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Policy

Flawed proposed Oregon opioid policy opposes CDC guideline, creates risks

The misapplication of the CDC guideline on opioid prescribing for chronic pain has caused confusion, suffering, and harm to patients. Fundamentally, policies and practices that support tapering to specified doses or involuntary opioid tapering runs counter to guidance from the CDC, FDA, the U.S. Surgeon General, the American Medical Association, and the American Academy of Pain Medicine.

The state of Oregon has continued to push forward proposed policy that misapplies the CDC guideline and has NO EVIDENCE BASE. For this reason, colleagues and I submitted numerous correspondences to the Oregon Task Force (HERC) that is proposing this policy be imposed on hundreds of thousands of Medicaid recipients.

Once more, I write to HERC to underscore the national opposition to this terrible pain care plan.

Please see my formal request for Oregon to cease and desist opioid tapering place that both lack evidence and place patients at risk.

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Response to Draft Report on Pain Management Best Practices

The Comprehensive Addiction and Recovery Act (CARA) of 2016 led to the creation of the Pain Management Best Practices Inter-Agency Task Force (Task Force), whose mission is to determine whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices. The Task Force has released its draft report and has been open for public commentary. I have submitted my comments which are attached here in PDF. Text is pasted below.

My primary recommendation is for the Task Force to recommend the full adoption of the National Pain Strategy within the Best Practices Report.

Click here to submit a formal comment.


March 31, 2019

U.S. Department of Health and Human Services
Office of the Assistant Secretary for Health
200 Independence Avenue SW, Room 736E
Attn: Alicia Richmond Scott, Pain Management Task Force Designated Federal Officer
Washington, DC 20201

I applaud your Department’s leadership in first developing and now releasing the Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations for public commentary. The Pain Management Best Practices document is a comprehensive review of gaps in or inconsistencies between best practices for pain management (including chronic and acute pain) developed or adopted by Federal agencies. As the government is formulating the best policy to help address our country’s public health crises in pain, I wish to bring attention to the Health and Human Services approved National Pain Strategy (NPS).

The NPS is a critically important follow-up to the landmark Institute of Medicine’s (IOM) 2011 report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research.  A core recommendation of the 2011 IOM Report: Relieving Pain in America is (Recommendation 2-2): “The Secretary of the Department of Health and Human Services should develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and resources.”

As Co-Chair of the Oversight Panel (with Dr. Linda Porter – NIH) we convened a Task Force organized into six thematic working groups and comprised of approximately 80 members, with broad representation and expertise in accord with the recommendations of the IOM committee. Screening and selection of the NPS Task Force members was a multi-step process, performed according to FACA’s requirements.

The National Pain Strategy is a roadmap toward achieving a system of care in which all people receive appropriate, high quality and evidence-based care for pain. The NPS consists of 17 strategic goals provide a time frame for completion of deliverables and presented as short (approximately one year), medium (two to four years), and long term (within five years). Stakeholders best positioned to achieve the deliverables are identified and metrics to assess progress are suggested. The report was intended to initiate a longer-term effort to create a cultural transformation in how pain is perceived, assessed, and treated—a significant step toward the ideal state of pain care. The NPS also aligns thematically, strategically, and metrically with international policies, therefore staging the US to participate fully in global alliances.

I therefore recommend that the Pain Management Best Practices document specifically recommend the full adoption of the National Pain Strategy. While HHS has already approved and recommended the NPS for implementation, having it fully endorsed in the Best Practices document will have multiple benefits. It will avoid confusion due to overlap with some of the recommendations in the Best Practices document and the NPS. Furthermore, the NPS currently provides a tactical, time-based, metric driven roadmap that is ready for full implantation now. Calling out the need for resources and leadership to implement the NPS will allow HHS to achieve meaningful results in the near-term, all while the Best Practices plan is considered and a similar time-based, metric driven roadmap developed with appropriate stakeholders identified and input obtained. Endorsement and recommendation for full implementation of the NPS would be a success for HHS, the Pain Management Best Practices Task Force and for United States citizens who suffer from acute, chronic and cancer pain.

