Peer Reviewers of Medical Studies Have Conflicts of Interest

By Crystal Lindell

How much are medical studies impacted by financial conflicts of interest? New research shows the problem may run deeper than most people realize. 

The authors of peer-reviewed studies in medical journals usually have to disclose whether or not they received money from pharmaceutical companies or medical device manufacturers. But new research published in JAMA looks at the next layer: the peer reviewers themselves.

Due to the “traditionally opaque nature of peer review,” it’s difficult to investigate the issue, but an international team of researchers studied peer reviewers at high-impact medical journals like The BMJ, JAMA, The Lancet, and The New England Journal of Medicine.

They looked specifically at nearly 2,000 U.S-based physicians who served as peer reviewers. 

What they found is both unsurprising and alarming. Between 2020 and 2022, more than half (58.9%) of the peer reviewers analyzed had received at least one industry payment. In total, the peer reviewers received a staggering $1.06 billion in industry payments. 

It should be noted that companies don’t spend that kind of money out of some noble love of medicine. No, they are doing it because it helps increase their profits or advances their interests. 

Most of that money – $1 billion or 94 percent – was paid directly to individuals or to their institutions to help fund research programs. That’s why academics who churn out studies are highly prized at universities and research institutes.

The rest of the money – $64.18 million – was in the form of general payments, which includes everything from speaker fees and “honoraria” to food, drink, lodging and travel expenses. 

The median general payment to a peer reviewer was $7,614, while the median research payment was $153,173. 

Interestingly, the average male reviewer had a significantly higher total payment ($38,959) than the average female reviewer ($19,586). 

The authors also broke down differences between medical specialties. Doctors who specialize in cardiology, rheumatology, oncology, immunology or addiction treatment were the most likely to get payments (73.5%), followed by surgeons (72%), psychiatrists (65%), hospital-based specialists (47%) and primary care physicians (38%).

Those results shed light on which fields of medicine may be more susceptible to conflicts of interests.

The study’s authors came to the only conclusion that makes sense given all this data: "Additional research and transparency regarding industry payments in the peer review process are needed."

I agree that this is clearly an issue that needs to be addressed. But we shouldn’t have to wait for more research to start taking action. We need stronger policies at medical journals to help contain the potential harm it’s causing. 

At the very least, peer reviewers should have to disclose conflicts of interest. While that may conflict with the policy of some journals to keep peer reviewers anonymous, given the potential for bias and other negative consequences, it seems the financial disclosures should take precedence. 

Since peer reviewers also have the ability to reject research before it’s even published, they should have their names and potential conflicts listed in the publications. 

Beyond that, medical journals need to start having difficult conversations about whether peer reviewers should even be allowed to review studies that involve companies or industries that pay them. 

While it may not be entirely possible in our for-profit healthcare system, that doesn’t mean it shouldn’t be explored. After all, the study did not find that 100% of peer reviewers accepted payments. So clearly some peer reviewers found a way to do the work without an obvious conflict of interest.

It isn’t just medical journals that do a poor job flagging the conflicts of peer reviewers. When PNN made a Freedom of Information Act (FOIA) request to the CDC seeking more information about the “Core Expert Group” involved in the agency’s 2016 opioid guideline, most of the documents we received back were heavily edited or redacted.

The CDC’s FOIA office said the group was exempt from our request because of “deliberative process privilege” and that disclosing their conflicts would have been “a clearly unwarranted invasion of personal privacy.”  

Why Conflicts Matter

Why do conflicts of interest matter? The easiest way to understand it is that whenever money is involved, it can potentially lead to what is essentially a boss-employee power dynamic. And typically, people don’t like to upset their bosses. 

Intuitively, most people also understand that if a medical device company funds medical device research, the researchers are incentivized to manipulate both the research methods and results in hopes of providing the funder the results they seek. 

Sometimes it’s deliberate, but sometimes it just happens on a subconscious level. People naturally favor people who give them money. However, in this case, the result of that favoritism could harm the health of millions of patients. 

In one high-profile example from 2018, a top cancer researcher failed to disclose the millions of dollars in payments he received from drug and healthcare companies.

As ProPublica and The New York Times reported, Dr. José Baselga, then-chief medical officer at Memorial Sloan Kettering Cancer Center in New York, had a number of undisclosed conflicts of interests. 

One such conflict may have led Baselga to put a positive spin on the results of two Roche-sponsored clinical trials — trials that many others had considered disappointments. He did this without disclosing the more than $3 million in consulting fees he’d received from Roche. He also left out that he had a stake in a company Roche had acquired. 

Baselga resigned just days after the news investigation came out, but journalists just don’t have the resources to constantly investigate every single researcher for conflicts of interest. That’s why medical journals must regulate the issue themselves. 

Yes, most medical journals already have policies requiring study authors to disclose conflicts of interest, but as this new research makes clear, that’s not enough. It’s past time for peer reviewers to be required to do the same. 

After all, it’s not just because the public deserves to know. Our lives could depend on it. 

Pain Patients Get ‘Substantial Relief’ from Scrambler Therapy

By Pat Anson, PNN Editor

A little-known therapy for Complex Regional Pain Syndrome (CRPS) and other painful neuropathic conditions is finally getting some attention from a prominent medical journal.

“Scrambler therapy is the most exciting development I have seen in years — it’s effective, it’s noninvasive, it reduces opioid use substantially and it can be permanent,´ says Thomas Smith, MD, a professor of oncology at the Johns Hopkins University School of Medicine and co-author of a review recently published in The New England Journal of Medicine.

Scrambler therapy – also known as Calmare pain therapy -- sends mild electric signals through the skin via electrodes placed near areas where chronic nerve pain is felt. Similar to transcutaneous electrical nerve stimulation (TENS), the idea is to “scramble” pain signals being sent to the brain and reduce central sensitization.

Some patients get immediate relief after a 30-minute scrambler session, but most will have to undergo a series of treatments on successive days to have a prolonged analgesic effect. Smith says many patients “get really substantial relief.”

“The duration of relief usually increases with each day of treatment, and in contrast to TENS, analgesic effects have been reported to last for weeks, months, or even years after a treatment course,” wrote Smith, who reviewed 381 clinical trials of TENS and scrambler therapy with his co-author.

“The major limitation with respect to our understanding of electroanalgesia is the small number of well-designed, large, randomized, sham-controlled clinical trials of TENS and scrambler therapy.”

In one small study, patients getting scrambler therapy had a 91% reduction in pain and reduced their use of opioids and other pain relievers by 75 percent.

“If you can block the ascending pain impulses and enhance the inhibitory system, you can potentially reset the brain so it doesn’t feel chronic pain nearly as badly,” Smith says. “It’s like pressing Control-Alt-Delete about a billion times.”

Scrambler therapy seems to be most effective in patients with CRPS or those who develop neuropathic pain after chemotherapy. It’s also been used to treat fibromyalgia, shingles, diabetic neuropathy and post-operative pain.

