Excedrin Brands Recalled Due to Faulty Packaging

By Pat Anson, PNN Editor

One of world’s most widely used over-the-counter pain relievers has turned into a real headache for GlaxoSmithKline (GSK).

The British pharmaceutical giant has recalled over 433,000 bottles of Excedrin because of holes found in bottles of five Excedrin brands: Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets and Excedrin Tension Headache Caplets.

There have been no reports of any injuries as a result of the faulty bottles, but GSK recalled them because of the risk of Excedrin tablets falling out and being swallowed by young children. Under U.S. federal law, the tablets must be sold in child resistant packaging.

“While the likelihood there are bottles on the market with holes is low, we are asking anyone who has purchased large-sized Excedrin (50 count and above) to check their Excedrin products and if there is a visible issue, contact GSK Consumer Relations at 1-800-468-7746 for a full refund. If your Excedrin bottle is not damaged, the product is safe to use as directed on the label,” GSK said in a statement.

GsK IMAGE

GsK IMAGE

“We take product safety very seriously at GSK and while we have not received any complaints or safety concerns to date on this potential problem, we are still letting consumers know so they can check their Excedrin bottles themselves. We sincerely apologize for any inconvenience, and please be assured we are working closely with the bottle manufacturer to fix this problem as quickly as we can.”

The bottles were sold at pharmacies, stores and online from March 2018 through September 2020. There was no explanation given for what caused the holes or why it took so long for GSK to recognize there was a problem and order a recall.

In January, GSK temporarily halted production of Excedrin Extra Strength and Excedrin Migraine due to “inconsistencies” in their ingredients. That led to spot shortages of the pain relievers.

In 2012, an Excedrin manufacturing plant in Nebraska was shut down for several months after Excedrin bottles were found to contain broken and stray tablets for other medications. At the time, the Excedrin brand was owned by Novartis.

An FDA investigation found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in over-the-counter drugs produced at the Nebraska plant. GSK now holds majority ownership of Excedrin through a joint venture with Novartis.

A recent study found GSK to be the most heavily fined drug company in the United States.  GSK paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs.

A Little Shop of Horrors: VA Opioid Guideline for Veterans

By Richard Lawhern, PNN Contributor

As a volunteer patient advocate and healthcare writer, I read a very large volume of scientific and policy literature. And as a 21-year military veteran myself, I am particularly interested in Veterans Administration policies for treatment of chronic pain. Thus I reviewed with interest the VA’s 2017 Clinical Practice Guideline for Opioid Therapy for Chronic Pain.  

I also checked with a medical professional who practices in the VA hospital system to verify that the “guidance” of this document is still in force. It is. 

In my view, the VA opioid guidance is a “little shop of horrors” guaranteed to drive patients into medical collapse, and in some cases suicide. These direct quotes from the VA guideline should illustrate my concerns:

  • “Since [2010], there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans…. At the same time, there is a mounting body of research detailing the lack of benefit and severe harms of [long-term opioid therapy].”

  • “We recommend against initiation of long-term opioid therapy for chronic pain.”

  • “We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments.”

  • “If prescribing opioid therapy for patients with chronic pain, we recommend a short duration… Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits.”

  • “We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder.”

  • “If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits…. There is no absolutely safe dose of opioids.”   

  • “As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose… Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose.” 

My VA colleague, who asked not to be identified, offers the following observations concerning VA policies in treating pain. This is paraphrased to protect the physician from retaliation:   

“The VA simply does not allow me the flexibility I need to manage my patients’ pain. All that is said about honoring our veterans and all the expressions of pride in the level of care the VA provides veterans thus ring hollow. The VA exhibits far greater pride in the percent reduction in opioid prescriptions it has been able to achieve, even giving out awards to physicians who make particularly large contributions to this effort.”

Let’s also compare these highly restrictive policies with a June 2020 letter from the American Medical Association to the CDC’s Chief Medical Officer on the pending revision of the 2016 CDC guideline:

  • “We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens.”

  • “Some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies.”

  • “A CDC Guideline only focused on ‘opioid prescribing’ will perpetuate the fallacy that by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end.”

  • “The CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs.”

  • “It is clear that the CDC Guideline has harmed many patients — so much so that in 2019, the CDC authors and HHS issued long-overdue … clarifications that states should not use the CDC Guideline to implement an arbitrary threshold.”  

The AMA recommended that the CDC should advocate explicitly for the repeal of all federal and state legislation that places hard limits on opioid prescribing.  Another recommendation is that physicians should treat both chronic pain and opioid addiction among the few patients who deal with both issues.  Discharging these patients or forcibly tapering them should no longer be automatic.

AMA is also on public record with the position that so-called “high prescriber” letters issued by prosecutors and state Prescription Drug Monitoring Programs (PDMPs) constitute a witch hunt against physicians and their sickest patients, and is a violation of legal due process.  

Not addressed by either the AMA or the VA is the reality that there are presently no field-tested tools that reliably evaluate quantitative risk of opioid tolerance, dependence or addiction in individual patients. 

As Nora Volkow, MD, and Thomas McMillan, PhD, of the National Institutes of Health wrote in The New England Journal of Medicine:  

“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities... Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV).

However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes.”  

A further complicating factor for the VA is that we now know beyond any reasonable contradiction that their attempt to restrict opioid prescribing is unsupported by science. 

There is no relationship between rates of opioid prescribing versus rates of overdose-related mortality. The demographics simply don’t work:  Although they have the highest rate of opioid prescribing for pain, seniors over age 62 have the lowest rates of overdose-related mortality.  Youths under age 19 receive the fewest number of opioid prescriptions, but have three to six times higher overdose mortality relative to seniors.

It is arguable that the VA guideline is just as fatally flawed as the CDC guideline, and is responsible for significant numbers of patient medical collapses and suicides among veterans.  Both documents fail conclusively on grounds of both medical science and medical ethics and both should be withdrawn immediately.

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

Prescription Opioid Use at 20-Year Lows

By Pat Anson, PNN Editor

Prescription opioid use in the United States is expected to decline for the ninth consecutive year in 2020, with per capita consumption of opioid medication falling to its lowest level in two decades, according to a new report by the IQVIA Institute, a data analytics firm.

Although fewer opioids are being prescribed, U.S. drug overdose deaths have reached record levels, driven largely by illicit fentanyl and other streets drugs, not pain medication.

In the past year alone, IQVIA estimates there was a 17 percent decline in the amount of prescription opioids dispensed in morphine milligram equivalent (MME) units. The decrease is being driven by changes in prescribing policy, government regulation and insurance reimbursement policies, as well as disruptions in healthcare caused by the COVID-19 pandemic.

In the early stages of the pandemic, IQVIA researchers say there was a 44% decline in the number of new patients prescribed opioids, likely the result of providers and patients canceling non-emergency visits, dental appointments and elective surgeries. As the economy reopened in early summer and healthcare visits resumed, opioid prescribing for pain returned to baseline levels, as did prescriptions for addiction treatment drugs.

