CDC Admits Rx Opioid Deaths ‘Significantly Inflated’

By Pat Anson, Editor

Researchers with the Centers for Disease Control and Prevention have acknowledged that the agency’s methods for tracking overdose deaths are inaccurate and have significantly overestimated the number of Americans that have died due to prescription opioids.

In an editorial appearing in the American Journal of Public Health, four researchers in the CDC’s Division of Unintentional Injury Prevention say many overdoses involving illicit fentanyl and other synthetic black market opioids have been erroneously counted as prescription drug deaths.

“Availability of illicitly manufactured synthetic opioids (e.g., fentanyl) that traditionally were prescription medications has increased. This has blurred the lines between prescription and illicit opioid-involved deaths,” they wrote. “Traditionally, the Centers for Disease Control and Prevention (CDC) and others have included synthetic opioid deaths in estimates of ‘prescription’ opioid deaths. However, with IMF (illicitly manufactured fentanyl) likely being involved more recently, estimating prescription opioid–involved deaths with the inclusion of synthetic opioid–involved deaths could significantly inflate estimates.”

How inflated were the overdose numbers?  Using the agency’s “traditional definition” for prescription opioids, the CDC estimated that 32,445 Americans died from overdoses of pain medication in 2016.

Under a new “conservative definition” – one that excludes the “high proportion of deaths” involving synthetic opioids like fentanyl – the death toll from prescription opioids is cut nearly in half to 17,087 overdoses.

The researchers note that even that estimate is likely wrong for a variety of reasons:

• The number of deaths involving diverted prescriptions or counterfeit drugs is unknown
• Toxicology tests cannot distinguish between pharmaceutical fentanyl and illicit fentanyl
• Drugs are not identified on death certificates in 20% of overdose deaths
• Multiple drugs are involved in almost half of drug overdose deaths

The editorial by CDC researchers Puja Seth, Rose Rudd, Rita Noonan and Tamara Haegerich carries a disclaimer that their views “do not necessarily represent the official position” of the CDC.  But given the agency’s past reluctance to let employees speak to the media without prior approval, it’s highly unlikely the editorial was not cleared beforehand.

A spokesperson for the CDC said the agency first noticed the growing number of deaths caused by illicit fentanyl in  2015 and changed the way it calculated opioid overdoses that year. She said the explanation for the change was being published now "to document the method in peer-reviewed literature."

However, as one of our readers pointed out, the inflated overdose numbers can still be found on the agency's website, with only a vague explanation that some may be fentanyl-related:

"In 2016 there were 32,445 deaths involving prescription opioids, equivalent to about 89 deaths per day. This was an increase from approximately 22,598 in 2015. However, a significant portion of the increase in deaths was due to deaths involving synthetic opioids other than methadone, which likely includes illegally-made fentanyl."

President Trump's opioid commission warned last year that a better system was needed to keep track of overdose deaths. “We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the commission said in its final report.

The CDC has recently implemented a new overdose surveillance system in 32 states that supplements data from death certificates with toxicology tests and death scene investigations to more accurately reflect which drugs are involved in overdose deaths.

Lies and Damned Lies

We’ve written before about how confusing, flimsy and exaggerated the numbers can be for overdoses (see “Lies, Damned Lies, and Overdose Statistics”). Last October, PNN reported that the Drug Enforcement Administration changed its definition of prescription drug deaths for three consecutive years in an annual report, apparently in an effort to inflate the number of Americans dying of overdoses.

In 2016, we reported that within one week the CDC and the White House Office of National Drug Control Policy released three different estimates of the number of Americans that died from prescription opioids the year before. The numbers were wildly different, ranging from a low of 12,700 to a high of 17,536 deaths.

To be clear, one overdose is too many. But if we are ever going to find real solutions to the overdose crisis, we need to find accurate numbers to reflect what is causing so many drug deaths. Pinning the blame on prescription opioids, pain patients and prescribers has only led to a growing catastrophe in pain care –  where doctors are too fearful to prescribe opioids and patients can’t get treatment. 

As the CDC researchers say in their editorial, "inaccurate conclusions” not only mask what’s driving the overdose crisis -- they mask the solutions too.

“Obtaining an accurate count of the true burden and differentiating between prescription and illicit opioid-involved deaths are essential to implement and evaluate public health and public safety efforts,” they wrote. “If deaths involving synthetic opioids—likely IMF—are categorized as prescription opioid overdose deaths, then the ability to evaluate the effect of interventions targeting high-risk prescribing practices on prescription opioid–involved deaths is hindered. Decreases in prescription opioid–involved deaths could be masked by increases in IMF deaths, resulting in inaccurate conclusions. ”

Human Rights Watch Investigating U.S. Pain Treatment

By Pat Anson, Editor

Human Rights Watch is well-known internationally for its groundbreaking reports on human rights violations around the world. The organization has recently reported on the torture of prisoners in Sri Lanka, forced labor in Thailand, and corruption and mass arrests in Saudi Arabia.

Pain News Network has learned the New York-based non-profit is turning its attention closer to home – by launching an investigation into the treatment of chronic pain patients in the United States. The impetus for the investigation began when researchers were studying the treatment of cancer and palliative care patients – and began to see poorly treated pain as a human rights issue.

“People we interviewed who didn’t have access to appropriate medications for their pain were essentially giving testimony that was almost exactly the same as the testimony we were getting from the victims of police torture,” says Diederik Lohman, Director of Health and Human Rights for Human Rights Watch.

“And we realized this was actually one of those issues that almost no one was paying attention to. People were facing tremendous suffering that actually could be relieved pretty easily through very inexpensive palliative care and pain management.”

In many third world countries, Lohman says opioid pain medications like morphine are difficult to obtain, even for patients dying of cancer.

“They would say the pain was just unbearable, that they would do anything to make it stop, and many of them would tell us that they asked their doctors to give them something to put them out of their misery,” he told PNN.

Recently those same stories have been coming from pain patients in the United States.  

“As we started looking at this issue more closely, we started hearing more and more stories of chronic pain patients in the U.S. who had been on opioids, who were being told by their physicians that 'We have to take you off.'  And we started hearing stories of patients who were having a lot of trouble finding a doctor who’s willing to accept them as a patient,” said Lohman.

Lohman says Human Rights Watch is well aware of the addiction and overdose crisis in the U.S. But he says the “right balance” needs to be found between keeping opioids off the street and making sure medications are still available to legitimate patients.

‘CDC Clearly Knows What’s Going On’

Part of the investigation will focus on the role played by the opioid guidelines released by the Centers for Disease Control and Prevention in 2016, which discourage doctors from prescribing opioids for chronic pain. Although voluntary and intended only for family practice physicians, the CDC guidelines have been widely adopted as mandatory rules by other federal agencies, states and insurers.  

The impact of the guidelines was sudden and powerful. Within a year of their release, a PNN survey of over 3,100 pain patients found that 71 percent had their opioid medication stopped or reduced. Nearly 85% said their pain and quality of life were worse.

“The CDC clearly knows what's going on and they haven’t taken any real action to say, ‘That is not appropriate, involuntarily forcing people off their medications. That’s not what we recommended,'" Lohman said. “When a government puts in place regulations that make it almost impossible for a physician to prescribe an essential medication, or for a pharmacist to stock the medication, or for a patient to fill their prescriptions, that becomes a human rights issue.”

Human Rights Watch is looking for testimonials from chronic pain patients who have been forced or encouraged to stop their opioid medication by physicians or pharmacists. They’d also like to hear from patients who have been forced or encouraged to seek alternative forms of treatment, but who then found those treatments financially or geographically inaccessible.

Input from doctors affected by the opioid guidelines, regulations and anti-opioid climate is also welcome.

Investigators are particularly interested in hearing from patients and doctors in West Virginia, Massachusetts, Maine, Washington, North Carolina, Florida and Montana.

