Doctors Not Advising Parents to Dispose of Pain Meds

By Pat Anson, Editor

Keeping prescription opioids away from children may seem like a no-brainer, but a surprising number of parents fail to do that. And their doctors are part of the problem

Nearly half of parents whose child had opioid pain medication leftover from a surgery or illness say they kept the painkillers at home, according to a report by the C.S. Mott Children's Hospital National Poll on Children's Health. In many cases, an excess amount of opioids was prescribed and doctors did not advise parents to dispose of the leftover medication.

"We found that the amount of pain medication prescribed for children is frequently greater than the amount used, and too few parents recall clear direction from their provider about what to do with leftover medication," says Matthew Davis, MD, director of the poll and professor of pediatrics and internal medicine at the University of Michigan's C.S. Mott Children's Hospital.

"This is a missed opportunity to prevent prescription drug misuse among children. Many parents simply keep extra pain pills in their home. Those leftover pills represent easy access to narcotics for teens and their friends."

The survey results are based on a poll of nearly 1,200 parents with at least one child aged 5 to 17.

Nearly a third of the parents (29%) said their child had been prescribed at least one pain medication in the last five years. Most prescriptions (60%) were for opioids such as oxycodone and hydrocodone, while only 8% were for non-opioid pain relievers. Nearly a third of the parents could not recall the type of medication their child was given and half said they had pain medication leftover.

Most parents said their child’s healthcare providers discussed how often to take the medication (84%), when to cut down (64%) and possible side effects (61%). But only a third (33%) reported that the doctor discussed what to do with leftover medication.

“The majority of parents did not recall getting direction from their child’s provider on what to do with leftover pain medication; without guidance, many parents simply kept the extra pain pills in the home,” the report said.

“This raises a fundamental question about how providers approach the task of prescribing pain medication to children: are they prescribing ‘just enough’ medication for a standard recovery, or additional doses ‘just in case’ there is prolonged pain? Providers should make careful decisions regarding the amount of narcotic pain medication prescribed to children, and parents should feel comfortable asking questions about the amount of medication prescribed.”

What did the parents do with leftover pain medication? Nearly half (47%) kept the drugs at home, while 30% disposed of it in the trash or toilet.

Only 8% returned it to the doctor or pharmacy, 6% used it for other family members and 9% didn't remember what they did with them.

Twice as many parents (56%) with no guidance from their provider kept leftover pain pills at home, compared to parents whose providers discussed what to do with them (26%).

“Parents need clearer guidance on all aspects of administering prescription medications for their children. This is particularly true for pain medication,” the report found.

Does Excedrin Reduce Empathy?

By Pat Anson, Editor

A popular over-the-counter pain reliever may do more than just relieve minor aches and pains. Ohio State researchers say acetaminophen -- the active ingredient in Excedrin and hundreds of other pain medications -- can also make us feel less empathy for the physical and emotional pain of others.

"We don't know why acetaminophen is having these effects, but it is concerning," says Baldwin Way, an assistant professor of psychology at Ohio State’s Wexner Medical Center's Institute for Behavioral Medicine Research.

“Empathy is important. If you are having an argument with your spouse and you just took acetaminophen, this research suggests you might be less understanding of what you did to hurt your spouse's feelings."

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. The study findings were published in the journal Social Cognitive and Affective Neuroscience.

Way and his colleagues divided 80 college students into two groups, giving half of them a liquid containing 1,000 mg of acetaminophen, while the other half drank a placebo solution that contained no drug. The students didn't know which group they were in.

After waiting an hour for the drug to take effect, the students read eight short scenarios in which someone suffered some sort of physical or emotional pain. For example, one scenario was about a person who suffered a knife wound and another was about a person whose father died. Participants were then asked to rate the pain of each person on a scale ranging from 1 (no pain at all) to 5 (worst possible pain).

Students who took acetaminophen rated the pain of the people in the scenarios to be less severe than those who took the placebo.

"These findings suggest other people's pain doesn't seem as big of a deal to you when you've taken acetaminophen," said Dominik Mischkowski, co-author of the study and a former PhD. student at Ohio State, who is now at the National Institutes of Health.

In a second experiment, students met and socialized with each other briefly. Each participant then watched, alone, an online game that purportedly involved three of the people they just met. In the game, two of the students excluded the third person from the activity.

Participants were then asked to rate how much pain and hurt feelings the students in the game felt, including the one who was excluded.

Results showed that people who took acetaminophen rated the pain and hurt feelings of the excluded student as less severe than the participants who took the placebo.

"Participants had the chance to empathize with the suffering of someone who they thought was going through a socially painful experience," Way said. "Still, those who took acetaminophen showed a reduction in empathy. They weren't as concerned about the rejected person's hurt feelings.

“Because empathy regulates pro-social and anti-social behavior, these drug-induced reductions in empathy raise concerns about the broader social side effects of acetaminophen, which is taken by almost a quarter of U.S. adults each week.”

An earlier Ohio State study found that acetaminophen also dulls emotions.

The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Iowa Pain Patient Ends Hunger Strike

By Pat Anson, Editor

All Ryan Lankford wanted was a new doctor and a cheeseburger.

Now that he has the former, he can chow down on the latter.

The 40-year old Iowa man ended his week-long hunger strike Thursday after finally finding a doctor willing to treat his chronic pain.

“I have some good news.  I have a primary care physician!” Lankford said in a message to supporters.

Lankford, who was “fired” by his doctor at UnityPoint Health last month for reasons that were not made clear, suffers from chronic pain in his right arm, stemming from an attack of flesh eating bacteria in 2009. Surgeons were able to save the arm after removing infected tissue, but neuropathic pain in the scar tissue never went away.

After losing his doctor, Lankford was forced to take “dangerous amounts of Tylenol” instead of tramadol, a weaker acting prescription opioid that helped take the edge off his pain.

