CDC: We Need Safer, More Effective Pain Relief

(Editor’s Note: Debra Houry is director of the CDC's National Center for Injury Prevention and Control, which is developing new opioid prescribing guidelines that the agency plans to adopt in January 2016. We have many questions about the guidelines and the manner in which they are being drafted, and asked for an interview with Dr. Houry. She declined, as did CDC Director Tom Frieden. Dr. Houry did offer to write a column about the guidelines for our readers and we agreed to publish it.)

By Debra Houry, MD, Guest Columnist

At CDC I see the numbers.  The numbers of people dying from an overdose of opioid pain medications.  And, many of these unintentional deaths were in patients taking medications for chronic pain.

But to me, it’s not about numbers.  It’s about the people.  I’m concerned about stories we’ve heard at CDC from people like Vanessa and Carl, who were both prescribed opioid pain medications after car crashes. Vanessa was 17 years old when she was prescribed opioids the first time, and within several years, she was abusing IV drugs and was afraid she was going to die with a needle sticking out of her arm. Carl became addicted quickly and suffered from withdrawal when he tried to stop. He became a drug dealer to get access to the drugs that would prevent the unbearable withdrawal symptoms caused by his opioid addiction. Thankfully both Vanessa and Carl got into treatment and have been in recovery for several years now.

As an ER doctor I’ve cared for people like Carl and Vanessa suffering from traumatic injuries or in chronic pain. I’ve also had to be the one to tell families that they lost a loved one to an overdose of prescription opioids.  I see the risks. It worries me when patients return because their opioid medications are no longer effective at relieving their pain, and they need larger and larger doses.  Although opioids are powerful drugs that are important to manage pain, they have serious risks, with multiple side effects and potential complications, some of which are deadly.

But I want patients for whom the benefits outweigh the risks, to be able to get these important pain medications. And, I need to be able to treat pain more safely and effectively so that people can have relief without the risk of abuse, overdose or death.

Since 1999, we’ve seen a dramatic increase in the amount of opioid pain medications prescribed in the U.S. and at the same time overdose deaths from these medications have quadrupled.  The evidence is becoming clearer that overprescribing these medications leads to more abuse and more overdose deaths. Guidelines that help doctors and other health care providers work with their patients to determine if and when opioid medications should be given as part of their overall pain management strategy need to be updated.  

Most of the existing guidelines have focused safety precautions on high-risk patients, and have recommended use of screening tools to identity patients who are at low risk for opioid abuse. However, opioids pose a risk to all patients, and currently available tools cannot rule out risk for abuse or other serious harm outside of end-of-life settings.  

We must find a better way to treat pain so that diseases, injuries or pain treatments themselves don’t stop people from leading full and active lives. That is why CDC is working with doctors, other health care providers, partners, and patients on urgently needed guidelines based on the most current facts about safer and effective pain treatment. In a national health crisis like this one, our priorities are clear. First, take swift action to protect and save lives. Second, use world class science and proven processes to determine further improvements. And third, use the facts to prevent this situation from happening in the future.

The upcoming CDC guidelines will provide recommendations on providing safer care for all patients, not just high-risk patients. The guidelines will also incorporate recent evidence about risks related to medication dose and encourage use of recent technological advances, such as state prescription drug monitoring programs.

The guidelines are intended to help providers choose the most effective treatment options for their patients and improve their patients’ quality of life. Currently, 44 Americans die each day as a result of prescription opioid overdose. By providing the tools to help physicians make informed prescribing decisions, we can improve prescribing and help prevent deaths from prescription opioid overdose.

Thank you to the many Pain News Network readers who took the time to share your thoughts with us.  As we move forward, we will continue to look for opportunities to work with you on the critical issue of safer, effective pain management.

Debra Houry, MD, is a former emergency room physician and professor at Emory University School of Medicine in Atlanta. In 2014, she was named director of the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention.

Dr. Houry can be emailed at vjz7@cdc.gov and reached on Twitter at @DebHouryCDC.

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.

For a look at the first draft of the CDC’s opioid prescribing guidelines, click here.

Feds Unveil Opioid Mapping Tool

By Pat Anson, Editor

Big Brother is watching your doctor. And now you can watch too.

In a graphic display of just how closely the government is tracking the prescribing of opioid pain medication, the Centers for Medicare & Medicaid Services (CMS) has released an interactive online map that allows ordinary citizens to follow opioid prescribing trends across the United States.

The map not only permits users to see the number and percentage of opioid prescription claims for each state filed under Medicare Part D – but to drill down on the data to counties, ZIP codes and even prescribers. Over 31 million people are enrolled in Medicare Part D, which subsidizes the cost of prescription drugs for Medicare beneficiaries.

“The opioid epidemic impacts every state, county and municipality. To address this epidemic, while ensuring that individuals with pain receive effective treatment, we need accurate, timely information about where the problems are and to what extent they exist,” said CMS Acting Administrator Andy Slavitt. 

“This new mapping tool gives providers, local health officials, and others the data to become knowledgeable about their community’s Medicare opioid prescription rate.”

The data used in the mapping tool is from Medicare Part D prescription drug claims in 2013, when over 80 million claims for opioids were filed at a cost of $3.7 billion.

The names of Medicare patients are not included in the online map, but prescribers can be looked up by name.

“By openly sharing data in a secure, broad, and interactive way, CMS and the U.S. Department of Health and Human Services (HHS) believe that this level of transparency will inform community awareness among providers and local public health officials,” the CMS said in a statement.

That kind of easy access to prescribing data -- without any context -- is chilling to Mark Ibsen, a Montana doctor who stopped prescribing opioid pain medication to patients because he feared prosecution or losing his medical license.

"Let's keep threatening data bases on car dealers and the crashes that happen, or pharmacies and who dies from their meds, or oncologists and what they prescribe, or police officers and who they have shot, or people we have dated and where they live," Ibsen said in an email to Pain News Network.

