Orthopedic Surgeons Advised to Limit Opioids

By Pat Anson, Editor

The American Academy of Orthopaedic Surgeons (AAOS) has joined the chorus of physician organizations calling for greater efforts to address the “growing opioid epidemic” in the U.S.

The AAOS Board of Directors has adopted an Information Statement on Opioid Use, Misuse and Abuse in Orthopaedic Practice that calls for limits on opioid prescribing and improved efforts to educate physicians, caregivers and patients about opioid misuse.

Orthopaedic surgeons are the third highest prescribers of opioids behind medical doctors and dentists, according to the AAOS.

"A culture change has created the current opioid epidemic, and only a culture change -- led by physicians unafraid to limit opioid prescriptions -- will solve the epidemic," said David Ring, MD, a member of the AAOS Patient Safety Committee. "It's up to us to treat pain with less dependence on opioids. This information statement outlines the steps and strategies to help get us there."

Among the recommendations:

Standardized opioid prescribing policies that set ranges for acceptable amounts and duration of opioids for various surgical and non-surgical conditions and procedures. Opioids should not be prescribed for pre-operative and non-surgical patients.

Patients at greater risk for opioid use, such as those with symptoms of depression and poor coping strategies, should be identified and treated for these conditions prior to elective surgery.  

Surgeons should practice empathetic and effective communication. Patients are more comfortable and use fewer opioids when they know their doctor cares about them.

Partnerships need to be established among hospitals, employers, patient groups, state medical and pharmacy boards, law enforcement agencies, pharmacy benefit managers, insurers and others to combat opioid abuse.

Improved opioid tracking. A single nationwide tracking system would allow surgeons and pharmacists to see all prescriptions filled by a given patient.  

Physicians should be stricter about prescribing opioids and monitor their effectiveness..

Health care providers must recognize that patients with terminal illnesses and “other appropriate conditions” should have access to opioids.

The recommendations also call for an “opioid culture change.”

“Making opioids the focus of pain management has created many unintended consequences that often put both patients and their families at increased risk of addiction and death. Peace of mind is the strongest pain reliever. Studies have found that opioids are associated with more pain and lower satisfaction with pain relief,” the AAOS guidelines state.

The AAOS represents over 40,000 physicians and health care providers in osteopathic and orthepaedic medicine. It is one of 27 physician organizations that have joined the American Medical Association’s Task Force to Reduce Opioid Abuse.

Opioid Abuse Down; Deaths Up in U.S.

By Pat Anson, Editor

A new study has found conflicting trends in the abuse and misuse of opioid pain medication in the U.S.

From 2003 to 2013, the “nonmedical” use of prescription opioids decreased in American adults from 5.4 percent to 4.9 percent. At the same time, however, rates of opioid abuse and opioid related deaths increased.

Drug overdose deaths associated with prescription opioids rose sharply during those ten years, from 4.5 deaths per 100,000 people to 7.8 deaths per 100,000 in 2013.

The study, which was published in JAMA, the official journal of the American Medical Association, is certain to fuel further debate about opioid pain medication and whether further efforts are needed to limit its prescribing.

"We found a significant decrease in the percentage of nonmedical use of prescription opioids, as well as significant increases in the prevalence of prescription opioid use disorders, high-frequency use, and related mortality,” the study says.

“Furthermore, the increases identified in this study occurred in the context of increasing heroin use and heroin-related overdose deaths in the United States, supporting a need to address nonmedical use of prescription opioid and heroin abuse in a coordinated and comprehensive manner."

“The most disturbing statistic is the increase in mortality per 100,000,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Unfortunately the data doesn't help sort out if the deaths are occurring in patients or non-patients.  It is important to know because the required interventions will differ depending on the reasons for overdose within both groups.  

“For example the definition of ‘nonmedical use’ is defined as use without a prescription or with a prescription for how the opioid makes the individual ‘feel’.  Of course an opioid is supposed to make people feel better.  Is that nonmedical use or is it therapeutic use defined as nonmedical use?”

It didn’t take long for critics of opioid prescribing to weigh in. JAMA also published an editorial that immediately pointed a finger at patients, not addicts.

“Most opioids misused by patients originate from prescription medication. Most patients who overdose on prescription opioids are taking their medications differently than prescribed or are using opioids prescribed to someone else. These 2 main types of nonmedical opioid use represent a major cause of morbidity and mortality,” wrote Lewis Nelson, MD; David Juurlink, MD, and Jeanmarie Perrone, MD.

"The chronic, relapsing nature of opioid addiction means most patients are never 'cured,' and the best outcome is long-term recovery. The lifelong implications of this disease far outweigh the limited benefits of opioids in the treatment of chronic pain, and in many cases the risks inherent in the treatment of acute pain with opioids.”

“Oh my goodness, this is terrible,” said Janice Reynolds a chronic pain sufferer and patient activist. She said the editorial was full of “myths and “lies” that discount the use of opioids to relieve pain.

“There is, despite their claims, much research which supports its use,” Reynolds said in an email.

Coincidentally, all three authors of the editorial – Nelson, Juurlink and Perrone – are members of panels developing opioid prescribing guidelines for the Centers for Disease Control and Prevention (CDC). Currently those guidelines recommend “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are also recommended for acute or chronic pain.  A complete list of the guidelines can be found here.

Nelson is a member of the CDC's "Core Expert Group," a panel that advised the CDC on initial development of the opioid guidelines.

Juurlink, who is considered a “stakeholder” by the CDC, is a board member of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the overprescribing of opioids.

Perrone has an even more important role with the CDC, serving on a three member peer review panel that will help finalize the opioid guidelines. Another member of the peer review committee, David Tauben, MD, is also a PROP board member.

The CDC has informed Pain News Network that the peer reviewers were asked to disclose any conflicts of interest, including any financial, professional or other interest relevant to their work -- and nothing was found to warrant removal from the peer review panel.

"PROP (Physicians for Responsible Opioid Prescribing) is considered a professional membership organization and wasn’t considered a conflict of interest unless  there was a financial and promotional relationship identified," said Shelly Diaz, a CDC spokesperson.

"The Peer Reviewers  disclosed no financial interests or other  promotional relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. When reviewers  reported interests related to intellectual property, other (travel, gifts), public statements and positions, or additional information provided, their statements were carefully reviewed by the CDC guideline development staff to determine if the interests would have an effect on the suggestions."

Study: Long-Term Opioid Use Often Ineffective

By Pat Anson, Editor

Less than half the people on long-term opioid therapy achieve relief from chronic pain, according to a new survey that found opioids even less effective in younger women. However, most respondents still considered opioids to be very or extremely helpful.

Over two thousand women and men enrolled in group health plans in Washington State and northern California were surveyed about their long-term use of opioids. The study, published in the Journal of Women’s Health, is believed to be the first to look at differences in the effectiveness of opioids between the sexes.    

Only about 20 percent of the patients on long term opioid therapy were classified as having a favorable “global pain status” – which is a measure of overall pain and function. Nearly 28% had an intermediate status and over 52% had an unfavorable global pain status.

Women between the ages of 21 and 44 were much more likely than men in the same age group to have an unfavorable status (66% vs. 40%). That finding is significant because younger women face unique risks from opioid use, such as reduced fertility and risks to a developing fetus during pregnancy.

"Given the high rates of chronic opioid use in women along with evidence of poor relief from pain and concerning risks, particularly in reproductive-aged women, we need more effective and safer options for managing pain in this population," Susan Kornstein, MD, Editor-in-Chief of the Journal of Women's Health and  Executive Director of the Virginia Commonwealth University Institute for Women's Health.

Over half the women and men with “unfavorable” pain status were depressed, unemployed, laid off or not working for health reasons.

“Our observational data indicate that for typical COT (chronic opioid therapy) patients in community practice the probability of experiencing good pain control and favorable levels of functioning is relatively low,” the study found. “However, regardless of global pain status, in every age–sex group, the majority of patients rated opioids as very or extremely helpful in relieving pain.”

Researchers admitted they could not assess whether pain and function had improved or deteriorated from the time patients began using opioids. They also could not explain why opioids appear to be more effective in men than women.

“Women tend to have greater pain severity, and are more likely to be prescribed opioids to treat their pain.  However, opioids work less well in women,” said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“Rather than stopping medications that are not working well, often the opioid prescriptions are continued and the dose increased—this can set women up to have more side effects and even greater pain.”

