Study Finds Antidepressants Make Tramadol Less Effective for Pain Relief

By Pat Anson, PNN Editor

Common antidepressants interact with the opioid medication tramadol to make it less effective for pain relief, according to a small new study from University Hospitals (UH) in Cleveland. The findings suggest that some patients who exceed their prescribed dose of tramadol may be under-medicated and are seeking more effective pain relief.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have increased in recent years because it is widely perceived as a “safer” opioid with less rick of addiction. Many patients, however, say tramadol is not as effective as hydrocodone, oxycodone and other opioids.  

UH researchers reviewed the prescription records of 152 patients who received tramadol for at least 24 hours.

Those patients who were also taking the antidepressants Prozac (fluoxetine), Paxil (paroxetine) or Wellbutrin (bupropion) required three times more tramadol per day to control their breakthrough pain, compared to patients not taking the antidepressants.

Previous studies on healthy volunteers have shown effects on blood levels when combining tramadol with those particular antidepressants. However, this was the first study to document the effects of this interaction in a real-world setting with pain patients.

"We knew that there was a theoretical problem, but we didn't know what it meant as far as what's happening to pain control for patients," said Derek Frost, PharmD, a UH pharmacist and lead author of the study, which was published in the journal Pharmacotherapy.

Frost says millions of Americans may be suffering the ill effects of this drug-to-drug interaction.

"Tramadol relies on activation of the CYP2D6 enzyme to give you that pain control," Frost said. "This enzyme can be inhibited by medications that are strong CYP2D6 inhibitors, such as fluoxetine, paroxetine and bupropion.

“Many chronic pain patients are taking antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs), which many of these CYP2D6 inhibitors fit into. There are a lot of patients who experience both, unfortunately. The likelihood that somebody on one of these offending agents and tramadol is relatively high."

Frost says the problem has a relatively easy fix.

"We have a lot of other antidepressants available that are in the same class of medication that don't inhibit this particular enzyme, such as Zoloft (sertraline), (Celexa) citalopram and Lexapro (escitalopram)," he said. "You also have other options for pain control - non-opioid medications such as NSAIDs. If we need to use opioids, a scheduled morphine or a scheduled oxycodone would avoid this interaction."

Tramadol is a synthetic opioid that was rescheduled by the Drug Enforcement Administration in 2014 as a Schedule IV controlled substance, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse. Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

American Pain Society Files for Bankruptcy

By Pat Anson, PNN Editor

The American Pain Society (APS) filed for bankruptcy Friday after an overwhelming vote by its members to dissolve the financially troubled medical organization. In a membership vote last month, 93% voted in favor of a recommendation by the APS board of directors to file a voluntary petition for Chapter 7 bankruptcy.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS was targeted as a defendant by Simmons Hanly Conroy and several other law firms seeking to recover billions of dollars in damages in opioid litigation cases.

In a press release, APS said efforts to resolve the “meritless” lawsuits without lengthy and expensive litigation were unsuccessful.

“It’s the perfect storm and now pointless to continue operations just to defend against superfluous lawsuits.  Our resources are being diverted to paying staff to comply with subpoenas and other requests for information and for payment of legal fees instead of funding research grants, sponsoring pain education programs, and public policy advocacy,” APS President William Maixner, DDS, said in a statement.

“As a result, the Board of Directors no longer believes APS can continue to fulfill its mission and meet the needs of our members and the pain care community.”

Press coverage of the APS often parroted what the opioid lawsuits alleged. The Guardian, for example, called the APS a “pawn of big pharma” and claimed the organization “pushed doctors to prescribe painkillers.”

The Guardian’s coverage was based largely on a report by Sen. Claire McCaskill (D-MO), who accepted over $400,000 in campaign donations from Simmons Hanly in her failed bid for re-election in 2018. APS is named as a defendant in several opioid lawsuits filed by Simmons Hanly, which stands to make hundreds of millions of dollars in contingency fees if the lawsuits are successful. The Guardian failed to mention any connection between Simmons Hanly and McCaskill.

The APS’ bankruptcy filing likely brings an end to its monthly publication, The Journal of Pain, which has been rated among the top five scientific journals in pain science. The current issue features research articles on diverse topics such as meditation for low back pain, diagnostic codes for fibromyalgia, whether opioids are effective for chronic noncancer pain, and the use of virtual reality to relieve arm pain.

“APS has been advocating for increased investment in research for many years, and it is particularly ironic that APS’s voice will go silent at this critical time in our history, when increased investment in pain research has finally become a reality in an effort to combat the opioid crisis,” said Roger Fillingim, PhD, an APS past president and professor of psychology at the University of Florida School of Dentistry.  

“There is a sad irony that the professional organization best poised to provide the spectrum of science to improve the prevention and treatment of pain and related substance abuse is defunct,” said APS President-elect Gary Walco, PhD, director of pain medicine at Seattle Children’s Hospital.

“Now, more than ever, our nation needs the collective efforts of leading scientists and clinicians who hold patients’ well-being at the highest premium.  The principal focus on punishing those in industry that may have contributed to the problem is shortsighted and far from sufficient.”

The APS is the second professional pain management organization to cease operations this year. In February, the Academy of Integrative Pain Management (AIPM) also shutdown. Opioid litigation has not only been costly for APS and AIPM, it has contributed to steep declines in financial support from pharmaceutical companies for other pain organizations, medical conferences and patient advocacy groups.   

How Opioid Critics and Law Firms Profit From Litigation

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has long been known as one of the most strident critics of opioid prescribing. The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) has claimed that drug makers and a web of industry-funded groups are to blame for the nation’s addiction and overdose crisis.

Kolodny has accused the so-called “opioid lobby” of undermining the CDC opioid guideline, claimed pain patients are being “effectively manipulated” by drug makers, and called the American Cancer Society a “shady organization” because it accepts outside funding. 

Kolodny even spoke about an “opioid mafia” as he testified as an expert witness in Oklahoma’s opioid lawsuit against Johnson & Johnson.

“We’ve seen Johnson & Johnson promote opioids in this unbranded campaign, funding front groups, patient groups meant to look like grassroots organizations that promoted opioids, funding professional groups that were promoting opioids,” Kolodny testified.  

“We know that Johnson & Johnson participated in the Pain Care Forum, a group that I have referred to as the opioid mafia, working to protect their stake in the opium supply into the United States.”

Kolodny’s hyperbole is catnip to compliant reporters who can usually count on him to return their calls and provide a good quote.  A psychiatrist and former chief medical officer for the addiction treatment chain Phoenix House, Kolodny is the go-to source for many news organizations covering the opioid crisis. He now co-directs an opioid research program at Brandeis University that is funded by a federal grant.

Kolodny’s has long maintained that he is free of any conflicts of interest and that PROP has never accepted funding from the pharmaceutical industry.

“I don’t believe physicians should be helping drug companies market their products,” he testified in Oklahoma. “It’s very easy to fool yourself when it’s profitable to fool yourself.”