He decided to go on a hunger strike last week, as a form of protest not only against his own situation, but because thousands of chronic pain patients face similar problems finding doctors.

“I’ve been getting messages from just all corners of the United States. It’s been unreal. I didn’t know that this many people would be with me on this,” Lankford said.

“A lot of people were thanking me that somebody has the guts to do something like this. And there were a lot of them, just a heartbreaking amount of people, that have also been thrown out of pain management practices and dismissed from primary care practices. And denied medications by pharmacies.”

Lankford only drank water during the hunger strike and lost 15 pounds. Going without food sapped his energy and he was sleeping 12 hours a day, but he wasn’t as hungry as he expected.

“After about four or five days, you don’t really notice that anymore. The fatigue gets to be the biggest trick,” Lankford told Pain News Network.

Despite his exhaustion, Lankford kept looking for a new doctor.

RYAN LANKFORD

“I was making some calls around and I finally found a primary care physician that was willing to at least talk to me. Instead of the usual, ‘We don’t take chronic pain patients,’ and then click,” said Lankford

All it took was one visit with the new doctor, who didn’t even know Lankford was on a hunger strike.

“He asked me what I was on, and when I told him tramadol and gabapentin, his response was ‘That's it?! For THAT?!’ He started my meds back up straight away,” said Lankford.

While the notion of being unable to find a doctor might seem strange to healthy people, it’s become a common occurrence for pain sufferers. Many doctors are afraid to prescribe opioid painkillers, fearing oversight by the DEA or even prosecution.

Finding a pain management specialist has been particularly difficult in Iowa, according to Lankford, ever since a Des Moines physician was indicted for involuntary manslaughter for overprescribing opioids in 2012. Dr. Daniel Baldi was later found not guilty by a jury, but the case had a chilling effect on opioid prescribers.

Local media seemed uninterested in Lankford’s hunger strike. Only WHO-TV, the NBC affiliate in Des Moines, ran a story, which you can watch by clicking here.

“WHO was the only one, and they reached out pretty fast,” said Lankford, who is grateful for the attention his hunger strike did get, especially from pain patients.

“Although today marks the end of my hunger strike, don't think for a second that I'll EVER stop speaking up for chronic pain patients and the injustices we face, and don't ever think I would ever forget about all of the great people I have met in the last week or so,” Lankford said in a note on his Facebook page, called “Ryan’s Hunger Strike for Chronic Pain.”

You guys are all rock stars and stronger than anyone can ever know. I'm thinking I will leave this page up as a place to discuss pain issues with like-minded people because frankly, many people on my personal FB just don't ‘get it,’ nor would I expect them to.”

CNN Gets It Wrong About Pain Patients

By Sarah Daniels, Guest Columnist

You may have seen last night’s CNN town hall meeting on “Prescription Addiction: Made in the USA.”

I couldn’t believe it when Dr. Drew Pinsky said that real compliant pain patients are “a very tiny minority” of prescription opioid users.

I’m so sick of being grouped in with addicts! Because of all the new CDC regulations, I had to go weeks without my medication after being on high doses of opiates for a long time.

No one would give me my medication. Every pharmacy I went to said they were out. One pharmacy had the medication and was getting ready to fill it when the head pharmacist came over and told me unfortunately they wouldn't be able to give me the script. When I asked why she said they didn’t have it. I explained I was told they did and it was being filled. She said it wasn’t enough.

I asked if my doctor could write a different script for a temporary amount, would they be able to fill it and she just handed it back to me saying, "Like I said, I’m sorry, I can’t help you."

Then I went to a hospital pharmacy that did have the medication and they actually told me they needed to save it for patients who had short-term pain like surgeries for broken ankles. When I asked how someone's broken ankle pain was more important than my chronic pain from my genetic illness they asked me to quiet down and leave. If I didn't they would have to call security.

I was being polite and respectful, because I know as a pain patient you have to be the best advocate you can be, especially with all the stigma attached to opiates. I was also being quiet because I am never loud when discussing my pain meds, as you never know who is listening.

I never fight or argue or really raise my voice with anyone. I am a happy person despite my illness. I am grateful and thankful for each day I wake up and am able to spend with the people I love.

I did not appreciate someone making me out to be a completely different person than I am. It was like they actually felt threatened by me. Give me a break. I was in a wheelchair.

Now I’m not able to find the medication. My doctor wrote me a script for the medication because we have both decided it is the only thing and best thing for me to be on. It gets me out of bed and still, I can’t get it.

Now I am forced to go to a new pain clinic with new meds, where they're making me stop medical marijuana, which is the only thing keeping me from a feeding tube. They are making me come in for a visit once a week and each week I have to get drug tested and get labs drawn which costs $16. The visit itself costs $35.

SARAH DANIELS

They also want me to see a pain psychologist twice a week (who I already saw with my previous pain specialist and was cleared by). God only knows what that costs.

I’m on disability. It barely covers my insurance and yet I have to do all of these things to be compliant. I have to come up with the money for all of these appointments and procedures, find someone who will be able to drive me, as I am disabled and cannot do so on my own, and also be  well enough to even leave my house to make these appointments, just so that I am considered compliant. So that I can take a medication that I’m not sure will even work.

I am just disgusted by what is going on. As pain patients we are left in the dust. Nobody stands up for us. We try to stand up for ourselves, we are pretty strong, but we need bigger louder forces on our side.

Sarah Daniels lives in the Detroit, Michigan area. She suffers from Ehlers Danlos syndrome and gastroparesis. Sarah is a proud supporter of the Ehlers Danlos National Foundation and the Gastroparesis Patient Association for Cures and Treatments (G-Pact).

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.

Fentanyl Blamed for Half of Massachusetts Overdoses

By Pat Anson, Editor

New studies in Massachusetts and Rhode Island show that the nation’s fentanyl problem may be much worse than previously thought, while the abuse of opioid pain medication may not be as bad as it is often portrayed.

