Opioid Prescribing Limits Failed to Reduce Overdoses in British Columbia

By Pat Anson, PNN Editor

British Columbia’s opioid guideline failed to have any significant impact on overdoses, hospital admissions or deaths in the year after it was adopted, according to new research published in CMAJ Open. The study is the latest to show that opioid prescribing limits have been misdirected and ineffective in slowing North America’s opioid crisis.

The College of Physicians and Surgeons of British Columbia released strict professional guidelines for the “safe prescribing” of opioids and sedatives in 2016, after the Canadian province was hit by a wave of overdoses and deaths. The BC guidelines, which are similar to the CDC’s opioid guideline in the United States, warn doctors to be cautious about opioid prescribing and to avoid increasing doses over 90 morphine milligram equivalents (MME) per day.

Researchers at the University of British Columbia wanted to see how effective the BC guideline was in reducing overdoses, so they analyzed health data on over 68,000 patients on long term opioid therapy. A previous study by the same research team found a “modest” reduction in opioid use in the 10 months after the guideline was introduced, as well as more tapering.

Did the reduced prescribing result in fewer overdoses?  No.

Researchers found no significant change in opioid overdose hospital admissions, opioid overdose mortality, all-cause emergency department visits, all-cause mortality, or all-cause hospital admissions after the BC guideline was adopted. They also found no evidence that pain patients turned to street drugs after their opioid prescriptions were reduced or stopped.

“Concern has been expressed that policies focused on reducing prescribing of opioid analgesics could increase opioid-related deaths if patients unable to access prescription opioids for adequate pain relief turned to street drugs and were exposed to dangerously high levels of synthetic opioids. Our study did not find evidence that the standards and guidelines had the unintended consequence of increasing opioid overdose hospital admissions or opioid overdose mortality,” wrote lead author Richard Morrow, a senior research analyst at UBC.

Critics say the lack of evidence is proof that opioid prescribing has little to do with British Columbia’s overdose crisis.   

“The results are not unexpected and demonstrate the folly of limiting opioids to pain patients in a futile attempt to deal with overdoses from illicit street drugs. The policy has created considerable pain and anxiety along with a worsening quality of life for nothing,” said Marvin Ross, a patient advocate with the Chronic Pain Association of Canada. 

British Columbia’s Coroners Office expects 2020 to be a record breaking year for overdoses in the province, with about five drug deaths every day. A recent study found that the vast majority of BC’s overdoses involved illicit fentanyl and other street drugs. Only 2.4% of the nearly 1,800 fatal overdoses in BC from 2015 to 2017 involved opioid medication alone.

Stricter opioid prescribing policies have also been ineffective in slowing the overdose crisis in the United States. Prescription opioid use in the U.S. is at its lowest level in 20 years, while more Americans are dying from overdoses than ever before.

FDA Tightens Regulation of Fentanyl Medication

By Pat Anson, PNN Editor

Illicit fentanyl may be a deadly scourge on the black market, but for thousands of Americans in severe cancer pain, prescription fentanyl is an essential medicine. And for some, the potent synthetic opioid may soon be harder to obtain.

The U.S. Food and Drug Administration recently announced plans to tighten its Risk Evaluation and Mitigation (REMS) program for transmucosal immediate-release fentanyl (TIRF) products. TIRF medicines such as Actiq and Subsys are approved for breakthrough pain in cancer patients, who regularly take other opioids around-the-clock and are considered “opioid tolerant.”

TIRF lozenges, sprays and tablets are so effective that they’re often prescribed off-label for other types of breakthrough pain. The problem with that, according to the FDA, is that up to 55% of patients prescribed a TIRF medicine are not opioid tolerant and received a TIRF prescription for an unapproved use.

“Data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid tolerant,” FDA Commissioner Stephen Hahn, MD, said in a statement. “With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices. These changes will also improve our ability to monitor for adverse events and ensure safe use of these medicines.”

