Positive Results for New Osteoarthritis Drug

By Pat Anson, Editor

Two pharmaceutical companies have announced positive results from a Phase 3 study of an experimental non-opioid pain reliever that has a history of safety concerns.

Teva and Regeneron are jointly developing fasinumab as a treatment for chronic pain from osteoarthritis of the knee and hip. The companies say patients treated for 16 weeks with fasinumab injections had significantly less pain and improved function compared to a placebo.

"We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids," said George Yancopoulos, MD, President and Chief Scientific Officer of Regeneron.

Fasinumab is a humanized antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Fasinumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

Teva and Regeneron say fasinumab was “generally well tolerated” in the Phase 3 study, with similar adverse events (AEs) as in previous trials. Treatment was discontinued due to AEs in 6 percent of the fasinumab patients, about the same as the placebo group. The companies plan to present further details at an upcoming medical conference.

Regeneron recently halted high-dose trials of fasinumab because the risk of harm outweighed the benefits of the drug. There is some concern that NGF antibodies work too well and encourage osteoarthritis patients to become more active, which accelerates joint deterioration. No cases of joint damage were observed in the current study.

Regeneron and Teva are currently enrolling osteoarthritis patients in three additional Phase 3 clinical trials, including one assessing the long-term safety of fasinumab and two trials comparing fasinumab to standard pain therapies.

There is intense competition about drug companies to develop non-opioid pain relievers that don’t have the risk of addiction and overdose. Pfizer and Eli Lilly are jointly developing a similar NGF inhibitor called tanezumab, which was given fast track designation by the FDA in 2017 to speed its development.

Like fasinumab, there are safety concerns about tanezumab. The FDA ordered a partial halt to clinical studies of tanezumab in 2010 after Pfizer said a small number of osteoarthritis patients taking the drug needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.”  Most clinical studies of tanezumab did not resume until 2015.

FDA Warns Veterinarians of Pet Owners Abusing Opioids

By Pat Anson, Editor

Doctors and patients aren’t the only ones under scrutiny for prescribing and using opioid pain medication. Pet owners are also coming under suspicion for diverting and abusing opioids intended for their animals.

The Food and Drug Administration today warned veterinarians to be cautious when prescribing opioids and be on the alert for people who may be using their pets to gain access to the drugs.

“We recognize that opioids and other pain medications have a legitimate and important role in treating pain in animals – just as they do for people,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“But just like the opioid medications used in humans, these drugs have potentially serious risks, not just for the animal patients, but also because of their potential to lead to addiction, abuse and overdose in humans who may divert them for their own use.”

Only one opioid is currently approved by the FDA for use in animals, a potent fentanyl medication for post-surgical pain that is sold under the brand name Recuvyra.  

The maker of another fentanyl based product -- carfentanil -- voluntarily surrendered approval for the drug in March because of growing signs it was being diverted. Carfentanil is so potent it was used by veterinarians as an anesthetic on elephants.   

With few options to choose from, some veterinarians are legally prescribing tramadol and others opioids intended for humans to relieve pain in pets. The FDA is recommending veterinarians use alternatives to opioids whenever possible and look for signs of opioid abuse by pet owners and their own employees.

“We’re advising veterinarians to develop a safety plan in the event they encounter a situation involving opioid diversion or clients seeking opioids under the guise of treating their pets; and taking steps to help veterinarians spot the signs of opioid abuse,” Gottlieb said.

Possible warning signs of opioid abuse are suspicious injuries to animals, a pet owner asking for specific medication by name, or asking for refills of lost or stolen medication.

Gottlieb’s statement was released one week after a small study published in the American Journal of Public Health suggested that some pet owners are purposely injuring their animals to gain access to opioids.

"Our results indicate that we should be paying more attention to how opioid abusers are seeking their drugs -- including through veterinary clinics," said Lili Tenney, deputy director of the Center for Health, Work & Environment at the Colorado School of Public Health.

In a survey of 189 Colorado veterinarians, 13 percent reported they had seen a client who they believed had purposefully injured a pet or made them ill. Nearly half the vets said they knew of a pet owner or employee who was abusing opioids; and 12 percent suspected a staff member of diverting opioids or abusing them.

Colorado and Maine require veterinarians to look at a pet owner’s medication history before dispensing opioids or writing a prescription.  Over a dozen states require veterinarians to report when they prescribe opioids to a prescription drug database.

The New Face of the Opioid Crisis

By Pat Anson, Editor

Caylee Cresta doesn’t have any illusions about being the next Internet star or YouTube sensation. But the 23-minute video she posted on what it’s like to be a chronic pain patient during an age of opioid hysteria has become a hit in the pain community.

“This video should be made to go viral,” one fan said.

“Caylee you did an amazing, persuasive presentation. Maybe you should be a lobbyist!” another one wrote.

“Single best piece of chronic pain patient advocacy I have ever seen. Absolutely brilliant!” wrote Chuck Malinowski.

Caylee’s video is not addressed to the pain community, but to the public at large. The 26-year old Massachusetts woman with fiery red hair looks directly into the camera and earnestly asks people to set aside their misconceptions about pain, addiction and the opioid crisis.

“I do not suffer from addiction and yet stigma will tell you that I do.  And that is a myth that we are going to change,” she says. “Don’t ever brush off the plight of the chronically ill because your lives can change in an instant, just as ours have.

“The fight against opiates is an uneducated one. This is a movement that lacks understanding in its most basic form. Every lawmaker is taking on this fight without ever consulting even a single chronically ill person. What does that mean? That means that the people who depend on these medications aren’t even being considered when taking them away.”

In her video, Caylee spends little time discussing her own experience as a pain patient. While still in high school, Caylee developed a rare and incurable neurological disorder called Stiff-person syndrome, which is characterized by strong muscle spasms and stiffness. The spams are so severe her lungs have collapsed twice.

“I’ll get such strong spasms in my throat and chest cavity that they create so much air that can’t escape (my lungs) that it just made them literally pop,” she told PNN. “My muscle spasms can break my bones, they’ll get that strong.”

Caylee’s symptoms were usually dismissed by doctors and it took years for her to get a proper diagnosis. Last year, a doctor at a pain clinic dropped her as a patient after getting a warning letter from Medicare that she was prescribing too many opioids. Caylee went without opioids for months, which is when her lungs burst.

Living in Fear

Although Massachusetts has a reputation as having some of the best healthcare in the world, Caylee now drives 3 hours one-way to see a neurologist in Connecticut.

