USA TODAY Investigation: VA knowingly hires doctors with past malpractice claims, discipline for poor care

A USA TODAY investigation finds the Department of Veterans Affairs has repeatedly hired healthcare workers with problem pasts, like neurosurgeon John Henry Schneider, whose license had been revoked after a patient death. USA TODAY

https://www.usatoday.com/story/news/politics/2017/12/03/usa-today-investigation-va-knowingly-hires-doctors-past-malpractice-claims-discipline-poor-care/909170001/

Neurosurgeon John Henry Schneider racked up more than a dozen malpractice claims and settlements in two states, including cases alleging he made surgical mistakes that left patients maimed, paralyzed or dead.

He was accused of costing one patient bladder and bowel control after placing spinal screws incorrectly, he allegedly left another paralyzed from the waist down after placing a device improperly in his spinal canal. The state of Wyoming revoked his medical license after another surgical patient died.

Schneider then applied for a job earlier this year at the Department of Veterans Affairs hospital in Iowa City, Iowa. He was forthright in his application about the license revocation and other malpractice troubles.

But the VA hired him anyway.

He started work in April at a hospital that serves 184,000 veterans in 50 counties in Iowa, Illinois and Missouri.

Some of his patients already have suffered complications. Schneider performed four brain surgeries in a span of four weeks on one 65-year-old veteran who died in August, according to interviews with Schneider and family members. He has performed three spine surgeries on a 77-year-old Army veteran since July — the last two to try and clean up a lumbar infection from the first, the patient said.

Schneider’s hiring is not an isolated case. 

A VA hospital in Oklahoma knowingly hired a psychiatrist previously sanctioned for sexual misconduct who went on to sleep with a VA patient, according to internal documents. A Louisiana VA clinic hired a psychologist with felony convictions. The VA ended up firing him after they determined he was a “direct threat to others” and the VA’s mission.

As a result of USA TODAY’s investigation of Schneider, VA officials determined his hiring — and potentially that of an unknown number of other doctors — was illegal.

Federal law bars the agency from hiring physicians whose license has been revoked by a state board, even if they still hold an active license in another state. Schneider still has a license in Montana, even though his Wyoming license was revoked.

VA spokesman Curt Cashour said agency officials provided hospital officials in Iowa City with “incorrect guidance” green-lighting Schneider’s hire. The VA moved to fire Schneider last Wednesday. He resigned instead.

Cashour also said the VA would look into whether other doctors had been improperly hired.

“We will take the same prompt removal action with any other improper hires we discover,” he said.

A USA TODAY investigation in October revealed how the VA has for years concealed shoddy care and mistakes by medical workers when they leave the agency, allowing them to escape their pasts and potentially endanger patients elsewhere.

The results of the investigation of Schneider and other VA practitioners with problem pasts reveal potentially dangerous shortfalls when they join the agency as well.

More: VA conceals shoddy care and health workers’ mistakes

More: Exclusive: Botched surgery, delayed diagnosis at a one-star ‘house of horrors’ VA hospital

The VA Medical Center in Iowa City is pictured in 2014.(Photo: Press-Citizen file photo) (Photo: Press-Citizen)

In response to the findings, Cashour said the agency is also initiating an “independent, third-party clinical review” of the care Schneider provided with complications in Iowa City relayed to USA TODAY by patients or family members.

In an interview, Schneider maintained that he has not provided substandard care. He blamed poor outcomes for patients on other providers involved in their treatment or on unfortunate complications not caused by his care.    

Schneider said his insurance company decided to settle some of his prior cases regardless of their merit, and he filed an appeal of the Wyoming revocation, a case that’s still pending. 

“I’m a neurosurgeon; neurosurgeons across the country get litigation because of complications related to surgery,” he said.

Of 15 malpractice complaints identified by USA TODAY, four were settled, and two were dropped by plaintiffs. Six others were deemed valid by a trustee after Schneider filed bankruptcy in 2014, court records show. The trustee rejected the other claims.

More: VA still in critical condition, Secretary David Shulkin says

More: Lawmakers rip VA on failure to report potentially dangerous medical providers

One malpractice lawyer and neurosurgeon who is not familiar with Schneider’s case said that in general, having a dozen malpractice claims in as many years raises red flags.

“That’s certainly not usual. It’s definitely an outlier.” said Larry Schlachter, author of Malpractice: A Neurosurgeon Reveals How Our Health Care System Puts Patients at Risk. 

For Schneider’s former patients and their family members, news of his hiring at the VA and return to the operating room after his Wyoming license was revoked came as a shock.  

“What in the world?” said Scherry Lee, who is awaiting payment for a malpractice complaint against Schneider after a failed neck surgery in Wyoming in 2012. She says it left her in debilitating pain with difficulty speaking and swallowing. “How does this happen, especially with a neurosurgeon?”

A trail of malpractice claims

Less than two months after Montana issued Schneider a medical license in 1997, Jason Zimmerman was rushed to the emergency room at St. Vincent Healthcare in Billings.

He had excess fluid building up around his brain that was creating dangerous intracranial pressure, according to court records. A tube and valve system that had been implanted to drain excess cerebrospinal fluid had malfunctioned.

His family sued Schneider and a practice partner alleging they provided substandard care and Zimmerman suffered “profound neurological injury” that left him permanently impaired, the complaint says.

He and his family members ultimately dropped their malpractice suit because they worried Zimmerman’s prior substance abuse would impede the case, his sister Wendy Conaway told USA TODAY. Schneider blamed his partner for the injuries.

But it was only the first of four malpractice claims he would face over the next five years from surgical patients at St. Vincent hospital. The others settled for undisclosed amounts, court records show.

They included the case of Lloyd Hickey, who was paralyzed from the waist down after Schneider allegedly implanted a device improperly in his spinal canal, and Carmen Riddle, who lost bladder and bowel control after three spine surgeries by Schneider. The wife of Thomas Deiling settled her wrongful death claim against Schneider after her husband died from complications after four surgeries.

“I continued the lawsuit hoping I could force him out of practice, but I couldn’t because of the cap on medical negligence lawsuits,” Jeanine Deiling said in a recent interview. She said Schneider failed to properly diagnose and quickly treat a pervasive infection that ended up eating away at her husband’s spine.  

Her best hope, Deiling said, was to add hers to the list of malpractice claims, and “if enough lawsuits added up, he’d never be able to get malpractice insurance and he’d have to quit practicing.”

Schneider did stop performing surgeries in Montana, but he started performing them in Wyoming instead. And he formed a company, Northern Rockies Insurance Company, that provided his own malpractice insurance, a move that eventually helped land him in bankruptcy and unable to pay off all his claims.

At hospitals in Cody and Powell, Wyo., and a surgical center in Sheridan, Wyo., Schneider performed operations between 2006 and 2012 that eventually prompted at least eight more malpractice complaints.

Online biography for John Henry Schneider. (Photo: www.udemy.com/user/dr-schneider/)

The case that captured the attention of Wyoming Board of Medicine officials was Russell Monaco, a father of two who went under Schneider’s knife in 2011 for a procedure to decrease pressure on nerves in his lower back, according to a wrongful death suit filed by his wife, Kathy.

After the operation, he was prescribed a litany of narcotics that can depress breathing, including fentanyl, oxycodone, valium, and Demerol. Monaco’s oxygen levels dropped dangerously low, but Schneider discharged him anyway, medical board records show.

