CDC: Emergency Room Overdoses Up Sharply

By Pat Anson, Editor

Emergency room visits for opioid overdoses have soared by 30 percent in 16 states, according to a new Vital Signs report by the Centers for Disease Control and Prevention. The CDC called the report a “wake-up call to the fast-moving opioid overdose epidemic.”

Between July 2016 and September 2017, there were over 142,000 suspected opioid overdoses treated in hospital emergency rooms in the 16 states. Overdoses increased for men and women in all age groups, in all regions of the country, and in rural and urban areas.

The new report does not specify how many patients died or if the overdoses involved prescription opioids or illegal opioids like heroin and illicit fentanyl. A previous report by the CDC indicated that over half the nation’s fatal overdoses are now linked to fentanyl, a synthetic opioid increasingly available on the black market.

“Long before we receive data from death certificates, emergency department data can point to alarming increases in opioid overdoses,” said CDC Acting Director Anne Schuchat, MD. “This fast-moving epidemic affects both men and women, and people of every age. It does not respect state or county lines and is still increasing in every region in the United States.”

Ten of the 16 states studied had significant increases in emergency room overdoses, with the number of overdoses in Wisconsin up by an alarming 109 percent.  Opioid overdoses in Delaware also doubled.

Midwestern states saw the biggest increase overall, with a 70% increase in overdoses, followed by the West (40%), Northeast (21%), Southwest (20%) and Southeast states (14%).

Overdoses declined by 15% in Kentucky, and by smaller amounts in Massachusetts, New Hampshire and Rhode Island. Schuchat said the decline could be related to the increased availability of drugs like naloxone, which can rapidly reverse the effects of an opioid overdose.

Failure of Opioid Guidelines Ignored  

The Vital Signs report did not examine the apparent failure of the CDC’s opioid prescribing guidelines to have any impact on the overdose rate. The agency's controversial guidelines were not even discussed during a 30-minute briefing Schuchat had with reporters today.

Since the CDC guidelines were released in March 2016, many pain patients say their opioid doses have been reduced or eliminated, and the quality of their pain care has deteriorated. Some patients abandoned by doctors are having trouble finding new ones willing to treat them.

A recent report from the Massachusetts Department of Public Health found that prescription opioids were involved in only about 15% of the fatal overdoses in 2017, while fentanyl was involved in 83 percent of the opioid deaths in that state.

Critics Pan Medicare Plan to Reduce High Dose Opioids

By Pat Anson, Editor

Over 1,200 people have left public comments in the Federal Register about changes to Medicare's Part D prescription drug plan, most of them sharply critical of rules that would make it harder for Medicare patients to obtain high doses of opioid pain medication.

Under the proposed regulations for 2019, a ceiling for opioid doses would be set at 90mg morphine equivalent units (MME) for all Medicare beneficiaries.  Any prescription at or above that level would trigger a “hard edit” rule requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose – with the insurer being the final arbiter in deciding who gets the higher dose.  

If adopted, critics say the rule would force many high-dose opioid patients to be abruptly tapered to lower doses, causing severe pain and withdrawal symptoms -- and possibly leading to illegal drug use and suicide.

“Suddenly dropping opioid doses will cause acute opioid withdrawal, exacerbation of pain, and increased disability with decreased productivity. It also increases the risk that patients will migrate to riskier alternatives such as heroin or fentanyl,” wrote David Kan, MD, an addiction psychiatrist.

“The proposed rule change is in the right spirit but very, very risky in reality. I urge CMS to reconsider the arbitrary dose limit on opioids. The unintended consequences are potentially devastating to our patients and community.”

“This is archaic medicine and does more harm than one can imagine,” wrote pain patient Henry Yennie. “The DEA, HHS, private insurers, and now CMS are pursuing policies and restrictions that will cause harm and suffering to millions of people... You are complicit in the pain, suffering, and documented damage that will result.”

“I cannot understand how Medicare can be so uncaring about the pain people have,” wrote Mikal Casalino, a 72-year old pain patient. “Limiting the dosage to an arbitrary amount is not going to be helpful for individuals. Each person who needs medication deserves the best care possible, and that will depend on both condition and need.”

“I think it is absolutely ludicrous to imagine that a third party could presume to place a maximum daily or monthly limit on my, or any other chronic pain patient's, medication. Each person's tolerance for and requirement of medication varies tremendously. How could you possibly imagine that you could come up with a generic formula which could fit every chronic pain patient across the board?” wrote Cyrynda Walker.

A joint letter opposing the rule change was submitted by 180 doctors and academics, including some who assisted in drafting the CDC’s controversial 2016 opioid prescribing guidelines. The letter points out that a 48 percent reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients in the context of multiple regulatory initiatives, and it will accelerate patient abandonment,” the letter warns. “The plan avows no metric for success other than reducing certain measures of prescribing. Neither patient access to care nor patient health outcomes are mentioned.”

The public comment period on the CMS proposal ended March 5. To see the comments that were posted, click here.

CMS Seeking ‘Dialogue’ About Opioids

According to CMS, 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Medicare officials said the goal of the “hard edit” rule is to get pharmacists, doctors and insurers to “engage in a dialogue” about the risks associated with high dose opioid prescriptions.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said CMS deputy administrator Demetrios Kouzoukas in announcing the rule changes last month. “We believe these actions will reduce the oversupply of opioids in our communities."

To reduce the risk of “unintended consequences” from the hard edit rule, CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

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

Unless changes are made, the proposed Medicare Part D rules for 2019 will be finalized April 2.

A Canadian Asks ‘Where the Hell Am I?’

By Ann Marie Gaudon, Columnist

I hear more and more stories like Elizabeth Matlack’s, a lifelong chronic pain sufferer who recently wrote about her problems getting adequate pain medication in Canada. (See “Who Benefits From My Suffering?”).

Not only do I live in a chronically pained body, I feel pain for her. I feel pain for all of those who struggle each and every day, who are now being medically abandoned. Imagine, the only thing any of them has ever done is to end up with a pained body. As I read these stories, there seems to be no stem to the flow. I am beginning to ask myself, “Where the hell am I?”

Just like Elizabeth, I am also Canadian. All my life I’ve lived here and felt so grateful for it. All my life I basically felt safe. I felt secure. I felt that my needs were looked after. I was damned proud of our medical system too. From a blood test to chemotherapy, whatever might come my way, I had faith that I’d be cared for and that I wouldn’t have to claim bankruptcy to get it.

I’ve known for many years that treatment for chronic pain has always been woefully inadequate. I held out hope that good people with good intentions would come to care about this too. In a safe place like Canada, surely it was just a matter of time.

Then I was aghast and insulted to hear that our very own prime minister said that chronic pain was “low grade, but very annoying.” In a cooperative place like Canada, surely someone will educate him to let him know the degree of suffering, disability and high rate of suicidality chronic pain patients have.

ANN MARIE GAUDON

Won’t noble physicians with an intense desire to ease that suffering and do justice to their oaths come soon to advocate for us and improve our care? As I look around today, not seeing a trace of this, I am forced to ask myself, “Where the hell am I?”

I’ve lived enough years to know that people don’t generally do things for no reason and the reasons are plentiful. Money, fame, prestige, power, a moral sense of self-righteousness; there are a lot to choose from. Who benefits from a fabricated war on defenseless chronic pain patients while chasing the wrong crisis with a boat load of unproven assumptions?