“Any other doctor that I’ve seen over the years has literally looked at me and in one way or another and said, ‘Your prognosis is so dim. It’s so rare.’ They’re not even willing to take me on as a patient. My doctor has stuck by me and tried everything there is to try,” she says. 

Caylee has tried stem cells, chemotherapy and many other treatments. The only thing that works is opioid medication. Although she is once again able to get prescriptions for opioids, she often has trouble getting them filled. She and her husband went to 20 pharmacies one day before finding a pharmacist willing to fill her script.

“You live every single day in fear.  Every time you fill your prescription you go, okay, I’m going to have a life for another month. But you live that whole month with such anxiety and wondering what’s going to happen next,” she said. 

Caylee hopes her YouTube video will help educate the public about the daily challenges of being in pain and give some hope to pain sufferers.

“I want to fight for people going through this. I truly want to fight for them. I just want to let people know that they’re not alone. I want them to know that we’re all in this together,” says Caylee.

“What is probably the most humbling is when I get messages like ‘I would do anything for the world to be able to see this’ or ‘I would do anything for this to go viral and for people to understand what we go through.’ When I get messages like that, that let me know that these people feel like somebody is speaking for them, that touches me in a way that I can’t even explain.”

Long-Term Opioid Use Rare After Wisdom Teeth Removed

By Pat Anson, Editor

Anti-opioid activists have long claimed that thousands of young people have become addicted to opioid pain medication after having their wisdom teeth removed.

“Would you give your child heroin to remove a wisdom tooth?” is how a provocative 2016 anti-opioid billboard in New York City’s Times Square put it.

But a large new study published in JAMA found that the risk of long-term opioid use after wisdom tooth removal is relatively rare – although still a cause for concern.

The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist. The risk of long-term use was nearly 3 times higher for young people prescribed opioids than for those who were not (0.5%).

Although the overall risk of long-term use is small, researchers say the sheer number of wisdom tooth removals warrants caution when prescribing opioids.

"Wisdom tooth extraction is performed 3.5 million times a year in the United States, and many dentists routinely prescribe opioids in case patients need it for post-procedure pain," said lead author Calista Harbaugh, MD, a research fellow and surgical resident at the University of Michigan’s Institute for Healthcare Policy and Innovation.

"Until now, we haven't had data on the long-term risks of opioid use after wisdom tooth extraction. We now see that a sizable number go on to fill opioid prescriptions long after we would expect they would need for recovery, and the main predictor of persistent use is whether or not they fill that initial prescription."

Harbaugh and her colleagues looked at insurance claims for opioid prescriptions between 2009 and 2015. Hydrocodone (70%) was the most common opioid prescribed after wisdom tooth removal, followed by oxycodone (24%). Long-term opioid use was defined as two or more prescriptions filled in the year after wisdom tooth removal.

But other factors besides dental surgery raised the risk of long-term opioid use. Teens and young adults who had a history of chronic pain or mental health issues such as depression and anxiety were more likely to go on to regular use after filling their initial opioid prescription.

"These are some of the first data to the show long-term ill effects of routine opioid prescribing after tooth extractions. When taken together with the previous studies showing that opioids are not helpful in these cases, dentists and oral surgeons should stop routinely prescribing opioids for wisdom tooth extractions and likely other common dental procedures," said senior author Chad Brummett, MD, co-director of the Michigan Opioid Prescribing and Engagement Network.

There are no specific prescribing guidelines for wisdom tooth removal. The American Dental Association recommends that dentists first consider non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief. It also supports the CDC opioid guidelines, which recommend that opioids be limited to no more than 7 days' supply for acute pain.

A small 2016 study found that over half the opioids prescribed to patients after wisdom tooth removal or dental surgery go unused, with many of the leftover pills being abused or stolen by friends and family members. On average, dental patients received 28 opioid pills and – three weeks later – most had pills leftover.

How Common Is Opioid Addiction?

By Roger Chriss, PNN Columnist

As the opioid crisis continues to worsen, there is increased scrutiny of both prescribing levels and fatal overdose rates. The goal of reducing opioid prescriptions is to decrease the exposure to opioids, on the theory that medical use of opioid analgesics is closely linked with addiction and overdose risk.

But how valid is that theory? A key issue in the crisis is opioid addiction rates, which can be divided into medical and non-medical addiction.

Medical Opioid Addiction Rates

The National Institute on Drug Abuse (NIDA) reports that 8 to 12% of patients on long-term opioid therapy develop an opioid use disorder.

“The best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent,” NIDA Director Nora Volkow, MD, told Opioid Watch.

The NIDA estimate is well-researched and widely accepted. But there are other estimates, each with important qualifications.

Cochrane found in a major review of studies of long term opioid therapy for non-cancer pain that only 0.27% of participants were at risk of opioid addiction, abuse or other serious side effects.

In another large study, The BMJ reported that only about 3% of previously opioid naïve patients (new to opioids) continued to use them more than 90 days after major elective surgery.

Other addiction rates include numbers as low as 1% and as high as 40%. But details matter. Much of the difference in addiction rates stems from three factors:

1. How well screened the patient population is

2. How carefully monitored the patients are during opioid therapy

3. How the criteria for opioid use disorder are applied

In other words, a well-screened and closely monitored population of adults with no risk factors may well have an addiction rate of 1%. The recent SPACE study by Erin Krebs, MD, in which over 100 people with knee osteoarthritis and low back pain were put on opioid therapy for a year, saw no signs of misuse, abuse or addiction. There were also no overdoses.

Non-Medical Opioid Addiction Rates

It’s also important to look at the percentage of people who become addicted to opioids without ever having an opioid prescription. Here the addiction rates are much higher.

A 2009 study in the American Journal of Psychiatry found that among treatment-seeking individuals who used OxyContin, 78% had not been prescribed the drug for any medical reason. The OxyContin was “most frequently obtained from nonmedical sources as part of a broader and longer-term pattern of multiple substance abuse.”  

The 2014 National Survey on Drug Use also found that about 75% of all opioid misuse starts outside medical care, with over half of opioid abusers reporting that the drugs were obtained “from a friend or relative for free.”

Heroin is considered highly addictive, with nearly one in four heroin users becoming dependent. Importantly, most people who try heroin already have extensive experience with other substances, including opioid medication, and many have serious mental illness. There is no research on the addictive potential of heroin in drug-naive people.