Sincerely,

Sean Mackey, MD, PhD
Redlich Professor
Chief, Division of Pain Medicine
Director, Stanford Systems Neuroscience and Pain Laboratory
Department of Anesthesiology, Perioperative and Pain Medicine, Neurosciences and Neurology, by courtesy

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National Doctors’ Day 2019

Today is a day to honor our doctors for their dedication and hard work in helping to cure disease and improve the health and well-being of our citizens. National Doctors’ Day marks the date that Crawford W. Long, MD administered the first ether anesthetic on March 30, 1842 to allow surgical removal of a neck tumor. Doctors Day was first observed in Winder, GA on March 30, 1933 and in 1991 the U.S. Congress officially declared March 30 as Doctors’ Day in the U.S.

As a pain physician, I note that this day is marked by an event important to both Anesthesiologists and Pain Medicine physicians. Without that first successful administration of ether anesthesia, the only way to have performed that surgery would have been unbelievably painful. This event opened the doors to the modern surgical approaches and the search for safe and effective treatment for pain.

I want to particularly recognize those docs who have dedicated their lives to helping to reduce pain and improve quality of life in those suffering from chronic pain. We have made much progress. However, we have much hard work remaining to achieve our goal of a revolution in the way we assess, treat and manage those with pain. Working together we can make that goal a reality. Happy National Doctors’ Day!

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Pain and Addiction Leaders Raise Alarm on Oregon Force Tapering Opioid Proposal

With the incredible dedication and efforts of multiple clinicians and patients advocated for those in pain, we a submitted a letter to Oregon HERC expressing deep concerns about Oregon’s proposal to force a vulnerable group of its citizens to taper off of opioids. Special thanks go out to Andrea Anderson, Dr. Stefan Kertesz, Kate Nicholson, and Dr. Beth Darnall who did most of the heavy lifting. We submitted the letter for today’s meeting, March 14, 2019 and released the following press release below. There are several versions of the letter:

The full letter can be found here: Oregon HERC 3-7-19

  • We were required to trim that letter to 1000 words or less for the formal electronic submission. That letter can be found here: Oregon HERC 3-12-19
  • Amara Moon, Wendy Sinclair, and Terri Lewis – with Andrea Anderson’s help – separately solicited support from a large number of Oregonians to submit a separate letter endorsing our letter which can be found here: Oregon Patient Signatures for HERC
  • The press release (also copied below) can be found here: HERC Oregon Taper Press Release

Any credit I get for these letters and efforts is better given to the efforts of those who worked behind the scenes to bring this together. Additionally, I was humbled and awed by the outpouring of support from all the clinicians and leaders across the globe that signed on to this letter. You have my deep respect and appreciation.

Candidly, for those of you who know me, I try to avoid this topic of opioids. While I appreciate its importance, I am most focused on finding solutions for our public health problem of pain in this country and globally. However, when Andrea reached out to me and after speaking with Dr. Darnall, it became clear that there are times when people of good conscience cannot blindly allow bad policies to move forward unchallenged. Particularly when those policies target a vulnerable portion of our society who have the least means to fight back. I acknowledge and respect the State of Oregon’s authority to develop and enforce their own policies. But I cannot ignore state policies that propose to experiment on its population based on faulty or absent data, that is devoid of a plan for careful patient protections, and devoid of a plan to address the unintended consequences, and with no clear means of monitoring the impact. Not while I breathe and can protest. Our patients deserve better.

PRESS RELEASE

More than 100 of the foremost leaders in pain and addiction medicine, public health, and bioethics have raised critical concerns about a proposal in Oregon to deny opioid pain medications to a broad population of Medicaid patients.

On March 14, the Oregon Health Authority will vote on a proposal that would force Medicaid patients off opioid medications without their consent. The move, which would affect patients with more than 170 medical conditions, is an unprecedented attempt by a state government to arbitrarily deny opioid analgesic medications to broad classes of patients without regard for their individual conditions or if they have benefited from this class of medicine.

The expert letter, whose signatories included the current and several former presidents of professional medical associations and leaders of patient advocacy groups, characterized the policy as being scientifically unsound.

“(Oregon’s) broadly drawn policies for non-consensual forced opioid tapering lack evidence of benefit or safety and entail significant risks of harm,” the letter states.