Lawyers for Johnson & Johnson have opened a window into a profitable sideline Kolodny has as a paid consultant and expert witness for law firms involved in opioid litigation.

Kolodny stands to make upwards of half a million dollars working for the law firm of Nix Patterson & Roach, one of three outside law firms hired by Oklahoma Attorney General Mike Hunter to handle the case against Johnson & Johnson.

“It’s very easy to fool yourself when it’s profitable to fool yourself.”

— Dr. Andrew Kolodny

Kolodny testified that he’s being paid $725 an hour by Nix Patterson and could collect up to $500,000 for his services – possibly even more, depending on the length of the Oklahoma trial. Under questioning, Kolodny also acknowledged that he was paid $725 an hour as a consultant for at least one other law firm involved in opioid litigation.

“I don’t think it should be a secret that I’m being compensated,” Koldony said, adding that he worked for Nix Patterson about ten hours a week before the trial started and 40 hours a week since it began four weeks ago. At his hourly rate, Kolodny’s weekly pay would be $29,000.

Nix Patterson can easily afford to pay Kolodny. According to the terms of their contingency agreement with Oklahoma, the three law firms stand to collect up to 25% of any damages and penalties. With $17.5 billion being sought from Johnson & Johnson, Nix Patterson’s share could theoretically add up to nearly $2.5 billion. 

Purdue Pharma and Teva Pharmaceuticals have already settled out-of-court with Oklahoma for far less — $270 million and $85 million respectively.  Nix Patterson’s share of the Purdue settlement alone was $31.6 million.

Compensation Not Disclosed

Koldony’s work as a paid witness in opioid litigation is not disclosed on Brandeis University’s website, PROP’s website or on the website of the Steve Rummler Hope Network, a non-profit that is the “fiscal sponsor” of PROP.  

A non-profit fiscal sponsorship is an IRS loophole that allows the Rummler Hope Network to collect tax deductible donations on PROP’s behalf — even though PROP is not a registered charity. The identity of PROP’s donors and the size of their donations have never been disclosed.

Kolodny serves on the medical advisory committee of the Rummler Hope Network, along with PROP President Jane Ballantyne, MD. Coincidentally, Ballantyne worked as a paid consultant for Cohen Milstein Sellers & Toll – another law firm involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois.

(Editor’s note: In an earlier version of this article, PNN incorrectly reported that Kolodny’s work in opioid litigation was not properly disclosed in two 2017 articles published by the Journal of the American Medical Association (JAMA). Kolodny’s work in opioid litigation apparently didn’t begin until after those articles were published and was disclosed in an April 2018 JAMA article. PNN regrets the error.

On September 4, 2019 Kolodny changed two of his JAMA disclosure statements to include his work as a paid expert in malpractice lawsuits. “I received compensation for work as an expert in malpractice litigation involving opioid prescribing. When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”)

Kolodny testified in the Oklahoma trial that he also did some consulting for attorney Linda Singer at Cohen Milstein, which The New York Times profiled in 2014 as a politically influential law firm that was laying the groundwork for opioid lawsuits around the country. Singer was the lead outside counsel for the City of Chicago and Santa Clara County, California, two of the first jurisdictions to file opioid lawsuits.

“The lawsuits follow a pattern: Private lawyers, who scour the news media and public records looking for potential cases in which a state or its consumers have been harmed, approach attorneys general. The attorneys general hire the private firms to do the necessary work, with the understanding that the firms will front most of the cost of the investigation and the litigation. The firms take a fee, typically 20 percent, and the state takes the rest of any money won from the defendants,” the Times reported.

Singer left Cohen Milstein in 2017 to join Motley Rice, yet another law firm that specializes in healthcare litigation. PNN was unable to verify whether Kolodny was still on the payroll of Cohen Milstein, Motley Rice or any other law firms. He refused to discuss his work in opioid litigation.

“I’m not interested in answering any questions or talking to you,” Kolodny told this reporter.

PharmedOUT’s Paid Expert Witness

Another vocal critic of opioid prescribing is Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University Medical Center that seeks to expose deceptive marketing practices in the healthcare industry.

In a recent column in STAT News, Fugh-Berman and two of her grad students echoed many of Kolodony’s complaints about opioid manufacturers — claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were eroding public health.   

“The eerily similar attacks on the guideline… raise the question of whether this is a coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline,” they wrote. “There’s certainly a credible motive for opioid manufacturers to do this: The CDC guideline is an effective, evidence-based tool that has helped decrease inappropriate and dangerous prescribing of opioids for chronic pain patients.”

DR. ADRIANE FUGH-BERMAN

Unlike Kolodny, Fugh-Berman does disclose on PharmedOUT’s website that she is “a paid expert witness.” It is not disclosed, however, which law firms Fugh-Berman works for, what cases she is working on, or how much she is paid.

After initially agreeing to a telephone interview with PNN, Fugh-Berman abruptly cancelled. She did answer a few questions by email.

“I am a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices, including litigation brought by several states and cities against opioid manufacturers.  My expert witness work has been disclosed to Georgetown, in my publications, and on our website,” Fugh-Berman wrote.

(Update: In testimony in California on August 15, 2019, Fugh-Berman said she billed $500 an hour for her testimony in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case to date.)

Like PROP, PharmedOUT does not disclose it donors, which Fugh-Berman calls “a common practice.”

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said.

Fugh-Berman did disclose that Kaiser Permanente sponsored PharmedOUT’s recent opioid conference, which featured a speech by Kolodny entitled “How the Opioid Lobby Protected the Status Quo” and a talk by a Kaiser doctor on “How Kaiser Permanente Promotes Rational Prescribing.”  

Lobbying and Campaign Donations

Law firms involved in opioid litigation have played a significant role in some political campaigns and in shaping news coverage of the opioid crisis. The national firm of Simmons Hanly Conroy — which claims to have “effectively invented large-scale, multi-defendant opioid litigation” — represents dozens of states, counties and cities that are suing drug companies. According to reports, Simmons Hanly’s contingency fee will be as high as one-third of the proceeds from opioid settlements.

In the 2018 congressional election, Simmons Hanly spent nearly $1.2 million on lobbying and donated over $1 million to candidates, according to OpenSecrets.org. Missouri Sen. Claire McCaskill (D) received five times more than any other candidate — nearly $410,000 — from donors affiliated with Simmons Hanly.

In February of that year, McCaskill released a report that was sharply critical of physician and patient advocacy groups for accepting money from opioid manufacturers. At least two organizations cited in the McCaskill report — the American Academy of Pain Medicine and the American Pain Society (APS) — are named as defendants in opioid lawsuits filed by Simmons Hanly. The APS recently filed for bankruptcy, citing the high cost of defending itself against “meritless” law suits.

The report made headlines for McCaskill, who ultimately lost her bid for re-election, but continues to make news today — most recently in the STAT news column written by paid expert witness Dr. Fugh-Berman.