The Massachusetts Department of Public Health released new data showing that over half of the opioid overdose deaths in the state in 2015 were related to fentanyl, a powerful synthetic opioid that is more potent and dangerous that heroin.

It was the first time toxicology tests were used to detect the presence of fentanyl, a method that is far more accurate than the death certificate codes that the Centers for Disease Control and Prevention uses to classify opioid-related deaths. 

“The first-time inclusion of data on fentanyl allows us to have a more honest and transparent analysis of the rising trend of opioid-related deaths that have inundated the Commonwealth in recent years,” said Secretary of Health and Human Services Marylou Sudders.

Of the 1,319 opioid overdose deaths in Massachusetts for which a blood test was available, over 57 percent had a positive result for fentanyl.

The state’s findings do not distinguish between prescription fentanyl that is used to treat more severe forms of chronic pain and illicit fentanyl sold by drug dealers. But it seems likely the vast majority of deaths involve the latter.

illicit fentanyl powder

Massachusetts also released new data from its prescription drug monitoring program for the first quarter of 2016, showing that relativity few pain patients prescribed a Schedule II opioid medication had signs of abusing the drugs. Schedule II opioids include hydrocodone products such as Vicodin and Lortab.

Of the nearly 350,000 patients who had an opioid prescription, the state identified only 484 people (or 0.0014%) as “individuals with activity of concern.” The method used to identify possible abuse was someone receiving Schedule II opioid prescriptions from 4 or more providers and having them filled at 4 or more pharmacies during a three month period.   

Rhode Island Overdoses

Rhode Island this week also released a report showing a "significant increase" in fentanyl-related overdoses. Blood tests detected fentanyl in about 60 percent of the state's overdose deaths in the last two and a half months. There have been 28 fentanyl-related overdoses in Rhode Island so far this year.

“People are injecting, swallowing, and snorting this drug without realizing that they are often breathing their last breaths. Unfortunately, fentanyl kills, and it kills quickly,” said Nicole Alexander-Scott, MD, Director of the Rhode Island Department of Health.

Deaths linked to prescription opioids have been in decline in Rhode island for several years. The prescribing of Schedule II and Schedule III drugs in the state has fallen by over a third since 2011.

"The shifts in prescription and illicit drug overdose deaths also began roughly when more focused efforts were undertaken nationally to reduce the supply of prescription drugs," the health department said in a statement.

source: rhode island department of health

‘Alarming’ Rise in Fentanyl Overdoses

In recent years Rhode Island, Massachusetts and other eastern states have seen a surge in the illicit fentanyl drug trade. The white powdered drug is usually mixed with heroin or cocaine to boost their potency, but in recent months counterfeit pain medication made with fentanyl has appeared on both coasts. The “death pills” are blamed for at least 14 deaths in California and 9 in Florida.

COUNTERFEIT NORCO PILLS

“The counterfeit pills are a newer thing that is going on and that is popping up in different places. It’s certainly something we’re keeping an eye on,” said Erin Artigiani, deputy director of the Center for Substance Abuse Research (CESAR) at the University of Maryland.

CESAR tracks emerging trends in illegal drug use through a nationwide network of more than 1,500 researchers and volunteers.

“It’s very alarming. It’s something we’re very concerned about. And it’s something that local researchers and other members of the network are worried about as well,” Artigiani said.

The appearance of fake pain medication  came just as the CDC finalized guidelines that discourage primary care physicians from prescribing opioids for chronic pain. Artigiani stopped short of saying there’s a connection, but admits some pain patients may be seeking opioids on the streets.

“There are people that are looking for other sources or maybe got cutoff by their doctor or maybe their doctor had second thoughts about prescribing pain medications for one reason or another,” said Artigiani. “The people making and selling these illegal drugs are meeting market demand. So if there’s an increase in people looking for pills, then they’re going to make something to sell to those people.”

‘Biased’ CDC Reports

Pain News Network asked to interview someone at CDC about the Massachusetts fentanyl deaths and was told no one would be available.

“We aren’t able to provide comment on non-CDC research,” a spokesperson said in an email. “At CDC we don’t publish state drug overdose death rates for Rx opioids (or for any specific drug type) due to variability in states reporting drugs involved with deaths.”

While CDC may not consider the state data all that reliable, it has not hesitated to use reports from local medical examiners and death certificates in its reports on opioid overdose deaths.

The agency’s most recent report on 2014 overdoses said the U.S. was experiencing an “epidemic of drug overdose” that it blamed largely on prescription opioids.

“Natural and semisynthetic opioids, which include the most commonly prescribed opioid pain relievers, oxycodone and hydrocodone, continue to be involved in more overdose deaths than any other opioid type,” the report states.

Only briefly does the report acknowledge the “emerging and troubling” number of deaths related to illicit fentanyl. Like Massachusetts, CDC cannot distinguish between illicit fentanyl and prescription fentanyl, an important point because all fentanyl related overdoses are classified by the agency as prescription opioid deaths.

The CDC also admits some opioid-related deaths may be counted twice in its reports and some heroin-related deaths may have been misclassified as prescription opioid overdoses.

“We already know that the CDC's info is biased. Not because they are bad people, but because of the way that data is reported to them. Garbage in, garbage out,” says Terri Lewis, PhD, a rehabilitation specialist, medical researcher and patient advocate.

“There is so much variability in the collection of data at the state level, along with the fact that data collection and reporting is voluntary, not mandatory, that one simply cannot rely on the data set. Of course they won't tell you that.” 

The CDC uses data on death certificates known as International Classification of Disease (ICD) codes, which do not determine the cause of death, only the conditions that exist at the time of death. Someone could die from lung cancer, for example, but because they were on opioids to relieve cancer pain, an ICD code box for opioids may be checked by a doctor or coroner. Autopsies and toxicology tests are not usually conducted to verify ICD coding.