Under the strengthened REMS program, prescribers and pharmacies will be required to document a patient’s opioid tolerance for every TIRF prescription that is written or dispensed, including refills. A new patient registry is also being established for everyone who receives a TIRF medicine, so the prescriptions can be monitored for signs of misuse, addiction and overdose.

“All patients prescribed for outpatient use must be enrolled in the registry prior to receiving the first TIRF prescription. The Patient Enrollment Form is used to ensure that patients are aware of the registry requirement and that patients have been counseled appropriately about the safe use of the TIRF medicines, including the risk of respiratory depression, the need to be opioid tolerant as defined in labeling and proper storage of the TIRF medicines,” an FDA spokesperson explained in an email to PNN.

The email said the patient registry would not be available to law enforcement. Prescribing information will only be collected by TIRF manufacturers and will not publicly identify individual patients or prescribers.

“Collection of patient registry information is intended to help assure the safe use of these products, not for law enforcement purposes,” the email said. “FDA’s disclosure laws and regulations relating to information in FDA’s possession protect from public disclosure any information where the release would constitute a clearly unwarranted invasion of personal privacy.”

That pledge is noteworthy, because prescription drug monitoring programs (PDMPs) and other databases are being weaponized by law enforcement agencies to target physicians, pharmacies and patients who are deemed to be lawbreakers based on the dose and quantity of opioid prescriptions.

Fewer TIRF Prescriptions

Why the FDA is acting now is a bit unclear, because the number of people prescribed TIRF products has been declining for years, from about 14,400 patients in 2012 to just 4,700 patients in 2017. TIRF medications in 2017 accounted for just 0.02% of all opioid prescriptions dispensed at retail pharmacies.  

Reports of deaths and other adverse events from using the drugs have also fallen sharply. The FDA’s Adverse Events Reporting System received over 20,500 reports of adverse events involving Actiq in 2018, but there were only a few dozen cases in 2019.

“I would like to know what data the FDA has that prompted this action,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “TIRF opioids are rarely abused or associated with overdoses.”

Webster is also concerned that the additional paperwork and scrutiny by the REMS program may discourage doctors and pharmacists from writing or filling TIRF prescriptions. 

“Since TIRF opioids are only indicated for cancer related pain, more barriers to prescribing these medications may mean they will not be prescribed.  That would be unfortunate because the TIRFs are the most effective treatment for severe breakthrough pain,” Webster said. “I hope this policy is more than just checking a box for the FDA, and that they plan to measure the impact on patients' access to the medication and on their pain relief.”

The tougher REMS regulations for TIRF products go into effect in March 2021.

Gabapentinoids Riskier for Surgery Patients

By Pat Anson, PNN Editor

Another study is casting doubt on the use of gabapentinoids such as Lyrica (pregabalin) and Neurontin (gabapentin) for pain relief during and after surgery.

Gabapentioids are a class of nerve medication originally developed to treat convulsions, but the drugs are increasingly being used as a trendy alternative to opioids for acute and chronic pain. Some U.S. hospitals are even using gabapentinoids for surgical pain and have phased out or reduced the use of opioids.

In an analysis of over 5 million adults admitted for major surgery in the U.S. from 2007 to 2017, researchers at Harvard Medical School found that using gabapentinoids with opioids increases the risk of overdose, respiratory depression and other adverse events. Researchers say the additional risk was “extremely low” and would result in one additional overdose for every 16,000 patients.

“Our findings add to the growing evidence that gabapentinoids can potentiate the respiratory depressant effects of opioids,” researchers reported in JAMA Network Open. “The events were rare… (but) patients receiving multimodal pain management therapy that includes gabapentinoids should be closely monitored for possible respiratory depression.”

The study did not examine whether gabapentiniods were effective in treating surgical pain or if they improved the analgesic effect of opioids.

In an editorial also published in JAMA Network Open, a pain management expert said more studies were needed to see if gabapentiniods were worth the additional risk.

“The evidence in support of the analgesic benefit of gabapentinoids combined with opioids for postoperative analgesia is equivocal; there is no real support that adding gabapentinoids to opioid pain relievers offers additive, much less synergistic, enhancements to pain control,” wrote Joseph Pergolizzi, Jr, MD, Chief Operating Officer of NEMA Research.  

