How Did We Come to Abandon America’s Pain Patients?

https://filtermag.org/2019/07/15/abandon-americas-pain-patients/amp/

Overdoses—not those involving prescription opioids, but of heroin and illicit fentanyl, often combined with benzodiazepines—continue to go up. But opioid prescribing continues to go down. Pain patients are untreated and suffering. Pharmaceutical companies are being sued and settling. Law enforcement is cracking down on providers. And many physicians, caught in the middle, have stopped prescribing because they don’t want to get in trouble and possibly lose their livelihood.

This situation is continuing despite the Centers for Disease Control and Prevention (CDC) emphasizing in a commentary published this spring that their guideline on prescribing for chronic pain, released in 2017, is being misapplied.

The CDC authors wrote in April:

Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks. Such actions disregard messages emphasized in the guideline that clinicians should not dismiss patients from care, which can adversely affect patient safety, could represent patient abandonment, and can result in missed opportunities to provide potentially lifesaving information and treatment.

So what has gone so terribly wrong? Because it has.

The Victims

Ian Lewis, who lives in Ohio, having grown up in Tennessee, is 37 years old. He had his most recent surgery on July 8.

His pain started in middle school. He began suffering in seventh grade, but nobody believed that he was in pain. His serious congenital spine problems were discovered when he was 12 years old. He had two blown-out discs, 16 fractures, and a cut durum bleeding into the spinal cord.

Ian’s mother, Terri Lewis, PhD, who teaches for the Rehabilitation Institute at Southern Illinois University in Carbondale, has been his caretaker throughout.

“Up to this point everybody had denied the pain that he was expressing,” said Lewis. He then got excellent care at Vanderbilt in Tennessee, she said, but in 2003 his pain increased. He had two more surgeries, but never healed. For 10 years, he got along on opioids, a “combination of legal and street,” said Lewis. “Cannabis was also pretty helpful, he discovered.”

The problem was the opioid crackdown. After it happened, medical providers  “went all around the block to try not to label this as chronic pain, to call it trouble sleeping, or anxiety, but what he was given—antipsychotics—didn’t help,” said Lewis. “Why didn’t they label it as chronic pain?”

Ian had received nothing at all as a child, when nobody believed that he was in pain. “I can speculate it’s because we don’t recognize pain in kids,” said his mother.

The images below show the fractured Harrington rods that were removed from Ian’s back during his latest surgery, and his back after the operation.

 

 

 

 

 

 

Photos courtesy of Terri Lewis

According to the National Institutes of Health, nearly 50 million American adults suffer chronic pain. They typically face onerous and invasive requirements to obtain repeat opioid prescriptions, and live with the constant threat of being cut off—if they can get them in the first place.

Unfortunately, there is no way to assess the number of patients who have been subject to opioid dose reduction of an informal nature, said Stefan Kertesz, MD, professor of medicine and addiction scientist at the University of Alabama at Birmingham School of Medicine. “Neither is there a there a formal survey to assess the number of patients who have been discontinued, either voluntarily or against their will.”

The situation is difficult because nobody can tell how large the problem is if no data is collected, and because a major policy chance is being enacted with no entities reporting outcomes, Kertesz told Filter. (This study came close in terms of looking at outcomes, but not overall prevalence.)

The suffering caused by denial of opioids sometimes becomes unbearable, and numerous suicides for this reason have been reported.

Gail Groves Scott, an opioid use disorder policy researcher,and doctoral student in health policy, told Filter about a relative of hers who killed herself. The relative had been a urologist, but had switched to prescribing buprenorphine. She developed a pain disorder and probably a substance use disorder as well, and was most likely going to lose her license.

“She was ashamed,” said Scott. “She didn’t have staff, and was probably really struggling financially.” She put fentanyl patches all over her body and died that way.

As for her patients on buprenorphine, “They had nowhere to go, but luckily there were fewer than 20.” She was in Tennessee, where registration requirements deterred new clinics and resulted in a reduction of patient slots.

In general, “Doctors are really nervous about taking a new patient who is on a controlled substance,” said Scott. Asked why, she listed concern about substance use disorder, concern about whether a patient’s previous doctor had been prescribing appropriately, and fear of oversight and potential sanctions.

Why Is the CDC Being Misinterpreted?

Deborah Dowell, MD, MPH, chief medical officer at the CDC’s Injury Center, told Filter that the 2017 guideline was meant to help “primary care clinicians work with their patients to consider all safe and effective treatment options for pain management,” and that “CDC encourages clinicians to continue to use their clinical judgment, base treatment on what they know about their patients, maximize use of safe and effective non-opioid treatments, and consider the use of opioids only if their benefits are likely to outweigh their risks.”

Dowell also referred to the recent CDC commentary, noting that it highlighted “the misapplication of the CDC guideline” and raised “awareness about issues that could put patients at risk.”

