Opioid Addiction Rates Redux

By Roger Chriss, PNN Columnist

The Oklahoma opioid trial is garnering attention for what could be a pivotal role in determining the liability of Johnson & Johnson and other drug makers in the opioid crisis. A key point hinges on a seemingly simple question: What percentage of people on long-term opioid therapy develop addiction?

Dr. Timothy Fong, a UCLA psychiatrist and defense expert, refuted claims by prosecution witness Dr. Andrew Kolodny that people who take opioid pain medication over extended periods have a 25% chance of becoming addicted. Fong said other studies suggest that patients who take opioids over long periods might have addiction rates closer to 1 to 3 percent.  

There is an extensive literature on these estimates, including NIH studies and published research from leading experts. I covered some of them in a PNN column last year (see “How Common Is Opioid Addiction?”)

“The best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent,” NIDA director Nora Volkow, MD, told Opioid Watch.

Why are there so many different estimates? There is an important distinction between the incidence and prevalence of a medical condition. Briefly, incidence represents the probability of occurrence of a given medical condition in a population within a specified period of time. In contrast, prevalence gives the proportion of a particular population found to be affected by a medical condition.

The distinction is not just semantics and is critical in epidemiology. As explained in Physiopedia, “incidence conveys information about the risk of contracting the disease, whereas prevalence indicates how widespread the disease is.”

Besides obvious difficulties in determining incidence (the necessary clinical trials will never receive approval) and measuring prevalence (the required public health monitoring is well beyond our current capability), we instead have to rely on proxy measures derived from prescription drug databases, medical records and surveys.

We also have to make decisions about the “specified period of time” when determining incidence and the assessment of the “medical condition’ for prevalence.

There is no universally agreed upon time frame for the development of addiction or opioid use disorder after opioid initiation, whether medical or non-medical. Similarly, the definition of opioid use disorder has evolved over the years.

Further, in many cases incidence and prevalence are calculated based on assumptions made by researchers. For instance, in an Annual Review of Public Health article co-authored by Dr. Kolodny, a 2010 study is cited that found 26% of chronic pain patients met the criteria for opioid dependence and 35% met the criteria for opioid use disorder. This seems to be the source of the 25% claim used by Kolodny in the Oklahoma opioid trial.

But the 2010 study doesn’t distinguish between incidence and prevalence. It is also not clear how many of the surveyed pain patients had an opioid use disorder diagnosis before the onset of medical opioid therapy.

A similar critique can be levied against the authors of a 1980 letter in The New England Journal of Medicine that claimed opioid addiction was rare in pain patients. Some have claimed publication of the letter helped launch the opioid crisis. 

The problem with all of these studies is that they are retrospective in nature, limited to a particular patient population, and constrained by the diagnostic criteria in use at the time. And the estimates derived from such studies do not necessarily implicate or exonerate Johnson & Johnson.

Moreover, it is possible that addiction rates have varied over time and were influenced by factors that were not yet understood or even known. For example, recent research has found an association between opioid overdoses and drug diversion among family and friends, cold weather, altitude above sea level, and medical cannabis legalization.

The NIH work that Dr. Volkow refers to in her Opioid Watch interview works to account for all of these factors. So as Volkow stated last year, the “best and most recent estimate" stands at about eight percent. Improved public health surveillance, epidemiological research, and patient monitoring may shift this number up or down, and will increase confidence in the estimate.

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

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

Disabled Workers and Chronic Pain Patients Need a Voice in Congress

By Amanda Siebe, Guest Columnist

I’ve always wanted to serve my community. Nine years ago, I thought the best way to do that would be as an EMT and firefighter. I wanted to be there for people in their hour of need to provide help and comfort. But in 2011, that goal came to an abrupt end.

While working as a restaurant manager, I fell and badly sprained my ankle. What should have been six weeks of recovery turned into full body Reflex Sympathetic Dystrophy (RSD). Because my employer placed more value on profits than they did on my health and safety, I continued to work in the kitchen, repeatedly slipping and falling before abandoning my crutches.

That simple injury ended up taking my dignity, financial stability, and eventually it will take my life. All because my employer didn’t have another manager to run the restaurant while I recovered.

Because of my disability, I never thought much about running for political office. But as I watched the lack of representation the disabled community has and felt the impact policies and funding cuts have on my life, I began to wonder: How could I not run?

I may not have the body that I once did, but my mind and passion are still sharp, as is the case with many disabled individuals. My wheelchair has not made me any less of a person or any less deserving of a representative who looks like me and understands my plight.

So here I am, taking a stand to say that while we may be disabled, we’re still worthy of quality life and pursuit of happiness.

I’m running in the 2020 election as a Democrat in Oregon’s 1st Congressional District to fight for the care and benefits we deserve and were promised.

Federalize Workers Compensation

AMANDA SIEBE

As a disabled worker, I was assured there was a safety net to catch us if we got hurt, but I quickly realized that’s not the case. We aren’t told that workers compensation is run by private insurers who have more loyalty to their shareholders than to injured workers. These companies increase profits by denying injured workers medical care, leaving them to suffer as they fight to justify every treatment, medication and benefit.

Currently, each state dictates the worker compensation laws these companies follow, resulting in injured workers getting better treatment in some states than in others. A worker in New York is no more valuable than a worker in Alabama. That’s wrong and must change.

We must end this system of profits over people. We need to federalize workers compensation and prevent lobbyists and private interest groups from ripping apart our safety net. Workers who give their time, bodies and lives to employers must receive the care and respect they deserve.

End Forced Tapering of Pain Patients

Patients with chronic and debilitating pain have been hit especially hard during the opioid crisis. Patients on stable doses of prescription opioids for years are being forcibly tapered and left to suffer. Less than 3% of chronic pain patients become addicted to opioid medication, but doctors are still taking many patients off of these drugs.

When patients are forcibly tapered without properly managing their pain, it forces some to turn to the bottle, the street or suicide for pain management. Thousands have already died as a result of losing their opioids. This must stop.

Increase Disability Payments

After my injury, I went from being the family breadwinner, earning about $50,000 a year, to trying to survive on $735 a month. Young disabled people are especially hard hit because we don’t have decades of high-earning work history to draw on, resulting in lower benefits. That’s if they can even get on SSDI. Those who become disabled before 45 often won’t get approved for disability or have to fight for years to get it.

We must stop using age as a determinate of disability. If disability doesn’t discriminate based on age, then neither should our government.

Currently, there are 554,000 homeless people in our country. Of those, 40% are disabled and 30% are elderly. The average Social Security Disability benefit is $880, while the average rent for a 1-bedroom apartment in Portland, Oregon is $1,400.

