It's Time for Chronic Pain Patients to Act

By Alessio Ventura, Guest Columnist

I am a chronic pain sufferer who recently had multiple emergency surgeries due to sepsis infection after a shoulder replacement.

I have had 17 surgeries since 2008, including major back surgery, rotator cuff repair, biceps tendonitis, knee surgery and hernia surgery. Bottom line: my body is now wracked with arthritis and post-surgical pain.

I have tried several pain treatment modalities over the years, including Lyrica, Cymbalta, chiropractic, injections, NSAIDs, and acupuncture. The only effective treatment in my case has been the legitimate, professional application of opioid medicine by pain management physicians.

I have severe allergic reactions to NSAIDs, which kill 15,000 per year and send 100,000 to the hospital.  A friend of mine died from a stroke because of NSAIDs.

After my recent surgeries related to the shoulder replacement and subsequent infection, my wife had to travel to 25 different pharmacies before she finally found someone willing to fill my scripts for Oxycontin and Percocet.

This is not unusual though. Each month is a long trek to find pain medicine. What has happened due to government restrictions on opioids is a reduction in the supply of opioid medicine. The drug companies see the writing on the wall and are slowly trying to get out of the business.

ALESSIO VENTURA

At the same time, the government sets limits on how much a pharmacy can stock. That is according to pharmacists I have spoken to, but is denied by the DEA and FDA in response to letters I have written.

It truly is a nightmare. Each month, you have to go to pharmacy after pharmacy before you find a pharmacist willing to dispense the medicine, which pharmacists are under no legal obligation to provide. Many pain patients go into withdrawal each month as they search, while at the same time enduring intractable pain.

Most of us have tried every single alternative to opioids, but the anti-opioid hysteria paints a picture that there are better and safer therapies. That simply is not true. The only thing that works for many of us is an opioid-based medicine.

The madness is spreading. New Jersey governor Chris Christie has signed into law a bill that limits the first script for opioids to 5 days. After the four surgeries I’ve had since August, I was bedridden and could not visit a doctor after 5 days. They could not identify the infectious agent as they were unable to grow it in cultures. Eventually I was treated with 3 broad spectrum antibiotics, which in addition to killing the infection, also killed the "good" bacteria in my system, which caused severe fatigue and gastrointestinal side effects.

Many acute traumas, like when someone is shot or in a horrible car accident, will not provide for easy travel to visit a doctor to refill an opioid after 5 days, and it is currently illegal for a doctor to call in a script for controlled substances. This caused a run on opioid medicine in New Jersey as hospitals and surgery centers accumulated as much as they could, and with the cutback by drug companies, many people could not get their scripts filled.

My 85 year old mother in New Jersey had back surgery recently. My sister drove to 30 pharmacies -- starting in Bridgewater and working her way along Route 22 toward Newark -- and she was unable to get our mother’s scripts filled. My mother was in horrible pain and my sister had to rush her back to the ER. It was horrible. My sister broke down in tears at the ER as she explained her plight and the suffering of my mother.

There is a reason why army medics carry morphine to the battlefield. It is the only thing that has a chance to address severe acute pain.

In addition to supply limits, there is the prescription drug monitoring system. The government now tracks every single opioid that you legally acquire. If for whatever reason you find yourself away from home and cannot see your physician and you attempt to refill or get new pain medicine because of an injury, surgery or chronic pain, you will not be able to do it legally without first getting in touch with your doctor so they can coordinate care. Often this is not possible.

If you do get pain medicine while away without coordinating, you will be investigated and may be subject to arrest. Your doctor may also drop you from their practice. Your rights as a patient, especially your privacy rights and your right to seek pain relief, are now severely trampled.

Politicians are playing with fire as the opioid hysteria grows. More people will commit suicide rather than live with intractable pain, because politicians think they know more than doctors treating patients.

Who is going to listen to us? Politicians and some in the medical community conveniently conflate overdose data from the illegal use of opioids with legitimate use for intractable pain. They are also dismissive and try to tell us that we should try alternatives. For example, Lyrica is now being pushed by many, but it was developed only for a specific class of nerve pain, and possible side effects include suicide, weight gain, and a host of other things.

I almost committed suicide myself after being prescribed Lyrica and Cymbalta. I went from 190 pounds to 300 pounds, and had suicidal thoughts almost from the outset. When I told my doctors, they said, "Give it more time, the side effects will subside".

After the Lyrica and Cymbalta were stopped, I stayed on OxyContin and had bi-weekly testosterone shots. I lost all of the weight and the suicidal thoughts went away. It was a miracle.

There is a literal civil war occurring now between physicians who understand pain, and others who refuse to admit the truth about the efficacy of legitimate pain management via the use of opioids. Unless we all collectively speak up and scream loudly, meaning writing formal, respectful, but firm and forceful letters to our representatives, they will continue to step on us and cause our lives to be living hell.

It is time. Find out who your state and federal representatives are. Find out who your local, state, and federal health organization leaders are. Write formal letters, not emails or phone calls, to your representatives. After you write your letters, request meetings with your representatives and go to that meeting. Do whatever you can in a professional, respectful, but aggressive way in order to bring attention to our plight.

The time is now. Failure to act most assuredly means an end to our rights, a lifetime of pain, more illegal use of drugs, and in many cases, death.

Alessio Ventura was born in Italy, came to the U.S. at 17, and finished high school in Newark, New Jersey. He worked for Bell Laboratories for 35 years as a network and software engineer. Alessio has been married for 35 years and has 4 adult children, including triplets.

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.

FDA Nominee Called for DEA to Stop Policing Pain Care

By Pat Anson, Editor

President Trump has nominated a doctor who has proposed radical changes in the regulation of opioid pain medication as the next head of the Food and Drug Administration.

Scott Gottlieb, MD, is a former deputy FDA commissioner and has worked as a consultant to several drug companies. He is currently a fellow at the conservative American Enterprise Institute.

If confirmed by the U.S. Senate as FDA commissioner, The Washington Post reports the 44-year old Gottlieb is “likely to try shaking it up in significant ways,” by speeding up the agency’s approval of new drugs – what President Trump has called a “slow and burdensome” process.

Also of note to pain patients, pharmacists and doctors is that Gottlieb may seek to reduce the role of the U.S. Drug Enforcement Administration in regulating and policing opioid pain medication.

In a column published in The Wall Street Journal in 2012 – which carried the headline -- "The DEA’s War on Pharmacies – and Pain Patients” – Gottlieb wrote that patients would suffer less if medical regulators, not law enforcement agencies, monitored the dispensing and consumption of opioid medication.

scott gottlieb, md

“What can be done? We should free the DEA from the dual mandate to be both regulator and cop,” Gottlieb said. “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. But the DEA tactics aren’t stemming the illegal activity.”

At the time the DEA had just slapped severe penalties on drug wholesaler Cardinal Health for shipping large amounts of opioids to four Florida pharmacies that were essentially operating as pill mills. The backlash from that case led pharmacies across the country to start turning away pain patients with legitimate opioid prescriptions.

“Cardinal has suspended sales to hundreds of pharmacies that it deems ‘suspicious,’ even those in good standing that retain their DEA license to sell narcotics,” wrote Gottlieb. “Pharmacies, in turn, are closely scrutinizing which prescriptions they will fill, making things like baggy pants and a tattoo a liability if you need medicine.”

Calling the DEA the “wrong enforcer” for the job, Gottlieb proposed a radical move: Have the DEA concentrate on street drugs and drug cartels, while the Department of Health and Human Services regulates doctors, pharmacies and others involved in dispensing pain medication.

“Public-health agencies inside the Department of Health and Human Services (HHS) would have more expertise in making the distinctions between illicit diversion and the legitimate practice of medicine. Regulating these activities requires close knowledge of how medical-practice decisions are made, as well as the ability to collaborate with provider groups to enlist them in achieving regulatory goals. Some of the DEA’s resources and mission could be statutorily given to HHS,” Gottlieb wrote.