Darnall, who has studied the medical and psychological risks of long-term opioid use by women, says safer alternatives to opioids need to be found.

“For many years there was a common perception that opioids were a ‘solution’ to pain. We must continue to look beyond opioids to comprehensive treatments that have low risks for patients. Such treatments may include acupuncture, pain psychology, self-management, physical therapy, and occupational therapy.  A primary problem is lack of access to these low-risk, effective treatments.”

CDC Should Consider Marijuana as Alternative to Opioids

By Ellen Lenox Smith, Columnist

Presently in our country, those that are successfully using opioids for pain relief are feeling dirty and lost -- largely due to fears about addiction and  overdoses. Pain patients often have to cope with physicians who are reluctant to prescribe opioids and pharmacies that are sometimes unwilling to fill their prescriptions.

The Centers for Disease Prevention and Control (CDC) is considering new guidelines that would encourage doctors to shift even further away from prescribing opioids, leaving the patient with little effective medication to turn to.

Why is the CDC not even considering the use of medical marijuana to help these people in need?

The Boston Herald recently reported that hundreds of opioid addicts are being treated successfully in Massachusetts with medical marijuana.

“We have a statewide epidemic of opioid deaths,” said Dr. Gary Witman of Canna Care Docs, which issues medical marijuana cards in seven states. “As soon as we can get people off opioids to a non-addicting substance — and medicinal marijuana is non addicting — I think it would dramatically impact the amount of opioid deaths.”

Witman is treating about 80 patients at a Canna Care clinic who are addicted to opioids, muscle relaxants or anti-anxiety medications. After enrolling them in a one-month tapering program and treating them with cannabis, Witman says more than 75 percent of the patients have stopped taking the harder drugs. Medical marijuana gave them relief from pain and anxiety — and far more safely than opioids.

Patients across the country are also learning they can use cannabis for pain relief, decreasing or even eliminating their use of opioids.  Marijuana works far better than other substitutes since it is not synthetic and does not cause organ damage or deaths like opioids can in some circumstances.

Medical marijuana works naturally on what is known as the “endocannabinoid system,” binding to neurological receptors in the brain that control appetite, pain sensation, mood and memory.

Here in Rhode Island, my husband and I have witnessed the amazing transition of pain patients on opioids that chose to transition to medical marijuana.  Most that turn to cannabis do so to eliminate the side effects of opioids and concerns about their long term use. They still achieve pain relief but know they are gaining that relief in a safer manner -- no organ damage, no teeth getting destroyed, no concerns of addiction and no deaths.

Marijuana may still be illegal at the federal level, but it is legal in 23 states and the District of Columbia, and millions of people are discovering its therapeutic benefits. The CDC should consider adding medical marijuana to the list of “non-opioid” therapies in its guidelines.

Ellen Lenox Smith and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition. 

For more information about medical marijuana, visit their website.

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

Medical marijuana is legal in 23 U.S. states and the District of Columbia, but is still technically illegal under federal law. Even in states where it is legal, doctors may frown upon marijuana and drop patients from their practice for using it.

How the CDC Gets Opioids So Wrong

By Crystal Lindell, Columnist

Look, I get it. I really do. Heroin is just such an easy thing to be against. I mean, it’s a drug. It’s a bad drug. It’s illegal. And people literally die after using it.

What’s not to hate?

But here’s the problem. Somewhere in this conversation about how heroin is bad, people started thinking that all opioids are bad. Even the legal ones. The ones that help people. The ones that actually save lives.

And thus, we have now ended up with another government agency trying to regulate medications that so many of us need. Not medications we want. Or that we think might be good. Medications we need.  

Last month the Centers for Disease Control and Prevention (CDC) released new draft guidelines that would -- if adopted-- sharply reduce the prescribing of opioids for both chronic and acute pain in the U.S. It’s mostly an effort to curb heroin use and non-medical use of opioids. Which, again, I get. Those are easy things to hate.

The CDC has since come out and said they would review the guidelines and look at public input, before finalizing them. But what changes, if any, they’ll make is unclear.

Among the 12 guidelines are recommendations like doctors should only prescribe opioids as a last resort, and chronic pain patients should have comprehensive treatment plans that go beyond just handing them a bottle of hydrocodone.

As someone who literally needs daily morphine to take showers, I’m extremely wary about the recommendations. And I’m also extremely weary of how the CDC chose to announce them.

They revealed all of them during an online webinar, which I wasn’t able to attend live. Seeing as how it’s 2015 though, I assumed I’d be able to watch it later on demand via my computer. Alas, although the CDC recorded the webinar, it didn’t make it available to watch on demand. I even went so far as to reach out to their marketing person and ask for the slides or a special link, but I never got a response. The whole thing seems pretty shady.

Thankfully, Pain News Network editor Pat Anson did attend the webinar and was able to detail all 12 guidelines. The best way to explain how wrong the CDC is about all this is just to take them one by one. You can see the official language here, but I’m just going to use laymen’s terms to sum them up:

1. If possible, use “non-pharmacological therapy" and non-opioid pain relievers for treating chronic pain. Use opioids as a last resort.

First of all, because of all the stigma associated with opioids, many doctors are already doing this. But it’s to the detriment of those suffering. When I first got sick, the doctors tried to give me prescription-strength Aleve. It literally did nothing for me. And eventually I was in so much pain that I would lay in bed at night and plan out how I wanted to take a knife to my wrists in the bathtub. That’s not hyperbole, that’s the truth.

Eventually, the doctors gave me a really low dose of hydrocodone. It did nothing for me either, and it wasn’t until I tried doubling the dose, and then doubling that dose, that I realized I didn’t have to live every second of every day feeling like someone had just dropped a cinder block on my ribs and then stabbed me with a butcher knife.

Also, I’m guessing that by “non-opioids” they mean nerve medications like Cymbalta and Lyrica, which people have somehow started to believe are a one-to-one swap for opioids, without all the side effects. But that’s just not the case. Nerve medications come with their own set of horrible side effects and withdrawal symptoms, and many people, like myself, find that they don’t actually help treat the pain.

It took way too long for me to get the medications I needed. And requiring doctors to try everything else first will only exacerbate that. You wouldn’t tell someone who just go out of surgery that they should try acupuncture before giving them pain pills. And you shouldn’t do it with someone in chronic pain either.

2. Establish a treatment plan.

Well, duh. Doctors should be doing this even if they aren’t prescribing opioids.

Unfortunately, doctors aren’t neglecting to create treatment plans because they want to give away opioids like candy, they’re neglecting to create treatment plans because they don’t have the time or the patience to have these kind of in-depth conversations.

3. Discuss the risk and benefits of opioids with patients.

Again, duh. But this should apply to all prescription medications. There’s nothing special about opioids.

4. Favor short-acting opioids over extended-release/long acting opioids.

This is the recommendation that makes it most obvious that they didn’t actually consult with any chronic pain patients. Anyone who uses opioids will tell you how much better extended release pills are than short-acting, quick hit opioids.

That’s because extended release pills don’t result in that insane cycle that a typical hydrocodone dose will give you — a burst of pain relief, followed by a crash that leaves you begging for death, and reaching for more meds before it’s time for your next dose.

One of the best decisions I ever made was to go on eight-hour time release morphine. The steadiness of the dose has helped me maintain the same dosage for almost two years. And by avoiding the insane lows that come with short-acting opioids, my pain stays at a more manageable level.

5. Prescribe the lowest possible effective dose, and implement additional precautions when increasing the dosage to 50 mg (morphine equivalent) or more per day. Also, avoid going over 90 mg a day.

I’m just going to say it. I’m on as much as 60 mg of opioids on the daily. There. Now you know. I take a lot of drugs.

But you know why I take that many drugs? Because every day when I wake up it feels like I just got whacked in the chest with a baseball bat, and then hit by a freight train, and then thrown off a bridge. Every day. Again, that is not hyperbole. That is my life. And proposing arbitrary limits on how much medication you think I need to deal with is infuriating.

6. Long-term opioid use usually begins with treating acute pain. So, when opioids are used for acute pain, doctors should give out the lowest possible dose of short-acting opioids and they should only prescribe enough for three days or less.

Look, I’ve had surgery. And it took me a serious week to recover from having my gallbladder out. And I needed that hydrocodone every single day I was on it — all seven days. I’m glad the folks at the CDC can hop out of bed three days after having their stomach cut open, but we aren’t all so lucky.

