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.

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.   

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.

FDA Commissioner Resigns Unexpectedly

By Pat Anson, PNN Editor

The head of the U.S. Food and Drug Administration resigned unexpectedly Tuesday, just days after a critical report on 60 Minutes that alleged the FDA “opened the floodgates” to the opioid crisis.  

“I’m immensely grateful for the opportunity to help lead this wonderful agency,” FDA commissioner Scott Gottlieb, MD, tweeted. ”This has been a wonderful journey and parting is very hard.”

In a lengthier statement to FDA staff, Gottlieb cited family reasons for his departure.

“There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children,” Gottlieb said, indicating he would remain on the job until next month.

Gottlieb is a 46-year old cancer survivor and a former consultant to several drug companies. He commutes to Washington DC from his home in Westbury, Connecticut, where he lives with his wife and three daughters.   

President Trump tweeted that Gottlieb “has done an absolutely terrific job” and “he and his talents would be greatly missed!”

SCOTT GOTTLIEB, MD

There was no indication that Gottlieb was in trouble or that he was forced out. The FDA is currently involved in a number of complex and controversial regulatory issues, from high drug prices and e-cigarettes to medical marijuana and the opioid crisis.

The timing of Gottlieb’s departure is puzzling, however, because he tweeted two months ago that he had no intention of resigning after hearing from friends about speculation in the news media that he was leaving.

“I want to be very clear — I’m not leaving. We’ve got a lot of important policy we’ll advance this year,” Gottlieb tweeted, adding a famous quote from Mark Twain that reports of his death “have been greatly exaggerated.”

The 60 Minutes report alleged that the FDA caved into lobbying pressure from the pharmaceutical industry in 2001 by changing the warning labels on OxyContin and other opioid medications to indicate they were effective for long term use.

Gottlieb was not working at FDA when the agency made its labeling decision, but pledged last week in a lengthy essay that the FDA would “learn from past mistakes” and take “a much more aggressive approach to regulatory action” involving opioids.

Gottlieb joins a long list of agency directors and cabinet members who have resigned from the Trump administration, including former Health and Human Services Secretary Tom Price, who was forced out over excessive travel expenses and other ethical lapses, and former CDC director Brenda Fitzgerald, who resigned after it was disclosed she invested in tobacco and drug companies.

Future Pain Pills

By Roger Chriss, PNN Columnist

The Food and Drug Administration announced this week that it would require drug makers to conduct new studies on the effectiveness of opioid pain medication and whether long-term use of the drugs lead to addiction. The FDA’s unprecedented action was due in no small part to a 60 Minutes report that said the agency “opened the floodgates” to the opioid crisis by approving the use of opioids for chronic pain. 

With opioid medication coming under scrutiny again – and perhaps more regulatory action – this is a good time to assess where we stand with development of newer and safer painkillers.  

Many analgesics already on the market have too many risks or too few benefits. A recent meta-analysis in JAMA concluded that opioids “may provide benefit for chronic noncancer pain, but the magnitude is likely to be small.”

And a new Cochrane review on acetaminophen (Tylenol) for hip or knee osteoarthritis found “only minimal improvements in pain and function.”

So new analgesics, whether safer opioids or non-opioid drugs, are urgently needed. Fortunately, there has been significant progress.

NKTR-181, from Nektar Therapeutics, is a new kind of opioid under “fast track” FDA review. It was designed with safety in mind, because it enters the nervous system slowly as a result of its unique chemical structure. NKTR-181 is the only abuse-deterrent opioid in the drug development pipeline designed to reduce the “high” and “drug liking” that can lead to addiction. Practical Pain Management recently gave it four out of five stars as a future analgesic.

Desmetramadol, from Syntrix Pharmaceuticals, is another opioid in early testing. Developed with support from the National Institute on Drug Abuse, desmetramadol is designed as a safer version of tramadol, a Schedule IV opioid. Researchers are looking at the results of a recent clinical trial to see whether the new drug “provides the safety and pain relief of tramadol without its metabolic issues.”