The largest part of the problem of reported death certificates is that of variability – local jurisdictions have wide variation in the preparation of individuals who complete these reports, and few are actually physicians or medical examiners. Often local coroners are appointed or elected,” said Lewis. “Until every state is doing exactly the same thing, we have muddy statistics. 

“Massachusetts has enacted one of the most sweeping changes to their reporting systems in the country – for that they are to be commended.  Distinguishing drugs by the manner of their death is important information for policy managers.” 

Until other states and CDC follow Massachusetts’ lead, we may never know the extent of the fentanyl problem. The CDC’s reliance on ICD codes not only distorts the true nature of the nation’s drug problem, but can lead to the misallocation of resources aimed at combating it.. 

The Obama administration recently asked Congress for an additional $1.1 billion to fight opioid abuse. Most of the money is earmarked for addiction treatment for prescription opioids, not for getting fentanyl off the streets.    

How Long Does OxyContin Last?

By Pat Anson, Editor

The pain relieving effects of OxyContin, Purdue Pharma’s best-selling opioid painkiller, often wear off early and the company has been aware of the problem for many years, according to a lengthy investigation by the Los Angeles Times.

The Times investigation of OxyContin, which was based on court records and thousands of “confidential” Purdue documents, found that a single dose of the extended release painkiller often doesn’t last for the intended 12 hours and that it performs more like “an 8-hour drug.” That makes some patients take extra doses or stronger ones, raising the risk of abuse and addiction.

“Such results shouldn’t come as a surprise. After all, the FDA doesn’t require drugs to work as promised for all patients. What was eye-popping about The Times’ findings was how Purdue responded when doctors told them their patients weren’t getting the full 12 hours of relief promised,” The Times said in an editorial.

“Instead of recommending that such patients take OxyContin more than twice per day — which might make it less appealing than cheaper generic opioids with short durations — Purdue’s representatives told doctors to stick to the 12-hour regimen and prescribe higher-strength pills.”

Purdue quickly issued a statement rejecting The Times’ story, saying it was “short on facts.”

“In an attempt to resurrect a long-discredited theory, the paper ignores the clinical and regulatory data that directly contradicts their story,” Purdue said. “Over the course of two years, Purdue Pharma provided the LAT (Los Angeles Times) with more than a dozen hours of briefings and discussions regarding the clinical evidence supporting OxyContin’s 12-hour dosing and the regulatory requirement that we promote the product as such. Unfortunately, the paper disregarded this information, instead publishing a story that’s long on anecdote and short on facts.”

Purdue said the FDA rejected claims over a decade ago that OxyContin was misbranded as a “twice-a-day” drug and was being prescribed inappropriately.

The Times published its own rebuttal to Purdue’s statement online, which you can see by clicking here.

Pain News Network asked readers what they thought about OxyContin’s pain relieving qualities and got a mixed response.

“Worked like a dream for me, but too expensive,” wrote one patient on our Facebook page, who said she switched to generic oxycodone.

“Doesn't start working for 3 hrs. Seems like it ends at the 9th hour. Not really happy about that, but what can you do?” wrote another patient, who said she had too many side-effects from other pain medications.

“It only lasted 5-6 hours for me. Stopped taking it years ago because it was ineffective,” said another pain patient.

Since its introduction in 1996, OxyContin has reportedly generated over $31 billion in revenue for Purdue, but it also created a tainted legacy that the company is still trying to shed two decades later. Many believe OxyContin helped spark the so-called opioid “epidemic” because its sales reps initially told doctors the drug had a low risk of abuse and addiction.

In 2007, a class action lawsuit against Purdue for deceptive marketing ended with several company executives pleading guilty to a felony count of misbranding OxyContin. The company and its executives were fined $634 million.

In 2010, Purdue introduced an abuse-deterrent formula of OxyContin that makes it harder for drug abusers to crush or liquefy the tablet for snorting or injecting. Some patients have complained the new formulation isn't as effective or causes gastrointestinal problems.

Iowa Pain Patient Goes on Hunger Strike

By Pat Anson, Editor

An Iowa man who was released as a patient by his doctor last month has gone on a hunger strike, vowing to never eat again until “pain patients are treated better.”

“He fired me. Basically they don’t want chronic pain patients anymore,” says Ryan Lankford of Des Moines. “Between my experiences and reading stories online from so many people being treated the same way I am, I just thought I needed to make a statement and do something, if nothing else to raise awareness.

“I know it’s kind of pie in the sky. I just think at this point I don’t think I have anything to lose.”

The 40-year old Lankford suffers chronic pain in his right arm, stemming from an attack of flesh eating bacteria in 2009. Surgeons removed infected tissue and muscle to save Lankford’s arm, but the remaining nerves are encased in scar tissue and still cause neuropathic pain.

Lankford said his doctor at UnityPoint Health told him he was being discharged for making “inappropriate remarks.”  

“They wouldn’t say what the remarks were or to whom, but it was pretty clear they were tired of taking care of me, because at the same time I had told my doctor that the pain meds weren’t working as well anymore,” Lankford said.

“He said don’t try any of the other clinics because we have your records and you’re not going to be taken by any of our affiliates either.”

A call to UnityPoint Health for comment was not returned.

Since being discharged, Lankford says he has been taking “dangerous amounts of Tylenol” because he is no longer able to get tramadol, a weaker opioid pain medication that helped take the edge off his chronic pain.

“I’m unable to find anyone in Iowa to even prescribe me tramadol,” Lankford said. “If they hear you’re a pain patient and you’re trying to find a primary care provider they hang up the phone on you. They just plain don’t want you.”

Lankford says it’s been difficult to find doctors willing to treat his pain ever since a Des Moines pain management specialist was indicted in 2012 on seven counts of involuntary manslaughter for overprescribing opioids. Dr. Daniel Baldi was later found not guilty by a jury, but the case had a chilling effect on opioid prescribers in Iowa and around the country.