Relatively little is known about the complex and concealed world of nonmedical opioid use. Researchers like UCSF’s Daniel Cicerone are working to fill this gap by collecting information on overdoses to get a more accurate picture on the type of opioids being used.  

Risk Management

Opioids remain an essential part of modern medicine, from trauma and battlefield medicine to surgery, end-of-life care and long-term management of chronic, progressive degenerative conditions. This makes risk management vital.

Current tools to screen patients include the long-standing COMM tool and the new NIDA TAPS tool. Novel approaches using genetic testing for opioid risk may eventually help clinicians better assess risk, too. And improved data analytics may also help reduce addiction.

"Understanding the pooled effect of risk factors can help physicians develop effective and individualized pain management strategies with a lower risk of prolonged opioid use," says Ara Nazarian, PhD, a researcher at Beth Israel Deaconess Medical Center.

The Krebs SPACE study achieved an admirable level of safety by carefully screening and monitoring patients during opioid therapy. A similar patient-focused approach that acknowledges the low rate of medical opioid addiction and works to minimize it further is likely to bring benefits to both individuals and society at large.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Mayo Clinic: Opioid Prescribing Has Not Changed

By Pat Anson, Editor

Numerous studies have shown that opioid prescriptions are falling. The trend started in 2011 and appears to have accelerated since the release of the CDC’s 2016 opioid prescribing guidelines.

The volume of opioid medication filled last year fell by 12 percent, the largest decline in 25 years, according to the IQVIA Institute.  Prescriptions for hydrocodone – once the most widely prescribed drug in the country – have fallen by a third since their peak. Even the CDC has reported that opioid prescriptions have dropped by about 5% each year between 2012 and 2016.

Anecdotally, many patients tell us opioids are harder, if not impossible, to obtain. Nearly half of the 3,100 patients PNN surveyed last year said they were getting a lower dose. And one in four said they were no longer prescribed opioids.

But according to Mayo Clinic researchers, opioid prescribing hasn't changed that much and remains at high levels. In a study published in the British Medical Journal (BMJ), they report that opioid prescriptions for Medicare and privately insured patients have remained relatively stable over the past few years. And the average daily dose of opioids is well above what it was 10 years ago.

“If you’re hearing the message that prescription opioid use is starting to decline, I think we need to counter that message and say in most populations it really isn’t moving very much.” says lead author Molly Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Our data suggest not much has changed in prescription opioid use since about five years ago.”

Why the discrepancy? Jeffrey says most of the previous studies only looked at market-level data – the amount of opioids that drug makers reported producing and selling. She and her colleagues dug a little deeper, looking at insurance claims for 48 million U.S. patients between 2007 and 2016.  

Over that 10-year period, the rate of opioid use by privately insured patients remained relatively flat at 6 to 7 percent. The average daily dose for that group, about two pills of 5-milligram oxycodone, remained the same.

The rate of opioid use by Medicare patients 65 and older peaked at 15% in 2010 and decreased slightly to 14% by 2016. Their average daily dose, three 5 mg pills of oxycodone, also remained relatively unchanged.

Rates of opioid use by disabled Medicare patients also haven't changed much, peaking at 41% in 2013 and falling to 39% in 2016. Their average daily dose remains relatively high, about eight 5 mg oxycodone pills. 

“Our research of patient-level data doesn’t show the decline that was found in previous research,” says Jeffery. “We wanted to know how the declines were experienced by individual people. Did fewer people have opioid prescriptions? Did people taking opioids take less over time? When we looked at it that way, we found a different picture.”

The Mayo study includes an interesting disclaimer. While the researchers looked at data from patient insurance claims, they never surveyed or spoke to any patients about their opioid use. The researchers said they would “engage” with patients in future blog posts and press releases.

You can share your views with Molly Jeffery by email at jeffery.molly@mayo.edu or @mollyjeffery on Twitter.

Chronic Pain Patients Caught in Debate Over Opioids

By Will Stone, KJZZ

It started with a rolled ankle during a routine Army training exercise. Shannon Hubbard never imagined it was the prologue to one of the most debilitating pain conditions known to exist, called ­­­­­­­complex regional pain syndrome.

The condition causes the nervous system to go haywire, creating pain disproportionate to the actual injury. It can also affect how the body regulates temperature and blood flow.

For Hubbard, it manifested years ago following surgery on her foot — a common way for it to take hold.

“My leg feels like it’s on fire pretty much all the time. It spreads to different parts of your body,” the 47-year-old veteran said.

Hubbard props up her leg, careful not to graze it against the kitchen table in her home east of Phoenix. It’s red and swollen, still scarred from an ulcer that landed her in the hospital a few months ago.

“That started as a little blister and four days later it was like the size of a baseball,” she said. “They had to cut it open and then it got infected, and because I have blood flow issues, it doesn’t heal.”

She knows it’s likely to happen again.

Over the past three years, I’ve been prescribed over 60 different medications and combinations; none have even touched the pain,” she said.

Hubbard said she’s had injections and even traveled across the country for infusions of ketamine, an anesthetic that can be used for pain in extreme cases. Her doctors have discussed amputating her leg because of the frequency of the infections.

“All I can do is manage the pain,” she said. “Opioids have become the best solution.”

For about nine months, Hubbard was on a combination of short- and long-acting opioids. She said it gave her enough relief to start leaving the house again and do physical therapy.

But in April that changed. At her monthly appointment, her pain doctor informed her the dose was being lowered. “They had to take one of the pills away,” she said.

Hubbard knew the rules were part of Arizona’s new opioid law, which places restrictions on prescribing and limits the maximum dose for most patients. She also knew the law wasn’t supposed to affect her — an existing patient with chronic pain.

Hubbard argued with the doctor, without success. “They didn’t indicate there was any medical reason for cutting me back. It was simply because of the pressure of the opioid rules.”

Her dose was lowered from 100 morphine milligram equivalents daily (MME) to 90, the highest dose allowed for many new patients in Arizona. She said her pain has been “terrible” ever since.

“It just hurts,” she said. “I don’t want to walk, I pretty much don’t want to do anything.”

Hubbard’s condition may be extreme, but her situation isn’t unique. Faced with skyrocketing drug overdoses, states are cracking down on opioid prescribing. Increasingly, some patients with chronic pain like Hubbard say they are becoming collateral damage.

New Limits On Prescribing

More than two dozen states have implemented laws or policies limiting opioid prescriptions in some way. The most common is to restrict a patient’s first prescription to a number of pills that should last a week or less. But some states like Arizona have gone further by placing a ceiling on the maximum dose for most patients.