He went home and took the medications as prescribed, the lawsuit says, but his family found him dead the next morning. The coroner determined the cause of death was “mixed drug overdose.”

“I tried to wake him up and yelled and the girls came down screaming,” his wife, Kathy Monaco, told USA TODAY. “It was horrible, I mean, I live that day over every day.”

The Wyoming Board swiftly placed restrictions on Schneider’s license and ultimately revoked it in 2014.

Schneider filed bankruptcy in December that year, leaving malpractice claimants hanging without payment even now, including the Monaco family.

In an interview, Schneider laid blame for Monaco’s death on a physician assistant who prescribed the medications. He said an aide in the operating room caused Hickey’s paralysis, and he blamed Riddle’s injury on a hematoma caused by medications prescribed by another provider. In Deiling’s case, Schneider asserted standard tests didn’t initially pick up the infection or indicate he needed more timely treatment.

Vetting revelations

The VA hiring process is seemingly rigorous.

Applications are vetted, education and licenses verified, references checked, and interviews conducted. For clinical hires, a review and approval by a professional standards board also is required.  

But when applicants disclose prior problems with medical licensing short of revocation, malpractice or criminal histories, VA hospital officials have discretion to weigh the providers’ explanations and approve their hiring anyway.

The VA hospital in Muskogee, Okla., hired a psychiatrist in 2013 with multiple disciplinary actions against his Oklahoma license, including for sexual misconduct, according to internal documents obtained by USA TODAY.

Hospital officials knew about his past, but approved his hiring anyway with the condition he be closely monitored during his probation period, the documents show.

And yet the psychiatrist, Stephen Lester Greer, went on to have a sexual relationship with a VA patient and ended up pleading guilty in August to witness tampering for trying to persuade the patient to lie about it to federal investigators.

More: Candid Veterans Affairs nominee faces big challenges to fix entrenched bureaucracy

More: VA vows changes on bad health care providers, lawmakers take action after USA TODAY investigation

The VA hired a psychologist to work at a clinic in Lafayette, La., in 2004, despite his revealing previous felony convictions on his application, according to the internal documents, which don’t identify the provider by name. The VA didn’t run a criminal background check until a year after he started work. It showed eight arrests, including for burglary, drug dealing and reckless driving resulting in death.

Still the VA allowed him to continue practicing until two years ago. By that time, the VA had received multiple complaints about patient mistreatment by the psychologist. An internal investigation found he was a “direct threat to others, (and) to the Department’s mission.” The VA fired him earlier this year.

The VA hospital in Jackson, Miss., hired ophthalmologist Daniel K. Kim, despite his being sanctioned by licensing authorities in Georgia. During his subsequent surgeries at the VA, a World War II veteran was blinded in 2006 and he allegedly implanted the wrong lens in another patient’s eye in 2012. Kim has denied any wrongdoing, and a VA investigation suggested a nurse assisting Kim caused the blinding.

More: Veteran patients in imminent danger at VA hospital in D.C., investigation finds

More: Senators author bill forcing VA to report more problem medical providers, faster

Psychiatrist David Houlihan landed a job at a VA hospital in Wisconsin in 2002 and was promoted to chief of staff two years later, even though the Iowa Board of Medicine had charged him with engaging in an inappropriate relationship with a patient and taking patient medications home.

He went on to earn the nickname “candy man” at the Tomah, Wis., VA because of the prolific amounts of narcotics he prescribed. The VA fired Houlihan in 2015 after revelations a 35-year-old veteran patient had died from mixed drug toxicity at the facility. He has denied any wrongdoing, but agreed to surrender his medical license in Wisconsin earlier this year.

Some of the VA’s policies can attract medical workers with past malpractice or licensing problems. Agency clinicians aren’t required to have malpractice insurance — the federal government pays out claims using taxpayer dollars — making the VA a good fit for providers who may have difficulties securing malpractice insurance in the private sector if past issues have rendered them too risky.

The Iowa City VA had been looking for a full-time neurosurgeon for nearly a year when Schneider came along.

In his job application, Schneider disclosed “all the issues” and the VA hired him after a “group of his medical peers thoroughly reviewed” his file and “approved his competency,” the VA said in a prepared statement provided to USA TODAY.

Schneider began work in April at an annual salary of $385,000.

Complicated surgeries

Complications soon began cropping up.

Schneider, who describes himself as a spinal specialist, performed surgery in July to remove a benign tumor from a 65-year-old patient’s brain.

Richard Joseph Hopkins survived three more brain surgeries for ensuing complications before dying Aug. 23 from infection.

“Rick was strong, he was a bull,” his sister Annette Rainsford said. “Why would you go into someone’s head four times?”

James Wehmeyer, a 77-year-old Army veteran, said Schneider performed his first spinal procedure in July. The neurosurgeon subsequently did two more operations to try and clean up infection from the first, prompting concerns something might be amiss with his treatment.

“I thought that, but I didn’t know,” he said. “I’m not a doctor.”  

Wehmeyer said it’s been a month since his last surgery, and a nurse still visits him at home every three days to clean out the wound, which he said hasn’t healed.

“There’s a big hole in there they’re trying to close up,” he said.

At least three other patients suffered infections after procedures Schneider conducted at the Iowa City VA — two deep-wound and one superficial — but they were cured with antibiotics, Schneider said.

In September, Schneider was arrested on federal criminal charges of lying and trying to conceal assets in his bankruptcy case in Montana.

His patients in Iowa City showed up for surgery but had to be rescheduled when he didn’t show up for work. Schneider told his VA bosses what happened when he got back to Iowa.

He continued practicing.  

Schneider, who pleaded not guilty to the charges, said in an interview that infections suffered by his VA patients were not his fault, but rather complications that can occur in neurosurgery.

He said Hopkins’ case was a “tragic” example, where he developed two brain bleeds and then fluid buildup, each requiring another surgery.

“I’ve had a great run at the VA with zero issues,” he said. “Have I had to take patients back (for surgery) for post-op infection? Yes. I mean, I can’t prevent every infection.”

One of Schneider’s patients from Wyoming said that whatever the case, the VA never should have hired him.

“Here the veterans, they went and served their country, and they’re messed up and everything,” said Michael Green, who is awaiting payment for a malpractice claim that alleged Schneider placed a screw incorrectly in his lower spine. “And then turn that guy loose on them, that’s what doesn’t make sense.

Online obituary for Richard J Hopkins. (Photo: Handout)

‘SEAL Team’ Exposes VA: ‘A Health Care System That Runs Like the Post Office’

‘SEAL Team’ Exposes VA: ‘A Health Care System That Runs Like the Post Office’

https://www.newsbusters.org/blogs/culture/lindsay-kornick/2019/04/25/seal-team-exposes-va-healthcare-system-runs-post-office

CBS’s SEAL Team has been mostly quiet this season regarding social issues. In its place, recent episodes have taken a deeper perspective into the lives of soldiers during and after deadly missions. This week’s episode offers the latest example with a critical look at Veterans Affairs.

The April 24 episode “Medicate and Isolate” takes a more somber look at some of the soldiers suffering from past trauma. Clay (Max Theriot) who was injured in a recent bombing attack, has been staying with former SEAL Team member Brett Swan (Tony Curran). Sadly, Brett suffers from his own war injuries and must attend an appointment with Veterans Affairs for prescriptions. While Clay has never visited a VA hospital, he’s still disheartened to see it up close.

