FDA Bans Use of Codeine and Tramadol in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration is tightening restrictions on the use of codeine and tramadol in young children.

The agency says the opioid medications carry "serious risks" for children under the age of 12, including slowed or difficult breathing and possibly even death. The FDA is also recommending against the use of codeine and tramadol by breastfeeding mothers due to possible harm to their infants.

Codeine is approved to treat mild pain and cough, while tramadol is used to treat moderate pain. Codeine is usually combined with other medicines, such as acetaminophen, in prescription pain medication, as well as in some over-the-counter (OTC) cough and cold remedies. The FDA action only applies to prescription codeine.

"We know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, casing dangerously high levels of active drug in their bodies," said Doug Throckmorton, MD, deputy director for regulatory programs, at the FDA Center for Drug Evaluation and Research.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk."

In a review of adverse event reports from 1969 to 2015, the FDA said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18. The agency also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol by children.

The majority of serious side effects with both codeine and tramadol occurred in children younger than 12, and some cases occurred after a single dose.

The FDA is requiring drug makers to add a tougher warning to the labels of codeine and tramadol products, alerting healthcare providers and parents that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12.

The new labeling also cautions against their use in adolescents between 12 and 18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease. Breastfeeding mothers will also be warned not to use the medications.

The FDA said it is considering additional regulatory action for the OTC codeine products that are available in some states. It is also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

The agency did not recommend or suggest any alternatives to codeine and tramadol to treat childrens' cough or pain. OTC medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) also have risks and side effects.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," said Throckmorton.

In 2015, the FDA approved the use of OxyContin in children ages 11 to 16  who are in severe pain, a move widely panned by addiction treatment activists who claimed kids would get easily hooked on the painkiller. 

New Test Identifies Poor Drug Metabolizers

By Pat Anson, Editor

We hear regularly from readers who say they were discharged by their doctor after failing a urine drug test. Often it’s a case of an opioid painkiller not being found, which leads the doctor to believe a patient is selling or diverting their medication.

“The doctor said after 12 years of never having a bad urinalysis or anything ever happening, such as lost medication, asking to receive more or an early prescription, they said no medication was in my system. No one would retest and I was cut off cold turkey!” a pain patient recently told us.

“I went through hell trying to clear my name, horrible withdrawal with no doctor supervision or help, was labeled and thought I would die. This is a terrible way to treat anyone, especially someone with an untreatable life-long pain condition.”

Why are patients being falsely accused? In many cases, it’s because they have genetic differences that make them a low or high metabolizer of certain opioids. A painkiller like hydrocodone, for example, can quickly be utilized or pass through their system -- with little or no trace of the drug left behind.

Urine drug tests that are typically done in a doctor’s office -- known as point-of-care (POC) tests – do not identify these poor drug metabolizers. And studies show that about 30 percent of POC tests have “false negative” findings about opioid medication.

“Just because it may not show up in their system may not mean that they’re not taking it. There are two rational justifications for that. One is a bad drug test and the other is a patient may be a poor or ultra-rapid metabolizer of the medication that is being prescribed to them,” said David McCrea, CEO of Insight Diagnostics.

“I think most (doctors) understand how faulty the point of care tests can be, especially pain physicians. But I’m not sure the average physician understands how much a person’s individual metabolism can affect their drug test.”

Insight Diagnostics recently began offering a new testing service – called Genetically Enhanced Medication Monitoring (GEMM) – that combines a saliva-based genetic test with a laboratory test that more precisely identifies drug molecules in a patient’s urine. When used together, the two tests can reassure a doctor that a patient is telling the truth about their drug use.

“This is a game changing test that will allow physicians to uncover why some patients say, ‘I am taking my medication, I am taking it as prescribed and it’s just not showing up.’ This is scientific information that can validate a patient’s assertion,” McCrea told PNN.

“Certainly there are going patients that are going to try and game the system. But for those patients that are in chronic pain and are doing what they signed their pain contracts to do, this allows for a deeper dive for the physician to determine whether the patient is actually taking their medication, or they can’t metabolize it or they over-metabolize it.”

McRae says GEMM costs "a couple hundred dollars at the most” and is covered by Medicare and most private insurers. It doesn’t offer immediate results, as POC tests do, but the findings are far more accurate. They can also help physicians identify medications that will be metabolized normally by a patient and will be more effective. 

Genetic tests cannot be used to explain “false positive” findings from a POC test – the detection of a drug that isn’t actually there. But laboratory testing can. Retesting a urine sample is more expensive, but it can help prevent patients from being falsely accused – something that happens far too often.   

A recent survey of doctors and health care providers by PNN and the International Pain Foundation found that 20 percent had discharged a patient for failing a drug test in the past year. About four percent of patients said they had been "fired" by a doctor over a failed test.

“I failed a drug test which said I was positive for 4 drugs I have never taken in my life and was negative for opiates when I was taking Norco. My doctor abruptly stopped treating me even after I demanded my sample be retested,” a patient told us. “These drug tests are not reliable and should not be used and pain contracts should be illegal since they are forced on the patient.”

Click here to see a short promotional video about GEMM.

No Opioid Painkillers Prescribed to Prince

By Pat Anson, Editor

Nearly a year after pop superstar Prince was found dead of an accidental drug overdose in his Minnesota home, we still don’t know where he obtained the fentanyl that killed him.

Court documents released today show that none of the opioid painkillers found in Prince’s home were prescribed to him. At least one opioid prescription bottle bore the name of Kirk Johnson, Prince’s former drummer and a longtime friend. Other opioid medications were found stashed throughout Prince’s Paisley Park home near Minneapolis.