Dowell went on to say that the guideline did not apply to anyone but primary care clinicians treating chronic pain for patients 18 and older. It was not intended, she said, for patients in cancer treatment, for example, patients with post-surgical pain, or patients with acute sickle cell crises.

Yet the guideline has been applied—or misapplied—to all of these groups.

What’s more, Dowell said, there was nothing in the guideline’s dosage recommendation that should have resulted in hard limits for cutting off opioids. The guideline states: “When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should… avoid increasing dosage to ≤90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

Yet this is what is happening. “High dose prescriptions, which overwhelmingly accrue to long-term recipients, have fallen 61 percent according to [pharmaceutical consulting company] IQVIA,” said Kertesz.

The details of the CDC guideline are not objectionable. Yet neither is it particularly encouraging to doctors who prescribe opioids needed for pain.

Dowell noted that that 2017 guideline also does not support abrupt tapering or sudden discontinuation of opioids, which can result in severe withdrawal symptoms, leading some patients to “seek other sources of opioids.” In addition, she said, “policies that mandate hard limits conflict with the guideline’s emphasis on individualized assessment of the benefits and risks of opioids given the specific circumstances and unique needs of each patient.”

Yet these policies are abundant, even prevalent. Abrupt tapering and discontinuation is happening, far too often.

Dowell also noted that patients receiving medication-assisted treatment (with methadone or buprenorphine, both opioids) for opioid use disorder (OUD) do not fall under the guideline, which concerns only chronic pain, not OUD. In fact, the guideline recommends offering these medications to patients with OUD.

The details of the CDC guideline are not objectionable. Yet neither is it particularly encouraging to doctors who prescribe opioids needed for pain. And the guideline’s widespread misinterpretation gives reason to question whether it puts too little emphasis on the importance of opioid prescribing to relieve suffering—and too much on the possibility of opioid prescriptions leading to OUD.

The CDC acknowledges the rarity of this latter scenario. When I asked Dowell how many patients who take opioids as prescribed actually develop OUD (as opposed to becoming physically dependent, which every long-term opioid user does), she replied in an email:

“One [2014] study* found that, among patients prescribed opioids for pain, rates of opioid use disorder diagnosis ranged from 0.7% with lower-dose (≤36 MME) chronic therapy to 1.3% for medium dose chronic therapy to 6.1% with higher-dose (≥120 MME) chronic therapy (versus 0.004% with no opioids prescribed).”

So for addiction rates of 0.7 -6.1 percent across all doses, virtually all pain patients are now either suffering in untreated pain or under threat of it? How did this happen?

“The guideline has been institutionalized to forcibly change patients’ care.”

By issuing the recent comment, the CDC basically admitted that misapplication of its guideline has had a chilling effect on prescribing. But it’s also important to acknowledge the limits of the CDC’s influence.

The CDC doesn’t regulate doctors. After the guideline was released, many in the addiction field did not think doctors would reduce prescribing, as there was no enforcement behind it.

It turned out, they were wrong. Still, scaremongering politicians’ pronouncements, law enforcement crackdowns, Pharma lawsuits and relentless media “opioid epidemic” coverage have all played their part.

Kertesz supported the initial CDC guideline, but became concerned about its interpretation. “Over the last three years, I have seen patients harmed,” he told Filter. “I have written repeatedly about the fact that the CDC’s guideline was good but was misapplied. Broadly speaking, it was a reasonable document, but it has been institutionalized to forcibly change patients’ care.”

This March, he, along with other experts and Human Rights Watch, submitted a letter making this point to the CDC. It caused distress at the agency, which did not believe it had caused the denial of pain medication.

“I asked them how difficult would it be for the CDC to issue a defense of the guideline, with a little clarification?” Kertesz said. That day, a CDC official told him it was very difficult. But on April 24, in the New England Journal of Medicine, that clarification came.

“That’s courage in action,” said Kertesz, who is somewhat of a hero to pain patients across the country.

Why Physicians Are Frightened

Regardless of what the CDC says, it’s doctors who do the prescribing—and they’re the ones who don’t want to do it any more.

Scott, now an opioid use disorder policy researcher, previously worked as a pharmaceutical representative, selling many drugs for addiction and pain. Even then—well before the CDC guideline—she saw doctors’ hesitancy to prescribe.

“Doctors were becoming more aware,” she said. “We know that there was overprescribing. There was also an increase in electronic health records and prescription drug monitoring programs, which made everyone more aware of who was an outlier. This impacted physicians’ comfort level in prescribing opioids.

“They say that they want to know who has addiction and who doesn’t, but the real reason is they are terrified, of administrative and legal problems.”

“Nobody saw what was going to happen,” Mark A. Weiner, MD, representing the American Society of Addiction Medicine, told Filter. “Pain doctors are coming to me and my colleagues to answer the question of who’s who”—meaning which patients on opioids for pain have pain, and which are addicted.