With the Oklahoma trial now heading into its fifth week, enormous amounts of money are at stake. A verdict against Johnson & Johnson could lead to a cascade of settlements in hundreds of other opioid lawsuits that could cost the pharmaceutical industry up to $50 billion. States, cities and counties would certainly benefit from a settlement of that size. So would the law firms that represent them – and their paid witnesses.

U.S. Pain Foundation Founder Pleads Guilty to Fraud and Tax Evasion

By Pat Anson, PNN Editor

Paul Gileno, the former CEO and founder of the U.S. Pain Foundation, has pleaded guilty to fraud and tax evasion charges stemming from his misuse of funds from the Connecticut-based non-profit.

Gileno, 46, waived his right to be indicted and pleaded guilty Monday before U.S. District Judge Victor Bolden in Bridgeport, Connecticut. He faces up to 25 years in prison, but as part of the plea agreement prosecutors agreed to ask for a lesser sentence because of Gileno’s “prompt recognition and affirmative acceptance of personal responsibility.” A sentencing date has not been set.

According to court documents, Gileno embezzled nearly $1.6 million from the foundation from 2015 to 2017 and failed to report the income on his personal tax returns. For that, he owes an unpaid federal tax of over $532,000. Gileno must also pay a fine and make full restitution to the foundation and Internal Revenue Service, as well as tax penalties and interest.

Prosecutors say Gileno used the foundation’s bank account to write checks to himself and issued payments to other people for his own benefit. The money was used to pay for personal expenses, such as Gileno’s mortgage, car payments and a $3,600 visit to Universal Studios in Orlando, Florida. The misuse of funds went undetected for three years.

“Gileno failed to maintain accurate books and records of the United States Pain Foundation and in a number of instances, made false and fraudulent representations to the Board regarding the expenditures,” prosecutors said.

PAUL GILENO

“I hope your readers realize I did make mistakes but that should not take away from all the good work I did and the organization I created,” Gileno said in an email to PNN. “The board has been the same for the past 9 years and I hope they continue to help people with pain and use the programs we created together."

As he awaits sentencing, Gileno said he was “trying to focus my life on my two boys who are 5 and 4 and need their dad."

Acting CEO Nicole Hemmenway did not respond to a request for comment on Gileno’s guilty plea, but the foundation released a statement.

“While the last year has been difficult, the organization has never lost sight of its guiding mission to educate, empower, support, and advocate for the 50 million Americans living with chronic pain,” the foundation said. “We are thankful that resolution of these issues is coming to an end, and are committed to continuing to serve people with pain, stronger than ever.”

As PNN has reported, Gileno was forced to resign in May, 2018 after “financial irregularities” were finally discovered by the board. A few months later, Gileno confessed in an email to misusing charitable funds.

“I am sad to say that I made some big mistakes over the past few years and took money from US Pain for my personal use. I make no excuses for this. I did take money and I will pay the ultimate price,” Gileno wrote.

According to an audit released last month and U.S. Pain’s 2018 tax return, Gileno misappropriated over $2,055,000 from the charity from 2016 to 2018. The misused funds were reported to the IRS as “excess benefit transactions,” a broad category that includes unauthorized compensation, reimbursement for personal expenses, and payments to Gileno’s family members.

In addition to the $32,537 that Gileno was paid for roughly five months of work in 2018, he collected over $166,000 in excess benefits. The latter amount includes a $36,000 payment to an unidentified company owned by Gileno. It is not clear what the payment was for.

Gileno’s wife, sister and step-daughter were paid nearly $71,000 in wages in 2018. It is not clear what work they did. Gileno’s sister also received an unspecified amount of severance pay and maternity leave.

The auditor also reported that U.S. Pain has been unable to recover any money from a $100,000 investment in SMJ Homes, a real estate business owned by Gileno’s brothers. A promissory note from the company was due in February 2019, but has not be repaid, according to the audit.  

Gileno disputes the auditor’s finding and says most of the money was paid back.

“U.S. Pain has failed to tell you that the investment that was made with my brothers have been mostly paid back and they were paid 4 years of interest at 6 percent a year which was paid monthly and was deposited by people from U.S. Pain. It was never a surprise U.S. Pain cashed all the checks,” Gileno wrote. 

The foundation at one time claimed to be the nation’s largest non-profit patient advocacy group. While it’s unclear how many members U.S. Pain actually has, it remains well-funded. Major corporate donors to U.S. Pain include Abbvie, Amgen, Lilly, Sanofi, Novartis, Teva, Abbott, Pfizer and other pharmaceutical companies.   

After Gileno’s departure, the board scrapped a $2.5 million prescription co-pay program with Insys Therapeutics, a controversial drug maker whose founder and four former executives were recently convicted of racketeering.

U.S. Pain says it has implemented new policies, oversight measures and a system of checks and balances to ensure that only appropriate expenses are paid by the foundation.

Chronic Pain Patients in Alberta Revolt

By Marvin Ross, Guest Columnist

Last week the Chronic Pain Association of Canada issued a press release calling upon the Alberta health minister to investigate the College of Physicians and Surgeons of Alberta (CPSA) for “its unwarranted and secret cautioning and sanctioning” of doctors who prescribe opioid medication.

The press release came after a public meeting of pain patients in Edmonton organized by the group Help Alberta's Pain. Numerous patients showed up to complain about the poor quality of pain care in Alberta.

The meeting was so successful that the organizer, Tracy Fosum, told me that more meetings are being arranged in Edmonton, Calgary, Sherwood Park, Lethbridge and one in Northern Alberta.

An estimated 1.25 million Albertans suffer from chronic pain and 125,000 have long used opiate analgesics in order to function. In March, an Edmonton pain practice shutdown, throwing nearly 1,000 of these patients out of care.  

“Thousands of Albertans with pain have lost specialist and primary care because the College of Physicians and Surgeons of Alberta has forced doctors to stop prescribing opiates. The province's pain specialists are retiring in large numbers, citing College intimidation,” Barry Ulmer, Executive Director of the Chronic Pain Association of Canada said in a statement.

In response, the CPSA issued a statement from Registrar Dr. Scott McLeod calling such claims “misinformation” and denying there was an exodus of pain physicians from the profession.   

“Many Albertans suffer with severe daily pain and need medical assistance to allow them to live productive lives with their family, friends and in the workplace. We understand the challenges these Albertans face and encourage physicians to work with their patients to find a sustainable solution,” McLeod said. “Responsible prescribing does not include abrupt discontinuation or tapering of opioids or abandoning patients who use opioids.”

McLeod said the CPSA has been successful in reducing overdoses and opioid prescriptions. Accidental overdose deaths in Alberta from prescription opioids have been cut in half, there has been a 20% decline in opioid prescribing since 2016, and 13% fewer patients received an opioid in 2018 compared to 2016.

Patients Denied Treatment

Tracy Fosum recently appeared on the Roy Green syndicated radio show to talk about her personal experiences as a long time chronic pain patient in Alberta. Suffering from what even I recognized as the classic signs of a heart attack, she went to a local Edmonton hospital. Staff were suspicious of Tracy because of her high opioid use and, after a cursory exam, suggested she go home and take some NSAIDs for what they decided were chest muscle spasms.

