DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” acting DEA Administrator Uttam Dhillon said in a statement.

“DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. To make a comment online, click here. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.

Kolodny Clarifies His Conflicts of Interest

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has revised his conflict of interest statements for two articles he co-authored in the Journal of the American Medical Association (JAMA) to include his work in malpractice lawsuits involving opioid medication.

Kolodny, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), is a longtime critic of opioid prescribing. He recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson, a case the state won with a $572 million judgement against J&J.

“I am writing to provide additional information to clarify conflict of interest disclosures in 2 articles I published in JAMA in 2017 and 2018.  During this time, I received compensation for work as an expert in malpractice litigation involving opioid prescribing,” Kolodny wrote in a Sept. 4 letter to JAMA’s editors.

“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.”

The two JAMA articles in question, which were co-authored by former CDC director Thomas Frieden, MD, both dealt with the opioid crisis and the federal policy response to it.

JAMA disclosure policy is very clear and requires authors to list “all relevant financial interests, activities, relationships and affiliations,” including payments for employment, consultancies and expert testimony.

During the Oklahoma trial, Kolodny admitted under questioning by J&J lawyers that he was being paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny anticipated being paid up to $500,000 by the end the Oklahoma trial.

“I don’t think it should be a secret that I’m being compensated,” he said.  

Kolodny also acknowledged working for the law firm of Cohen Milstein Sellers & Toll in a similar capacity, also for $725 an hour. Cohen Milstein is heavily involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois. 

Kolodny’s work in opioid litigation was disclosed in the April 2018 JAMA article.

DR. ANDREW KOLODNY

His revised disclosure statement for that article is vague, stating that he worked as “a medical expert for states and counties that have filed suits against opioid manufacturers and as an expert witness in malpractice cases involving opioid prescribing.” It does not identify which states, counties and law firms he worked for or what companies were being sued. 

JAMA policy calls for “complete disclosure of all potential conflicts of interest” covering a three-year period prior to an article being submitted. If an author received funding from the pharmaceutical industry, for example, he or she would be expected to identify the company involved.   

“It is encouraging that Dr. Kolodny has recognized that his very profitable work supporting plaintiffs in opioid lawsuits might constitute a conflict of interest when he writes about opioid policy and clinical practice,” said Bob Twillman, PhD, a healthcare policy consultant and former Executive Director of the Academy of Pain Management. “Of course, these aren't the only two articles Dr. Kolodny has co-authored, and he has done numerous presentations at professional meetings as well, so I wonder if he will seek to correct all the rest of those relevant disclosure statements.

“I think it's also interesting that, when I disclose my conflict, I am always required to specifically name the entity involved, yet Dr. Kolodny names neither the jurisdictions nor the law firms for which he was working. It seems a little like a double standard to me, and I wonder how the editorial boards of the relevant journals feel about that.”

In March 2017, Kolodny co-authored a research letter in JAMA Internal Medicine on a study he designed that looked into funding that patient advocacy groups and professional organizations received from opioid manufacturers. Many of those organizations publicly opposed the CDC’s controversial opioid prescribing guideline, which Kolodny and other PROP members helped draft.

“The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest,” Kolodny and his co-authors wrote. “Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

Kolodny’s disclosure statement for the 2017 article states that he was a member of PROP and Chief Medical Officer for the addiction treatment chain Phoenix House (which he has since left). It makes no mention of his work in opioid litigation or malpractice lawsuits, which appear to have begun in 2012 when he started working with Linda Singer, then from the law firm of Cohen Milstein.

Lucrative Sideline

Kolodny is not the only critic of opioid prescribing to develop a lucrative sideline as a medical expert or paid witness. Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive healthcare marketing practices, has also been paid handsomely for her testimony.

In August, Fugh-Berman testified in California that she was paid $500 an hour for her work in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case, according to Northern California Record.

Fugh-Berman has written several op/eds claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were part of a “coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.”

Fugh-Berman discloses on PharmedOUT’s website that she is a paid expert witness, but she won’t say who funds her organization.

“(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 in an email to PNN.  

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has also stoutly defended the CDC guideline and warned against excessive opioid prescribing.

“Most prescribing physicians feeding the opioid epidemic are well meaning, naïve, or just too busy to recognize the dangers,” he wrote in a physician guide for opioid prescribing published by Kaiser Permanente.

Over the past decade, Munzing has established a profitable career as an expert witness for the Medical Board of California, DEA, FBI and DOJ, working mostly on cases that involve doctors flagged for overprescribing opioids.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1.3 million in DOJ contracts since 2017 and is currently working on over two dozen DEA investigations.

After he left Phoenix House, Kolodny became the co-director of an opioid research program at Brandeis University that is funded with over $8.5 million federal grants, according to GovTribe.com.

The Visible Few Pain Patients

By Dr. Lynn Webster, PNN Columnist

I receive several emails a week from people who ask for help because their treatment options have been limited or eliminated. They are in terrible pain, and they don’t know what to do.

One such person, Sharon Berenfeld, MD, recently shared an experience she had visiting her doctor.

“Dr. Webster, I came across a publication of yours. It struck a nerve with me. My pain is intractable. I have tried everything,” she wrote. “Before the exam room door even closed, [my doctor] announced to me, ‘If you think I’m just here to refill your pills, you can leave now.'

"I left in tears. I was being judged and punished for having a complication from cancer treatment. I completely understand the opioid crisis. But I feel impotent to do anything."

Who Are the Visible Few?

Earlier this year, Fox News' three-part series, Treating America's Pain: Unintended Victims of the Opioid Crackdown, showed the terrifying circumstances of people in pain and doctors under siege. One individual’s decision to commit suicide as a result of the crackdown on opioid prescribing embodies the struggles of people in pain and their providers' inability to meet their needs.

The visible few are the small number of people whose stories have been heard by journalists, media consumers and government officials. Their stories reflect millions of Americans suffering from chronic pain who live in the shadows and are invisible to most of us. 

The needs of people in pain and the challenges providers face when treating them have been overshadowed by the government's attempts to deal with the opioid crisis. The well-intentioned CDC Guideline for Prescribing Opioids for Chronic Pain has affected 20 million Americans with severe disabling pain.

It also is having consequences for everyone else in the healthcare system. Prescription opioids have been demonized and blamed for our current drug crisis.

Unintended Consequences

The CDC guideline was supposed to be voluntary. However, in practice, the guideline has been treated as a policy with the strength of a law, and it has had severe unintended consequences. Many people are worse off in its wake. Here is a summary of the most substantial effects of the guideline.

• Providers feel pressured to reduce the amount of opioids that they prescribe, regardless of their patients' individual needs. About 70% of physicians have reduced their opioid prescribing or stopped it completely.