It’s no wonder when our government pays starvation wages as a benefit that so many disabled and elderly become homeless. We can reduce our nation’s homeless rate by over half just by making SSI and SSDI comparable to a living wage. We must ensure our most vulnerable citizens have a basic quality of life, too.

IMAGE BY NATALIE BEHRING

The disabled community needs many other things that have gone ignored by Congress. While the Americans With Disabilities Act of 1994 was a huge step forward, it hasn’t been updated in 25 years. We need the ADA to match the knowledge and technology of today.

Many people provide care to disabled family members while still holding down a full-time job. It’s time we paid these family caregivers, who save insurers and healthcare providers hundreds of billions of dollars each year. Paying them would give needy families financial stability and independence.

Medicare For All

We’re an important voice in the healthcare debate and we need to be part of the conversation. If we are to have Medicare For All, then it needs to cover all conditions, all medications and all medically necessary treatment for all patients. Medicare as it currently stands is underfunded and not good enough. We need to fight for universal healthcare coverage so patients no longer have to fight for proper care.

Even though 1 in 5 adults are disabled, we are sorely under-represented in Congress. We need representatives who understand the unique situations and problems we face. We’ve been forced to sit on the sidelines as others decide our care, benefits and future. It’s time we had a say.

For too long, we’ve been victims of circumstance — told that we can’t run for office because our bodies prevent us from giving everything we have. That’s a lie.

Running for Congress isn’t what I thought I’d do be doing with the time I have left, but everyone deserves representation. We’re a part of this country and it’s time we were treated as such. It’s time for the disabled community to unite and be represented. We deserve better. 

Amanda was diagnosed in 2012 with Reflex Sympathetic Dystrophy (RSD), also known as Complex Regional Pain Syndrome (CRPS). Since her diagnosis, she has advocated for chronic pain and disability rights. In 2016, Amanda was the recipient of the WEGO Health Advocate Rookie of the Year Award.

Amanda has dedicated her life to improving her community and has fought to teach her 11-year-old son, Keagan, the same. Further information about Amanda’s congressional campaign can be found on her website.

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Canadian Doctors Prescribe Opioids to Keep Patients Off Street Drugs

By Pat Anson, PNN Editor

So-called “safe injection sites” – supervised clinics where intravenous drug users can inject themselves -- remain controversial in the U.S. Efforts to establish such sites in San Francisco and Philadelphia are mired in political and legal opposition.

But supervised injection sites are already operating in several Canadian cities, where they are seen as an important resource in reducing the risk of overdose and getting drug users into treatment.

Some Canadian doctors, however, believe the injection sites leave out a key population – illicit drug users who don’t normally inject drugs. Rather than run the risk of those patients turning to risky street drugs, they are prescribing opioid medication to them.

“We have to be willing to step outside of our comfort zone and out of the medical establishment comfort zone and say that we need to keep people alive,” Dr. Andrea Sereda, a family physician at the London Intercommunity Health Centre in Ontario told Global News.

Sereda is prescribing hydromorphone tablets to about 100 patients, most of whom were homeless and using street drugs. So far there have been no fatal overdoses, half the patients have found housing, and they have regular contact with healthcare providers.

“It’s not just a prescription for pills, but it’s a relationship between myself and the patient and a commitment to make things better,” Sereda said. “That involves me taking a risk and giving them a prescription, but it also involves the patient committing to doing things that I recommend about their health and us working together.”

Sereda says her “safer supply” program is only intended for patients who have failed at addiction treatment programs where methadone or Suboxone are usually prescribed.

A similar pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients, who ingest them on site under staff supervision. At another clinic in Toronto, hydromorphone is prescribed to 10 patients who would normally rely on the black market, where drugs are often tainted with illicit fentanyl or its lethal chemical cousin, carfentanil.

“I’ve had people who, literally, their urine is just all carfentanil,” Dr. Nanky Rai, a physician at Parkdale Queen West Community Health Centre told Global News. “That’s really what terrified me into action.”

Other physicians are warming up to the idea. Last week over 400 healthcare providers and researchers sent an open letter to Ontario Premier Doug Ford asking that high dose injectable hydromorphone be made widely available to illicit drug users.

“We could rapidly implement hydromorphone prescribing,” Jessica Hales, a Toronto nurse practitioner, said in a statement. “Clients want this. Prescribers are eager to deliver it. But it is not covered under the Ontario Public Drug Plan, which is how almost all of my clients access prescription drugs.”

What About Pain Patients?

But patient advocates say the safe supply movement should be expanded to include pain patients who have lost access to opioid medication or had their doses drastically reduced.

“The Chronic Pain Association of Canada fully endorses the safe supply initiative, but asks why we’re helping one group while hurting the other, pointlessly. Safe supply is equally critical for the million or so unfortunate Canadians, including children, who suffer high-impact chronic pain and can no longer obtain the drugs they need,” Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, said in a statement. 

“These patients have long been sustained by the pharmaceuticals and don’t abuse them. But now they’re routinely forced down or completely off their medications, blamed for overdoses they have no part in.”

Some pain patients are turning to street drugs. In PNN’s recent survey of nearly 6,000 chronic pain patients in the United States, eight out of ten said they are being prescribed a lower dose or that their opioid prescriptions were stopped. Many are turning to other substances for pain relief. About 15 percent have obtained opioid medication from family, friends or the black market, or used street drugs such as heroin and fentanyl.

“I know seven people personally that have gone to the streets to get pain relief. Four of them died because it was mixed with fentanyl. Two committed suicide,” one patient told us.

“I have been without a prescription for two years and have been getting medication on the street. I cannot afford this and I have no criminal history whatsoever. I have tried heroin for the first time in my life, out of desperation and thank God, did not like it,” wrote another patient.

Barry Ulmer says these patients need a safe supply too.

“Prescribing opiates safely to those with addiction makes sense. But simultaneously denying legitimate pain patients their medications doesn’t. It’s pointless — and cruel. Let’s give people with pain the same respect and care we give people with addiction,” he said.

Study Finds Antidepressants Make Tramadol Less Effective for Pain Relief

By Pat Anson, PNN Editor

Common antidepressants interact with the opioid medication tramadol to make it less effective for pain relief, according to a small new study from University Hospitals (UH) in Cleveland. The findings suggest that some patients who exceed their prescribed dose of tramadol may be under-medicated and are seeking more effective pain relief.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have increased in recent years because it is widely perceived as a “safer” opioid with less rick of addiction. Many patients, however, say tramadol is not as effective as hydrocodone, oxycodone and other opioids.  

UH researchers reviewed the prescription records of 152 patients who received tramadol for at least 24 hours.

