Being Taken Off Methadone Is Inhumane

By Wendy Cooper, Guest Columnist

I am a pain patient and diabetic entering my second week of detox.  My doctor will no longer prescribe methadone because he’s afraid of being targeted by the DEA for not following the “voluntary” CDC guideline.  He said they are putting doctors in prison by the hundreds and it’s just no longer worth the risk. 

I was on methadone for years.  I am also a gastric bypass patient, so I will not be able to take any type of NSAID (non-steroidal anti-inflammatory drug) for pain. 

When my doctor first suggested methadone I was totally confused.  I told him, “But wait, that’s for drug addicts.”  Well it is, but it’s also very effective for pain control.  After taking it for a month I was so happy.  It totally handled my pain and I didn’t have all of the other side effects, like making me sleepy and lethargic.  My mind was clear. I had my life back.  Yes, for many methadone works.  Sadly, it used to work for me, too.  

I am now back on insulin every day due to the pain, after having been off of insulin for years. Methadone did that.  It started the ball rolling in a positive direction. I was able to exercise more and take care of my family, because the pain relief helped get my diabetes under control. Not anymore. 

Supposedly the danger is because methadone, which has been around for over 50 years, has an effect on the respiratory system.  Well, this is true of many medications if they are not taken correctly.  If I take too much of my insulin, it will have an effect on my respiratory system too — as in me not breathing at all because I will be dead. 

Tons of medications have dangerous side effects if not taken properly.  What used to happen is you would weigh the benefits and the risks with your physician and then the patient would make an informed decision. 

WENDY COOPER

Why does the government have the right to take away medication that has changed my life for the better?  Why am I being treated like a child by assuming I will not take my medication correctly?  I can’t think of any valid reason for this except MONEY.  Methadone is $35 per month, while buprenorphine (Suboxone) is close to $300. 

Buprenorphine is not a good fit for pain patients.  We are much more likely to go to the emergency room for an acute event than non-pain patients.  What will they give us for pain? 

It’s my understanding that pain medications are complicated when you are facing surgeries while on buprenorphine.  I have four surgeries scheduled this year.  Am I supposed to wean myself every time I get ready for one of my surgeries? 

I always felt safer from any type of addiction issue because methadone took away the “feel good” effects of Percocet.  If I hurt myself, I could take a Percocet and it would help with the additional pain. 

I don’t have an addiction problem, but like most pain patients I am concerned about developing one. I’ve always felt it is my responsibility to take precautions and govern myself with my own guidelines.  Well, that benefit is gone.  I don’t want to live anymore. This is inhumane. 

Wendy Cooper lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to:  editor@PainNewsNetwork.org. 

Canada’s Chronic Pain Task Force Surveying Patients

By Marvin Ross, Guest Columnist 

In typical government fashion, the Canadian Chronic Pain Task Force continues to delay taking a stand on the plight of pain patients by initiating a new survey, while still blaming doctors and patients for the opioid crisis. 

The Task Force was established last year to help Health Canada better understand the needs of chronic pain patients. Their preliminary report in June found that anxiety and fear about opioids were causing pain to go untreated:

“Some Canadians have been unable to access opioid medications when needed for pain and function. Others have faced undue barriers to obtaining or filling their opioid prescriptions, and some have had their opioid dose abruptly lowered or discontinued. This has resulted in unnecessary pain and suffering, and has led some Canadians to obtain illegal drugs to treat their pain. We must do more to strike the right balance – to promote opioid prescribing practices that balance the benefits and risks of these medications based on the individual needs of each patient.”

Those initial findings were consistent with the results of a survey of over 700 pain patients conducted by the Chronic Pain Association of Canada (CPAC). That survey found that nearly half of Canadian patients had their pain medication reduced, many were in much greater pain, had severely diminished quality of life, lost doctors or had poor relations with them, attempted suicide or turned to street drugs for help.

At that point, the Task Force response should have been to make recommendations to reverse those negative impacts on patients. Two evaluations that replicate each other should be sufficient to take action to relieve the suffering caused by Canada’s 2017 opioid prescribing guideline.

But that is apparently asking too much as they've decided to do another survey through invitations to their online questionnaire. These are the key questions: 

• What challenges and barriers to understanding, preventing, or managing pain exist in your community and in Canada?  

• What needs to be done to respond to these challenges and barriers? 

• What is working to address pain in your community and in Canada? Please provide specific examples of practices and/or activities. 

• What is it about these practices/activities that makes them successful?  

• What should be the 3 top priorities for research in pain from your point of view?  

• What would help to better integrate research and new knowledge into education and training, policy, clinical practice, and everyday life?  

• What other strategies would help us to better understand, prevent, and/or manage pain in Canada?

Well, the main barrier to managing pain is the adherence by doctors to the prescribing guideline and their fear of losing their medical licenses if they don’t. Nothing will restore functioning to those impacted without rescinding that. The rest of the questions are inane. 

Where Is the Evidence?

As I pointed out in an earlier PNN article, Health Canada implemented the guideline based on weak evidence that the increase in opioid deaths result from inappropriate prescribing by doctors and misuse by patients. PNN columnist Ann Marie Gaudon attempted to obtain the research that Health Canada used to justify their claims and it was like pulling teeth, as you’ll see in this phone call. 

When the research was finally obtained, it didn’t prove a link between prescribing and overdoses. When CPAC sent them a critique of their studies, Health Canada replied that they have much more evidence, but then ignored requests for copies. CPAC has submitted a Freedom of Information request and is waiting for a response. 

Health Canada and the Chronic Pain Task Force continue to base their work on the many myths and misperceptions associated with opioid prescribing, which were debunked in a review recently published in Pain Management Nursing.  

A policy based on faulty logic to solve a problem (addiction and opioid overdoses) caused a new problem by condemning innocent people to unnecessary pain and suffering. Meanwhile, the original problem only grows worse. It is time to go back to the drawing board and accept what every Sociology 101 student knows. There are unintended consequences. Until that happens, nothing will be improved for anyone.   

But then, to make matters worse, this week Health Canada announced nearly $3 million in funding “to help people living with chronic pain.” Most of the money will apparently be spent on treating and preventing addiction, not treating pain. Saskatchewan will get $1.7 million from the Substance Use and Addictions Program and Alberta will get $1.2 million to “improve care delivery including opioid prescribing practices.” 

Health Canada does not seem to be able to distinguish between people with chronic pain and those with substance abuse problems. They are not the same and it is insulting to combine them. It is time that Health Canada learned to distinguish between dependence and addiction. 

Marvin Ross is a medical writer and publisher in Dundas, Ontario.

DEA Warns Doctors About Extortion Scam

By Pat Anson, PNN Editor

It’s no secret that doctors are under increased scrutiny from the Drug Enforcement Administration and other law enforcement agencies for their opioid prescribing practices.