This has been going on for years, according to Weiner. “They say that they want to know who has addiction and who doesn’t, but the real reason is they are terrified, of administrative and legal problems.” Weiner supports law enforcement, but “do they think everybody’s an addict?” He believes that prescription drug monitoring programs can help—but only if they are used properly. Used improperly, they just contribute to the problem.

Like many, Weiner cites the “pendulum”—one of his presentation slides has a moving pendulum in it. “On one side is 1985-2000, where people said we need to treat all the pain we can,” he said. “Then the pendulum started moving, through the middle part—the rational approach.”

But now, it’s swung too far to the other side. Weiner helps move it back toward the middle by reassuring physicians who provide palliative care for cancer and hospice that “it’s okay” to prescribe opioids. “I’m an addiction doctor, not a pain doctor, so I they listen,” he said. “But I often hear they’re not happy with it.” That’s because it’s their livelihoods on the line.

“The focus on prescribing is not unimportant,” said Richard Saitz, MD, professor at Boston University Schools of Medicine and Public Health. “Yes, exposure to opioids is a factor in developing opioid addiction, but it isn’t the sole factor, and focusing on prescribing of opioids is a bit like looking for the keys under the lamppost because that is where the light is.”

Rather, he told Filter, it’s important to focus on appropriate prescribing for the individual. Of course, nobody would argue with that medically. “But instead, PDMPs and insurance regulations focus on what is easily countable and set population goals to reduce and eliminate. As a result clinicians want less and less to do with opioid prescribing, even for acute pain.”

What the CDC guideline did, said Saitz, was give clinicians who were already uncomfortable prescribing opioids back-up to just taper or not prescribe.

Pharma Lawsuits’ Chilling Effects on Prescribing

A string of high-profile lawsuits against opioid manufacturers—the first in Chicago in 2016, the most recent in Oklahoma—have further impacted prescribing by adding to physicians’ discomfort, although the chill started before then. State medical boards and the American Medical Association, too, seem more concerned about overprescribing than patient abandonment.

The lawsuits definitely had a chilling effect on Pharma itself, and on the organizations Pharma supported. As for cancer and other conditions, pain patient advocacy often comes from the treatment field.

Loss of Pharma funding for pain advocacy groups has been significant. Lawsuits have alleged that Pharma used organizations like the American Pain Society, which is now disbanding, to promote their products.

In 2016, about the same time that Pharma companies started getting sued, they cut off the American Pain Society and others, said Bob Twillman, PhD, former executive director of the Academy of Integrative Pain Management and current clinical associate professor at the Department of Psychiatry, University of Kansas Medical Center. They no longer took booths at conferences. And they started reserving their cash for settlements. “Pain is still a valid specialty, but now, everybody’s too scared to prescribe.”

They were suing companies for dishonestly marketing products that relieved pain, so it wasn’t convenient to acknowledge the value of these products.

A combination of finance and politics motivates the lawsuits, Twillman told Filter. “There’s money there.” There is the money that Oklahoma, for example, will receive—but also a motive for prosecutors who may want to get elected to higher office.

But Kertesz said that the prosecutors are doing their job. “They have one goal, which is to secure as much money as possible, not to worry about people who aren’t getting pain medication,” he said. “That’s not their department.”

And Kertesz, like Scott, is skeptical of all Pharma marketing. “I view it as a public menace,” he said. “I don’t think it’s wrong to get money out of the pharmaceutical companies.” But he does think the money should go to treating people. “I have a concern about significant portions of the settlement money going to pay scholars,” he said, referring to academic appointments.

“The other thing that concerned me about the attorneys general,” Kertesz said, “is they seem to want to preserve a pristine, simple, one-directional narrative, and anything that acknowledged the value of pain care was a threat to the lawsuit.”

So they left that part out. They were suing companies for dishonestly marketing products that relieved pain, so it wasn’t convenient to acknowledge the value of these products. And that directly hurt pain patients.

None of this is black-and-white. But the attempt to make it so has demonized pharmaceutical companies, prescribers and patients.

“Callous paternalism will be a poor substitute for care, resulting in promoting harm, suffering and a contempt for the healthcare delivery system.”

“There is no question that prescription opioids have been mis-prescribed and over prescribed,” H. Westley Clark, MD, JD, dean’s executive professor with Santa Clara University, told Filter. “There is no question that a few opioid prescribers devolved into being quasi-drug dealers. There is also no question that some patients have developed opioid use disorders as a result of imprudent opioid prescriptions.”

“However, in our zeal to curtail the excessive prescribing of opioids for the treatment of pain, we have trampled on the clinical needs of those individuals who have benefited from the use of opioids for the treatment of pain, said Clark, a former director of the Center for Substance Abuse Treatment at the federal Substance Abuse and Mental Health Services Administration.

