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If adopted, the CDC’s draft guidance for primary care physicians would lead to further restrictions on the prescribing of opioid pain medications for both acute and chronic pain.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

Daily Marijuana Safe and Effective for Chronic Pain

By Pat Anson, Editor

Chronic pain patients who use medical marijuana daily for a year suffered no serious side effects and significantly improved their levels of pain, mood and quality of life, according to a new study in Canada.

The clinical study by researchers at McGill University in Montreal is one of the first to test the long term safety and efficacy of medical marijuana. It’s been published online in the Journal of Pain, the official journal of the American Pain Society.

“Quality-controlled herbal cannabis, when used by cannabis-experienced patients as part of a monitored treatment program over one year, appears to have a reasonable safety profile,” wrote lead author Mark Ware, an associate professor in Family Medicine and Anesthesia at McGill University and one of the world’s leading experts on medical marijuana.

Pain News Network had a lengthy interview with Ware about his research earlier this year.

In his most recent study, Ware and his colleagues assessed the long-term health of 216 medical marijuana users with chronic non-cancer pain who consumed a standardized dose (12.5% THC) of up to 5 grams of marijuana daily through inhaling or vaporization. They were compared to a control group of 215 chronic pain sufferers who did not use marijuana. Both groups were monitored over the course of the one year study.

Researchers said the cannabis users had no serious side effects compared to the control group, and had a significant improvement in their pain, anxiety, depression, anger and fatigue.

“We noted significant improvements in pain intensity and the physical dimension of quality of life over one year among the cannabis users compared to controls; there was also significant improvement among cannabis users in measures of the sensory component of pain, symptom distress, and total mood disturbance compared to controls. These findings, while not the primary outcomes of the study, are nevertheless important in considering the overall risk-benefit ratio of medical use of cannabis,” Ware wrote.

IMAGE COURTESY DRUG POLICY ALLIANCE

“The results suggest that cannabis at average doses of 2.5g/d in current cannabis users may be safe as part of carefully monitored pain management program when conventional treatments have been considered medically inappropriate or inadequate.”

The marijuana group did report more non-serious side effects, such as headache, nausea,  dizziness, and respiratory problems associated with smoking.

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.”

Bridging the Language Gap Between Doctor and Patient

By Pat Akerberg, Columnist

Like me, some of you may be hooked by a TV Series called Grey’s Anatomy.  The setting is a Seattle teaching hospital.  It’s a drama revolving around the surgical adventures and personal lives of a bright new surgical resident, Meredith Grey, her neurosurgeon husband, senior surgeons, and a group of Meredith’s fresh out of medical school counterparts.

The format begins with some type of traumatic emergency or compelling medical issue.  During rounds, residents are expected to provide a technically astute bedside rundown of a patient’s status right in front of them, their attending surgeon, and other residents to demonstrate their medical competence with confident dispatch. 

The patients are often fearful and overwhelmed as they glaze over in reaction to the stream of impersonal medical terminology washing over them like a tidal wave. 

Attuned to the shortfalls of foreign medical jargon, the attending surgeon typically intervenes.  Instead they slow down, address the patient by name, and compassionately translate the technical terms into everyday language. 

They bridge the gap by talking with the patient vs. at them. 

You can sense heightened tensions ease as patients respond positively to the difference in approach.  They begin to understand, enabling them to make more informed decisions. 

Using lay terms to describe and diagnose (a patient-centered approach) takes no more time or effort than using confusing text book terminology does (a disease centered approach). 

Having experienced the difference between the two approaches firsthand, I urge medical practitioners to adopt the patient-centered one and simply “tell it like it is”.

When I first heard my initial diagnosis of trigeminal neuralgia, it was so rare I had never heard of it.  When I asked my neurologist what it was and what caused it, his disease-centered explanation was to repeat the label and pass it off as just bad luck. 

Fast forward to an intimidating brain surgery -- “micro-vascular decompression” -- offered as a potential fix.  My neurosurgeon gave me a complex video to watch on-line.

When that surgery damaged my nerve leaving me in even worse pain, I was referred elsewhere to deal with the painful complication – “anesthesia dolorosa.”  What?

Marinating in medical terminology all along, the onus was on me to find a way to figure out what they were saying, what was happening to me. 

Through the internet, a patient-centered on-line support group, a compassionate and wise  neurologist/research scientist, and a few years later, I am better equipped now to translate my “bad luck.”

But it’s just not enough for our doctors to understand what’s going on with us.  We’ve been told by medical science for years that there’s a patient factor equally as important.  It’s called a “mind-body” connection, proven to enhance more favorable outcomes.

So why hijack such an influential connection that holds such positive potential by using hard to understand impersonal terms and technical jargon?

Here’s a sampling of some of the disease-based medical terms that doctors used standing between my pain and my understanding of it:  micro vascular decompression, iatrogenic, neuropathic pain syndrome, trigeminal deafferentation, anesthesia dolorosa, central nervous system sensitization, allodynia, hyperalgesia, dysthesias, intractable, refractory to treatment, paradoxical reaction, and progressive disorder, among others.