“The opioid epidemic has captivated the country for a decade, although it lost attention this year in the face of the COVID-19 pandemic. Patients with chronic pain and addiction have also been affected by disruptions to life and healthcare during COVID, when hospitals, doctors’ offices, and drug treatment facilities were closed,” Murray Aitken, Executive Director IQVIA Institute for Human Data Science, said in a statement.

“While the human toll of the opioid epidemic is being addressed differently across the country, efforts in managing prescription opioids and in supporting medication-assisted treatment are showing measurable progress in many states.”

Prescription opioid use peaked in 2011 and has been in steep decline ever since. By the end of 2020, IQVIA projects per capita annual opioid consumption to fall to 298 MME, nearing a level last seen in 2000.

SOURCE: iqvia iNSTITUTE

SOURCE: iqvia iNSTITUTE

“Based on usage in the mid-1990s, it may be difficult to reduce current prescription opioid levels further, as pain medications are necessary for some patients, including cancer patients, until other non-addictive or disease-modifying treatments are available,” the IQVIA report found.

Over the past decade, the greatest decline in prescription opioid use has been in the highest risk categories. Prescriptions written for 90 MME or more per day – a level considered risky by the CDC – have fallen by 70 percent since 2011.

Co-prescribing of opioids with benzodiazepines – an anti-anxiety medication – is also falling rapidly. The number of patients taking both drugs has declined from 86 million in 2016 to less than 60 million in 2020. Opioids and benzodiazepines both slow respiration, and patients who take them in combination are believed to be at higher risk of an overdose.

Overdoses Still Rising

Despite the historic decline in prescription opioid use, U.S. overdose deaths hit a record high last spring, according to a new report from the CDC.  For the 12 months ending in May 2020, over 81,000 people died of a drug overdose.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a health advisory, adding that the deaths were largely driven by illicit fentanyl, heroin, cocaine and psychostimulants such as methamphetamine. Opioid pain medication is not even mentioned in the CDC report.

“The disruption to daily life due to the Covid-19 pandemic has hit those with substance use disorder hard,” CDC director Robert Redfield said in a statement. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.”

Some federal agencies haven’t gotten the message and continue to blame opioid medication and prescribers for the nation’s overdose epidemic.

A new report released this week by the Office of Inspector General (OIG) for Health and Human Services warns that thousands of Medicaid patients in six Appalachian states are being prescribed “harmful amounts” of opioids. The report also identifies 19 physicians with “questionable prescribing practices” and said they will be referred to law enforcement.  

“OIG, along with its law enforcement partners, will review the prescribers with questionable prescribing patterns for possible investigation. OIG will also refer the beneficiaries at serious risk for opioid misuse or overdose to their respective State Medicaid agencies for review and possible followup to ensure that they are receiving appropriate care,” the report states.

“Further, we encourage States to provide greater access to data from prescription drug monitoring programs, including sharing these data with State Medicaid agencies. We also encourage States to analyze data to help identify patients who may be at risk and to promote appropriate opioid prescribing practices.”

Senate Report Finds Opioid Makers Paid Millions to Non-Profits

By Pat Anson, PNN Editor

The U.S. Senate Finance Committee has released a new report accusing patient advocacy groups and professional pain societies of being front organizations for opioid manufacturers.

The 39-page report by Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) identifies $65 million in payments made by drug companies to 10 non-profit organizations since 1997. The report alleges that the groups “echoed and amplified the business interests of their pharmaceutical donors” by promoting the use of opioid medication.

Teva Pharmaceuticals, Pfizer and Purdue Pharma were the biggest donors to tax-exempt groups. The largest beneficiaries were the American Chronic Pain Association, International Association for the Study of Pain, American Academy of Pain Medicine, American Pain Society and the U.S. Pain Foundation.  

“Tax-exempt advocacy organizations like the ones we looked at are created with good intentions. They can be forces for good, advocating and highlighting issues that might not otherwise receive the warranted attention,” Sen. Grassley said in a statement. “But we’ve found that the possibility of donor influence could and has undermined the efforts to develop and advocate good policy.”

“Our bipartisan investigation shows how pharmaceutical companies use tax-exempt groups to help seed the market for their products by shaping the views of patients, doctors and policymakers,” Sen. Wyden said. “The potential dangers presented by opioids makes this Trojan horse-style of marketing particularly troubling, but make no mistake that such practices are widespread across the pharmaceutical industry, and consumers are often left in the dark.” 

Ironically, several organizations cited in the Senate report have either ceased operations or scaled back their advocacy efforts after significant cuts in funding from the pharmaceutical industry. The American Pain Society, for example, filed for bankruptcy in 2019 due to declining donations and the cost of defending itself in opioid litigation cases.

“Advocacy groups and professional organizations are reasonable forums to help provide science-based information to people in pain about how to minimize harm from opioids or any other treatment. Without industry support, many of the organizations would not exist,” said Lynn Webster, MD, a past president of the American Academy of Pain Medicine.

“We saw this with the bankruptcy of the American Pain Society, a preeminent scientific organization trying to advance the science to help people in pain. The government doesn't provide this support so, thankfully, industry has stepped in to partially fill the void.” 

‘Nothing New Here’

Webster and other critics said there was little new information in the report from the Senate Finance Committee, which has been looking into donations from the pharmaceutical industry since 2012. 

“It's puzzling why the senators would choose to finally put out a report on material they gathered eight years ago. Pretty much everything in this report has been reported repeatedly over those eight years. There really is nothing new here, and it's sad that the senators haven't put their efforts into more productive endeavors, such as promoting greater access to safe and effective pain care for the 50 million Americans with chronic pain,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management, which also shutdown in 2019. 

“Instead, they seem to be intent on rehashing stale information that pretty much everyone has accepted and from which they have moved on. They need to move on, as well, and use their positions with the Finance Committee to help improve pain care coverage, especially in Medicare and Medicaid, which is part of their committee's oversight area.” 

To improve the transparency of industry donations, Grassley and Wyden are recommending that the Centers for Medicare and Medicaid Services (CMS) expand its Open Payments database to require drug and medical device manufacturers to report payments made to tax-exempt organizations. They also called on the Secretary of Health and Human Services (HHS) to develop guidelines requiring members of federally funded task forces and research groups to disclose their funding ties.  

“Industry has long been supporting advocacy groups and professional organizations. This is not unique to pain organizations or advocacy groups. Almost every area of healthcare has industry support,” said Webster, who was one of the first doctors investigated by the Senate Finance Committee.

Webster says the report overlooks the fact that the opioid crisis is largely being fueled by illicit fentanyl and other street drugs, not pain medication. And that efforts to limit opioid prescribing have been harmful to many patients.

