West Virginia Moves to Stop Opioid Madness

By Kenny Brooks, Guest Columnist

When most people think of West Virginia, they think about mountains, coal mines and miners.  The number of coal miners in West Virginia suffering from black lung, cancer and other chronic illnesses plays a significant role in the state's high rate of disability, estimated at nearly 20 percent of the population. 

Many military veterans in West Virginia also suffer from lifelong pain and disability, as do injured public safety employees, police, firefighters and paramedics. I was severely injured as a paramedic in a work related accident and now live with arachnoiditis, a painful inflammation in my spine that will never go away.

All of this pain and disability has a significant impact on our state. The per capita income of West Virginia is only about $37,000 a year, making it one of the poorest states in the union.  About 23% of West Virginians live below the national poverty line.  We rank 5th highest in suicide and have the highest overdose death rate in the country.

West Virginia was one of the first states to crackdown on pill mills and doctors who overprescribe opioids, but opioid overdoses continue rising, especially from heroin, illicit fentanyl and addicts taking pain medication.

The CDC’s opioid prescribing guidelines only made things worse for real pain patients, causing many to be under treated or abandoned by doctors who took an oath to relieve pain and suffering.

West Virginia lawmakers have seen enough of this suffering. In an unprecedented move, the legislature this month passed Senate Bill 339, with the goal of restoring the integrity of chronic pain management in the state.

The bill was introduced by State Senator Tom Takubo, DO, a pulmonary physician who specializes in treating patients suffering from lung and breathing problems.  Dr. Takubo understands the ethical duty to act, and to help alleviate chronic suffering and pain from incurable chronic conditions.

Senate Bill 339 was approved unanimously by both the House and Senate, and was signed this week into law by the governor.  It recognizes that regulations have caused “patients seeking pain treatment to suffer from a lack of treatment options” and that “prescribers should have the flexibility to effectively treat patients who present with chronic pain.”

The bill also establishes a commission -- called the Coalition for Responsible Chronic Pain Management -- to advise the legislature if a “less cumbersome” manner exists to regulate pain care in the state.

The Coalition will consists of the following members:  The Dean of the School of Public Health at West Virginia University, a physician board certified in pain management, three physicians licensed to practice in West Virginia, a licensed pharmacist, a licensed chiropractor, a licensed physical therapist experienced in the area of chronic pain, and a consumer of healthcare services directly impacted by pain clinic regulations – in other words, a pain patient.

We have about a month before the appointments are made and I am hopeful that I will be appointed as the patient representative. I hope to bring to the Coalition not only my experience as a pain patient, but my experience as a paramedic.  I spent many hours in school years ago learning about medical and legal issues, and believe I have a unique perspective to bring to the table.

My goals are simple: to change the regulations and prescribing guidelines back to individualized patient centered care, not addiction centered algorithms. I am also concerned about doctors being afraid to treat pain patients due to legal reprisals.

I hope to bring a voice of reason to the Coalition, and to help other states look at what we are doing in West Virginia to stop the opioid madness.  

Kenny Brooks is an arachnoiditis survivor and former career firefighter in Montgomery County, Maryland.  He loves his family, his church, his dog, his friends, and he feels very blessed to have a great team of medical doctors and pharmacists who understand quality of life medical care. Kenny became more involved in politics following the sad consequences he witnessed in other arachnoiditis patients due to the CDC guidelines. 

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

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

Limiting Opioids for Acute Pain Will Hurt Everyone

By Patricia Young, Guest Columnist

There is a bill in Congress that, if passed, will have a great negative impact on most people in this country. The legislation by Senators John McCain (R-AZ) and Kristen Gillibrand (D-NY) would limit your doctor’s ability to treat short term acute pain by restricting the supply of opioids to 7 days. This would be a prescription that could not be renewed.

Several states have passed or are considering similar measures to limit the initial supply of opioid medication to a week or less.

I am not sure how these senators came up with the magic number of 7 days for all types of acute pain, but this will cause much undue suffering for innocent people.

As a registered nurse who worked in hospitals and nursing homes for 32 years, I have firsthand knowledge of what happens when acute pain goes untreated. Patients who suffer from acute pain often cannot sleep and become agitated at a time when rest is imperative for healing.

There are many painful and complicated surgeries that make a blanket 7 day restriction on opioid medication absurd. Post-surgical patients often do not stay in the hospital long and the continuation of pain medicine is vital to their healing process. Gastrointestinal surgery often results in an open wound requiring constant dressing changes for weeks.

Most people will eventually be adversely affected if such a bill if passed. Pain is real and comes with most surgeries and many medical conditions.

I recently had arthroscopic hip surgery. I had not been prescribed pain medicine for over a year. At one time I was taking opiates daily, but taking them in that fashion never worked for my chronic pain issues and caused adverse reactions, such as gastroparesis and severe sleep apnea. However, I knew that I would not do well after hip surgery without some pain relief.

I told my surgeon about the adverse reactions and he gave me a prescription for Percocet to use for the first 2 weeks following surgery. I felt good that this doctor had my history and I trusted him to regulate my pain medicine.

I had my surgery done as an outpatient and returned home the same day. My husband took the prescriptions signed by my surgeon to the pharmacy and returned with all of the medications, except for the Percocet. By this time I really needed some pain relief and called the pharmacy to see what happened. I was told that they were not going to fill the prescription for Percocet. They told me my Medicare Advantage Plan (Aetna) was rejecting payment for it.

This was the type of news you just do not need after a painful surgery! I immediately went from feelings of anger to hopelessness. In a couple of weeks I was going to begin 3 months of grueling physical therapy so I could walk again. I also wondered what people did for pain after more complicated surgeries which take longer to recover from. What is happening? Is the government regulating our healthcare so that an insurance company or Medicare can deny coverage for a surgeon’s prescription for post-op pain?