• Insurance companies set prescription limits based on the guideline. In some cases, they override physicians' recommendations. That means insurers, rather than doctors, are making decisions about how to treat pain.

• Pharmacy chains are also limiting the amount of opioids they dispense, based on the guideline rather than on doctors' prescriptions..

• The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services have set dosage limits. Providers advocating for patients who need higher amounts must navigate a complicated appeals process.

• State attorneys general have used the guideline to evaluate whether a doctor is prescribing for a legitimate medical purpose. Deviation from the guideline has been used to accuse doctors of criminal conduct.

• In a desperate search for pain relief, some patients have turned to street drugs.

Where We Are Now

The CDC guideline has left a trail of misunderstanding in its path. Its authors acknowledged misapplication of the guideline in the New England Journal of Medicine, emphasizing that their intention was to provide guidance rather than to establish a mandate.

"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 the guidance,” they wrote.

In a separate article in the JAMA Network, the guideline's authors said, “The number of people experiencing chronic pain is substantial, with U.S. prevalence estimated at 11.2% of the adult population. Patients should receive appropriate pain treatment based on careful considerations of the benefits and risks of treatment options.”

There are other signs of recognition that the guideline has been misinterpreted. For example, CDC Director Robert Redfield, MD, wrote in a letter to Health Professionals for Patients in Pain (HP3), “The CDC is working diligently to evaluate the impact of the guideline and clarify its recommendations to reduce unintended harm.”

The American Medical Association's House of Delegates passed a series of resolutions on the guideline at an interim meeting in November 2018.

“Physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the morphine milligram level thresholds found in the CDC guidelines for prescribing opioids,” the AMA delegates said.

There is also some light being shined on the issue in a report by The Pain Management Best Practices Inter-Agency Task Force.

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

As the opioid odyssey continues, there are signs that the visible few are beginning to be heard. This is an important step to helping the invisible millions with chronic pain receive the care they deserve.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find him on Twitter: @LynnRWebsterMD.

The information in this column 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.

Outcomes Matter When Opioids Are Tapered

By Roger Chriss, PNN Columnist

The drug overdose crisis has led to a rethinking of pain management. Prescription opioids are now seen as risky medications with potentially serious side effects, including addiction and overdose. As a result, there is an increasing push to discontinue or taper patients on long-term opioid therapy.

A recent op/ed in the Annals of Internal Medicine by physicians Roger Chou, Jane Ballantyne and Anna Lembke claims there is “little benefit” from long-term opioid use and “many patients” would benefit from tapering. They even suggest that the use of addiction treatment drugs such as Suboxone should be expanded to include pain patients dependent on opioids.

“Evidence indicates that long-term opioid therapy confers little benefit versus nonopioid therapy, particularly for function. Opioid use disorder (OUD) occurs in a subset of patients, and quality of life may be adversely affected despite perceived pain benefits,” they wrote.

“We argue that achieving effective, safe, and compassionate tapers requires implementing and incentivizing tapering protocols, recognizing prescription opioid dependence as a distinct clinical condition necessitating treatment, and expanding the indication for buprenorphine formulations approved for OUD to include prescription opioid dependence.”

It should be noted Chou is one of the co-authors of the CDC’s controversial opioid prescribing guideline, while Ballantyne and Lembke are board members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). Ballantyne, who is president of PROP, was part of the “core expert group” that advised the CDC when it was drafting its guideline.

What Happens to Tapered Patients?

The goal of improving patient safety is admirable. However, there is relatively little data on what happens to patients during tapering or after opioids are discontinued. The evidence is mixed at best.

A 2018 review in Pain Medicine of 20 studies involving over 2,100 chronic pain patients found that most patients had less pain or the same amount of pain when tapering was completed. But the studies were not controlled and the evidence was of marginal quality, with large amounts of data missing.

A 2019 study in the journal Pain evaluated outcomes in 49 former opioid users with chronic pain. The findings showed that about half the patients reported their pain to be better or the same after stopping opioids, while the other half reported their pain was worse.

There are risks associated with tapering that also need to be considered, such as uncontrolled pain, suicide, overdose and early death. The tapering process itself can be extremely challenging and patient outcomes after discontinuation are not necessarily positive.

A recent study in the Journal of General Internal Medicine looked at what happened to chronic pain patients being treated at a large urban healthcare system in the year after they were tapered.

For about 5 percent of patients, “termination of care” was the primary outcome – a vague category that means there was no record of them seeking further treatment. Some of those patients may have miraculously gotten better and required no healthcare. And some may have died.

“These findings invite caution and demonstrate the need to fully understand the risks and benefits of opioid tapers,” the authors warned.

Another study in the same journal is also concerning. Researchers at the University of Washington followed 572 patients who were treated with opioids at a Seattle pain clinic. About 20 percent of the patients died, a high mortality rate, but the death rate was even higher for patients who were tapered. Seventeen of them died from a definite or possible overdose.

“In this cohort of patients prescribed COT (chronic opioid therapy) for chronic pain, mortality was high. Discontinuation of COT did not reduce risk of death and was associated with increased risk of overdose death,” the authors concluded.

"We are worried by these results, because they suggest that the policy recommendations intended to make opioid prescribing safer are not working as intended," said lead author Jocelyn James, assistant professor of general internal medicine at the University of Washington School of Medicine. "We have to make sure we develop systems to protect patients."

In other words, opioid discontinuation does not necessarily lead to better outcomes, as Chou, Ballantyne and Lembke suggest. The blind push to taper patients at all costs to reduce opioid prescribing can have tragic consequences — which no one seems to be tracking.

“Crucially, today’s opioid prescribing metrics take no count of whether the patient lives or dies. Data from two recent studies strongly suggest it is time to start counting. The sooner quality standards are revised in favor of genuine patient protection, the better,” says Stefan Kertesz, MD, an Alabama physician and researcher.

Outcomes matter. And they need to be reasonable for the patient. A person with a self-limiting condition like low back pain may well benefit from opioid discontinuation. But some patients with more chronic conditions do not get better, and their needs cannot go ignored.

The Canadian Psychological Association emphasizes caution and patient safety in a recent position paper on the opioid crisis:  “Tapering must always be done gradually under physician or nurse practitioner supervision, with the patient's consent, and with ongoing support and monitoring of pain and functioning, as well as management of withdrawal symptoms."

The use of prescription opioids should always take patient risks and benefits into consideration. It also requires knowing about outcomes when taking patients off opioids. At present there is too much interest in numbers and too little interest in people.

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.

