PMTF Day 2 pt 1 Welcome and Recap
ALICIA RICHMOND SCOTT: Welcome to the second
day of the inaugural meeting of the Pain Management
Best Practices Inter-Agency Task Force.
My name is Alicia Richmond Scott, and I’m
the Designated Federal Officer, or DFO, for
the task force, and I serve as the liaison
between the task force and HHS.
I’m responsible to ensure that all task force
operations comply with the provisions set
forth in the Federal Advisory Committee Act
and that no ethical statutes or regulations
What I would like to do now is to allow for
the task members– we’re going to do roll
So if you would use your microphone to announce
yourself, just your name, and then we’ll move
to the next person quickly.
SANDRA ADKINSON: Sandra Adkinson.
AMANDA BRANDO: Amanda Brando.
RENE CAMPOS: Rene Campos.
JIANGUO CHENG: Jianguo Cheng.
DANIEL CLAUW: Dan Clauw.
JONATHAN FELLERS: Jonathan Fellers.
HOWARD FIELDS: Howard Fields.
ROLLIN GALLAGHER: Rollin Gallagher.
HALENA GAZELLE: Helena Gazelka.
NICK HAGEMEIER: Nick Hagemeier.
SHARON HERTZ: Sharon Hertz.
JAN LOSBY: Jan Losby.
MICHAEL LYNCH: Mike Lynch.
JOHN MCGRAW: John McGraw.
MARY MEAGHER: Mary Meagher.
JOHN PRUNSKIS: John Prunskis.
MARK ROSENBERG: Mark Rosenberg.
MOLLY RUTHERFORD: Molly Rutherford.
FRIEDHELM SANDBRINK: Friedhelm Sandbrink.
BRUCE SCHONEBOOM: Bruce Schoneboom.
CINDY STEINBERG: Cindy Steinberg.
ANDREA TRESCOT: Andrea Trescot.
HAROLD TU: Harold Tu.
SHERIF ZAAFRON: Sherif Zaafron.
VANILA M. SINGH: Vanila Singh.
ALICIA RICHMOND SCOTT: Wonderful.
What I would also like for everyone, if you
have cell phones, please either put them on
silent or please put them on vibrate, please.
Again, I would like to thank the task force
members for their participation in today’s
And with that, I would like to motion to convene
Do I have a second?
ALICIA RICHMOND SCOTT: Thank you.
The task force meeting for day two is officially
Now I would like to invite the chair of the
task force, Dr. Vanila Singh to please come.
VANILA M. SINGH: All right, good morning,
How’s everyone feeling today?
I hope refreshed after a nice dinner.
We want to welcome you to day two of the inaugural
task force meeting and really acknowledge
yesterday’s wonderful speakers, both those
who were invited guest speakers, certainly
from the secretary to the Admiral, the Assistant
Secretary for Health.
And then we had many guest speakers who came
to represent different areas who actually
were not on our task force.
And of course, to acknowledge all of those
of you who partook in what was an amazing
I wanted to highlight some of the discussion
I have those, actually, on a computer that
are being brought to me in just a moment.
But we’re going to take this moment to reiterate
our task force’s mission, the narrow mission.
We had great discussion that got into a bit
of team models, electronic records, health,
IT, and flow, and all of those are pertinent
certainly in our charge, which is really to
look at best practice guidelines and to identify
gaps and inconsistencies and make recommendations
on that basis.
In lieu of that, we want to ensure also, with
the amazing discussion that I anticipate we’re
going to have today, that we stay within those
narrow guidelines, not because all those topics
aren’t pertinent, but we want to make sure
that those that are emphasized are really
those that will be included in our clinical
guideline recommendations at the end.
This is our time to hash it out and really
see what is valuable, because that report,
the longer it is, as we all know, the less
valuable it gets.
So we want to be on point and really start
to think about what we’re already seeing in
terms of gaps and inconsistencies.
Now, we’ve just broached the topics.
We’re letting the public know a lot of our
hard work will be at the level of the subcommittee
structure this summer, which is something
that by end of day, we will be voting on our
I think most of you are now familiar and have
received the suggested structure that we have.
In so far as yesterday’s highlights, they
were amazing and we just wanted to, again,
review them so that when we have our clinical
topic discussions today, which will be actually
most of our task force discussion– 25 minutes
are allotted to each topic, and I believe
we have six topics– our highlights, really,
where we went yesterday were about solutions,
that pain management must be patient-centric,
patients are living with pain on a daily basis,
there is stigma when seeking pain treatment,
better insurance coverage for the right care,
patients are not reimbursed for certain treatments,
patients need better access to care, not enough
pain specialists, primary care physicians
have to be considered sizably, given their
front line role, they have to be provided
with the education and knowledge and background
and support, multiple approaches are needed
for pain, not one size fits all.
And I think that gets us into the precision
medicine that is a big topic nowadays.
Many patients try multiple therapies in addition
It’s common that many therapies were explored,
often before opioids were utilized in some
On the other hand, some folks were remarking
that when opioids are the first choice, that’s
also an issue to tackle.
Integrated pain management, incorporating
multiple clinical specialties into the treatment
Financial reimbursement is a component that
complicates the clinical management of pain.
The low cost of opioids has made them an affordable
alternative that financially is preferred
by insurance companies than more expensive
And then one of the most important themes,
I think, that was showcased in many of the
discussions and PowerPoints was striking a
balance, that it being important to minimize
unintended consequences, looking at data to
better understand problems and then the solutions
to those problems, it can help guide a better
understanding, a deeper understanding of what
we’re doing, clinical indications and targeted
And finally, education, once again a key need,
both for providers and patients and family
members, whether it is options, treatments,
expectations, or the use of naloxone, for
And with that, we’re going to get started.
Unfortunately today, our Deputy Surgeon General
Rear Admiral, Sylvia Trent Adams, will not
be joining us.
There are many, many topics in the commission
corps that are going on right now, and I was
actually very understanding of it because
of all that they are dealing with actually
in that realm.
What we do expect is our Deputy Chief Technology
We are reaching out to him to ensure– now
just so you know, everybody resides in this
building, and there are multitudes of issues
that arise that actually sometimes very easily
supersede what we are doing, and this happens
to me all the time.
So just in defense of my colleagues, I just
want to let you know it has nothing to do
with what they feel about the Pain Task Force.
There are just unexpected issues that arise,
and it gets to tell you that there’s a lot
This is our headquarters.
This is the Central Command Center, if you
HHS has many different buildings around here,
as well as in Rockville, Maryland, Bethesda,
many different places, but we’re at Command
We’re going to give him time, and we’ll keep
moving on with the program and agenda.
So while we’re waiting for our Deputy Chief
Technology Officer, what we wanted to do was
really spend day two on discussing our clinical
We got into it yesterday, and I think a lot
of folks started to share their viewpoints.
We know that Dr. Trescot was out there, Cindy
Steinberg got some points in, Dr. Rosenberg,
I want to hear from everybody, but I really
encourage those who’ve not had an opportunity
yet to share their great insights, because
your purpose in being here is much larger
than your own self, that we need to make sure
that our patients know that all clinical viewpoints,
all research viewpoints, and scientific perspectives
are all present.
So with that, we’re going to delve into this
And if need be, we will then take a break
and let our speaker come when they come.
So is everybody ready for this?
All right, this is going to be us.
So in addition to each clinical topic, I will
invite our identified task force member expert
to provide a short, five minute overview of
This will be followed by a discussion of the
task force on each topic.
Now that person who’s going to give the five
minute overview is just really setting the
stage with their background and expertise,
but we have multiple people in each of these
categories who have expertise in it, and we
encourage the cross-pollination, if you will,
because that, of course, allows us to see
the various perspectives.
So we encourage great discussion, and I have
a shortlist of folks I will call on if that
discussion isn’t happening.
Just be aware of that.
The first one that we will get into is prevention
and treatment, and in this particular topic,
we will invite Dr. Gallagher.
You don’t have to come up to the podium to
provide an overview, and with that, are you
Where is Dr. Gallagher?
Right over there, right, of course.
We are alphabetical order.
That’s what makes it easy for us.
So please go forth.
ROLLIN GALLAGHER: Thank you, and I’ve written
this out so I don’t go on too long.
And a lot of things I’m going to say are things
that we sort of mentioned yesterday.
So I’m going to emphasize some of the points
that I think are really important.
And when we think about prevention and treatment,
they’re really the same thing.