"Whatever useless data we can, thinking because it may be useful, using it, regardless of ANY forethought about harm, unintended consequences, or impact on prescribers, patients, business or law enforcement. This has gotten so carried away. I'm done. Whatever evil idea is going on, whoever thought this up, needs to be reeled in."

A look at the national map shows that Alabama, Oklahoma and Nevada have the highest rates of opioid prescribing for Medicare Part D beneficiaries. Over 7 percent of the claims in those states were filed for opioid pain medication, compared to a national average of 5 percent.

Counties and ZIP Codes can have much higher rates, as the map below shows. ZIP code 89081 is north of Las Vegas, near Nellis Air Force Base. Over 34% of the Medicare claims filed by two prescribers in that ZIP code were for opioids.

“The opioid abuse and overdose epidemic continues to devastate American families,” said CDC Director Tom Frieden, MD. “This mapping tool will help doctors, nurses, and other health care providers assess opioid-prescribing habits while continuing to ensure patients have access to the most effective pain treatment. Informing prescribers can help reduce opioid use disorder among patients.”

The CDC is trying to rein in opioid prescribing by issuing guidelines for primary care physicians, who prescribe most of the nation’s opioids. Those guidelines, which are expected to be released in January, encourage doctors to prescribe non-opioid pain relievers and “non-pharmacological” treatments for chronic non-cancer pain.

A recent survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that 90 percent are worried they will lose access to opioid pain medication if the guidelines are adopted. Many also believe the guidelines will lead to more addiction and overdoses, not less.

Opioid Use Stabilized in U.S. Decade Ago

By Pat Anson, Editor

The use of prescription drugs has soared in the United States since the turn of the century, with nearly six out of ten adults taking a prescribed medication at least once in the last 30 days, according to a new survey.

But while the use of blood pressure medication, statins and anti-depressants rose sharply from 1999 to 2012 -- the use of opioid pain medication appears to have stabilized and gone into decline over a decade ago.

“Although increased use of narcotic analgesics may raise concern about their potential misuse or abuse, it should be noted that use stabilized after 2003-2004. This flattening trend may reflect increased awareness of prescription opioid drug misuse or abuse, although underreporting of these drugs may have increased with awareness regarding their potential for abuse,” wrote lead author Elizabeth Kantor, PhD, formerly of the Harvard T.H. Chan School of Public Health, who is now with the Memorial Sloan Kettering Cancer Center.

The study findings are published in JAMA, the official journal of the American Medical Association.

The use of opioids rose from 3.8% of adults in 1999 to 5.7% in 2004, according to the study. Since then they have begun to decline slightly. The use of non-opioid pain relievers also appears to have leveled off. 

The data for the survey was compiled differently than most other studies of prescription drugs, which rely on pharmacy databases and insurance claims, not on actual use of the drugs.

The survey involved nearly 38,000 adults across the U.S. and was collected during household interviews.  Participants were asked if they had taken a prescription drug during the last 30 days. If they responded “yes” they were asked to name the medication or to show the drug’s container.

Although other studies have indicated that opioid prescribing is in decline, the Centers for Disease Control and Prevention (CDC) claims there is an “urgent need for improved prescribing practices.” It plans to issue new prescribing guidelines for primary care physicians in January that would limit the quantities and doses of opioids for both acute and chronic pain.  A complete list of the guidelines can be found here.

The opioid hydrocodone was once the most widely prescribed medication in the U.S. But hydrocodone does not appear in the list of top ten drugs used by participants in the survey, nor does any other opioid. The most commonly used prescribed medication in 2011-2012 was simvastatin, followed by lisinopril, levothyroxine, metoprolol, metformin, hydrochlorothiazide, omeprazole, amlodipine, atorvastatin, and albuterol.

“Eight of the 10 most commonly used drugs in 2011-2012 are used to treat components of the cardiometabolic syndrome, including hypertension, diabetes, and dyslipidemia. Another is a proton-pump inhibitor used for gastroesophageal reflux, a condition more prevalent among individuals who are overweight or obese. Thus, the increase in use of some agents may reflect the growing need for treatment of complications associated with the increase in overweight and obesity,” said Kantor.

The researchers found that prescription drug use increased from 51% of adults in 1999-2000 to 59% in 2011-2012. The prevalence of polypharmacy (use of five or more prescription drugs) nearly doubled, from 8% to 15% of those surveyed.

What’s Killing Middle-Aged White Americans?

By Pat Anson, Editor

A quiet epidemic of chronic pain, suicide, alcohol abuse and drug overdoses has killed a “lost generation” of nearly half a million middle aged white Americans in the last 15 years, according to a startling new study by Princeton University researchers.

Using data culled from a variety of sources and reports, researchers found a disturbing increase in the death rate for whites aged 45 to 54. Between 1999 and 2013, the mortality rate for middle aged whites rose by 2% annually, a reversal from previous decades when their death rate declined by an average of 1.8% a year.

The spike in mortality is estimated to have led to the early deaths of 488,500 white Americans, a figure comparable to the number of deaths caused by the AIDS epidemic.

 “This change reversed decades of progress in mortality and was unique to the United States; no other rich country saw a similar turnaround,” researchers Anne Case and Angus Deaton wrote in the study published in the Proceedings of the National Academy of Sciences. “This increase for whites was largely accounted for by increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.”

No other race or ethnic group saw such an increase in mortality. African-Americans, Hispanics and those aged 65 and older continued to see their mortality rates fall.

The rising death rate for middle-aged whites was accompanied by declines in physical health, mental health and employment, as well as increases in chronic joint pain, neck pain, sciatica and disability.

It also coincided with a sharp increase in the prescribing of opioid pain medication, and seems likely to fuel a chicken and egg debate over which came first.