The Arizona Opioid Epidemic Act, the culmination of months of outreach and planning by state health officials, was passed earlier this year with unanimous support.

It started in June 2017, when Arizona Gov. Doug Ducey, a Republican, declared a public health emergency, citing new data, showing that two people were dying every day in the state from opioid overdoses. He has pledged to come after those responsible for the rising death toll.

He has pledged to come after those responsible for the rising death toll.

“All bad actors will be held accountable — whether they are doctors, manufacturers or just plain drug dealers,” Ducey said in his annual State of the State address, in January 2018.

The governor cited statistics from one rural county where four doctors prescribed 6 million pills in a single year, concluding “something has gone terribly, terribly wrong.”

Later in January, Ducey called a special session of the Arizona legislature and in less than a week he signed the Arizona Opioid Epidemic Act into law. He called it the “most comprehensive and thoughtful package any state has passed to address this issue and crisis to date.”

The law expands access to addiction treatment, ramps up oversight of prescribing and protects drug users who call 911 to report an overdose from prosecution, among other things.

Initially, Arizona’s major medical associations cautioned against what they saw as too much interference in clinical practice, especially since opioid prescriptions were already on the decline.

Gov. Ducey’s administration offered assurances that the law would “maintain access for chronic pain sufferers and others who rely on these drugs.” Restrictions would apply only to new patients. Cancer, trauma, end-of-life and other serious cases were exempt. Ultimately, the medical establishment came out in favor of the law.

Pressure On Doctors

Since the law’s passage, some doctors in Arizona report feeling pressure to lower patient doses, even for patients who have been on stable regimens of opioids for years without trouble.

Dr. Julian Grove knows the nuances of Arizona’s new law better than most physicians. A pain doctor, Grove worked with the state on the prescribing rules.

“We moved the needle to a degree so that many patients wouldn’t be as severely affected,” said Grove, president of the Arizona Pain Society. “But I’ll be the first to say this has certainly caused a lot of patients problems [and] anxiety.”

“Many people who are prescribing medications have moved to a much more conservative stance and, unfortunately, pain patients are being negatively affected.”

Like many states, Arizona has looked to its prescription-monitoring program as a key tool for tracking overprescribing. State law requires prescribers to check the online database. Report cards are sent out comparing each prescriber to the rest of their cohort. Clinicians consider their scores when deciding how to manage patients’ care, Grove said.

“A lot of practitioners are reducing opioid medications, not from a clinical perspective, but more from a legal and regulatory perspective for fear of investigation,” Grove said. “No practitioner wants to be the highest prescriber.”

Arizona’s new prescribing rules don’t apply to board-certified pain specialists like Grove, who are trained to care for patients with complex chronic pain. But, said Grove, the reality is that doctors — even pain specialists — were already facing pressure on many fronts to curtail opioids — from the Drug Enforcement Agency to health insurers down to state medical boards.

The new state law has only made the reduction of opioids “more fast and furious,” he said.

Grove traces the hypervigilance back to guidelines put out by the Centers for Disease Control and Prevention in 2016. The CDC spelled out the risks associated with higher doses of opioids and advised clinicians when starting a patient on opioids to prescribe the lowest effective dosage.

Psychiatrist Sally Satel, a fellow at the American Enterprise Institute, said those guidelines stipulated the decision to lower a patient’s dose should be decided on a case-by-case basis, not by means of a blanket policy.

“[The guidelines] have been grossly misinterpreted,” Satel said.

The guidelines were not intended for pain specialists, but rather for primary care physicians, a group that accounted for nearly half of all opioids dispensed from 2007 to 2012.

“There is no mandate to reduce doses on people who have been doing well,” Satel said.

In the rush to address the nation’s opioid overdose crisis, she said, the CDC’s guidelines have become the model for many regulators and state legislatures. “It’s a very, very unhealthy, deeply chilled environment in which doctors and patients who have chronic pain can no longer work together,” she said.

Satel called the notion that new prescribing laws will reverse the tide of drug overdose deaths “misguided.”

The rate of opioid prescribing nationally has declined in recent years, though it still soars above the levels of the 1990s. Meanwhile, more people are dying from illicit drugs like heroin and fentanyl than prescription opioids.

In Arizona, more than 1,300 people have died from opioid-related overdoses since June 2017, according to preliminary state numbers. Only a third of those deaths involved just a prescription painkiller.

Heroin is now almost as common as oxycodone in overdose cases in Arizona.

A Range Of Views

Some physicians support the new rules, said Pete Wertheim, executive director of the Arizona Osteopathic Medical Association.

“For some, it has been a welcome relief,” he said. “They feel like it has given them an avenue, a means to confront patients.” Some doctors tell him it’s an opportunity to have a tough conversation with patients they believe to be at risk for addiction or overdose because of the medication.

The organization is striving to educate its members about Arizona’s prescribing rules and the exemptions. But, he said, most doctors now feel the message is clear: “We don’t want you prescribing opioids.”

Long before the law passed, Wertheim said, physicians were already telling him that they had stopped prescribing, because they “didn’t want the liability.”

He worries the current climate around prescribing will drive doctors out of pain management, especially in rural areas. There’s also a fear that some patients who can’t get prescription pills will try stronger street drugs, said Dr. Gerald Harris II, an addiction treatment specialist in Glendale, Ariz.

Harris said he has seen an increase in referrals from doctors concerned that their patients with chronic pain are addicted to opioids. He receives new patients — almost daily, he said — whose doctors have stopped prescribing altogether.

“Their doctor is afraid and he’s cut them off,” Harris said. “Unfortunately, a great many patients turn to street heroin and other drugs to self-medicate because they couldn’t get the medications they need.”

Arizona’s Department of Health Services is working to reassure providers and dispel the myths, said Dr. Cara Christ, who heads the agency and helped design the state’s opioid response. She pointed to the recently launched Opioid Assistance and Referral Line, created to help health care providers with complex cases. The state has also released a set of detailed prescribing guidelines for doctors.

Christ characterizes this as an “adjustment period” while doctors learn the new rules.

“The intent was never to stop prescribers from utilizing opioids,” she said. “It’s really meant to prevent a future generation from developing opioid use disorder, while not impacting current chronic pain patients.”

Christ said she just hasn’t heard of many patients losing access to medicine.

It’s still too early to gauge the law’s success, she said, but opioid prescriptions continue to decline in Arizona.