In recent months, the number of patients being dropped by doctors or weaned off opioids appears to have increased, possibly because of recent guidelines released by the CDC, which discourage opioid prescribing for chronic pain. Those guidelines are voluntary and only meant for primary care physicians, but many doctors appear to be adopting them, even pain management specialists.

Two pain clinics in Tennessee recently said they would stop prescribing opioids to chronic pain patients because of "changing regulations."

"I was told yesterday my pain doctor would no longer give me my short acting opioids," a Michigan pain patient told us. "He is also unsure if I'll be able to continue my long acting opioid one, which I've been on for around six years. This after telling me I have been a model patient. He used the recent death of Prince as a reason."

Hunger Strike Began Thursday

Lankford has not had any food since Thursday afternoon and is only taking water. He’s created a Facebook page called “Ryan’s Hunger Strike for Chronic Pain” where people can track his progress.

“I'm fully aware of what I'm doing, and what the consequences could be. It's time for action, since the powers that be won't heed our words. Once again, NOT a SUICIDE THREAT. This is legitimate political protest, and anyone who tries to forcibly stop me will be subject to legal action,” Lankford posted on Facebook.

Lankford hopes his hunger strike will draw attention not only to his own plight, but those of countless pain patients around the country who are in similar situations.

“We’ve been writing letters, talking online and making phone calls for ages and it hasn’t gotten us anywhere. Maybe something a little more drastic is in order,” he said.

Researchers Say NSAIDs Cause Heart Damage

By Pat Anson, Editor

Researchers have known for many years that non-steroidal anti-inflammatory drugs (NSAIDs) increase the risk of heart attack and stroke. Now they may finally be learning why the pain relievers can be harmful.

In experiments on heart cells from rats and mice, scientists at the University of California, Davis, found that NSAIDs reduced the activity of cardiac cells at pharmacological levels found in humans. Their study was recently published in the Journal of Molecular and Cellular Cardiology.

“We knew these non-steroidal anti-inflammatories had negative side effects for heart disease and stroke risk, “ said lead author Aldrin Gomes, a UC Davis associate professor of Neurobiology, Physiology and Behavior. “But now we have an idea of some of the mechanisms behind it.”

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Several studies have found that NSAIDs increase the risk of cardiovascular disease and other health problems, but the exact cause has been unclear.

The UC Davis researchers compared naproxen, considered the safest over-the-counter NSAID, with a more potent anti-inflammatory, the prescription drug meclofenamate sodium (MS).

They found that MS increased reactive oxygen species, impaired mitochondrial function, decreased proteasome function, and increased cardiac cell death. Naproxen did not affect proteasome function or cause heart cells to die, but it did impair mitochondrial function and increase reactive oxygen species produced in cardiac cells.

“We were surprised to see that many of the NSAIDs we tested were causing the cardiac cell to die when used for prolonged periods,” said Gomes. “Some people are taking these drugs too often, and this is a problem. These drugs are abused.”

For moderate pain, Gomes suggests rubbing an anti-inflammatory topically onto the pained area, which would not expose the entire body to the drug. Taking an antioxidant like vitamin C before ingesting a NSAID may also reduce cardiac cell death.

Last year the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The agency said studies have shown the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

The FDA said people who have a history of heart disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk. But the risk is also present for people who don't have heart problems.

“Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” said Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

In a major study published recently in the European Heart Journal, a number of leading heart specialists warned that there is no "solid evidence" that NSAIDs are safe.

"When doctors issue prescriptions for NSAIDs, they must in each individual case carry out a thorough assessment of the risk of heart complications and bleeding. NSAIDs should only be sold over the counter when it comes with an adequate warning about the associated cardiovascular risks. In general, NSAIDs are not be used in patients who have or are at high-risk of cardiovascular diseases," said co-author Christian Torp-Pedersen, a professor in cardiology at Aalborg University in Denmark.

Prince Sought Addiction Treatment Before Death

By Pat Anson, Editor

The late pop icon Prince was planning to meet with an addiction treatment doctor in the hours before he died in a last ditch effort to kick an addiction to opioid painkillers, according to the Minneapolis Star Tribune.

Howard Kornfeld, MD, an opioid addiction specialist in California, was called by Prince representatives the night of April 20 because Prince “was dealing with a grave medical emergency,” according to William Mauzy, a prominent Minneapolis attorney working with the Kornfeld family.

Prince’s body was found the next morning in an elevator at his Minneapolis home. An autopsy has been performed and the body cremated, but the official cause of death has not yet been released. Foul play or suicide are not suspected.

Kornfeld, who runs Recovery Without Walls, an upscale addiction treatment center in Mill Valley, California, is considered a pioneer in the use of buprenorphine to treat both addiction and chronic pain. The medication has long been sold under the brand name Suboxone, but is usually prescribed just to treat addiction.

Kornfeld was unable to meet with Prince immediately, but planned to fly to Minneapolis for “a lifesaving mission” on April 22. 

“The plan was to quickly evaluate his health and devise a treatment plan,” Mauzy told the Star Tribune, which said several other sources corroborated Mauzy’s account.

Kornfeld’s son Andrew took a red-eye flight to Minneapolis on the morning of April 21 to lay the groundwork for Prince’s treatment program with his father. He was one of three people at Prince’s Paisley Park compound when the entertainer's body was found.

Mauzy said Andrew Kornfeld was the one who called 911 because the others “were in too much shock.” Kornfeld did not know the address and could only tell the dispatcher, “We’re at Prince’s house.”

Paramedics arrived within five minutes but were unable to revive the 57-year old Prince.

Sources told the Star Tribune that painkillers were found at the scene and have become the focus of the investigation.  Investigators are trying to determine where Prince got the pills and who prescribed them.