“Our work is heavily reliant on the testimonies of people who are directly affected. That’s been our methodology of work for many years,” says Lohman. “We would like for our work to actually help move things in the right direction. But it’s important to document what’s going on.”

(Update: Human Rights Watch has been flooded with responses to this story. At this time, they do not need any additional stories from pain patients. They plan to complete their investigation and release their findings by the end of the year.)

How the Opioid Crisis Has Changed

By Roger Chriss, Columnist

The CDC recently released its first annual “Surveillance Report of Drug-Related Risks and Outcomes,” a lengthy and data filled study that documents the changing nature of the opioid crisis. Much attention is paid to declining rates of opioid prescribing, rising rates of heroin and fentanyl overdoses, and the increasing number of multiple or “poly-drug” overdoses.

According to the report, efforts to rein in opioid prescribing have succeeded in ways that are often not recognized:

• Opioid prescriptions fell 4.9% each year between 2012 and 2016.
• High-dose opioid prescriptions (above 90 MME) dropped 9.3% annually from 2009 to 2016.
• In 2016, there were 66.5 opioid prescriptions per 100 persons, down from 72.4 opioid prescriptions per 100 persons in 2006.

Much of this decline came before the release of the 2016 CDC opioid guidelines and subsequent efforts by state governments, health insurers, and drug store chains like CVS to reduce prescribing.

In 2016, opioid prescribing in the U.S. was at about three times the level of 1999 -- still high, but  down from the peak of four times the 1999 level. At the current rate of reduction, we will reach twice the 1999 level sometime next year and be back to 1999 levels by early 2021 at the latest. Ongoing moves by regulators and insurers to reduce opioid prescribing may accelerate this process.

Clearly, as the report states and many pain patients already know, healthcare providers are “becoming more cautious in their opioid prescribing practices.”

Tragically, similar success is lacking in the overdose crisis.

In 2015, the most recent year covered in the report, 52,404 people died of drug overdoses. About 63% of those deaths involved an illicit or prescription opioid, with heroin being the most common cause in 12,989 deaths. The other 37% of deaths involved non-opioids such as cocaine and methamphetamines. Over 5,000 deaths were identified as suicides and nearly 3,000 were identified as having undetermined intent.

The CDC report estimates that about 2 million people are addicted to prescription opioids and nearly 600,000 Americans are addicted to heroin. These numbers have remained largely unchanged since 2012, meaning that there has been little if any progress in preventing opioid addiction.

Limits on opioid prescribing have also not resulted in fewer deaths. Overdose fatalities are still rising sharply, mostly because of heroin and illicit fentanyl.

"Prescription opioid pain relievers were formerly driving the crisis, but by 2015 they shared equal measure with heroin, synthetic opioids other than methadone (mostly illicit fentanyl), and – increasingly-- cocaine and methamphetamines,” the report found.

In the two years since 2015, the final year for overdose data in the report, drug deaths have spiked higher. In 2016 there were 63,632 fatal overdoses and the early analysis for 2017 suggests the numbers are even worse. The handful of states that are seeing a decrease in drug deaths are attributing it largely to the increased use of naloxone to revive overdose victims.

Also alarming is that in 2015, around 33 percent of heroin users had initiated use with that drug rather than with opioid analgesics or some other substance. And heroin, illicit fentanyl, and virtually every other drug are now readily available on darknet markets.

At present, overdose rates are rising for virtually every major class of drug. The only class of drug that has seen a drop is prescription opioids.  

The opioid crisis is real, though as the CDC report shows, it is fast becoming an overdose crisis driven primarily by more potent and risky street drugs. Opioid medication is just one of many substances involved and its role is decreasing.

The CDC report concludes ominously: “Additional measures are now urgently needed to address a diverse and evolving array of drug types.”

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.

Senator’s Letter Ignores Constituent’s Chronic Pain

By Pat Anson, Editor

Pain News Network received hundreds of comments and emails from readers responding to the open letter we published from Charles Malinowski, a 59-year old California man who suffers from Reflex Sympathetic Dystrophy (RSD) and other chronic pain conditions.

Malinowski is no longer able to obtain opioid medication and blames the CDC opioid guidelines for his “unspeakable and crippling pain.”

CHARLES MALINOWSKI

“Within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that,” Malinowski wrote in his letter. “Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick.”

Malinowski’s letter to Senator Kamala Harris (D-CA) hit home with many readers, who say they’ve been abandoned by doctors who are fearful of prescribing opioid medication.  

“You are correct in saying the CDC is in effect murdering us. I too suffer from chronic pain and am unable to obtain pain meds from a doctor due to CDC guidelines,” wrote one reader.

“I just read your letter and cried all the way through it. My son in law will turn 50 this month and has been living with RSD for over 8 years. His story is a carbon copy of yours. Since the change in his meds about a month ago, (he) is now showing signs of heart trouble,” wrote Jo Ellen.

“Charles you are not alone and this attack on pain patients is affecting every pain patient nationwide,” wrote Pam. “This is terrorism at its finest folks. How many more pain patients will die due to a fictitious opioid epidemic?”

“I’m stuck in bed suffering inhuman pain 24-7 days a week. I’m lucky I have sanity now to write this. For 17 years I was under the watchful eye of a very educated doctor. Now abandoned by all in the medical field,” wrote Christine.

“This exact thing happened to my husband. He unfortunately passed away from a heart attack 6 months later,” wrote Sharon. “I pray your letter falls into the correct place to save your life and many others that are now in the same situation.”

And what about Sen. Harris, who Malinowski wrote his letter to?

She sent him a form letter that completely ignored his severe pain and life-threatening situation. It focused instead on combating opioid abuse and treating addiction.

“Thank you for reaching out to me to express your concern about the opioid crisis,” Sen. Harris wrote. “This administration and Congress must treat opioid abuse as a public health crisis. We need more funding to combat the opioid epidemic that is threatening millions.”

Malinowski replied to Sen. Harris with a second letter.

“I was very disappointed to discover that your response to me was an apparent boilerplate letter about continuing the already out-of-control hysteria over the so-called opioid epidemic,” Malinowski wrote. “My letter had nothing to do with controlling the illicit dispersal of opioids.

SEN. KAMALA HARRIS (D-CA)

"My letter was about the new CDC opioids guidelines being a literal death sentence for people like me. This is a literal death sentence because medication we depend upon is being withheld from us in a grossly and medically irresponsible manner. How you could have completely missed the blatantly obvious topic of my letter and responded so completely off-topic is simply beyond me. I think your response was shamefully ignorant and completely irresponsible.”

Unfortunately, this is not the first time we’ve heard from patients who wrote to their senator or congressman about the poor state of their pain care and gotten a form letter in response about the “opioid epidemic.” Which is no reason to stop trying or holding politicians accountable.  

“I want to hear from you. Contact me,” Sen. Harris says on her homepage. 

PNN tried to contact you, Sen. Harris. We emailed, called and left messages at your offices in Washington and Los Angeles several times in the last two weeks. Not only were we unable to speak to anyone on your staff, we couldn't even get someone to answer your phone. And we have yet to get a reply.

Neither has Charles Malinowski.  

(Update: On January 26, I finally received a reply from Sen. Harris.  But her emailed letter was yet another misdirected form letter. It thanked me for reaching out "to share your views opposing abortion."   

CDC Ignored Warning About Opioid Guidelines

By Pat Anson, Editor

A consulting company hired by the Centers for Disease Control and Prevention warned the agency last year that many doctors had stopped prescribing opioid pain medication and that chronic pain patients felt “slighted and shamed” by the CDC’s opioid guidelines.

“Some doctors are following these guidelines as strict law rather than recommendation, and these physicians have completely stopped prescribing opioids,” PRR warned in a report to CDC in August 2016, five months after the CDC released its guidelines.

