Anti-Anxiety Meds Raise Risk of Opioid Overdose

By Pat Anson, Editor

Taking opioid painkillers with benzodiazepines – a class of anti-anxiety medication that includes Xanax and Valium – significantly raises the risk of an emergency room visit or hospital admission for an overdose, according to a large new study.

Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. Nearly 30% of fatal overdoses in the U.S. linked to opioids also involve benzodiazepines.

Researchers at Stanford University School of Medicine analyzed private insurance claims for over 315,000 people prescribed opioids from 2001 to 2013.

In 2001, they found that 9 percent of opioid users also received a prescription for a benzodiazepine. By 2013, the co-prescribing rate nearly doubled to 17 percent.

Their study, published in The BMJ, found that use of both drugs was associated with a substantially higher risk of an emergency room visit or inpatient admission for opioid overdose.

“We found that opioid users who concurrently used benzodiazepines were at an increased risk of opioid overdose and that eliminating concurrent benzodiazepine/opioid use could reduce the risk of opioid overdose by 15%,” wrote lead author Eric Sun, MD, an assistant professor at Stanford University School of Medicine.

“Providers should exercise caution in prescribing opioids for patients who are already using benzodiazepines (or vice versa), even in a non-chronic setting. Indeed, we note that the association between concurrent benzodiazepine/opioid use and the risk of opioid overdose was broadly similar for both intermittent and chronic opioid users.”

The Food and Drug Administration recently expanded the warning labels on opioids and sedatives because of the risk of overdose. Insurance companies are also actively discouraging doctors from prescribing the two together..

A recent study by the Centers for Disease Control and Prevention ranked Xanax (alprazolam) as the fourth deadliest drug in the United States, while Valium (diazepam) was ranked tenth. Xanax was involved in about a quarter of the overdoses involving opioid pain medication.  

New Opioid Relieves Pain Without the ‘High’

By Pat Anson, Editor

Nektar Therapeutics has announced positive results from Phase III study showing that a new opioid medication significantly reduces pain without the high levels of euphoria that can lead to abuse and addiction.

The company also said the Food and Drug Administration has given the medication – known as NKTR-181 – “fast track” designation for the treatment of moderate to severe chronic pain, a status that allows for an expedited review of the drug.

Many pain sufferers say they do not get "high" or experience euphoria from opioid pain medication. But drug makers and government regulators are seeking to develop painkillers with less risk of abuse and addiction.  

"The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study," said clinical investigator Martin Hale, MD, medical director of Gold Coast Research.

"While standard opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction.  The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions."

The placebo controlled study involved 610 patients with moderate to severe chronic low back pain who had not taken opioids before. During the open-label phase of the study, pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The company said over half the patients (51.5%) on NKTR-181 reported their general overall status and quality of life "improved" or "very much improved" compared to patients taking a placebo. 

They also reported better overall quality of sleep, with less sleep disturbance and fewer sleep problems. There were no differences in daytime sleepiness on NKTR-181 versus placebo. The drug was generally well-tolerated, although some patients reported nausea, constipation and somnolence.

Nektar is currently conducting another Phase III study to evaluate the safety and tolerability of NKTR-181 in 638 patients with chronic low back pain or chronic non-cancer pain.

The company says NKTR-181 is the first opioid molecule to provide pain relief without high levels of euphoria and sedation. The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier in order to slow its rate of entry into the brain.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

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.

Survey Shows Doctors Shunning Chronic Pain Patients

By Pat Anson, Editor

Chronic pain patients are not only having problems getting opioid medication, most are finding it hard just finding a doctor willing to treat their pain, according to a new survey.

Nearly 3,400 patients, doctors and healthcare providers responded to the online survey by Pain News Network and the International Pain Foundation, which was designed to assess the impact of the CDC’s opioid prescribing guidelines after one year.

The guidelines are voluntary and only intended for primary care physicians, but are being implemented throughout the U.S. healthcare system, often with negative consequences for patients. Over 70 percent of patients said they are no longer being prescribed opioid medication or are getting a lower dose. 

Asked if it has become easier or harder to find a doctor willing to treat their chronic pain, nearly half of patients said it was harder and 11% said they were not able to find a doctor. 

