Insurers Behind Medicare’s ‘Big Brother’ Opioid Policy

By Pat Anson, Editor

The insurance industry appears to have played a major role in the development of a new strategy by the federal government to combat the abuse of opioid pain medication.

As Pain News Network has reported, the plan calls on pharmacists to report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients (see “Medicare Takes ‘Big Brother’ Approach to Opioid Abuse”). Individual profiles of patients, their behavior, and opioid use would also be created and shared among insurance providers.

The plan was outlined earlier this month by the Centers for Medicare & Medicaid Services (CMS) in the agency’s proposed “Opioid Misuse Strategy.” 

The CMS plan closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  It states that all physicians should follow the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, even though the guidelines are voluntary and explicitly state they are not intended for all prescribers.

The white paper was drafted largely by insurance companies – called “Partner Champions” -- including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

“These HFPP Partner Champions have committed themselves to the creation of an HFPP White Paper that describes the best practices for serious consideration by all healthcare payers and other relevant stakeholders to effectively address and minimize the harms of opioids,”  the white paper states.

“Through coordinated action, payers, including members of the HFPP, have the opportunity to dramatically influence and reduce opioid misuse in the U.S. Simple actions performed systematically across a large group of stakeholders can considerably decrease the toll of prescription opioid misuse and OUD (opioid use disorder) in the U.S.”

Physicians and Patients Left Out

No other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were involved in a “special session” of the HFPP last October that led to the drafting of the white paper.

“It’s concerning that CMS appears to have developed a policy proposal regarding opioid prescribing solely on the basis of advice from a group dominated by the insurance industry, without asking for input from affected healthcare professional groups,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of physicians who specialize in pain care.

“We have to be mindful of the vested interests of insurance companies in this issue. Some advocates have argued that pharmaceutical manufacturers have wielded outsized influence in previous policy decisions, but there has been precious little focus on the influence of payers, which seems obvious in this case.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs.

“Who exactly are the individuals who put this information together for CMS… and what is their true aim?” asks Ingrid Hollis, the mother of a chronic pain patient. “It looks to me like collusion between insurance companies and federal agencies to cut costs.

“Senior citizens and those disabled with progressive painful diseases or injuries deserve better treatment than this. To single this community out for draconian policies based on what looks like purely profit motives in the name of ‘harm reduction’ is inhumane. Who is truly being harmed here?”

“When they describe insurance companies involved in their efforts as ‘Champions,’ it calls to mind comic book and movie heroes like Superman.  Superman was noble, his motives pure.  I don't think of profit-conscious insurers as being noble or pure in motive,” said Anne Fuqua, a disabled nurse, pain patient and patient advocate. 

“Involving insurance companies in setting policies that directly or indirectly impact prescribing and/or reimbursement presents a conflict of interest.”

Stewards, Stockers and Demanders

Under the proposed CMS policy, information about doctors and patients who’ve been red flagged by pharmacists for suspicious prescribing would be shared through a CMS database with all insurers. The companies would then be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

The HFPP white paper goes further, recommending that insurers develop profiles of each patient and classify them in one of three groups based on their behavior:

  1. “Stewards” (patients who follow guidelines)
  2. “Stockers” (patients who stockpile unused medications)
  3. “Demanders” (patients who ask for medication)

“Segmenting patients by intentions/behaviors with regards to opioid prescriptions could help payers better target messages and disseminate tailored communications that are most salient to the recipient,” the white paper states.

“For example, stewards may be those who are more likely to adhere to the CDC guideline and seek non-pharmacologic or non-opioid pharmacologic therapies for chronic pain and stockers may be those who are likely to ask for an opioid prescription/have received an opioid prescription for chronic pain in the past.”

A data analysis of patients and doctors, according to the white paper, could also be used by insurers to develop computer models to identify “problematic actors and schemes” and “deny payments for prescriptions that do not conform to general prescribing practices.”

“The HFPP strongly encour­ages collaborative efforts to develop and widely disseminate effective strategies to identify: patients at risk of opioid misuse or OUD, providers whose opioid prescribing patterns fail to comply with quality indicators (such as the CDC Guideline for Prescribing Opioids for Chronic Pain), and methods that are particularly ef­fective at preventing or treating OUD,” the white paper states.

But critics say the profiling of patients and doctors, as well as the sharing of data from prescription drug monitoring programs (PDMPs), amounts to an invasion of privacy.

“PDMP data contains some of the most sensitive health information that is produced.  When PDMPs were introduced, confidentiality protections were stressed and prescribers and pharmacists could review the information,” says Anne Fuqua.

“Now, CMS is discussing their plan to provide open access to insurers participating in their database.  They flip between arguments that this will help insurers make sure people get needed treatments for addiction and fraud detection.  It's clear that detection of fraud and conserving on drug costs is the primary focus.”

Non-Opioid Treatments Encouraged

Like the CDC guidelines, the white paper discourages the use of opioid pain medication, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as an alternatives, as well as “non-pharmacological” treatments like cognitive behavioral therapy and chiropractic care. Addiction treatment drugs such as buprenorphine and methadone are strongly recommended for anyone showing signs of opioid use disorder.

“Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy,” the paper states.

Critics say the recommendations – and threats of sanctions against those who don’t follow them -- could interfere with the doctor-patient relationship.

"Proposals, like CMS' Opioid Misuse Strategy, aimed at combatting the prescription drug abuse crisis, while important, must be careful to not leave patients with a legitimate medical need without access to the treatments they and their doctors have determined are the best course of care,” the Alliance for Patient Access, a national network of physicians, said in a statement to PNN.

“Patient access can be impeded when physicians and patients feel threatened that they are being watched, may be reported, or their personal information shared by pharmacists and insurers. When that happens patients suffer and the physician-patient relationship, one based on trust, is strained.” 

“It should not be a surprise that insurance companies have been aggressively opposing the use of branded opioids. Their fiduciary responsibility is to their shareholders, not to patients,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Decisions by insurance companies are causing many patients to suffer. This is not right.”

“Patients and doctors don’t want insurance companies and other parties determining what is best for them.  Doctors have a medical degree, the experience, the knowledge and treatment plans are determined by the medical condition they are treating,” says Ingrid Hollis.

“They act in the best interest of the patient, and have pledged the Hippocratic Oath of ‘Do no harm.’ Can the same be said of the bean counters in the insurance industry? Insurance is interested in cost cutting and maximizing profits.  Doctors are trying to save lives.”

CMS has not said when it plans to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency has only said that in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

The HFPP white paper was released publicly for the first time Tuesday on the CMS website, without any explanation of its broader meaning or impact on Medicare and Medicaid policies.

An HFPP infographic urging people "to fight healthcare fraud, waste and abuse" was also released on the government-run website, without any indication that it was largely developed by the insurance industry.

Spinal Cord Stimulators Reduce Opioid Use

By Pat Anson, Editor

Most patients who have a spinal cord stimulator significantly reduce their use of opioid pain medication one year after their implant, according to new industry-funded research.

In an analysis of private and Medicare insurance claims from 5,476 patients who received a spinal cord stimulator (SCS), opioid use declined or stabilized in 70 percent of the patients. Opioid use was higher among patients who had the stimulator removed.

The study, presented at the annual meeting of the North American Neuromodulation Society (NANS), was sponsored by Abbott (NYSE: ABT), a manufacturer of SCS systems and other medical devices.

"Given the epidemic of opioid addiction and abuse, these findings are important and confirm that spinal cord stimulation therapy can offer strong benefits for patients struggling with chronic pain," said Ashwini Sharan, MD, president of NANS and director of Functional and Epilepsy Surgery at Vickie and Jack Farber Institute for Neuroscience.

"Based on these results, we concluded it may be possible to improve outcomes by offering our patients spinal cord stimulation earlier, before opioid dependence and addiction can occur."

Spinal cord stimulators have long been considered the treatment of last resort for chronic back and leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain.

New technologies have been developed to make the devices more effective, easier to recharge and to reduce complications such as paresthesia – a tingling or buzzing sensation.

And with government regulators and insurers discouraging the use of opioid pain medication, the medical device industry is urging patients and doctors to take another look at SCS devices.