“Pain patients who have relied on these drugs for years are now left with little to no pain management options. Chronic pain is already stigmatized. Now chronic pain patients face the stigma of addiction, even when they are using opioids responsibly for pain management.”

PRR is a well-connected marketing and public relations firm based in Seattle that has worked for a number of companies and public agencies, including the Environmental Protection Agency, Starbucks, Nike, and the University of Washington.

PRR was hired by the CDC to improve the agency’s public image and to develop a communication strategy to help educate the public about the CDC’s controversial opioid guidelines.

Those guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and only intended for primary care physicians. But they’ve been widely adopted as mandatory throughout the U.S. healthcare system, causing additional pain and anxiety for millions of pain sufferers.

“Chronic pain patients feel or perceive that the CDC has failed them because doctors are making extreme generalizations in determining appropriate care for their pain patients,” PRR found.

The PRR report to CDC was obtained by Pain News Network under the Freedom of Information Act.  Excerpts from the report can be seen by clicking here.

PRR recommended that CDC take a number of steps to understand why the guidelines were being so poorly received by patients.

“CDC should consider conducting more research to understand the fears and concerns of patients with chronic pain conditions. Understanding this group’s perceptions and fears of the PDO (prescription drug overdose) guidelines will help the CDC more successfully communicate with patient advocacy groups and will help insure their targeted messages are being disseminated to patients,” PRR recommended.

“Overall, this will help CDC message and communicate to those living with chronic pain and help providers and patients understand best care options available to enhance and improve quality of life.”

No CDC Response to Recommendations

There is no evidence that CDC has followed through on the recommendations. When asked if the agency had conducted any research or surveys of pain patients in response to the PRR report, the CDC gave us only a brief and vaguely worded statement. Note the use of the word “will.”

“CDC will evaluate the uptake, utility, and public health impact of the guideline and will monitor and assess physician and patient response to the guideline; based on this information, we will update the guideline in the future, as needed.

CDC continues to develop resources for patients and providers about the risks and benefits of opioid therapy for chronic pain to improve the safety and effectiveness of pain treatment and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death.”

CDC pledged in March 2016 to make changes to the guideline “if new evidence becomes available” and said it was “committed” to evaluating the guideline’s impact – “both intended and unintended.”

But in the 17 months since that pledge was made, there has apparently been no effort by CDC to assess the guideline’s impact on pain care, doctors, patients, suicides, addiction or overdoses -- at least none that the agency will talk about.

“We’ve provided you our statement,” a CDC spokesperson said in an email.

PRR also declined to answer any questions about its report or if any follow-up research is being done.

“We are proud of our work, and we respect client communications protocols. Therefore, we refer you to the CDC to ask your questions directly,” said Jennifer Lynch, PRR’s business development manager.

For the record, this reporter was one of five individuals interviewed by PRR last summer, and asked a series of questions about the CDC guideline. Others who were surveyed include Barby Ingle of the International Pain Foundation, Paul Gileno of the U.S. Pain Foundation, chiropractor Sean Konrad, and Dr. Lynn Webster, a pain management expert and past president of the American Academy of Pain Medicine.   

“I was contacted by the PRR firm as well.  I was told that the CDC wanted to know what they did wrong with the opioid prescribing guidelines,” recalled Webster. “I think it is clear that the CDC should have had more input from the pain community in developing the opioid guidelines.

“Any intervention by the CDC or any government agency that affects millions of people should be accompanied with a plan to assess the effect of the intervention. In other words, the CDC should have planned to measure the effect on intended goals and any unintended consequences from the intervention.”

"CDC recommends close follow-up for patients who are using opioids to treat chronic pain, but they don’t seem to be eager to apply that same advice to their own intervention," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. "CDC seems to be eager to evaluate the impact of its guideline in terms of metrics such as number of opioid prescriptions written, but they seem to have little concern about assessing the extent to which decreased prescribing is adversely affecting people with pain.

"In all the discussion about the evidence base supporting the guideline, what seems to have gotten lost is a need to develop the evidence base to show how effective or ineffective that intervention has been. Unfortunately, this lack of evaluation is consistent with CDC’s lack of interest in evaluating the prevalence and demographics of chronic pain itself."

Guidelines Made Pain Care Worse

There have been many unintended consequences caused by the guidelines. In a survey of over 3,000 patients and nearly 300 healthcare providers by PNN, eight out of ten patients said their pain and quality of life had grown worse. Many patients are having suicidal thoughts, and some are hoarding opioids or turning to illegal drugs for pain relief.   

Over half of the healthcare providers said they had stopped prescribing opioids or were prescribing lower doses. Many providers also believe the guidelines are ineffective or have made pain care worse:

• 40% believe CDC guidelines have been harmful to patients, while only 22% consider them helpful
• 67% believe guidelines have made it harder for pain patients to find a doctor
• 63% believe the guidelines have not improved the quality of pain care
• 66% believe guidelines have not been effective in reducing opioid abuse and overdoses
• 35% of providers are worried about being prosecuted or sanctioned for prescribing opioids

“I am not sure the CDC is aware of the increased legal trouble many physicians are experiencing as a result of the guidelines. Most of these physicians are just trying their best to help people in pain but are being accused of criminal conduct,” said Webster.

Webster was apparently the only pain management physician interviewed by PRR. The company also reviewed 11 online articles and blogs (about half written by doctors), which gave the guidelines mixed reviews.  PRR's bare bones analysis could hardly be called comprehensive, yet two federal health officials portrayed it as a ringing endorsement of the guidelines by physicians.

“Practitioners are excited to see action taken to address the PDO epidemic,” wrote Tonia Gray and John O’Donnell of the Substance Abuse and Mental Health Services Administration in an appendix to the PRR report. “From our scan of responses, PRR found that many agree this is a step in the right direction to help providers make informed decisions and stem the PDO issue.”

That assessment certainly doesn't reflect the thoughts of Dr. Webster.

“I would urge the CDC to reassess their process and attempt to understand the unfortunate consequences their well-intended but misinformed decisions have had,” said Webster.

“One presumably unintended consequence is the recommendations/guidelines have been adopted as rules and laws, which has resulted in a significant change in care for millions of patients.  The guidelines were never intended to do that – they lack the backing of scientific evidence to be treated as a law.”

CDC has made few efforts to remind doctors, insurers, politicians and state regulators that the guideline is voluntary and only intended for primary care physicians. One of the few was a letter from a top CDC official to Richard Martin, a retired Nevada pharmacist disabled by chronic back pain.

“All of you at the CDC and like-minded groups, individuals, etc. are causing hundreds of thousands, if not millions of people, to suffer in pain needlessly,” wrote Martin, who sent 27 letters and emails to the agency before getting a response from Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention.

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients,” wrote Houry, who oversaw the development of the guideline. “The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

Houry’s letter to Martin was dated June 1, 2016, a full two months before CDC received the PRR report, suggesting that CDC was already aware that problems were developing with the guideline and that many physicians considered it mandatory.

CDC 'Propaganda'

To be clear, PRR’s review of patient and doctor attitudes about the guideline was only a small part of the work it performed for CDC. PRR also provided media training to CDC officials, analyzed news and social media coverage of CDC projects, developed logos and brands, shot promotional videos and pictures, and performed other work traditionally associated with public relations projects.

PRR also developed a series of fact sheets and graphics to help CDC promote the opioid guideline – many of which are still in use today.

The graphics advise doctors that “opioids are not first-line or routine therapy for chronic pain” and that physicians should “start low and go slow” when opioids are prescribed. They also encourage doctors to tell patients that “there is not enough evidence that opioids control chronic pain effectively long term.”

One PRR graphic claims that "as many as 1 in 4 people" who take opioids long-term become addicted. The graphic is based on a single study that even the author admits may have been biased and used unreliable data. A longtime critic of the CDC calls the graphic "propaganda."