“The epidemic of pain which the opioids were designed to treat is real enough, although the data here cannot establish whether the increase in opioid use or the increase in pain came first. Both increased rapidly after the mid-1990s. Pain prevalence might have been even higher without the drugs, although long-term opioid use may exacerbate pain for some, and consensus on the effectiveness and risks of long-term opioid use has been hampered by lack of research evidence,” wrote Case and Deaton.

“Pain is also a risk factor for suicide. Increased alcohol abuse and suicides are likely symptoms of the same underlying epidemic, and have increased alongside it, both temporally and spatially.”

“The findings are astonishing, and a testament to the enormous toll opioids are taking in the U.S.,” said David Juurlink, MD, who heads the Division of Clinical Pharmacology and Toxicology at the University of Toronto. “It is very difficult to argue against cause-and-effect here. In my view it is a damning indictment of the widespread use of opioids for chronic pain, and should cause prescribers and patients alike to reflect on the role of these drugs, which have essentially no evidence behind them.”

Juurlink, who is a board member of Physicians for Responsible Opioid Prescribing (PROP), is advising the Centers Disease for Disease Control and Prevention (CDC) about its draft guidelines for the prescribing of opoids. He says it’s no coincidence that deaths in middle-aged whites rose just as opioid prescribing increased.

“It is an unarguable fact that opioids play a causal role in a good many of these deaths. People have drunk alcohol to excess for millenia, and have taken benzodiazepines needlessly for decades. And yet we see a striking surge in poisoning deaths coincident with surging opioid sales,” Juurlink wrote in an email to Pain News Network.

“As for suicide, you can put me on the record as speculating that opioids trigger suicide in some patients, and perhaps quite a high number. I raise this point because it's sometimes asserted that opioids can prevent suicide in patients with chronic pain. There is no evidence that this is true, but there are ample grounds to assert that they might in fact be a component cause.”

Another recent study published in JAMA found that drug overdose deaths associated with opioids nearly doubled in the last decade, rising from 4.5 deaths per 100,000 people in 2003 to 7.8 deaths per 100,000 in 2013.

But others says opioids are the not the cause of rising deaths, but more a symptom of a deeper problem.

“I can tell you absolutely that opioids do not lead this dysfunction.  Abuse, addiction, disability, and suicide are symptoms of a failing healthcare system,” says Terri Lewis, PhD, a rehabilitation specialist and patient advocate. “This population of white Americans has also been largely uninsured or underinsured.  They turn to self medication practices that involve alcohol because that is what is available.  Their acute care is often dependent on emergency room services where there is no continuity or recovery model in place.”

Deaths Hit Least Educated Hardest

The Princeton study found that death rates related to drugs, alcohol and suicides rose for middle-aged whites at all education levels, but the largest increases were seen among those with the least education. For those with a high school degree or less, deaths caused by drug and alcohol poisoning rose fourfold; suicides rose by 81 percent; and deaths caused by liver disease and cirrhosis rose by 50 percent.

“All cause” mortality rose by 22% for this least-educated group. Those with some college education saw little change in overall death rates, and those with a bachelor's degree or higher actually saw death rates decline.

The researchers speculated that financial stress may have played a role in the rising death rate. Median household incomes of whites began falling in the late 1990s, and wage stagnation hit especially hard those with a high school or less education.

“These were folks who were also disproportionately represented in the downturn of the economy and loss of jobs from rural communities,” says Lewis. “When the economy failed, their disability and reduced level of functioning did not allow them to migrate into other locations or jobs – their educational levels and physical limitations simply imposed too much of a barrier.  The loss of employment put many onto the disability roles.” 

The rise in mortality occurred in all regions of the U.S., although suicide rates were marginally higher in the South and West than in the Midwest and Northeast. In each region, death by way of accidental drug and alcohol poisoning rose at twice the rate of suicide.

In all age groups researchers said there were marked increases in deaths related to drug and alcohol poisoning, suicide and chronic liver disease and cirrhosis. The midlife group differed only in that the number of deaths was so large that it changed the direction of their overall mortality.

If that trend is not reversed, researchers warn, there will be an enormous cost to the healthcare system. 

“A serious concern is that those currently in midlife will age into Medicare in worse health than the currently elderly. This is not automatic; if the epidemic is brought under control, its survivors may have a healthy old age. However, addictions are hard to treat and pain is hard to control, so those currently in midlife may be a ‘lost generation’ whose future is less bright than those who preceded them,” they said.

Heroin: The Coming Tsunami

By Percy Menzies, Guest Columnist

The unintended consequences of legalization of marijuana in several states, coupled with the political unrest in the Afghanistan, Pakistan and Burma, are combining to create a heroin epidemic of a magnitude that has never before been seen in the United States.

Non-medical use of marijuana is legal in Colorado and Washington, and medical use of the drug is legal in 23 states. States are developing plans to grow marijuana in their respective counties to meet the expected demand for medicinal marijuana.

With the availability of legal marijuana growing nationwide, demand for Mexican marijuana is drying up. So, Mexican farmers are switching to opium, the easy-to-grow crop that is used to produce heroin.

More Mexican heroin is being smuggled every year into the United States, hidden in vehicles or carried across the border in backpacks. The number of heroin seizures along the southwest border has quadrupled since 2008, according to the Drug Enforcement Agency.

As the supply increases, heroin is becoming cheaper and more available than ever before.

Exacerbating the problem is that Afghanistan and Burma, which together produce 90 percent of the world's heroin supply, have borders that are insecure, making smuggling into Iran, India, China, Thailand, Pakistan, the former Soviet Republics and Russia relatively easy.

With the availability of legal marijuana growing nationwide, demand for Mexican marijuana is drying up. So, Mexican farmers are switching to opium, the easy-to-grow crop that is used to produce heroin.