Last month a North Carolina physician was told to surrender his DEA license by investigators with the state medical board. “They called me on the phone and said they were coming by in two hours to get you to surrender your license,” Dr. Thomas Kline told PNN.

In southern California, a doctor who recently paid a $125,000 fine to settle allegations of illegal opioid prescribing says federal prosecutors threatened to ruin his practice and reputation if he didn’t pay up.

“They could care less if I was innocent or guilty. They wanted to see how much they could gouge out of me,” said Dr. Roger Kasendorf, an osteopathic physician in La Jolla. “It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic.”

It didn’t take long for criminals to realize that other doctors could be vulnerable to extortion. And with no small amount of irony, the DEA’s San Diego Field Division recently issued an unusual alert warning doctors about scam telephone calls from con artists posing as DEA agents, who threaten physicians with arrest and prosecution for violations of federal drug laws.

“DEA continues to receive reports of calls threatening legal action if an exorbitant fine is not paid immediately over the phone. The callers identify themselves as DEA personnel and instruct their victims to pay the ‘fine’ via wire transfer to avoid arrest, prosecution and imprisonment,” the DEA alert warns.

The scam artists – who use fake names, DEA badge numbers or even the actual names of senior DEA officials – threaten to revoke DEA licenses if thousands of dollars are not paid by wire or in untraceable gift cards.

The threat is not an idle one, because doctors cannot prescribe opioid medication and other controlled substances without an active DEA license.

“DEA employees do not contact practitioners or members of the public by telephone to demand money or any other form of payment,” the DEA said. “Notification of a legitimate DEA investigation or legal action is made via official letter or in person.”

The alert urges anyone receiving a telephone call from a person claiming to be a DEA employee demanding money to report the threat using DEA’s online form or by calling 877-792-2873.

11 Myths About the Opioid Epidemic

By Pat Anson, PNN Editor

If you’re a journalist, researcher or student interested in learning more about the opioid epidemic – or a patient or healthcare provider just trying to make sense of it -- a revealing new analysis debunks many of the myths and falsehoods being told about opioid pain medication.

“Misperceptions about the Opioid Epidemic: Exploring the Facts” was recently published in the journal Pain Management Nursing. Unlike most articles in medical journals, this one is not hidden behind a paywall – so the comprehensive and heavily footnoted research is available to everyone for free.

Co-authors Cathy Carlson, PhD, a professor at Northern Illinois School of Nursing, and June Oliver, APRN, a clinical nurse pain specialist at Swedish Covenant Hospital in Chicago, worked on the article for over four years, compiling research on 11 common myths about opioids that are repeated ad nauseam by the media, politicians, law enforcement and others.   

“We identified many more than this, but you have to put a limit on how long an article can be, so we narrowed them down to what we thought were the most important ones,” Carlson told PNN. “What concerned us is that this is all being presented by politicians and other important entities. It's just perpetuating the fear and sensationalizing it.”

Misperception #1 is the number of deaths attributed to opioid medication. The next time you see a statistic reported like “more than 63,600 people died of drug overdoses” in 2017, you should recognize that thousands of deaths were counted multiple times.  That’s because the Centers for Disease Control and Prevention doesn’t count “deaths” – it counts the number of drugs involved in overdose deaths.

The actual number of Americans who died from opioid overdoses in 2017 was not 63,000 – but about 49,000.

“If a person died of fentanyl, heroin and prescription opioids, that’s three deaths. We went from one person that actually died to three deaths counted in the categories because they put one under each,” explained Carlson. “It’s never known which drug they actually died from. So, we can never say prescription opioids caused the death. We can only say they were present at the time of death.”

Another myth is that more Americans die from opioid overdoses than in motor vehicle accidents, a claim first made by the National Safety Council (NSC) that’s been widely repeated in the media.  

“The opioid crisis in the United States has become so grim that Americans are now likelier to die of an overdose than in a vehicle crash,” The New York Times reported.

Carlson and Oliver say the NSC used a “confusing mismatch of statistical categories” to inflate the overdose numbers and make them more “attention grabbing.”

What are the actual facts? Nearly 30,000 Americans died in motor vehicle accidents in 2014, but the number of prescription opioid deaths was about half that.

“It doesn’t make as good of a story if you include it. We do believe it is purposely misleading,” says Carlson. “It’s the change theory. They have this need for change and they’re supplying it with statistics that sensationalize the issue.”

CDC’s Anti-Opioid Bias

Some of the other myths debunked by Carlson and Oliver include claims that the U.S. is the biggest consumer of opioids; that long-term use of opioid medication is not supported by evidence; that prescription opioids often lead to heroin use; and that statistics published by CDC are of high quality.

“We have a lot of issues with data collection. It’s not the CDC’s fault, they can only use what’s given to them. And states vary considerably in their accuracy in keeping statistics for overdose deaths,” Carlson said. “We’d like to see better data collection, especially through state and county medical examiners, so the statistics reported by the CDC are more accurate.”

But the CDC is not held blameless for the cascade of misinformation. Carlson says the agency has an anti-opioid bias that is repeated in many of its studies and policy statements.

“If you read what they do publish, they obviously have a viewpoint. It’s not a neutral viewpoint that gives you both good and bad. They are pushing you in a certain direction,” she said.

The CDC’s controversial 2016 opioid guideline – intended only for primary care physicians treating non-cancer pain – has been implemented as policy or law in dozens of states.

“I’m disappointed in what has occurred with CDC guidelines. Many people question the guidelines and that they weren’t always based on evidence,” Carlson said. “They were meant for primary care providers, not for pain management specialists, not for surgeons, and they’re making them apply to everyone. They are supposed to be guidelines. There are always people out on the Bell Curve and they don’t take that into consideration either.”

Carlson says Americans should be cautiously skeptical about much of the information they’re getting about the opioid crisis.  

“We’re mostly asking for discernment. To be aware of what you’re reading,” she said. “We want you to think about these statistics and look at the glaring gaps and reporting of statistics.”

FDA Reviewing New Osteoarthritis Drug

By Pat Anson, PNN Editor

A decade long effort to bring a new non-opioid pain reliever on the market is a step closer to reality – although lingering questions remain over the safety of the drug.

Pfizer and Eli Lilly have announced that the U.S. Food and Drug Administration has accepted for review a Biologics License Application for tanezumab as a treatment of chronic pain due to moderate-to-severe osteoarthritis (OA). The FDA set December 2020 as a goal for making a decision on the application.

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

"The FDA acceptance of the tanezumab application represents a significant milestone, and the breadth of our regulatory submission reflects the extensive clinical data we have gathered for tanezumab over the course of its development," Ken Verburg, Pfizer’s tanezumab development team leader, said in a statement.

"There is an urgent need for innovation in the treatment of osteoarthritis, as there have been no new classes of medicines available for this debilitating condition in more than a decade. If approved, tanezumab would be a first-in-class treatment for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics."