In patient-centered terms, here’s the translation that could have happened upfront to help me and save precious time and energy:

“I’m sorry that an unfortunate surgical complication occurred damaging your nerve.  The numbness and increased pain mean your nervous system is reactively firing constant pain signals now.”   

“Abnormal facial sensations will happen.  Simple things that normally don’t hurt will, like talking, a kiss, or breeze.  Things that normally hurt can hurt more.”  

“Science and medicine have not yet caught up with how to help with this difficult to treat condition.   However, research is ongoing for new medications and effective approaches. Other surgeries are not advisable.” 

“Neuropathic pain can slowly progress and create other issues.  I will do all I can to help you.”    

Understanding the story the terminology tells hasn’t yielded any answers or relief for me yet, but my reality is no longer lost in the obscurity of a medically precise barrage of unsettling terms.

An important step towards reaching acceptance is being able to name and claim our stories before we can hope to move them in any other direction.  I find that there is something empowering about unraveling my own story well enough to be able to name it and talk about my experience in my own terms.

It’s a way of taking our power back.  The unnecessary gap is pulled closer together.  The story doesn’t go away. It still stays with us, but differently.   

We become the authors.  Armed with greater understanding and hard-won wisdom, we can choose the words we use to connect with our doctors or others.  We can edit things in or out, and decide what, how, and with whom we’ll share.  

We can humanize what we’re experiencing so we’re back in the center where we belong -- no longer overshadowed by diagnostic, confusing, or impersonal terminology.

To really bridge the gap for a stronger mind-body connection, our physicians need to do more of the same in return.

Pat Akerberg suffers from trigeminal neuralgia, a rare facial pain disorder. Pat is a member of the TNA Facial Pain Association and serves as a moderator for their online support forum. She is also a supporter of the Trigeminal Neuralgia Research Foundation.

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.

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.

CDC Maintains Secrecy Over Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) is refusing to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians. The proposed guidelines, which were released this week, have angered many pain patients who think they could lead to sharp reductions in the prescribing of opioids for both acute and chronic pain.

“The anonymity of the reviewers engaged in this process is important during the ongoing development of these guidelines, as it allows reviewers to provide honest and independent comment and feedback,” said Courtney Lenard, a health communication specialist in the CDC’s National Center for Injury Prevention and Control. The panel of advisors is known within the CDC as the Core Expert Group.

“The Core Expert Group includes a limited number of CDC scientific staff, primary care professional society representatives, state agency representatives, experts in guideline development methodology, and other subject experts,” said Lenard.

Pain News Network has learned through a reliable source that about 15 people are in the Core Expert Group, only one of which is a physician with expertise in pain management.

The other members were “physicians and non-physicians, many of whom have been involved in efforts to rein in (opioid) prescribing.”

“Input from the pain management community in developing the guideline was, essentially, non-existent,” said the source, who identified Jane Ballantyne, MD, a professor of Anesthesiology and Pain Medicine at the University of Washington as the sole member with pain management expertise.

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

Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing.

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.

Asked if he was also a member of the CDC’s Core Expert Group that drafted the guidelines, PROP founder Andrew Kolodny said that he had no comment. Kolodny, who is chief medical officer for Phoenix House, which operates a chain of addiction treatment clinics, also said he would have no comment on the guidelines themselves.

Phoenix House was recently the subject of a highly critical report by Reuters, which claimed that in recent years the publicly funded institution “has consistently failed to provide the quality of care necessary to help addicts kick the habit.”

CDC Guidelines for Prescribing

Now that the draft guidelines have been released, the CDC plans to consult with a “Stakeholder Review Group” that includes over a dozen professional organizations involved in the field of pain management. Only two “stakeholders” – the American Chronic Pain Association and the American Cancer Society – represents pain patients.  A full list of the Stakeholder Review Group will be listed at the end of this article.

Secrecy has surrounded the development of the CDC's guidelines from their inception and continues today. The CDC refused to provide an advance copy of the guidelines before they were released Wednesday during an online “webinar.” Even after their release, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on the guidelines after a 48-hour window of opportunity.

“Given the public health need to respond to the prescription overdose epidemic, it was critical to identify a public participation method and comment period that was rapid and efficient so that comments could be immediately provided to peer reviewers for their consideration,” explained the CDC’s Lenard in an email.

The first prescribing guideline recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of all patients who are prescribed opioids, both for illicit drugs and prescribed medications. Smaller doses and quantities of opioids are also recommended – including a “three or fewer days” supply of opioids for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids. A complete list of the guidelines can be found here.

“We’re concerned about some of the provisions in here, and by the fact that such guidelines issued by CDC are often accepted, sometimes rather uncritically, by state health departments and licensing boards, and thus quickly become standards of practice,” said Bob Twillman, Executive Director of the American Academy of Pain Management, which is one of the stakeholder groups that will be consulted by the CDC.