“The controlled substances were not contained in typical prescription pill bottles, but rather, were stored in various other containers such as vitamin bottles. Bottles containing these controlled substances were located in multiple areas of the complex, including Prince’s Bedroom,” a search warrant said. 

“Investigators have been searching for the source of the controlled substances found in Prince’s residence. Through this investigation, interviews with those who were at Paisley Park the morning Prince was found deceased have provided inconsistent and, at times, contradictory statements.” 

Assistants to the entertainer told investigators that “Prince recently had a history of going through withdrawals” and they had arranged a meeting for him to meet with an addiction treatment specialist.

Prince was found dead in an elevator at his home on April 21, 2016 and speculation immediately focused on a possible opioid overdose. A medical examiner later reported that Prince died from an accidental overdose of fentanyl, but did not say where the drug came from.

Prince did not have a prescription for fentanyl, a potent synthetic opioid that is used in skin patches and lozenges to treat severe pain. Illicit fentanyl is widely sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers.

Prince died less than a week after his private plane made an emergency landing in Moline, Illinois, where paramedics reportedly treated him for an opioid overdose.

The Minneapolis Star Tribune reported last year that Prince weighed only 112 pounds at the time of his death and had so much fentanyl in his system that it would have killed anyone.

According to the newspaper, some of the pills found in Prince’s home were labeled as “Watson 853” – a stamp used to identify generic pills containing hydrocodone and acetaminophen that are sold under the brand name Lortab. When one of those pills was tested, it was found to contain fentanyl and lidocaine.

A week before he died, Dr. Michael Schulenberg wrote an oxycodone prescription for Prince under Johnson's name to protect the singer’s privacy, according to investigators.  But in a statement released today, Schulenberg's attorney denied prescribing opioids to Johnson or "any other person with the intent that they would be given to Prince."

The Star Tribune reported that investigators turned over the results of their investigation to the U.S. attorney’s office earlier this year.  No arrests have been made and no charges have been filed.

Fuzzy Opioid Math and Media Theatrics

By Roger Chriss, Columnist

The Centers for Disease Control and Prevention recently produced a map that shows how prescription opioid use varies widely from state to state. Californians, for example, are prescribed opioids at about half the rate as people in Ohio and West Virginia.

The CDC also tells us that doctors “wrote 259 million prescriptions for painkillers in 2012, enough for every American adult to have a bottle of pills.”

Because an epidemic is a statistical phenomenon, defined by numbers derived from data, caution is required when presenting and interpreting such results.

The media has been anything but cautious in using these numbers as fodder for sensational anti-opioid reports.

CDC GRAPHIC

“These pills didn’t just end up in patients’ hands; they also proliferated to black markets, were shared among friends and family, landed in the hands of teens who rummaged through parents’ medicine cabinets, and so on,” Vox reported, overlooking the fact that less than one percent of legally prescribed painkillers are diverted.

Some use the prescribing numbers to make a case for extreme measures to stop opioid addiction and overdose.

“In 12 states there are more opioid prescriptions than people,” David Brooks wrote in The New York Times, before suggesting an approach to addiction treatment that sounds like it came out of Les Misérables.

“Something like half of all sufferers drop out of treatment within a few months, so it might be worth thinking about involuntary commitment,” Brooks said.

“Legally, by prescription, we have created an epidemic of death,” chimed in New Hampshire attorney Cecie Hartigan in an op/ed published by the Concord Monitor.  “What point is there in alleviating pain for people if it’s going to kill so many of them?  Except in cases of end-of-life care, opioids should not be prescribed.”

Unfortunately, a prescription is not a unit of measure, and statements like these only add to the hysteria and fuzzy math.

An “opioid prescription” is as imprecise as a “bottle of alcohol.” Obviously, a bottle may be small or large, and the alcohol it contains may be strong or weak. As a result, having a small bottle of beer with dinner would be unremarkable, but drinking a large bottle of vodka would be alarming.

This is the mistake in the CDC graphic and opioid prescription counts. A prescription is a paper or electronic document, specifying a particular drug in a particular strength given in a particular quantity -- which makes it unsuitable for statistical use. A prescription for 5 tablets of 50 mg of tramadol cannot be usefully compared with a prescription for 30 tablets of 25 mg of oxycodone.

The CDC’s fuzzy math paves the way for a lot of confusion. Media reports give dramatic percentages of people using prescription opioids, warning of dire consequences from even a few pills.

“If patients get their hands on a second dose, one out of seven will form an addiction. In the event that patients must take a long-acting opioid, about 25% will still be using the drug one year later,” Dr. Manny Alvarez wrote in the Fox News website, apparently unaware less than two percent of people prescribed opioids actually become long term users.  

National Public Radio reported that 57% of American adults in a recent poll said they had been prescribed a narcotic painkiller, and then went on to claim that “as many as 1 in 4 people who use opioid painkillers get addicted to them.”

There are 242 million adults in the U.S. population, so if 57% were prescribed opioids and one fourth of them became addicted, that would give us 34.5 million people addicted to painkillers. This is clearly not the case.

The American Society of Addiction Medicine reports that there are approximately 2 million prescription opioid addicts. These people need treatment, not media theatrics.

Moreover, 259 million prescriptions does not mean that 259 million people have a year’s supply of an opioid. In most cases, people receive a short course of a weak opioid, enough to help with acute pain after trauma or surgery.

As for long-term opioid use, the National Institutes of Health states that “an estimated 5 to 8 million Americans use opioids for long-term management.” Studies show that only a small percentage become addicted to their medication.