More Mexican heroin is being smuggled every year into the United States, hidden in vehicles or carried across the border in backpacks. The number of heroin seizures along the southwest border has quadrupled since 2008, according to the Drug Enforcement Agency.

As the supply increases, heroin is becoming cheaper and more available than ever before.

Exacerbating the problem is that Afghanistan and Burma, which together produce 90 percent of the world's heroin supply, have borders that are insecure, making smuggling into Iran, India, China, Thailand, Pakistan, the former Soviet Republics and Russia relatively easy.

As a result, there are 1.6 million heroin addicts in Afghanistan, which translates to 5.3 percent of the population – one of the highest heroin addiction rates in the world. There are 1.8 million heroin addicts in Pakistan. Heroin is so ubiquitous in parts of Afghanistan and Pakistan that it is easier to find than life-saving medications.

Burma's Shan State is its main area for heroin production, and it is regaining its notoriety as part of the Golden Triangle. The heroin is smuggled from Burma primarily into three countries, China, India and Thailand.

Drug traffickers are becoming bolder, and rather than relying on land routes, they are increasingly shipping heroin through sea routes to lightly patrolled coasts in African, where it is then distributed to Europe, and eventually North America.

During the past 18 months, the Combined Maritime Forces, a partnership of 30 seafaring nations including the U.S., Canada and Saudi Arabia, has seized 4,200 kilograms of heroin traveling on that route, according to the Wall Street Journal.

It is simple economics: as supply goes up, price goes down. As price goes down, use goes up.

Heroin use in the United States has already reached a new high since people addicted to prescription opiates switch to heroin because it's so much cheaper. Street prices range from $5 to $10 for one button of heroin, good for one use, compared to $50 or more for one tablet of a prescription opiate.

Heroin addiction has been growing steadily in the United States for more than a decade, and overdose deaths more than doubled from 2010 to 2012, according to the Centers for Disease Control and Prevention report released in October.

The U.S. is unprepared for the coming tsunami. We were caught unprepared for the “man-made” addiction to prescription pain medications. Heroin quickly became the “generic” version for the prescription opioids and may well become the primary drug of choice.

The treatment of opioid addiction is further complicated by the fact that the two most widely used medications to treat opioid addiction, methadone and buprenorphine, are abusable and their use is restricted. The widespread use of buprenorphine has inadvertently contributed to increased addiction.

We have a lot of work to do, especially in the area of prevention and offering evidence-based treatment programs. It's not going to be enough to just expand needle exchange programs and distribute Narcan (naloxone) kits that can reverse opioid overdoses. Few patients, policymakers, medical and law enforcement professionals are aware of treatment options, especially the class of non-addicting medications like naltrexone (a drug closely related to naloxone) that protect patients from relapsing.

We need to aggressively combat this problem by educating people on the danger of heroin addiction and by offering viable treatments options for those addicted to heroin.

Percy Menzies is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri.

He can be reached at: percymenzies@arcamidwest.com

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.

Study Finds ‘Notable Downturn’ in Opioid Abuse

By Pat Anson, Editor

A “notable downturn” in the abuse of opioid pain medication in the United States is being overshadowed by a sharp rise in heroin use, according to a large new study outlined in a letter to the New England Journal of Medicine.

In the nationwide study of over 15,000 patients being treated for addiction, the number of addicts who abused opioids alone fell from 70% in 2010 to less than 50% in 2014.

At the same time, however, researchers at Washington University School of Medicine in St. Louis found that many addicts were using heroin and opioids concurrently. Forty-two percent said they had taken heroin and prescription opioids within a month of entering treatment, up from nearly 24 percent in 2008.

"We see very few people transition completely from prescription opioids to heroin; rather, they use both drugs," said lead author Theodore J. Cicero, PhD. "There's not a total transition to heroin, I think, because of concerns about becoming a stereotypical drug addict."

The use of heroin alone – although still relatively low -- more than doubled from 2008 to 2014, from 4.3% to 9% of the addicts under treatment.

Heroin has spread beyond inner cities into suburban and rural areas, according to Cicero. His research also found regional variations in the use of heroin and prescription opioids.

"On the East and West coasts, combined heroin and prescription drug use has surpassed the exclusive use of prescription opioids," Cicero said. “This trend is less apparent in the Midwest, and in the Deep South, (where) we saw a persistent use of prescription drugs -- but not much heroin.”

The study did not make clear how many of the addicts were legitimate pain patients who took opioids to relieve their pain or whether they were recreational users who started taking opioids to get high.

Cicero says a crackdown on "pill mills" and doctors overprescribing opioids has made it harder to get the drugs. For those who are addicted, heroin has become the new drug of choice.

"If users can't get a prescription drug, they might take whatever else is there, and if that's heroin, they use heroin," he said.

Heroin is more accessible and cheaper today, said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“Political events triggered the present heroin problem. 90% of the world's heroin comes from just three countries - Afghanistan, Burma and Mexico. The Afghan and Burmese heroin was a perfect cash crop for insurgency groups and the heroin addiction spread rapidly in countries bordering Afghanistan and Burma. Mexico is a bigger problem for us because farmers in that country have switched to growing the poppy,” said Menzies in an email to Pain News Network.

Opioids aren’t the only “gateway” drug to heroin, according to Menzies. He believes the increasing use of buprenorphine (Suboxone) to treat addiction is fueling the heroin epidemic because addicts have found they can use the drug to ease systems of withdrawal.

“We are seeing more and more patients getting exposed to heroin and it is going to get worse. Sadly, the heroin addiction is being sustained by buprenorphine preparations,” Menzies said.

Menzies has more to say about buprenorphine, marijuana legalization, and "the coming tsunami" in heroin use in this guest column.