Later, Tracy went to another hospital emergency room, where she was forced to wait for six hours as, she contends, they mistook her for a drug seeking addict. While trying to convince them to do an EKG, she went into cardiac arrest and collapsed. Fortunately, Tracy survived but ended up with heart damage because she had to wait too long.

Meanwhile, the Ontario College of Physicians and Surgeons is in the process of revising their opioid prescribing guidelines. A new draft policy states: “Physicians must not taper patients inappropriately or arbitrarily. Physicians are reminded that it is not always possible or appropriate to taper below a specific dose, nor is it usually appropriate to suddenly or rapidly taper prescriptions.”

The proposed guideline also states that “arbitrarily refusing to prescribe these drugs in all cases and without consideration for the circumstances of the patient may lead to inadequate patient care.”

While this is a step in the right direction, the problem is that patients have little recourse other than filing a formal complaint if a doctor provides poor treatment. A formal complaint can take months to years to resolve and ruins a doctor/patient relationship.

I am personally familiar with one case where a chronic pain patient was refused care by a doctor unless she agreed not to take any opioid medication. That doctor was sanctioned for refusing a patient on narcotics and refusing to prescribe narcotics, but the sanction was simply “Don't do that. You cannot refuse.” That patient now has no doctor because no one will take her on.

The Colleges can revise their rules and recommendations all they want, but they also need to ensure that doctors adhere to them.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He is a regular contributor to the Huffington Post.

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.

Gabapentinoids Raise Risk of Suicide and Overdose in Younger People

By Pat Anson, PNN Editor

Gabapentinoids – a class of nerve medication widely prescribed to treat chronic pain – increase the risk of suicide, overdose, traffic accidents and head or body injuries in younger people, according to a large new study published in The British Medical Journal.

Sales of the two main gabapentinoids, pregabalin (Lyrica) and gabapentin (Neurontin), have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

A team of researchers followed nearly 192,000 people enrolled in the Swedish Prescribed Drug Register who filled prescriptions for gabapentinoids on at least two consecutive occasions from 2006 to 2013. That information was compared to data in the Swedish Patient Register, which collects information on hospital admissions and outpatient care, as well as the Swedish Cause of Death Register.

Over the study period, researchers found that patients taking gabapentinoids had higher rates of suicide or suicidal behavior (5.2%), unintentional overdose (8.9%), traffic accidents (6.3%) and head or body injuries (36.7%) than the general population.

The risks were strongest for people who were prescribed pregabalin and were most pronounced among adolescents and young adults aged 15 to 24.  Patients aged 55 and older taking gabapentinoids were not at greater risk.

Researchers believe the drugs may have more impact on younger people because they have faster metabolisms, which could lead to withdrawal problems that affect their impulsivity and emotions.

“Overall, gabapentinoids seem to be safe for a range of outcomes in older people. However, the increased risks found in adolescents and young adults prescribed gabapentinoids, particularly for suicidal behaviour and unintentional overdoses, warrant further research,” said lead author Seena Fazel, MD, of the University of Oxford in England.

“If our findings are triangulated with other forms of evidence, clinical guidelines may need review regarding prescriptions for young people, and those with substance use disorders. Further restrictions for off-label prescription may need consideration.”

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while gabapentin is approved for epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off-label to treat back pain, depression, migraine and other chronic conditions.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A recent clinical review found little evidence the drugs should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The CDC’s controversial opioid guideline, for example, calls gabapentin and pregabalin “first-line drugs” for neuropathic pain.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Study Debunks Myths About Origins of Opioid Abuse

By Pat Anson, PNN Editor

It’s become a popular myth – and for some, a propaganda tool – to claim that opioid pain medication is a gateway drug to heroin and other street drugs.

An opioid education campaign called The Truth About Opioids – funded with taxpayer dollars from the White House Office of National Drug Control Policy — declares in big bold letters on its website that “80% of heroin users started with a prescription painkiller.”

The 80% figure stems from a 2013 study that found four out of five new heroin users had previously abused prescription opioids by using them non-medically.

Importantly, the heroin users were not asked if they had a valid prescription for opioids or even where they got them – but that doesn’t stop federal agencies from citing the study as proof that illegal drug use often starts with a legal opioid prescription.

The Drug Enforcement Administration last year used the 80% figure to justify steep cuts in the supply of prescription opioids, claiming in the Federal Register that addicts often get hooked “after first obtaining these drugs from their health care providers.”

“The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care,” Roger Chriss explained in a PNN column last year.

A new study by researchers at Penn State University debunks the myth that the opioid crisis was driven primarily by doctors’ prescriptions. The researchers conducted a series of surveys and in-depth interviews with opioid abusers in southwestern Pennsylvania -- a region hard hit by opioid addiction -- asking detailed questions about their drug use.

The study was small – 125 people were surveyed and 30 of them were interviewed – but the findings provide a an important new insight into the origins of opioid abuse and the role played by painkillers.

"What emerged from our study -- and really emerged because we decided to do these qualitative interviews in addition to a survey component -- was a pretty different narrative than the national one,” said lead author Ashton Verdery, PhD, an assistant professor of sociology, demography and social data analytics at Penn State. "There's a lot about that narrative that I think is an overly simplistic way of thinking about this."

‘Opioids Were Never the First Drug’

Verdery and his colleagues found that over two-thirds of those interviewed (66.7%) first abused a prescription opioid that was given, bought or stolen from a friend or family member. Another 7% purchased the drugs from a stranger or dealer. Only one in four (26%) started by abusing opioid medication that was prescribed to them by a doctor.

“We found that most people initiated through a pattern of recreational use because of people around them. They got them from either siblings, friends or romantic partners," said Verdery. “Participants repeatedly reported having a peer or caregiver in their childhood who had a substance use problem. Stories from childhood of witnessing one of these people selling, preparing, or using drugs were very common. Being exposed to others’ substance use at an early age was often cited as a turning point for OMI (opioid misuse) and of drug use in general.”

And prescription opioids were not the gateway drugs they are often portrayed to be. Polysubstance abuse was common and usually began with drugs such as alcohol, marijuana, cocaine, methamphetamine, prescription sedatives and prescription stimulants.

“It is important to note that interviewees universally reported initiating OMI only after previously starting their substance use career with another drug (e.g., alcohol, marijuana, cocaine). Opioids were never the first drug used, suggesting that OMI is likely associated with being further along in one’s drug using career,” Verdery reported in the Journal of Addictive Studies.

Verdery says additional studies are needed on the origins of drug abuse and that researchers should focus on the role that other substances play in opioid addiction. Only then can proper steps be taken to prevent abuse and addiction before they start.

"We think that understanding this mechanism as a potential pathway is worth further consideration," said Verdery. "It's not just that people were prescribed painkillers from a doctor for a legitimate reason and, if we just crack down on the doctors who are prescribing in these borderline cases we can reduce the epidemic.”