“A good line of demarcation would be at the point of care. Doctors prescribing narcotics, drug distributors and pharmacies could come under the supervision of HHS. The department would also take responsibility for apportioning active ingredients to manufacturers of narcotics, educating doctors on proper prescribing, and investigating pharmacies and providers who appear to have gone rogue.”

Gottlieb wrote that column five years ago and it is not known if he still holds those beliefs. The current political atmosphere in Washington about opioids may also cool his enthusiasm for stripping the DEA of one of its primary jobs. But it is interesting that he proposed it.

Gottlieb’s ties to the pharmaceutical industry may come under scrutiny during confirmation hearings. Activists are already lining up in opposition to his expected nomination, calling some of Gottlieb's ideas about deregulation “dangerous.”

“Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry and the U.S. Senate must reject him,” said Dr. Michael Carome, Director of Public Citizen’s Health Research Group

“Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. The Senate must reject the nomination and demand a nominee who is better suited to protect public health.”

Are We Near an Opioid Tipping Point?

By Roger Chriss, Columnist

We are fast approaching a tipping point in the opioid medication crisis.

Consider all that is happening:

The Centers for Medicare and Medicaid Research (CMS) wants to adopt the CDC guidelines as mandatory rules for prescribing opioids to Medicare recipients. CMS has proposed a daily ceiling on opioid medication as low as 90 milligrams morphine equivalent dose (MED) for millions of people.

The National Committee for Quality Assurance (NCQA) has proposed a daily limit on opioids of 120 MED for no more than 90 consecutive days.

The Pentagon and the Department of Veterans Affairs are also seeking greater restrictions on opioids, including a recommendation not to prescribe them for chronic pain to anyone under the age of 30.

States are clamping down on the dose and duration of opioid prescriptions. Maine has passed legislation severely restricting opioid prescribing, joining states like New Jersey, Virginia and Washington in tightly regulating opioids. Although there are exceptions for cancer pain and end-of-life care, people with chronic or intractable pain are being forced to taper their dose or replace opioids with less effective options.

Taxes on opioids are under consideration in New York and in California, which is also looking at prohibiting people under 21 from receiving oxycodone.

Rhetoric is reaching propaganda-like levels of hyperbole in the so-called war on opioids. The Hill recently ran a blog post with the headline “Chemical weapons of mass destruction on US soil.” It opens with the statement that “America is under attack. Chemical weapons of mass destruction are now in every city nationwide in the form of opioid drugs.”

The Huffington Post Canada has a similarly alarmist post claiming that “fully one-third of Americans who are given prescription opioids become addicted within two months.” It also claims that "pharmaceutical companies in Brazil and China are bucking the trend by running training seminars urging doctors to prescribe more painkillers rather than less.”

In an interview in MedPageToday, Dr. Daniel Clauw states that "I haven't prescribed an opioid for chronic pain in at least a decade," without ever clarifying what the outcomes were for his patients.

Predictions about the crisis are more dire. A recent article in MarketWatch headlined “America’s battle with drugs: Fatal overdoses spike among white, middle-aged men” said researchers at Columbia University have predicted that fatal drug overdoses “will peak at 50,000 annual deaths in 2017 before declining to ‘a non-epidemic state’ of 6,000 deaths in 2035.”

We are on the verge of an opioid tipping point, approaching the kind of prohibition the U.S. tried with alcohol almost 100 years ago. But rather than a Constitutional amendment, state governments and federal regulatory agencies are coming together like a swarm of angry bees to attack opioid substance abuse by clamping down on people who receive opioid therapy.

This is like trying to stop car thieves from driving recklessly by imposing new rules and regulations on safe drivers in their own cars.

The consequences of these restrictions are easy to see. People forced into rapid tapering to get their opioid dose into compliance with CDC guidelines are enduring dangerous side effects. People abruptly cut off from their pain medication are so overwhelmed by the pain of debilitating medical conditions that they contemplate or even commit suicide.

A column in STAT News recently discussed the “inhumane treatment” of pain patients, which Dr. Lynn Webster anticipated in his 2014 article, “Pain and Suicide: The Other Side of the Opioid Story.”

So why the race to restrict opioid medication? Is it so policymakers and legislators can say they did something? Are they playing defense and trying to pre-empt addiction? Does the rhetoric insulate them from facing the consequences for people with chronic or intractable pain?

Maybe the goal is to prevent addiction no matter the cost. But the cost is being born by the many people currently being successfully treated with opioid therapy.

This tipping point is a misguided step in a pointless direction. Even if it does help prevent a single case of substance abuse, it requires sacrificing the quality of life of thousands of people enduring the pain of chronic illness.

Worse, tipping points can happen very fast. But recovering from a tipping point and restoring balance in a system takes time. Which leads to a final question: How long will chronic and intractable pain patients have to suffer before policymakers and politicians see the harm restrictive opioid prescribing is causing?

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is from Washington state, where he works as a technical consultant who specializes in mathematics and research.

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.

Little Known Committee Setting New Rules for Opioids

By Pat Anson, Editor

You can add the NCQA to the alphabet soup of agencies and organizations trying to rein in opioid prescribing.

Like the CDC, FDA, DEA and CMS, the National Committee for Quality Assurance (NCQA) is targeting high doses of opioid pain medication, as well as patients who see multiple prescribers and use multiple pharmacies.

NCQA is a little known non-profit organization that plays a big role in determining the standard of care expected of healthcare providers. It manages accreditation programs for physicians, medical groups and health insurance plans by measuring and ranking their performance against a set of standards known as the Healthcare Effectiveness Data and Information Set (HEDIS).

In other words, NCQA decides who is doing a good job and who is not, based on guidelines that it sets for the healthcare industry. That makes it a very powerful and influential organization.

In a proposed new HEDIS standard for opioid prescribing, NCQA will set a daily ceiling on opioid medication at 120 milligrams morphine equivalent dose (MED) when prescribed for 90 consecutive days or longer. The number of prescribers would also be limited to no more than four, as would the number of pharmacies.

Any insurer or provider in violation of these standards would be red flagged, and if too many violations are found they risk losing their accreditation, a heavy price to pay for anyone in the healthcare industry.

In a statement explaining the proposal, NCQA said opioids may be prescribed for acute conditions such as post-surgical pain and for chronic pain conditions “such as sickle cell disease or late stage cancer.”

“The appropriate use of opioids can be vital to pain management, but there is limited evidence for the long-term beneficial effects of opioid use for chronic pain management for nonterminal conditions. In addition, long-term daily use of opioids can lead to increased tolerance (higher doses are needed to feel the effects). Taking excessive amounts of opioids can result in overdose, which may lead to death. Long term opioid use can lead to addiction or dependence; therefore, patients prescribed opioids should receive regular, rigorous monitoring and screening.”

Critics says the proposal makes no allowance for patients who are currently stable on high doses of opioids above 120 MED, who may be involuntarily tapered to a lower dose under the new HEDIS standard.

"HEDIS measures typically seek to advance improvements in care quality by incentivizing health care systems to focus on particular procedures or outcomes. Historically there have been occasional challenges with promotion of health quality measures that made sense at the system level, but turned out not to be very good when routinely applied to individual patients across the board,” said Stefan Kertesz, MD, a primary care physician and Associate Professor at the University of Alabama at Birmingham School of Medicine. 

“What seems desirable at the system level (overall lower opioid prescribing) may put patient-centered care at risk. Most importantly, the impact of this proposed quality metric might be to push providers to engage in involuntary opioid discontinuation on currently stable patients, a course of action that the CDC Guideline did not recommend."

The CDC guidelines released last year are voluntary recommendations intended only for primary care physicians. However, they are being implemented as mandatory rules for all prescribers by many insurance companies and in several states.