Somebody somewhere does. You can be sure that there are too many hands in too many pockets to count. They all knew that chronic pain patients would be collateral damage, but the one thing they all have in common is they just don’t care.

Our Canadian government willingly let this happen under the disingenuous guise of “we have to protect you from your pain medications.” Imagine, you’ve been stable with nature’s gift of the most effective medication for your severe pain and now you can’t have it.

No Opioids Webinar

On the same day as I read about Elizabeth, I watched a webinar about how to treat chronic pain without opioids. The narrator was a physician who reportedly specialized in chronic pain. He was very efficient with his colour-coded columns of the categorizations of diseases and which treatments were suited to each.

Then something caught my eye. I noticed a chronic disease called interstitial cystitis was grouped together with pain central sensitization disorders. In bold font on the chart for this group was written: “NO Opioids!!”

Ironically, a few days before this, I was contacted by a woman diagnosed with this very disease. She was admitted into a hospital, where she emailed me. She wrote that a scope into her bladder revealed mass inflammation and lesions that the urologist described as “looking like cigarette burns throughout her bladder.” Her body was breaking down. Too much pain for too long. She was admitted with excessive sweating, soaring blood pressure, fever, and shaking uncontrollably.

It's likely her fight-or-flight response had become pathological in the face of intolerable, relentless pain. I have recently read that unrelieved pain complicates all other co-existing conditions through these stress mechanisms. She is also diabetic.

What would those who promote Canada’s new opioid guidelines -- which have made a mockery of chronic pain – suggest for this woman?  Would she be offered chiropractic care to make her right as rain? Perhaps Advil because that has an anti-inflammatory in it?

The webinar doctor made jokes along the way, such as “No one ever died from mindfulness.” So maybe we’ll start with meditation. She can’t think straight right now? Then maybe she should try yoga on her stretcher.

What became crystal clear watching the webinar is that these people don’t know a damned thing about chronic pain, especially severe pain. But so much worse yet – they don’t care to know -- so long as they get to pontificate about the demon opioid medication and the demons who have been taking them.  

The reality is that this woman has a significant risk of being dead soon. We know the guidelines have already played an unspeakable part in the deaths of chronic pain patients in the way of medical collapse and suicide. But no one seems to care about that either.

This isn’t the place that I grew up in. This isn’t the place where I felt safe, secure and cared for. This is an immoral place where those at the top serve their own political agenda. Yes, I said political because there’s no medical facts driving this out-of-control freight train.

This is an unethical place where the suffering are drop-kicked off a cliff and where the self-righteous and self-serving call down, “It sure sucks to be you.”

I don’t recognize Canada anymore. I’ve never lived in a place with such cruelty inflicted on such a vulnerable group. I didn’t grow up in a place with such a pervasive ultra-conservative meanness, where those in power exclusively serve themselves and to hell with the underdog – let them suffer until the bitter end.

Who benefits from Elizabeth’s suffering? Somebody somewhere does. As for the Canada I used to know and love, I can no longer see it or feel its reassurance. I guess I’ll have to continue to ask, “Where the hell am I?”

Because at this point, I just can’t figure it out.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, 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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Opioids, Fentanyl and Medical Malpractice

By Jennifer Kilgore, Columnist

One night in 2016, Richard Goldblatt had an acute pancreatitis attack.

“I was sitting at home, and all of a sudden I had this God-awful pain that wouldn’t go away,” he told us. The pain was so bad that at the time, I thought someone had stabbed me!”

His wife and oldest son brought him to the nearest emergency room, where medical professionals examined him, gave him something for the pain and asked him for his medical history. Richard told them he had recently removed a melanoma spot on his left shoulder, had a complete right knee replacement in 2002, and rectal repair in 2006, which had caused permanent nerve damage around the scar and, curiously, in both feet. He’d been in terrible pain ever since.

At first, he did receive opioid medication capable of quelling his nerve pain – though that didn’t last. Richard kept asking his surgeon why his feet hurt if he’d had rectal repair, as it made no sense.

“He [the doctor] kept telling me it was hemorrhoid pain, and he didn’t know why my feet were hurting all the time. I didn’t find out what really happened until around 2009 or 2010, when I was finally seen by a neurologist and examined properly. He told me that the surgeon knew he’d made an error. That being said, I have suffered ever since. I was also told it was too late to have any recourse in regard to that doctor.”

Richard started seeing a pain specialist, who tried all sorts of treatments – nothing helped. They even introduced him to the most radical of treatments: the fentanyl patch.

The fentanyl transdermal patch is meant for people who have tried other opioid or narcotic medications and need something much, much stronger. This provides around-the-clock pain relief for 72 hours in the form of a skin patch that allows medication to sink directly into the bloodstream and absorb quickly.

The list of warnings for the patch is long and thorough. Don’t take other medications with the patch. Don’t drink alcohol while using the patch. Don’t use the patch except exactly as directed by your doctor.

Richard did all of those things… and he still had problems.

“Yes, it eventually helped,” he said. “Yes, it did calm and deaden the pain… [but] I was never told about the basic warnings… I found out the hard way.”

Richard did not abuse fentanyl. But, as it turned out, heat – body heat, in the case of Richard – affects the use of the patch and causes it to absorb more quickly into the bloodstream. Fentanyl patch doses are meant to last for 72 hours. Richard’s high body temperature ensured that the patch would only last one or two days.

Richard ended up in the emergency room three different times in 2017 because of withdrawal, as his body heat caused the patch to absorb medication more quickly into his body, leaving him without more Fentanyl to sustain him over the lifetime of the patch. Neither his pain management specialist nor the emergency room doctors, however, realized this at the time.

Meanwhile, after the acute pancreatitis episode, Richard began to rapidly lose weight, which made little sense because he was still hungry and eating food. Doctors put him through the paces, making him take blood tests, MRIs, CT scans, ultrasounds – all of which came back clear.

“I was led to believe that everything was back to normal,” Richard said. “I was discharged with that idea and instructed that I could go back to my life as if nothing had happened. I was back at the ER in a week.”

His frustrations were mounting. This time he was told it was gastroenteritis and that he had a list of allergies. Richard already knew he was allergic to wheat and shellfish, so this was no surprise. He just wanted to know why he felt so awful and why he kept losing weight.

He was having new symptoms, too – he noticed an oily yellow discharge that smelled absolutely foul. When he informed his doctors, they prescribed Creon, a medication intended for exocrine pancreatic insufficiency, or EPI. This means your body is missing important enzymes it needs to digest food, and nutrients are passing through the body unabsorbed, which would explain why he was losing so much weight even though he was eating food. However, at the time, he was on such a low dose of Creon that it didn’t seem to be working.

Richard met with another gastroenterologist who wanted to do an endoscopic ultrasound, but his insurance wouldn’t cover it. Then another doctor wanted to cut out his gallbladder. Another wanted to put him on Cymbalta – “I told him, ‘No thanks.’ No more drugs in my system.”

By that time, Richard had lost almost 60 pounds. The case manager in charge of his file finally managed to get him to a doctor who could think outside of the box and diagnosed him with exocrine pancreatic insufficiency, which is what the Creon medication should have helped.

There was still a missing piece to the puzzle, however. The cause of his troubles? Opiate use.

According to his doctors, the fentanyl he was prescribed for his progressive nerve pain aggravated an underlying pancreatic condition. As EPI is normally caused by genetics, behavior or malnutrition, it only made sense that Richard’s opiate use, which at that time was in such high dosages, threw his body into high gear and revolted against him.