AMA Opposed to ‘Blacklisting’ of Doctors Over Rx Opioids

By Pat Anson, PNN Editor

The American Medical Association is hardening its opposition to public and private policies that seek to limit opioid prescribing. The AMA House of Delegates this week passed resolutions calling for prescribing guidelines to be amended to allow physicians to use their own clinical judgement to decide if higher doses of opioids are medically necessary. The AMA’s ruling body also called for an end to the “blacklisting” of doctors who prescribe high doses.

The AMA didn’t always feel this way about guidelines. When the CDC released its controversial opioid guideline in 2016, the AMA sent a letter to CDC Director Thomas Frieden that “applauded the CDC for treating the epidemic of opioid overdose deaths as a high priority.” And Patrice Harris, MD, a psychiatrist who chaired an AMA Task Force to Reduce Opioid Abuse, said the AMA was “largely supportive of the guidelines.”

Harris, who recently became the AMA President, now says the guidelines “have no basis in science.”

“Physicians can’t be expected to fight the epidemic with one hand tied behind their back, handicapped by policies that limit choices for patients and have no basis in science,” Harris said in a statement.

The AMA House of Delegates finally took a stand against the CDC guideline last November, when it passed resolutions opposing the “misapplication” of the guideline by pharmacists, insurers, pharmacy benefit managers, states and regulatory agencies.  

Although the 2016 guideline is voluntary, it has resulted in many patients being forcibly tapered to lower doses, cutoff entirely or even abandoned by their doctors – all under the guise of preventing opioid addiction and overdoses.

This week’s resolutions by the AMA’s ruling body went a step further, calling for an end to the “inappropriate use” of the CDC guideline to set dosing limits and blacklist physicians who exceed them.  

RESOLVED that our AMA support balanced opioid sparing policies that are not based on hard thresholds, but on patient individuality, and help ensure safe prescribing practices, minimize workflow disruptions, and ensure patients have access to their medications in a timely manner, without additional, cumbersome documentation requirements.

RESOLVED that our AMA oppose the use of “high prescriber” lists used by national pharmacy chains, pharmacy benefit manager companies or health insurance companies when those lists do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having their prescriptions filled at their pharmacy of choice.

RESOLVED that our AMA incorporate into their advocacy that clinical practice guidelines specific to cancer treatment, palliative care, and end-of-life be utilized in lieu of CDC’s Guideline for Prescribing Opioids for Chronic Pain as per CDC’s clarifying recommendation.

The CDC’s so-called clarification came in a commentary published April 24 in The New England Journal of Medicine. Three authors of the guideline did not take any responsibility for the poor implementation of their recommendations, but acknowledged that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.”

Nearly two months later, not a single word of the CDC guideline has been clarified or changed, and insurers, pharmacies and many states continue to enforce its voluntary recommendations as mandatory policy.

Doctors who prescribe high doses of controlled substances are also being blacklisted by the DEA and state medical boards, which routinely use prescription drug monitoring programs (PDMPs) to identify and target physicians who are considered “high prescribers.”

Federal prosecutors have also sent letters to hundreds of physicians warning them that their opioid prescribing practices could subject them to criminal prosecution — often without any evidence that their patients were harmed by the drugs.

Misleading CDC Study Links Prescription Opioids to Binge Drinking

By Pat Anson, PNN Editor

A new study by the Centers for Disease Control and Prevention has found that over half of people who misuse prescription opioids also binge drink, increasing their risk of dying from an overdose.

“We are losing far too many Americans each day from overdoses,” CDC Director Robert Redfield, MD, said in a statement. “Combining alcohol and opioids can significantly increase the risk of overdoses and deaths.”

Binge drinking and misuse of opioid medication are never a good idea, whether done separately or in combination. Unfortunately, the CDC study is written in ways that mislead and further worsen the stigma associated with prescription opioid use. And it fails to acknowledge the role CDC itself has played in the growing use of alcohol for pain relief.

The study, published in the American Journal of Preventive Medicine, is based on survey of over 160,000 people who participated in the National Survey on Drug Use and Health from 2012 to 2014. After analyzing their answers, CDC researchers came to some sweeping conclusions about Americans getting high on pills and alcohol.

“Prescription opioids were responsible for approximately 17,000 deaths in the U.S. in 2016. One in five prescription opioid deaths also involve alcohol,” wrote lead author Marissa Ether, PhD, CDC Division of Population Health.

“More than half of the 4.2 million people who misused prescription opioids during 2012–2014 were binge drinkers, and binge drinkers had nearly twice the odds of misusing prescription opioids, compared with nondrinkers.”

The statement that prescription opioids “were responsible” for 17,000 deaths is misleading because it is based on data from death certificates and coroner reports that only indicate the medications were present or “involved” in overdoses. Other substances may have played a role or perhaps even caused those 17,000 deaths.

In 2016, over twice as many fatal overdoses involved heroin and illicit fentanyl, but CDC researchers “did not consider the use of illicit opioids” for their binge drinking study. Apparently, street drug users are teetotalers who do not drink.

And who were the binge drinkers who misused prescription opioids? They were recreational users of opioid medication who did not take the drugs for pain relief. “Misuse” in the study was defined as “use without a prescription or use only for the experience or feeling it causes.”

To be clear, pain patients with legitimate opioid prescriptions that are used appropriately were not included in the study. These patients are actually less likely to be binge drinkers — defined as four or more drinks by a woman, or five or more drinks by a man — and they are warned repeatedly not to mix their medications with alcohol. Including them would have significantly changed the study findings.

Patients Using Alcohol for Pain Relief

Perhaps the biggest oversight by CDC researchers is the 2012-2014 time frame chosen for their study – which is well before the agency released its controversial 2016 opioid prescribing guideline.

One of the key findings from a recent PNN survey of nearly 6,000 patients is that the guideline has limited their access to prescription opioids so severely that some are turning to alcohol for pain relief. Nearly one out of five patients surveyed said they had used alcohol for pain relief since the guideline came out.

“It has caused many pain patients to be cut off their pain medication,” one patient told us. “After losing my meds 16 months ago, I just started using alcohol and I never used alcohol. I don't like alcohol, but what are my options?” 

“Since my doctor stopped prescribing even my small amount of opioids I deal with days where I can’t even get out of bed because I hurt so much and I’m stuck turning to alcohol, excessive amounts of acetaminophen and NSAIDs,” another patient said. 

“The CDC guidelines are killing people,” one woman wrote. “My fiancé has been refused even the most mild stenosis treatment because he admitted using alcohol to treat his pain when he has no other treatment. He's mildly suicidal as well. We have two young kids.” 

“I lost a good friend to suicide because she was not able to get pain medications to relieve her pain and it was too much for her to handle,” a patient said. “Sadly, she is not the only one. I'm hearing about more and more. I'm also hearing about people turning towards alcohol.” 

“All they are doing is pushing chronic pain patients to find relief in other ways such as alcohol, illicit drugs or harming themselves to get the pain relief they do desperately seek,” wrote another patient. 