Arizona saw a 33 percent reduction in the number of opioid prescriptions in April, compared with the same period last year, state data show. Christ’s agency reports that more people are getting help for addiction: There has been about a 40 percent increase in hospitals referring patients for behavioral health treatment following an overdose.

Shannon Hubbard, the woman living with complex regional pain syndrome, considers herself fortunate that her doctors didn’t cut back her painkiller dose even more.

“I’m actually kind of lucky that I have such a severe case because at least they can’t say I’m crazy or it’s in my head,” she said.

Hubbard is well aware that people are dying every day from opioids. One of her family members struggles with heroin addiction and she’s helping raise his daughter. But she’s adamant that there’s a better way to address the crisis.

“What they are doing is not working. They are having no effect on the guy who is on the street shooting heroin and is really in danger of overdosing.” she said. “Instead they are hurting people that are actually helped by the drugs.”

This story is part of a partnership that includes KJZZ, NPR and Kaiser Health News. It is republished with their permission.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Oregon Opioid Plan Would Do 'Substantially More Harm'

By Pat Anson, Editor

A proposed change in Oregon’s Medicaid program would result in the forced tapering of many pain patients off opioid medication and do “substantially more harm than good,” according to a group of pain physicians, academics and patient advocates.

At issue is a recommendation by a task force to limit Oregon Health Plan coverage of opioids to just 90-days for five broad chronic pain conditions – including fibromyalgia and chronic pain caused by trauma.  Medicaid patients with those conditions taking opioids beyond 90 days would lose coverage for the pain relievers and be encouraged to use alternative pain therapies such as yoga, acupuncture and physical therapy, which would be covered under the plan.

“We recently learned of efforts by the Oregon Medicaid Pain Task Force to deny coverage of opioids beyond 90 days for most chronic pain conditions and, effectively, to mandate the taper of current patients receiving opioid therapy. We believe that such efforts risk doing substantially more harm than good,” wrote Kate Nicholson, a civil rights attorney and pain patient, in a letter to Oregon health officials. The letter was co-signed by over a dozen  physicians, academics and advocates.

“An across-the-board denial of opioid therapy for the huge umbrella category of chronic pain is as destructive as is liberally prescribing opioids for all types of chronic pain,” the letter warns. “The denial of coverage to the Medicaid population, in particular, is likely to have a disproportionate impact on individuals with disabilities, on the sickest patients and those with multiple chronic conditions.”

Oregon’s Health Evidence Review Commission will review the proposal at its August 9th meeting. The commission could give final approval as early as October, but the opioid restrictions would not go into effect until 2020, according to the Bend Bulletin.

“Individuals with chronic pain really face debilitating conditions that impact quality of life, yet we’re faced with this significant opioid epidemic where we know there’s a lot of misuse and overprescribing,” Dr. Dana Hargunani, chief medical officer for the Oregon Health Authority, told the Bulletin. “We’re trying to use evidence to guide us, but we really welcome public input into the process. I know it’s a really significant issue for many individuals.” 

Opioid prescribing in Oregon has been declining for years – as it has nationwide – yet the state has “one of the highest rates of prescription opioid abuse in the nation,” according to the Oregon Health Authority. An average of three Oregonians die every week from an opioid overdose. However, many of those deaths involve the “non-medical” use of opioid pain relievers by drug abusers, not patients.

The 2013 National Survey on Drug Use and Health found Oregon to have the highest rate of non-medical use of prescription pain relievers in the country.

“I’m very sad for the people who OD’d,” pain patient Steve Hix told the Bulletin. “But what’s that got to do with me?”

Older Americans Rarely Abuse Opioid Medication

By Pat Anson, Editor

Three out of four older Americans who are prescribed opioid pain medication say they take it less often or in lower amounts than prescribed, according to a new national poll. Only 6 percent said they took opioids more frequently or in higher doses than prescribed.

The online survey of over 2,000 adults between the ages of 50 and 80 was conducted in March by the University of Michigan's Institute for Healthcare Policy and Innovation.  The poll was sponsored by AARP and Michigan Medicine, U-M's academic medical center.

Nearly a third of those surveyed said they received an opioid prescription in the past two years, usually for arthritis, back pain, surgery or injury. About half of those had leftover medication.

While most were cautious about their use of opioids, what they did with the leftover meds was cause for concern. The vast majority (86%) said they kept it in case they had pain again. Only 9% threw their opioids in the trash or flushed it down the toilet, and 13% returned it to an approved location.

"The fact that so many older adults report having leftover opioid pills is a big problem, given the risk of abuse and addiction with these medications," said Alison Bryant, PhD, senior vice president of research for AARP. "Having unused opioids in the house, often stored in unlocked medicine cabinets, is a big risk to other family members as well.”

The researchers suspect that many older adults fear that they will not be able to obtain pain medication when needed because of laws and guidelines that discourage opioid prescribing. Several states now mandate that initial opioid prescriptions for acute pain be limited to a few days’ supply.

Ironically, while many older Americans may worry about losing access to opioid medication, nearly three out of four (74%) support restrictions on the number of days and pills that can be prescribed. And nearly half would support laws that require leftover medication to be returned.

The poll also found that doctors do not consistently warn patients about the risks associated with opioids. While 90% of those surveyed said their prescribing doctor talked with them about how often to take pain medication, only 60% were warned about side effects and less than half of the doctors cautioned patients about the risks of addiction and overdose or what to do with leftover pills.

A full report on the National Poll on Healthy Aging can be found by clicking here.

Chronic Pain and Opioids Impact Sexual Health

By Pat Anson, Editor

What’s more important to you?  Pain relief or an active sex life?

The question is not as frivolous as it sounds. According to a recent study published in Pain Medicine, chronic pain patients who take opioid medication are significantly more likely to experience a lack of desire and to be less satisfied with their sex lives, especially if they take opioids long-term.

Of course, anyone with a chronic illness is more likely to have sexual health issues – whether its desire, function or attracting another partner.  But the issues seem more pronounced with those who take opioids.  

Danish researchers surveyed over 11,500 randomly chosen adults. Slightly more than half the women and a little less than half the men said they suffered from chronic non-cancer pain.

Pain sufferers who did not use opioids were 38% more likely to be unhappy with their sex lives and 46% more likely to report a lack of desire than people who were pain free. So just being in pain is a big factor by itself.

But long-term opioid users were 69% more likely to report dissatisfaction with their sex lives and were twice as likely to experience low or no sexual desire.

Short-term opioid users were 35% more likely to be unhappy with their sex life and 82% more likely to have less desire.