Amanda Greening was bedridden by CRPS at the young age of 20, but was able to walk again after several sessions of scrambler therapy. Amanda’s father wrote a column for PNN on her recovery. So did a local TV station:

Although scrambler therapy was approved by the FDA in 2009 for patients with chronic or neuropathic pain, the procedure is still not widely available or covered by insurance. Only one company makes the scrambler device, which costs about $65,000, and practitioners have to undergo several days of training to use it. Treatments cost about $300 per session.

Like other pain treatments, scrambler therapy doesn’t work for everyone. About 10 to 20% of  patients have no analgesic response -- a risk many would be willing to take, if it means freeing themselves from a lifetime of pain.

Hospitals Plan to Ration Healthcare as Coronavirus Spreads

By Pat Anson, PNN Editor

With face masks, surgical gowns, hospital beds and ventilators in short supply, some U.S. hospitals are preparing to make stark choices about which patients to treat – and who not to treat – during the coronavirus pandemic.

The Henry Ford Health System, which operates dozens of medical centers and emergency rooms in the Detroit metropolitan area, has contingency plans to take critically ill patients off ventilators and out of intensive care if they have little chance of recovery.

“Some patients will be extremely sick and very unlikely to survive their illness even with critical treatment. Treating these patients would take away resources for patients who might survive,” the plan states. “Patients who are treated with a ventilator or ICU care may have these treatments stopped if they do not improve over time.”

Under the Henry Ford policy, patients suffering from terminal cancer, organ failure or severe trauma “are not eligible for ICU or ventilator care” and would be given pain control instead.

When a document from the 50-page plan – a letter addressed to patients informing them about the policy – began circulating outline, it was met with outrage.

“Reading that policy truly removes the usually veiled thoughts about the disabled being less than, not enough, or not fully whole. Being shown that one is not ‘eligible’ to continue living is despicable,” Koa Kai, a pain patient and advocate for the disabled, told PNN.  

“I question the ethics and danger of policies such as this, and outright reject their use. We are seeing humanity stripped down to its most basic elements now. As the hysteria continues, it continues to bring both the best and worst out in humanity.”  

Henry Ford officials were quick to point out their contingency plan was prepared for a worst-case scenario and has not yet been implemented. It was shared with other health care systems in Michigan to help them develop similar plans – which is apparently how it leaked..

“Gathering the collective wisdom from across our industry, we carefully crafted our policy to provide critical guidance to healthcare workers for making difficult patient care decisions during an unprecedented emergency,” Dr. Adnan Munkarah, Henry Ford's executive president and chief clinical officer, said in a statement.

“It is our hope we never have to apply them and we will always do everything we can to care for our patients, utilizing every resource we have to make that happen.”

Michigan reported nearly a thousand new coronavirus cases Saturday, bringing the state’s total to 4,650 cases. At least 111 people have died from the virus in Michigan – with most of the deaths occurring in the Detroit area.

Michigan Gov. Gretchen Whitmer, a Democrat who has been feuding with President Trump, told a radio station Friday that medical supply vendors told her they’ve been told “not to send stuff” to her state. Whitmer complained earlier that the number of masks and gowns sent to Michigan by the federal government was inadequate. The state reportedly hasn’t received a single ventilator.

‘We Are on the Precipice of Rationing’

Ventilators are medical appliances that force air into and out of the lungs – essentially doing the breathing for patients who are unable to breathe on their own. Connecting a sick patient to a ventilator – and taking them off – are life-and-death decisions.

“When patients’ breathing deteriorates to the point that they need a ventilator, there is typically only a limited window during which they can be saved. And when the machine is withdrawn from patients who are fully ventilator-dependent, they will usually die within minutes,” lead author Robert Truog, MD, a medical ethics professor at Harvard Medical School, wrote in an op/ed recently published in The New England Journal of Medicine.

Some hospitals in New York City are so overwhelmed with coronavirus patients they may have to start rationing ventilators and other critical medical supplies. The state has over 52,000 confirmed cases, nearly half of the nation’s total.

“Today was the worst day anyone has ever seen, but tomorrow will be worse. We are on the precipice of rationing. Needless to say, these decisions run counter to everything we stand for and are incredibly painful,” wrote Meredith Case, an internal medicine resident at Columbia/New York-Presbyterian Hospital, in a March 25 Twitter thread

Two days later, the situation had not improved.

“Yesterday brought another onslaught. Endless overheads calling for anesthesia and respiratory therapy for intubations. Friends at other hospitals having the same experiences. We are rising to a challenge that already overwhelms us,” Case tweeted. “Frustrating to realize that different things are in shortage in different places. Some will soon run out of vents, others CRRT machines, others nursing staff, others rooms or physical space.”

‘The Ethical Thing To Do’

As stark as it sounds, rationing scarce medical resources is “the ethical thing to do” during a pandemic, according to an op/ed in The New England Journal of Medicine.  

“Because maximizing benefits is paramount in a pandemic, we believe that removing a patient from a ventilator or an ICU bed to provide it to others in need is also justifiable and that patients should be made aware of this possibility at admission,” wrote lead author Ezekiel Emanuel, MD, a professor at the Perelman School of Medicine, University of Pennsylvania.

“Undoubtedly, withdrawing ventilators or ICU support from patients who arrived earlier to save those with better prognosis will be extremely psychologically traumatic for clinicians — and some clinicians might refuse to do so. However, many guidelines agree that the decision to withdraw a scarce resource to save others is not an act of killing and does not require the patient’s consent.”

Who decides which patients should be taken off ventilators? In many cases, the decision is made by a hospital triage officer or a triage committee composed of providers who have no direct responsibility for the care of a patient.  

“In the weeks ahead, physicians in the United States may be asked to make decisions that they have never before had to face, and for which many of them will not be prepared,” Dr. Truog wrote in his op/ed. “Though some people may denounce triage committees as ‘death panels,’ in fact they would be just the opposite — their goal would be to save the most lives possible in a time of unprecedented crisis.”

‘Ruthless Utilitarianism’

In response to growing concerns about healthcare being rationed during the coronavirus outbreak, the Office for Civil Rights (OCR) at the Department of Health and Human Services issued a bulletin Saturday warning healthcare providers not to discriminate against patients, regardless of age or disability.

“Our civil rights laws protect the equal dignity of every human life from ruthless utilitarianism,” said Roger Severino, OCR Director. “Persons with disabilities, with limited English skills, and older persons should not be put at the end of the line for health care during emergencies.” 

Severino was responding to a complaint from advocates for the disabled in Alabama. Under a state emergency plan, patients with “severe mental retardation, advanced dementia or severe traumatic brain injury” could be considered “poor candidates for ventilator support” during a pandemic. Patients with AIDS or compromised immune systems could also be taken off ventilators.

