Education Campaign Launched for OTC Pain Relievers

By Pat Anson, Editor

You’ve probably seen the numbers. The Centers for Disease Control and Prevention estimates that over 47,000 Americans died of drug overdoses in 2014. Over 60 percent of them involved some type of opioid, a category that includes both prescribed pain medications and illegal drugs such as heroin.

Rarely mentioned by the CDC is the number of Americans harmed by over-the-counter (OTC) pain relievers such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). Acetaminophen overdoses kill about 150 Americans every year and send 78,000 to the hospital.

With opioids becoming harder to obtain for chronic pain sufferers, many are turning to OTC pain relievers – often excessively. A recent survey of pain patients found that 43% knowingly took more than the recommended dose of OTC pain medicine and 28% experienced complications from an overdose.

To help consumers learn more about the risks posed by OTC pain medications, the Alliance for Aging Research has released two animated videos about how to safely choose, take, and store OTC pain relievers. They explain the difference between acetaminophen – which is widely found in products like Tylenol and Nyquil – and NSAIDs, which includes both ibuprofen and aspirin.

"With so many options, it is important for someone to choose an OTC medication that does the best job of treating their pain, while also being aware of its potential risks to their health," said Lindsay Clarke, Vice-President of Health Programs for the Alliance for Aging.

"For older adults, understanding their options is even more important, as age may increase the risk of certain OTC pain medication side effects. These films offer a great overview of what someone needs to know before taking their OTC pain medication."

The videos were produced with support from McNeil Consumer Healthcare, the maker of Tylenol and Motrin.

A survey of over 1,000 pain sufferers by the American Gastroenterological Association (AGA) found that many routinely ignore OTC medicine labels, putting them at risk of serious side effects such as stomach bleeding, ulcers, liver damage, and even death.

"Pain is incredibly personal, but taking more than the recommended dose of OTC pain medicine can cause significant stomach and intestinal damage among other complications," said Byron Cryer, associate dean at the University of Texas Southwestern Medical Center, Dallas.

Gastroenterologists say most patients who experience complications from overdoses of OTC medicine are trying to manage chronic pain or arthritis. Eight out of ten (79%) also report taking multiple symptom OTC medication in the past year for allergies, cold or flu symptoms – which can greatly increase their exposure to both acetaminophen and ibuprofen.

“It is a growing concern because people living with chronic pain and taking multiple medicines often don’t recognize the side-effects of taking too much,” explained Charles Melbern Wilcox, MD, professor of medicine in the division of gastroenterology and hepatology at the University of Alabama at Birmingham.

Sherri’s Story: A Final Plea for Help

By Pat Anson, Editor

“I’ve been thinking about ending my life if I don’t get the help I need.”

Those are chilling words for anyone to hear. And in the last two years of her life, Sherri Little said them often to family, friends and doctors.  After decades of struggling with chronic pain from fibromyalgia, inflammatory bowel disease, severe colitis and other conditions, the 53-year old California woman was desperate and depressed when she checked into the emergency room at Cedars-Sinai Medical Center in Los Angeles on July 3, 2015.

What happened over the next four days is not entirely clear, but we know that Sherri took her own life. Her body was found in the bathtub of a hotel room across the street from Cedars-Sinai on the morning of July 7, with several prescription bottles and an empty bottle of wine nearby. Sherri had been sober for many years.

“I attest this is the first drink of alcohol in 16 years -- just to give me the courage to end my life alone,” Sherri wrote in a suicide note found in her hotel room.

“Several documents found inside the location underscored her pain, suffering and suicidal ideations,” reads the coroner’s report. “A check of the decedent’s laptop also contained a pictured document written by the decedent titled ‘Why I Killed Myself’ by Sherri Little.”

We’re telling Sherri’s story --- with the help of her mother, friends and patient advocate – not in a ghoulish attempt to recreate her final days, but to lend a name, a face and a voice to the untold number of chronic pain sufferers who have also been overwhelmed by pain, depression and loss of hope.  Like Sherri, many felt abandoned by a healthcare system that was unwilling or simply unable to treat them.

sherri little

Over 42,000 Americans killed themselves in 2014 according to the CDC, but experts believe the actual number is higher. Many suicides go unreported or are misclassified as accidental, covered up by grieving family members or accommodating medical examiners.

Sherri’s death was no accident, but it’s taken several months for her mother to come to terms with it.

“I’ve got to get her story out there,” said Lynda Mannion, Sherri’s mother. “She got to the point in the last year or so she could hardly eat solid food at all. She was just drinking her nutrition. I guess she must have lost 20 to 30 pounds in the last year.

“She would say, ‘I can’t go on living like this. If I can’t get some help, if somebody doesn’t believe me, I just can’t go on living like this.’ She didn’t seem to be extremely afraid of dying, considering the alternative, living with the pain she was in. But I never expected her to do it.”

A few months before she died, Sherri gave an interview to Tina Petrova in Toronto for a soon-to-be released documentary called Pain Warriors. 

“Sherri Little and I first became friends on Facebook, united by our common passion of pain patient advocacy. She initially reached out to me after hearing that I had a film in development I was producing on chronic pain and said, ‘Do I have a story for you!’ And indeed, she did,” says Petrova.

In this short clip, Sherri doesn’t talk about suicide and appears hopeful about her future.

But just weeks later, Sherri wrote the following in an email to Petrova:

“I was acutely suicidal last night after being verbally abused by a doctor who can't even get me any pain relief anymore,” said Sherri. “In a last ditch effort to save my life I am going to Cedar Sinai ER in LA with my patient advocate.”

Sherri was referring to Lisa Blackstock, a professional advocate who founded Soul Sherpa to help guide patients through the healthcare system. Blackstock had been a volunteer at Cedars-Sinai for several years and knew her way around one of the most respected hospitals in Los Angeles. 

The day before she went to the hospital, Sherri was still having suicidal thoughts.

“I woke at 3am today, ready to give up the fight and end my life. This is not dramatic or blaming of you, but just a statement of fact: my life has not been worth living for 2 years,” Sherri wrote in an email to Blackstock.

The two women went to Cedars-Sinai together and were in the emergency room for 11 hours before Sherri was finally admitted as a patient with severe abdominal pain on the evening of July 3rd.

Over the next two days, Sherri was examined by doctors and a psychiatrist, who concluded she was a “moderate” suicide risk because she had never actually tried to take her own life.

“Patient is at moderate risk of harm to self, but does not meet criteria for involuntary psychiatric treatment at this time,” the psychiatrist wrote in Sherri’s medical records, which were provided to Pain News Network by her mother.

cedars-sinai medical center

Sherri was scheduled for a colonoscopy on July 6, but never had the procedure.  For reasons that are not clear, she became frustrated with her treatment and left the hospital the night before.

“She left against medical advice,” Sherri’s discharge notes say. “Efforts were made to talk to her about the seriousness of her decision. She explained that she understood but, however, would like to leave against medical advice.”

