Why Water Soaking Works

By Forest Tennant, PNN Columnist

There is no medical treatment older than water soaking. It is legend and still works. Adhesive Arachnoiditis and other Spinal Canal Inflammatory Disorders (SCID’s) are particularly helped by water soaking – so much so that we consider it an essential treatment.

Why water soaking relieves pain has been a mystery until recent times. It is known that damaged or “dead” nerves won’t conduct  the body’s natural electric currents, so electricity backs up and is trapped or retained in body tissues. The result is more inflammation and pain “all over.”

Electricity has a negative charge and water tends to have a positive charge, so it pulls out excess electricity from the body, reducing inflammation and pain. If the water contains a mineral, it will pull out even more electricity. That is why mineral hot baths and Epsom Salts are so effective.

The lumbar-sacral spinal canal is loaded with nerve roots. They constantly conduct electric currents that go from the spinal cord to the legs, feet, bladder, sex organs and intestine.

Any damage, by any cause, to the spinal canal nerve roots causes a backup of electricity which is painful and produces even more inflammation. To prevent disease progression, daily water soaking can be most helpful.

Types of Water Soaking

You don’t have to have a jacuzzi or pool to do water soaking. A bathtub is great, but most of us take showers. When you shower, keep the water as hot as you can stand, and massage and stretch your back muscles as the hot water runs over your back. Soaking for 10 to 15 minutes in a jacuzzi, pool or bathtub is preferable, but hot showers morning and night is about as good.

Don’t forget the Epsom Salts. The body normally excretes its excess electricity into the air, mainly through nerve ends in the hands, head and feet. Foot soaking, particularly with Epsom Salts or other herbal salts, is an age-old remedy that attracts the electric currents that travel down the sciatic and other leg nerves.

Another soaking technique is a warm, water-soaked towel or other wet wrap placed over the lower back for 5-10 minutes. Remember, water soaking isn’t an “all wet” idea.

Forest Tennant is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Arachnoiditis Research and Education Project . Readers interested in subscribing to the  bulletins should send an email to tennantfoundation92@gmail.com.

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

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.”

Exercise Is Best Treatment for Low Back Pain, But Why?

By Pat Anson, PNN Editor

There has long been a consensus that the best way to treat chronic lower back pain (CLBP) – the world’s leading cause of disability – is by staying active and exercising. But a new study by Australian researchers failed to identify precisely why exercise is beneficial.

“A lot of treatments have stemmed from studies for people with CLBP, but the one with the most consistent evidence of benefit is exercise,” says senior author Matt Jones, PhD, an exercise physiologist, clinician and researcher at the UNSW Sydney School of Medical Sciences. “Despite decades of research in the area and more than 100 studies we analysed in our review, we still do not have a good idea of why exercise might be effective for CLBP.”

Jones and his colleagues recently reported their findings in the journal Musculoskeletal Science and Practice. They reviewed 110 research papers on CLBP conducted in Australia, United States, China, Brazil and Europe, and found little agreement on why researchers thought exercise relieved lower back pain.

“Researchers proposed common reasons as to why exercise was beneficial, including improvements in fitness – for example, core stability, aerobic fitness – and improvements in mood and confidence,” Jones said. “But the effects of these proposed reasons on outcomes for people with CLBP were seldom examined in the papers.

“There have been trends in research over time, where everyone focuses on a ‘flavour of the month’ – like motor control or McKenzie therapy, for example – but because the effects of exercise are broad and it impacts on many different systems in the human body, it’s difficult for researchers to pinpoint exactly why they think it might be benefiting people with pain.”

At any given time, over 500 million people worldwide are suffering from CLBP, which is “non-specific” back pain lasting three months or longer – not the severe back pain caused by degenerative disc disease, spinal injuries, arthritis and other chronic conditions. CLBP mostly affects adults of working age in lower socioeconomic groups, who often have physically demanding jobs.

A 2018 review published in The Lancet by an international team of researchers found that CLBP is often treated with bad advice, inappropriate tests, risky surgeries and painkillers. The authors said there was limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) were not recommended at all.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Professor Rachelle Buchbinder of Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

Jones said the aggressive treatments may not work because they don’t address underlying psychological reasons for back pain.