Americans More Likely To Get Opioid Prescriptions After Surgery

By Julie Appleby, Kaiser Health News

Americans and Canadians are seven times more likely to fill a prescription for opioid pain pills in the week after surgery than Swedes, says a study published Wednesday, one of the first to quantify international differences.

More than 75% of patients in the U.S. and Canada filled a prescription for opioids following four common surgeries, compared with 11% of Swedes, researchers report in JAMA Network Open. Americans also received the highest doses of opioids.

So, are Americans and Canadians wimpier than Swedes when it comes to pain, or is something else going on?

“There are a lot of tough people in lots of places,” demurred Mark Neuman, an associate professor of anesthesiology at the University of Pennsylvania Perelman School of Medicine and a co-author of the study.

He pointed to a host of other potential factors, from cultural differences to variations in marketing, regulation and long-standing, ingrained prescribing habits.

“It’s possible that in the U.S. people think about opioids as pain relief in a drastically different way than in other places,” he said.

Researchers examined four types of surgeries — minimally invasive types of appendectomy and gallbladder removal, as well as arthroscopic surgery to repair a torn meniscus in the knee and breast tumor removal. All the surgeries occurred from 2013 to March 2016, a time of growing concern about opioid dependence in the United States but before more recent guidelines suggesting that fewer pills are needed following many common surgeries.

Even so, “for the same exact surgery, the same exact tissue trauma, we have seven times more people in the U.S. getting opioids,” said Neuman.

On average, patients in the U.S. filled prescriptions for about 33 pills, each equivalent to 5 milligrams of oxycodone, he said, although the type of drug varied. Swedes who filled prescriptions had an average of 26 pills, while Canadians had 22.

Canadians and Swedes were also far more likely to get codeine or tramadol — painkillers that rely on a different mechanism in the body and are considered weaker types of opioids. Americans were far more likely to get hydrocodone or oxycodone, some of which were heavily marketed to physicians by drugmakers. States and cities are currently suing manufacturers, alleging they misrepresented the drugs’ risks and didn’t properly monitor suspiciously large sales, contributing to the opioid crisis.

The study does not comment on the marketing aspect but did note two factors that might account for some of the difference in the types of drugs prescribed. One is that, during the research period, low-dose codeine was available over the counter in Canada. Tramadol is still not classified as a controlled substance there, although it has been a controlled substance in Sweden since 2007 and in the U.S. since 2014.

“While prescribers may view these so-called weak opioids as safer alternatives, data suggests that both codeine and tramadol have the potential for misuse and life-threatening adverse effects,” the study says.

The U.S. and Canada were chosen because they have the highest per capita consumption rate of opioids in the world. Sweden was picked as a European counterpoint because researchers could obtain detailed prescription information from databases there.

While the study was large — following about 129,000 patients in the U.S. with job-based insurance, 84,600 in Canada’s Ontario province and 9,800 in Sweden — it did have limitations. For one, researchers could not track how many pills patients actually took of those prescribed, or the number of patients who didn’t fill prescriptions they were given. Secondly, they don’t have data on how well patients felt their pain was controlled following surgery.

“It’s possible that in Sweden everyone’s pain treatment is less than in the U.S., although I think that is unlikely,” said Neuman, noting that other studies have shown that patients in the U.S. often do not take all the pills they’ve been prescribed following surgeries.

Fewer Pills Being Prescribed

In addition, for certain types of surgeries, patients do not report greater dissatisfaction when prescribed fewer pills after surgery. Researchers in Michigan, for example, recently reported on what happened after dozens of hospitals recommended new prescribing guidelines — drawn up after studying how many pills patients actually took — following certain surgeries. While recommendations were often for far fewer than 30 tablets, researchers found no increase in reported pain.

Like the group in Michigan, some academic medical centers and other experts have recently issued guidelines calling for fewer pills following many procedures. Those grew out of concern that patients with what is called acute pain — the kind following surgical procedures, for example — were given far too many pills.

An analysis of Medicare data by Kaiser Health News with researchers at Johns Hopkins Bloomberg School of Public Health, for example, found prescribing from 2011 to 2016 exceeded levels now recommended by organizations like Johns Hopkins. For example, Medicare patients took home 48 pills in the week following coronary artery bypass, 31 following laparoscopic gallbladder removal, 28 after a lumpectomy and 34 after minimally invasive hysterectomies.

According to postsurgical guidelines spearheaded by Johns Hopkins last year, those surgeries should require at most 30 pills for a bypass, and 10 pills for minimally invasive gallbladder removal, lumpectomy and minimally invasive hysterectomy.

Postsurgical opioid use can lead to long-term dependency in a small but significant percentage of patients, studies have shown, but unused pills can also be a danger. Those tablets can make their way to the street or fall into the hands of other family members.

Researcher Dr. Chad Brummett, who worked on the guidelines in Michigan, said he thinks prescribing amounts in the U.S. and Canada have likely dipped in recent years, given the increased attention. Still, he cautioned that the amounts likely remain too high in both countries and that the new study illustrates the wide disparity between North America and at least one European country.

“We know that marketing in the U.S. has affected prescribing in all domains, including surgery,” said Brummett. “This study and others show that [surgeons] in the U.S. and Canada can drastically reduce prescribing standards without adversely affecting patient care.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

How Pain Patients Feel About the Opioid Crisis

By Pat Anson, PNN Editor

We received an overwhelming response from readers to Diana’s Franklin guest column on how the opioid crisis has affected her. Diana has suffered from scoliosis since she was a child and now has degenerative disc disease. For many years oxycodone helped Diana manage her chronic back pain, but she can no longer get it.

Diana considers herself collateral damage of a crisis she had nothing to do with.

“The government stopped allowing my doctor to prescribe any opioids, leaving many of his patients, including myself, without any pain medication at all,” Diana wrote.

“I can hardly get up to go across the room without help and every step causes extreme pain. I can't think straight and wind up exhausted because every ounce of energy I have goes to fighting the pain.”

Diana’s story hit home with hundreds of readers who left comments or sent us emails.

“Just recently my doctor said that he was gonna have to stop prescribing me my opioid pain medication,” wrote Jeffrey Ticich, who suffers from scoliosis, stenosis, a herniated disc, and recently had his right leg amputated.

“When my doctor takes my opioid pain medication away from me, I will start looking for a burial plot. I have suffered most of my life with severe chronic acute pain and I will not suffer anymore. There has got to be a solution for patients that are suffering and not abusing their opiate pain medication.”

“I am a disabled law enforcement officer. I was hurt in a car crash years ago responding to a rape in progress. The only way I've had any quality of life is with the pain medication,” wrote a man who didn’t want his name used. “Life has been really rough since (they) restricted pain medication. Also think of all the injured veterans. What a way to say thanks for your service.”