Weaning off Fentanyl

Fentanyl withdrawal should be done under the supervision of a medical professional. It is an extremely addictive medication because of its euphoric tendencies, which can make users compulsive and need more to get the same effect. However, withdrawing from it properly can minimize symptoms.

Patients might supplement their withdrawal program with methadone or buprenorphine, which can lessen the severity of symptoms. A doctor might simply taper the fentanyl, however, which is weaning the patient off until they are no longer taking it. Many users require an in-patient program to succeed. Symptoms of Fentanyl withdrawal can include nausea, vomiting, increased pain, chills, irritability, stomach cramps and more.

When Richard asked his doctor’s thoughts about weaning him off fentanyl use, the doctor told him in an email that “opiates cause or aggravate a severe form of irritable bowel and will aggravate any pancreas condition you have.”

Now Richard is trapped in a physical hell against a national medical backdrop that could not be more against him.

The fentanyl patch regimen he has been prescribed is aggravating his congenital pancreatic condition, and he cannot treat one without denying the other. If he chooses a lesser opioid, his progressive nerve pain will spike and leave him unable to physically function. If he uses fentanyl, it inflames his damaged pancreas.

Meanwhile, the statute of limitations has run out against his surgeon, depriving him of judicial remedies – as lawyers have already informed him.

“I’ve been turned down a couple times,” he said.

It is a difficult climate right now in the medical field, with the opioid crisis raging across the country and even legitimate fentanyl patch doses that are clearly not abuse being regarded with suspicion.

The Drug Enforcement Administration raided the office of a prominent pain management physician, Dr. Forest Tennant, the day after he testified as an expert in a negligent homicide case. Other physicians are tapering their patients or having them sign pain contracts, even though they are clearly suffering on their regimens.

Then there are patients like Richard, who have medications that they need, but have suffered at the hands of doctors’ ineptitude. And who is going to pay once the statute of limitations has run out?

“I guess I’ll have to wait until I’m dead and some researcher can have my pancreas examined to prove my point,” Richard said. That is the only thing he says he can look forward to, “as this disorder will eventually kill me.”

In January 2018, Richard let us know his new pain management specialist ordered him to withdraw from the fentanyl, as prescribing that medication was “against his principles.”

On the plus side, four days into the withdrawal (“which was complete hell,” Richard said), his pancreas started producing the necessary digestive enzyme again. Fentanyl had suppressed his pancreas’ ability to work and made him too sensitive to medications. Now that he’s gone cold turkey, he is able to eat properly – but suffers from intractable nerve pain.

“I have been told that recovering from this trip into hell could take a very long time,” Richard said. The only question is whether he can handle the pain until he fully recovers.

This article originally appeared in Enjuris and is republished with permission.

Jennifer Kain Kilgore is an attorney editor for both Enjuris and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

You can read more about Jennifer on her blog, Wear, Tear, & Care.  

Bill Would Create 3-Day Limit on Opioids for Acute Pain

By Pat Anson, Editor

A bipartisan bill has been introduced in Congress that would impose a national 3-day limit on opioid prescriptions for acute short-term pain and authorize another $1 billion to subsidize the addiction treatment industry.

The CARA 2.0 Act is a follow-up to the Comprehensive Addiction and Recovery Act of 2016. It is sponsored by four Democrats and four Republicans: Senators Rob Portman (R-OH), Sheldon Whitehouse (D-RI), Amy Klobuchar (D-MN), Maria Cantwell (D-WA), Shelley Moore Capito (R-WV), Dan Sullivan (R-AK), Maggie Hassan (D-NH), and Bill Cassidy (R-LA).

“The opioid epidemic truly is a national crisis that is affecting families and communities across the country, and in West Virginia, we’ve become far too familiar with its consequences,” Sen. Capito said in a statement. “While we’ve accomplished a lot in terms of drawing attention to the drug epidemic and providing resources to help address it, it’s painfully clear that we still have a long way to go and need to be doing even more.

Several states have already enacted measures to limit opioid prescriptions for acute pain – usually limiting them to five or seven days’ supply. CARA 2.0 would make a 3-day limit mandatory nationwide for “pain with abrupt onset and caused by injury or other process that is not ongoing.”

The bill would exempt patients with chronic pain and cancer, as well as those in hospice and palliative care. It is not clear how the 3-day limit would apply to patients recovering from surgery or for those whose pain lasts longer than 3 days.

Under the bill the U.S. Attorney General would be authorized not to renew or register the licenses of physicians to prescribe controlled substances if they do not abide by the initial 3-day limit.

It also requires doctors to consult with the prescription drug monitoring database (PDMP) in their state before writing a prescription for a controlled substance to make sure a patient isn’t already getting opioid treatment. Prescribers who repeatedly fall “outside of expected norms or standard practices” would be reported to law enforcement and their state licensing boards.

The latter provision was initially proposed by Sen. Cassidy under the Protection from Overprescribing Act.

"I’m glad the Protection from Overprescribing Act is included in this bill, so law enforcement gets the information they need to identify providers who are overprescribing and fueling this crisis,” said Cassidy, who is a licensed physician.”  “In Louisiana, there is about one opioid prescription for every person. I and other physicians took an oath to first, do no harm. Some doctors are selling these prescriptions for profit. This is doing harm and it must be stopped.”

If passed, the bill raises the penalty for opioid manufacturers who fail to report suspicious orders for opioids from $10,000 to up to $500,000.

States would be allowed waive the limit on the number of patients a physician can treat with buprenorphine (Suboxone), an addiction treatment drug. There is currently a cap of 100 patients per physician.

The bill also seeks to create a national network of addiction treatment facilities, to be funded by $200,000,000 in grants annually from 2019 to 2023. The grants would only be available to large non-profit treatment programs that already have facilities nationwide, such as Phoenix House. 

Sessions Creates New Task Force to Target Rx Opioids

By Pat Anson, Editor

U.S. Attorney General Jeff Sessions has announced the creation of a new task force targeting manufacturers and distributors of opioid pain medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

“We are attacking this crisis at its root: the diversion and overprescription of opioid painkillers,” Sessions said at a news conference. “We will use criminal penalties.  We will use civil penalties.  We will use whatever tools we have to hold people accountable for breaking our laws.”

Sessions also said the Justice Department would file a “statement of interest” in hundreds of lawsuits filed by states, counties and cities seeking to recover billions of dollars in damages from opioid manufacturers who used deceptive marketing practices. Such a statement could result in the federal government joining as a party in the lawsuits and recovering damages.

Sessions said the government had borne “substantial costs” as a result of the opioid crisis, including $4 billion paid by Medicare for opioid pain medication in 2016.

“The hard-working taxpayers of this country deserve to be compensated by those whose illegal activity contributed to those costs.  And we will go to court to ensure that the American people receive the compensation they deserve,” Sessions said.

“These are not our last steps.  We will continue to attack the opioid crisis from every angle.  And we will continue to work tirelessly to bring down the number of opioid prescriptions, reduce the number of fatal overdoses, and to protect the American people.”

Sessions’ announcement avoided any mention of the growing scourge of black market opioids, such as heroin, illicit fentanyl and counterfeit medication, which are now responsible for most overdose deaths. He also did not acknowledge that opioid prescribing has been declining for several years and that less than one percent of legally prescribed opioids are diverted.