“Chronic pain is tricky and there are a lot of factors that can contribute to it – so, it's not simply biological aspects of tissue damage, but there are psychosocial elements at play, as well things like a person’s mood or confidence in their own abilities to do something,” he said. “Today’s evidence suggests CLBP likely comes from the brain and nervous system being a bit over-protective and generating a pain response – despite no obvious physical damage to the body.”

Although his review did not address what specific exercises were most effective for CLBP, Jones and his team recommended 33 “mechanisms” that people can use to relieve back pain, such as building muscle strength and flexibility or through social support and coping strategies.

“Many scientists have investigated this question before and the short answer is, there are no specific exercises recommended to alleviate CLBP,” he said. “But there are literally hundreds of studies on exercise for people with chronic pain, not only CLBP, and researchers consistently find exercise is one of the most effective treatments – it might not cause huge reductions in pain and disability, but it does help.”

Ehlers-Danlos Is Common Cause of Intractable Pain

By Forest Tennant, PNN Columnist

Ehlers-Danlos Syndrome (EDS) is the best known of the hereditary collagen disorders. From birth, persons with EDS are preprogrammed to start dissolving collagen at some location in the body, as it causes a defect in the way collagen is produced or maintained throughout all tissues.

The fine and soft tissues that are the most susceptible to dissolution are found in the joints, ligaments, eyes, spine, gums and intestine. When these tissues deteriorate and begin to dissolve, inflammation, pain and neurologic impairments begin. The tissue may or may not rebuild and usually leaves permanent damage, pain and/or disability.

Collagen deterioration may start in childhood or middle age. An early sign is being double-jointed or extremely flexible.

It is unknown currently what the exact mechanism is, or what precipitating factors such as virus or trauma that initiate this reaction. Regardless, collagen dissolution will move to a new and different locations once the hereditary preprogramming begins.

EDS commonly hits the spinal canal and spine. The first major problem may be a cerebral spinal fluid leak, protrusion of a disc, Tarlov cyst or arachnoiditis. Given its predilection to hit the spine, EDS may produce the complication of Intractable Pain Syndrome (IPS). In fact, it seems to be emerging as the first or second most common cause of IPS.

EDS Screening Test

Our research has found that a high percentage of patients who have EDS don’t know it. If you have developed a spine or pain problem without an injury or other obvious cause, you should be screened for EDS.

This questionnaire was recently published to help screen people for EDS.   

1. Do you have pain in multiple locations?

2. Do you have extreme fatigue?

3. Are you clumsy sometimes and fall or walk into objects?

4. Are some of the joints in your hands, feet, elbow, hips or knees “loose” or quite flexible?

5. Have you had a lot of sprains or joint dislocations?

6. Is your skin thin in places?

7. Are you double-jointed or able to bend your fingers, arms, or ankle backward?

8. Are your hands and feet cold much of the time?

9. Do you bruise easily or have bruises that suddenly occur?

10.  Is your skin “stretchy” in some places?

11.  Are you constipated a lot?

12.  Do you suffer from heart burn or frequent episodes of food regurgitation? 

If you answered “Yes” to 6 or more of the 12 questions, you should see a doctor and have the diagnosis confirmed by a genetic test or skin biopsy.

If you have EDS or a hereditary collagen disorder, there are foods, supplements and hormones you can take to help restore and rebuild lost tissue. Click here to see them. These tissue building recommendations from the IPS Research and Education Project are meant to complement and supplement your treatment program, but are not a substitute for inflammation and pain control.

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.  

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.

COVID Vaccines Appear Safe and Effective, But Key Questions Remain

By Bernard J. Wolfson, Kaiser Heralth News

The recent rollout of two newly authorized COVID-19 vaccines is a bright ray of hope at the pandemic’s darkest hour.

We now have a path that can lead us to happier times — even as we watch and suffer from the horrible onslaught of new infections, hospitalizations and deaths that mark the end of this regrettable year.

Health care workers and nursing home residents have already begun to get shots in the first phase of the rollout. Vaccinations should start to be available to the general public sometime in the first few months of next year.

The two vaccines — one developed by Pfizer and BioNTech, the other by Moderna — use the same novel genetic approach. Their development in under a year, shattering all records, is a marvel of science. It’s also a cause for concern for millions of Americans who fear the uncertainty of an unknown technology.