Lisa Blackstock didn’t learn about Sherri’s release until it was too late.

“Despite a HIPAA release (patient release form) on file naming me as Sherri's contact, the doctor did not contact me and decided there was no reason to place her on a 72-hour involuntary hold,” Blackstock wrote in a letter to the coroner’s investigator. “Sherri was allowed to leave the hospital, in pain and suicidal, and the physicians responsible for her care failed miserably.

“I am a long-term volunteer at Cedars, and, until this incident, had great respect for them.  Changes in healthcare law have resulted in substandard care for many patients depending upon their insurance coverage types, as well as hospital administrators dictating care for patients rather than skilled physicians.”

A spokeswoman for Cedars-Sinai said the hospital was unable to comment and wouldn’t even confirm Sherri had been a patient there.

“State and federal privacy laws prevent hospitals from releasing information about patients without their consent, including whether an individual may or may not be a current or former patient,” wrote Sally Stewart in an email to PNN.

Cocktail of Medications

Long before she was admitted to Cedars-Sinai, Sherri was prescribed a potent cocktail of medications for her pain and depression; including the opioids tramadol and hydrocodone, as well as Lyrica (pregabalin), Ambien (zolpidem), and Klonopin (clonazepam).    

Lyrica, Ambien and Klonopin have all been linked to increased risk of suicide.  

Lyrica has an FDA warning label that states the drug “may cause suicidal thoughts or actions” and Ambien’s label warns that “depression or suicidal thinking may occur.”

Klonopin belongs to a class of sedatives known as benzodiazepines, which are increasingly being linked to overdoses, especially when combined with opioids. Klonopin’s label also warns of “suicidal behavior and ideation.”

Why were doctors prescribing these drugs to someone who was suicidal? And why did Cedars-Sinai release Sherri with the drugs in her possession?

“They discharged her with all of them at Cedars, which I found just incredibly irresponsible,” says Blackstock.

According to the autopsy report, the coroner found only trace amounts of opioids and Ambien in Sherri’s system, but apparently never looked for the other drugs. Her official cause of death is listed vaguely as “combined effects of medications.”

Were the same drugs that Sherri took for her pain and depression – which were ineffective in helping either – used as instruments in her death? 

We may never know the answer.

“I have fought to get help for the disease I am dying of – pseudomembranous colitis – for years without help from anyone,” Sherri wrote in her suicide note. “I do not want to be resuscitated. There is nothing left for me but to be tied to a hospital bed in great pain.” 

Sherri was divorced and did not have any children. But a close circle of friends and loved ones are anxious to have her story told and her memory preserved.

“She was beautiful from the time she was little. She was beautiful up to the day she died.  She looked 20 years younger than she was,” recalls Sherri’s mother, Lynda.

“She loved to help people. She wanted to help people and she couldn’t understand why nobody would help her. She would have been there for anybody.”

“Sherri was one of those rare people that could light up the room upon entering,” recalls her friend, Tina Petrova. “During the all too short time I knew Sherri, her key focus above all was advocating for pain patients, speaking up, getting involved. Her search for treatments for her own painful conditions took a back seat to her passion to help others.

“I can just see her high above us saying, “But you have to DO SOMETHING!’”

Sherri’s advocacy will continue, thanks to a website Petrova created to honor Sherri's memory and the documentary that she’s producing on chronic pain in North America.

What can the rest of us learn from Sherri’s struggle?

Perhaps those lessons are best learned through her own words -- and the advice that Sherri gave to other pain sufferers:

E-coli Bacteria Used to Produce Morphine

By Pat Anson, Editor

While politicians and regulators in the U.S. try to decrease access to opioid pain medications, scientists are developing new techniques to mass produce them.

The latest development is at Kyoto University in Japan, where researchers have learned how to tweak E coli bacteria so that they pump out thebaine, a morphine precursor that can be modified to make opioid pain relievers.

The genetically modified Escherichia coli – a common gut microbe -- produces 300 times more thebaine than a recently developed method involving yeast.

"Morphine has a complex molecular structure; because of this, the production of morphine and similar painkillers is expensive and time-consuming. But with our E coli, we were able to yield 2.1 miligrams of thebaine in a matter of days from roughly 20 grams of sugar,” said lead author Fumihiko Sato of Kyoto University.

"Improvements in opiate production in this E. coli system represent a major step towards the development of alternative opiate production systems."

Sato’s study is published in the journal Nature Communications.

 Escherichia coli

Morphine is extracted from opium poppy sap in a process that typically takes up to a year. Morphine can then be converted to opiates such as codeine, hydrocodone or even heroin.

Scientists at Stanford University last year engineered the yeast genome so that it produces opiate alkaloids from sugar. The genetically altered yeast cells grow so rapidly they convert sugar into hydrocodone in just three to five days. That raised fears that opioids could be produced cheaply and easily, provided that one has access to the necessary yeast strain.

With E coli, Sato says that such a production risk is unlikely.

"Four strains of genetically modified E coli are necessary to turn sugar into thebaine," explains Sato. "E coli are more difficult to manage and require expertise in handling. This should serve as a deterrent to unregulated production."

In 2011, Sato and colleagues engineered E coli to synthesize reticuline, another morphine precursor. In the new system, the team added genes from other bacteria and enzyme genes from two strains of opium poppies, Coptis japonica, and Arabidopsis.

"By adding another two genes, our E coli were able to produce hydrocodone, which would certainly boost the practicality of this technique," Sato said. "With a few more improvements to the technique and clearance of pharmaceutical regulations, manufacturing morphine-like painkillers from microbes could soon be a reality."

Opioid pain medications are widely available in the United States, where the focus is often on their potential misuse. But the World Health Organization estimates that 5.5 billion people worldwide have little or no access to opioids because of their limited supply and high cost.

Law Enforcement and Pain Patients

By John Burke, Guest Columnist

I first need to tell you that I spent 48 years in law enforcement and recently retired in 2015 after commanding a large enforcement initiative in southwestern Ohio. I have extensive experience in  prescription drug abuse as it pertains to law enforcement and have written a monthly article for the past 15 years in Pharmacy Times magazine on the topic of drug diversion.

I am the past national president of the National Association of Drug Diversion Investigators and current president of the International Health Facility Diversion Association. In short, I am no stranger to the issues surrounding the abuse and diversion of pharmaceuticals.

I am also a self-declared pain patient advocate who strongly believes that the vast majority of controlled substances that are consumed in the U.S. are taken by legitimate pain patients.  Pain patients have no real lobbying group that can apply pressure on politicians – who are often oblivious to the plight of pain patients as they scramble to get reelected!

In 1990, I was fortunate enough to be assigned to form and command the Cincinnati Police Department’s Pharmaceutical Diversion Unit (PDU). In the early 1970’s I had seen prescription drug abuse on the streets and knew that it was a much bigger problem than was being hailed by the news media. In starting PDU, I made a point to try and educate the media on the subject, and we were very successful in doing that as it was a brand new issue as far as they knew and they flocked to our press conferences.