“Healthcare organizations incorporating this ventilator triage protocol into their disaster plans and attempting in good faith to follow it will be considered to be in compliance with the standard of care necessitated by the prevailing proclaimed respiratory disaster,” the Alabama plan states.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

“It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.”

— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

Steep Decline in New Opioid Prescriptions

By Pat Anson, PNN Editor

The number of doctors writing new prescriptions for opioid pain medication has fallen by nearly a third in recent years, according to a large but limited study that documents a dramatic shift in opioid prescribing patterns in the U.S.

Researchers at Harvard Medical School studied health data for over 86 million patients insured by Blue Cross Blue Shield from 2012 to 2017, and found that first-time prescriptions for patients new to opioids – known as “opioid naïve” patients -- declined by 54 percent.

At the start of the study, 1.63% of Blue Cross Blue Shield patients were being treated with new opioid prescriptions. Five years later, only 0.75% were.

The study also found a shrinking pool of doctors willing to start opioid treatment. The number of doctors who prescribed opioids for opioid naive patients decreased by nearly 30 percent, from 114,043 to 80,462 providers.

The research findings, published in The New England Journal of Medicine, do not provide any context on the patients’ health conditions or the severity of their pain and injuries. As such, it is a data-mining study that provides no real information on the harms or benefits of opioids.

"The challenge we have in front of us is nothing short of intricate: Curbing the opioid epidemic while ensuring that we appropriately treat pain," lead investigator Nicole Maestas, PhD, an associate professor of health care policy at Harvard Medical School, said in a statement. "It's a question of balancing the justified use of potent pain medications against the risk for opioid misuse and abuse."

First-time prescriptions for opioids are usually used to treat short-term acute pain caused by trauma, accidents or surgery. They rarely result in long-term opioid use or addiction, but have become a major target for healthcare policymakers and anti-opioid activists. Several states have adopted regulations that limit the initial supply of opioids to 7 days or less.

While the number of doctors starting opioid therapy has fallen dramatically, Harvard researchers say many are still engaged in “high-risk prescribing” – which they defined as new prescriptions for more than 3 days’ supply or a daily dose that exceeds 50 morphine milligram equivalent (MME).

More than 115,000 of these “high-risk prescriptions” were written monthly for Blue Cross Blue Shield patients. Over 7,700 of the prescriptions exceeded 90 MME per day, a dose that researchers say puts patients at a substantially higher risk of an overdose. The study did not identify whether any of those high-dose patients experienced an overdose.

Opioid prescriptions in the U.S. have fallen sharply since their peak in 2010, but have yet to slow the rising tide of overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

Heart Transplants Surge as Overdoses Increase

By Pat Anson, PNN Editor

One of the more ghoulish and yet beneficial aspects of the overdose crisis is that it has led to a surge in organ transplants. In 2000, only about 1 percent of organ donors were overdose victims. By 2017, when over 70,000 Americans died from drug overdoses, over 13 percent of organ donors were overdose victims.

A new study by researchers at Brigham and Women’s Hospital has documented how the number of hearts available for transplant has increased dramatically, particularly in states like Pennsylvania that have been hard hit by the overdose crisis.  

"In the U.S., the drug crisis is clearly not uniform, and neither is the rate of recovered hearts from drug-intoxication-related deaths," said lead author Mandeep Mehra, MD, the medical director of Brigham's Heart and Vascular Center.

Mehra and his colleagues analyzed CDC data on overdose deaths and from the Organ Procurement and Transplantation Network, and reported their findings in The New England Journal of Medicine.

They found major increases in drug-related deaths and organ harvesting in Pennsylvania, New York, Ohio and other Northeast states, and in Florida and Texas. Overall, the team estimated that 6.24 hearts were recovered for every 1,000 lives lost due to drug intoxication.

NEW ENGLAND JOURNAL OF MEDICINE

Among the 37,232 donors whose hearts were transplanted from 1999 through 2017, the percentage of those who died from overdoses rose from 1.5% to 17.6 percent. And as the number of hearts available for transplant grew, the waiting list for donated hearts began shrinking in 2016. According to the United Network for Organ Sharing, there are currently 45 people in the U.S. waiting for a heart transplant.

"This is a very important outcome indicating that people are now adopting organs from drug-intoxication-related deaths as a viable source for lifesaving donor organs," said Mehra. "Although we support organ donation recovery from this source, those of us in the transplant community also strongly support effective efforts to combat the drug overdose crisis. We must pursue ways to target the crisis while simultaneously looking for new ways to increase the availability of viable donor organs."

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply and because drug addicts are more likely to be infected with HIV, hepatitis and other communicable diseases. But those risks have been minimized with modern testing.

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are over 113,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

Should Rx Opioids Be Limited for Cancer Patients?

By Pat Anson, PNN Editor

At a time when many chronic and acute pain patients are losing access to opioid medication, patients suffering from cancer pain are treated differently. They’re usually exempt from opioid guidelines that typically focus on limiting prescriptions for “noncancer pain.”

But some oncologists are starting to question whether opioids should be routinely prescribed to cancer patients.

“As an oncologist, I cannot help but reflect on that qualifier. It suggests that a cancer diagnosis gives us permission to prescribe opioids with impunity. Patients with cancer can become addicted, like anyone else. Yet oncologists use these potent, seductive drugs freely, perhaps without sufficient regard for the risk of dependence and abuse,” writes Alison Loren, MD, in an op/ed published in The New England Journal of Medicine.

“Treating patients who are terminally ill from cancer is an important indication for these drugs. But what about patients with cancer who aren’t dying, the ones we hope to cure? Woven into our language about the opioid epidemic is an implication that oncologists can hand out opioids as if there were no tomorrow. But for many people with cancer, there is now indeed a tomorrow.”

Loren, who is a professor at the Perelman School of Medicine at the University of Pennsylvania, says many patients whose cancer was once thought incurable are living for a decade or longer. Thanks to advances in cancer treatment, there are more than 15 million cancer survivors in U.S. and their ranks are growing

“With this progress comes new challenges. Especially poignant — albeit rare — is the one I face when I see a patient who is cancer-free but addicted to medications I’ve prescribed,” wrote Loren. “I am responsible for this predicament, and it feels monstrously cruel — second only to allowing the dependence to continue. Sometimes, like those with ‘noncancer pain,’ our patients veer into abuse.”

A new study by researchers at the University of Colorado School of Medicine found signs of opioid abuse in a small percentage of cancer patients. Out of 811 patients given opioids after treatment for oral or oropharynx (neck) cancer, 68 patients (7%) were still using opioids six months later.

"You shouldn't need opioids at the six-month point," says Jessica McDermott, MD, an investigator at the CU Cancer Center. “We felt like (opioid misuse) was a long term problem for some of our head and neck cancer patients, but didn’t know how much of problem.”

McDermott doesn’t advocate taking opioids away from cancer patients, but says doctors should know which patients are more at risk of opioid misuse, such as those having a previous opioid prescription or a history of smoking and alcohol use.

