CDC Report Ignores Suicides of Pain Patients

By Pat Anson, Editor

The suicide rate in the United States continues to climb, with nearly 45,000 people taking their own lives in 2016, according to a new Vital Signs report by the Centers for Disease Control and Prevention.

The suicide rate in the U.S. is so high it rivals the so-called “opioid epidemic.” The number of Americans who died by suicide (44,965) exceeds the overdose deaths linked to both illicit and prescription opioids (42,249).  The nationwide suicide rate has risen by over 30 percent since 1999.

“Unfortunately, our data shows that the problem is getting worse,” said CDC Deputy Director Anne Schuchat, MD. “These findings are disturbing. Suicide is a public health problem that can be prevented.”  

Contrary to popular belief, depression is not always a major factor in suicides. The report found that less than half of the Americans who died by suicide had a diagnosed mental health issue. Substance abuse, physical health problems, and financial, legal or relationship issues were often contributing factors. So was the availability of firearms, which were involved in nearly half of all suicides.

But while CDC researchers can go into great detail about the methods, causes, demographics, ethnicity and even the drugs used by suicide victims, they did not investigate anecdotal reports of a growing number of suicides among pain patients.

“Our report found that physical health problems were present in about a fifth of individuals as circumstances considered to lead up to suicide," Schuchat said in a conference call with reporters. "That doesn’t differentiate whether it was intractable pain versus other conditions that might have been factors.”

Asked directly if lack of access to opioid medication may be contributing to pain patient suicides, Schuchat said that federal agencies were “working on comprehensive pain management strategies,” but they were not investigating patient suicides, such as the recent tragic death of a Montana woman.

“We don’t have other studies right now. But I would say that the management of pain is a very important issue for the CDC and Health and Human Services,” she said.

PNN asked a CDC spokesperson if the agency was conducting any studies or surveys to determine whether the CDC's 2016 opioid guideline was contributing to patient suicides, and what impact it was having on the quality of pain care. The boilerplate response we received essentially said no, and that the CDC was only tracking prescriptions. 

"Through its quality improvement collaborative and its work with academic partners, CDC is evaluating the impact of clinical decisions on patient health outcomes by examining data on overall opioid prescribing rates, as well as measures such as dose and days’ supply, since research shows that taking opioids for longer periods of time or in higher doses increases a person’s risk of addiction and overdose," Courtney Leland said in an email.

As PNN has reported, the CDC’s guideline may be contributing to a rising number of suicides in the pain community.  In a survey of over 3,100 pain patients on the one-year anniversary of the guideline, over 40 percent said they had considered suicide because their pain was poorly treated.

Most patients said they had been taken off opioids or had their doses reduced to comply with the  CDC guideline, which has been widely adopted throughout the U.S. healthcare system. Many patients say they can’t even find a doctor willing to treat them.

‘Making Plans to End This Life’

“I am scared to death as pain for me is unbearable. If I cannot get a prescription for relief I will probably be one of those (suicide) statistics because as far as I'm concerned, my quality life would be gone and no longer worth living. I will be sure to leave a note telling the CDC to go to hell too,” one PNN reader said.

“If my life is reduced to screams of agony in my bed while my father has to watch, if that happens and I can’t take anymore suffering, I will leave a note (probably a very long one), and in it I will say that the people who are making these guidelines into law, should be charged with my homicide,” another patient wrote.

“My suicidal ideation has increased exponentially. I have now resorted to cutting and punishing myself in order to distract from the physical chronic pain I suffer with,” said another patient. “I am struggling terribly and can’t even get sleep. I have been making plans to end this life and if the pain continues without treatment, it will not be hard to do.”

“My wife has been talking about suicide as the only option to escape her chronic pain and migraine headaches. I am starting to think the same thoughts,” wrote a man who also suffers from chronic pain. “Many chronic pain patients left without a doctor or opiate painkillers will commit suicide to escape the pain and suffering. My wife and I included.”

British Columbia Revising Its Guideline

The Canadian province of British Columbia was one of the first to adopt the CDC guideline as a standard of practice for physicians. In April 2016, British Columbia declared a public health emergency because overdose deaths from illicit fentanyl, heroin and prescription drugs were soaring. In response, the College of Physicians and Surgeons of British Columbia released new professional standards and guidelines that were closely modeled after the CDC’s.

Two years later, the British Columbia guidelines are now being revised because too many patients were being denied care or abandoned by doctors fearful of prescribing opioids.

“Physicians cannot exclude or dismiss patients from their practice because they have used or are currently using opioids. It’s really a violation of the human rights code and it’s certainly discrimination and that’s not acceptable or ethical practice,” college registrar Heidi Oetter told The Globe and Mail.

Under the old guidelines, British Columbia doctors were strongly encouraged to keep opioid doses below 90 milligrams of morphine a day – the same recommendation as the CDC’s. Now they’re being told to use their own discretion and to work with patients in finding an effective dose.

“Hopefully it’s clear to physicians that the college is really expecting that they exercise good professional discretion, that they are really engaging patients in informed consent discussions and that patients are really aware of the potential risks that are associated with opioids, particularly if they’re taking them in conjunction with alcohol or sedatives,” Oetter said.

Not only were the old guidelines harmful to patients, they were ineffective in reducing overdoses. British Columbia still has the highest number of overdoses in Canada, with 1,448 deaths last year.

Overdoses also continue to soar in the United States – mostly due to illicit fentanyl and other street drugs. Will the CDC change its guideline -- as promised -- because it is harming patients and failing to reduce overdoses?

"CDC will revisit this guideline as new evidence becomes available," the agency said in 2016. "CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Today’s report on suicides indicates the agency has no plans to do either.

New Campaign Against Bogus Online Pharmacies

By Pat Anson, Editor

The U.S. Food and Drug Administration has launched yet another campaign against illegal online pharmacies, sending warning letters to the operators of 53 websites that they must stop marketing oxycodone, tramadol and other opioid medications.

"This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis,” said FDA Commissioner Scott Gottlieb, MD.  “Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives.”

Gottlieb said the FDA would take additional steps in coming months to stop the online sale of opioids and their shipment through the mail. The agency also plans to hold a summit June 27 with internet stakeholders, researchers and advocacy groups to find new ways to work collaboratively to address the problem.

Last September, the FDA sent similar warning letters to over 500 online pharmacies as part of an international operation called Pangea X. Interpol said it seized over $51 million in illicit and counterfeit medications as a result of the investigation. Over 400 people were arrested worldwide and 3,584 websites shut down.

The problem with these law enforcement efforts is that many of the bogus pharmacies are quickly back online under different names and website addresses.  

Some of websites being targeted in the latest FDA crackdown operate brazenly, offering opioids and other controlled substances without a prescription.

“One advantage of buying medication through our website is that it’s cheap and exciting. Sometimes, what happens is that the drug can only be bought with a prescription, and getting prescription is not that simple,” one operator claims. “(We provide) the solution to this. We don’t require any prescription or proof of recommendation. If you need any sort of medication, just go to our website, log in and place the order. After the payment is made, the order is finalized and shipped to your place.”

Another website claims “you won’t need a written prescription from a doctor as we have doctors within our team who will write your prescription free of cost.”