Really, they just go together in clinical
systems, health systems, and that’s really
what we need to aspire to.
And when I was thinking, I was going to put
up a slide, but we’re not having slides this
But I always think of the chronification model,
the acute to chronic pain model, and I think
I was really pleased with Dr. Azar’s and others’
comments yesterday that we really need to
start from the moment of pain and really apply
our system to that pain right from there to
prevent chronification and all the complications,
the terrible complications that we talked
I’ll try to get through this fast so that
we’ll have plenty of time for discussion,
and I apologize again for repeating some of
the things we discussed yesterday.
So this phenomenological cascade from acute
to chronic, and that’s sort of the neurophysiologic
and the neurobehavioral consequences of uncontrolled
pain at the start, and its interaction with
personal characteristics of the patient.
Unfortunately, health systems characteristics
in terms of access to what’s needed, specifically
for a, first of all, a diagnosis, a identification
of risk factors, and contributing factors
from the person to their body to their brain
And then being able to identify those factors
and identify the right treatments for those
Multiple different mechanisms, different treatments
for each mechanism, pull together in a coordinated
fashion for good health care and to prevent
the trajectory towards chronification and
chronicity and complex chronic pain with all
of its tragedies.
So let’s consider three levels of prevention.
I always think of prevention in three levels,
cause I’m a public health guy training with
MPH, et cetera, and been thinking about population-based
health for pain for decades now.
Primary prevention, OK, what do we do to avoid
injuries and disease?
Well, very simple, seat belts, right?
Great, great innovation.
Didn’t take a lot, but took a lot to get the
Obesity management, conditioning and exercise,
diet, all those things that prevent diseases
like diabetes and cancer, smoking cessation,
treatment interventions for kids.
So avoiding pain-causing diseases is primary
Whole health approaches, like Dr. Sandbrink
mentioned yesterday in his presentation to
the VA, get patients engaged in their health.
Don’t have them only come when it hurts or
when it’s getting worse or when they have
a complication, but let’s bring them in early
on, and get them as part of our health care
So we need– our gap’s really, we need a population-based
implementation of whole health approaches.
All right, secondary prevention, that’s where
we start really in the health care system
often to reduce the risk of chronification.
Routine behavioral health screening for patients
presenting in primary care with various chronic
It’s a no brainer, gang.
We know that depression, anxiety, PTSD, SUD,
all those things are risks.
So let’s get them upfront, identify them,
and bring in the mental health team, the behavioral
health team, and the integrative services,
Because you know what?
A lot of patients, if they’re given a choice,
will say, yeah, I’ll try the yoga, or let
me do some massage and some meditation and
And then maybe I’ll start with an NSAID or
something, or a Tylenol, but let’s do it that
way instead of making it, oh, well they failed
all these medications algorithms.
Now we’ll send them over to integrated health
or complementary health.
Let’s get it upfront.
In the VA, for example, as Dr. Sandbrink mentioned,
we have STORM, which identifies risk for opioid
use and abuse right off the bat, which is
The gap is these services aren’t available
for most of our patients, except for in health
systems that are now making them available.
Some now are, some private insurance are encouraging
people to access these things.
We also need to access and create access to
Because we’re social animals.
Half of our brain is involved in social interactions
and support, and we can do these CBT and various
other things in groups.
It’s cost-effective, it brings people together,
they feel supported by each other, and they
move ahead more quickly, and it’s cost effective.
So we need access in primary care, and the
gaps are that implementation, even though
we’ve developed some really nice stepped care
models in the VA and researched them and shown
that there are effective.
Like, for example, in Indianapolis, Kurt Kroenke,
Matt Bair, and group have done an algorithm-driven
medication management plus CBT, modified CBT,
given by an advanced practice nurse that works.
And it’s been shown, tested against treatment
This happened six years ago, eight years ago,
and we implemented it system-wide the VA now.
It’s implementation of these proven practices
that save money and do better than routine
care, and that’s a real problem for us.
And then for some of the complementary interventions,
we need credentialing across systems so that
we know what we’re getting is good and works
based on the evidence.
We need fully-staffed interdisciplinary pain
teams fully available to primary care.
I don’t mean you have to wait six months for
I mean right away, when things aren’t going
this way, but going this way or this way,
a person is about to lose their job, don’t
make them lose a job and then– because you’re
failing in primary– you get them right into
your pain medicine team right away, evaluate
them, and get them going in the right direction.
But don’t let them get into the chronification
So gaps, we need to have access to behavior
I came up in the era of the ’80s and ’90s
when we had pain rehabilitation programs.
We had full staffing and everything, occupational
medicine, behavioral medicine, psychology,
orthopedics, everybody was on my team, and
we got people back to work who had been out
of work an average of two years.
90% were work ready by the time they left.
We don’t have that anymore.
It was carved out by managed care.
All health systems basically ruined the pain
system that we had developed that was working.
But we need to have those rehabilitative services,
intensity at the level of need for the patients,
Earlier, not after they’ve been out of work
two years, before they actually go out of
work, and that’s important.
So we have a huge gap there.
Psychological services, as mentioned by Peter
Staats and others in the interventional field–
we need psychological services to be available
to evaluate patients.
So we can get them in shape so they’ll do
well with procedures and function well afterwards.
We’ve mentioned the acute perioperative and
pain setting, and Dr. Poovendran from the
ASA mentioned the importance of having acute
perioperative pain teams.
And why is that important?
Because there’s a lot you can do in a hospital,
including psychological service as part of
But in terms of interventions and different
medication management strategies, to prevent
overuse and over exposure to opioids, but
also to get people in better shape before
And these teams need to be staffed fully and
also be available.
Of course, there’s a gap there in terms of
providing models that work cost effectively
in health systems.
So hospitals are going to have to figure this
out, but it’ll save money for health systems
in the long run.
And there has to be models for the handoff
to primary care.
Again, we talked about medical records.
Having an electronic medical record is a great
boon if we could find ways that we don’t lose
the face to face connectivity, and the handoff
between hospital systems and primary care
has to be smooth and transparent about all
the risks and the things that are working.
Tertiary prevention, reversal of chronification.
So we all know about the consequences, depression,
suicide, work loss, substance use disorder,
PTSD when pain recurs, oh my god, it’s happening
again, catastrophizing, all those things.
We need to have intensive treatment available
for those problems when they’re co-occurring
with a pain problem.
Not that we’re going to cure the pain, but
we’re gonna get the patient back to functioning
and a quality of life.
We don’t have those systems.
We in the VA have now, from 2 to 20, in about
five, six years, I think it was.
So we have some, but across the country, nowhere
And those intense services need to be available
even without chronic rehabilitation programs.
In the past, as I’ve said, most insurers,
many insurers funded these programs in the
’80s and 90s; 90s.
Of course, that doesn’t happen anymore.
So we have a lot of work to do in terms of
policy and working with health insurers in
the field and health system to make sure that
we get access to these services for our patients,
not based on whether we have the checkbook,
but so even people without a lot of money
can actually afford to use them.
And then finally, the big gap is education.
I was co-chair of the subcommittee of the
national pain strategy and the IPRCC IOM study,
and we recommended education at all levels,
but particularly at primary care.
Every residency should have pain education.
We’ve asked for improved and more education
to even specialists, but certainly primary
care, and then patient education, as Dr. Sandbrink
So there are a lot of gaps.
We have a huge challenge ahead.
I could write– many of us could write a book
about all this– but in 10 minutes, probably,
I’ve discussed a lot of these different things,
and I’m delighted that we’ll have a chance
to sort them out here and go forward.
VANILA M. SINGH: Great, thank you so much,
Dr. Gallagher, for your thoughtful comments.
What we want to do is begin opening the board
And for those folks who have specific items
that they want to share, I would say go right
Otherwise, I’ll begin calling on my shortlist.
So please, go ahead.
This is a good time, prevention and treatment.
Yes, please, go ahead, Doc.
DANIEL CLAUW: So I just want to expand upon
some of the opportunities to do probably secondary
prevention, but not primary prevention, is
it’s become very clear in epidemiologic studies
that you can, to a large extent, identify
people that are going to have chronic pain
as adults by looking at who has chronic pain
as a teen or an adolescent.
And so as we move forward, we have to think
a bit about our committee making sure that
we reach down into the pediatric population,
because it’s clear that the way pediatricians
and other people that see children have been
classically trained that these pain conditions
that are seen in children are benign, they’re
The child that has functional abdominal pain,
growing pains, any number of different headaches,
painful menstrual periods, is at high risk
of being an adult that has chronic pain.