7. Doctors need to check in with any patients on long-term opioids.

Again, duh. And again, this is something that should apply to any person on any drugs.

8. Doctors should go over the pros and cons of the drugs. Also, they should give patients naloxone if there’s a chance of things going wrong with the opioids.

Okay. Look. It’s always a good idea to go over the pros and cons of any drug. I’m not sure how many times I have to write this, but yes, doctors should do this with EVERY drug.

As for naloxone, I don’t personally feel like I need it because I only use my opioids responsibly. But if a doctor thinks it’s a good idea, I’m not going to argue about it. The key word there though is “doctor.” I don’t believe the CDC needs to be involved.

9. Doctors should review the patient’s history of controlled substances.

I mean, yeah, I guess if someone just got out of rehab for heroin that should probably be a red flag. But I don’t think someone with trigeminal neuralgia should be denied treatment because one time in high school they got caught with pot.

10. Providers should drug test everyone on long-term opioids.

Look, this is already pretty much policy across the country. While my doctor doesn’t do it to me, I did sign a contract saying he could. And, yes, it does kind of suck.

For example, what if you’re being under medicated and need some Mary Jane? What if you just don’t want to feel like a common criminal every time you go to the doctor? Or what if you already just peed? It sucks. And it just adds to the stigma that so many opioids patients already deal with.

11. Doctors should not prescribe opioids and benzodiazepines together.

If your doctor is doing this, find a new doctor. This is basic “these medications don’t mix” stuff.

12. Doctors should offer treatment for people with opioid use disorder (aka addiction to opioids).

Yes. Yes they should. It’s called medical care.

So there they are, all 12 guidelines. Most of them can be summed up as, “Doctors need to talk to their patients more.” And like I said, that’s a philosophy that could apply to all doctors, all patients, and all drugs.

It’s quite obvious from reading through these guidelines that the CDC didn’t really consult with anyone in chronic pain who is using opioids responsibly — and that’s really the worst part about all this.

Look, it’s not like I’m saying you should be able to get time-release morphine over the counter. I get that there has to be some regulation. And I truly do believe that doctors should do a better job explaining various drugs to patients before they hand them a script for hydrocodone.

But I think doctors need to do a better job explaining all drugs. And when the CDC releases uneducated guidelines like this without input from as many as 11.5 million Americans who are on long term opioid therapy, all they’re doing is perpetuating an unfair stigma that does more harm than good.

People who don’t know any better are always making off-handed remarks to me about how, “You need to get off all those drugs.” And I always stop whatever I’m doing to explain to them that it’s “all those drugs” that give me the ability to live my life. Would they rather I laid on the couch all day contemplating suicide? Because that is the alternative.

Again, no hyperbole. That’s just my life.

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.

Are the CDC Opioid Guidelines Really Voluntary?

By Pat Anson, Editor

When is a medical guideline voluntary and when does it become a “standard of practice” that doctors are expected to follow?

That is one of the key questions in the ongoing debate over controversial guidelines for opioid prescribing unveiled last month by the Centers for Disease Control and Prevention (CDC).

The draft guidelines recommend “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are also recommended when the drugs are used to treat acute or chronic pain.  A complete list of the guidelines can be found here.

The CDC says the guidelines are needed to help primary care providers. Many lack adequate training in pain management and opioid prescribing, yet they treat the vast majority of chronic pain patients.

“It’s important to note that CDC is not a regulatory agency, unlike the Food and Drug Administration.  Physicians are not required to use the guideline, instead it is intended to support informed clinical decision making regarding the provision of safer, more effective pain treatment for patients,” said Courtney Leland, a spokesperson for the CDC.

But the CDC’s own internal documents make clear that the agency’s ultimate goal is for the guidelines to be widely adopted.

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings,” the agency says in briefing papers obtained by Pain News Network.  “CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.”

“Clearly the intent of CDC is that the guideline be distributed to and adopted by state public health entities and certifying organizations as if it had the legal authority of a regulation,” a representative with the American Cancer Society wrote in a recent letter to CDC Director Tom Frieden.  

The letter said the American Cancer Society “cannot endorse the proposed guidelines in any way” because they “have the potential to significantly limit cancer patient access to needed pain medicines.”

Experts and patient advocacy organizations say the guidelines – voluntary or not – could quickly be adopted by state licensing boards and have a chilling effect on doctors who prescribe opioids.

“If a healthcare provider receives correspondence from the CDC, the assumption can be made that more often than not, the healthcare provider will consider such correspondence relevant and necessary to follow so as to not face any backlash from the CDC or similar agency,” said Shaina Smith, Director of State Policy and Advocacy for the U.S. Pain Foundation, one of the nation’s largest patient advocacy organizations.

“A guideline coming from CDC will be viewed as having a stronger pedigree than a guideline coming from a professional society or other source, and will thus be more likely to be adopted as reflecting a standard of practice, or adopted as a rule by state licensing boards,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Once in place, Twillman says a guideline or rule could be used in court by a disgruntled patient to challenge the competency of their doctor.

“If a prescriber is sued, one of the things that will be raised at trial is whether or not the prescriber demonstrated that the care provided conforms to the standard of practice. Standard of practice is a bit of an ill-defined term, but I can guarantee you that one question that would be asked in making this determination is, ‘Did you, or did you not, provide care that conforms to the most up-to-date and evidence-based guidelines?’ Any prescriber who can’t show that the care in question conformed to guidelines is going to be in a world of hurt,” Twillman wrote in an email to Pain News Network.

“It can get further complicated because guidelines also come up in disciplinary hearings by licensing boards and other agencies. Again, the same question will be asked, and again, a prescriber whose treatment does not conform to guidelines will be in jeopardy.”

Guidelines Can Become Laws

Twillman says there are precedents for guidelines to turn into laws. Such was the case in Washington State in 2007, when the Agency Medical Director’s Group (AMDG) adopted what was then the nation’s toughest guidelines for physicians who treat pain and prescribe opioids. In 2010, Washington’s Governor signed many of those same guidelines into law, the first in the world to set specific dosing levels for opioids.

Interestingly, two key members of the AMDG were Drs. Gary Franklin and David Tauben, who now sit on CDC panels that are helping to develop and draft the agency’s opioid guidelines. A third CDC panelist, Dr. Jane Ballantyne, has spoken at several hearings in favor of the AMDG guidelines.

Ballantyne and Franklin are the President and Vice-President, respectively, of an advocacy group called Physicians for Responsible Prescribing (PROP), which seeks to reduce the overprescribing of opioid pain medication. Tauben is a board member of PROP, as are two other CDC panelists providing input on the opioid guidelines.

The CDC says it is only fulfilling its mandate to protect the public from a serious health issue.

“Although CDC has not previously issued guidelines on opioid prescribing, we have consulted on and supported guideline development by professional organizations,” said the CDC’s Leland, citing as an example guidelines developed by the American College of Emergency Physicians on the use of opioids in hospital emergency rooms.

“CDC is the nation's health protection agency, operating to strengthen our nation’s public health systems. One way we do this is by developing and issuing guidelines and recommendations on any number of health issues, including those guiding clinical practice,” Leland added. “Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose.”

Leland says the agency is currently revising its draft opioid guidelines – after getting input from healthcare providers and some patients – and remains on track to finalize and release the guidelines in January 2016.

Benzos May Increase Dementia Risk

By Pat Anson, Editor

Anti-anxiety drugs often prescribed to chronic pain patients increase the risk of dementia and Alzheimer's disease when used long term, according to clinicians with the American College of Osteopathic Neurologists and Psychiatrists.

Benzodiazepines --  also known as benzos -- include brand name prescription drugs such as Valium, Ativan, Klonopin and Xanax. They were approved by the U.S. Food and Drug Administration to treat psychiatric conditions, but are also prescribed "off label" to treat bipolar disorder, insomnia, post traumatic stress disorder, and chronic pain.

A Canadian study of 9,000 patients found those who had taken a benzodiazepine for three months or less had about the same dementia risk as those who had never taken one.

But taking benzos for three to six months raised the risk of developing Alzheimer's by 32 percent, and taking them for more than six months boosted the risk by 84 percent.

Similar results were found by French researchers studying more than 1,000 elderly patients.

"Current research is extremely clear and physicians need to partner with their patients to move them into therapies, like anti-depressants, that are proven to be safer and more effective," saidHelene Alphonso, DO, Director of Osteopathic Medical Education at North Texas University Health Science Center in Fort Worth.