The new task force – called the Prescription Interdiction & Litigation (PIL) Task Force -- will include senior officials from the Attorney General’s Office and the Drug Enforcement Administration. It appears to be focused solely on prescription opioids.

“The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law,” the DOJ said in a statement.

Sessions directed the task force to improve coordination with the Department of Health and Human Services – which includes the FDA, CDC and the Centers for Medicare and Medicaid Services (CMS) – in sharing healthcare data to identify “patterns of fraud related to the opioid epidemic.”

The Attorney General's single-minded focus on pain medication as the cause of the opioid crisis has angered many pain patients and advocates.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech earlier this month. "People need to take some aspirin sometimes and tough it out.”

“I hope Sessions falls down, hits his head and breaks a hip and has to take two aspirin and get over it,” wrote one PNN reader.

“Jeff Sessions is an instrument of hate. He has succeeded in driving a wedge through the most sacred trusts -- the relationships between doctors and patients. Doctors now fear and loathe their patients for putting their licenses at risk, and patients fear and loathe their doctors for abandoning their compassionate care plans,” wrote another reader.

"This is exactly why we don't need, a group of people that know nothing about what they are making laws for. Jeff Sessions, if you or one of your family had Reflex Sympathetic Dystrophy, you would never have made a fool out of yourself with your aspirin remarks," said another.

Survey Finds Media Bias in Coverage of Opioid Crisis

By Pat Anson, Editor

Nearly two-thirds of health journalists believe the treatment of chronic pain is a major cause of the opioid epidemic, according to a new study that suggests many reporters are biased or ignorant about the true nature of the overdose crisis.

“The CNN Effect: The Mediaization of Pain Policy” was released by the PAINS Project, a coalition of patient advocates and pain management experts that seeks to make chronic pain a public health priority. “The CNN Effect” is a term first used in the 1990’s to describe the impact of 24-hour cable news on public policy.

“One of PAINS’ foundational working assumptions is that the media shapes public perception, public perception translates into votes, and votes equal public policy,” the PAINS report explains. “This theory can also be applied to public health policy related to both chronic pain and the opioid crisis.”

To test that theory, PAINS worked with Mugur Geana, PhD, a professor at the William Allen White School of Journalism at Kansas University, in a survey of over 1,000 health journalists who cover chronic pain or the opioid crisis.

While the response rate was low – only 193 reporters and editors completed the survey – the results do provide some insight into the mindset of journalists and how they cover opioid stories.

The survey’s major finding was that many journalists believe there is a direct relationship between chronic pain and opioid substance abuse – even though studies have shown that it is relatively rare for pain patients to become addicted. Sixty three percent of the journalists surveyed believe that chronic pain was a major cause of the opioid epidemic and over a third (36.5%) believe that overprescribing of opioids by doctors was the primary cause.

Most of those surveyed also believe that opioid abuse is a bigger public health problem than chronic pain, even though pain patients outnumber opioid abusers by a 50 to 1 margin.  Nearly 70% “strongly agree” that opioid abuse was a major problem, compared to less than half who think chronic pain is a major problem.

“Another interesting finding was the very low use of people living with chronic pain as drivers or main sources for stories - compared to medical and academic sources, for example. We keep hearing from patient advocates that their stories seldom make it above the fold (if they make it in the paper at all), and that was reflected in our findings,” Geana said in an email.

Asked what primary sources they used to prepare stories, about 70% of health journalists said they turned to “medical experts” and nearly half said they used local, state or federal agencies. Only about 20% said they used “anecdotal stories from patients” as a primary source.

“Of particular interest to PAINS was evidence that patients are not considered ‘expert’ resources by health journalists. People living with chronic pain seem to be approached only to provide illustrating examples for stories that are driven primarily by information from other published articles/stories, academic sources, and data provided by federal agencies,” the PAINS report found.

“Although the low response rate does not allow conclusive results, this study does imply a bias among healthcare journalists and the need for pain advocacy organizations to help those reporting on these issues to engage with articulate chronic pain patients who can relay their experiences in a way that journalists/reporters find authoritative. Otherwise, reporting on chronic pain and the opioid crisis will continue to be what could be called an ‘echo chamber.’”

The CNN Effect

One example cited by PAINS of the “CNN Effect” was a 60 Minutes report last year that was highly critical of a law passed by Congress that limited the ability of DEA agents to investigate companies that distribute pharmaceutical drugs. After the report aired, Sen. Claire McKaskill (D-MO) invited former DEA investigators who appeared in the 60 Minutes segment to speak at a roundtable discussion on the opioid issue with her Senate colleagues.

PAINS asked Sen. McCaskill and her staff to include medical experts and pain patients in the roundtable and was turned down.

“Initially, we were told that it was simply too close to the date set to extend additional invitations. PAINS sent her staff a list of five highly qualified individuals to participate in the roundtable and offered to facilitate their participation. In response, PAINS’ Director was invited to attend, contingent upon Senator McCaskill’s approval. Two days later the invitation was rescinded,” the PAINS report said.

McCaskill recently released a report that was sharply critical of patient advocacy groups and medical pain societies for accepting nearly $9 million in funding from opioid manufacturers. Among the groups mentioned was the Center for Practical Bioethics, a non-profit closely affiliated with the PAINS Project, which received $163,000 from opioid makers.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” McCaskill's report alleges.

As PNN has reported, McCaskill has received over $6 million in campaign donations from law firms since 2005, including some currently involved in litigation against opioid manufacturers. According to OpenSecrets.org, contributors affiliated with the law firm of Simmons Hanly Conroy have donated over $300,000 to McCaskill, who is running for reelection this year.  

Simmons Hanly Conroy represents dozens of states, counties and cities that are suing Purdue Pharma and other drug makers over their marketing of opioids, and stands to pocket one-third of the proceeds from any settlement, according to reports.

How the Opioid Crisis Has Changed

By Roger Chriss, Columnist

The CDC recently released its first annual “Surveillance Report of Drug-Related Risks and Outcomes,” a lengthy and data filled study that documents the changing nature of the opioid crisis. Much attention is paid to declining rates of opioid prescribing, rising rates of heroin and fentanyl overdoses, and the increasing number of multiple or “poly-drug” overdoses.

According to the report, efforts to rein in opioid prescribing have succeeded in ways that are often not recognized:

• Opioid prescriptions fell 4.9% each year between 2012 and 2016.
• High-dose opioid prescriptions (above 90 MME) dropped 9.3% annually from 2009 to 2016.
• In 2016, there were 66.5 opioid prescriptions per 100 persons, down from 72.4 opioid prescriptions per 100 persons in 2006.

Much of this decline came before the release of the 2016 CDC opioid guidelines and subsequent efforts by state governments, health insurers, and drug store chains like CVS to reduce prescribing.

In 2016, opioid prescribing in the U.S. was at about three times the level of 1999 -- still high, but  down from the peak of four times the 1999 level. At the current rate of reduction, we will reach twice the 1999 level sometime next year and be back to 1999 levels by early 2021 at the latest. Ongoing moves by regulators and insurers to reduce opioid prescribing may accelerate this process.

Clearly, as the report states and many pain patients already know, healthcare providers are “becoming more cautious in their opioid prescribing practices.”

Tragically, similar success is lacking in the overdose crisis.