Those patients who were also taking the antidepressants Prozac (fluoxetine), Paxil (paroxetine) or Wellbutrin (bupropion) required three times more tramadol per day to control their breakthrough pain, compared to patients not taking the antidepressants.

Previous studies on healthy volunteers have shown effects on blood levels when combining tramadol with those particular antidepressants. However, this was the first study to document the effects of this interaction in a real-world setting with pain patients.

"We knew that there was a theoretical problem, but we didn't know what it meant as far as what's happening to pain control for patients," said Derek Frost, PharmD, a UH pharmacist and lead author of the study, which was published in the journal Pharmacotherapy.

Frost says millions of Americans may be suffering the ill effects of this drug-to-drug interaction.

"Tramadol relies on activation of the CYP2D6 enzyme to give you that pain control," Frost said. "This enzyme can be inhibited by medications that are strong CYP2D6 inhibitors, such as fluoxetine, paroxetine and bupropion.

“Many chronic pain patients are taking antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs), which many of these CYP2D6 inhibitors fit into. There are a lot of patients who experience both, unfortunately. The likelihood that somebody on one of these offending agents and tramadol is relatively high."

Frost says the problem has a relatively easy fix.

"We have a lot of other antidepressants available that are in the same class of medication that don't inhibit this particular enzyme, such as Zoloft (sertraline), (Celexa) citalopram and Lexapro (escitalopram)," he said. "You also have other options for pain control - non-opioid medications such as NSAIDs. If we need to use opioids, a scheduled morphine or a scheduled oxycodone would avoid this interaction."

Tramadol is a synthetic opioid that was rescheduled by the Drug Enforcement Administration in 2014 as a Schedule IV controlled substance, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse. Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

American Pain Society Files for Bankruptcy

By Pat Anson, PNN Editor

The American Pain Society (APS) filed for bankruptcy Friday after an overwhelming vote by its members to dissolve the financially troubled medical organization. In a membership vote last month, 93% voted in favor of a recommendation by the APS board of directors to file a voluntary petition for Chapter 7 bankruptcy.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS was targeted as a defendant by Simmons Hanly Conroy and several other law firms seeking to recover billions of dollars in damages in opioid litigation cases.

In a press release, APS said efforts to resolve the “meritless” lawsuits without lengthy and expensive litigation were unsuccessful.

“It’s the perfect storm and now pointless to continue operations just to defend against superfluous lawsuits.  Our resources are being diverted to paying staff to comply with subpoenas and other requests for information and for payment of legal fees instead of funding research grants, sponsoring pain education programs, and public policy advocacy,” APS President William Maixner, DDS, said in a statement.

“As a result, the Board of Directors no longer believes APS can continue to fulfill its mission and meet the needs of our members and the pain care community.”

Press coverage of the APS often parroted what the opioid lawsuits alleged. The Guardian, for example, called the APS a “pawn of big pharma” and claimed the organization “pushed doctors to prescribe painkillers.”

The Guardian’s coverage was based largely on a report by Sen. Claire McCaskill (D-MO), who accepted over $400,000 in campaign donations from Simmons Hanly in her failed bid for re-election in 2018. APS is named as a defendant in several opioid lawsuits filed by Simmons Hanly, which stands to make hundreds of millions of dollars in contingency fees if the lawsuits are successful. The Guardian failed to mention any connection between Simmons Hanly and McCaskill.

The APS’ bankruptcy filing likely brings an end to its monthly publication, The Journal of Pain, which has been rated among the top five scientific journals in pain science. The current issue features research articles on diverse topics such as meditation for low back pain, diagnostic codes for fibromyalgia, whether opioids are effective for chronic noncancer pain, and the use of virtual reality to relieve arm pain.

“APS has been advocating for increased investment in research for many years, and it is particularly ironic that APS’s voice will go silent at this critical time in our history, when increased investment in pain research has finally become a reality in an effort to combat the opioid crisis,” said Roger Fillingim, PhD, an APS past president and professor of psychology at the University of Florida School of Dentistry.  

“There is a sad irony that the professional organization best poised to provide the spectrum of science to improve the prevention and treatment of pain and related substance abuse is defunct,” said APS President-elect Gary Walco, PhD, director of pain medicine at Seattle Children’s Hospital.

“Now, more than ever, our nation needs the collective efforts of leading scientists and clinicians who hold patients’ well-being at the highest premium.  The principal focus on punishing those in industry that may have contributed to the problem is shortsighted and far from sufficient.”

The APS is the second professional pain management organization to cease operations this year. In February, the Academy of Integrative Pain Management (AIPM) also shutdown. Opioid litigation has not only been costly for APS and AIPM, it has contributed to steep declines in financial support from pharmaceutical companies for other pain organizations, medical conferences and patient advocacy groups.   

We Are More Than Our Pain

By Carol Levy, PNN Columnist

I was referred to a neurologist who specializes in headaches. Trigeminal neuralgia is very different from a headache, but any port in a storm. I called to make an appointment and was told all new patients must agree to meet with a psychologist. If you refuse, you do not get the appointment.

This seemed like an inherent bias: Patients with head pain must have psychological issues. Does this mean the doctors are prejudging the truthfulness of their pain complaints?

Despite misgivings about seeing a psychologist, I made the appointment.

A few weeks later, the neurologist admitted me into the headache unit of the local hospital. Everyone in the unit had to have a one-on-one meeting with the psychologist.

“Tell me about your life,” she said.

I told her the most salient fact: “I am essentially alone in the world. My family abandoned me decades ago. And when you don’t work it is hard to make friends.”

Her suggestion: “You should go to counseling. They can teach you how to make friends.”

Well, there's a good idea. Except...

Before the pain started, I had no trouble making friends. Since the pain is a different story. Trying to make friends is hard when you don’t have the glue necessary to start a new relationship. I never married and I never had children because the pain took that part of my life away from me.

At my age, a senior citizen, that is often the opening question when you meet new people: “Are you married?” or “How many grandkids do you have?” No and none.

“Do you work? Are you still working?” Again, no. I haven't worked in over 40 years because of the pain.

If I am honest and say, “No to all of those. I have been disabled by a pain disorder since 1976,” the response tends to be a mouth falling open, followed by “Oh, I'm sorry.” Or a somewhat glazed look and a turn away to speak with someone else.

How do you overcome this? I haven't a clue.

But it started me thinking. When, if ever, did any of my doctors ask, “How are you dealing with this?”

I see this often mentioned in support groups: “My doctor never seems to have the time or the interest to find out about me, about how this is affecting my life.”

I am not sure if they don't ask because they don’t care or because it is something they can’t treat with a pill. Maybe they are afraid of hearing the truth for too many of us: “I'm not dealing well with it.”