“I've suffered with neuropathy for almost 15 years. It's very painful, especially in my lower legs. I find it difficult to even walk to the mailbox and back,” said Leslie Rowland, who is 70. “I too am a case of collateral damage when it comes to pain meds. I've loved to fish all my life but had to give it up this year due to the pain. Please, someone with a voice needs to be heard for people like me. All I want is not to be in pain 24/7 and to have a decent quality of life.”

CDC Guideline Unchanged

Many pain patients thought their voices were finally being heard last April, when CDC Director Robert Redfield, MD, acknowledged that many insurers, pharmacies, states and practitioners were implementing the agency’s 2016 opioid guideline as a mandatory policy.

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm. The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy,” said Redfield.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms.”

Five months later, not a word of the CDC guideline has changed. And many doctors, insurers and pharmacies are still reducing opioid dosages or cutting off patients.   

“My pain doctor keeps reducing my pain medicine dose to the point that it's almost ineffective, thanks to our government's unrealistic guidelines. And instead of going after the real culprits of the problem (the dealers), they're putting the blame on the doctors,” wrote Richard Parrish. “Those of us who really need help are paying the price for our inept government's prescribing guidelines. THIS HAS GOT TO STOP!”

“I have been in pain since last October from neck pain that travels to the back of my ear from whiplash,” wrote Lois Henkin. “I have been to all kinds of doctors, had physical therapy, had facet joint shots, cervical steroid shots, etc. with no change in the pain.

“I was put on gabapentin for the pain, with no results. I switched to Tramadol, which works, but now because of the opioid crisis, I am not even given 1 pill a day. This is not fair to people that have severe pain. Just limit the meds to the drug addicts.”

Many readers, like Debra Christian, said they felt abandoned and misunderstood.

“Unless you live in chronic pain, then you don't understand it, nor do you know what it does to a person and how it changes the person they were,” Christian wrote. “We don't have lives. We’re just existing.

“This is a problem. This is a travesty. This is a financial burden. And I am an American who wants to still work, but I can’t. It will be up to me to fight with whatever strength I have left, if I want any quality from my life that I and so many others deserve.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated.

Opioid Overdoses Drop, But Fentanyl Crisis ‘Likely to Get Worse’

By Pat Anson, PNN Editor

Opioid overdose deaths fell by nearly 5 percent in 25 U.S. states last year, according to a new analysis from the Centers for Disease Control and Prevention -- one of the first reports to document a significant decrease in opioid overdoses.

The 25 states covered in the report are participating in the CDC’s State Unintentional Drug Overdose Reporting System (SUDORS), which tracks overdose deaths through toxicology, medical examiner and coroner reports. SUDORS is considered more reliable than other databases because it provides more details on the types of drugs involved – both legal and illegal.

Opioid overdoses fell overall by 4.6% in the first six months of 2018, driven in large part by a 6.6% decline in deaths involving prescription opioids. The CDC found that less than a third (28.7%) of the overdoses were linked to opioid pain medication. Most overdoses involve illicit drugs.

“Prescription opioid deaths stabilized nationally from 2016 to 2017, and the number of opioid prescriptions filled has been decreasing for several years, as efforts to reduce high-risk prescribing have increased. Findings from this report suggest these efforts might have fostered decreases in prescription opioid deaths without illicit opioids,” researchers said.

While the data about prescription opioids is encouraging, the report paints a grim picture about the abuse of other substances. Nearly 63% of the opioid overdoses involved a non-opioid drug such as cocaine, methamphetamine or benzodiazepines.

Overdoses linked to illicitly manufactured fentanyl (IMF) rose by 11.1% in 2018, with fentanyl or a fentanyl analog involved in nearly nine out of ten opioid deaths.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Fentanyl analogs such as carfentanil can be even stronger. Most drug users have no idea what they’re getting, because fentanyl is often added to heroin, cocaine and other drugs to boost their potency, or used in the production of counterfeit medication.

Fentanyl Dominates Black Market

A new report from the RAND corporation, a nonprofit research organization, suggests the fentanyl problem will be hard to eradicate. Researchers looked at synthetic opioid markets in the U.S. and other parts of the world, such as Canada and Estonia — where fentanyl first appeared 20 years ago..

“Once fentanyl gains a foothold, it appears capable of sweeping through a market very quickly,” wrote Bryce Pardo, lead author of the study and an associate policy researcher at RAND. “We know of no instance in which fentanyl attained a dominant position in the marketplace and then lost that position to another less potent opioid. To date, fentanyl’s spread appears to be a one-way ratchet.

“One of the most important — and depressing — insights in this analysis is that however bad the synthetic opioid problem is now, it is likely to get worse before it gets better.” 

RAND researchers say the surge in fentanyl and other synthetic opioids is driven by supply-side factors more than user demand. China's pharmaceutical and chemical industries are poorly regulated, allowing producers to cheaply produce fentanyl and ship it to buyers anywhere in the world. Mexican drug traffickers smuggle most of the fentanyl that enters the U.S., although some of it is shipped in the mail or by commercial delivery services.

DEA IMAGE

Unconventional strategies may be needed to address the fentanyl crisis. The RAND researchers advocate several innovative approaches, such as supervised drug consumption sites, creative supply disruption, drug product testing, and heroin-assisted treatment, which is available in some countries. Sweden has developed an online market with fentanyl analogs sold primarily as nasal sprays.

"It might be that the synthetic opioid problem will eventually be resolved with approaches or technologies that do not currently exist or have yet to be tested," said Beau Kilmer, study co-author and director of the RAND Drug Policy Research Center. "Limiting policy responses to existing approaches will likely be insufficient and may condemn many people to early deaths."

RAND researchers say there is little reason to believe that tougher sentences, including homicide laws for low-level drug dealers and couriers, will make a difference.

Last week the Mexican navy found over 25 tons of powdered fentanyl on a Danish ship docked at a Mexican port, one of the largest fentanyl shipments ever seized. The shipment originated from Shanghai, China.

Chinese officials are pushing back on claims that they’re not doing enough to stop fentanyl exports, saying the U.S. needs to stop blaming other countries for its own drug problems.

“A small group of people produce fentanyl illegally in China and mail them to the U.S. and other regions, driven by the exorbitant profit and at the request of criminals overseas, including those in the U.S. The Chinese government has zero tolerance for this. Once we find clues, we chase them down and spare no one,” Liu Yuejin, deputy head of the China National Narcotics Control Commission, told Bloomberg.

“I think the most important thing for U.S. politicians is to face the reality: What’s the root cause of such large-scale abuse of fentanyl in the U.S.? They need to find out and come up with solutions.”  