And this is independent of psychological factors.
There’s a lot that’s been written and talked
about, the psychological risks for becoming
a chronic pain patient, but some of them are
just the way someone is hardwired, the way
they process pain in their brain, and those
individuals are very easy to identify in clinical
practice and could be put into prevention
programs that may be successful at preventing
people from being the fibromyalgia patients
and the other patients that none of us really
can manage very well.
Because they’ve had these symptoms for decades
and have gotten a lot of maltreatment and
mistreatment over the years before they finally
get diagnosed with something like fibromyalgia.
But risk factors like– one of the biggest
risk factors that’s been identified in epidemiologic
studies for someone subsequently developing
chronic pain is poor sleep.
And again, those are very easy, simple interventions,
sleep hygiene programs and things like that,
that could be– the interventions could be
done at the level of the population, because
these are things that are really simple for
individuals to do on their own.
And actually– I’ll talk a little bit about
it when I talk about providers– not moved
from being a person with pain to a patient
Entering our health care system or any health
care system around the world often makes people
worse rather than better when they have acute
pain, and we need to be mindful of that.
ROLLIN GALLAGHER: Let me just make a comment
David Oslin at the University of Pennsylvania
and the VA created a system of screening for
risk factors like that when patients come
into primary care.
It’s called the Behavioral Health Lab, where
he has trained clinicians available, and when
they screen for four above on pain, sleep
problems, mood problems, et cetera, they get
automatically referred to a telephone interview,
in-depth interview by a trained behavioral
health clinician who takes the data and then
makes sure they are immediately sent to the
right treatment for further in-depth clinical
So those kinds of systems need to be developed
so you can do that right away.
AMANDA BRANDO: As the other– as probably,
I think, the only pediatrician in the room,
I’d like to second what Dr. Clauw said.
I think challenges in the pediatric realm
is access to care as well to behavioral health.
It’s a huge problem and very limiting to get
our children access.
So even though we do identify patients who
have risk factors that have been discussed
and in need of behavioral health, it’s very
hard to access those services.
So I think teaching the children in our sickle
cell practice, I can say we have the luxury
of hiring a psychologist that’s a full time
part of our team.
And we have started introducing those services
and that person very early on when we assume
care of a patient as part of our team to help
develop coping skills and adjustment to a
chronic pain syndrome of sickle cell disease
in particular, and I’ll talk a little bit
about that when I address the special populations,
but I completely agree.
MARK ROSENBERG: I’d like to talk a little
bit about the emergency department from the
standpoint of prevention, if I could.
The emergency department, just some numbers.
We see $141 141 million visits a year, up
to 46% to the emergency departments with an
acute pain or chronic pain syndrome.
17% of those patients leave the emergency
department– up to 17%– leave with a prescription
Even though the prescription tends to be only
a few days rather than a month’s supply, it
does start the patient down that pathway when
they go to the primary care doc and they say,
you know what, I’m taking this Percocet and
it’s working, and they get more prescriptions
for it, so on and so forth.
We decided to open up an emergency department
that was opioid-free.
Very quickly, we found that that was impossible,
because the patients who comes in run over
by a truck, who has a fractured pelvis and
femur, benefits very nicely from something
stronger than a nonsteroidal.
But we were able to put together a program
called Alto, which is using alternatives to
So it’s really an evidence-based program,
a non-addicting medication using not only
the medication, but nerve blocks, trigger
It’s truly multi-modal and multi-disciplinary.
In the first year, we were able to decrease
our opioid usage in the fourth-largest emergency
department in the country by 57%, by year
two, over 80% with improved patient satisfaction
and increased visits of three groups of patients.
Pediatric patients, a mom did not want them
exposed to opioids, so brought them to our
hospital so they knew they weren’t.
Geriatric patients and those who are already
addicted or dependent or had a history of
The best way to stop opioid use is not to
give opioids at all.
We know that.
Several other hospitals have tried this.
The VA’s doing it and had great success.
We’re seeing it in community hospitals, rural
hospitals, and otherwise.
And it’s accepted by docs, RNs, the nurses,
and by patients.
This is something that really prevents even
prescribing opioids to many people who need
So Alto 1.0 was really this part.
2.0 is starting MAT and also getting other
hospital physicians to buy into this and coming
up with their own Alto programs.
Our OBGYN department started their own Alto
initiative and have decreased their use of
opioids by 50% in two groups of patients,
c-sections and I think pelvic surgery.
Alto 3.0, we just started a fellowship program
of mental health and addiction, which is that
whole continuum we were talking about yesterday.
But I do think there’s a great opportunity
in emergency departments to really look at
using alternatives first.
Let me just give you an example.
Somebody who comes in with renal colic, which
is something that we typically just go to
an opioid, now we’re treating them with Toradol,
easy enough, IV lidocaine, and acetaminophen,
and some saline, and we’re getting great success.
The other thing that’s kind of anecdotal is
we’re actually seeing the kidney stone passed
in the emergency department, when in the past,
we would send them home with the stone.
So we’re getting great success, and very few
patients even need rescue opioids with that
type of thing.
Five basic and great, great success.
VANILA M. SINGH: Who’s next?
MARY MEAGHER: Yeah, I wanted to chime in with
a specific example of how behavioral health
interventions can be used preventively.
That’s from a recent publication from the
Journal of Pain, and it illustrates how relatively
brief, just a five hour intervention with
acceptance and commitment therapy, followed
by a follow-up phone call and providing the
manual to patients led to significant reductions
in pain reports, the duration of pain post-surgically.
And these are VA patients that have a high
risk for developing persistent pain, but also
more likely to have persistent use of opioids
and opioid misuse.
And this is a paper by Lilian Dindo and colleagues
out of the VA.
So what they did was they delivered this five
hour intervention prior to orthopedic surgery,
and it was administered by two clinical psychologists
in a group setting.
So it’s a very cost-effective short-term intervention,
and it led to a significant reduction in pain
persistence and opioid use.
Now the effect was moderated by the post-surgical
So the effect is greater in people who don’t
have post-surgical complications.
So this is the beginning of preventive work.
We need more research in this area, but it
suggests that we can see psychosocial interventions
having a pretty robust effect.
And the importance of this is the longer people
are on opiate medications, the more likely
they’re going to transition to misuse and
So any intervention that can reduce time on
opioids has a great potential.
And this is just to show that behavioral health
does not need to be extensive to have impact.
VANILA M. SINGH: I’m going to move to Dr.
I think she has her name tag up.
Unfortunately, it doesn’t really tell us the
order so we’re just going to go by integrity,
and then we’ll move.
But we haven’t heard from her today.
HALENA GAZELKA: We’ll just fight it out.
I just wanted to make a comment about education,
because I think that’s one of the unifying
things that’s kind of come up in what Dr.
Rosenberg and what Harold said yesterday.
I think we’ve created a culture that pain
is abnormal, and that we must do something
And I do believe that we have to be attentive
I’m a pain physician.
But I also believe that pain is part of life,
and that removing it is not always realistic,
and Harold talked about this a little bit
So education, when patients come to the hospital,
that there’s going to be pain, it’s anticipated,
and this is how we’re going to manage it.
But it’s not just the patients, it’s our nursing
staff, too, and the rest of us on the staff
as well, because we have these numbers where
we ask the patient, how bad is your pain?
Is it zero, is it a 10 out of 10, is that
the worst thing you can ever imagine?
It’s a 10 out of 10.
And so as an illustration, I once went into
a patient room with a resident, and I asked
the patient, I said, if we took a chainsaw
and cut your leg off without any anesthetic
right now, you couldn’t hurt any worse than
you do right now?
And this was a patient with a good sense of
humor, and they said, well, yes, I could hurt
So I think that those pain scores are so arbitrary,
and when we set a goal that you’re going to
have a 4 out of 10 pain score, that means
take a pill to get rid of it.
When really, we need other services in our
We need massage therapy to be available to
We need acupuncture, complimentary therapies,
psychological therapies, because suffering
in the hospital is not all about physical
But I can’t really offer those to my patients
because number one, they’re not available
in spite of the institution that I work in,
and number two, their insurance would never
And so, I’d like to be able to offer even
my hospitalized patients not only education
about what to expect during their hospitalization,
but also other therapies that will be helpful
other than taking some sort of a pill.