The real crisis is with illicit drugs. Focusing exclusively on prescription opioids as the source of the problem is like sending all the fire trucks to one burning house when the whole city is burning down.
— Dr. Lynn Webster

“Senators Grassley and Wyden seem not to acknowledge there are people in pain who, for a variety of reasons, don't have any treatment option other than opioids. In fact, the senators simply don't acknowledge the millions of Americans in pain. This is negligence or worse,” Webster said.

“Prescription opioids can be abused and have led to problems, but the real crisis is with illicit drugs. Focusing exclusively on prescription opioids as the source of the problem is like sending all the fire trucks to one burning house when the whole city is burning down.”

Campaign Donations

There is a certain amount of hypocrisy in congressional complaints about industry funding. A database maintained by OpenSecrets shows that Grassley and Wyden have long benefited from campaign contributions from donors affiliated with the healthcare industry. From 2015 to 2020, Wyden accepted about $2.75 million from health professionals, pharmaceutical companies, hospitals, nursing homes, and insurers. Grassley accepted about $1.1 million from the same groups over that period. 

Law firms involved in opioid litigation, which stand to make billions of dollars in contingency fees from opioid lawsuits filed by states, cities and counties, have also been prolific donors to Congress.  

For example, the law firm of Simmons Hanly Conroy donated nearly $500,000 to Sen. Claire McCaskill (D-MO) during her campaign for re-election in 2018. McCaskill lost the election, but not before releasing her own report critical of pharmaceutical donations to non-profit groups. The American Academy of Pain Medicine and the American Pain Society, two of the organizations cited by McCaskill, were both being sued by Simmons Hanly Conroy.

Potentiation: How to Make Opioid Medication More Effective

By Forest Tennant, PNN Columnist

The oldest measure to either minimize the dosage or make an opioid more effective has been to add a chemical agent that makes the opioid act longer and stronger. This concept is known as “potentiation” and there are many examples of it throughout history.

Various herbs such as Boswellia (frankincense) were used with opium in ancient times to make it more potent. The Greek physicians Dioscorides and Galien recorded the use of opium combined with cannabis for many therapeutic purposes.

Physicians during the American Revolution titrated alcohol with opium for tuberculosis. The legendary gambler and gunslinger John Henry “Doc” Holiday survived many years with this regimen for his tuberculosis or sarcoid.

British physicians combined aspirin with morphine around the turn of the 19th Century. Later they determined that a stimulant-type drug, such as cocaine, made morphine more effective for the person with severe pain. This was called the Brompton Cocktail, named after the Royal Brompton Hospital in London, where it was used to treat cancer patients in the 1920’s.

Beginning around World War II, American pharmacological companies began combining the opioids codeine, hydrocodone and oxycodone with substances such as aspirin, caffeine, acetaminophen, ibuprofen and phenacetin. Today, the most popular potentiating combinations are acetaminophen with codeine, hydrocodone or oxycodone.

An opioid should almost never be taken alone by a person with Intractable Pain Syndrome. Why? First, you don’t get the full effect of the opioid. Second, without a potentiator, you will need to take a higher opioid dose when a lower one would suffice and have fewer risks.

Every IPS patient needs to identify at least two potentiators that won’t bother their stomach or cause headache, drowsiness or dizziness.

Available Potentiators

  • Caffeine Tablet

  • Mucuna

  • Boswellia

  • Gabapentin

  • Taurine

  • CBD Products

  • Adderall

  • Methylphenidate

  • Dextroamphetamine

  • Benadryl

  • GABA

Consider switching to an opioid with acetaminophen, such as Vicodin or Percocet, or take a potentiator with your opioids. Don’t take alcohol, marijuana or a benzodiazepine (Xanax, Ativan, Valium, Klonopin) at the same time you take an opioid. Separate the two by at least an hour to avoid over-sedation. 

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation has given financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

AMA ‘Greatly Concerned’ By Rising Number of Opioid Overdoses

By Pat Anson, PNN Editor

The American Medical Association is once again urging states, regulators and policymakers to waive limits and restrictions on prescriptions for opioid medication and other controlled substances during the COVID-19 pandemic.

In a briefing paper released this week, the AMA said it was alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl. The AMA cited recent reports from the Pacific Northwest that thousands of people were unexpectedly dying from causes other than COVID-19, such as fentanyl-laced counterfeit pills and medical conditions aggravated by delays in getting routine healthcare.    

“The AMA is greatly concerned by an increasing number of reports from national, state and local media suggesting increases in opioid-and other drug-related mortality—particularly from illicitly manufactured fentanyl and fentanyl analogs,” the AMA said. “More than 40 states have reported increases in opioid-related mortality as well as ongoing concerns for those with a mental illness or substance use disorder.”

The AMA urged states to adopt new DEA guidance giving more flexibility to physicians treating patients with opioid use disorder (OUD). The DEA has already waived federal requirements for in-person visits before prescribing addiction treatment drugs such as buprenorphine (Suboxone), methadone and naltrexone.

For patients in pain, the AMA recommended that states take a number of steps to make it easier to obtain pain medication during the pandemic:

  • Authorize physicians to prescribe opioid medication to existing patients without an in-person visit

  • Waive limits on prescriptions for opioids and other controlled substances, including limits on dose, quantity and refills

  • Waive requirements on electronic prescribing; authorize prescriptions to be sent to pharmacies via telephone

  • Waive drug testing and in-person counseling requirements for opioid refills; allow for telephone counseling

  • Enhance home-delivery medication options for patients with chronic pain

The AMA urged many of these same measures be adopted in the early stages of the pandemic.

In a recent letter to the DEA, the AMA strongly recommended that the agency keep its relaxed prescribing guidelines in place indefinitely.

“There is an urgent need to ensure that patients with pain and patients with OUD receive evidence-based care, and this need will not cease with the end of the COVID-19 pandemic,” wrote James Madara, MD, Executive Vice President and CEO of the AMA..

“The AMA strongly recommends, therefore, that all of the flexibilities that have been put in place by DEA during the COVID-19 PHE (public health emergency) be kept in place at a minimum until both the COVID-19 and the opioid public health emergencies come to an end.”

PROP Plans to Hire New Executive Director

By Pat Anson, PNN Editor

An influential anti-opioid activist group -- Physicians for Responsible Opioid Prescribing (PROP) – is raising money to hire a new Executive Director to replace Dr. Andrew Kolodny, PNN has learned.

There is no indication that Kolodny is leaving PROP, a volunteer organization that he founded in 2011 to “turn the tide of opioid overprescribing.” But in an unsigned email sent to supporters this week, PROP asked for donations so it could hire a new Executive Director, a position long held by Kolodny.

“We’ve retrenched and brainstormed and have great plans to expand our reach and impact. Our next big step is to hire a paid staff person. Will you help to make this plan a reality? We are trying to raise $100,000 by December 31st to ensure that we can hire an executive director with resources to take PROP's work to the next level. Please help by donating what you can,” the email said.