The clinical trial data for the Pfizer and Moderna vaccines show that when both shots of the dual-injection immunization are taken, three weeks to a month apart, they are about 95% effective — at least at preventing severe COVID illness.

However, “a vaccine that remains in the vial is 0% effective no matter what the data show,” says Dr. Walter Orenstein, a professor of infectious diseases at the Emory University School of Medicine in Atlanta and associate director of the Emory Vaccine Center.

Hence, the imperative of persuading millions of people, across racial, cultural, religious, political and generational lines, to get immunized when a vaccine becomes available to them. A survey published this month showed 45% of respondents are taking a wait-and-see approach to vaccination.

Because the vaccines were developed under duress as the coronavirus exacted its deadly toll, the premium was on speed — “warp speed.” So although the number of people in the COVID-19 trials is as large as or larger than in previous vaccine trials, some key questions won’t be answered until millions more are vaccinated.

For example, we don’t know to what extent the vaccines will keep us from transmitting or contracting the virus. We don’t know whether irreversible side effects might emerge, or who is at higher risk from them. And we don’t know whether we’ll need to get vaccinated every year, every three years, or never again.

Skepticism about the vaccines reside in many quarters, including among African Americans, many of whom have a long-standing mistrust of the medical world; the vocal “anti-vaxxers”; and people of all stripes with perfectly understandable doubts. Not to mention communities with language barriers and immigrants without documents, who may fear coming forward.

Here are answers to some questions you might be asking yourself about the new vaccines:

Q: How can I be sure they’re safe?

There’s no ironclad guarantee. But the federal Food and Drug Administration, in authorizing the Moderna and Pfizer vaccines, determined that their benefits outweighed their risks.

The side effects observed in trial participants were common to other vaccines: pain at the injection site, fatigue, headache, muscle pain and chills.

“Those are minor side effects, and the benefit is not dying from this disease,” says Dr. George Rutherford, a professor of epidemiology at the University of California-San Francisco.

Saturday, the Centers for Disease Control and Prevention reported six cases of anaphylactic allergic reaction in the first 272,000 people who got the Pfizer vaccine outside the clinical trials. This has led the CDC to recommend that people receiving the vaccine be observed for up to 30 minutes afterward. It’s possible other unexpected adverse effects could pop up down the road.

“The chances are low, but they are not zero,” says Orenstein. There’s not enough data yet to know if the vaccines pose an elevated risk to pregnant or lactating women, for example, or to immunocompromised people, such as those with HIV. And we know very little about the effects in children, who were not in the initial trials and for whom the vaccines are not authorized.

Q: Why should my family and I take it?

First of all, because you will protect yourselves from the possibility of severe illness or even death. Also, by getting vaccinated you will be doing your part to achieve a vaccination rate high enough to end the pandemic. Nobody knows exactly what percentage of the population needs to get inoculated for that to happen, but infectious disease experts put the number somewhere between 60% and 70% — perhaps even a little higher. Think of it as a civic duty to get your shots.

Q: So, when can I get mine?

It depends on your health status, age and work. In the first phase, already underway, health care workers and nursing home residents are getting vaccinated. The 40 million Moderna and Pfizer doses expected to be available by year’s end should immunize most of them.

Next in line are people 75 and older and essential workers in various public-facing jobs. They will be followed by people ages 65-74 and those under 65 with certain medical conditions that put them at high risk. Enough vaccine could be available for the rest of the population by late spring, but summer or even fall is more likely. Already, some distribution bottlenecks have developed.

On the bright side, two other vaccines — one from Johnson & Johnson, the other from AstraZeneca and Oxford University — could win FDA authorization early next year, significantly increasing the supply.

Q: Once I’m vaccinated, can I finally stop wearing a mask and physical distancing?

No. Especially not early on, before a lot of people have been vaccinated. One reason for that is self-protection. The Moderna and Pfizer vaccines are 95% effective, but that means you still have a 5% chance of falling ill if you are exposed to someone who hasn’t been vaccinated — or who has been but is still transmitting the virus.

Another reason is to protect others, since you could be the one shedding virus despite the vaccination.

Q: I’ve already had COVID-19, so I don’t need the vaccine, right?

We don’t know for sure how long exposure to the virus protects you from reinfection. Protection probably lasts at least a few months, but public health experts say it’s a good idea to get vaccinated when your turn comes up — especially if it’s been many months since you tested positive.