In 2015, the most recent year covered in the report, 52,404 people died of drug overdoses. About 63% of those deaths involved an illicit or prescription opioid, with heroin being the most common cause in 12,989 deaths. The other 37% of deaths involved non-opioids such as cocaine and methamphetamines. Over 5,000 deaths were identified as suicides and nearly 3,000 were identified as having undetermined intent.

The CDC report estimates that about 2 million people are addicted to prescription opioids and nearly 600,000 Americans are addicted to heroin. These numbers have remained largely unchanged since 2012, meaning that there has been little if any progress in preventing opioid addiction.

Limits on opioid prescribing have also not resulted in fewer deaths. Overdose fatalities are still rising sharply, mostly because of heroin and illicit fentanyl.

"Prescription opioid pain relievers were formerly driving the crisis, but by 2015 they shared equal measure with heroin, synthetic opioids other than methadone (mostly illicit fentanyl), and – increasingly-- cocaine and methamphetamines,” the report found.

In the two years since 2015, the final year for overdose data in the report, drug deaths have spiked higher. In 2016 there were 63,632 fatal overdoses and the early analysis for 2017 suggests the numbers are even worse. The handful of states that are seeing a decrease in drug deaths are attributing it largely to the increased use of naloxone to revive overdose victims.

Also alarming is that in 2015, around 33 percent of heroin users had initiated use with that drug rather than with opioid analgesics or some other substance. And heroin, illicit fentanyl, and virtually every other drug are now readily available on darknet markets.

At present, overdose rates are rising for virtually every major class of drug. The only class of drug that has seen a drop is prescription opioids.  

The opioid crisis is real, though as the CDC report shows, it is fast becoming an overdose crisis driven primarily by more potent and risky street drugs. Opioid medication is just one of many substances involved and its role is decreasing.

The CDC report concludes ominously: “Additional measures are now urgently needed to address a diverse and evolving array of drug types.”

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.

Should Gabapentin Be a Controlled Substance?

By Pat Anson, Editor

The U.S. Drug Enforcement Administration should consider scheduling gabapentin (Neurontin) as a controlled substance, according to researchers who studied the recreational use of the drug in Kentucky.

Gabapentin is a nerve medication approved by the Food and Drug Administration to treat epilepsy and post-herpetic neuralgia (shingles), but it is also widely prescribed off-label to treat fibromyalgia, migraines, neuropathy and other chronic pain conditions. The Centers for Disease Control and Prevention even recommends gabapentin as a safer alternative to opioids.

Sales of gabapentin have soared in recent years. About 64 million prescriptions were written for gabapentin in the U.S. in 20l6, a 49% increase in just five years.

But drug abusers have also discovered that gabapentin can heighten the effects of heroin, marijuana, cocaine and other substances.

"People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some," said Rachel Vickers Smith, PhD, an assistant professor at the University of Louisville School of Nursing. “Some have said it gives them a high similar to opioids. It had been easy to get a prescription for gabapentin and it's very cheap."

Vickers Smith and her colleagues recruited 33 people from Appalachian Kentucky who used gabapentin recreationally and asked them about their drug use. Many reported they started taking gabapentin over 10 years earlier for a legitimate medical condition, such as pain and anxiety. Over time, they started using the drug to help them relax, sleep and get high.

“Focus group responses highlighted the low cost of gabapentin for the purpose of getting high and noted increasing popularity in the community, particularly over the last 2 years. Gabapentin was a prominent drug of abuse in two cohorts of the primarily opioid-using individuals. Providers should be aware of gabapentin’s abuse potential, and a reexamination of the need for scheduling is warranted,” researchers reported in the journal Psychology of Addictive Behaviors.

In 2017, Kentucky became the first state to classify gabapentin as a controlled substance, which makes it more difficult for the medication to be prescribed. Ohio’s Substance Abuse Monitoring Network also issued an alert warning of gabapentin misuse across the state.

‘Snake Oil of the 20th Century’

Gabapentin was first approved by the FDA in 1993 and sold by Pfizer under the brand name Neurontin. A few years later, it was so widely prescribed that a top Pfizer executive called gabapentin “the snake oil of the twentieth century” in an email. The company was later fined hundreds of millions of dollars for promoting Neurontin’s off-label use.

"Early on, it was assumed to have no abuse potential," says Vickers Smith. "There's a need to examine it in further detail, especially if prescribing it is going to be encouraged."

Federal health officials have only recently started looking into the misuse and abuse of gabapentinoids, a class of nerve medication that includes gabapentin and pregabalin (Lyrica).

"Our preliminary findings show that abuse of gabapentinoids doesn't yet appear to be widespread, but use continues to increase, especially for gabapentin," FDA commissioner Scott Gottlieb, MD, said last week at a conference on opioid prescribing. "We're concerned that abuse and misuse of these drugs may result in serious adverse events such as respiratory depression and death. We want to understand changes in how patients are using these medications."

Gottlieb said FDA investigators are looking at websites and social media where opioid users discuss their use of gabapentinoids.

"We know we need to investigate and respond to signs of abuse as soon as signals emerge. We need to get ahead of these problems," he said.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has a low potential for addiction and abuse.  

Getting the Story Right About Opioids

By Pat Anson, Editor

Many chronic pain patients feel they are wrongly portrayed in the media as malingerers and addicts – and that the growing difficulty they have just getting their pain treated is being ignored by the medical profession.

There’s a fair amount of truth to that.

Which is why two recent articles in Politico and The New England Journal of Medicine – both written by doctors – are worth highlighting for PNN readers. They help dispel many of the myths about pain patients and the role they played in the so-called opioid epidemic.

“As an addiction psychiatrist, I have watched with serious concern as the opioid crisis has escalated in the United States over the past several years, and overdose deaths have skyrocketed,” Sally Satel, MD, wrote in Politico. “I have also watched a false narrative about this crisis blossom into conventional wisdom: The myth that the epidemic is driven by patients becoming addicted to doctor-prescribed opioids, or painkillers like hydrocodone.”

Dr. Satel practices at a methadone clinic, lectures at the Yale University School of Medicine and is a resident scholar at the American Enterprise Institute, a conservative think tank.  She has also done her homework about the opioid crisis, recognizing that the nation’s growing scourge of overdose deaths is “overwhelmingly attributable” not to prescription opioids, but to illegal ones like heroin and illicit fentanyl.

Satel also acknowledges that opioid prescriptions in the U.S. have been declining for years and that only a small percentage of pain patients become addicted. Yet insurers, pharmacies and regulators continue to tighten access to opioid medication, and anti-opioid activists rant about pain patients getting hooked after taking a few “heroin pills.”

“We must be realistic about who is getting in trouble with opioid pain medications. Contrary to popular belief, it is rarely the people for whom they are prescribed. Most lives do not come undone, let alone end in overdose, after analgesia for a broken leg or a trip to the dentist,” Satel wrote.

“We need to make good use of what we know about the role that prescription opioids plays in the larger crisis: that the dominant narrative about pain treatment being a major pathway to addiction is wrong, and that an agenda heavily weighted toward pill control is not enough.”

That narrative clearly has been harmful to patients. Satel cites a PNN survey of over 3,000 patients, which found that over 70% were no longer prescribed opioids or had their dose cutback after the CDC’s opioid prescribing guidelines were released in 2016.  Nine out of ten patients said the guidelines had worsened the quality of pain care in the United States, and 60 percent said it had become harder or impossible for them to find a doctor willing to treat their pain.

