60 Minutes Fails to Consider Pain Patients

By Laura Mills, Kate M. Nicholson, and Lindsay Baran

In a Feb. 24 segment, CBS’s 60 Minutes accused the Food and Drug Administration (FDA) of igniting the overdose epidemic in the United States with its “illegal approval of opioids for the treatment of chronic pain.” While the program highlighted the adverse consequences of misleading pharmaceutical marketing and lax government oversight, this segment failed to consider the perspective of patients who legitimately use opioids for pain, stigmatized them as drug-seekers, and propagated misconceptions about the overdose crisis, such as the idea that opioid treatment for chronic pain is indisputably illegitimate and is driving overdose deaths in the U.S.

When OxyContin went to market in 1996, its FDA label said that addiction was “very rare” when the medication was used to manage chronic pain. Although that warning was enhanced in 2001, the market for OxyContin was already booming: advertising spending for the drug increased from $700,000 in 1996 to $4.6 million in 2001. Lawsuits allege that Purdue Pharma, the maker of the drug, targeted high-prescribing physicians and continued to aggressively market OxyContin even after it learned its product had become a go-to drug for illicit use. The lack of government oversight and Purdue’s practices certainly deserve media scrutiny that could help shed light on actions that may underlie the overdose crisis.

However, the guests featured in the 60 Minutes segment gave the impression that the use of opioids for chronic pain is illegitimate or illegal, that prescription opioids are still driving overdose deaths in the United States, and that the use of prescribed opioids to manage chronic pain is equivalent to “heroin addiction.”

These are false narratives that do real harm to pain patients, who have been regularly stigmatized in the media and elsewhere as drug-seekers. In presenting this report, 60 Minutes failed to tell the other side of the story: that of pain patients who rely on these medications to function, and that of the medical community which largely agrees that opioids may help patients whose pain isn’t resolved by other means.

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Chronic pain is a large category that includes pain associated with incurable illnesses, severe neurological conditions, and catastrophic trauma as well as more common ailments like arthritis. There is growing agreement that using opioids across this broad category was inappropriate and did harm, and that it is important to balance the potential benefits of opioids with misuse and diversion risks. But the medical community still largely agrees that, for some patients, opioids provide benefits. Indeed, the Centers for Disease Control, the Federation of State Medical Boards, a 2011 report by the Institute of Medicine, and all applicable medical and government guidelines on prescribing opioids have reaffirmed that opioids may be appropriate for patients whose chronic pain isn’t resolved by other means. 

Re-evaluating the use of opioids in long-term pain makes sense given recent history, but rushing to judgment before we do so can do real harm and risks violating a fundamental component of the right to health, including the right to adequate treatment for pain.  In over 80 interviews with patients, physicians, and experts, a recent Human Rights Watch report found a disconcerting trend: chronic pain patients are being forced off opioid medications simply because doctors fear regulatory oversight and reprisal. In many cases, physicians acted against their better medical judgment. Even when they believed their patients’ health was improved by long-term opioid treatment, they felt they had no option but to reduce patients’ doses dramatically or cut them off completely. They felt a wide range of pressures, from fear of Drug Enforcement Agency or state medical board scrutiny to the heavy bureaucratic burden created by insurance companies through their efforts to discourage opioid prescribing.

When deprived of their medication, the consequences for patients can be devastating: their health declines to the point where they can no longer work, do simple chores, or take care of their personal hygiene.  Several patients said they had turned to alcohol or illicit drugs to manage their pain when they were deprived of care.

Take Maria Higginbotham, whose story is included in the report. She has undergone 12 operations to prevent the collapse of her spine. Unfortunately these operations, which failed to relieve her pain, also left her with adhesive arachnoiditis, an incredibly painful condition that causes the nerves of the spinal cord to “stick together.”

Re-evaluating the use of opioids in long-term pain makes sense given recent history, but rushing to judgment before we do so can do real harm and risks violating a fundamental component of the right to health.
— Human Rights Watch

Maria is now being forced to a lower dose of medication by a provider who believes she needs opioids, but is afraid of attracting law enforcement scrutiny of his practice. Previously, Maria could function independently; she now requires assistance to go to the toilet.  To suggest that Maria has no legitimate right to these medications—and that her need for them is misguided, inappropriate or the result of drug misuse — is stigmatizing to all patients like her.