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem. Other estimates put the addiction rate higher and some lower.

prr designed graphic

It’s been difficult to assess how much PRR was paid for its work. Invoices sent to CDC indicate the original budget for the project was $240,596, but there were numerous delays and changes in the work performed. The invoices have been heavily redacted by the agency at the request of PRR, which considers the information proprietary.     

Pfizer Agrees to Support CDC Opioid Guideline

By Pat Anson, Editor

Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s "voluntary" recommendations as policies or even law.

As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them. We have tried to keep you informed and aware of these facts.

Now one of the world’s largest drug makers has agreed to not make any statements that conflict with the CDC guideline and to withdraw support for any organizations that challenge it. Pain News Network is among them.

In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”

That voluntary guideline discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.

Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a $10,000 charitable grant awarded to PNN. Pfizer had sponsored PNN’s newsletter for the past year.  

"Kindly note Pfizer recently entered into an agreement with Santa Clara County, California that places limits on Pfizer’s ability to provide opioids-related funding to outside organizations.  After careful consideration, we regret to inform you that we are unable to support your request and must rescind the previous approval notification," the email said.

“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”

Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and exaggerated their benefits.

“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”

Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release and little known pain medication called Embeda.

As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no studies supporting the use of opioids long-term for pain relief. Pfizer signed a nearly identical agreement with the city of Chicago last year to avoid litigation.

Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.

In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses.

Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

The Case for Opioid Therapy

By Jordan LaMark, Guest Columnist

I take opioid pain medication and I am not ashamed of it. I refuse to feel guilty for needing medication.

I am not an addict. I do not deserve to be treated like a criminal – and for that matter, neither do addicts. I should not have to jump through hoops, be subjected to intense scrutiny, and constantly be forced to prove how much pain I’m in to receive my medication. It shouldn’t be a battle to receive treatment.

I live with Ehlers Danlos syndrome, a chronic incurable condition that causes daily unceasing pain. The pain wears at me, saps my energy, and severely restricts my functionality.

I also battle many other symptoms -- chronic fatigue, nausea, dysfunction of my autonomic nervous system, and failure of my digestive tract that requires me to be fed by a surgically implanted feeding tube (which is also very painful, and has altered my core muscles and posture). I sometimes need a wheelchair to get around and often cannot leave the house for days.

I spend most of my time dealing with my medical conditions. My pain medication gives me some relief and improves my functionality without negative side effects. I also use many other techniques to deal with my pain, including several forms of therapy, and I’ve had two surgeries to treat severe endometriosis.

Despite all of this, I am a happy person and do as much as I physically can, spending time with my family, going to church and daytime events, even the beach. Now, however, I am afraid that there may come a point when I may be unable to obtain the medication that improves my quality of life.

JORDAN LAMARK

There is no doubt an opioid abuse problem in our nation. However, the answer is not to enact reactionary laws and restrictions that make it harder for patients with a legitimate need to receive their medication. The conversation about opioids has been focused on acute patients and those who have had surgery or an injury, but has neglected to mention the unintended victims of anti-opioid campaigns: chronic pain patients who will most likely need medication for the rest of their lives.

Neglected also is that most of the abuse of prescription opioids takes place outside of the doctor-patient relationship. The World Health Organization tells us the risk of dependence and diversion is low when opioids are prescribed for pain. Studies also show that physician prescribed opioids are not the primary source of diversion and that theft from the drug distribution chain is an important source of illicit pain medication.

The CDC, along with other organizations and federal and state governments, has overstepped its authority by releasing a set of guidelines for opioid prescribing. Although the guidelines do not prohibit the prescription of opioids, they have increased the complexity and effort involved in getting them. This has had the same effect as declaring them illegal. Most doctors that I’ve talked to flatly state that they don’t prescribe opioids anymore.

I recently saw a pain doctor at one of the best hospitals in the country and was told that their policy is to not prescribe opioids to non-cancer patients. When asked what I should do, since in my case other methods either have not worked or cannot be used due to side effects, the doctor said he did not have a suggestion and wished he could prescribe them for me, but was unable to.

Many patients are having their dosages reduced in response to the CDC guidelines, and some are left with the heart-wrenching prospect of having their medication completely cut off. Many are now being forced to undergo monthly drug tests in order to receive treatment, even when there is no reason to suspect abuse. Our criminal justice system treats suspects as “innocent until proven guilty,” but the same logic does not seem to apply in this case.

I have personally had a pharmacist at a major chain refuse to fill my prescription and lie about the reason why, and then make negative comments about it to my face. I have had several doctors express concerns about legal action and increased government interference in opioid prescription, and cite these as reasons for not prescribing.

One pain specialist gave me several reasons that doctors are now hesitant to prescribe opioids. Number one, of course, was public and government pressure, followed by the increased complexity of prescribing and the fear of losing his license.

Another reason cited was the lack of an “equation” to tell doctors what and how much to prescribe. I think that is a faulty argument. Psychiatric drugs, for example, do not have such an equation or rubric --that is left up to the doctor’s discretion, as it should be.

I have been denied coverage for a treatment because my condition was not on my insurance company’s list of those approved to receive the treatment. Someone who had never met me decided he or she knew better than my doctor (and I) what potentially life-saving treatment I could receive.

Doctors often suggest “alternative treatments” such as cognitive behavioral therapy, which is usually not covered by insurance; acupuncture, which is almost never covered; and physical therapy, which becomes very expensive even with insurance if you are going several times a week for months. Medical marijuana is not covered and is prohibitively expensive. These alternative therapies, while worth trying, do not help everyone.  ­

If the medical industry and government are really serious about promoting alternative, non-opioid therapies, then they should be made affordable. Continuing to say “opioids are bad” and promoting restrictive laws does not stop illicit drug use and only hurts those who need them. These decisions should not be made by insurance companies or the government, they should be up to the individual physician and patient.

I have a feeding tube that was surgically placed and has forever altered my body. I have an open wound that causes pain and infections. The surgery carried risk, the act of changing the tube every few months carries a risk, and the tube’s mere presence is a risk. And yet, it’s all worth the risk because it keeps me alive. My pain medication takes the life that the tube has saved and makes it a life worth saving.

The medical industry does not have to bow to public or political pressure. This is the time for doctors and patients to stand up and reject reactionary responses. Do not take away the only relief many of us have.

Jordan LaMark lives with Ehlers-Danlos Syndrome and comorbid conditions, including Mast Cell Activation Syndrome (MCAS) and gastroparesis, for which she has a permanent feeding tube.

Jordan is the founder of Digesting that Facts, a website about living with her various medical conditions that includes educational information and research articles.

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.

CDC: Opioid Prescribing Peaked in 2010

By Pat Anson, Editor

The Centers for Disease Control and Prevention admitted something today that most doctors and pain patients could have told the agency several years ago: prescriptions for opioid painkillers are declining.

In its newest Vital Signs report, the CDC analyzed prescription drug data compiled by QuintilesIMS from 2006 to 2015, and found that opioid prescribing in the U.S. peaked in 2010.  More recent data indicates the downward trend continued in 2016.

The CDC's new report undermines one of the main reasons behind the agency’s 2016 opioid prescribing guidelines, which falsely claimed that “opioid prescriptions per capita increased from 2007 to 2012,” when, in fact, they actually declined (see chart below).  

“Overall, opioid prescribing in the United States is down 18 percent since 2010,” said CDC Acting Director Anne Schuchat, MD.  

But even with that downward trend in prescribing, the CDC maintains opioid doses are still too high and contributing to the nation’s overdose crisis.

“Despite these overall declines, the bottom line remains we still have too many people getting opioid prescriptions for too many days at too high a dose,” said Schuchat. “In addition, the dramatic increase we’ve been seeing in heroin overdose is another tragic consequence of exposing too many people to prescription opioids, since most people who use heroin started off with misusing prescription opioids.”