ALICIA RICHMOND SCOTT: Thank you for that.
We’re down to our last, I think, 90 seconds
on this topic.
And so just real quickly, who– is it Dr.
Hertz who was next?
SHARON HERTZ: I don’t know if I was next,
but I want to make a plea for us to be very
careful about our language and certain things
that we’re saying in terms of precision, because
I’m hearing a lot of overlapping concepts
and mixing of terms.
For instance, I just heard the longer someone’s
on an opioid, the longer they’re going to
stay on an opioid.
There’s an article that came out that showed
that people who are on opioids long-term were
on opioids more than seven days after surgery.
Well, of course they were.
But the other part of the article says the
same thing happens for insets.
So we’re mixing concepts.
What happens to the progression of pain over
time is one concept.
What happens to the use of medications over
time is a separate concept.
What the underlying issue is with the medication,
and we generally, when we’re talking about
issues, are referring to opioids, is very
important to be defined.
For instance, from an HHS perspective, misuse
and abuse are kind of used in the same realm
But at FDA, we are very interested in dissecting
differences between abuse, which we define
as intent to get high, if you will, reinforcing
effects of the drug, versus misuse, which
is using it not as prescribed.
And when those get bundled together, they
fail to recognize certain important things,
that often misuse is not about intent to get
reinforcing effects, but attempt to better
And we’ve heard repeatedly about a failure
of providers to adequately manage pain for
a variety of reasons, hence the reason we’re
So as we each convey our different perspectives,
my plea is that we are very careful to define
what we’re saying, not to just use terms or
Because at the end of the day, I don’t think
it’s going to serve the purpose well, and
that’s my plea.
VANILA M. SINGH: I think those are great points,
actually, and we can start to tease those
out, but I think they’re very important points
about what physical dependence, tolerance,
and what those mean, and what drives that
behavior versus addiction, which is an entirely
different issue, and then the misuse, abuse.
And maybe that’s one of the big things that
we will help to define here as that also gets
It also gets into both the provider behavior
When someone asks for more, whether it’s physical
dependence or whether it’s tolerance, that’s
a different motivation, and I think we have
to also understand that.
I just want to say something quickly to Dr.
Rosenberg’s point of using Toradol.
30 milligrams of Toradol is about equivalent
in analgesic potency of 10 milligrams of morphine.
So that’s there, but we also know there’s
limitations with Toradol.
We know that there’s concerns with orthopedic
surgery using any kind of NSAID in terms of
And so really, the point is that many medicines
have different issues and problems.
We also know that even though they had a primary
goal of limiting opioids in the emergency
department, when someone comes in with a major
traumatic injury at the end of the day, the
analgesic effects of opioids were still superior
in those certain situations, and that’s an
appreciation of the right clinical indications,
and then the awareness following that of when
the appropriate time is to start to switch
over to other non-addictive strategies.
So I thought that was important.
One of the things I wanted to share real quickly
was in the emergency room at Stanford, we
have hip fractures that come in with the demographic
that often is on the elderly side.
And so in a money-losing fashion, I believe,
for our department, we still made it a point
to give femoral nerve blocks.
They often would be– some would be taken
straight to surgery, so it wasn’t something
we’d necessarily do, but we would do a single
shot, but leave a catheter in if they were
going to be pushed off for a day or two.
Those results have been stunning because in
that demographic, we actually limited significantly
the opioid exposure, and actually, the whole
motivation for that wasn’t so much about the
opiate addiction issue and crisis that we’re
in, but rather to decrease the confusion,
nausea, all the negative effects of opioids.
And even in the recovery room following surgeries,
it’s really to get earlier discharge or to
have improved functionality when we put nerve
blocks in post-op or even with total knee
So there’s a lot of applications, and there
are a lot of advantages when we mention mitigating
opioid use, particularly in the acute pain
realm, which I think we should talk about.
And then I love the distinction of talking
about what progression of pain turning into
chronic pain, versus progression of drug use
turning into long-term drug use.
Two different things, one could, again, be
a tolerance issue and a physical dependence
issue with limited outcome and benefit versus
a chronic pain issue.
So just summarizing some of those greater
points that everyone brought up and what it
means to us.
And we’ll move on to our next topic, and we
can bring in these overriding issues on those.
And so I want to introduce Dr. Jonathan Fellers
to produce our overview on this.
Dr. Fellers will speak on the mental health
and addiction issue, and then will be very
happy to hear with the rest of us on that.
JONATHAN FELLERS: Great.
Thank you for allowing me to speak.
So I’m an addiction psychiatrist.
So this is a topic that I address on a daily
So why is this such an important topic in
There’s an incredible amount of overlap, actually,
with pain and addiction and other mental health
So SAMHSA has published some data.
One figure that’s kind of striking is in patients
with chronic pain, what percentage may have
an addictive disorder going on concurrently?
And it’s 32%.
So it’s a high amount of overlap, and of patients
with opioid use disorder– so, like in treatment–
how many of them have chronic pain?
And it can range anywhere from 29% to 60%.
60% are numbers usually you see at a methadone
So they’re very co-morbid conditions, addiction
and pain, and that’s the case, also, for mental
Often, people with chronic pain in particular
develop co-morbid depression, anxiety, and
other disorders, either as a consequence or
the pain as a consequence.
We don’t really know what came first.
Pain is an independent risk factor for suicide,
and so it’s a very relevant topic for us as
Most of the guidelines now that we’ve already
talked about have really promoted using a
biopsychosocial approach to the treatment
and management of pain, and it’s not surprising
given the co-morbidities of why that is so
And we’ve already spoken about some of the
results of that, that by integrating care
of addiction and mental health disorders with
the treatment of pain, you have more successful
But that still leaves us with a lot of gaps
as far as what do we do in certain situations,
and how do we approach those things.
In general, all guidelines recommend a multimodal
approach, but that’s really challenging to
deliver for our patients.
So I’m just going to overview a few of the
gaps as I see them, and so this is not by
any means an exhaustive list.
But from my perspective, I take care of a
lot of patients with opioid use disorder,
and they will also experience painful conditions
in their lifetime, and it’s a real challenging
area to address.
Patients have a lot of fear about what’s going
to happen when they have to take opioids again,
if that’s necessary for a surgical procedure.
There is still unclear guidance of what do
you do with buprenorphine, for example, around
Should you stop it, should you continue it,
how do you manage the pain through that process?
Both approaches seem valid, but there’s not
really clear guidance of what’s the best practice
for doing that.
People with severe opioid use disorder also
end up in the hospital with really painful
In my practice, I see a lot of patients in
the hospital with serious complications of
injection drug use such as endocarditis, osteomyelitis,
other things like that, and the challenge
these patients pose to the hospital system
in management is really quite striking.
It’s not always the case that opioids are
always the best solution for their pain problems.
Often, interventional procedures can be very
helpful, but if there’s a co-occurring infection
going on, we can be precluded from actually
doing some of these things.
So how do you do open heart surgery on someone
with a serious opioid use disorder?
It’s really challenging.
There’s a big gap in knowledge and best practices.
Now, our institution has utilized a lot of
We use a lot of ketamine, actually, in that
perioperative realm, but it’s an area that
is definitely out there.
I also want to speak a little bit about the
fact that people on opioids, because of this
in a hyperalgesia that they’ve had, or people
with chronic pain, when they have an acute
pain issue, it’s even more challenging to
We don’t really have great guidelines on how
to do the acute on chronic process.
I do want to also add that medication-assisted
treatment can be very beneficial for patients
with chronic pain, but there’s not really
We know MAT is great for opioid use disorder,
but what about the chronic pain patient?
There is some evidence out there that it can
be very effective for pain management as well,
but that’s a gray area, not really FDA-approved
in any way.
And there’s some really good studies out there,
but I think it’s being underutilized and there’s
a lot of gap there as well.
I also want to talk about tailoring treatments.
So if someone does have a lot of co-morbidities–
so I spoke a lot about addiction.
That’s because I primarily deal with addiction.
But with mental health disorders, if there’s
co-occurring mental health disorders, I think
we spoke a little bit about this in the prevention
Is there a tailored approach that we can take
with someone with co-occurring depression
or anxiety that we can prevent or better manage
their pain outcomes, set better expectations
from the get go?
I want to put in another plug for access to
mental health and addiction services.
It’s very challenging.
Maine has sometimes been described as the
most rural state in the nation.
