'National Pain Strategy' Report Released

By Pat Anson, Editor

The National Institutes of Health has quietly released a draft copy of its National Pain Strategy, a long awaited report designed to advance pain research, healthcare and education in the U.S.

The report calls chronic pain a “complex disease and a threat to public health” and identifies several areas where physicians and the healthcare system are failing pain sufferers.

“Access to high-quality integrated care based on clinical evidence is hindered by many challenges, including a payment system that does not support optimal care. Pain management often is limited to pharmacological treatment offered by a single primary care practitioner or to procedure-oriented and incentivized specialty care that is not coordinated and not aligned with the best available evidence or expected outcomes,” the report says.

“Even when interdisciplinary care is provided, creating and executing a care plan is often fragmented, with poor communication among clinicians and without consideration of patient preferences. The clinician or team’s choice of therapy may be based on practice experience or on insurance coverage, rather than one informed by a comprehensive pain assessment, clinical evidence or best practices.”

The report only briefly addresses the controversy over the abuse and diversion of opioid painkillers, and how some pain sufferers are being denied pain medication by their doctors and pharmacists.

“The reluctance of many clinicians to prescribe these medications, and patients’ concerns over stigmatization associated with opioids may jeopardize quality pain control in the population. Only a small percentage of practitioners and patients account for the majority of opioid-related risk through abuse of prescribing privileges and inappropriate management of prescriptions,” the report said.

Other key findings of the report:

• People with pain are too often stigmatized in the health care system and in society, which can lead to delayed diagnosis, misdiagnosis, and bias in treatment.
• Significant barriers to pain care exist, especially for populations disproportionately affected by pain.
• Although pain is widespread in the population, research is lacking on the prevalence, impact, and outcomes of most common chronic pain conditions.
• Significant improvements are needed in pain management practices.
• Primary care doctors are not sufficiently trained in pain assessment and treatment.  
• Greater collaboration is needed between primary care doctors and pain specialists.

“I agree that collaboration between primary and pain specialists is helpful in some cases, though I do not believe it is mandatory,” said Celeste Cooper, a retired nurse and patient advocate who reviewed the report.

“To think that a primary physician cannot complete continuing education courses for management of mild to moderate chronic pain is ridiculous. Primary physicians are on the front lines. They will be held accountable for prevention strategies, but they aren’t able to make assessments for treating pain? This seems like tying their hands behind their backs.’

The National Pain Strategy is an outgrowth of the 2011 Institute of Medicine report, “Relieving Pain in America,” which found that 100 million Americans suffer from chronic pain.

One critic of the new report says it lacks vision and will not make pain care better.

 “I think the report reflects that it has been developed by (and for) special interest groups who are not very skilled at planning or project management. This report is ungainly and lacks a real focus -- and so I think people in pain will be wondering what exactly they can expect to be different and better for them,” said patient advocate David Becker in an email to Pain News Network.

“I think it is unethical for special interest groups to assume that any and every individual in pain cannot be cured and should not receive stem cell therapy or other curative/regenerative care. In this regard, it reinforces the received view -- and a self- serving view -- that people in pain should be treated indefinitely by medical care."

While not perfect, Cooper said she was encouraged by the report's recommendations.

"Looking at chronic pain as a public health issue is the right approach in my opinion. It will avail resources that wouldn’t otherwise be accessible. The report is comprehensive, there will be roadblocks in implementing all the suggestions, but hopefully generations to come will benefit. As an educator, I was impressed on seeing short-term to long-term goals. This strategy provides a mechanism for reassessment and revision," Cooper said in an email.

The Interagency Pain Research Coordinating Committee is accepting public comments on the National Pain Strategy until May 20, 2015.

Comments can be emailed to NPSPublicComments@NIH.gov.

FDA Issues Guidance on Abuse Deterrent Opioids

By Pat Anson, Editor

The U.S. Food and Drug Administration has released its long-awaited guidance on abuse-deterrent opioids, beating a Congressional deadline and a potential loss of $20 million in funding.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about abuse-deterrent properties and recommends to drug makers how clinical studies should be conducted to evaluate their effectiveness.

Abuse deterrent formulas are intended to make it harder for drug abusers to crush or liquefy a narcotic painkiller for snorting or injecting. But the evidence is mixed that they actually work.

“It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria. Moreover, the fact that a product has abuse -deterrent properties does not mean that there is no risk of abuse.  It means, rather, that the risk of abuse is lower than it would be without such properties. Because opioid products must in the end be able to deliver the opioid to the patient, there may always be some abuse of these products,” the FDA said in its report.