“Considering that combination analgesic regimens generally reduce overall opioid consumption, this study is important because it shows that this may not necessarily translate to reducing opioid-associated adverse events. As combination analgesia gains traction for in-hospital acute painful conditions, such as postsurgical pain, it is important to be guided by evidence rather than intuition.”

No Significant Analgesic Effect

A recent study by Canadian researchers also found little evidence to support the use of gabapentinoids for surgical pain.

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

These and other findings contradict guidelines published by the American Pain Society in 2016, which advocate “around the clock” use of gabapentin, pregabalin and other non-opioid drugs both before and after surgery.

The risk of becoming addicted or dependent on opioids after surgery is actually quite low. A 2016 study found that only 0.4% of elderly patients who were prescribed opioids for post-operative pain were still using them a year after their surgeries. Another study by Harvard researchers found that only 0.2% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Growing Concerns About Opioid Tapering

By Roger Chriss, PNN Columnist

A common belief about the opioid crisis assumes that patients develop a substance use disorder from taking opioid medication, and that many derive no long-term benefit from opioids and need to be tapered.

There is some truth to this, but reality is much more complicated.

First, not all patients who take opioids become addicted. The National Institute on Drug Abuse reports between 8 and 12 percent of patients prescribed opioids for chronic pain develop an opioid use disorder (OUD). Even that estimate may be too high, because the diagnosis of OUD is sometimes mistaken.  

In a recent study of 90 patients diagnosed with OUD at three Veterans Health Administration medical centers, physician Ben Howell and colleagues found that nearly a third of the diagnoses were probably wrong.

“Our study identified significant levels of likely inaccurate OUD diagnoses among veterans with incident OUD diagnoses. The majority of these cases reflected readily addressable systems errors,” researchers concluded. “If these inaccuracies are prevalent throughout the VHA, they could complicate health services research and health systems responses.”

Second, not all people who are tapered off prescription opioids improve. A new study in the Journal of Pain Research looked at 40 chronic pain patients who were tapered from an average daily dose of 80 MME (morphine milligram equivalent) down to 19 MME. The results were disappointing. There was only minor improvement in the patients’ cognitive function and no improvement in their quality of life, depression and anxiety.

There is at present no well-established approach to opioid tapering and little effort made to study patient outcomes.  In a recent paper, lead author Stefan Kertesz, MD, and colleagues say there is a “pill dynamic” approach to tapering that focuses on dose reduction alone.

"When a multi-faceted, complex health issue becomes a public health crisis, the desire to ‘solve’ or ‘mitigate’ takes hold with a momentum of its own. A crisis deserves no less. However, nationally adopted quality metrics have convinced some patients with pain that their survival and functioning are no longer concerns for the systems in which they receive care. This outcome is unacceptable," they concluded.

Patient Suffering and Suicides

The risks of forced opioid tapering are so urgent that nearly 100 physicians, academics and patient advocates recently published an open letter in the journal Pain Medicine warning of “an alarming increase in reports of patient suffering and suicides” caused by aggressive tapering:

“We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies — and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

We call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.”

The public health issue of opioid overdoses is complex, urgent and largely driven by street drugs, not pain medication. Opioid prescriptions are at 20-year lows, and the American Medical Association recently said it was “alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl.”

And as National Institute of Drug Abuse director Nora Volkow, MD, stated in a recent blog post:

“Although deaths from opioids continue to command the public’s attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis. We face a complex and ever-evolving addiction and overdose crisis characterized by shifting use and availability of different substances and use of multiple drugs (and drug classes) together.”

Opioid tapering is no more a universal good than opioid prescribing was a universal evil. And opioid tapering will no more solve the overdose crisis than opioid prescribing alone caused it. Instead, opioid tapering may harm the very people it is intended to help, and it may not help the crisis that it is motivated by. Better public health policy and clinical practice are urgently needed.