JOHN BURKE

In addition to the arrests, we provided community education on prescription drug abuse, but sadly we said very little about a victim I got to know well -- the chronic pain patient. I can’t honestly say that pain patients entered my mind in those days, as we stayed focused on those illegally diverting pharmaceuticals. We also specialized on the diversion of medications inside healthcare facilities, a huge problem that exists still today.

We entered a time in the 1990’s when pain patients were deemed to be undertreated, new opioid medications were developed and marketed, and as we entered the 21st century, pain pill abuse started to skyrocket. Most of this century has seen a concentration on pharmaceutical diversion issues, with the spotlight on OxyContin until Purdue Pharma successfully marketed an abuse deterrent formulation in 2010. Since then, heroin has exploded onto the illicit drug scene, accelerating the overdose death rate as even the smallest of communities cry for help.

I saw a chronic pain patient up close and personal about 10 years ago. She was my mother-in-law and she came to live with my wife and I in our home. She had been a pain patient since elementary school. Her leg was permanently fused together and over the years she fought doctors who insisted that amputation was the best route to take for her welfare.

One day, her husband came to me and said that his wife was experiencing a particularly bad time with her pain relief and was moaning most of the night, unable to sleep. Since I had participated in dozens of continuing education programs with renowned pain specialists, I did know a little about pain management -- at least enough to ask if they had told her doctor so that her pain medication could be adjusted.

The answer was that she doesn’t take any pain medication due to the fact that her former doctor, several decades deceased, had told her never to take anything stronger than an aspirin or she would get addicted! I was shocked at this and advised him to go back to her current doctor and request some pain medication for a person who had suffered with daily pain for over 60 years at this point.

Her young physician told her that she was unable to prescribe a controlled substance, something that was blatantly false, but was nonetheless a reality for this almost lifetime pain patient. I then assisted them in finding a pain specialist and after one visit she was prescribed a pain patch and immediately started using something she should have had access to years before.

Her relief was incredible. Although not pain free by any means, she came crying to me that it was by far the most significant pain relief she had ever had in her life. No doubt it was, when aspirin was the only analgesic she was taking for chronic pain. This pain had flourished for decades due to the advice of a well-intentioned, but misinformed physician, who warned her about addiction issues when her pain was becoming unbearable.

I offer no apologies for the aggressive prosecutions of criminal doctors and those who prey on drug addicts by prescribing or dispensing controlled substances merely to line their pockets rather than to provide quality pain care. These people had no intention to provide pain relief to patients, and in the end did great damage to legitimate patients by giving the public the erroneous thought that virtually all people on pain meds are nothing more than addicts!

Every presentation I give, I make it a point to remind the audience that the vast majority of pain medications are prescribed by competent caring prescribers, dispensed by caring pharmacists, and end up in the hands of those who desperately need these drugs to perform every day functions we take for granted.

Right now there is incredible pressure by uninformed politicians to suggest some drastic changes in how opioids are prescribed and dispensed in this country. Law enforcement has plenty of good laws to go after the outliers vigorously, and I strongly urge we continue to do that, but with the full realization that the plight of pain patients’ needs to be protected in the meantime. Balance is important in most things in life and this issue is certainly no exception.

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.

Senate Confirms Califf as FDA Commissioner

By Pat Anson, Editor

The U.S. Senate has overwhelmingly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration after months of controversy over his ties to the pharmaceutical industry and criticism of the agency’s regulation of opioid pain medication.

The vote was 89-4 for Califf, a cardiologist and medical researcher at Duke University, who pledged earlier this month to use tougher language in warning labels for extended release opioids and to prioritize development of non-opioid alternatives for pain. Califf also endorsed the CDC’s controversial opioid prescribing guidelines, even though some of the FDA’s own experts believe the guidelines lack scientific evidence.

"If addiction to opioids and misuse of opioids is the enemy, then we underestimated the tenacity of the enemy," Califf told The Associated Press after his nomination was confirmed. "We've got to adjust."

Califf was pressured into changing the FDA’s opioid policies after his nomination was held up by Democratic presidential candidate Sen. Bernie Sanders of Vermont, and Sens. Joe Manchin of West Virginia (D) and Ed Markey of Massachusetts (D).

DR. ROBERT CALIFF

Manchin, Markey, Sen. Richard Blumenthal of Connecticut (D) and Sen. Kelly Ayotte of New Hampshire (R) voted against the nomination. Sanders was on the campaign trail and did not vote on the nomination.

"FDA stands for Food and Drug Administration, but over the last 20 years it really stands for ‘fostering drug addiction,' " Markey said in a speech on the Senate floor.

Both Markey and Manchin have vowed to “change the culture” at FDA to combat what they call a “pandemic” of opioid abuse and overdoses.

“I just think he’s the wrong person at this time of need for the position that we need to shake it up,” said Manchin. "The FDA needs new leadership, new focus and a new culture."

Califf founded Duke University’s Clinical Research Institute, which primarily works with and is funded by pharmaceutical companies. He listed over a dozen drug makers in a conflict-of-interest disclosure for a recent article he wrote in the New England Journal of Medicine.

“Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public,” said Dr. Stephen Ostroff, the FDA’s chief scientist, who has served as acting head of the agency for the past year.

Obama Rejects Limits on Opioid Prescribing

By Pat Anson, Editor

President Barack Obama declined to endorse a sweeping proposal by some governors to put limits on the number of opioid painkillers that doctors can prescribe, saying such a policy would be unfair to rural Americans who don’t have easy access to pain medication or addiction treatment programs.

"If we go to the doctors right now and say 'Don't overprescribe' without providing some mechanisms for people in these communities to deal with the pain that they have or the issues that they have, then we're not going to solve the problem,” Obama said. "Because the pain is real. The mental illness is real. In some cases, addiction is already out there. In some cases these are underserved communities when it comes to the number of doctors and nurses and practitioners."

Over the weekend, a committee of the National Governors Association unanimously voted to develop treatment guidelines that could include limits on opioid prescribing. The proposed guidelines could be voted on by the governors at their next meeting in August.

Although no specific figure was put on the number of opioid doses that could be prescribed at one time, Vermont Gov. Peter Shumlin (D) said it should be no more than 10 pills for treatment of acute pain. Shumlin has complained in the past that opioids “are passed out like candy in America.”

Shumlin’s proposal was quickly endorsed by Republican Gov. Matt Bevin of Kentucky, a sign that the guidelines would have bipartisan support among the nation’s governors.

President Obama met with the governors Monday at the White House and endorsed their bipartisan approach to addressing the so-called opioid epidemic.

"This is an area where I can get agreement from Bernie Sanders and Mitch McConnell. That doesn't happen that often," Obama said.

The president of the American Medical Association said Obama was right to question the potential consequences of putting additional restrictions on doctors and patients.

