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.

Lyrica and Neurontin Ineffective for Low Back Pain

By Pat Anson, Editor

Lyrica, Neurontin and other anti-convulsant drugs are ineffective for treating low back pain and may even be harmful to patients, according to a new study published in the Canadian Medical Association Journal.

Prescriptions for anti-convulsant drugs have soared in recent years, as doctors seek “safer” alternatives to opioid pain medication.  Lyrica (pregabalin) and Neurontin (gabapentin) belong to a class of anti-convulsant nerve medications known as gabapentinoids. They are primarily used for treating nerve pain and fibromyalgia, but are increasingly being prescribed off-label to treat lower back and neck pain.

Australian researchers reviewed 9 placebo-controlled randomized trials and found high quality evidence that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea.

“The take-home message is that anti-convulsants are not effective and can lead to adverse effects in people with low back pain and radiating leg pain (eg, sciatica), so they should not be recommended to this patient population,” lead author Oliver Enke, MD, a researcher at the University of Sydney Medical School, told Helio Family Medicine.

Low back pain is the world’s leading cause of disability. Guidelines for treating low back pain usually recommend physical therapy, exercise and non-opioid pain relievers rather than stronger analgesics such as opioids or anti-convulsants.

A 2017 study published in PLOS Medicine also warned that pregabalin and gabapentin were ineffective for low back pain and have a “significant risk of adverse effects.” 

PNN readers often complain about side effects from Lyrica and Neurontin.

“I have used both medicines and neither help with lower back pain for me,” said Sheri. “I will say the mental confusion and memory loss on Lyrica is very real, but it takes a slight edge of pain away in my body as a whole from the fibromyalgia.”

“I can vouch that Lyrica does not help with back pain,” said Debra. “It helped with the nerve pain but I thought I was literally losing my mind. I couldn't remember simple words or synonyms for words.”

“I've been taking gabapentin for almost six months; it has helped my peripheral neuropathy, but I still suffer every day from arthritis in every joint of my body, including my lower back,” another reader wrote.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries.

Neurontin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is also widely prescribed off-label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses. About 68 million prescriptions were written for gabapentin in the U.S. last year, compared to 44 million in in 2013.

There have been increasing reports of gabapentinoids being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances. Gabapentin is not currently scheduled as a controlled substance by the DEA, while pregabalin is classified as a Schedule V controlled substance, meaning it has a low potential for addiction and abuse.  

OxyContin, Heroin and the Opioid Crisis

By Roger Chriss, PNN Columnist

The roles of heroin and OxyContin in the opioid crisis are frequently mischaracterized and misunderstood. Such is the case with a recent op/ed in The Washington Post.

“In the 1990s, when the industry began aggressively marketing prescription opioids such as OxyContin, heroin was a minimal presence in American life," wrote Keith Humphreys, PhD, a professor of psychiatry at Stanford University

This is an unfortunate and common error about the role of heroin in the opioid crisis. Humphreys is repeating what many politicians and policymakers have also claimed. It’s important to correct this error because otherwise we will misunderstand how to treat heroin addiction, what our options are for pain management, and how to create sound policies to address the opioid crisis.

In fact, the U.S. has long had a major problem with heroin. Mexican black tar heroin arrived decades before OxyContin, and opioid addiction is usually a result of recreational use starting during adolescence, with addiction due to medical care being uncommon.

According to the book “Dark Paradise” by historian David Courtwright, researchers estimated the number of heroin addicts in the U.S. during the 1990s at a half million or more, about the same level as in the mid-1970s. This is also close to the 626,000 heroin addicts that the National Institute of Drug Abuse estimates for 2016.

Fatal overdoses involving Mexican black tar heroin were increasing even before OxyContin was introduced by Purdue Pharma in 1996. Sam Quinones notes in “Dreamland” that Oregon’s Multnomah County had only 10 heroin overdose deaths in 1991, about the time Mexican drug dealers arrived in Portland, but by 1999 there were 111 heroin overdoses.

So the idea that “heroin was a minimal presence in American life” isn’t supported by data. Neither is the claim that heroin traffickers “set up shop in the areas of the United States with the highest prevalence of prescription opioid addiction.”