Hundreds of leading physicians and experts from with varying views on the efficacy of opioids have called attention to the dangers of involuntarily discontinuing opioids for the estimated 18 million Americans who currently use them for long-term pain, a practice the CDC and other medical bodies do not encourage. These dangers include medical destabilization, the lost ability to work and function, and suicide. The National Council on Independent Living (NCIL), a national disability rights organization, shares these concerns, which have a disproportionate impact on people with disabilities living with chronic pain who already face major barriers to accessing healthcare.  The American Medical Association has similarly criticized the indiscriminate discontinuation of opioids, and has underscored that the stigma surrounding opioids now affects cancer and palliative care patients who, despite explicit exemptions, face increased barriers to access as well

While liberal prescribing undoubtedly caused harm, further perpetuating inflammatory and stigmatizing ideas about people who rely on opioids helps legitimize the growing reluctance of physicians to prescribe these medications to those who they believe need them. At a time when the prescribing of opioids has dropped precipitously and drug overdose deaths are largely attributed to illicit substances, such harm ought to figure into the conversation.

It’s true that there is a lack of high quality data studying the efficacy of opioids beyond 12 weeks, but it is also the case that most medications approved for the treatment of pain reflect studies of similar duration.  This is in part because doing long-term, placebo-controlled trials with real human beings who are suffering presents practical and ethical challenges. 

FDA Commissioner Scott Gottlieb recently responded to the concerns raised by 60 Minutes, by announcing that the agency will conduct new studies into the efficacy of opioid analgesics for chronic pain, a move that he signaled could have an impact on how these drugs are marketed in the future. We agree that more research is critical and have backed initiatives such as the National Pain Strategy that call for much needed additional research into chronic pain. In the meantime, the dangers of reinforcing an incomplete or incorrect narrative and of stigmatizing patients are real—60 Minutes should ensure it doesn’t do either in its coverage, and should show all sides of the story.

This article was originally published on the Human Rights Watch website and is republished with permission.   

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Laura Mills is a health researcher at Human Rights Watch and author of the HRW report, “Chronic Pain, the Overdose Crisis, and Unintended Harms in the U.S.”

Kate M. Nicholson is a civil rights and health policy attorney. She served for 20 years in the Department of Justice’s civil rights division, where she drafted current regulations under the Americans With Disabilities Act. She gave a TEDx talk about chronic pain, “What We Lose When We Undertreat Pain.

Lindsay Baran is the policy analyst at the National Council on Independent Living (NCIL), the longest-running national cross-disability grassroots organization run by and for people with disabilities.

Human Rights Watch: CDC Guideline Needs Revision

By Pat Anson, PNN Editor

Federal and state efforts to reduce opioid prescribing have harmed pain patients across the country and caused many doctors to arbitrarily cutoff or taper patients who need opioid medication, according to a new report from Human Rights Watch.

“Not Allowed to Be Compassionate” -- a 99-page report by the New York based non-profit -- highlights the many unintended consequences of the 2016 CDC opioid guideline, which discourages doctors from prescribing opioids for chronic pain. The report recommends the CDC revise the guideline to explicitly state that patents should not be involuntarily tapered off opioids and that some patients may require high doses.

“Many individuals with chronic pain are being involuntarily tapered from essential medicines that are vital to their daily functioning, depriving them of their right to health,” the report found.

“Health care providers in some cases are even turning away such individuals, insurance companies and programs are refusing coverage, and state governments are preventing physicians from using their medical judgement to provide appropriate care.”  

Although voluntary and only intended for primary care physicians, the CDC guideline has been widely adopted by regulators, law enforcement and insurance companies, with little or no effort made to measure its impact on pain patients and the quality of their care.

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One of the most surprising things Human Rights Watch learned, according to researcher Laura Mills, is how little the government knows — or is willing to say — about cutbacks in opioid prescribing.  

“We went into this report hoping we’d be able to find some data. And what we found is, if there is data, none of it has been published,” Mills told PNN. “We don’t know how many people committed suicide. We don’t know how many people are alive or dead within a year of tapering. We don’t know how many people are hospitalized.

“And that’s a huge risk because essentially we’re letting dramatic policy changes take effect very quickly. Many of these may be justified, but we aren’t measuring in real time what’s happening. At least none of these organizations are doing it in a way that’s public.”