"The complexity of the problem makes it difficult to create a successful one-size-fits-all approach," Dr. Steven Stack said in a statement to the Associated Press.

WHITE HOUSE PHOTO

The proposed guidelines could also include policies similar to those adopted by insurer Blue Cross Blue Shield of Massachusetts, which requires prior authorization for opioid prescriptions. Some patients are also required to use a single pharmacy for their opioid prescriptions. The policies have resulted in a 50 percent reduction in claims for long acting opioids such as OxyContin, and a 25 percent reduction in claims for short-acting opioids, according to Blue Cross Blue Shield.

According to the Centers for Disease Control and Prevention (CDC), heroin and opioid overdoses are killing as many as 78 American a day, although the agency admits its numbers may not be accurate.

Vermont’s Shumlin has emerged as one of the nation’s most vocal critics of opioid prescribing practices. His state and others in the Northeast have been have been hit hard by opioid and heroin overdoses.

“As long as opioid medications remain the default mainstay therapies for chronic pain, these drugs will constitute an ever-present risk for diversion and addiction. We need to address the prescription opioid crisis at its source: opioid medications, as we know them, must be made obsolete,” Shumlin wrote in a recent letter to U.S. senators who are drafting legislation to reform the Food and Drug Administration and the National Institutes of Health (NIH).     

Shumlin urged the senators to provide additional funding to NIH for clinical research into affordable and non-addictive alternatives to opioids.

Take Our Survey About Hospital Pain Treatment

By Pat Anson, Editor

Over the last few months, we’ve received hundreds of reader comments about the poor quality of their pain care in hospitals and emergency rooms. Many said they their pain was not treated or undertreated, while others said they were misdiagnosed or labelled as addicts if they asked for pain medication.

In an effort to keep the dialogue going and see just how common these problems are, Pain News Network and the International Pain Foundation (IPain) are conducting a survey of pain sufferers about their treatment in hospitals. The survey, which you can take by clicking here, should only take a few minutes to complete.

One reason we’re doing the survey is because a group of U.S. senators recently proposed that Medicare no longer require hospitals to ask patients about the quality of their pain care. The senators believe questioning patients about their pain leads to over-prescribing "because physicians may feel compelled to prescribe opioid pain relievers" to improve their hospital's ranking in patient satisfaction surveys.

“Why would we want to reduce pain care or stop asking about a person’s comfort and pain levels?” asked Barby Ingle, president of IPain, who knows from experience what it’s like to go untreated or undertreated in a hospital. Barby recently wrote a column about ways to make your hospital stay easier.

“The International Pain Foundation has been hearing increasing stories of undertreated pain care in ER and hospital settings over the past few years,” she said. “With such a large outcry from pain patients across the country saying ‘don’t go the hospital for pain, they don’t know how to treat pain,’ we know there is a problem. How can it be addressed? Surveying the pain community will help put a spotlight on this issue and show lawmakers, providers, insurance companies, and the pain community that we need more focus on our pain care needs, not less.”

A recent development that will affect future pain care in hospitals is the release of new guidelines for post-surgical pain management. The American Pain Society is encouraging physicians to use opioids alongside “multimodal therapies” such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), Lyrica, Neurontin, and cognitive behavioral therapy to treat patients in post-operative pain.

“Cognitive behavioral therapy? Really? So you cut into my nerves and tissue and muscles for 6 hours, and the pain is all in my head?” is what Janet Lynn wrote about that idea.

“So when the NSAIDs shut down a person’s kidneys or cause massive stomach irritation and bleeding is it time to give a patient a narcotic pain med?” asked Sharon Storck

Even doctors aren’t immune from poor treatment in hospitals. Family practice physician Lisa Kehrberg, who has severe abdominal pain from visceral neuropathy, recently wrote about one of her experiences in a hospital (see “My Journey From Doctor to Chronic Pain Patient”)

“The first surprise was, after admission, they refused to treat my excruciating pain. I was doubled over, rocking, vomiting, and crying with the worst pain of my life. Worse than labor, appendicitis, or anything else I'd experienced,” wrote Dr. Kerhberg. “Doctor after doctor walked in and witnessed this and continued to refuse ordering opioids. After all the tests were complete and normal, the doctors were very rude to me and implied this was all a psychological problem.”

Has this ever happened to you? Are you satisfied with the quality of your pain care in hospitals? Take our survey and let us know, by clicking here.

From Bad to Worse for Pain Patients?

By Pat Anson, Editor

Has the pendulum swung too far against pain patients?

The answer is "Yes" according to some leading pain management experts at the annual meeting of the American Academy of Pain Medicine (AAPM) in Palm Springs.  The AAPM represents 2,400 physicians and health care providers, including some who have stopped prescribing opioid pain medication because they fear prosecution or sanctions if they prescribe to patients who might abuse the drugs.

"There are a variety of primary care doctors that are dropping out altogether (from prescribing opioids). They will not allow it. They're saying everybody has to go to a pain management expert or you don't get anything. And its abrupt," said Bill McCarberg, MD, President of the AAPM. "For that group of patients, you're cutting everybody off inappropriately. There are some of those patients who probably need those medications, who do better with medications."

McCarberg, who volunteers at a health clinic in San Diego, says even opioids with abuse deterrent properties are difficult to prescribe because they are expensive and usually not covered by insurance. He is not optimistic about the continued use of opioids in pain management.

"In my experience over the last year its gotten worse and I think a year from now it will be even worse," McCarberg said. "When you come back here in five years, in ten years, we'll be having the discussion about the pendulum being over here, patients suffering.  About you getting shoulder surgery and getting nothing but acetaminophen to treat your shoulder because nobody is willing to give you more (opioids). That's what I worry about."

"I think that's right. I think the pendulum has swung in the direction of things being worse for patients very rapidly and very dramatically. And I don't think its finished swinging yet," says Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

"I think its the general atmosphere, the whole focus on opioid overdoses and all of that stuff.  That's what is driving the CDC's actions and every bit of the press that's out there is about that problem. And until we get the other side of the story out there and point out that not treating pain has negative consequences too, including people dying, until we can get that story out there and get some traction with it, patients are in a bad place."

PROP President Speaks to AAPM

Although the AAPM has "very significant concerns" about the quality of evidence and "negative bias" in some of the CDC's proposed opioid prescribing guidelines, it invited a controversial figure who helped draft them to its annual meeting. Jane Ballantyne, MD, who is president of Physicians for Responsible Opioid Prescribing (PROP), served on a CDC advisory panel known the "Core Expert Group." The CDC guidelines discourage primary care physicians from prescribing opioids for chronic pain.

Ballantyne, who gave a talk at the AAPM meeting on "Pain Curriculum Development for Primary Care Practitioners," recently come under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the primary goal of doctors that treat chronic pain. 

Several patient advocates asked AAPM to remove Ballantyne from the program.

