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.

A Toxic Violation

By Mia Maysack, PNN Columnist

On Saturday, I woke up to an experience far too common.

A column I wrote on my pursuit of holistic health had been shared in an online community for people with pain and chronic illness. The column was referred to as "shameful” and full of "bull crap." I was accused of being "insane,” a "bootstrap ableist" and “spreading hysteria.” You get the idea.

This type of toxic negativity online is mostly faceless and comes from hiding behind the comfort of a device screen. It doesn't belong in a supposedly safe space, nor does it help or improve anything. Even on my worst, most painful, dark and isolating days, I never have nor will I use that as an excuse to tear others down. 

Some people in the pain community claim to desire understanding, acceptance, empathy and compassion -- all the while offering anything but.

So many also demand change without the realization they’re contributing to the very problems they claim to want to resolve. It would seem the only fingers being lifted are to spread hate -- as opposed to directing that same passion toward legislative reform, writing a bill, calling Congress or signing a petition, for example.   

If we're not physically healthy enough to contribute fully to life, then bullying should be the last thing we’ve got the energy and time for.   

This takes me back to the very first (and last) "support group” I attempted to be a part of prior to starting my own. It’s prestigious, well known and in cahoots with many other affiliations.

Because I'm not spiteful and feel there's already enough hurt to go around, I won’t name or put them down.

In that group are thousands of people from around the world who could attest to the way I felt all my life. I hoped that that I’d finally came across a place where I belonged.

But when confiding to these people about a treatment plan gone awry (I still live with the repercussions to this day), they turned on me -- claimed I was just attempting to scare them, making things up, and that I should've kept the information to myself. Even my medical background was called into question, despite the grief I was still enduring over loss of career.

To make matters worse, prior to me even seeing any of this, the group’s administrators muted further commentary so I wasn't even able to defend myself or the way my words had been twisted. But they still left it there as a spectacle for all to see. It struck me to the core for multiple reasons, so I ultimately chose to step away and haven't looked back. 

Those of us who have come to a point of using our last bit of energy to reach out cannot afford being pushed off the ledge we are already on. The fact that isn't being contemplated or taken into any consideration is a sickness in itself. This toxic negativity is real and may be why my approach is internalized by others at times, even though that's not the whole picture of who I am.

How I live with multiple intractable, lifelong and incurable diseases is by continuing to study and having an intimate relationship with science via my own body chemistry.   

Whether it's a convenient truth or not, there's merit to the parasympathetic system. There’s power in working through trauma, taking ownership over our thoughts, approaching ourselves as a whole person and not allowing the conditions themselves to dictate our identity.

I've often been asked how I am able to live my life under the scrutiny of what I go through.  I don’t claim that I’m fixed, cured or have anything close to all of the answers. But I do know that instead of complaining, wallowing, and holding onto anger and resentment -- I choose to not allow this to define me.  My heart is poured into service, volunteerism and fighting for human rights -- for everybody, even those who throw dirt on my name. 

We are not wrong for how we feel. It's reactionary to lash out or play the blame game by turning on each other. It only intensifies the battle we're already in. Just because someone else's journey looks different and doesn't align with yours does not excuse, justify or make it acceptable to judge, ridicule or belittle them.

As long as those toxic violations remain a part of our approach to ourselves and one another, we shall remain sick.  

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

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.

U.S. Overdose Crisis Could Be Worse Than We Thought

By Pat Anson, PNN Editor

The number of deaths attributed to opioid overdoses in the U.S. could be 28 percent higher than reported due to incomplete death records, according to a new study appearing in the journal Addiction. Researchers at the University of Rochester say nearly 100,000 overdose deaths may not have been counted because the opioid involved was not identified.

The discrepancy is pronounced in several states, such as Pennsylvania, Alabama, Mississippi, Louisiana and Indiana, where the actual number of overdoses caused by legal and illicit opioids could be twice as high as current estimates.