In other words, alcohol use is acceptable to the CDC — as long as it is not combined with prescribed opioid medication. This is your nation’s health protection agency at work.

Doctor Accused of Overprescribing Opioids Fights to Keep Her License

By Pat Anson, PNN Editor

A northern California doctor who is beloved by many of her patients could lose her medical license because of allegations by the state medical board that she overprescribed opioid medication and other drugs. Dr. Corrine (Connie) Basch runs a solo primary care practice in Arcata, a small city in rural Humboldt county.

“They were looking to put a head on a spike so they could claim they were doing something about the opioid crisis,” Basch told PNN. “I am not considered a negligent doctor in town, nor am I a pill mill. And it would have taken them all of ten minutes to figure that out if they had asked anyone in my community if there was a problem here.”

A formal complaint against Basch by the Medical Board of California, first reported by the Lost Coast Outpost, centers on her treatment of five pain patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication. Although Basch had tapered them to lower doses, the complaint alleges the amounts are still excessive and the combination of drugs places the patients at risk of overdose and death.

Board Executive Director Kimberly Kirchmeyer is seeking the revocation or suspension of Basch’s license for excessive prescribing, gross negligence and failure to maintain adequate medical records.

At no point in the 25-page complaint is it alleged that any of Basch’s patients have overdosed or been harmed while under her care.  The board began its investigation of Basch in early 2018 but didn’t file the accusation until last month – suggesting it didn’t think there was any imminent threat to her patients.

“They went after me for no good reason, conducted an ‘investigation’ that was so obviously flawed, published a defamatory accusation on the Internet prior to giving me a chance to defend myself or even correct the factual errors, revealed private details of my patients’ cases on the Internet when those people live in a small town where people already know each other’s business, and would force a small town doc who treats poor people  to come up with several years’ income to defend herself and her license,” Basch said.   

DR. CONNIE BASCH

All five of the patients in the medical board complaint were already on high doses of opioids and benzodiazepines before Basch started treating them. She tapered these “legacy” patients to lower doses, but some remained on opioid doses as high as 664 MME (morphine milligram equivalent) – well above the CDC guideline’s recommended ceiling of 90 MME.   

The CDC and FDA recently acknowledged that patients should not be forcibly tapered to lower doses and that doctors should “work with patients” before tapering or discontinuing opioids. Basch was already using that approach in her own practice. She says patients who’ve become tolerant to opioids should be weaned slowly and it could take 6-12 months just to get them off benzodiazepines.

“I’ve helped a lot of people get off pain meds,” she said. “Some of my patients stay on meds. I have a patient who is super functional on 145 MME. She’s comfortable, she can sleep through the night, and she works. I don’t see a need to lower her, except that she’s afraid. They’re all feeling insecure. They want to get off (pain meds) because there will be literally no one left to prescribe.”

Afraid to Prescribe

In recent years, California’s medical board has aggressively gone after doctors who prescribe opioids at high doses. The state’s controversial “Death Certificate Project” has resulted in threats of disciplinary action against hundreds of physicians, often years after they wrote an opioid prescription for a patient who fatally overdosed. Some doctors received warning letters even though the cause of death was suicide or involved multiple drugs – both legal and illegal.

These and other enforcement actions have had a chilling effect on doctors statewide.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” Dr. Robert Wailes, a pain specialist and chair of the California Medical Association’s Board of Trustees, told Kaiser Health News.

Should Basch lose her license or stop practicing, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

“There are now two docs I know of in our area who have retired early because of similar accusations, and another older doc who lives in a small coastal community south of us who is going through a similar thing right now,” said Basch. “There’s nowhere even to get primary care up here. And if you call and say you want to be a new patient and chronic pain is anywhere on your problem list, you are denied. So these people are literally going to be left with no one.” 

‘Medical Board Malpractice’

Basch has received over 300 letters of support from patients and several from colleagues in the medical community. Her attorney plans to present them as evidence to the medical board.

“Dr. Corrine Basch is my beloved primary care physician,” one patient wrote. “Taking away her right to assess her individual patients for risk vs benefit, forcing a bureaucratic, possibly ill-conceived set of ‘guidelines’ is what I consider Medical Board Malpractice.

“FEAR caused by actions such as yours are keeping legitimately suffering human beings from having a quality of life they deserve. THIS IS SHAMEFUL.”

“I have had my share of doctors over the years but I never had a doctor like Connie. She has ultimately saved my life and I am not just saying that,” wrote another patient who credits Basch for his sobriety after years of addiction to pills and alcohol.

“You don’t punish someone for doing the right thing and helping people get off of drugs. That is not how you fix the opiate problem plaguing America you do it by employing more people like Dr. Connie who knows the right way to get a person clean.”

Basch, who is 55, continues to practice and is gathering evidence to support her case. A hearing date has not been set on the medical board’s complaint.

“They went after the wrong person this time,” she says. “Shaming and humiliating doctors who have lived lives of service, and placing them in a position where they have to give up their calling because the cost of defense is too great late in their careers, is shameful.”   

Should Postpartum Pain Control Be a Crap Shoot?

By Lynn Webster, MD, PNN Columnist

Anticipating the birth of my second grandchild should have been a purely joyous time. My daughter was about to become a mother for the second time. The miracle of life would unfold again in our family, as it does for thousands of families, every day, all around the world.

My daughter was scheduled to have a repeat cesarean section (I am sharing this story with her permission). The first operation was uneventful, apart from the fact that it produced my first, adorable grandchild.

However, this time I was concerned that my daughter’s post-op pain might not be adequately treated. Since her first C-section three years ago, the hospital system where she delivers has made a public commitment to reducing the amount of opioids prescribed for acute pain by 40 percent.

I worried that the hospital’s choice to lessen the amount of drugs prescribed, rather than focusing on patients' clinical needs, might mean my daughter's need for pain control would be unmet.

The idea of my daughter enduring inadequately treated pain haunted me, as it would any father, but as a pain specialist, it may have troubled me even more. I have seen the unspeakable suffering that insufficiently managed pain can cause. I also know that inadequately treated acute pain can lead to chronic pain.

The thought that my daughter might be the victim of the hospital’s well-intended attempt to reduce opioid use was highly unsettling to me, but there was little I could do about it. Doctor or not, I could not be sure that my daughter would receive the individualized treatment she deserved after her surgery.

So, several weeks before her scheduled operation, I advised my daughter to talk to her surgeon. Specifically, I asked her to find out how her post-op pain would be treated.

The irony of the situation was not lost on me. This was the first time in my career as a pain specialist and anesthesiologist that I had to worry a family member might suffer from ineffectually managed post-op pain. It was humbling. I felt as impotent and powerless as any other bystander.

I know the hospital system is addressing the number of people who abuse drugs, and their response may well be appropriate in some cases. But my daughter isn’t contributing to the problem. Why should she have to pay the price for the inappropriate behaviors of others?

Pain control was no longer only a professional concern for me. It was now very personal.

