Canada Fights Wave of Fake Pain Pills

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

NORTH BAY POLICE PHOTO

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

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

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

Painkillers Cause Chronic Pain? Rats!!!

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

Patient advocates had a mixed reaction to the study.

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

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

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

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

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

Most Patients Don’t Think Opioids Are Risky

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Are CDC Opioid Guidelines Causing More Suicides?

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

DONALD BEYER

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

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

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

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

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

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

Impact of CDC Guidelines

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

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

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

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

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

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

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

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

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

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

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

Unintended Consequences

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

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

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

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

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

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

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

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

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

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

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

FDA Approves New Drug Implant

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.