Brett: Little different from your Rain Man suite at the military hospital.

Clay: Yeah, they definitely leave this out of those flashy recruiting videos.

Brett: This is a soldier’s reward for serving. A health care system that runs like the post office.

Actually, if it were run like the post office it might be better. The setting features overworked and understaffed members who tend to the soldiers. “My workload doesn’t offer me as much time as I’d like to review your paperwork,” the one nurse who attends to Brett says. After Brett and Clay wait all day to meet with the doctor seeking treatment for Traumatic Brain Injury, they are told he has to cancel and the next available appointment is in two months. There are places that treat mail with more dignity and efficiency than our soldiers.

While the episode makes a statement at the end insistent that “the characters and incidents in this episode are fictional and do not represent the majority of Veterans or their experience with the VA,” it’s not too lenient on it, admitting that “challenges faced by these men and women are all too real.”

Bureaucracy and indifference plague government-run health care, something we learned all too well about from the Obama VA scandal in 2014. Just like Brett, there are real soldiers who are put through an unproductive system of waiting lists, red tape and understaffed workers. Unfortunately for them, their plight isn’t always highlighted on primetime.   

As Brett puts it so eloquently, “These old-timers bled on the sands of Iwo Jima to defend our right to be an inefficient nation.” Such is the description for any government-run health care: inefficient and poorly run. Keep this in mind the next time you hear someone call for “Medicare for All.”

In the end, sadly, Brett’s dismay at the results (or lack thereof) from the VA center drive him to commit suicide. Even worse, his case is not an isolated one. We deserve better, and the men and women who defend our nation deserve more.

 

This message is for the Mothers & Fathers of our nation’s youth. It contains graphic images of what could happen to your child returning home from our Armed Forces. It demonstrates the sad truth for your son or daughter, for you and for your loved ones that to die on the battlefield is better than returning home to this #Betrayal. My prayers go out to each member of our military forces and the horrors facing them on returning home. Robert D. Rose Jr. BSW, MEd, USMC Semper Fidelis

 

Efficacy of opioids versus placebo in chronic pain: a systematic review and meta-analysis of enriched enrollment randomized withdrawal trials

https://www.dovepress.com/efficacy-of-opioids-versus-placebo-in-chronic-pain-a-systematic-review-peer-reviewed-fulltext-article-JPR

Conclusion

This meta-analysis of FDA-required double-blind, randomized, placebo-controlled clinical trials of opioid analgesics for the treatment of chronic pain has shown that there is an ample evidence base supporting the efficacy of opioid analgesics for at least 3 months’ duration, a standard period for the evaluation of treatments for chronic pain and other chronic disorders. This evidence base is at least as large as that for any other class of analgesics, and analysis of responders demonstrates clinically meaningful improvements. We have not focused on the risks of opioids, nor the risk–benefit balance, and hope that our review at least characterizes the evidence base for efficacy in order to inform these important broader discussions.

Introduction: Opioids have been used for millennia for the treatment of pain. However, the long-term efficacy of opioids to treat chronic non-cancer pain continues to be debated. To evaluate opioids’ efficacy in chronic non-cancer pain, we performed a meta-analysis of published clinical trials for μ-opioid receptor agonists performed for US Food and Drug Administration approval.
Methods: MEDLINE and Cochrane trial register were searched for enriched enrollment randomized withdrawal studies (before June 2016). Selection criteria included: adults, ≥10 subjects per arm, any chronic pain condition, double-blind treatment period lasting ≥12 weeks, and all μ-agonist opioids approved in the USA.
Results: Fifteen studies met criteria. Opioid efficacy was statistically significant (p<0.001) versus placebo for pain intensity (standardized mean difference: −0.416), ≥30% and ≥50% improvement in pain (risk difference: 0.166 and 0.137), patient global impression of change (0.163), and patient global assessment of study medication (0.194). There were minor benefits on physical function and no effect on mental function.
Conclusion: Opioids are efficacious in the treatment of chronic non-cancer pain for up to 3 months in randomized controlled trials. This should be considered, alongside data on opioid safety, in the use of opioids for the treatment of chronic pain.

Keywords: opioid analgesics, non-cancer pain, long-term efficacy, EERW trials, opioid efficacy; evidence-based medicine

Introduction

Opioids have been used for millennia for the treatment of pain and remain an important therapeutic option. While the American Academy of Pain Medicine, the American Pain Society, the US Federation of State Medical Boards, and the Centers for Disease Control and Prevention endorse the use of opioids, when appropriate, for the treatment of chronic pain, efficacy of long-term opioid use remains controversial.16 In addition, there are significant risks associated with opioids and these agents have contributed to the epidemic of opioid abuse, addiction, and overdose deaths in the USA.710 Given these serious risks, the assessment of evidence for the long-term analgesic efficacy of opioids for treating chronic pain is crucial.

The US Food and Drug Administration (FDA) requires randomized, double-blind, placebo-controlled studies of at least 3 months’ duration in order to approve an opioid for the treatment of chronic pain. This reflects the need to balance accrual of sufficient data representative of long-term treatment against the scientific and ethical challenges of longer-term randomized, placebo-controlled trials, including dropouts, missing data, concomitant treatments, and long-term use of placebo. The 3-month duration is the standard clinical trial duration accepted by the FDA for many chronic conditions including hypertension, asthma, depression, schizophrenia, bipolar disorder, and anxiety.

In order to inform the ongoing controversy over whether there is evidence that opioids are efficacious for the treatment of chronic pain, we have gathered the randomized controlled trials required by the FDA for approval, and have performed a meta-analysis of their results. These trials are by regulatory expectation 3 months in duration. This review does not address the risks of opioids. A coherent position on the risk–benefit balance of opioids for the treatment of chronic pain requires an accurate and data-driven assessment of both their risks and their benefits. Thus, the purpose of this review is not to minimize, or characterize, the risks of opioids, but rather to ensure that the debate over the risks and benefits of opioids is informed by an accurate assessment of their benefits.

Methods

Data sources and searches

MEDLINE and Cochrane Central Register of Controlled Trials 2012 were searched for all relevant studies published before June 2016. The search strategy for MEDLINE is presented (see Methods in Supplementary materials) and was customized for the Cochrane Central Register of Controlled Trials 2012 (in which only the Intervention and Population sections were used). Additional studies were identified through the examination of references from identified trials, systematic reviews, and authors’ own databases.

We searched for enriched enrollment randomized withdrawal (EERW) studies published in English with double-blinded outcome assessments that compared any opioid (including combinations and dual mechanism analgesics administered via the oral, transdermal, nasal, sublingual, or transmucosal routes) to placebo for ≥12 weeks during the randomized double-blind treatment phase of the study in patients with any chronic non-malignant pain condition.

Study selection

Inclusion and exclusion criteria

Trials with participants ≥18 years of age with any type of chronic nonmalignant pain, including but not limited to chronic low back pain (CLBP), chronic neuropathic pain, diabetic peripheral neuropathic pain (DPNP), osteoarthritis (OA), arthritis, rheumatoid arthritis, phantom limb pain, fibromyalgia, post-herpetic neuralgia, or musculoskeletal pain. Studies of acute or post-surgical pain and cancer pain were excluded. Studies of specific μ-agonist opioids, μ-agonist opioids with additional pharmacological activity (eg, tramadol and tapentadol), or combination opioids (eg, hydrocodone/acetaminophen) approved for the treatment of pain were included. Agents with oral, transdermal, nasal, sublingual, or transmucosal routes of administration were included. Studies were included if they had a minimum of 10 patients per arm and reported pain intensity (PI) as an outcome. The present study protocol has been published on PROSPERO (http://www.crd.york.ac.uk/PROSPERO/; registration No: CRD42015026378).