Online Pain Pharma then displays images of four smiling “doctors” with specialties in radiology, emergency care, radiology and rheumatology. The names appear fictitious and the pictures are stock photo images that can be purchased from a website that sells images of “Smiling Medical People With Stethoscopes.”

image from onlinepainpharma.com

Dr. Anna Mariya may be a radiologist for Online Pain Pharma, but on a pediatrician's website she’s an orthopedic specialist named Dr. Bagavativarasyar.  

The FDA warning letters were sent to nine online pharmacy operators, most of which have multiple websites. They were given 10 working days to respond.

• AnonShop
• Eassybuyonline
• Instabill ECS-Rx
• Medstore.biz
• One Stop Pharma
• RemedyMart
• RxCash.Biz
• TramadolHub
• XLPharmacy

"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder.”

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. About half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

FDA Monitors Social Media for Drug Abuse Trends

By Pat Anson, Editor

A recent letter in The New England Journal of Medicine sheds some light on how the Food and Drug Administration tracks changing patterns of drug use on Facebook, Twitter and other social media.

The FDA began monitoring social media – what it calls “proactive pharmacovigilance” – about a decade ago, primarily as an early warning system for adverse events involving medication.

More recently, the agency has used active surveillance of social media to study the abuse of opioid painkillers and gabapentinoids, a class of nerve medication that includes gabapentin (Neurontin) and pregabalin (Lyrica). Gabapentinoids are increasingly being prescribed as “safer” alternatives to opioids.

“To understand why usage patterns are shifting, the FDA used a social media ‘listening platform’ to set up a dashboard to track traditional social media sites (such as Twitter, Facebook, Instagram, blogs, and forums) that we monitor for conversations about opioids,” explained FDA commissioner Scott Gottlieb, MD, and co-authors Douglas Throckmorton, MD, and Janet Woodcock, MD, two senior FDA officials.

“When we find mention of additional substances on social media or elsewhere, we conduct more specific searches for relevant, publicly available conversations through our listening platform, as well as through Reddit, Google, and various online forums that don’t require registration or subscription. These may include forums associated with drug misuse or abuse, such as Bluelight.org and talk.drugabuse.com.”

What did the FDA learn about gabapentinoids on social media? Preliminary findings indicate the abuse of gabapentinoids isn’t widespread, but their use continues to increase, especially for gabapentin.

The FDA is also actively monitoring the social media sites of kratom vendors. As PNN reported last month, one vendor received a warning letter from the FDA for sharing on its Facebook page a CNN story about the herbal supplement as a possible treatment for pain and opioid addiction. The vendor only said the story was “positive news for kratom,” but the FDA said that amounted to the illegal marketing of an unapproved drug.

“The FDA thus faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” Gottlieb wrote. “The right approach to regulating these substances is best determined through a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used.”

To be clear, the FDA’s surveillance of social media isn’t very different from what private enterprise is already doing. NUVI, for example, provide social media monitoring to companies “to get real-time insights into what people are saying about your brand online.”  Companies also sell software that track keywords, hashtags and user profiles on social media. And PatientsLikeMe, the largest online patient network with over 600,000 members, sells some of its data to the FDA and healthcare industry.

At PNN, we do stories all the time about opioids, kratom, gabapentinoids and other drugs. Is Pain News Network under surveillance by the FDA? Are reader comments on our website and social media being monitored? We don’t know. But in an age of growing concern about Internet privacy and the sharing of personal data, we thought you should know that the answer could be yes.

CEO of U.S. Pain Foundation Resigns

By Pat Anson, Editor

The founder and CEO of the U.S. Pain Foundation – an advocacy group representing chronic pain patients -- has resigned under pressure.

Paul Gileno resigned Tuesday, May 29th at the request of the foundation’s board of directors, according to a statement released on Thursday by U.S. Pain. It is highly unusual for a non-profit’s board of directors to remove its CEO. No explanation was offered for Gileno’s sudden departure

Nicole Hemmenway, U.S. Pain’s chairperson, has been appointed as interim CEO. A search for Gileno’s replacement is underway.

“The organization is stable and excited to be moving forward on its mission – to empower, educate, connect and advocate for people living with chronic conditions that cause pain,” said  board member Ellen Lenox Smith. “The Board has complete faith in Nicole and the wonderful staff that makes up our organization.”

U.S. Pain has recently faced criticism over its relationship with Insys Therapeutics, an Arizona drug maker under investigation for its marketing of Subsys, an oral fentanyl spray blamed for hundreds of overdose deaths. Former Insys executives and sales representatives have been charged with racketeering and bribing doctors to prescribe Subsys off-label. A four day supply of Subsys can cost nearly $24,000.

In recent years, Insys has donated over $3.1 million to U.S. Pain, with most of the money going to a prescription discount program to help patients pay for Subsys and other medications prescribed for breakthrough cancer pain. Critics say the program was primarily designed to benefit Insys by allowing the company to bypass Medicare rules governing illegal kickbacks.

“Co-pay assistance programs (also called copay charities) were created to get around this restriction. Medicare allows copay charities to cover Medicare co-pays, so pharmaceutical companies funnel money through these groups to cover co-pay costs for Medicare patients while bilking Medicare, which bears the full cost of unnecessarily expensive drugs,” a group of critics said in a blog post by The Hastings Center.  

Last week Pfizer agreed to pay a $24 million fine to resolve federal charges that it used a similar co-pay assistance program to pay kickbacks to Medicare patients. “Pfizer used a third party to saddle Medicare with extra costs," said U.S. attorney Andrew Lelling.

In a statement released in February, Gileno defended U.S. Pain’s acceptance of funding from Insys for the co-pay assistance program.

"This funding, like any funding we receive, does not influence our values,” Gileno said. “The funding we receive is not used to promote one type of treatment over another.”

According to a report released by Missouri Sen. Claire McCaskill, U.S. Pain received $2.5 million from Insys in 2017 – an amount three times larger than what the non-profit received from all donors in 2015.

(Update: U.S. Pain has a statement on its website saying its copay assistance program with Insys ended “as of August 2018” and that “U.S. Pain will not accept funding from Insys going forward.”)

Gileno founded the Connecticut Pain Foundation in 2006 after a back injury forced him to abandon his catering business. In 2011, he launched U.S. Pain, which now claims to be the nation’s largest patient advocacy group. It's growth was fueled by marketing partnerships and donations from dozens of pharmaceutical companies and healthcare organizations.

In its 2016 promotional material, U.S. Pain claimed to have over 90,000 members and over 225,000 social media followers, including 59,000 followers on Twitter. However, that was reduced to less than 14,000 followers in early 2018 after Twitter purged from its system millions of fake accounts.

(Update: U.S. Pain has revised the way it counts actively “engaged members.” The organization now says its has over 15,000 members, 1,500 volunteers and a social media reach of more than 217,000 followers.)

In 2015, Gileno was paid a salary of nearly $404,000, according to U.S. Pain's tax return. Gileno says the 2015 compensation was for “back pay” from 2006 to 2012. The foundation has not publicly released its tax returns for 2016 or 2017, so we don’t know how much Gileno was paid for those years.