"How, in good conscience, can you include someone with her views about pain teach other physicians, or influence future curriculum for physicians, on how to effectively treat pain? It is clear from her writings that she doesn’t understand pain, or painful disease processes. Should someone with views like this be influencing our present and future doctors?" wrote Ingrid Hollis of Families for Intractable Pain Relief in a letter to the AAPM.

"While I appreciate your concerns about including Dr. Ballantyne as a member of the faculty, the Academy will not comply with your request that it remove her from the program," responded Phil Saigh, Jr., Executive Director of AAPM. "The Academy is committed to the free exchange of information and perspectives among pain physicians and other clinicians.  It is this commitment that ensures that diverse perspectives are examined rather than creating a one-size-fits-all approach to education. To remove Dr. Ballantyne from the program would not be true to that commitment."

Ballantyne's presentation was low key and did not focus on opioid use. She spoke about improving pain curriculum in medical schools, an area where there is broad agreement that change is needed. 

"Pain education has been really, really bad. And a large part of the problem, in terms of primary care, is actually managing those with chronic pain and not having received any education on how to do that," said Ballantyne, who explained that her own education and training in the 1970's focused on pain medication and injections, and did not include other disciplines such as psychology.

"The evidence suggests strongly that entry level pain management training is widely inadequate across all disciplines in the United States. Only a few medical schools in Canada and the U.S. offer courses on pain," she said. "The young primary care physicians that I work with are suddenly faced with this extremely complex disease, chronic pain, and they have only been taught to see it in a unitary way. That's what leads to a very simple treatment goal, which is simply to reduce pain intensity.

JANE BALLANTYNE, MD

"When we treat chronic pain we do an awful lot more or want to achieve an awful lot more than simply reducing pain intensity. We want to improve people's lives. We want to help them function better. We want to improve their state of mind and their mood, and have to pay attention to all the other factors that contribute to the disease. Chronic pain is a complex disease that is not simply a focus on pain intensity. And that's one thing we can really help in our teaching."  

Post-Surgical Pain Guidelines Reduce Use of Opioids

By Pat Anson, Editor

The American Pain Society (APS) has released new guidelines for post-surgical pain management that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain.

According to studies, more than half of patients who undergo surgery receive inadequate pain relief, which can heighten the risk of developing chronic pain, mood disorders and disability.

The 32 recommendations were developed by a panel of nearly two dozen experts that reviewed over 6,500 scientific studies. Most of the recommendations were adopted unanimously.

“The intent of the guideline is to provide evidence-based recommendations for better management of postoperative pain, and the target audience is all clinicians who manage pain resulting from surgery,” said lead author Roger Chou, MD, a prominent researcher who also co-authored the proposed opioid prescribing guidelines developed by Centers for Disease Control and Prevention.

Like the CDC guidelines, the APS guidelines encourage the use of non-pharmacological therapies and non-opioid medications, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurotin) and pregabalin (Lyrica). Those treatments would be used along with opioids for post-operative pain.

“Because of the availability of effective non-opioid analgesics and non-pharmacologic therapies for postoperative pain management, the panel suggests that clinicians routinely incorporate around the clock non-opioid analgesics and non-pharmacologic therapies into multimodal analgesia regimens,” the guideline states.

“Systemic opioids might not be required in all patients. One study suggests that it should be avoided when not needed, because limited evidence suggests that perioperative opioid therapy might be associated with increased likelihood of long-term opioid use, with its attendant risks.”

Chou says using multiple approaches to pain management provides better pain relief than a single analgesic.

“Randomized trials have shown that multimodal anesthesia involving simultaneous use of combinations of several medications -- acting on different pain receptors or administered through different techniques -- are associated with superior pain relief and decreased opioid consumption compared with use of a single medication administered by one technique,” Chou said.

The APS panel also recommends that non-pharmacological therapies, such as cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS), can be used as effective adjuncts to pain medication.

Other recommendations in the APS guidelines include:

• Adults and children can be given acetaminophen and/or NSAIDs for postoperative pain management
• Oral administration of opioids is preferred over intravenous (IV) administration
• Spinal analgesia (epidurals) is appropriate for major thoracic and abdominal procedures
• Use of benzodiazepines, tramadol and ketamine is not recommended for postoperative pain.
• Clinicians should consider giving preoperative doses of celecoxib (Celebrex) to adult patients
• Gabapentin (Neurotin) and pregabalin (Lyrica) can be considered for postoperative pain relief.  The drugs are associated with lower opioid requirements after surgery.

The guidelines recommend the physicians consult with a pain management specialist when a patient has a tolerance for opioids, or a history of substance abuse or addiction.

“Adequate pain treatment should not be withheld from patients with active or previous opioid addiction because of fears of worsening addiction or precipitation of relapse. In addition to the ethical requirement to address postoperative pain, poorly treated pain can be a trigger for relapse,” the guidelines say. “An interdisciplinary approach using pharmacologic and nonpharmacologic interventions might be required to achieve successful postoperative outcomes and should be considered as part of the perioperative management plan in these patients.”

The APS post-operative pain guidelines, which are being published in the Journal of Pain, was endorsed by the American Society for Regional Anesthesia. A link to the guidelines can be found here.

Shocked by Senators’ Letter on Patient Surveys

By Janice Reynolds, Guest Columnist

Last week I felt like my world had shattered.  Sounds extreme, I know, but someone who I believed in had turned on me both as a professional and someone living with persistent pain. It was not only me that Sen. Susan Collins (R-Maine) denied, but the pain community as a whole. 

An article and editorial in the Portland Press Herald told how Collins and 25 other senators had written a letter to the Secretary of Health and Human Services questioning whether patients should be asked about their pain control in hospital satisfaction surveys. After reading it, I felt sucker punched.  I have always supported and believed in Susan Collins, but how can I now? 

“I believe the pendulum has swung too far in favor of controlling pain, although I am not suggesting that the pain people experience is not real,” Collins said, although the rest of her letter certainly suggests that she does just that. (See “Senators Seek to Silence Pain Patients”)

The comment that I find truly disturbing is, “Currently, there is no objective diagnostic method that can validate or quantify pain. Development of such a measure would surely be a worthwhile endeavor.” 

The pain community has battled this notion forever. In 1968 Margo McCaffery wrote that pain is what the person says it is and exists when the patient says it does.  She was heavily ridiculed for that, although the World Health Organization included it in both their position statements on cancer pain and on chronic pain, and considers pain treatment a human right.

SEN. SUSAN COLLINS (R-MAINE)

So much of what Collins said appears to be from the Centers for Disease Control and Prevention (CDC) and Physicians for Responsible Opioid Prescribing (PROP). The comments rather prove my belief that the CDC’s attack on opioids and addiction is really more of an attack on people with pain, no matter the reason. To see the letter and the list of senators who signed it, click here.

The next day the Press Herald had an editorial which proved even worse. “Collins and the other senators question whether it’s wise to put such a high premium on these subjective judgments. Prompt pain relief is appropriate for some patients, but overuse of painkillers can cause harm, and a person in pain will not always be the best judge of whether the care was appropriate,” the paper said.