“I was generally satisfied with the proposed guidelines,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids, who lost his teenage daughter to a single dose of OxyContin in 2006.

“My main concern at this stage is how the federal government will reconcile these guidelines with the FDA REMS guidelines for long-acting opioids, which were voluntary guidelines issued a few years ago by FDA and have not been effective at deterring the overprescribing,” Jackson told Pain News Network. “Hopefully the CDC's guidelines will supersede the wholly inadequate FDA guidelines.  I would also like to see the CDC implement a very intensive training program to support the implementation of their new guidelines."

Pain Patients Worried

Pain patients – including many who already find it difficult to get opioids for pain relief – are angered and worried by the CDC’s recommendations.

“This terrifies me. I take two Norco per day, it barely keeps my pain at tolerable levels so I can do fun things like shower and get out of bed. I already jump through hoops to get my prescriptions every month.” said Cynthia Mittel. “To arbitrarily take away my only chance to have a life halfway worth living is evil and very short-sighted! Government at its finest. Guess we'll all be getting our drugs off the street now!”

“This is such a slap in the face to the millions of pain sufferers in this country," wrote Sue B. "We are not addicted to opioids! We need them in order to live. Would you think of putting these strict guidelines on insulin? It is not our fault drug abusers use our meds, our lifelines, to sell and get high, yet we are constantly punished.”

“We are not treated properly now. We get drug tested and insulted now. I cannot believe this is even coming up after the last change in guidelines,” wrote Kryste Southwick.  “Why do junkies have more meaning than chronic pain patients? Why are you stripping us of what little lives we can have? Do your research people. If this happens there will be A LOT of suicidal blood on YOUR hands.”

“This is wrong of the CDC to try and force their guidelines in people who live with chronic pain. I am monitored by my rheumatologist for my pain medication. I do not abuse my medication nor am I addicted to them,” said Suzanne Stevenson. “These guidelines the CDC want to impose are wrong and unfair to so many people. What right does the CDC have in this matter? None!”

Many have wondered why the CDC is acting as the lead agency in creating the prescribing guidelines – a role traditionally played by the Food and Drug Administration. The FDA has yet to release a statement about the CDC guidelines or say what role – if any – it had in drafting them.

"CDC and FDA are federal partners and collaborate on many different issues and at many different levels, prescription drug overdose being one of them. FDA has been involved in the review process of the guidelines and we will continue to work with them on this prescription drug overdose epidemic," said the CDC's Lenard.

CDC officials have long been critical of opioid overprescribing and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"CDC’s top focus in developing these guidelines is improving patient safety and reducing the risk that any more patients will die from an overdose related to mixing medications, using alcohol while on treatment, or taking a dangerous dose of opioids," said Lenard.

"We want to provide tools that primary care physicians can use to help determine when and how to safely initiate, maintain, and discontinue use of opioid therapy for chronic pain outside the setting of end-of-life care.  We understand that pain is a complex problem and that some patients will require treatment with a pain specialist. These guidelines are not intended to guide that care. We want patients currently on opioid therapies to work with their doctors to stay safe while managing their pain."

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

The CDC said it will now consult with the “stakeholders” group --and will then submit the guidelines to a peer review panel  -- before releasing a final version in January, 2016.

Members of the stakeholders group include the following: American Academy of Neurology; American Academy of Pain Management; American Academy of Pain Medicine; American Academy of Pediatrics; American Academy of Physical Medicine and Rehabilitation; American Cancer Society; American Chronic Pain Association; American College of Medical Toxicology; American College of Obstetrics and Gynecology; American Geriatrics Society; American Hospital Association; American Medical Association; American Pain Society; American Society of Addiction Medicine; American Society of Anesthesiologists; American Society of Hematology; American Society of Interventional Pain Physicians; and Physicians for Responsible Opioid Prescribing.

Power of Pain: 9 Tips for Cooking with Chronic Pain

By: Barby Ingle, Columnist

For those of us living with pain, we wish for a life worth living -- one that permits us to enjoy our family and friends.

Preparing and sharing a meal is something I enjoy doing, but pain can make even the simplest cooking tasks more difficult, especially those that affect our hands, fingers, wrists, elbows, and shoulders.

Here are nine tips I’ve learned to make cooking easier:

1. Use pots and pans with two handles

2. Buy a food processor, especially if you have difficulty with manual cooking tasks like chopping, cutting, and slicing.

• Choose a food processor that is manageable for you and your physical limitations
• Before you buy one, be sure you are able to change the blades easily and remove the plastic bowl and plastic lid from the processor
• Consider mini food processors for your needs

3.  Use specialty cooking tools such as "Rocker" knives.

• The two-handled design adds strength and control to cutting and chopping, while the rocker blade design has the motion built right in.

4.  Use a stool to sit on while you prepare and cook food.

• Cooking can be a long process, depending on how complicated the meal is you are preparing
• When counter work starts to increase your pain or when standing over the stove is wearing you out, be prepared to pull up a stool

5.  Crock pot meals

• Crock pots are helpful for people with pain to be able to cook nutritious meals, but in less time and more simply.