"A substantial share of fatal drug overdoses is missing information on specific drug involvement, leading to underreporting of opioid-related death rates and a misrepresentation of the extent of the opioid crisis," said senior author Elaine Hill, PhD, an economist and assistant professor in the University of Rochester Medical Center. "The corrected estimates of opioid-related deaths in this study are not trivial and show that the human toll has been substantially higher than reported, by several thousand lives taken each year."

Hill and her colleagues found that almost 72 percent of unclassified drug overdoses that occurred between 1999 and 2016 involved prescription opioids, heroin or illicit fentanyl — translating into 99,160 additional opioid-related deaths.

Researchers discovered the discrepancy while studying the economic, environmental and health impact of coal mining and oil and gas drilling. Appalachia and other regions of the country hit hardest by the opioid crisis overlap with areas where there is coal mining and shale gas development.

As a part of her research, Hill was attempting to determine whether the shale boom improved or exacerbated the opioid crisis. She discovered that close to 22 percent of all drug-related overdoses were unclassified, meaning the drugs involved in the cause of death were not reported.

A 2018 study at the University of Pittsburgh reached a similar conclusion, estimating that as many as 70,000 opioid related-deaths were not reported. Coroners and medical examiners in many states often did not specify the drug that contributed to the cause of death.  

Critics have long complained that overdose data reported by the CDC and other federal agencies is flawed or cherry-picked. CDC researchers admitted in 2018 that deaths attributed to opioid medications were “significantly inflated” because overdoses involving illicit fentanyl were erroneously counted as prescription opioid deaths. Toxicology tests cannot distinguish between pharmaceutical fentanyl and illicit fentanyl.

The overdose data is further muddied because multiple drugs are involved in almost half of all drug overdoses.

Poor Overdose Data Concentrated in Several States

In their study, Hill and her colleagues obtained overdose death records from the CDC’s National Center for Health Statistics. Using statistical analysis, they correlated information on unclassified overdose deaths with potential contributing causes, such as previous opioid use and chronic pain conditions.

While the overall percentage of unclassified deaths declined over time – apparently due to efforts to improve overdose data -- the number remained high in several states. In Pennsylvania, for example, the official number of opioid-related deaths was 12,374. Researchers estimate that the actual number of deaths was 26,586.

"The underreporting of opioid-related deaths is very dependent upon location and this new data alters our perception of the intensity of the problem," said Hill. "Understanding the true extent and geography of the opioid crisis is a critical factor in the national response to the epidemic and the allocation of federal and state resources."

The CDC recently reported that drug overdose deaths dropped 4.1% in 2018 – the first decline in nearly three decades -- led by a significant drop in overdoses involving hydrocodone, oxycodone and other painkillers. But deaths linked to illicit fentanyl, methamphetamines and psychostimulants are surging, threatening to reverse the overall trend.

“One thing that we’re seeing is that the decline doesn’t appear to be continuing in 2019. It appears rather flat, maybe actually increasing a little bit,” said Robert Anderson, PhD, Chief of the Mortality Statistics Branch, National Center for Health Statistics.

Drugs Kill in Other Ways

All of these studies miss the mark, according to research published in PLOS ONE, because they don’t include deaths caused by infectious disease, drunk driving, suicide, and cardiovascular disease — all of which are affected by drug use.

"The basic records being kept are annual reports on the number of deaths from drug overdose. But that's only part of the picture,” said Samuel Preston, a professor of sociology at the University of Pennsylavnia. "Drugs can kill in other ways."

In 2016, 63,000 deaths were attributed to drug overdoses, but Preston and his colleagues estimate that the actual number of drug-associated deaths was around 142,000. Drug use shaved off nearly a year-and-a-half of life for men and three-quarters of a year for women.

"It's not just about the supply of drugs, but that there's something else behind all of it that causes people to either use drugs or alcohol or commit suicide because they've lost interest in their life," said co-author Dana Glei, a Georgetown University demographer.