Supporters who click the donate button on the email will be taken to a PayPal account operated by the Steve Rummler Hope Foundation, which is PROP’s “fiscal sponsor.” PROP is not a charity, but can collect tax deductible donations under the foundation’s non-profit status.

Like PROP, the Rummler foundation’s main goal is to reduce opioid prescribing. Kolodny works closely with the organization and serves on its Medical Advisory Committee, along with PROP President Dr. Jane Ballantyne.   

Kolodny declined to talk with this reporter about what his future role with PROP will be.

“I haven’t had a good experience answering questions from you in the past, so I’m not going to talk with you,” Kolodny told me in a brief phone call.

‘Heroin Pills’

It would be hard to overstate the influence that Kolodny and PROP have had on opioid prescribing in the United States. A psychiatrist who specializes in addiction treatment and former Chief Medical Officer at Phoenix House, Kolodny is the public face of PROP. He lobbied Congress and federal health agencies for years to limit opioid prescribing, and gives frequent media interviews on opioid-related issues.

In a 2015 C-SPAN interview, Kolodny called opioid painkillers “heroin pills” and suggested pain patients shouldn’t trust their own doctors.  

“I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case,” he said. “We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

PROP achieved its greatest success in 2016, when the CDC released its controversial opioid prescribing guideline, which several PROP members helped draft. Although voluntary, the guideline was soon adopted as mandatory policy by many states, insurers, law enforcement and health organizations

DR. ANDREW KOLODNY

DR. ANDREW KOLODNY

Opioid prescriptions were declining even before the guideline was released and now stand at their lowest level in over a decade. But overdoses keep rising, fueled largely by illicit fentanyl and other street drugs, not pain medication.

PROP’s fundraising pitch takes credit for the decline in prescriptions and doesn’t even mention the role of street drugs in the overdose epidemic.

“PROP has helped turn the tide of opioid overprescribing.The good news is that opioid prescribing has decreased. The bad news is that the US still leads the world in opioid consumption, drug companies continue to undermine progress, and -- since the SARS CoV-2 pandemic -- opioid overdose deaths are on the rise again while prescription opioid use remains a route to opioid addiction and death,” the PROP email states.

‘Killer Kolodny’

Kolodny has drawn the ire of many pain patients, who blame him for their increased suffering, loss of access to opioids, and anecdotal evidence of a rising number of suicides in the pain community.  A small group of patient advocates recently staged a “Killer Kolodny Rally” outside Brandeis University, where he co-directs opioid research at the Heller School for Policy and Management.   

Kolodny dismissed the rally, telling the Brandeis student newspaper that the protestors who want him fired worked for the opioid industry or had fallen under its sway, and were “trying to controversialize science.”      

“There were climate change scientists who were similarly attacked and their universities stood by them, and I think that Brandeis would stand by science,” Kolodny said. 

Many pain patients believe Kolodny has enriched himself by promoting the use of Suboxone, an addiction treatment drug. That unproven allegation led Kolodny to ask for and receive a letter from Indivior, Suboxone’s manufacturer, stating that he does not have a financial interest in the company.    

As PNN has reported, Kolodny has made a substantial amount of money working as a consultant and expert witness for law firms involved in opioid litigation. During Oklahoma’s lawsuit against Johnson & Johnson, Kolodny testified that he was being paid $725 an hour and would collect up to $500,000 for his services in that trial alone.  

Kolodny has not always been upfront about who is paying him. Last year he revised his conflict of interest statements on two medical journal articles to include his work in malpractice lawsuits. The articles were co-authored with former CDC director Thomas Frieden.

Help Us End the Suffering of Chronic Pain Patients

By Anne Fuqua, Guest Columnist

In 2014, a good friend of mine suffered a heart attack after his opioid pain medications were stopped abruptly. This was despite the fact his records showed that he was a responsible and compliant patient who worked full-time.

Following his death, I started logging the deaths I became aware of on a spreadsheet. Initially, this was just my version of a memorial. I have pain too, and at times wondered if I’m going to wind up on this same memorial.

Every month for the past six years, I have had to add at least one more name to that list, sometimes multiple names. I knew many of these patients and considered them to be my friends.

Some had no quality of life and chose to end their suffering. Some fought to live with all the strength they could muster, but fell to heart attacks, strokes and ruptured aneurysms that occurred after their medication was involuntarily tapered, stopped abruptly or during periods of severe uncontrolled pain. 

For others, the cascade of physiologic changes that help our bodies respond to stress can become harmful in themselves if left unchecked, causing effects that may shorten life even if the person does not suffer one specific event like a heart attack or stroke.

ANNE FUQUA

ANNE FUQUA

Still others were desperate to live but also desperate to get relief. They went to the illicit drug market when they failed to get the surgery, physical therapy or medication that they felt could improve their quality of life. 

There is a name for abandoned pain patients, left to fend for themselves. Dr. Steve Passik coined the term “opioid refugee” in 2012. Tragically, some of these opioid refugees have died in their quest for relief. They sought relief that would allow them to get restful sleep, enjoy quality time with loved ones, and give them the ability to fulfill responsibilities to their family and society.

CSI Opiods Survey

In 2016, I was fortunate enough to become friends with Dr. Stefan Kertesz, a physician I respect immensely. Dr. Kertesz and his colleague, Dr. Allyson Varley, assembled a team of some of the most respected healthcare providers and thought leaders in the field to advise and support their work. Their goal is to understand what exactly happens when a person with chronic pain dies by suicide. 

After over 2 years of tireless efforts to obtain funding, they have begun a pilot project, a survey of people who have lost someone to suicide. I am helping them understand how to reach out to the people who have lost loved ones. The project has the support of the Department of Medicine at University of Alabama at Birmingham. 

If you would like to know more about Drs. Varley or Kertesz, I would encourage you to Google them so you can see for yourself the quality of their work and their dedication to underserved populations. You may also want to check out Dr. Kertesz’s Tedx Birmingham talk on suicides in the pain community.

Our initial work is a pilot study, We wish to learn how many surviving family members and close friends are willing to come forward and complete a survey after losing a loved one to suicide. For now, we are examining suicides where the patient who died had experienced a change in their opioid medication prior to their death, whether it was decreased, increased or stopped. 

If you have lost a loved one, there are two ways that you can participate. We have a brief online survey you can complete that’s entirely confidential. You can take the survey by clicking here or on the banner below. If you are unable to complete this survey all at once, click “save and return later” and you will be able to save your responses and return to the point you left off at a later time. 

If you would feel more comfortable speaking with someone, you can call toll-free (866) 283-7223. There is no payment for doing the survey. Official study information, approved by a University Institutional Review Board, is online at the survey website.

We may eventually get funding to study other types of deaths. We are asking anyone who has lost a loved one to suicide following a change in opioid dose to consider responding to our survey. If enough people do come forward, it will help to make the case that these terrible losses need to be studied closely, rather than ignored.

