Opioids Provide Only ‘Modest’ Relief for Low Back Pain

By Pat Anson, Editor

Lower back pain may be the world’s leading cause of disability, but there is surprisingly little evidence about the best ways to treat it – including the use of opioid pain medication.

A new study published in JAMA Internal Medicine adds a little clarity to the issue.

In a systematic review of 20 clinical studies involving nearly 7,300 patients, researchers found evidence that opioid medications provide only “modest” short-term relief from lower back pain.

“In people with chronic low back pain, opioid analgesics provide short and/or intermediate pain relief, though the effect is small and not clinically important even at higher doses,” said lead author Andrew McLachlan, PhD, a professor of pharmacy at the University of Sydney in Australia.

Opioids were found to be no more effective than non-steroidal anti-inflammatory drugs (NSAIDs). About half of the patients involved in the studies dropped out because they didn’t like the side-effects of opioids or because they found them to be ineffective.

“Our review challenges the prevailing view that opioid medicines are powerful analgesics for low back pain. Opioid analgesics had minimal effects on pain, and even at high doses the magnitude of the effect is less than the accepted thresholds for a clinically important treatment effect on pain,” McLachlan wrote.

Although nearly a quarter of the opioid prescriptions written in the U.S. are for low back pain,  medical guidelines often recommend against it.

“Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction,” wrote Gary Franklin, MD, in a position paper  adopted by the  American Academy of Neurology.

Franklin, who is vice-president of Physicians for Responsible Opioid Prescribing (PROP), also helped draft the recent opioid guidelines adopted by the Centers for Disease Control and Prevention.

“Evidence is limited or insufficient for improved pain or function with long-term use of opioids for several chronic pain conditions for which opioids are commonly prescribed, such as low back pain,” the CDC guidelines state. “Several non-opioid pharmacologic therapies (including acetaminophen, NSAIDs, and selected antidepressants and anticonvulsants) are effective for chronic pain. In particular, acetaminophen and NSAIDs can be useful for arthritis and low back pain.”

A large study recently published in the British Medical Journal reached a different conclusion than CDC – finding that there was little evidence that acetaminophen – also known as paracetamol – was effective in treating low back pain. Another study published in The Lancet reached a similar conclusion.

Who should patients believe with all this conflicting advice?

Perhaps the best therapy can’t be found in a pharmacy or drug store.

A recent study published in JAMA Internal Medicine found that regular exercise and education about its benefits reduce the risk of developing lower back pain by as much as 45 percent.

“If a medication or injection were available that reduced LBP (low back pain) recurrence by such an amount, we would be reading the marketing materials in our journals and viewing them on television. However, formal exercise instruction after an episode of LBP is uncommonly prescribed by physicians,” wrote Timothy Carey, MD, and Janet Freburger, PhD, of the University of North Carolina at Chapel Hill.

Over 80 percent of us suffer acute low back pain at least once in our lives, and about half will experience a recurrence within one year. 

Lyrica Linked to Birth Defects

By Pat Anson, Editor

A drug widely prescribed to treat fibromyalgia, neuropathy and other chronic pain conditions increases the risk of major birth defects, according to a new study published in Neurology, the medical journal of the American Academy of Neurology.

Women taking pregabalin were six times more likely to have a pregnancy with a major defect than women who were not taking the drug, the study found. The birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. Birth defects due to chromosomal abnormalities were not included in the results.

Pregabalin is the generic name of Lyrica, which is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed “off label” to treat a variety of other conditions. Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is currently approved for use in over 130 countries.

The international study involved nearly 700 pregnant women in seven different countries. Four of the 125 women who took pregabalin during pregnancy had children with central nervous system defects, or 3.2 percent. That compares to a birth defect rate of just 0.5% in the 570 women who did not take pregabalin.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain, 39 were taking it for psychiatric disorders, including depression and anxiety, five were taking it for epilepsy, and one for restless leg syndrome.

Most of the women started taking pregabalin before they became pregnant. All of them stopped taking the drug at an average of six weeks into their pregnancies.

A small number of women also took another anti-seizure drug during their pregnancy. Women in that group had a 6 percent chance of a major birth defect, compared to 2 percent of the women who did not take another anti-seizure medication.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.

“Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”

A spokesman for Pfizer said the study was small and the findings could have been influenced by other factors.

"As the authors agree, the study has significant limitations and cannot be used to draw definitive conclusions," Steven Danehy said in an email to Pain News Network. "The study was small, did not account for other medical conditions or medications, and the women taking Lyrica had higher rates of smoking and diabetes, all of which can negatively affect pregnancy outcomes."  

Because women are more likely than men to have a chronic pain condition such as fibromyalgia, they are the biggest consumers of Lyrica.

The FDA warning label for Lyrica does not specifically warn pregnant women not to take the drug. But it does caution them to consult with a doctor if they are pregnant or plan to become pregnant.

“It is not known if Lyrica will harm your unborn baby. You and your healthcare provider will have to decide if you should take Lyrica while you are pregnant. If you become pregnant while taking Lyrica, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry,” the label says.

The label also cautions men to see a doctor if they plan to father a child while taking Lyrica. 

“Animal studies have shown that pregabalin, the active ingredient in Lyrica, made male animals less fertile and caused sperm to change. Also, in animal studies, birth defects were seen in the offspring (babies) of male animals treated with pregabalin. It is not known if these problems can happen in people who take Lyrica,” the warning label states.