Q: How long before our lives get back to normal?

“If everything goes well, next Thanksgiving might be near normal, and we might be getting close to that by the summer,” says Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee. ”But there would have to be substantial acceptance of the vaccine and data showing the virus moving in a downward direction.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Can Cannabis Be Used to Treat Opioid Addiction?

By Pat Anson, PNN Editor

Canadian researchers – with funding from U.S. taxpayers – are proposing a novel treatment for opioid use disorder: Cannabis.

In a paper published in the journal Drug and Alcohol Dependence, researchers from the University of British Columbia (UBC) and the BC Centre on Substance Use (BCCSU) say cannabis could help people being treated for opioid addiction by reducing their risk of exposure to illicit fentanyl and other street drugs.

The finding is based on urine drug tests of 819 people being treated for opioid addiction in Vancouver, BC, the first major city in North America to experience an outbreak of fentanyl-related overdoses. Addiction treatment usually involves taking opioid agonist drugs (OATs) such as buprenorphine or methadone.

The researchers found that over half the participants (53%) tested positive for fentanyl, suggesting they were still using street drugs. Those who tested positive for THC -- the psychoactive compound in cannabis -- were about 10 percent less likely to have fentanyl in their urine.

"These new findings suggest that cannabis could have a stabilizing impact for many patients on treatment, while also reducing the risk of overdose," said lead author Eugenia Socías, MD, a clinician scientist at BCCSU. "With overdoses continuing to rise across the country, these findings highlight the urgent need for clinical research to evaluate the therapeutic potential of cannabinoids as adjunctive treatment to OAT to address the escalating opioid overdose epidemic."

Socias and her colleagues say cannabis may play an important role in keeping people in addiction treatment programs. Previous research at BCCSU found that drug users initiating OAT who used cannabis daily were about 21 percent more likely to be retained in treatment after six months than non-cannabis users. People who stay in treatment face much lower risks of dying from an overdose, acquiring HIV or suffering other harms of drug use.

‘Gateway Drug’

The research at UBC and BCCSU was funded, in part, by grants from the U.S. National Institute on Drug Abuse, which is part of the National Institutes of Health (NIH).

The NIH has taken a dim view of cannabis in the past, calling marijuana a “gateway drug” for some users, particularly adolescents. A 2015 study funded by NIH found that nearly a third of those who use marijuana develop some degree of marijuana use disorder.

“Whether smoking or otherwise consuming marijuana has therapeutic benefits that outweigh its health risks is still an open question that science has not resolved,” said Nora Volkow, MD, Director of the National Institute on Drug Abuse.

Public health officials in British Columbia have proposed some controversial solutions to the opioid crisis, including decriminalization of all illicit drugs. A treatment center in Vancouver currently provides diacetylmorphine -- prescription heroin – to drug users to keep them from using street heroin that is often laced with fentanyl, a synthethic opioid that is 50 to 100 times more potent than morphine.

The Canadian Institutes of Health Research recently approved funding for a pilot study in Vancouver to evaluate cannabis as an adjunct therapy to OAT.

"Scientists are only just beginning to understand the role cannabis might play in supporting people's well-being, particularly those who use other substances," said co-author M-J Milloy, PhD, the Canopy Growth professor of cannabis science at UBC. "This study will help us understand if and how cannabis might have a role in addressing the overdose crisis."

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.

A Pain Poem: Zooming to Christmas

By Carol Levy, PNN Columnist

‘Twas the night after Thanksgiving
And all through the house
No one was stirring,
The only sound was my oww’s

It took all my strength
To bend and to stretch
In hopes of getting
Myself undressed.

Christmas will be at my house,
Said my Aunt Joan.
Don't anyone worry
All you'll need is a phone.

The Zooming will work,
I said with a grin.
To myself I added,
“This year the pain won’t win.”

So many other times
If I groaned or I grimaced
The others round the table
Gave me a look saying, “You're finished.”

Covid is awful,
Zooming a wonderful thing.
I can take my pills or sit silently,
And move the camera away from me.

Santa is giving me
Quite a gift.
Where the pain can’t be seen,
Or called a grift.

This year I expect better,
I know that sounds weird.
But it seems social distancing and masks
Are gifts to be cheered.