Isn't part of being a healer taking the whole person into account? Doctors have precious little time to spend with us. Maybe they should take a few extra minutes to learn about the essence of who we are and what the pain has done to our basic core.

There is no medicine or surgery for the effect the pain has on our lives. But being able to say, especially to our doctors, what it has taken from us could help others see us as something more than our pain.  

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Always Check Your Medical Bills and Insurance Statements

By Barby Ingle, PNN Columnist

Recently I received a medical bill and noticed my insurance did not cover any of the costs of my treatment for an emergency care visit. This particular visit happened when I woke up in pain and feeling like I couldn’t take a full breath. I thought it might be a partial lung collapse, something that I have experienced before.

About a month after the emergency care visit, I receive a bill from the provider. The first thing that I checked on the bill was my vital information: name, address, phone and insurance card ID. They had the wrong first and last name and my social security number instead of my plan number.

No wonder the insurance company denied it! It looked like someone else was trying to be me and got the details wrong.

I have done many interviews and articles over the years about medical billing. If I didn’t know how to catch these mistakes, I would have gotten stuck paying the entire bill.

Studies show that 8 in 10 medical bills have at least one minor mistake. These mistakes add up and cost society more than $68 billion in unnecessary healthcare spending, according to Medliminal Healthcare Solutions, a company that helps patients find and fix medical billing errors.

When I checked into the emergency care center that day, I was not able to speak very well and my husband handled the check-in process. He presented my drivers license and insurance card.

When the nurse called me back, she said my name incorrectly, close but incorrect. I corrected her and told her to make sure it is correct in the system because if data such as my name is not correct, the insurance won’t pay. She confirmed my name and the spelling and updated her system. The billing still got it wrong.

When I went back to the emergency care center with the medical bill, the front desk lady said the information was in their system correctly, but billing is done by another group and sometimes data gets mixed up. She gave me the info to contact the billing company.

After returning home, I called the billing company. Their representative said they had my name correct but corrected my insurance information. They are going to re-bill my insurance. My co-pay portion should only be 20% of the bill.

It literally came down to multiple people making little mistakes that led to me receiving a bill that was incorrect. If I didn’t check and see the errors, I would have gotten stuck paying the full amount.

Over the years this has happened quite a number of times to me and I am sure it happens to others. If you don’t compare your explanation of benefits (EOB’s) and provider bills against each other, you could pay more than you should for medical services. This can also happen if you don’t check your medical records. If a medical record is incorrect, you may not care at the time, especially if you received the appropriate care.

But what if you’re in an emergency situation where you can’t check and verify what is in the system? You may end up being given medications that you no longer take due to out-of-date prescription and medical records. You may even be denied coverage because of misinformation in your records.

What billing data should you check? Start with your name, date of birth, date of service, services provided and insurance information. For your medical records, check your name and date of service. Make sure to view your lab results, radiology reports, surgical reports, follow-up care suggestions, and daily notes from nurses and providers.

Also check your insurance EOB’s to see if the co-pays and deductibles you’ve paid matches up with their data, and you get the maximum coverage under your plan. Always check and correct medical information and bills. If you are doing it by phone, record the call if you are in a state where that is allowed. If not, then take good notes. Be sure to keep a copy of every provider bill, EOB, email and letter for your records.

Over a lifetime of chronic illness, you’ll save yourself thousands of dollars and get access to better care.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.  

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

The Push for Stem Cell Censorship Has Begun

By A. Rahman Ford, PNN Columnist

A new study published in journal Stem Cell Reports, entitled “How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments,” looks at over a hundred videos by stem cell patients posted on YouTube. 

The study appears to have an underlying anti-democratic agenda – to shame YouTube and other internet platforms into removing positive patient testimonials about stem cell therapy (SCT).  Indeed, the use of the pejorative term “peddle” in the article’s title immediately undermines the study’s credibility.

This research epitomizes how propaganda can masquerade as scientific research, and how data can be twisted to meet its masters’ agenda.

The study comes on the heels of a recent federal judge’s decision that the FDA could regulate stem cells made from adipose tissue – a patient’s own fat cells. Although SCT critics generally praised the ruling as a victory for government oversight, outlets like the Washington Post lamented that it would likely not deter clinics from offering the therapy. 

A New York Times article accused the FDA of not acting until patients were harmed, and using enforcement actions that consist only of warning letters without any real teeth.  

STAT News even criticized the National Institutes of Health for allowing stem cell clinics to “co-opt” the nation’s clinical trial database.

Stem cell critics have apparently realized that the three previous stages of their vilification campaign have failed. These stages were:

1. Vilify the patients:  Promote the condescending narrative that patients are desperate, ignorant and too stupid to research stem cell therapy for themselves and decide whether it is best for them.

2. Vilify the clinics: Stem cell clinics are run by shady charlatans who engage in duplicitous business practices that take advantage of desperate, ignorant and pitiful Americans by selling them “unproven” products that couldn’t possibly help them.

3. Vilify the federal government: Federal agencies have not acted quickly or robustly enough to enforce the regulations that govern regenerative medicine, thus tacitly approving the growing “wild west” of clinics offering SCT.

The Push for YouTube Censorship

Critics now appear to be setting their sights on a fourth vilification stage.  In their desperation, they have decided to take a more authoritarian turn towards internet censorship.

The new study’s authors examined 159 YouTube testimonials from patients who had SCT for ALS, multiple sclerosis, Parkinson’s, cerebral palsy and spinal cord injury.  Not surprisingly, they found that most of the videos were published by providers and nearly all discussed the benefits of SCT in improving pain, overall health and quality of life. 

The authors concluded the YouTube testimonials “may be a potent marketing tool” and “are likely to have a wider reach and significant impact on influencing health behavior.” 

The article’s final sentence reveals the authors’ true motive: “Adopting multiple approaches, including patient education, enhancing patient treatment options, and regulatory oversight, are required to make a significant dent in reducing the number of clinics providing unproven SCTs.”

Setting aside the numerous, glaring and egregious methodological shortcomings of the study, the more important issue is one of broader public policy.  These authors appear to be implicitly advocating that YouTube and other internet sites censor videos that are “misleading” or “deceptive” or not published by “reputable organizations.” 

And who or what is to determine whether any particular video meets this criteria?  Wired published an article with the ominous headline “YouTube Testimonials Lure Patients to Shady Stem Cell Clinics,” implicitly calling on YouTube to take action. The notion isn’t farfetched. YouTube has been in the news a lot recently for censoring videos, using nebulous criteria and subjective standards.   