Tramadol Raises Risk of Low Blood Sugar

By Pat Anson, PNN Editor

Patients who take the opioid tramadol are at greater risk for developing hypoglycemia – a condition caused by very low blood sugar -- than those taking other pain medications, according to researchers at the University of California San Diego.

Prescriptions for tramadol – a synthetic opioid sold under the brand names Ultram and ConZip – have been increasing because it is perceived as a “safer” opioid with less rick of addiction. Tramadol is currently ranked among the top five prescribed opioids in the United States.

As tramadol use has grown, so have documented cases of adverse effects such as dizziness, nausea, headaches and constipation — all common side effects of opioids.

The link to hypoglycemia was discovered by accident when researchers at UCSD’s Skaggs School of Pharmacy and Pharmaceutical Sciences analyzed more than 12 million reports from the FDA’s Adverse Event Reporting System from January 2004 to March 2019.

“The impetus was the recent dramatic surge in tramadol popularity and prescriptions,” said Tigran Makunts, PharmD, first author of the study published in Scientific Reports. “We wanted to have an objective data-driven look at its adverse effects and bumped into a dangerous, unlisted and unexpected hypoglycemia.”

The researchers compared adverse events involving tramadol to those linked to other widely prescribed opioids and non-opioid medications, such serotonin and norepinephrine reuptake inhibitors (Cymbalta, Effexor XR) and NMDA receptors (ketamine and memantine).

Only tramadol produced a significant risk of developing hypoglycemia. There was a 10-fold greater risk of hypoglycemia using tramadol than virtually every other opioid except methadone, which is typically used to treat addiction.

Hypoglycemia is often related to the treatment of diabetes, but can also occur in persons without diabetes. Left untreated, hypoglycemia can lead to serious complications, such as neurocognitive dysfunction, vision loss, greater risk of falls and loss of quality of life.

“The takeaway message is to warn physicians about the likelihood of low blood sugar, in particular if the patient is predisposed to diabetes,” said senior author Ruben Abagyan, PhD, a professor of pharmacy at UCSD.

“It may be beneficial to monitor glucose levels when initiating tramadol or methadone in both diabetic and non-diabetic patients. Alternative opioids or non-opioid pain medications may be safer to use with patients at risk of hypoglycemia or any complications associated with hypoglycemia.”

Tramadol was classified in 2014 by the DEA as a Schedule IV controlled substance, a category that means it has a low potential for abuse. A recent study, however, by Mayo Clinic researchers found that patients who took tramadol for post-surgical pain have a slightly higher risk of prolonged use than those taking oxycodone or other short acting opioids.

In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.

Oklahoma Judge Orders J&J to Pay $572 Million in Damages

By Pat Anson, PNN Editor

In a precedent setting case, an Oklahoma judge has ruled that Johnson & Johnson is partly responsible for fueling Oklahoma’s opioid crisis and ordered the health care giant to pay $572 million in damages.

“The opioid crisis has ravaged the state of Oklahoma and must be abated immediately,” said Cleveland County District Judge Thad Balkman, reading his decision aloud from the bench.

Balkman said J&J concocted a ‘marketing scheme” for opioid pain medication that overstated the drugs’ effectiveness and underplayed their risks. The company’s subsidiary, Janssen Pharmaceutical, produced less than one percent of the opioids prescribed in Oklahoma, but supplied 60% of the ingredients in painkillers sold by other companies.  

“They developed and carried out a plan to directly influence and convince doctors to prescribe more and more opioids, despite the fact that defendants knew increasing the supply of opioids would lead to abuse, addiction, misuse, death and crime,” the judge said.

Oklahoma had asked for $17.5 billion from J&J to pay for addiction treatment, emergency care, law enforcement and other services needed to address the opioid crisis. J&J said it would appeal the judges “flawed” ruling.

"Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome," Michael Ullmann, Executive Vice President and General Counsel for J&J, said in a statement. “This judgment is a misapplication of public nuisance law that has already been rejected by judges in other states.

"The unprecedented award for the State's 'abatement plan' has sweeping ramifications for many industries and bears no relation to the Company's medicines or conduct." 

Balkman’s ruling is not legally binding on any other court, but as the first opioid case to go to trial, it is expected to have a significant impact on negotiations to resolve nearly 2,000 lawsuits filed by states, cities and counties against opioid makers, distributors and pharmacies. Many of those cases have been consolidated before a federal judge in Ohio.

Oklahoma previously reached a $270 million out-of-court settlement with Oxycontin-maker Purdue Pharma and an $85 million deal with Teva Pharmaceutical. Endo International and Allergan recently agreed to pay $10 million and $5 million respectively to two Ohio counties to avoid going to trial.

Compared to the cost and bad publicity that J&J went through defending itself in Oklahoma, those settlements look prescient.

As PNN has reported, three law firms that acted as lead outside counsel for Oklahoma stand to collect 25% of the damages and penalties awarded to the state. Oklahoma’s star witness, anti-opioid activist Dr. Andrew Kolodny, testified that he was paid $500,000 for his services at a rate of $725 an hour.

Cost of MS Drugs Soars Despite Competition

By Pat Anson, PNN Editor

The cost of multiple sclerosis drugs has soared over the past decade for Medicare patients to nearly $76,000 per patient annually, according to a new study published in JAMA Neurology.

"We're not talking about patients without health insurance here," said senior author Inmaculada Hernandez, PharmD, assistant professor of pharmacy at the University of Pittsburgh. "We're talking about insured patients, under Medicare. Still, they are paying much more for multiple sclerosis drugs than they were 10 years ago."

Hernandez and her colleagues looked at Medicare Part D claims data from 2006 to 2016 for disease modifying therapies (DMTs) that reduce the frequency and severity of multiple sclerosis (MS) flare-ups. MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue.

Some of the most widely used DMTs for treating MS are Copaxone, Tecfidera and Avonex. Although there’s a fair amount of competition between the drugs -- the FDA has approved 19 DMTs for MS – prices have risen in tandem for nearly all of them.

The annual list prices of the drugs more than quadrupled over the 2006-2016 study period, far outpacing inflation.

Not only did the researchers find steep increases in list prices -- the starting point before rebates, coupons or insurance kicks in -- but also in the ultimate costs to both Medicare and its beneficiaries.

"We wanted to see how increases in list prices translated to increases in out-of-pocket spending, and we discovered that actual price increases do get passed down to patients, and that can negatively affect access," said Hernandez.

Alvaro San-Juan-Rodriguez

When it was first introduced by Biogen in 1996, Avonex had an annual list price of about $8,700. Two decades later, Avonex costs nearly $76,000 per patient per year.