The case for limiting the use of benzodiazepines is particularly strong for patients 65 and older, who are more susceptible to falls, injuries, accidental overdose and death when taking the drugs. The American Geriatric Society in 2012 labeled the drugs "inappropriate" for treating insomnia, agitation or delirium because of those risks.

"It's imperative to transition older patients because we're seeing a very strong correlation between use of benzodiazepines and development of Alzheimer's disease and other dementias. While correlation certainly isn't causation, there's ample reason to avoid this class of drugs as a first-line therapy," said Alphonso.

In its draft guidelines for the prescribing of opioid pain medication, the Centers for Disease Control and Prevention (CDC) recommends that opioids and benzodiazepines not be prescribed concurrently whenever possible. A CDC study found that about 80% of unintentional overdose deaths associated with opioids also involved benzodiazepines. Nearly 6,500 people died from overdoses involving benzodiazepines in 2010.

Opioids, benzodiazepines and muscle relaxants are all central nervous system depressants. Mixing the drugs is potentially dangerous because their interaction can slow breathing and raise the risk of an overdose death.

In a study of over 35,000 patient visits for acute and chronic pain, recently published in the journal Pharmacoepidemiology and Drug Safety,  researchers found that the prescribing of benzodiazepines was three to four times more likely when opioids were also prescribed.

Over a third of the patients prescribed opioids for chronic musculoskeletal pain were given a sedative. And patients with a history of psychiatric and substance abuse disorders were even more likely to be co-prescribed opioids and sedatives.

"Multi drug use is the trailing edge of the opioid epidemic," said Mark Sullivan, MD, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. "We are making progress on decreasing opioid prescribing, but co-prescribing of opioids and sedatives has not decreased.

"Patients who are on long-term combined opioid and benzodiazepine therapy are often on a treadmill. They feel relief when they take their medications and withdrawal when they stop, so they continue this combined therapy, even though many function poorly and some will die as a result."

Over 50,000 visits to emergency rooms in 2011 involved a combination of benzodiazepines and opioids, according to the Substance Abuse and Mental Health Services Administration (SAMHSA)

Pain Meds Top Concern of Work Comp Industry

By Pat Anson, Editor

The use of opioid pain medication is the number one issue faced by the worker’s compensation industry, according to a new survey that calls the long-term use of opioids in the U.S. an “extremely significant problem” for insurers and employers.

The annual survey of nearly two dozen insurers, state worker compensation agencies and self-insured employers was conducted by CompPharma, a consortium of pharmacy benefit managers that helps members develop procedures to control work comp costs.

The survey found that drug spending by the worker compensation industry increased by 6.4% last year, the first increase since 2009. Pharmacy spending in work comp cases was estimated at between $5 and $7 billion in 2014.

“During the past several years long-term opioid use has become the single biggest concern identified by respondents. While program managers and work comp executives have long known about the relatively high usage of narcotics in work comp, the depth and breadth of understanding of the issue continues to increase. Throughout the survey, respondents mentioned narcotics, opioids, addiction, specific drugs, dependency, and related terms, even when responding to other questions,” CompPharma said in a report on the survey.

Asked to rate the severity of the opioid problem on a scale of one to five, respondents gave it an average ranking of 4.75, which was called “a clear indicator of the level of the industry’s anxiety over a problem that it was somewhat slow to fully grasp.”

Payers also expressed concern about the cost of new opioids and abuse deterrent opioids, which are formulated to make it more difficult for the drugs to be snorted or injected.

“They say follow the money well here you go,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “If patient well-being and safety were the concern of payers they would rapidly adopt abuse deterrent formulations and lobby Congress to find safer and more effective therapies.  Neither are occurring.”

Webster said the cost of opioids was the “genesis for the anti-opioid movement” and claimed the work comp industry was fueling efforts to limit opioid prescribing.

“We need to ask why cost to payers trumps patients reporting effectiveness,” Webster said in an email to Pain News Network.  “There should be a Senate investigation to see if this has been an orchestrated attack.  If so it should be criminal.” 

Payers who were surveyed said they had developed a variety of ways to limit the cost of opioids or make them harder to get.

“Respondents noted several approaches to controlling cost, with a more diverse range of solutions and more specificity in solutions than we’ve previously seen. The majority of the respondents implemented programs, upgraded approaches, hired staff, or altered DUR (drug utilization review) processes pertaining to opioids. This shows how seriously these respondents take the issue,” the report states.

Payers were also concerned about physicians dispensing opioid pain medications out of their own offices, which often cost more than opioids obtained at a pharmacy.

“Physician dispensing also drastically and artificially inflates the cost of workers’ compensation pharmacy costs. Physician-dispensed prescriptions typically cost three to ten times the amount of the same prescription filled by a retail pharmacy. More recent studies point to longer claim duration, more claimants prescribed opioids for longer periods, higher overall medical costs, higher indemnity expense, and poorer outcomes associated with claims with physician-dispensed drugs,” the report said.

The survey also found a greater willingness on the part of the work comp industry to utilize urine drug testing. Four years ago, half of the survey respondents said they were using drug tests to monitor employees who had filed work comp claims. The 2014 survey found that three-quarters of respondents have implemented or will implement a drug testing program.

CDC Opioid Guidelines Being Revised

By Pat Anson, Editor

In the wake of growing criticism by pain sufferers and patient advocacy groups, the Centers for Disease Control and Prevention (CDC) is revising its controversial guidelines for primary care physicians who prescribe opioids.

“CDC is currently in the midst of the scientific process and the draft guidelines document is still being revised, without final language that we can disseminate at present. At each step of this process, we’ve incorporated feedback and revisions have been made.  We do not want clinicians using these guidelines until they are finalized,” said Courtney Leland, a CDC spokesperson in an email to Pain News Network.

The extent of the revisions is unclear and the agency says it is still on track to finalize the guidelines in January, 2016.

The draft guidelines released last month recommend “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients who continue using the drugs for acute and chronic pain.  A complete list of the guidelines can be found here.

“Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose,” said Leland.

Many pain patients are worried the guidelines could further restrict their access to opioid pain medications. The CDC has also been criticized for a lack of transparency in developing the guidelines and for seeking little public input.

In a letter to CDC Director Tom Frieden, the American Cancer Society called for the guidelines’ development to be suspended until numerous issues are addressed.

“We believe the proposed guidelines have the potential to significantly limit cancer patient access to needed pain medicines. We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines, and the transparency of the entire process,” wrote Christopher Hansen, President of the American Cancer Society Cancer Action Network.

“Our concerns are so serious that we cannot endorse the proposed guidelines in any way and suggest suspending the process until the methodological flaws are corrected and more evidence is available to support prescribing recommendations.”

Hansen’s letter was also addressed to Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, which is developing of the guidelines.

In an email Monday to a “Stakeholders Review Group” composed mainly of physician organizations, Houry invited the groups to listen to a conference call on October 21 to update them on the drafting of the guidelines.  

“As a reminder, the recommendations in the document you reviewed are pre-decisional, draft, and confidential. We ask that you refrain from sharing them widely at this point because they are not yet final, will change based on the feedback we received through the various comment processes, and we do not want clinicians to refer to the guidelines until we complete the peer review, revisions, and clearance process,” Houry wrote.

Secrecy had surrounded the development of the guidelines from the beginning and continues today. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

Even the number of public comments the agency has received about the guidelines is unclear. In her email to stakeholders, Houry said there were “more than 250 comments.” But Pain News Network was told there were “more than 1,200 comments from patients, health care professionals, and members of organizations.”

When asked to explain the discrepancy, a CDC spokesperson said the agency had actually received just 167 emails during the public comment period, “but note that this is just the number of emails and doesn’t necessarily equate with the number of comments incorporated within each of the email messages.”

As many as 11.5 million Americans are on long term opioid therapy. The American Cancer Society called on the CDC to give those patients and the public a better chance to review and comment on the guidelines.

“We have concerns that the attempts to solicit public input on the draft guidelines were cursory and did not allow adequate opportunity for thoughtful responses. While a public webinar was held to discuss the recommended guidelines, it was not well advertised and many interested parties were denied access because the webinar lacked sufficient capacity,” Hansen wrote in his letter to the CDC.