I explained to my pharmacy that my prescription for Percocet was for acute pain following a surgery. The pharmacy decided to look into it. I was fortunate, I was allowed this one prescription filled, but no more. The pharmacy said they would not fill another prescription for a painkiller even if prescribed by my surgeon.

I was only partially relieved now. I knew I had a painful road ahead with 3 months of physical therapy. I looked at the bottle of pain pills and thought this must last throughout my 6 month estimated recovery time. I made the decision to not take a pain pill that day. Yes, I was having a great deal of pain, but I felt I had to take them sparingly. I lost several nights of sleep due to pain because I was afraid to use my pain medicine.

By the 6th day post-op, I had only taken 3 Percocet pills and my pain level was an 8 while lying still. I called my insurance company to verify that I would get no more prescription coverage for pain medicine as the pharmacy had said. I was told different information. My insurance would allow coverage for another prescription, if my surgeon writes one, as long it was not over 180 pills for a month.

My fears about pain during physical therapy were eased and I was relieved that I could start taking my pain pills as prescribed. But why would a pharmacy tell me the wrong information?

This may be why people have to go to several pharmacies to get pain prescriptions filled. It is not because they are addicts or misusing their medication, but because pharmacies are too afraid to fill legitimate prescriptions.

Do cookie cutter rules and policies for pain treatment really promote healthcare for everyone? Or are they simplistic solutions to try and put a band aid on a problem that is completely different -- the disease of addiction?

Patricia Young lives in Florida. In a previous guest column, Patricia shared her experience about being falsely accused of having a “history of addiction.”

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

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

Prescriptions Plummet in Medical Marijuana States

By Pat Anson, Editor

Medical marijuana is giving some serious competition to the prescription drug industry. A new analysis of Medicaid claims found that prescriptions to treat pain, nausea, seizures, psychosis and depression plummeted in the 23 states and District of Columbia where medical marijuana was legal in 2014.

If all 50 states had medical marijuana laws that year, researchers say the potential savings to Medicaid and taxpayers would have been over a billion dollars.

“We found statistically and economically meaningful reductions in prescription drug use associated with the laws. This finding suggested that patients in states with such laws were substituting medical marijuana for prescription drugs,” W. David Bradford and Ashley Bradford, a father-daughter team of researchers at the University of Georgia, reported in the journal Health Affairs.

Previous studies have shown that prescriptions for opioid pain medication have fallen in states where medical marijuana is legal.

The new study was more comprehensive and included nine clinical areas that cannabis could be used to treat: anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders, and spasticity (muscle spasms).

Five of the nine clinical areas had significant drops in prescribing where medical marijuana was legal:

• 17% decline in anti-nausea medication
• 13% decline in antidepressants
• 12% decline in psychosis medication
• 12% decline in anti-seizure drugs
• 11% decline in pain medication

The study found no significant association between medical marijuana laws and drugs used to treat anxiety, glaucoma, sleep disorders or spasticity.

“There is no question that we see patients constantly turning to cannabis, to get off their other medications, mainly to eliminate the side effects they are experiencing.  At this time, this is a huge advantage to us all -- we get a healthier solution to help us with our medical issues and Medicare and Medicaid are seeing a reduction of costs,” said Ellen Lenox Smith, a PNN columnist, medical marijuana user and caretaker in Rhode Island.

“However, until we are able to receive insurance reimbursement like Germany started providing in March, we have to still pay out of pocket. So until we are treated fairly like this in the U.S., we will continue to be paying more for this safer help than if we went to the pharmacy to purchase medication with our co-pays. For me, however, the cost is worth the quality of life I have been able to achieve using cannabis.”

In the current study, researchers cautioned that using fewer prescription drugs is not necessarily a good thing for every marijuana user.

“Our findings do raise important questions about individual behavior. For example, it is plausible that forgoing medications with known safety, efficacy, and dosing profiles in favor of marijuana could be harmful under some circumstances,” said the Bradfords. “In addition, patients who switch from a prescription drug that requires regular physician monitoring to marijuana may interact with their doctor less often, and their adherence to other important treatment regimens could suffer.”

Previous studies have found a significant decline in use of opioid medication by patients who use marijuana and that marijuana users are not at greater risk of alcohol and drug abuse.

Currently medical marijuana is legal in 29 states and the District of Columbia.

Insufficient Evidence: How Opioid Deniers Spin Studies

By Roger Chriss, Columnist

Opioid medications are coming under fire again as being ineffective for chronic pain management.

Charles Pattavina, MD, president of the Maine Medical Association, told the Portland Press Herald that "there is no clinical indication for opioid medication for the treatment of chronic pain."

And Stanford psychiatrist Anna Lembke, MD, said in Vox that “if opioids worked long-term, I would have no problem with patients taking them.”

But sweeping generalizations like these oversimplify a complex situation. Chronic pain is a highly heterogeneous feature of a wide variety of diseases and disorders. And opioids are a broad class of pain medications that come in different doses and are administered by different routes.

Thus, a claim that opioids do not work for chronic pain is too simplistic. Medical researchers investigate carefully posed questions about specific drugs and conditions using the statistical method known as hypothesis testing.

Researchers cannot and do not investigate if “opioids” work for “chronic pain.” Good research is more narrowly focused, such as these clinical studies:

“Tapentadol extended release for the management of chronic neck pain”

“Effectiveness and Safety of Once-Daily Extended-Release Hydrocodone in Individuals Previously Receiving Immediate-Release Oxycodone for Chronic Pain”

“Oxycodone for neuropathic pain in adults”

The results are equally specific. In the first example above, the authors conclude that “our results suggest that tapentadol ER, started at 100 mg/day, is effective and well tolerated in patients with moderate-to-severe chronic neck pain, including opioid-naïve subjects.” Similarly precise statements are found in any such article.