The agency has been under pressure from Congress to move faster in developing guidelines for abuse deterrence. An appropriations bill passed late last year would have moved $20 million in funding from the FDA’s Commissioner’s office if the guidance wasn’t released by June 30.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret Hamburg, MD. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

So far only four opioids have been approved with abuse-deterrent formulas, OxyContin, Embeda, Targiniq and Hysingla. The latter was recently introduced by Purdue Pharma as the only “pure” hydrocodone extended release product with abuse-deterrence.

Purdue’s reformulated version of OxyContin was the first opioid to have abuse deterrence. It was introduced in 2010, at a time when the painkiller was widely being abused.

A recent study by researchers at Washington University’s School of Medicine in St. Louis found that over a quarter of drug abusers entering treatment facilities admitted they still abused OxyContin. About a third of the abusers said they had found a way to inhale or inject it. The rest took the painkiller orally.

One unintended consequence of reformulating OxyContin is that 70% of the drug abusers who stopped using it and who switched to other narcotics started using heroin.

"The newer formulations are less attractive to abusers, but the reality is -- and our data demonstrate this quite clearly -- it's naïve to think that by making an abuse-deterrent pill we can eliminate drug abuse. There are people who will continue to use, no matter what the drug makers do, and until we focus more on why people use these drugs, we won't be able to solve this problem,” said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

Some patients believe the reformulated version of OxyContin is less effective as a pain reliever and causes gastrointestinal problems because it is harder to digest.

The FDA said it would take “a flexible, adaptive approach” to the future evaluation and labeling of abuse-deterrent products.

“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”

Over 16,500 deaths in the U.S. were linked to opioids in 2010. According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Acetaminophen Ineffective for Back Pain

By Pat Anson, Editor

The world’s most widely used over-the-counter pain reliever is ineffective in treating low back pain and provides little benefit to people with osteoarthritis, according to a new study published in the British Medical Journal.

In a systematic review of a dozen research reports (a study of studies), Australian researchers also questioned many of the conventional treatments for back pain and other musculoskeletal conditions.

Acetaminophen -- also known as paracetamol – is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. It is often recommended by doctors worldwide for back pain and osteoarthritis.

"Clinicians should carefully weigh benefits and harms when making treatment decisions. Paracetamol is not efficacious and potentially harmful. In this context we cannot justify its continued use for these prevalent diseases,” said Professor David Hunter of the University of Sydney.

The researchers found “high quality” evidence showing that patients taking acetaminophen are at greater risk of liver toxicity and nearly four times more likely to have abnormal results from liver function tests.

"World-wide, paracetamol is the most widely used over-the counter medicine for musculoskeletal conditions so it is important to reconsider treatment recommendations given this new evidence," said lead author, Gustavo Machado of The George Institute and the University of Sydney.

Low back pain is the leading cause of disability worldwide, and osteoarthritis of the hip or knee is the 11th highest contributor to global disability.

"This latest research, the most comprehensive systematic review of its kind, reaffirms this with an even larger, global patient base, and has for the first time also established that the effects of paracetamol for knee and hip osteoarthritis are too small to be of clinical importance." said senior author Manuela Ferreira of the George Institute for Global Health and the University of Sydney.

"We urgently need to take stock of the evidence for common musculoskeletal conditions, a largely under-recognized health priority, and make sure people are receiving appropriate care."

Treatments known to be effective for low back pain include counseling, physical therapy, exercise and psychological therapies such as cognitive behavioral therapy.

Aerobic exercise, strengthening exercise, weight management and anti-inflammatory medicines have been shown to provide benefit for patients with lower limb osteoarthritis.

A recent study published in The Lancet found that acetaminophen had no effect on pain, disability, function, sleep quality, or quality of life for people with low back pain.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. 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.

Study Claims 10% of Pain Patients Addicted to Opioids

By Pat Anson, Editor

Estimating rates of opioid abuse and addiction has never been easy. Dozens of different studies have come to startling different conclusions, and there is even disagreement over the definition of abuse and addiction.

Now a professor at the University of New Mexico is weighing in on the subject -- and his conclusions are likely to stir even more debate.

In a systematic review of 38 research reports (a study of studies) published in the journal PAIN, lead author Kevin Vowles and his colleagues estimate that up to 30 percent of the opioids prescribed for pain are misused and that about 10 percent of pain patients are addicted to them.

They also question whether opioids should be prescribed at all for chronic pain.

“It is not clear whether the risks of opioid use outweigh the potential for benefit. The efficacy of opioids and their suitability for the long-term management of chronic pain still remain very much in question and while this uncertainty in effectiveness is well established, it stands in somewhat stark contrast to the clinical reality of chronic pain treatment, where rates of prescriptions have skyrocketed such that opioids are now among the most frequently prescribed medications,” wrote Vowles.

“We are not certain whether the benefits derived from opioids, which are rather unclear based on the extant literature, compensate for this additional burden to patients and health care systems.”