As Pain News Network has reported, over 50 invitations to the webinar were sent to groups representing physicians, insurance companies, pharmacists, anti-addiction advocacy groups and other special interests. Only two patient advocacy groups – the American Cancer Society and the American Chronic Pain Association (ACPA) – were invited.

“U.S. Pain Foundation was disappointed to have learned that the CDC drafted the proposed prescriber guidelines on opioid medications without, in the organization’s opinion, appropriately notifying the pain community at-large,” said Shaina Smith, Director of State Policy and Advocacy for the U.S. Pain Foundation, one of the nation’s largest patient advocacy organizations. “U.S. Pain feels it was not afforded the opportunity to participate in these important discussions which could have a significant impact on the lives of individuals with pain.

“Despite the CDC stating that 55 diverse organizations were invited to join the webinar's discussion, none of the collaborating patient advocacy organizations U.S. Pain works alongside were granted an invitation. Furthermore, pain patients were not alerted of this opportunity until after the guidelines were made available to the public.”

Repeated calls and emails to Penney Cowan, executive director of the American Chronic Pain Association (ACPA), for comment on the guidelines were not returned.

"We apologize, but Ms. Cowan has been traveling extensively and will not be back in the office until Oct 20th.  She indicated that she does not have time in her schedule to discuss this," a spokesperson for ACPA explained in an email.

High Use of Opioids by Older Adults with COPD

By Pat Anson, Editor

Canadian researchers have found significantly high rates of opioid use among older adults with chronic obstructive pulmonary disease (COPD), according to a large study published in the British Journal of Clinical Pharmacology. Over half of the patients received a new opioid prescription after their COPD diagnosis.

"The new use of opioids was remarkably high among adults with COPD living in the community," said Nicholas Vozoris, MD, a respirologist at St. Michael's Hospital in Toronto. "The amount of opioid use is concerning given this is an older population, and older adults are more sensitive to narcotic side effects."

The study is based on records for more than 120,000 adults in Ontario age 66 and older with COPD, a progressive lung disease that makes it harder to breathe. COPD causes coughing, wheezing, shortness of breath, chest tightness and other symptoms. Most people who have COPD smoke or used to smoke, according to the National Institutes of Health.

Between 2003 and 2012, 70 per cent of the COPD patients who lived in their own home were given a new opioid prescription, while about 55% of those living in long-term care facilities received a new opioid prescription. Many were given multiple opioid prescriptions, early refills, and prescriptions that lasted more than 30 days.

Opioids might be prescribed more frequently among older adults with COPD to treat chronic muscle pain, breathlessness and insomnia.

"Sometimes patients are looking for what they think are quick fixes to chronic pain and chronic breathing problems," said Vozoris. "And physicians sometimes believe that narcotics may be a quick fix to COPD symptoms."

Common side effects of opioids in older adults include falls and fractures, confusion, memory impairment, fatigue, constipation, nausea, vomiting and abdominal pain. Vozoris says opioids may also negatively affect lung health by reducing breathing rates and volume, which can result in decreased blood oxygen levels and higher carbon dioxide levels.

"This is a population that has chronic lung disease, and this drug class may also adversely affect breathing and lung health in people who already have chronically compromised lungs," he said.

Most of the opioid prescriptions were written by family physicians, usually for pain medications that combine an opioid with acetaminophen.

"Patients and prescribers should reflect on the way narcotics are being used in this older and respiratory-vulnerable population," said Dr. Vozoris. "They should be more careful about when narcotics are used and how they're being used."

A study published in Clinical Interventions in Aging warned about the risk of “polypharmacy” in older adults, who often take multiple medications written by different providers.

“The elderly population is especially challenging when one has to consider all of the pharmacodynamic changes that occur with normal aging. The side effect profile of opiates is similar for all age groups; however the elderly population is at a greater risk for these side effects given their comorbidities and high incidence of polypharmacy. Using opiates appropriately and at the most efficacious dosage for the severity and type of pain becomes crucial in the elderly,” the study said.

The Risks of Non-Opioid Pain Medications

By Emily Ullrich, Columnist

As a chronic pain patient for some years now, I have realized the necessity of self-advocacy and have made it a point to become extremely well-educated in regard to patient choices in pain treatment. I also pay very close attention to the constant barrage of anti-opioid propaganda that consumers are exposed to -- an agenda being pushed by the DEA, CDC, and powerful special interest groups.

As a patient advocate and delegate to the Power of Pain Foundation, I am also more aware of the increasing limitations and access to opioid pain treatment that patients are being subjected to. As pain patients, we must be aware of our options, and demand explanations from the medical community and government as to the real reasons why we are being denied or severely limited access to opioids.

The scariest part of this situation is that non-opioid pain medications are now being thrust upon us as one of the “preferred” treatments for chronic pain in the CDC’s draft guidelines for opioid prescribers.

First, it is important to consider the following facts:

Unless a doctor is board certified in pain treatment, he or she receives little to no education in pain management under the current standard medical curriculum. Yet pain is the number one reason people go to a doctor or hospital.

This contradiction causes an enormous gap in knowledge and understanding when it comes to pain, and leads to a tremendous level of under-treated or untreated pain. Many well-intentioned, but uninformed doctors are intimidated by the prevailing climate of opioid hysteria and feel pressured to treat their patients' pain with newer, non-opioid therapies. Many of these medications are being prescribed to patients in an “off-label” fashion.

Two of the most commonly prescribed non-opioid “pain medications” are Lyrica (pregabalin) and Neurontin (gabapentin), both of which were initially approved by the FDA as anti-seizure drugs. The dangers of these medications are too often minimized by doctors, government agencies, and the media -- and to some degree remain unknown (particularly in the long-term).

One thing that has recently been unearthed is that these medicines prevent the formation of new brain synapses. This is not a minor side effect. It can lead to short and long-term memory loss, as well as Alzheimer's disease, among other things.

It can also mean that the brain becomes incapable of neuroplacticity. According to the Huntington Outreach Project at Stanford University, our brains rely on neuroplasticity to “compensate for injury and adjust their activity in response to new situations or changes in their environment.” In lay terms, these drugs cause brain damage.

In addition to the under-reported peril involved in the use of these drugs (and many others that are being used in place of opioids), they also have long and worrisome side effects. The potential side effects of both Lyrica and Neurontin are far too many to list, but include vomiting of blood, pancreatitis, hearing loss, non-Hodgkin's lymphoma, “oncologic” (cancerous) potential, heart disease, heart attack, acute kidney failure, and “life-threatening angioedema with respiratory compromise.”

Compare these potential side effects to those of opioids. When used appropriately, the major side effects of opioid pain medication are constipation and dependence -- both of which also happen to be listed as side effects of Lyrica and Neurontin.

When one sees that the most frequently prescribed non-opioid “pain medications” can cause cancer, heart attack, kidney failure, etc., we must question the motives behind this movement to eliminate or greatly reduce the use of opioids. When used properly, opioids have a proven track record of pain relief. So, why are we being told they are so dangerous?

One loathes the idea that a doctor might have ulterior motives when prescribing or that the FDA, DEA, and CDC may have less than ethical intentions. However, it seems necessary to consider the possibility that drug companies may further sicken patients with their “treatments” to ensure lifetime consumers who are forced to buy additional medications to treat the conditions caused by their very own products.

You can easily look up the financial contributions made by “Big Pharma” to your doctors, politicians, special interest groups, and other influential voices in the medical community by visiting ProPublica’s “Dollars for Docs,” Medicare’s Open Payments Database, and OpenSecrets.org.

Pfizer for example – the maker of Lyrica and Neurontin – was the top contributor in the health care industry to candidates and political parties during the 2014 election cycle – donating over $1,534,000 to both Democrats and Republicans alike. The top two recipients were Sen. Cory Booker (D-NJ) and Senate majority leader Mitch McConell (R-KY).

We must ask these difficult questions and have these taboo conversations for our own good. It is unfortunate that our society has come to this, but if we continue not to question, we will continue to be marginalized. Pain patients suffer enough. We need solutions, not restrictions.

I, for one, will continue to use alternative therapies and choose responsible opioid therapy over newer and more dangerous medications, as long as the law allows. I will continue to push for answers and I hope readers will be incentivized to join me.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS/RSD), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, Endometriosis, chronic gastritis, Interstitial Cystitis, Migraines, Fibromyalgia, Osteoarthritis, Periodic Limb Movement Disorder, Restless Leg Syndrome, Myoclonic episodes, generalized anxiety disorder, insomnia, bursitis, depression, multiple chemical sensitivity, and Irritable Bowel Syndrome.