In a 2018 New Year’s message to U.S. Pain members, Gileno said he “would never sell out.”

“Not once has the creation of this foundation been about boosting my ego, finding public notoriety or obtaining fame. I am here to serve you. I will never jeopardize our mission or passion to gain five minutes of fame for myself," Gileno said.

"The work of U.S. Pain Foundation is 100% genuine. There are no strings attached or ulterior motives. All that I care about is further enhancing the lives of people suffering with pain, and we will continue to do so in a discreet and powerful manner."

PAUL GILENO

Gileno has been criticized by some in the pain community for a passive approach to patient advocacy that avoided public controversy and protest. Some say he also has an overbearing personality that rubbed people the wrong way.

“There are so many reasons I could cite as to why it’s good to have Paul out, but I am biased because he was one of my biggest bullies and a thief to others in the chronic pain community,” a longtime patient advocate who asked to remain anonymous told PNN. “I am hoping the leadership at U.S. Pain Foundation will do better than they have in the past.”

Interim CEO Nicole Hemmenway has been a key member of U.S. Pain since its inception. She has lived with Complex Regional Pain Syndrome (CRPS) most of her life.

“We’re very focused on the future. We have a lot of wonderful programs and events coming up – a training program for chronic pain support group leaders in June; our Pain Awareness Month campaign and related activities this September; and our first retreat for pediatric patients this November,” Hemmenway said in a statement.

Is CDC Opioid Guideline Harming Cancer Patients?

By Pat Anson, Editor

It was only intended for primary care physicians who treat chronic non-cancer pain, but the CDC’s opioid prescribing guideline has had a sweeping effect on the practice and quality of pain management in the United States.

The guideline is also causing confusion among oncology specialists who treat cancer and adding to the “already appalling burden of unrelieved cancer pain,” according to an op/ed being published in JAMA Oncology.

Two experts in oncology and palliative care at the University of Pennsylvania say some of the CDC’s recommendations are based on weak evidence and conflict with national cancer pain guidelines.

"This lack of evidence, coupled with conflicting and competing contemporary guidelines from diverse authoritative agencies and organizations carry the potential to confuse, if not seriously jeopardize, pain management for patients with cancer who are living with moderate to severe pain, adding to an already appalling burden of unrelieved cancer pain," wrote Neha Vapiwala, MD, and Salimah Meghani, PhD.

Meghani is a Professor of Nursing and Chair of Palliative Care at the University of Pennsylvania School of Nursing, while Vapiwala is a Professor of Radiation Oncology and Vice Chair for Education in the Perelman School of Medicine at the University of Pennsylvania.

Although the CDC guideline is intended for chronic pain patients outside of active cancer treatment, it includes patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”

Meghani and Vapiwala say the CDC’s inclusion of “cancer survivors” is a mistake because it is not uncommon for cancer pain to persist long after the cancer is treated.  

“Unfortunately, this arbitrary distinction is not consistent with the evidence of pain trajectory in cancer survivors,” the wrote. “More important, similar levels of pain were reported in survivors who were still receiving cancer treatment and those who had completed active cancer treatment.”

The CDC guideline also conflicts with the guideline of the National Comprehensive Cancer Network (NCCN), which is widely used by oncology physicians. The NCCN recommends that doctors use both short and long-acting opioids when treating flares from cancer pain, while the CDC recommends against long-acting opioids because of the potential risk of addiction.

The CDC also recommends that non-pharmacologic therapy such as meditation and non-opioid drugs such as gabapentin (Neurontin) be used for chronic pain. But Meghani and Vapiwala say there is little evidence those therapies work in managing moderate to severe pain.  They're urging the CDC, NCCN, American Medical Association and other organizations to develop more uniform guidelines based on solid evidence.

"Many of the current recommendations around opioid prescribing practices stem from expert consensus rather than empirical research, which is urgently needed to generate and develop informed guidelines for patients with chronic cancer-related pain," they wrote. "Clinicians who care for patients with cancer are frustrated by an increasingly overwhelming set of institutional, regulatory, and policy requirements around opioid prescribing that can interfere with being good stewards and advocates for their patients with pain.”

Cancer Patients Denied Opioids

Some cancer patients say the CDC guideline has interfered with their treatment.

“I had a painful radical surgery for cancer and was only provided 3 days of low-dose opioids per CDC guidelines and suffered terribly for 2-3 months. Still have persistent pain 5 months later due to poor acute pain control,” one PNN reader told us.

“My brother in law was just diagnosed with stage 4 pancreatic cancer with metastasis to the liver and his first oncologist refused to treat his pain adequately due to the CDC guidelines, telling him I'm not risking my license for you,” another reader said.

“I have a family friend who is a cancer patient in her mid-sixties. Her doctor pulled her off of her morphine without warning, and she has been left to suffer,” wrote another.

“I'm stuck with a bad physician in order to get pain management. No other doctor in this county will do pain management,” said a patient who has to drive 45 miles to get treatment. “My doctor misdiagnosed my stomach illness and missed my cancer all together.”

Other patients say their pain is just as bad or worse than cancer pain – and don’t understand why they are treated differently under the CDC guideline.

“These are guidelines, not meant for all patients. And to exclude ONLY cancer patients is outrageous,” wrote one patient who was born with a rare and painful digestive disease. “Why should I have to be penalized because I have a rare disease and not cancer? These rules and regulations that are coming out make me wish I had a cancer diagnosis.”

Don’t Take Away Our Medicine

By Lynn Joyce, Guest Columnist

I am a 62-year-old woman who -- aside from my intensely painful back --- enjoyed a full life of work, swimming, going to the gym, outings to various places with my husband and friends, and running my household.

A few years ago, my back pain became so severe I had to move from my primary care doctor to pain management after all the solutions we tried, including physical therapy, various pain treatments, x-rays and MRIs could not diagnose or in the end treat me. I went to a doctor in Sarasota who gave me pain medicine. which helped a little. I also had several procedures under anesthetic, which again did not totally relieve the pain.

I was desperate, as I spent much of the day and night with ice packs on my back to ease the pain. My ordinary life went down the drain, my husband got fed up with me not being able to accompany him and looking after my home went downhill.

I cried as I went to bed early with a sleeping pill to take away the pain -- though this did not always work as the pain woke me up. I tried various types of pain medicine and the one that worked best was oxycodone.

Nearly a year ago my doctors finally found a combination of drugs that made me pain free and able to resume my normal life. I was ecstatic to be able to do all the things I enjoyed again and to be able to run my home and look after my family.

I then had a shock a month ago when my doctor told me that my medicine would have to be reduced. I had two tearful visits to his office, where he told me that starting July 1st I would receive only one oxycodone a day.  

LYNN JOYCE

My doctor knows that this is not even a therapeutic dose and yet is being forced to break his sacred oath to "First do no harm." After getting my life back, I was so upset that I would have to go back to my previous existence, where every day is full of pain and there is very little joy.

I am not a drug addict. I am a person that needs medication for a condition that curtails my enjoyment of life, just as much as another person who needs a drug to alleviate their condition or keep them alive. My doctor should be allowed and supported in the care of his patients, not vilified by government and media alike.