"If a patient needed opioids for pain, I wouldn't keep them away, but especially if they have risk factors, I might counsel them more about the risks of addiction and misuse, and keep an eye on it," McDermott says.

Loren would take opioids away from a cancer patient at risk of misuse. She shared the story of a leukemia patient with a long history of substance abuse who was found dead in her hospital bed.

“Her leukemia was in remission. The possibility that she may have overdosed haunts me,” Loren wrote. “Oncologists are accustomed to giving opioids, but we must also be comfortable taking them away, and sometimes giving them in limited doses or not at all.”

Is Addiction or Untreated Pain Causing Patient Suicides?

By Pat Anson, Editor

A new op/ed in The New England Journal of Medicine focuses on an aspect of the overdose crisis that’s rarely discussed – how opioids are a “silent contributor” to the nation’s rising suicide rate. But critics say the article misses the mark on why a growing number of pain patients are having suicidal thoughts and taking their own lives.

Most people already know that drug overdoses are soaring in the United States, but few recognize that suicides are at their highest level in nearly 30 years. In 2016, more Americans died from suicides (44,965) than from opioid overdoses (42,249).

“The significant increases in both opioid-overdose deaths and suicide rates in our country have contributed to reduced life expectancy for Americans. These two epidemics are intermingled, and solutions to address the opioid crisis require that we tailor interventions to preventing opioid-overdose deaths due to suicidal intent,” wrote co-authors Maria Oquendo, MD, and Nora Volkow, MD.

Volkow is the longtime director of the National Institute on Drug Abuse, while Oquendo is a Professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and past president of the American Psychiatric Association.

Volkow and Oquendo believe many suicides are misreported as “undetermined” or accidental drug overdoses, and that “the true proportion of suicides among opioid-overdose deaths is somewhere between 20% and 30%, but it could be even higher.”

They also engage in a familiar pattern of demonizing opioid pain medication, citing studies showing that patients with “opioid use disorder” (OUD) from prescription opioids are more likely to have suicidal thoughts and “whose motivation to live might be eroded by addiction.” 

“Notably, two populations that are more likely than others to receive opioid prescriptions — patients with chronic pain and those with mood disorders — are also at greater risk for suicide,” they wrote.

That may all be true. The suicide rate among chronic pain patients is probably increasing. But what’s puzzling is that Volkow and Oquendo never acknowledge the role that the federal government has played in contributing to that trend. Anecdotal evidence is building that suicides started climbing after the CDC released its 2016 opioid prescribing guidelines and pain medication became harder to get. 

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide,” Stefan Kertesz, MD, a professor of medicine at the University of Alabama at Birmingham School of Medicine, recently told PNN.

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or even acknowledged by government bureaucrats like Volkow, who was an early supporter of the CDC guidelines.

In a survey of over 3,100 pain patients on the one-year anniversary of the guidelines, over 40 percent told PNN they had considered suicide because their pain was poorly treated. Many patients feel the healthcare system has turned its back on them.

“Even though I can barely function my doctor wants to stop my meds completely. With no hope, suicide seems like the best and only choice to get relief from the pain. I never thought doctors would be so uncaring, along with the government,” wrote one patient.

“I never thought I would even consider suicide, but death looks good when every move you make is painful, 24 hours a day, 7 days a week. The guidelines are not fair to me, my husband, and my children. No one can judge anyone else's pain level,” said another patient.

“I frequently contemplate suicide. I lay in bed on many nights crying because there is no comfortable positions and the spasms are relentless,” said a disabled nurse in Maine who is no longer able to obtain opioids.

“In the past year, six chronic patients I know who were no longer able to get their pain medication have committed suicide. I personally have researched the quickest and surest way of ending my own life. And no, it doesn’t include opioids,” wrote another patient.

“I nearly committee suicide last summer and again last November because of undertreated pain,” said one woman. “It is ridiculous beyond belief when my neighbor’s dog gets prescribed pain meds for a torn claw and I get treated like a criminal for having a chronic pain condition.”

Undertreated Pain

Patient advocates say these suicidal thoughts are often not the result of addiction or OUD, but because chronic pain is increasingly untreated or undertreated.

“The diagnosis of OUD is overwhelmingly made by physicians who are untrained in making the diagnosis,” says Stephen Nadeau, MD, a Professor of Neurology and Clinical Health Psychology at the University of Florida College of Medicine. “Most patients in chronic pain are under-dosed and/or suffer from inadequately treated depression. We don’t know the exact figures on prevalence of under-dosing but we do have studies that suggest that depression is detected only 20% of the time.”

“There is emerging data to suggest that increasing numbers of opioid overdose-related deaths may be a consequence of undertreatment of both pain and depression.  But the dominant public narrative is demanding even less treatment of pain when opioids are the chosen therapy,” says Red Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, a patient advocacy group.    

Lawhern believes many suicides can be attributed to the “epidemic of despair” first documented by Princeton researchers Anne Case and Angus Deaton.  They believe that the reduced life expectancy of Americans is not just due to substance abuse, but linked to unemployment, poor finances, lack of education, divorce, depression and loss of social connections – issues that Volkow and Oquendo fail to address.

“Their article is seriously deficient for failure to mention that both substance abuse and suicide generally are closely associated with depression and isolation -- both of which are consequences of economic hard times.  It is simply wrong to imply that opioid use disorder (itself an incorrect term) is the ‘cause’ of suicide, when both are driven jointly by socio-economic factors,” Lawhern wrote in an email.

What can be done to prevent suicides in the pain community? Volkow and Oquendo say more doctors should be trained to recognize the warning signs of suicide and patients should be screened for suicide risk and then referred for addiction treatment. Nowhere do they suggest better pain management.   

Getting the Story Right About Opioids

By Pat Anson, Editor

Many chronic pain patients feel they are wrongly portrayed in the media as malingerers and addicts – and that the growing difficulty they have just getting their pain treated is being ignored by the medical profession.

There’s a fair amount of truth to that.

Which is why two recent articles in Politico and The New England Journal of Medicine – both written by doctors – are worth highlighting for PNN readers. They help dispel many of the myths about pain patients and the role they played in the so-called opioid epidemic.

“As an addiction psychiatrist, I have watched with serious concern as the opioid crisis has escalated in the United States over the past several years, and overdose deaths have skyrocketed,” Sally Satel, MD, wrote in Politico. “I have also watched a false narrative about this crisis blossom into conventional wisdom: The myth that the epidemic is driven by patients becoming addicted to doctor-prescribed opioids, or painkillers like hydrocodone.”

Dr. Satel practices at a methadone clinic, lectures at the Yale University School of Medicine and is a resident scholar at the American Enterprise Institute, a conservative think tank.  She has also done her homework about the opioid crisis, recognizing that the nation’s growing scourge of overdose deaths is “overwhelmingly attributable” not to prescription opioids, but to illegal ones like heroin and illicit fentanyl.