Pfizer and Eli Lilly are jointly developing tanezumab, which was given “fast track” designation by the FDA in 2017 to help speed its development. The companies submitted data to the FDA from 39 clinical studies evaluating the safety and efficacy of tanezumab on more than 18,000 patients.

A Phase 3 clinical study in 2018 found that osteoarthritis patients who were given two injections of tanezumab had significant improvement in their pain and physical function compared to a placebo.

Not all of the studies have been positive, however. Another Phase 3 study last year found that over 6% of osteoarthritis patients taking a 5 mg dose of tanezumab experienced rapidly progressive OA in their joints. There was significant improvement in their pain and physical function, but the patients’ overall assessment of their condition was no better than those treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Patients in the same study taking a lower 2.5 mg dose of tanezumab did not have any significant improvement in their pain, quality of life or overall condition. And 3.2% experienced rapidly progressive osteoarthritis. The license application accepted by the FDA is for that smaller 2.5 mg dose.

In 2010, Pfizer reported some osteoarthritis patients taking tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.”

There is some concern that NGF antibodies work too well and encourage osteoarthritis patients to become more active, which accelerates joint deterioration. More than 27 million Americans live with osteoarthritis, 11 million of whom have moderate-to-severe OA.

Tanezumab is also being evaluated as a treatment for cancer pain due to bone metastases in a Phase 3 study. At one time, it was studied as a possible treatment for low back pain, but Pfizer and Eli Lilly are now mainly focused on tanezumab as a treatment for osteoarthritis.

Most People Keep Their Leftover Rx Opioids

By Dr. Lynn Webster, PNN Columnist

"Who Is Keeping Their Unused Opioids and Why?"

That’s an important question, especially since we're currently in the midst of a drug crisis. The last thing we want is more prescription drugs being diverted onto the street and circulated for non-medical use. The issue was the subject of a research article published last year in Pain Medicine.

The authors surveyed 235 patients who received hydrocodone prescriptions following emergency room visits between July 2015 and August 2017. All were given information about how to safely dispose of their unused hydrocodone. Researchers contacted the patients a month after they were discharged, asking what they planned on doing with their leftover pills. 

Over half said they had no intention of giving them up. Only 100 of the 235 said they would follow advice and dispose of their unused medication.  

When asked why they were keeping their leftover pills, patients said it was “in case I have pain,” “just in case” and “You never know. If I need it [when I'm traveling out of the country], I can use it.”

A larger national study conducted in 2015 had similar findings. Over 60 percent of patients prescribed opioids said they planned on keeping their leftover pills for future use.

Policy Changes May Be Making the Problem Worse

Over the past several years, partly in an effort to decrease the number of unused opioids, there has been a sweeping change in attitudes and practices of dispensing opioids in emergency rooms. According to the CDC, rates of prescribing opioids in ERs decreased by a third from 2006 to 2017.  

Since patients now receive fewer opioids from the ER than in the past, they are likely to have fewer unused pills. However, paradoxically, that may create more incentive for them to hold onto the unused opioids in case they need them in the future.

It is not just emergency rooms that are providing patients with fewer opioids. Increasingly, patients discharged following surgeries receive less opioid medication or none at all, even though 80 percent of them feel their post-op pain was inadequately treated. 

Under-treated acute pain can cause permanent harm. In a recent issue of Anesthesiology, Editor-in-Chief Evan Kharasch, MD, and several of his colleagues penned an editorial, “Rational Perioperative Opioid Management in the Era of Opioid Crisis.”

They said there was little evidence to support the view that limiting opioids for post-operative pain was reducing abuse. Instead, it was leading to unintended consequences and “opioid phobia.” The authors specifically note that poorly controlled acute pain can lead to chronic pain.

People Worry Whether They Will Get Pain Medication

Many people clearly want to hold onto their unused medications. This is not new. However, the problem may worsen because, more than ever, patients fear that they will not be able to get opioid medication when they need it.

Keeping unused opioids is ill-advised for many reasons, the most important of which is that opioids should never be used except under the direction of a qualified provider. But there's another side to the story. If providers are going to refuse to treat pain, people will want to hold onto the medication they have been prescribed in order to avoid future suffering.

Of course, the intention of limiting the amount of opioids prescribed is to reduce the amount of drugs that could be diverted for non-medical use. But policies and practices designed to limit the amount of unused opioids may actually be dangerously creating a need to preserve, rather than dispose of, unused medication.

To paraphrase Dr. Kharasch, let us avoid making people in pain pay with unnecessary suffering for the opioid overprescribing sins of others.   

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed are those of the author alone and do not reflect the views or policy of PRA Health Sciences.

Coronavirus Outbreak Raising Fear of Drug Shortages

By Pat Anson, PNN Editor

As the coronavirus spreads around the world, so are fears about drug supply shortages. While the prescription or over-the-counter medication you take may not come directly from China – the epicenter of the outbreak – chances are one of its ingredients does.

According to a recent study, nearly two-thirds of the world’s supply of acetaminophen comes from China. Known as paracetamol outside the United States, acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus. It’s also used in opioid pain medications such as Vicodin.

While there’s no sign yet of an acetaminophen shortage, quarantines, travel restrictions and supply disruptions in China caused by the COVID-19 virus are causing some concern.

“One of the ugly secrets of the pharmaceutical industry is that the vast majority of raw materials that go into a prescription drug are produced overseas, mostly in China and India,” Geoffrey Joyce, PhD, chair of the Department of Pharmaceutical and Health Economics at the USC School of Pharmacy told the Los Angeles Times. “The coronavirus shutting down China or India for an extended period of time is likely to have a substantial impact on the supply of many drugs.”

Another academic expert made an even more alarming prediction.

“You’re going to see shortages,” William Comanor, PhD, a professor of health policy and economics at UCLA told The Times. “Tell your readers to stock up on generics!”

Vague Warning from FDA

There is already a shortage of at least one drug, although the head of the Food and Drug Administration didn’t identify what it was in an unusually vague statement released last night.

“A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” said FDA Commissioner Stephen Hahn, MD.

“It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”

The FDA has contacted over 180 drug manufacturers around the world to remind them they have a legal obligation to notify the agency of any supply disruptions. About 20 pharmaceutical drugs that the FDA calls “non-critical” either come directly from China or have ingredients that come from there.

“We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date,” Hahn said.

The FDA is taking Chinese drug manufacturers at their word. Because of federal travel restrictions, FDA inspectors are not currently traveling to China to see for themselves.

Hahn’s statement also warned about manufacturing problems at dozens of Chinese facilities that make “essential” medical devices – but again without identifying what those devices are.

“We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market,” said Hahn.