I recognize this initial effort has a narrow focus. There are many grieving families who want their loved one’s death to be counted even if it was not a suicide. The way the survey is set up, if you report that the person you lost did not die by suicide, it is going to ask for your contact information. You can provide the research team with your contact information so you can be notified about future studies. 

I still keep my own list of deaths as I learn about them, my memorial. It’s important to know that my list is private. Dr. Kertesz and Dr. Varley do not take names off my list. That’s because university research can only be done with consent. If you have a name for my list, whether they died by suicide or not, contact me and I will add your friend or loved one. I make statistics about the deaths -- but no names -- available to policymakers and patients involved with advocacy work. The list itself will not be made public. 

If you are like me, you are apprehensive about what will happen next. I think most of us are exhausted from the fight for better pain care and desperate for change. Change cannot come soon enough when you are the one who is suffering. This is the first step towards ending needless suffering and loss of life.

Anne Fuqua is from Birmingham, Alabama. She lives with her cat Gabby and has primary generalized dystonia and arachnoiditis.

12 Holiday Gifts on Life With Chronic Pain

By Pat Anson, PNN Editor

If you live with chronic pain or illness and want to have a friend or family member get a better understanding of what you're going through -- here are 12 books and videos that would make great gifts over the holidays. Or you can always “gift” one to yourself.

Click on the cover to see price and ordering information. PNN receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon. As an Amazon Associate, we earn from qualifying purchases. 

Finding a New Normal: Living Your Best Life with Chronic Illness by Suzan Jackson

For nearly 20 years, Suzan Jackson has lived with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) — a condition she shares with two of her sons. In this book, Jackson shares what she and her family have learned about living well with chronic illness and finding a “new normal” through strong relationships, healthy emotions and finding joy in everyday life. The emphasis is on living life, not just enduring it.

War on Us by Colleen Cowles

Lawyer Colleen Cowles looks at how the war on drugs and myths about addiction have created a dysfunctional drug policy that prosecutes doctors for treating pain and stigmatizes patients for seeking relief. The U.S. has spent over a trillion dollars fighting the war and has little to show for it except some of the highest rates of addiction, overdose and incarceration anywhere in the developed world.

Ketamine Infusions: A Patient’s Guide by Berkley Jones

Berkley Jones looks at the increasing use of ketamine, a non-opioid analgesic, in treating chronic pain, depression, post-traumatic stress disorder and anxiety. This book is a useful guide if you are considering ketamine infusions and want to know how to select a provider, what to expect during infusions and possible side effects. Although primarily used to treat depression, some pain patients say ketamine is effective in treating neuropathy and CRPS.

Bitten: The Secret History of Lyme Disease and Biological Weapons by Kris Newby

Author Kris Newby began looking into the origins of Lyme disease after she was bitten by a tick and became seriously ill. Her research led her to a secret U.S. government program during the Cold War that used insects as biological weapons to spread disease. Newby believes the Lyme outbreak that began 50 years ago and has infected millions of Americans may have been the result of a military experiment gone wrong.

Vagina Problems: Endometriosis, Painful Sex and Other Taboo Topics by Lara Parker

A memoir by Lara Parker that explores — with unflinching honesty — her battle with endometriosis, a chronic vaginal condition that makes daily life difficult and sex painful. As a teenager, doctors initially dismissed Parker’s pain as “bad period cramps” and suggested her pain was psychological. She nearly checked herself into a mental institution before finally getting a proper diagnosis.

A Quick Guide to CBD by Dr. Julie Moltke

CBD won’t cure you of chronic pain, but Dr. Julie Moltke says cannabidiol can reduce pain, inflammation, anxiety and insomnia — and help make life more livable. This handbook is intended for beginners who want to learn how and when to take CBD, and are puzzled by all the hype surrounding vapes, oils, gummies and edibles on the market.

Pain Warriors by Tina Petrova

A documentary produced by patient advocate Tina Petrova that examines the poor treatment and medical neglect faced by millions of pain sufferers in North America. The film is dedicated to Sherri Little, a chronic pain patient who committed suicide after one last attempt to get effective treatment. Available on DVD or for streaming on Amazon Prime.

Together: The Healing Power of Human Connection by Dr. Vivek Murthy

This timely book by former U.S. Surgeon General Dr. Vivek Murthy looks at the importance of human connections and how loneliness affects our health and society at large. To combat loneliness, Murthy recommends spending at least 15 minutes each day connecting with people we care about and to give them our undivided attention.

Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban

Wonder why that generic drug you take doesn’t seem to work? About 90% of pharmaceutical drugs are generic and most are manufactured overseas. While generics are promoted as cheaper alternatives to brand name drugs, journalist Katherine Eban found the generic drug industry rampant with greed, fraud and falsified manufacturing data — resulting in many patients consuming drugs that are ineffective or have dangerous side effects.

In Pain: A Bioethicist’s Personal Struggle with Opioids by Travis Rieder, PhD

Travis Rieder is a professor of bioethics at Johns Hopkins University who severely injured his foot in a motorcycle accident and became dependent on opioids while recovering from surgery. In this book, he shares his frustration with the healthcare system and how it often abandons patients to pain, addiction or both. Rieder serves on a CDC advisory panel that is helping the agency prepare an update of its controversial 2016 opioid guideline.

The Chronic Pain Management Sourcebook by David Drum

A comprehensive guide about chronic pain by medical journalist David Drum, who summarizes the many causes, types and treatments of pain. Drum also has tips on managing stress, anxiety, lack of sleep and depression. The book is easy to understand and would be a useful resource for family members, friends and caretakers who want to understand and help someone living with chronic pain.

A Little Book of Self Care: Trigger Points by Amanda Oswald

This well-illustrated book provides 40 simple, step-by-step exercises you can use to manage back pain, migraine and other painful conditions. Author Amanda Oswald explains how “trigger points” — small knots of muscles and connective tissue — can be relieved through self-massage and the “power of touch” without visiting a chiropractor or physical therapist.

These and other books and videos about living with chronic pain and illness can be found in PNN’s Suggested Reading section.

 

GlaxoSmithKline Most Heavily Fined Drug Company

By Pat Anson, PNN Editor

The pharmaceutical industry has long been criticized for engaging in illegal or unethical activities, such as fraud, kickbacks and price gouging. A new study published in JAMA shines a light on the scale of the problem, finding that Big Pharma paid over $30 billion in financial penalties for illegal activities in the United States.

Researchers looked at state and federal settlements from 2003 to 2016 and found that almost every large pharmaceutical company had paid a fine for illegal activity. The biggest transgressor was GlaxoSmithKline (GSK), which paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs. In one settlement alone, GSK was fined $3 billion for encouraging doctors to prescribe its antidepressants to children.  

The fines paid by GSK were over three times higher than the amounts paid by Pfizer ($2.9 billion) and Johnson & Johnson ($2.6 billion) during the study period. Researchers say only four of the 26 drug companies they analyzed were not assessed a penalty.