Satel also acknowledges that opioid prescriptions in the U.S. have been declining for years and that only a small percentage of pain patients become addicted. Yet insurers, pharmacies and regulators continue to tighten access to opioid medication, and anti-opioid activists rant about pain patients getting hooked after taking a few “heroin pills.”

“We must be realistic about who is getting in trouble with opioid pain medications. Contrary to popular belief, it is rarely the people for whom they are prescribed. Most lives do not come undone, let alone end in overdose, after analgesia for a broken leg or a trip to the dentist,” Satel wrote.

“We need to make good use of what we know about the role that prescription opioids plays in the larger crisis: that the dominant narrative about pain treatment being a major pathway to addiction is wrong, and that an agenda heavily weighted toward pill control is not enough.”

That narrative clearly has been harmful to patients. Satel cites a PNN survey of over 3,000 patients, which found that over 70% were no longer prescribed opioids or had their dose cutback after the CDC’s opioid prescribing guidelines were released in 2016.  Nine out of ten patients said the guidelines had worsened the quality of pain care in the United States, and 60 percent said it had become harder or impossible for them to find a doctor willing to treat their pain.

The Story of Mr. P

Patient abandonment and the growing lack of access to pain treatment is presented in the story of “Mr. P” – as told in the NEJM by Drs. George Comerci, Joanna Katzman and Daniel Duhigg, who are colleagues at a pain clinic in Albuquerque, New Mexico. Mr. P was prescribed opioid medication for two years when his doctor adopted a no-opioids policy in his practice.

“Mr. P. was given a prescription for a month’s worth of oxycodone and advised to find another prescriber in the future.  Not unexpectedly, six other physicians refused to prescribe him opioids, and he ended up in our pain clinic, sobbing in the exam room, terrified that he’d end up ‘back in my old life’ if he had to buy his pain medications on the street,” the doctors wrote.

“In the past year, our university-based interdisciplinary pain clinic has seen a flood of cases like Mr. P.’s. The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics. The fallout is a growing pool of patients who are forced to navigate their transition off prescribed opioids, often with little or no assistance or guidance, with the potential for disastrous results.”

What is happening to these abandoned patients who can’t find adequate treatment?

“We fear that an injudicious approach involving blanket refusals to prescribe opioids and adoption of unreasonable prescribing and dispensing regulations will increase patient suffering. Furthermore, the worst-case scenario is for patients to obtain prescription opioids illegally and eventually transition to more dangerous drugs, such as heroin,” the doctors warned.

The opioid crisis continues to spiral out of control. Government efforts to intimidate doctors and dictate prescribing levels are not only harming patients, they may be making things worse. A recent report from the CDC found that illicit fentanyl – not prescription pain medication -- was responsible for over half the overdoses in ten states.

As Dr. Satel points out, if we ever hope to fix the problem and find the right solutions, we need to stop focusing on patients and doctors.

“We cannot rely on doctors or pill control policies alone to be able to fix the opioid crisis. What we need is a demand-side policy. Interventions that seek to reduce the desire to use drugs, be they painkillers or illicit opioids, deserve vastly more political will and federal funding than they have received,” she wrote. “If we are to devise sound solutions to this overdose epidemic, we must understand and acknowledge this truth about its nature.”

Stem Cell Regulation and a Rule Too Many

By A. Rahman Ford, Columnist

The New England Journal of Medicine recently published an op/ed rather benignly entitled “Rejuvenating Regenerative Medicine Regulation.”  

The authors, R. Alta Claro and Douglas Sipp, argue that the Food and Drug Administration did not go far enough in regulating stem cell therapies in its recently released final guidance, and that further restrictions need to be placed on Americans seeking to use their own cells to heal themselves. Both authors are affiliated with RIKEN, a Japanese research institute that is developing stem cell technology.

Although clothed in the flowing garb of humaneness, medical ethics and protecting the sick and disabled, the authors’ posture reveals itself to be strikingly paternalistic.  Rather than “rejuvenate” regenerative medicine with ideas that would invigorate and fertilize a forward-thinking, democratic regulatory regime, Claro and Sipp instead articulate positions so extreme that they operate as more of a death knell to stem cell innovation.  Indeed, the authors seem to have issued a eulogy for a promising and precocious corpus of medicine that has barely attained its infancy.

In their view, the FDA guidance is “a positive step,” but more needs to be done.  To assist in the effort, they urge institutions at the state level to “crack down” on malfeasant clinics and agitate for state legislatures to pass stricter informed consent laws, as was recently done in California. 

To justify further restrictions on the availability of stem cell therapies, they claim that the “explosion of stem cell marketing in the United States” has led to “predatory” clinics offering “untested stem cell treatments [that have] exposed patients to unjustifiable risks.” 

They further claim that the FDA has fallen short in in its staged approach to enforcing the new rules against clinics deemed to be in violation.  The authors even go so far as to assail the 21st Century Cures Act because it created “a pathway to approval that is at risk of putting cell and tissue products on the market before they have been adequately tested.”

A bare endorsement of the FDA’s “minimal manipulation” and “homologous use” tests would have been troubling enough, and the authors do endorse those tests in their article.  As I wrote in an earlier column, the agency’s guidance is unduly burdensome when it comes to autologous therapies – which involve stem cells that are extracted from a person and administered to the same person to relieve conditions such as chronic pain. 

In Clara and Sipp’s view, those suffering from pain and other chronic illnesses are part of the problem, because it was largely “patient demand” that helped “drive the growth of unproven therapies.”  Such a placing of blame upon chronically ill patients is disappointing. 

Equally disappointing is the authors’ disregard of those same patients’ constitutionally-protected privacy interest in their own bodies and their own cells, an interest which – as with abortion rights – would require a compelling interest on the part of the federal government to justify excessive regulation.  Unfortunately, an uncited reference to “numerous documented reports of medical accidents” involving stem cells does not a compelling interest make.

Texas Should be the Model

However, the authors are correct that states must be more involved in setting stem cell policy.  The problem is that they chose the wrong example.  Rather than emulate the restrictive policies of California, the Texas example should be the model that other states follow.  Texas has passed legislation making autologous stem cell therapies more accessible to its residents and has even buttressed it with “right to try” legislation.  

The Texas effort was spearheaded by tireless patient advocates who were able to communicate to state lawmakers their truly human stories.  Lawmakers heard and felt that pain – some personally because of their own experiences with pain and disability.  The result was stem cell choice, in a state-led regulatory model that can hopefully be a nationwide blueprint, as Washington state was for marijuana legalization.

Stem cell policy-making must not be a strictly elite enterprise.  It must be democratic process, as embodied by the Congress when it overwhelmingly passed the Cures Act and its provisions which help expedite stem cell cures.  The people’s voice must be preponderant, and bolstered by thoughtful, reasonable rules that privilege choice, promote fairness, and protect us from physical and legal injury.