The researchers noted there was extremely wide variation in the rates of opioid misuse and addiction in the studies they analyzed. Rates of “problematic use” ranged from less than 1% all the way up to 81%.

One study -- a review of 25 research reports – left the barn door wide open by broadly estimating the “prevalence of problematic opioid use behavior” at 0% to 50% of pain patients.

“The vagueness inherent in these definitions, areas of overlap among them, and their sometimes interchangeable use have made it difficult to determine exact rates and types of problematic opioid use,” conceded Vowles.

Exactly what constitutes opioid misuse is also debatable.

Vowles defined misuse as “opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects.” Such a definition means a patient who has stopped using a prescribed opioid – even if they no longer have pain – is misusing the medication.

(Several years ago this writer was sent home from the hospital after surgery with a two week supply of Vicodin. Fortunately, the surgery was successful and the pain subsided after a few days. A half empty bottle of Vicodin sat unused in my medicine cabinet for years before I had sense enough to throw it out. Under Vowles’ definition, I had “misused” the Vicodin.)

Studies by some of the nation’s largest drug screening companies consistently show that many Americans don’t take the drugs that are prescribed for them. A large study by Quest Diagnostics found that 60% of Americans failed to take a medication as prescribed by their physicians and that 42% had no drugs in their system. Should they be included in estimates of misuse?

Rates of addiction in the studies analyzed by Vowles also varied greatly – from 0.7% of pain patients up to 34.1%.

An adjusted analysis by Vowles estimated the average rate of addiction at 8% to 12% -- a figure nearly double the estimate of the National Institutes of Health (NIH). According to the NIH, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

“Misuse, abuse and addiction mean different things to different researchers,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“We must keep in mind that behaviors determine the diagnoses of misuse, abuse and addiction and these behaviors are subjective interpretations. Subjective interpretations are influenced by one's biases and perspective.  Misuse to one researcher can be addiction to another. Unfortunately there has not been a standard interpretation of behaviors and I doubt there ever will be due to personal beliefs about opioids and addiction.”  

While Webster doesn’t take issue with the design of the study – he does dispute the overall conclusion that the risks of opioid abuse outweigh the benefits.  

“It is undoubtedly true that some people should not be prescribed opioids.  But even using their reported averages for abuse and addiction, a majority of people do not abuse or become addicted and therefore shouldn't necessarily be denied treatment particularly if there is no other option,” Webster wrote in an email to Pain News Network. 

Ironically, only one study analyzed by Vowles even looked at the recreational abuse of opioids – perhaps the biggest contributor to the so-called “epidemic” of prescription drug abuse in the U.S.  That study estimated the rate of abuse by pain patients at just 8% -- far below their estimated rates of misuse.

Vowles admits there are several limitations to his study.

“The most obvious is the degree of variability within this literature. In spite of our attempts to minimize the impact of this variability, the range of misuse and addiction was incredibly broad,” he wrote.

“These sources of variability will likely continue to cloud our ability to make precise estimates. There is clearly room here for a series of carefully controlled studies where sources of variability are held constant, or as constant as possible, to more clearly illuminate prevalence rates of problematic opioid use in individuals with chronic pain.”

Survey: Two-Thirds of Patients Unable to Get Hydrocodone

By Pat Anson, Editor

About two-thirds of pain patients say they were no longer able to obtain hydrocodone after the opioid painkiller was reclassified by the U.S. government from a Schedule III medication to a more restrictive Schedule II drug, according to the results of a new survey.

Many patients who had been taking hydrocodone at the same dose for years said their doctor would no longer prescribe the painkiller. Over a quarter (27%) said they had suicidal thoughts after being denied a prescription for hydrocodone.

The survey of over 3,000 patients was conducted online by the National Fibromyalgia & Chronic Pain Association (NFMCPA) and the findings presented this week at the annual meeting of the American Academy of Pain Medicine. An abstract of “Hydrocodone Rescheduling: The First 100 Days” can be found here.

Hydrocodone was rescheduled by the Drug Enforcement Administration in October of last year to combat an “epidemic” of prescription drug abuse. The rescheduling limits patients to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

The reclassification quickly made a drug that was once the most widely prescribed pain medication in the country – at nearly 130 million prescriptions each year – to one of the hardest to get.

Other key findings of the survey:

• 88% of respondents believe the change to Schedule II denies pain patients the right to adequate pain care.
• 75% believe the change will not prevent prescription drug abuse.
• 72% believe the change is harmful to pain patients.
• 18% said it led to a "worsened relationship" with their doctor.
• 30% reported "issues" with their pharmacy filling prescriptions.

Patients also reported higher expenses due to increased doctor’s visits, higher co-pays, greater transportation costs to visit the doctor and multiple pharmacies, and lost income due to inability to work because of pain.