NCQA is seeking public comment on its opioid proposal, not only from physicians, but patients as well. To post a comment, click here (a detailed registration is required). Comments will be accepted until March 22.

CMS Public Comments End

Meanwhile, the Centers for Medicare and Medicaid Services (CMS) has ended its public comment period on new rules for opioids under Medicare’s Part D prescription drug plans. CMS wants to adopt the CDC’s guidelines as official Medicare policy, but make them mandatory for all prescribers and patients. Punitive action could be taken against providers and patients who don’t follow them.

A CMS ceiling on opioid doses would be set as low as 90 MED. Patients who receive opioids from more than 3 prescribers or more than 3 pharmacies during a 6 month period could potentially be dropped from Medicare coverage. Doctors and pharmacists could also be dropped from the Medicare network.

“These changes pose serious risks to some patients who currently receive opioids,” said Kertesz in a letter to CMS signed by 82 other physicians, including some who helped draft the CDC guidelines.

The letter warns that pain patients are already being involuntarily tapered by doctors off high opioid doses, causing some to stop working and become bedridden.

“While some small studies do report favorable outcomes from voluntary opioid tapers carried out by experts, there exist no data to justify involuntary dose tapering carried out by clinicians lacking expertise. And worse, there are a rising number of reports of patient harms, including suicide and death,” the letter states. “CMS mandates will cause previously stable patients to suffer acute withdrawal with or without medical complications, including death.”

To see a full copy of the letter, click here.

As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS plan, which closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of private 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 only accepted public comment on its opioid proposals that were emailed, instead of using the Federal Register, where all comments become official public record and are easily available for public inspection. The agency routinely uses the Federal Register for other rule and policy changes.

Asked by PNN why the Federal Register was not used this time, a CMS spokesman said the agency would have no comment. The agency plans to publish its final rules on April 3. Posting the rules in the Federal Register and asking for public comment would have delayed their implementation.

PBS Documentary Brings Chronic Pain Out of Shadows

By Pat Anson, Editor

Many chronic pain sufferers are frustrated with how they are depicted in the media – often as lazy, whining, drug seeking addicts.

A new documentary that's begun airing on local PBS stations is trying to change that narrative.

“I wanted to give a voice to people who live in the shadows. People in pain are often ignored and treated as outcasts or druggies,” says Lynn Webster, MD, a leading expert on pain management, past President of the American Academy of Pain Medicine, and co-producer of “The Painful Truth”

LYNN WEBSTER, MD

“The film tries to demonstrate the lack of humanity that exists today towards people in pain. It also reveals some of flaws in our public policy that has contributed to the current pain and addiction crisis. I hope that the film will be a seed for a cultural transformation in attitudes and respect for the most hurting among us.”

The hour-long documentary is a sequel to Webster’s 2015 award-winning book, The Painful Truth, in which he shares the personal stories of chronic pain patients he treated for over 30 years in the Salt Lake City, Utah area. 

Webster may be retired now as a practicing physician, but he’s determined to have pain sufferers treated with more compassion and respect, not only by the media, but by government, regulators, insurers and their own doctors.

“I've had patients who begged me for alternatives to opioids when their insurance wouldn't cover anything else that would give them relief,” says Webster. “I've had patients who could not find a respite from their pain and chose to end their suffering by taking their own life. I've cried with, and comforted, the caregivers of my patients, people who are on the front lines every single day doing everything they can to help their loved ones regain the life they once knew.”

Webster and co-producer Craig Worth traveled over 70,000 miles gathering stories from patients and documenting their daily struggles. They also interviewed caretakers, doctors, patient advocates, addiction specialists and law enforcement officers.

The Painful Truth has already aired in a number of markets. For a listing of PBS stations and air dates, click here.  

The documentary can also be watched online, courtesy of PBS in Montana, by clicking here.

Webster is encouraging pain sufferers to reach out to their local PBS stations and ask them to broadcast The Painful Truth. He says when documentaries air on local public television, it is common for the host station to include a panel discussion with community members.

“If your local public station decides to air this documentary and you would be willing to make yourself available for a panel discussion, I would encourage you to reach out to your station to offer your participation. It could be a great opportunity to discuss how important it is to transform the way pain is perceived, judge and treated,” Webster says.

“I am realistic about the film. It won't be the solution, but it may open some eyes and more importantly some hearts that could result in better pain care in America.”

For a preview of The Painful Truth, watch the clip below:

3 Things You Need to Know About Opioid Pain Meds

By Janice Reynolds, RN, Guest Columnist

A recent guest column on PNN suggested that we need to admit opioid medications are dangerous.  Yes, they can be dangerous, but the bigger question is why are they singled out for “special” treatment? 

All medications have the potential to be dangerous, yet opioids are the only class of medication being treated as if they are the gateway to Armageddon.  Due to “fake news” and “alternative facts,” many see opioids as bad for acute pain, as well as persistent pain.

This hysteria has even affected the use of opioids to treat non-pain medical conditions -- one being as a first line therapy for potential heart attack or heart failure. Opioids cause blood vessels to dilate and lower blood pressure; getting more oxygen to the heart, decreasing anxiety, and reducing the risk of a heart attack. 

Chemotherapy drugs and bio-therapies are all very dangerous medications, causing a variety of injurious side effects, as well as secondary cancers in some cases.  Generally, when given in a hospital setting, precautions are needed to prevent others from being exposed to them. Typically, these are used for cancer, but they also have non-cancer uses and for some pain syndromes; such as methotrexate for rheumatoid arthritis. 

After a cancer is cured or in remission, many patients are left with pain disorders caused by the cancer or medication.  Because they no longer are seeing an oncologist, many recovering cancer patients are not able to get their “chronic pain” treated, especially with opioids.

Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen have long been known to be dangerous. They are black boxed by the FDA for cardiac events and gastrointestinal bleeding. Nephrologists will tell you they are the leading cause of chronic kidney failure. They can also potentiate heart failure. 

These side effects are not from overdosing, but can occur even when taken as prescribed.  Most side effects are not even included on the label of over-the-counter ibuprofen. It has been estimated 20,000 people a year die from ibuprofen. 

As a colleague said to me years ago, “If I prescribe an NSAID and the person dies, nothing will happen to me.  If I prescribe an opioid and they die I will be investigated.”

Safety is a huge issue with any medication, especially in older adults. As we age, our metabolic and elimination systems become less effective, and there is an increase in comorbid conditions that frequently results in more medications. 

The Beers Criteria has been around since 1991, with the last revision in 2012.  It lists medications which should not be used or rarely used by older adults.  These are medications that are inappropriate, potentially dangerous, and can worsen serious health conditions.  The list is evidenced based. NSAIDs are on it (and have been for a long time) while opioids, except for Demerol and Darvon (no longer on the market), are not. A few other medications used for pain, such tricyclic antidepressants (TCAs) are on the list as well. 

Taken in excess, acetaminophen (Tylenol) can damage the liver, heart medications can permanently damage the heart, and blood pressure medication or any drug which causes sedation can lead to death.  

Drug Interactions

Overdose deaths involving opioids are nearly always in someone who is opioid naïve or taken in combination with other medications or alcohol. Interactions between alcohol and other medications can frequently cause problems and may even be fatal.  

If alcohol and opioids are taken together and a problem develops, why is the opioid held at fault? Medications which cause sedation are the likeliest culprits to cause a fatal interaction with opioids. Alcohol interacts with nearly all medications, some worse than others. 

Other medication interactions can increase how a drug works or decrease its effectiveness.  NSAIDs and many other non-opioid pain medications have a higher risk profile for interacting with other drugs. TCA and anti-arrhythmics have a fatal interaction potential, for example.  Pregablin (Lyrica) has 26 potential major interactions.  NSAIDs interact with several medications, including antidepressants (SSRIs) and anticoagulants.