“Those living with chronic non-cancer pain need to be heard,” he continued. “Their opinions need to a part of the dialogue for treatment. Those experiencing intractable pain are stakeholders in the discussion about the appropriate treatment of pain, but their opinions have been dismissed and their input trivialized. It is time to return to a rational approach to pain management, an approach that takes into consideration of input of those who suffer from pain, making sure that they are a part of the treatment team.”

“Otherwise,” he concluded, “callous paternalism will be a poor substitute for care, resulting in promoting harm, suffering and a contempt for the healthcare delivery system.”

Moving the Pendulum

“I certainly see liberal prescribing as playing a role,” said Kate Nicholson, a civil rights attorney who advocates for pain patients, of the overdose crisis. “I think people can become addicted, of course.”

Nicholson, who has a pain history of her own, and does most of her advocacy work for free, cites the National Institute on Drug Abuse/CDC incidence range of 0.7 to 6.1 percent.

Andrew Kolodny, MD, is co-director of Opioid Policy Research at the Heller School for Social Policy and Management at Brandeis University and a leading advocate for much stricter controls on opioid prescribing. He did not want to be quoted in this article but his testimony was instrumental in the Oklahoma lawsuit.

Rather than the NIDA-CDC figures, Kolodny instead uses a cross-sectional OUD prevalence figure, which includes people who had a history of misuse and in general were not well-screened before being prescribed opioids, said Nicholson. One article Kolodny cites gives figures of 3.5 percent for severe OUD symptoms and 58.7 percent for “no or few symptoms.”

“What I find difficult is that the treatment of pain is being framed as responsible for spawning a crisis.”

“We know that most who misuse did not receive medications directly from a doctor and already had a developed history of using other strong substances,” Nicholson said. “But, sure, some people undoubtedly got hurt from liberal prescribing. What we need is a return to nuance. What I find difficult is that the treatment of pain is being framed as responsible for spawning a crisis—and so patients in pain are beleaguered and disregarded.”

Amid the suffering, there have been rays of hope. The CDC’s April comment was one of them. And in New Hampshire this month, one physician was reprimanded for cutting back on a patient’s painkillers.

Pain patients—for all the stigma, lack of funding and other obstacles they face—are continuing to speak out. If we want the pendulum to swing back to somewhere rational, we have to hear them.

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* Edlund MJ, Martin BC, Russo JE, DeVries A, Braden JB, Sullivan MD. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription. Clin J Pain 2014;30:557–64.

Top photo by Ryan Park on Unsplash

The author wishes to dedicate this piece to “all of the physicians who bravely treat pain patients with opioids, and to the patients who have been suffering through this nightmare.”

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DEATH on the Battlefield is Preferable

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Trump WH Seeks To Monitor The Disabled To Ensure They Aren’t “Too” Happy

https://mavenroundtable.io/theintellectualist/news/trump-wh-seeks-to-monitor-the-disabled-to-ensure-they-aren-t-too-happy-1GE1YTfza0KHKw1oGIOrYA/

A new policy proposal by the Trump administration calls for the surveillance of disabled people’s social media profiles to determine the necessity of their disability benefits. The proposal, which reportedly aims to cut down on the number of fraudulent disability claims would, monitor the profiles of disabled people and flag content that shows them doing physical activities. When it comes down to it, the policy dictates that disabled people shouldn’t be seen living their lives for fear of losing vital financial aid and, possibly, medical care.

The administration has been working closely with the Social Security Administration in an effort to reduce false claims believing that social media holds a cache of information regarding eligibility of Social Security Disability Benefits. They believe that by monitoring the social media accounts of disability benefit recipients, they can root out false claims and reduce the overall amount of money spent on the programs.

The proposal, like many of its policies regarding disabled people, shows a fundamental misunderstanding of disability and takes advantage of how social media operates in order to cut them off from the support they need. Disabled people don’t all function in the same way, and disability is not a set of stereotypes like taking selfies staring longingly at the world. They live lives while managing their energy for the activities they can handle and trying to make those they cannot more accessible.

Additionally, studies have shown that a majority of social media users show only the good in their lives, not the hardships or difficulties. Disabled people should be allowed to share the full scope of their existence without fear they’ll be accused of lying—and even fraud—by the United States Government which will likely reason that if a disabled person is seen going to the mall or taking time to swim or jog, they can be working.

The truth about disability is that it isn’t a series of down moments but both highs and lows that comprise the lives of the disabled. Simply because disabled people are seen exercising, dancing or shooting hoops does not mean that they have the ability to sustain that level of energy all day. This type of policy also plays upon the assumption that people with disabilities all function and move about in the world in the same way, which is entirely untrue. There are wheelchair users who can walk, people with cerebral palsy that can run and amputees that are bionic. It is just as dangerous to assume that disabled people should have to “overcome” their disabilities to do what they love as it is to assume there is nothing they want to do. One person’s body should never be considered a prescription for another.