Drug Tests Show Kratom Use Doubled in U.S.

By Pat Anson, PNN Editor

Kratom use in the U.S. appears to have doubled in the last two years, according to a large analysis of urine drug tests by Millennium Health. The first of its kind study also found that nearly 1 out of 4 people who tested positive for kratom were abusing opioids, benzodiazepines or other substances.

Kratom is an herbal supplement that millions of Americans use to self-treat their chronic pain, anxiety, depression and addiction. It comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever.

Millennium Health analyzed over 400,000 urine samples collected from 2017 to 2019, using liquid chromatography mass spectrometry to test for mitragynine and 7-hydroxymitragynine, two alkaloids that are the active ingredients in kratom.

The drug tests were ordered for patients by doctors in primary care, pain management and addiction treatment. As a result, the findings may not represent the typical kratom user.

Positivity rates for kratom doubled over the study period, rising from 0.9% in January 2017 to 1.8% in November 2019. Use of kratom rose in every section of the country, with the highest positivity rates reported in Idaho (4.2%), Montana (2.9%), Colorado (2.3%), Utah (2.3%) and Florida (2.1%).

The American Kratom Association generously estimates that over 15 million Americans use kratom. As interest in the herbal supplement has grown, so have the number of doctors ordering drug tests to see if their patients are using it.

“There are clinicians out there, that are caring for these type patients, that are likely to have kratom users in their population. It’s a small number, about 2 percent or so, but it’s likely increasing,” says Eric Dawson, PharmD, Vice-President of Clinical Affairs for Millennium.

One of the more surprising aspects of the study was how many kratom users were abusing other substances. For urine samples testing positive for kratom, nearly 25% were also found to be positive for non-prescribed opioids and 22% tested positive for non-prescribed benzodiazepines, an anti-anxiety drug.

Methamphetamine, fentanyl, cocaine and heroin were also more likely to be detected in positive samples for kratom versus those that tested negative.

SOURCE: MILLENNIUM HEALTH

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Many also use kratom to self-treat alcoholism or opioid addiction.

“You have these two camps, very pro-kratom and very anti-kratom. We purposely tried not to fall into either one and simply answer the questions we were being asked and see what the data is,” Dawson told PNN. “I’m very interested to see what happens to kratom moving forward in the next few years because the benefits are very compelling, but conversely so are the negatives. It’s quite an interesting compound for sure.”  

Most federal agencies take a dim view of kratom. The FDA says kratom is addictive, has opioid-like qualities, and should not be used for any medical condition. The CDC has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

Although kratom remains legal at the federal level, several states have banned kratom and some counties and cities have enacted local ordinances prohibiting sales.

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

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.

Be Strong and Proud on Rare Disease Day

By Roger Chriss, PNN Columnist

This coming Saturday, February 29 is Rare Disease Day worldwide. The day recognizes thousands of rare diseases and disorders that together impact millions of people worldwide, both patients and their caregivers.

The goal of the day is to raise the profile of the rare disease community and to spread the word: “Rare is many, rare is strong and rare is proud!”  

According to the National Organization of Rare Disorders (NORD), there are over 7,000 rare diseases that are chronic, progressive, degenerative, disabling and frequently life threatening. Many rare diseases are familiar to chronic pain patients, from Trigeminal Neuralgia and Chiari Malformations to Porphyria and Ehlers-Danlos syndrome.

A disease is considered rare in the U.S. when it affects fewer than 200,000 people, while in Europe a disease is rare if it affects fewer than 1 in 2,000 people.

Because there are so many disorders, a total of 300 million people worldwide are thought to be affected by rare diseases. And though each disease is unique, many share common features like chronic pain and limited mobility, and require complex medical care.

Events are planned throughout the week leading up to February 29. NORD is hosting a variety of events, including a gathering at the International Spy Museum in Washington, DC on Saturday.