We should not seek rules that only preserve a place for the status quo in a rapidly advancing medical technology landscape that threatens to make a dusty relic out of old ways of thinking.  The orthodox "clinical trial" medical regulatory paradigm favored by the FDA simply does not work for regenerative medicine and stem cell therapies.  So rather than fear-mongering by focusing on a conjured-up phantom of rampant medical malfeasance, we should embrace the future. 

Fear of change is understandable and expected from certain quarters.  But the millions of Americans in chronic and intractable pain are not the ones who are afraid, and are not as docile and ignorant as they may be portrayed.

Although their argument is flawed, the title Charo and Sipp selected is resounding.  Regenerative medicine and stem cell policies must indeed be about rejuvenation, not more regulatory entanglement.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

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

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

The Opioid Blame Game

By Roger Chriss, Columnist

Nearly 40 years after it was published, a short letter to the editor in The New England Journal of Medicine is today being blamed by various media outlets for having “kicked off” or “fueled” or “sparked” the opioid epidemic.

The one paragraph letter, written by researchers at Boston University Medical Center, has attracted media attention because of a new letter to the editor by Canadian academics Pamela Leung, Erin Macdonald, MD, PhD, Irfan Dhalia, MD, and David Juurlink, MD, PhD. They claim that the 1980 letter “was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy.”

The authors are not the first to notice this. The New Yorker made the same claim in 2013, to little effect.

Now, however, the media has latched onto the 1980 letter’s statement that “addiction is rare in medical patients with no history of addiction,” by declaring it to be the spark that ignited an explosion of opioid overdoses and deaths.

If only it were that simple.

The opioid epidemic has already been blamed on OxyContin and Purdue Pharma, drug seeking pain patients, physician overprescribing and pill mills, and even a small study by Russell Portenoy, MD, in 1986.

But conspicuously absent are many other contributing factors, including:

• Managed healthcare looking for cheap treatment options
• Health insurers pushing to reduce healthcare costs
• Employers expecting workers to return to work sooner
• Patients wanting a quick pain cure

Another commonly cited villain is the campaign to treat pain as the "5th Vital Sign.” But that did not occur in a vacuum. The rise of chronic pain paralleled increasing levels of acute pain, for reasons such as:

• Better trauma care for car crash and gunshot victims
• Early and aggressive cancer care
• Increasing rates of diabetic neuropathy and amputation
• More injection therapy and surgery to treat damage and deterioration in the spine and joints

Medical care improved in many important ways in the 1980’s, including the advent of minimally invasive surgery and chemotherapy for a wide variety of cancers, as well as the discovery of drugs that turned once deadly diseases like AIDS and leukemia into chronic conditions that could be medically managed. There have also been many well-intentioned attempts to treat increasingly common degenerative diseases and disorders that may have caused more pain in some patients.

In other words, there is plenty of blame to go around. But media coverage ignores these larger issues.

Instead, CNN draws a parallel between the 1980 letter and a lawsuit filed last week by Ohio’s Attorney General against five opioid manufacturers. And the CBC’s coverage includes a link to a 2011 YouTube video produced by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), perhaps because David Juurlink himself is on the PROP Board of Directors. An old lecture on the evils of opioids is beside the point here

The real question here is: Does finger pointing at a NEJM letter from 1980 help people today who are suffering from opioid addiction?

The research literature on opioid addiction in the 1970’s and 80’s strongly resembles today’s efforts. Even high school health classes back then discussed methadone clinics and medication-assisted treatment, the importance of long-term maintenance therapy, and the value of safe injection sites and needle exchange programs for heroin users.

This leads to a far more important question: Why aren’t we using these treatments more widely?

This blame game isn’t helping opioid addicts. As media reports identify the 1980 letter as another target of blame for the opioid crisis, we should be asking why we’ve made so little progress since then in treating addiction.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

An Epidemic of Fake Opioid News

By Roger Chriss, Guest Columnist

The New England Journal of Medicine recently published a study called “Opioid-Prescribing Patterns of Emergency Physicians and Risk of Long-Term Use.” It looked retrospectively at Medicare patients and found that some emergency room physicians prescribed up to three times more opioids than others did.

The article did not even mention words such as “abuse” or “addiction” in any context. Moreover, the data was for the period between 2008 and 2011, long before the 2016 CDC opioid guidelines or the various efforts by the FDA, DEA and state governments to restrict opioid prescribing.

The result of this study has been a surprising explosion of fake news about the opioid crisis. It is almost ironic that the spread of this news looks more like an epidemic than the actual opioid crisis does.

The New York Times published the article "Long-Term Opioid Use Could Depend on the Doctor Who First Prescribed It” on February 15, marking the first step in the outbreak of this new opioid meme.

The article noted that the study looked at elderly people in the opening paragraph, but did not mention the decline in opioid prescribing between the study period and the present.

Moreover, the article stated that "as the opioid epidemic continues to devastate communities around the country, the study was the latest attempt to identify a starting point on the path to excessive use.” This was stated despite the fact that all the study showed is that people who take opioids are more likely to become dependent or addicted to them. Clearly this result is both axiomatic and not a priori interesting.

A day later there were more articles, such as “Physicians’ opioid prescribing patterns linked to patients’ risk for long-term drug use” from the Harvard School of Public Health and “How Long You Stay On Opioids May Depend On The Doctor You See In the E.R.” from the Kaiser Family Foundation.  

Both articles add more drama to the study’s results, though each does mention that the study was done on Medicare patients. Oddly, the Harvard article waited until almost the very end to tell us that, as if this is an incidental point with respect to the study and its results.

On February 16, the fake news took a turn toward the dramatic and dire. The Chicago Tribune came up with an article called "Your ER doctor could determine your likelihood of long-term opioid use."  We are told that "physicians are often reluctant to change treatment regimens when patients are happy with what they have,” as an explanation for why doctors were resisting not prescribing opioids.

Vox took the fake news to a whole new level with an article called "Certain doctors are more likely to create opioid addicts. Understanding why is key to solving the crisis."  The Vox reporter provides a quote from the lead author of the study:

“'For patients, Barnett said the message is clear: “Patients should ask their physicians, ‘What are the side effects of me taking this opioid and do you think my pain could be treated effectively [another way], because I know how dangerous these medicines can be."

Opioids have now become dangerous medications.

Now imagine that the first headline from The New York Times had said “Medicare Patients Receive Different Amounts of Pain Medication depending on ER Physician.” That would be a fair a description of what was reported in the original NEJM article.

And consider this alternate interpretation of The Chicago Tribune quote about happy patients: These patients are elderly, at low-risk of addiction, and being treated successfully with a well-known medication. This is not something to worry about, especially since the opioid crisis is being driven by illicit substances used primarily by younger people and outside of medical settings.

Forgotten in all of this reporting is the data from the CDC and other government agencies, which clearly shows that opioid prescribing is down considerably compared to just a few years ago, while at the same time the number of overdoses and deaths involving opioids used illicitly has risen.