TOP 10 MOST HEAVILY FINED DRUG COMPANIES

  1. GlaxoSmithKline $9.8 billion

  2. Pfizer $2.9 billion

  3. Johnson & Johnson $2.6 billion

  4. Abbott Laboratories $2.5 billion

  5. Merck $2.1 billion

  6. Eli Lilly $1.8 billion

  7. Schering-Plough $1.6 billion

  8. Wyeth $1.6 billion

  9. Bristol Myers Squibb $1.4 billion

  10. Novartis $1.2 billion

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“Among the large pharmaceutical companies included in this study, 85% had evidence of financial penalties for illegal activities. Given the scope and nature of the illegal activities involving financial penalties, physicians and regulators should exhibit vigilance over the activities of large pharmaceutical firms,” wrote lead author Denis Arnold, PhD, a professor of business ethics at Belk College of Business, University of North Caroline at Charlotte.

“Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.”

Because the study period ended in 2016, it did not include any recent settlements with drug companies involving opioid litigation. Nor did it cover fines paid outside the U.S., such as the $490 million fine that GSK paid for bribing Chinese doctors to prescribe its medications.

“This has been a deeply disappointing matter for GSK," chief executive Sir Andrew Witty said in a formal apology to the Chinese government in 2014.

Not much has changed at GSK over the years. This year the company agreed to pay $4.5 million in fines in Australia for marketing and price violations involving the pain relief gel Voltaren.  The British pharmaceutical giant was also recently fined $2.8 million by Romania for failing to supply the country with asthma medication.

Drug company executives rarely serve prison time for illegal activities and the large fines do not appear to be much of a deterrent against unethical behavior. The nearly $9.8 billion paid by GSK amounts to less than 2 percent of its total revenues during the study period. On average, GSK’s illegal activities went on for over seven years before the company stopped them, according to the JAMA study.

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

Fraud Alert for Speaker Programs

In recent years, federal watchdogs have become increasingly concerned about the use of speaker fees, free meals, entertainment and other kickbacks paid by healthcare companies to promote their drugs and medical devices. In the last three years, companies paid nearly $2 billion to healthcare providers for speaker-related services.

In a special fraud alert released this week, the Office of Inspector General (OIG) for the Department of Health and Human Services warned against the practice, saying high-priced speaker programs “may be subject to increased scrutiny.” The OIG cited cases where speaker programs were held at wineries, stadiums and restaurants where expensive meals and alcohol were served at no charge to attendees.

“OIG is skeptical about the educational value of such programs. Our investigations have revealed that, often, HCPs (healthcare providers) receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend,” the report warns.

“Furthermore, studies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. This remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”

Tax on Prescription Opioids Costly for Pain Patients

By Anastassia Gliadkovskaya, Kaiser Health News

Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure.

But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had to be hospitalized.

“You just keep thinking: Am I going to get sick? Am I going to get sick?” Angevine said in a phone interview. “Am I going to be able to live off the pills I have? Am I going to be able to get them on time?”

His pharmacy did not tell him the reason for the shortage. But Angevine isn’t the only pain patient in New York to lose access to vital medicine since July 2019, when the state implemented an excise tax on many opioids.

The tax was touted as a way to punish major drug makers for their role in the opioid epidemic and generate funding for treatment programs. But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York. Instead of the anticipated $100 million, the tax brought in less than $30 million in revenue, two lawmakers said in interviews. None of it was earmarked for substance abuse programs, they said.

The state’s Department of Health, which has twice this year delayed an expected report on the impact of the tax, did not respond to questions for this story.

The tax follows strong efforts by federal and New York officials to tamp down the use of prescription opioids, which had already cut back some supply. Now, with some medications scarce or no longer available, pain patients have been left reeling. And the law appears to have missed its target: Instead of taking a toll on manufacturers, the greater burden appears to have fallen on pharmacies that can no longer afford or access the painkillers.

Among them is Epic Pharma. Independent Pharmacy Cooperative, a wholesaler, confirmed it no longer sells medications subject to the tax, but still sells those that are exempt, which are treatments for opioid addiction methadone and buprenorphine and also morphine. AvKARE and Lupin Pharmaceuticals said they do not ship opioids to New York anymore. Amneal Pharmaceuticals, which manufactures Angevine’s oxymorphone, declined to comment, as did Mallinckrodt.

Since the tax went into effect, Cardinal Health, which provides health services and products, published an extensive 10-page list of opioids it does not expect to carry. Cardinal Health declined to comment.

The New York tax is slowly gaining attention in other states. Delaware passed a similar tax last year. Minnesota is assessing a special licensing fee between $55,000 and $250,000 on opioid manufacturers. New Jersey Gov. Phil Murphy proposed such a tax this year but was turned down by the legislature.

More Expensive Prescriptions

The company that makes the first point of sale within New York pays the tax. That isn’t always the drug maker. It can mean wholesalers selling to pharmacies here are assessed, explained Steve Moore, president of the Pharmacists Society of the State of New York.

Independent Pharmacy Cooperative (IPC) said about half its revenue from opioid sales in New York would have gone to taxes. Mark Kinney, the company’s senior vice president of government relations, said the law is putting companies in a very difficult position. When wholesalers like IPC left the opioid market, competitive prices went with them.

Without these smaller wholesalers, it’s hard for pharmacies to go back to other wholesalers “and say, ‘Hey, your prices aren’t in line with the rest of the market,’” Moore said.

Indeed, nine independent pharmacies told KHN that when they can get opioids they are more expensive now. They have little choice but to eat the cost, drop certain prescriptions or pass the expense along.

“We can trickle that cost down to the patient,” said a pharmacist at New London Pharmacy in Manhattan, “but from a moral and ethics point of view, as a health care provider, it just doesn't seem right to do that. It’s not the right thing to ask your patient to pay more.”

In addition, Medicare drug plans and Medicaid often limit reimbursements, meaning pharmacies can’t charge them more than the programs allow.

Stone’s Pharmacy in Lake Luzerne was losing money “hand over fist,” owner Leigh McConchie said. His distributor was adding the tax directly to his pharmacy’s cost for the drugs. That helped drive down his profit margins from opioid sales between 60% and 70%. Stone’s stopped carrying drugs like fentanyl patches and oxycodone, and though that distributor now pays the tax itself, the pharmacy is still feeling the effects.

“When you lose their fentanyl, you generally lose all their other prescriptions,” he said, noting that few customers go to multiple pharmacies when they can get everything at one.

If pharmacies have few opioid customers, those price hikes have less impact on their business. But being able to manage the costs is not the only problem, explained Zarina Jalal, a manager at Lincoln Pharmacy in Albany. Jalal can no longer get generic oxycodone from her supplier Kinray, though she can still access brand-name OxyContin.