Face Mask Shortages

As for personal protective equipment --- such as face masks, gloves and surgical gowns – Hahn said the FDA has “heard reports of increased market demand and supply challenges” but was unaware of widespread shortages. China makes about half of the world’s supply of surgical masks but has stopped virtually all exports.

“Before the outbreak of the epidemic, we used to export 600,000-700,000 surgical masks a month, but now the amount is zero," David Peng, manager of a Chinese medical supplier, told the Chicago Tribune.

Walgreens, Home Depot, Lowe’s and other retailers in the U.S. are scrambling to meet demand for masks or have sold out.

The CDC has been urging healthy people not to use masks and other protective gear because they want those products available at healthcare facilities if the coronavirus outbreak becomes severe. Regular hand washing is the preferred alternative.

“CDC does not recommend that people who are well wear a facemask to protect themselves from respiratory illnesses, including COVID-19. You should only wear a mask if a healthcare professional recommends it,” the CDC says.

“A facemask should be used by people who have COVID-19 and are showing symptoms. This is to protect others from the risk of getting infected. The use of facemasks also is crucial for health workers and other people who are taking care of someone infected with COVID-19 in close settings (at home or in a health care facility).”

Who is most at risk of coronavirus? Unfortunately, its people who are already sick and have compromised immune systems, as Dr. Lynn Webster explained in a recent column.

“The people with increased risk for experiencing severe symptoms, and possibly dying of COVID-19, are seniors and those with chronic illness. Of course, many people in chronic pain are part of both risk groups. The mortality rate of COVID-19 has been reported to be about two percent,” Webster said. “People with chronic pain may be more susceptible to viruses in general, because chronic pain can change the way our immune systems work.”

For more information from CDC on the coronavirus outbreak, including symptoms, prevention and answers to frequentely asked questions, click here.

Fighting Medical Injustice in North Carolina

By Michael Harmon, Guest Columnist

I’m writing on behalf of my wife Lynda, a 30-year victim of fibromyalgia. Lynda was hit by a drunk driver in 1985 and despite years of neurological testing and procedures, we were unable to stop this dreaded disease from spreading throughout her body.

By 1993, she was confined to a chair and faced 24/7 pain. Regrettably, the only plausible outcome in her mind was possible suicide, a place many with chronic pain find themselves.

Then we found a doctor willing to prescribe methadone. The medication worked and Lynda was given back a small semblance of life. It was still a very limited lifestyle, but she could occasionally shop, go to dinners, drive and take care of her house. 

Two other doctors carried on this fight for the next 20 years, with the same prescription and same dosage. They were years that my daughter and I counted as bonus years, given the dark periods of the early 1990’s.

Then the CDC got involved with its 2016 guideline establishing voluntary, not mandatory, amounts allowed for opioid prescriptions. The guideline led to forced tapering of patients, and penal sanctions and revocation of medical licenses for doctors found to be non-compliant with the new “standard of care.”

LYNDA HARMON

In 2018, Lynda’s pain doctor started the tapering protocol, and immediately we saw her tailspin into a dark depression. She knew what was coming! Her methadone dosage was cut to about 15-20% of her normal prescription levels of the past 25 years.

By early 2019 she was once again in a chair, rocking in pain, 24/7. And yes, suicide was once again on the table. But hey, the government was happy, the politicians were happy, and her doctor wasn’t going to lose her livelihood!

Befriending Dr. Thomas Kline

I met Dr Thomas Kline in February of 2019 after reading an article he wrote that chronicles in detail over 30 pain patients who took their lives as a result of being tapered. I befriended this “true healer” and wanted to help him bring awareness of this injustice any way I could.

After 6 months of talking and working on these issues, Dr. Kline asked me one day if he could help Lynda. I knew he was not taking patients and I never asked him to help Lynda, I just wanted to help him bring light to this terrible problem.

Dr. Kline met Lynda in August and after lengthy interviews, examinations and medical testing, Lynda switched her pain care to Dr. Kline. We were delighted!  

DR. THOMAS KLINE

The protocol of methadone was slowly and professionally raised each month, and by January 2020 Lynda’s mood lifted. Thoughts of suicide disappeared, and movement of her extremities became easier and free of pain. You could tell her life was being returned to her.

Then came the news of last Monday, February 17 that Dr. Kline was under investigation by the North Carolina Medical Board.

He was told to surrender his DEA license, which means he can no longer prescribe opioid medication. All 34 of his patients were left in limbo, basically thrown to the wolves.

Who could do such a thing? Is this truly a medical board of doctors who made an oath to alleviate pain and suffering? Tell me, what are these 34 patients supposed to do? No doctor will take their case, for fear of losing their own livelihood.  

Lynda has only a few days left of her last prescription, as she was due to pick up her monthly meds last Tuesday, the day after receiving the news of Dr. Kline’s suspension. This type of oversight is inhumane and should have no place in a modern society. I would argue that we treat our pets better than this!  

Now don’t get me wrong, I am fully supportive of the President’s effort to fight the opioid crisis on the streets of America, on our borders, internationally and in hospitals. I agree wholeheartedly to the jailing of doctors that write scripts to bogus patients who profit from the sale of the drugs on the street. This is abhorrent.  

But the people we are talking about, people like my wife, have been on these medical protocols for chronic pain for 10, 20 and 30 years plus! They are functioning citizens of our society. These people have mortgages, car payments, and children in college. How are they going to work without the medicines needed to overcome their daily pain?   

Some are military veterans who were busted up and blown up, defending our freedom. One veteran commenting on the tapering of his pain meds was recently quoted as saying, “Once again my country has asked me to lay down my life!” 

Lynda and I consulted with three doctors last week, doctors of the highest repute, and each of them had no answer to this horrible matter. How can this be?  

Perhaps Dr. Kline’s DEA license will be reinstated, maybe not. Life will go on for this kind man and perhaps he will begin to enjoy the retirement he had seen for himself and his family when he moved to Raleigh. For that I am happy. This truly is a doctor who cares, and cares enough to push the limits in order to help improve the human condition.  

But what about his 34 patients? What about other patients around the country who, like Lynda, are on the threshold of suicide?  What are they going to do? They no longer have a Dr. Kline in their lives or a government that cares. If they did care, they would not be investigating a great doctor like Dr. Kline. They'd be empowering him and others to get in the middle of this injustice and fix it! 

Michael and Lynda Harmon live in South Carolina.

Pain News Network invites other readers to share their stories with us. Send them to:  editor@PainNewsNetwork.org.

Pain Patients Left in Limbo by Dr. Kline Investigation

By Pat Anson, PNN Editor

They call themselves the “NC 34” – thirty-four patients left in limbo after the North Carolina Medical Board told their doctor this week to surrender his DEA license. Without that license, Dr. Thomas Kline can no longer prescribe opioid pain medication and other controlled substances.

Kline’s 34 patients, who all suffer from chronic and rare diseases, now face the imminent prospect of withdrawal and uncontrolled pain when they run out of opioid medication in the next few weeks or days.