The data also shows that most people who abuse opioids are young, not elderly. In other words, physician prescribing is not a major driver in the opioid crisis and Medicare patients are not representative of substance abusers at all.

In a matter of days, an article in a respected medical journal describing a retrospective study of the Medicare population has morphed into some doctors being more likely than others to create opioid addicts and unlucky patients are getting hooked.

This is an epidemic spread of fake news, of a dangerous meme, and of a new challenge for chronic and intractable pain patients. Accurate information is the best defense, but that takes work.

Roger Chriss suffers from Ehlers Danlos syndrome. Roger is from Washington state, where he works as a technical consultant who specializes in mathematics and research.

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

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

Controversy Grows over Journal Article on Pain Treatment

By Pat Anson, Editor

It’s not uncommon for colleagues in the medical profession to disagree. Egos and different medical backgrounds can sometimes lead to heated discussions about the best way to treat patients. But those arguments are usually kept private. 

That is why it is so unusual for a prominent pain physician to publicly call for another doctor to resign or be fired from her faculty position at a prestigious medical school.

“I believe she should resign her academic post,” says Forest Tennant, MD, referring to Jane Ballantyne, MD, a professor at the University of Washington School of Medicine, who recently co-authored a controversial article in the New England Journal of Medicine (NEJM) that said reducing pain intensity should not be the goal of doctors who treat chronic pain. The article also suggests that patients should learn to accept their pain and move on with their lives.

“For somebody in her position as a professor at a university to call for physicians to quit treating pain – or pain intensity – whether acute, chronic, whether rich, poor, disabled or what have you, is totally inappropriate. And it’s an insult to the physicians of the world and an insult to patients. And frankly, she should not be a professor.” Tennant told Pain News Network.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity.”

Tennant is a pain management specialist who has treated patients for over 40 years at his pain clinic in West Covina, California. He’s authored over 300 scientific articles and books, is editor emeritus of Practical Pain Management, and is highly regarded  in the pain community for accepting difficult, hard-to-treat patients that other doctors have given up on.

dr. forest tennant

Tennant was surprised the influential, peer-reviewed New England Journal of Medicine, which reaches over 600,000 people each week, even published the article.

“I know that they’re biased and they’ve got all their medical device people there and all their academia and all that, but I think they have a responsibility also. They are supposedly representing medicine,” says Tennant. “Why do I have a medical degree if I’m not supposed to treat pain intensity? Give me an answer to that. She didn’t have an alternative did she?”

dr. jane ballantyne

Exactly what Ballantyne and co-author Mark Sullivan, MD, meant to say is open to interpretation. Pain News Network has been unable to get comment from either about the controversy.

They began their article by saying “pain that can be relieved should be relieved,” but then veer off in another direction, stating that chronic pain should not be treated with opioid pain medication.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain,” they wrote, dismissing the pain intensity scales that are widely used by physicians to measure pain levels.

“We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn't a simple measure of something that can be easily fixed.”

Ballantyne and Sullivan offered no alternative “fixes” for pain treatment, other than patients learning to live with pain and sitting down for a chat with their doctors.

“Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope,” they wrote.

Angry Comments from Readers

The article infuriated both patients and physicians, including dozens who left angry comments on the NEJM website.

“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 Michael Shabi, who identified himself as 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. I have had 21 neurological surgeries and procedures and live in constant pain. So why in the heck do you people have such a problem in hearing us?” asked pain patient Kerry Smith.

“Only an idiot might conclude that one can dismiss the effects of living with a healthcare problem that reminds you of its presence with every move you make,” wrote Terri Lewis, PhD, a specialist in rehabilitation.

Both Ballantyne and Sullivan have lengthy careers in medicine and have been active in organizations that discourage the use of opioids. 

According to the University of Washington website, Ballantyne received her medical degree from the Royal Free Hospital School of Medicine in London and trained in anesthesiology at John Radcliffe Hospital in Oxford. She moved to Massachusetts General Hospital in Boston in 1990 and then to the University of Washington in 2011, as a Professor of Education and Research and as Director of the UW Pain Fellowship. 

Last year Ballantyne was named president of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. She also serves as an expert adviser to the Centers for Disease Control and Prevention (CDC) as it develops controversial new guidelines that discourage primary care physicians from prescribing opioids. Ballantyne is one of five PROP board members who are advising the CDC on the guidelines.

Sullivan is a Professor of Psychiatry and Behavioral Sciences -- also at the University of Washington School of Medicine -- and is executive director of Collaborative Opioid Prescribing Education (COPE), a program that educates healthcare providers about safe opioid prescribing practices. He is also a PROP board member.

Sullivan has authored several research articles on opioids, including a recent one warning about the co-prescribing of sedatives and opioids.

“He’s not as well known,” says Tennant. “He doesn’t carry the public influence that she does. She’s sitting on federal committees, advising CDC that pain patients should not be treated and the intensity scale should not be used. I cannot imagine anyone making that statement. I can’t imagine the New England Journal of Medicine publishing it. The atrocity here is just awful.

dr. mark sullivan

“Any semblance of decency left among physicians in PROP, if that’s what they believe, then I think the whole organization ought to close its doors. I didn’t know they were going to say we didn’t want pain treated at all. They said they wanted to use opioids responsibly. Well, that’s fair. But that’s not what she said.”

Tennant is urging the pain community to contact Paul Ramsey, the CEO of UW Medicine and Dean of the School of Medicine to ask that Ballantyne be fired. He’s gotten a few takers, including Becky Roberts, who suffers from arachnoiditis.

“I do not feel she should be teaching new medical students. Professor influence is big when you are a student. I am sure if any one of them read her article, most were probably shocked,” Roberts said in an email to Pain News Network.

“They did not get into medicine because they are uncaring. Compassion for other human beings is why they went to medical school. To help heal human beings is their goal. I really do think she needs to be removed from that position. How long has she been teaching this kind of logic?”

The UW School of Medicine has about 4,500 students enrolled in undergraduate, professional, and post-graduate programs. 

The Importance of Treating Chronic Pain

By Emily Ulrich, Columnist

If you are a chronic pain sufferer, by now you may have read about the proposed opioid guidelines by the Centers for Disease Control and Prevention (CDC), and a recent article about opioids in the New England Journal of Medicine. In the latter, Jane Ballantyne, MD, and Mark Sullivan, MD, wrote that reducing pain intensity – pain relief – should not be the primary goal of doctors who treat pain patients. They suggest that patients should learn to accept their pain and move on with their lives.

This statement is nothing short of infuriating to me and I imagine to anyone who has to live with chronic pain. Many of us have already heard a doctor say, “I don't prescribe pain medicine. Pain won't kill you.”

There are so many things wrong with that ideology, and the “facts” that are being used to support it in the anti-opioid movement, that it's difficult to know where to begin. There are years of research that show that pain left untreated or under-treated does in fact kill. It may not happen right away, but it greatly affects our quality of life and kills us slowly in a variety of ways.