Apparently, SCT critics have jumped on the YouTube censorship bandwagon.  It’s a wagon that seems to claim a new victim every day, and its victims are usually those who threaten the status quo.  Unfortunately, it’s a wagon that travels the pothole-riddled road of authoritarianism.  It’s a road patrolled by people in strange uniforms, with sophisticated and articulate weapons, who dispense a vicious propaganda, and who always claim to have your best interest at heart.

Please make sure to call, email and/or tweet your state and federal legislators to voice your support for the availability and affordability of stem cell therapy.  The people who suffer with pain and disability will not be silenced and will not be censored.  Our democratic voice will be the response to their authoritarianism.

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. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

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

Kratom Helps Me with Pain and Addiction

(Editor’s note: The author of this column is using the pseudonym “Marc Smith’ because he fears his employment and healthcare could be jeopardized if his true identity were known.)

By Marc Smith, Guest Columnist

I have had a long and treacherous battle with health problems and substance abuse. Starting at age 14, I was diagnosed with multiple reoccurring bone tumors on my right leg below the knee. This led to six major surgeries; three for tumor removal and three for MRSA bacterial infection treatment and debridement.

My knee is completely damaged from the tumor destroying the top of my tibia and the bacteria completely eating away at my meniscus and cartilage. I have severe chronic and acute pain in that leg. I am not a candidate for a knee replacement due to the bone being too damaged and it is not a stable site for an artificial joint.

I have also been in a severe car accident that lacerated my left arm, broke the fibula in my left leg and tore the meniscus in my left knee.

The treatment of these ailments came with a lot of prescribed narcotic pain medications on a regular basis from age 14 on. My tolerance to these medications grew astronomically over 15 years until they stopped working effectively.

I eventually was buying OxyContin on the street and abusing it heavily. This led to IV heroin and cocaine use, and the loss of anything of real value I had.

I struggled with this crippling addiction for 18 years. I tried methadone, Suboxone, Vivitrol and complete abstinence -- with no significant success with any of them. Finally, I tried a strong 12-step recovery program. It worked temporarily, but the physical pain would become too much and I would relapse on opiates.

A year ago, I found kratom and decided to try it for pain relief. It helps me with pain, helps me sleep, curbs craving, and allows me to function and participate in daily life without being in extreme pain. I do not have extreme tolerance building problems with kratom like I did with opioids. The side effects are extremely minor and do not impair my judgment or ability to function.

I am up at 4:30 AM every day and at the gym by 4:45 cycling for an hour. I have found the recumbent bike does not hurt my leg that badly. I lost weight due to exercise and diet changes that kratom helped me make. I am much more positive about taking care of myself and am able to be present for life.

My pain hasn’t completely vanished, but it is manageable due to kratom. My spiritual growth has been a big factor as well in my 12 months of sobriety. These two things working in harmony have literally saved my life. I am a completely different person and my family has their son back.

I do not want to die and the fact that this harmless plant is being targeted makes me scared for my life. Let’s focus on rehabilitation and recovery methods. Let’s focus on illicit fentanyl and other synthetic chemicals, not a natural botanical. Please, take a step back and look at kratom success stories like mine.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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

FDA Warns Kratom Vendors

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued two more warning letters to kratom vendors – Cali Botanicals of Folsom, California and Kratom NC of Wilmington, North Carolina – for making unproven claims that kratom can treat pain, addiction, depression, anxiety and other medical conditions.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years millions of Americans have discovered kratom -- including many who have lost access to opioid medication -- and found it to be an effective treatment.   

The FDA, however, considers kratom an unapproved drug that shouldn't be used to treat any medical condition.

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” said acting FDA Commissioner Ned Sharpless, MD.

“As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”

What makes kratom dangerous? Sharpless cited FDA studies that found salmonella bacteria and heavy metals in a relatively small number of kratom products.  Kratom has also been linked to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The FDA said Cali Botanicals and Kratom NC were using websites and social media to make unproven claims about kratom's ability to treat medical conditions. Cali Botanicals, for example, makes these claims about kratom's benefits:

• “Kratom is able to reduce the pain levels that reach the brain in a way that’s very similar to opioid drugs.”

• "Kratom is seen as life-saving by former addicts, who found kratom to be the only way they could overcome their addictions."

• “Consumption of kratom can reduce pain and swelling to an injury.”

• “Addicts can wean themselves off of their addictions by replacing their drugs with kratom. It has similar effects as opioids, but without the same dependency. Kratom also helps with the withdrawal symptoms.”

• “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction."

• “Some researchers have even claimed that kratom can protect you against cancer!”

With the exception of that claim about preventing cancer, those are the same benefits that many kratom users report anecdotally.

"For over two years now I have enjoyed drinking my kratom tea a couple of times a day. It helps promote my mood and energy like a cup of coffee would. The tea also relieves my aching joints and muscles, making my chronic fatigue and pain much more bearable," Kim DeMott wrote in a recent PNN column.  

"Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics. And I am devastated that the FDA is working to ban the only thing that has helped me in the past 28 years," fibromyalgia sufferer Mary Ann Dunkel wrote in another guest column.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide. Currently, the DEA doesn't even list kratom in its annual report on drug threats. 

Anxiety Is a Symptom, Not a Diagnosis

By Dr. David Hanscom, PNN Columnist

Every living creature on this planet survives by avoiding threats and gravitating towards rewards. The driving force is staying alive and survival of the species. This is accomplished by the nervous system taking in data from the environment through each body sensor and analyzing it.

The first step in this process is for your brain to define reality. A cat is a cat because your brain has unscrambled visual signals and determined the nature of the animal. A cat’s meow is analyzed from the auditory receptors. Your nervous system then links the two inputs together to associate the sound as one that emanates from a cat.

The reason why I am presenting the obvious is to make the point that nothing exists without your brain gathering data, unscrambling it and determining what is.

One of the responsibilities of the central nervous system is to maintain the delicate balance of the body’s chemistry. There are numerous chemicals to keep track of. When there is a threat, hormones will be secreted that increase your chances of survival.

Some of the core response hormones are adrenaline, noradrenaline, endorphins, histamines and cortisol. I won’t list the effects of each of these survival hormones, but the net result is an increased capacity to flee from danger.

All of these allow you to leap into action, but what compels you to do so? It is a feeling of dread that we call anxiety. It is so deep and uncomfortable that you have no choice but to take action.

Anxiety is a symptom, not a diagnosis, disease or disorder. Therefore, it isn’t treatable by addressing it as the problem. Once you understand anxiety is only a warning mechanism, you can address the causes of it.

The Curse of Consciousness 

The universal problem of being human is what I call the “Curse of Consciousness.” Recent neuroscience research has shown that threats in the form of unpleasant thoughts are processed in a similar area of the brain as physical threats and with the same chemical response.  