‘Agonizing Pain Like Torture’

The report tells the story of Maria Higginbotham, a Seattle-area woman with an aggressive form of degenerative disc disease. Multiple surgeries not only failed to relieve her pain, they left her with adhesive arachnoiditis, a chronic inflammation of spinal nerves.

Although bedridden and in constant pain, Higginbotham’s doctor is planning to reduce her dose of opioid medication by 75 percent to comply with the CDC guideline.  

“I’m 57 years old and I’m almost completely bedridden due to agonizing pain like torture,” Higginbotham said. “I cannot hold my 15-month-old grandson. I cannot hold my beloved dogs, I can’t bend over to touch them. I cry out in my sleep because I can’t find a way to get comfortable.

“I can barely get myself off of my toilet. Sometimes I have to get off the couch by getting on my hands and knees and pulling myself up because I can’t stand up it hurts so badly.”  

Higginbotham’s doctor told Human Rights Watch he had no choice but to cut her opioid dose, even though he knows the medication is helping her. 

“There’s a lot of talk in the pain medicine world that if you do not get people down to 90 morphine equivalents, you set yourself up for a liability, especially if something were to happen to that patient,” he said. “We still feel like we’re vulnerable to being held liable for patients if they’re over that guideline limit, even when you know they’re not addicted and they’re benefiting (from opioids).”  

You can learn more about Maria Higginbotham and the Human Rights Watch report in this video:

Right to Health

Although the consequences to pain patients like Maria Higginbotham have been “catastrophic,” Human Rights Watch stopped short of calling them a human rights violation.  International law gives cancer and palliative care patients a right to pain management, but it is less clear about non-cancer pain. Chronic pain patients may have a “right to health,” but they don’t have a right to opioids.

“While opioid analgesics are the cornerstone of cancer pain management, these medications do not play a central role in chronic pain management and are, indeed, controversial. The available evidence suggests that effective treatment of chronic pain requires a multidisciplinary approach, using pharmacological and non-pharmacological tools,” the report found.

“Nonetheless, the right to health clearly applies to chronic non-cancer pain patients, as does the prohibition of torture, cruel or degrading treatment or punishment, and some of the same broad principles that apply to pain management for palliative care patients apply to chronic non-cancer pain patients.” 

In addition to a revision of the CDC guideline, Human Rights Watch is calling for better insurance coverage of alternative pain therapies and a new system of metrics that measure not just “crude reductions in opioid prescribing,” but also a patient’s quality of life and quality of pain care.

Documentary Looks at Pain Relief as Human Right

By Steve Weakley

A new documentary calls pain relief a basic human right.  That is one of the tantalizing premises of “Hippocratic,” a film about the life of one of the pioneers of palliative care in India, Dr. M.R. Rajagopal.  

For over 20 years, Rajagopal has battled conditions that cause palliative care patients in India to suffer needlessly. Despite being home to most of the world’s legally grown opium, morphine and other opioid medications are often inaccessible in India to patients dying of cancer and other chronic illnesses.   

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Rajagopal points out that the Indian Narcotics Act of 1987 reduced prescriptions of opiates in his country by 94 percent in just 12 years.  Under that law, even a minor mistake in prescribing opioids could send a doctor to prison for 10 years. 

“When you torture someone for political reasons, they can sign a confession and escape.  Here, (pain patients) don’t even have that option… they can’t fight back.  It’s a very one-sided war,” says Rajagopal.

In “Hippocratic,” Rajagopal points out that medicine and the profit motive compound the lack of effective pain care.  About 80 percent of the healthcare industry in India is privatized, and when doctors prescribe opiates they often steer patients toward expensive name brand drugs, when nearly identical generics cost only pennies.  He warns against unchecked medical profits and makes a passionate plea for universal health care.

The 88-minute film is most moving in the moments where it demonstrates the power of compassion as the primary purpose of treatment.  A four-year old girl, writhing and screaming in unbearable pain, is seen reaching up and kissing Rajagopal on his forehead after he administers her medicine.

You can watch a trailer for “Hippocratic” below:

In 2014, Rajagopal won an award for extraordinary activism from Human Rights Watch, a non-profit that has done extensive work on human rights abuses and the suffering of palliative care patients worldwide.