X-RAY OF PATIENT WITH MEDTRONIC SCS DEVICE

"As our society has been seeking ways to stem opioid abuse and addition, our company offers treatment options that can reduce their exposure to opioid medication," said Allen Burton, MD, medical director of neuromodulation at Abbott in a news release. "Data like these are critical to helping us demonstrate that spinal cord stimulation can reduce exposure to opioids while giving patients comprehensive pain relief."

Abbot recently purchased St. Jude Medical, giving the medical device maker its first exposure to the SCS and neuromodulation market, which has an estimated value of $5.3 billion.

"Non-medical pain relief is a focus with attention on the dangers of pain medication and the need to find alternatives to reduce chronic pain," said Bruce Carlson, Publisher of Kalorama Information, a research firm that tracks the neuromodulation market. "Abbott builds on its cardiovascular device properties with this deal, and that is a big focus of press coverage.  St. Jude's impressive spinal cord offering should not be obscured in this transaction."

Pain Patients Sound Off on Opioid Cutbacks

By Pat Anson, Editor

In our last newsletter, we asked readers if their doctors had recently reduced or stopped prescribing opioid pain medication, and to share their stories with us.

We heard back from dozens of people, all of them angry and frustrated with the state of pain care and the government agencies that regulate pain medication in the U.S.

“We are disgusted with the DEA and uneducated callous physicians' war on chronic pain patients and their doctors. Suicides are skyrocketing and lives are being destroyed,” wrote Connie Potter, a registered nurse in New Mexico.  “The number of people I see whose lives are worthless and destroyed is appalling.” 

Connie said that her husband, who suffers from severe back pain, dystonia and fibromyalgia, is being prescribed about a third of the pain mediation he used to get.

“No one wants to give pain meds in southern New Mexico. My friend with acute MS (multiple sclerosis) has had his already pathetic meds dosages halved,” she said.

Many pain sufferers are being told by doctors that they are required to reduce or eliminate opioid prescribing, even though guidelines released last year by the Centers for Disease Control and Prevention are voluntary, not mandatory.

“I was told in November that as of January 1, 2017 my medication would be reduced by half because the government is mandating this across the United States,” wrote 46-year old Cindy, who has suffered from back and pelvic pain since childhood. 

“I am still trying to grasp how this could happen!  I am every doctor's dream patient. I do whatever they ask whatever they suggest - anything!  How the hell am I supposed to make it through a day of work when I can't sit? This is crazy!  Do I seriously not have any recourse?”

“These doctors don't give a s*** anymore, all they care about (is) lowering their opiates prescriptions, so they don't have to deal with the backlash from our stinking government,” said David Cole, who has perineural neuropathy.

“I've been using opioids for the last 14 years to control to my pain and manage my life,” wrote Eli. “Then came the infamous CDC 'recommendations' and in March of 2016 I was cut down 50% on my dosage. Was difficult to do it, and couldn't have pulled it off without the help of cannabis.”

Even though medical marijuana is legal in California, where Eli lives, most doctors don’t want to prescribe opioids to someone using cannabis. So he's been tapered again to a lower dose. And he may be on his last refill.  

“My life began falling apart when they cut my dose in half, and hasn't been the same since. I've grown much more dependent on help from others and can barely shop. This anti-opioid madness has got to stop," he says.

Treated Like Addicts

Many readers say they are tired of being treated like criminals or addicts.

“Being treated like an incompetent, drug seeking/selling, whiny and lazy hypochondriac by non-medical and/or elected individuals is not an issue I anticipated,” wrote Ellen Rames, who is disabled at the age of 65. “It feels like the eyes of judgment are on me every day. It shouldn't be this way.”

“Twenty five years of taking opioids without a problem and now I feel like criminal trying to get them,” said Kaye Ingram, a disabled coal miner. “I (am) just sick of being piss tested every month and being threatened.”

“I'm tired of being treated like a druggie or addict when I ask for relief,” said Mike Schmidt, who has chronic pain after 15 surgeries on his neck and back. At the age of 72, the retired drug and alcohol counselor says he’s not worried about addiction.

“I have always taken medication at the prescribed dosage or less,” says Schmidt.  “I found morphine to be an effective pain relief for me after trying different medications and not liking the side effects.”

“It angers me to no end that I can't get decent sleep and that I spend most days in a chair because some people abuse medications that I legitimately need, and for which I have a proven record of responsible use,” said G.D. King, who has suffered from chronic back pain for over 25 years.

“Clearly I understand that the government doesn't want citizens dropping dead willy-nilly from overdoses.  But the fact that these deaths are the result of abusive and/or illegal activity for which I must pay a very steep personal price does not incline me toward sympathy for those who engage in these activities.”

Illegal activity is what some patients are considering to get pain relief.

“Pot isn't legal where I am so guess I'd have to break the law, or well, heck, since heroin is easier to get than a legitimate pain prescription, I guess that might be another choice.  Do these people have any common sense?” asked Donna.

Suicide is seen as an alternative by some.

The government needs to get out of our doctor’s offices and our pharmacies and quit attempting to practice medicine by lumping all persons into the same category.

“I feel that there needs to be more reporting on the suicide rate among chronic pain sufferers.  These people who are pushing for stopping opioid use to prevent overdose and death from opioids are only trading one form of death for another,” said Sam, a retired counselor who has worked with suicidal clients.  “I support euthanasia and the legalization of physician assisted suicide for the terminally ill, but I think it should also be allowed for those who suffer chronic pain that are not getting relief.”

Others believe the campaign against opioids is more about corporate profits, not healthcare or preventing addiction.

“This is strictly a dollars and cents issue, with the insurance companies not wanting to fulfill their contractual obligations. I know firsthand, as my insurer cut me off completely in 2016,” wrote Russ. “My family already is prepared that when I die because of their incompetence, the major lawsuits will begin unabated against any agency or company that was implicit in this conspiracy, and a conspiracy it is.

“The government needs to get out of our doctor's offices and our pharmacies and quit attempting to practice medicine by lumping all persons into the same category.”

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A Pained Life: The Hand of a Stranger

By Carol Levy, Columnist

I went to the Women’s March on Philadelphia Saturday. I am very politically minded.  I love doing these things. And each and every time, I have the same problem

I forget about the pain. I forget about the specifics, logistics and potential for pain.

I have trigeminal neuralgia, which causes severe pain on the left side of my face. It can be set off just by touch. I am also legally blind on that side.

It puts me in a precarious position. It is essential that I not let anyone get close enough to accidentally brush against my face. For me, the innocuous sign of an outstretched hand or arm is dangerous. And since I can't see on that side, I have no idea how close someone might be to touching and triggering the pain.

I did not expect the size of the crowd, which was estimated at 50,000 people. Small rallies are bad enough, but this one was so enormous that as soon as I left the train station and went towards the designated rally area, I was engulfed in a sea of people.

And I was petrified. Thousands of people were bearing in on me.

I tried to make my way through the mass of people. Everyone was very nice. “Excuse me. Excuse me,” I said.  Some moved, but some could not with the press of so many bodies.

image courtesy of philadelphia mayor's office

One woman smiled as I explained to her I was trying to reach the borders of the rally, so I would not be in the midst of so many people. For this kind of event it was an odd thing to say. She looked at me quizzically. I figured I had better explain.

I have learned to be hesitant about explaining my condition. My family has been nasty about the pain. Strangers, even friends and acquaintances, can and have been unpleasant about it. As way too many of us know firsthand.

This was a “'talk with the stranger in the next seat” moment. I would never see her again, so there was no risk in explaining and no worry if she didn't understand or could not care less. Plus, my need outweighed my concerns about how she might react.

Her reaction was unexpected. She put her arm around me and held out her hand. Taking mine in hers, she led us through a bastion of folks. When we got to an area less crowded, she let go and I continued on.

What a wonderful experience and for so many reasons, not the least of which was I said what I needed and I was heard.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Even a Little Exercise Is Better Than None

By Pat Anson, Editor

We often hear from pain sufferers who say they’d like to exercise more, but can’t because their pain levels have left them bedridden or stuck on a couch. Others believe a workout at the gym will only make their pain worse.

But two new studies have found that you don’t need to be a gym rat to get the health benefits from exercise.

You may not even need to stand up!