“The board has no idea how irresponsible their actions were taking away Dr. Kline's DEA license, because the board has adversely affected the lives of 34 of Dr. Kline's chronic pain patients, all of whom are pain refugees and all of whom require opiate therapy on a daily basis in order to have some semblance of a quality of life,” says Leslie Bythewood, a Kline patient who lives with hypothyroidism and Chiari malformation of the brain, which causes severe migraines and cluster headaches.

“When our pain meds run out, we are going to go through not only withdrawal but our original pain is going to rise exponentially and make our lives miserable, insufferable and totally unlivable once again.”

As PNN has reported, the North Carolina Medical Board won’t say why it is investigating the 76-year old Kline, who until now had no record of any complaint or disciplinary action taken against him.

Kline has no idea why his practice has come under scrutiny. In recent years, he’s become an outspoken advocate for pain patients — maintaining that doctors should decide when and how to treat their patients with opioids, not state medical boards or the DEA.

Kline says he was pressured by state investigators into surrendering his DEA license when they made a surprise visit to his office in Raleigh on Monday – a decision he now regrets.

“I was never notified when these inspectors came out that it was voluntary. They called me on the phone and said they were coming by in two hours to get you to surrender your license,” Kline told PNN. “I’ve been telling doctors, ‘Never surrender your license.’  But I thought this was something different. And it threw me for a loop as to why this is coming from the medical board.”

‘I Have 7 Days of Meds Left’

Kline’s medical license remains active and he can still see patients, he just can’t write prescriptions for opioids or other controlled medications. Kline has urged all 34 patients to find new prescribers.  

“All of the patients have been searching and searching and searching and they can’t find anyone,” says Kline, who treats several out-of-state patients who travel hundreds of miles to see him because they can’t find a local provider willing to treat them.

Opioid hysteria, fear of prosecution and medical discrimination have made doctors and pharmacists reluctant to accept new pain patients, particularly those on high opioid doses.  

“Right now, prospects are slim of finding either a provider or a pharmacy.  I don't know what is going to happen,” said Jeff Geurin, a disabled Air Force veteran in Georgia who was injured in a parachute accident.

“I have severe chronic pain, the only relief from which has come from high-dose opiate medications.  After the VA discontinued all veterans off pain meds in 2015, and shortly thereafter the civilian doctors, I was out of options. I was planning my suicide in 2018, and two weeks before my planned exit, Dr. Kline rescued me.”

While under Kline’s care, Geurin says he’s been able to live a relatively normal life. He was thrilled recently to land a job as a 911 dispatcher.

“I have about 7 days of meds left, so I'm going to be hurting and withdrawing while starting a new job. I'm scared, I'm angry, and I'm sad for all the other patients of Dr. Kline who have been ripped from stability and pain control for no good reason,” Geurin wrote in an email. 

“This board is putting all our lives at risk by keeping him from prescribing to us.”

— Kristina Mitchell, Kline patient

“There's another patient that is already talking of suicide. And what are you supposed to say to him? No, don't do it? That would be like telling the people trapped in the North Tower on 9/11 not to jump, they have to stay in the tower and burn to death.”  

“I am almost ready to check myself out of this life, because I can't seem to find a single caring physician since Dr. Kline lost his DEA license, and I know for a fact that I simply cannot live with this constant, intense pain,” said Bythewood.

“I deserve the right to proper medical care. A diabetic isn’t denied insulin, but pain patients are being targeted because of an opioid epidemic,” said Colleen Davis-Harrison, a Kline patient who has multiple sclerosis and arachnoiditis, a chronic inflammation of spinal nerves. “I will support Dr. Kline and my fellow patients. I just hope no one gets hurt or does something stupid while others wait to see what’s in the cards for us.” 

“I do not have another doctor to write my prescriptions. I had already exhausted all of my options in my state when I went to Dr. Kline,” said Kristina Mitchell, a patient with Ehlers-Danlos syndrome (EDS) who lives in Virginia. “Without him I don't know what I will do. Withdrawal is not my concern, that won't last. The full force of my pain coming back is my greatest fear and I know I can't handle it. 

“I hope this gives you a general idea of what an amazing, good, caring and life-saving doctor Kline is. Without him, myself and 33 other people may not be here today. This board is putting all our lives at risk by keeping him from prescribing to us.” 

Duping of Healthcare Providers

Will Kline be able to get his DEA license back? One expert says that is unlikely. 

“I have never heard of any controlled substance registrant who surrendered or otherwise lost a controlled substance registration being able to get it back from the DEA,” said attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers.

Barnes tells clients not to be intimidated by DEA or medical board investigators who claim that surrendering a license is only temporary.

“If you surrender that authority, it doesn’t matter if there used to be a piece of paper. Surrendering of the authority is saying ‘I’m giving up my right to prescribe.’ This is part of the duping of healthcare providers, where they think they are doing one thing. In reality they’re doing something that’s permanent,” Kline told PNN.  

The North Carolina Medical Board’s investigation of Kline apparently began a few months ago, when it asked him for the records of nine patients. A spokeswoman for the board told PNN that investigations of healthcare providers typically take six months to a year to complete. 

In the interim, Barnes says the board should be proactive and make sure the “NC 34” are getting the care that they need. 

“The board should ensure that each of those patients receive a referral to a qualified, certified pain treatment professional who is capable of meeting these patients’ unique medical needs,” Barnes said. “The medical board really has an obligation, not just to give a paper with some addresses on it, but to make certain that each of these individuals is accepted into a practice and actually receives medical care.”

“The medical board has made a big mistake and has taken one of the finest doctors I have ever known, the only doctor I have ever trusted,” says Jess Stewart, another Kline patient who lives with EDS. “He wasn’t a pill mill doctor and instead of being worried about him I would be more focused on the illicit fentanyl out on the streets. You see, it’s actions like this that are forcing people to the streets. 

“Do I need another doctor? Now I do, thanks to the board. But there was nothing wrong with the one I had.”

North Carolina Investigating Pain Patient Advocate

By Pat Anson, PNN Editor

Dr. Thomas Kline, a North Carolina physician who is an outspoken advocate for chronic pain patients, is under investigation by his state’s medical board, PNN has learned.

Kline voluntarily surrendered his DEA license to North Carolina Medical Board investigators on Monday, which temporarily prohibits him from prescribing opioid pain medication and other controlled substances to his patients.

The reason for the investigation has not been made public. Kline’s practice in Raleigh, NC specializes in treating patients with chronic and rare diseases, including some on relatively high doses of opioid medication. Kline has been a vocal critic of efforts to rein in opioid prescribing.

"Dr. Kline surrendered his DEA license voluntarily, at the request of the NC Medical Board. In connection with the surrender of his DEA license, Dr. Kline also provided medical records of his patients to NC Medical Board,” Kline’s office said in a statement. 