Opioids do not by themselves cause addiction. However, some people have the potential to become addicted to them, especially if they have an addictive personality.  Many other medications can also lead to addiction, such as benzodiazepines, barbiturates, amphetamines (e.g. Adderall), and caffeine.  Alcohol and nicotine are the leading potentially addictive drugs.

Physical dependence should never be confused with addiction, as they are two separate issues.  This misunderstanding about opioids and addiction has been long standing.  Many of us who have cared for dying patients have had a family member worry about their loved one becoming addicted, even when days away from death.

Opioids have a long history of relieving pain and it is untrue there is a lack of evidence concerning their use.  One of the difficult things with any medication, including opioids, is the fact that not everyone responds to them the same way or at the same dose.  For example, while some will respond to opioids for fibromyalgia or migraines, most do not.

The most insulting, cruel, demeaning and wrong thing someone can say to a person in pain is “You only think it works for you.”

There is no pain syndrome called “chronic pain.” And separating non-cancer pain from cancer-related pain is irresponsible and morally wrong. 

From the Journal of Pain Research:

"These claims are primarily philosophical, rather than medical or physiologic. As mentioned, pain mechanisms do not discriminate between cancer and noncancer pathophysiology. Patients with cancer or those without cancer have essentially identical pain-generating physiologies, and thus the same mechanisms for the development of their pain (eg, inflammatory pain in a cancer patient will be the same physiological process as in a noncancer patient). Further, cancer patients are living longer and their original pain generators become chronic pain in and of themselves, little different from patients without cancer."

So why should we have this discussion? Three reasons:

1. It is said we should accept erroneous beliefs and statements because this is what “everyone” believes based on opioid phobia, and to not do so would make us appear stupid. But who is being stupid here?
2. To emphasize the fact that no other medication is being restricted and villainized the way opioids are. This is based on opioid phobia, and the prejudice and bigotry shown towards people in pain.  Benefits and risks are a discussion between the patient and a knowledgeable provider, and should not be the purview of regulators, the media, politicians or opioid-phobics. 
3. Everyone needs to be knowledgeable about the dangers associated with medications. Few providers do a good job catching potentially dangerous interactions.

The worst case scenario is that people in pain are dying and some are being arrested after being denied effective treatment in emergency rooms.

I repeat: The benefits and risks of opioids need to be left to the patient and their doctor.

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including one on cooking with pain. 

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.

Do Opioids Raise or Lower Risk of Suicide?

By Pat Anson, Editor

Robert Rose has little doubt what the fallout will be from tougher guidelines for opioid pain medication being adopted by the Departments of Defense and Veterans Affairs. The 50-year old Marine Corps veteran calls the guidelines a “death sentence” for thousands of sick and wounded veterans like himself.

“Suicides are going to increase. No doubt about it. Alcoholism is going to increase. Veterans dying from accidental overdoses are going to increase. Deaths caused by veterans turning to street drugs are going to increase,” says Rose.

The VA and the Pentagon released the new opioid guidelines for veterans and active duty service members last month. (See “Tougher Opioid Guidelines for U.S. Military and Veterans”). It urges VA and military doctors to taper or discontinue opioids for patients on high doses, and strongly recommends that no opioids be prescribed for chronic pain patients under the age of 30.

Some VA doctors didn’t wait for the new guideline to be released. Rose, who suffers from chronic back pain due to service related injuries, was on a relatively high dose of morphine for 15 years before he was abruptly taken off opioid medication by his doctor last December.

Rose is in so much pain now that he rarely leaves the house.

“People cannot live in the amount of pain that I’m doing. They can’t do it. It’s just unimaginable to think that people can survive at this level for any length of time and be denied pain care,” Rose told PNN.

“Many, many, many days I was asking God to take me home because I couldn’t deal with the pain anymore.”

robert rose

Suicidal thoughts are not uncommon in the veteran community. Over half the veterans being treated at VA facilities suffer from chronic pain, as well as high rates of depression and post-traumatic stress disorder.  A recent study by the VA estimated that 20 veterans killed themselves each day in 2014.

Some have associated the high rate of suicide with opioid pain medication. The new VA guideline recommends that patients be closely monitored for suicide risk during opioid therapy, especially if they have a history of depression or bipolar disorder.

But there is no mention in the 192-page guideline that undertreated or untreated pain can also be a risk for suicide. The guideline is actually dismissive of suicide risk in patients being weaned off opioids:

“Some patients on LOT (long term opioid therapy) who suffer from chronic pain and co-occurring OUD (opioid use disorder), depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to ‘prevent suicide’ in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases.”

Do Opioids Raise Risk of Suicide?

Are suicidal patients better off without opioids, as the guideline suggests?

“When I’m doing clinical work, that’s a question that I face on almost a daily basis,” says Mark Edlund, MD, a Utah psychiatrist who treats patients with chronic pain, mental health and substance abuse problems. “If people are being prescribed opioids, does that increase their risk for suicide?”

Edlund co-authored a recent study published in the American Journal of Public Health, which found that the number of suicides involving opioids more than doubled from 1999 to 2014, a period when opioid prescribing sharply increased.     

“There’s a good theoretical reason to think they are linked. Opioids can easily cause death. We know that opioid prescriptions have been going up,” says Edlund. “To me the results make complete sense. And they fit within a model you could make of increased access to opioids would increase suicide.”

Edlund, who is a research scientist with RTI International, co-authored the study with Jennifer Braden, MD, and Mark Sullivan, MD, both researchers at the University of Washington. Sullivan is a longtime critic of opioid prescribing practices and a board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Edlund is not a member of PROP, but has participated in some PROP research studies and says he is "largely in agreement" with the group's goals.

While his study found an association between opioid medication and suicides, Edlund admits it failed to prove causation – definitive proof that opioids contribute to suicidal thoughts or actions. In fact, recent research indicates that less than 5 percent of the attempted suicides in the U.S. involve opioids.  

“If you really wanted to get into causality, that would be very difficult to assess,” he said.  “I think there are competing explanations. What may be true for one person may not be true for another. Maybe for some people opioids are not helping with their pain and they’re worsening depression. But on the other hand, I’m sure there are some people that are using opioids and it improves their functioning and decreasing their pain. That part is hard to disentangle.”

The United States has seen a disturbing increase in suicides for over a decade. In 2014, nearly 43,000 Americans committed suicide, over twice the number of deaths linked to accidental opioid overdoses.

Most often suicides are blamed on depression, mental illness, financial problems, or drug and alcohol abuse. No statistics are kept on how many Americans kill themselves due to untreated or poorly treated pain, but there are a growing number of anecdotal reports of patients killing themselves after having their opioids reduced or eliminated (see “Chronic Pain Patient Abandoned by Doctor Dies”).

“I can't go on like this,” Bianca recently wrote to PNN. “They've cut my medicine to less than half of what I was taking.  I also have had suicidal thoughts, but pray to God that I don't.”

“I think of killing myself every day since… my doctors stopped prescribing (opioids). Why have they not been looking at this very issue, which is pain?” asked Tom.

“I will kill myself if they take me off it. Barely helps my pain anyways. The new anti-opiate laws by the government will cause my death,” wrote another pain patient. “I am certain many others will commit suicide.”

“I have suicidal thoughts every day since being taken off opioids. Life was bad before, now it is hell,” said Thomas. “Let’s place an ice pick in these doctors’ spines and see how long they last 24 hours per day, seven days a week. These ivory tower idiots would have a quick change of mind.”

Those are the patients that Mark Edlund worries about.

“That’s the personal clinical issue that I wrestle with. Which of those patients that I see will the opioid increase risk of suicide or decrease it? If it’s a legitimate pain patient who benefits from opioids, then yeah, it’s going to decrease the risk,” he said.

Do Opioids Lower Risk of Suicide?