PROP Founder Calls Opioids ‘Heroin Pills’

By Pat Anson, Editor

The founder of an advocacy group that seeks to reduce the prescribing of opioid pain medication is calling the drugs “heroin pills” and says patients may not be able to trust doctors who prescribe them.

Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing, appeared on C-SPAN this weekend to speak about the Obama administration’s efforts to combat prescription drug abuse and the increasing use of heroin. He also answered calls from viewers, including one woman who recently started taking a pain medication for arthritis and was worried about becoming addicted.

“In general, if someone’s calling me and asking me about this medication, as a physician my inclination would be to tell you to listen to your doctor and to trust your doctor,” Kolodny told the woman.

“Unfortunately when it comes to opioids, we’re in a situation where many of the prescribers have very bad information about these drugs, they’re really underestimating how addictive and how risky they are and overestimating how helpful they can be.  So I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case. This is a really difficult situation. We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

Kolodny also compared opioid pain medication to heroin during an addiction conference Friday at the University of Richmond.

“When we talk about opioid painkillers we are essentially talking about heroin pills,” Kolodny said, according to a story in the Richmond Times Dispatch.

He told the conference opioids were “very important medications” to ease suffering at the end of life or after major surgery, but were often not appropriate for chronic pain.

“The bulk of the U.S. opioid consumption is not for end-of-life care or acute pain. The bulk is for common chronic conditions where leading experts who study them say opioids are more likely to harm patients than help them.”

On C-SPAN, Kolodny said many patients taking opioids for chronic pain mistakenly believe the drugs are helping them, when “the vast majority of them are not doing well.”

“What may be happening for many of them is that the opioid is actually treating withdrawal pain. They may not really be getting pain relief when you’re on a consistent dose over a very long period of time,” Kolodny said.

Kolodny and Physicians for Responsible Opioid Prescribing (PROP) are drawing new attention because of a significant role the organization appears to be playing in the drafting of opioid prescribing guidelines by the Centers for Disease Control and Prevention (CDC). As Pain News Network has reported, at least five PROP board members, including Kolodny, are on CDC advisory panels that are developing the guidelines. A link to PROP literature recommending “cautious, evidence-based opioid prescribing” can also be found -- unedited -- on the CDC’s website.

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. All three were heavily involved in developing restrictive opioid prescribing guidelines in Washington state.

Kolodny and PROP board member David Juurlink, MD, are members of a “Stakeholder Review Group” that is also providing input on the CDC guidelines.

Those guidelines recommend that “non-pharmacological therapy” and non-opioid pain relievers be used to treat chronic pain. Lower doses and quantities of opioids are recommended for acute pain. A complete list of the guidelines can be found here.

The CDC is currently revising the guidelines to meet a January deadline, using "rapid reviews" of clinical evidence “to address an urgent public health need.” The agency blames opioid pain medication for the overdose deaths of over 16,000 Americans annually.

Many pain patients are worried they won’t be able to obtain opioids if the guidelines are adopted. In an online survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation, 95 percent said the guidelines and other government regulations discriminate against them. Most patients also said non-opioid pain relievers didn’t work for them and that their insurance usually didn’t cover therapies like acupuncture, massage and chiropractic care.  

In a conference call last week with stakeholders, CDC officials said the guidelines are being modified to emphasize that they are mostly intended for new patients and that patients currently taking opioids will still have access to the drugs.

“We do need a better answer for these 10 to 12 million Americans who are already on opioids,” Kolodny said on C-SPAN. “We’ll need a compassionate way of helping that population. I think what might be a little easier to do is to prevent what I would call ‘new starts.’ We need to get the medical community to understand that for most patients with chronic pain, long term opioids may not be safe or effective. And let’s avoid getting patients stuck on these medications, medications that are highly addictive.”

Kolodny said existing patients should have easier access to addiction treatment.

“One of the most effective medications for opioid addiction is a drug called buprenorphine or Suboxone,” said Kolodny, who is chief medical officer for Phoenix House, a non-profit that operates addiction treatment clinics.

“Unfortunately there are federal limits on the number of patients a doctor can treat with this medicine. And what we’re seeing is in parts of the country, like West Virginia and Appalachia, and in communities that have been hit very hard, you have doctors who have maxed out on the number of patients they can treat, which is a maximum of one hundred. And there are patients on waiting lists for this medication who are actually dying of overdoses while waiting on this list to be able to get buprenorphine.”

Ironically, buprenorphine is an opioid that is used to treat both addiction and pain. Although praised by Kolodny and other addiction specialists as a tool to wean addicts off opioids, some are fearful the drug is overprescribed and misused. Many addicts have learned they can use buprenorphine to ease their withdrawal symptoms and some consider it more valuable than heroin as a street drug.

Over three million Americans with opioid addiction have been treated with buprenorphine.  According to one estimate, about half of the buprenorphine obtained through legitimate prescriptions is either being diverted or used illicitly.

CDC Updates Opioid Prescribing Guidelines

By Pat Anson, Editor

The U.S. Centers for Disease Control and Prevention (CDC) is “still revising and making lots of changes” to its controversial draft guidelines for opioid prescribers, according to a source who listened to a CDC conference call today updating “stakeholders” about the guidelines.

But CDC officials gave few specifics on what modification have been made, and said the dozen guidelines will remain under a strict embargo until they are released in January.

“Overall, they tried hard to give the sense that they really listened and responded to our comments. But, of course, all they did was talk in generalities about changes that have been made, and we won’t see it again until it’s published,” the source told Pain News Network.

The draft guidelines ignited a storm of controversy in the pain community when they were released last month. The CDC is recommending “non-pharmacological therapy” and non-opioid pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients in acute or chronic pain.  A complete list of the guidelines can be found here.

A survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that many are worried about losing access to opioid pain medications if the guidelines are adopted. Nearly 93 percent believe the guidelines would be more harmful than helpful to pain patients. Many also believe they will not decrease the use of illegal drugs but actually increase them, causing even more addiction and overdoses.