“Patients suffering from chronic non-cancer pain should be aware that it can have a negative impact on their sexual desire and satisfaction with sex life, and that using opioids, especially long-term, can add an additional negative impact on their sex life,” lead author Hanne Birke, an oncology researcher at Rigshospitalet (Copenhagen University Hospital) told Reuters.

Only 57 percent of people on long-term opioids reported having sex during the past year.  That compares to 62% of pain patients on short-term opioids, 68% of pain sufferers not taking opioids and 77% of people who were pain free.  

Short-term opioid use was defined as having one prescription filled in the previous year, while long-term use was having opioid prescriptions dispensed in at least six months during the previous year.

Chronic pain and opioid use has long been linked to sexual health problems.

“Chronic pain ‘highjacks’ sensory nerve fibers, thereby making it harder or impossible for pleasurable stimuli to elicit a response,” said Anne Murphy, a researcher at Georgia State University in Atlanta, who wasn’t involved in the study. “On top of that, opiates suppress the activation of sensory nerve fibers which would have an obvious impact on sexual pleasure.”

But many people who were pain free also reported sexual health issues. About 19% of men and 14% of women without chronic pain were unhappy with their sex lives. And 7% of men and 19% of women without pain reported a lack of sexual desire.

Pain Management Not the Same as Addiction

By Marvin Ross, Guest Columnist

It's bad enough that mental illness is, for some strange reason, paired with addiction. But now the Canadian Mental Health Association (CMHA) wants to include pain management as part of its “National Pain and Addictions Strategy.”

Addiction is a terrible affliction for the person addicted, for their family and for society. Of that, there is no question. But it is now considered a mental illness and I have no idea why. As I wrote once before, “Addictions at some point involve choice. You made a decision to go into a bar and start drinking or to snort coke, take opioids or inject heroin. No one has a choice to become schizophrenic, bipolar, depressed or any other serious mental illness. There is no choice involved whatsoever.” 

I also cited smoking, which most people of my generation did and most of us quit. I smoked two  packs a day and quit because my wife has asthma and was pregnant. I was motivated.

I also pointed out that during the Vietnam War, 40% of troops used heroin and the government was fearful of what would happen when they came back. Fortunately for all, 95% of those troops gave up heroin without any intervention whatsoever. They were no longer in a dangerous war zone trying to escape anyway they could.

Chronic pain patients are generally neither addicts nor mentally ill. What they are addicted to is being as pain free as they can be. Chronic pain results from any number of valid medical conditions, severe trauma and/or botched surgical procedures. For many, opioid medication is necessary to have any quality of life.

But CMHA sees opioid prescribing as an inevitable bridge to addiction:

“CMHA is currently collaborating with research partners to explore the efficacy of multidisciplinary care teams and their role in pain management and opioid tapering. CMHA also believes that creating a National Pain Strategy that includes addictions would allow for more effective training and would better prepare physicians and primary care providers to treat pain in Canada.”

CMHA is correct when they say that pain is poorly managed in Canada and not well understood. But what expertise do they have to make recommendations on how pain should be treated? Their primary recommendation is that we should find alternatives to opiates. And, if we must give patients opiates, there should be an exit strategy, so they do not take them for too long.

This is based on the false assumption that addiction is being fueled by those with chronic pain, even though overdose deaths in Canada are predominantly among males aged 30-39 and involve illicit fentanyl. Contrast that to the demographics of chronic pain, which is mostly seen in women and older adults over the age of 56.

Those are two totally separate populations!

If opioid medication is a contributor to this problem, then why did opioid prescriptions in Canada decline by over 10% between 2016 and 2017, while opioid overdose deaths rose by 45% over the same period? 

The CMHA calls for an increase in alternative therapies to treat chronic pain. This is the definition of alternative medicine from the New England Journal of Medicine:

“There cannot be two kinds of medicine -- conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments.”

Opioids work for chronic pain, as found in a 2010 Cochrane Review and by a more recent review in the Journal of Pain Research.

Jason Busse, the chiropractor who helped draft Canada’s 2017 opioid guideline, told me in a Twitter debate that this second study was only for 3 months so it is not relevant for the long term use of opioids. However, Prozac was approved for use by the U.S. Food and Drug Administration after two clinical trials of 6 and 8 weeks duration. Many people use Prozac for years.

Neither chiropractic, massage or acupuncture have been shown to be effective for chronic pain. Many doctors are also pushing anti-epilepsy drugs like gabapentin (Neurontin) as an alternative to opioids, but they do not always work and have major side effects. The same is true for its sister drug, pregabalin (Lyrica).

There is some evidence that medical cannabis may help with chronic pain, but it is very expensive and, even when prescribed, is not covered by public or most health plans.

Members of my family suffer with chronic pain and they do not want a National Pain and Addictions Strategy. What they want is continued access to the pain medication that has helped them carry on as normal a life as possible. There is no euphoria when they take these meds, other than the euphoria that comes from reducing their pain levels sufficiently so they can enjoy a trip to the cinema, theatre, dinner with friends and whatever else gives pleasure.

In June, I attended a meeting in Oshawa, Ontario arranged by chronic pain patients with a representative of the College of Physicians and Surgeons of Ontario. About 30 pain patients attended from all over Ontario and told the doctor how much they were being forced to suffer because their medication was reduced. One woman said she is not capable of getting out of bed to care for her children and would consider suicide if it weren't for them. Similar comments were made by others, but the doctor was unmoved and left early.

If CMHA (and others) can call for decriminalizing drugs and providing the addicted with safe drugs, why can no one be willing to provide pain patients with the same? It is inhumane.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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.

Southern States Identified as Opioid Hotspots

By Pat Anson, Editor

If you suffer a sprained ankle, you’re 14 times more likely to get opioid pain medication at a hospital emergency room in Arkansas than one in North Dakota. That’s one of the unusual findings uncovered by researchers at Penn Medicine, who found a wide variability between states in opioid prescribing for a relatively minor injury.

Researchers analyzed private insurance claims for over 30,000 patients who visited hospital ERs in the U.S. for an ankle sprain from 2011-2015.

Nationwide, about 25% of the patients received an opioid prescription, with the chances of getting an opioid in Arkansas (40%) much better than in North Dakota (2.8%). The states with the highest prescribing rates were in the South and Southeast; while the lowest prescribing states were in the upper Midwest and Northeast.  