According to Quinones, the Mexican drug gang the “Xalisco Boys” went into communities that were not a part of the established drug trade and were not subject to turf wars or other forms of gang violence. They wanted to fly below the radar, to avoid detection by law enforcement, and deliberately avoided carrying guns, driving fancy cars, or living large.
So the Xalisco Boys went to smaller cities like Portland and rural communities like Appalachia that were specifically chosen because they were low risk. And they were there well before 1996 and the advent of OxyContin.

Humphreys makes an additional error with his claim that about 80 percent of Americans who became heroin addicts started out with prescription opioids, according to an assessment from the National Institutes of Health. The 80% statistic varies significantly with time and place. As I wrote in a previous column,  non-medical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in New York and Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively.

It's also important to note that “prescription opioids” does not necessarily mean prescribed opioids. Many addicts don't have a prescription and steal, buy or borrow pain medication. The National Institute on Drug Abuse estimates that about 10 percent of patients legally prescribed opioids develop an opioid use disorder. And only about 5 percent of those who misuse their medication transition to heroin.

There is also a disturbing new trend in heroin use. A study in JAMA Psychiatry last year found that about one-third of heroin users had no prior experience with any opioid, prescription or otherwise. Heroin users often have extensive prior drug use with a variety of different substances, along with a history of severe childhood trauma or mental illness.

Humphreys’ claim that the “heroin-addicted were transfers from prescription opioids” ignores another route on the path to opioid addiction. In “Drug Dealer, MD,” Stanford psychiatrist Anna Lembke says some drug addicts switched from heroin to prescription opioids in the late 1990s and early 2000s because of the increased availability of the latter.

None of this is meant to exonerate OxyContin or Purdue Pharma. Barry Meier’s recent book “Pain Killer” does a good job of explaining the history of the company and why it is the focus of so many lawsuits. Purdue was fined over $600 million for the illegal marketing of OxyContin and important questions about the company’s actions remain to be answered.

Heroin addiction has been a major presence in American life for generations. The current opioid crisis may have been jump-started with prescription drugs, but heroin came long before OxyContin. It is better to view OxyContin as gasoline tossed on a smoldering fire, rather than blame OxyContin for heroin. The crisis is more complicated and pervasive than that.

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.

Opioid Medication Made My Chronic Pain Worse

By Robert Gripp, Guest Columnist

After 18 years of largely untreatable chronic pain, I found myself with an intrathecal pain pump delivering huge quantities of fentanyl to my spine every day. And I was still in debilitating pain.

I was on my second pain pump (they have to be replaced about every seven years) when the pump began to act up and I started into withdrawal. I immediately saw my new doctor, who had taken over my care when my original doctor retired at age 75.

He had the pump manufacturer’s representative there to help figure out what was going on. It turned out the pump was unreliable, and the doctor recommended it be powered off. I was sent home with minimal meds to detox.

Detox was the absolute most horrible experience I have ever encountered, but at the end I was virtually pain free. The reason was that I had developed opioid-induced hyperalgesia (OIH), which increased my sensitivity to pain.

ROBERT GRIPP

OIH is a well-documented syndrome, but my doctors had missed the hallmark signs of it, which are changes in the location and characteristics of your pain, as well as little or no relief from pain when the dosage is increased.

I am now 63 years old and have a new life. I have some pain, but nothing that is not well controlled with little or no opioids.

I do not believe that all patients who take high doses of opioids experience hyperalgesia, nor does the literature support any such conclusion. My purpose is to caution anyone on high doses for an extended period. If it is not helping you or your pain is worse after increasing the dosage, you should be aware of this condition and its potential.

Overzealous lawmakers and over-reaching insurance companies who want to limit opioids due to the addiction crisis don’t have a clue. Limiting opioids is making it harder for pain patients who really need them. But my experience is also something that needs to be better understood and the condition of hyperalgesia needs to be more publicized.

Our tendency is to believe more pain medicine is better when our pain worsens. I have to wonder how many people are out there in tremendous pain being caused by the very medicine given them to abate it. I am afraid it is way too many.

I hope my story helps someone get a new life, without having to stumble onto it as I did.