Selection methodology

Two authors independently screened titles and abstracts using the Abstrackr software to identify manuscripts that met the abovementioned inclusion criteria.11 Full-text articles were obtained for manuscripts that appeared to meet the inclusion criteria or were likely to meet the inclusion criteria. The full text of these manuscripts was read to determine final inclusion in the meta-analysis. Any disagreement on manuscript inclusion was resolved through discussion among the authors.

Data extraction and quality assessment

Data extraction methodology

Two authors independently extracted data from each manuscript using the Systematic Review Data Repository (SRDR) form (http://srdr.ahrq.gov/; retrieved: June 1 2016). A third author subsequently confirmed that primary and secondary endpoints matched the SRDR form. The SRDR is an open collaborative web-based repository for systematic data review. The SRDR form was developed to include participant characteristics, interventions, treatment arms, adverse events (AEs), primary and secondary outcomes, country(s) of study, number of study sites, trial design, blinding, clinical setting, method of recruitment, group similarities at baseline, and assessment bias. If data were not available or incomplete, manuscript authors were contacted to provide the missing data.

Quality assessment

Risk of bias was assessed based on the guidelines available through the Cochrane Risk of Bias Tool of the SRDR (http://handbook.cochrane.org/chapter_8/table_8_5_a_the_cochrane_collaborations_tool_for_assessing.htm). We defined high-quality studies (ie, low bias studies) as those with no major methodological flaws that fulfilled 6 or more of the 11 internal validity criteria.12

Data extracted

The following outcome measures were extracted from the selected publications: change in PI score from randomization baseline to week 12 or study endpoint, categorical evaluation of responders/non-responders (≥30% and ≥50% improvement as calculated based on changes between week 12 and pain at the beginning of the open-label titration phase), patient assessments of global improvement (eg, patient global impression of pain [PGIC] and patient global assessment of study medication [PGASM]), assessment of patient change in function (eg, Roland–Morris Disability Questionnaire [RMDQ] and Western Ontario and McMaster Universities Arthritis Index [WOMAC]), rescue medication dose consumption, and health-related quality of life (eg, 36-Item Short-Form Survey [SF-36]).

Safety outcomes collected included: the proportion of patients with ≥1 AE, ≥1 serious AE (SAE), discontinuing treatment due to AEs and/or withdrawal symptoms post-randomization; AEs during the open-label titration phase were not collected.

Data synthesis and analysis

The primary outcome was standardized effect size, defined as the treatment difference (mean difference in PI score between active and placebo) divided by the SD. We pooled data from all manuscripts regardless of whether the endpoint was presented as mean change from randomization baseline to week 12 or as the least squares mean difference (LSMD) at week 12; if both results were available, the mean change from randomization baseline to week 12 was used. The mean change from baseline was calculated from the reported mean baseline and week 12 data; the SD of the change was calculated by assuming a correlation of 0.50 between baseline and week 12 responses. The standard mean difference (SMD) was calculated with 95% CIs. The change in PI from randomization baseline to week 12 was reported as the LSMD and standard error (SE); in case SD or SE were not available, they were calculated based on the following formula: SE = SD/square root (N). When SD values were not available, the manuscript authors were contacted. We were able to obtain all unpublished SD values. The number of subjects randomized was used in all analyses except in situations where a different N value was more appropriate to use (eg, some manuscripts did not present data for 100% of patients in PGIC tables; in this situation, we calculated the total number of patients randomized based on the percentage of reporting patients).

A binary random-effects meta-analysis using the restricted maximum likelihood method was conducted to assess ≥30% and ≥50% responder rates. The results are reported as risk differences (RDs). The same approach was used for PGIC results (combining “very much improved” and “much improved” responses) and PGASM (combining “excellent” and “very good” results). Function endpoints were not reported in all manuscripts, and for manuscripts that did report function endpoints, a variety of different measures were used (RMDQ, WOMAC, and Oswestry Disability Index). Therefore, no meta-analysis was performed; instead, these data were presented in a tabular format. Quality of life measures (mean change from baseline to week 12; SF-36 or SF-12v2) were combined and a meta-analysis was conducted using a linear regression model. The numbers of patients who discontinued treatment due to an AE were subjected to a binary random-effects meta-analysis using the restricted maximum likelihood method. The results are presented as RDs. In order to assess the percent of patients who benefited from the study drug, a weighted mean was calculated for the percentage of patients who met inclusion criteria (ie, found the study drug both efficacious and tolerable) and were randomized to the randomized double-blind treatment phase. The statistical analysis was performed using the OpenMetaAnalyst Software.13

Meta-analysis findings

A total of 2,018 references were identified from our search; of these, 26 full-text articles were obtained for screening and 15 met our inclusion criteria (Figure 1).1428

Figure 1 Study flow diagram.

Included studies

A summary of the characteristics of EERW trials included in the meta-analysis is presented in Table 1 and Table S1. Fourteen of the 15 studies were considered high-quality studies (having low bias; Table S2). Hydrocodone was evaluated in 4 trials; oxymorphone, oxycodone, buprenorphine and tapentadol in 2 trials each; and hydromorphone, morphine/naltrexone, and tramadol in 1 trial each. CLBP was evaluated in 10 studies, DPNP in 2 studies, OA in 2 studies, and 1 study evaluated a combination of CLBP and OA patients.

Table 1 Study design and subject disposition by study

Notes: aNumber of sites initiated. bConcomitant analgesics were not allowed during the dosed titration. The paper does not state anything about concomitant analgesics for the period following this.

Abbreviations: CLBP, chronic low back pain; DPNP, diabetic peripheral neuropathic pain; ER, extended release; OA, osteoarthritis; OLP, open label phase; RBTP, randomized blinded treatment phase.

Study design

All included studies were randomized, double-blind, placebo-controlled EERW studies as defined by the literature search inclusion criteria. All included studies used a parallel group design during the randomized double-blind treatment phase. In 13 of the 15 trials, patients were initially titrated to an individualized effective dose and then either allowed to continue their individualized dose or randomized to the placebo group during the randomized double-blind treatment phase. In 1 trial,14 all patients were titrated to the highest dose of the study drug and subsequently randomized to a high-dose group, a low-dose group, or the placebo group. In another trial,15 all patients were allowed to adjust the titrated dose after randomization for the first 4 weeks and then the dose was fixed for the next 8 weeks.

The open-label titration phase lasted between 2 and 8 weeks and the randomized double-blind treatment phase lasted 12 weeks for all studies (Table 1). Most studies made efforts to prevent or reduce discontinuation of patients randomized to the placebo group in the randomized double-blind treatment phase by allowing the use of rescue medication (12/15) and/or tapering the opioid in placebo patients (10/15; Table 1). All studies analyzed the intent-to-treat population for primary and secondary outcomes.