Sometimes researchers will perform a meta-analysis or review in which they assemble a collection of existing research articles and, after a statistical analysis, attempt to draw broader conclusions. Examples include:

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

“Opioids for chronic pain: new evidence, new strategies, safe prescribing”

“The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop”

The last article above is often cited by opioid deniers, even though it concludes that “evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function.”

"Evidence is insufficient” means that no determination can be made one way or the other about opioid medications. It does not prove that opioids are ineffective for chronic pain.

This leads to the final defense of opioid deniers: Demand an impossibly high standard of evidence. Specifically, they want the “gold standard” of clinical research: a double-blind, placebo-controlled, randomized trial of a specific drug for a particular condition.

To satisfy this standard, we would have to test every opioid medication against every medical condition causing chronic pain in a variety of different groups of people. This would mean thousands of trials, each performed multiple times, before any meaningful conclusions could be drawn about opioid medications in general. The time and costs involved would be prohibitive in the extreme.

So instead we use observational data and statistical methods to derive reasonable conclusions, as found in the articles above. This approach is widely used in many areas of medical research. In pain research, it has clarified how certain opioid medications can be used to address various chronic pain conditions.

To be clear, opioid therapy can help manage a variety of forms of chronic pain. Not all pain, and not for all patients. And always under the care and guidance of medical professionals.

The goal of opioid therapy is to improve quality of life, and available evidence strongly supports that it does so.

Roger Chriss suffers from 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.

Warriors Coach in ‘Excruciating' Back Pain

By Pat Anson, Editor

Golden State Warriors coach Steve Kerr is in “excruciating pain” and may miss the rest of his team’s first round playoff series against the Portland Trail Blazers after his chronic back pain "took a turn for the worse." Kerr warned other back pain sufferers "to stay away from surgery."

Kerr was unable to attend Game 3 Saturday night and doesn't know when he’ll return. Sources told the San Jose Mercury News that Kerr was in so much pain he was barely able to walk, which “was scary because it wasn’t a feeling he’s had before.”

The team had only given vague reports that Kerr has an “illness” and is “not feeling well.”

"This past week, for whatever reason, things got worse and my symptoms got worse," Kerr said at a news conference Sunday.  "With things getting worse, I just made the decision that I couldn't coach. As of now, I'm consulting with my doctors. I'm hoping for some improvement. If I get some improvement, I'll get back on the sidelines. 

"I'm not going into details on the symptoms, it's just discomfort and pain. It's not fun. And I can tell you, if you're listening out there,  if you have a back problem, stay away from surgery. I can say that from the bottom of my heart."

In the past, Kerr has complained of headaches, nausea and neck pain.

Kerr missed the first 43 games of the 2015-16 NBA season due to complications from surgery for a ruptured spinal disk. The dura membrane that surrounds Kerr’s spinal cord was punctured during the operation, causing spinal fluid to leak. A second surgery was performed to stop the leak.

“It’s very rare, it does happen occasionally, but it happens when there’s an accidental nick of the dura that surrounds the spinal cord. But I lost spinal fluid, took about a month to figure out what was going on, a lot of headaches, some other symptoms,” Kerr said in October 2015.

Headaches, nausea, and burning, stinging or tingling pain in the back and legs are the classic symptoms of adhesive arachnoiditis, an inflammation that causes scar tissue to build around spinal nerves, causing them to adhere or stick together. The disease is progressive, incurable and difficult to treat.  Many patients developed arachnoiditis after surgeries or epidural steroid injections that permanently damaged their spines.

Neither Kerr or his doctors have said he has arachnoiditis.

There’s a great deal of debate in the medical community over the value of spinal injections, surgeries, spinal cord stimulators and other “interventional” procedures to treat back pain. About 9 million epidural steroid injections are performed annually in the United States, often as a substitute for opioid pain medication.

Patients Could Be Jailed in Florida Drug Crackdown

By Pat Anson, Editor

The Florida legislature is close to passing a bill that would require mandatory minimum sentences for anyone convicted of selling, purchasing or possessing illicit fentanyl.

Critics say the legislation could result in pain patients being sent to jail when they unwittingly buy counterfeit painkillers on the black market that are made with fentanyl.

House Bill 477 was approved unanimously by the Florida House this week.  Similar legislation is under consideration in the Senate. Both bills would put fentanyl, carfentanil, and their chemical cousins in the same drug class as heroin.

Fentanyl is a synthetic opioid 50 to 100 more potent than morphine.  It is available legally by prescription to treat severe pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is usually mixed with heroin or used to make counterfeit drugs.

As currently written, the House bill requires anyone convicted of having as little as 4 grams of fentanyl to get a mandatory three year prison term; 14 grams would carry a 15-year sentence; and 28 grams would result in 25 years behind bars.

Judges would have zero discretion to alter the sentences. If the drugs result in someone dying, suspects would face a charge of first degree murder.

While the legislation is primarily aimed at cracking down on dealers, critics say patients desperate for pain relief could also face prison if they buy counterfeit oxycodone and other painkillers laced with fentanyl.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times.

"You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl. A handful of pills could get you three years. If you buy just 44 pills, you could end up with 25 years in prison."

Newburn was surprised the Florida legislature didn’t learn its lesson from previous efforts to require lengthy prison terms for oxycodone and hydrocodone traffickers. Rigid enforcement of the law led to 2,300 people being sent to prison, including some patients who were simply look for pain relief, according to Reason.com.