The FDA held a public meeting on Monday to update stakeholders in the rare disease community on the agency’s efforts to improve treatment for rare diseases. That includes a new request for applications to its Orphan Products Grant Program, which funds clinical trials of so-called “orphan” drugs that could potentially be used to treat rare diseases.

The National Institutes of Health is coordinating panel discussions on Friday, February 28 in Bethesda, MD to improve diagnosis and treatment, expand clinical trial resources, and increase awareness of rare diseases.

In all, NORD lists over 400 events in 106 countries marking Rare Disease Day, including conferences, research presentations, exhibits, walks, rallies and a variety of fundraisers.

Rare Disease Day started in 2008 with the first events held in Canada and Europe. The date February 29 was chosen because it is rare (Rare Disease Day is on February 28 in non-leap years).

Treatment Often Limited

Rare diseases and disorders often go undiagnosed and untreated. Due to their rarity, expertise, treatment and resources are limited for people living with a rare disease, who can also face discrimination at work and school.

Research on rare diseases can actually help improve understanding of more common disorders and lead to new treatments. For instance, Yale neuroscientist Dr. Stephen Waxman discovered the gene SCN9A and its role in two painful hereditary neuropathies. Treatments for these disorders may help people with many other forms of peripheral neuropathy, as Waxman explains in his book, “Chasing Men on Fire.”

Moreover, rare diseases are often misunderstood. They do not look like typical illness and may require unusual forms of medical care. So Rare Disease Day also represents a chance to raise awareness about the importance of research, specialist centers, and healthcare professionals who work on such disorders.

Although most rare diseases do not have a cure, they can all be managed and patient lives improved. Rare Disease Day is an opportunity to focus on promising research, improving patients’ lives, and promoting action.

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.

FDA Approves First Intravenous Preventive Treatment for Migraine

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first intravenous treatment for the prevention of migraine in adults, adding to an increasingly crowded field in new migraine drugs.

Lundbeck, a Danish pharmaceutical company, said Vyepti (eptinezumab-jjmr) would be available in April 2020. The recommended dose is 100 mg every 3 months; although some patients may benefit from a dose of 300 mg. Price details were not released.

Vyepti is a humanized monoclonal antibody that prevents migraines by blocking a key protein — calcitonin gene-related peptides (CGRP) -- from binding to nerve receptors in the brain.

Since 2018, the FDA has approved three injectable CGRP inhibitors for migraine prevention and recently approved the first oral tablet for migraine treatment. Vypeti is the first CGRP blocker to be administered intravenously.

“With the approval of Vyepti, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy,” Dr. Deborah Dunsire, President and CEO of Lundbeck, said in a statement.

The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine) involving over 1,700 patients. Treatment benefit was observed for both doses of Vyepti as early as one day after infusion, and there was a sustained reduction of migraines through the second dose.

“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75 percent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Dr. Peter Goadsby, a professor of neurology at King’s College, London and the University of California, San Francisco. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”

Patients were allowed to continue using other migraine or headache medications during the trials. About 2 percent of patients treated with Vyepti discontinued treatment due to adverse reactions, such as an upper respiratory infection and hypersensitivity that causes facial flushing and rash.

Lundbeck has submitted an application for market authorization of Vyepti in Canada and plans to file in the European Union during 2020, followed by the submission of drug applications in other countries around the world, including China and Japan.

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

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.”

I Can’t Imagine Life Without Kratom

By Kimberley Flink, Guest Columnist

I'm 59, a native Floridian and spent most of my entire life actively outdoors. About five years ago, I woke up and could barely move, my body was wracked with intense muscle pain. I was in tears simply brushing my teeth, taking a shower, holding a coffee cup or even opening a door.

If I had to attempt to describe the pain, it would be similar to doing a triathlon and never practicing a day for it. Every muscle ached and throbbed in constant, chronic soreness. I felt like a little old lady when walking, standing and sitting, with groans of pain to boot.