Efficacy

Primary endpoint: PI

With regard to primary endpoint measurements, the change from randomization baseline to week 12 was reported by 4 studies as the LSMD,14,1618 and by all other studies as the mean change (Table S1).15,1928 The effect of opioids was statistically significant (p<0.001) versus placebo for the change in PI score from randomization baseline to week 12 (SMD=−0.416; 95% CI: −0.521 to −0.312; Figure 2) as assessed by binary random-effects model meta-analysis using the restricted maximum likelihood method. Only 1 study15 did not report a statistically significant difference versus placebo for the mean change in PI from randomization baseline to week 12 (Figure 2); however, the change in area under the curve between study drug and placebo, which was the study’s primary endpoint, was statistically significant.

Figure 2 Change in PI from randomization baseline to week 12 with active study opioid drug versus placebo.

Notes: The standardized mean difference effect size was −0.416 and p<0.001, with a lower bound estimate of −0.521 and an upper bound −0.312.

Abbreviation: PI, pain intensity.

Other efficacy endpoints

Responder rates were reported in 12 manuscripts (Tables S3 and S4).1619,2228 However, 2 were excluded since they reported respondent analysis as increment in pain from baseline of the blinded period rather than reduction in pain from the baseline at the beginning of the open-label titration phase.26,27 A binary random-effects meta-analysis using the restricted maximum likelihood method demonstrated a statistically significant difference between study drug and placebo for both ≥30% (RD estimate [SE]: 0.166 [0.028], p<0.001) and ≥50% (0.137 [0.022], p<0.001) decrease from baseline in PI (Table 2; Figure 3). PGIC was reported in 5 manuscripts1618,23,25 (Tables S3 and S4) and meta-analysis combining patients “very much improved” and “much improved” showed a statistically significant difference between study drug and placebo in PGIC (RD estimate [SE]: 0.163 [0.029], p<0.001; Table 2). PGASM was assessed in 5 manuscripts,14,15,19,21,24 (Tables S3 and S4) and meta-analysis combining “excellent” and “very good” response showed a statistically significant difference between study drug and placebo (RD estimate [SE]: 0.194 [0.056], p<0.001; Table 2). Functional outcomes were reported in 5 manuscripts (Tables S3 and S4);18,22,25,27,28 however, a variety of assessment types were reported. Three manuscripts18,27,28 reported RMDQ (mean [SD] change from baseline to week 12; study drug vs placebo: 0.4 [4.83] vs 0.7 [5.32], −1.29 [4.98] vs −1.57 [4.82], and 0.6 [5.37] vs 1.2 [5.72]), 1 manuscript22 reported WOMAC (study drug vs placebo: 1.6 [18.0] vs 5.8 [16.8]), and 1 manuscript25 reported functional outcomes on the Brief Pain Inventory (BPI) scale (study drug vs placebo: −3.0 [2.07] vs −2.6 [2.38]) (Table S3). Due to a low number of manuscripts reporting functional outcome data and the different outcome measure used, no meta-analysis was performed. Of these 5 manuscripts reporting functional data, 2 showed a greater improvement in function in the study drug group compared to placebo.22,25 Quality of life data were reported in only 3 manuscripts16,18,25 (Tables S3 and S4); therefore, no meta-analysis was performed. Physical component summary values were greater for study drug than for placebo in all 3 manuscripts (10.11 vs 6.12, 0.1 vs −2.3, and 7.52 vs 3.62), while mental component summary values were greater for study drug versus placebo for 2 manuscripts16,25 (7.19 vs 3.34 and 0.20 vs −0.8; Table S3). No meta-analysis of rescue medication dose consumption was conducted due to insufficient data. The overall weighted mean (SD) of the percentage of patients who were randomized from the open-label titration phase was 63.2% (7.4). Data are presented for each manuscript in Table 1.

Table 2 Summary of secondary endpoints

Note: aValues are the risk difference (RD) estimates (SE).

Abbreviations: AE, adverse event; PGASM, patient global assessment of study medication; PGIC, patient global impression of pain; SE, standard error.

Figure 3 Percentage of patients with ≥30% or ≥50% improvement with active study drug versus placebo.

Notes: The graph shows the mean (SD) percent of patients with improvement, from each study that reported these data. A binary random-effects meta-analysis using the restricted maximum likelihood method was performed showing a statistically significant difference between active study drug and placebo for both ≥30% and ≥50%.

Safety endpoints

Reported AEs and SAEs post-randomization were similar between study drug and placebo in all studies (Table 3). The overall weighted mean discontinuation rate was numerically higher for placebo (42.1%) than study drug (31.0%), and was likely related to discontinuation due to lack of efficacy in the placebo group. There was a small but statistically significant difference in the percentage of patients who discontinued due to an AE in the study drug group versus the placebo group (RD estimate [SE]: 0.021 [0.008], p=0.011). The proportion of patients who discontinued due to SAEs was not included in this analysis because no manuscript reported it. The average rate of discontinuation due to opioid withdrawal was similar between study drug and placebo (Table 3).

Table 3 Summary of AEs

Notes: aOnly data for the 300 mg doses of tramadol were used in this meta-analysis.

Abbreviations: AE, adverse event; ND, no data; SAE, serious AE.

Discussion

The recent claims that opioids lack efficacy for chronic pain have created controversy among physicians, prescribers, regulators, scientists, and the general public regarding whether the benefits of opioid use outweigh the public health risks of abuse and other complications.2730 Chou et al state “evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving pain” based on the opinion that studies of ≤1 year duration do not provide evidence of “long-term” efficacy.4 Clearly if there is no benefit then no amount of risk should be tolerated. This review was, therefore, performed in order to gather together the key evidence to facilitate understanding opioid efficacy within the paradigm of FDA studies required for approval, and to perform a meta-analysis in order to quantify opioid efficacy for chronic pain and assess consistency of effects across studies conducted for ≥3 months’ duration. This meta-analysis was limited to EERW-designed studies, since this design is by far the most commonly utilized for regulatory approval and therefore supports combinability.

Several systematic reviews and meta-analyses regarding the efficacy of opioids in chronic pain have been published; however, these studies were published nearly a decade ago4,3133 and the more recent ones are not meta-analyses.4,34,35 Additionally, many studies included in previous reviews are not relevant to our study because they report alternate routes of administration (eg, intravenous),4 have short study durations,31,36 are open-label32,34 or observational studies,35 have restricted pain types,33,36 or compare different study designs.31,33,36 Although most of these meta-analyses concluded that opioids were efficacious for the treatment of chronic non-cancer pain,3134,36 a review specifically focused on studies designed for FDA approval (ie, of ≥3 months’ duration) for chronic pain has not been done.

The EERW design provides an opportunity to evaluate both “effectiveness” (outcomes in the open-label titration phase) and “efficacy” (outcomes in the randomized, double-blind, placebo-controlled phase). The present meta-analysis demonstrated the “effectiveness” of opioids since a majority of patients (63%) demonstrated a clinically meaningful response. The pharmacological efficacy of opioids for the treatment of chronic pain was evidenced by statistically significant differences between study drug and placebo in change in pain score from randomization to week 12 and in response rates.