"When you look back on how the last mandatory-minimum heroin law was applied, you see that it targeted not just just traffickers but a lot of low-level offenders, people who were never supposed to be targeted by the bill in the first place," said Newburn. "We had a heroin mandatory-minimum law for 18 years. Lawmakers promised us it would deter drug use, but now we’re in the midst of the worst heroin crisis we’ve ever seen. And the answer to that is to pass another mandatory minimum?"

Florida was one the first states where counterfeit pills laced with fentanyl began to appear. In early 2016, nine people died in Florida’s Pinellas County after ingesting counterfeit Xanax, an anxiety medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA warned in a report last year. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.”

As opioid prescriptions have become harder to obtain, some pain patients are turning to the black market for relief. In a recent survey of over 3,100 patients by PNN and the International Pain Foundation, 11 percent said they had obtained opioids illegally on the black market in the year after the CDC’s opioid guidelines were released.    

Readers Sound Off on Fibromyalgia Drugs

By Lana Barhum, Columnist

In my previous column, “Lyrica, Cymbalta and Savella: Do They Work?” I shared research studies and my own experience with the three medications approved for use in treating fibromyalgia.

Clinical studies on all three drugs don’t seem to offer enough creditable evidence that they are effective in managing fibromyalgia symptoms.  Moreover, they carry very harsh side effects, including weight gain, edema, nausea, headaches, vertigo, sleep issues, and changes in blood pressure.

My experience was similar. Lyrica, Cymbalta and Savella were ineffective for me, and had some tough and life-altering side effects.

It makes me wonder why doctors are still prescribing these medications and why the Food and Drug Administration continues to allow them to stay on the market. 

In 2012, German researchers aimed to assess the benefits and harms of Cymbalta and Savella in treating fibromyalgia.  Ten studies with over 6,000 fibromyalgia patients were reviewed. 

The results were that 22 percent of patients reported substantial relief and 21 percent had to quit treatment due to unpleasant side effects.

In reader comments on our website and Facebook page, many of you had comparable experiences:

“Tried all 3…nothing but weight gain and dizziness. No pain relief. Still haven't found anything that works.”

“I've had multiple spinal surgeries and fusions, and have severe nerve damage. And severe chronic pain. So, I've taken all three of these meds. Without success.”

I will not discount the fact that Lyrica, Cymbalta and Savella work for some people, but they appear to help only about 20 to 30 percent of patients who try them:

“I take one 60mg (of) Cymbalta a day, and it doesn't take away all the pain, but it does make it a bit more bearable.”

“I am using all three. There is relief but in moderation.”

“I have been on Lyrica since 2007 and do have relief of my Fibro pain. I am also on Cymbalta, a muscle relaxant and pain med that really (does) make a difference with my Fibro, arthritis and osteo pain.”

“Tried Savella, no good. Lyrica did not decrease pain enough to continue. I've used Cymbalta and had good results. Best results have been from using Gabapentin (Neurontin) since 1996, up to 3600 mg daily.”

“I'm back on Lyrica and Cymbalta. I know of the side effects with this medicine but it is the only option that remotely helps.”

The effectiveness of Lyrica and Cymbalta, in particular, has been hyped up with aggressive advertising by their manufacturers. And while research and patient experience show improvement on any of the medications is spotty at best, doctors continue to prescribe them.  This is yet another example where the medical field, in general, has not done a good job in treating, understanding or advocating for fibromyalgia patients.          

Side effects reported by readers to the three drugs include dizziness, mood changes, cognitive issues, swelling, sleep issues, weight gain, increased blood pressure, blackouts and more.  Many of these side effects have a detrimental effect on the daily lives of fibromyalgia sufferers – as if our lives were not difficult enough.

“Lyrica was the worst! I became a sleep-walking zombie. I was so out of it at night that I rarely made it to bed laying down. I would find myself in weird places asleep, such as with my head resting on the faucet in the bathroom sink. Or, I would sleepwalk and fall, like down the stairs. Certainly not good for helping my pain!”

“Lyrica did nothing for me. Cymbalta changed my personality completely. I became mean and hateful. When I asked the (doctor) about it, he's like, yeah that can happen.”

“I have taken Neurontin, Lyrica, Savella, and currently take Cymbalta. Neurontin gave me bad nausea, and the feeling of bugs crawling all over my body. Lyrica made me gain a lot of weight, and didn't help my pain at all. The Savella was the worst for me, it gave me very bad suicidal thoughts, so bad I had to stop taking it, it also never helped with pain.”

If only there was an ideal treatment for fibromyalgia -- one that would offer real relief from the worst symptoms and with few side effects.  But such a treatment could only come with a real understanding about the causes and symptoms of fibromyalgia, and I don’t feel medical research has gotten there yet.

The worst part of my experience with fibromyalgia is trying countless treatments to no avail. And there is nothing worse than being told, as I was, by a medical provider that if you expect real relief, you should also expect side effects and learn to cope with them. That statement shows what little understanding and empathy the medical community has about fibromyalgia, its process, and its difficulties.

I wish I had some good treatment advice to offer, but the fact is, like so many of you, I am exhausted. Years of trying medication after medication has left me weary of the medical community and the companies that manufacture fibromyalgia drugs. 

I have accepted defeat and refuse to try anything new.  Neurontin, Cymbalta, and muscle relaxers offer me some relief from nerve pain, depression, and muscle spasms, so I continue to take them.   Even so, I still live with widespread muscle and tissue pain, and a whole host of other symptoms fibromyalgia brings in its wake.

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

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

FDA Bans Use of Codeine and Tramadol in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration is tightening restrictions on the use of codeine and tramadol in young children.