I don’t know if that’s true, with Alaska,
but it’s very challenging to access mental
health care, let alone addiction expertise
in a lot of the communities in our state.
And if we are espousing using this multimodal
approach, how are we realistically going to
be able to deliver that given the geographic
span of our catchment areas.
I want to talk about reimbursement, because
I think that is one way that can drive the
ability to deliver those bill services.
It’s not really included at this point.
I’m fortunate that my hospital has identified
the fact that having an addiction professional
see patients in the hospital with these acute
issues is a cost-saving measure, because prior,
we weren’t providing addiction services for
And I’m not a money maker for the hospital,
but I may be a money saver for the hospital.
And so looking at approaches of population
health-based ways of managing patients, versus
fee for service for everything.
And then I’m going to put another plug in
for education, because I do believe it really
Patient education, setting expectations of
pain– that was already talked about– provider
education, and that goes from medical students
all the way through residency and attendings.
Finally, I just want to raise one maybe rather
controversial issue, but I’d like to know
more about the fact that patients perceive
opioids as being effective, and it’s very
challenging when they really perceive this
medication as helpful.
And yet, our objective evidence that it is
helpful is not there.
And this is an area of great concern, I think,
and something that we really need to address.
It’s kind of the elephant in the room, because
patients like taking opioids.
They take care of a lot of different things,
but they don’t always lead to the outcomes
that we want and have a lot of dangers as
And that’s a gap that we haven’t really addressed
yet and spoken about.
So a lot of things to talk about.
VANILA M. SINGH: Great.
Thank you, Dr. Fellers.
OK, the floor is open, and I did want to first
go straight to Dr. Meagher, because she had
actually had some points as well that were
So, please go ahead.
MARY MEAGHER: Yes, OK.
Thank you for this opportunity.
We’ve been learning over and over again that
chronic pain is best managed by multi-disciplinary
teams that include behavioral health providers.
And we’ve also repeatedly heard that access
to those providers is limited for a variety
And this leads them to under-treatment of
the psychological risk factors, lack of identification
of those risk factors, and much of this stems
from limited education and training, but also
limited incentives to integrate the biopsychosocial
approach into health care in order to optimize
the care of pain and co-occurring mental health
in substance abuse disorders.
There’s poor enforcement of mental health
and substance abuse parity laws, and a need
to modify payment systems.
I wanted to speak with the overview of I see
the major issues that we need to address.
We also have a problem of we heard yesterday
from Cindy, that there just aren’t enough
providers out there.
It’s hard to find a good pain provider, a
good health psychologist, clinical health
psychologist, who really knows what they’re
doing as well.
So I think we need incentives to train psychologists,
social workers, to provide that type of care
and to work collaboratively.
And I’ve been thinking about incentive structures,
but one simple one that’s been suggested by
the APA is that we think about loan forgiveness
programs to incentivize the mental health
provider workforce that’s there to train in
that area, and those that are currently in
the workforce to get additional training to
specialize in these areas.
There’s considerable evidence that psychological
interventions help chronic pain patients develop
psychological flexibility and the coping skills
that they need to help reduce pain interference
so they can get on with living their lives.
Sometimes that leads to a reduction in pain,
sometimes it doesn’t, but it usually leads
to an improved quality of life where the person
is able to engage more fully in their work
and social lives, and their quality of life
There’s evidence that typically their mood
also improves with the provision of those
types of treatments, and we’ve been talking
a lot about cognitive behavioral therapies,
but there are more recent evidence-based approaches
such as acceptance and commitment therapy,
which involves mindfulness components, but
also helps to get patients to identify their
core values, their reasons for living, their
meaning in life, and to connect with that
so that they can start to align their behavior
with what they truly value.
So that they live their life even in the face
of pain, and that motivation can be critical
to getting people moving again.
And mindfulness strategies help people to
limit the degree to which they struggle with
either trying to avoid pain through an over-reliance
on opiates, or catastrophizing about their
pain, two extremes.
So that strategy is getting more traction.
Another relatively recent approach that’s
been shown to outperform cognitive behavioral
therapy, at least in one study, is an approach
called emotion awareness and expression training,
and it’s Mark Lumley’s model, and it’s an
integrated approach as well.
So there are other empirically-supported treatments
out there that I think we need to be looking
at beyond cognitive behavioral therapy.
Psychological interventions can also help
those addicted to opioids, and can be integrated
into medication, medication-assisted treatment,
and there’s evidence that doing so improves
And notably, the VA is starting to expand
training and implementation of a particular
form of behavioral health intervention and
contingency management to improve outcomes.
So we know that we could improve outcomes
for patients and the transition from the current
system, outside of the VA and other DOD-related
organizations, is going to require significant
policy changes before these can be widely
We’ve talked about the risk factors for opioid
use among chronic pain patients, and looking
at that literature, we see that the most consistent
risk factor is past or present opioid or other
substance abuse disorder.
And notably, individuals who start using substances
of abuse early on, alcohol or other substances
of abuse, are at extremely high-risk.
Moreover, opioid overdoses in this population
more often include a second substance of abuse.
Benzodiazepines are often involved, but also
we see a high rate of alcohol co-use occurring.
And there’s a limited attention to screening
for these conditions.
And then, secondly, psychiatric co-morbidity
has been discussed over the past few days,
and pain is often co-morbid with anxiety and
depression, as is addiction.
So we need to be doing more to screen for
psychiatric conditions such as depression,
bipolar disorder, PTSD, and other conditions.
And I think the key here is going to be education
I wanted, though, to make this a little bit
more vivid and put a face to this by sharing
a personal story, a personal reason for my
agreeing to serve on this task force which
is, I lost a sister to an opiate overdose.
She was age 50 at the time.
She’s just one of the tragedies of this epidemic,
and her story is rather complex.
She was a nurse practitioner.
She also had a master’s degree in mental health
Her husband, ex-husband, was a physician.
So she had ample medical knowledge.
She was highly educated and well connected
to the medical community, but she also suffered
from alcohol use disorder and mood disorder.
And there was a family history of mood disorder
and alcohol use disorder.
She had a history of early binge drinking
and tobacco use.
All of these are red flags.
She as an adult had been struggling with alcohol.
After a six month period of sobriety, she
relapsed, and she got into a serious motor
And she had to have surgery, and she was prescribed
OxyContin, and she died a little bit over
three months later of an overdose.
It’s possible that her health care providers
tried to conduct a risk assessment with her,
and that she just was not forthcoming.
I wasn’t present to help with her care.
She was refusing help from me.
She’d let my mother and her oldest daughters
help her, but she was keeping us at a distance.
So I really don’t have more than what I was
getting through them.
But I did know that what she did receive was
just only pharmacological treatment.
She did not see a psychologist or an integrative
pain management team during her care.
And I think this story illustrates the importance
of enhancing better psychological screening
and intervention for these types of patients
that are extremely high risk.
It’s clear that many patients are not, but
this particular subgroup is extremely high
risk, and we’re missing them at times.
My sister left behind five girls.
They were ages 10 to 20 at the time of the
overdose, and they’re just a few of the hidden
tragedies of this epidemic, and we don’t see
these numbers, their numbers, in some of the
statistics we’re looking at.
So thank you for listening.
VANILA M. SINGH: Thank you so much for sharing
When you first told me about it, I thought
that was so potent, and we wanted to let you
at your own comfort level share it.
But I think that once again reiterates the
purpose of why we are all here, that these
stories are not far away.
We’ve all felt them near and far.
And of course, our empathy is there, and our
compassion, I hope we can showcase that in
our task force because it’s real.
And it really gets into perhaps like risk
stratification, but even when the availability
of resources are there, it’s a very challenging
subject for folks to open up about, and it
really gets into the depths of their own struggles.
And even with their closest of kin and providers
and husband was a specialist, it obviously
showcases that it’s not easy to be forthcoming.
And I think sometimes that is what folks who
are not in the health care realm miss.
They don’t understand that we are not treating
a car that is the Toyota Corolla that’s missing
its brake pads, and that it’s that easy to
diagnose, that there’s so much behind it.
And it just brings to the human condition,
the complexities of both the body and mind,
and once again, thank you so much for that,
Is there anybody else who wants to speak with–
I think Dr. Rutherford and then Dr. Schoneboom,
and then Cindy will go after that.
So three in a row?
Oh, and then Dr. Zaafran, thank you.