Finally, after several trips to the doctor, they diagnosed me with fibromyalgia and a series of drugs were prescribed: anti-depressants, muscle relaxers, gabapentin and all the typical prescribed pharma arsenals.

Nothing helped with the pain. Instead they gave me side-effects that ranged from horrid headaches, weird sensations in my body, and the list goes on. So I set out to approach a holistic natural path.

Marijuana made me overeat and I didn't like staying high. I cleaned up my diet, took organic superfoods and spent tons on supplements, all to no avail.

Then a friend recommended kratom. And from the first day of taking it I was literally in tears, thanking God for a respite.

I do not even take the recommended dosage, so as to not overuse it, and I do not take kratom every single day, so I do not become addicted.  On the days I don’t take it, I'm suffering and hardly able to get out of bed.

KIMBERLEY FLINK

I cannot imagine my life without kratom, as I am now able to spend time with my granddaughter, go on short outings and function somewhat normally. I do not get high, overeat and have no ill side effects. It gives me a little energy and dials down the pain level severely. 

It would be a serious injustice to not have kratom available to people like myself, who suffer with chronic pain and do not want the heavy-duty drugs that people get addicted to or take their life by overdosing.

To compare kratom with alcohol, nicotine, opioids or other drugs that can cause death is absurd. I know what addiction is and those who say otherwise are simply abusing kratom. Or they’re using some other black market, knock-off product.

Kratom is the only thing that has given me a good portion of a quality life back. I thank God for it!

Kimberley Flink lives in Florida.

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

Patients with Arachnoiditis and Ehlers-Danlos Need Adrenaline for Pain Control

By Dr. Forest Tennant, PNN Columnist

In this era of opioid controversy and tragedy due to forced opioid reduction, the scientific information on adrenaline-type agents can help control constant, intractable pain and help reduce opioid use.

Overlooked in the opioid controversy is the key point that an adequate supply of adrenaline-related neurotransmitters – such as dopamine and norepinephrine – are necessary in the brain and spinal cord for pain relief. Unfortunately, constant intractable pain depletes the natural supply of endorphin, dopamine, adrenaline and noradrenalin, and their levels must be replaced to adequately control pain.  

Persons with a severe, intractable pain condition like Adhesive Arachnoiditis (AA) and/or a genetic connective tissue disorder like Ehlers-Danlos syndrome (EDS) will need an adrenaline agent, also called a stimulant, for pain control, maximal function, keeping opioid dosages stable, and preventing sedation and overdose. 

Adrenaline agents have long been known to boost or potentiate opioids, enhance pain relief, and allow less opioid to be used. A study by this author found that the simultaneous use of a stimulant and clonidine lowered opioid dosage by 30 to 50 percent. 

The use of a stimulant in this manner is not new. In the 1920’s, physicians at the Royal Brompton Hospital in London found that a stimulant was a necessary ingredient in the famous “Brompton Cocktail” for relief of severe pain. Today, modern pain relief agents often add caffeine as a stimulant to make the codeine and oxycodone more potent.

Most observers believe that an adrenaline agent given to an intractable pain patient will automatically raise blood pressure and pulse rate. This is generally a myth, because the person with intractable pain often depletes their reserve of dopamine, noradrenalin and adrenaline.  

The use of an adrenaline agent will serve to replace these depleted neurotransmitters and will not generally cause blood pressure and pulse rate to rise. Periodic monitoring is, however, recommended to be continued.  

Multiple Benefits  

A person with intractable pain due to AA, EDS, Reflex Sympathetic Dystrophy (RSD), or another severe and tragic condition will usually have the following conditions – all of which will benefit by an adrenaline agent:

• Weight Gain

• Attention Deficit Disorder (ADHD)

• Depression

• Sedation

• Fatigue

• Memory Loss

Descending Pain

Recent research has learned that constant, intractable pain establishes a “biologic battery” in the brain and spinal cord. This “battery” sends electric currents down the autonomic (non-spinal cord nerves) nervous system. Symptoms of this descending pain include excess heat, muscle spasms, jerking, tremors, sweating and “all-over” pain.  