The agency says the opioid medications carry "serious risks" for children under the age of 12, including slowed or difficult breathing and possibly even death. The FDA is also recommending against the use of codeine and tramadol by breastfeeding mothers due to possible harm to their infants.

Codeine is approved to treat mild pain and cough, while tramadol is used to treat moderate pain. Codeine is usually combined with other medicines, such as acetaminophen, in prescription pain medication, as well as in some over-the-counter (OTC) cough and cold remedies. The FDA action only applies to prescription codeine.

"We know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, casing dangerously high levels of active drug in their bodies," said Doug Throckmorton, MD, deputy director for regulatory programs, at the FDA Center for Drug Evaluation and Research.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk."

In a review of adverse event reports from 1969 to 2015, the FDA said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18. The agency also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol by children.

The majority of serious side effects with both codeine and tramadol occurred in children younger than 12, and some cases occurred after a single dose.

The FDA is requiring drug makers to add a tougher warning to the labels of codeine and tramadol products, alerting healthcare providers and parents that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12.

The new labeling also cautions against their use in adolescents between 12 and 18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease. Breastfeeding mothers will also be warned not to use the medications.

The FDA said it is considering additional regulatory action for the OTC codeine products that are available in some states. It is also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

The agency did not recommend or suggest any alternatives to codeine and tramadol to treat childrens' cough or pain. OTC medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) also have risks and side effects.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," said Throckmorton.

In 2015, the FDA approved the use of OxyContin in children ages 11 to 16  who are in severe pain, a move widely panned by addiction treatment activists who claimed kids would get easily hooked on the painkiller. 

New Test Identifies Poor Drug Metabolizers

By Pat Anson, Editor

We hear regularly from readers who say they were discharged by their doctor after failing a urine drug test. Often it’s a case of an opioid painkiller not being found, which leads the doctor to believe a patient is selling or diverting their medication.

“The doctor said after 12 years of never having a bad urinalysis or anything ever happening, such as lost medication, asking to receive more or an early prescription, they said no medication was in my system. No one would retest and I was cut off cold turkey!” a pain patient recently told us.

“I went through hell trying to clear my name, horrible withdrawal with no doctor supervision or help, was labeled and thought I would die. This is a terrible way to treat anyone, especially someone with an untreatable life-long pain condition.”

Why are patients being falsely accused? In many cases, it’s because they have genetic differences that make them a low or high metabolizer of certain opioids. A painkiller like hydrocodone, for example, can quickly be utilized or pass through their system -- with little or no trace of the drug left behind.

Urine drug tests that are typically done in a doctor’s office -- known as point-of-care (POC) tests – do not identify these poor drug metabolizers. And studies show that about 30 percent of POC tests have “false negative” findings about opioid medication.

“Just because it may not show up in their system may not mean that they’re not taking it. There are two rational justifications for that. One is a bad drug test and the other is a patient may be a poor or ultra-rapid metabolizer of the medication that is being prescribed to them,” said David McCrea, CEO of Insight Diagnostics.

“I think most (doctors) understand how faulty the point of care tests can be, especially pain physicians. But I’m not sure the average physician understands how much a person’s individual metabolism can affect their drug test.”

Insight Diagnostics recently began offering a new testing service – called Genetically Enhanced Medication Monitoring (GEMM) – that combines a saliva-based genetic test with a laboratory test that more precisely identifies drug molecules in a patient’s urine. When used together, the two tests can reassure a doctor that a patient is telling the truth about their drug use.

“This is a game changing test that will allow physicians to uncover why some patients say, ‘I am taking my medication, I am taking it as prescribed and it’s just not showing up.’ This is scientific information that can validate a patient’s assertion,” McCrea told PNN.

“Certainly there are going patients that are going to try and game the system. But for those patients that are in chronic pain and are doing what they signed their pain contracts to do, this allows for a deeper dive for the physician to determine whether the patient is actually taking their medication, or they can’t metabolize it or they over-metabolize it.”

McRae says GEMM costs "a couple hundred dollars at the most” and is covered by Medicare and most private insurers. It doesn’t offer immediate results, as POC tests do, but the findings are far more accurate. They can also help physicians identify medications that will be metabolized normally by a patient and will be more effective. 

Genetic tests cannot be used to explain “false positive” findings from a POC test – the detection of a drug that isn’t actually there. But laboratory testing can. Retesting a urine sample is more expensive, but it can help prevent patients from being falsely accused – something that happens far too often.   

A recent survey of doctors and health care providers by PNN and the International Pain Foundation found that 20 percent had discharged a patient for failing a drug test in the past year. About four percent of patients said they had been "fired" by a doctor over a failed test.

“I failed a drug test which said I was positive for 4 drugs I have never taken in my life and was negative for opiates when I was taking Norco. My doctor abruptly stopped treating me even after I demanded my sample be retested,” a patient told us. “These drug tests are not reliable and should not be used and pain contracts should be illegal since they are forced on the patient.”

Click here to see a short promotional video about GEMM.

Is Your Medical Marijuana Safe to Use?

By Ellen Lenox Smith, Columnist

When you smoke, ingest or administer medical marijuana into your body, it is important to know that it is safe to use. Ideally, the marijuana was grown organically and is pesticide free.

Here are simple tips that might help you to determine where you stand.

Purchasing from a Private Grower:

• Be sure to check with them to see what products they use for the soil and nutrients, to be sure the plants are growing organically.
• Most growers will at some point have to face a bug infestation. Make sure they got rid of them by using an organic product. You do not want to ingest toxic substances.
• You also need to know how they work on being consistent in creating their oils, tinctures, topical ointments and edibles. It is important when you find a medication that is compatible with your body, and that you be able to purchase it again and have similar results.