Federal guidelines suggest a minimum of 150 minutes of exercise a week are needed to promote good cardiovascular health. But researchers at Northwestern University wanted to see if a lesser goal could improve overall health.

They measured the physical activity of 1,600 adults with osteoarthritis in their hips, knees or feet; and found that just 45 minutes of moderate physical activity a week improved their function and reduced pain

"We were interested in seeing what kind of physical activity might be beneficial to promote good function down the road,” said Dorothy Dunlop, a professor of rheumatology and preventive medicine at Northwestern University Feinberg School of Medicine.

“We found moderate-intensity activity rather than light activity, such as pushing a grocery cart, to be more valuable to promote future function."

Using sophisticated accelerometers to monitor movement, the researchers found that participants who engaged in moderate activity, such as brisk walking, for at least 45 minutes a week were 80 percent more likely to improve or sustain high future function.

The findings, published in the journal Arthritis Care & Research., were true for both men and women. The beneficial effects of the exercise were also long term. About a third of participants improved or had high function after two years.

"The federal guidelines are very important because the more you do, the better you'll feel and the greater the health benefits you'll receive," Dunlop said. "But even achieving this less rigorous goal will promote the ability to function and may be a feasible starting point for older adults dealing with discomfort in their joints.”

"Even a little activity is better than none," she added

Chair Yoga Relieves Pain of Osteoarthritis

A second study at Florida Atlantic University found that “chair yoga” is an effective way to reduce pain and improve quality of life in older adults with osteoarthritis.

As the name implies, the Sit-N-Fit Chair Yoga program was developed to help those who cannot stand during exercise or participate in traditional yoga. Chair yoga is practiced sitting in a chair or standing while holding the chair for support.

IMAGE COURTESY OF FLORIDA ATLANTIC UNIVERSITY

In a study of 131 older adults who have osteoarthritis, participants attended 45-minute chair yoga sessions twice a week for 8 weeks.

Researchers measured their pain, pain interference (how it affects one's life), balance, gait speed, fatigue and functional ability; before, during and after the sessions.

Compared to a control group enrolled in a health education program, the chair yoga group showed a greater reduction in pain, pain interference and fatigue during the sessions, as well as an improved gait. The reduction in pain interference lasted for about three months after the chair yoga program was completed.

"The effect of pain on everyday living is most directly captured by pain interference, and our findings demonstrate that chair yoga reduced pain interference in everyday activities," said Ruth McCaffrey, emeritus professor in FAU's College of Nursing and co-author of the study published in the Journal of the American Geriatrics Society.

"The potential impact of this study on public health is high, as this program provides an approach for keeping community-dwelling elders active even when they cannot participate in traditional exercise that challenges their balance," said co-author and principal investigator Patricia Liehr, PhD, a professor in FAU's College of Nursing.

Osteoarthritis is the most common form of arthritis and the leading cause of long-term disability in older adults. It affects about a third of Americans over the age of 65.

‘Confusing’ Email Warns of Drug Shortages in Florida

By Pat Anson, Editor

The Florida Department of Health is apologizing for a “confusing” email sent Friday that warned of possible prescription drug shortages in the state due to the recent suspension of a wholesale drug distributor.

Earlier this week, the McKesson Corporation agreed to pay a record $150 million fine for failing to track and report suspicious orders of opioid pain medication and other controlled substances.   As part of the settlement with the Drug Enforcement Administration, McKesson suspended sales of controlled substances from wholesale distribution centers in Colorado, Ohio, Michigan and Florida.

Late Friday morning, the Florida health department sent an email with the subject line “Emerging Health Threat” to pharmacists in the state warning of possible drug shortages.

“The DEA recently suspended McKesson Corporation’s sales of controlled substances from distribution in Florida. This suspension could impact your patients’ ability to fill their prescriptions and you may want to advise them about the potential implications. As a practitioner, you should be aware of the possibility of drug shortages and consider alternative treatment options when prescribing controlled substances.”

About six hours later, the health department sent out a second email, apologizing for the first one:

"A recent message that was sent out regarding the DEA’s suspension of McKesson Corporation’s sales of controlled substances from distribution in Florida was found to be confusing. This suspension will impact one distribution center in Florida and impacts only the handling of hydromorphone. The Florida Department of Health and Division of Medical Quality Assurance apologize for any confusion that may have resulted from that message.”

There was no explanation for why the first “confusing” email was sent or why there was such an abrupt change in tone in the second one. No press release was issued by the health department warning of possible drug shortages in Florida. 

A spokesperson for McKesson confirmed that the suspension of its Florida distribution center will only impact hydromorphone, an opioid medication sold under the brand names Dilaudid and Exalgo.

"We do not anticipate our pharmacy customers will experience any negative impacts as a result of the temporary suspension," wrote Kristin Hunter in an email to PNN.

"The Lakeland, FL distribution center will be suspended for one year from distributing hydromorphone ONLY (not ALL controlled substances). There will be no change to the distribution of non-controlled pharmaceutical and over-the-counter products. Customers that typically receive controlled substances from an affected distribution center are now being served by one of the other 28 DCs (distribution centers) in McKesson’s network with no interruption in service."

This is the second time McKesson has been accused of violating the Controlled Substances Act. In 2008, the company paid a $13.25 million fine after it failed to identify and report suspicious orders for opioid pain medication from independent and small pharmacies. 

As part of a settlement with the DEA, the company agreed to implement a system to detect such orders.

However, the DEA says McKesson “did not fully implement or adhere to its own program” and continued to supply pharmacies with “an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic.”

From 2008 to 2013, the company processed over 1.6 million orders for controlled substances in Colorado, but reported only 16 of them as suspicious, according to the DEA.

A pharmacist told WFTX-TV in Naples that suspending distribution centers and potentially disrupting the supply of opioids isn’t helpful because it only makes it harder for chronic pain patients to get their medications.

 "It's a terrible way of policing, essentially what they're going to try do is, rather than go in and physically shut down what they call 'pill mill physicians' or 'dirty doctors' they cut the supply," said Fort Myers pharmacist T. J. Depaola, who says some patients unable to get medication turn to the black market for pain relief.

"You have patients that were being treated for chronic pain; all of a sudden they couldn't get meds, they went to heroin because that's the closest thing to what they were on before."

Finding pain relief in Florida is already difficult. Because of the state’s crackdown on pill mills, many doctors are now unwilling to prescribe opioids and patients report pharmacies are often reluctant to fill legitimate prescriptions.  

A pharmacist who asked to remain anonymous told Pain News Network that many Florida pharmacies already operate under a strict quota system, in which they are allotted a certain number of painkillers per month. He predicted McKesson’s suspension will have a snowball effect, driving patients from one pharmacy to another in search of a dwindling supply of opioids.

“With the DEA restriction on McKesson hydromorphone supplied pharmacies, and with a shift of patient population to pharmacies using alternative suppliers, the latter pharmacies will now exceed the (quota) sooner and exhaust the supplies sooner. It is crazy,” he said.

Further tightening the supply are plans by the DEA to reduce the amount of almost every Schedule II opioid pain medication manufactured in the U.S. by 25 percent or more in 2017. The quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, is being reduced by a third. The DEA said it was cutting the opioid supply to prevent diversion and because of declining demand for painkillers.

I Lost a Good Doctor Because of CDC Guidelines

By Roger Bigelow, Guest Columnist

My doctor responded quickly to the CDC opioid prescribing guidelines by sending a letter to all his patients informing them he would no longer prescribe any opiates to patients in his practice. He gave patients about 4 months’ notice to either find alternative treatment or a doctor who would prescribe opiates.

He had been my general practitioner for about 15 years and had even taken opiates himself when he battled a rare form of cancer recently. He is now in remission.

My doctor and I were friends. In fact, we were members at the same country club. He confided in me. He is by all accounts an outstanding provider. You would be hard pressed to find a better practitioner. Skilled and caring.

He told me the sole reason for changing his opiate policy was fear of the CDC. He demonstrated a "What do you want me to do?" kind of attitude that I suspect is common.

I had expected him to align with his patients, as he has taken an oath to do so. I didn't expect him to cave in so easily. He made no exceptions. I was even more taken aback, given he was a cancer survivor.