The survey is believed to be the first to report on the experiences of pain patients treated with hydrocodone since the rescheduling took effect. The respondents were overwhelmingly female, which reflects the demographics of fibromyalgia and many other chronic pain conditions.

Hydrocodone isn’t the first pain medication to be in short supply. A report released last month by the Government Accountability Office (GAO) faults the DEA for poor management and “weak internal controls” of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was difficult to obtain for eight and a half years.

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

Patients Deserve to Know the Truth about Cymbalta

By Crystal Lindell, Columnist

Look, yes, Cymbalta probably saved my life. But it also sucks. So, I’m not surprised people are suing Eli Lilly, the makers of the drug. 

I can still remember talking to a nurse over the phone at the Mayo Clinic’s pain rehab program when she mentioned Cymbalta. It was the same pain program my insurance company would eventually deny, prompting the Mayo Clinic to ask for $35,000 up-front, and prompting me to laugh in their faces and instead buy a $7 Yoga DVD at Best Buy and hope for the best. 

Anyway, yeah, the nurse. She was all, “Oh! Cymbalta is a WONDERFUL drug! So many people love it! And it works so well! That’s a great drug to go on when you go off opioids!”  

But all I could think was, “Obviously you have never been on Cymbalta or opioids or had chronic pain, because Cymbalta sucks.”

I always tell people I was tricked into starting the drug. 

My doctor, whom I really do love, put me on it about a year and a half ago. He brought it up at my first appointment with him -- the same appointment I also decided to confess that I was having suicidal thoughts daily. He told me he was putting me on Cymbalta because it had been shown to help with pain. I’d later find out that was only half the reason. 

When I went to a follow-up appointment, the doctor asked if  Cymbalta had helped with my pain at all. And because my pain is stronger than the U.S. military, it hadn’t. But, then came the reveal. 

“Well, how’s your mood?” he asked, slowly.  

“Actually, better,” I replied, realizing that had been his secret plan all along. 

But you know what? I can sincerely tell you that I didn’t want to kill myself anymore. I mean, I still thought about it, but the drug had sort of diluted the thoughts, and made them less of a legitimate option and more of a fleeting idea I had in passing. 

And I totally get why my doctor did what he did. Because when someone is suicidal, it just makes sense that staying alive is the one and only goal. So, in the beginning I was fine with whatever worked — and it just so happened that Cymbalta is what worked for me. 

Until it didn’t. 

Cymbalta was able to keep the suicidal thoughts away, but it also kept a lot of other thoughts away too. Like my creative thoughts, my writing thoughts and, honestly, my sex thoughts. The drug straight up slaughtered my sex drive.  

It also made me so tired. Like, sleep-for-16-hours-a-day tired. Yes, it had help from all the other drugs I’m on, but I can clearly tell you that the fatigue is worse than it was before I started taking Cymbalta.

So, a couple months ago I tried to go off it. I chose the only method I knew and cut it out cold turkey. Within just two days, my writing voice came back like the great flood. And I was getting turned on by my boyfriend again. I even got to see and understand 8 a.m. again for the first time in like a year. 

All was well with the world. Except when suddenly it wasn’t. Because Oh. My. God. The withdrawal symptoms from Cymbalta were hell. 

Less than a week after my last pill, I was getting so dizzy that I seriously thought I had a new disease. Then, there was this thing called the brain zaps, that I didn’t understand until they happened to me. In short, it literally felt like my brain was being, well, zapped by electricity. 

There was also nausea and vertigo and just an overall feeling of falling off a skyscraper. 

I can honestly tell you that going off Cymbalta was worse than going off any opioid I’ve ever been on. At least with opioids it only takes like 18 hours to get out of your system, and when it’s over, it’s over. Cymbalta lingered. It took it’s time with me. It gradually poured on the withdrawal symptoms in a tortuous piling on. 

So, a week after I went off it, I went back on it.

Apparently though, I’m not the only one staring down at a lifetime of daily Cymbalta doses. According to the Internet, (always a reliable source) there’s a possible class action lawsuit being brought against Eli Lilly.

“Studies show that between 50% and 78% of Cymbalta users experience antidepressant withdrawal symptoms after discontinuing the drug. Yet the drug label misleadingly states that Cymbalta withdrawal symptoms occur in only 1% to 2% of cases,” claims attorney Steven D. Gacovino.

You can read more about it here.

Now, I literally have no idea how legit this whole thing is. Can you really fill out a form on a random website and be part of  a class action lawsuit? I have no idea. But I can tell you that I totally submitted the form. 

If nothing else, doctors should be telling their patients about this. They should have a conversation that goes something along the lines of, “Hey, this drug might quell your suicidal thoughts, but you’re never going to be able to go off of it. I mean, you will, but it will be hell. You’ll probably get vertigo and brain zaps and you may not be able to stand up without falling over. Also, there’s no telling how long those withdrawal symptoms are going to last.”