The Centers for Disease Control, the Federation of State Medical Boards, and all other government or professional guidelines on opioid prescribing do not recommend forced tapering patients currently on opioid therapy, other than in situations where adverse events put the patient at risk. Non-consensual, forced opioid tapering risks destabilizing a patient’s physical and mental health in ways that have resulted in increased pain and suffering, disability, and even suicide.

Oregon’s proposal may also place physicians in the untenable position of having to choose between violating the ethics of their profession – to do no harm – or complying with the state-issued mandate.

Oregon proposes to replace opioid therapy with integrative and complementary treatments like yoga or counseling services. While the experts laud expanded coverage for such modalities, there is no firm evidence that these treatments offer sufficient pain care for patients with complex conditions. Most importantly, these treatments do not mitigate risks associated with opioid tapering.

The experts also warned Oregon Health Officials of the dangers of proceeding with this untested practice, especially as the state lacks the infrastructure to ensure that patients would be carefully monitored, supported, and cared for during or after any forced, non-consensual opioid taper.

The risks of involuntary tapering and the importance of facilitating access of medications to patients who need them have been highlighted by a growing chorus of health experts from many sides of the opioid debate, such as the American Medical Association and media outlets such as the New York Times, Reuter’s, Los Angeles Times, and Medpage. Oregon’s forced tapering proposals, in particular, have garnered attention as the most aggressive in the nation. The international watchdog organization, Human Rights Watch, highlighted Oregon’s forced tapering proposals in its recent report outlining human rights violations in pain care, as have the opinion pages of the New York Times and the Wall Street Journal.

The authors of the letter concluded: “(Oregon’s proposal) is a large-scale experiment on medically, psychologically, and economically vulnerable Oregonians, at a moment when Oregon has already seen a significant reduction in opioid prescribing and prescription opioid-related deaths.”

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Call for Action on Forced Opioid Tapering Proposal in Oregon

Yesterday we submitted a letter to Oregon Governor Kate Brown opposing a proposed community-based forced prescription opioid tapering in patients taking long-term prescription opioids. Our letter expresses concerns over a lack of evidence to support reductive policies that center on forced opioid tapering, particularly rapidly and to extremely low doses. We appreciate the Governor’s desire to reduce the impact that opioids have had on her state. However, this current proposal is misguided and has the potential of serious unintended consequences. The American Medical Association in partnership with the Oregon Medical Association also submitted a letter expressing their concerns of this proposed policy and the impact on patients.

The good news is that there are solutions available to help the dual public health crises in pain and opioids facing Oregon and the rest of our nation. A good first step would be to fully implement the HHS National Pain Strategy (NPS). In the NPS, we developed a detailed 17 point strategic plan to better assess and care for our patients with pain.

N.B. I have to thank the wonderful efforts of Andrea Anderson (Executive Director at Alliance for the Treatment of Intractable Pain) and her team, as well as Drs. Stefan Kertesz and Beth Darnall for their help in generating our letter under tight time deadlines.

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Stanford Back Pain Education Day 2016

We will be hosting our second Back Pain Education Day on September 11, 2016 at Cemex Auditorium. 

If you are suffering from chronic back pain, please join us for an exciting day filled with lectures from Stanford pain experts and information on community resources, research opportunities, and state-of-the-art back pain treatments! 

All attendees will be provided a free lunch in addition to goody bags and other giveaways.

TOPICS COVERED

  • Pain and the brain
  • Back pain and sleep
  • Gold Standard Self-Management: what you can do to help your back pain
  • Pain psychology: harnessing the power of your mind-body connection
  • Movement as back pain medicine

Read about last year’s event.

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Pain and Opioid Use Among Seniors: Issues and Emerging Trends

Our country has both challenges with chronic pain as well as opioid misuse, abuse, diversion and overdose deaths. Recognize we use opioids to treat pain, how do we address this conundrum? This was the topic of a Senate Special Committee on Aging on February 24th, 2016. I was honored to testify on behalf of the Institute of Medicine and was asked to represent the work we did on the IOM Reliving Pain in America Committee. This effort was led by Chairman Senator Susan Collins (R-ME), Ranking Member Richard Donnelly (D-IN; sitting in for Senator Claire McCaskill (D-MO) who was just diagnosed with breast cancer), and joined by Senators Warren, Casy, Kaine, and Blumenthal. The full hearing can be found here: http://1.usa.gov/1WJzkz5.