Surely we don’t need opioid detention centers or opioid prohibition. That would not help the people struggling with opioid addiction or people living with chronic pain disorders.

Ignore the fuzzy opioid math and related theatrics, and focus on the 2 million people struggling with opioid addiction and the 5 to 8 million people living with chronic pain conditions. They deserve our care and consideration, and certainly won’t benefit from media melodrama.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Get the Facts Right About Opioids

By Barby Ingle, Columnist 

This past week Tucker Carlson aired a series of reports on Fox News about opioids and addiction. After night two of watching the “Drugged” special segments, I wondered if Fox would be willing to tell the patient side of the story and wrote to some Fox News producers I know to see if they wanted to interview me.

I didn’t know the specific producer for Carlson, but the next morning I received an email from her. I immediately responded and said yes, I would come on the show. We set it up for Thursday or Friday. Well, on Thursday we bombed Afghanistan with the “Mother of All Bombs” and they were unable to get me in.

The producer did say that they would be doing additional segments on the topic and that they are interested in bringing me on sometime in the next few weeks.

I watched the rest of the series, and on Wednesday Carlson said that 60 percent of veterans have chronic pain. That didn’t sound right to me and I wondered where Carlson got his facts from. He never said in his broadcast.

When I looked it up, I found a 2014 study in JAMA Internal Medicine that said 44% of military personnel develop chronic pain after a combat deployment. Also, not all of them are taking opioids as Carlson reported. Only 15% are taking opioids – compared to 4% in the general population.

When I get my chance to speak to Carlson or any other news outlet, I always suggest that we not take opioids off the table as a form of treatment for those with chronic pain. It is not the right thing to do in my educated opinion as a chronic pain patient. There are hundreds of treatment options, but many patients can’t afford them and insurance often won’t pay for them. You can’t leave patients without options.

Many people I know, including one of my best friends, committed suicide because of lack of proper and timely care. She wasn’t looking for opioids, she was looking for relief. She jumped from a 10-story building in New York.

Another friend spent months fighting for her medication after her insurance would no longer pay for her infusion therapy. Once her doctor finally gave her a prescription for fentanyl patches, she went home, put on all 60 patches and tried to commit suicide. She was found in time by her husband and was in a coma at a hospital for about a week.

When she awoke, she was pissed that they didn’t let her die. She wanted to die because she didn’t know how she was going to get any pain relief going forward. My friend is in an even worse situation now because the attempted suicide is on her medical record. She wants infusion therapy, but is denied it -- even though it gave her life back when she did have access to it.

I have been living with chronic pain for 20 years. This year I have been unable to find a provider who will even charge my insurance company for the infusion therapy that keeps me out of my wheelchair. I choose not to use opioids daily because they don’t work for me. But I don’t want to take them away from someone who they do help. That decision needs to be on an individual basis, between a provider and their patient.

We need to encourage pharmaceutical companies to address the addiction and tolerance in pain medications, and one way is the use of abuse deterrent formulas. Another is to get insurance companies, Medicare and workers compensation to cover alternative treatments so that we have more options. And for those who tried and failed with other treatments, we need to keep opioid medication available.

Patients also need to be responsible for their own actions and choices. Recently my doctor gave me a new script. Before filling it, I went home, Googled it, and saw the medication has potential negative side effects. I will be talking with my provider again in a week and will let him know that the medication is not right for me.

Patients need to be proactive about reading medication labels and inserts, and looking up information on our treatment options. We must educate ourselves and we must ask our providers questions. Being a responsible patient will lower the risk of abuse, and increase our access to proper and timely care.

Addicts are going to abuse no matter what is available. We chronic pain patients are simply asking for a seat at the table. Instead we are portrayed as wrong doers, who just want to get high on pain pills.

Carlson ended his week long series by saying he will continue to bring different voices and information to his viewers. His producer personally echoed that sentiment to me. I hope to be given the chance soon to come on his program and tell the patient side of the story, and the many challenges we face getting proper and timely pain care.  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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.

Studies Identify Riskiest Patients for Opioids

By Pat Anson, Editor

Two studies released this week suggest that pre-existing medical conditions and substance abuse play a strong role in determining whether a patient becomes a long-term opioid user or is hospitalized by an overdose.

The findings could help doctors identify pain patients more likely to develop opioid addiction, instead of flatly assuming that opioids are risky for everyone.

The first study, published in JAMA Surgery, looked at over 36,000 adults who were given a limited supply of opioids to control their pain after surgery. None of the patients had an opioid prescription in the year preceding their operation.

Only about 6 percent of the patients were refilling opioid prescriptions three to six months after their surgery.

The rate didn’t differ significantly between those who had a minor operation and those who had major surgery.

When researchers dug deeper, they found that many of the long term opioid users had similar medical issues. People with arthritis were about 60 percent more likely to keep filling prescriptions, while smokers were about 25 percent more likely. Those who suffered from depression and anxiety were about 20 percent likely to keep taking opioids.

"This points to an under-recognized problem among surgical patients," said lead author Chad Brummett, MD, director of the Pain Research division in the University of Michigan Medical School Department of Anesthesiology. "This is not about the surgery itself, but about the individual who is having the procedure, and some predisposition they may have."

More than 50 million surgical procedures are performed in the U.S. every year. If the study's findings hold true for all patients, researchers say over 2 million people who were "opioid naïve" before surgery could wind up receiving the drugs for months afterward.

Medical Conditions Linked to Overdoses

The second, much larger study looked at a database of over 18 million patients who had an opioid prescription between 2009 and 2013. Over 7,200 opioid overdoses that required hospitalization were identified.  