“I have been unable to find a doctor to treat my pain. I was going to a pain doctor but she suddenly dropped all her chronic pain patients to focus on surgery,” said a patient who added that he is now buying pain medication on the black market.

“I have found a new primary care doctor that is OK with prescribing Valium but stated she won't treat chronic pain because ‘the DEA is watching all of us,’” wrote another patient.

"I have been told by more than one doctor that they cannot legally prescribe over the guidelines. They are very concerned about being investigated and as a result refuse to treat pain with an appropriate dose of opioids," said another patient.

HAS IT BECOME EASIER OR HARDER TO FIND A DOCTOR TO TREAT YOUR CHRONIC PAIN?

"I was weaned off opiates last summer," said a patient. "My lower back and head are now in constant pain. I tried to hang myself last December but failed and spent a few days in hospital. Everyone thinks it was bad fall. Next time I won't fail."

"You have taken away my life. I am no longer a member of society, but more importantly, I can no longer function as a mother to two disabled children. I have exhausted all alternative methods of treatment. What do I do now? Illicit drugs or suicide?" asked one mother.

Doctors and healthcare providers are well aware that pain patients are losing access to treatment. Over two-thirds (67%) acknowledge that it is harder for patients to find a doctor.  A small number (9%) admit they’ve stopped treating chronic pain patients.

“I feel a standard of care for pain management has been needed, but the chronic pain patient is being lost in the process,” wrote a pain management provider. “For the first time in 5 years, I had to tell a patient I did not know what to do to help them. Pain management needs regulations, but should not cause the quality of life of chronic pain patients to suffer.”

"The manner in which (the guideline) was issued and received seemed to cause a response in which patients were basically titrated off all medication. Over half of my patients were treated this way," said a psychologist.

"Further, there appeared to be little or no assistance or cooperation in this process of removing a patient's analgesic medication. Overall, I believe that the response to CDC guidelines has harmed legitimate pain patients."

Doctors Worried About Prosecution

Why are some doctors shunning pain patients? They’re not worth the risk or hassle may be the simplest way to explain it. Consider some of the problems healthcare providers say they've dealt with in the past year:

• 59% say a pharmacy refused to fill an opioid prescription for a patient
• 57% say insurance refused to pay for a pain treatment they thought necessary
• 36% are worried about being prosecuted or sanctioned for prescribing opioids
• 20% have discharged a patient for failing a drug test
• 15% are referring more patients to addiction treatment
• 10% have lost a pain patient to suicide

Only 12 percent said their patients were better off without opioids and just 16% said their patients were getting safer and more effective treatment since the guidelines were released. Over a third (38%) believe their patients have more pain and a reduced quality of life.

The survey also found a sizeable number of doctors and providers who mistakenly believe the CDC guidelines are mandatory for everyone. While 70% correctly recognize them as voluntary, 20% think they are mandatory and 10% of healthcare professionals admit they simply don’t know.

"When a government agency suggests treatment guidelines, they will become the law. That is currently happening. We have reduced the number of pain patients and are no longer accepting new pain patients. The fear of prosecution is very real," wrote one pain management doctor.

"They are being interpreted as mandates and creating fear about ever using opioids to treat pain appropriately," said a provider who treats geriatric patients.

“(They) need to make it even more clear that these guidelines are geared for primary care and not experienced board certified pain doctors. Creating hysteria is what this is doing,” said a pain management doctor.

“While well meaning, the guidelines are incredibly biased and my colleagues are using them as an excuse to arbitrarily exclude patients from opioids when they clearly need them,” wrote an emergency room doctor.

ARE THE CDC GUIDELINES VOLUNTARY OR MANDATORY RULES EVERYONE HAS TO FOLLOW?

There is a strong divergence between patients and providers about the safety and effectiveness of opioids. Nearly two-thirds of doctors and providers (64%) think there are safer and better alternatives than opioids, while only about 7 percent of patients think so.    

Another area of disagreement is whether the guidelines are causing more harm than good. The vast majority of patients -- over 95 percent -- believe they have been harmful, while only 40 percent of doctors and providers think so. Nearly one in four healthcare professionals (22%) believe the guidelines have been helpful to patients, while only about 1% of patients think so.