“Dr. Kline will cooperate with the Board in order to ensure the well-being of his patients. Dr. Kline cares deeply about his patients and their needs at this time. However, he can no longer provide them with opiate pain medication.” 

The state medical board would not comment on the investigation.

DR. THOMAS KLINE

“At this point there has been no public action taken, so I’m not able to confirm or deny what may have occurred with this licensee,” said Jean Brinkley, a spokeswoman for the North Carolina Medical Board. “Investigations are confidential under North Carolina law, so until there’s been an action that’s made public, we can’t discuss it.”

The medical board has no public record of any complaint or disciplinary action against Kline. “As of now, Dr. Kline has an active medical license with no specific restrictions from the board,” Brinkley told PNN.

Without his DEA license, Kline will be unable to prescribe opioids and other controlled substances until the state’s investigation is completed. A typical “quality of care” investigation by the board takes six months to a year to complete, according to Brinkley.

“The average number of days to close a case, from the date it was opened to the date it was closed, was 104 days in 2019. But I will say quality of care cases, because of the need to obtain an independent medical review, typically take longer than that,” she said.

In public hearings, news stories, social media and his own YouTube channel, Kline seeks to expose some of the myths surrounding opioid medication and the damage done to millions of patients who’ve been abruptly tapered off opioids because of fears about addiction.

“This has never been done before in the history of medicine, at least in this country, where people are forced to stop taking medicine that is effective, is working, without side effects, against their will,” Kline says in his YouTube series, Medical Myths Revealed.

“I’ve talked to people that have post traumatic stress about going to the doctor. They lie awake for 3 or 4 days before they go see the physician for fear of another reduction in their pain medicine. This is just awful.”

Many of Kline’s patients will face the same fate, If they are unable to find a new doctor willing to prescribe opioid medication.

Last year the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid medication. The agency said it received reports of “serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.” The harm includes withdrawal symptoms, uncontrolled pain, psychological distress and suicide.

In another video, Kline said he researched federal law and could not find a single reference to “overprescribing” opioids.

“Is prescribing high doses a criminal act? No. We’re doctors. We prescribe what is needed. There is no dosage limit for opiates. You can use 1,000 milligrams a day or 10 milligrams a day. It doesn’t matter as long as you’re not getting side effects,” he said.

The CDC’s controversial 2016 opioid guideline recommends no more than 90 MME (morphine milligram equivalent) a day. Although the guideline is voluntary and only intended for primary care physicians treating chronic pain, it has been implemented as law or policy in dozens of states, and by the North Carolina Medical Board.

Over 2,000 people died of opioid overdoses in North Carolina in 2018. As in other states, the vast majority of the deaths involved heroin or illicit fentanyl, not prescription opioids.

Voltaren Arthritis Gel Approved for OTC Despite Safety Risks

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved three drugs for over-the-counter (OTC) sale that were previously only available by prescription. One of them is Voltaren Arthritis Pain, a topical gel made by GlaxoSmithKline.

The active ingredient in Voltaren gel is diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that’s been linked to cardiovascular disease and other serious health problems. The gel contains a 1% solution of diclofenac sodium.

Voltaren Arthritis Pain was first approved by the FDA in 2007 as a prescription drug for the temporary relief of osteoarthritis joint pain in the hands, knees and feet. When taken as directed, the agency considers the gel safe to use.

“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research.

“Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

The FDA said Voltaren Arthritis Pain may take up to 7 days to work. Consumers should stop using it and seek medical attention if their arthritis pain is not improved in 7 days or if they need to use the product for more than 21 days.

The warning label cautions that diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Liver damage may also occur if the gel is used more often or longer than directed, or when used with other products containing diclofenac. The label cautions that diclofenac and other NSAIDs increase the risk of heart attack, heart failure and stroke.

Diclofenac One of Riskiest NSAIDs

Diclofenac is not well-known in the United States, but it is the most widely used NSAID in the world. Some experts consider diclofenac so risky it should be banned as an OTC drug.

A large 2018 study in Denmark found that people using diclofenac were 50 percent more likely to have cardiovascular problems, such as atrial fibrillation, heart failure and stroke.

For every 1,000 people who used diclofenac, the study estimated that four would develop a major health problem within a year.

“It is time to acknowledge the potential health risk of diclofenac and to reduce its use. Diclofenac should not be available over the counter.”

— Dr. Morten Schmidt, Aarhus University Hospital

"It is time to acknowledge the potential health risk of diclofenac and to reduce its use," wrote lead author Morten Schmidt, MD, Aarhus University Hospital. “Diclofenac should not be available over the counter, and when prescribed, should be accompanied by an appropriate front package warning about its potential risks.”

Diclofenac was rated as one of the seven riskiest NSAIDs in a 2016 study published by the British Medical Journal. Researchers estimated the risk of heart failure doubled for people taking diclofenac at very high doses.

“The selective COX 2 inhibitors and diclofenac have repeatedly been associated with higher cardiovascular risk, and therefore it seems prudent to avoid them and consider lower risk naproxen at the lowest effective dose,” researchers warned.

According to the FDA’s Adverse Events Reporting System, there have been over 19,000 serious medical cases involving diclofenac sodium since 2010, including 2,294 deaths.  

As PNN has reported, the FDA has effectively slammed the door shut on new opioid pain medications because of the controversy over opioid addiction and overdose. The agency is promoting the use of “safer” non-opioid drugs and recently approved a cocaine-based analgesic nasal spray.

Study Finds Acetaminophen Eases Social Pain

By Pat Anson, PNN Editor

Most everyone has faced rejection at some point in their lives, such as a divorce, losing a job or being “ghosted” by a friend. Being excluded from a relationship often triggers stress, anxiety, depression and sometimes even a desire for revenge.

Taking the pain reliever acetaminophen ­may not be a prescription for curing the blues, but it can ease social pain and help you forgive others, according to an unusual study published recently in the Annals of Behavioral Medicine. The study adds to a growing body of research that suggests over-the-counter pain relievers have psychological effects on humans.

Researchers in California enrolled 42 healthy young adults in a placebo-controlled trial to see if taking acetaminophen has an effect on social pain.

“Research has shown that physical pain and social pain are influenced by some of the same biological processes in the brain and body. Based on this research, we thought that acetaminophen, which is commonly used to treat physical pain, might also be able to reduce social pain,” explained senior author George Slavich, PhD, director of the UCLA Laboratory for Stress Assessment and Research.

For 20 consecutive days, a third of the study participants took 1,000mg of acetaminophen daily, while the rest took a placebo pill or no pill at all.

Participants also completed a daily questionnaire that assessed their level of social pain by asking them to think about a person who had wronged them recently. Did they I hope that person “gets what’s coming to them” for what they did?

From their answers, researchers developed a numerical “Hurt Feelings Scale” for every participant.