Schuchat did not explain how her theory could account for the fact that heroin overdoses were increasing at a time when opioid prescriptions were declining. The association between heroin use and prescription painkillers is a common misconception at best, and a misleading half-truth at worst.

While many heroin users start out with painkillers (as well as tobacco, marijuana, alcohol and other drugs), most obtain their opioids illegally through friends, relatives and the black market. Heroin use by patients who are legally prescribed painkillers is actually quite rare, although the CDC's acting director makes it sound like one of the leading causes of overdoses.

"We're now experiencing the highest overdose drug death rates ever recorded in the United States, driven by prescription opioids and illicit opioids like heroin and illicitly manufactured fentanyl," Schuchat said.

Contrary to its own prescribing guideline, the CDC found that the average per capita daily morphine equivalent dose (MME) has been in decline for nearly a decade, from 59.7 MME per capita in 2006 to 48.1 MME in 2015.

The latter dose is well below the highest recommended limit of 90 MME in the CDC guidelines.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVELANT DOSE (MME)

Source: CDC/QuintilesIMS

The CDC also found a wide variation in prescribing practices around the country, with six times more opioids per resident dispensed in the highest-prescribing counties than in the lowest-prescribing ones.

Many of the high-prescribing counties are in rural, economically depressed areas such as Appalachia, where there are high rates of disability, suicide and unemployment; suggesting that the so-called "opioid epidemic" is actually more of an epidemic of despair. Other factors associated with high rates of opioid prescribing are a high percentage of white residents, high rates of uninsured or Medicaid recipients, and high rates of patients with diabetes and arthritis.

CDC Guidelines Making Opioid Problem Worse

By Gary Nations, Guest Columnist

I’m a medically retired police officer with over 22 years of service. I have been in chronic pain management for many years now and my condition will never get better.

Throughout my time dealing with workers compensation and the public employee retirement system in Mississippi, I have been examined by no less than five medical doctors. Unfortunately for me, the conclusion is my condition is progressive and will only get worse.

I’ve had four neck surgeries and one lower back surgery due to on-the-job injuries. For the past few years I have found a pain management regimen that allows me to have somewhat of a normal life, although I still experience pain 24/7. I would love to see a substance that relieved pain without the problems caused by opioid medication.

The recent upswing in deaths from opioid abuse is tragic. However, the guidelines developed by the CDC for doctors to reduce opioid dosages for pain patients like me will cause more problems than it solves.

I believe some of the actions taken so far have created a vacuum and worsened the epidemic, which I believe is about to get much bigger.  Some people are going to abuse some type of substance no matter what. That’s an unfortunate fact that cannot be stopped.

Cutting the dose of medication for people in my position who need it will force them to violate the law to maintain their level of pain management and quality of life.

GARY NATIONS

This could prove a disaster, as we know many street drugs contain powerful opioids such as fentanyl, which the DEA has been very unsuccessful in stopping. Some of these street drugs are counterfeit. They appear to be a medication that a doctor would prescribe, yet they contain other drugs that cause people to overdose and die. From what I read and understand, this is what happened to the entertainer Prince. Some patients may also tire of the constant pain and commit suicide with street drugs.

The Declaration of Independence endows each citizen the right to life, liberty and the pursuit of happiness. I believe the CDC’s attempt to curb the opioid overdose and death rate is very noble. However, I also believe in the long run it will violate citizens’ rights, do much more harm than good and end up in the civil courts. As I’m sure you are aware, in some cases large sums of money are paid out each year in legal cases for “pain and suffering.”

There is no way the CDC can tell what medication and how much medication I or anyone else needs to attempt to maintain their current level of activity, quality of life and pursuit of happiness.  Only a qualified physician with medical training, medical records and medical images can understand what a patient may or may not need. The CDC needs to remember there are many people with very legitimate needs for these controlled substances. 

Last year was the first time in over ten years I could enjoy hunting and fishing again. I became active enough that I went from 255 pounds down to 215 pounds. I started feeling better and asked my doctor to drop my “breakthrough” pain meds from 120 to 90 per month. I’ve since realized I really need about 100 per month, but I get by.

The key here is I volunteered to stop taking 30 pills per month. Yes, my doctor was surprised.  However, because of rule changes, I can’t get my pain meds from that doctor anymore. I have to drive one hour each way to a pain management doctor to get my meds now. The long drive is very painful and the cost is higher.

Cutting my current pain management regimen will result in me being in more pain than I am now. It will cause me to be unable to exercise my right to hunt and fish. It will cause me to be unable to do yard work, such as mowing the lawn. Not being able to mow the lawn will result in an additional expense of $80 to $100 per month during the warm weather months.

It will cause me to once again be unable to travel and engage in some aspects of the only hobby I can currently enjoy, amateur radio. In other words, much of my liberty will be taken and my quality of life heavily impacted. My only income is Mississippi Public Employees Retirement System disability payments. Some citizens that are currently able to work with proper pain management may also have to seek disability if their doses are cut.

As I stated, I believe the effort to stop drug abuse and addiction is very noble. However, the route to solving this opioid problem should not include violating the rights of our disabled citizens or cause some patients to become criminals while trying to maintain what little normalcy and quality of life they have now.

I’m seeking your help to stop the CDC from punishing citizens that need to be on long term pain management and to get the CDC to reevaluate how it is handling a very important problem. I believe it’s time for someone to help us by filing for an injunction or a class action lawsuit to stop this craziness.

Gary Nations lives in Mississippi.

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Difference Between Addiction and Dependence

By Michael Thompson, Guest Columnist

When a person consumes alcohol or takes a mood altering medication, several things start to happen. First, they begin to develop a tolerance for it, so that over time it takes more of the drug to get the same effect. That can lead to abuse and addiction.

A person may also develop a dependence on a drug.  That means they have a clinical need for a medication.  

Many pain sufferers have found they need more opioid medication to provide relief from their pain, but that doesn’t mean they abuse or misuse it. It also doesn’t make them addicts.

I am dependent on my blood pressure medication to keep my blood pressure in check, but I’m not addicted it. Diabetics are dependent on their medication, but they are not addicted. 

Last year the CDC came out with opioid prescribing guidelines for general practitioners. But restricting the legal prescribing of these drugs will have no effect on the fact that most addicts don’t get their medication from Walgreens or Wal-Mart.  They get their drugs from Bobby the Rat behind Walgreens, or behind the pool hall from Billy the Snitch or Joe the Jerk.  What Bobby, Billy and Joe are selling is heroin, counterfeit painkillers and other illegal drugs.

What effect do these restrictive guidelines have on the illegal use of opioids?  None whatsoever.  The prescribing of opioid painkillers has been on the decline for years.  Most people who overdose are killing themselves with illegal drugs, not drugs obtained from their family doctor. 

Sure, everyone has heard of doctor shopping junkies who will go to an unscrupulous physician, who for $20 in cash will write an opioid prescription without even an examination. But the number of addicts pales in comparison to the number of legitimate chronic pain suffers who have been on these quality-of-life saving drugs for years without ever abusing their medications. Most have no idea where to find Bobby, Billy or Joe, or how to go about buying illegal drugs on the street.

Millions of older adults suffer from osteoarthritis and other neurologically painful conditions for which there is no cure, but there is treatment.  Many are on high doses of pain medication and have been taking these drugs for years, without ending up in the gutter shooting heroin or with a tag on the toe, lying on a tray in in the county medical examiner’s office.  They are not the ones causing headlines. 

Many doctors wrongly believe the CDC guidelines are rules that apply to all who prescribe opioid medication.  They fear that the DEA will come barging in if they go over a minimal amount, prosecute them and take away their license.  Their fear has left many chronic pain patients hanging out to dry, including some who will die because their pain is not being appropriately treated. 