Most of us know that chronic pain causes depression, anxiety, and even suicidal thoughts. There is also a very long list of comorbidities that often come with chronic pain, including hormonal and metabolic imbalance, impaired immune function, skin rashes, ulcers, incontinence, high blood pressure, and much more -- all of which ultimately lead to a decline in quality of life and overall health.

Unrelieved pain can also permanently change the brain and nervous system, preventing the brain from fully resting and developing new cells to repair brain damage. Research shows that the brains of pain patients can deteriorate over the course of a year at a rate which would take a healthy person's brain one to two decades. Cerebral atrophy causes seizures and dementia, both of which can lead to death, and both of which are preventable in pain patients when given adequate pain care.

Staggeringly, none of this seems to have been taken into consideration by the CDC or the doctors who have written this recommended “treatment” approach. One is perplexed by the “sweep it under the rug” mentality of these doctors, and the many who will be influenced by the CDC and the anti-opioid suggestions published in the New England Journal of Medicine.

The facts are this: Opioid misuse is not epidemic in the U.S. (opioid overdose is not even in the top 20 causes of death), but chronic pain is pandemic.

The overwhelming majority of pain patients who use opioids do not abuse or divert them. Yet the majority of patients are under-treated or even untreated for chronic pain. The roots of this mistreatment are myriad, and some are steeped in socio-economic factors such as gender, race, and disability. Minorities are more likely to have their pain minimized or ignored.

In addition, doctors have an exaggerated fear of addiction. Many fear repercussions from the DEA or their state medical board if they prescribe too many opioids, and there is a general lack of pain education on the part of many doctors.

Most of all, money is running the show. It seems that the American healthcare system sees us as useless members of society, who can either be eliminated or turned into eternal consumers. Treating us only with drugs that have dangerous side effects requires a whole new set of medications to treat the host of new ailments that their drugs have given us.

Another cog in the “Big Pharma” takeover of chronic pain (where we are offered treatments such as Lyrica, Neurontin, antidepressants, NSAIDs, biologics, etc., instead of inexpensive and proven opioid therapy) is that the CDC consulted with addiction treatment specialists, as well as insurance and drug company influenced “researchers” who have a conflict of interest.

Dr. Ballantyne, who is a member of the CDC's "Core Expert Group," reports receiving grants from Pfizer and being president of Physicians for Responsible Opioid Prescribing (PROP). She also served as a consultant to a law firm that litigates against opioid drug makers. Dr. Sullivan reports receiving grants from drug makers developing abuse deterrent products and personal fees from Janssen and Relievant.

We have to speak up. We have to educate ourselves and sometimes our doctors. Many of us don't realize (and some doctors don't want us to realize) that we have a basic human right to pain care. According to the Journal of American Society of Anesthesiology, “the unreasonable failure to treat pain is poor medicine, unethical practice, and is an abrogation of a fundamental human right.”

Doctors and patients must acknowledge that chronic pain is deadly. It can cause countless fatal conditions, not the least of which are heart attack, stroke and brain damage. And while opioids are not the only route to reduced pain, they are very important players in the path to pain relief. For most of us, opioids are part of a multi-modal treatment to lessen our pain, as well as a treatment of last resort.

The “alternative treatments” suggested by the CDC, Ballantyne and Sullivan include therapies most of us have either tried or had fail; or they are already part of our overall pain therapy.

In their article Ballantyne and Sullivan write, “Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope.”

I agree with them on this one point. However, they left out one essential element, the treatment plan that the patient and doctor come up with. For most of us, a main component of treatment is opioids.

Now is the time to speak up, before we have brain damage or die. Join me in creating a #PainedLivesMatter movement.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS/RSD), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, Endometriosis, chronic gastritis, Interstitial Cystitis, Migraines, Fibromyalgia, Osteoarthritis, Periodic Limb Movement Disorder, Restless Leg Syndrome, Myoclonic episodes, generalized anxiety disorder, insomnia, bursitis, depression, multiple chemical sensitivity, and Irritable Bowel Syndrome.

Emily is a writer, artist, filmmaker, and has even been an occasional stand-up comedian. She now focuses on patient advocacy for the Power of Pain Foundation, as she is able.

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

Study Finds ‘Notable Downturn’ in Opioid Abuse

By Pat Anson, Editor

A “notable downturn” in the abuse of opioid pain medication in the United States is being overshadowed by a sharp rise in heroin use, according to a large new study outlined in a letter to the New England Journal of Medicine.

In the nationwide study of over 15,000 patients being treated for addiction, the number of addicts who abused opioids alone fell from 70% in 2010 to less than 50% in 2014.

At the same time, however, researchers at Washington University School of Medicine in St. Louis found that many addicts were using heroin and opioids concurrently. Forty-two percent said they had taken heroin and prescription opioids within a month of entering treatment, up from nearly 24 percent in 2008.

"We see very few people transition completely from prescription opioids to heroin; rather, they use both drugs," said lead author Theodore J. Cicero, PhD. "There's not a total transition to heroin, I think, because of concerns about becoming a stereotypical drug addict."

The use of heroin alone – although still relatively low -- more than doubled from 2008 to 2014, from 4.3% to 9% of the addicts under treatment.

Heroin has spread beyond inner cities into suburban and rural areas, according to Cicero. His research also found regional variations in the use of heroin and prescription opioids.

"On the East and West coasts, combined heroin and prescription drug use has surpassed the exclusive use of prescription opioids," Cicero said. “This trend is less apparent in the Midwest, and in the Deep South, (where) we saw a persistent use of prescription drugs -- but not much heroin.”

The study did not make clear how many of the addicts were legitimate pain patients who took opioids to relieve their pain or whether they were recreational users who started taking opioids to get high.

Cicero says a crackdown on "pill mills" and doctors overprescribing opioids has made it harder to get the drugs. For those who are addicted, heroin has become the new drug of choice.

"If users can't get a prescription drug, they might take whatever else is there, and if that's heroin, they use heroin," he said.

Heroin is more accessible and cheaper today, said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“Political events triggered the present heroin problem. 90% of the world's heroin comes from just three countries - Afghanistan, Burma and Mexico. The Afghan and Burmese heroin was a perfect cash crop for insurgency groups and the heroin addiction spread rapidly in countries bordering Afghanistan and Burma. Mexico is a bigger problem for us because farmers in that country have switched to growing the poppy,” said Menzies in an email to Pain News Network.

Opioids aren’t the only “gateway” drug to heroin, according to Menzies. He believes the increasing use of buprenorphine (Suboxone) to treat addiction is fueling the heroin epidemic because addicts have found they can use the drug to ease systems of withdrawal.

“We are seeing more and more patients getting exposed to heroin and it is going to get worse. Sadly, the heroin addiction is being sustained by buprenorphine preparations,” Menzies said.

Menzies has more to say about buprenorphine, marijuana legalization, and "the coming tsunami" in heroin use in this guest column.