As a result, I have had to change doctors, as he left little option. The only pain doctor near where I reside in southern Vermont does not write maintenance prescriptions. I've lost a very good doctor and am now under greater scrutiny.

It's pretty sad when you lose a doctor you had been with for so long. I feel somewhat fortunate to have found another doctor, but it's not a positive change. Not at all.

It's a pretty sad situation we have, where political powers push a false agenda upon the public. If you listen to our "media," you would soon come to the belief that the heroin abuse crisis is solely caused by careless doctors overprescribing. And of course it’s Big Pharma’s fault for developing such effective medications. All it takes is young Jimmy taking two leftover Percocet tablets from the medicine cabinet -- and next thing you know, young Jimmy is plunging a needle into his vein.

Never mind the open borders, drug cartels, counterfeit medications, internet transactions and problems with wholesale distribution. And, of course, young Jimmy (and his divorced parents) are not accountable because addiction is a disease, not a conscious act. So addicts get Suboxone and free needles, while patients with documented medical conditions get cut off -- ironically driving many to street drugs like heroin.

They don't seem to care about the 11 million chronic pain patients who use opioid medication daily.

It's clearly about the money. It always is. With the government paying more and more people (Medicare, Medicaid, Obamacare) and facing an aging population, this is really all about saving our social health programs from destruction.

Prior to accident driven disability, Roger Bigelow worked for nearly 20 years with the New York State Bureau of Narcotics Enforcement, where he helped develop the world’s first prescription drug program designed to curb diversion and fraud. Roger is a national expert on the subject of drug diversion, as well as a chronic pain patient who has endured 17 surgeries.

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.

Medication Could Reverse Peripheral Neuropathy

By Pat Anson, Editor

Blocking a sensory nerve signal with medication could prevent or even reverse symptoms of peripheral neuropathy, according to new research published in the Journal of Clinical Investigation

About 20 million Americans suffer from peripheral neuropathy, which often causes a painful stinging or burning sensation in the hands or feet.  

"Peripheral neuropathy is a major and largely untreated cause of human suffering," said lead author Nigel Calcutt, PhD, a professor of pathology at the University of California San Diego School of Medicine. "It has huge associated health care costs."

In studies on diabetic laboratory rats, Calcutt and his colleagues identified a molecular signaling pathway that, when blocked with the drug pirenzepine, promotes sensory neuron growth and prevents or reverses the nerve damage caused by peripheral neuropathy.

The discovery suggests that pirenzepine and other anti-muscarinic drugs – a class of nerve medication that is already used to treat Parkinson’s disease, motion sickness, irritable bowel syndrome and other conditions – could be used as a new treatment for peripheral neuropathy.

"This is encouraging because the safety profile of anti-muscarinic drugs is well-characterized, with more than 20 years of clinical application for a variety of indications in Europe," said senior study author Paul Fernyhough, PhD, a professor in the departments of pharmacology and therapeutics and physiology at the University of Manitoba in Canada. "The novel therapeutic application of anti-muscarinic antagonists suggested by our studies could potentially translate relatively rapidly to clinical use."

The first symptoms of peripheral neuropathy are usually a tingling or numbing sensation in the toes, feet, and hands caused by small fiber nerve damage. The symptoms progress, spread and become more painful, dramatically affecting quality of life.

Researchers say treating the disease in its early stages is key.

“Since small fiber degeneration develops early in the human disease and can be reliably quantified using a variety of minimal or noninvasive techniques that can be applied iteratively, future clinical trials of anti-muscarinic drugs might feasibly focus on reversal of these early indices of neuropathy,” they said.

“Further, as anti-muscarinic drugs were effective in augmenting collateral (nerve) sprouting in our in vitro assay, this new therapeutic approach may be most effective during the early stages of a dying-back neuropathy prior to overt and/or complete fiber loss.”

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Small fiber neuropathy can also be caused by lupus, HIV, Lyme disease, celiac disease or chemotherapy.

Do Addicts Need Safe Havens to Shoot Up?

By Barby Ingle, Columnist

Lately I have been having more trouble sleeping than usual. At 3 am one night while lying in bed, my mind wandered to the more than 50 personal friends I have lost to suicide, medical complications, delays in treatment, and other health issues since 2012.

By 4 am I was watching the news. I had turned on the TV because my husband moved into a position that activated his “snore button” and I wasn’t going to be able to fall back asleep with that noise.

Then a news promo came across the screen. Next up, the announcer said, we will be discussing a proposal in San Francisco to provide addicts with a supervised facility to shoot heroin and other illegal drugs. Clean needles would be provided at no cost.

They think this will reduce the chances of an overdose death. Similar proposals have been made in other cities, like New York, Seattle and Baltimore.

I couldn’t believe what I was hearing.

I hit rewind and played it again. It really was happening! With the flood of thoughts that came to me, I knew I would never get to sleep and started thinking about the implications if this type of clinic was allowed.

How many ways would it affect our society? What message is it sending? Do I want my tax dollars to go to this type of clinic? Shooting heroin is illegal and there are people who support this?

The CDC put opioid guidelines in place last year for medications that are legal, prescribed and monitored. The guidelines caused many physicians to cut off or lower opioid doses -- even though it was not what some doctors felt was best for their patients. This has led to more suicidal thoughts, attempts, and actual deaths in the pain community.

I know one lady who was unable to get her opioid prescription filled for months. When they finally filled it, she used all the medication at one time to try and kill herself. Why? She didn’t want to face not being able to get the medication again and to go through the withdrawal pain of being without it.

She didn’t die. She was found and placed in a coma in intensive care. When the woman awoke days later, she was angry that her life had been saved.  

We are cutting off pain patients from medication that is legal because abusers may overdose and die. Yet there are plans to give drug abusers who are choosing to behave illegally a safe-haven, while denying legitimate patients access to the care their providers deem necessary.

We already have naloxone and similar medications available for people who overdose. Due to the great lobbying efforts of the “stop the abuse” team, naloxone is now available without prescription in 33 states. So basically it’s wrong to prescribe opioids, but if you choose to abuse them, we want to provide a place for you to use them safely. I am flabbergasted.

Can the legit pain patient show up and get opioids at these clinics as well?

I know if I was a heroin addict where I would be living. I would have my butt planted in a safe-haven drug facility so I could never have to go through withdrawal, be monitored so I don’t overdose, not have to pay for the care, and live the life I want.

That sounds much better than the life of the chronic pain patient, who comes in monthly at their own expense to get a prescription refilled. They are often drug tested, and if anything suspicious is found in their system, they are often taken off opioids and abandoned by their doctors.

Let’s circle back with this argument. Currently, legit pain patients are getting cut off from legally prescribed medications that help them be more productive and live better lives. This leads to withdrawal, which can cause death, and an increase in suicidal thoughts and actions. Some start looking for illegal means to help alleviate their pain.

Are we going to at least provide them with Suboxone, naloxone or methadone to help them come off the opioids more humanely?

We are helping drug abusers find new ways to keep abusing, while chronic pain patients are being ignored and discounted.

Let us not forsake one group for another. We need to find ways that address both pain and addiction concurrently, that don’t affect either side negatively or take away the rights of one group to give more rights to another. Let’s lower suicide statistics for those in chronic pain and overdose statistics for those who are abusing. It can be done. Silly proposals to provide safe-haven drug facilities for illegal drug use are wrong.

I am so looking forward to hearing everyone’s opinion in the comment section. Maybe there is something I am missing as to why anyone would think this is a good idea?

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

CDC Guidelines Study: The Devil Is in the Details

By Stephen Ziegler, PhD, Guest Columnist

JAMA Internal Medicine has published a research letter that purports to be an examination of the relationship between funding from opioid manufacturers and opposition to the prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in March of 2016.

The authors examined the written comments made to the CDC during the open comment period, asserted that those who had received funding were more likely to oppose the CDC guidelines, and concluded that their “findings demonstrate that greater transparency is required about the financial relationship between opioid manufacturers and patient and professional groups.”

The following commentary, while critical of information contained in the article written by Caleb Alexander, Andrew Kolodny and others, nevertheless concludes with some positive suggestions for the future.