My fear was reinforced by a June 3 The Wall Street Journal article by Sumathi Reddy, “The Push for Fewer Opioids for New Mothers.” In it, Reddy describes the national effort to reduce the amount of opioids used postpartum. 

Of course, opioids should not be used if there are safer and more effective alternatives. But some hospitals are taking aggressive steps to eliminate the use of any opioids. As a result, the individual needs of a patient may be lost in an effort to tackle a public health problem.

Something seems out of kilter with that line of thinking. It reminds me of the adage of not seeing the forest for the trees.

The American College of Obstetricians and Gynecologists (ACOG) recently published new guidelines for treating postpartum pain. The guideline does not exclude the use of opioids from post-op pain control. In fact, the recommendation for opioid use seems to be logical and consistent with patient-centered care.

Fortunately, my daughter’s OB is an excellent and caring clinician. Her approach is patient-centered, and she provided my daughter -- cautiously -- with the necessary analgesics to help her manage her recovery. My daughter did not like the way the medication made her feel, but without it she would not have been able to care for her newborn. 

An ACOG recommendation specifically states that postpartum pain management should involve shared decision-making. My daughter needed to understand the risks and benefits of opioids before deciding whether or not to accept them to treat her pain. This approach worked for her. The mother of my new, healthy, precious grandchild deserved no less.

All mothers across the world deserve the same level of care. I fear, in some cases, they may not be as lucky as my daughter. They may not receive the care they need, and the joy of giving birth may be superseded by the agony of unmanaged acute pain.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is a former president of the American Academy of Pain Medicine, author of the award-winning book “The Painful Truth” and co-producer of the documentary “It Hurts Until You Die.” He lives in Salt Lake City with his wife and now two granddaughters.

You can find him on Twitter: @LynnRWebsterMD.

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.

Crackdown on Opioids and Benzodiazepines Ignores Their Benefits

By Roger Chriss, PNN Columnist

The overdose crisis is driving a lot of panicky policy to more closely regulate the prescribing of scheduled drugs, from oxycodone and other opioids to clonazepam and other benzodiazepines, which are used to treat anxiety.

A California doctor was recently accused of unprofessional conduct and could lose her license for prescribing “excessive amounts of opioid medications and benzodiazepines.” And a New Jersey doctor faces criminal charges for prescribing the so-called “Holy Trinity” of opioids, benzodiazepines and muscle relaxers.

The crackdown on opioids and benzodiazepines may help reduce overdose fatalities, but it also risks depriving people of beneficial drugs. Research is finding new benefits for familiar drugs that may slow diseases and improve quality of life.

In a recent Phase III clinical trial, a “novel” combination drug was shown to ease Charcot-Marie-Tooth disease. The drug – called PXT3003 -- provided “meaningful improvement” for people with a hereditary neuropathy that results in a progressive loss of sensation and motor function.

This is a significant advance for people with Charcot-Marie-Tooth disease, which currently has no treatment. The FDA recently gave PXT3003 its “fast track” designation, which speeds the development of drugs for which there is an unmet medical need.

PXT3003 is a combination of three familiar drugs, naltrexone (an opioid receptor blocker), baclofen (a muscle relaxant), and sorbitol (an alcohol sugar). The how and why of this combination of drugs is not well-understood at present. The manufacturer Pharnext says there are “multiple main mechanisms of action” that improve nerve, muscle and immune cells.

In other words, research on existing drugs with known risk profiles has led to a novel treatment. Ordinarily, the use of an opioid and a muscle relaxant is regarded as clinically inadvisable and is actively counseled against in many prescribing guidelines.

Benzodiazepine Research

A similar outcome is occurring with long-term benzodiazepine therapy in congestive heart failure (CHF). An editorial in Psychotherapy and Psychosomatics reported that low-to-moderate doses of benzodiazepines “seem to be helpful in silent myocardial ischemia, angina, essential hypertension, and CHF, especially in patients with comorbid anxiety.”

This builds on research from Taiwan in 2014 showing that anti-anxiety medications are “associated with a decreased risk of cardiac mortality and heart failure hospitalization in patients after a new myocardial infarction.”

Long-term benzodiazepine therapy is already seen as important in the treatment of rapid eye movement sleep behavior disorder, a condition in which causes people to act out vivid and violent dreams, often injuring themselves or bed partners. Low-dose clonazepam therapy for months or even years turns out to be a highly effective treatment.

In the same fashion, benzodiazepines are used to treat stiff-person syndrome, a rare neurological disorder that causes extreme muscle rigidly and spasms that can make walking impossible. According to the National Institutes of Health, therapy to treat stiff-person syndrome includes “anti-anxiety drugs, muscle relaxants, anti-convulsants, and pain relievers.”

‘Political Interference’ in Medicine

But treatments for these disorders and the development of new regimens for other disorders may be impeded under current federal and state laws and guidelines. Recently a coalition of six physician groups called on state legislatures to end their “political interference” in the practice of medicine and the patient-physician relationship.

“The insertion of politics between patients and their physicians undermines the foundation of trust this relationship is built on and inhibits the delivery of safe, timely, and comprehensive care. Outside interference endangers our patients’ health by limiting, and sometimes altogether eliminating, access to medically accurate information and to the full range of health care,” the coaltion warned.

“Physicians should never face imprisonment or other penalties for providing necessary care. These laws force physicians to decide between their patients and facing criminal proceedings.”

— Coalition of physician groups

“Physicians should never face imprisonment or other penalties for providing necessary care. These laws force physicians to decide between their patients and facing criminal proceedings. Physicians must be able to practice medicine that is informed by their years of medical education, training, experience, and the available evidence, freely and without threat of criminal punishment.”

The statement was released by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Congress of Obstetricians and Gynecologists, American Osteopathic Association and American Psychiatric Association.

As the past couple of years have shown, prescribing guidelines have a way of leading to blanket prohibitions. And a risk of blanket prohibitions is that we may miss important benefits.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Prescription Opioids Play Minor Role in Massachusetts Overdoses

By Pat Anson, PNN Editor

Two new studies in Massachusetts – one of the states hardest hit by the overdose crisis – highlight the role of multiple substances in most overdose deaths and how limiting the supply of prescription opioids has failed to reduce the number of drug deaths.

Researchers at Boston Medical Center's Grayken Center for Addiction analyzed toxicology reports on nearly 2,250 fatal overdoses involving opioids in Massachusetts between 2014 and 2015. Overdose data in Massachusetts is considered more reliable because it is one of the few states to extensively use toxicology testing.

Only 9 percent of the deaths in Massachusetts involved prescription opioids alone. Most of the overdoses (72%) involved illicit fentanyl or heroin, while one in five (19%) involved a combination of heroin, fentanyl or prescription opioids.

Other substances such as alcohol, marijuana, stimulants (cocaine and methamphetamine) and non-opioid medications (benzodiazepines and gabapentin) were also frequently involved.

“Using multiple substances, in addition to opioids, is the rule rather than the exception for opioid-related deaths,” researchers reported in the journal Drug and Alcohol Dependence.

