Buprenorphine can be abused and is a popular street drug that is used to get high or to ease withdrawal pains from illegal opioids such as heroin. An implant will be much more difficult to abuse, since it can’t be crushed or liquefied for snorting or injecting. It’s also less likely to be diverted.

Probuphine is expected to cost about $1,000 a month. It consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm. Administering Probuphine will require special training because it must be surgically inserted and removed.

The most common side effects are pain at the implant site, as well as itching, redness, headache, depression, constipation, nausea, vomiting, back pain, toothache and oral pain. The FDA is requiring post-marketing studies to establish the safety and effectiveness of the implants.

Probuphine was developed using a patented implant technology called ProNeura, which is designed to provide continuous levels of medication in the blood. Titan is also developing implants to treat Parkinson’s disease and hypothyroidism, and its CEO told Pain News Network that ProNeura could also potentially be used to deliver pain medication.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” said Titan CEO and President Sunil Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting.”

“It is part of our plan to move into pain because pain and opioid addiction are so interconnected and we think there are ways, by treating patients with a less abuse-able formulation, you could actually help alleviate the addiction problem,” Behshad Sheldon, President and CEO of Braeburn, told PNN in an earlier interview.

The Coming ‘Economic Bonanza’ in Addiction Treatment

By Pat Anson, Editor

The addiction treatment industry is lobbying hard for a proposed rule change to expand the number of patients that doctors can treat for opioid addiction. At stake is hundreds of millions of dollars in potential new business, much of it paid for by taxpayers.

The Obama administration has proposed doubling the maximum number of patients that a doctor can prescribe with buprenorphine from 100 to 200. Buprenorphine is an opioid that can be used to treat both pain and addiction. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

For many years the drug was sold exclusively under the brand name Suboxone, but it is now produced by several different drug makers and generates nearly $2 billion in sales annually.

Because buprenorphine is an opioid that can also be abused, prescribers have to register with the Drug Enforcement Administration and undergo special training. Over 33,000 doctors have done so, but most are limited to just 30 patients.

About 10,000 physicians are currently allowed to prescribe buprenorphine to the maximum number of 100 patients.

Many addiction experts say the patient limits have restricted access to a valuable treatment tool, especially in rural areas where fewer doctors are certified to prescribe buprenorphine. According to the Health and Human Services Department (HHS), about 2.3 million people who are dependent on opioid pain medication or heroin could benefit from buprenorphine treatment, but many lack access to the drug because of limits on prescribers.

In a joint letter to HHS Secretary Sylvia Burwell, the American Psychiatric Association, American Academy of Addiction Psychiatry, and the American Osteopathic Academy of Addiction Medicine stated that as “the number of people addicted to these opioids increases, there continues to be a shortage of physicians who are appropriately trained to treat them. The shortage severely complicates and impairs our ability to effectively address the epidemic, particularly in many rural and underserved areas of the nation.”  

While the goal of treating opioid addiction is laudable, little attention has been paid to the diversion of buprenorphine or the financial incentives that doctors have to prescribe it.

“This proposed rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine,” HHS says in an extensive analysis of the rule change. “We believe that this may translate to a financial opportunity for these physicians.”

HHS broadly estimates the added cost of treating new patients at between $43.5 million and $313 million in the first year alone. Many of the patents are low-income and the bills for treating them – about $4,300 annually for each patient – will often be paid by Medicaid. The Obama administration has asked Congress for an additional $1.1 billion to fight opioid abuse, with much of the money earmarked for addiction treatment.

The additional cost to taxpayers for expanding buprenorphine treatment, according to HHS, will be more than offset by the health benefits achieved by getting opioid addicts into treatment, which the agency generously estimates at $1.7 billion in the first year.

But some addiction experts have sounded a note of caution, warning that buprenorphine prescribing has already become a lucrative cash cow for some unscrupulous doctors.

“In northeast Tennessee, I am not aware of any buprenorphine provider that accepts insurance. Here buprenorphine clinics charge $100 cash at the time of service and require weekly visits for refills. This amounts to a cost to patients of over $5,000 yearly for medical services. This is a significant economic barrier for patients who typically have little or no income,” wrote Jack Woodside, MD, a professor at East Tennessee State University College of Medicine, in a public comment on the proposed rule change.

“From the provider's perspective, collecting $5,000 yearly from 100 patients amounts to an annual gross income of $500,000, with low overhead and no costs associated with billing insurance. This economic bonanza is causing many physicians to abandon traditional medical practices. A primary care physician remarked that he earns as much in one day in the buprenorphine clinic as he does the rest of the week in primary care.”