Illicit Opioids: The Harms Associated With Conflation of Data

The research letter, like many articles authored by those who are rightly concerned about addiction and overdose, begins by asserting that an association exists between increases in opioid prescribing and “large increases in addiction and overdose deaths in the United States.”

However, there are several problems with such a statement. First, association is not causation. For example, while a positive association exists between the size of a fire and the number of fire engines on the scene, fire engines for the most part do not cause fires -- they are only associated with it. Further, it is misleading and harmful to lump all opioids, prescription and illicit, together.

While conflating the two may help create better headlines and fuel the hysteria, such conflation is misleading because studies continue to indicate that two opioids, illicit fentanyl and heroin, are major drivers in the alarming increase in addiction and overdose, not prescription opioids.

Moreover, lumping all opioids together can be harmful because it ignores the size and complexity of the problems associated with the use and abuse of illicit and licit drugs. Because drug abuse remains a moving target, it is important to draw distinctions between a variety of factors and sources so that solutions can be tailored and refined. One size does not fit all.

Unclear Methodology Used to Classify Comments

Another problem with the JAMA article was the lack of measurement clarity regarding content analysis and how the authors categorized (coded) the comments that were submitted to the CDC during the open comment period.

According to the authors, the comments were classified as belonging in one of four mutually exclusive categories: “supportive, generally supportive with recommendations, generally not supported with recommendations, and not supportive.”

While it is unclear whether the coding occurred before or after the comments were reviewed, one section of the paper the authors pointed out that about 6% of the comments “were coded as supportive by 1 reviewer and not supportive by the other; a third reviewer adjudicated these cases.”

The first question that comes to mind is: who was the reviewer? Since it is likely that the authors were not randomly selected, it remains unclear what criteria was used to adjudicate disputes related to coding, especially when we know that two reviewers were at opposite ends of the spectrum and the coding scheme was central to the study.

Along these same lines, what constitutes opposition to the CDC guidelines? Was opposition binary (yes/no), was it mixed (and if so, where was the line), or did opposition exist along a range (strong or weak)?

When dealing with qualitative data (words as opposed to numbers), there are tendencies in terms of direction, but the devil is in the details. This is notable because there were likely many different reasons commentators and organizations were not supportive of the CDC prescribing guidelines, such as, but not limited to:

  1. The secretive nature of the entire process
  2. The short time frame the CDC allotted for public comments (initially less than 24 hours)
  3. Allegations that the process violated the Federal Advisory Committee Act
  4. Strong recommendations based on weak evidence
  5. Committee membership that lacked balance and broad stakeholder involvement
  6. An anti-prescription opioid agenda or bias by some committee members
  7. The fixation on dosing limits ignored the problems associated with converting dosage from one opioid to another, the differences in patients, and the potential for unintentional overdose at any dosage level
  8. The lack of balance and selective nature of the literature cited in the guidelines
  9. The failure to recognize that non-pharmacologic therapy and alternatives to opioids may not be effective or covered by insurance
  10. An ironic lack of transparency and full disclosure concerning potential conflicts of interest among those involved in the guidelines at various levels from start to finish

Conclusion

While the reduction of harms associated with the use of prescription drugs and illicit opioids such as heroin remains essential to improving the public health, it serves no laudable purpose to continually lump all opioids together.

Drug abuse is a highly complex bio-psycho-social phenomenon that requires recognition that not all people, nor problems, are the same. We must also not lose sight of the fact that millions of Americans are suffering from chronic pain, alternatives to opioids may not be as effective or covered by insurance, and the overwhelming majority who take prescription opioids use them responsibly.

In regards to the conflicts of interest issue, while the authors eventually admitted that the “CDC did not prompt or require organizations to disclose their financial associations as part of their comments,” I agree that disclosing real or potential conflicts of interest in the future is good for all involved. However, such disclosure should not be limited to just the pharmaceutical industry. It should also include government agencies and those in the substance abuse community.

I have and continue to provide consultation to government and the pharmaceutical industry about the need for balanced solutions that help ensure appropriate access, while at the same time prevent abuse. I care about the under-treatment of pain, as I am sure that those in the substance abuse community care about those suffering from addiction.

Consequently, what both the pain community and the substance abuse community need to focus on is finding common ground and forging balanced solutions, since finger pointing, bullying or taking a zero-sum game approach only impedes progress.

Stephen J. Ziegler, PhD, is a Professor Emeritus of Public Policy at Indiana University-Purdue University in Fort Wayne, Indiana.

Dr. Ziegler conducts research, provides continuing medical education, and consults on the topics of opioid risk management and the impact of drug regulation and enforcement on the treatment of pain. He has been published in several peer reviewed journals and serves as a reviewer for several journals such as the Journal of Opioid Management, Pain Medicine, Cancer, and the Journal of Medical Ethics. Prior to obtaining his law degree, Dr. Ziegler worked as a police detective and as a Task Force Officer for the U.S. Drug Enforcement Administration.

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.

Bias and Conflict of Interest in Opioid Guidelines Study

By Pat Anson, Editor

A new study published in JAMA Internal Medicine is claiming that some patient advocacy groups and medical organizations that opposed the Centers for Disease Control and Prevention’s opioid prescribing guidelines had a conflict of interest.

Ironically, the two main authors of the study appear to have a conflict of interest themselves, as well as a bias against opioid pain medication.

In their review of 158 organizations that made public comments on the CDC guidelines – which discourage doctors from prescribing opioids from chronic pain – researchers found that about one third (38%) of those that accepted funding from opioid manufacturers opposed the guidelines. This alleged conflict of interest should have been disclosed, they say.

“A major concern is that opposition to regulatory, payment, or clinical policies to reduce opioid use may originate from groups that stand to lose financially if sales of opioids decline,” wrote senior author G. Caleb Alexander, MD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.

“Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

One of the co-authors who designed the study is Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the CDC guidelines and was itself accused of numerous conflicts of interest. Kolodny is the former chief medical officer of Phoenix House, which runs a chain of addiction treatment centers and was PROP’s chief source of financial support until recently.

Alexander, who is a widely published researcher who has collaborated several times with Kolodny on other opioid-related studies, failed to disclose in the JAMA study that he has accepted funding from Otsuka Pharmaceuticals. The Japanese drug company makes Abilify, an anti-psychotic medication prescribed off-label to treat chronic pain. The amount paid to Alexander in 2015 was relatively small, a $668 fee for consulting, but according to the criteria used in his own study, it represents a conflict of interest.

Any amount of money accepted from an opioid manufacturer was considered a conflict of interest in Alexander and Kolodny’s study, whether it was a grant, gift, advertising or some other material support. No evidence was required to prove the money swayed an organization one way or another. In fact, nearly two-thirds (62%) of the organizations that accepted funding from opioid makers supported the CDC guidelines, disproving their own theory.   

“I’ll be the first to say that our method of assessing financial relationships is somewhat imprecise,” Alexander told Pain News Network. “This study was not designed for causal inference. This study doesn’t permit us to say what the effect of these funding relationships has been. But one has to wonder, when this amount of money is being spent, what the effects are.”

PROP and the “Opioid Lobby”

The claim that many medical organizations and patient advocacy groups have come under the influence of the “opioid lobby” has long been used by Kolodny.

“CDC’s plan was effectively blocked by intense pressure from the opioid lobby, which sees more cautious opioid use as a financial threat,” wrote Kolodny in a newsletter sent to PROP supporters in December 2015, after the CDC guidelines were temporarily delayed after a public outcry and threats of a lawsuit.

Kolodny’s smear campaign was widely covered uncritically by the news media, even though there was no evidence cited to support it.

“This is a big win for the opioid lobby,” Koldony told the Associated Press.

“The story here is how the opioid lobby is using the Cancer Action Network to discredit a public health effort to limit opioid prescribing,” Kolodny told The Hill.

“Here’s background on shady organization now attacking CDC’s draft opioid guideline,” Kolodny posted on Twitter.

Kolodny did not respond to a request for comment for this story.

Like his co-author, Alexander also is convinced there is a quid-pro quo between opioid manufacturers and groups that they fund.   

“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” Alexander told the AP last year. “It’s an artificial conflict, but there are lots of vested interests behind it.”