If nothing else, patients deserve to know the truth. I deserved to know the truth.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Fed Report Blames DEA for Painkiller Shortages

By Pat Anson, Editor

Poor oversight by the U.S. Drug Enforcement Agency has led to a sharp increase in shortages of some prescription drugs – including many opioid painkillers – according to a new government study that calls the shortages “a risk to public health.”

The lengthy report by U.S. Government Accountability Office (GAO) faults the DEA for “weak internal controls” and poor management of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. All of the drugs belong to a class of medications that affect the central nervous system and are used to treat seizures, manage anxiety, and relieve pain.

The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was in short supply over the course of four different shortages, with a combined duration of over eight and a half years.

“While we cannot establish a causal relationship between shortages of drugs containing controlled substances and DEA’s management of the quota setting process, the shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

The shortages have only grown worse in recent years, according to many pain patients, physicians and pharmacists, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.

The DEA has blamed major pharmacy chains such as CVS and Walgreens for some of the shortages, claiming the companies made a “business decision” not to fill as many prescriptions for opioids, after they were fined tens of millions of dollars for violating rules for dispensing controlled substances.

But even small, independent pharmacies have complained that controlled substances are harder to obtain. In a 2013 survey of over 1,000 pharmacists, the National Community Pharmacists Association (NCPA) found that most had experienced delays of at least one week in obtaining shipments of painkillers and other controlled substances.

“Community pharmacists repeatedly cited having their supplies or shipments of controlled substances abruptly shut off by their wholesalers, which may have done so due to perceived pressure, intimidation or a lack of clear guidance from law enforcement officials, such as the Drug Enforcement Administration,” said B. Douglas Hoey, CEO of NCPA, which represents over 23,000 independent pharmacies.

Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA under a quota system to discourage diversion, while the Food and Drug Administration regulates what conditions the medications can be taken for. Drug manufacturers are required every year to apply to the DEA for quotas to make their drugs, but according to the GAO the DEA rarely responds in timely manner.

“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs,” the GAO said.

The DEA and FDA are supposed to work together when shortages of controlled substances develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”

The inter-agency rivalry has at times led to finger pointing.

“DEA officials also said that they do not believe FDA appropriately validates or investigates the shortage information it posts on its website and that posting this information encourages manufacturers to falsely report shortages to obtain additional quota. However, FDA reports that it takes steps to investigate and confirm the shortages on its website,” the GAO report states.

The GAO recommended the DEA perform periodic data checks to better manage the quota process, improve the processing of quota applications, and do a better job coordinating with the FDA on how to handle drug shortages when they develop.

Surveys Find Most Americans Not Worried About Painkiller Risks

By Pat Anson, Editor

Health officials, regulators and politicians have been warning for years about the so-called epidemic of prescription drug abuse in the U.S. But two new surveys show that most Americans are not as concerned about the abuse of pain medications and don’t want the government to restrict access to them.

A survey of over 1,000 Americans by the National Safety Council found that only 1 in 5 (19%) consider prescription pain medication a serious safety threat. Two-thirds of those taking opioids are not worried about side effects and only 12% are concerned about addiction.

The survey found broad support for opioids among those who take the medications.

• 78% believe opioids are the fastest way to treat pain.
• 71% believe opioids are the “best overall solution” for pain.
• 69% believe opioids are the “most appropriate solution” for pain.
• 52% believe opioids are safer than other pain medications.
• 42% wrongly believe it is legal to share opioids with family and friends.

"Forty-five people die every day from overdosing on prescription painkillers," said Deborah A.P. Hersman, president and CEO of the National Safety Council. "These medications are federally controlled substances and gateway drugs to heroin. Sharing drugs is never worth the risk, especially when non-addictive, over-the-counter pain relievers are often better options."

A second survey of 1,600 Americans, conducted by the non-profit Alliance for Aging Research, found an overwhelming majority opposes the government restricting access to medication that contains acetaminophen -- the world’s most widely used over-the-counter (OTC) pain reliever.

Over 50 million people in the U.S. use acetaminophen each week for pain and fever – many not knowing the medication has long been associated with liver injury and allergic reactions such as skin rash. Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and 450 deaths.

The Food and Drug Administration has considered requiring a doctor’s prescription for acetaminophen products such as extra-strength Tylenol.  But the vast majority of survey participants disagree with the concept of restrictions.

• 75% of those under age 60, and 70% of respondents over age 60, believe the FDA should not require a doctor's prescription to buy extra-strength Tylenol or an equivalent store brand.
• 52% of those under age 60, and 45% over age 60, believe that requiring a prescription will make it more difficult to obtain safe pain medications.
• Only 11% of those under age 60, and 19% over age 60, would go to a doctor for a prescription for acetaminophen.
• 77% of those under age 60 and 68% of those over 60 prefer consumer education to government restriction as a way to protect people from acetaminophen overdose.