Another thing that the general public does not understand about disability and the internet is that attention to disability issues often operates within an economy of “Inspiration Porn.” Abled people often film, post, share and circulate photos and videos of disabled people doing extraordinary things as a litmus test to how “poor” life could be with a disability and how disabled people achieve “in spite of” their disabilities (quite often, this type of posting occurs without the disabled person’s permission). And, while many disability advocates disdain this type of media representation and are vocally calling for an end to inspiration porn, there’s a not-so-often talked about number of disabled people who play upon these stereotypes for their advocacy and to further their own quest for disability rights.

Quite often, in order for disabled people to be seen as needing help, nondisabled people need to see them as pitiful, helpless and ripe for a nondisabled person to swoop in and play hero. Without the ability to do so, a great many nondisabled people would not pay attention to disability issues. Disabled people know that, and it would appear the U.S. Government does as well. Public sympathies rarely side with disabled people who appear confident and comfortable in their own bodies. Therefore, there will be little outrage for cuts to disability benefits for active disabled people.

Aside from the cruelty it takes to cut necessary funds from a disabled person’s life because of a moment of activity, it seems willfully ignorant. Many in society already see disabled as “fakers” trying to take money from unsuspecting people, and this policy would only raise those tensions among the public. Disabled people are people, and as such, lead complex lives with ups and downs like the rest of the population. Relying upon a reductive narrative of disability is dangerous and will cost lives. Due to this, the administration should look inward and learn how to #BeBest.

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CDC’s new opioid guidelines will be used by plaintiffs bar, WLF says

https://legalnewsline.com/stories/510704148-cdc-s-new-opioid-guidelines-will-be-used-by-plaintiffs-bar-wlf-says#.XSopWi6hyUg.facebook

WASHINGTON (Legal Newsline) – A Washington, D.C.-based public-interest law firm that has been outspoken about the Centers for Disease Control and Prevention’s handling of an opioid guideline development team argues the agency’s new guidelines, which were issued this month, will “no doubt” have an effect on future litigation.

Richard Samp, chief counsel for the Washington Legal Foundation, argues plaintiffs law firms, including Cohen Milstein Sellers & Toll PLLC, will use the CDC’s approval and release of the guidelines to their advantage.

“Will the plaintiffs bar use these guidelines in their pending litigation? I have no doubt that, yes, they will,” Samp told Legal Newsline.

The CDC released its new guidelines regarding prescriptions for opioid painkillers, such as Vicodin and OxyContin, March 15. The guidelines, which are voluntary, recommend primary care physicians:

* Use non-opioid therapy for chronic pain management, outside of active cancer, palliative and end-of-life care;

* Prescribe the lowest possible dosage when opioids are needed; and

* Always exercise caution when prescribing opioids, monitoring patients closely.

“Overprescribing opioids — largely for chronic pain — is a key driver of America’s drug-overdose epidemic,” CDC Director Tom Frieden said in a statement. “The guidelines will give physicians and patients the information they need to make more informed decisions about treatment.”

Samp says WLF takes no issue with the guidelines themselves, but the agency’s procedures used to develop the guidelines.

“We’re not medical experts,” he said. “We take no issue on whether guidelines should be issued, or what they should say.

“But we do recognize there is a broad spectrum of views as to what could be done, and the process used by the CDC did not provide a fair opportunity for everyone to participate.”

For one, Samp argues the CDC did not follow the Federal Advisory Committee Act.

FACA, which became law in 1972, governs the behavior of federal advisory committees.

Under the law, an advisory committee is defined as “any committee, board, commission, council, conference, panel, task force, or other similar group” that dispenses “advice or recommendations” to an agency or government official.

Committees composed of full-time officers or employees of the federal government do not count as advisory committees under FACA.

The CDC has argued that its Core Expert Group, or CEG, didn’t qualify as an advisory committee under the federal law.

WLF, in a 13-page letter sent to Frieden in November, countered that the CEG indeed fell under the definition and was required to comply with each of the law’s “numerous obligations,” including opening all meetings to the public; publicly releasing all documents that the CDC made available to the CEG; and preparing and publicly releasing minutes of all CEG meetings.

Instead, the CDC complied with none of the requirements, Samp and General Counsel Mark Chenoweth wrote in their letter for WLF.

“(The CDC) nominated this advisory group to help come up with these guidelines, but the group met totally in secret,” Samp said.

“Only after the initial draft guidelines were released did they say who was on the advisory group.”

A complete list of the Core Expert Group members and other internal documents surrounding the prescribing guidelines surfaced in September.

The names on the list included Jane Ballantyne, a paid consultant for Cohen Milstein.

Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and in 2014 was named president of the Physicians for Responsible Opioid Prescribing, or PROP. PROP’s mission, according to its website, is to “reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.”

WLF, in its letter, pointed out that Ballantyne was one of “numerous” members of the CEG who were on record — well before joining the committee — as “strongly supporting the need to tighten opioid prescribing standards.”