Does the opioid lobby even exist? Are patient advocacy groups so easily swayed by their funding sources? Kolodny and Alexander’s study presented little evidence of either, yet they still managed to get it published in an influential journal published by the American Medical Association.

“No one in the pharmaceutical industry has ever asked me or anyone that is on our voting board to publicly state a specific stance on any issue regarding treatment options. Not one pharmaceutical representative has ever asked anyone from iPain to comment on the CDC guidelines,” said Barby Ingle, a PNN columnist who is President of the International Pain Foundation (iPain), a patient advocacy group.

Ingle, who did submit her own personal comments on the CDC guidelines, says it is very difficult to get funding from drug makers.

“We have gotten to the point of not even applying for funding unless we are contacted,” said Ingle. “Even when notified of funds available, iPain did not receive the funding requested and it turned out to be a waste of time on our part.”

What is a Conflict of Interest?

“These people perhaps don’t quite understand what is the definition of a conflict of interest,” said Richard Samp, chief counsel of the Washington Legal Foundation, which threatened to sue the CDC for violating federal law when it drafted the opioid guidelines.

“As I understand conflict of interest under federal law, that generally means that somebody has been appointed to serve in one position, but they have some other financial or ideological interest that conflicts with the interests that they’re supposed to have,” Samp told PNN.

“That was the focus of our criticism of the process that CDC went through in adopting its draft guidelines, which were written with the assistance of an advisory group that included people who had very severe conflicts of interest. For example, one particular member of the group, Jane Ballantyne, was a paid consultant for a plaintiffs’ law firm that had a vested interest in suing opioid manufacturers.”

Dr. Ballantyne is the President of PROP, the organization founded by Kolodny. At least four other board members of PROP, including Kolodny himself, served on various CDC panels that advised the agency during the drafting of the guidelines, a matter that the agency refused to disclose for several months.   

“What they are talking about (in the JAMA study) is not a conflict of interest. They’re just talking about the fact that some people who file comments with federal agencies have a particular point of view,” said Samp. “Every citizen regardless of his or her point of view and regardless of his or her background has a right to comment on what our government is doing.”

Another way to look at whether there is a conflict of interest is offered by Stephen Ziegler, PhD, in a commentary for Pain News Network (see "CDC Guidelines Study: The Devil Is in the Details").

“Association is not causation. For example, while a positive association exists between the size of a fire and the number of fire engines on the scene, fire engines for the most part do not cause fires -- they are only associated with it,” Ziegler wrote.

Ziegler says it’s time for the pain community and the addiction treatment community to end the finger pointing and bullying over opioids, and start finding common ground.

“It is misleading and harmful to lump all opioids, prescription and illicit, together. While conflating the two may help create better headlines and fuel the hysteria, such conflation is misleading because studies continue to indicate that two opioids, illicit fentanyl and heroin, are major drivers in the alarming increase in addiction and overdose, not prescription opioids,” Ziegler wrote.

The American Academy of Pain Medicine (AAPM), an association of pain management physicians, also released a statement about the JAMA study, saying it agreed that “disclosure is one means of managing conflicts of interest.” 

While the AAPM cautiously supported the CDC guidelines, it also warned that their widespread implementation could lead to problems.

“It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately,” the AAPM said.

Since the guidelines were released in March 2016, many pain patients have complained to PNN that their opioid doses have been reduced or eliminated, and that it’s become difficult to find a doctor willing to treat chronic pain. Others have said they are contemplating suicide because their pain is going untreated.

How to Cope With Fibromyalgia Fog

By Lana Barhum, Columnist

My day job in the legal field can be pretty demanding, involving numerous phone calls, emails, deadlines, and other verbal and written communications. Some days, fibromyalgia fog makes my job a whole lot harder. 

Whether it is memory issues, trying to find the right words, misplacing things, or transcribing phone numbers correctly, fibro fog can affect the quality of my work.

It also affects my personal life, sometimes leaving me forgetful, confused, flustered carrying on conversations, and even lost trying get to destinations often traveled.

Fibro fog is the term used to describe the cognitive difficulties associated with fibromyalgia. According to a 2015 review in Rheumatology International, some fibromyalgia patients reported that fibro fog is even more difficult to manage than their pain and fatigue.

At least half fibromyalgia patients “experience distressing subjective cognitive impairment,” according to a 2015 report in Arthritis Care and Research.  

Fibro fog can cause short term memory loss, distraction, forgetfulness, difficulty in carrying on conversations, inability to process new information and occasional disorientation.  In most cases, fibro fog is a mild symptom, but for some people it can be quite scary, especially for those used to functioning at very high levels.

Fibro fog can leave me temporally disorientated and unable connect my thoughts. My thoughts come in, but they are not being processed correctly, or in a way I can properly put into words. And that can be stressful and frightening.

Causes of Fibro Fog

The reasons for fibro fog are not well understood.  But doctors speculate fibro fog is a result of fibromyalgia patients' inability to get restorative sleep.

"Therefore they're chronically fatigued," says Corey Walker, MD, a rheumatologist at the Intermountain Health Care System in Logan, Utah. "Their minds aren't rested." 

Non-restorative sleep is the number one sleep issue among fibromyalgia patients. Even after getting a full night's sleep, you may still wake up feeling exhausted, or as if you have not slept at all. Up to 90% of fibromyalgia patients experience non-restorative sleep, according to a 2016 report in the Journal of Pain and Relief by researchers at Luigi Sacco University Hospital in Milan, Italy. These sleep problems can contribute to pain, daytime fatigue, and fibro fog.

"A large percentage of FM patients report sleep disturbance, including difficulties in falling or staying asleep, early morning awakenings and non-restorative sleep," says Maurizio Rizzi, MD, and colleagues. The researchers conclude managing sleep disorders could actually reduce fibromyalgia symptoms, including fibro fog.

Other theories blame pain levels for fibromyalgia fog. When people experience fibromyalgia pain, the belief is that some parts of their brains do not receive enough oxygen, causing confusion and disorientation. Pain also stimulates areas of the brain involved in cognitive tasks. Quite simply, it is just hard to concentrate when you are in pain.

Overexertion, extreme fatigue, stress and side effects of fibromyalgia medications are also blamed for fibro fog.  My fibro fog is worst when I am exhausted, and as a single parent, I have been known to push myself to the point of cloudiness. Overstimulation, such as background noise and fluorescent lights, is also a fibro fog trigger, along with not getting a good night's sleep.  All of these things can make it harder to focus on the things I need to do.

Coping With Fibro Fog

While there are no specific treatments for fibro fog, you can alleviate fibro fog by following your doctor's treatment plan. Your doctor may also prescribe medications to manage specific symptoms.  For example, he or she may prescribe a sleep aid to help improve sleep, and if sleep quality is better, you’ll feel more alert and focused. 

Here are some other strategies for coping with fibro fog.

Get Quality Sleep. Because lack of sleep is a big reason for fibro fog, improving sleep habits may provide relief. For example, try going to bed at the same time every night and get up in the morning at the same time every day. 

Stay Active. Even though you struggle with pain, you should still keep moving. Low impact activities, such as walking, are easy to do. Try to stay active throughout the day by sitting less, taking stairs more often, and parking further away.

Maintain a healthy diet. Cognitive functions do improve when you eat real food. This includes fruits and vegetables, whole grains, lean meat, and low-fat dairy.

Avoid caffeine. Most people think caffeine helps with alertness and awareness. But, caffeine makes symptoms worse for fibromyalgia patients, and contributes to sleep issues. Moreover, it is a stimulant that gives you energy and forces you to crash once it wears off.

Stop stressing. Stress triggers and worsens fibro fog.  Do your best to avoid stressful situations. Try relaxation breathing when you are feeling overwhelmed.

Keep a calendar. A calendar is a lifesaver when you can't think straight.  Keep track of appointments and events on a paper calendar or computer program.  Set timers and alarms as appointment reminders.

Have routines. Having routines for simple tasks helps, too.  For example, you may want to keep your purse, coat, and keys in the same place, so you are less likely to be searching when you need them and fibro fog is making it difficult to think straight.

Don’t Take Life So Seriously

Like most other fibromyalgia symptoms, there is no magic, one-size-fits-all solution to combat fibro fog. It usually requires a combination of strategies and habits to reduce cognitive issues. You will need to try and practice coping strategies until you find what works for you.