This curse is that none of us can escape our thoughts, so we are subjected to an endless hormonal assault on our body. This translates into more than 30 physical symptoms and many disease states, including autoimmune disorders and intractable pain. The worst symptom is relentless anxiety.  

In my personal experience and working with thousands of pain patients, it is the mental pain -- manifested by anxiety – that becomes intolerable. Anxiety is the essence of human suffering and physical pain is the final insult.  

Since this unconscious survival mechanism has been estimated to be a million times more powerful than your conscious brain, it isn’t responsive to rational interventions to manage or control it. Without anxiety that is unpleasant enough to compel you take action, you wouldn’t survive. Neither would you survive without the drive to seek physiological rewards. 

Direct Your Own Care

Try to view anxiety as the fuel gauge in your car. It lets you know that you are being threatened. Whether the threat is real or perceived doesn’t matter. But you have to allow yourself to feel it before you can understand and deal with it.  

If anxiety is the measure of your body’s survival hormones, then the only way to decrease it is to lower them. This can be accomplished directly through relaxation techniques or by indirectly lowering the reactivity of your brain to dampen the survival response.  

This is accomplished by stimulating your brain to rewire so the response to a threat results in a lower chemical surge and is of shorter duration. The term for this is “neuroplasticity.” Your brain changes every second with new cells, connections and myelin. 

By not wasting energy trying to treat or solve your anxiety, you now have the energy to pursue a new path with a remarkable surge in energy, life forces and creativity.   

How is this accomplished? Learning tools to calm and rewire your nervous system is the core of the Direct your Own Care (DOC) project. These approaches have been known for centuries, but have been buried under the weight of modern information overload and the rapid pace of life.  

DOC is a four-stage process for you to understand the nature of your pain and relevant issues that allows you to figure out your own version of a solution. The clarity you get will help you connect to your own capacity to heal by developing skills to auto-regulate your body’s chemistry from anxiety to relaxed.  

Success in learning to adjust your body’s chemical makeup is based on awareness and openness to learning so change can occur. It is remarkably simple and consistent. Join me in living your life in a manner that you could not conceive was possible – even better than before you were crushed by pain. 

Dr. David Hanscom is retired spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

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

How West Virginia Became the Epicenter of the Opioid Crisis

By Douglas Hughes, Guest Columnist 

Aggressive promotion by the distributors of OxyContin, the best pain medication ever formulated (when properly used), led to excessive prescribing by West Virginia doctors. 

This caused a methamphetamine drug problem in the state to morph into a prescription opioid epidemic, mostly due to unused opioids squirreled away in medicine cabinets.  Adolescents ignored by their guardians had complementary party favors of these excess opioids. This is why so many families were affected. 

After a few years of this, once the addiction problems were exposed, the excess prescribing stopped. Those desiring to misuse OxyContin went to pain clinics and lied to receive more.  Since we don’t have tachometers on our foreheads to gauge real subjective pain, lying to doctors was effective for many to get drugs to abuse.  

Not wanting to assist pain specialists and willing to deny legitimate intractable pain treatment, the West Virginia legislature passed the “Chronic Pain Clinic Licensing Act.”

When implemented on January 1, 2015, the goal to deny licenses to a dozen new and existing pain clinics was achieved. This left only pills being hoarded in medicine cabinets, which were quickly depleted.  

OxyContin distribution was suspended to pharmacies in most of West Virginia in 2015. 

These two efforts stopped most OxyContin prescribing and decimated legitimate disabled intractable pain sufferers in West Virginia, the state with the highest incidence of industrial and worker compensation injury cases. 

For the sake of argument, let’s estimate pain clinic patients were 50% legitimate pain sufferers and 50% abusers lying in order to get opioids.  Each of those twelve pain clinic closures turned a thousand or more patients onto the streets.  Some wanted to abuse, while others desperately sought to replace critical pain treatment denied to them by state law.  Some turned to street drugs as their answer. 

In 2015, West Virginia police departments reported that pain pills seized from drug arrests fell a remarkable 89 percent. The opioid crisis was shifting rapidly to heroin, as the drug sub-culture always does when a drug source changes. The prescription opioid epidemic in West Virginia essentially ended in 2015.  There was no memo from the CDC.

Those thousands of good and bad patients from pain clinics were both naive to the strength and use of heroin.  Dosing, once regulated by prescription, now was more lethal. Learning how to prepare and inject heroin without becoming infected, overdosing and dying was problematic. There were record overdose deaths in 2015, even though there were fewer pain pills. 

Counterfeit medication and heroin laced with illicit fentanyl appeared and record overdose deaths continued in 2016 and 2017 because there were so many inexperienced street drug users.  

Since 2015, West Virginia has wasted millions of dollars annually chasing imaginary diversion and investigating and prosecuting good physicians. This satisfied everyone except legitimate pain patients, who were left suffering and dying in their beds.  A suicide epidemic ensued.

West Virginia lacks a prevention component to their drug crisis response, which insured the re-occurrence of another epidemic. Apparently, we are satisfied with this catastrophe. May we have another?   

Douglas Hughes is a disabled coal miner and retired environmental permit writer in West Virginia.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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

FDA Seeks Feedback on Opioid Blister Packs

By Donna Gregory Burch

I’ve been hoarding a bottle of oxycodone tablets from my back surgery last year. I probably shouldn’t admit it, but I keep them tucked away in the back of a bathroom drawer in case my chronic back and fibromyalgia pain gets so intense that I need something stronger than the tramadol or medical marijuana I normally use for daily pain.

I’m doing exactly what the Food and Drug Administration doesn’t want me to do. In fact, if an FDA proposal is adopted, there will be far fewer patients like myself with stashes of leftover opioids.

The FDA is soliciting public comments on a proposal to require drug makers to manufacture certain opioids in “blister packs” for acute pain situations such as patients recovering from injuries and minimally-invasive surgery. Opioids listed in the FDA’s Federal Register notice include hydrocodone, tramadol, oxycodone and codeine.

In a nutshell, the FDA would like doctors to have the option to prescribe 5, 10 or 15-count opioid tablets in foil wrappers, similar to those annoyingly difficult-to-open packages used for cold-and-flu medications.

If you’ve ever been sick as a dog with a cold and used all of your strength to wrestle a Dayquil capsule out of its foil wrapper, then you know the type of packaging I’m talking about.

The FDA’s proposal is intended to reduce the number of unused opioids that could wind up in the hands of children and others who might abuse or divert them. Based on published studies, most “opioid naïve” patients who are new to opioids don’t actually take all of the tablets prescribed to them for acute pain. The FDA believes all of those leftover pills stashed in medicine cabinets could be contributing to the so-called opioid crisis. 