In contrast to other forms of pain, descending pain isn’t well controlled by opioids and anti-inflammatory agents. The drugs clonidine and tizanidine are less effective. Only adrenaline agents stop it. Some adrenaline agents for persons with AA and EDS include:

• Phentermine

• Adderall

• Phendimetrazine

• Methylphenidate

• Dexedrine

• Modafinil  

Every person with intractable pain due to AA, EDS, RSD, cancer or other painful disease, should educate themselves on adrenaline agents and discuss them with their medical practitioners in order to either lower their opioid dosage or keep it from escalating.   

Simply stated, a person with intractable pain needs at least a small dose of an adrenaline agent for pain relief and optimal function. 

Forest Tennant, MD, MPH, DrPH, has retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project of the Tennant Foundation, and is republished with permission. Correspondence should be sent to veractinc@msn.com.  

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

FDA Scoffs at ‘Third Way’ Forward in Stem Cell Therapy

By A. Rahman Ford, PNN Columnist

In a commentary recently published in the journal Stem Cells and Development, Jeffrey Gimble, MD, and his co-authors make a measured critique of the FDA’s cautious regulation of autologous stem cells, including cells derived from adipose tissue, a person’s own body fat.  

Gimble, who is the co-founder of Obatala Sciences, a Louisiana stem cell company, shares the FDA’s concerns about the rapidly evolving field of regenerative medicine and proposes a “third way” forward that protects patients, while loosening federal regulation of the industry.

Gimble and his co-authors take aim at “rogue” predatory clinics offering stem cells in a “wild west” medical landscape. In their view, a “combustible mix of unmet needs, an ambiguous regulatory pathway, untested therapies, and clinics rapidly rushing in to fill a void” is at the root of several cases of patients being injured by stem cell procedures.

Sadly, the authors are parroting fictionalized, unsubstantiated stem cell propaganda to support their position.

Gimble and his colleagues contend that autologous cell therapies should be exempt from the FDA’s conventional clinical trial process, which was intended for pharmaceuticals, not a person’s own stem cells.

In their view, primary authority for policing stem cell practitioners should be at the state level, with accreditation agencies, state medical boards and specialty societies. In essence, they want the FDA to relinquish oversight of stem cell therapy.

Gimble and his co-authors recommend the FDA re-evaluate how it categorizes tissues as “structural” or “cellular” to recognize the different safety profiles of stem cells products.  They also think the FDA should work with accreditation agencies like AABB and FACT to develop meaningful accreditation standards, along with a national registry for stem cell therapies.

An Imperfect Way Forward?

This measured “third way” seeks to carve a compromise between the FDA’s regulationist faction and “wild west” stem cell providers -- a new ideological center that synthesizes the aspirations of two opposing parties in an effort to achieve a compromise.

It must be stated that there are serious questions as to whether the authors’ proposed polarity is in fact an artifice created for the specific purpose of legitimizing their “third way.” Upon serious inspection, the authors’ stated “dangers” of stem cell clinics may actually be a disingenuous straw man created for their own business interests.

To promote their own agenda and to gain favor with the FDA, Gimble and his co-authors seem to have thrown stem cell clinicians like Dr. Mark Berman under the proverbial bus. Berman, who is a defendant in a FDA lawsuit over his use of autologous cells, recently won a victory in federal court. The judge found that the FDA may not have regulatory authority over Berman’s procedures and that a trial needs to be held to resolve the issue.

FDA Scoffs at Compromise

Nevertheless, the impetus behind the authors’ recommendations is to move forward with bringing stem cells to patients faster and in a safer manner. Regrettably, the FDA does anything but take the authors seriously. In a lengthy response to the Gimble article, Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, merely reiterates the agency’s firmly-established regulationist position.