Over time, researchers found that acetaminophen significantly reduced hurt feelings, but only for participants who had a more forgiving attitude towards others.

“When combined with a tendency to forgive, taking acetaminophen substantially reduced how much social pain people felt over time. More specifically, participants taking acetaminophen who were high in forgiveness exhibited an 18.5% reduction in social pain,” said Slavich. “Based on the findings from our study, it appears as though acetaminophen acts synergistically with peoples' ability to forgive to alleviate the feelings of social pain that are commonly associated with rejection and exclusion.”

Slavich and his colleagues say anger and sadness are normal responses to social rejection, but can lead to long-term health consequences if they persist. However, the researchers stopped short of recommending acetaminophen as a treatment for social pain.  

“Experiencing a socially painful life event, like a relationship break-up, is one of the strongest predictors of developing depression in adolescence and adulthood. Social pain is also associated with decreased cognitive functioning and increased aggression and engagement in self-defeating behaviors, like excessive risk taking and procrastination,” Slavich said.

“Although the idea of prescribing acetaminophen to individuals undergoing difficult interpersonal situations may be attractive, we are not aware of any studies that have shown acetaminophen to be an effective prophylactic against psychiatric disorders for persons currently experiencing socially stressful circumstances.”

Similar Findings in Other Studies

A 2015 Ohio State study also found that acetaminophen seems to dampen human emotions. Student volunteers who took acetaminophen had fewer emotional highs and lows, and were less likely to react to images that normally produce an emotional response, such as pictures of a child crying or happily playing with a cat.

A second study at Ohio State found that acetaminophen can make people feel less empathy for the physical and emotional pain of others.

It’s not just acetaminophen. A review of studies at UC Santa Barbara concluded that ibuprofen and other over-the-counter pain relievers have an overlapping effect on us, both physically and emotionally.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.”

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury, as well as heart, kidney and blood pressure problems.

Missouri Finds Managing Pain Without Opioids Isn’t Easy

By Lauren Weber, Kaiser Health News

Missouri began offering chiropractic care, acupuncture, physical therapy and cognitive-behavioral therapy for Medicaid patients in April, the latest state to try an alternative to opioids for those battling chronic pain.

Yet only about 500 of the state’s roughly 330,000 adult Medicaid users accessed the program through December, at a cost of $190,000, according to Josh Moore, the Missouri Medicaid pharmacy director. While the numbers may reflect an undercount because of lags in submitting claims, the jointly funded federal-state program known in the state as MO HealthNet is hitting just a fraction of possible patients so far.

Meanwhile, according to the state, opioids were still being doled out: 109,610 Missouri Medicaid patients of all age groups received opioid prescriptions last year.

The going has been slow, health experts said, because of a slew of barriers. Such treatments are more time-consuming and involved than simply getting a prescription.

A limited number of providers offer alternative treatment options, especially to Medicaid patients. And perhaps the biggest problem? These therapies don’t seem to work for everyone.

The slow rollout highlights the overall challenges in implementing programs aimed at righting the ship on opioid abuse in Missouri — and nationwide. To be sure, from 2012 to 2019, the number of Missouri Medicaid patients prescribed opioid drugs fell by more than a third — and the quantity of opioids dispensed by Medicaid dropped by more than half.

Still, overdoses linked to legal and illicit opioids killed an estimated 1,132 Missourians in 2018 and 46,802 Americans nationally, according to the latest data available. Progress to change that can be frustratingly slow.

“The opioids crisis we got into wasn’t born in a year,” Moore said. “To expect we’d get perfect results after a year would be incredibly optimistic.”

Despite limited data on the efficacy of alternative pain management plans, such efforts have become more accepted, especially following a summer report of pain management best practices from the U.S. Department of Health and Human Services. States such as Ohio and Oregon see them as one part of a menu of options aimed at curbing the opioid crisis.

St. Louis chiropractor Ross Mattox, an assistant professor at chiropractic school Logan University, sees both uninsured patients and those on Medicaid at the CareSTL clinic. He cheered Missouri’s decision to expand access, despite how long it took to get here.

“One of the most common things I heard from providers,” he said, “is ‘I want to send my patient to a chiropractor, but they don’t have the insurance. I don’t want to prescribe an opioid — I’d rather go a more conservative route — but that’s the only option I have.’”

And that can lead to the same tragic story: Someone gets addicted to opioids, runs out of a prescription and turns to the street before becoming another sad statistic.

“It all starts quite simply with back pain,” Mattox said.

Practical Barriers

While Missouri health care providers now have another tool besides prescribing opioids to patients with Medicaid, the multistep approaches required by alternative treatments create many more hoops than a pharmacy visit.

The physicians who recommend such treatments must support the option, and patients must agree. Then the patient must be able to find a provider who accepts Medicaid, get to the provider’s office even if far away and then undergo multiple, time-consuming therapies.

The effort and cost that go into coordinating a care plan with multiple alternative pain therapies is another barrier.

“Covering a course of cheap opioid pills is different than trying to create a multidisciplinary individualized plan that may or may not work,” said Leo Beletsky, a professor of law and health sciences at Northeastern University in Boston, noting that the scientific evidence of the efficacy of such treatments is mixed.

And then there’s the reimbursement issue for the providers. Corry Meyers, an acupuncturist in suburban St. Louis, does not accept insurance in his practice. But he said other acupuncturists in Missouri debate whether to take advantage of the new Medicaid program, concerned the payment rates to providers will be too low to be worthwhile.

“It runs the gamut, as everyone agrees that these patients need it,” Meyers stressed. But he said many acupuncturists wonder: “Am I going to be able to stay open if I take Medicaid?”

Structural Issues 

While helpful, plans like Missouri’s don’t address the structural problems at the root of the opioid crisis, Beletsky said.

“Opioid overutilization or overprescribing is not just a crisis in and of itself; it’s a symptom of broader structural problems in the U.S. health care system,” he said. “Prescribers reached for opioids in larger and larger numbers not just because they were being fooled into doing so by these pharmaceutical companies, but because they work really well for a broad variety of ailments for which we’re not doing enough in terms of prevention and treatment.”

Fixing some of the core problems leading to opioid dependence — rural health care “deserts” and the impact of manual labor and obesity on chronic pain — requires much more than a treatment alternative, Beletsky said.

And no matter how many alternatives are offered, he said, opioids will remain a crucial medicine for some patients.

Furthermore, while alternative pain management therapies may lessen opioid prescriptions, they do not address exploding methamphetamine addiction or other addiction crises leading to overdoses nationwide — even as a flood of funds pours in from the national and state level to fight these crises.

“Prescribers reached for opioids in larger and larger numbers not just because they were being fooled into doing so by these pharmaceutical companies, but because they work really well for a broad variety of ailments.”