Please note they are no longer distinguishing between acute pain, pain in a cancer setting, pain in a non-cancer setting, or end of life pain.  They also ignore the fact that “no prompt treatment of pain” causes harm as well (that is why they call it torture). Both articles claim opioids are gateway drugs for heroin. Of course, no acknowledged expert in pain management was even consulted for the articles (because they are all in the pockets of the evil pharmaceutical companies mu-ha-ha-ha).  Interestingly, nobody seems to care that non-opioid pain medication is also brought to us by pharmaceutical companies.

What about these patient satisfaction surveys?  Are they really a problem or is this more hype to discredit people with pain?

As a hospital nurse for over 20 years I cannot think of one time where a provider wrote a prescription for opioid pain medication just to avoid getting a bad patient satisfaction score.  In reality the problem is the exact opposite; doctors and nurses who are bad at pain management, who don’t believe a patient’s report of pain, and who lack the knowledge to effectively relieve pain really don’t give a darn about a bad evaluation. 

There are, unfortunately, still many providers who fit into those categories.  I can’t tell you the number of times I got in trouble with a physician for advocating for a patient. But there are many providers who are good at pain management, knowledgeable, and compassionate as well.  I imagine these are the ones the senators really have a problem with.

Could someone please give me a definition of overprescribe?  It seems, in this case, it would mean prescribing any opioid or making a legitimate effort to manage a patient’s pain. 

In a hospital setting there are many reasons for opioids to be used, as it is the only medication shown to be effective for severe pain.  People can be in pain due to surgical procedures, trauma, intractable pain (pain was out of control at home), broken bones, pain flares, post stoke pain, shingles, gallstones, kidney stones, cellulitis, deep vein thrombosis, myocardial infarctions, cancer metastasis, organ impingement by a tumor, and many more reasons including comorbidities when someone is dying. 

Most times there is a combination of opioids, non-opioids, and non-pharmaceutical interventions (such as warmth or cold, physical therapy; some hospitals even have therapeutic touch and Reiki available).  Many patients’ may have opioids ordered but never need them all. There are also times when opioids are ordered, correctly, for reasons other than pain (gasp).  One thing we know is that untreated or undertreated pain in surgical or trauma cases can lead to persistent chronic pain

The person experiencing the pain knows it best.  Managing it should be a partnership between patient and provider.  There will never be an objective test for most types of pain, partially because it occurs for many different reasons. Someone may have multiple reasons for pain as well, which complicates it even further. 

Pain has a long history of stigma, prejudice and bias.  It may be the stoic nature of many cultures, and partly the bully syndrome that perceives someone in pain as weaker.  People in pain have been seen as malingers, drug seekers, liars, tricksters, and worse.  In women it has been called anxiety or worse. 

The senators want to eliminate two questions used in patient satisfaction surveys: “How often was your pain well-controlled?” and “How often did the hospital staff do everything they could to help you with your pain?”

To say the person experiencing pain is not the best judge of those questions is ludicrous.

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 a regular 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.

Drug Tests Scare Off Some Chronic Pain Patients

By Pat Anson, Editor

Urine drug testing has become standard protocol for many patients who are prescribed opioid pain medication. But a new study suggests the practice may be counterproductive, because it increases the odds a patient won’t come back for further treatment.

In a study involving 723 chronic pain patients being treated at a pain clinic, researchers at the University of Houston and the University of Texas Medical Branch at Galveston found that nearly a quarter (23.75%) who were given a urine drug screen on their first visit failed to show up for the next appointment. 

The odds were even higher for those who tested positive for an illicit drug, but the “no show” trend also applied to patients whose drug tests were negative.

“Even those who tested negative for illicit substances in the UDS (urine drug screen) were more likely to be no-shows compared to those who did not get tested. This raises concerns that the UDS administered early in the doctor-patient relationship might have an inadvertent impact on injuring patient expectations of trust,” the researchers reported in the journal Pain Physician.

Only about 10% of those who weren’t tested skipped their follow-up appointment.

“It is a balancing act,” said Partha Krishnamurthy, director of the Institute for Health Care Marketing at the University of Houston’s Bauer College of Business. “On one hand, concerns about patient safety and public health necessitate the monitoring of patients on opioid medications. On the other hand, aggressive monitoring may interfere with the therapeutic alliance.”

Routine use of urine drug tests is one of the main recommendations in the CDC’s draft guidance for opioid prescribing, which calls for primary care physicians to “use urine drug testing before starting opioid therapy and consider urine drug testing at least annually.”

The scientific research behind that recommendation is considered weak, as is much of the evidence that standard “point of care” urine drug tests are reliable or accurate.

“I've only been saying that UDT (urine drug tests) harms patients and the patient/provider relationship for the past seven years and not a single physician, researcher, or healthcare provider of any kind supported my position.  I guess common sense wasn't enough but now we have evidence,” said Mark Collen, an independent scholar and patient advocate. 

“As I've stated previously in regards to UDT, the entire pain community will end up on the wrong side of history and it looks like that's beginning to occur.”     

Researchers say one possible solution to the high-rate of patient “no shows” is for doctors to delay drug screening of new patients until they’ve had a chance to develop rapport and trust with them.

“Not testing is not an option,” the researchers said, while at the same time warning that routine testing may only make prescription drug abuse worse.

“If the patients are disengaging from the clinic, where are they going? Is the illicit market place their next stop? Thus, while UDS may induce the problematic patients to go away from the clinic, the problem of opioid misuse may continue to persist.”

Senators Seek to Silence Pain Patients

By Pat Anson, Editor

We’ve run several columns recently about the poor quality of pain care in hospitals and how many pain sufferers are treated as drug seeking addicts. Emily Ulrich’s column about her mistreatment in hospitals (“The Danger of Treating ER Patients as Drug Seekers”) really hit a nerve, generating hundreds of comments on our website and Facebook page from readers who shared their own hospital horror stories.

This makes a recent letter from a bipartisan group of U.S. senators all the more striking, because it seeks to silence hospital patients who are unhappy about their pain care.

In the letter to Health and Human Services Secretary Sylvia Mathews Burwell, Sen. Susan Collins (R-Maine) and 25 of her colleagues claim that many pain sufferers get opioid pain relievers far too easily in hospitals. To see the letter and the list of senators who signed it, click here.

“For millions of patients who are suffering from illness or injury, prompt delivery of pain control which may or may not include opioid pain relievers is proper and humane,” the letter states. “Yet inappropriate use of opioid pain relievers does not provide any clinical benefit and may actually pose a risk of harm. The evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures.”

At issue is a Medicare funding formula that requires hospitals to prove they provide quality care through patient satisfaction surveys. The formula rewards hospitals that provide good care and are rated highly by patients, while penalizing those who do not. 