The Hidden Dangers of Self-Medicating with OTC Drugs

By James Campbell, MD, Guest Columnist

The Centers for Disease Control and Prevention (CDC) recently unveiled guidelines for primary care physicians on the use of opioids for chronic pain. Not surprisingly, the guidelines urge physicians to first try non-pharmacologic and non-opioid treatments before resorting to opioid therapy.

If you’re one of the millions of Americans living with pain on a daily basis, it’s likely you’re not a stranger to over-the-counter (OTC), non-prescription pain medications such as naproxen (brand name Aleve), ibuprofen (Advil and Motrin), aspirin and acetaminophen (Tylenol).

In fact, most of my patients with chronic pain began their quest for relief with a cocktail of OTC pain relievers, muscle relaxants and even alcohol, before seeking professional help and eventually graduating to prescription treatments such as opioids, anti-depressants and anticonvulsants.

While OTC pain medications are generally safe when taken at their recommended doses, it’s all too common for patients to unknowingly put themselves at risk of a fatal accidental overdose or serious drug-drug interactions by mixing OTC pain medications or taking them in combination with prescription treatments for pain or other common health conditions.

Given the sheer magnitude of serious adverse events and fatalities associated with opioids, the hidden, yet preventable dangers of the pain medications on your pharmacy shelves are not often discussed.

Let’s take one of the most common OTC pain relievers: acetaminophen. When used as directed within the advised dosing guidelines, acetaminophen is safe and effective. However, if a person takes more than one medication that contains acetaminophen and exceeds the maximum recommended dose, they may be at risk of serious liver damage.

This happens so often that acetaminophen overdose is the leading cause of calls to poison control centers in the United States -- more than 100,000 instances per year – and are responsible for more than 56,000 emergency room visits.

In fact, in 2011, in an effort to reduce the risk of severe liver injury from acetaminophen overdose, the Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription medications, including combination acetaminophen and opioid products, to no more than 325 mg per tablet, capsule or other dosage unit.

Then in 2014, the FDA recommended that health care professionals discontinue prescribing and dispensing prescription combination products that contain more than 325 mg of acetaminophen.

While the FDA’s efforts may help curb accidental overdose related to prescription medications that contain acetaminophen (Tylenol with codeine, for example), it does little to address the risks of OTC acetaminophen or other OTC pain medications such as ibuprofen, a type of non-steroidal anti-inflammatory drug (NSAID), which can cause gastrointestinal bleeding and injury, and cardiovascular side effects when taken on a chronic basis.

Drug Interactions

In addition to the risk of overdose, people taking multiple OTC and prescription medications for pain and other conditions are also at risk of serious drug-drug interactions. Simply put, any “drug” – whether it be a medicine, vitamin, supplement or even alcohol – that enters your body and alters your natural internal chemistry has the potential to interact or alter the intended effect or unintended side effect of other medications.

Even though most medications are accompanied by warnings about combining them with other drugs, most vitamins and supplements are not -- so, unless you’re a licensed medical professional, it’s virtually impossible to recognize the potential for drug-drug interactions.

If you’re using OTC medications, whether alone or with prescription medications, to cope with pain on a daily basis, here are three precautionary steps you can take to safeguard yourself against the risk of accidental overdose or drug-drug interactions.

1) Recognize that ALL medications, whether OTC or prescription, can cause harm if used improperly, and the fact that some medications are available without a prescription does not mean they are inherently safe. Read the labels that come with your medications. Tylenol, Advil and Vicodin are household names, so it can be easy to overlook their “generic” names (or the active ingredient in each).

For example, the generic name for Tylenol is acetaminophen, while that of Vicodin is acetaminophen hydrocodone. Without close examination of either label, a person taking Vicodin and Tylenol together could be inadvertently exceeding the recommended dosage of acetaminophen.

2) Consult a medical professional before you take more than one medication on a daily basis. If your chronic pain is being treated by a physician, be sure to tell them (even if it’s on your medical history) about any OTC or prescription medications you are currently taking. This includes vitamins and other supplements that may seem harmless, but could interact with your pain medications.

3) If you are independently treating your chronic pain, make a list of all the medications, vitamins and supplements you take on a regular basis and share them with your local pharmacist. Pharmacists can identify potential drug-drug interactions like taking acetaminophen and ibuprofen on a long-term basis, which can result in an increased risk of developing kidney problems.

The American Chronic Pain Association also recommends using the same pharmacy for all your prescriptions, so that the pharmacist can screen health information and current medications to avoid the pitfalls of overdose and drug interactions.

As a neurosurgeon with a special interest in pain for over 30 years, I’m empathetic to the daily struggle that patients face and their desperate quest for relief, seeking anything and everything that can simply make the pain stop.

For the patients who are fighting this seemingly endless battle with pain without the help of a medical professional, I hope I’ve provided some useful information and practical advice to help avoid serious risks associated with self-medicating. However, people living with moderate to severe chronic pain may benefit from a consultation with a licensed pain management specialist, who can help guide you toward steps that will help reduce your pain. 

James Campbell, MD, has spent the last 30 years pioneering efforts to improve the diagnosis and treatment of patients with chronic pain. 

Dr. Campbell is professor emeritus of Neurosurgery at Johns Hopkins University School of Medicine and is the founder of the Johns Hopkins Blaustein Pain Treatment Center - one of the largest pain research centers in the U.S. He is also a former president of the American Pain Society. 

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.

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

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.