Researchers found that a previous diagnosis of substance abuse was the single factor most strongly associated with an overdose.  Bipolar disorder, schizophrenia, stroke, renal disease, heart failure and non-malignant pancreatic disease were also strongly associated with overdose risk. 

The risks linked to many of these pre-existing health conditions were so strong they outweighed the risk associated with taking high daily doses of opioids over 100 mg morphine equivalent dose (MED).

“The authors have been able to demonstrate in a very large population there are many risk factors far more important than opioid dose that predict overdose,” said Lynn Webster, MD, a leading expert in pain management and past president of the American Academy of Pain Medicine. 

“I have been lecturing and writing for a decade that dose is less of a contributing factor for overdoses than mental health and history of substance abuse disorders. This study supports what I have been saying.”

The study also identified the prescription opioids most strongly associated with overdose were fentanyl, morphine and methadone. Interestingly, the use of benzodiazepines and antidepressants was riskier than taking hydrocodone, oxycodone and tramadol.   

The study, published in the journal Pain Medicine, was conducted by Venebio, a Virginia-based research group.

"Pain and its management are complex and multidimensional, and the risk of an opioid overdose is likewise dependent on many factors," said Barbara Zedler, MD, lead author and chief medical officer of Venebio. "Primary care professionals express concern about prescription opioid misuse and find managing patients with chronic pain to be stressful. Many feel inadequately trained in prescribing opioids and treating or managing opioid use disorder or addiction." 

Venebio has developed an opioid risk screening tool – called the Venebio Opioid Advisor (VOA) – to help doctors identify patients at risk of having an opioid overdose. According to company officials, VOA predicts the likelihood of an overdose with nearly 90 percent accuracy.

“The apparent accuracy is extraordinary and if broadly implemented should save lives,” said Webster. “I hope the CDC, CMS (Centers for Medicare and Medicaid Services) and policymakers study this paper before they suggest further changes that could cause more suffering and harm for people in pain.”

According to the CDC, over 15,000 overdose deaths in U.S. in 2015 were linked to prescription opioids, although there’s no way of knowing whether the drugs were taken medically or recreationally. Another 18,000 overdoses involved heroin or illicit fentanyl, which have replaced painkillers as the driving force behind the nation’s opioid epidemic.

Bill Would Strictly Limit Opioids for Acute Pain

By Pat Anson, Editor

A bipartisan bill has been introduced in Congress that would put strict limits on the prescribing of opioid medication for the treatment of short-term, acute pain.

The bill by Senators John McCain (R-AZ) and Kirsten Gillibrand (D-NY) would require doctors to limit the initial supply of opioids for acute pain to seven days, a prescription that could not be renewed. The legislation is similar to recent laws adopted in several states, including New Jersey, Arizona and New York.

“Our bipartisan bill would target one of the root causes of the opioid addiction crisis, which is the over-prescription of these powerful and addictive drugs for acute pain,” said Gillibrand. “Too many lives have been destroyed, too many families have been torn apart, and too many communities all over New York are suffering because of this tragic epidemic.”

“One of the main causes for the alarming increase in drug overdoses in the United States is the over-prescription of highly addictive opioids,” said McCain. “We have a long way to go to end the scourge of drugs across our communities, but this legislation is an important step forward in preventing people from getting hooked on these deadly drugs.”

Anti-opioid activists and government regulators have long claimed that even just a few painkillers can easily lead to addiction and death.

“You take a few pills, you can be addicted for life. You take a few too many and you can die,” former CDC Director Thomas Frieden recently told the Washington Post.

But only a small percentage of pain patients become addicted or overdose on prescription opioids. And research shows that less than two percent of patients who are prescribed opioids for acute pain become long-term users.

Under current federal law, doctors must receive a license from the Drug Enforcement Agency (DEA) to prescribe a schedule II, III, or IV controlled substance. The registration must be renewed every three years.

The 7-day limit would not apply to opioid medication used in the treatment of chronic pain or cancer pain, or for patients in hospice care, end-of-life care or palliative care. However, it would prevent doctors from prescribing any opioids for any type of pain if they don't promise to limit prescriptions for acute pain:

“The Attorney General shall not register, or renew the registration of, a practitioner…  who is licensed under State law to prescribe controlled substances in schedule II, III, or IV, unless the practitioner submits to the Attorney General, for each such registration or renewal request, a certification that the practitioner, during the applicable registration period, will not prescribe any schedule II, III, or IV opioid, other than an opioid prescription… for the initial treatment of acute pain in an amount in excess of the lesser of a 7-day supply (for which no refill is available) or an opioid prescription limit established under State law.”

Schedule II opioids include painkillers with “a high potential for abuse” such as hydrocodone, fentanyl, morphine, and codeine. Schedule III opioids have “a potential for abuse” and Schedule IV opioids have “a low potential for abuse.” Opioids such as Suboxone and buprenorphine, which are generally used to treat addiction but are also being abused, are exempted from the legislation.

Anti-anxiety and antidepressant drugs such as Xanax, Soma and Valium – which are classified as Schedule IV controlled substances – are also not covered by McCain and Gillibrand’s bill, even though they are involved in a substantial number of overdoses. The bill was assigned to the Senate Judiciary Committee.

“It’s only too obvious, a careless clueless Congress and state governments have forgotten the lessons of the drug wars and prohibition as they seem intent on repeating the mistakes of the past instead of learning from them when it comes to opioids,” said David Becker, a social worker and patient advocate in New York.