MOLLY RUTHERFORD: Thanks, Mary, for sharing
I have family members with addiction as well,
and worry about them daily.
Just wondering when we’re going to get that
There were a few things that I wanted to address
that have come up.
One was innovative ways to incorporate behavioral
In my practice, for example, I had used telemedicine.
Like I said, I don’t bill insurance, but there
are many of my patients who would benefit
from counseling for many reasons.
So I partnered with some licensed counselors
and just patched them in.
In Kentucky, they were able to bill for those
So I have one room with a computer, and they
can see each other.
It’s just basically like a Skype visit.
So we’re able to do that that way.
And then just going back to what Dr. Feller
said, I think he made an excellent point,
which is that we do need to educate people
about opioids and the data, which suggests
that in a lot of chronic pain problems, they
I’m seeing a patient now who I’m trying to
taper off of his opioids for many reasons,
and he’s not addicted, he’s dependent.
And he said I was the first person who looked
at him and said, I don’t think these medicines
are helping you.
He has chronic low back pain, and he doesn’t
have major neurologic problem associated with
It’s basically most likely muscle spasm, maybe
Sorry, I can’t pronounce that.
So I think that was an excellent point that
we should incorporate in what we do here.
And then, I want to go back to what I mentioned
briefly yesterday, which was the stigma, which
I think that we have to address this with
people with addiction and with people with
Just, what I heard broke my heart from so
many of the people with pain who spoke yesterday,
that they felt like they were being judged
in some way.
And the worst possible, in their mind, for
someone to think they were an addict, oh my
I mean, that just speaks to the level of stigma
that we still have around substance use.
Most of us did experiment with alcohol and
drugs in our teenage years, and thank god.
I was not– I did, I did, experimented, and
thank god I don’t have the disease of addiction,
because it runs through my family.
So I think if we can remember that in all
of this, as we talk about not limiting pain
prescriptions or opioid prescriptions for
people that absolutely need them, but also
so just educating doctors and anyone who has
contact with people who are suffering, just
reminding them that whether they legitimately
have pain or they are drug seeking, they still
deserve our compassion and they still deserve
SBIRT is another way that we can screen.
I don’t know if you know that acronym, Screening,
Brief Intervention, Referral to Treatment.
So that is an excellent way for a primary
care physicians to get comfortable deciding
who is appropriate for maybe an opioid pain
prescription and who’s not, and who maybe
needs to go on to get treatment for addiction.
VANILA M. SINGH: Yeah, and I think that gets
into the risk stratification strategies that
we can talk about.
Also, weighing on drug seeking versus legitimate
So I think pain is pain, and then behavior
on top of that, that is by the risk of history,
whether it’s family and whatnot, other issues.
That’s also another thing we’re going to have
to disentangle, be very clear, and help society
with understanding what is what.
So again, the stigma really shouldn’t be there
for any of them, and I think you’d mentioned
that yesterday about stigma regardless of
where someone falls on that spectrum and what
the complexities are.
We’re going to move on, but thank you for
BRUCE SCHONEBOOM: Good morning, and thanks
for the opportunity to provide just a couple
of brief comments related to the topic.
First of all, I want to say I’m sorry for
your loss, and related to your family and
wanted to share that none of us are immune
My professional association, we lost a past
president to addiction.
She was a victim, because she suffered from
chronic pain, oral maxillofacial pain, and
was self-medicating and diverting from the
workplace, and she overdosed.
She was a personal friend of mine, and we
memorialize her at our national meeting through
a lecture in her honor to make sure that we
do not forget that this disease can touch
at all levels throughout society.
In terms of access, we talked about lack of
access to providers.
I wanted to say there is also a lack of utilization
of qualified providers.
Cindy and I were talking earlier this morning.
There are over 200,000 nurse practitioners
in this country, but there are artificial
barriers in their ability to treat patients.
There are scope of practice barriers at the
state level, including prescriptive authority,
there are regulatory barriers at the state
and federal level.
If we could remove those, we could provide
access to qualified providers to a broader
population, and I would encourage that this
task force explore removing those artificial
barriers, including in the VA system.
There are artificial barriers there for veterans
to get access to specialty care, just because
of policy that are in the way.
VANILA M. SINGH: The recent buprenorphine
limits that were raised, they were including
NPs and PAs.
Is that correct?
Right, they were inclusive in that?
I think that was right.
BRUCE SCHONEBOOM: And they should include
CRNAs as well.
Many CRNAs in certain states have prescriptive
authority, and they should be included in
that provider group.
VANILA M. SINGH: Thank you.
CECELIA SPITZNAS: Thank you.
So, two things.
I think that in terms of gaps, there’s a lot
that can be done related to adherence that
maybe suggestions around payment models for
that would be useful, because it’s not just
checking the PDMP, but checking the PDMP more
frequently, looking at urine testing, doing
consent, doing contracts.
When CDC did their environmental scan or their
literature review, there was not a lot of
support for these kinds of things, but also,
people who are practicing today know that
these things really help them be able to tell
if somebody is moving into having a substance
use disorder versus somebody is pretty adherent
and doing pretty well and can be managed without
a lot of additional bells and whistles.
And I think that the bells and whistles are
important for people.
We may be seeing more problems now related
to fentanyl overdose, but people are getting
these medicines to start off from prescribed
They’re still getting them out of medicine
cabinets, and users are still getting them
from other people.
So everybody who has a prescription really
has an obligation to hold onto their own prescription
and take it themselves, and if they’re not
taking it and they’re selling it, we should
be very concerned about that.
And that brings me to just the situation with
I think that I’m pragmatic.
I know that people do use casually when they’re
young, but it is not a normal behavior for
youths to be using a prescription that’s not
prescribed to them.
And I think it’s incumbent on us to really
try to prevent any iatrogenic addiction that
comes up in this population if the medicines
are not truly necessary, for people who have
sports injuries, people who have their wisdom
I had a discussion about that, and I think
that there’s a lot of ways that we can really
minimize population-wide exposure where possible,
especially in ambulance setting and in the
ER through use of alternatives.
And I don’t think there’s very much out there
about any of that.
I think that the situation with young people,
if you look at misuse in the 12 to 17-year-old
category, it far outweighs how much heroin
use is going on, even if you consider the
national household survey may be massively
What’s going on with young people, primarily
teens 12 to 17, really, really starts with
prescription misuse, and that very much increases
in the 18 to 25-year-old range, and then in
the 18 to 25-year-old range, that’s when heroin
starts picking up, and now fentanyl, because
a lot of heroin now is fentanyl.
So we had an interesting discussion about
pediatrics last night, and I think that to
the extent that pediatricians can be made
more aware and family medicine docs can be
made more aware and we can target our efforts
towards youth to really just help protect
them and improve the care for them, because
there’s very little addiction treatment available
for them if they do become addicted.
And if you think about it, there’s a lot of
parents who are out there who are concerned
about their child being addicted.
VANILA M. SINGH: Thank you for that.
And I think that was something, actually,
that we had brought up of the ONDCP Steering
Committee back in July, that the points of
contact for youth are of course parents, principals–
another way of saying school– and then pediatricians.
And that has to be loud and clear, a big awareness
campaign, because much is going on in that
sector, and it’s certainly not going to be
reported by a 14-year-old about what they’re
So I’m going to move on.
I know you have something more to say, but
please, Cindy, go ahead.
CINDY STEINBERG: Thank you.
I’m going to make a plea for better data on
pain, and I feel like it’s going to be very
difficult for us to make really good policy
without better data.
We really throw around a lot of different
numbers, and it’s because epidemiologically,
we do not collect any regular statistics on
And I think we absolutely need to ask for
that on a regular basis.
We don’t know what syndromes, how many people
are suffering from what syndromes.
We hear there’s 23 million people with severe
We need better data on that to understand
There’s a hundred million people, when the
IOM had to do that study, they had a commission
a separate epidemiological study because they
had no numbers to go on.
And I feel like we really need that, because
each of us talks from their experience and
I appreciate what the addiction specialists
have said in the room, but again, I’m going
to emphasize that what we do know from CDC
is that there are roughly two million– I
think it’s 1.7– with opioid use disorder.
There are, again, 23 million who NIH has said
have lived with severe pain.
I see those people with severe pain.
I’m talking about the people that are disabled
by pain, and there are so many conditions
that lead to this.