Robert Gripp lives in Texas.

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.

CDC Head Wants Opioid Guidelines for Acute Pain

By Pat Anson, Editor

When Dr. Robert Redfield was appointed as director of the Centers for Disease Control and Prevention in March, he told CDC staff the opioid epidemic was “the public health crisis of our time” and pledged to “bring this epidemic to its knees.”

After three months in the job, Redfield has finally given his first media interview and provided some vague details about how he will tackle the opioid crisis. He told The Wall Street Journal that the CDC would develop opioid prescribing guidelines for short-term acute pain and use a new enhanced data system to track overdoses in hospital emergency rooms.

“We’re going to continue to expand our efforts,” Redfield said. “We’re going to be able to track this epidemic in real time, which I think is really important to be able to respond.”

The CDC has been roundly criticized in the past for how it tracked and counted opioid overdoses – erroneously mixing illicit fentanyl deaths with those linked to prescription opioids – so any improvement in that area is welcome.

DR. ROBERT REDFIELD.

But for the agency to even consider prescribing guidelines for acute pain is puzzling – considering how disastrous its guidelines have been for chronic pain. Since their botched release during a sketchy webinar in 2015, the CDC’s “voluntary” guidelines for primary care physicians have been widely adopted as mandatory by insurers, regulators and providers – who have used them to deny treatment, abandon patients, and forcibly taper many off opioid prescriptions. The DEA even targets physicians who exceed the CDC's recommended dosage for opioids. 

“I was forced tapered. How could the CDC take over my medical treatment? How is this legal? The CDC had never assessed me yet changed my pain medicine,” PNN reader Patti asks.  “I've gone from being an active woman to spending my days in bed or on the couch. I live in non-stop pain 24/7.”

Patti is not alone. In a PNN survey of over 3,100 patients last year, over 90% said the CDC guidelines have been harmful to patients and nearly half said it was harder for them to find a doctor willing to treat their pain. Ten percent don't have a doctor at all.

There are also troubling reports of patients committing suicide because their pain is so poorly treated.

"My son committed suicide 4 months after his docs took him off all pain meds," said Rick. "I knew right then the reason for his suicide. But, it goes unrecognized by doctors and other officials, and his suicide autopsy mentioned nothing about pain meds. This will continue, suicides vastly increased until post medicinal suicides (are) recognized and accounted for."

"My 70 year old mother committed suicide last month after being cut off at pain management. Although she could barely walk and was in constant pain, she was the most positive person. Something needs to be done," said Janie Jacobs.

“Wishing for it to be over is a pervasive daily thought. I have to work diligently to chase those thoughts away,” pain patient Leanne Gooch wrote in a recent guest column for PNN. “My doctors can’t or won’t treat me because my chronic pain contributed to all the addicts all over the world. I’ll admit that’s a ridiculous statement when they admit they’ve gone too far in denying me proper medical care.”   

The quality of pain care in the U.S. has gotten so bad that Human Rights Watch launched an investigation into the treatment of pain patients as a possible human rights violation.

“What kind of quality of life do I even have when I can barely move?” asks Amy, who suffers from myofascial pain and is confined to a wheelchair.  “I really want to lead a functional life and to have a family. It's not a lot to ask. I'll never have it this way, though. Please give me back some tramadol. Please allow me hydrocodone if I really need it. Please help me. Please help all of us.”

The CDC guidelines have also failed to achieve a key objective. While opioid prescribing has declined (a trend that began years before the guidelines were released), opioid overdoses have spiked higher, driven by a scourge of illegal opioids sold on the black market. Americans are now more likely to die from an overdose of illicit fentanyl than they are from pain medication.

Several states and insurers have already adopted regulations limiting the initial use of opioids for acute pain to a few days supply. The CDC has weighed in on the issue as well.

"When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed," the agency says in its chronic pain guidelines. 

According to a spokesperson, the CDC was working with the Agency for Healthcare Research and Quality (AHRQ) to develop a report reviewing the effectiveness of opioid and non-opioid therapies for acute pain.