With regard to secondary endpoints, opioids were found to marginally improve physical function in the present meta-analysis. Therefore, the use of opioids alone to improve physical function is not supported by this review; whether opioids improve the effectiveness of rehabilitative treatments for chronic pain requires further study. Opioids did not have an appreciable positive or negative effect on mood. The PGASM measure allows subjects to aggregate multiple aspects of their experience, including pain relief, improvement in physical and emotional function, side effects, and convenience, into a single measure.37 In the present meta-analysis, these measures were congruent with the primary finding that opioids are efficacious for the treatment of chronic non-cancer pain. However, it is worth noting that the forest plot (Figure 2) showed that the efficacy estimates appear heterogeneous across studies. While the reasons for this are not certain, possible reasons include differences in study design methodology, inclusion and exclusion criteria, statistical analyses, concomitant and rescue medications, dosing, and numerous other factors.

It is worth noting that AE rates in the double-blind periods were similar between study drug and placebo, with dropouts due to AEs being higher in the drug group while dropouts due to loss of efficacy were higher in the placebo group. However, because patients with significant tolerability issues during the open-label titration phase are deliberately excluded from the randomized double-blind treatment phase, AE rates in the randomized double-blind treatment phase of EERW studies do not represent rates that would occur in prospective parallel clinical trials;38 however, AE rates may be more reflective of ongoing AE rates in clinical practice, where, like in the EERW designs, patients with poor tolerability or efficacy are taken off treatment with opioids relatively early after a trial of therapy.

In a recent meta-analysis evaluating the efficacy of opioids for CLBP, the authors concluded that opioids provided “moderate short-term relief” but the effect is not clinically important.39 In that meta-analysis, Shaheed et al define “clinically important” arbitrarily as a group mean difference in pain or disability >20 points on a 0–100 scale,39 while clinical importance is more usefully viewed as a multidimensional concept that encompasses multiple factors including efficacy, safety, and availability of other treatments.40 It is worth noting that the efficacy of opioids is at least as large as that of any other treatment for chronic pain.38 Thus, requiring a group mean difference of 20 points on a 0–100 pain scale would lead to a nihilistic conclusion that no pharmacological treatments for chronic pain are useful.While the effectiveness of existing treatments for chronic pain leaves plenty of room for improvement, and considering that only a small minority of patients do not experience clinically meaningful treatment responses, discarding entirely all analgesics approved for chronic pain contradicts numerous treatment guidelines, international treatment guidelines, widespread patient experience, and the FDA approval process.

These authors, as well as others,4 defined a 12-week treatment period as “short-term.” While 3 months is indeed short in comparison to the years patients may use opioid treatment for chronic pain, 3-month treatment periods are considered the regulatory standard for assessing long-term efficacy of a treatment in placebo-controlled clinical trials of chronic conditions.41 Indeed, the efficacy of all major drug and nondrug therapies for chronic pain is based on a similar body of evidence (ie, the number of studies and duration of those studies are similar for all chronic pain treatments).42 Thus, the body of evidence for the efficacy of opioids is similar in terms of duration of studies to that for other approved classes of analgesics.42

The 3-month trial duration is not entirely arbitrary: beyond several months, the internal validity of clinical trials tends to degrade due to dropouts, addition of concomitant treatments (permitted or not), noncompliance with treatment, and other factors. While it is desirable in theory to conduct prospective studies of longer duration, so that important complications that take time can emerge, and the durability of efficacy can be directly observed, the feasibility of and the technical requirements for such studies have not yet been addressed. Finally, the inclusion of EERW studies in our meta-analysis allows a richer interpretation of “long-term” efficacy: the EERW design is utilized to assess the efficacy of treatment that has been administered for potentially lengthy periods of time prior to randomization. This design, also called the randomized discontinuation design, has been used in multiple therapeutic areas where it is important to determine whether patients responding to long-term open-label treatment are, in fact, responding to the pharmacological effects of the drug, or just the non-specific effects of treatment (such as the placebo response). Such studies have been performed for decades in oncology,43 depression,44 rheumatoid arthritis,45 cardiology,46 schizophrenia,47 and numerous other indications.48 Therefore, the superiority after randomization of active treatment over placebo among patients who have already demonstrated a longstanding response to open-label medication can be interpreted as long-term efficacy that is not due to a placebo effect or other non-specific factors.

Many of these products have also undergone long-term open-label extension studies to provide information on the durability of treatment responses achieved during the randomized controlled trials; we did not examine these studies in this review; however they generally demonstrate that PI reductions in patients studied in randomized controlled trials remain durable for extended periods.4963

This meta-analysis has several limitations. First, it only included EERW studies, therefore only included results from patients who responded to opioids during the open-label titration phase. The pros and cons of the EERW design are beyond the scope of this review, and have been amply reviewed elsewhere.41,64,65 To summarize, the advantages of the EERW study design are that it is accepted by the FDA for registration of drug treatments,41 can minimize the amount of time subjects receive ineffective or poorly tolerated treatment, may offer improved assay sensitivity, and yields open-label data that may be more relevant to clinical practice than only double-blind data. Another advantage of the EERW design is that the open-label titration phase of typical EERW studies mimics clinical practice with individual titration to optimized doses, an important design feature for medications with high inter-patient variability in optimal dose and a relatively narrow therapeutic index.41 Perceived disadvantages to the EERW design include questions about generalizability of both efficacy and AE data, challenges in comparing outcomes to standard prospective parallel treatment designs, and more complex interpretation.41,64,66 An additional limitation of note is that most of the studies included in the meta-analysis focus on CLBP, which has been a frequently used model of chronic pain because of the prevalence of the condition, and hence, the practicality of conducting clinical trials.

Many of the manuscripts screened in the present analysis failed to report critical information. This necessitated requesting data from manuscript authors, a cumbersome and time-consuming process. We recommend that journals continue to refine and require minimum quality standards for proper interpretation and ease of use in meta-analyses.65 Initiatives like CONSORT (http://www.consort-statement.org/) and the EQUATOR network (http://www.equator-network.org/) have been put in place to foster adequate reporting of randomized controlled trials.

Acknowledgments

The authors would like to thank Gaelen Adam for her assistance with the literature search and Bryant Smith for teaching the authors how to use several software programs that made this meta-analysis possible. The authors would also like to thank Dr. Steven Ripa, Dr. Peter Schmidt, Mary Ma, and Linda Noa for providing missing data from studies used in this meta-analysis, and Joseph Lau for his constructive review of the manuscript. This meta-analysis used methods and software tools developed by The Center for Evidence Synthesis in Health at Brown University. Support for this research was partially provided by Analgesic Solutions and partially by the Opioid Post-Marketing Requirement Consortium (OPC), an industry working group composed of pharmaceutical companies that hold an approved New Drug Application for extended release/long-acting opioids working together at FDA’s request to conduct certain post-market required studies. The OPC includes Allergan, Plc, BioDelivery Systems International, Inc., Collegium Pharmaceuticals, Inc., Daiichi Sankyo, Inc., Depomed, Inc., Egalet Corporation, Endo Pharmaceuticals Inc., Janssen Pharmaceuticals Inc., Mallinckrodt, Inc., Pernix Therapeutics Holdings, Inc., Pfizer Inc., Purdue Pharma, L. P., and West-Ward Pharmaceuticals Corp. Current affiliation for Diana S Meske is Collegium Pharmaceutical Inc, Canton, MA, USA.

Disclosure

Nathaniel Katz has acted as a consultant for Allergan, Plc, Collegium Pharmaceuticals, Inc., Depomed, Inc., Egalet Corporation, Endo Pharmaceuticals Inc., Janssen Pharmaceuticals, Inc., Mallinckrodt, Inc., Pfizer Inc., and Purdue Pharma, L. P. Diana S Meske was employed by Analagesic Solutions when the work was completed for this manuscript, however at the time of publication she was employed by Collegium Pharmaceutical Inc. The authors report no other conflicts of interest in this work.