New York’s Medicaid Mandatory Generic Drug Program requires insurers to provide advance authorization for the use of brand-name prescriptions, delaying the approval process. Sometimes patients wait several days to get their prescription, Jalal explained.

“When I see them suffer, it hurts more than it hurts my wallet,” she said.

One of Jalal’s customers, Janis Murphy, needs oxycodone to walk without pain. Now she is forced to buy a brand-name drug and pays up to three times what she did for generic oxycodone before the tax went into effect. She said her bill since the start of this year for oxycodone alone is $850. Lincoln Pharmacy works with Murphy on a payment plan, without which she would not be able to afford the medication at all. But the bill keeps growing.

“I’m almost in tears because I cannot get this bill down,” she said in a phone interview.

Several pharmacists raised concerns that patients who lose access to prescription opioids may turn to street drugs. High prescription prices can drive patients to highly addictive and inexpensive heroin. McConchie of Stone’s Pharmacy said he now dispenses twice as many heroin treatment drugs as he did a year ago. Former opioid customers now come in for prescriptions for substance use disorder.

Cost of Percocet Doubled

Trade groups and some physicians and state legislators opposed the tax before it went into effect, voicing concerns about a slew of potential consequences, including supply problems for pharmacists and higher consumer prices.

New London Pharmacy said one of its regular distributors stopped shipping Percocet, a combination of oxycodone and acetaminophen. Instead, the pharmacy orders from a more expensive company. The pharmacist estimated that a bottle of Percocet for which it used to pay $43 now costs up to $92.

“Even if we absorb the tax, we’re not getting a break from reimbursements either,” a pharmacist who spoke on the condition of anonymity explained, adding that insurance reimbursements have not increased in proportion to rising drug costs. “We’re losing.”

Latchmin Raghunauth Mondol, owner of Viva Pharmacy & Wellness in Queens, has also seen that problem. The pharmacy used to be able to purchase 100 15-milligram tablets of oxycodone for $15, but that’s now $70, she said, and the pharmacy is reimbursed only about $21 by insurers.

Other opioids are just not available.

Mondol said she has been unable to obtain certain doses of two of the most commonly prescribed opioids, oxycodone and oxymorphone—the drug Angevine was on.

After Angevine lost access to oxymorphone, his doctor put him on morphine, but it does not give him the same relief. He’s been in so much pain that he stopped going to physical therapy appointments.

“It’s a marathon from hell,” he said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

Patient Advocates Critical of Canadian Pain Task Force Report

By Pat Anson, PNN Editor

A new report from the Canadian Pain Task Force is being called “political propaganda” and “shameful” by patient advocates.

The 75-page report was released last week by the task force, an advisory panel created by Health Canada in 2018 to help it address the needs of nearly 8 million Canadians who live with chronic pain. Like many of their counterparts in the United States, Canadian pain patients often have trouble getting access to opioid medication because of fears the drugs will lead to misuse and addiction.

The task force said it released its second report “with a sense of urgency” because the COVID-19 pandemic had reduced access to healthcare and social services for many people. The report calls chronic pain a “legitimate disease” and said better efforts were needed to provide access to pain treatment, improve public awareness and reduce stigma associated with chronic pain.

“Recent dramatic increases in opioid-related overdose deaths in North America have heightened awareness around the risks associated with both short- and long-term opioid use for chronic pain. However, efforts undertaken to respond to the overdose crisis have led to challenging unintended consequences for people living with chronic pain,” the report found.

“Some people in Canada have been unable to access opioid medications, and others who previously relied on opioids to manage their pain have been unable to continue their medications, or have had significant adjustments to lower their prescriptions, sometimes against their will.”

The task force also released findings from surveys and interviews with nearly 2,000 Canadians – both patients and providers -- who often had “differing expectations” about how chronic pain should be treated. Patients complained of limited access to specialists, long wait times, and treatments that didn’t work or were harmful.

“Many people living with chronic pain have experienced trauma in the context of medical care. They may have had invasive investigations and procedures or negative interactions with health professionals. Such experiences can be damaging on their own, but when compounded with previous trauma can lead to more drastic challenges such as changes in sense of self, view of the world, and nervous system dysregulation, which may all contribute to increased pain and difficulties coping,” the report found.

‘Nothing New’

But outside of announcing $3.5 million in funding for three local health projects, no immediate steps were announced by Health Canada or its task force to improve pain care for Canadians. The panel is not expected to release its third and final report until December 2021.

“There is nothing new in this report,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, a patient advocacy group. “Have they forgotten this is a 3-year study, which will not be completed until 2021? In the meantime, while they fiddle, Canadians continue to suffer and die when the solutions are already there, yet we continue to spend over $3 million taxpayer dollars. So where is the sense of urgency?”

The task force outlined its “next steps” with a vaguely worded statement that “leadership and resources are needed to amplify, spread, and accelerate current activities, coordinate responses, address current gaps and inequities, and reduce the variability across jurisdictions.”    

“This is simply a carefully constructed document to create the appearance of having listened to patient input, and to suppress the substance of changes demanded by both patients and doctors. It is political propaganda of the worst sort,” said Richard Lawhern, PhD, a patient advocate and co-founder of the Alliance for the Treatment of Intractable Pain (ATIP).

“Contrary to the biased declarations of this report, there is no evidence that increased availability of prescription opioids in medical treatment has been a significant factor in causing the public health crisis.”

Nothing illustrates the folly of government policies better that the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication.
— Chronic Pain Association of Canada

Ulmer was frustrated that the report didn’t more broadly address how efforts to prevent addiction and overdoses have harmed pain patients.

“The fact that addiction and overdose deaths continue to soar should convince them they have taken the wrong path. But it hasn’t. Now they have pain patients deprived of their medications, with reduced quality of life, increased pain, patients committing suicide, as they are no longer able to cope, with some seeking street drug dealers to see if they can find some relief,” Ulmer said.

“Nothing illustrates the folly of government policies better that the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication.”
  
Ulmer said the report’s brief discussion of opioid medication was “illogical, gutless, and shameful” and called on the Canadian government to “cease their war on pain patients” by immediately withdrawing Canada’s opioid guideline – without waiting for a final report from the task force.

Understanding the Difference Between Prescription Fentanyl and Illicit Fentanyl

By Roger Chriss, PNN Columnist

The opioid overdose crisis is now being driven by fentanyl. But misunderstandings over what fentanyl is, where it comes from, how it is used and why have become so pervasive that they plague discourse and debate about the crisis. News reports about “fentanyl overdose deaths” appear almost daily.

October saw a particularly tragic death. As reported by the Daily Courier in Prescott, Arizona, a 14-year-old high school student died of an overdose after taking what investigators suspect was a counterfeit pill “laced with the potent narcotic painkiller fentanyl.”

The tragedy of this death cannot be overstated. Nor can thousands of other overdose fatalities caused by fentanyl. But the nature of the drug needs to be better understood if we are to prevent such deaths moving forward.