Collins and her colleagues asked Burwell for a “robust examination” of the patient surveys – and strongly suggested that questions about pain management be eliminated. The Medicare survey has 32 questions for patients about their hospital experience, including two that ask if a patient's pain was "well-controlled" during their hospital stay and if hospital staff did "everything they could" to help a patient with pain.

“Currently, there is no objective diagnostic method that can validate or quantify pain. Development of such a measure would surely be a worthwhile endeavor,” the letter says. “In the meantime, however, we are concerned that the current evaluation system may inappropriately penalize hospitals and pressure physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently.”

Some doctors agree with that sentiment.  

“I’ve just had conversations with several physicians in the last week and they were saying they felt pressured by patient satisfaction surveys,” Andrew MacLean, deputy executive vice president and general counsel of the Maine Medical Association, told the Portland Press Herald. “This type of inquiry would be helpful and we applaud the senator’s efforts.”

More people suffer from chronic pain than heart disease, diabetes and cancer combined, and pain is a major reason why people even seek admission to a hospital; so the senators are proposing that the opinions of a large segment of hospital patients be ignored, not that it isn't happening already. Pain patients frequently tell us they go without appropriate pain treatment in hospitals because they are quickly labeled as drug seekers. Some have horrific stories of mistreatment.

“My sister had Complex Regional Pain Syndrome (CRPS/RSD), went to 3 different hospitals was treated the same way. Finally she got a doctor that did his job, only to find out she had stage 4 cancer. She died less than 2 months from the time she got diagnosed,” wrote Melissa.

“My 13 year old daughter went in with chest pain and they told me she was having an anxiety attack. They did nothing. Two days later we found out from the children's hospital that she had a hole in her heart and could have died. ER doctors are the absolute dumbest, cruelest people I have ever met,” said Shannon.

“I used to work in an ER. Patient came in with tremors, talked of pain. She was quickly diagnosed as a pregnant drug addict who received no care and was sent home,” wrote another reader anonymously. “Two days later her husband brought her back demanding treatment. Doctor wanted to put her into rehab when she went into labor along with seizures. It wasn't drugs it was meningitis. She and the baby BOTH died.”

“I take Norco for chronic back pain. I go to the ER for a different medical issue and I get the looks and nothing to relieve my pain. I recently herniated a second disk in my back and was given nothing in the ER. I refuse to go to another one. If I am bleeding out or literally dying I don't know if I would go into another ER. All they do is judge because they can't feel my pain,” wrote Mistye Staten.

“Last time I was in the hospital and asked for medicine to control the pain I was told no. I said I at least wanted Ibuprofen and the nurse yelled at me to stop asking for narcotics,” said Amanda Hunt.

A recent study at Temple University Hospital in Philadelphia found that the rate of opioid prescribing dropped by about a third after tougher guidelines were adopted to discourage doctors from prescribing the drugs.

Only 13% of the doctors believed patients with legitimate reasons for opioids were denied appropriate care after the guidelines were implemented. A large majority – 84% of the doctors -- disagreed or strongly disagreed that patients were denied appropriate pain relief. Ironically, the researchers did not ask any pain patients what they thought about their hospital care.

Senator Alleges Conflict of Interest in Fed Pain Panel

By Pat Anson, Editor

An influential U.S. senator is raising questions about possible conflicts of interest on a federal panel that was highly critical of the CDC’s controversial opioid prescribing guidelines.

“I was alarmed to read of efforts by the members of the Interagency Pain Research Coordinating Committee (IPRCC) to weaken efforts underway at the Centers for Disease Control and Prevention (CDC) to develop guidance on opioid prescribing practices,” wrote Oregon Sen. Ron Wyden (D) in a letter sent to Health and Human Services Secretary Sylvia Burwell.

As Pain News Network has reported, several members of the IPRCC said the guidelines were “ridiculous” and “an embarrassment to the government” at a December meeting.

“Several non-Federal IPRCC members, their organizations, or both, appear to be recipients of funding from major pharmaceutical companies that manufacture opioids or related products at levels that raise serious concerns regarding the potential for conflicts of interest,” wrote Wyden. “These financial and professional relationships raise serious concerns about the objectivity of the panel’s members that deserve additional review.”

december, 2015 meeting of iprcc.

Wyden mentioned several of the panel members by name, including Myra Christopher and Dr. Richard Payne of the Center for Practical Bioethics, Penney Cowan of the American Chronic Pain Association and Cindy Steinberg of the U.S. Pain Foundation. All three non-profit organizations get a substantial portion of their funding from pharmaceutical companies, including Purdue Pharma, the manufacturer of OxyContin. Purdue gave over $100,000 to U.S. Pain Foundation in 2014, according to Wyden.

“I do not and have never been paid by a pharmaceutical company,” said Steinberg, who became a patient advocate after she suffered a serious back injury in an accident. Steinberg, who is National Policy Director for U.S. Pain Foundation, currently receives a small stipend of about $8,000 a year.

“I am fortunate in that my husband works to supports us.  I do this work despite my daily, debilitating chronic pain, often needing to lie flat in meetings to control the pain and lay across two plane seats to travel because I am passionate about improving pain care in this country,” Steinberg said in an email to Pain News Network.

“If anyone watches the video of the IPRCC meeting they will see that they had to bring in a special small sofa for me to lie on every hour so that I could participate. I am proud to do this work and am honored to represent the voice of millions of disempowered Americans who suffer from the pernicious disease of chronic pain and desperately need more and better treatment options."

Penney Cowan, another member of the federal panel mentioned by Wyden, also serves on the CDC “workgroup” that recently endorsed the agency’s recommended guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.  

“When treating a person with pain, a health care provider needs to determine what is best for that individual based on physical examination, test results and what is important to the individual. The recommendations seem very clear on that point,” Cowan wrote in an email to PNN. “The American Chronic Pain Association advocates for a balanced approach to pain management - that means that all therapies such as PT (physical therapy), counseling, biofeedback and stress management, OT (occupational therapy), nutritional guidance and more should be available and used based on their appropriateness for each individual.”

Wyden’s letter does not mention that some IPRCC members who were most critical of the CDC guidelines are federal employees of the Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ), who as government workers are not allowed to accept financial contributions.

The senator’s letter and an Associated Press story about it also fail to mention that the CDC itself has a foundation that accepts funding from healthcare companies such as Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer,  companies which stand to benefit from the CDC guidelines because they offer non-opioid treatments or tests. The CDC Foundation accepted over $157 million from donors last year.  

Up to 11 million Americans use opioids daily to treat their chronic. A survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that many fear losing access to opioid pain medication if the guidelines are adopted.

Constipation Ad Leads to Laughs and Anger

By Pat Anson, Editor

Next to the game itself, probably the one thing people talk about the most to day after the Super Bowl are the TV commercials.

One commercial that is making quite a few lists as one of the worst is by drug maker AstraZeneca promoting its opioid induced constipation (OIC) drug. The black and white commercial features a constipated man envious of others (even a dog) who can easily go to the bathroom.