If you have ever suffered from chronic, intense pain you are aware that it is all consuming.  It literally takes over your life.  Many, like me, who once led active lives on high doses of opioids, are now housebound, unable to shop, cook, clean or in many cases even just walk from the bedroom to the kitchen. 

It is a horrible existence, sitting in a chair all day, just trying to make it from morning to evening, and then unable to sleep because the pain is so intense.  Many of these once functional chronic pain sufferers have had their medication cut in half or more. 

As a personal example, I have two torn rotator cuffs that won’t heal.  I have had two surgeries that failed to correct the problem.  My surgeon says he won’t do any more surgeries because the rotator cuffs just continue to tear.  But that’s not all.  I have no cartilage left in my knees, a detached bicep tendon in my left elbow, and peripheral neuropathy in my feet and hands that causes them to burn and ache.  It’s been years since I was able to wear shoes. 

Before the CDC guidelines came out, I was on 6 pills of opioid medication a day.  I had been on this dose for five years and never once abused my medication or took more than was prescribed.  I was able to play golf and worked out three times a week, which helped me to keep my weight off.  When my pain specialist cut my dose in half, I literally crashed and burned.  Since then I have been practically home bound.  My story is similar to that of many other chronic pain sufferers.

So what do we do?  Practically every chronic pain patient has been running from one doctor to another, trying to find someone who will maintain them on the medication that helped them to live a somewhat normal life.  Imagine going to a new specialist, only to find the waiting room filled with dozens of other “new patients” trying to find someone, anyone, who wasn’t terrified of the DEA.

Is the CDC aware that their guidelines for primary care doctors have turned into rules for everyone?  Surely someone has told them about this.  Surely they know.

What’s to become of us?  Will we see a spike in the suicide rate of older adults who can no longer stand the daily struggle?  Will anyone care?

There are a lot of organizations that have tried to explain that the guidelines are not hard and fast rules and that they apply only to general practitioners. But fear is a stronger motivator than common sense. 

It cannot be that drug addicts are more important than patients. Don’t suffer in silence. Call, write a letter, or email your senators and congressman.

Don’t know who represents you in Congress? You can look them up by clicking here.

Michael Thompson is a retired clinical social worker and a licensed chemical dependency counselor. He lives in Texas.

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.

Medicare Modifies Opioid Prescribing Plan

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) is moving ahead with plans to align its Medicare Advantage and Part D prescription drug plans with the CDC’s opioid prescribing guidelines.

However, the agency has modified a policy to ensure that high doses of opioids that are medically necessary can still be prescribed.

Like the CDC guideline, CMS is recommending a daily ceiling on opioid pain medication at 90 mgs of a morphine equivalent dose (MED).  If a dose exceeds that level, Medicare insurers are expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist. 

Under a previous proposal, insurance companies could also impose a “hard edit” that could not be overridden on prescriptions that exceed 200 mgs of MED. The modification allows a pharmacist to override the edit if the prescribing physician says the dose is medically needed.

“Point of sale edits are not intended to substitute physician judgment or dictate a prescribing limit. If a sponsor (insurer) chooses to implement a hard edit, CMS expects the sponsor to rely only on prescriber attestation that the MED is medically necessary to override the hard edit, and to not require additional clinical criteria,” a senior CMS official said in a news briefing.

“The edits are not to stop prescriptions. They’re to provide information to sponsors in real time as a preventative step, so that prescribers are aware of the amount of opioids that patients are receiving as well as that they may be receiving opioids from other doctors.  They are not prescriber limits and they are not to substitute for prescriber judgement.”

CMS said there was a “significant number of comments” from the public about its opioid prescribing proposal. Some doctors and patient advocacy groups expressed concern that pain patients who are medically stable on high opioids doses would be forced to taper to lower doses.

“My tentative judgement, based on quickly looking at the documents today, is that CMS carefully stepped back from the absolute requirement that would have caused patients at over 200 (MED) mgs to have a sudden crisis in their care,” said Stefan Kertesz, MD, a practicing physician and Associate Professor at the University of Alabama at Birmingham School of Medicine.

“That doesn’t mean that they have foresworn this course of action in the future, but they clearly registered that they heard concerns from patients, doctors and others, and to me that is a hopeful sign.”

CMS is still moving ahead with plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who prescribe high doses and the patients who receive them. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers are expected to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

As PNN has reported, the insurance industry appears to have played a major role in drafting the OMS plan, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper goes far beyond fraud prevention, however, by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  The white paper was drafted largely by insurance companies, including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Why the CDC Needs to Recognize Palliative Care

By Barbara Nelson, PhD, Guest Columnist

A little over a year ago, the Centers for Disease Control and Prevention released its “Guideline for Prescribing Opioids for Chronic Pain.” Its goal is to help reduce the raging and heartbreaking overdose epidemic in the U.S.

Unexpectedly, the guideline has exposed the extraordinary need for palliative care for millions of patients who may live for decades with intractable pain. These patients now face enormous obstacles getting medically-needed opioids for effective pain control, especially when the dose exceeds the highest recommendation made in the guideline of 90 morphine milligram equivalents (MME) per day.

This unbending recommendation is too low to provide pain control that will keep many intractable pain patients out of agony.  In the last year, untold numbers of chronic pain patients requiring palliative care lost the correct opioid dose for their diseases -- making work, self-care, and family interactions harder or impossible.

I have seen this suffering, both personally and professionally.  I have an incurable and progressive neurological pain disease that, before diagnosis and some pain control, left me unable to read. My disorder profoundly changed my life as I previously knew it.

The dosage recommendations in the CDC guideline show no compassion for those with intractable pain, who will probably need higher opioid doses for the rest of their lives. Only later, when faced with terminal illness and imminent death, will official support for adequate pain control be acknowledged.

How Did We Get Here?

The objective of the guideline was to reduce opioid addiction and overdoses by limiting the dose and duration of prescriptions written by primary care doctors.

The guideline begins with support for “appropriate and compassionate” pain control for those with chronic pain.  It pays special attention to the chronic pain care needed by those fighting cancer, needing palliative care, or facing terminal illness. These three categories of pain are excluded from the CDC’s suggested highest daily opioid dosages because of their well-researched requirements for higher than average pain control, 

There is a problem to this approach, however.

The differences between these three categories are unclear to many doctors and patients. Most frequently, palliative care is confused with end-of-life or hospice care for cancer.  But palliative care is different from end-of-life care, because in palliative care there is no assumption of imminent death, nor is there a decision to withhold medication that might curtail the disease itself.

Chronic obstructive pulmonary disease (COPD), multiple sclerosis and sickle cell anemia are routinely considered diseases that can require palliative care, and these patients may live decades after their diagnoses.

The CDC guideline defines palliative care “as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. Palliative care can begin early in the course of any serious illness that requires excellent management of pain or other distressing symptoms.”

Not all diseases requiring palliative care also require opioids.  But those patients who require both palliative care and opioids are virtually invisible in the guideline.  Invisible patients get neither appropriate nor compassionate pain care.

The Need for a Palliative Care Appendix

The CDC should produce an appendix for all prescribers – not just primary care doctors – that would help them provide fully adequate pain relief to palliative care patients with life-long pain rather than near-death pain.  

The appendix could start by examining the legislative or regulatory language used in the 13 states that define intractable pain and that allow higher than typical opioid dosing.  The appendix also needs to emphasize research on the most painful long term diseases, which will offer physicians a wider variety and more specialized array of treatment options than is available from a focus on generalized chronic pain. 

The appendix could begin with the recognition that intractable pain patients needing palliative care do not get “high” or “euphoric.” Opioids are medicines that reduce pain and let them live closer to normal lives.