"We have two problems in the U.S. A drug addiction problem and a chronic pain problem. We should not be attempting to treat one problem if that will also create a worsening problem in those that suffer from the other," wrote a primary care doctor. "We need to work on a solution to the addiction problem while still allowing those with chronic pain that need the opioids in order to sustain an acceptable quality of life."

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11. For more on how the guidelines are affecting patients, click here.

To see the complete survey results, click here.

Survey Finds CDC Opioid Guidelines Harming Patients

By Pat Anson, Editor

The CDC’s opioid prescribing guidelines have harmed chronic pain patients, reduced access to pain care, and failed to reduce drug abuse and overdoses, according to a large new survey of patients, doctors and healthcare providers. The survey also found signs of a dramatic shift away from opioid prescribing over the past year.

Today marks the one-year anniversary of the guidelines, which discourage the prescribing of opioid medication for chronic pain. The guidelines are meant to be voluntary and only intended for primary care physicians, but are being widely implemented throughout the U.S. healthcare system and having many unintended consequences.

According to the survey, over 70 percent of pain patients say they are no longer prescribed opioid medication or are getting a lower dose. While reducing opioid prescriptions may have been the ultimate goal of the guidelines, it came with a heavy price: Eight out of ten patients say their pain and quality of life are worse. Many are having suicidal thoughts, and some are hoarding opioids or turning to illegal drugs for pain relief.

“I had a doctor pull me off methadone cold turkey after taking it successfully for 15 years for no reason other than the CDC's guidelines. I was in the worst pain of my life,” said one patient.

"The CDC needs to stop practicing medicine without a license. They are hurting more chronic pain patients than they are helping," said another.

"These guidelines are so incredibly wrong. People are already suffering, myself included. And it's going to get so much worse," predicted one patient.

“The ‘War on Drugs’ has devolved into a war on patients,” wrote a primary care doctor. “The government should spend its time, effort, and money on research to find a pain treatment with fewer harmful effects than narcotics and butt out of the doctor-patient relationship.”

HOW HAVE THE CDC GUIDELINES AFFECTED YOUR OPIOID PRESCRIPTIONS?

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).

“This survey shows that patients and providers are in agreement about the harm the guidelines have caused since their release last year,” said Barby Ingle, president of iPain. “When we have government agencies or insurance companies impose poor practices on the pain community, we see failure. A failure to stop abuse and overdoses, hoarding behaviors by well-intentioned patients, increased use of illegal drugs and, worst of all, suicides increase.”

There was broad agreement between patients, doctors and healthcare providers that the guidelines have been harmful to patients. When asked if the guidelines had improved the quality of pain care in the United States, over 90 percent said no.

"I have been on a high dose of opioids for twenty years. I was having a quality of life and enjoyed living. Now I want to die every day. I am in excruciating pain and have no quality of life. I am on more drugs than ever and all I want is to die," said a patient..

“Not only do I have less pain relief but I am not able to be as active and am sad and frustrated about that. Something has to change, what’s happening is not sane or humane,” wrote a fibromyalgia sufferer.

HAVE THE CDC GUIDELINES IMPROVED THE QUALITY OF PAIN CARE?

Eight out of ten respondents said the guidelines have not been successful in reducing opioid abuse and overdoses. That view is supported by recent reports showing that opioid overdoses are soaring around the country, and are now being driven primarily by heroin and illicit fentanyl, not prescription painkillers. 

Some patients admit they are turning to the black market for pain relief.

"Eleven of the 36 people in my support group have admitted using illegally obtained pain medication. Three of those have resorted to heroin because it is cheaper," one patient said.

“I was able to find illegal sources of medication. However, the prices are high. I have been trying to avoid heroin but I may have to make a switch in the future if I don't find another doctor to manage my pain,” said another patient.

"My pain clinic sent a letter to all of their patients stating they would no longer prescribe opiates,” said a patient. “No other practice would accept me in the area so I have been able to obtain my former meds through the black market. The prices are high and I am tempted to move to heroin as it's much less expensive.”

HAVE THE CDC GUIDELINES BEEN SUCCESSFUL IN REDUCING OPIOID ABUSE AND OVERDOSES?

"I have found a source of illegal hydrocodone that I have been testing (making sure not laced with fentanyl) in extremely small does. If that turns out clean I will move to the black market for my drugs since it will end up cheaper," another patient wrote.