“Furthermore, it is clear they could care less how their opioiphobia harms not only people in pain but their loved ones and those that care and depend on them. It’s clear they never had a real plan to help people in pain but allowed doctors, insurers, and researchers to do their own thing -- unless headlines showing the harms of their lazy laissez faire policies threatened their careers.”

Why Pain Patients Should Worry About Chris Christie

(Editor’s Note: Last month President Donald Trump named New Jersey Gov. Chris Christie as chair of a new commission that will study and draft a national strategy to combat opioid addiction..

Gov. Christie has been a prominent supporter of addiction treatment and anti-abuse efforts.

He also recently signed legislation to limit initial opioid prescriptions in New Jersey to five days, a law that takes effect next month.)

white house photo

By Alessio Ventura, Guest Columnist

Unfortunately, Chris Christie's crackdown on opioids will have extremely negative consequences for people with acute and chronic pain in New Jersey. It is equivalent to gun control, where because of crime and mass shootings, innocent gun owners are punished.

The fact is that only a small percentage of opioid deaths are from legitimate prescriptions. Most overdose deaths are from illegal drugs or the non-medical use of opioids.

The government crackdown on opioids has created a literal hell on earth for people with severe pain, who often can no longer find the medication they need. This has become a major issue, even though there are other drugs that are just as dangerous when misused:

• Every year 88,000 people die from alcohol poisoning. There is no government war on alcohol.
• Every year over 40,000 people die from antidepressants. There is no government war on antidepressants.
• Every year 15,000 people die from non-steroidal anti-inflammatory drugs (NSAIDs) and 100,000 are hospitalized. There is no government war on NSAIDs.

Deaths from alcohol, antidepressants and NSAIDs far exceed deaths from opioids, yet it is opioid medication that gets all of the attention.

So when we see Chris Christie leading a new opioid commission, we chronic pain patients know full well that this just means more restrictions for us. Addicts and criminals will continue to support their habit through the illegal market, and pain patients will continue to live a life of hell that will only get worse. Most of us don’t go to the black market to buy pain medication. We drive around in excruciating pain looking for a pharmacy that can fill our prescriptions.

We also cringe in fear every time we see the "opioid epidemic" headlines and the new initiatives to combat overdoses, because we know that we will pay the price, not the addict or criminal.  It’s like when a nut case opens fire and kills people. Gun owners know that new restrictions will impact them, not the criminals.

New Jersey’s 5-Day Limit on Opioids

Gov. Christie recently pushed for and convinced the New Jersey legislature to pass very restrictive pain medicine laws. Physicians in New Jersey were very much opposed to Christie's model, but it was forced upon them anyway. Since I am originally from New Jersey and most of my family still lives there, I know firsthand the devastating consequences these restrictions could have on family members.

I have had 18 invasive surgeries since 2008 and recently suffered from a sepsis infection after shoulder replacement surgery. The infection required 3 additional surgeries, two of which were emergency surgeries as the infection spread. I was fed broad spectrum antibiotics intravenously 3 times per day.

I also suffer from chronic pain from arthritis. I have tried every other pain treatment modality, and opioid-based pain medicine is the only one that works for me.

There is no way I would have been able to get up after a 5 days to visit my doctor just to refill pain medicine. But if New Jersey’s law were instituted in Florida, where I now live, it would require me to do just that. After the surgery, I was dealing with horrible pain in my shoulder, along with severe fatigue and other complications. Thank God that Florida law still allows for prescriptions of pain medicine beyond 5 days.

Chris Christie is now leading a study for President Trump, and my fear is that a new executive order will be forthcoming which will force the New Jersey model of restricting pain medicine across every state, including Florida.

Let me relay to you a recent experience of my 85 year old mother, who had invasive back surgery in New Jersey. They sent her home after 2 days in the hospital with a prescription for a 5 day supply of Percocet, and strict orders to "NOT MOVE FROM BED.”

There is already a shortage of pain medicine in New Jersey pharmacies. My sister took the script, started at a pharmacy in Bridgewater, and worked her way on Route 22 toward Newark. She visited 30 pharmacies along the way and was unable to find the medicine. She called me in tears because my mother was in terrible pain.

My sister even took my mother to the ER, but they would not give her any medicine for pain.

Thankfully, after asking several friends for help, my sister received a call from her best friend, who found a pharmacy that had Percocet. My mother received significant relief from the pain medicine, but 5 days was not nearly enough. My sister lives with my mother and was able to take her on the 4th day to see the doctor about a refill, but she never should have gotten out of bed. She was under strict orders to stay in bed, use a bed pan and not to get up until two weeks after the surgery.

Yet now on the 4th day she had no choice because of her pain. The patient has to be present to receive a new script for opioids in New Jersey, so my sister could not visit the doctor's office to pick up a script for her without my mother's presence.

This is an unbelievable intrusion into the doctor-patient relationship. Why is it that politicians are so hell bent on government intrusion when it comes to legitimate use of medicines? This is insanity.

It is time for a full court press in Washington DC. If you have acute, chronic or intractable pain, then you better wake up and do something to preserve your rights. Chronic pain is a disease, and for people who have tried all modalities and found that opioids are the only solution, you are about to lose access to the medicine that gives you some semblance of a normal life. I anticipate that an executive order mirroring the misguided New Jersey restrictions will be issued by President Trump, in essence trampling on your ability to obtain pain relief.

I am imploring you to make our voices heard. We should not be further punished because of people with addiction illness. Of course they need to be helped, but restricting access for law abiding, non-addicted patients is an outrage. It is already difficult enough to get pain medicine in Florida, often requiring visits to 20 or more pharmacies before one finds a pharmacist willing to fill a script.