"The aging of our population means that more Americans will be faced with persistent pain," says Cynthia Bens, Vice President of Public Policy for the Alliance for Aging Research. "Potential barriers to OTC medication access may have unintended health consequences for seniors who rely on OTC pain relievers that contain acetaminophen to reduce their pain and maintain their quality of life."

The survey also offered insights into the amount of pain people experience:

• More than 18% of respondents age 60 and over have bad or severe pain, while 37% have daily pain.
• 70% of those aged 60 and over use OTC pain medication.
• For those under age 60, bad or severe pain is experienced by 15%, while 25% experience daily pain.
• 81% of those under age 60 use an OTC pain medication.

The FDA recommends taking no more than 4,000 mg of acetaminophen in a 24-hour period. In 2011 the agency asked drug makers to limit acetaminophen to 325 mg per tablet or capsule. The FDA also required a “Boxed Warning” label – the agency’s strongest warning – which is used to call attention to serious risks.

OxyContin Still Being Abused by Addicts

By Pat Anson, Editor

Drug addicts are still finding ways to snort and inject OxyContin, five years after the painkiller was reintroduced in an abuse deterrent formula.

Researchers at Washington University School of Medicine in St. Louis surveyed almost 11,000 opioid abusers at 150 drug-treatment facilities and found that over a quarter of them still abused the painkiller, even though the new formulation of OxyContin is harder to crush or liquefy. Their study is being published in JAMA Psychiatry.

The abuse-deterrent formulation of OxyContin was introduced by Purdue Pharma in 2010, at a time when the painkiller was widely being abused. Nearly half of patients entering drug treatment facilities that year for opioid abuse said they had used OxyContin to get high at least once in the previous 30 days.

Two years later, after the abuse-deterrent formulation was introduced, the percentage of opioid abusers entering rehab who used OxyContin had fallen to 26 percent.

"We found that the abuse-deterrent formulation was useful as a first line of defense. OxyContin abuse in people seeking treatment declined, but that decline slowed after a while," said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

"The newer formulations are less attractive to abusers, but the reality is -- and our data demonstrate this quite clearly -- it's naïve to think that by making an abuse-deterrent pill we can eliminate drug abuse. There are people who will continue to use, no matter what the drug makers do, and until we focus more on why people use these drugs, we won't be able to solve this problem."

The findings are not unexpected, according to a prominent pain physician.

“No one should expect that ADF's (abuse deterrent formulations) are not going to be abused.  They will.  Some ADF's will be more effective in deterring certain methods of abuse like injecting or snorting.  People who want to abuse can just take more orally or with enough effort can overcome the ADF technology,” said Lynn R. Webster, MD, a past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“As long as an opioid has rewarding properties a certain part of society will seek them out for abuse.  This is why we need to be realistic about what an ADF can accomplish.  We need to decrease the demand and eventually replace the type of opioids that produce liking with drugs that are not as rewarding but more effective.”   

Researchers say about a third of the addicts who still abused OxyContin had found a way to inhale or inject it. The rest took the painkiller orally. Even more worrisome, almost half of the drug abusers surveyed in 2014 reported they had used heroin in the 30 days before they entered treatment.

"Some people found ways to get around the abuse-deterrent formulation so that they could snort or inject it, and others simply swallowed the pills," Cicero explained. "But many people switched to heroin, and that's a major concern."

Cicero says 70% of the addicts who stopped using OxyContin and switched to other drugs were using heroin.

“Abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including ADF technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country,” Cicero wrote in the study.

“We agree with Dr. Cicero that abuse-deterrent formulations are a valuable public health tool that must be part of any comprehensive approach to combatting prescription drug abuse. The report parallels other studies that show reformulated OxyContin is associated with a reduction in abuse,” said David Haddox, MD, V.P. of health policy at Purdue Pharma.  

“The product’s label states that OxyContin has physical and chemical properties expected to make abuse via injection difficult and to reduce abuse via snorting. The label also states that abuse of OxyContin by these routes, as well as the oral route, is still possible.”

Many pain patients with legitimate prescriptions for OxyContin say the abuse deterrent formulation is not as effective at providing pain relief as the old one. Others complain about side effects such as gastrointestinal problems.

Abuse deterrent technology is a key part of the Food and Drug Administration’s efforts at combatting the so-called epidemic of prescription drug abuse. Over 16,500 deaths in the U.S. were linked to opioids in 2010.

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Spider Venom Could Take the Sting Out of Chronic Pain

By Pat Anson, Editor

Black widow spiders are well known for their dangerous, painful and sometimes even lethal bites. The venom of a female black widow is 15 times as toxic as a rattlesnake’s.