6.  Electric can opener to use on canned food or soups

• Soup is simple to prepare and nutritious
• Make sure you have canned soups available for when you are having bad pain days or the ingredients to make soup when you don’t feel up to cooking. Soup will warm you and soothe you.
• Use a ladle to pour soup into the bowl

7.  Double the size of your meals

• Create planned leftovers which you can freeze and have available for another day
• You will be glad you have nutritious meals in your freezer on days you don't feel well enough to cook

8.   Food Storage

•  Get food storage containers which are easy for you to open and easy for you to stack
•  Prepare and store foods which you commonly use and have them in ready-to-eat condition.

9.   Organize your kitchen

•  Get a stove with controls on the front rather than the back
•  Install cabinet handles which are easy to grasp
•  Install vertical dividers to store pans and trays so that they are not stacked
•  Raise the front bottom edge of the refrigerator so it closes automatically
•  Store frequently used items in cupboards between knee and shoulder height
•  Store kitchen items near the area they are used
•  Store spices in a drawer or on the counter rather than in a high cupboard

There are many choices and designs for cooking tools and kitchen aids that can make cooking easier, such as ergonomic, lightweight cooking tools, which have easy grips and non-slip handles.

Spatulas, spoons, ladles, whisks and other cooking tools which feel comfortable in your hand can greatly improve manual dexterity, reduce pain, and compensate for swollen and deformed joints.

What tips have you learned to make cooking easier?

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

Yoga Reduces Chronic Pain of Arthritis

By Pat Anson, Editor

A few weeks of yoga can significantly improve the health and mental well-being of people suffering from the two most common forms of arthritis, according to a new study at Johns Hopkins University.

Researchers found that 8 weeks of yoga classes reduced pain and improved the energy, mood and physical activity of patients with rheumatoid arthritis or knee osteoarthritis. The study, published in the Journal of Rheumatology, is believed to be the largest randomized trial to examine the effect of yoga on the physical and psychological health of arthritis sufferers.

"There's a real surge of interest in yoga as a complementary therapy, with 1 in 10 people in the U.S. now practicing yoga to improve their health and fitness," said Susan Bartlett, PhD, an adjunct associate professor of medicine at Johns Hopkins and associate professor at McGill University.

"Yoga may be especially well suited to people with arthritis because it combines physical activity with potent stress management and relaxation techniques, and focuses on respecting limitations that can change from day to day."

Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion. About 1.5 million Americans and 1% of adults worldwide suffer from RA.

Knee osteoarthritis (OA) is even more common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA, which causes thinning of cartilage and progressive joint damage.

Johns Hopkins researchers recruited 75 sedentary adults with either knee osteoarthritis or RA. Participants were randomly assigned to either a wait list or eight weeks of twice-weekly yoga classes, plus a weekly practice session at home. Their physical and mental well-being were assessed before and after the yoga sessions by researchers who did not know which group the participants had been assigned to.

Those doing yoga reported a 20% improvement in pain, energy levels, mood and physical function, including their ability to complete physical tasks. Walking speed also improved to a lesser extent, though there was little difference between the groups in tests of balance and upper body strength. Improvements in those who completed yoga were still apparent nine months later.

"For people with other conditions, yoga has been shown to improve pain, pain-related disability and mood," said Clifton Bingham III, MD, associate professor of medicine at Johns Hopkins University School of Medicine and director of the Johns Hopkins Arthritis Center.

"But there were no well-controlled trial of yoga that could tell us if it was safe and effective for people with arthritis, and many health professionals have concerns about how yoga might affect vulnerable joints given the emphasis on changing positions and on being flexible. Our first step was to ensure that yoga was reasonable and safe option for people with arthritis.”

Participants were screened by their doctors prior to joining the study, and continued to take their regular arthritis medication. Instructors in the yoga classes also had additional training to modify poses to accommodate people with limited physical ability.

“Find a teacher who asks the right questions about limitations and works closely with you as an individual. Start with gentle yoga classes. Practice acceptance of where you are and what your body can do on any given day," Bingham said.

CDC: Opioids ‘Not Preferred’ Treatment for Chronic Pain

By Pat Anson, Editor

New draft guidelines by the Centers for Disease Control and Prevention (CDC) would – if adopted -- sharply reduce the prescribing of opioids for both chronic and acute pain in the U.S. The proposed guidelines may also trigger a turf battle between the CDC and the Food and Drug Administration over which agency has primary responsibility for the safe prescribing of medication.

In an unusual online “webinar” held by the CDC, the agency today unveiled a dozen draft guidelines for physicians to follow when prescribing opioids. The first recommends “non-pharmacological therapy” as the preferred treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of patients both before and during opioid use, and that smaller doses and quantities be prescribed. Only “three or fewer days” supply of opioids is recommended for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids.

Pain patients listening to the webinar expressed alarm over some of the recommendations.

“I would caution the CDC that putting these dosage limits in here would cause problems for patients,” said Marjorie. “These recommendations have severe ramifications.”