On today’s call, CDC officials said their most important goal was to maintain access to opioids for pain patients. They also emphasized that the guidelines are voluntary for primary care physicians, who treat the vast majority of pain patients. Language such as “usually” and “whenever possible” are being added to a number of guidelines to give prescribers more flexibility, according to the source.

One guideline that has raised serious concern would put an upper limit on opioid prescribing to a daily dose of 90 mg of morphine equivalent. One stakeholder during the call said that threshold was “arbitrary” and “perhaps dangerous.” CDC officials said the language in that guideline was modified extensively to emphasize that is intended for new patients, not patients who are already taking opioids at or above that dosage level.

The CDC said it received over 1,200 comments on the guidelines during a 48 hour window when it accepted comments from stakeholders and the public last month.  Although as many as 11.5 million Americans are on long term opioid therapy, public participation has been minimal in the guidelines development. Only two patient advocacy groups were included among the dozens of stakeholders and special interests invited to listen to today's conference call. A complete list of the stakeholders will be listed at the end of this article.

The CDC’s update came as the Obama Administration announced new efforts aimed at addressing prescription drug abuse. Over 40 organizations representing doctors, dentists, nurses, physical therapists and educators announced that over half a million of their members would  complete opioid prescriber training in the next two years. In addition, several media outlets, the National Basketball Association, Major League Baseball and other companies said they would donate millions of dollars for public service announcements about the risks of prescription drug misuse.

Call for Congressional Investigation

Meanwhile, the American Academy of Pain Management (AAPM) is urging the House Energy and Commerce Committee to look into how the CDC developed the opioid guidelines. In a letter to committee chairman Rep. Fred Upton (R-MI), the AAPM said the process used in developing the guidelines was “deeply flawed” by secrecy and a lack of transparency, as well as potential conflicts of interest with many of the outside advisers the CDC consulted with.  

“We urge you to strongly encourage CDC to withdraw this draft guideline and, should they decide to start over, to engage in a process that is more transparent and inclusive of the needs and views of all clinicians and patients—both those with pain and those who misuse opioid pain relievers,” wrote Bob Twillman, PhD, Executive Director of AAPM.

“Unless these questions are adequately addressed, the organizations with clinicians who strive to treat chronic pain, and in fact do so with opioids, will not support them but will, by necessity, be forced to actively oppose them.”

Washington Post Calls Guidelines “Promising”

Secrecy surrounding the CDC guidelines has been one reason they haven’t gotten much coverage in the mainstream news media. One example is the Washington Post, which has yet to run a story on the guidelines or the controversy surrounding their development.

But that oversight didn’t stop the Post’s editorial board from weighing in on the issue. In an editorial headlined “The CDC’s promising plan to curb America’s opioid dependence,” the Post said the guidelines would turn opioid prescribing “in an appropriately more cautious direction.”

The editorial also dismissed a letter from the American Cancer Society opposing the guidelines, saying its concerns about cancer patients being denied pain relief were “overstated.”

“It’s true, as the cancer society letter notes, that the CDC guidelines are more than mere suggestions and will influence ‘state health departments, professional licensing bodies or insurers.’ That is precisely why they can be so beneficial,” the Post said.

“Until now, government, medicine and the private sector have too often underestimated the risks, individual and societal, of widespread opioid prescription. The CDC has the prestige and authority to correct the balance. After incorporating valid comments from the cancer society and other interested parties, the CDC plans to publish in early 2016, and we see no reason to delay.”

CDC's Stakeholder Review Group:

American Academy of Neurology; John Markman, MD
American Academy of Pain Medicine; Edward C. Covington, MD
American Academy of Pain Management; Bob Twillman, PhD
American Academy of Pediatrics; Roger F. Suchyta, MD, FAAP
American Academy of Physical Medicine and Rehabilitation; Christina Hielsberg
American Cancer Society; Mark Fleury, PhD
American Chronic Pain Association; Penney Cowan
American College of Medical Toxicology, David Juurlink, BPharm, MD, PhD
American College of Obstetrics and Gynecology; Gerald “Jerry” F. Joseph, Jr, M.D.
American Geriatrics Society; Mary Jordan Samuel
American Hospital Association; Ashley Thompson
American Medical Association; Barry D. Dickinson, PhD
American Pain Society; Gregory Terman MD, PhD
American Society of Anesthesiologists; Asokumar Buvanendran, M.D.
American Society of Addiction Medicine; Beth Haynes, MPPA
American Society of Hematology; Robert M. Plovnick, MD, MS
American Society of Interventional Pain Physicians; Sanford M. Silverman, MD
Physicians for Responsible Opioid Prescribing; Andrew Kolodny, MD

CDC Cites ‘Urgent Need’ for Prescribing Guidelines

By Pat Anson, Editor

In the wake of growing criticism over its draft guidance for opioid prescribing, the Centers for Disease Control and Prevention (CDC) has released a new study it claims is proof of an “urgent need for improved prescribing practices.”

The agency released its first multi-state report from a federal surveillance system that analyzes data from eight states’ prescription drug monitoring programs (PDMP).

The report, published in the Morbidity and Mortality Weekly Report (MMWR) Surveillance Summary,  tracked prescribing patterns during 2013 in California, Delaware, Florida, Idaho, Louisiana, Maine, Ohio and West Virginia -- about a quarter of the U.S. population.

The report found that prescribing patterns varied widely by state, not just for opioid pain medications, but for stimulants and benzodiazepines, a class of anti-anxiety drugs.

Louisiana ranked first in opioid prescribing, and Delaware and Maine had relatively high rates of prescribing extended-release (ER) opioids. Delaware and Maine also ranked highest in opioid dosage and in the percentage of opioid prescriptions written. California had the lowest prescribing rates for both opioids and benzodiazepines.