Researchers in Israel recently found that very low doses of an opioid actually reduce suicidal thoughts. Patients in four Israeli hospitals – most of whom had a history of suicide attempts – had a significant decline in suicidal ideation after being given tiny doses of buprenorphine (Suboxone), a medication widely used to treat addiction.

“The study could not prove that opioids treat mental pain—it wasn’t designed to do so—but it did show that buprenorphine decreases suicidal ideation.  Perhaps the study’s most important contribution is its implication that treatments that help us withstand mental pain may prevent suicide,” psychiatrist Anne Skomorowsky wrote in Scientific American.

“(The) study provides a rationale for thinking about opioids in a new way. More than that, it suggests that interventions that increase our capacity to tolerate mental anguish may have a powerful role in suicide prevention.”

Suicide is a topic that is rarely addressed in the national debate over the so-called opioid epidemic. But as efforts continue to restrict or even eliminate opioid prescribing, patients like Robert Rose warn that we could be exchanging one epidemic for another.

“Them taking the pain meds away (from me) was God kicking me in the ass and telling me to get back into the world of the living. Now I have something to fight for,” says Rose, who bombards politicians, government officials and regulators with a steady stream of emails warning of the harm opioid guidelines are causing.

“Unfortunately since the VA adopted the CDC guidelines this is exactly what many veterans have done… turned to suicide. And with Medicare/Medicaid considering adopting the same policies, those suicides, your families, friends and neighbors, will spill over into the civilian populace with staggering implications for many,” Rose said in a recent email.

“Instead of tens of thousands of veterans being affected, it’s going to be tens of millions. And the loss of life is going to be devastating to families, communities and to the workforce.” 

A Letter to Medicare From a Worried Pain Patient

Editor’s Note: This Friday marks the deadline for the public to comment on opioid prescribing guidelines proposed by the Centers for Medicare and Medicaid Services (CMS). As PNN has reported (see “Medicare Planning to Adopt CDC Opioid Guidelines”), the guidelines are likely to limit access to opioid pain medication for millions of Medicare beneficiaries. They would also empower insurance companies to take punitive action against pharmacies, doctors and patients that don’t follow the guidelines.

The following is a letter written in opposition to the CMS guidelines by Ms. Judith Botamer. She has graciously agreed to let us publish it here in the interest of getting more people to send their own comments to CMS. 

All comments should be emailed to CMS no later than March 3 to this address:

AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

As a disabled chronic pain patient, I strongly oppose the Centers for Medicare and Medicaid Services’ plan to accept policies from the recent CDC Guideline for Prescribing Opioids for Chronic Pain. I implore you to take action so that this mandate does not become a reality for the 100 million Americans who suffer with chronic pain, including many on Medicare.

The CDC guideline is simply a voluntary guide intended for primary care physicians only. The CMS guideline as written gives no margin or credence to pain management doctors who already have strict opioid policies, as well as an established ongoing relationship with their patients.

Your currently drafted policy makes the guidelines mandatory for all doctors, patients and pharmacists, and imposes a ceiling on the highest dose of opioids that can be prescribed. This gives physicians no discretion in determining what is right for their patients. That was never the CDC’s intent, nor is it feasible to expect all chronic pain patients to be able to maintain the level of care that their doctor has established for them.

I am permanently disabled with neuropathy, RA, fibromyalgia, torn disks, TMJD and migraines, as well as many other pain conditions for which there is no cure. At the young age of 53, I sometimes feel my life is over. If not for pain control from opioid medication, it surely would become a reality.

I never asked to be overcome with this much pain from so many “invisible illnesses.”  As a prior athlete, I am challenged daily to accept the reduced quality of life for myself and, in turn, for my family. Fortunately, my empathetic pain doctor will prescribe me enough medication so that I am functioning. If my current regimen were to be lowered to the amount set forth in this guideline, I would not be able to fully care for myself, perhaps be bedridden, and be left with a dramatically diminished quality of life.

This mandate actually takes away my right to a quality of life that I deserve. The burden of being struck with legitimate pain conditions should not equate to the loss of a right to live life with dignity, just as any other patient with any other chronic illness.

Many doctors are now frightened of prescribing pain medication for fear the CDC, DEA or FDA would sanction their license, when they simply want to fulfill their oath of “do no harm.” And let's be clear, not prescribing pain medication to a patient who is suffering, is doing harm! Not only for the patient, but for our communities and society as a whole.

To this point, on June 1, 2016, Dr. Debra Houry, the director of the CDC’s National Center for Injury Prevention and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to try taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. 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.”
  

I truly hope that there is no collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.” Taking pain medication away from a pain patient will not stop the criminals, drug cartels or addicts. Those issues are worlds away. Pain patients are not addicts or looking for a “high.” They depend on their medication just as a diabetic depends on insulin for life quality.

Please join me and become an empathetic advocate for the millions who suffer in silence as a result of just a few who break the law and displace attention away from the real tragedy: Pain patients being denied medical treatment, being treated as criminals, and their doctors being threatened for only doing the right thing!

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,
Judith A. Botamer

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.

The Magical Opioid Number

By Roger Chriss, Guest Columnist

Numbers can be impressive. They seem like powerful evidence or useful metrics in regulations and legislation.

In 2016, the Centers for Disease Control and Prevention issued its guidelines for opioid prescribing, setting a recommended daily limit on opioid doses at 90 morphine milligram equivalent (MME). Now the Centers for Medicare and Medicaid Services (CMS) is on the cusp of adopting that number as a requirement for Medicare recipients. Physicians around the country have already started using it and so has the Veterans Administration.

In addition, Maine has passed a state law with a maximum 100 MME allowed for opioid prescribing starting on July 1, 2017. New Jersey, Virginia and other states are also passing laws restricting opioid prescribing by dose or duration, often citing the CDC guidelines as justification. 

But this number is all but arbitrary. The CDC guidelines recognize that the 90 MME ceiling was based on limited evidence. Obviously, patients are not safe at either 80 MME or doomed at 100 MME.

Nor can this number be used to calculate the safe number of days or doses for an opioid prescription. It is a magical number. And magical numbers can lead to magical thinking.

In fact, the 90 MME from the CDC cannot even be reliably calculated. The CDC offers an app that allows physicians to calculate the 90 MME. Its basic methodology is described here. Web sites like Practical Pain Management also offer an opioid calculator, and third-party developers have created opioid conversion apps.

But it turns out that the results of these calculators are inconsistent. Dr. Jeffery Fudin and his students have shown that the various methods of calculating MME produce significantly different outcomes.

Thus, how much of a morphine equivalent dose an individual is actually allowed to receive depends on which method is used. This uncertainty makes the 90 MME level clinically less than meaningful and potentially dangerous.

Existing research does show an increased risk of addiction and overdose as the daily dose of an opioid medication rises. But this is exactly what we should see. Most substances are more dangerous in larger quantities, after all. But each patient is different: gender, age, health status, prior opioid exposure, and other factors all play a significant role in determining a safe and effective dose of an opioid medication.

A cutoff like 90 MME is at best arbitrary. At worst it leaves some patients undertreated, and may harm patients who are forced to taper to the 90 MME threshold from a higher dose that has been safe and effective for them.

In addition, it is not entirely clear how the magic number of 90 MME was determined. The CDC developed its guidelines in a largely closed-door process that involved outside consultants whose identity was not revealed at the time. Most magical numbers are like this: their justification is thin and often obscured.

Meanwhile, the CMS and states like New Jersey and Maine are ignoring more important numbers. A recent STAT News article reported that opioid prescriptions have been falling since 2012 and that the misuse of pain relievers bottomed out in 2014. In other words, opioid prescribing is no longer a driving factor in the opioid crisis -- street drugs are.