I hope you all have
Pain free holidays.
But even if there is pain,
It can be a time for hoorays.

Family and friends together
So close, yet not near.
Can make it a holiday
We don't have to fear.

If the pain starts to get us,
We won’t have to leave the table.
Just turn the webcam away,
And do what we're able

The point of this poem
Is to find a way
To keep the negative people
From making it a bad holiday.

My hope is for none of the negativity
That’s often brought.
It happens too often,
What getting together has wrought.

My wish to you all
Is the same as old Mr. Claus
Merry Christmas to all,
Full of fun and guffaws.

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

FTC Warns CBD Companies About False Health Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is once again going after companies that make unsubstantiated claims about the health benefits of cannabidiol (CBD) products. The crackdown, called “Operation CBDeceit,” is part of the agency’s ongoing effort to protect consumers from misleading advertising.

The FTC announced that six sellers of CBD oils, topical creams, gummies, lozenges and other products have signed administrative settlements agreeing not to make any further deceptive claims that CBD can treat pain, migraines, arthritis, cancer, heart disease and other health conditions.

“These CBD sellers lacked the scientific proof to back up their extreme claims. In fact, they often didn’t have any proof at all. But that didn’t stop them from saying these benefits were clinically proven. In truth, CBD is not a magical cure-all and there is no competent and reliable scientific evidence for these kinds of over-the-top health claims,” said Andrew Smith, Director of the FTC Bureau of Consumer Protection.

The FTC complaint against Utah-based Bionatrol Health alleged the company claimed its CBD products treat pain better than prescription medications like OxyContin. The company also allegedly deceived customers who ordered one bottle of its CBD oil by changing the order to five bottles without their consent.

The proposed settlement requires Bionatrol to pay $20,000 to the FTC and to notify customers about the FTC order. Similar settlements were reached with the other five companies.

This isn’t the first time the FTC and other federal agencies have gone after sellers of CBD, kratom and other dietary settlements for making unsubstantiated health claims.

The enforcement actions are sporadic and usually only target small companies. Sometimes a warning letter is as far as it goes and the company makes only a minor change in its marketing claims.

FTC IMAGE

In March 2019, for example, the FTC and Food and Drug Administration sent a warning letter to Nutra Pure, telling the company its hemp and CBD oils were unapproved drugs under federal law and “may not be legally introduced or delivered for introduction into interstate commerce.”

Nearly two years later, the company is still selling hemp and CBD oils, and has a disclaimer on its CBDPure website stating that its products “are not intended to diagnose, prevent, treat, or cure any disease.”

But when this reporter posed as a customer in an online chat with “Catherine,” a CBDPure representative, we were assured that CBD can treat pain and other health conditions.  

Customer: “Hi I'm wondering if you can recommend a CBD product for arthritis pain.”

Catherine: “Our oils are 300, 600 or 1000 mg CBD in full spectrum hemp oil. People with a mild condition or just looking to improve health start with the 300mg or 600mg. People with more severe or chronic conditions typically purchase the 1000 mg CBDPure hemp oil or 750 mg CBDPure soft gel.” 

Customer: “Will they help with pain and other health conditions?” 

Catherine: “Yes. There are numerous studies showing CBD has the ability to provide therapeutic benefits in the treatment of various conditions, including chronic pain, arthritis, anxiety/depression, nausea, epilepsy, insomnia and sleep issues, fibromyalgia, glaucoma and many other ailments.” 

Customer: “That's interesting. I have a friend with fibromyalgia. Is there something that can help her?” 

Catherine: “Yes. Same deal. Ideally, you start off with a lower mg dose and increase the amount you take weekly until you find what works for your body chemistry.” 

Customer: “And it'll eventually make the pain go away once you find the right dose?” 

Catherine: “Yes. It really depends on how your body tolerates and adapts to these dietary supplements.”

FTC officials say false claims about the therapeutic benefits of CBD and other supplements create a “real potential for serious harm to consumers health and safety.” But in a briefing with reporters announcing the six settlements reached in Operation CBDeceit, they acknowledged their investigation did not find any evidence about customers being harmed by the companies’ products.

“We’re not here saying CBD products are dangerous or that CBD products can’t offer benefits. Just that if you’re going to tout health benefits of your products, those claims have to be truthful and they have to be substantiated by the science,” said Smith.

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.