In most states, only a small minority of prescribers are responsible for most opioid prescriptions. The report also found that people who obtained opioid prescriptions often received benzodiazepine prescriptions as well, despite the risk for adverse drug interactions.

The wide variance between states was cited as a reason to bring more uniformity to prescribing practices.

“A more comprehensive approach is needed to address the prescription opioid overdose epidemic, including guidance to providers on the risks and benefits of these medications,” said Debra Houry, MD, director of CDC’s National Center for Injury Prevention and Control.

“Every day, 44 people die in American communities from an overdose of prescription opioids and many more become addicted,” said CDC director Tom Frieden, MD. "States are on the frontline of witnessing these overdose deaths.  This research can help inform their prescription overdose prevention efforts and save lives.”

Last month the CDC unveiled a dozen draft guidelines for primary care physicians who prescribe opioids. The guidelines recommend “non-pharmacological therapy” and non-opioid pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for acute or chronic pain.  A complete list of the guidelines can be found here.

Critics faulted the CDC for developing the guidelines in secret and with little input from patients or pain management experts.

Earlier this month, the California Medical Association sent a highly critical letter to Frieden and Houry saying it had “significant concern” about the secretive nature the agency used in developing the guidelines, which it said were “not appropriate nor transparent.”

“It is deeply concerning that the details behind the 12 recommendations are being made available to some unknown organizations and individuals for review and comment, but not to the general public. The information available to the public was so limited and the time to comment so brief, that it created the perception that the end result has already been determined,” wrote Luther Cobb, MD, President of the California Medical Association, which represents over 40,000 healthcare providers.

“The public must also be able to assess the potential biases and the opioid prescribing expertise for those involved in the creation of the guidelines. The public needs to know who was involved as well as their qualifications and conflicts.”

Cobb called on the CDC to publicly release all materials and recommendations used to develop the guidelines and to allow for a public comment period of 90 days.

The CDC accepted public comments for just 48 hours after releasing the guidelines during an online webinar last month.  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.

Patients Predict More Drug Abuse Under CDC Guidelines

By Pat Anson, Editor

Guidelines for opioid prescribing being developed by the Centers for Disease Control and Prevention (CDC) will worsen the nation’s drug abuse problem and cause even more deaths, according to a large new survey of pain patients. Many also fear they will lose access to opioids if the guidelines are adopted.

Over 2,000 acute and chronic pain patients in the U.S. participated in the online survey by Pain News Network and the Power of Pain Foundation. Over 82 percent said they currently take an opioid pain medication.

When asked if the CDC guidelines would be helpful or harmful to pain patients, nearly 93% said they would be harmful. Only 2% think the guidelines for primary care physicians will be helpful.

Nearly 90% of patients said they were “very worried” or “somewhat worried” that they would not be able to get opioid pain medication if the guidelines were adopted.

“Over 2,000 pain patients participated in our survey – an indication of just how seriously many of us take the CDC’s proposed guidelines,” said Barby Ingle, president of the Power of Pain Foundation.

DO YOU THINK THE CDC GUIDELINES WILL BE HELPFUL OR HARMFUL TO PAIN PATIENTS?

“We are the ones feeling the pain daily, minute by minute. We are the ones who these guidelines will affect. Even if the guidelines are not law, other agencies, providers and insurance companies will adopt them. There is already an issue with patients receiving proper and timely care across the country, and this will add to the crisis in pain care that already exists.”

The draft guidelines released last month by the CDC 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 in acute or chronic pain.  A complete list of the guidelines can be found here.

Although the goal of the CDC is to reduce the so-called epidemic of prescription drug abuse, addiction and overdoses, a large majority of pain patients believe the guidelines will actually make those problems worse – while depriving them of needed pain medication.

“I've been closely monitored by a pain management specialist and successfully taken opioids for over 10 years with no abuse or addiction issues,” said one patient. “They have saved my life, independence, and improved my quality of life and daily function. Now I'm terrified of going back to the pain I endured for years.”

“Some pain patients may turn to the streets for relief, if they can afford it,” said another.

“Attempted suicide, pain and withdrawal symptoms would be a major epidemic,” predicts one patient.

“The level of functioning afforded me through pain medication will greatly diminish or disappear, along with an unbearable increase in pain levels. I will either seek pain relief via medical marijuana or consider ending my life,” said one patient.

 “This is absurd. Why is it assumed that anyone who has a prescription for opiate medication is going to sell it or become addicted?” asked another patient.

When asked to predict what impact the guidelines will have on addiction and overdoses, over half said they would stay the same and over a third said they will increase. Less than 5% believe the CDC will achieve its goal of reducing addiction and overdoses.

"There will be a higher incidence of abuse and addiction. People will continue to find ways to get the medication that works for them. Without appropriate supervision, abuse, addiction and overdose will actually increase," said one patient.

"I have a friend who eventually became addicted to heroin when NY state made it hard for her to get tramadol. It was easier for her to get street drugs for her back injury pain," said another.

WHAT IMPACT WILL THE CDC GUIDELINES HAVE ON ADDICTION AND OVERDOSES?

"I believe the CDC should stick to their title, Centers for "Disease" Control. There are many areas of research desperately needed much more than new rules to control a doctor's ability to properly treat and manage chronic pain patients," one respondent said.

Asked what would happen if the guidelines were adopted – and given the choice of various scenarios – large majorities predicted more suffering in the pain community, as well as suicides, illegal drug use and less access to opioids. Only a small percentage believe patients will exercise more, lose weight and find better alternatives to treat their pain.