Helping physicians assist patients in organizing self-directed palliative care is another necessity, because most patients will not have access to a palliative care practice, let alone to one that is appropriate for their conditions. 

For patients with rare diseases, the CDC should emphasize the role of the doctor as learner as well as expert, as he or she must take the time to become familiar with a disease they may have never seen before. 

Yes, there may be some patients who attempt to scam the palliative care approach. However, I doubt that this kind of long-term pain is easily faked. The CDC guideline itself asks physicians to make dozens of new medical judgments. Acknowledging intractable chronic pain patients who require palliative care is just one more.

If the CDC does not add a palliative care appendix to the guideline, perhaps the American Academy of Pain Medicine, the American Medical Association or the American Academy of Hospice and Palliative Medicine could convene a group of all stakeholders to thoughtfully discuss the issues of pain treatment within palliative care.  Civil rights organizations that focus on inequality, including medical inequality, could contribute to this effort. 

Groups outside the CDC could also expand the mandate beyond training primary care physicians about opioid dosages, to include pain treatment for diseases requiring palliative care.

The conflict over opioid guidelines that are treated as laws or regulations, instead of recommendations, is not going away.  Several states, insurers and federal agencies have adopted versions of the CDC guideline, and others are sure to follow.  

Providing adequate pain control to palliative care patients would not make legislators, regulators or citizens any less committed to reducing misuse of opioid prescriptions.  In fact, drawing attention to palliative care would demonstrate a welcome dose of wisdom that millions of Americans would applaud.

Without an appendix to the CDC guideline or some other booklet that promotes correct palliative pain care, how will outstanding doctors be protected from unwarranted intrusions by insurance companies and drug enforcement organizations?  How will patients who deal correctly with pain that most people can’t imagine receive the palliative care that they deserve? They won’t.

The CDC’s “one-size-fits-all” guideline is bad medicine and bad policy. It ignores millions of intractable pain patients who require higher opioid doses.  

Everyone needs to recognize the importance of palliative care. You may need it someday. And unless changes are made, you won’t get appropriate medication either.

Barbara J. Nelson, PhD, is Dean Emerita of the UCLA Luskin School of Public Affairs and is Professor Emerita of UCLA’s Public Policy Department. She is the founder of The Concord Project, which builds social capital that allows people from divided communities to work together on projects of mutual benefit.

Barbara also directed The Leadership and Diversity Project, improving policy education and policy making through creative inclusion and enacted equality.  She served on the board of the Greater Los Angeles United Way.

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

CDC: Painkillers No Longer Driving Opioid Epidemic

By Pat Anson, Editor

A top official for the Centers for Disease Control and Prevention has acknowledged that prescription painkillers are no longer the driving force behind the nation’s so-called opioid epidemic.

In testimony last week at a congressional hearing, Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, said that heroin and illicit fentanyl were primarily to blame for the soaring rate of drug overdoses.

“Although prescription opioids were driving the increase in overdose deaths for many years, more recently, the large increase in overdose deaths has been due mainly to increases in heroin and synthetic opioid overdose deaths, not prescription opioids. Importantly, the available data indicate these increases are largely due to illicitly manufactured fentanyl,” Houry said in her prepared testimony before the House Energy and Commerce Committee's Oversight and Investigations Subcommittee.

The CDC blamed over 33,000 deaths on opioids in 2015, less than half of which were linked to pain medication.  

While painkillers may be playing less of a role in the overdose epidemic, Houry believes pain medication is still a gateway drug for many abusers. She cited statistics from Ohio showing that nearly two-thirds of the people who overdosed on heroin or fentanyl received at least one opioid prescription in the seven years before their deaths.  

"The rise in fentanyl, heroin, and prescription drug involved overdoses are not unrelated,” Houry said. “While most people who misuse prescription opioids do not go on to use heroin, the small percentage (about four percent) who do account for a majority of people recently initiating heroin use.”

Houry also disputed reports that efforts to reduce opioid prescribing have led to increased use of illegal drugs. It was her office that oversaw the development of controversial CDC guidelines that discourage doctors from prescribing opioids for chronic pain. 

DEBRA HOURY, MD

“Some have suggested that policies meant to limit inappropriate opioid prescribing have led to an increase in heroin use by driving people who misuse opioids to heroin,” Houry testified.  “Recent research, however, has indicated otherwise. One study found that the shift to heroin use began before the recent uptick in these policies, but that other factors (such as heroin market forces, increased accessibility, reduced price, and high purity of heroin) appear to be major drivers of the recent increases in rates of heroin use.”

The “recent research” Houry cited was a report published in the New England Journal of Medicine in January, 2016 – a full two months before the CDC opioid guidelines were even released. She offered no evidence to support her claim that the guidelines were having no impact on heroin use.

Some Patients Turning to Illegal Drugs

According to a recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to turn to illegal drugs for pain relief.

Over 70 percent said their opioid doses have been reduced or cutoff by their doctors in the past year. And one out of ten patients (11%) said they had obtained opioids illegally for pain relief since the guidelines came out. 

“The one person I know who says the recent guidelines have helped (is) my neighbor who is a heroin dealer. He says business has quadrupled since doctors have started becoming too afraid to help people in pain,” one patient wrote.

“This has caused me far more pain and suffering in my life, and increased my stress and anxiety, and depression, because nobody seems to care that I suffer like this,” said another patient. “This has also caused me to turn to using heroin, because I have nothing left now at this point and cannot suffer like this.”

“Because people are unable to get adequate pain relief from prescribed medications due to the fear instilled to doctors by these ‘guidelines,' most people, in my experience, are turning to heroin. This explains not only an increase in overdoses but also an increase in suicide from chronic pain patients,” wrote another.

“I found it easier to get medications through the black market than through my doctor. I spend about $1,000 per month in medications through the black market, but in the end that is less than the deductible on my insurance. And they deliver to my house!” a patient said.  

“My fear right now is that I've been using medications I buy from a dealer. They appear to be real and thus far I've been OK, but I'm afraid that I may eventually hit a bad batch laced with fentanyl,” said a patient. 

Houry’s testimony came on the same day the Drug Enforcement Administration warned that counterfeit painkillers made with fentanyl have killed dozens of people in the Phoenix area.

The DEA said at least 32 deaths in the last 18 months in Maricopa County, Arizona have been linked to fake pills laced with fentanyl that were disguised to look like oxycodone tablets. In nearly 75% of the overdoses, examiners also found dipyrone (Metamizole), a painkiller banned for use in the U.S. since 1977. 

Fentanyl is a synthetic opioid 100 times more potent that morphine. It is sold legally in sprays, patches and lozenges to treat severe chronic pain.

counterfeit oxycodone (dea photo)

The DEA says illicit batches of fentanyl are being made in China and exported to Mexico, where drug dealers mix it with heroin or turn it into counterfeit medication before smuggling it into the U.S.

The DEA released detailed demographic information on the age, sex and ethnicity of the people who overdosed in Arizona. It did not say how many of the dead were patients looking for pain relief.    

Doctors Oppose 'Perverse' Limit on Opioid Painkillers

By Pat Anson, Editor

A group of 80 doctors, pharmacists, academics and health researchers have signed a joint letter opposing “perverse” new guidelines being proposed to limit high doses of opioid pain medication.

The National Committee for Quality Assurance (NCQA) is a little known non-profit organization that accredits healthcare organizations and ranks their performance against a set of standards known as the Healthcare Effectiveness Data and Information Set (HEDIS).

In a proposed new HEDIS standard for opioid prescribing, NCQA would set a daily ceiling at a 120 milligram morphine equivalent dose (MME) when opioids are prescribed for 90 consecutive days or longer. Any insurer or provider in violation of that standard would be red flagged, and if too many violations are found they risk losing their accreditation.