I mean, out of this support group that I started
18 years ago, I have people with CRPS, trigeminal
neuralgia, migraines, chemotherapy induced
chronic pain, and I could go on and on about
the number of conditions that lead to serious
So I really want to make a plea that we need
And another point I really want to make is
that when people also talk about co-morbid
conditions with pain, I need to emphasize
what it is like to live with the severe kind
of pain that I’m talking about.
You’ve heard– actually, one of the people
speaking yesterday said, well, I kind of sometimes
wish I had cancer.
And I’ll tell you the difference.
So people, unfortunately, who have a diagnosis
of cancer, it’s a big blow, it’s severe, it’s
scary, but many people now can go on to have
a normal life.
They get their treatment, and then they go
back to their job.
They can socialize with friends.
When you are living with severe pain, you
don’t have another life.
I want to give you the example of Phil Pizzo.
I don’t think I’m telling anything.
He actually has told this story many times.
He was the former dean of Stanford Medical
School, and he was the head of the IOM committee.
And he went up in a group that I was with
and told his story, that he didn’t totally
understand pain as he was going through the
IOM report, and this was a huge landmark report.
And afterwards, he developed a chronic back
And he starts to tell his story.
Here he was, dean of Stanford Medical School,
and he had this increasingly severe back pain
to the point where he did not leave his house.
He could not socialize anymore, he couldn’t
have a normal life, he couldn’t work.
He said, I was becoming more and more isolated,
and I realized how devastating the pain is
to somebody’s life.
I’m talking 24/7.
You can never escape this.
It is like being tortured 24/7.
You feel like you’re disembodied from your
I’ve experienced it.
I know many people that live with this all
And so I really want to caution us in taking
this– like, he became incredibly depressed.
I mean, who wouldn’t become depressed when
you’re isolated, you’re all alone, you have
no more career?
I mean, imagine this.
You can’t sleep, you can’t socialize, you
have no friends anymore.
It is devastating to live with this kind of
pain, and this is the kind of pain that we’re
talking about with severe pain.
We’re not talking about pain that you can
go on and live with, that most people experience.
Unfortunately, I think that everyone’s had
an experience with pain, so they think they
You don’t understand chronic pain until you
live with it.
And he was a good example, and so I just want
to caution us about being too cavalier about
VANILA M. SINGH: Thank you, Cindy.
Appreciate that reminder, and there are complex–
I mean dozens of pain syndromes that we haven’t
even broached the topic on.
I certainly have seen that in our clinic,
the darkness that ensues.
With that, we’re going to end this session
with Dr. Zaafron and then we’re going to move
on, because we’re actually behind already,
which is fine.
But please, thank you.
SHERIF ZAAFRON: Thanks.
One of the gaps that I think we have is that
we, whether it be the perioperative setting
or the hospital setting in general, we run
into many, many patients who are already on
medications for depression, medications for
a multitude of mental health issues.
One of the struggles that I have, whether
it be as an anesthesiologist seeing a patient
beforehand or working with hospital-based
physicians, is trying to identify who are
those who are at risk, either those who have
already been diagnosed with some kind of addiction
or those potentially who are at risk for having
And how do we manage those?
When somebody comes in and has an ejection
fraction of 20%, we get a cardiac clearance,
or we might get a pulmonary clearance for
a lung issue.
I don’t think we’ve ever developed guidelines
for getting psychiatric or psychological clearances
before a patient is going through the perioperative
And I wonder if this is one of those things
that we need to think about.
Those patients who identify themselves at
risk will tell you, and they’ll say, I want
to make sure that you’re very careful with
me and how I get treated while I’m in the
How many of those patients don’t know to express
that or don’t even know that they’re at that
So I think one of the things that we can try
to understand here– and there there’s obviously
some experts in the room– to try to help
us identify those who are at risk and how
do we triage them.
Those who are already addicted, how do we
And how do we help shepherd them through that
process without making the condition even
VANILA M. SINGH: Thank you for those comments.
I think that’s a really important point.
In the pain clinic, because we’re doing all
kinds of the multimodal, multi-disciplinary
approaches, I can tell you for anyone who
we think may be a candidate for an intrathecal
pump placement or a spinal cord stimulator,
we actually do do the gamut, because we’re
already primed for it with this patient population.
And those criteria actually should be applied,
of course, to not just the pain procedures,
which are often much less invasive when compared
to the larger surgeries that are going on.
I think that’s an excellent point.
And then we can always bring back some of
Our next discussion set is going to be on
special populations, and I’m going to introduce
Dr. Amanda Brandow to be our primary speaker,
and the floor is open for you, Dr. Brandow.
AMANDA BRANDOW: Thank you, Dr. Singh, for
the invitation to serve on this task force
and to speak on the topic of special populations.
In the context of acute and chronic pain,
there are several special populations that
need to be considered, including sickle cell
disease, pediatric and adolescent health,
women’s health, among many others that I have
not had time to mention.
I will discuss a few important points about
pain and individuals with sickle cell disease
as an example of a special population for
consideration as we move forward in our charge.
I would also like to acknowledge and thank
Mr. Bell for telling his story about living
with sickle cell disease in addition to all
the other patients that spoke yesterday.
I’m always humbled.
I’ve been caring for children and adolescents
and young adults with sickle cell disease
for over 10 years, and I’m always humbled
to hear patients speak and share their story,
and I always learn more about what they’re
So sickle cell disease is a hemoglobinopathy
that is autosomal recessively inherited, and
diagnosed at birth in the United States on
the newborn screen.
It is a multi-organ system disease associated
with sickling of red blood cells, recurrent
ischemia reperfusion injury, hemolysis, and
There are approximately 100,000 people in
the US living with sickle cell disease, and
over three million worldwide.
Importantly, sickle cell disease disproportionately
affects minority populations, and in the United
States, sickle cell disease almost exclusively
affects African-American people.
Data support 1 in 400 African-American people
in the United States live with sickle cell
disease, and approximately 8% of African-American
people carry sickle cell traits.
Abrupt and unpredictable onset of severe acute
pain, termed painful crises or vaso-occlusive
painful events, and chronic daily pain are
the most common complications of sickle cell
disease and drive patients to seek acute care
in the emergency department, outpatient clinic,
and hospital setting.
Pain is also shown to be a marker of mortality
for individuals with sickle cell disease for
reasons that aren’t entirely understood, and
data support that people who experience three
or more acute painful episodes a year die
The average mortality age for patients with
sickle cell disease is in the mid 40s for
both males and females.
Pain in sickle cell disease is quite unique
in that occurs throughout the lifespan from
infancy to adulthood, and develops directly
from the disease.
During infancy, pain can occur as early as
six months of age, and usually presents as
painful swelling of the hands or feet, termed
During the toddler and childhood age groups,
pain increases in frequency and severity,
and becomes more diffuse, with a predilection
for the long bones, chest, and back.
Pain also drives patients to seek care in
the emergency department and hospital, and
is also managed quite frequently by parents
During adolescence, we see pain increase in
frequency and severity, requiring more emergency
department visits and increased hospital length
And we also begin to see the emergence of
a chronic pain syndrome in approximately 30%
of individuals with sickle cell disease that
has more recently been described in the last
five to seven years.
During adulthood, this chronic pain persists
in approximately 30% of patients.
There’s continued episodes of acute severe
pain superimposed on chronic pain, increased
opioid requirements, and increased prevalence
of other sickle cell disease co-morbidities
that contribute to the chronic pain syndrome,
some of which we heard about yesterday from
The biology of this transition from severe
acute intermittent pain to chronic daily pain
is really an active area of investigation
or to identify novel targets for opiate-sparing
The biology of sickle cell disease pain is
very complex, varied, and arises from multiple
mechanisms depending on whether an individual
is suffering from acute or chronic pain.
Components of sickle cell disease include
nociceptive pain from vaso-occlusion, or vascular
obstruction and ischemia, from sickled red
blood cells, and persistent and chronic inflammation.
Sickle cell disease pain also has neuropathic
components that likely arise from nervous
system sensitization that is either centrally
or peripherally mediated.
Pain can also arise from sickle cell disease
co-morbidities, including avascular necrosis
of the hips or shoulders ultimately leading
to joint replacements, bony infarcts, and
severe chronic leg ulcers.
The ability to differentiate the different
components of sickle cell disease pain, both
biologically and clinically, is therapeutically
In addition, the driver of the pain can change
during the life course of the disease, and
more than one mechanism can occur in the same
individual at the same time.