Emily is a writer, artist, filmmaker, and has even been an occasional stand-up comedian. She now focuses on patient advocacy for the Power of Pain Foundation, as she is able.

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.

Take Our Survey About the CDC Opioid Guidelines

(Editor's Note: This survey is now closed. To see our stories about the survey results, click here and here. For a complete look at all of the survey result, visit the "CDC Survey Results" tab at the top of this page or click here.)

By Pat Anson, Editor

As we’ve been reporting over the last several days, chronic pain patients had little role or voice in the development of opioid prescribing guidelines recently announced by the Centers for Disease Control and Prevention (CDC).

The guidelines for primary care physicians are aimed at reducing rates of addiction and overdose, but they are likely to lead to further restrictions on the prescribing of opioid pain medication for both acute and chronic pain.

The CDC recommends “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients who continue using the drugs.  A complete list of the guidelines can be found here.

While the CDC is no longer accepting public comment on the guidelines, your opinion matters to us and it’s not too late to let your feelings be known.

Pain News Network and the Power of Pain Foundation are joining forces to conduct a survey of pain patients to see what they think of the CDC’s guidelines.

To take our quick survey, click here.

“As pain patients, we already have major roadblocks in our health care system to get access to proper and timely treatment. I predict these new CDC guidelines will have a devastating impact on our pain care,” says Barby Ingle, founder and president of the Power of Pain Foundation. “Many more people will suffer from arbitrary guidelines set by a panel of people who are not in the everyday trenches with pain patients. These guidelines force the same care for all. We are not all the same.

“Taking our survey about the CDC's opioid prescribing guidelines gives patients a voice in this process. Raise your voice and be heard, something that was not done when the guidelines were drafted. Share your story, share your experiences and share what it’s like to live in the pain community as the expert of your pain.”

Some of the questions we’re asking include whether you think opioids are overprescribed;  what effect the guidelines will have on rates of addiction and overdoses;  whether pain patients should be required to take urine drug tests; and if the guidelines discriminate against pain sufferers.

In addition to taking the survey, Ingle says it’s time for pain sufferers to step up and be better advocates for themselves.

“We must participate in studies and surveys on this topic, and write letters to those trying to dictate our lives and what appropriate care should be,” she says. “The only way to ensure access to proper and timely care is to keep the relationship between the patient and their providers."

The CDC is planning to release the prescribing guidelines in January.  Although voluntary, some experts predict the guidelines could quickly be adopted by state health departments and licensing boards, making them “standards of practice” for physicians.

Special Interest Groups Behind CDC Opioid Guidelines

By Pat Anson, Editor

Dozens of organizations representing physicians, pharmacies, insurance companies and other special interest groups were invited to participate in an online “webinar” last week, when the Centers for Disease Control and Prevention (CDC) unveiled its controversial new guidelines for opioid prescribing.  But there were only two seats at the cyber table for groups representing pain patients – the people most affected by the proposed guidelines.

The CDC has provided a list to Pain News Network of over 50 organizations that were sent invitations to the webinar – the first and only time the CDC publicly disclosed its prescribing guidelines and sought public input. A full list of the invited groups will be listed at the end of this article.

Among the organizations that were invited were the pharmacy chain CVS Caremark and insurers Blue Cross Blue Shield, Humana, Cigna and Kaiser Permanente.

“It is unbelievable that the CDC would include payers in the development of treatment guidelines. Payers profit from depriving patients access to treatment,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine. “I cannot express the magnitude of my level of disappointment in the CDC.”

If adopted, the CDC’s draft guidance for primary care physicians would lead to further restrictions on the prescribing of opioid pain medications for both acute and chronic pain. A full list of the guidelines can be found here.

The agency is promoting “non-pharmacological therapy” such as exercise and cognitive behavioral therapy as an alternative to opioids – treatments usually not covered by insurance. The goal is to reduce the so-called epidemic of overdoses and prescription drug abuse.

“Since opioid prescribing and overdoses have been steadily declining since 2010, the motivation for all the restrictive guidelines is, I believe, primarily profits and greed of the big players under Obamacare,” said Forest Tennant, MD, a prominent pain physician and researcher in West Covina, California. 

“Have you seen the unbelievable profits the insurance, hospital, pharmaceutical, and drug store chains are now making?  To keep up the gravy train, the big players have to continue to reduce patient benefits and physician payments. There is no question in my mind. Patients and their families and advocates have to speak loudly, firmly, and progressively going forward.”

Patients and their advocates have played only a minimal role in the development of the CDC guidelines. The only two patient advocacy groups invited to the webinar were the American Chronic Pain Association and the American Cancer Society.

One group that was well represented at the webinar were non-profits focused on fighting addiction and drug abuse, includingThe Partnership at Drugfree.org,  Safe States, Community Anti-Drug Coalitions of America, Harm Reduction Coalition, ShatterProof, and Physicians for Responsible Opioid Prescribing (PROP).

As Pain News Network has reported, PROP has played a significant role behind the scenes in the development of the CDC’s opioid prescribing guidelines. At least five PROP board members, including President Jane Ballantyne, MD, Vice-President Gary Franklin, MD, and PROP founder Andrew Kolodny, MD, are on CDC panels that developed the guidelines. Kolodny is chief medical officer for Phoenix House, a non-profit that operates a chain of addiction treatment clinics.

Was CDC "Hoodwinked" by Experts?

“I am surprised that the CDC would secretly align with PROP and others with conflicts, especially since many, if not most of their proposed guideline statements are not scientifically based,” said Jeffrey Fudin, PharmD, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“CDC should be ashamed at their approach, as they were obviously hoodwinked by the presumed experts, most of whom have no formal training in pain management whatsoever.  I am surprised that participants were not required to disclose potential conflicts. It disgusts me that the very stakeholders that are paying for opioids are on a panel with an agenda to save money by denying opioid use.”

The CDC said it selected a “diverse” panel of experts for its various committees, including the "Core Expert Group" (CEG) that apparently played the largest role in developing the guidelines. A list of CEG members and peer reviewers will be listed at the end of this article.

"For a guideline to be credible, it is important to eliminate or effectively manage sources of bias. These sources of bias might include financial relationships with industry, intellectual preconceptions, and previously stated public positions. Prior to participation, CDC asked CEG members to reveal potential conflicts of interest. Members could not serve if they held conflicts that could be anticipated to have a direct and predictable effect on the recommendations," the agency said in internal documents obtained by Pain News Network.

According to those documents, CEG members Ballantyne and Franklin did not disclose they were PROP office holders or indicate they had a conflict of interest as members of PROP. 

Ballantyne did disclose that she served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies.  Ballanytne also disclosed that she serves on a special advisory committee reviewing opioid abuse deterrence for the Food and Drug Administration.

"There is strong evidence that increased prescribing for chronic pain has produced increases in dependence, overdose and death without improving pain relief, function or quality of life for many individuals with common chronic pain diagnoses," wrote Ballantyne in a recent letter on behalf of PROP to an official with the National Institutes of Health, which is developing the National Pain Strategy. 

Franklin did not disclose any conflicts, although he played a significant role in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation. For that, Franklin was honored by the workers compensation industry for "his pioneering research and outspokenness on the overprescribing of opioid pain medications."

“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 Franklin in a position paper published last year in Neurology, the journal of the American Academy of Neurology.

The CDC said it carefully reviewed the financial relationships and "intellectual preconceptions" of CEG members --- and "determined the risk of these types of activities to be minimal."

A request for an interview with Debra Houry, Director of the CDC’s National Center for Injury Prevention and Control, which selected the panels, vetted the members, and oversaw development of the guidelines, was declined.

Guidelines "Bad News" for Pain Patients

Patient advocacy groups are only now waking up to the fact that they’ve had little role or voice in the CDC guidelines -- which are scheduled to be released in January. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

"The CDC's draft guidelines regarding pain therapy are bad news for thousands of patients living with daily pain. They ignore the needs of patients and offer no real solutions to help physicians manage patients' pain. In addition, these guidelines were developed behind closed doors and have not been made publicly available. It is imperative that the CDC be transparent as they develop these guidelines," said Srinivas Nalamachu, MD, a member of the Alliance for Patient Access.