The proposed standard “will pose a serious risk to some patients currently receiving opioids,” according to the letter drafted by Stefan Kertesz, MD, a primary care physician and Associate Professor at the University of Alabama at Birmingham School of Medicine. 

The letter was signed by a diverse group of healthcare providers, including some who helped develop the CDC’s opioid prescribing guidelines. Those guidelines are voluntary and intended only for primary care physicians, but are being widely adopted and made mandatory throughout the U.S. healthcare system.

Ironically, the NCQA's limit of 120 MMEs is actually higher than the CDC's recommended limit of 90 MMEs.

“We must distinguish between the language of the CDC Guideline itself, and the perverse care decisions that the NCQA ‘Opioid High Dosage’ binary measure will incentivize,” the letter states.

Kertesz and his colleagues say the proposed standard would force many doctors to taper patients off high opioid doses “despite the lack of any evidence to assess its impact on risk to patients, and the reality that the CDC Guideline did not endorse this approach.”

“Put simply, the ‘Opioid High Dosage’ measure will accelerate a reconfiguration of care that has never been tested in prospective trials and that could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death), protracted abstinence syndrome, and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain,” they wrote.

The letter concludes by urging the NCQA to abandon its high opioid standard until evidence is available to assess the potential harm to patients.

In a statement explaining its proposal, NCQA said “there is limited evidence for the long-term beneficial effects of opioid use” and suggested opioids were only appropriate for acute pain and chronic pain conditions “such as sickle cell disease or late stage cancer.”

The NCQA just ended a public comment period on its opioid proposal. Several PNN readers have complained they were unable to post comments on the NCQA website.

Should CDC’s Opioid Guidelines Be Revised?

By Pat Anson, Editor

Suicidal patients. Illegal drug use. Hoarding of pain pills. Pharmacists refusing to fill prescriptions. Doctors worried about going to jail. Chronic pain going untreated.

Those are some of the many problems uncovered in a PNN survey of nearly 3,400 pain patients, doctors and healthcare providers, one year after the release of opioid prescribing guidelines by the Centers for Disease Control and Prevention (see "Survey Finds CDC Opioid Guidelines Harming Patients"). The guidelines were meant to be voluntary and are only intended for primary care doctors, but they're being widely implemented throughout the U.S. healthcare system – often with negative consequences for the patients they were intended to help.

Over 70 percent of patients say doctors have either reduced or stopped their opioid medication. Eight out of ten say their pain and quality of life are worse. Nearly half are having suicidal thoughts and some are hoarding opioids or turning to the black market for pain relief.

And hardly anyone believes the guideline has been successful in reducing opioid abuse and overdoses.

“This is astounding, but not surprising,” says Lynn Webster, MD, a leading expert in pain management and a longtime critic of the CDC guideline. “It may be time for the CDC to consider inviting the pain community to help revise the guideline to more align with a public health policy that finds a better balance of avoiding opioid related problems, while also allowing opioids to be used in a responsible way.  

“The CDC should not have issued the guideline without a plan to measure its possible benefits and unintended consequences.”

Does the CDC even have such a plan? PNN asked the agency if one exists and also for a comment on the survey findings. We have yet to get a response. 

The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the guidelines, also declined to comment on the survey findings.

“I’m not going to want to comment either way,” said Andrew Kolodny, MD, before launching into a defense of the guideline.

“Since the CDC guideline came out, the bad news on opioids for chronic pain continues to increase. The evidence keeps getting stronger and stronger that opioids are lousy drugs for most people with chronic pain,” said Kolodny, who is Co-Director of the Opioid Policy Research Collaborative at Brandeis University.

“Opioids for chronic pain should be a rare treatment. And unfortunately the practice is widespread. Millions of people like your readers are victims of this aggressive prescribing,” he told PNN.

CDC Pledged to Revise Guideline if Needed

The closing words of the CDC guideline say the agency is “committed” to revising it if evidence is found that it's not helping patients or doctors.

“CDC will revisit this guideline as new evidence becomes available,” the agency pledged last year. “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.”

Some critics are skeptical that CDC has any intention to revise the guideline.

“I am not aware of any actions which would demonstrate that the CDC is actually open to revising their guideline, especially when they knew of the problems in advance of its release,” said Stephen Ziegler, PhD, a Professor Emeritus of Public Policy at Indiana University-Purdue University.

“Instead of revising, did they instead opt to hire a PR firm? The negative outcomes, while unintended, were nevertheless foreseeable.”

Ziegler is referring to a contract the CDC signed last year with PRR – a Seattle-based public relations firm – to provide research and analysis for the agency. The research wasn’t focused on the “intended and unintended” impact of the guidelines, but on why they were received so poorly in the pain community.   

“They’ve heard a lot of outrage about this,” a source at PRR told us. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

Lynn Webster thinks the CDC needs to do more than hire a public relations consultant.

“I think it is time for Congress to ask the CDC to provide them a detailed report on the impact the opioid prescribing guideline has had on access to appropriate pain management, quality of care for people in pain, access to insurance coverage of alternative and complementary therapies recommended by the guideline, impact on the number of opioid related overdoses, rate of change reported in treatment for opioid use disorder, and change in possible suicide rate with people in pain due to inadequately treated pain,” said Webster, a former President of the American Academy of Pain Medicine.

Voluntary Recommendations Become Mandatory

Some believe the problem isn’t so much the wording of the guideline as the way it is being implemented by physicians, states, insurers and other federal agencies like the Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). They’ve turned the CDC’s voluntary recommendations for primary care doctors into mandatory rules that all prescribers have to follow. 

“I've said about both the CDC guideline and the Washington state guidelines from years ago, that what they actually say isn't so bad. I can live with most of it. The problem is that people take what is there and turn it into something it shouldn't be,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“With respect to the CDC guideline, the problem is that everyone is trying to turn it into laws, rules, and criteria for prior authorization for payment, and those things absolutely shouldn't be done. If everyone treated it as what it is -- a series of expert-drafted suggestions -- we'd be doing OK. It might even have helped a lot of people.”

Millions of veterans and Medicare beneficiaries are about to learn what Twillman means about the guideline being turned “into something it shouldn’t be.”  

CMS is planning to adopt new rules to “better align” its policies with the CDC’s.  Medicare’s “Opioid Misuse Strategy” not only makes the guidelines mandatory, it allows insurance companies to take punitive action against doctors, pharmacists and patients who don’t follow them.

The VA and Pentagon have also released new guidelines that take the CDC’s recommendations a big step further. They strongly recommend against prescribing opioids long-term to anyone under the age of 30, and urge VA and military doctors to taper or discontinue opioids for any patients currently receiving high doses.

“You should take a look at the VA guideline that just came out, if you don’t like the CDC guideline,” says Andrew Kolodny. “The VA guideline is even stronger. It says don’t give opioids. Opioids are not preferred. Don’t do it.”

Lost in the shuffle of all these new rules and regulations is the voice of pain patients. Many who responded to our survey are fearful of becoming disabled or bedridden if opioids are taken away from them. And some believe the government has an ulterior motive.

“This is a silent genocide aimed squarely at Baby Boomers. An expedited way to avoid paying Social Security benefits to those who are approaching retirement or are receiving benefits. I am ashamed of our country,” wrote one patient.

“Completely wrong approach which will, I believe, result in more addiction as patients experiencing intolerable suffering are forced to look outside the medical system for relief,” said another.

“This is going to backfire on the CDC, Medicare, Medicaid, etc. The CDC is punishing every single person on pain medications,” wrote another patient. “People will die because of this, but they don't seem to care about any of the consequences of these guidelines. Being in pain is a terrible thing, I know from experience. I wouldn't even be able to work if it weren't for my pain medication. This is all very stressing, and I only see bad results coming out of this.”

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11 by Pain News Network and the International Pain Foundation (iPain).

To see the complete survey results, click here.