Fentanyl is not one drug. It is better thought of as a family of synthetic opioids that are structurally similar, and includes sufentanil and remifentanil. These are pharmaceutical fentanyls, used clinically as anesthetics and essential for medical procedures such as open heart surgery.

Collectively, these drugs are part of a super-family known as fentanyl analogues. There are dozens of such drugs. Some are compounds developed by pharmaceutical companies for legitimate medical use, and others are manufactured illegally for use as street drugs. These forms of fentanyl are commonly referred to as “illicitly manufactured fentanyl” by government agencies like the CDC. The DEA has classified “fentanyl-related substances” as Schedule I controlled substances, meaning they are illegal to manufacture, distribute or possess.

To make this even more complicated, the fentanyl drug carfentanil is used legally in the U.S. as a tranquilizer for elephants and other large animals. The DEA authorizes production of a minute quantity of carfentanil for veterinarians every year. But illicit carfentanil from overseas occasionally shows up on the street and causes fatal overdoses.

Further muddying matters is the new fentanyl-like street drug isotonitazene, which is known colloquially as “iso.” It is “fentanyl-like” in its risks and harms, but is not technically a fentanyl analogue. “Iso” is instead related to etonitazene. Neither of these drugs has any recognized medical use in humans.

Risks Are Very Different

In other words, there is a vast gulf between pharmaceutical fentanyl and illicitly manufactured fentanyl. The former is a tightly controlled Schedule II prescription medication, approved for use in hospitals and to treat breakthrough cancer pain. The latter is an illegal substance cooked up in illicit labs that is often added to heroin or used to make counterfeit pills, which are then sold on the street or online.

This distinction is critical for understanding the opioid overdose crisis. The risks of a prescription opioid like fentanyl when given for medical use to a legitimate patient are very different from the risks of an illicit opioid being used non-medically by a random street buyer. Importantly, the risks for medical use can be addressed and managed. The risks of illicit use are much harder to deal with and often prove fatal.

The distinction also leads to confusion. The abundance of fentanyl on the street is rarely a result of diversion, and is unrelated to the supply of pharmaceutical fentanyl. These are different drugs, much as the cocaine nasal spray recently approved by the FDA as a local anesthetic is completely separate from the cocaine bought on the street. Pain experts are now pushing for a new classification for illicit fentanyl analogues, in the hope of clarifying this difference.

But fentanyl has so saturated the street drug market that more than a name change will be needed. As Ben Westhoff explains in the book “Fentanyl, Inc.”, preventing future opioid deaths will require “sweeping new public-health initiatives, including treatment programs and campaigns to educate everyone, from users and medical providers to teachers and police, about the drugs’ dangers.”

Understanding the difference between pharmaceutical fentanyl and illicitly manufactured fentanyl is an essential step in the effort to reduce overdose deaths.

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. 

DEA Expanding Surveillance of Prescription Drug Data

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration is making plans for a major expansion of its monitoring of prescriptions for opioids and other controlled substances, with the goal of identifying virtually every prescriber, pharmacy and patient in the country that shows signs of drug diversion or abusing their medication.

In a request for proposal (RFP) made in early September, the DEA asked software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances. The RFP was first reported by the website Filter.

Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.  

“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers.

“DEA agents have no business second guessing health care providers’ decisions on medical need and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”

‘Unlimited Access’ to Prescription Data

Hundreds of medications would be covered under the DEA’s surveillance program, including drugs used to treat pain, opioid use disorder, anxiety, and attention deficit hyperactivity disorder (ADHD).  Under the program, DEA investigators would have “unlimited access” to prescription data compiled over the last five years, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment.

The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to quickly identify the patients involved.

“The subpoena process would be that we would generate a DEA Administrative Subpoena and send it to you for the unmasking of specified patients. The data provider would then need to respond to us providing the unmasked patient information that was requested within three business days,” the DEA said in response to a contractor who inquired how the subpoena process would work.      

Asked how many DEA investigators would have access to the prescription data, the agency said there could be over a thousand.

“We would start with 1,100 users and would renegotiate if more were needed. It is unlikely that 1,100 users will all access the system concurrently but is hypothetically possible in the future,” the agency replied.

Why the DEA is seeking to expand its monitoring of opioid prescriptions is unclear. In recent years, the number of prescriptions has fallen by about a third and the DEA itself estimates that less than one percent of legally prescribed opioids are diverted.

Bypassing PDMPs

State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA is seeking, but law enforcement access to the data usually requires an active investigation or warrant – no data mining or fishing expeditions allowed. To maintain patient privacy, some states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. Last year, the DEA had to sue Colorado to get access to the state’s PDMP data.

The DEA’s plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”      

The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required by law to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.”

Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs.  For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.

“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN. 

‘Appalling for People’s Health’

The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts, because it is a primary ingredient of Suboxone. 

“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment. 

“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”

This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”

The DEA deadline for receiving proposals from software contractors was October 20. No contract awards have been announced. The surveillance program could begin as early as December 1, 2020 and continue for a minimum of one year, with an option for up to four years. The potential cost of the program has not been disclosed.

I Deserve To Have My Chronic Pain Managed

By Marguerite Morgan, Guest Columnist

I have lived with chronic pain the majority of my 53 years of life. It’s hard to make the people that cross my path understand that I cannot do things I used to take for granted. Things like attending concerts and other venues, or keeping my home up and my appearance up are the things that I miss and bother me the most. 

Those I love have seen my decline and know that I am truly suffering. The only reason I am suffering is because of the lies told by the CDC. They admitted that their statistics were off regarding overdoses because they combined deaths caused by illegal drugs with those that were prescribed.

These so-called experts turned on those of us who take our opioid medication responsibly and have blamed us for the addiction issues in this country. Laws were made and bills were passed on this false information and now there are millions suffering. 

It's not right that our government continues to uphold the CDC opioid guideline, knowing that we are suffering and medications that will help are denied to us. We are treated like garbage for illnesses, diseases and injuries that doctors can't treat without fear of being raided by the DEA. Their medical licenses are way more important than our quality of life.

Nothing seems to be changing either and it probably won't in my lifetime. But I will continue to fight for those who need advocacy because there are a few good doctors willing to take a chance. 

MARGUERITE MORGAN

MARGUERITE MORGAN

We are dying every day either by suicide or from being cut off from pain medication. Our hearts quit because they just can't take the pain that causes.

I just want to know why those that die from abusing drugs intentionally are more important than those of us who take our prescribed medication as directed. It seems life has truly turned upside down and nothing seems right anymore.

I suffer from intractable pain caused by an injury to my spine. I also have inflammatory rheumatoid arthritis, osteoarthritis, Addison’s disease, fibromyalgia and degenerative disc disease, to name just a few of my painful conditions.

I deserve to have this pain managed. I deserve to enjoy and take part in life, instead of just seeing it pass me by through my living room window. 

Marguerite Morgan lives in Washington state.

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