The Story of Mr. P

Patient abandonment and the growing lack of access to pain treatment is presented in the story of “Mr. P” – as told in the NEJM by Drs. George Comerci, Joanna Katzman and Daniel Duhigg, who are colleagues at a pain clinic in Albuquerque, New Mexico. Mr. P was prescribed opioid medication for two years when his doctor adopted a no-opioids policy in his practice.

“Mr. P. was given a prescription for a month’s worth of oxycodone and advised to find another prescriber in the future.  Not unexpectedly, six other physicians refused to prescribe him opioids, and he ended up in our pain clinic, sobbing in the exam room, terrified that he’d end up ‘back in my old life’ if he had to buy his pain medications on the street,” the doctors wrote.

“In the past year, our university-based interdisciplinary pain clinic has seen a flood of cases like Mr. P.’s. The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics. The fallout is a growing pool of patients who are forced to navigate their transition off prescribed opioids, often with little or no assistance or guidance, with the potential for disastrous results.”

What is happening to these abandoned patients who can’t find adequate treatment?

“We fear that an injudicious approach involving blanket refusals to prescribe opioids and adoption of unreasonable prescribing and dispensing regulations will increase patient suffering. Furthermore, the worst-case scenario is for patients to obtain prescription opioids illegally and eventually transition to more dangerous drugs, such as heroin,” the doctors warned.

The opioid crisis continues to spiral out of control. Government efforts to intimidate doctors and dictate prescribing levels are not only harming patients, they may be making things worse. A recent report from the CDC found that illicit fentanyl – not prescription pain medication -- was responsible for over half the overdoses in ten states.

As Dr. Satel points out, if we ever hope to fix the problem and find the right solutions, we need to stop focusing on patients and doctors.

“We cannot rely on doctors or pill control policies alone to be able to fix the opioid crisis. What we need is a demand-side policy. Interventions that seek to reduce the desire to use drugs, be they painkillers or illicit opioids, deserve vastly more political will and federal funding than they have received,” she wrote. “If we are to devise sound solutions to this overdose epidemic, we must understand and acknowledge this truth about its nature.”

I Think of Death Every Day

(Editor’s note: Pain News Network regularly receives emails and comments from readers in physical and emotional distress because their chronic pain is not being treated or is undertreated. Many have been abandoned by their doctors. And some are having suicidal thoughts.

The following email came from “Sharon” – who lives with chronic pain from neuropathy and a severe hip injury. Sharon gave us permission to publish her email, as long as her full name was not disclosed. Some readers may find her story disturbing, but it is representative of what’s occurring in the pain community and therefore worth sharing.)

By Sharon

When I first got ill, I was an avid backpacker and ran a health food store. A very healthy and health conscious 37-year old woman.

I tried every alternative treatment.  The first was hypnosis. Then I tried colonics, lemon and oil heat packs, acupuncture, massage. The list goes on. NOTHING TOUCHED THE NERVE PAIN. 

I had an old .357 handgun. The same type police carried at one time. I also had an old .45.  I thought about it every single day. 

But I didn’t want my family or friends to find me like that.  A bloody picture in their heads whenever they thought of me.  

Taking your own life because of the ignorance of others, just isn’t fair.  To be pushed into it by others. Especially when there is medication that works.

Once I finally decided to try opiates, no doctor would listen to me.

I did everything they asked. I jumped through all the hoops. Multiple times. 

I was shamed over and over again, because I was in pain. I was called a malingerer. 

Never thought I would get sick at such a young age.   I thought I’d be healthy and happy like the all the other healthy women in my family.  

I finally did find a wonderful, caring doctor.  He treated me until just last year. When he was shut down.

I’m lucky. I did find another doctor. It took about 3 weeks. It was Christmas time.  Almost impossible. 

I like this clinic. But I have to drive 80 miles round trip.  

I’m 60. I’m not in good health. My husband passed away a few years ago.

My sweet little grandmother took her own life at 92. She was an amazing woman. 

I hope I never have to do that.  

But it’s in me. I could. I think of death every day.

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.

Tell Medicare to Stop Its War on Pain Patients

By Richard A. Lawhern, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published a deeply biased and scientifically unsupported guideline for the prescription of opioid pain relievers.  Congress made this “guideline” mandatory in the Department of Veterans Affairs three months before it was even published.  The VA has since enacted practice guidelines that effectively eliminate opioids as a treatment option for many veterans. 

Now the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) are doubling down on this bureaucratic atrocity.

CMS has posted in the Federal Register and is inviting public comment on its plans to change the rules for Medicare Part D prescription drug plans in 2019.  

They propose that "all sponsors [are] to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at 90 morphine milligram equivalent (MME)" – which is the dose ceiling recommended by the CDC.

The so-called “sponsors” are insurance companies that provide health care coverage funded by taxpayers to 54 million Medicare beneficiaries. If implemented, this proposal will effectively deny reliable pain treatment to millions of seniors, poor and disabled people.  When applied to private health insurance and Medicaid as they inevitably will be, these regulations will damage all U.S. citizens.

As I have commented to CMS, their proposals “mandate a dangerous, unfounded and medically unethical intrusion into medical practice by third parties operating without face to face knowledge of the patient. These … changes will damage and deny care to large numbers of the 1.6 million patients whom CMS estimates are presently treated with opioids above 90 morphine milligram equivalent dose per day.”   

Few pain patients ever display diagnostic symptoms of opioid use disorder. Yet drug-related overdoses have risen steadily in the past ten years -- despite restrictions on the medical supply of opioids -- a death toll largely associated with illegal opioids and nonprescription drugs. Managed medical exposure to opioids contributes almost nothing to the widely hyped “opioid crisis.”

Over-regulation of prescribing is already harming hundreds of thousands of stable patients coerced into opioid doses below therapeutic levels.  Mandated VA restrictions on opioid prescribing are directly responsible for hundreds of deaths among veterans. 

All for nothing.  And CMS is about to do more of the same.

A major study in the British Medical Journal illustrates the foolishness of the CMS proposal.  Diagnoses of opioid abuse disorder were tracked for 565,000 opioid-naïve post-surgical patients between 2008 and 2016. Only 0.6% were later diagnosed with Opioid Abuse Disorder (OAD).  Less than 1% renewed their prescriptions up to 13 weeks.  OAD incidence was only weakly sensitive to dose level from less than 20 to over 120  MME  per day.   

Another large study in JAMA Internal Medicine shows the incidence of extended post-surgical opioid prescriptions at just 0.174% to 0.9%, depending on the type of surgery.

CMS is trying to “solve” a non-problem by means guaranteed to create far worse problems.

The CDC Guidelines ignored the natural variability in liver enzymes governing the way opioids are broken down in the body.  Imposing hard limits on MME in “safety” audits will cause therapy failure in hundreds of thousands of patients who can benefit from opioids, but only at significantly higher doses than entertained by CDC and CMS. 

In January 2018 public hearings before the FDA Opioid Policy Steering Committee, the American Academy of Pain Management recommended against hard limits on opioid analgesics.  Other speakers advocated for leaving practice standards to medical professional associations which guide doctors in each specialty.  CMS has ignored both recommendations.

Forcing pain patients to go through an “exceptions” process before extending prescriptions beyond seven days is inappropriate and dangerous nonsense.  Prevailing practice allows for prescription duration sufficient to treat anticipated pain levels.  The alternative is to drown doctors in useless paperwork and to prompt patients to defer needed surgery because they fear being left without pain control.