The magical number of 90 MME is simply not justified. The relative risk of prescription opioids, in particular for people with chronic or intractable pain, is quite low. This fact was ignored in the CDC guidelines and in state government regulation. But it should be obvious: Most Americans have taken opioids at some point in their lives, whether after trauma or surgery or as a part of dental care. And it is abundantly clear that the majority have not become addicted to opioids. Again, the magic number is not real.

On February 9, 1950, Senator Joe McCarthy gave a speech in Wheeling, West Virginia, claiming that the U.S. State Department was infested with Communists, specifically 205 of them. This number helped launch a wave of political repression, fear-mongering, and social paranoia that we now refer to as McCarthyism. Nothing good came of that era, except maybe a cautionary note about how magical numbers can contribute to tragic results.

We are facing a similar risk with opioids, a magical number motivated by magical thinking by regulators and policymakers -- none of which is likely to help address the opioid crisis or the tragedy of addiction.

Instead, millions of people who may benefit from short-term opioid therapy after trauma or surgery will be denied effective medication for pain management, and tens of thousands of people with chronic conditions for whom opioid therapy is a critical component in maintaining a reasonable quality of life will be harmed. These are real numbers that we really need to pain attention to.

Roger Chriss suffers from Ehlers Danlos syndrome. Roger is from Washington state, where he works as a technical consultant who specializes in mathematics and research.

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.

Signing a Pain Contract in the Age of Opioid Phobia

By Crystal Lindell, Columnist

I know, I know. Opioids seem to be all that pain patients talk about these days. Blah, blah, blah. We get it, you need drugs. Let’s move on already.

But I don’t have that luxury. Opioids are, for better and for (mostly) worse, a huge part of my life. And I recently decided that I was:

A. Going to need to continue taking at least a small dose of hydrocodone long-term

B. That I really needed a slighter larger, “small dose” to be able to function.

I have what’s called intercostal neuralgia on my right side and the best way I can think to describe it is that I always feel like I have three broken ribs. The pain is no joke. And although it seems to be more manageable these days, it lingers and it hurts like hell, and opioids are the only thing I have found that even kind of helps.

Without hydrocodone I am in too much pain to shower regularly, check email, do my makeup or even sit a restaurant and eat.  With hydrocodone I can pretty much do all those things, like a typical health person who’s just a bit high. 

And yes, I know they are addictive, I know how hard they are to get off of, and I know that withdrawal is hell. I’ve been through it. I took myself down to 5 mg a day from 60 mg day when my pain became more manageable. It wasn’t easy. It took about a year for my brain to deal with that, and the withdrawal issues sucked.

So, when I say I need to be on hydrocodone, I say it with all the wisdom and caution that comes from the personal experience of dealing with opioids — and their side effects. 

And honestly, I’m among the lucky ones. When I called my doctor to ask if I could up to 10 mg a day, he agreed and knew I wouldn’t be asking if I hadn’t given lots of thought to the pros and cons of that choice. 

But that doesn’t mean dealing with opioids doesn’t also suck. 

First, I had to drive two hours each way to see him, because that’s how far away the closest university hospital is to my house and my case is too complex for the local small town doctors. And, as a reminder, I live my daily life feeling like I have three broken ribs. Driving two hours each way sucks. 

Then, when I got there, I had to take a drug test. Some politician somewhere decided people on opioids shouldn’t be using pot. Okay. But peeing in a cup sucks when you’re a woman. It gets all over your hands. You miss the cup and don’t collect enough. It’s just messy. 

But fine. Whatever. 

I peed in a cup. Good news. I’m clean. Well, I mean, aside from the hydrocodone, I’m clean. 

Signing a Pain Contract

Then, I had to sign what is formally called the “Controlled Substances Medication Agreement” — basically an opioid pain contract. At first blush it doesn’t seem like a big deal. As long as I’m a good person, there shouldn’t be any issues, right?

But the thing is literally 21 bullet points long. And it feels like I signed away all of my rights. 

The contract includes things like bullet point number 8, which requires that I get my prescription filled at the same pharmacy every month.

This is annoying because I use my local small town pharmacy, which is closed on Sundays, holidays and every night at 7 p.m. And if I’m due for a refill on a Sunday or out of town for work when my prescription expires, I can’t get it filled early, as bullet point number 14 clearly explains. 

Bullet point 14 also says I have to keep all my drugs in a locked cabinet or safe, and if they’re ever stolen I can’t get an early refill. Guys, that’s just not practical. I take these meds as needed, and sometimes that means I’m at the grocery store or visiting a friend or eating at Taco Bell, and then suddenly they are needed. And at those times, they are in my purse, which doesn’t have a lock on it. 

Bullet point number 11 says I can’t go to the emergency room for opioids, which sucks because sometimes my pain spikes and the only thing that gets it under control is a shot of dilaudid, which I usually get at the ER. I guess now when my pain spikes, I’m supposed to drive two hours to my doctor and hope he’s available to deal with it. 

Oh, and if I’m ever too sick to make that drive, nobody is allowed to pick up my hydrocodone prescription unless I have pre-authorized them, as per bullet point number 13. Of course, it has to be a written prescription — doctors cannot legally call in or fax hydrocodone  prescriptions anymore. 

I also agreed to get random drug tests, allow pill counts. and basically just give up all of my dignity. 

Fine. Okay. I need these medications. So I signed on the dotted line. And I guess I just have to hope I never get robbed, have a flare up or need a refill on a Sunday. 

The thing about opioids is that everyone assumes that if they ever need these drugs they will be able to get them. That anyone who’s truly deserving doesn’t have anything to worry about. But I have to tell you something: I’m a good person. I’m in real pain. I need these drugs. And I’m barely able to get them.

I understand how powerful these drugs are. Going off morphine was literally hell for me. But you know what else is hell? Living every day of your life feeling like you have three broken ribs. 

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Heroin Tops Painkillers as Leading Cause of Overdoses

By Pat Anson, Editor

One in four drug overdoses in the United States can now be blamed on heroin, according to a new report by the Centers for Disease Control and Prevention that shows deaths linked to prescription painkillers falling.

The report found that fatal drug overdoses have more than doubled in the U.S. since 1999, with overdose death rates growing the fastest among whites and middle aged Americans.

In 2015, the overdose death rate was 16.3 per 100,000 people, up from 6.1 deaths per 100,000 in 1999. Ten percent of the deaths in 2015 were classified as suicides, 84% were accidental and the remainder undetermined.

The report by the CDC’s National Center for Health Statistics further documents the changing nature of the nation’s drug problem. Overdose deaths involving natural and semisynthetic opioid painkillers – such as hydrocodone and oxycodone – remain high, but have fallen from 29% of all overdoses in 2010 to 24% in 2015.

At the same time, deaths involving heroin have tripled, from 8% of overdoses in 2010 to 25% in 2015 – making heroin the leading cause of drug overdoses.

Deaths involving synthetic opioids, a category that includes both fentanyl and tramadol, rose from 8% of overdoses in 2010 to 18% in 2015. The U.S. has seen a surge in illicit fentanyl being sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers. More recent data from some states, like Massachusetts and Ohio, show that deaths involving fentanyl now exceed those linked to heroin and painkillers.

PERCENTAGE OF OVERDOSE DEATHS BY DRUG CATEGORY (SOURCE: CDC)

Perhaps the only bright spot in the report is that overdose deaths involving methadone have declined from 12% of deaths in 2010 to 6% in 2015.

The CDC analysis is based on death certificate codes, a database that is not always considered reliable because of wide variability in reporting from state to state.

“At autopsy, the substances tested for and the circumstances under which the toxicology tests are performed vary by jurisdiction,” wrote lead author Holly Hedegaard, MD, a medical epidemiologist with the National Center for Health Statistics.

“Additionally, drug overdose deaths may involve multiple drugs; therefore, a single death might be included in more than one category when describing the percentage of drug overdose deaths involving specific drugs. For example, a death that involved both heroin and fentanyl would be included in both the percentage of drug overdose deaths involving heroin and the percentage of drug overdose deaths involving synthetic opioids excluding methadone.”