— Dr. Leo Beletsky, Northeastern University

The Show-Me State’s refusal to expand Medicaid coverage to more people under the Affordable Care Act also hampers overall progress, said Dr. Fred Rottnek, a family and addiction doctor who sits on the St. Louis Regional Health Commission as chair of the Provider Services Advisory Board.

“The problem is we relatively cover so few people in Missouri with Medicaid,” he said. “The denominator is so small that it doesn’t affect the numbers a whole lot.”

But providers like Mattox are happy that such alternative treatments are now an option, even if they’re available only for a limited audience.

He just wishes it had been done sooner.

“A lot of it has to do with politics and the slow gears of government,” he said. “Unfortunately, it’s taken people dying — it’s taken enough of a crisis for people to open their eyes and say, ‘Maybe there’s a better way to do this.’”

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

American Agony: A New Book Exposes the War Against Pain Patients

By Pat Anson, PNN Editor

A provocative new book is shining a light on the opioid crisis in ways that may surprise you. In “American Agony: The Opioid War Against Patients in Pain,” author Helen Borel accuses government bureaucrats, law enforcement and the media of inciting opioid hysteria with a steady drumbeat of misinformation and propaganda about opioids – resulting in the needless suffering of millions of Americans and the deaths of thousands by suicide.   

“American pain patients are at risk of being underdosed, tapered without consent, and most horrible of all, cold-turkeyed. All without legal or medical protections to rescue them from the horrors of sudden withdrawal symptoms and cardiovascular and other complications leading to death arising out of this sudden disruption in their physiologic equilibrium,” Borel wrote.

“Further muddying the opioid hysteria waters are outright confabulations by the feds (HHS, CDC, DEA) who gossip about nonexistent drug abuse by patients on medically, ethically and legally prescribed opioid analgesics. And these same autocrats should feel guilty about the multitude of suicides their thoughtless actions have caused and are still causing. For shame!”

As a registered nurse, psychotherapist and medical writer, Borel was already familiar with important role of opioid medication, which she calls the “best treatment for most chronic pain.”

But her interest was piqued by reading Pain News Network and other online outlets, where she learned about the suffering and suicides of patients, the harassment and prosecution of doctors, and the disastrous impact of the 2016 CDC opioid guideline on American pain care.

“When I saw on Twitter the people talking about what was going on, I went to your website and other sites, and I saw all the information,” Borel told PNN.

“And I began to get angry that people were not being medicated. And I said to myself I’d like to bring all this information together in one place where everyone could access it.”

American Agony does just that. It’s a comprehensive examination of the opioid crisis, including a detailed look at its heroes and villains. There is no shortage of the latter, from the “haughty federal horde” that drew up the CDC guideline to the “American Nazis in full DEA regalia” who harassed doctors and lied to the press and public about opioid therapy.

Borel says the DEA should be dissolved, reorganized and rebranded as the Illicit Drug Enforcement Administration (IDEA), an agency focused solely on controlling illegal drugs    

“Until the government gets out of medical care, and out of proscribing severe limits on opioid therapy, grief will be a daily presence in pain patients lives. Others who can’t wait for common sense to infuse itself into mini-brained government officials will continue to end their lives in suicides. Now, there’s an epidemic the CDC should be working to eliminate!” she wrote.

‘Crazy Psychiatrists’

Borel holds particular disdain for the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) and its founder, Dr. Andrew Kolodny, a psychiatrist and addiction treatment specialist who has testified as a highly paid expert witness in lawsuits against opioid manufacturers.

“I think the government is stupid and they have a lot of hubris. That includes PROP, the tiny little band of crazy psychiatrists, the craziness and the haughtiness and the nonsense of PROP,” says Borel. “I think Freud would be appalled at these psychiatrists. They don’t have any feelings for patients. I don’t understand it.”

Borel dedicates chapters in her book to the “Suboxone Hoax,” “DEA Gestapo Actions” and the “Ominous Overreach of the Department of Justice.”

She also has a lengthy section on steps that pain patients can take to protect themselves, such as demanding the enforcement of HIPAA and other privacy laws, suing for negligence and medical malpractice, and refusing to pay for unnecessary medical exams and tests.     

“The more of these negligent practices that can be published, the sooner the public will stop putting up with the murdering of American pain care promulgated by the DOJ, the DEA and the VA,” she wrote. “You do not have to put up with the cold-turkeying of your opioid medication. This is flat out medical malpractice, will lead to rapidly declining health, unbearable pain, thoughts of suicide and too often suicide itself.”

American Agony is featured in PNN’s Suggested Reading section, along with other informative books on chronic pain and pain management.

Four Indicted in Compound Pain Cream Scam

By Pat Anson, PNN Editor

Greed and fraud have gone hand-in-hand in the opioid crisis, with drug and genetic test companies, pain clinics, spine surgeons, information technology vendors, addiction treatment doctors and even patient advocacy groups profiting from opioid hysteria or pushing bogus treatments.

You can add to the list pharmacies making compound pain creams.

A federal grand jury has indicted four people in Southern California for healthcare fraud, mail fraud, illegal kickbacks and money laundering as part of a scheme that defrauded two insurers into paying $22 million for medically unnecessary compound pain creams. Some of the creams cost as much as $15,000 per tube.

The fraudulent bills were sent to the U.S. military’s TRICARE health plan and the International Longshore and Warehouse Union’s Pacific Maritime Association Welfare Plan.

Prosecutors say the Orange County-based Professional Compounding Pharmacy (PCP) paid marketers about half of the payments it received from insurers as an incentive to recruit doctors and patients willing to write or accept pain cream prescriptions.

Patients were given $200 each to receive treatment at two bogus pain clinics and to participate in “sham clinical pain studies” on the effectiveness of compound creams as an alternative to opioids.

Among those arrested were James Bell, the owner of PCP and two medical marketing companies, and Dr. Michael Edwards, a Huntington Beach physician who allegedly set up the phony clinics.

Prosecutors say TRICARE was defrauded out of $19 million and the ILWU Plan lost $3 million. The scheme peaked in the first half 2015 and continued into 2016. The fraudulent billings dropped significantly in the second half of 2015, when the insurers reduced their reimbursement rates for compound creams.

This isn’t the first time compound creams have caught the attention of federal investigators.  A 2018 report from the Office of Inspector General for the Department of Health and Human Services found over 500 pharmacies had suspiciously high costs for compound creams and other topical medications billed to Medicare.

Medicare spending for topical medications has skyrocketed, rising from $13.2 million in 2010 to $323.5 million in 2016. Most were prescribed for pain, using ingredients such as lidocaine, a non-opioid anesthetic, or diclofenac, an anti-inflammatory drug.

Do compound pain creams work? A 2019 study at Walter Reed National Military Medical Center concluded the creams should not be used to treat chronic pain. One month after treatment began, researchers found no significant differences in the pain scores of patients who used compound creams and those who used placebo creams.