SOURCE: PENN MEDICINE

"Although opioids are not - and should not - be the first-line treatment for an ankle sprain, our study shows that opioid prescribing for these minor injuries is still common and far too variable," said M. Kit Delgado, MD, an assistant professor of Emergency Medicine and Epidemiology at Penn, who was lead author of the study published in the Annals of Emergency Medicine.

"Given that we cannot explain this variation after adjusting for differences in patient characteristics, this study highlights opportunities to reduce the number of people exposed to prescription opioids for the first time and also to reduce the exposure to riskier high-intensity prescriptions.”

Nearly two-thirds of the opioid prescriptions were for hydrocodone – a potent painkiller that was reclassified as a Schedule II controlled substance in 2014 to make it harder to obtain.

Most patients received only a 3-day supply of opioids for their ankle sprains, although 5% were given more than 30 tablets. Less than 1% of the patients were still getting opioid prescriptions 30 days after the initial one.  

The study period preceded the release of the CDC’s opioid guidelines and came before many states enacted laws that limit the supply of opioids for acute pain. Some health experts are calling for more specific guidelines for ankle sprains and other health conditions.

"There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said senior author Jeanmarie Perrone, MD, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

"Medical, surgical, and subspecialty societies should convene to propose best practices similar to the popular 'Choosing Wisely' campaign, acknowledging that pain management for most diagnoses can be accomplished with non-opioids. And certainly, ankle sprains are a model example."

Alabama District Leads Nation in Opioid Prescribing

A recent study published in the American Journal of Public Health also found high opioid prescribing rates in the South, Appalachia and rural West.  Researchers at the Harvard T.H. Chan School of Public Health focused on opioid prescribing in congressional districts, rather than the state or county level.

"It is important for public health research to focus on geographical units such as congressional districts as it allows for elected representatives to be more informed about important issues such as the opioid epidemic. Because a congressional district has a named elected representative, unlike say a county, it brings a certain degree of political accountability when it comes to discussing the opioid epidemic," said S. V. Subramanian, professor of population health and geography.

The study found that Alabama's Fourth Congressional District had 166 opioid prescriptions per 100 people, the highest rate of any district in the nation. Congressional districts in Kentucky, Tennessee, Mississippi, Arkansas, Virginia, and Oklahoma rounded out the top ten areas with the highest prescribing rates. Other high prescribing rates were found in districts in eastern Arizona, Nevada, northern California, rural Oregon, and rural Washington.

The Republican congressman who represents Alabama’s 4th District said the opioid crisis is worse in rural areas because there are fewer jobs and opportunities.

“I think this crisis, particularly in rural America, corresponds directly to President Trump’s popularity in my district,” Rep. Robert Aderholt said in a statement. “People here have felt left behind and have seen their jobs and opportunities disappear. Due to the epidemic of depression, some people have turned to prescription drugs to dull the pain.  However, I believe that President Trump’s renewed focus on these areas and increasing jobs has resonated here strongly.”

Harvard researchers say the lowest opioid prescribing rates were concentrated in congressional districts in urban areas, including Washington, DC, New York, Boston, Atlanta, Los Angeles, and San Francisco.

Positive Findings for New Osteoarthritis Drug

By Pat Anson, Editor

Pfizer and Eli Lilly have announced positive findings in treating osteoarthritis pain with an experimental non-opioid drug that has a history of safety concerns.  

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

In the 16-week clinical study, osteoarthritis patients who were given two injections of tanezumab had significant improvement in their pain, physical function and assessment of their symptoms compared to a placebo. Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage.

“There is a substantial need for innovative new treatment options for osteoarthritis, as many patients are unable to find relief with currently available medicines and continue to suffer,” Ken Verburg of Pfizer Global Product Development said in a statement.

“We are encouraged by these results, which speak to the potential of tanezumab as a non-opioid treatment option for pain reduction and improvement in physical function.”

Preliminary safety data showed that tanezumab was generally well tolerated, with about 1% of patients discontinuing treatment due to adverse events. Rapidly progressive osteoarthritis was observed in about 1.5% tanezumab-treated patients, but none in the placebo arm.

The U.S. Food and Drug Administration granted “fast track” designation to tanezumab last year to help speed its development as a new treatment for osteoarthritis and chronic low back pain.

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 after Pfizer reported some osteoarthritis patients receiving tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.”  Most clinical studies of tanezumab did not resume until 2015.

“We look forward to continuing to advance tanezumab in our ongoing global Phase 3 development program, which includes six studies in approximately 7,000 patients with osteoarthritis, chronic low back pain and cancer pain,” said Christi Shaw, senior vice president of Eli Lilly. In studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence.

Regeneron recently halted high-dose trials of fasinumab, another NGF inhibitor, because the risk of harm outweighed the benefits of the drug. There is some concern that NGF antibodies work too well and encourage osteoarthritis patients to become more active, which accelerates joint deterioration.

DEA Adopts Rule to Further Limit Opioid Production

Pat Anson, Editor

The U.S. Justice Department has finalized a new rule that will allow the Drug Enforcement Administration to reduce the amount of opioid pain medication a drug maker can produce if it finds the opioid is being diverted or misused.

The controversial change in the opioid production quota system was adopted despite warnings from patients, doctors and drug makers that it targets the wrong the problem and could worsen shortages of some pain medications.

The DEA maintains the rule change will “encourage vigilance” on the part of opioid manufacturers to prevent their drugs from being abused.

“These common-sense actions directly respond to the national opioid epidemic by allowing DEA to use drug diversion as a basis to evaluate whether a drug’s production should be reduced,” said DEA Acting Administrator Uttam Dhillon in a statement. “This also opens the door for increased communication and better information sharing between DEA and individual states, as we work together to address the opioid problem plaguing our country.”

The final rule greatly enhances the roles played by states and other federal agencies in setting opioid production quotas. It requires DEA to share proposed quotas with state attorneys general, who could object to a quota and demand a hearing.

The rule also allows DEA to consider “relevant information” from all 50 states, the Department of Health and Human Services, Food and Drug Administration, the Centers for Disease Control, and the Centers for Medicare and Medicaid Services, before setting a quota.

"DEA must make sure that we prevent diversion and abuse of prescription opioids. Today's new rule, by taking diversion of these opioids into account, will allow the DEA to be more responsive to the facts on the ground. More importantly, it will help us stop and even prevent diversion from taking place,” said Attorney General Jeff Sessions.

Sessions announced the proposed rule changes in April, and DEA received over 1,500 public comments during an unusually short comment period. A clear majority opposed the new rule.

