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."

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."

CDC Opioid Guidelines Could Lead to Malpractice

By Terri Lewis, PhD, Guest Columnist

The recent issuance of draft guidelines for opioid prescribing by the Centers for Disease Control and Prevention (CDC) posits some troubling guidelines for physicians – troubling because they prioritize the practice of prescribing over the treatment of patients. They infer that the use of opioids is tantamount to the onset of addiction and equate dosing levels with metrics unrelated to a patient resuming activities of daily living.

To ignore the individual patient’s needs in favor of applied population modeling for prescription overdose is tantamount to the institutionalization of malpractice and violates the very tenets of person-centered health care. 

Physicians are moving to an environment that will redefine and reclassify conditions associated with chronic pain based on a body systems approach.  In the arena of musculoskeletal systems alone, there are 99 classifications associated with pain levels that range from acute to chronic to intractable. All have the potential to require lifetime treatment at levels beyond those associated with acute pain. 

Medicating a person so that the impairment imposed by acute pain does not convert to chronic pain or disability is a very important concept in our health care decisions – both as providers and as consumers.  While long term opioid prescribing may have negative implications for some, this is largely a failure of models of care and not a failure of consumer utilization.  

A review of death and injury data maintained by the CDC indicates that prescription drug overdose is not even in the top 15 leading causes of death in the U.S. The number of overdoses that occur in the population annually should not be the primary filter through which we consider the needs of persons with chronic pain. 

The third largest measured harm to patients is associated with care by a physician or hospital – conditions over which patients have no control and which can result in lifetime injury. Wrong diagnosis, wrong prescribing, failure to rescue, hospital acquired infections, improper surgeries and other forms of malpractice all create conditions of significant injury that can lead to chronic pain.  Far more risk to the patient is associated with covering up harmful industry practices and the institutionalization of biases that opiod treatment causes addiction.  Correlation is not causation.

Before starting long term opioid therapy, providers should establish treatment goals with all patients, including realistic goals for aftercare, restoration of functional activities, and pain reduction.  No medication, including opioids, should be prescribed unless it is for conditions for which it was clinically trialed, or when there is clinically meaningful improvement in pain reduction and function that outweighs risks to patient safety.

Before starting any therapy, providers should discuss with patients risks, limitations, and realistic benefits of opioid therapy, as well as the patient’s and provider’s responsibilities for managing that therapy.  A careful history, an understanding of the context to which the patient will operate, the supportive resources available, and the daily demands upon their independence and functioning, are critical indicators for monitoring performance that have far more important meaning than dose limitations. 

The important question is not whether opioids are contraindicated by regulation, but whether opioids are likely to return the patient to a state of functional behavior or have a role in helping them maintain their independence and daily activities. 

When opioids are started, providers should prescribe the dose that is most likely to benefit the patient. For some, this will be a very low dose, but for others it may take more due to conditions associated with their personal genetic characteristics. Patients can build a tolerance to low dose medications when they are prescribed doses that do not alleviate pain.  Rather than being afraid to over-medicate, we should be just as concerned about the impact of under-medication in building tolerance.

The CDC’s recommendation that 3 days or less supply of prescribed opioids for non-traumatic acute pain may well fall short of individual needs.

Providers should evaluate patients frequently when starting long-term opioid, anti-epileptic, or anti-psychotic drugs alone or in combination.  Evaluation should include serum levels, behavioral observations, assessment of adaptive behavior and progress toward adaptive functioning. 

Patient contracts are ethically troublesome and tantamount to withholding medications based on characteristics or behaviors that may have nothing to do with patient outcomes. It is unethical to hold a person in chronic pain hostage to the withholding of effective treatment, and many believe this should not be the basis for informed consent conversations.  These conversations frequently occur within the first or second doctor visit, when little is understood about the patient, their condition, its causation, or direction for treatment. 

Another one of the CDC’s recommendations is for urine drug testing of patients on long term opioid therapy.  Urinalysis often falls far short as a metric for adherence and compliance with a prescribing routine. Differences in individual rates of metabolism may well cause providers to make errors of judgment when analyzing drug test results.  Many urine tests have significant rates of poor performance, physicians may not understand the potential for false positives and negatives, and some labs fail to employ procedures that are consistent. 

These tests also have the potential to add many hundreds of dollars to the patient’s bill, a cost for which they cannot be reimbursed on many insurance plans.  Failing a drug test may unnecessarily stigmatize the patient and impair the treating relationship. 

Risks and Benefits of Opioids

When the benefits might not outweigh harms of continued long term opioid therapy, providers should work with patients to periodically evaluate dosing, add other non-pharmacological therapy and, if possible, discontinue opioids when treatment so indicates. 

All patients are not equally vulnerable.  Before starting, and periodically during continuation of opioid therapy, providers should incorporate into the management plan strategies to mitigate risk, including patient and family education, gathering of information about the impact of the health condition on long term function and independence, interaction with other medications or foods, and rescue support if indicated.

Most providers are now required to review the patient’s history of controlled substance prescriptions by using prescription drug monitoring databases to determine whether the patient has access to excessive opioid dosages or dangerous combinations of medications. Used properly, this is an effective tool.  But it is important for providers to understand that this data itself has limitations and may be biased by the availability of medications, prescriber behavior practices, and pharmacy filling practices. 

Many a user has been accused of abuse for data that reflects limitations that have nothing to do with the patient.  Providers should be very careful about drawing conclusions and should balance this information with other indicators – patient reports, community supports, consumer functioning, and so forth.

It is important to understand that persons with chronic pain are, by their very nature, patients with complex care needs who have injuries to multiple body systems.  Chronic pain is a total body experience, no matter the origin of the injury or illness.  The person is not going to be “cured” and cure is not the treatment goal.  Returning the person to the best function possible is the goal, along with assuring them that you will be a partner in helping them achieve a quality of life through treatment they can depend on.

We have to change our thinking about approaches that require us to treat to the dose, and stop interpreting this issue of pain care within the acute care model. Those who would divert us from this goal are not leading the public conversation toward an effective national pain strategy.

Terri Lewis, PhD, is a specialist in Rehabilitation practice and teaches in the field of Allied Health.  She is the daughter and mother of persons who have lived with chronic pain.

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.