“Our study draws attention to the heterogeneity of the problem at hand and that there is not a one-size-fits-all approach to addressing the overdose epidemic, which is increasingly driven by polysubstance use.”

Over half of the Massachusetts overdoses involved someone with a diagnosed mental illness. Homelessness and a recent incarceration also raised the risk of a fatal overdose involving both opioids and stimulants.

"As a provider, these findings indicate a pressing need to address and treat not just opioid use disorder, but other substances that patients are misusing," said lead author Joshua Barocas, MD, an infectious disease physician at BMC. "To truly make a difference in reducing opioid overdose deaths, we must tackle issues such as homelessness and access to mental health services. This means not only investing in treatment but also implementing tailored programs that address the specific barriers to accessing care."

Opioid Prescriptions Down 39% since 2015

The number of opioid prescriptions has declined significantly in Massachusetts over the last four years, according to a recent report from the state’s Department of Public Health. In the first quarter of 2019 there were over 518,000 prescriptions filled for Schedule II opioids such as hydrocodone and oxycodone – a 39% decline from the first quarter of 2015.

But the decrease in prescriptions has failed to make much of a dent in Massachusetts’ opioid overdose rate, which peaked in 2016 with 2,100 deaths and remains stubbornly high.  

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

In 2018, nearly nine out of ten opioid-related deaths (89%) in the state involved illicit fentanyl, with cocaine (39%), heroin (32%), and benzodiazepines (40%) such as Xanax also commonly found.

Only about ten percent of the overdose deaths in the fourth quarter of 2018 involved prescriptions opioids, virtually unchanged from the 2014-2015 study.

Federal Task Force Releases ‘Roadmap’ to Treat Pain Crisis

By Pat Anson, PNN Editor

A federal advisory panel has released its final report on recommended best practices for acute and chronic pain management, calling for a balanced approach to pain treatment that focuses on individualized patient care – not rigid guidelines that triggered a pain crisis for millions of Americans.

“There is a no one-size-fits-all approach when treating and managing patients with painful conditions,” said Vanila Singh, MD, Task Force chair and chief medical officer of the HHS Office of the Assistant Secretary for Health. “Individuals who live with pain are suffering and need compassionate, individualized and effective approaches to improving pain and clinical outcomes. This report is a roadmap that is desperately needed to treat our nation’s pain crisis.”

Unlike previous federal efforts that focused primarily on limiting access to opioid medication while expanding access to addiction treatment, the 116-page report by the Pain Management Best Practices Inter-Agency Task Force took a more comprehensive approach to pain management that focused on the needs of patients, improving their quality of life, and establishing a “therapeutic alliance” between patient and clinician.   

The panel sought and received feedback from over 5,000 patients, advocates and healthcare providers on issues such as suicide, patient abandonment and the stigma associated with chronic pain. Several patient stories were incorporated into the final report.

Even longtime critics of federal pain care policies were impressed.

“This report from the HHS Pain Management Task Force is exceptional, in my view. Rarely have I seen a report that is of such high quality, with such reasonable, common-sense recommendations,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “The willingness to recognize concerns expressed by people with pain and by healthcare providers is not something we have often seen, and it is refreshing to see those comments play an important role here.”

“I truly hope this is a huge step forward,” said Andrea Anderson, a pain sufferer and patient advocate. “I think there was much to be praised, such as the focus on individualized patient care, the need for multi-disciplinary treatment teams with care-coordination, a more robust focus on post-surgical pain management, an emphasis on moving complementary and integrative health approaches into the main stream of pain treatment, and the need for further education and research  on a number of important topics.”

No Repeal of CDC Guideline

The task force did not call for a repeal of the CDC’s controversial opioid prescribing guideline, but said the guideline should be clarified and updated with better evidence to supports its recommendations..

“The Task Force recognizes the utility of the 2016 CDC Guideline for many aspects of pain management and its value in mitigating adverse outcomes of opioid exposure. Unfortunately, misinterpretation, in addition to gaps in the guideline, has led to unintended adverse consequences. Our report documented widespread misinterpretation of the CDC Guideline — specifically, the recommendation regarding the 90 morphine milligram equivalents (MME) dose,” the report found.

“Educating stakeholders about the intent and optimal application of this guideline and re-emphasis of its core beneficial aspects are essential. Instances have been reported where the CDC Guideline was misapplied to the palliative care and cancer populations with pain and to providers who care for these patient populations.”

The task force called for a more “even-handed approach” to opioid prescriptions that allows doctors to use their own clinical judgement on how to treat patients.

“Various health insurance plans, retail pharmacies, and local and state governments are implementing the CDC Guideline as policy, limiting the number of days a patient can receive prescription opioids even when the seriousness of the injury or surgery may require opioids for adequate pain management for a longer period. A more even-handed approach would balance addressing opioid overuse with the need to protect the patient-provider relationship by preserving access to medically necessary drug regimens and reducing the potential for unintended consequences,” the task force said.

That kind of thinking is heresy to anti-opioid crusaders and politicians who consider the CDC guideline a cornerstone of the government’s war on drugs. Even before the task force report was finalized, 39 state and territory attorney generals wrote a letter of protest.   

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment that causes nearly 50,000 deaths annually,” the letter warns. “It is incomprehensible that officials would consider moving away from key components of the CDC Guideline.”

Critics have also claimed that some task force members have a conflict-of-interest because of their financial ties to pharmaceutical companies. Oregon Sen. Ron Wyden (D) — who has received millions of dollars in campaign donations from healthcare companies and insurers — recently told Mother Jones that the task force was “being used as part of the industry’s broader effort to water down the CDC’s recommendations on opioid prescribing.”

The 29 members who served on the task force included representatives from the FDA, CDC, VA and Office of National Drug Control Policy; as well as academic and medical experts in pain management, addiction treatment, pharmacy, oncology, psychiatry and interventional medicine. There was only one patient advocate, Cindy Steinberg of the U.S. Pain Foundation.

Interestingly, Harold Tu, MD, the lone dentist on the panel, is the father-in-law of Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guideline. Tu voted in favor of the task force’s final report.

The report’s recommendations are voluntary and not binding on the Department of Health and Human Services or anyone else. The task force was created in 2016 by the Comprehensive Addiction and Recovery Act to “determine whether there are gaps in or inconsistencies between best practices for pain management.”

Those gaps have been identified. Whether anyone will get to work and fill them is unclear.

“I think the task force provided a very good analysis of the problem with recommendations that if implemented should help millions of Americans with pain and reduce the problem with opioids,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine and a PNN columnist.

“My concern is that there doesn't appear to be any teeth to the recommendations. I would like to have seen some specifics but that may have been too much to expect at this stage.”

Liability Trial of Opioid Drug Maker Could Set Precedents

By Jackie Fortier, Kaiser Health News

All eyes will be on Oklahoma this week when the first case in a flood of litigation against opioid drug manufacturers begins. Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

Rx Opioids ‘Useful Products’

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Food and Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths.

“Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News. KHN is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.