 

The potential legal consequences could be substantial

AMA welcomes CDC’s revised view on opioids guidelines

“The AMA appreciates that the CDC recognizes that patients in pain require individualized care and that the agency’s 2016 guidelines on opioids have been widely misapplied. The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients.

I have stated many times before that it would appear that many practitioners and healthcare corporations have decided that they had a favorite sentence, paragraph or page out of the 90 odd pages of the CDC opiate dosing guidelines and they used that verbiage to profess that they were following the CDC guidelines.

Just whose responsibility is it for these guidelines being widely mis-applied ?  Was it the DEA going from office to office admonishing prescribers about not adhering to these guidelines… I have heard quotes of DEA agents going into a practice and telling the prescriber that the prescriber’s pts were not being weaned FAST ENOUGH and another statement that a prescriber was told that the prescriber would not “look good in orange”.

Could the legal dept of many of these healthcare corporations have taken the position to CYA the corporation and thus suggesting to whatever part of the corporation would believe that they have the authority to create corporate policies and procedures to mandate how – or if – pts with pain are treated ?

Let’s consider some hypotheticals , could the misapplication of the guidelines be consider MALPRACTICE ?

Could the using of these opiate dosing conversion programs that all have same/similar foot notes warning that the results produced by these prgms are CRUDE ESTIMATES AT BEST and not to be used as black/white answers… but as a starting point to titrate the pt’s pain management meds to optimize the pt’s pain management an quality of life. In fact here are some parts of the CDC guidelines that appear to reinforce this:

Here is four quotes from the CDC opiates guidelines:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”

“Clinicians should consider the circumstances and unique needs of each patient when providing care.”

“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

What if a spouse has committed suicide because of having their pain medication reduced or taken away because of the misapplication of the CDC guidelines ?  I made this post a few years back

Since I am not an attorney…. these hypotheticals could just be scratching the surface of the total number of potential legal/financial liabilities, it could all depend if it is a independent practitioner or a healthcare corporation. The first there could be several dozens of pts involved while the latter could there could be hundreds or thousands of pts involved.  Of course, law firms will probably go after the deeper pockets and the most pts being harm first.

 

 

Rocky Care at For-Profit Rehab

Rocky Care at For-Profit Rehab

https://www.medpagetoday.com/publichealthpolicy/ethics/79403

In the midst of the opioid crisis, drug rehabilitation and treatment facilities might be more popular than ever. Mother Jones conducted a 5-month investigation into American Addiction Centers (the only such chain that’s publicly traded) to highlight the for-profit rehab ecosystem in the U.S.

Mother Jones found myriad problems with the company’s business model and outcomes, portraying it as a money-making machine that failed its patients with allegations of neglect and death. It’s now facing multiple lawsuits.

One instance: Cody Arbuckle, a 23-year-old man, was living in an AAC “therapeutic recovery home” when he died from an Imodium overdose, a coroner determined. Police reports and a lawsuit allege that staff at the facility didn’t check on Arbuckle for hours. The lawsuit also claims that call center representatives, who received a commission until last summer, routinely lied to potential patients about facilities and treatment, even promising one-on-one time with a doctor when, in fact, patients wouldn’t see one at all. Arbuckle’s is just one of many patient deaths Mother Jones found at AAC facilities. AAC said its mortality rate was lower than the industry average but didn’t provide numbers.

AAC’s CEO, Michael Cartwright, said it was “a lie” that patients weren’t looked after.

Fox News Report About Harms to CPP’S due to CDC Guideline

Fox News Report About Harms to CPP’S due to CDC Guideline

According to event organizers Thursday’s gala raised approximately $80,000 to help fight for change to the opioid crisis

A local foundation aims to curb the opioid crisis

https://abc57.com/news/a-local-foundation-aims-to-curb-the-opioid-crisis

SOUTH BEND, Ind – The 525 Foundation held its annual gala on Thursday to bring awareness and help change the opioid crisis.

“We are here to remember Nick and Jack and the thousands of others who unknowingly dying at hands of prescription drugs,” 525 Foundation gala emcee Maureen McFadden said.

The foundation was formed in 2016 a year after Mike and Becky Savage lost their sons due to opioid use at a graduation party.

525 Foundation Co-founder Becky Savage explained the tragic events.

“The 525 foundation started about three years ago, it was about a year after we lost our sons from prescription drug misuse they were at a graduation party where they decided to participate in experimentation of prescription medication about a year later we thought you know what we should take their story and use their story to help other people so that this doesn’t happen to somebody else,” Savage said.

There were over 300 people in attendance at Thursday’s gala.

Former NFL Quarterback Terry Bradshaw attended and explained how he heard about the foundation and its message to children.

“It’s a message that has to be told and it has to be told and told and told we have to constantly remind our children of the danger of drugs,” Bradshaw said.

One of the foundations efforts is putting drug drop-off boxes in elect Martin’s to help get prescription pills off the streets

“525 makes, I think it should make everyone realize that the opioid epidemic attacks everyone in our community,” St. Joseph County Prosecutor Ken Cotter said.

According to event organizers Thursday’s gala raised approximately $80,000 to help fight for change to the opioid crisis

It is reported that we currently spend 81 billion/yr in fighting the war on drugs…  The amount that this gala raised would be about what we now spend every ONE-HALF SECOND in fighting the war on drugs.  That $80,000 would purchase the abstinence medication Vivitrol to treat 4-5 substance abusers for ONE YEAR.

I wonder if these two teenagers had gotten into the liquor cabinet at the house where the graduation party was held and had died of alcohol toxicity or drove home in a drunken state and had a accident that killed both of them… if their parents would have created a  foundation to help change alcoholism that kills about 100,000 people every year ?

No mention of the person(s) who brought the drugs to the party…  NO CONSEQUENCES ?

I feel sorry about their loss, but personal responsibility should be a primary concern and the consequences for a person’s lack of personal responsibility is not something that our society can change, no matter how much many wish that we could.

 

No Shortcuts to Safer Opioid Prescribing

No Shortcuts to Safer Opioid Prescribing

https://www.nejm.org/doi/full/10.1056/NEJMp1904190

Since the Centers for Disease Control and Prevention (CDC) released its Guideline for Prescribing Opioids for Chronic Pain in 2016,1 the medical and health policy communities have largely embraced its recommendations. A majority of state Medicaid agencies reported having implemented the guideline in fee-for-service programs by 2018, and several states passed legislation to increase access to nonopioid pain treatments.2 Although outpatient opioid prescribing had been declining since 2012, accelerated decreases — including in high-risk prescribing — followed the guideline’s release.2,3 Indeed, guideline uptake has been rapid. Difficulties faced by clinicians in prescribing opioids safely and effectively, growing awareness of opioid-associated risks, and a public health imperative to address opioid overdose underscored the need for guidance and probably facilitated uptake. Furthermore, the guideline was rated as high quality by the ECRI Guidelines Trust Scorecard. In addition, the CDC (including the authors of this Perspective, who were also authors of the Guideline) engaged clinicians, health systems leaders, payers, and other decision makers in discussions of the guideline’s intent and provided clinical tools, including a mobile application and training, to facilitate appropriate implementation.4

Efforts to implement prescribing recommendations to reduce opioid-related harms are laudable. Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies,5 which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice. The panel also noted the potential for misapplication of the recommendations to populations outside the scope of the guideline. Such misapplication has been reported for patients with pain associated with cancer,5 surgical procedures,5 or acute sickle cell crises. There have also been reports of misapplication of the guideline’s dosage thresholds to opioid agonists for treatment of opioid use disorder. Such actions are likely to result in harm to patients.