There are legitimate people who are truly suffering and need the medication that is being taken from them. I am one of these people -- the other side of this so-called crisis – and we are being ignored and used as scapegoats by the government.

I do not understand how such arbitrary, draconian laws can be passed in a modern society. This government’s heavy-handed solution to the "opioid crisis" is targeting the wrong people. We are not the ones selling drugs like fentanyl and heroin, we are just people with an illness. We are not lawbreakers, although some of us may be driven to escape the pain with illegal drugs or, in some tragic cases, suicide.

There are studies that totally refute the reasoning behind these opioid laws and guidelines, doctors who have tried to stop this from happening to their patients, and those who know the science and social reasons that show we are not the cause. We are not out there selling our drugs or "doctor shopping."

I see and read daily about politicians and stores that are jumping onto the false bandwagon to further their own careers and profits. Pharmacies that are too afraid or are taking a false moral stance about the prescriptions they will or won't fill.

There has been mishandling of prescriptions in the past, but systems have been put in place to remedy that. Yet the media screams about this person or that who has overdosed and stores like Walmart that will limit a person’s medication to seven days. I hope there are the few that get opioids for short term use if they need it, but they are not long-term pain sufferers who need their therapeutic doses daily to ameliorate their pain.

I have read that companies are being forced by the DEA to reduce their drug production so much that there are worries about hospitals not having enough to treat patients or with surgeries being delayed.

Those of us that need long term drug treatment are your family member, a friend, or a familiar stranger like the postal worker who you see every day. We are not the archetypal addict that people think of when the words “drug user” comes up. Think of a time in your life when you or someone you care about was in pain and were helped by medication to make it go away.

We have that pain every day and it doesn't go away without our medicine. The government or anyone else in a position of power who keeps on pushing this inhumane agenda should walk in our shoes for a day.

Lynn Joyce lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.

When Do Guidelines Become Guidelines?

By Marvin Ross, Guest Columnist

Blaming doctors for failing to prescribe to guidelines that did not exist is the latest in the strange research coming out on the use of opioid pain medication.

That was the case for a recent study led by Dr. Tara Gomes, Dr. David Juurlink and others at the Institute for Clinical and Evaluative Studies (ICES) in Toronto, Canada. Both of these authors have a long list of research reports on opioids and Juurlink was one of the central players in the development of the Canadian guidelines for prescribing opioids for non-cancer pain. Juurlink is also a board member of Physicians for Responsible Opioid Prescribing (PROP), which is notorious for their anti-opioid views.

This particular study, called “Clinical indications associated with opioid initiation for pain management in Ontario, Canada,” is published online in the journal Pain. Gomes and Juurlink set out to evaluate prescribing patterns for patients who are “opioid naïve” to see if their prescriptions complied with guidelines adopted in the U.S. and Canada. In many cases, they did not.

“The U.S. and Canadian clinical guidelines for prescribing opioids for chronic non-cancer pain suggest that doctors should avoid initiating opioids at daily doses above 50 MME,"  Gomes is quoted saying in an ICES press release.

"Our study found that nearly one-quarter of Ontarians taking an opioid for the first time received a daily dose exceeding this threshold, and for certain indications such as knee, hip and shoulder surgeries and Caesarean sections, the dose was even higher.”

Here is the problem with their work. Gomes and Juurlink looked at prescription opioid claims for over 650,000 people in Ontario from April 1, 2015 to March 31, 2016 and compared them to guidelines that did not exist during the study period.

They defined as inappropriate any initial opioid dose that exceeded 50 MME (milligram morphine equivalent) or had a duration exceeding 7 days’ supply.  According to their findings, 17 percent of the opioid prescriptions were for periods longer than 7 days and almost one quarter (23.9%) were for dosages over 50 MME. This prescribing, they said, was not in line with North American guidelines.

By guidelines, they mean the Centers for Disease Control and Prevention guidelines that were released on March 18, 2016 --- two weeks before the end of the study period. The U.S. guidelines have never been formally accepted in Canada, although they were used to help shape the Canadian opioid guidelines that were released in 2017, a full 13 months after the study period.

How can one say that doctors were not compliant with prescribing guidelines when those guidelines did not exist at the time they prescribed? Doctors may be very clever, but I do not know of any who are capable of abiding by guidelines that only exist in the future

Aside from the study being biased and wrong, the misleading findings were picked up and portrayed by several Canadian news outlets as another example of doctors fueling the so-called opioid crisis. The Ottawa online policy paper Ipolitics ran a story with the headline, “A quarter of prescription drugs in Ontario exceeded dosage guidelines.”

Dr. Gomes also appeared on a popular radio show in Toronto saying, “We’re not really aligned right now with the guidelines in Canada.”

I have filed a formal retraction request with Dr. Michael Schull, the CEO of ICES. Schull referred my complaint to Gomes herself, who replied via e-mail on May 17 with:

“Your point regarding the timing of the guidelines in contrast with the timeframe of our study is an important one, and one that we made sure to address through our communications related to this study. In particular, in our study, we speak to the evidence related to harm associated with opioid doses above 50MME as being a core reason why attention should be paid to the high proportion of new opioid patients who are exceeding these doses. It is not simply that these doses exceed thresholds now recommended in guidelines, but that they have been shown in the literature to be associated with considerable risk of harm. We therefore need to consider how to mitigate this harm whenever possible.”

I pointed out in my reply that neither the media reports nor the press release cautioned about the discrepancy between the study period and the release of the guidelines, and I requested a public clarification and retraction. Schull replied that you cannot retract a study just because someone disagrees with it.

This is more than a simple disagreement. You cannot compare apples to oranges as they did. Schull’s final e-mail to me was we will agree to disagree, and I should take it up with the editors of Pain. Francis Keele, the editor in chief of Pain, informed me via e-mail on May 26 that they will be looking into the matter.

Broadcaster Roy Green, who has taken up the defence of chronic pain patients in both the U.S. and Canada through his syndicated radio show, offered Gomes the opportunity to bring with her 3 medical doctors to have an on-air debate on her research with him and me. So far, she has refused to respond.

I did point out to her boss that she works at the expense of taxpayers and since she is willing to discuss her work with a journalist who knows little or nothing of the topic, she has an obligation to talk to us.

I am not holding my breath.

(Update: Mr. Ross has been informed by the editor of Pain that the Gomes study has been revised to clarify to that the CDC and Canadian opioid guidelines were not in effect during the study period.) 

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.

Spinal Injection Bill Would Raise Healthcare Costs

By Pat Anson, Editor

Republicans and Democrats often claim that reducing the cost of healthcare is one of their major goals. But a bipartisan bill that is sailing through Congress with little debate will do just the opposite, raising the cost of some epidural, facet joint and other spinal injections used to treat pain by as much as 25 percent for Medicare beneficiaries.

Critics say the legislation is little more than a money grab by doctors who perform the procedures, under the guise of preventing opioid addiction.

The “Post-Surgical Injections as an Opioid Alternative Act” (HR 5804) is one of nearly 60 bills to combat the opioid crisis approved last week by the House Energy and Commerce Committee. It moves to the full House for a vote.