“This does nothing to stop addiction or overdose deaths. Addicts will find a high anywhere and where they find it now is street drugs! Illicit drugs are what’s killing, not doctor prescribed opioids filled at a pharmacy. The reporting you all are using is inaccurate and false,” wrote Amy Vallejo.

“By creating quotas, and thereby shortages, you are committing torture,” said Kimberley Comfort, who lives with arachnoiditis, a chronic spinal disease. “There is no reason why people having surgeries, people who suffer from incurable diseases, should be left to suffer when we are a nation that has the ability to take care of its citizens. The DEA does not have a clear understanding of the so-called opioid crisis and therefore needs to cease and desist making opiates harder to get.”

“Again, we have the DEA making laws and quotas on something they should not be. Let them worry about the drugs coming in from China, Mexico etc. which are illegal,” said Sarah Yerxa. “By cutting the quotas all they are doing is sending needy pain patients to the streets, which will just raise the addiction... and overdose problem.”

Opioid Shortages

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Many hospitals and hospices now face a chronic shortage of intravenous and injectable opioids, which are used to treat patients recovering from surgery or trauma. The shortage has been primarily blamed on manufacturing problems, although some critics say it has been worsened by the DEA production cuts.

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Tony Mack, CEO and chairman of Virpax Pharmaceuticals, told PNN in an earlier interview.

“I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

In a public notice announcing the rule change, the DEA said it was not responsible for “perceived shortages” of injectable drugs and blamed the “manufacturer induced shortages” on “internal business decisions.”

The agency also deflected criticism that it was targeting the wrong problem. Recent studies indicate that overdoses involving illicit fentanyl, heroin and other street drugs now outnumber deaths linked to prescription opioids.   

“The DEA acknowledges that prescriptions for opioid drug products have decreased over the last several years due to the stepped up civil, criminal, and regulatory enforcement efforts of the agency. However, while there is a downward trend in prescribing, these Schedule II prescription opiates continue to have a high potential for abuse and dependence and require the annual assessment of quotas,” the DEA said.

The agency also claimed prescription opioids were “inextricably linked” to overdoses from heroin and illicit fentanyl, because many addicts start by taking pain medication from family medicine cabinets and then move on to street drugs.

The DEA statement defies some of its own analysis. Less than one percent of legally prescribed opioids are diverted, according to a 2017 DEA report, which also found that admissions for painkiller abuse to publicly funded addiction treatment facilities have declined significantly since 2011, the same year that opioid prescriptions began dropping.

Pain Patients Urge FDA to Fix CDC Guideline

By Pat Anson, Editor

Chronic pain patients are losing access to opioid medication, can’t find doctors willing to treat them, and are often treated as addicts, pain sufferers told FDA officials during an emotional public hearing Monday.

The Food and Drug Administration called the meeting to hear from pain patients about “challenges or barriers” they face in accessing treatment. Much of the testimony focused on the Centers for Disease Control and Prevention's 2016 prescribing guideline, which discourages opioids from being prescribed for chronic pain and has been widely adopted throughout the U.S. healthcare system.

“FDA, we are begging you. Correct the CDC’s egregious mistakes. Tell the country the truth about prescription opioids. They are safe and effective for 99% of us,” said Rose Bigham, who lives with chronic pain caused by Ankylosing Spondylitis, fibromyalgia and Crohn’s disease. “My new worst nightmare is being admitted to the hospital, being in agony and being denied pain relief.”

“CDC Guidelines have been a disaster for pain patients,” Rick Martin, a pharmacist disabled by chronic back pain, said in prepared testimony. “There is plenty of anecdotal evidence showing involuntary (opioid) tapering is rampant across the U.S.  Many, many stories of patients who are inhumanely suffering, some with suicidal ideation.

“The FDA needs to take action.  The FDA says it wants to know about challenges or barriers to accessing treatment. The challenge and the barrier is the CDC guideline. It should be immediately suspended.  It should be reviewed and modified with pain management physicians and patient input.”

“It seems to me we are asking for our right to have a normal life. I don’t feel like we should have to beg others for our right to live. It is not by another person’s hand to dictate how my life goes,” another pain sufferer said.

Dozens of pain patients and advocates attended the day-long hearing in Silver Springs, MD, including many who came from out-of-state at their own expense. Some fought back tears as they testified. Hundreds more watched the meeting online.

Many patients said they had tried non-opioid medications or alternative pain therapies, and found them ineffective or had side effects. One woman who took the FDA-approved medication Lyrica said it made her suicidal.

“I am a three-time suicide survivor because of medications you guys approve... and I have actually given up on FDA approved medications. I only take herbs in raw forms. Every one of those drugs that you approved for me to take led me to almost die,” said Kelly Devine. “Stop controlling everything any person wants to use to treat whatever form of whatever disease they are dealing with. Let people have the choice of what we put in our body."

“I don’t know if you are aware, but pain patients are being extorted into having dangerous invasive procedures," another patient warned. "It’s happening all over the country. Pain doctors are saying, ‘You want your meds, you have to go have an ESI (epidural steroid injection).’ Extorting patients into having procedures just to get meds is not right.”

‘Too Many Prescriptions for Opioids’

The FDA’s public hearing was a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S. 

President Trump’s opioid commission held five public hearings in 2017 without ever inviting a pain patient to testify.  The CDC also ignored the pain community when it secretly drafted its opioid guideline, relying instead on the advice of addiction treatment specialists, anti-opioid activists and academics. And the DEA ignored warnings from patients that further cuts in opioid production quotas could lead to shortages of pain medication, which are now occuring at many hospitals.

Will the FDA seek changes in the CDC guideline? The early indications are not promising.

“Unfortunately, the fact remains that there are still too many prescriptions being written for opioids,” FDA commissioner Scott Gottlieb, MD, said in a lengthy statement apparently written before the hearing began.  “We don’t want to perpetuate practices that led to the misuse of these drugs, and the addiction crisis. At the same time, we don’t want to act in ways that are poorly targeted, and end up disadvantaging legitimate patients.”

Gottlieb said the FDA was encouraging medical professional societies to develop their own opioid guidelines for different medical conditions. But he stopped short of calling for changes in the CDC guideline itself, saying it provides "helpful guidance to prescribers.”

“The CDC guidelines reinforce the need to treat pain carefully and adopt opioids as a last resort medication for most conditions,” said Gottlieb, who did not attend the hearing but will be briefed on it, according to FDA staff.