“The pharmaceutical and biotechnology industries claim that the high prices reflect the expense of research and development and need to incentivize continued innovation. These claims are never backed up with transparent data,” said Daniel Hartung, PharmD, and Dennis Bourdette, MD, in an editorial in JAMA Neurology. “These drugs have long since recouped any cost of drug development, yet their prices have continued to rise.

“What is driving this increase is uncertain. However, the simplest explanation is that pharmaceutical and biotechnology companies increase prices because they can, they do it to increase their profit margins, and there are few limits on what they can charge.”

Hartung and Bourdette say neurologists who prescribe DMTs should be more aware of their cost. A generic DMT made by Mylan, for example, sells for about $2,000 a month, compared to a branded version that sells for about $6,000.  

Is Ketamine an Opioid?

By Pat Anson, PNN Editor

A drug used to treat depression and pain is being touted as possible solution to the opioid crisis.

This week a South Carolina drug maker said it would partner with a medical device company to sell ketamine in take home medication bags that can be administered by an ambulatory pain pump. The idea is to give patients recovering from surgery a safer alternative to opioids.

“We are proud to partner with InfuTronix Solutions to deliver opioid-free pain medication to patients across the country,” Nephron Pharmaceuticals CEO Lou Kennedy said in a statement. “The overuse of opioids is a crisis in America. Non-narcotic pain management is a cost-saving way that companies like ours can help save lives.”

Non-narcotic? Opioid-free?

That’s not what a team of researchers at Stanford University concluded last year after studying how ketamine works in the brain. In a small clinical study, they gave a dozen patients diagnosed with depression a combination of ketamine and naltrexone – an opioid-receptor blocker. To their surprise, naltrexone stopped ketamine from working as an antidepressant.

In effect, the researchers discovered that ketamine works just like oxycodone, hydrocodone and other painkillers – by activating opioid receptors in the brain. 

“Everything that I was taught, and everything that I’ve always taught my students — all of the evidence supports the fact that ketamine is not an opioid,” said lead author Boris Heifets, MD, a clinical assistant professor of anesthesiology, perioperative and pain medicine. “I was really surprised at the results.”

“And the results were so clear that we ended the study early to avoid exposing additional patients to the ineffective combination treatment,” said co-lead author Nolan Williams, MD, a clinical assistant professor of psychiatry and behavioral science.

The Stanford research, published in The American Journal of Psychiatry, caught psychiatrists and pain management experts by surprise. Some urged caution about the long-term use of ketamine until more can be learned about potential side effects such as addiction. Some depressed patients taken off ketamine have shown signs of withdrawal and became suicidal.

“Given the rapid relapse and potential suicide risk, it is hard to know what to recommend to clinicians. Should they really continue to use the agent beyond an acute course? For how long? In whom?” Alan Schatzberg, MD, a Stanford professor of psychiatry and behavioral sciences, warned in a commentary. “The drug’s opioid properties need to be considered when considering how best to use it.”

‘A Black Eye to Ketamine’

Talk like that has given ketamine a bad rap, according to experts at Johns Hopkins University School of Medicine. They’ve published a commentary of their own, defending the use of ketamine as a necessary treatment for depression that doesn’t respond to typical antidepressants.

“A (Stanford) study done late last year delivered a black eye to ketamine, and as a result of the coverage, there was a wholesale acceptance by both potential patients and physicians that ketamine is an opioid,” says Adam Kaplin, MD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins.

“This is most worrisome if people continue to think this way, particularly in the wake of the opioid epidemic; clinicians won’t refer patients for a treatment, despite that it has been shown to be incredibly effective for many patients with treatment-resistant depression.”

Kaplin says there is ample evidence that ketamine sticks to NMDA receptors in the brain that are involved in learning and memory. Because these NMDA receptors are found together with opioid receptors, Kaplin says it’s no surprise that the can meddle with one another, like interference picked up on a phone call or static on the radio.

“This interference and cross-talk does not mean that ketamine is an opioid, and to wrongly label it as such could eventually keep patients from essential antidepressant medications that could make a huge difference in their quality of life,” said Kaplin, who plans on opening a ketamine clinic.

The debate over whether ketamine is an opioid comes at a time when its use is expanding.  Ketamine was approved by the FDA in 1970 solely as a surgical anesthetic to be taken intravenously or by injection. But a growing number of clinics now offer off-label infusions of ketamine to treat depression, post-traumatic stress disorder and difficult chronic pain conditions such as Complex Regional Pain Syndrome (CRPS).

Demand has grown so much there are reports of ketamine shortages. Although ketamine itself is inexpensive, the infusions can cost several hundred dollars and are not covered by insurance.

Ketamine Nasal Spray

Not until this year did the Food and Drug Administration approve the use of ketamine to treat depression, when it okayed a nasal spray (Spravato) made by Janssen Pharmaceuticals that contains a ketamine compound.

The FDA approved Spravato even though 2 out of 3 short term trials failed to prove its effectiveness. The spray was effective in a longer trial, but only when taken with a conventional antidepressant.

Because of the risk of abuse and side effects, Spravato can only be administered in a doctor’s office, where patients can be observed for two hours after taking a dose. A single dose will cost about $900.

The FDA has called the herbal supplement kratom an opioid because it acts on opioid receptors, but the agency has not taken that step with ketamine. Given current attitudes about opioids, it’s fair to say the FDA would have never approved Spravato if it was considered an opiate.

In addition to its medical uses, ketamine is used as a recreational party drug – known as “Special K” -- because it can cause hallucinations and intense dream-like states.

Whether taken to get high or to treat pain and depression, it’s clear that ketamine is a potent drug that has both harms and benefits. And experts say it needs to be viewed with caution until we know with more certainty how it works.

“Unfortunately, when one approaches ketamine as another antidepressant rather than a drug of abuse, this type of trap is easy to fall into, and in the end, such mistakes can be catastrophic,” Schatzberg said in his commentary. “We have witnessed four decades of supposedly new and safer opioids that have turned out often to be, if anything, even more abusable and lethal."

Surgeons Reduce Rx Opioids Without Increasing Pain

By Pat Anson, PNN Editor

Surgeons in Michigan have reduced the amount of opioid medication prescribed to patients recovering from common operations by nearly a third -- without causing patients to feel more postoperative pain.

In a new research letter published in the New England Journal of Medicine, a team from the Michigan Opioid Prescribing Engagement Network (OPEN) reported on the results of a statewide effort to get surgical teams to follow prescribing guidelines for postoperative pain.

In just one year, surgeons at 43 Michigan hospitals reduced the number of opioid pills prescribed to patients after nine common operations, from an average of 26 pills per patient to an average of 18.