The bill would partially reverse a decision made by the Centers for Medicare and Medicaid Services (CMS) in 2016 to cut the Medicare reimbursement rate for epidurals and other injections.  The interventional procedures – which do not involve opioids -- can cost several hundred dollars per injection.

The American Society of Interventional Pain Physicians (ASIPP) lobbied unsuccessfully to get the reimbursement cuts overturned – until it found two Illinois Republican congressmen willing to sponsor HR 5804, Rep. John Shimkus and Rep. Raja Krishnamoorthi.

“We first went to the CMS, then HHS, with no success in reversing draconian cuts for interventional techniques. CMS and the administration told us that it requires an Act of Congress,” ASIPP says on its website. “As a first step toward this, Shimkus and Krishnamoorthi have introduced H.R. 5804, which reverses some of the cuts for Ambulatory Surgery Center procedures. This is only the beginning. We have many other cuts to be reversed.”

According to OpenSecrets.org, Shimkus and Krishnamoorthi have both received $10,000 in campaign donations from ASIPP. The organization has spent over $500,000 on lobbying and donations so far in the 2017-2018 election cycle.

‘I Find It Hard to Trust CMS’

Shimkus introduced the ASIPP bill on May 15th and two days later helped shepherd it through its first and only hearing before the House Energy and Commerce Committee.

During the hearing, Shimkus claimed that by cutting the cost of spinal injections, CMS created a disincentive for doctors to perform the procedures and encouraged them to prescribe opioids instead.

“A lot of us were surprised to see CMS reduce the reimbursement rate for non-opioid pain treatments like epidurals for post-surgery pain,” Shimkus said. “I find it hard to trust CMS when those of us in this arena think their cut has led to more opioid use.

“A lot of us believe the inability to use epidurals to treat pain and prescribe opioids is not healthy for our country.”

To be clear, the CMS reimbursement cuts do not prevent any doctor from performing injections – it only made the shots less profitable. And Shimkus offered no evidence that the lower reimbursement rates encourage more opioid use – although he convinced many of his colleagues that they did.  

“I do think it's important in this crisis to be specific with CMS to make sure that we are not discouraging the use of non-opioid alternatives based on reimbursement-related issues,” said Rep. Larry Bucshon, MD (R-IN), who is a cardiologist. “In my experience over the years, CMS makes reimbursement decisions based on the financial incentives to do so, not necessarily, in my opinion, based on what is the appropriate therapy.”

“I don't agree that epidurals are not an alternative (to opioids) already. They are. They are. I just had a conversation with a surgeon about that. So that's not so,” said Rep. Anna Eshoo (R-CA).  “Imagine being able to manage pain without taking an opioid. We could do 20 other things together and it wouldn't equal that."

Rep. Frank Pallone (D-NJ) wasn’t buying any of it.

“I don’t think we have gotten any objective criteria to suggest that what CMS did is going to lead to more people taking opiates,” Pallone said. “I don't think there is any evidence to suggest that this legislation will lead to decreased opioid prescribing or a decreased prevalence of addiction.

“I think we are setting a bad precedent with the bill. I don't think that we, as Congress, are in a good position to pick and choose winners amongst therapies and procedures. I just don't think we know enough to understand the consequences of doing that to understand the relative value and the efficacy of different therapies and procedures on the market.”

Despite those concerns -- and after just 30 minutes of debate that included no public testimony -- committee members overwhelmingly supported the bill by a vote of 36 to 14. Nine Democrats joined with all Republicans on the committee in voting yes.

“What we are doing is temporarily reversing cuts to non-opioid treatment that we all agree save money and lives, then collecting to help ensure we are reimbursing providers at the most appropriate levels possible,” Shimkus said.

“That’s ASIPP talking,” says Terri Lewis, PhD, a researcher and longtime advocate for the pain community. “What does Shimkus know? Shimkus doesn’t know anything. There is no data to support that.”

Health Risks of Spinal Injections

There was no discussion by the committee about the effectiveness of epidurals and other spinal injections -- or of the health risks associated with their use.

Epidural injections have long been used to relieve pain during childbirth, but they are also increasingly being used to treat back pain, despite reports there is little evidence the shots are effective.

The FDA has also warned that the use of steroids in spinal injections – a procedure that’s never been approved by the agency -- “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

“Here we have a procedure that they’re trying to slip under the swimming pool fence that is not FDA approved, that relies on materials that are not regulated and/or contraindicated, and they’re trying to pull a fast one. And they could very easily do it in this climate of opioid hysteria,” said Lewis.

As PNN has reported, some pain management experts believe spinal injections are overused – in part because they’re more profitable for doctors than using opioids or other procedures.  

“Probably everything that gets compensated well is over-utilized because it’s the compensation system. It’s a reimbursement system that pays more for treatment procedures than outcomes,” said Lynn Webster, MD, a past president of the American Academy of Pain Medicine.

A 2012 report by the General Accounting Office – a report requested by Rep. Pallone – found that unsanitary injection practices in ambulatory care clinics expose thousands of patients every year to blood borne pathogens such as hepatitis and HIV.  A perfectly sanitary needle can also go astray and puncture sensitive membranes in the spinal cord, leaving patients with serious and sometimes permanent injuries.      

“When it comes to spinal injections after surgery the risk to the patient, related to adverse events, increases substantially because spine surgery comes with risks of dural tears and accidental cuts,” says Terri Anderson, a Montana woman whose spine was damaged after receiving steroid injections for a ruptured disc in her back.  She now suffers from adhesive arachnoiditis, a chronic inflammation in the spinal membrane that causes severe pain.

“It is unconscionable that harmful injections would be pushed on unsuspecting pain patients,” Anderson said in an email to PNN. “It looks like the large hospital corporations and interventional pain professional societies have been busy lobbying our congressional representatives.  Apparently our healthcare system has become a profitable venture that indirectly contributes to many election campaigns in the U.S.”

No date has been set for a full House vote on HR 5804. To become law, it must pass both the House and Senate and then be signed by President Trump.  There is little opposition to the bill because many critics only recently learned that it was even being considered by Congress. 

“If this is allowed to stand, we have a problem,” says Lewis. “Another thing is Congress directing the practice of medicine. We’ve had just about enough of that.”

Poorly Rated Hospital May Become Model for Pain Care

By Pat Anson, Editor

A New Jersey hospital that has been widely praised for significantly reducing the use of opioid pain medication in its emergency room continues to receive poor ratings from Hospital Compare, a Medicare website that tracks the quality of care in the nation’s hospitals.

The one star overall rating for St. Joseph’s Regional Medical Center in Paterson, New Jersey puts it in the bottom 6 percent of hospitals nationwide.

Despite the poor rating and complaints from patients about poor pain care, St. Joseph’s anti-opioid initiative – known as ALTO (Alternatives to Opioids) -- is being held up as a national model for combatting opioid abuse. ALTO requires emergency room doctors to first consider non-opioid treatments, such as NSAIDs, ibuprofen and nerve block injections, for patients suffering pain from accidents, trauma and chronic conditions.