Remember to be kind to yourself when you struggle with mental unclarity.  Slow down if you are feeling frustrated and regain focus.  Lastly and most importantly, stop pushing yourself to adjust and just take care of yourself.

I have learned to not take life so seriously and to have a tongue-in-cheek attitude about my cognitive struggles. There are plenty of foggy -- yet funny – moments, like when I put my keys in the fridge and the milk in the cabinet.  I can either get depressed or laugh at these silly mishaps.  Taking yourself lightly will give you an emotional boost and put a smile on your face, and there are plenty of good health benefits when you are happier.

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

To learn more about Lana, visit her website.

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

Pain Community Reacts to ‘Big Brother’ Medicare Policy

By Pat Anson, Editor

Here we go again.

That’s seems to be the reaction from many in the pain community to plans by the federal government to have pharmacists report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients. (See “Medicare Takes Big Brother Approach to Opioid Abuse”)

The Centers for Medicare & Medicaid Services (CMS) says its new strategy to fight opioid abuse is aimed at “incentivizing prescribing behavior” by having pharmacists identify and report doctors who may be overprescribing opioids and patients who may be abusing them. 

“It is a terrible idea to pit pharmacist against physicians. It is an unbelievably perverse way to solve a serious healthcare problem that requires trust and collaboration among all the stakeholders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Many, many people with pain and addiction are going to be harmed by this decision.”

“This will only serve to further increase stigma and increase distrust between patients, their prescribers, and pharmacists,” says Anne Fuqua, a former nurse, chronic pain sufferer and patient advocate.

“Just the words ‘incentivized prescribing’ makes me shudder.  It may well help root out a limited number of substance abusers and decrease pharmacy claims for Medicare Part D and Medicaid, but this is neither an effective manner to intervene when substance abuse does exist nor an ethical way to decrease prescription drug benefit claims.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs. Under the new policy, information about doctors and patients who’ve been red flagged by pharmacists would be shared through a database with all insurers. The companies would be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

“A policy like this, that encourages pharmacists to report the prescriber or patient to the insurer for investigation, is dubious enough.  It's even more serious that the allegations would be entered in a database whether or not they are proven,” said Fuqua. “This would be like your doctor saying they think it's possible a patient is misusing medication and then emailing this to all the doctors in your state.  Every element of this reeks of big brother and directly contradicts treating addiction as a health issue.”

“It appears that CMS is dictating that pharmacists perform activities that are both outside of their training and the legal authority granted to them under the state's practice act,” said Steve Ariens, a retired pharmacist and patient advocate. “Pharmacists don't have access to the patient's entire medical records. They are being told by CMS to both diagnose and prescribe what is right for a patient.”

“Many of the pharmacists I know are already overworked with other regulations to the point of PDMP’s not being updated in a timely manner. I know of patients who have been affected by this personally,” said Barby Ingle, president of the International Pain Foundation and a PNN columnist.   

“What a pharmacist believes about a medication’s appropriateness should not come into play when they are not trained on the medical aspects of chronic conditions. Pharmacists know about medication, but not in-depth information on diseases we are living with and therefore should not be making the call on what they deem suspicious on behalf of a prescriber.”

Medicare Policy Based on CDC Guidelines

CMS is basing many of its policy decisions on opioid prescribing guidelines released last year by the Centers for Disease Control and Prevention. The guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and meant only for primary care physicians. But they are being widely adopted by insurers and doctors throughout the country as a “standard of care,” even though the scientific evidence supporting many of the guidelines is weak.

CMS seems unconcerned by that lack of evidence.

“Where sufficient evidence was not available, the CDC guidelines are based on expert opinion, as noted by the CDC,” the agency said in a 30-page briefing paper on its Opioid Misuse Strategy.

“The guidelines were formed by consensus of mostly people with agendas, biased against opioids, and totally insensitive to the needs of people in pain. The dose limits suggested by the CDC guidelines are arbitrary, not evidence based,” said Dr. Webster. “

“Let's be clear about the CDC guidelines.  A major reason the guidelines were developed was to reduce cost of drugs for payers.  If Medicare and Medicaid patients have an increasing incidence of opioid use disorder it is because these people do not have any alternative treatments for their pain other than an opioid. 

“If CMS is going to endorse the guidelines that have little to no science basis, then they should mandate all of the alternative therapies to opioids have unlimited coverage and that payers be mandated to provide adequate coverage for the underlying reasons that lead to opioid use and mental health disorders.  This would more likely reduce the incidence of an opioid use disorder.”

CMS is not requiring insurers to cover alternative pain therapies, such as massage and acupuncture, but says it is a prioritizing efforts to develop more evidence to support their use.

Public Not Informed

CMS convened a “cross-agency working group” to develop its opioid misuse strategy, and says it is “working closely” with other federal agencies such as the CDC, Food and Drug Administration, National Institutes of Health, and the White House Office of National Drug Control Policy. Members of the working group were not identified.

“CMS sought representatives from every component of the agency to ensure a broad range of expertise and perspectives. This diverse group assessed the benefits, limitations, and improvement opportunities within CMS’s current policies and programs. The group then defined desired outcomes from the perspective of CMS’s unique role as a leading payer of health care and identified key actions to achieve those outcomes,” the agency said in a statement on its website.

But CMS never held a public hearing or sought public comment prior to the strategy’s release last week. Several medical organizations and patient advocacy groups contacted by Pain News Network were unaware the policies were even being developed. 

“I was not even aware that these new CMS policies were being created and as a patient on Medicare, I think that we should have been notified at minimum,” said Barby Ingle. “Our opinion as patients in the program should have been a part of the voice of something that will affect proper and timely access to care.”

“Society would never tolerate any other patient group being treated in this manner,” said Anne Fuqua. “It's no accident that this provision has been given so little attention.”

On its website, CMS says it now welcomes “input from clinicians, patients, consumers, caregivers, manufacturers, researchers and others.” But it never makes clear how interested parties can comment or participate, such as a notice or public comment period published in the Federal Register.

The secretive actions of the agency – so far – are similar to those used by the CDC in developing its opioid prescribing guidelines. For several months, the CDC refused to identify members of a “core expert group” that helped draft the guidelines, which were released in September 2015 to a small and mostly selected online audience.

Initially, the public was given only 48 hours to comment on the CDC guidelines -- a decision that was reversed after a public outcry and threats of a lawsuit. Over 4,300 public comments were later received online, most of them in opposition to the guidelines, which were released virtually unchanged in March 2016.

CMS has not responded to repeated requests for an interview about its opioid misuse policies. It is not clear when the policies will be initiated, who was involved in drafting them, or where the idea came from.

CMS caved into political pressure last year when it agreed to drop pain related questions from patient satisfaction surveys. Politicians, hospitals, the American Medical Association, and other health organizations all claimed the questions encouraged the overprescribing of opioids. CMS officials said there was no evidence that was true, but agreed to eliminate the questions in 2017 patient surveys. The agency is still working on a future set of questions to replace them.

‘Substantial Evidence’ Marijuana Relieves Chronic Pain

By Pat Anson, Editor

A major new study released today on the health effects of medical marijuana has found “substantial evidence” that cannabis is an effective treatment for chronic pain in adults.

The lengthy study by a committee of the National Academies of Sciences, Engineering, and Medicine looked at over 10,000 scientific reports on marijuana and its active chemical compounds. The committee studied a range of possible impacts marijuana can have on pain, cancer, mental health, injuries and other health conditions.

Marijuana is now the most popular illicit drug in the United States, although it is legal under state law in 28 states and the District of Columbia.

A recent survey found over 22 million Americans have used marijuana in the past month, with nine out of ten users saying their primary use was recreational. Only about 10 percent reported they used cannabis solely for medical purposes. 

“For years the landscape of marijuana use has been rapidly shifting as more and more states are legalizing cannabis for the treatment of medical conditions and recreational use,” said Marie McCormick, the committee chair and a professor of pediatrics at Harvard Medical School.