“I have been on and off opiates for a few years. I do not have cravings for opiates. I am not addicted to opiates. I do think there has been a demonization of opiates among the medical community, as well as the CDC possibly and definitely the DEA,” said Chardonnay. “How do you decide which patients to continue, that really get benefits from this, and how do you decide which patients take them to get high?”

The CDC took comments about the guidelines during the webinar, but refused to answer any questions about them. The agency said it would finalize its guidelines in early November to submit to the Department of Health and Human Services, with the goal of publishing them in January, 2016.

The CDC’s guidelines were not publicly available before the webinar, there was little advance notice about it, and there were numerous technical problems for some people who tried to participate online. There were so many complaints about lack of access to the webinar, the CDC said it would hold a second one tomorrow.

While the CDC recorded the webinar, it is not making it available for people to watch or listen to afterwards. The draft guidelines, outlined below, will also not be available on the CDC’s website.

(Update: PNN has obtained a transcript of the webinar through the Freedom of Information Act. You can see the transcript by clicking here.)

CDC Draft Guidelines for Opioid Prescribing

1. Non-pharmacological therapy and non-opioid pharmacological therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting long term opioid therapy, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

3. Before starting and periodically during opioid therapy, providers should discuss with patients risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy, providers should prescribe short-acting opioids instead of extended-release/long acting opioids.

5. When opioids are started, providers should prescribe the lowest possible effective dosage. Providers should implement additional precautions when increasing dosage to 50 or greater milligrams per day in morphine equivalents and should avoid increasing dosages to 90 or greater milligrams per day in morphine equivalents.

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of short-acting opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days will usually be sufficient for non-traumatic pain not related to major surgery.

7. Providers should evaluate patients within 1 to 4 weeks of starting long-term opioid therapy or of dose escalation to assess benefits and harms of continued opioid therapy. Providers should evaluate patients receiving long-term opioid therapy every 3 months or more frequently for benefits and harms of continued opioid therapy. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids when possible.

8. Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid-related harms are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state Prescription Drug Monitoring Program data to determine whether the patient is receiving excessive opioid dosages or dangerous combinations that put him/her at high risk for overdose. Providers should review Prescription Monitoring Program data when starting opioid therapy and periodically during long-term opioid therapy (ranging from every prescription to every 3 months).

10. Providers should use urine drug testing before starting opioids for chronic pain and consider urine drug testing at least annually for all patients on long-term opioid therapy to assess for prescribed medications as well as other controlled substances and illicit drugs.

11. Providers should avoid prescribing of opioid pain medication and benzodiazepines concurrently whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually opioid agonist treatment in combination with behavioral therapies) for patients with opioid use disorder.

The CDC said the guidelines were developed after a series of meetings with a “core expert group” and “independent peer reviewers” that the agency did not identify by name.

CDC officials have long been critical of opioid prescribing practices and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"If the evidence of their guidelines are of the quality of their research on opioid overdoses, then we are in big trouble. They claim they will be using evidenced based material in forming these guidelines, however they have never shown any desire to correctly evaluate evidence for its strength and value,” said Janice Reynolds, a retired nurse and longtime activist in the pain community.

“I am sure their information came from addiction disease doctors who have an arrogance based model of practice and many don’t care about pain management.  Much of their information comes from PROP."

PROP (Physicians for Responsible Opioid Prescribing) is a controversial organization that has lobbied Congress and criticized the FDA for not doing more to limit access to opioids. A link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

“The CDC knows nothing about pain management and possibly less about pharmacology, so why should anyone listen to them?” asked Reynolds. “Their complaints against opioids only increases the misery of people with pain and does little to prevent deaths as most people with an addiction to prescription medications obtain their meds not by legitimate prescriptions.”

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

The CDC does not normally get involved in setting guidelines for prescription drugs, a responsibility that falls on the FDA – which regulates drugs and determines which ones can be used to treat medical conditions. A spokesman for the FDA who handles opioid issues told Pain New Network he was unaware the CDC was drafting its own opioid guidelines.

How I Finally Took Myself Off Cymbalta

By Crystal Lindell, Columnist

To be fair, the first time I took myself off Cymbalta, it was less of a “took myself off” situation and more of a “I ran out of medication and money, and couldn’t get my refill for a few days so I just thought I’d skip a few doses” situation.

But it turns out that going off that stuff cold turkey is seriously hell. It made me dizzy and nauseous, and basically electrocuted my brain every few minutes with something called “brain zaps.” When I finally realized that all of this was because I didn’t refill my prescription, I went to the pharmacy, got another dose, and about a day later, got my brain back.

Except I didn’t really get my brain back, because Cymbalta essentially turns your brain off.

Being on Cymbalta, which is now available as a generic called duloxetine, made me so tired that 16 hours of sleep felt like I just pulled an all-nighter. It killed my sex drive. It canceled out all my creative thoughts. And it basically made me feel like I was living in a London fog every day. I could sort of see the world, but not really. Also, it made me gain 30 pounds.