After commending the authors for their “desire to accelerate the scientific investigation and development of stem cell therapies,” Marks demonstrates the FDA’s backward-looking posture by stating the agency’s regulation of stem cells “is distinct from the practice of medicine” and should be left alone.

“This is an existing paradigm that has been in place for decades,” Marks wrote. “Autologous cellular therapies do hold tremendous promise, but they will only find their way into routine clinical practice to bring benefit to all patients if they are held to the same standards to demonstrate safety and efficacy as other unproven medical products.”

Marks attempts to bolster his argument by citing patient safety, the dearth of research on adipose-derived stem cells and the unethical “bad actor” clinics that exploit desperate patients. However, the spirit of his position reveals a resistance to any sort of change whatsoever.

Marks and the FDA are living in the past. They consider your cells to be unproven medical products. Apparently, they have yet to realize that the stem cell poles have already shifted.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

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.

Did OxyContin's Reformulation Really Lead to More Heroin Use?

By Roger Chriss, PNN Columnist

A common belief in the opioid overdose crisis is that the reformulation of OxyContin in 2010 led to a large-scale shift to heroin. Seven years after making the pills hard-to-crush to discourage snorting or injecting, The Washington Post reported the abuse-deterrent reformulation had made OxyContin “the chief driver of the explosion in heroin overdose deaths.”

The primary source of this claim is a National Bureau of Economic Research (NBER) paper that states “a substantial share of the dramatic increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin.”

The NBER paper used data from the National Survey on Drug Use and Health (NSDUH) and the Drug Enforcement Administration to assess usage levels of OxyContin and other prescription opioids, and data from the National Vital Statistics System to measure overdose deaths.

The researchers found that “states with the highest initial rates of OxyContin misuse experienced the largest increases in heroin deaths.”

But this conclusion is now being challenged. A recent study in the journal Addiction Behavior looked at NSDUH data from 2005 through 2014 to evaluate the impact of the reformulation on individuals with a history of OxyContin misuse.

The results showed “no statistically significant effects of the reformulation” on prescription opioid misuse or heroin use. In fact, researchers found a “net reduction in the odds” of heroin initiation after the reformulation.

“Thus, the reformulation of OxyContin appears to have reduced prescription pain reliever misuse without contributing to relatively greater new heroin use among those who misused OxyContin prior to the reformulation,” the authors concluded.

Psych Congress also reported there was little evidence of a shift to heroin from prescription opioids, saying drug trafficking data “don't fully support the often-heard conclusion that efforts to limit access to prescription opioids led to a mass migration to heroin."

Murky Data

The reason for the different conclusions is not clear. But much of what is assumed about abuse-deterrent reformulation is not holding up. Last summer, STAT News reported that rates of OxyContin abuse were similar or higher three years after the drug was reformulated. According to one survey, less than 5 percent of long-term abusers gave up OxyContin, suggesting the reformulation didn’t accomplish much.

Data on heroin use also includes considerable uncertainty, and applying state-level data-sets to understand individual usage patterns is tricky. Plus, data on overdose fatalities can be hard to parse since many victims die with multiple drugs in their systems, and toxicology reporting varies by state.

Since OxyContin’s reformulation, six other opioid medications have been approved by the FDA with abuse deterrent properties, costing drug makers hundreds of millions of dollars in research and development expenses.

Figuring out what happens after a prescription opioid is reformulated is important. Current public health policy and prescribing practices are assuming risks and benefits based on limited evidence. If something different or perhaps more complex is happening, then we need to look harder and make changes.

The implications here are also important, including determining liability and damages in the opioid lawsuits, developing effective public health measures for addiction treatment and the overdose crisis, and creating better risk assessment for pain management.

The impacts of the OxyContin reformation may be smaller and more subtle than previously thought. If the new findings hold, then we may have to rethink the benefits of abuse-deterrent formulations and the trajectory of heroin use. In other words, we need to keep looking closely at the overdose crisis and not assume we have it fully figured out.

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