Andrew Kornfeld reportedly had a small amount of buprenorphine to give to Prince, but it was never administered, according to Mauzy.

The Star Tribune story appears to add credence to reports in TMZ and other tabloids that Prince suffered from chronic hip pain and was addicted to opioid pain medication. Just days before his death, TMZ said Prince’s plane made an emergency landing in Moline, Illinois, where he was briefly hospitalized for an overdose of Percocet. He left against medical advice and flew back to Minneapolis a few hours later.

Survey: Painkillers Bigger Problem than Alcohol

By Pat Anson, Editor

A new poll is adding further fuel to the fire over opioid abuse and the disproportionate amount of attention it gets compared to other health problems.

The survey by the Kaiser Family Foundation found that two-thirds of Americans consider the abuse of opioid pain medication an extremely or very serious problem. And four out of ten said they knew someone who was addicted to prescription painkillers, often a close friend or family member.

The problem is so serious that more Americans now consider painkillers a bigger problem than alcohol (66% vs. 57%), even though four times as many Americans die from alcohol related causes than from opioids.

Nearly 19,000 Americans died from prescription opioids in 2014, according to the Centers for Disease Control and Prevention. The National Institutes of Health estimates 88,000 people die annually from alcohol related causes.

Alcohol misuse is also estimated by NIH to cost the U.S. economy nearly $250 billion annually, while the “economic burden” of opioid abuse was estimated by the DEA at $53 billion in 2011.   

The Kaiser Foundation poll comes in the middle of an election season, as the White House and Congress consider various funding measures to address the so-called epidemic of opioid abuse and addiction.

The survey found that a large majority of Americans believe federal and state governments, doctors, and individuals who use prescription opioids are not doing enough to fight opioid addiction. Only about a third said police officers weren’t doing enough to enforce drug laws, a sign that many Americans don’t consider opioid abuse just a law enforcement issue.

Asked which policy efforts would be very or somewhat effective in reducing opioid abuse, over eight in ten said doctors and medical students should have better training in pain management and that there should be increased access to addiction treatment programs.  Less than half said putting warning labels on prescription opioids explaining the risk of addiction would be effective. Respondents were not asked if access to opioid pain medication should be reduced.

Policies Rated Very or Somewhat Effective in Fighting Opioid Abuse

  • 88% Increase pain management training
  • 86% Increase access to addiction treatment
  • 84% Public education and awareness programs
  • 83% Increase research about pain and pain management
  • 82% Monitor doctors’ prescribing habits
  • 63% Encourage disposal of extra pain meds
  • 60% Reduce stigma of opioid addiction
  • 48% Put addiction warning labels on opioid bottles

Putting the issue in perspective, while most Americans consider painkiller abuse a serious problem, the issue ranks well behind several other health problems such as cancer, diabetes, obesity and heart disease.

Health Problems Considered Extremely or Very Serious

  • 86% Cancer
  • 78% Diabetes
  • 74% Lack of access to mental healthcare
  • 73% Obesity
  • 72% Heart disease
  • 71% Contaminated drinking water
  • 70% Heroin abuse
  • 66% Painkiller abuse
  • 61% Lack of access to healthcare
  • 57% Environmental contamination
  • 57% Alcohol abuse
  • 54% Lack of access to affordable food

The Kaiser Foundation survey was conducted in mid-April in a random telephone sample of 1,201 American adults. The poll is estimated to have a sampling error of 3 percent.

To see the complete results of the Kaiser poll, click here.

FDA Approves New Version of Oxycodone

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended released version of the opioid painkiller oxycodone that has abuse deterrent properties unlike anything else on the market.

The drug – called Xtampza – can be ingested in capsule form, but users can also sprinkle the capsule contents on soft foods or into a cup, and then directly into the mouth.

The medication, which can also be ingested through a feeding tube, is the sixth opioid pain medication with an abuse deterrent formula to be approved by the FDA.  

Xtampza is made by Massachusetts-based Collegium Pharmaceutical (NASDAQ: COLL) with proprietary technology that combines oxycodone with fatty acid and waxes to form small spherical beads that are placed inside the capsule.

The beads are designed to resist breaking, crushing, chewing, dissolving and melting, methods long used by drugs abusers to snort or inject opioids.  

collegium pharmaceutical image

collegium pharmaceutical image

That novel approach is different from other abuse deterrent formulas, which generally make it harder for tablets to be crushed or liquefied; or come with a chemical irritant to discourage tampering.

“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids,” said Michael Heffernan, CEO of Collegium.

Another advantage of Xtampza is that it gives an alternative to patients who have trouble swallowing tablets or capsules, a condition know as dysphagia.  

"People like me live with dysphagia that prevents us from swallowing normally all the time. Up until this new drug coming out, people not able to swallow have had to rely on liquids and patches for relief - not being able to take their oxycodone," said PNN columnist Ellen Lenox Smith, who suffers from Ehlers Danlos syndrome and sarcoidosis. She testified in favor of Xtampza's approval for the U.S. Pain Foundation.

"Although this is a medication not compatible to my body, I testified on it's behalf for those people around the country not able to take their medications and thus not getting the relief they deserve. I am thrilled that this got approved so soon and that people will have this as an option and hope that this safer  formula will help to calm the nerves of all the people out there concerned about addiction to opiates," Smith said.

“Xtampza ER also allows for flexible dosing administration for patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be very dangerous with currently marketed ER products,” said Dr. Jeffrey Gudin, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center.

Xtampza, which is designed to be taken twice a day by patients who need around-the-clock pain relief, comes with an FDA warning to take the medication with food. Taking it on an empty stomach could lead to inadequate pain control.

Collegium plans to launch Xtampza ER in the U.S. in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone.

Tennessee Pain Clinics to Stop Using Opioids

By Pat Anson, Editor

One of the largest healthcare systems in Tennessee will no longer prescribe long term opioid pain medication to patients at two of its pain management clinics.