So, to sum up, Cymbalta really sucks.

The worst part about this whole thing though isn’t the side effects. It’s that my doctor originally put me on Cymbalta to help with my chronic pain, but it actually did nothing at all to help that.

Although I will admit that it did curb all those suicidal thoughts that I was having because I wasn’t on enough pain medication and I thought I was going to feel like a semi-truck was crushing my ribs all day, every day, for the rest of my life.

But eventually I did get on the right mix of pain meds, and I realized my future wasn’t quite as bleak as I had thought. And so, even after that horrible experience of kind-of, accidentally going off Cymbalta last winter, I decided that I really wanted to go off it completely. And I thought maybe I’d just try the cold turkey thing again.

And before you’re all, “OMG!! You are an idiot!! Why would you ever take yourself off a drug like that cold turkey?” There are three things you should know:

1. I’ve had doctors, including one at the freaking MAYO CLINIC, tell me before to go off all sorts of drugs cold turkey, including sleeping pills, antidepressants, and opioids. So I got the impression that all this business about not going off certain drugs cold turkey is more of a suggestion than a recommendation.

2. My doctor never told me NOT to go off Cymbalta cold turkey. Ever. Not one time. Not even in passing as he shook my hand at the end of the appointment. Not even when I told him I was thinking about going off the drug and he shut me down by saying, “Just stay on it. It’s probably doing more than you think.” I also live in a really small town, with one small pharmacy, and they never gave me any sort of information when I picked up my prescription telling me about the side effects of going off it cold turkey.

3. (And probably most important) The dosing is such that going off Cymbalta cold turkey is kind of your only option. As far as I can tell, the lowest dose is 20 mg and it only comes in capsules, so you can’t just cut them into smaller and smaller pieces until you’ve weaned off it. After you're on the smallest dose, there’s no choice but to go cold turkey.

Also, honestly, I really did think the withdrawal symptoms would subside after maybe a day. I was wrong. After about a week, I couldn’t take it anymore and I went back on Cymbalta.

I really, really wanted off this drug though, so I decided to call Dr. Google. And I found out that some people were just opening the capsules and pouring a little more out each day until they got down to nothing. I decided to do the same thing. And, while it ended up taking me a few months of meticulously opening the capsules and eyeing it every day, I finally got completely off Cymbalta. And I was lucky enough to avoid most of the side effects that I experienced when I went off it cold turkey.

When I confessed all this to my doctor though, I’m pretty sure he A) Totally did not believe me about the brain zaps, and B) Was secretly judging me for my methods — especially since the makers of Cymbalta explicitly say you should not open the capsules.

I've written before about how horrible Cymbalta is though, and how people are actually suing Eli Lilly, the makers of the drug, because they’ve been kind of shady with how they portray the withdrawal symptoms.

“Studies show that between 50% and 78% of Cymbalta users experience antidepressant withdrawal symptoms after discontinuing the drug. Yet the drug label misleadingly states that Cymbalta withdrawal symptoms occur in only 1% to 2% of cases,” claims attorney Steven Gacovino, one of several lawyers suing Eli Lilly on behalf of patients.

That’s a pretty big difference. So maybe my doctor really didn’t know that it could be an issue for me to go off Cymbalta cold turkey and that’s why he never mentioned it. Or maybe he really did think it was helping me more than I realized. I don’t know.

I do know that I’m really glad I got off that drug. I also know that if any other chronic pain patient ever asks me my opinion about Cymbalta, I will definitely advise them against taking it for pain.

I just hope it’s not too late.

Crystal Lindell is a journalist who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome.

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

The 7 Psychological Stages of Chronic Pain

By Jennifer Martin, PsyD, Columnist

Have you ever wondered if other people with chronic health conditions feel the same way you do?

Throughout my years with chronic pain and illness, along with the hundreds of patients I have counseled, I have found that, while everyone copes in their own way and experiences their condition uniquely, there are common feelings that most of us share.

When I first began counseling chronic pain patients, I often used Elizabeth Kübler-Ross’s “Five Stages of Grief” to help them understand what they were going through. 

But as time went on, I reflected on what I experienced with my own chronic conditions and also on my patients’. It seemed that these stages, while very helpful, didn’t fully explain the broad range of emotions that people with chronic illness experience. 

After all, Kubler-Ross developed them to explain the responses to grief and loss. Having a chronic illness can be viewed as a type of loss, but they were not developed specifically to explain the emotions of people experiencing chronic conditions.

I used Kübler-Ross’s stages as a model to develop the Seven Psychological Stages of Chronic Pain and Illness: 

1. Denial

In this stage, we are in a state of shock and refusal. We wonder how our life is going to change and how we are going to live with those changes. Denial and shock help us to cope and make survival possible.

This stage can be dangerous for people with chronic pain and illness because if they are in denial about their condition, they may not take the necessary steps to get themselves the treatment they need.

Example: “It’s not a big deal, it will go away” or “The doctor is wrong, I don’t have diabetes.”