Other highlights from the report:

• West Virginia, New Hampshire, Kentucky and Ohio had the highest overdose rates in 2015
• Nebraska, South Dakota, North Dakota and Texas had the lowest overdose rates
• The age-adjusted overdose death rate among whites in 2015 was 240% higher than in 1999
• The overdose rate for whites was nearly double that of blacks and three times higher than Hispanics
• Overdose deaths grew among all age groups, but surged over 500% for adults aged 55 to 64

The report helps document a disturbing increase in deaths among middle-aged white Americans, first reported by Princeton University researchers in 2015.

Anne Case and Angus Deaton estimated that a "lost generation" of nearly half a million Americans died from a quiet epidemic of chronic pain, suicide, alcohol abuse and drug overdoses from 1999 to 2013.  

“This change reversed decades of progress in mortality and was unique to the United States; no other rich country saw a similar turnaround,” Case and Deaton reported in the Proceedings of the National Academy of Sciences. “This increase for whites was largely accounted for by increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.”

The rising death rate for middle-aged whites was accompanied by declines in physical health, mental health and employment, as well as increases in chronic joint pain, neck pain, sciatica and disability.

Study: Suboxone Usually Fails To Stop Opioid Use

By Pat Anson, Editor

A drug widely prescribed to treat opioid addiction fails so often that two-thirds of the pain patients who took it during addiction treatment wound up getting opioid prescriptions again, according to a large new study by the Johns Hopkins Bloomberg School of Public Health.

Researchers analyzed pharmacy claims for over 38,000 people who were prescribed Suboxone (buprenorphine) between 2006 and 2013, and found that 67 percent of them filled a prescription for an opioid painkiller in the year after Suboxone treatment.

Nearly half of the patients – 43 percent -- filled an opioid prescription during treatment. Most patients continued to receive similar amounts of opioids before and after Suboxone treatment.

Suboxone is a combination of two different medications: buprenorphine, a short-acting opioid similar to methadone, and naloxone, an anti-overdose drug.

During most of the years analyzed in the study, Suboxone was the only combination of buprenorphine and naloxone that was available. It is now sold under several different brand names.

The Johns Hopkins study, which was funded by Centers for Disease Control and Prevention, found that about two-thirds of the patients who received Suboxone stopped filling prescriptions for it after just three months.

The findings, published in the journal Addiction, raise questions about the effectiveness of Suboxone and addiction treatment in general, at a time when the federal government is spending hundreds of millions of dollars to subsidize the addiction treatment industry.

"The statistics are startling," said lead author G. Caleb Alexander, MD, "but are consistent with studies of patients treated with methadone showing that many patients resume opioid use after treatment."

Researchers say the continued use of pain medication during and after addiction treatment suggests that many patients did not have well-coordinated treatment for their addiction or their chronic pain.

“There are high rates of chronic pain among patients receiving opioid agonist therapy, and thus concomitant use of buprenorphine and other opioids may be justified clinically. This is especially true as the absence of pain management among patients with opioid use disorders may result in problematic behaviors such as illicit drug use and misuse of other prescription medications,” Alexander wrote.

Prescriptions for Suboxone and other brands of buprenorphine have soared in recent years as the U.S. grapples with an “opioid epidemic” that was initially fueled by painkillers, but is now increasingly caused by heroin and illicit fentanyl. Sales of buprenorphine now exceed $2 billion annually and are likely to keep growing.

Last year the federal government nearly tripled the number patients that can be treated with buprenorphine by an eligible physician. Raising the limit from 100 to 275 patients was intended to give addicts greater access to treatment, especially in rural areas where few doctors are certified to prescribe buprenoprhine.

An additional $1 billion in funding for addiction treatment was approved by Congress last year under the 21st Century Cures Act. Much of that money will be used to pay for buprenorphine prescriptions.

Addicts long ago discovered that buprenorphine can be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked it as the third most diverted opioid medication in the U.S. in 2014. 

Tougher Opioid Guidelines for U.S. Military and Veterans

By Pat Anson, Editor

It’s going to be even harder for U.S. military service members and veterans – especially younger ones -- to obtain opioid pain medication.

The Department of Veterans Affairs and the Department of Defense have released a new clinical practice guideline for VA and military doctors that strongly recommends against prescribing opioids for long-term chronic pain – pain that lasts longer than 90 days.

The new guideline is even more stringent than the one released last year by the Centers for Disease Control and Prevention (CDC).

It specifically recommends against long-term opioid therapy for patients under the age of 30.  And it urges VA and military doctors to taper or discontinue opioids for patients currently receiving high doses.

The 192-page guideline (which you can download by clicking here) is careful to note that the recommendations are voluntary and “not intended as a standard of care” that physicians are required to follow.

But critics worry they will be implemented and rigidly followed by military and VA doctors, just as the CDC guidelines were by many civilian doctors.

“I am concerned that many of these veterans with moderate to severe pain who may be well-maintained on long-term opioid therapy as part of a multidisciplinary approach or whom have already tried non-pharmacological and non-opioid therapies and found them insufficient will be tapered off their medication for no good reason except that their physicians will be fearful to run afoul of these new guidelines,” says Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation, a patient advocacy group.

Although much of the research and clinical evidence used to support the new guideline was considered “low or very low” quality, a panel of experts found “mounting evidence” that the risk of harm from opioids -- such as addiction and overdose – “far outweighed the potential benefits.”

“There is a lack of high-quality evidence that LOT (long term opioid therapy) improves pain, function, and/or quality of life. The literature review conducted for this CPG (clinical practice guideline) identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain.”

The panel of experts was comprised of a diverse group of doctors, nurses and pharmacists within the Departments of Defense and Veterans Affairs, including specialists in pain management and addiction treatment. 

“We recommend against initiation of long-term opioid therapy for chronic pain,” reads the first of 18 recommendations of the expert panel, which said that only “a rare subset of individuals” should be prescribed opioids long term.

Instead of opioids, the panel recommends exercises such as yoga and psychological therapies such as cognitive behavioral therapy to treat chronic pain, along with non-opioid drugs such as gabapentin (Neurontin).

“In light of the low harms associated with exercise and psychological therapies when compared with LOT these treatments are preferred over LOT, and should be offered to all patients with chronic pain including those currently receiving LOT.”

Another strong recommendation of the panel is that opioids not be prescribed long-term to anyone under the age of 30, because of the damage opioids can cause to developing brains. 

“Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD (opioid use disorder) and overdose.”

Of the seven studies used to support this claim, four were rated as “fair quality” and three were considered “poor quality.”

“That strikes me as an extremely weak evidence base for such a sweeping recommendation,” said Steinberg. “There is no mention of severity of pain condition which is extremely relevant in this population, many of whom sustained devastating and gruesome battlefield injuries such as blown off limbs.”

The panel recommends alternatives to opioids for mild-to-moderate acute pain. If opioids are prescribed temporarily for acute short-term pain, immediate release opioids are preferred.

Risk of Suicide Discounted

Pain is a serious problem for both active duty service members and veterans. A study found that nearly half the service members returning from Afghanistan have chronic pain and 15 percent reported using opioids – rates much higher than the civilian population.

The incidence of pain is even higher among veterans being treated at VA facilities. Over half suffer from chronic pain, as well as other conditions that contribute to it, such as depression and post-traumatic stress disorder. Even more alarming is a recent VA study that found an average of 22 veterans committing suicide each day.

The new guideline recommends that patients be monitored for suicide risk before and during opioid therapy, but curiously there is no mention that undertreated or untreated pain is also a risk for suicide. For patients being tapered or taken off opioids, doctors are advised not to take a threat of suicide too seriously.

“Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to ‘prevent suicide’ in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT.”