Buprenorphine Abuse

HHS acknowledges there could be “unintended negative consequences” to increased prescribing of buprenorphine – one of them being diversion.  Buprenorphine is a popular street drug, with addicts using it to either get high or to ease their withdrawal pains from illegal opioids like heroin. In 2014, the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. 

Some experts say the drug naltrexone is a better treatment option than buprenorphine. Naltrexone also reduces cravings, but it is not an opioid and is non-addicting.

“As I have been saying for longest time, buprenorphine is a double-edged sword. I contend greatly expanding the access of opioids contributes to the spread of addiction and a major factor in relapse,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“We are seeing more and more patients getting exposed to heroin and it is going to get worse. Sadly, the heroin addiction is being sustained by buprenorphine preparations.”

A 2013 study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for the "non-medical" use of buprenorphine – meaning many users took the drug to get high.

 

“It is important to note that studies have found that the motivation to divert buprenorphine is often associated with lack of access to treatment or using the medication to manage withdrawal—as opposed to diversion for the medication's psychoactive effect.  Thus, the overall effect of this rulemaking on diversion is not clear,” HHS says in its analysis.

Clear or not, many of the same government regulators and anti-opioid activists who want to restrict access to opioid pain medication are some of the biggest supporters of expanding access to buprenorphine.

They include Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), a program funded by Phoenix House, which operates a chain of addiction treatment centers in 10 states and the District of Columbia. 

Kolodny, who is Phoenix House’s chief medical officer, has long advocated the use of buprenorphine, calling it “one of the most effective medications for opioid addiction” on C-SPAN last year. During the same interview, Kolodny likened other opioid pain medications to “heroin pills.”

Kolodny declined to comment to Pain News Network for this story.

Patient Limits “Indefensible”

Under the proposed rule change, only doctors who are certified in addiction medicine or addiction psychiatry will be eligible for the expanded limit on buprenorphine prescribing. The rule changes also favor physicians in larger “qualified practices” – excluding many primary care physicians and other doctors who don’t offer additional therapies such as addiction counseling.

HHS is accepting public comment on the rule change until the end of this month. The vast majority of the nearly 300 comments received so far are from doctors, including many who are angry that the restrictions on buprenorphine aren’t being loosened further:

“The current limit is indefensible. There are not enough doctors now who are willing to deal with addicted patients, there is no need to further limit which doctors can treat more patients. The goal should be to get as many doctors as possible treating as many patients as they can comfortably handle,” wrote Jon Robertson, MD.

“We should have an immediate increase in the number of opiate addicts/heroin addicts we can treat with buprenorphine. We should have an unlimited number of patients we can treat,” said Peter Rogers, MD. 

“Why is it that I can give 10,000 patients OxyContin, yet I cannot meet the need in my community to treat addiction? No other specialty of medicine, no other physician, has any limit on any prescribing, especially during an epidemic,” wrote Anne Pylkas, MD.  “I am not a thief, I am not a charlatan or a quack. I am not a pill mill. I take insurance. I do not make millions on the backs of the helpless.”

 “It makes no sense to limit physicians to an arbitrary number of patients that can be treated to get the patients out of opiate addiction,” wrote Raymond Moy, MD. “Instead of making it hard to treat opiate addicts, why don't you make it harder to create opiate addicts? Make all these regulations apply to doctors prescribing opiates.”

“I practice in a rural area with a shortage of physicians to treat opioid addiction. My staff is capable of treating many more than 100 patients, so our contributions to the community's health are hampered by the current limits,” said Nels Kloster, MD, who runs a treatment center in Vermont. “There are many more persons seeking this treatment, but we have to turn them away due to this artificial restriction to our services.”

Only a few commenters warned that buprenorphine is already widely available on the black market and some doctors are likely to abuse the system.

“While it seems logical that increasing the patient limit would increase the ability to get people into the system, it does have some very serious downsides,” wrote Karl Hafner. “Several of these providers (at least in our area) are what most would consider pill mills. This only puts more medication on the street for abuse.

"By increasing the limit you will move physicians from doing this as part of a practice to just doing Suboxone and they will become pill mills. Do not increase the cap unless it is tied to treatment programs. There are plenty of providers.”

In a recent column in the Journal of Psychiatric Practice, one expert also warned of unintended consequences if the cap on buprenorphine prescribing is raised.

“Buprenorphine is an effective treatment for opioid use disorder; however, with increased access and availability, its abuse and diversion may be inevitable,” warned Daryl Shorter, MD, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine.

“This real-world, almost paradoxical, phenomenon demonstrates the complexity inherent in the treatment of addictive disorders -- a medication intended to treat substance use disorder that has its own abuse potential, upon gaining popularity and increased availability, will inevitably be explored by drug abusers for reward and reinforcement purposes.”