2. Pleading, Bargaining & Desperation

This is the stage where we want more than anything for life to be what it once was. We become fixed on anything that could make our illness and pain go away -- or anything that could give us some semblance of the life we once had. 

We may find fault in ourselves and what we think we could have done differently. We may even bargain with the pain or illness because we would do anything not to feel them anymore. Guilt is common when bargaining. 

Example: “Please just don’t let this ruin my life” or “If you make the pain go away, I promise I’ll be a better person.”

3. Anger

After we conclude that our pleading and bargaining is not going to change the diagnosis, anger sets in. 

Anger is a necessary stage of the healing process. Feelings of anger may seem endless, but it is important to feel them. The more you truly feel anger, the more it will begin to subside and the more you will heal.  Your anger has no limits and it may extend to your doctors, family, friends and loved ones.

Anger is often felt later on when the illness and pain progresses, or holds us back from doing the things we would like. 

Example: “This isn’t fair! I didn’t do anything to deserve this!” or “Just give me something that will make me feel better!”

4. Anxiety and Depression

Feelings of emptiness and grief appear at a very deep level.  This depressive stage feels as though it will last forever.  It is important to understand that this depression is not a sign of mental illness.  It is the appropriate response to a loss or a life-altering situation. 

We may withdraw from life and wonder if there is any point in going on.  Depression after a loss is too often seen as unnatural or something that needs to be snapped out of.  Being diagnosed with a chronic illness or experiencing chronic pain is a loss – a loss of the life you once had.

Having a chronic pain or illness may also bring up feelings of anxiety; anxiety about what the future holds, anxiety about not being able to live up to expectations, anxiety about social situations, anxiety about medical bills, etc.

Example: “I’m going to be in pain forever so why even bother?” or “I’m going to be in debt forever.  How am I ever going to pay off these medical bills?”

5. Loss of Self and Confusion

Having chronic pain or illness may mean giving up some key aspect of what made us who we were.  It may mean an inability to be physically active like we once were.  It may mean not being able to be as sociable as we would like or it may even mean giving up a career. 

You may wake up one day and not recognize the person you are now.  You may question what your purpose in life is now.  This stage may occur at the same time as anxiety and depression, or it may be separate.

Example: “I don’t even recognize myself anymore.” or “My career was my identity.  Who am I without that?”

6. Re-evaluation of Life, Roles and Goals

Having a chronic condition often means giving up a lot.  We are forced to re-evaluate our goals and futures.  We are forced to re-evaluate who we are as a husband, wife, mother, father, sibling or friend.  While we once had a successful career that gave us purpose, we may find ourselves beginning to question what we can do for work in the future and how we can contribute to our families. 

While we were once able to do it all, we are now re-evaluating what absolutely has to get done during our days and how we can accomplish these goals while still remaining in a positive mood.  Re-evaluating your life, roles and goals is a crucial first step in accepting your condition.

Example: “I may not be able to be a nurse anymore but maybe I could teach classes a couple times per week.” or “I can’t be as physically active with my husband anymore so what else can I do to show him I love him?

7. Acceptance

Acceptance is often confused with the idea of being “OK” with what has happened. This is not true.  Many people don’t ever feel OK about having to live with pain or an illness for the rest of their lives.

This stage is about accepting the reality of your situation and recognizing that this new reality is permanent. We will never like this reality and it may never be OK, but eventually we accept it and learn to live life with it. It is the new norm with which we must learn to live.

We must make adaptations and alterations to our lives. We must find new things that bring us joy.

Example: “I’m not going to let this define me. I will learn to deal with this the best I can.”

It's important to remember that these stages are not linear.  While some people begin in the denial stage, move through each stage and end with acceptance, many people jump back and forth throughout the stages.  I hope that these stages give some comfort to those who are experiencing chronic conditions.

Jennifer Martin, PsyD, is a licensed psychologist in Newport Beach, California who suffers from rheumatoid arthritis and ulcerative colitis. In her blog “Your Color Looks Good” Jennifer writes about the psychological aspects of dealing with chronic pain and illness. 

Jennifer is a professional member of the Crohn’s and Colitis Foundation of America and has a Facebook page dedicated to providing support and information to people with Crohn’s, Colitis and Digestive Diseases, as well as other types of chronic pain.

Zohydro 'Not a Public Health Risk'

By Pat Anson, Editor

Eighteen months after the introduction of Zohydro, there is little evidence the controversial painkiller is being abused or diverted, according to a new report from a nationwide drug monitoring program.

"Zohydro is not a public health risk and has shown little tendency to increase over the time it has been available," stated the report by the Researched Abuse, Diversion and Addiction-Related Surveillance System (RADARS). "The drug is either not desirable or unavailable for abuse."

The report covered the first quarter of 2015. RADARS monitors hundreds of hospitals, poison control centers and addiction treatment clinics in the U.S. to track the abuse, misuse and diversion of prescription drugs.