But that venom also contains an ingredient that could be developed into a new class of potent painkilllers.

Researchers in Australia have identified seven compounds in the venom of spiders that block the body's ability to send signals to the brain through what is called the pain pathway – also known as Nav 1.7 channels.

"A compound that blocks Nav 1.7 channels is of particular interest for us. Previous research shows indifference to pain among people who lack Nav 1.7 channels due to a naturally-occurring genetic mutation - so blocking these channels has the potential of turning off pain in people with normal pain pathways," said study leader Glenn King, PhD, of The University of Queensland's Institute for Molecular Bioscience.

King and his colleagues built a system that can rapidly analyze the protein molecules in spider venoms. They studied the venom of over 200 spider species and found that 40% of the venoms contained at least one compound that blocked human Nav 1.7 channels. Of the seven promising compounds identified so far, one is particularly potent and has a chemical structure that suggests it has a high level of chemical, thermal, and biological stability, which would be essential for administering in a new medicine.

"Untapping this natural source of new medicines brings a distinct hope of accelerating the development of a new class of painkillers that can help people who suffer from chronic pain that cannot be treated with current treatment options," said researcher Julie Kaae Klint, PhD.

Researchers have only scratched the surface. There are over 45,000 species of spiders, many of which kill their prey with venoms that contain hundreds - or even thousands - of protein molecules that block nerve activity.

"A conservative estimate indicates that there are nine million spider-venom peptides, and only 0.01% of this vast pharmacological landscape has been explored so far," says Klint.

The study is published in the British Journal of Pharmacology.

Researchers are also studying the potential of venom in cone snails for its potential for blocking pain signals in humans. German scientists at the Pharmaceutical Institute of the University of Bonn say one advantage of the peptides found in snail venom is that they decompose quickly and are unlikely to cause dependency.

A pharmaceutical drug derived from cone snail neurotoxins has already been developed and marketed under the brand name Prialt. The drug is injected in spinal cord fluid to treat severe pain caused by failed back surgery, injury, AIDS, and cancer.

New Opioid ‘Film’ Nears FDA Approval

By Pat Anson, Editor

The Food and Drug Administration has accepted a new drug application (NDA) for a new opioid film patch that could give chronic pain patients an alternative to hydrocodone and other painkillers that have become harder to get prescriptions for.

Image courtesy of biodelivery sciences

The buprenorphine film – to be sold under the brand name Belbuca -- was developed by Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI) for the management of chronic pain requiring daily, long-term opioid treatment. The companies are hoping for final FDA approval by October, 2015.

Buprenorphine is an opioid that has long been used as an addiction treatment drug sold under the brand name Suboxone, but it can also be used to treat chronic pain.

"NDA acceptance represents an important step forward in our commitment to bringing to patients new therapeutic options for the treatment of chronic pain. We believe that Belbuca is a significant advancement in pain care, and an important extension to Endo's portfolio of products," said Rajiv De Silva, President and CEO of Endo.

Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes hydrocodone and most opioid painkillers. Many pain patients are having difficulty getting prescriptions for hydrocodone and other Schedule II drugs filled.

"The FDA's acceptance of our Belbuca NDA is a significant milestone for BDSI and in our partnership with Endo," said Dr. Mark Sirgo, President and CEO of BDSI. "We believe that Belbuca can offer those suffering with chronic pain with a novel treatment approach.”

Belbuca contains one-tenth to one-twentieth the amount of buprenorphine as Suboxone and other products that are used to treat opioid addiction.  Although the dose of buprenorphine is smaller, Sirgo says Belbuca film is effective in treating pain because the drug is absorbed through the inside lining of the cheek and enters the blood stream faster. In a Phase III study, he said the film was effective in treating patients who were taking a “hefty dose” of opioids equivalent to 160 mgs of morphine a day.

Belbuca is also less likely to be abused, according to Sirgo, because the patches are difficult to grind or liquefy for snorting or injecting.

Buprenorphine is already used to treat pain in transdermal skin patches made by Purdue Pharma under the brand name Butrans.

Hysingla & Zohydro: Same Church, Different Pew?

By Dr. Jeffrey Fudin

Same church different pew you ponder?  It’s not that simple. 

Almost a year to the day since the availability of Zohydro ER (hydrocodone extended release, manufactured by Zogenix), there is now another kid on the block; Hysingla ER (hydrocodone extended release, manufactured by Purdue). Nobody can deny that Zogenix paved a pretty hefty path to bring and keep this on the market.

Along the way was a pretty disheartening road.  But no matter how many unearthed faults were found in the path, they were minuscule compared to the faulted rhetoric among media sensationalists and politicians. With one road block after another, it became clear that politicians were more interested in saying something (anything) for the attention than they were about the truth. In fact, their futility and sensationalistic journalism promulgated numerous blogs here.  