“We launched ALTO two years ago to offer a real solution to a rapidly growing opioid epidemic,” said Mark Rosenberg, DO, Chair of Emergency Medicine at St. Joseph’s, who was recently named to a federal task force charged with developing "best practices" in pain management for federal agencies.

"I’m very proud to report that we have reduced opioid prescriptions by 82 percent here in the St. Joseph’s Emergency Department. We are stopping addiction before it starts.”

St. Joseph’s has drawn congressional attention for its opioid policy. Last month, New Jersey Senators Robert Menendez and Cory Booker and Rep. Bill Pascrell – all Democrats – introduced legislation in Congress that would create a nationwide pilot project based on the ALTO program.

“The opioid crisis in our country is staggering and epic in its evil,” Sen. Booker said at a news conference. “The work being done here at St. Joseph’s Medical Center is innovative, it is inspiring, and it is shining light against the darkness.”

SEN. CORY BOOKER SPEAKS AT APRIL, 2018 NEWS CONFERENCE

“The ALTO program here at St. Joe’s is at the forefront of innovative thinking and new approaches to treating pain -- to fighting opioid addiction,” said Sen. Menendez.  “We want to see every hospital and provider across New Jersey and across this nation follow St. Joe’s lead, and our bill provides the necessary federal resources to help make it possible.” 

The Alternatives to Opioids in the Emergency Department Act is one of dozens of bills being considered in Congress to combat opioid addiction and overdoses. It would provide $30 million in funding to other hospitals to build their own ALTO programs. After a three-year demonstration project, the Secretary of Health and Human Services would submit a report to Congress on the results and issue recommendations for broader implementation.

St. Joseph's One Star Rating

In patient satisfaction surveys and other quality measures, St. Joseph’s consistently ranks poorly. It is one of 260 hospitals in the country given a one-star rating by Hospital Compare. Over 3,400 hospitals were ranked higher, getting two to five stars.

To be fair, St. Joseph’s is a teaching hospital in a low-income neighborhood and has one of the busiest emergency rooms in the country. The American Hospital Association believes Hospital Compare unfairly penalizes teaching hospitals and those that serve low-income areas, where many people lack access to insurance and medical care.

Hospital Compare evaluates hospitals on 7 major quality measures. St. Joseph’s is rated below the national average on safety, readmission, patient experience, timeliness of care and efficient use of medical imaging. The hospital was rated as average for mortality and effectiveness of care.

ST. JOSEPH'S REGIONAL MEDICAL CENTER

The quality of pain care is difficult to assess at St. Joseph’s because Medicare dropped all pain questions from its patient satisfaction survey last year – largely due to political pressure and unproven claims that the questions encouraged doctors to prescribe more opioids.

One pain quality measure that still exists is the average amount of a time a patient with a broken bone had to wait before getting pain medication in St. Joseph’s ER. It is 51 minutes, slightly longer than the national average of 49 minutes.

HospitalInspections.org, a website maintained by the Association of Healthcare Journalists, also found deficiencies in St. Joseph’s emergency room. An October 2017 report faulted the ER for failing to stabilize several patients or provide them with a screening exam or pain assessment. Some patients left the hospital in frustration after waiting for hours without being treated.  

One patient who fell down a flight of steps suffered injuries to her face and arm when she landed on concrete. She waited in St. Joseph’s emergency room for over seven hours before leaving without treatment. There was no record of her getting Tylenol or Motrin while waiting, which is hospital policy.

Another patient suffering from abdominal pain after a Caesarean section waited over five and a half hours in the ER before leaving. There was no record of her getting Tylenol or Motrin either.

Delays in Getting Pain Treatment

St. Joseph’s emergency room gets mixed reviews on Yelp, with many patients complaining of delays in getting treatment.

“This is by far the worst hospital in the state of NJ, my little cousin and I came here because she was in excruciating pain and the waiting room was EMPTY, they literally took over an hour to check her temp and register her,” wrote one reviewer, who even posted a photo of the empty waiting room. 

“Arrived at St Joe's due to vomiting, stomach pain and headache all night. After waiting 50 minutes to get vital signs taken I start vomiting in the lobby,” wrote another patient who eventually left. “I just got frustrated and asked to be discharged and went to primary doctor. Needless to say, I had a gallbladder infection and severe dehydration all diagnosed by primary doctor. 6 hours in the ER for nothing.”

ST. JOSEPH'S EMPTY WAITING ROOM

“St. Josephs isn't in the best part of town, but the care here, especially for children is excellent. During a scare with our 1 month old, the emergency room staff were excellent and comforting,” wrote one father.

“The nurses and doctors were nice to me, but they moved like snails,” wrote a pregnant woman who went to the ER because she was cramping and bleeding. “The pain was unbearable, and it took them until I threw up on the floor for them to move a little faster. And I was there for 3 hours before I was finally told I was unfortunately miscarrying.”  

Granted, these may be just isolated cases in a busy hospital that treats over 60,000 patients a year. But before Congress passes legislation holding up any hospital as a national model for how pain should be treated, they might want to start asking St. Joseph's patients what they think.

The widespread belief that giving opioids in the ER often leads to addiction is a myth anyway. A recent large study of opioid prescriptions filled in emergency rooms found that only 1.1% of patients progressed to long term opioid use. That compares to 2% of patients given opioids in other hospital settings.  

Reducing Supply of Opioids Will Not Stop Drug Diversion

By Roger Chriss, Columnist

Drug diversion is a massive problem. It plagues the entire drug supply chain, from manufacturer through wholesaler and distributor, to drug stores and dispensaries, all the way to consumers. It is particularly important for opioid pain medications because of the ongoing opioid crisis.

It is well established that the non-medical use of pharmaceutical drugs is an increasing public health concern. Most pharmaceutical drugs used non-medically are obtained from family and friends. There is little to no organized crime involved. And importantly, doctor shopping is rare.

An under-appreciated issue here is scale. According to the DEA, less than 1 percent of legally prescribed opioids are diverted. The sharing or selling of individual prescription pills is small compared to the impact of diversion higher up in the supply chain. For instance, Effingham Health systems just agreed to pay a $4.1 million settlement as a result of a DEA investigation into reports that tens of thousands of oxycodone tablets were believed to have been diverted for four years.

Similar reports about large-scale diversion abound. The Associated Press reported incidents of diversion at about 1,200 VA facilities rose from 272 in 2009 to 2,926 in 2015.

And in 2013 Walgreens was charged $80 million for poor record-keeping and dispensing violations that let millions of doses of controlled substances to enter the black market.

In 2007, the Drug Enforcement Administration estimated that prescription drug diversion in the United States was a $25 billion-a-year industry. About one of every four thefts of methadone and OxyContin were attributed by the DEA to employee pilferage at pharmacies, hospitals and other healthcare facilities.

More recently, a 2017 survey by Porter Research, 96 percent of healthcare workers said drug diversion occurs frequently in healthcare. And 65 percent believe most diversion goes undetected.

Pill mills are even worse. In the book “American Pain,” journalist John Temple describes the impact of Florida pill mills on the east coast a decade ago.

“Florida pumped millions upon millions of doses of those narcotics—oxycodone, mostly—northward, not through a major criminal organization like the cartels of Mexico, but via thousands of individuals who streamed up and down Interstate 75 or flew from Tri-Sate Airport in Huntington, West Virginia, to Miami International, on a flight nicknamed the Oxy Express,” Temple wrote.