 In a letter sent to CDC Director Tom Frieden, a coalition of patient groups said they were “deeply concerned” that the prescribing guidelines are “inconsistent with established best practices” and show an “extreme imbalance” in the agency’s views about opioids.

They also complained about the webinar.

“The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines,” the letter states.

It’s not the first time pain patients have been largely excluded from an issue that’s important to them, according to David Becker, a patient advocate and longtime critic of regulators and leaders in pain care.

“Until people in pain work together in common cause to have a real voice in pain care, then the designs of others in government and industry will continue to impose inhumane, degrading, and ineffective treatment on them - without their advice or consent,” Becker said.

Interestingly, the only media outlet invited to the CDC webinar was Consumer Reports, which last year did a cover story and special report on “The Dangers of Painkillers.”

Groups and organizations invited to the CDC webinar:

• American Academy of Family Physicians
• American Academy of General Physicians
• American Academy of Neurology
• American Academy of Pain Management
• American Academy of Pediatrics
• American Academy of Physical Medicine and Rehabilitation
• American Board of Internal Medicine
• American Cancer Society
• American Chronic Pain Association
• American College of Obstetrics and Gynecology
• American College of Occupational and Environmental Medicine
• American College of Physicians
• American College of Preventive Medicine
• American Geriatrics Society
• American Hospital Association
• American Insurance Association
• American Medical Association
• American Pain Society
• American Pharmacists Association
• American Physical Therapy Association
• American Public Health Association
• American Society of Addiction Medicine
• American Society of Anesthesiologists
• American Society of Clinical Oncology
• American Society of Health-System Pharmacists
• American Society of Hematology
• American Society of Interventional Pain Physicians
• Association of American Medical Colleges
• Blue Cross/Blue Shield(s)
• Brandeis PDMP Center of Excellence
• Cigna
• Clinton Global Initiative
• Colorado Department of Regulatory Agencies
• Community Anti-Drug Coalitions of America
• Consumer Reports
• CVS Caremark
• Federation of State Medical Boards
• Harm Reduction Coalition
• Kaiser Permanente Southern California
• MaineCare
• National Association of Boards of Pharmacy
• National Association of State Alcohol/Drug Abuse Directors
• National Association of State Medicaid Directors
• National Comprehensive Cancer Network
• National Conference of State Legislatures
• National Governors Association
• National Safety Council
• Pew Charitable Trusts
• Physicians for Responsible Opioid Prescribing
• Safe States
• ShatterProof
• Trust for America’s Health
• The Partnership at Drugfree.org
• American Association for the Treatment of Opioid Dependence
• Appalachian Regional Commission
• Association of State and Territorial Health Officials
• American College of Emergency Medicine
• National Association of County and City Health Officials
• Society of General Internal Medicine
• Core Core Violence & Injury Prevention Program (VIPP) grantees
• CDC Prevention for States grantees

Core Expert Group members:

• Pam Archer, MPH; Oklahoma State Department of Health
• Jane Ballantyne, MD; University of Washington/PROP President
• Amy Bohnert, MHS, PhD; University of Michigan
• Bonnie Burman, ScD; Ohio Department on Aging
• Roger Chou, MD; Oregon Health and Sciences University
• Phillip Coffin, MD, MIA; San Francisco Department of Public Health
• Gary Franklin, MD, MPH; University of Washington/PROP Vice-President
• Erin Krebs, MD, MPH; Minneapolis VA Health Care System/University of Minnesota
• Mitchel Mutter, MD; Tennessee Department of Health
• Lewis Nelson, MD, New York University School of Medicine
• Trupti Patel, MD; Arizona Department of Health Services
• Christina A. Porucznik, PhD, MSPH; University of Utah
• Robert Rich, MD, FAAFP; American Academy of Family Physicians
• Joanna Starrels, MD, MS; Albert Einstein College of Medicine of Yeshiva University
• Michael Steinman, MD; Society of General Internal Medicine
• Thomas Tape, MD; American College of Physicians
• Judith Turner, PhD; University of Washington

Peer Reviewers:

• Matthew Bair, MD, MS, Indiana University
• Jeanmarie Perrone, MD, University of Pennsylvania
• David Tauben, MD, University of Washington/PROP board member

Chronic Pain Groups Blast CDC for Opioid Guidelines

By Pat Anson, Editor

A coalition of pain organizations and advocacy groups says newly drafted prescribing guidelines by the Centers for Disease Control and Prevention (CDC) would – if adopted -- result in the denial of opioid pain medication to patients with legitimate medical needs.

In a highly critical letter to CDC director Tom Frieden, the groups said they were “deeply concerned” that the prescribing guidelines are “inconsistent with established best practices” and show an “extreme imbalance” in the agency’s views about opioids.

The CDC’s draft guidance recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain. Smaller doses and quantities of opioids are also recommended for patients being treated for acute or chronic pain. A complete list of the guidelines can be found here.

“By addressing only how to limit or avoid opioids, the new guidelines will inevitably result in fewer prescriptions overall - including those needed by patients with legitimate medical needs,” the letter states.

“Chronic pain advocacy organizations hear daily from increasing numbers of constituents who are not being able to access the opioid medications they’ve relied on to live with their chronic painful conditions. That is not an outcome that anyone involved in chronic pain and prescription opioid diversion and abuse wants but this guideline will produce.”

The letter, which was signed by the U.S. Pain Foundation, American Chronic Pain Association, American Academy of Pain Management and several other groups, was also addressed to Debra Houry, Director of the CDC’s National Center for Injury Prevention and Control, which oversaw the development of the guidelines.

The letter also takes the CDC to task for a lack of transparency in how the guidelines were developed and presented during an online “webinar.”

“The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines,” the letter says.

As Pain News Network has reported, a lobbying organization that seeks to reduce the prescribing of opioids appears to have played a significant role in developing the guidelines. At least five board members of Physicians for Responsible Opioid Prescribing (PROP) are on CDC panels involved in developing the guidelines, including two board members who belong to a key committee that helped draft them.

The CDC has refused to make public a list of members on the “Core Expert Group” that drafted the guidelines, claiming their anonymity was important “to provide honest and independent comment and feedback.”

PROP President Jane Ballantyne, MD, and PROP Vice-President Gary Franklin, MD, are members of the Core Expert Group; and PROP board member David Tauben, MD, is on a peer review panel that will finalize the guidelines, according to internal agency documents obtained by Pain News Network.

In addition, PROP founder and Executive Director Andrew Kolodny, MD, and PROP board member, David Juurlink, MD, are part of a “Stakeholder Review Group” that are providing input on the guidelines.

The CDC and PROP appear to have a close working relationship -- a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

“CDC’s review panel members and experts represent diverse perspectives on this topic and were selected to minimize conflict of interest among members, enhance objective assessment of the evidence, and reduce scientific bias,” the agency said in a statement to Pain News Network. “Representation from advocacy organizations (e.g. pain management societies, societies focused on responsible opioid prescribing) and professional organizations (e.g. specialties by which opioids are commonly prescribed) were selected to ensure that patients and providers impacted by these recommendations would have a voice in the development process.”

Activists in the pain community were alarmed to learn about PROP's role.

“There are too many powerful lobbyists and competing interests at the federal level,” said Terri Anderson, a chronic pain sufferer and patient advocate.  “Organizations such as PROP, and many other professional medical societies, are exploiting the needs of both addicts and pain patients for their own financial gain.”

CDC's "Rapid Review" of Evidence

Secrecy continues to surround the prescribing guidelines, which are intended to help primary care providers that treat a majority of chronic pain patients. Even though the draft guidelines were released during last week’s webinar, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

There has also been little news coverage about the guidelines, in large part because the CDC never notified reporters or issued a news release about the webinar.

The CDC said it “streamlined” development of the guidelines so experts could conduct “rapid reviews” of clinical evidence to meet “an urgent public health need.” The agency plans to publish the final guidelines in January 2016 after they undergo peer review.

“Given uncertain benefits and substantial risks, experts agreed that opioids should not be considered first-line or routine therapy for chronic pain outside of end-of-life care,” the agency said in a review of evidence sent to stakeholders and peer reviewers.

“Non-pharmacologic therapy including exercise therapy and CBT (cognitive behavioral therapy) should be used to reduce pain and improve function in patients with chronic pain. If pharmacologic therapy is needed, non-pharmacologic therapy should be used in combination with non-opioid pharmacologic therapy to reduce pain and improve function.”

The pain organizations called that an “extreme” position in their letter to the CDC.