Many patients could find themselves being tapered or taken off opioids if the guideline is taken literally by their doctors. The expert panel strongly recommends against opioid doses greater than a 90 mg morphine equivalent (MME) daily dose and urges caution for doses as low as 20 MME. 

“This again fails to recognize that patients differ widely in severity of pain, individual response to medication, body size and weight and tolerance for pain,” says Steinberg.

“I worry that, as we have seen with the CDC guidelines, clinicians will begin tapering patients who may be well-maintained on stable does of medication for fear of running afoul of sanctioned limitations rather than being guided by what is best for their patients. These limitations are in direct conflict with FDA approved labeling which is based on safety and efficacy trials and does not include dose thresholds.”

The VA and Department of Defense opioid guideline will affect millions of service members, veterans and their families. Nearly 1.5 million Americans currently serve in the armed forces and over 800,000 in the National Guard and Reserves.  The Veterans Administration provides health services to another 6 million veterans and their families.

The guideline is the second major initiative by the federal government so far this year aimed at reducing opioid prescribing. As Pain News Network has reported, the Centers for Medicare and Medicaid Services (CMS) has announced plans to fully implement the CDC’s opioid prescribing guidelines.

CMS is taking those voluntary guidelines a step further by mandating them as official Medicare policy and taking punitive action against doctors and patients who don’t follow them. CMS provides health insurance to about 54 million Americans through Medicare and nearly 70 million through Medicaid.

China Agrees to Crackdown on Fentanyl

By Pat Anson, Editor

China is finally taking steps to stop the production of illicit fentanyl, a synthetic opioid blamed for thousands of drug overdoses in the U.S. and Canada.

China’s National Narcotics Control Commission announced this week that it is “scheduling controls” against four fentanyl-class substances – carfentanil, furanyl fentanyl, valeryl fentanyl, and acryl fentanyl, starting on March 1, 2017.  The announcement came after several months of talks between the Chinese government and the U.S. Drug Enforcement Administration.

"Fentanyl-related compounds represent a significant and deadly component of the current opioid crisis.  These actions will undoubtedly save American lives and I would like to thank my Chinese counterparts for their actions on this important issue," said Acting DEA Administrator Chuck Rosenberg in a news release.

"It shows China's attitude as a responsible big country," Yu Haibin, the director of the Office of the National Narcotics Control Committee, told the Associated Press. "It will be a strong deterrent."

DEA officials say China’s move is a potential “game-changer” in the opioid epidemic, because it will close a loophole that allowed Chinese laboratories to manufacture fentanyl and its chemical cousins legally.

DEA PHOTO

The substances were then shipped to Mexico before being smuggled into the U.S. and Canada, where they were often mixed with heroin or used in the manufacture of counterfeit oxycodone and other painkillers. Traffickers also purchased pill presses from China, according to the DEA.

COUNTERFEIT OXYCODONE

“The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyls is only detected upon laboratory analysis,” the DEA warned in a report last summer.

Fentanyl is up to 100 times more potent than morphine. It is legally prescribed in lozenges and patches to treat severe pain. Carfentanil is so potent it is used by veterinarians as an anesthetic on elephants.

Illicit fentanyl is mixed with heroin to increase its potency, but dealers and buyers may not know exactly what they are selling or ingesting. Massachusetts, Rhode Island, Ohio and other states have reported an “alarming surge” in fentanyl related deaths. In some states, the number of deaths from illicit fentanyl now exceeds those from prescription opioids.

Two public health researchers have speculated that a “malicious actor” could be behind some of those deaths.

“These highly potent pills could have been created by a malicious actor to intentionally poison consumers or attract the attention of law enforcement to redistributors,” wrote Traci Green, PhD, Boston University School of Medicine, and Michael Gilbert, MPH, Epidemico Inc., in a research letter published in JAMA Internal Medicine.

Waiting for My Pain Medication to Be Stripped Away

By Sheryl Donnell, Guest Columnist

Up until recently, I thought I was coming through this opioid crisis unscathed. My pain management doctor has been with a top clinic for many years and is highly respected and generally above reproach.

We did not have that dreaded conversation virtually everyone else with chronic pain I know has had -- until September 13th, 2016.

That night, I fell and broke 5 bones in my foot, which was already affected with Chronic Regional Pain Syndrome (CRPS). The pain was so incredibly severe.

I laid on the floor from 2 am to 10 am before I could stay alert enough, and not pass out from shock and pain, to get to a phone to call my husband upstairs for help (he is deaf in one ear). It took 4 paramedics to get me off the floor and into an ambulance.

Once at the hospital, even though I was writhing in agony and still passing out literally from pain, the doctor never examined me or my foot. She didn't care I had been on an ice cold floor for 6 hours. All she heard was "chronic pain patient" and she was done with me.

SHERYL DONNELL

I begged her to call the pain experts my doctor worked with so she could get some guidelines for treating me, but she didn't see a reason. I asked if she was familiar with CRPS, and she proudly said no and it didn't matter. She sent me for x-rays. No sooner did I get back in my room from another horrifyingly painful experience did she announce nothing was broken and to go home.

I sat there stunned. I had heard the bones break. I knew there were fractures. I begged the nurses to do something. I had not even been given a single Tylenol. This doctor firmly believed I was a drug seeker and wanted to bounce me.

The nurse started reading my discharge papers, which said, "Come back if you have any of these symptoms." I started crying harder. I said I have every one of those right now! She was practically in tears herself.

Then my husband asked, “What will he do when we get home? We can't even get her into the house!” The nurse told him to call the paramedics again to help get me back inside my home, which we did.

My husband called in 24-hour care workers to help me so I could manage a bit. It was agony going to the bathroom, even with a bedside commode my mother brought.

The following morning, the paramedics came back and helped me into the car. We went downtown for a pain injection to try to stop a progression of my CRPS. While there I insisted on new x-rays, which my pain doctor of 9 years grudgingly agreed to -- mostly to shut me up. He said come back in a week for another shot.

I asked for an increase in my pain medication. My biggest shock that day was his response. He said there was no reason for an increase! What? We went home to 24-hour care and instructions to start weight bearing exercises asap!

A full week later with not a single call, we returned to my pain management doctor for my second injection. He casually mentioned the results of my x-rays, which showed that I had 5 broken bones in my foot. No call for an entire week. I was left to think I was nuts and was trying to bear weight on a severely fractured foot!

I was not offered, nor were my requests for additional pain medication granted. I was told to come in every week for four more weeks (in great agony and great difficulty) for pain injections which did very little. However, I did not have a spread of my CRPS.

I did lose about 8 weeks of my life again. My pain levels were so extreme I did nothing but sit in my recliner and do a lot of crying. And realize how lucky I was to have family support, the ability to pay for 24-hour caregivers, and to be believed I was in the kind of pain I said I was in. My adult daughter moved home for a month to help me and my husband with caregiving duties.

What do other people do?

Even after my 6 weeks of pain injections, when I requested a short term increase in pain medication to help me rehab my still very painful foot once I was cleared by my orthopedist, I was again turned down by my pain management doctor.

It is now 5 months after I broke my foot and I cannot complete my rehabilitation because my pain is still so intense. I know if this had happened 5 years ago, I would not be suffering like this.

Even though my pain has worsened and I need to rehabilitate my injury, the CDC has arbitrarily changed the rules and I must suffer. My doctor's hands are tied.

I lose more and more days spent doing things I enjoy or need to do because the CDC’s “experts” sat in a room and made decisions based on flawed data and street drugs; not real patients who follow the rules of their pain contracts and don't seek out multiple doctors or illegal methods to get medication. I follow all the rules, just like 99.5% of my peers.

We are suffering and living in fear that we will be next to have our medication stripped away from us, through no fault of our own. And then the real terror begins.

Sheryl Donnell lives in Illinois. She suffers from CRPS and fibromyalgia.

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.