And none of this is remotely new. In the book “Dark Paradise,” historian David Courtwright explains: “Diversion from maintenance programs posed a real danger, given that perhaps half of all licitly manufactured barbiturates and amphetamines ended up on the black market.”

So the claim by Attorney General Jeff Sessions that "It’s a common sense idea: the more a drug is diverted, the more its production should be limited” is both simplistic and misguided.

Sessions is assuming that limiting production will reduce diversion. But economic theory suggests the opposite may be true. Reducing supply leads to scarcity, which generally increases value. This in turn may create stronger incentives to divert more opioids into the black market.

Moreover, there is no evidence that people who divert medication are aware of and responding to DEA production quotas. Instead, the consensus is that people divert what they need and think they can get away with. In other words, diversion is an exercise in what economists call the “Tragedy of the Commons,” in which individuals each use a collective resource for their own benefit without regard for the effects on others.

And Sessions’ idea implies that reducing production won’t have any effect on medical practice. But there is an abundance of evidence to the contrary. There is an ongoing shortage of injectable opioids at hospitals around the country. And despite claims to the contrary, opioid analgesics cannot always be replaced or substituted with other pain relievers.

Thus, more intelligent and nuanced approaches are needed. For instance, the NIH is sponsoring research to use advanced data analytics to detect drug theft and diversion in hospitals. Similar efforts at wholesalers, distributors, pharmacies and dispensaries are worth considering.

So while diversion is a major problem, it is neither new nor limited to individual consumers with prescriptions for opioids or other medications that have a street value or abuse potential. The seemingly obvious response of reducing supply could easily backfire. Instead, securing the entire supply chain, from manufacturer through distributor to point-of-sale to consumers, is a vital step in making sure that only the intended recipients of pharmaceutical drugs have access to them.

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.

What Every Patient Should Know About NarxCare

By Rochelle Odell, Columnist

Walmart and Sam’s Club recently announced that by the end of August their pharmacists will start using NarxCare, a prescription tracking tool that analyzes real-time data about opioids and other controlled substances from Prescription Drug Monitoring Programs (PDMP’s).

Recent studies question the value of PDMP’s, but 49 states have implemented them so that physicians, pharmacists and insurers can see a patient's medication history. Granted, there is a need for monitoring the select few who doctor shop and/or abuse their medications, albeit that number is only in the 2 percent range.

What is NarxCare? Appriss Health developed NarxCare as a “robust analytics tool” to help “care teams” (doctors, pharmacists, etc.) identify patients with substance use disorders. Each patient is evaluated and given a “risk score” based on their prescription drug history. According to Appriss, a patient is much more willing to discuss their substance abuse issues once they are red flagged as a possible abuser.

“NarxCare automatically analyzes PDMP data and a patient’s health history and provides patient risk scores and an interactive visualization of usage patterns to help identify potential risk factors,” the company says on its website.

“NarxCare aids care teams in clinical decision making, provides support to help prevent or manage substance use disorder, and empowers states with the comprehensive platform they need to take to the next step in the battle against prescription drug addiction."

Sounds great doesn't it? Except prescription drugs are not the problem and never really have been. Illicit drug use has, is, and will continue to be the main cause of the addiction and overdose crisis. 

Even the name NarxCare has a negative connotation. “Narx” stands for narcotics. And in today's environment, narcotics is a very negative word. NarxCare makes me feel like a narcotics police officer is just around the corner.

Each patient evaluated by NarxCare gets a “Narx Report” that includes their NarxScores, Overdose Risk Score, Rx Graph, PDMP Data and my favorite, the Red Flags. The scores are based on the past two years of a patient’s prescription history, as well as their medical claims, electronic health records and even their criminal history.

Ohio, Michigan, Indiana, Iowa, and several other states are using NarxCare to supplement their own PDMPs. And Walmart isn’t the only big retail company to adopt it. Kroger, Ralphs, Kmart, CVS, Rite Aid and Walgreens are already using NarxCare. There’s a good chance your prescriptions are already being tracked by NarxCare and you don’t even know it.

But NarxCare doesn’t just analyze opioid prescriptions. It also tracks other controlled substances, such as antidepressants, sedatives and stimulants. If a patient is on any combination of those drugs, their risk scores and their chances of being red flagged will be higher – even if they’ve been safely taking the medications for years.

There are several other ways a patient can be red flagged, such as having multiple doctors or pharmacies. But what if you moved and changed physicians? What if you had the same physician for many years and he/she retired or moved away? What if your pharmacy refused to fill your prescription and you had to go pharmacy hunting every month? What if you had dental surgery and your dentist placed you on a short-term pain medication?

Unfortunately, the NarxCare scores do not reflect any of that. How can raw data on prescription medications be an indicator of abuse? I believe there is some merit in tracking and weeding out the rare abuser, but NarxCare doesn't factor in all the “what if’s” that can happen to law-abiding and responsible patients. 

As pain patients, we need to be acutely aware of the negative impact this analytics tool can have. Many of us have already been required to sign pain contracts, take drugs tests, and undergo pill counts. In 2019, Medicare will adopt policies making it even harder for patients to get high doses of opioid medication. Some insurers are already doing it. We're already being policed enough as it is.

I intend to ask my physician, pharmacist and case manager if they utilize NarxCare. So should you. If they say yes, ask them why. Ask your doctor if they believe you are at risk for substance use disorder. Why is their judgement and treatment of you being second guessed by anyone?

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

FDA Uncovers Errors in Opioid Database

By Pat Anson, Editor

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA - a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. "The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year."

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two prominent healthcare research firms. The company released a statement saying it identified the problems in its opioid database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

If confirmed, the database errors would be the second admission by federal agencies this year that their analysis of opioid prescriptions relied on faulty data. In March, four researchers in the CDC’s ironically named Division of Unintentional Injury Prevention acknowledged that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths.

Overdose Crisis Boosts Organ Donations

By Pat Anson, Editor

Drug overdose deaths have reached unprecedented levels in the United States, with over 63-thousand people dying in 2016 from overdoses involving antidepressants, illicit fentanyl, heroin, prescription opioids and other drugs.

Those deaths have led to an unexpected gift for thousands of Americans who needed organ transplants. Researchers at University of Utah Health and Brigham and Women's Hospital say there has been a steady increase in the number of organs available for transplantation – due in large part to the escalating overdose crisis. They documented an 11-fold increase in the proportion of organ donors who died of drug overdoses from 2000 to 2016.

"We were surprised to learn that almost all of the increased transplant activity in the United States within the last five years is a result of the drug overdose crisis," said Mandeep Mehra, MD, medical director of the Heart and Vascular Center at Brigham and Women's Hospital and lead author of a research letter published in The New England Journal of Medicine.

Mehra and his colleagues examined transplantation records and found no significant change in the recipients' chance of survival when the organ donation came from an overdose victim. The survival rate of 2,360 patients after receiving a heart or lung transplant from donors who died from overdoses was no different than those who received organs from donors who died from gunshot wounds, asphyxiation, head injuries or stroke.