“Conspicuously absent from the CEG, however, were physicians and others with experience in treating patients suffering from chronic pain,” Samp and Chenoweth wrote.

The foundation called Ballantyne’s inclusion the “most egregious.”

Ballantyne disclosed her services as a paid consultant for Cohen Milstein to the CDC, but didn’t recuse herself. The plaintiffs law firm is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.

The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers, and another by the California counties of Orange and Santa Clara.

It also is trying to assist the New Hampshire Attorney General’s Office in a similar investigation over drug makers’ marketing of the powerful prescriptions. However, a state judge recently struck down the contingency fee agreement between the attorney general and Cohen Milstein.

“Clearly, if the CDC issues guidelines that essentially urge states to change prescribers’ practices and to implicitly criticize past prescribing practices, that’s something you would expect Cohen Milstein in its lawsuits around the country against drug companies to tout,” Samp explained. “It’s in the direct financial interest of plaintiffs lawyers to have these CDC guidelines adopted.

“That’s why we think it was a terrible mistake to include people like Jane Ballantyne on its advisory group, when she clearly has an interest in the outcome.”

Andrew Kolodny, a senior scientist at the Heller School for Social Policy and Management at Brandeis University and PROP’s executive director and co-founder, has countered that Ballantyne is “one of the most respected pain specialists in the country,” which is why the CDC asked her to join its expert group.

No doubt in response to the public outcry over the development of its guidelines, the CDC announced in December it planned to publicly post the guidelines and seek comment.

“We received feedback from our partners that a formal public comment period would be helpful, and we are augmenting our process to incorporate a 30-day public comment period into our guideline development,” the agency said in a statement.

The public comment period ended Jan. 13, pushing back the agency’s original release date. The CDC had hoped to release the opioid guidelines in January.

Also in December, the CDC said it would convene the National Center for Injury Prevention and Control’s Board of Scientific Counselors, a federal advisory committee, to review the draft guidelines.

“I would like to think that the CDC’s decision in December to slow things down might have been based, in part, on our complaints,” Samp said. “But they never really corrected the problem.

“It again displays their misunderstanding of what is required by FACA.”

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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https://www.cato.org/blog/senators-manchin-braun-are-attempting-practice-medicine-without-license-fighting-wrong-war

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Opioid Labeling Bill Drawing Fire from Chronic Pain Advocates

www.nationalpainreport.com/opioid-labeling-bill-drawing-fire-from-chronic-pain-advocates-8840456.html

Posted on July 13, 2019 by Ed Coghlan

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Column: Condemn the opioid epidemic, sure. But remember those of us in chronic pain who need help.

https://www.chicagotribune.com/columns/ct-living-in-chronic-pain-opioid-use-essay-20190713-qkh4jjsdm5gtxgc6452tseljce-story.html

Chicago Tribune reporter Katherine Rosenberg-Douglas is injected with anesthesia ahead of a spinal injection procedure on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas needs aggressive pain management after breaking her back while rollerblading years ago.

Maybe it would be easier if I looked like I was dying.

Easier for the pharmacists, doctors, impatient friends, well-meaning family and the suspicious people who eye me up and down when I use my handicapped parking placard. It wouldn’t be easier for me — I already feel like I’m dying.

I broke my back while Rollerblading when I was 21. After three surgeries beginning at age 30, I’ve recovered enough that I’ve gone on to what looks like a normal life. I’m a married mother of twin 4-year-olds, so I am relatively stressed, but fortunately, I’m otherwise relatively healthy.

I’m also on a fentanyl patch delivering slow and steady pain relief to keep me feeling like I can get out of bed, and morphine for breakthrough pain when life requires more of me than merely getting out of bed — and anyone who has ever had a 4-year-old knows each day is far more demanding than that. Just driving my kids to school or sitting for longer than 20 minutes at a time is a struggle.
[Most read] Column: Put this Serena Williams quote on all the motivational posters. The world needs to hear it. »

So is driving to the pharmacy, or to my doctor, both of which I must do every 30 days. To obtain a controlled substance in Illinois, one must visit a pain specialist because family physicians can’t prescribe this type of medicine long-term.
Chicago Tribune reporter Katherine Rosenberg-Douglas undergoes a spinal injection procedure on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has faced increasingly onerous regulations in managing her pain amid the opioid epidemic.
Chicago Tribune reporter Katherine Rosenberg-Douglas undergoes a spinal injection procedure on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has faced increasingly onerous regulations in managing her pain amid the opioid epidemic. (Erin Hooley / Chicago Tribune)

When we moved to Illinois in 2016, I had been on prescription opioids for almost a decade. I actually called up doctors and asked receptionists if they were taking new patients, and if the doctor prescribed opioids. After what I took to be stunned silence, I was either told they didn’t give that information on the phone or they couldn’t say because it was on a case-by-case basis.