Purchasing from a Marijuana Dispensary:

If you are going to a medical marijuana dispensary or compassion center to purchase cannabis, you have the right to ask those same questions.

• Do they know who their suppliers are and where the marijuana was grown?
• Do their suppliers grow organically?
• Ask how they make sure there is consistency in creating their tinctures, oils, edibles, drinks, etc.

Americans for Safe Access (ASA) has created standards for medical marijuana called Patient Focused Certification (PFC), a non-profit, peer reviewed, third party certification program for the medical cannabis industry.

PFC addresses product and safety concerns “to promote the adoption of safe and reasonable industry standards and regulations from seed to consumption.”

If you see a marijuana package carrying the PFC label, like the image to the right, it has met their standards and has been certified.

Don’t be shy. This is your life and your body. Be sure to know that whoever you purchase your medication from, that it is being grown safely for you!

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen 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.

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.

High Fat Diet Raises Osteoarthritis Risk

By Pat Anson, Editor

Saturated fatty acids are prime suspects in the onset of osteoarthritis, according a new study by Australian researchers who say fat changes the composition of cartilage, particularly in the hip and knee.

It’s one of the first studies to look at the association between osteoarthritis and saturated fatty acids found in foods such as butter, coconut oil, palm oil and animal fat.

When combined with simple carbohydrates in a high-fat, high carbohydrate diet – often called "junk food" – researchers found that fatty acids weaken cartilage and produce osteoarthritis-like changes in the knee.

"We also found changes in the bone under the cartilage on a diet rich in saturated fat," said Professor Yin Xiao of Queensland University of Technology’s Institute of Health and Biomedical Innovation. "Our findings suggest that it's not wear and tear but diet that has a lot to do with the onset of osteoarthritis

"Saturated fatty acid deposits in the cartilage change its metabolism and weaken the cartilage, making it more prone to damage. This would, in turn, lead to osteoarthritic pain from the loss of the cushioning effect of cartilage.”

Osteoarthritis is a joint disorder that leads to progressive joint damage. It can affect any joint in the body, but is most commonly felt in weight bearing joints such as the knees and hips. Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis.

Xiao and his colleagues tested a variety of saturated fats and found that long term use of animal fat, butter and palm oil was the most damaging to cartilage. There was less damage caused by  lauric acid, a saturated fatty acid found in coconut oil.

"Interestingly, when we replaced the meat fat in the diet with lauric acid we found decreased signs of cartilage deterioration and metabolic syndrome so it seems to have a protective effect," said Sunder Sekar, a PhD student.

"Replacement of traditional diets containing coconut-derived lauric acid with palm oil-derived palmitic acid or animal fat-derived stearic acid has the potential to worsen the development of both metabolic syndrome and osteoarthritis."

Professor Xiao's previous research has found that antioxidants and anti-cholesterol drugs could slow the progression of joint damage caused by fatty acids.

The study was funded by the Prince Charles Hospital Research Foundation.

No Opioid Painkillers Prescribed to Prince

By Pat Anson, Editor

Nearly a year after pop superstar Prince was found dead of an accidental drug overdose in his Minnesota home, we still don’t know where he obtained the fentanyl that killed him.

Court documents released today show that none of the opioid painkillers found in Prince’s home were prescribed to him. At least one opioid prescription bottle bore the name of Kirk Johnson, Prince’s former drummer and a longtime friend. Other opioid medications were found stashed throughout Prince’s Paisley Park home near Minneapolis.

“The controlled substances were not contained in typical prescription pill bottles, but rather, were stored in various other containers such as vitamin bottles. Bottles containing these controlled substances were located in multiple areas of the complex, including Prince’s Bedroom,” a search warrant said. 

“Investigators have been searching for the source of the controlled substances found in Prince’s residence. Through this investigation, interviews with those who were at Paisley Park the morning Prince was found deceased have provided inconsistent and, at times, contradictory statements.” 

Assistants to the entertainer told investigators that “Prince recently had a history of going through withdrawals” and they had arranged a meeting for him to meet with an addiction treatment specialist.

Prince was found dead in an elevator at his home on April 21, 2016 and speculation immediately focused on a possible opioid overdose. A medical examiner later reported that Prince died from an accidental overdose of fentanyl, but did not say where the drug came from.

Prince did not have a prescription for fentanyl, a potent synthetic opioid that is used in skin patches and lozenges to treat severe pain. Illicit fentanyl is widely sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers.

Prince died less than a week after his private plane made an emergency landing in Moline, Illinois, where paramedics reportedly treated him for an opioid overdose.

The Minneapolis Star Tribune reported last year that Prince weighed only 112 pounds at the time of his death and had so much fentanyl in his system that it would have killed anyone.

According to the newspaper, some of the pills found in Prince’s home were labeled as “Watson 853” – a stamp used to identify generic pills containing hydrocodone and acetaminophen that are sold under the brand name Lortab. When one of those pills was tested, it was found to contain fentanyl and lidocaine.

A week before he died, Dr. Michael Schulenberg wrote an oxycodone prescription for Prince under Johnson's name to protect the singer’s privacy, according to investigators.  But in a statement released today, Schulenberg's attorney denied prescribing opioids to Johnson or "any other person with the intent that they would be given to Prince."

The Star Tribune reported that investigators turned over the results of their investigation to the U.S. attorney’s office earlier this year.  No arrests have been made and no charges have been filed.

Fuzzy Opioid Math and Media Theatrics

By Roger Chriss, Columnist

The Centers for Disease Control and Prevention recently produced a map that shows how prescription opioid use varies widely from state to state. Californians, for example, are prescribed opioids at about half the rate as people in Ohio and West Virginia.