"Everyone thought this was going to be some horrible, horrible thing. And it didn't materialize that way," said Errol Gould, PhD, Director of Medical Affairs for Pernix Therapeutics, which bought the rights to Zohydro from Zogenix Inc. earlier this year.

"There have been very few reports of people checking into treatment centers and reporting Zohydro ER as the drug they were abusing. In the past 18 months I can tell you there have been less than 40."

There was a storm of controversy surrounding Zohydro when it was introduced in March 2014. The first single ingredient  hydrocodone painkiller sold in the U.S. was approved by the Food and Drug Administration over the objections of its staff and an advisory committee -- which warned there was a potential for Zohydro to be abused even more than other hydrocodone products.

Addiction treatment experts also predicted Zohydro would fuel a new wave of painkiller addiction and overdoses. The Governor of Massachusetts even declared a state of emergency and tried unsuccessfully to ban Zohydro sales in his state.

"All the media attention sort of scared people, so there weren't a lot of prescriptions written in the beginning," said Gould. "But now over time the prescription rate has picked up. But we're still not seeing diversion. The abusers already know what hydrocodone is like and they're not going out and looking for Zohydro when they can get other things that are more readily available to them."

Only about 1,600 prescriptions are being written for Zohydro each week, a tiny fraction of the 130 million hydrocodone prescriptions that are filled each year in the U.S. Prescribing of Zohydro is also closely monitored to keep it away from pain patients who might misuse or abuse it.

"I think the growth has been slow. Most of that has been because of the prior perceptions. We fully expect that to change over time. It just takes time to change people's views and minds. We've had a bit of an uphill battle," said Doug Drysdale, President and CEO of Pernix. "The good news here from RADARS is that the product is not being abused. And I think that's very encouraging."

The biggest problem faced by Pernix going forward may not be the hysteria over Zohydro's introduction -- but competition from rival drug makers.

Purdue Pharma has introduced its own "pure" hydrocodone product -- sold under the brand name Hysingla ER. Hysingla is designed to be taken once a day, while Zohydro is meant to be taken twice daily for chronic pain. Both products are sold in abuse deterrent formulas that make them harder for drug abusers to snort or inject.

Until the introduction of Zohydro, most hydrocodone products on the market were combined with acetaminophen, which at high doses can cause liver damage. Hydrocodone combination drugs such as Vicodin, Lortab and Lorcet are the most commonly prescribed and abused painkillers in the U.S. In 2014 hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II medication to make it harder to obtain.

Montana Clinic to Reopen Without Doctor

By Pat Anson, Editor

A Montana health clinic that closed its doors last week will reopen on Monday, but without its owner -- who says he will not write opioid prescriptions for chronic pain patients because he is "paralyzed with fear" of being arrested.

"I don't think it's safe for me to continue seeing these patients until I get some reassurance that I can do it. I'm risking my well being by going in there.," said Mark Ibsen, MD, owner of the Urgent Care Plus clinic in Helena.

Ibsen says he left behind "tapering" prescriptions for opioids at lower doses to help wean patients off the drugs and prevent them from going into withdrawal.

"I have a couple who are upset and feel abandoned. And I have a lot of them who are upset and understanding," he said. "They've seen what I am going through. They've been watching me kind of deteriorate emotionally over the last few months. And I tell my patients I can't continue to do this, you've got to find someone else. This is dangerous for me."

image courtesy of mark ibsen

Ibsen fears being arrested like Dr. Chris Christensen, another Montana doctor who was recently charged with 400 felonies, including two counts of negligent homicide, in connection with the overprescribing of opioids. Ibsen himself was the target of a lengthy investigation by the Montana Board of Medical Examiners after he started treating some of Dr. Christensen’s former pain patients.

If he keeps writing prescriptions for opioids, Ibsen worries he'll be next.

"The DEA agents that met with me five different times will not meet with me again unless my lawyer is present. My only inference from that is that they have an open investigation. I haven't been able to confirm that , but you don't know that until they walk through the door and cuff you.  I have no idea, so I am paralyzed with fear," he said.

dr. mark ibsen

Pain News Network caught up with Ibsen in Las Vegas, where he is attending PAINWeek, the nation's largest conference for frontline practitioners in pain management. Ibsen hoped going to the conference would re-energize him, but found that many of the lectures focused on opioid abuse and diversion.--. the very subjects he's grown weary of.

"All I've seen is more evidence of hysteria," he said. "Prescription drug overdose is number 22 on the list of causes of death in America. And this so-called epidemic, I mean calling it an epidemic is insane."

Like Ibsen, other doctors around the country have also stopped writing prescriptions for opioids.

"Many of them with much less provocation than he's had," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management. "You worry you're going to lose your practice and lose your livelihood by doing something you don't intend to do. And the easiest way to do that is don't go there, don't prescribe."

Ibsen says he was prescribing opioids to about200 patients when he stopped. Some have gone to hospital emergency rooms seeking more medication, while others are in search of new doctors in a state where very few are willing to prescribe to new patients.

"My patients are now being shunned by other doctors and judged by the fact that they've seen me," Ibsen said.