The move is the latest fallout from the prescribing guidelines released last month by the Centers for Disease for Prevention (CDC), which discourage the use of opioids for treating chronic pain. Although the CDC guidelines are voluntary and meant only for primary care physicians, many doctors around the country are adopting them and either weaning their patients off opioids or cutting them off entirely.

"This change was considered for several months in response to changing regulations and increasing national opiate addiction rates, and we began notifying physicians and patients of this decision in early April," Jerry Askew, Tennova Healthcare’s vice president of external relations said in a statement.

Tennova Healthcare is managed by the Sisters of Mercy, an organization of Roman Catholic nuns. Tennova operates a chain of 17 hospitals in Tennessee, but its new opioid policy only applies to patients at two pain clinics affiliated with Tennova hospitals in Knoxville and Turkey Creek.  

“After 30 days of your receipt of this letter, we no longer plan to provide long-term opiate pain medication to our patients,” Tennova said in a letter to patients.

“While pain medication therapy is widely used, non-opiate alternatives can be equally effective and can be generally safer for the patients who use them. The Center in Knoxville will continue to provide effective and compassionate treatment with non-opiate options including non-opioid pain medications, interventional procedures such as injections and radiofrequency ablations; referral to neurology and spine specialists; physical and aquatic therapy; weight loss strategies; acupuncture; massage therapy; and lifestyle counseling programs.”

But many of those alternative treatments do not work and are not covered by insurance, according to a recent survey of over 2,000 patients by Pain News Network and the International Pain Foundation. Three out of four patients said over-the-counter pain relievers did not help them at all and over half said non-opioid prescription drugs like Lyrica and Cymbalta are also ineffective.   

Tennessee has one of the highest rates of opioid abuse in the country. The state took a series of steps last year to limit opioid prescribing, such as requiring pharmacies to limit opioids to a 30 day supply and requiring doctors at pain clinics to regularly give patients urine drug tests.

"The bottom line is that fewer opioid prescriptions are being written and fewer Tennesseans are experiencing the downside and disastrous consequences of a painkiller addiction," said Douglas Varney, commissioner of the Department of Mental Health and Substance Abuse Services. "We are succeeding in reducing the number of prescriptions being written. We have helped more people into treatment and recovery and rallied a new generation of Tennesseans to live a life free of addiction."

But patient advocates say the crackdown on painkillers is unfairly focused on pain sufferers, not on the addicts who abuse opioid medication.

“I am seeing literally hundreds of reports from people who are being denied renewal of opioid meds which work well for them and are frequently the only medical treatments that give them any quality of life. Doctors are giving up their pain management practices for fear of prosecution by the DEA,” said Richard Lawhern, PhD, who became an advocate after his wife developed trigeminal neuralgia, a chronic facial pain disorder.

“I am convinced that the CDC guidelines are creating what we will later recognize to be a wave of patient suicides due to resurgent pain and hopelessness, as well as a surge in patients seeking out street drugs because they cannot function without pain relief and are being forced by their doctors to do so.”

In recent weeks, at least 14 people died and dozens were hospitalized in California after ingesting counterfeit pain medication made with illicit fentanyl, a powerful and deadly analgesic. Some of the victims were pain patients. Fake pain pills are being sold by dealers in the Sacramento and San Francisco Bay areas, and have also been intercepted at the California-Mexico border.

Counterfeit Pain Pills Spread in California

By Pat Anson, Editor

At least seven people in the San Francisco Bay Area sought medical help after ingesting counterfeit pain medication laced with fentanyl, according to a new report from the Centers for Disease Control and Prevention (CDC).  The cases were reported in Contra Costa, Alameda, San Francisco and Santa Clara counties.

The fake pills were disguised to look like Norco, a widely prescribed opioid pain medication that combines hydrocodone with acetaminophen.

The pills are similar to counterfeit medication blamed in recent weeks for 14 fatal overdoses in the Sacramento area, except that they contain promethazine, an antihistamine that acts as a sedative and is sometimes used to boost the “high” from illicit opioids.

At least one of the fake tablets was also found to contain cocaine.

california poison control system

california poison control system

The CDC said all of the Bay Area patients had symptoms of opioid intoxication, but recovered within 24 hours. The pills were obtained from friends or bought off the street.  The outbreak lasted about two weeks, from March 25 to April 5, but was not publicly reported until today. There was no explanation for the three week delay in reporting what the CDC considers a "serious public health threat."

“The distribution of counterfeit medications, especially those containing fentanyl, is an emerging and serious public health threat,” the CDC said. “Efforts to identify the source of the current counterfeiting are ongoing. Patients with signs and symptoms of acute opioid overdose including central nervous system and respiratory depression, and in whom larger doses of naloxone are required to reverse symptoms, should raise suspicion for intoxication with a counterfeit product containing fentanyl.”

The CDC calls opioid abuse “the fastest-growing drug problem in the United States” and has often blamed that trend on prescription pain medication. However, as Pain News Network has reported, prescriptions for most opioids have actually been in decline for several years, especially for hydrocodone, at a time when opioid overdose deaths are rising.

Illicit fentanyl is a dangerous and sometime deadly opioid that is 50 times more potent than morphine. It has been blamed for thousands of overdose deaths in the U.S. and Canada. Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to prescription fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl typically is mixed with heroin and cocaine to make the drugs more potent, but is increasingly showing up in pill form – usually disguised as pain medication.

In February, a smuggler was caught with nearly 1,200 fake oxycodone pills at the California-Mexico border, the first time counterfeit pain medication made with fentanyl was seized at a border crossing in California.

In March, the DEA arrested four men in southern California who were operating four large pill presses to make counterfeit hydrocodone and Xanax, an anti-anxiety medication. At least two people died in Orange county late last year after ingesting fake Xanax made with fentanyl. Counterfeit medication has also recently been reported in Florida and Ohio.