There is no one-size-fits-all patient or treatment plan.  CMS should stand down from attempting to force restrictions on medical practice which have such predictable and horrid consequences.  

What Can Patients and Caregivers Do?

First, you can register your protest and concern with CMS before March 6th by selecting the “Comment Now!” buttons at this link.

You don’t have to be a doctor or researcher to do this.  Here are some examples of comments you might make.  Please edit them to fit your own situation.  Don’t copy these words exactly, as CMS will delete them.

    A. I am a chronic pain patient with ___________ (one or more diagnoses)

    B. My medical care will be greatly damaged by your regulation.

    C. I rely upon opioid medications to: (fill in)

• Preserve my way of life            
• Manage my incurable pain
• Allow for increased function
• Remain productive

     D. If CMS enforces a hard limit for opioid doses per day, this will give private insurance companies and pharmacies  an excuse to stop paying for my necessary prescriptions or dispensing them at all. 

     E. The proposed regulations are unsupported by any reliable science

     F. If enacted, these policies will: 

• Force even more doctors away from treating pain          
• Force more patients onto disability
• Create more demand for emergency room services
• Increase the rate of expensive and often ineffective surgical procedures
• Increase the rate of suicides

To review the comment process, feel free to visit the Facebook page for the Alliance for the Treatment of Intractable Pain (ATIP).

The second thing you can do is look up the Washington DC phone numbers of your House and Senate representatives. It’s easy. Just Google your state and the word “senators” or “Congress.”

Then call their office.  Tell the staffer who picks up that “I’m a pain patient and I vote in (name the state).  I want the Senator (Congressman or -woman) to tell the Centers for Medicare and Medicaid Services to withdraw their proposed regulation limiting the treatments I can receive.  If accepted, these regulations will destroy my life.”

It is time for people in pain and caregivers to speak up.  If we do not, then we will live – or die – as victims of a medical bureaucracy that doesn’t care about the damage it does to us.

Richard A Lawhern, PhD, is the co-founder and corresponding secretary for the Alliance for the Treatment of Intractable Pain (ATIP). He is a technically trained non-physician patient advocate with over 20 years experience in direct support to patients and caregivers in social media.  His work on public policy for pain management is widely published in multiple online and print media.

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.

Rare Disorders Require Unusual Care

By Roger Chriss, Columnist

A lawsuit challenging the constitutionality of listing cannabis as a Schedule I drug under the Controlled Substances Act is underway in New York City.

The plaintiffs, including an Iraq War veteran with PTSD and a 12-year-old girl with a rare seizure disorder, are claiming that the government’s decision to classify marijuana as an illegal controlled substance is irrational, unconstitutional and motivated by politics, not science.

The position of the federal government is simple: Marijuana has no accepted medical use and poses a significant risk of abuse and addiction.  But the situation is complex and emblematic of a larger issue – which is the medical treatment of people with rare and incurable disorders.

Modern medicine is an increasingly precise undertaking involving thousands of possible diagnoses, many with multiple treatment options.

There is a wide range of disorders that involve crippling anxiety, including post-traumatic stress disorder. There are also many seizure disorders, including conditions like Dravet syndrome and Lennox-Gastaut syndrome, that are extremely difficult to treat.

In the same fashion, there are hundreds of disorders that cause debilitating pain that persists for months, years or even a lifetime, including interstitial cystitis, Complex Regional Pain Syndrome, and trigeminal neuralgia.

Many of these disorders are rare and entirely unfamiliar to non-specialists. But even when the disorder itself is not so rare, its presentation may be rare in terms of severity. Fibromyalgia and osteoarthritis are common enough, but still can be debilitating in some cases.

As a result, research on such disorders is thin and clinical trials are few and far between. For instance, there are no studies of cannabis for small fiber neuropathy and only a handful on cannabis for cluster headaches. When trials do exist, they are easily criticized as being statistically underpowered because of the small number of participants.

Moreover, standard treatments do not necessarily work for everyone. Neuropathic pain sometimes responds well to neuroleptic drugs like gabapentin (Neurontin), but as a recent Cochrane review found, over half of those treated with gabapentin will not have worthwhile pain relief and may experience adverse side effects.

Usual Rules Don’t Apply

Many people with rare disorders are often medically atypical in other important ways. Patients with Ehlers-Danlos syndrome, for example, are famously intolerant of a wide range of medications. So the usual rules about medications may not even apply to people with rare disorders.

All of this creates obvious clinical difficulties. It is not easy to develop standards of care for rare disorders. General recommendations are based on limited clinical experience and testing, often with people whose reactions to common, generally well-tolerated medications are unpredictable and potentially dangerous. Thus, medications that are controversial may still be useful for people with rare disorders, especially if they are refractory to common treatments.

The opioid crisis has been national news for years, with many states, insurers like Kaiser Permanente and Intermountain Health, and drug store chains like CVS moving to reduce prescribing levels. But for some conditions, opioid medication remains one of the few viable alternatives.

For instance, the Mayo Clinic recognizes the value of opioids for refractory restless leg syndrome, calling them “a mainstay in the management of these patients.” And the National Institute of Neurological Disorders and Stroke acknowledges the complexity of neuropathic pain when it lists opioids and anticonvulsants as potentially useful.

The situation is similar for medical cannabis. The federal government gave marijuana Schedule I status in the 1970s, but many states legalized medical cannabis in the past two decades in part to deal with rare disorders that do not respond to conventional treatment. Clinical research is justifying this.  A 2017 trial of cannabidiol for drug-resistant seizures in Dravet Syndrome found that cannabis based medication reduced the frequency of convulsive seizures.

In other words, rare disorders involving problems such as severe pain, seizures or anxiety require highly specialized care using all available options. In many cases, people with these disorders have failed first-line therapies and even second-line therapies. They are facing choices that do not occur in everyday clinical practice but now have to be considered.

Thus, the issue here goes beyond rescheduling cannabis or reining in opioid prescribing. The average person has little if any medical need for these substances. But medicine has to address the needs of all people, and healthcare laws and regulations cannot ignore the reality that some people are living with challenging and rare disorders.

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.

Doctor Arrested for Off-Label Prescribing of Subsys

By Pat Anson, Editor

A Las Vegas pain management doctor has been arrested and charged with 29 counts of healthcare fraud and unlawful distribution of fentanyl.

Steven Wolper, MD, was indicted by a federal grand jury for illegally prescribing Subsys, a fentanyl-based oral spray, to 22 patients that the doctor falsely claimed had cancer. Most of the patients were Medicare beneficiaries. One died of an overdose after self-injecting Subsys.     

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

The Food and Drug Administration has only approved Subsys for the treatment of breakthrough cancer pain. Although off-label prescribing of drugs is common in the medical profession, federal prosecutors maintain that “there are no off-label uses approved” for Subsys and that Holper prescribed it “without a legitimate medical purpose and outside the usual course of professional practice.”

One of Wolper’s patients – referred to as “Patient A” in the indictment -- received several prescriptions for Subsys starting in 2014. Two years later the patient died after using a syringe to inject leftover Subsys directly into their arm.

“Hundreds of Subsys canister sprays were found in and around Patient A’s bedroom, bathroom, work place, and vehicle after Patient A’s death,” the indictment says. “If Patient A had not used remaining fentanyl from the used Subsys canisters Patient A received from defendant Holper, Patient A would not have died when he/she did.”