As PNN has reported, Human Rights Watch is now investigating the treatment of chronic pain patients in the United States.

“People we interviewed who didn’t have access to appropriate medications for their pain were essentially giving testimony that was almost exactly the same as the testimony we were getting from the victims of police torture,” said Diederik Lohman, Director of Health and Human Rights for Human Rights Watch.  “People were facing tremendous suffering that actually could be relieved pretty easily through very inexpensive palliative care and pain management.”

“Hippocratic” had a limited release in U.S. theaters last month, but can still be seen in New York City, Seattle, Fresno and a handful of other cities. It can also be rented online by clicking here.



Human Rights Watch Investigating U.S. Pain Treatment

By Pat Anson, Editor

Human Rights Watch is well-known internationally for its groundbreaking reports on human rights violations around the world. The organization has recently reported on the torture of prisoners in Sri Lanka, forced labor in Thailand, and corruption and mass arrests in Saudi Arabia.

Pain News Network has learned the New York-based non-profit is turning its attention closer to home – by launching an investigation into the treatment of chronic pain patients in the United States. The impetus for the investigation began when researchers were studying the treatment of cancer and palliative care patients – and began to see poorly treated pain as a human rights issue.

“People we interviewed who didn’t have access to appropriate medications for their pain were essentially giving testimony that was almost exactly the same as the testimony we were getting from the victims of police torture,” says Diederik Lohman, Director of Health and Human Rights for Human Rights Watch.

“And we realized this was actually one of those issues that almost no one was paying attention to. People were facing tremendous suffering that actually could be relieved pretty easily through very inexpensive palliative care and pain management.”

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In many third world countries, Lohman says opioid pain medications like morphine are difficult to obtain, even for patients dying of cancer.

“They would say the pain was just unbearable, that they would do anything to make it stop, and many of them would tell us that they asked their doctors to give them something to put them out of their misery,” he told PNN.

Recently those same stories have been coming from pain patients in the United States.  

“As we started looking at this issue more closely, we started hearing more and more stories of chronic pain patients in the U.S. who had been on opioids, who were being told by their physicians that 'We have to take you off.'  And we started hearing stories of patients who were having a lot of trouble finding a doctor who’s willing to accept them as a patient,” said Lohman.

Lohman says Human Rights Watch is well aware of the addiction and overdose crisis in the U.S. But he says the “right balance” needs to be found between keeping opioids off the street and making sure medications are still available to legitimate patients.

‘CDC Clearly Knows What’s Going On’

Part of the investigation will focus on the role played by the opioid guidelines released by the Centers for Disease Control and Prevention in 2016, which discourage doctors from prescribing opioids for chronic pain. Although voluntary and intended only for family practice physicians, the CDC guidelines have been widely adopted as mandatory rules by other federal agencies, states and insurers.  

The impact of the guidelines was sudden and powerful. Within a year of their release, a PNN survey of over 3,100 pain patients found that 71 percent had their opioid medication stopped or reduced. Nearly 85% said their pain and quality of life were worse.

“The CDC clearly knows what's going on and they haven’t taken any real action to say, ‘That is not appropriate, involuntarily forcing people off their medications. That’s not what we recommended,'" Lohman said. “When a government puts in place regulations that make it almost impossible for a physician to prescribe an essential medication, or for a pharmacist to stock the medication, or for a patient to fill their prescriptions, that becomes a human rights issue.”

Human Rights Watch is looking for testimonials from chronic pain patients who have been forced or encouraged to stop their opioid medication by physicians or pharmacists. They’d also like to hear from patients who have been forced or encouraged to seek alternative forms of treatment, but who then found those treatments financially or geographically inaccessible.

Input from doctors affected by the opioid guidelines, regulations and anti-opioid climate is also welcome.

Investigators are particularly interested in hearing from patients and doctors in West Virginia, Massachusetts, Maine, Washington, North Carolina, Florida and Montana.

“Our work is heavily reliant on the testimonies of people who are directly affected. That’s been our methodology of work for many years,” says Lohman. “We would like for our work to actually help move things in the right direction. But it’s important to document what’s going on.”

(Update: Human Rights Watch has been flooded with responses to this story. At this time, they do not need any additional stories from pain patients. They plan to complete their investigation and release their findings by the end of the year.)