“The Super Bowl is known for inspiring lots of eating and lavish spreads of food. So why would advertisers pay millions to air ads focusing on constipation?” asked Eric Deggans of National Public Radio.  “There may never be a great time to air ads like this, but to broadcast such spots in an event where viewers are eating stuff like guacamole dip and pizza surely is the worst.”

“Nothing livens up a Super Bowl like a commercial about opioid-induced constipation,” said ESPN’s Dan Graziano on Twitter.

“Opioid Induced Constipation commercial during the Superbowl? Should have aired that during the Pro Bowl. Nobody gives a sh** about it,” wrote Don on Twitter.

Most of the Tweets aimed for laughs, but one by comedian and talk show host Bill Maher quickly went viral – and not because most people thought it was funny.

“Was that really an ad for junkies who can’t sh**? America, I luv ya but I just can’t keep up,” wrote Maher.

The depiction of opioid patients as “junkies” really got under the skin of pain sufferers and patient advocacy groups, some of whom are sponsored by AstraZeneca.

“You’re a funny guy but for many #chronicpain is real and opioids are needed for quality of life,” replied CreakyJoint.org on Twitter.

“This has to be the dumbest f***ing tweet I have read all day. Don’t ever become sick, sir. Just be glad for your perfect DNA,” wrote Ryan Stevens.

“I’m offended. Ad NOT for junkies but for people with CHRONIC pain who HAVE to have medicine to SURVIVE,” tweeted Caroline Evans.

“I am appalled at this, basically calling all people with pain junkies and making the side effect OIC seem like its no big deal,” said Paul Gileno, U.S. Pain Foundation. 

AstraZeneca paid CBS big money for its one minute spot, perhaps as much as $10 million – yet the commercial never even mentions the drug’s name, Movantik, which the British drug maker introduced in 2014.

The commercial may also have the unintended effect of giving more ammunition to those who want to further restrict access to opioid pain medication, a major goal of the Obama administration.

"Next year, how about fewer ads that fuel opioid addiction and more access to treatment," asked White House Chief of Staff Denis McDonough on Twitter.

"Our Administration is determined to control opioid addiction as a public health threat," replied White House press secretary Josh Earnest.

What Alternatives do Pain Patients Have?

By Pat Anson, Editor

When the Food and Drug Administration last week endorsed the CDC’s controversial guidelines to limit opioid prescribing, the agency promised it would prioritize development of non-opioid alternatives for chronic pain relief.

“We are also working closely with industry and the National Institutes of Health to develop additional alternative medications that alleviate pain but do not have the addictive properties of opioids,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco, who co-authored a “special report” on the FDA's new opioid policies the New England Journal of Medicine.   

“The FDA has approved non-opioid medications for treatment of various chronic-pain syndromes, including gabapentin (Neurontin), pregabalin (Lyrica), milnacipran (Savella), duloxetine (Cymbalta), and others, and a number of promising development programs are in the pipeline. But we need more. The FDA will use all the tools at its disposal to move these alternatives along as expeditiously as possible, while remaining mindful that all medicines have risks.”

The four drugs mentioned by Califf all have mixed track records, and many chronic pain sufferers have told Pain News Network the medications either don’t relieve their pain or have intolerable side effects.

“Gaba (Neurontin) did nothing for me and Lyrica seemed to help a very little with nerve pain but it made me very shaky, as if I drank a gallon of coffee,” wrote Pam Cushion.

“The side effects of Cymbalta were more than I could bear. I got terrible pains in the skin on my upper back and shoulders, and it made me feel downright awful,” said Tracy W.

“As opiate medications are lowered, my Lyrica dosage has gone up. It does have side effects like weight gain and next day fogginess,” wrote Kenneth McKenna. “I look for physicians to use other medicines in a similar fashion, (due to of the opioid restrictions) which may turn out to be a worse problem than the opioids themselves.”

Both Lyrica and Neurontin are coming under scrutiny in the UK because of increasing reports they are being abused by addicts to get high. Since 2012, over 60 overdose deaths in the UK have been linked to pregabalin and gabapentin.

Researchers in British Columbia also recently warned about the limitations of gabapentin, pregabalin, duloxetine, and venlafaxine (Effexor) when used to treat neuropathic pain.

“The best available evidence now indicates that as few as one in ten people can expect much pain relief from these drugs,” said Dr. Aaron Tejani, a Clinical Assistant Professor in the Faculty of Pharmaceutical Sciences and a member of the University of British Columbia's (UBC) Therapeutics Initiative Working Group. “Many people who improve are getting a placebo effect, or would improve in time without any drug treatment.  Others end up sedated, with impaired thinking, balance disturbance, dry mouth, or other side effects that cause more harm than good.”

The drugs may be ineffective for most patients, but Tejani says many doctors continue to prescribe them because of an exaggerated belief in their effectiveness. From 2005 to 2014, the number of British Columbians receiving pregabalin increased by 17 fold, according to UBC Therapeutics. Over three times as many prescriptions for duloxetine were written during that period, while gabapentin prescriptions nearly doubled. The use of venlafaxine, mostly for depression or anxiety, has been stable.

“Increasing evidence suggests that drugs have relatively little useful role for most patients with chronic pain. We should be much more cautious about prescribing them, and warn patients about their side effects,” said Dr. Tom Perry, a Clinical Assistant Professor in the Department of Anesthesiology, Pharmacology and Therapeutics and Chair of the UBC Therapeutics Initiative team.

Califf Nomination Still Stalled

The FDA’s sudden reversal on many of its opioid policies may have been intended to reduce opposition in the U.S. Senate to Robert Califf’s nomination as the agency’s new commissioner. Early indications are that strategy may not have worked.

“I will continue to strongly pressure the FDA to strengthen its oversight of opioid medications and will continue to push for the strongest possible framework for drug approval to ensure that the agency doesn’t simply continue to approve ever stronger and more deadly opioid medications under this new process,” said Sen. Joe Manchin (D) of West Virginia, one of five senators who are blocking Califf’s nomination.

Manchin has been particularly critical of the FDA’s failure on several occasions to accept the advice of its advisory committees, which have been reluctant to support the approval of new opioids. Last week Califf promised to appoint new advisory panels to review every new opioid that doesn’t have abuse deterrent properties.

“I believe the FDA should use the advisory committee’s expert advice for all opioid medications, including abuse-deterrent formulations, which are just as addictive and can be just as deadly as non-abuse deterrent opioids. The FDA also needs to commit to adhering to the recommendations that the advisory committee puts forward,” said Manchin.

Sen. Edward Markey (D) of Massachusetts also believes the FDA policy changes “fall short of what is needed.”

“While this is a good start, even more is required to ensure the FDA’s approval process protects Americans from the dangers of opioid painkillers,” Markey said in a statement. "Whether an opioid is abuse deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers. That is why the FDA must change its decision not to seek expert advice about the risks of addiction before it approves abuse-deterrent opioids.”