Over the past year, patients reported many negative consequences from the guidelines, with very few positive outcomes – such as finding safer and more effective treatments.

• 84% say they have more pain and worse quality of life
• 42% have considered suicide because their pain is poorly treated
• 22% are hoarding opioids because they’re not sure of future access
• 20% say insurance refused to pay for a pain treatment they needed
• 19% say a pharmacy refused to fill their opioid prescription
• 11% have obtained opioids illegally for pain relief
•   4% found better and safer treatment than opioids
•   4% were given a referral for addiction treatment
•   4% were discharged by a doctor for failing a drug test
•   1% found that they don’t really need opioids

Suicidal thoughts and an increasing sense of desperation were common in many of the patient’s answers.

“My neighbor poured gasoline over her head and set herself on fire and died because she could not get any pain relief. To me it’s the same as taking chemo and radiation away from a cancer patient," said one patient.

"Should be very careful who they kick off meds. A friend hung himself in the bathroom, another lost his job and went homeless. I live in fear," said another.

"People are killing themselves because their chronic pain isn't being treated, and I become closer and closer to being one of those people," wrote another patient.

"So far I have lost three friends with chronic pain to suicide. I bet the CDC sees that as a win. Three less people to deal with. Bullets are cheaper than dealing with their chronic pain. It’s become a joke," a patient said.

To see a story on the impact the guidelines are having on doctors, providers and the availability of pain care, click here.

To see the complete survey results, click here.

Doctors and Pain Patients Often Disagree on Goals

By Pat Anson, Editor

If you’ve ever felt that you and your doctor are not on the same page when it comes to treating your chronic pain, you’re not alone.

A small study published in The Clinical Journal of Pain found that disagreements between primary care physicians and patients over priorities in pain management are common. Patients generally hope to reduce pain intensity and identify the pain’s cause, while physicians aim to improve physical function and reduce the side effects of opioid pain medication, such as dependency.

"We wanted to understand why discussions about pain between patients and doctors are often contentious and unproductive," said lead author Stephen Henry, MD, an assistant professor of internal medicine at University of California Davis.

"Primary care physicians treat the majority of patients with chronic pain, but they aren't always equipped to establish clear, shared treatment goals with their patients."

The study involved 87 patients receiving opioid prescriptions for chronic musculoskeletal pain and 49 internal or family medicine physicians at two UC Davis Medical Center clinics in Sacramento, California. In most cases, the patients were seeing their regular physicians. Patients receiving pain treatment as part of cancer or palliative care were excluded from the study.

Immediately following clinic visits between November 2014 and January 2016, the patients completed questionnaires to rate their experiences and rank their goals for pain management. The physicians also completed questionnaires about the level of visit difficulty, along with their own rankings of goals for the patient's pain management.

Nearly half of patients (48%) ranked reducing pain intensity as their top priority, while 22% said finding a diagnosis was most important to them. In contrast, physicians ranked improving physical function as the top priority for 41% of patients, while reducing medication side effects was most important for 26 percent of them.

Physicians also rated 41% of the visits with pain patients as "difficult" -- meaning their interactions were challenging or emotionally taxing. Primary care physicians usually rate about 15% of patient visits as difficult.

One surprise finding was that patients rated their office visits as fairly positive, even when their doctor did not. That may reflect the fact that patients tend to have positive relationships with their regular physicians, even though they don't always agree with them..

“Another possibility is that patients and physicians may not have realized that they prioritized different goals, because goals were not explicitly discussed during the visit. Some patients may assume that their treatment priority and their physicians’ treatment priority are the same, even when they are not,” Henry wrote. “Disagreements about goals may only become relevant during visits where patients and physicians disagree about treatment plans (e.g., whether to prescribe opioids).”

Henry says primary care physicians may have adapted to recommendations such as the CDC opioid guidelines, which emphasize functional goals and avoidance of long-term opioid therapy. Patients have yet to adapt to the guidelines and are still primarily interested in pain relief.

What can be done to help doctors communicate more effectively with their pain patients?

Henry recommends communication training for primary care physicians to ensure that patients are more aware of their goals. "It is critical for doctors and patients to be on the same page and not working at cross purposes," he said.

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.