• 90% believe more people will suffer than be helped by the guidelines
• 78% believe there will be more suicides
• 76% believe doctors will prescribe opioids less often or not at all
• 73% believe addicts will get opioids through other sources or off the street
• 70% believe use of heroin and other illegal drugs will increase
• 60% believe pain patients will get opioids through other sources or off the street
• 4% believe pain patients will find better and safer alternative treatments
• 3% believe fewer people will die from overdoses
• 1% believe pain patients will exercise more and lose weight

CDC officials and many addiction treatment experts contend that opioids are overprescribed – leading to diversion and abuse -- and that other types of pain medication or therapy should be “preferred” treatments for chronic pain.

But over 58% of the patients who were surveyed disagree or strongly disagree with the statement that opioids are overprescribed. Less than 16% agree or strongly agree that opioids are overprescribed.

Many patients said they were already having trouble obtaining opioid prescriptions.

"People are UNDER MEDICATED not getting relief. I do not believe addiction is a factor, I think people are not getting what they need, period!" wrote one patient.

"It's already very difficult to get any prescription pain meds that actually help reduce pain. With these changes many will suffer. Why should people who truly have chronic pain be penalized due to others abuse of their meds?" asked another patient.

DO YOU AGREE THAT OPIOIDS ARE OVERPRESCRIBED?

"It is already difficult to get my prescriptions that I have been safely using for years. If these additional restrictions of prescriptions, need for monthly doctor visits, etc. are put into place. I will only suffer more," wrote another patient. "Legitimate pain patients are not the problem, yet are greatly impacted by guidelines such as this. I ask that the CDC PLEASE consider unintended consequences for legitimate patients before they implement these recommendations. This could be tragic."

To see what pain patients are saying about the effectiveness of therapies recommended by the CDC, click 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.

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.

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.

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.

High Dose Patients Worried by CDC Opioid Guidelines

By Pat Anson, Editor

The draft guidelines for opioid prescribing released by the Centers for Disease Control and Prevention (CDC) this month have many chronic pain patients worried – especially those who are taking high doses of opioid pain medication.

The CDC guidelines state that physicians “should avoid” increasing opioid doses over a certain level -- 90 milligrams MEQ (morphine equivalent) a day. And if that dose isn’t high enough to relieve pain? Instead of increasing it, the CDC recommends that doctors “should consider working with patients to taper and discontinue opioids.”

“I am totally freaked out about this new limit,” says Gary Snook, a 62-year old Montana man who has Arachnoiditis, a chronic and painful inflammation of the spinal cord. “The new limit would leave me no option but suicide or becoming a felon.”

Snook needs high doses of opioids not only because of the damage done to his spine by a series of epidural injections for back pain – but because of a genetic condition that makes opioids less potent in his system. Snook takes extremely high daily doses of oxycodone – averaging the equivalent of 540 milligrams of morphine – or six times more than what the CDC recommends.

“I never feel high, still drive. The only side effect I notice from the meds is pain relief,” says Snook, who used to be on even higher doses.

He believes the CDC guidelines would amount to a death sentence for him.

gary snook

“I cannot sleep at night and my pain has been elevated from the stress of all this. I used to think doctors were limiting medication to force us into procedures which are not an option for me. Now I believe this is a well-planned extermination of a disadvantaged segment of society,” Snook says.

“The CDC draft and activity is disturbing.  Their guidelines are good, but their 90mg ceiling is a problem,” says Forest Tennant, MD, a pain management specialist who treats Snook. “The word ‘avoid’ in traditional pharmaceutical prescribing usually means don't exceed the dose unless absolutely necessary.  I would like to see the 90mg dosage be preceded or followed with the statement ‘whenever possible.’

"The major issue here is whether legacy patients -- those given high opioid dosages in the past when there were no alternatives -- can continue.  New patients seldom need to go over 90mg as we now have non-opioid neuro-inflammatory and neuro-hormonal therapies."

If the CDC guidelines are adopted, Tennant wonders if other doctors will continue to treat high dose patients like Snook.  Providers will still be able to prescribe high doses “off label” – but many physicians already feel pressured by insurers and the DEA to prescribe lower doses.

“I hear almost on a daily basis of patients being forced to reduce their opioid dose despite being stable and functional for years,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine.

“The suggested limit on opioid dose is without evidence. There are millions of people who have been on much more than 90 mg MEQ for years if not decades who are functional because of their dose. This recommendation is going to cause enormous suffering.”

“One appalling aspect of CDC involvement is simply the fact that this is an agency that deals with communicable diseases -- not intractable pain,” said Tennant. “Gosh knows which ‘experts’ they consulted to arbitrarily pick 90mg.”

As Pain News Network has reported, Physicians for Responsible Opioid Prescribing (PROP) – an advocacy group that is trying to reduce the prescribing of opioids – apparently played a significant role behind the scenes in developing the CDC’s 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 helped develop the guidelines. Kolodny is chief medical officer for Phoenix House, a non-profit that offers addiction treatment programs around the country.

The CDC’s “Core Expert Group” -- the panel that drafted the guidelines -- is dominated by researchers and government regulators who have little experience in treating pain patients.

“The last thing they want is for true experts to ever testify,” says Tennant.  

“The CDC has been manipulated by payers who want to reduce their costs of opioids and by individuals who just don't understand that there are people who find opioids lifesaving,” adds Webster.

Pain News Network has also reported that only two patient advocacy groups were among the 50 organizations invited to an online “webinar” -- the first and only time the CDC publicly disclosed its prescribing guidelines and sought public input. Other organizations that were invited were physicians’ groups, insurance companies, pharmacists and several non-profits focused on fighting addiction and drug abuse.

The CDC, which is no longer accepting public comment on the guidelines, plans to finalize them by January 2016 – leaving high dose patients like Gary Snook wondering about their futures.

“This is the smallest dose I have been on for a decade and it is a struggle. I have no side effects from these high doses and am always alert and coherent. I never share my medication as I would never make it until the end of the month,” he said. "I am suicidal on lower doses, but can have a life at these levels but have no hobbies and can't work although I would love too."