“In the post-surgical setting, following several common minimally or less-invasive surgical procedures, most opioid-naïve adults who used an opioid analgesic appeared to use only one to three days’ worth, or 15 or fewer, opioid analgesic tablets or capsules despite receiving prescriptions exceeding the number they used,” reads the FDA’s notice for public comment.  

“(We) anticipate that utilization of these fixed-quantity unit-of-use blister package configurations would substantially reduce the quantity of opioid analgesics dispensed per prescription compared to the status quo.”.

Obviously, physicians already have the authority to prescribe smaller quantities of opioids, but the FDA says these blister packages would encourage more rational “right-size” opioid prescribing. The notice stipulates that blister packs would not be required and that other options would still be available.

Other potential benefits of blister packaging cited by the FDA include:

• Reducing accidental childhood poisoning

• Being able to include additional labels on packaging on how to safely use and dispose of opioids

• Making it easier for patients and caregivers to determine if a third party has taken their opioid medication

The FDA is soliciting comments on its proposal through July 30. Read the public comment notice here. The notice includes instructions for submitting comments online, by email or in paper form.

So, what do you think? Would prescribing opioids in blister packaging for acute pain help curb the opioid crisis? Am I the only person who breaks out in a sweat when I have to pry medications from that kind of packaging? Share your thoughts (and struggles) in the comments! 

Donna Gregory Burch lives with fibromyalgia and chronic Lyme disease. Donna covers news, treatments, research and practical tips for living with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter.

Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

How Opioid Critics and Law Firms Profit From Litigation

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has long been known as one of the most strident critics of opioid prescribing. The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) has claimed that drug makers and a web of industry-funded groups are to blame for the nation’s addiction and overdose crisis.

Kolodny has accused the so-called “opioid lobby” of undermining the CDC opioid guideline, claimed pain patients are being “effectively manipulated” by drug makers, and called the American Cancer Society a “shady organization” because it accepts outside funding. 

Kolodny even spoke about an “opioid mafia” as he testified as an expert witness in Oklahoma’s opioid lawsuit against Johnson & Johnson.

“We’ve seen Johnson & Johnson promote opioids in this unbranded campaign, funding front groups, patient groups meant to look like grassroots organizations that promoted opioids, funding professional groups that were promoting opioids,” Kolodny testified.  

“We know that Johnson & Johnson participated in the Pain Care Forum, a group that I have referred to as the opioid mafia, working to protect their stake in the opium supply into the United States.”

Kolodny’s hyperbole is catnip to compliant reporters who can usually count on him to return their calls and provide a good quote.  A psychiatrist and former chief medical officer for the addiction treatment chain Phoenix House, Kolodny is the go-to source for many news organizations covering the opioid crisis. He now co-directs an opioid research program at Brandeis University that is funded by a federal grant.

Kolodny’s has long maintained that he is free of any conflicts of interest and that PROP has never accepted funding from the pharmaceutical industry.

“I don’t believe physicians should be helping drug companies market their products,” he testified in Oklahoma. “It’s very easy to fool yourself when it’s profitable to fool yourself.”

Lawyers for Johnson & Johnson have opened a window into a profitable sideline Kolodny has as a paid consultant and expert witness for law firms involved in opioid litigation.

Kolodny stands to make upwards of half a million dollars working for the law firm of Nix Patterson & Roach, one of three outside law firms hired by Oklahoma Attorney General Mike Hunter to handle the case against Johnson & Johnson.

“It’s very easy to fool yourself when it’s profitable to fool yourself.”

— Dr. Andrew Kolodny

Kolodny testified that he’s being paid $725 an hour by Nix Patterson and could collect up to $500,000 for his services – possibly even more, depending on the length of the Oklahoma trial. Under questioning, Kolodny also acknowledged that he was paid $725 an hour as a consultant for at least one other law firm involved in opioid litigation.

“I don’t think it should be a secret that I’m being compensated,” Koldony said, adding that he worked for Nix Patterson about ten hours a week before the trial started and 40 hours a week since it began four weeks ago. At his hourly rate, Kolodny’s weekly pay would be $29,000.

Nix Patterson can easily afford to pay Kolodny. According to the terms of their contingency agreement with Oklahoma, the three law firms stand to collect up to 25% of any damages and penalties. With $17.5 billion being sought from Johnson & Johnson, Nix Patterson’s share could theoretically add up to nearly $2.5 billion. 

Purdue Pharma and Teva Pharmaceuticals have already settled out-of-court with Oklahoma for far less — $270 million and $85 million respectively.  Nix Patterson’s share of the Purdue settlement alone was $31.6 million.

Compensation Not Disclosed

Koldony’s work as a paid witness in opioid litigation is not disclosed on Brandeis University’s website, PROP’s website or on the website of the Steve Rummler Hope Network, a non-profit that is the “fiscal sponsor” of PROP.  

A non-profit fiscal sponsorship is an IRS loophole that allows the Rummler Hope Network to collect tax deductible donations on PROP’s behalf — even though PROP is not a registered charity. The identity of PROP’s donors and the size of their donations have never been disclosed.

Kolodny serves on the medical advisory committee of the Rummler Hope Network, along with PROP President Jane Ballantyne, MD. Coincidentally, Ballantyne worked as a paid consultant for Cohen Milstein Sellers & Toll – a law firm involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois.

Kolodny testified in the Oklahoma trial that he also did some consulting for attorney Linda Singer at Cohen Milstein, which The New York Times profiled in 2014 as a politically influential law firm that was laying the groundwork for opioid lawsuits around the country. Singer was the lead outside counsel for the City of Chicago and Santa Clara County, California, two of the first jurisdictions to file opioid lawsuits.

“The lawsuits follow a pattern: Private lawyers, who scour the news media and public records looking for potential cases in which a state or its consumers have been harmed, approach attorneys general. The attorneys general hire the private firms to do the necessary work, with the understanding that the firms will front most of the cost of the investigation and the litigation. The firms take a fee, typically 20 percent, and the state takes the rest of any money won from the defendants,” the Times reported.

Singer left Cohen Milstein in 2017 to join Motley Rice, yet another law firm that specializes in healthcare litigation. PNN was unable to verify whether Kolodny was still on the payroll of Cohen Milstein, Motley Rice or any other law firms. He refused to discuss his work in opioid litigation.

“I’m not interested in answering any questions or talking to you,” Kolodny told this reporter.

(Update: In 2022 testimony in West Virginia, Kolodny testified that he started working on opioid litigation in 2012 with Linda Singer. It’s unknown if he disclosed that relationship to the CDC when he was advising the agency during the drafting of the 2016 opioid guideline. The CDC declined to provide that information to PNN after an FOIA request.