The CDC also tells us that doctors “wrote 259 million prescriptions for painkillers in 2012, enough for every American adult to have a bottle of pills.”

Because an epidemic is a statistical phenomenon, defined by numbers derived from data, caution is required when presenting and interpreting such results.

The media has been anything but cautious in using these numbers as fodder for sensational anti-opioid reports.

CDC GRAPHIC

“These pills didn’t just end up in patients’ hands; they also proliferated to black markets, were shared among friends and family, landed in the hands of teens who rummaged through parents’ medicine cabinets, and so on,” Vox reported, overlooking the fact that less than one percent of legally prescribed painkillers are diverted.

Some use the prescribing numbers to make a case for extreme measures to stop opioid addiction and overdose.

“In 12 states there are more opioid prescriptions than people,” David Brooks wrote in The New York Times, before suggesting an approach to addiction treatment that sounds like it came out of Les Misérables.

“Something like half of all sufferers drop out of treatment within a few months, so it might be worth thinking about involuntary commitment,” Brooks said.

“Legally, by prescription, we have created an epidemic of death,” chimed in New Hampshire attorney Cecie Hartigan in an op/ed published by the Concord Monitor.  “What point is there in alleviating pain for people if it’s going to kill so many of them?  Except in cases of end-of-life care, opioids should not be prescribed.”

Unfortunately, a prescription is not a unit of measure, and statements like these only add to the hysteria and fuzzy math.

An “opioid prescription” is as imprecise as a “bottle of alcohol.” Obviously, a bottle may be small or large, and the alcohol it contains may be strong or weak. As a result, having a small bottle of beer with dinner would be unremarkable, but drinking a large bottle of vodka would be alarming.

This is the mistake in the CDC graphic and opioid prescription counts. A prescription is a paper or electronic document, specifying a particular drug in a particular strength given in a particular quantity -- which makes it unsuitable for statistical use. A prescription for 5 tablets of 50 mg of tramadol cannot be usefully compared with a prescription for 30 tablets of 25 mg of oxycodone.

The CDC’s fuzzy math paves the way for a lot of confusion. Media reports give dramatic percentages of people using prescription opioids, warning of dire consequences from even a few pills.

“If patients get their hands on a second dose, one out of seven will form an addiction. In the event that patients must take a long-acting opioid, about 25% will still be using the drug one year later,” Dr. Manny Alvarez wrote in the Fox News website, apparently unaware less than two percent of people prescribed opioids actually become long term users.  

National Public Radio reported that 57% of American adults in a recent poll said they had been prescribed a narcotic painkiller, and then went on to claim that “as many as 1 in 4 people who use opioid painkillers get addicted to them.”

There are 242 million adults in the U.S. population, so if 57% were prescribed opioids and one fourth of them became addicted, that would give us 34.5 million people addicted to painkillers. This is clearly not the case.

The American Society of Addiction Medicine reports that there are approximately 2 million prescription opioid addicts. These people need treatment, not media theatrics.

Moreover, 259 million prescriptions does not mean that 259 million people have a year’s supply of an opioid. In most cases, people receive a short course of a weak opioid, enough to help with acute pain after trauma or surgery.

As for long-term opioid use, the National Institutes of Health states that “an estimated 5 to 8 million Americans use opioids for long-term management.” Studies show that only a small percentage become addicted to their medication.

Surely we don’t need opioid detention centers or opioid prohibition. That would not help the people struggling with opioid addiction or people living with chronic pain disorders.

Ignore the fuzzy opioid math and related theatrics, and focus on the 2 million people struggling with opioid addiction and the 5 to 8 million people living with chronic pain conditions. They deserve our care and consideration, and certainly won’t benefit from media melodrama.

Roger Chriss suffers from 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.

Get the Facts Right About Opioids

By Barby Ingle, Columnist 

This past week Tucker Carlson aired a series of reports on Fox News about opioids and addiction. After night two of watching the “Drugged” special segments, I wondered if Fox would be willing to tell the patient side of the story and wrote to some Fox News producers I know to see if they wanted to interview me.

I didn’t know the specific producer for Carlson, but the next morning I received an email from her. I immediately responded and said yes, I would come on the show. We set it up for Thursday or Friday. Well, on Thursday we bombed Afghanistan with the “Mother of All Bombs” and they were unable to get me in.

The producer did say that they would be doing additional segments on the topic and that they are interested in bringing me on sometime in the next few weeks.

I watched the rest of the series, and on Wednesday Carlson said that 60 percent of veterans have chronic pain. That didn’t sound right to me and I wondered where Carlson got his facts from. He never said in his broadcast.

When I looked it up, I found a 2014 study in JAMA Internal Medicine that said 44% of military personnel develop chronic pain after a combat deployment. Also, not all of them are taking opioids as Carlson reported. Only 15% are taking opioids – compared to 4% in the general population.

When I get my chance to speak to Carlson or any other news outlet, I always suggest that we not take opioids off the table as a form of treatment for those with chronic pain. It is not the right thing to do in my educated opinion as a chronic pain patient. There are hundreds of treatment options, but many patients can’t afford them and insurance often won’t pay for them. You can’t leave patients without options.

Many people I know, including one of my best friends, committed suicide because of lack of proper and timely care. She wasn’t looking for opioids, she was looking for relief. She jumped from a 10-story building in New York.

Another friend spent months fighting for her medication after her insurance would no longer pay for her infusion therapy. Once her doctor finally gave her a prescription for fentanyl patches, she went home, put on all 60 patches and tried to commit suicide. She was found in time by her husband and was in a coma at a hospital for about a week.