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply that may occur during an overdose. There are also fears the organs could be infected with HIV, hepatitis or other communicable diseases due to high rates of intravenous drug use by overdose victims. As a result, some organs harvested from overdose donors are discarded.

But researchers say those risks can be minimized with modern testing.

"I feel hopeful that doctors across the country will read this and feel confident that organs that pass the required tests are safe for transplant," said Josef Stehlik, MD, medical director of the Heart Transplant Program at University of Utah Health. "This awareness is especially important when organ procurement professionals have to decide on use of potential donors with this high-risk history."

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are nearly 115,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

"We must look to new ways to increase organ donor recovery by concentrating on greater use of marginal organs or by expanding the suitable donor pool by using new technologies to improve organ function before the transplant takes place," Mehra said.

A similar study recently published in the Annals of Internal Medicine also found an increase in the proportion of organ donors who died from an overdose. In 2000, only 1.1% of donors were overdose victims. By 2017, that grew to 13.4 percent.

"For people waiting on an organ transplant right now, I would like to think that our studies bring them hope that they could receive a transplant and have more donors that could help them," Dr. Christine Durand, a professor of medicine and oncology at Johns Hopkins University, told CNN. "We have an obligation to optimize the use of all organs donated. The donors, families and patients waiting deserve our best effort to use every gift of life we can."

FDA Commissioner Listening to Chronic Pain Patients

By Pat Anson, Editor

Chronic pain sufferers have long complained that they rarely get a seat at the table when important decisions are being made about opioid medication.

Last year President Trump’s opioid commission held five public hearings without ever inviting a patient, patient advocate or pain management physician to testify.  The Centers for Disease Control and Prevention also ignored the pain community in 2015 when it secretly drafted its opioid prescribing guideline, relying instead on the advice of addiction treatment specialists and anti-opioid activists.

Now there is a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S.

The Food and Drug Administration is seeking comments from patients only on the challenges they face finding treatment and on the effectiveness of opioids and other types of pain medication. Patients are invited to submit their comments by mail or in the Federal Register, and to attend a public meeting on July 9. Click here for more details.

The meeting is the latest in a series of step ordered by FDA Commissioner Scott Gottlieb, MD, to get more public input on how to deal with the opioid crisis.  In January, dozens of pain patients and their advocates expressed their concerns to the FDA’s Opioid Policy Steering Committee.

“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote in an online blog.

“We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients. This might include patients with metastatic cancer or severe adhesive arachnoiditis.”

SCOTT GOTTLIEB, MD

Gottlieb also signaled that the FDA is considering the development of prescribing guidelines for specific chronic pain conditions – not the one-size-fits-all approach taken by the CDC.

“We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs,” he wrote.

“In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.”

Although Gottlieb has angered some in the pain community with his crackdowns on kratom and stem cell clinics, he does appear to have a sympathetic ear for pain sufferers. In 2012, a full five years before becoming FDA commissioner, Gottlieb warned that heavy-handed enforcement actions by the DEA were interfering with patient care.  

“This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need,” Gottlieb wrote in a prophetic column published in The Wall Street Journal.

To leave a public comment for the FDA in the Federal Register, click here. Comments will be accepted until September 10, 2018.

Critics Say DEA Plan Could Worsen Opioid Shortages

By Pat Anson, Editor

Pain sufferers and patient advocates are overwhelming opposed to plans by the U.S. Drug Enforcement Administration to further restrict the supply of opioid medication to punish drug makers that allow too many of their painkillers to be diverted and abused. Health organizations also caution that the proposal could worsen an acute shortage of pain medication in the nation’s hospitals.

Over 1,500 people left public comments in the Federal Register on the DEA’s plan to change the rules governing opioid production quotas. Under the proposal, the DEA could arbitrarily reduce the amount of opioids a company can make -- even if it has no direct role in the diversion or abuse.

"It’s a common sense idea: the more a drug is diverted, the more its production should be limited," said Attorney General Jeff Sessions. 

But critics say the plan will not prevent opioid abuse and will likely harm patients.

“The DEA has no business deciding how much valid medicine can be produced. The doctors prescribing the medicine should dictate the amount. The DEA is going to cause a crisis,” wrote Tina Liles.

“Reducing opiate medication has done nothing to help the rate of overdose deaths in this country because opioid prescriptions are not the issue in this country it is illicit fentanyl and heroin,” said Nicole Garage.

“Limiting access to the only medication that helps to control severe, intractable pain will not stop the crisis; those who abuse or sell drugs illegally have not stopped due to current quotas and will not stop with any new quota reductions,” said James Loranc.

“The logic (behind) this DEA proposal is completely untested, unproven, and unsupportable. The shortages being seen in hospitals and by pain patients will only get worse with further DEA cutbacks, leading to more mistakes, waste, and higher costs, not to mention additional pain,” said Valerie Padgett Hawk, Director of a Coalition of 50 State Pain Advocacy Groups.  

Hospitals Rationing Opioids

The shortages mainly involve injectable opioids such as morphine, hydromorphone and fentanyl, which are used to treat acute pain in patients recovering from surgery or trauma. Hospitals have been forced to ration opioids or use other pain medications that are not as effective.

“With limited availability of some opioids, operations may have to be postponed or cancelled.  In some cases, this could prove life‐threatening to the patient,” wrote Janis Orlowski, MD, Chief Health Care Officer for the Association of American Medical Colleges. “We urge the DEA to remember that opioids are also an important part of treatment regimens for controlling acute and chronic pain in a variety of patients – including trauma, postoperative and patients with advanced stage cancer – and any limits on quotas should not negatively impact access for patients that have a legitimate and critical need for these medications.”  

“Please, I beg you, don't do this. My dear friend Sarah takes painkillers for her rheumatoid arthritis. Even with the medication it's terrible; without it, I have no doubt she'll kill herself. Her mental health is already fragile,” wrote Kelsey Hazzard. “This regulation will destroy her.”  

“For the love of God let the doctors and pharmacists handle prescribing and filling prescriptions and allow the patients and doctors to worry about how much opioid pain medication they need to take. This is none of the DEA’s concern!” wrote Brandon Tull, a disabled police officer who shared the tragic story of Jennifer Adams, a Montana pain patient who recently committed suicide.

“That suicide will probably be the first in a long line if you continue this attack upon innocent chronic pain sufferers!”

The public comment period on the DEA proposal ended May 4th. The public was given only 15 days to comment in the Federal Register on the rule change. Public comment periods are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25% in 2017, followed by a 20% cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Under the proposed rules, the DEA would be required to consult with states, Food and Drug Administration, Centers for Disease Control and Prevention, and the Department of Health and Human Services before setting opioid quotas. The rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics” with the legitimate needs of pain patients.    

Although overdose deaths from heroin, illicit fentanyl and other street drugs now surpass those from pain medication, the DEA claims prescription opioids are gateway drugs to long-term substance abuse.

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the DEA said.

According to the National Institutes of Health (NIH), only about 5 percent of patients taking opioids as directed for a year end up with an addiction problem. And the DEA itself estimates that less than 1% of legally prescribed opioids are diverted.