On September 4, 2019 Kolodny changed two of his JAMA disclosure statements to include his work as a paid expert in malpractice lawsuits. “I received compensation for work as an expert in malpractice litigation involving opioid prescribing. When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”)

PharmedOUT’s Paid Expert Witness

Another vocal critic of opioid prescribing is Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University Medical Center that seeks to expose deceptive marketing practices in the healthcare industry.

In a recent column in STAT News, Fugh-Berman and two of her grad students echoed many of Kolodony’s complaints about opioid manufacturers — claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were eroding public health.   

“The eerily similar attacks on the guideline… raise the question of whether this is a coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline,” they wrote. “There’s certainly a credible motive for opioid manufacturers to do this: The CDC guideline is an effective, evidence-based tool that has helped decrease inappropriate and dangerous prescribing of opioids for chronic pain patients.”

DR. ADRIANE FUGH-BERMAN

Unlike Kolodny, Fugh-Berman does disclose on PharmedOUT’s website that she is “a paid expert witness.” It is not disclosed, however, which law firms Fugh-Berman works for, what cases she is working on, or how much she is paid.

After initially agreeing to a telephone interview with PNN, Fugh-Berman abruptly cancelled. She did answer a few questions by email.

“I am a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices, including litigation brought by several states and cities against opioid manufacturers.  My expert witness work has been disclosed to Georgetown, in my publications, and on our website,” Fugh-Berman wrote.

(Update: In testimony in California on August 15, 2019, Fugh-Berman said she billed $500 an hour for her testimony in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case to date.)

Like PROP, PharmedOUT does not disclose it donors, which Fugh-Berman calls “a common practice.”

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said.

Fugh-Berman did disclose that Kaiser Permanente sponsored PharmedOUT’s recent opioid conference, which featured a speech by Kolodny entitled “How the Opioid Lobby Protected the Status Quo” and a talk by a Kaiser doctor on “How Kaiser Permanente Promotes Rational Prescribing.”  

Lobbying and Campaign Donations

Law firms involved in opioid litigation have played a significant role in some political campaigns and in shaping news coverage of the opioid crisis. The national firm of Simmons Hanly Conroy — which claims to have “effectively invented large-scale, multi-defendant opioid litigation” — represents dozens of states, counties and cities that are suing drug companies. According to reports, Simmons Hanly’s contingency fee will be as high as one-third of the proceeds from opioid settlements.

In the 2018 congressional election, Simmons Hanly spent nearly $1.2 million on lobbying and donated over $1 million to candidates, according to OpenSecrets.org. Missouri Sen. Claire McCaskill (D) received five times more than any other candidate — nearly $410,000 — from donors affiliated with Simmons Hanly.

In February of that year, McCaskill released a report that was sharply critical of physician and patient advocacy groups for accepting money from opioid manufacturers. At least two organizations cited in the McCaskill report — the American Academy of Pain Medicine and the American Pain Society (APS) — are named as defendants in opioid lawsuits filed by Simmons Hanly. The APS recently filed for bankruptcy, citing the high cost of defending itself against “meritless” law suits.

The report made headlines for McCaskill, who ultimately lost her bid for re-election, but continues to make news today — most recently in the STAT news column written by paid expert witness Dr. Fugh-Berman.

With the Oklahoma trial now heading into its fifth week, enormous amounts of money are at stake. A verdict against Johnson & Johnson could lead to a cascade of settlements in hundreds of other opioid lawsuits that could cost the pharmaceutical industry up to $50 billion. States, cities and counties would certainly benefit from a settlement of that size. So would the law firms that represent them – and their paid witnesses.

5 Million U.S. Cancer Survivors Live with Chronic Pain

By Pat Anson, PNN Editor

Over five million cancer survivors in the United States live with chronic pain, a fast-growing population that is expected to double by 2040 due to the aging of the population, early cancer detection and advances in treatment, according to a new study by the American Cancer Society.

Chronic pain is one of the most common side effects of chemotherapy and other forms of cancer treatment, but until now there has been little information on its prevalence among cancer survivors.

Researchers looked at data from the National Health Interview Survey from 2016-2017 and found that about a third of cancer survivors (34.6%) have chronic pain. About one in six (16.1%) have “high impact” chronic pain (HICP) – defined as pain that limits life or work activities on most days.

Based on that survey data, researchers estimate the total number of cancers survivors in the U.S. at 15.5 million. About 5.39 million of them have chronic pain and 2.51 million have high impact chronic pain.

“We found the prevalence of chronic pain and HICP among cancer survivors to be almost double that in the general U.S. population. Chronic pain and HICP were more prevalent in survivors who were unemployed and who had low socioeconomic status, inadequate insurance, and had some specific types of cancer,” researchers reported in JAMA Oncology.

“The patterns of chronic pain that we observed in cancer survivors may be explained by barriers to cancer care and pain management as well as by the type and extent of cancer treatment received.”

One barrier to pain management stems from efforts to rein in opioid prescribing to prevent abuse and addiction. While the 2016 CDC opioid guideline is intended for “noncancer” patients, it is also applies to patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”

Two experts in oncology and palliative care at the University of Pennsylvania say the CDC’s inclusion of cancer survivors was a mistake because it is not uncommon for cancer pain to persist long after a cancer is treated.  

“Unfortunately, this arbitrary distinction is not consistent with the evidence of pain trajectory in cancer survivors,” Neha Vapiwala, MD, and Salimah Meghani, PhD, wrote in an op/ed also published in JAMA Oncology. “Similar levels of pain were reported in survivors who were still receiving cancer treatment and those who had completed active cancer treatment.”

It’s not uncommon for cancer patients undergoing active treatment to be denied pain medication. Many doctors are reluctant to prescribe opioids, regardless of the diagnosis.

“My cancer doctor will no longer prescribe pain meds for me because I now see a pain doctor. The pain doctor doesn't understand the new cancer drug I'm on and that the side effects of this drug are pain, so he is very reluctant to manage my cancer pain,” a patient with lymphoma told us. “Many days I wonder if it would just be better to let the cancer take its course than to be scrutinized and treated like a criminal.”

April Doyle is being treated for Stage 4 terminal breast cancer, but a Rite Aid pharmacist refused to fill her prescription for Norco because he was worried about being fined or even losing his job. April’s video about the experience went viral.

“I have to take 20 pills a day just to stay alive,” she explains in the video. “Every time I take my pain pill prescription there, they give me the runaround. They don’t have enough in stock or they need me to come back tomorrow because they can’t fill it today. Or something stupid. It’s always something and it’s always some stupid excuse.”

The American Cancer Society study found that chronic pain was most common among cancer survivors treated for bone, kidney, throat-pharynx and uterine cancers.  About half still had pain after their cancer treatment ended.