On the one hand I suppose that was cultivating for this site and our readers, but unfortunately it was on the backs (perhaps literally) of legitimate pain sufferers that might otherwise benefit from an extended release formulation of hydrocodone.  Rehb.com provides some interesting infographics that break down nationally and by state, various permutations of how “Admissions to treatment facilities has been steady or rising for the past 20 years, yet it seems elected officials spend less and less of their time on the floor of the House and Senate talking about it.”

The indisputable facts are that since Zohydro ER release in March 2014, there have been over 50,000 prescriptions filled (almost 3 million capsules dispensed) yet an extremely low incidence of abuse, misuse, and diversion reported in the surveillance databases. 

Do note however that because schedule II drugs are not allowed automatic refills, each Rx is considered an initial fill, so the 50,000 prescriptions does not equate to 50,000 patients. I imagine we will see similar safety and surveillance data for Hysingla ER in the months ahead.

So, you ask, what are the differences?  On the surface it seems simple; 1 ) Hysingla ER is once daily dosing and Zohydro ER is twice daily dosing; 2 ) Hysingla ER has an FDA label as “abuse deterrent” and Zohydro ER does not (yet); and 3 ) Hysingla ER is a tablet and Zohydro ER is a capsule.

Let’s break this down, because ultimately it really should be about the patient.

History tells us that once daily or twice daily intended dosage forms sometimes require twice or three times daily dosing respectively.  Third party payers have notoriously used this as an excuse not to pay. By way of example, OxyContin (oxycodone extended release) is indicated for every 12 hour dosing, but it is not uncommon to see it appropriately prescribed every 8 hours instead of every 12 hours. The same is true for Avinza (morphine extended release).  Avinza is indicated for every 24 hour dosing, but it is not uncommon to see it prescribed every 12 hours instead of once daily. The best example where reality, practicality, and just plain good medicine flew in the face of the original package insert is brand name Duragesic, fentanyl transdermal (TD).   

The original package insert required every 72 hour changes of the patch.  Some patients didn’t receive adequate analgesia for that period of time – the manufacturer recommendation therefore was to raise the patch dosage to the next highest strength.  Sure, this would therefore raise the overall serum levels thus extending the therapeutic blood levels perhaps into the third day, but was it clinically the best thing for the patients and did it adhere to basic therapeutic principals?  The answer is no!  We always want to give the lowest effective dose.  If that could be achieved by remaining on the same fentanyl dose and changing it more frequently, then that is the proper approach.  See Medscape, Can Fentanyl Patches Be Replaced Sooner to Improve Pain Control?

To address point #1 above, the once daily practicality and convenience of Hysingla ER is of course a wonderful thing.  For a caregiver that can only get to the home once daily, it is a Godsend.  But, although it is a nice option for many, some patients might be better off on a lower overall 24 hour dose by using the every 12 hour dosage form of Zohydro ER.

To address point #2, abuse deterrent technology (ADT) is a wonderful thing too (kudos to Purdue), but ADT is not the be all and end all of substance abuse; it is simply another option.  To read more about that, see the Pharmacy Times article Abuse-Deterrent Opioid Formulations: Purpose, Practicality, and Paradigms. For the record, Zogenix ER has received FDA approval for their new abuse deterrent formulation.

And finally to address point #3, Hysingla ER is a tablet and Zohydro ER is a capsule.  From experience, it is clear that some patients are better able to swallow one compared to the other.  For some, the fear of swallowing a tablet (a form of phagophobia) is insurmountable.  For those that cannot swallow a tablet, I do prefer a capsule and the patient is told to sit or stand straight, place the capsule in their mouth, sip a mouthful of water, and look down towards the table or floor.  The capsule floats to the back of the throat – now swallow.  Although this often works, some might do better with a small tablet.

Hysingla ER is available by tablet in milligram strengths of 20, 30, 40, 60, 80, 100, and 120.

Zohydro ER is available by capsule in milligram strengths of 10, 15, 20, 30, 40, and 50.

For the benefit of media sensationalists and political mouthpieces, let me save you the trouble and embarrassment this time around, because if tempted, I will call you out publically again.  Hysingla ER 120mg is not 3 times more potent than Zohydro ER 40mg. They are equipotent because hydrocodone is hydrocodone is hydrocodone as explained in the previous post here, ZOHYDRO: What weighs more – A pound of feathers or a pound of hydrocodone?

Kudos to the two companies that fought to bring these new options to market for patients that can truly benefit from a single entity extended release dosage form of hydrocodone. 

Jeffrey Fudin, PharmD, is a Diplomate to the American Academy of Pain Management. 

Dr. Fudin practices as a Clinical Pharmacy Specialist and Director at the Stratton Veterans Administration Medical Center in Albany, NY.  

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