VX-150, from Vertex Pharmaceuticals, is a sodium channel inhibitor that late last year finished a “proof-of-concept” Phase II trial successfully. It acts specifically on sodium channels to block the pain caused by small fiber neuropathy. Because these channels are not expressed in the brain, VX-150 should have few if any cognitive side effects. Phase III clinical trials are expected to start later this year.

Tanezumab, from Pfizer and Eli Lilly, just completed a Phase III clinical study for chronic low back pain. The results showed that tanezumab injections were associated with a statistically significant improvement in low back pain compared with placebo. Tanezumab is also being studied as a treatment for osteoarthritis, although there are some lingering concerns about its side-effects.

Finally, the novel compound AT-121 from Astraea Therapeutics is showing promise as a non-addictive opioid analgesic. Researchers created AT-121 to bind to both the mu opioid receptor and the FQ peptide receptor, a combination that blocks the unwanted side effects of current opioid analgesics. Preclinical testing of AT-121 in animals found that it was more potent than morphine, but did not produce physical dependence or tolerance at high doses. The National Institute on Drug Abuse recently called AT-121 a “promising alternative to opioid pain medications.”

Improved understanding of the nervous system and of chronic painful disorders is also contributing to drug development. A recent review in Frontiers in Pharmacology looks at emerging “safer opioids” that provide effective pain relief with fewer side effects. The review explains that the new goal of drug developers is to target opioid receptors in injured or diseased tissues, while avoiding the brain to reduce cognitive side effects and minimize risk of abuse, addiction and overdose.

And new genetic research is identifying genes involved in painful neuropathies. For instance, a recent case report found that a variant in the gene PMP22 is linked to painful peripheral neuropathy in Charcot-Marie-Tooth Disease.

With the prevalence of chronic pain increasing as the population ages, the development of safer, more effective analgesics is critical. Advances in drug development techniques and better understanding of painful disorders should accelerate the process.  

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.

A Pained Life: We Are Survivors

By Carol Levy, Columnist

So many shows on TV celebrate "survivors" -- survivors of cancer and abuse are the most recent examples I have seen.

But those of us with chronic pain are never celebrated. Instead we are ignored, or worse, excoriated as being the cause of the "painkiller epidemic.”

60 Minutes recently did a story entitled "Heroin in the Heartland." In it, those who are prescribed opioid pain medications and their doctors are portrayed as pied pipers to the world of heroin.

The story was not about those who legitimately need, are prescribed, and sensibly use narcotic medications to tame their pain. Even a cursory sentence to negate the stereotype would have been gladly received.

We who live in chronic pain most often seem to be the “fall guy” for the ills of the world, at least when it comes to the use of opiates, both legal and illegal. To the media and maybe the world, we are not survivors, not under their definition: someone who overcomes a serious illness or situation.

After all, we have not “overcome.” We can't overcome, because our struggle is ongoing, every day, for some of us, every minute, every hour; fighting pain and often disability. Even on a good day, for many of us the fight is ever present; the fear of when it will return being in the forefront of all we do and think.

This is how the Merriam-Webster dictionary defines survivor:

1:  to remain alive after the death of : <he is survived by his wife>

2:  to continue to exist or live after : <survived the earthquake>

3:  to continue to function or prosper despite :  <they survived many hardships>

How does that not define us?

We continue every single day, doggedly putting one foot in front of the other. The more able among us continue to work, raise a family, and be an integral part of the community, despite being in severe pain. The amount of stamina, perseverance and strength that takes would take many an ordinary person down and out.

Others of us have pain so severe, so debilitating, that merely being able to go outside, to get to the store, for some even being able to get out of bed, is a Herculean task. And yet, we do it.

It can be hard for us to see and acknowledge this monumental task we succeed at each and every day, merely by getting through each day. We work so hard at the struggle and it becomes so second nature, that it is often invisible to us, just as our pain is invisible to the world. After all, if no one sees the pain, how can they see or understand the struggle?

So how do you define a survivor?

It is easy. Just look in the mirror.

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

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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.