“It is CDC’s singular focus on prescription opioid diversion, abuse, addiction, and overdose over any improved understanding of chronic pain incidence, prevalence, trends, and optimal interventions that reveals within CDC an extreme imbalance in its own risk-benefit sensibilities when it comes to this class of medications,” the letter says. “FDA requires safety and efficacy trials that all approved opioid medications have met. Detailed prescribing instructions are developed based on proven studies. Yet the new guidelines ignore the FDA’s prescribing expertise, recommending different maximum daily doses that appear in no guidelines or package inserts.”

The FDA appears to have played little -- if any -- role in developing the guidelines with the CDC, even though both agencies are in the Department of Health and Human Services, under the leadership of Secretary Sylvia Burwell. An FDA spokesman would only say that the agency “did have an opportunity to comment on the current version” of the guidelines.

“I would ask you to consider what Secretary Burwell's role is in allowing such divisiveness between CDC and FDA. Shouldn't Burwell be trying to have the federal government have a united front on opioids?” asked David Becker, a social worker and patient advocate.

“It seems to me there is a lack of leadership from the Obama administration on opioids. In addition, they can’t seem to deal with the politics of pain care -- they are not bringing parties together to settle their differences. On the contrary they seem to encourage factionalism and convulsing society.  Individuals in pain are merely pawns in the chess game of pain -- with little power and say over their care.”

PROP Helped Draft CDC Opioid Guidelines

By Pat Anson, Editor

An advocacy group that seeks to reduce the prescribing of opioid pain medication appears to be playing a significant role in the drafting and development of opioid prescribing guidelines by the U.S. Centers for Disease Control and Prevention (CDC).

Those guidelines, which were released last week, have frightened and angered many patients in the pain community because they could further restrict access to opioids for the treatment of acute and chronic pain.

Pain News Network has learned that at least five board members of Physicians for Responsible Opioid Prescribing (PROP) are involved in developing the CDC guidelines, including two that belong to a key committee that helped draft them. The CDC has refused to make public a list of members on the “Core Expert Group” that drafted the guidelines, claiming their anonymity was important “to provide honest and independent comment and feedback.”

A PROP board member also sits on the CDC peer review panel that will finalize the guidelines, which are intended for primary care providers who treat the majority chronic pain patients.

PROP has been lobbying Congress and federal health officials for years to reduce opioid prescribing and has apparently found a sympathetic ear at the CDC.  

PROP President Jane Ballantyne, MD, and Vice-President Gary Franklin, MD, are both members of the CDC’s Core Expert Group, and board member David Tauben, MD, is on the CDC’s peer review panel.

In addition, PROP founder and Executive Director Andrew Kolodny, MD, and PROP board member, David Juurlink, MD, are part of a “Stakeholder Review Group” that will provide input on the CDC guidelines.

A complete list of PROP’s Board of Directors can be found here.

Ballantyne, Franklin and Tauben all have ties to the University of Washington; where Ballantyne is a professor of Anesthesiology and Pain Medicine at the UW School of Medicine, Franklin is a research professor at the UW School of Public Health, and Tauben is the Chief of Pain Medicine at the UW School of Medicine.  All three were involved in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation.

“As a member of the Core Expert Group, I have been asked not to comment on the (CDC’s final) guideline until it is released,” said Ballantyne in an email to Pain News Network.

Ballantyne was hailed for her “wealth of experience on opioids” by Kolodny when she succeeded him as PROP’s President last year.

“I am delighted to be able to advance the mission of this important organization,” Ballantyne was quoted as saying in a news release. “Opioids are essential medications, especially when used to ease suffering at the end of life and when used short term for severe pain. Unfortunately, their widespread use for common, moderately painful conditions is harming many pain patients and fueling an addiction epidemic.”

Kolodny is chief medical officer for Phoenix House, a non-profit that operates a chain of addiction treatment clinics.

Juurlink is Canadian and a professor at the Sunnybrook Research Institute in Toronto. Juurlink also serves on the Medical Advisory Board of Advocates for the Reform of Prescription Opioids (ARPO), a non-profit based in Canada that seeks to “end the epidemic of death and addiction caused by prescription opioid drugs.” Kolodny also serves on ARPO’s Medical Advisory Board.

“I routinely see patients whose lives have been ruined by opioid painkillers — drugs like morphine, oxycodone and hydromorphone. Most of these patients started with back pain or arthritis; others were given a month’s worth of pills after surgery and simply continued taking them,” Juurlink recently wrote in an Op/Ed piece for the Toronto Star.

"Non-Pharmacological Therapy" for Chronic Pain

The CDC’s draft guidance on opioid prescribing recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain. Other guidelines recommend urine drug testing of all patients who are prescribed opioids, as well as smaller doses and quantities of opioids for patients being treated for acute or chronic pain. A complete list of the guidelines can be found here.

A veil of secrecy has surrounded the development of the CDC's guidelines. The agency refused to provide an advance copy of the guidelines before they were released during an online “webinar” and there was little public notice about the webinar itself. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

News coverage about the proposed CDC guidelines has also been scant, in large part because the CDC never notified reporters or issued a news release about the webinar.

“Media were not directly included because this public engagement period is part of the guideline development process and was intended to invite feedback specifically from providers, patients, and clinical organizations that would be impacted by these recommendations,” a CDC spokeswoman said.

The CDC did notify health insurance providers, professional medical organizations, research entities and some patient advocacy groups about the webinar and gave them 48 hours to submit comments by email. During that period, the agency said 167 emails were received from interested parties.

The CDC has rushed to complete the guidelines over the last few months, using "rapid reviews" of clinical evidence on the effectiveness of opioids -- resulting in a limited search of medical databases by years, languages and quality assessment. According to internal agency documents obtained by Pain News Network, the CDC plans a "rapid publication of the guidelines to address an urgent public health need."

Still unclear is why the CDC is acting as the lead agency in developing guidelines for prescribers, a role traditionally reserved for the Food and Drug Administration. The FDA broke its silence about the CDC’s guidelines with its first public comment today, revealing little about its role – if any – in drafting them.

“The FDA did have an opportunity to comment on the current version of CDC’s Guideline for Prescribing Opioids for Chronic Pain. The guidance has not been finalized yet, so the FDA does not have comments to share at this time,” said Eric Pahon, an FDA spokesman, in an email to Pain News Network.

Prescribing Guidelines Called a 'Travesty'

“I am really concerned about the whole process.  First it appears that conflict of interest was not managed well.  I can't understand why payer representatives are part of any guideline where their vested interest is to limit access to treatments.  They obviously profit from limiting dosing,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine. “The guidelines proposed by the CDC fail to address any of the root causes to either the addiction or pain epidemics in America.  This is a travesty.

“We need the CDC to recognize that addiction is a disease that needs access to care not available today.  We need to destigmatize the disease so people can get treatment without fearing prosecution and persecution. The CDC could lobby Congress to enact laws to increase access to treatment.  We need the CDC to recognize that pain is a disease as well and is associated with an alarming rate of suicides due to lack of effective therapies.  Making it harder for many patients to access opioids will increase the suicide rates among people with severe pain.”

Now that the draft guidelines have been released, they’ll be reviewed by the CDC’s Stakeholder Review Group that includes over a dozen professional organizations involved in the field of pain management.  Then they’ll be turned over to a three member peer review panel. The CDC hopes to finalize the guidelines for release in January.

PROP is already preparing for backlash from the pain community and some medical organizations when the final guidelines come out. PROP and other affiliated groups are lobbying the U.S. Senate Finance Committee to release details of its investigation into the financial ties that pharmaceutical companies had to certain doctors and non-profit pain organizations.

PROP’s goal, according to the Milwaukee-Wisconsin Journal Sentinel, is to silence critics before the CDC guidelines are released.

"By making the findings of the investigation public and exposing the financial relationships between pain organizations and opioid makers, it will be harder for them to claim that it is the interests of pain patients they are lobbying for," said PROP founder Andrew Kolodny.

The Senate Finance Committee began its investigation over three years ago, but has never released its findings. The investigation targeted Lynn Webster, along with other prominent pain physicians, and professional organizations such as the American Pain Society and the American Academy of Pain Medicine, both of which are part of the CDC’s Stakeholder Review Group.

A spokesman for the Senate committee said it is “unable to release documents or findings until the conclusion of any investigation and the committee's issuance of an official report."