The surgeries included minor hernia repair, appendix and gallbladder removal, and hysterectomies. Most were minimally invasive laparoscopic surgeries.

The ratings patients gave for their post-surgical pain and satisfaction didn't change from the ratings given by patients treated in the six months before opioids were reduced.

Researchers say patients only took about half the opioids prescribed to them, even as the prescription sizes shrank. They attribute this to improved counseling about pain expectations and non-opioid pain control options.

"The success of the statewide effort suggests an opportunity for other states to build on Michigan's experience, and room for even further reductions in prescription size," said Michael Englesbe, MD, a University of Michigan surgery professor. "At the same time, we need to make sure that patients also know how to safely dispose of any leftover opioids they don't take."

The study involved over 11,700 patients who had operations at hospitals participating in the Michigan Surgical Quality Collaborative. About half of the patients also filled out surveys sent to their homes after their operations, asking about their pain, satisfaction and opioid use after surgery.

The Michigan-OPEN team has been working since 2016 to reduce opioid prescribing and quantify the appropriate number of pills patients should take. Their research led to the the development of new guidelines that were first tested on gallbladder surgery patients before being expanded to other types of surgery.

Some hospitals have stopped giving opioids to surgical patients. Patients at Cleveland Clinic Akron General Hospital get acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes

It’s a common misconception that many patients become addicted to opioids after surgery. A 2016 Canadian study, for example, found that long term opioid use after surgery is rare, with less than one percent of older adults still taking opioid pain medication a year after major elective surgery.

Another large study in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Another fallacy is that leftover pain medication is often stolen, sold or given away. The DEA says less than one percent of legally prescribed opioids are diverted.

Panel Recommends All Adults Be Screened for Illicit Drug Use

By Pat Anson, PNN Editor

The next time you visit a doctor, he or she may want to know more than what medications you take or if you consume alcohol.

An influential national panel of health experts is recommending for the first time that U.S. doctors screen all adult patients for illicit drug use, including the nonmedical use of opioids and other prescription drugs. “Nonmedical” means the use of a friend’s or relative’s prescription or buying medications off the street. It can also mean using a legal medication more frequently or in higher doses than prescribed.

The U.S. Preventive Services Task Force concluded with “moderate certainty” that screening for illicit drug use would be beneficial because it would lead to a more accurate diagnosis and treatment for substance abuse.

Screening typically involves questions about drug use and frequency. This can include questions on routine intake forms or asking patients directly when they visit with a healthcare provider. Screening does not include drug testing, although nothing would stop a doctor from ordering such tests.

“Illicit drug use can have a devastating impact on individuals and families,” said task force co-vice chair Karina Davidson, PhD, a professor of behavioral medicine at the Zucker School of Medicine at Hofstra University. “Clinicians can help by screening their adult patients and connecting people who use illicit drugs to the care they need to get better.”

About 11.5% of Americans age 18 years or older reported using cannabis or illicit drugs in a national survey. Illicit drug use is more common in young adults ages 18 to 25 years (24.2%) than in older adults (9.5%).  About one in five illicit drug users reported the nonmedical use of psychotherapeutic drugs, including opioids, pain relievers, or other medications. Less than 8% reported using cocaine, hallucinogens, or inhalants.

Although illicit drug use is relatively common among adolescents (7.9%) aged 12 to 17, the task force said there was not enough evidence to support screening for Americans under the age of 18.

“We want to help prevent illicit drug use in teens, so we’re calling for more research on the benefits of screening,” said task force member Carol Mangione, MD, chief of general internal medicine at the David Geffen School of Medicine at UCLA. “Clinicians should continue to use their professional judgement to determine what’s best for their teen patients.”

The task force’s draft report is available for public comment through September 9. After the task force reviews the comments, it will issue a final report. The panel’s recommendations are not mandatory for healthcare providers, but like many federal guidelines – such as the 2016 CDC opioid guideline -- they could be adopted as a “standard of care” by medical associations and healthcare systems.  Some already recommend that providers routinely screen their patients about illicit drug use.

AG’s Call for Weakening of HIPAA Laws

Federal laws that have long protected the privacy of patients undergoing addiction treatment may also be changing. The National Association of Attorneys General wants Congress to end regulations that prevent doctors from sharing information about their patients’ addiction treatment histories.

In a letter recently sent to congressional leaders, 39 state attorneys general called on Congress to “replace the cumbersome, out-of-date, privacy rules” contained in the Health Insurance Portability and Accountability Act (HIPAA). One section of the law – known as 42 CFR Part 2 – sets strict rules about disclosing patient records for substance abuse treatment.

“These privacy rules were created more than 40 years ago in a time of intense stigma surrounding substance use disorder treatment. They were created to assure patients that they would not face adverse legal or civil consequences when seeking treatment by protecting confidentiality of substance use disorder patient records,” the AG’s said.

“Unfortunately, they now serve to perpetuate that stigma, as the principle underlying these rules is that substance use disorder treatment is shameful and records of it should be withheld from other treatment providers in ways that we do not withhold records of treatment of other chronic diseases. While maintaining confidentiality is imperative to encouraging individuals to seek and obtain treatment, the inability to share records among providers can burden coordination of care, potentially resulting in harm to the patient.”

Two bills under consideration in Congress, the Overdose Prevention and Patient Safety Act and the Protecting Jessica Grubb’s Legacy Act would amend 42 CFR Part 2 to allow for addiction treatment records to be shared. The bills have been endorsed by over 40 national healthcare organizations, including the American Hospital Association, the American Psychiatric Association, and the American Society of Addiction Medicine.

Study: Prescription Drug Databases Overestimate Opioid Misuse

By Pat Anson, PNN Editor

Prescription drug monitoring has long been seen as the gold standard for tracking the opioid crisis. Patients who fill an opioid prescription for more than three months are considered long-term users with a higher risk of misuse, addiction and overdose. Many pharmacy chains assign a “risk score” to these patients and their doctors could even get a warning letter from the government.

But in a small study of emergency room patients, Canadian researchers found the risk of opioid misuse by long-term users is small and one out of five patients who fill opioid prescriptions don’t even use them. Their findings suggest that prescription databases alone are a poor way to measure opioid misuse.

“The rate of long‐term opioid use reported by filled prescription database studies should not be used as a surrogate for opioid misuse,” said lead author Raoul Daoust, MD, a professor and researcher in the Department of Family Medicine and Emergency Medicine at the University of Montreal.

Daoust and his colleagues surveyed 524 patients who were discharged from a hospital emergency department (ED) with an opioid prescription for acute pain. Instead of just relying on a database to track their prescriptions, the researchers asked the patients about their opioid use.