"If an update to the CDC Guideline is warranted based on the scientific findings of these AHRQ efforts, CDC will undertake the scientific process to update the guideline, possibly including expanded guidance treating acute pain," Courtney Leland told PNN in an email.

Why does Dr. Redfield want to develop guidelines for acute pain? In his interview with The Wall Street Journal,  Redfield said his interest stems, in part, from a close family member’s struggle with opioid addiction.

“I think part of my understanding of the epidemic has come from seeing it not just as a public-health person and not just as a doctor,” he said. “It is something that has impacted me also at a personal level.”

The epidemic is also impacting chronic pain patients, in ways the CDC has yet to admit or acknowledge.

Over 600 Arrested in Healthcare Fraud Sweep

By Pat Anson, Editor

Over 600 doctors, nurses, pharmacists and other medical providers have been arrested in what the U.S. Justice Department is calling its largest healthcare fraud investigation.

Most of the charges involve false claims for opioid prescriptions or addiction treatment that resulted in $2 billion in fraudulent billings to Medicare, Medicaid and other health insurers. Many of the arrests occurred weeks or months ago, and were apparently lumped together by federal agencies to make the crackdown on healthcare fraud appear to be the "largest ever." 

“This is the most fraud, the most defendants, and the most doctors ever charged in a single operation -- and we have evidence that our ongoing work has stopped or prevented billions of dollars’ worth of fraud,” said Attorney General Jeff Sessions.

Federal officials also announced that they have excluded 2,700 individuals from participating in Medicare, Medicaid and other federal health programs, including 587 providers excluded for conduct related to opioid diversion and abuse. 

“Health care fraud is a betrayal of vulnerable patients, and often it is theft from the taxpayer,” said Sessions.  “In many cases, doctors, nurses, and pharmacists take advantage of people suffering from drug addiction in order to line their pockets. These are despicable crimes.”

A $106 million scheme uncovered in Florida alleged there was widespread fraudulent urine drug testing at a substance abuse treatment center. The owner, medical director and two employees at the sober living facility allegedly recruited patients and paid kickbacks to them for participating in bogus drug tests.

In California, an attorney at a compounding pharmacy allegedly paid kickbacks and offered incentives such as prostitutes and expensive meals to two podiatrists in exchange for bogus prescriptions written on pre-printed prescription pads. Once the fraudulent prescriptions were filled, about $250 million in false claims were submitted to federal, state and private insurers.

In Texas, a pharmacy chain owner, managing partner and lead pharmacist were accused of using fraudulent prescriptions to fill bulk orders for over one million hydrocodone and oxycodone pills, which the pharmacy then sold to drug couriers for millions of dollars. 

“Healthcare fraud touches every corner of the United States and not only costs taxpayers money, but also can have deadly consequences,” said FBI Deputy Director David Bowdich.  “Through investigations across the country, we have seen medical professionals putting greed above their patients’ well-being and trusted doctors fanning the flames of the opioid crisis.”

Since becoming Attorney General, Sessions has shown a particular interest in opioid prescriptions -- once urging pain patients to “tough it out” and take aspirin instead.

Last August, Sessions ordered the formation of a new data analysis team, the Opioid Fraud and Abuse Detection Unit, to focus solely on opioid-related health care fraud.  Five months later, Sessions launched a Justice Department task force targeting manufacturers and distributors of opioid medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

As PNN has reported, the data mining of opioid prescriptions -- without examining the full context of who the medications were written for or why – can be problematic. Last year the DEA raided the offices of Dr. Forest Tennant, a prominent California pain physician, because he had “very suspicious prescribing patterns.” Tennant only treated intractable pain patients, many from out-of-state, and often prescribed high doses of opioids to patients because of their chronically poor health -- important facts that were omitted or ignored by DEA investigators. Tennant has not been charged with a crime, but announced plans to retire after the DEA raid.

Sessions has also proposed a new rule that would allow the DEA to punish drug makers if their painkillers are diverted or abused. If approved, the agency could reduce the amount of opioids a company would be allowed to produce, even if the drug maker had no direct role in the diversion.

Most overdoses are not linked to opioid pain medication, but are more likely associated with illicit fentanyl, heroin, anti-anxiety drugs or antidepressants.