If convicted, the 66-year old Holper faces up to 20 years in prison for illegal distribution of a controlled substance and 10 years for health care fraud.

“Dr. Holper is charged with needlessly prescribing one of the deadliest forms of opioids and defrauding U.S. taxpayers,” said FBI Special Agent in Charge Christian Schrank. “With our law enforcement partners we will continue our fight to bring these suspected criminals to justice and protect our communities.”

Subsys has been blamed for hundreds of overdose deaths, and federal prosecutors have accused its manufacturer, Insys Therapeutics, of fraud and racketeering in promoting its use. The Arizona drug maker allegedly misled insurers into paying for Subsys and encouraged doctors to prescribe it off-label for non-cancer pain.

The government’s willingness to prosecute Dr. Holper and a handful of other doctors for the off-label prescribing of Subsys could have potentially troubling implications for Dr. Forrest Tennant, a prominent California pain physician whose home and pain clinic were raided by the DEA last November.

Tennant only treats intractable pain patients and makes no secret of the fact that he prescribed Subsys off-label to about two dozen of his patients in severe pain. He considers Subsys a useful medication to treat non-cancer patients  who would otherwise suffer without it.

“My contention is that its perfectly acceptable to prescribe (Subsys) off-label,” Tennant told PNN, adding that he has a letter from an FDA commissioner stating that fentanyl products are not prohibited from off-label use. “I think the number of doctors who prescribed Subsys off-label is up in the hundreds.”

Tennant has not been charged with a crime and has denied any wrongdoing. 

The grand jury indictment of Dr. Holper came one week after Attorney General Jeff Sessions said there would a be a 45-day “surge” in law enforcement efforts targeting doctors and pharmacists who prescribe and dispense high doses of opioid medication.

"Our great country has never before seen the levels of addiction and overdose deaths that we are suffering today. Sadly, some trusted medical professionals like doctors, nurses, and pharmacists have chosen to violate their oaths and exploit this crisis for cash -- with devastating consequences,” Sessions said in a news release announcing Holper’s indictment.

“Our goals at the Department of Justice for 2018 are to reduce the number of opioid prescriptions, the number of overdose deaths, and violent crime -- which is often drug-related. That's why I created the Opioid Fraud and Abuse Detection Unit and sent 12 top prosecutors to opioid hotspots around the country: to help us find the medical fraudsters who are flooding our streets with drugs. These prosecutors are already issuing indictments from Pittsburgh to Las Vegas.”

Report Alleges Opioid Makers Bankrolled Patient Groups

By Pat Anson, Editor

U.S. Senator Claire McCaskill (D-MO) has released a scathing report that is sharply critical of patient advocacy groups and medical pain societies for accepting money from opioid manufacturers.

The report found that Purdue Pharma, Janssen Pharmaceuticals, Mylan, Depomed and Insys Therapeutics provided nearly $9 million to over a dozen non-profits and medical societies from 2012 to 2017.  In many cases, the amount of the donations was not fully disclosed by the recipients.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” McCaskill's report alleges.

    Opioid Maker Payments to Advocacy Groups

• Purdue Pharma              $4,153,000
• Insys Therapeutics         $3,146,000
• Depomed                        $1,071,000
• Janssen                             $465,000
• Mylan                                  $20,250

Over the same five year period, physicians affiliated with the advocacy groups and medical societies accepted more than $1.6 million in payments from the opioid manufacturers.  

McCaskill, who is the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, has long been critical of opioid prescribing practices and the role they played in fueling the so-called opioid epidemic.  Her report suggests that advocacy groups that criticized the CDC’s 2016 opioid prescribing guidelines did so to curry favor with drug makers -- not because of the well-documented harm the guidelines were causing pain patients.  

“Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use — and ultimately, the financial interests of opioid manufacturers. These groups have issued guidelines and policies minimizing the risk of opioid addiction and promoting opioids for chronic pain, lobbied to change laws directed at curbing opioid use, and argued against accountability for physicians and industry executives responsible for overprescription and misbranding,” the report found.

"The fact that these same manufacturers provided millions of dollars to the groups described below suggests, at the very least, a direct link between corporate donations and the advancement of opioids friendly messaging. By aligning medical culture with industry goals in this way, many of the groups described in this report may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic."   

Top 10 Recipients of Funding from Opioid Makers

1. U.S. Pain Foundation                                                      $2.922,000
2. American Academy of Integrative Pain Management     $1,265,000
3. American Academy of Pain Medicine                              $1,199,000
4. American Pain Society                                                       $962,000
5. National Pain Foundation                                                   $562,000
6. Washington Legal Foundation                                           $500,000
7. American Chronic Pain Association                                   $417,000
8. American Society of Pain Management Nursing                $323,000
9. AAPM Foundation                                                              $304,000
10. Center for Practical Bioethics                                             $163,000

"Sen. McCaskill and the others haven’t spent the necessary time talking to us to understand how we do things and what we have to offer," Bob Twillman, PhD, Executive Director of the American Academy of Integrative Pain Management said in a statement. "It appears that they’ve simply looked at how much money we got from a set of pharma companies, constructed a narrative about what that means, and published it."

Perhaps the most surprising detail in the report is the amount of money Insys Therapeutics gave to the U.S. Pain Foundation – over $3.1 million --- with $2.5 million paid in 2017 alone. Insys is the manufacturer of Subsys, a potent fentanyl-based spray that has been blamed for hundreds of overdose deaths.

Former Insys executives and sales representatives have been charged with racketeering and bribing doctors to prescribe Subsys off label to non-cancer patients. The Arizona drug maker has also been accused of misleading and defrauding insurance companies to pay for Subsys, which can cost tens of thousands of dollars for each 30-day prescription.

U.S. Pain founder and president Paul Gileno released a statement defending his non-profit's acceptance of the Insys money. He said the funds were used by the organization to fund a co-pay assistance program for cancer patients.   

"This funding, like any funding we receive, does not influence our values. When it comes to opioids, we believe both that people with legitimate pain have a right to effective care and that systematic changes must be made to address the ongoing opioid crisis," Gileno said.

McCaskill’s report makes no mention of the increasing role played by illegal opioids, such as heroin and illicit fentanyl, in fueling the opioid epidemic. A recent CDC report blamed illicit fentanyl for over half of the overdoses in ten states -- including McCaskill's home state of Missouri.  

Law Firms Major Donors to McCaskill Campaign

According to OpenSecrets.org, McCaskill has received over $6 million in campaign donations from law firms since 2005, including some currently involved in litigation against opioid manufacturers. Contributors affiliated with the law firm of Simmons Hanly Conroy have donated over $300,000 to McCaskill, who is running for re-election this year.

Simmons Hanly Conroy represents dozens of states, counties and cities that are suing Purdue Pharma and other drug makers over their marketing of opioids, and would pocket one-third of the proceeds from any settlement, according to reports.

A statement on the Simmons Hanly Conroy website claims the law firm "effectively invented large-scale, multi-defendant opioid litigation" and is a "trusted ally to local and state governments who seek justice and reprieve from the often debilitating costs associated with fighting the opioid crisis."

According to a survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to consider suicide. Over 70 percent said their opioid medication had been reduced or cutoff by doctors, and 11 percent said they had obtained opioids illegally for pain relief since the guidelines came out.