I have often thought about suicide because of my pain. Many others have as well. If additional restrictions are forthcoming from Washington, then many of us will face life or death decisions. Please do not allow Chris Christie to tip the balance.

Alessio Ventura lives with chronic arthritis and post-surgical pain. He shared his experiences as a pain patient in a previous guest column. Alessio was born in Italy, came to the U.S. at age 17, and finished high school in New Jersey. He worked for Bell Laboratories for 35 years as a network and software engineer. 

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.

McCain Calls for New Study of Veteran Suicides

By Pat Anson, Editor

Arizona Senator John McCain has reintroduced legislation that calls for a comprehensive review of veteran suicides by the Department of Veterans Affairs (VA), including the role of opioids and other prescription drugs in their deaths.

Veterans suffer from high rates of chronic pain, depression and post-traumatic stress disorder (PTSD). According to a recent VA study, an average of 20 veterans die each day from suicide, a rate that is 21 percent higher than the civilian population.

“The tragedy of 20 veterans a day dying from suicide is a national scandal,” said McCain. “Combatting this epidemic will require the best research and understanding about the key causes of veteran suicide, including whether overmedication of drugs, such as opioid painkillers, is a contributing factor in suicide-related deaths.”

If passed, the Veterans Overmedication Prevention Act would authorize an independent study by the National Academies of Sciences of veterans who died of suicide, violent death or accidental death over the last five years – including what drugs they were taking at the time of their death.

The bill specifically calls for a listing of “any medications that carried a black box warning, were prescribed for off-label use, were psychotropic, or carried warnings that include suicidal ideation.”

SEN. JOHN MCCAIN

Dozens of medications prescribed to treat chronic pain, depression or PTSD are psychotropic – meaning they affect a patient’s mental state. They include tranquilizers, sedatives, antidepressants and anticonvulsants such as Lyrica (pregabalin), Cymbalta (duloxetine), Neurontin (gabapentin), Xanax (alprazolam), and Valium (diazepam). Many of the drugs also have warning labels that they “may cause suicidal thoughts or actions.”

McCain’s bill may bring new attention to something that is rarely discussed in the national debate over opioids and the overdose epidemic: many of the drugs prescribed "off label” as alternatives to opioids raise the risk of suicide and have other side effects.

“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,” Alessio Ventura wrote in a recent guest column for PNN. “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.”

Vietnam veteran Ron Pence was pressured by VA doctors to take Cymbalta for his chronic arthritis.

“The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems,” Pence wrote in a guest column.

“Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.”

As PNN has reported, the VA recently adopted new clinical guidelines that strongly recommend against the prescribing of opioids for chronic pain. The guidelines recommend exercise and psychological therapies such as cognitive behavioral therapy, along with non-opioid drugs such as Neurontin. No mention is made that Neurontin and other non-opioid drugs raise the risk of suicide, only that they “carry risk of harm.”

McCain’s bill would require the National Academies of Science to study the medications or illegal substances in the system of each veteran who died; whether multiple medications were prescribed by VA physicians or non-VA physicians; and the percentage of veterans who are receiving psychological therapy and its effectiveness versus other treatments.

West Virginia Admits Pain Patients Suffering

By Pat Anson, Editor

As Ohio, New Jersey and other states move to put further limits on opioid prescribing, West Virginia is acknowledging that its own efforts may have gone too far.

This week the West Virginia House of Delegates unanimously passed a bill that would create a commission to review state regulations on opioid pain medication and report back to the legislature on ways to make them “less cumbersome.”

Senate Bill 339 calls the abuse of pain medication in West Virginia “a nearly insurmountable plague,” but recognizes that efforts aimed at curbing abuse and overprescribing have “resulted in unforeseen outcomes often causing patients seeking pain treatment to suffer from a lack of treatment options.”

“Effective early care is paramount in managing chronic pain. To that end, prescribers should have the flexibility to effectively treat patients who present with chronic pain. However, there must be a balance between proper treatment for chronic pain and the abuse of the opioids found most effective in its treatment,” the bill states.

The legislation calls for the Dean of the School of Public Health at West Virginia University to serve as chair of the commission, which is to be known as the Coalition for Responsible Chronic Pain Management. Other members of the panel will include a board certified pain specialist, three physicians, a pharmacist, a chiropractor and a pain patient. 

The coalition will meet quarterly to review regulations on physicians and pain clinics, and will advise the legislature on ways to “further enhance the provider patient relationship in the effective treatment and management of chronic pain.”

Because the bill was amended in the House, it now returns to the West Virginia Senate for approval.

In many ways, West Virginia was ground zero for the nation’s overdose epidemic, and was one of the first states to crackdown on pill mills and the overprescribing of pain medication. Fewer opioids are now being prescribed, but West Virginia still leads the nation with the highest overdose death rate in the country.

At least 844 people died of drug overdoses in the state in 2016, a record number, compared to 731 in 2015. As in other parts of the country, addicts in West Virginia have increasingly turned to heroin and illicit fentanyl, which are more potent, dangerous and easier to obtain than prescription painkillers. Over a third of the overdose deaths in West Virginia last year were linked to fentanyl. Most of the deaths involved multiple drugs.   

Ohio Tightens Opioid Regulations

In neighboring Ohio, Gov. John Kasich last week announced new plans to limit opioid prescriptions to just seven days of supply for adults and five days for minors. Doses are also being limited to no more than 30 mg of a morphine equivalent dose (MED) per day.

The new regulations, which are expected to take effect this summer, are more than just guidelines – they are a legal requirement for prescribers. Although only intended for acute pain patients, many chronic pain patients are worried they will lose access to opioid medication.