I understand now that amid a deadly opioid crisis I must have sounded like a drug-seeker, though I just wanted to avoid wasting time or money. I have been dealing with this pain close to half my life, and we move often. I know how hard it can be finding a new doctor and transferring records to receive continuous care. In my first few weeks here I visited nine doctors, including neurosurgeons, orthopedic doctors and pain management specialists. They all agreed I needed strong pain medicine but said they weren’t the correct doctor to help me.
Relieving pain is a pain

The doctor I chose is about 30 miles from my home. He tells me it’s troublesome keeping up with his patient load as other area doctors leave the specialty. Thankfully, many pill mills have been shut down, but even good doctors have closed up shop as keeping up with ever-changing restrictions imposed by legislators has become increasingly arduous, my doctor told me.

Among the most asinine of guidelines pushed by various plans to end the opioid epidemic: A pain doctor’s records should show he or she is trying to reduce the number of medications and the dosage patients are on. If your formerly high cholesterol returned to a healthy level with a certain dosage, can you imagine your doctor cutting the dose in half on your next visit?
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It’s not clear to me what purpose the every-30-day visits serve, other than to pick up my written prescriptions — controlled substances can’t be called in. But just as these rules unnecessarily hurt those of us in real pain, they also won’t deter a junkie who wants a fix.
A monitor shows pain management specialist Dr. Richard Caner performing a spinal injection procedure on Chicago Tribune reporter Katherine Rosenberg-Douglas on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has needed opioids to control severe pain for more than a decade.
A monitor shows pain management specialist Dr. Richard Caner performing a spinal injection procedure on Chicago Tribune reporter Katherine Rosenberg-Douglas on July 2, 2019, at PrairieShore Pain Center in Lincolnshire. Rosenberg-Douglas has needed opioids to control severe pain for more than a decade. (Erin Hooley / Chicago Tribune)

I also pee in a cup at the visit. I didn’t know the true purpose of the urinalysis until about a year ago. I thought it was to ensure I wasn’t taking anything other than what my doctor prescribed. But it’s actually to ensure I am taking my drugs, not selling my fentanyl and morphine.

There also are no refills allowed on controlled substances and no bulk prescription by mail. There are no early fill dates. Not even at 29 days instead of 30, not even if you will be out of town. And if you’ll be out of state? Better to rearrange that trip. An out-of-state pharmacy likely won’t fill your prescription.

Even if intending to pick up the medication after day 30, I can’t drop off the piece of paper in advance. I must turn it in and wait for it to be filled. If this sounds insignificant, remember, the people affected are in many cases dying, or living in so much pain that sitting an hour in a waiting room is excruciating.

Say the pharmacy has in stock only some of the 150 morphine pills I take each month, something that happens to me every few months, because pharmacies try to keep quantities low to discourage robbery by drug seekers. If I agree to accept 90 pills, for example, I can’t get the remaining 60 without another prescription.
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My personal record for pharmacies visited in a single day is 14.
Doctors don’t decide if you need it, pharmacists do

Last month, I dropped off a prescription before I started work at 7 a.m. on a Sunday, and the pharmacist said she’d need to speak to the doctor so I probably wouldn’t get it until Monday. I had my doctor paged at 6:30 a.m. Agonizing hours passed before I called and pressed for the reason. She told me there were “great distances involved,” between my address, the doctor’s office and where I was visiting my parents for the weekend — although they’re all about a 45-minute drive, pretty standard for Chicagoland.

“It’s suspicious,” she said.

The previous month a pharmacist told me she wasn’t comfortable with the combination of fentanyl and morphine because, “It’s a lot of pain medicine.”

She filled the fentanyl patches but would not fill the morphine. When possible, I’ve used the same pharmacy chain for much of the past 10 years so there would be an easily accessible log of my prescription history, so I implored her to look. She said she had.

“If anything were to happen to you, I would lose my license, not your doctor,” she told me. I mentioned that without the morphine I’d taken for so long, she was putting me in a more perilous situation than if she did. True, she admitted. “But I have the right to refuse to fill any prescription for any reason, and I choose not to fill this for you.”

Then she gave me directions to a rival pharmacy chain’s store.
Chicago Tribune reporter Katherine Rosenberg-Douglas is helped to her ride from friend Courtney Holbrook with the help of medical assistant Mario Flores after undergoing a spinal injection procedure on July 2, 2019. Use of a fentanyl patch has helped to correct a pronounced limp.
Chicago Tribune reporter Katherine Rosenberg-Douglas is helped to her ride from friend Courtney Holbrook with the help of medical assistant Mario Flores after undergoing a spinal injection procedure on July 2, 2019. Use of a fentanyl patch has helped to correct a pronounced limp. (Erin Hooley / Chicago Tribune)
Pain you can’t see

I have a number of diagnoses. Failed back syndrome, a medical term that means just what it says and suggests surgery didn’t help. A “bone stimulator” was implanted during one surgery to encourage growth between pieces of cadaver bone and my own vetebrae, but too much bone grew in around my sciatic nerve, giving me sciatica, or a burning sensation from my rear down my left leg to my toes, which often are numb and tingling (I take another medication for nerve pain). My left leg has so much atrophied muscle that it drags behind my right and I had a pronounced limp, but the fentanyl patch largely has eliminated that by providing more steady pain relief. I am disabled, but no longer outwardly appear so, which, along with my age, probably accounts for the daily dirty looks people shoot me when I park in handicapped spaces.