I was prepared for this testimony and the Q&A session to be highly charged and potentially confrontational. After all, the media presents on an almost daily basis both young and old dying from opioid related deaths. Just the night before, Frontline presented a powerful contemporary look into the increasing heroin problem our country is facing. It is understandable to want to be angry, to react, to point fingers, and to dramatically restrict the use of opioids – all with the laudable goal of reducing opioid related negative consequences. I share that goal.

I am also highly motivated to care for people suffering in pain. As a Pain Medicine physician, I know that for chronic pain, opioids are rarely a first line agent. However, I see patients all the time that are taking their opioids responsibly and seeing a persistent increase in quality of life and decrease in pain. Patients like Leslie, age 73, whom I saw the day before flying to Washington D.C. Leslie has bad nerve pain in her legs and takes a small amount of opioid in the AM to help her function. She takes a second small amount in the evening that helps to reduce her pain so she can sleep. She has tried many other treatments (pharmacologic and otherwise) and finds that this approach has worked for her for many years. She displays no risky behaviors around her opioids. Her message to me was: “Don’t let them take away our medications without giving us something in return.” 

I went to D.C. with that message in mind. And to be clear to the readers – I am neither “pro-opioid” or “anti-opioid. I am “pro-patient”. And I receive no money from pharmaceutical industries.

My goal was to present our findings from the Institute of Medicine Relieving Pain in America report and the NIH/Health and Human Services National Pain Strategy (NPS). Both can be downloaded for free and found here: 1) http://bit.ly/1n8m2Qi and 2) http://1.usa.gov/1RxBMr3.

As mentioned, I was prepared for a contentious and emotionally charged testimony. It was anything but. I was pleasantly surprised by the leadership of Senator Collins and all the Senators for their knowledge, preparedness, lack of posturing and clear desire to understand the situation. They asked good questions; and they listened to the answers. Most importantly, they came off as being willing to consider both sides of this tremendously complicated set of problems. Problems that will not be solved with a simple single solution or two. But instead will require a comprehensive public health approach. I was joined by the following witnesses: 

  1. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, Centers for Medicare & Medicaid Services, Washington, D.C.
  2. Ann Maxwell, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General, U.S. Department of Health and Human Services, Washington, D.C.
  3. Steven Diaz, MD, Chief Medical Officer and Emergency Medicine Physician, Maine General, Augusta, ME
  4. Jerome Adams, MD, MPH, Health Commissioner, Indiana State Department of Health, Indiana

All made compelling opening comments and responded superbly to the questions. Each, of course, is looking at the problems through their own “lenses” and representing their view of the challenges and solutions. It is clear that it will take such a multi-disciplinary approach if we are to solve these problems. From my perspective, I am of the strong belief that release and implementation of the National Pain Strategy will be a critical part of the solution to both problems.

While there were many aspects of the hearing that I found compelling, there was one that particularly stood out. That was the discussion about the unintended consequences of patient satisfaction surveys on motivating physician behavior to prescribe more opioids to keep their patients happy. Senator Collins (with several other Senators) recently wrote a letter to Secretary Burwell outlining this concern: http://bit.ly/1TfPKl8. This is a very real issue and one that needs to be addressed. I had the opportunity to discuss this with Senator Collins afterwards and the fact that the problem extends well beyond the hospital environment and is of major concern in our outpatient settings. She seemed both interested and engaged. Bottom line, we need to make sure that we are: 1) optimizing the patient experience, 2) using the right tools/surveys to do so, and 3) not inadvertently motivated other behaviors that would be bad for the patients.

In closing, I need to thank Jim Jensen from the IOM (http://iom.nationalacademies.org/) and his staff who were wonderful in helping with the meeting. And a special shout out to the Mayday fund (http://www.maydayfund.org/), and Carol Schadelbauer and Alisa O’Brien from Burness (http://www.burness.com/) for their wonderful assistance.

This is both a challenging and exciting time. Challenging because of the very real problems with both pain and the opioid epidemic. Exciting because there are available solutions (e.g. National Pain Strategy) that can provide cultural transformation we need in how this country cares for those in pain – and help address this very real opioid problem. My oral testimony below outlines this in more detail. Overall, an incredible experience and one that I am hopeful will make an impact.