"Doctors are already feeling this pressure not to prescribe pain medications," Amy Monahan-Curtis told NBC News. "What I am hearing is people are already being turned away. They are not getting medications. They are not even being seen. "

Ohio has been down this path before. In 2012, it began a series of actions to restrict access to pain medication. By 2016, the number of opioid prescriptions in Ohio had fallen 20 percent, or 162 million doses.

As in West Virginia, however, the number of drug overdoses continues to soar. Ohio led the nation with over 3,000 drug overdoses in 2015, with many of those deaths linked to illicit fentanyl and heroin. The situation is so bad that some county coroners are storing bodies in temporary cold storage facilities because they’ve run out of room at the morgue.

Next month new regulations will go into effect in New Jersey that will limit initial opioid prescriptions to just five days of supply. Only after four days have passed can a patient get an additional 25 day supply.

That law is primarily intended for acute pain patients, but many chronic pain patients are worried they’ll be forced to make weekly trips to the doctor and pharmacy for their prescriptions, or not be able to get them at all.

“You can imagine my alarm and fear when I was told yesterday that I will likely have to have the dosage of my medications reduced soon,” said Robert Clayton, a New Jersey man who suffers from chronic back and neck pain.

“This is LUNACY. As a nurse who treats individuals with chronic pain and addiction issues, I can tell you these new laws are going to have catastrophic results. Most of the people abusing opiates and dying are the addicts who abuse heroin and other prescription drugs like benzodiazepines, not the chronic pain patients like myself and the other unfortunate souls who have a genuine need for these drugs through no fault of our own.”

According to a recent survey of over 3,100 pain patients by PNN and the International Pain Foundation, one in five pain patients are hoarding opioid medications because they fear losing access to them.

The Rest of the Opioid Story

By Roger Chriss, Columnist

Media reports about the opioid crisis in the U.S. are often grim and sensational.

The Economist declares that “states are losing the battle against deadly drugs like heroin and fentanyl.” Vox describes the opioid epidemic as “America’s worst drug crisis ever.” And CBS News warns that “opioid dependence can start within just a few days.”

But all this ignores a key point: Opioids are the best pain reliever we have, and they relieve a lot of pain.

The Institute of Medicine estimates that 100 million Americans will be in chronic pain at some point in their lives. Associated Press reporter Matthew Perrone laughed at this number in an interview that recently appeared in The Huffington Post, saying “That’s a damn lot of pain.” And Anna Lembke suggested the number may be much lower in her book, Drug Dealer, MD.

Let Perrone have his little laugh and assume Lembke is right. Perhaps there are only 25 million people in chronic pain. That’s still a lot of people -- the population of many nations in the world. It’s a population that also includes some of the worst diagnoses imaginable. They include diseases and disorders that rarely get better and often get worse, requiring the patient to live for years or even decades in pain.

These journalists and authors may not realize what this pain represents. This is the pain that lands you in the emergency room only if someone else takes you there. You are simply not capable of getting there on your own.

This is the pain that keeps you awake for days at a stretch because the brain simply cannot disengage. This is the pain that ends careers, shatters families and destroys relationships. It is not an achy muscle or a tender joint. Chronic pain is to ordinary pain as a hurricane is to a rain shower.

Opioids make a huge difference in the life of such people. According to The Washington Post, “the vast majority of those who have used strong painkillers for a long period say they work.” Lembke may trivialize multiple sclerosis or complex regional pain syndrome in her book, but people with these and other disorders deserve the best modern medicine has to offer. For pain management, that is often opioid medication.

Moreover, opioids are essential to modern healthcare, a reality often ignored by journalists.  Trauma and battlefield injuries could not be managed without the analgesic effects of opioids. The same is true for tens of thousands of cancer surgeries, organ transplants and hip replacements. And for the neuropathic pain caused by chemotherapy or the pain of a sickle-cell crisis. The list goes on and on. Opioids are an invaluable medical resource.

Of course, they must be used wisely. Developing a safer opioid would be wonderful, but this has proven difficult. Clearly not Purdue Pharma with OxyContin, which contributed greatly to the current opioid crisis before it was reformulated into a pill that is harder to abuse. Endo’s Opana ER is under review by the FDA and may be removed from the market for safety reasons.

Nektar Therapeutics has a new opioid called NKTR-181 that is showing promise in clinical trials. But it remains to be seen if it will come to market or if it will actually be any safer. Non-opioids like NSAIDs and Lyrica also have their own non-trivial risks.

In other words, drug development is hard. And despite enthusiastic media coverage of new drugs, often labeled as promising alternatives for “deadly opioids,” we shouldn’t expect a medication with no risk of abuse or addiction to appear any time soon, assuming that is even possible. And none of this matters if you are facing a major surgery, chemotherapy, or life with a chronic medical disorder right now.

Opioid medications are already here. They work. Their risks have been amply described in the media with phrases like “highly addictive opioid” or “dangerous opioid,” but never with modifiers like “life-saving” or “function-preserving.”

Few people doubt the need for careful opioid prescribing, the importance of prescription drug monitoring programs, and the value of shutting down pill mills, but too many are ignoring the medical importance of opioids. 

Everyone recognizes the tragedy of overdose deaths. Nothing can express the significance of the loss of a family member or friend to addiction and overdose. But let’s also not understate the importance of preserving life, of restoring function, and minimizing suffering. In other words, let’s prevent both tragedies. Let opioid medications do what they can do, and make sure they do that and nothing else.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Medicare Modifies Opioid Prescribing Plan

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Why the CDC Needs to Recognize Palliative Care

By Barbara Nelson, PhD, Guest Columnist

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

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

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

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

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

How Did We Get Here?