I understand why police, politicians and many doctors want to combat the opioid epidemic, but I’m tired of people throwing around that term and lumping me in with a group of drug abusers.

I support the spirit behind their efforts, but can’t support any more regulation on controlled substances. We have now overcorrected, and anyone who requires pain medicine is looked upon as a criminal.

It was once hard to imagine being in more pain than I am, but the current regulations added a new layer of suffering. Please remember opioids exist for a reason, and don’t let it get any more difficult for those already in agony.

kdouglas@chicagotribune.com

 

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Congressional Bills Target Patient Care Access, Opioid Treatment

https://patientengagementhit.com/news/congressional-bills-target-patient-care-access-opioid-treatment

The legislation would improve patient care access and access to medication assisted treatment for opioid use disorder.

July 12, 2019 – Bipartisan legislation in the House of Representatives and Senate would abolish administrative barriers that keep some providers from prescribing medication assisted treatment, thus expanding patient care access and treatment for substance used disorder (SUD).

The Mainstreaming Addiction Treatment (MAT) Act would specifically get rid of requirements that state prescribers must obtain a waiver from the Drug Enforcement Agency (DEA) to prescribe buprenorphine, a key substance used in medication assisted treatment.

Additionally, the legislation would require the Secretary of the Department of Health & Human Services (HHS) to create a national provider education campaign informing providers of the change in medication assisted treatment policy and encouraging them to integrate addiction treatment into their care offerings.

The legislation has been introduced into both the House and Senate, gaining bipartisan approval. House bill co-sponsors include Representatives Paul Tonko (D-NY), Antonio Delgado (D-NY), Ben Ray Lujan (DNM), Ted Budd (R-NC), Elise Stefanik (R-NY), Mike Turner (R-OH). In the Senate, Congresswomen Maggie Hassan (D-NH) and Lisa Murkowski (R-AK) sponsor the bill.

“Medication-assisted treatment is the gold standard for treating substance use disorder, and we need to break down the barriers that prevent more health care providers from treating patients in need,” Hassan said in a statement on her website. “I urge my colleagues in the Senate to support this commonsense, bipartisan measure in order to expand access to buprenorphine and help more people get on the road to recovery.”

It is ironic that providers can prescribe opioids but cannot freely prescribe medications used to treat opioid use disorder, Murkowski pointed out in a statement.

“By removing barriers to life-saving medication-assisted treatments that have been clinically proven to help patients safely reduce or even end their dependence on opioids, we can ensure Americans struggling with substance abuse have access to the treatment they need to fully recover,” she said.

The bill will also have positive implications for patients living in rural regions who often struggle with geographic barriers in place between them and physicians.

“This bill also addresses some of the geographical challenges that many face in Alaska, by allowing community health aides and practitioners to offer MAT working with a provider through telemedicine. Overcoming addiction is already difficult enough,” Murkowski said. “I’m proud to support this effort to increase access to recovery services and save lives.”

Passing such legislation will be critical to quelling the nation’s opioid epidemic, according to Representative Paul Tonko. Over 70,000 people died from an opioid overdose in 2017, he reported in a fact sheet about the House version of the bill. Meanwhile, only about one in five individuals are receiving the opioid treatment they need right now.

“The devastation of America’s opioid crisis has touched every part of our country, and access to treatment is a matter of life and death,” Tonko said. “Our national response needs to rise to meet the unprecedented scale of this crisis.”

Industry efforts to address the opioid epidemic stretch beyond Congress. Earlier this week, United Health Foundation announced a partnership with the Helen Ross McNabb Center and the University of Tennessee Medical Center to expand patient access to behavioral health providers.

The $1.05 million grant will allow the Helen Ross McNabb Center to expand the University of Tennessee’s emergency department services catered toward substance use treatment.

Specifically, the grant will help the Center drive patient education among those presenting in the ED with substance use disorder, refer at least 250 patients to outpatient treatment centers per year, and hire addiction specialists to work within the ED to consult on patients.

“Every day we see the devastating effects of substance abuse and addiction on East Tennesseans,” said Jerry Vagnier, president and CEO of the Helen Ross McNabb Center. “We are grateful to have a partner like the United Health Foundation to help us expand the reach of our resources and services to meet the needs of our neighbors and their families. Together we will improve the lives of the people we serve.”

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