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. 

Do Prescription Opioids Increase Social Pain and Isolation?

By Pat Anson, PNN Editor

Long-term use of opioid medication may increase social isolation, anxiety and depression for chronic pain patients, according to psychiatric and pain management experts at the University of Washington School Medicine.

In an op/ed recently published in Annals of Family Medicine, Drs. Mark Sullivan and Jane Ballantyne say opioid medication numbs the physical and emotional pain of patients, but interferes with the human need for social connections.

“Their social and emotional functioning is messed up under a wet blanket of opioids,” Sullivan said in a UW Medicine press release.

Sullivan and Ballantyne are board members of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. Ballantyne, who is president of PROP, was a member of the “Core Expert Group” that advised the CDC during the drafting of its controversial 2016 opioid guideline. She has retired as a professor of pain medicine at the university, while Sullivan remains active as a professor of psychiatry.

In their op/ed, Sullivan and Ballantyne say it is wrong to assume that chronic pain arises solely from tissue damage caused by trauma or disease. They cite neuroimaging studies that found emotional and physical pain are processed in the same parts of the human brain.  While prescription opioids may lessen physical pain, they interfere with the production of endorphins – opioid-like hormones that help us feel better emotionally.

“Many of the patients who use opioid medications long term for the treatment of chronic pain have both physical and social pain,” they wrote. “Rather than helping the pain for which the opioid was originally sought, persistent opioid use may be chasing the pain in a circular manner, diminishing natural rewards from normal sources of pleasure, and increasing social isolation.

“To make matters worse, the people who need and want opioids the most, and who choose to use them over the long term, tend to be those with the most complex forms of chronic pain, containing both physical and social elements. We have called this process ‘adverse selection’ because these are also the people who are also at the greatest risk for continuous or escalating opioid use, and the development of complex dependence.”

Sullivan and Ballantyne say doctors need to recognize that when patients have both physical and social pain, long-term opioid therapy is “more likely to harm than help.”

“We believe that short-term opioid therapy, lasting no more than a month or so, will and should remain a common tool in clinical practice. But long-term opioid therapy that lasts months and perhaps years should be a rare occurrence because it does not treat chronic pain well, it impairs human social and emotional function, and can lead to opioid dependence or addiction,” they wrote.

Angry and Depressed Patients

It’s not the first time Sullivan and Ballantyne have weighed in on the moods and temperament of chronic pain patients. In a 2018 interview with Pain Research Forum, for example, Ballantyne said patients often have “psychiatric comorbidities” and become “very angry” at anyone who suggests they shouldn’t be on opioids.

“I’ve never seen an angry patient who is not taking opiates. It’s people on opiates who are angry because they’re frightened, desperate, and need to stay on them. And I don’t blame them because it is very difficult to come off of opiates,” she said.

In a 2017 interview with The Atlantic, Sullivan said depression and anxiety heighten physical pain and fuel the need for opioids. “People have distress — their life is not working, they’re not sleeping, they’re not functioning,” Sullivan said, “and they want something to make all that better.”

JANE BALLANTYNE MARK SULLIVAN

In a controversial 2015 commentary they co-authored in the New England Journal of Medicine, Sullivan and Ballantyne said chronic pain patients should learn to accept pain and get on with their lives, and that relieving pain intensity should not be the primary focus of doctors. The article infuriated both patients and physicians, including dozens who left bitter comments.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation,” wrote a patient.

Ballantyne and Sullivan’s op/ed in Annals of Family Medicine has yet to produce a similar response, either pro or con. The article was submitted to the journal over a year ago, but is only being published now.

Ballantyne disclosed in her conflict-of-interest statement that she has been a paid consultant in opioid litigation lawsuits, while Sullivan disclosed that he provided expert testimony for the states of Maryland and Missouri.

Other PROP board members have also found a lucrative sideline testifying in lawsuits. The organization is currently conducting a fundraiser to hire a new Executive Director to “take PROP's work to the next level.”

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

“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

“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

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

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

“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.”