Three months after discharge, only 47 patients – about 9 percent – said they were still using opioids. Of those, 72% said they used opioids to treat their initial pain and 19% were using the drugs to treat a new pain condition.

The remaining four patients said they used opioids for another reason, suggesting possible misuse. That’s less than one percent (0.8%) of the original 524 patients.

“Within the limit of our study, our results suggest that the risk of long‐term opioid use for reasons other than pain is low for ED discharged patients with an opioid prescription treating an acute pain condition,” Daoust reported in the journal Academic Emergency Medicine.

Daoust’s findings are controversial because they throw into question the widely accepted theory that all opioid prescribing is risky, whether it’s for chronic or acute pain. The methodology used in his study was questioned by one critic.

"Emergency physicians should not be reassured by the authors' findings. The lack of a denominator, poor response rate (56%), and applied definition of misuse are significant limitations,” said Gail D'Onofrio, MD, a professor of emergency medicine and chair in the department of emergency medicine at Yale University.

D'Onofrio cites a 2017 CDC study, which found that the probability of long-term opioid use increases sharply after the first few days of treatment.

“Transitions from acute to long-term therapy can begin to occur quickly: the chances of chronic use begin to increase after the third day supplied and rise rapidly thereafter,” CDC researchers warned.

But that analysis is based solely on the number of opioid prescriptions – not actual opioid use. And Daoust found that studies like that are a poor way to measure risk.

“These studies used filled prescriptions databases that could overestimate opioid use since not all patients filling an opioid prescription consumed them. As a case in point, in this study, 21% of patients who filled their opioid prescription after the initial ED visit did not consume them,” Daoust reported.

What is the risk of long-term opioid use after an emergency room visit? In a large 2017 study by the Mayo Clinic, only about 1 percent of ER patients given an opioid prescription progressed to long term use – similar to what Daoust found.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

A 2018 study also questioned the value of prescription drug monitoring programs (PDMPs) which have long been promoted as critical tools in the fight against opioid abuse. The study found little evidence that PDMPs are reducing overdoses and that they may lead to unintended consequences such as patients turning to street drugs for pain relief.

Are Rx Opioids Scapegoats for the Opioid Crisis?

By Dr. Lynn Webster, PNN Columnist

The Washington Post recently published a series of stories about the volume of opioid medication distributed over the past several years in the United States. Over 76 billion pills were distributed from 2002 through 2012.

That sounds like a huge amount, but it is difficult to know what the number means. What is clear is that the stories are meant to suggest the number of pills is excessive and responsible for the rise in opioid overdose deaths. 

This presumed correlation is one reason for the recent lawsuits that have been filed against opioid manufacturers and distributors. It has also spawned policies that appear to have worsened, not prevented, overdoses.

Though the situation has been framed largely as a prescribing problem, the reasons for the drug crisis are many. While overprescribing has certainly been a factor, it is probably less important than other factors, such as joblessness, homelessness and despair, which are more challenging to address.

Let’s look at the data about the relationship between opioid prescriptions and overdose death rates. The number of opioid prescriptions in the United States peaked in 2012 and began a steady decline. By 2017, they reached a 15-year low.

Despite the decline in the number of opioids prescribed, overdoses from all opioids – both legal and illegal -- continued to increase. Overdoses involving prescription opioids represent only about 25% of the total number of drug overdoses.  

Obviously, something more than the supply of prescription opioids is driving overdoses higher.

No Correlation Between Opioid Prescriptions and Overdoses

After winning a year-long court battle with the Justice Department, the Post and HD Media, publisher of the Charleston Gazette-Mail in West Virginia, were able to access data from the DEA’s Automation of Reports and Consolidated Orders System (ARCOS).

The information in the database shows that, between 2006 and 2012, West Virginia received the largest per capita amount of prescription opioids. The state also experienced the highest opioid-related death rate during that period. Is there a correlation?

Kentucky also had a high number of pills and a high death rate, but as Jacob Sullum recently reported in Reason, Kentucky’s death rate in 2017 was actually lower than Maryland’s and Utah’s, where prescription rates are substantially lower. He also pointed out that although Oregon’s prescription rate was among the highest in the country, the rate of deaths involving pain pills in Oregon was just 3.5 per 100,000, lower than the rates in most states. 

Sullum further showed that Kentucky, Nevada, Oklahoma, Oregon, South Carolina and Tennessee were among the 10 states with the highest per capita prescribed pills during the 2006-2012 period. But they were not the states with the highest overdose rates. 

In a separate analysis, the CDC and Agency for Healthcare Research Quality found no correlation -- not even a weak one -- between opioid prescribing rates and overdoses when comparing data from each state. 

In addition, the rate of opioid prescribing is highest nationally for people 55 years and older, but that age group has the lowest rate.  

This lack of correlation between opioid overdoses and the volume of prescribed opioids is consistent internationally. In 2016, England prescribed the most opioids and saw the most overdose deaths in its history. However, the drug responsible for many of those deaths was heroin, not prescription opioids. 

There is a raging opioid crisis in West Africa where, despite a low prescription rate, the number of overdoses has surged. 

In 2018, Scotland's drug overdose rate exceeded that of the United States -- largely because of heroin. There is no evidence of an overall increase in opioid prescribing in Scotland. 

No Simple Answers to the Opioid Crisis

It is clear that the data does not support a simple answer to the opioid crisis. Focusing all of our efforts on decreasing the supply of prescriptions will not solve the problem and is already creating unintended consequences.

In fact, cocaine and methamphetamine were involved in more overdose deaths in the U.S. in 2018 than prescription opioids. As the supply of prescription opioids has decreased due to the policies of the last few years, people have moved from prescription opioids to other illicit drugs.

The solution to the opioid crisis must be multi-pronged. Overprescribing played a role in causing the crisis, but sociological factors appear to have driven the demand. We must consider what prompts people to turn to drugs in despair. A recent study published in SSM-Population shows job loss bears a significant correlation to opioid-caused deaths.

In addition, in the Proceedings of the National Academy of Sciences, Princeton University economists Anne Case and Angus Deaton (recipient of the 2015 Nobel prize in economics) showed mortality from substance use was linked to declining economic opportunity and financial insecurity.

Solving the drug crisis will not be easy. However, the disenfranchised members of our most impoverished communities deserve viable solutions to their problems. It is crucial to understand the degree to which job loss and hopelessness contribute to the drug problem.

Reputable data proves that the volume of opioids prescribed is not solely, or even primarily, responsible for the opioid crisis. Let’s focus on what is responsible.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth” and co-producer of the documentary, “It Hurts Until You Die.”

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.