We need better evidence in order to evaluate the benefits and harms of clinical decisions regarding opioid prescribing, including when and how to reduce high-dose opioids in patients receiving them long term. The CDC developed the guideline on the basis of the best available evidence, with input from a multidisciplinary group that included experts in pain management as well as representatives of patients and the public. In situations for which the evidence is limited, it is particularly important not to extend implementation beyond the guideline’s statements and intent. And yet in some cases, the guideline has been misimplemented in this way.

For example, the guideline states that “Clinicians should…avoid increasing dosage to ≥90 MME [morphine milligram equivalents]/day or carefully justify a decision to titrate dosage to ≥90 MME/day.”1 This statement does not address or suggest discontinuation of opioids already prescribed at higher dosages, yet it has been used to justify abruptly stopping opioid prescriptions or coverage.5 This recommendation also does not apply to dosing for medication-assisted treatment for opioid use disorder. The CDC based the recommendation on evidence of dose-dependent harms of opioids and the lack of evidence that higher dosages confer long-term benefits for pain relief. However, we know little about the benefits and harms of reducing high dosages of opioids in patients who are physically dependent on them.

Patients who are able to successfully taper their opioid use are likely to have a lower risk of overdose, and evidence is accumulating that they might experience reduced pain.4 Other patients may find tapering challenging; could face risks related to withdrawal symptoms, increased pain, or unrecognized opioid use disorder; and if their dosages are abruptly tapered may seek other sources of opioids or have adverse psychological and physical outcomes. Policies should allow clinicians to account for each patient’s unique circumstances in making clinical decisions.

The guideline offers guidance for caring for patients who are already taking opioid dosages of 90 MME or more per day long term, including guidance on when tapering the dose might be appropriate, the importance of empathetically reviewing risks associated with continuing high-dose opioids, collaborating with patients who agree to taper their dose, maximizing nonopioid treatment, and tapering slowly enough to minimize withdrawal symptoms. Patients exposed to high dosages for years may need slower tapers (e.g., 10% per month, though the pace of tapering may be individualized).1 Success might require months to years. Though some situations, such as the aftermath of an overdose, may necessitate rapid tapers, the guideline does not support stopping opioid use abruptly.1

Guidelines can improve patient outcomes when they lead to policies that reduce harm, while offering support and coverage for underused services (e.g., nonpharmacologic strategies, naloxone coprescribing, and treatment for opioid use disorder). However, policies invoking the opioid-prescribing guideline that do not actually reflect its content and nuances can be used to justify actions contrary to the guideline’s intent. The CDC has engaged quality-improvement organizations, payers, federal partners, state health departments, and others in discussions to encourage adherence to recommendations while avoiding actions that might cause harm. For example, the CDC worked with the American Society of Addiction Medicine to clarify that dosage thresholds in the guideline should not direct dosing of medication-assisted treatment for opioid use disorder.

Even guideline-concordant care can be challenging. Implementing recommendations with individual patients takes time and effort. An unintended consequence of expecting clinicians to mitigate risks of high-dose opioids is that rather than caring for patients receiving high dosages or engaging and supporting patients in efforts to taper their dosage, some clinicians may find it easier to refer or dismiss patients from care. Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks. Such actions disregard messages emphasized in the guideline that clinicians should not dismiss patients from care, which can adversely affect patient safety, could represent patient abandonment, and can result in missed opportunities to provide potentially lifesaving information and treatment.1

Effective implementation of the guideline requires recognition that there are no shortcuts to safer opioid prescribing (which includes assessment of benefits and risks, patient education, and risk mitigation) or to appropriate and safe reduction or discontinuation of opioid use. Starting fewer patients on opioid treatment and not escalating to high dosages in the first place will reduce the numbers of patients prescribed high dosages in the long term. In the meantime, clinicians can maximize use of nonopioid treatments, review with patients the benefits and risks of continuing opioid treatment, provide interested and motivated patients with support to slowly taper opioid dosages, closely monitor and mitigate overdose risk for patients who continue to take high-dose opioids, and offer or arrange medication-assisted treatment when opioid use disorder is identified. The CDC offers several tools to assist, including a pocket guide on tapering, a mobile app and online training with motivational interviewing components, and information about nonopioid treatments for pain.4 We are also working to identify ways to integrate recommendations into medical education and to support best practices among the next generation of medical professionals.

Appropriate implementation of the guideline includes maximizing use of physical, psychological, and multimodal pain treatments. However, these therapies have not been used, available, or reimbursed sufficiently. The CDC has supported research to better define the evidence and coverage gaps for nonopioid pain treatments and has articulated the need to improve insurance coverage.2,4 Efforts to support more judicious opioid use will become more successful as effective nonopioid treatments are increasingly available and used.

The CDC is evaluating the (intended and unintended) impact of the guideline and other health system strategies on clinician and patient outcomes and is committed to updating recommendations when new evidence is available. The CDC is funding the Agency for Healthcare Research and Quality to conduct systematic reviews on the effectiveness of opioid, nonopioid pharmacologic, and nonpharmacologic treatments for acute and chronic pain. Results of these reviews will assist in identifying research priorities and determining when evidence gaps are sufficiently addressed to warrant a guideline update or expansion. Until then, we encourage implementation of recommendations consistent with the guideline’s intent.

AMA welcomes CDC’s revised view on opioids guidelines

AMA welcomes CDC’s revised view on opioids guidelines

https://www.ama-assn.org/press-center/ama-statements/ama-welcomes-cdc-s-revised-view-opioids-guidelines

Statement attributable to 
Patrice A. Harris, M.D.
President-elect of the American Medical Association
Chair, AMA Opioid Task Force

“The AMA appreciates that the CDC recognizes that patients in pain require individualized care and that the agency’s 2016 guidelines on opioids have been widely misapplied. The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients.

“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.

“The AMA continues to urge physicians to make judicious and informed prescribing decisions to reduce the risk of opioid-related harms. Physicians began taking steps to reduce opioid prescribing even before the CDC released its guidelines. There has been a 22 percent nationwide decrease in prescription opioid prescriptions between 2013 and 2017, and indicators point to continued decreases.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs to ensure that patients have affordable, timely access to medically appropriate treatment, pharmacologic and non-pharmacologic. The nation’s physicians will work with CDC so our patients receive comprehensive, multidisciplinary, multimodal pain care based on medical science and effective clinical practice.”

###

Editor’s note: The AMA Opioid Task Force is chaired by AMA President-elect Patrice A. Harris, M.D., M.A. The AMA convened more than 25 national, state, specialty and other health care associations in 2014 to form the AMA Opioid Task Force to coordinate efforts within organized medicine to help end the nation’s opioid epidemic. Additional information on the AMA Opioid Task Force is available here. Real-time updates on the AMA’s work on opioids is accessible here.

The Stigma and Social Consequences of Chronic Pain: A Patient’s Story

Karen Smith describes her personal experience with Chronic Pain