When she awoke, she was pissed that they didn’t let her die. She wanted to die because she didn’t know how she was going to get any pain relief going forward. My friend is in an even worse situation now because the attempted suicide is on her medical record. She wants infusion therapy, but is denied it -- even though it gave her life back when she did have access to it.

I have been living with chronic pain for 20 years. This year I have been unable to find a provider who will even charge my insurance company for the infusion therapy that keeps me out of my wheelchair. I choose not to use opioids daily because they don’t work for me. But I don’t want to take them away from someone who they do help. That decision needs to be on an individual basis, between a provider and their patient.

We need to encourage pharmaceutical companies to address the addiction and tolerance in pain medications, and one way is the use of abuse deterrent formulas. Another is to get insurance companies, Medicare and workers compensation to cover alternative treatments so that we have more options. And for those who tried and failed with other treatments, we need to keep opioid medication available.

Patients also need to be responsible for their own actions and choices. Recently my doctor gave me a new script. Before filling it, I went home, Googled it, and saw the medication has potential negative side effects. I will be talking with my provider again in a week and will let him know that the medication is not right for me.

Patients need to be proactive about reading medication labels and inserts, and looking up information on our treatment options. We must educate ourselves and we must ask our providers questions. Being a responsible patient will lower the risk of abuse, and increase our access to proper and timely care.

Addicts are going to abuse no matter what is available. We chronic pain patients are simply asking for a seat at the table. Instead we are portrayed as wrong doers, who just want to get high on pain pills.

Carlson ended his week long series by saying he will continue to bring different voices and information to his viewers. His producer personally echoed that sentiment to me. I hope to be given the chance soon to come on his program and tell the patient side of the story, and the many challenges we face getting proper and timely pain care.  

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.

Studies Identify Riskiest Patients for Opioids

By Pat Anson, Editor

Two studies released this week suggest that pre-existing medical conditions and substance abuse play a strong role in determining whether a patient becomes a long-term opioid user or is hospitalized by an overdose.

The findings could help doctors identify pain patients more likely to develop opioid addiction, instead of flatly assuming that opioids are risky for everyone.

The first study, published in JAMA Surgery, looked at over 36,000 adults who were given a limited supply of opioids to control their pain after surgery. None of the patients had an opioid prescription in the year preceding their operation.

Only about 6 percent of the patients were refilling opioid prescriptions three to six months after their surgery.

The rate didn’t differ significantly between those who had a minor operation and those who had major surgery.

When researchers dug deeper, they found that many of the long term opioid users had similar medical issues. People with arthritis were about 60 percent more likely to keep filling prescriptions, while smokers were about 25 percent more likely. Those who suffered from depression and anxiety were about 20 percent likely to keep taking opioids.

"This points to an under-recognized problem among surgical patients," said lead author Chad Brummett, MD, director of the Pain Research division in the University of Michigan Medical School Department of Anesthesiology. "This is not about the surgery itself, but about the individual who is having the procedure, and some predisposition they may have."

More than 50 million surgical procedures are performed in the U.S. every year. If the study's findings hold true for all patients, researchers say over 2 million people who were "opioid naïve" before surgery could wind up receiving the drugs for months afterward.

Medical Conditions Linked to Overdoses

The second, much larger study looked at a database of over 18 million patients who had an opioid prescription between 2009 and 2013. Over 7,200 opioid overdoses that required hospitalization were identified.  

Researchers found that a previous diagnosis of substance abuse was the single factor most strongly associated with an overdose.  Bipolar disorder, schizophrenia, stroke, renal disease, heart failure and non-malignant pancreatic disease were also strongly associated with overdose risk. 

The risks linked to many of these pre-existing health conditions were so strong they outweighed the risk associated with taking high daily doses of opioids over 100 mg morphine equivalent dose (MED).

“The authors have been able to demonstrate in a very large population there are many risk factors far more important than opioid dose that predict overdose,” said Lynn Webster, MD, a leading expert in pain management and past president of the American Academy of Pain Medicine. 

“I have been lecturing and writing for a decade that dose is less of a contributing factor for overdoses than mental health and history of substance abuse disorders. This study supports what I have been saying.”

The study also identified the prescription opioids most strongly associated with overdose were fentanyl, morphine and methadone. Interestingly, the use of benzodiazepines and antidepressants was riskier than taking hydrocodone, oxycodone and tramadol.   

The study, published in the journal Pain Medicine, was conducted by Venebio, a Virginia-based research group.

"Pain and its management are complex and multidimensional, and the risk of an opioid overdose is likewise dependent on many factors," said Barbara Zedler, MD, lead author and chief medical officer of Venebio. "Primary care professionals express concern about prescription opioid misuse and find managing patients with chronic pain to be stressful. Many feel inadequately trained in prescribing opioids and treating or managing opioid use disorder or addiction." 

Venebio has developed an opioid risk screening tool – called the Venebio Opioid Advisor (VOA) – to help doctors identify patients at risk of having an opioid overdose. According to company officials, VOA predicts the likelihood of an overdose with nearly 90 percent accuracy.

“The apparent accuracy is extraordinary and if broadly implemented should save lives,” said Webster. “I hope the CDC, CMS (Centers for Medicare and Medicaid Services) and policymakers study this paper before they suggest further changes that could cause more suffering and harm for people in pain.”

According to the CDC, over 15,000 overdose deaths in U.S. in 2015 were linked to prescription opioids, although there’s no way of knowing whether the drugs were taken medically or recreationally. Another 18,000 overdoses involved heroin or illicit fentanyl, which have replaced painkillers as the driving force behind the nation’s opioid epidemic.