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

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

There is a problem to this approach, however.

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

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

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

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

The Need for a Palliative Care Appendix

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lyrica, Cymbalta and Savella: Do They Work?

By Lana Barhum, Columnist

If you have fibromyalgia, chances are your doctor has prescribed one or more of the three drugs approved for fibromyalgia by the U.S. Food and Drug Administration (FDA).   It is also likely you have been disappointed when they didn’t work and by the side effects they caused.

I have tried Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran). My experience is they don’t work well and clinical research doesn’t offer up enough credible evidence that they do.

Patient feedback on these medications is actually more telling than recent studies.  Just check any fibromyalgia online forum and you will find your unpleasant experiences with these medications aren’t unique and shared by many.

Lyrica

Lyrica was developed by Pfizer as a treatment for epilepsy, but it is now widely prescribed for many different types of pain. Lyrica was approved by the FDA in 2007 as the first drug specifically for the treatment of fibromyalgia. Pfizer notes on its website that Lyrica “significantly relieves fibromyalgia pain and improves physical function” in fibromyalgia patients.  But does it really?

An initial study from 2005, with results published in Arthritis & Rheumatology, found Lyrica to be effective at relieving pain in only 29% of the 529 fibromyalgia patients in the study group. 

A major shortcoming of the study was that weight gain affected 10% of the study participants.

What was also interesting about the Arthritis & Rheumatology study is that a large number of participants dropped out due to Lyrica's side effects, which included edema, dry mouth, weight gain, infection, increased appetite and constipation.

A 2014 study of out of the University of Calgary, with results published in the journal Therapeutic Advances in Drug Safety,  also found that Lyrica causes edema and weight gain in some patients. 

Those side effects, especially the weight gain, aren’t worth it for a drug that doesn’t seem to work well for most people. You would get more benefit from dietary changes for fibromyalgia than with Lyrica - at least that was my experience. 

All I got from taking Lyrica was a 40 pound weight gain that took me two years to take off. I made the mistake of staying on it for too long, believing that it would one day work for me.

Cymbalta

Cymbalta was originally developed and marketed by Eli Lilly as a treatment for depression. You may even remember some of the commercials for it. In 2008, Cymbalta become the second drug approved by the FDA to treat fibromyalgia.

While Cymbalta doesn’t have stellar ratings amongst fibromyalgia patients, it does outperform Lyrica in my opinion. Initial trials, with results published in The Primary Care Companion to The Journal of Clinical Psychiatry, show that over a third (36%) of study participants reported at least a 50% reduction in pain, based on a dosage of 60 mg once or twice per day.

A report published in the journal Expert Review of Clinical Immunology found that many participants dropped out of Phase I, II, and III trials of Cymbalta due to side effects, including nausea, headache, and sleep issues. 

Cymbalta has given me some pain relief over the years, but I have also made changes to my diet and lifestyle which may have helped as well.  If Cymbalta has helped me with anything, it is managing the depressed feelings fibromyalgia often leaves in its wake.

Savella

My Savella experience was far worse than my experiences with Lyrica and Cymbalta.  I could only stay on it for two weeks because the side effects were more than I could handle. Dizziness, vertigo, nausea, fatigue, and severe headache were a few of the side effects that stood out.  And I didn’t get any fibromyalgia pain or symptom relief.

Savella was developed by Forest Laboratories specifically for fibromyalgia and was approved by the FDA in 2009.

Like Lyrica and Cymbalta, studies confirm Savella’s poor performance. One double-blind study, reported in the journal Pharmacy & Therapeutics, found that only about one in four fibromyalgia patients (26%) were getting pain relief. 

The rate of discontinuation due to Savella’s side effects and treatment failure was also high -- nearly 43 percent.

In 2010, the consumer advocacy group Public Citizen petitioned the FDA to remove Savella from the market because it increased blood pressure in patients who didn’t have high blood pressure to start with. The group also argued Savella posed an increased risk for suicidal thoughts.

The FDA responded last year and denied Public Citizen’s petition, but said it would continue to monitor the safety of Savella.

My Thoughts

The only medication that I have seen that offers real improvement is Pfizer’s Neurontin (gabapentin), which is prescribed “off label” because it is not specifically approved to treat fibromyalgia by the FDA. Neurontin has helped my nerve pain and I also take muscle relaxers as needed, as I am frequent sufferer of muscle cramps and spasms. 

Studies have confirmed Neurontin’s effectiveness in treating fibromyalgia pain and improving sleep and fatigue. One double-blind study, with results published in Arthritis & Rheumatism, found that over half (51%) of fibromyalgia patients were finding relief with Neurontin.   

That’s not bad for a medication that was originally developed to manage seizures and whose formula has been the same since 1993. While it has helped me, I certainly understand Neurontin hasn’t helped everyone. There are even reports of Neurontin being abused by addicts. 

I am not sure why the makers of Lyrica, Cymbalta and Savella continue to market medications that don’t offer most people real results.  Yet, these medications remain available and doctors are still prescribing them to treat fibromyalgia. 

Let's just hope there are new fibromyalgia drugs on the horizon that actually work and give us real and reliable symptom and pain relief.

What has been your experience with Lyrica, Cymbalta and Savella?

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

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

CDC: Painkillers No Longer Driving Opioid Epidemic

By Pat Anson, Editor

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

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

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

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

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

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

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

DEBRA HOURY, MD

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

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

Some Patients Turning to Illegal Drugs

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

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

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

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

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

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

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

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

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

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

counterfeit oxycodone (dea photo)

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

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