Last month the CDC adopted guidelines that discourage primary care physicians from prescribing opioids for chronic pain. Several pain patients have told PNN recently that their doctors are now reducing their opioid doses or cutting them off entirely.

“Since the guidelines changed, my quality of life has been destroyed & relentless suffering has become my identity,” wrote a pain patient who said she lost access to the opioid medication she’s been using for pain relief for a dozen years.

“I never considered using drugs for anything other than what & how they were prescribed. I can't say the thought of seeking relief from constant suffering hasn't flirted with the possibility of something a little less legal, or regulated. The fact that I've considered something so obscene makes me sick, but the fact that my healthcare providers were forced to allow me to suffer & reach such a point of desperation is disgusting.”

In a survey of over 2,000 pain patients last fall by Pain News Network and the International Pain Foundation, 60 percent predicted patients would get opioids off the street or through other sources if the CDC guidelines were adopted. Another 70% said use of heroin and illegal drugs would increase.

Will CDC Opioid Guidelines Help Reduce Overdoses?

By Lynn Webster, MD, Guest Columnist

Politicians and some government officials tell us that the new CDC opioid guidelines will reduce deaths due to overdoses. But, based on the evidence we’ve seen so far, that is unlikely.

The latest CDC report shows a continual increase in opioid-related overdose deaths despite about a 25% decrease in the number of opioids prescribed.  This data demonstrates that an absolute reduction in opioid prescribing hasn’t resulted in the intended outcome – so far, at least. It may be counter-intuitive, but I think you’ll understand why in a moment.

The problem is more complex than the lawmakers, CDC, and regulators would have us believe. Simply reducing the amount of opioids prescribed will not necessarily affect overdose death rates as you might expect. In fact, it might do just the opposite.

What happens is that, when we reduce the amount of opioids that are prescribed, we force many of those with opioid addictions to switch to illegal opioids such as heroin and synthetic fentanyl, which are far more dangerous than prescription opioids.

If the amount of opioid prescribing were reduced dramatically, it would likely reduce the number of deaths from prescription opioids. But there would almost certainly be a significant increase in abuse of other drugs. That could result in more overdoses than we’re seeing now. We’ve already seen more deaths due to the increased use of heroin, but heroin is only one of many illegal drugs that can be abused.

Reducing the supply side of the addiction problem does not address the demand for opioids, nor does it help address the needs of people with the disease of addiction.

Of course, additional “collateral harm” can occur with people in pain who benefit from opioids, and it is unacceptable to any person with compassion. Denying prescriptions to people who have been benefiting from opioids is a misguided attempt to save the lives of people with opioid addictions at the expense of people with pain.

People with pain will suffer, and that suffering won’t save the lives of people with addictions who turn to illegal substances. Additionally, in all likelihood, we will see an increase in suicides from people who just cannot live with their level of pain.

There are about 104 suicides per day (compared to 44 opioid-related overdoses per day). In my opinion, intractable pain is a contributing factor in many of these suicides. I suspect that, as we see more and more people denied opioids for their pain, we will see an increase in the number of suicides. I base this on my experience of seeing many patients commit suicide in my practice despite having access to all of the available treatments.

Severe pain is not always compatible with choosing to live.

Reducing deaths related to over-prescribing opioids would be a good thing and must be a priority. But, if we want to reduce the amount of opioids prescribed for people in pain, then we must provide them another, safer way to handle their pain.

Trading opioid-related deaths for either death related to illegal drugs or to suicides because of pain, is not an acceptable solution. We need something better to offer people in pain, and we need it soon.

Lynn R. Webster, MD, is past President of the American Academy of Pain Medicine, Vice President of scientific affairs at PRA Health Sciences, and the author of “The Painful Truth.”

This column is republished with permission from Dr. Webster’s blog.

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 Nearing Decision on Drug Implant

By Pat Anson, Editor 

The U.S. Food and Drug Administration is expected to finally make a decision next month on a new drug delivery system to treat opioid addiction – an implant that could also be used someday to treat pain and other chronic illnesses that require steady doses of medication.

The latest results from a Phase 3 double blind study of a buprenorphine implant called Probuphine would appear to boost its chances of winning FDA approval. Titan Pharmaceuticals (NASDAQ: TTNP) said over 85% of the patients who had the implant for six months abstained from using illicit opioids, compared to about 72% of patients who used oral buprenorphine film strips that were taken daily.

The study findings were recently presented at the annual meeting of the American Society of Addiction Medicine in San Francisco.

"This was the first head-to-head comparison study of Probuphine and sublingual buprenorphine, demonstrating the efficacy of a long-acting six month buprenorphine implant," said lead investigator Richard Rosenthal, MD, Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. “If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option."

titan pharmaceuticals image

titan pharmaceuticals image

Probuphine is about the size of a matchstick and is implanted under the skin. For six months it delivers a steady dose of buprenorphine, a weaker acting opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone.

There are many advantages to an implant. The dosage is controlled and there’s little risk of abuse, diversion or overdose. Users also never have to remember to take a pill.

Probuphine’s path to the marketplace has been rocky at times. Titan and its partner, Braeburn Pharmaceuticals, were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study proving Probuphine’s effectiveness.  

Positive results from a Phase 3 trial were submitted in 2015 and in January of this year an FDA advisory committee voted 12 to 5 in favor of approving the implant. But then the agency added another delay by extending its decision date to May 27.  

The time may be ripe for approval this time around, as the FDA is under intense political pressure to do more to address the nation's opioid abuse epidemic. The Obama administration has proposed a rule change that would double the number of patients that a doctor can treat with buprenophine from 100 to 200. And Congress is considering funding proposals that would allocate another $1 billion to the war on drugs, with most of the money spent on addiction treatment.

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 in a recent interview 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.”