“This growing acceptance, accessibility, and use of cannabis and its derivatives have raised important public health concerns.  Moreover, the lack of any aggregated knowledge of cannabis-related health effects has led to uncertainty about what, if any, are the harms or benefits from its use.  We conducted an in-depth and broad review of the most recent research to establish firmly what the science says and to highlight areas that still need further examination.”

The committee could find only five good-to-fair quality studies on whether cannabis was an effective treatment for chronic pain.  In all five studies, the cannabis was either smoked or vaporized, and did not include other delivery methods such as food, creams or oils infused with cannabinoids.  

“Thus, while the use of cannabis for the treatment of pain is supported by well-controlled clinical trials... very little is known about the efficacy, dose, routes of administration, or side effects of commonly used and commercially available cannabis products in the United States. Given the ubiquitous availability of cannabis products in much of the nation, more research is needed on the various forms, routes of administration, and combination of cannabinoids,” the committee found.

"It is wonderful to see that what I experience is now being recognized and respected in the medical community," said Ellen Lenox Smith, a PNN columnist who uses marijuana to relieve pain from Ehlers Danlos syndrome.

"I have been allowed nightly rest due to a simple teaspoon of oil at night. Somehow, the next day I rarely need to turn to more, for it continues to calm the body into the next day for me."

Others have also found that cannabis reduces their need for pain relievers. In states where medical marijuana is legal, the committee found growing evidence that users were replacing opioids with cannabis.

“Recent analyses of prescription data from Medicare Part D enrollees in states with medical access to cannabis suggest a significant reduction in the prescription of conventional pain medications,” the committee found. “Combined with the survey data suggesting that pain is one of the primary reasons for the use of medical cannabis, these recent reports suggest that a number of pain patients are replacing the use of opioids with cannabis, despite the fact that cannabis has not been approved by the U.S. Food and Drug Administration (FDA) for chronic pain.”

For adults muscle spasms caused by multiple sclerosis, the committee said there was substantial evidence that short-term use of oral cannabinoids – marijuana-based products that are orally ingested – improved their symptoms.  In adults with chemotherapy-induced nausea and vomiting, there was also conclusive evidence that oral cannabinoids were effective in treating those symptoms.

There was a lack of data on the effects of cannabis on the immune system, and insufficient evidence to support or refute a link between cannabis and adverse effects on the immune status of individuals with HIV.  Limited evidence does suggest that regular exposure to cannabis smoke may have anti-inflammatory effect.

Regarding the link between marijuana and cancer, the committee found evidence that suggests smoking cannabis does not increase the risk for cancers often associated with tobacco use. However, the committee did find that smoking cannabis on a regular basis was associated with more frequent chronic bronchitis, coughing and other respiratory issues.

To download a free copy of the study, click here.

Medicare Takes 'Big Brother' Approach to Opioid Abuse

By Pat Anson, Editor

A new strategy being developed by Medicare to combat the abuse of opioid pain medication will encourage pharmacists to report physicians who may be prescribing opioids inappropriately. Patients that a pharmacist believes are abusing opioids could also be referred for investigation.

The strategy, which has yet to be finalized, was outlined by the Centers for Medicare & Medicaid Services (CMS) last week in a 30-page report on the agency’s “Opioid Misuse Strategy.”  It has not been widely publicized by CMS or reported in the news media.

“Many Medicare and Medicaid beneficiaries and their families have experienced opioid use disorder, commonly referred to as addiction,” the agency says in the report’s executive summary.

“Given the growing body of evidence on the risks of misuse… CMS is outlining our agency’s strategy and the array of actions underway to address the national opioid misuse epidemic.”

One strategy CMS will explore is “incentivizing prescribing behavior” by encouraging physicians and pharmacists to consult with prescription drug monitoring programs (PDMPs) to review each patient’s prescription drug history. The use of PDMPs is fairly widespread already, but CMS would take it a step further by encouraging pharmacists to report suspicious activity by prescribers and patients.

“Pharmacies would be able to identify prescribers with potentially illicit prescribing practices or beneficiaries (patients) who may be overusing opioids. This information can be referred to health plans to investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.”

Investigations of abuse or inappropriate prescribing would be shared with insurers enrolled in the giant Medicare/Medicaid system, even if the allegations are never proven. CMS contracts with dozens of private insurance companies to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“Part D plans can use CMS’s information sharing platform to identify leads for their own internal investigations and can report actions they have taken. For example, if one plan sponsor suspects a provider of inappropriate prescribing behavior, it can alert other plans to that possibility so that those plans can conduct their own evaluations and take coordinated action if warranted.

“The results of these projects are provided to plan sponsors so that additional actions can be taken, including initiating new investigations, conducting audits, or terminating physicians and pharmacies from their network.”

“It looks like ‘Big Brother’ is going to watch everyone,” says Rick Martin, a retired Las Vegas pharmacist who suffers from chronic back pain.

“Pharmacists are going to be even more paranoid than they already are," Martin wrote in an email. “Retail pharmacists don't have time for this. They aren't the police. Nevada has a PDMP. It already shows a significant decrease in prescribing patterns over the last several years, so it is working.  With the CMS, just who decides what are appropriate quantities and proper prescribing habits?”

CMS Using CDC’s Prescribing Guidelines

In developing its strategy, CMS is relying heavily on prescribing guidelines released in 2016 by the Centers for Disease Control and Prevention, which discourage doctors from prescribing opioids for chronic pain. CMS says it will use the “evidence-based guidelines” to determine what constitutes inappropriate prescribing. The guidelines include a recommendation that opioids be limited to no more than 90 mg of morphine equivalent milligrams a day, a dose that many patients in severe chronic pain consider inadequate. 

The CDC maintains the guidelines are “voluntary” and intended only for primary care physicians. However, under the CMS strategy, the guidelines would apply to all prescribers, except those treating cancer or patients in palliative care.

“I just hate to see something that CDC itself said was voluntary, was a recommendation, and really isn’t all that specific if you really read it, get turned into something that creates bright red lines. And if you step across the line, you’re going to get yourself in trouble. I don’t think that’s right,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, the nation's largest pain management organization.

CMS says the additional scrutiny of doctors and patients is needed because “the Medicare population has among the highest and fastest-growing rates of diagnosed opioid use disorder,” which the agency estimates at 6 out of every 1,000 beneficiaries. Addiction rates are higher among Medicaid beneficiaries, at 8.7 patients for every 1,000, a figure 10 times higher than patients covered by private insurance plans.

“Because there is no systematic policy of screening for opioid use disorder and patients are unlikely to volunteer that they are misusing their medication or are using opioids like heroin because of discrimination and stigma, these rates are likely underestimates,” CMS says.

Rick Martin believes the Medicare policies will make physicians even less likely to prescribe opioids and pharmacists less likely to fill legitimate prescriptions.

“Pharmacists, like the docs, are just plain scared. If they don't know you, many are reluctant to fill,” said Martin, who is enrolled in Medicare's Part D prescription drug plan.

“One pharmacy I went to refused to fill my bona fide legitimate prescription because it exceeded an arbitrary amount. The manager didn't want any extra scrutiny from DEA, the home office, the PDMP, the board of pharmacy, or the (drug) wholesaler. Even though I was in the system for over 2 years and had previously had even higher amounts filled.

“One of the pain docs I am working with told me he has gotten numerous letters from Humana and one other (insurer) because he is in the upper 1% of dispensing opioids. Well, duh!  He is an exclusive pain management doctor. They didn't compare him with other pain doctors, just ALL doctors. Stupid. What will the CMS do on top of what goes on already?”

Bob Twillman worries the CMS strategy will create distrust between physicians and pharmacists.

“We’ve been trying to make efforts over the last few years to get pharmacists and physicians to work more closely together. I’m concerned this could increase suspicion between the two and be counter to that effort,” said Twillman. “Getting prescribers and pharmacists to work together is an important thing in enhancing patient safety and if we do something like this and short circuit that effort we’re doing more harm than we are good.”

CMS did not say when it planned to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency only said in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

Also unclear is why CMS and the Department of Health and Human Services would take a major step affecting the healthcare of tens of millions of patients and their doctors in the final days of the Obama administration.

“The fact that this is coming out a couple of weeks before the new administration comes in does make it a little bit odd. It makes me wonder how many legs it has or whether it will carry over into the next administration,” said Twillman.