Several barriers to effective pain management
exist in the sickle cell disease population,
some of which I will touch on.
First, there is a significant lack of evidence
supporting the use of other non-opioid pharmacologic
therapy and non-pharmacologic therapy to treat
sickle cell disease pain.
Access to appropriate health care is also
a significant barrier of which we heard a
lot about over the last few days.
Importantly, individuals with sickle cell
disease are from very underserved populations
that suffer from many health care disparities.
Issues with discrimination, trust, negative
provider attitudes, and stigma, exist as many
individuals seek care for a blocked onset
of acute pain in the emergency department,
and are labeled as drug-seeking when they
advocate for pain medication that they know
works for them.
Finally, there are certain research barriers
related to operationalizing clinical trials
and continued research funding for this population.
As we move forward with the work on this task
force, it will be significantly important
to consider these special populations such
as sickle cell disease as we develop best
practices for pain management.
So thank you for your attention.
VANILA M. SINGH: Great.
Thank you so much for that.
I just want to put out that sickle cell disease
right now, there’s much talk on moving towards
a cure, understanding the barriers that have
existed in clinical trials.
And that has been significant, that in all
our years of training– I think I 21 years
ago graduated medical school– that really
very little has changed in this population.
And for Mr. Bell, I don’t know if you all
noticed, but he went through a lot to get
to us here and to share his message.
And so I think that, again, we’re grateful
that we hear that.
And back to Cindy’s point– she’s over there–
but this is one of dozens of pain syndromes,
diseases, underlying issues, that have their
own unique aspect to it.
And so again, it’s a simple term when we talk
about chronic pain, but really, it encompasses
And with that, I’m going to open up the floor.
Anyone want to get into their special populations?
Again, it could be– whether it’s pain syndromes
or within the mental health addiction arena.
Any thoughts there?
So we can start with–
MOLLY RUTHERFORD: This is actually– I’m sorry,
this is actually a question.
VANILA M. SINGH: I think we saw– so why don’t
we– we’ll start with Dr. Trescot, and then
we’ll go to Dr. Clauw, and then Dr. Gallagher,
and then Dr. Lynch.
ANDREA TRESCOT: I have a particular interest
in the perinatal period having been a pediatric
anesthesiologist in a former life, but also
the fact that so many of our patients, half
the population that we see, are at potential
risk of becoming pregnant during their chronic
And then the management of that chronic pain,
because of the fact that we have two patients,
the mother and the fetus, and many of the
things that can be used for the mother in
terms of pain are very bad for the fetus.
And then we’re expanding into that perinatal
period when we start talking about this resurgence
of the breastfeeding has led to even more
complications, because the medicines that
might be OK during pregnancy might not be
good during nursing.
And so that whole population is difficult.
VANILA M. SINGH: I’m going to take a moment
here, because we have been given a very wonderful
I see that our Surgeon General, Dr. Jerome
Adams, has just walked into the room.
Yesterday he came during public comment, which
was the one time that we actually could not
But Dr. Adams, if you have a few words, we
would love to have you come up front here
to the podium.
If that’s all right with our group for a moment.
So it is my honor today– so these are the
great surprises we get here at HHS– to introduce
the 20th Surgeon General of the United States
of America, my friend and colleague, Dr. Jerome
Adams, who also is an anesthesiologist.
He served as Indiana’s State Health Commissioner,
and has been absolutely going forth all around
the nation as our primary spokesperson from
HHS, the nation’s top Doc, and he has been–
we have both been– discussing pain issues
which have been coming his ways as well as
the rest of us.
So Dr. Adams, thank you.
JEROME ADAMS: Thank you so much.
VANILA M. SINGH: Appreciate it.
JEROME ADAMS: Thank you.
I had to give Dr. Singh a big hug, because
she has been working very hard to make this
all come together.
Those of you who’ve been involved in a task
force like this before know what a tremendous
undertaking it is.
And those of you who haven’t, it is insane
what it takes to make all of this happen.
So thank you for your tremendous work.
Thank you to the task force members, because
you didn’t have to be here.
You’re here because you care, and it’s critically
important that you are here.
It took a while to get this going, but it’s
been long overdue, and we’re just really excited
for the opportunity to advance the conversation.
I want to thank the folks who made public
I’ve been watching on webinar in between meetings.
I wish I could be here for the entire convening,
but I’ve been watching, and lots of great
comments all around, but it was really important,
I think, for us to hear from the public.
It’s easy for us to sit in our academic centers
or to sit-in our buildings here in D.C. or
all the places we come from and think we know
what’s going on, but to really hear what the
public is concerned about is critically important.
I don’t want to go on too long, because really,
this committee is about your conversation,
but I do want to say that we have dueling
We genuinely do.
We do have a crisis in regards to opioids,
a person dying every 12.5 minutes from an
But that said, we got there because the pendulum
over-swung from a crisis that existed decades
ago, and still exists, and that’s a crisis
of our inability to adequately address chronic
We need to do a better job of treating both
acute and chronic pain.
I’m about to go to NIH and speak to the NIH
Pain Consortium in just a few hours, and my
message to them is going to be, we need to
do a better job discovering new ways to treat
We need to make sure we do a better job of
implementation science, because one of the
big concerns for me is that we’ve got lots
of great ways to treat chronic pain, lots
of alternatives out there already, but we
aren’t adequately utilizing them.
Our systems right now aren’t making the right
choice, the easy choice.
And that’s why it’s so important that you’re
here to give us feedback to HHS, because Secretary
Azar– I know he spoke to you yesterday–
is committed to setting up a system that rewards
outcomes, and not one that rewards bad behaviors
and that perpetuates more of the same.
I want you all to know, as your United States
Surgeon General, it’s my job to make sure
that pendulum doesn’t over-swing.
We have to stop individuals from dying, but
we have to do it in a way that doesn’t hurt
folks with acute and chronic pain.
And there’s folks in the middle, too.
There’s folks who we know we could treat better
with fewer opioids, but the fact is, we’ve
stabilized them on opioids over the last several
And so we can’t pull the rug out from under
And I heard that loud and clear in the public
comments yesterday, that there are a lot of
folks out there who have been stabilized on
And again, scientifically, that may not be
the best option for them, but it’s better
than no option, and we can’t pull the rug
out from under them.
We have to make sure we are dealing with both
crises at the same time.
So again, thank you so much for taking the
time to be here, and if there’s anything my
office can do for you, please reach out and
let me know.
And to the public, I want you all to know
that I care about those individuals who are
I don’t want to meet another mother, another
father, who’s telling me the story of their
child overdosing on an opioid.
Every day, every day, I hear those stories,
but at the same time, I don’t want to hear
a story from a chronic pain patient who felt
like they were forced to go to illicit opioids
because there were no other alternatives available.
We have to reject the binary.
It’s not either/or, it’s got to be both, and
I’m convinced that we’ve got the right people
here on this task force and the right community
members giving us feedback to make sure we
find that appropriate balance.
VANILA M. SINGH: All right.
So we were going for Deputy Surgeon General
because I knew Dr. Adams was busy today, and
I’m so grateful.
The NIH Pain Consortium is meeting with private
and public partnerships right now.
We couldn’t help the clash of dates.
However, this is something that we have been
The letters that are coming in, of course,
first from the overdose fatality issues, but
nowadays, those very pain patients that we’re
discussing, and their sad desire to even commit
And so we have something great in front of
As you can see, all of our top officials at
HHS are devoted and are supportive of our
effort, and have been watching.
And so, there you go.
And Dr. Adams, thank you, again.
We appreciate it greatly.
–set this up there.
We will now resume our clinical topic discussion.
We were on our special populations Dr. Brandow
had mentioned, and got we got into the sickle
cell population discussion.
And Dr. Trescot was just wrapping up comments,
and then we were going to move on.
ANDREA TRESCOT: I will move on.
VANILA M. SINGH: Excellent.
And so, I know I’d discussed an order here.
So we’re going to Dr. Clauw and then Dr. Gallagher,
and then next it would be Dr. Lynch.
Please, go ahead.
DANIEL CLAUW: Yeah, I just want to point out
what I have observed to be a problem with
treating some of these special populations
in that they typically get treated by sub-specialists
who treat the underlying disease that that
person has, but have had no experience in
managing or treating pain.
So not withstanding, a few people in the sickle
cell field that have tried hard to understand
pain, that not all pain is nociceptive.
I’m a rheumatologist.
We have the same problem in rheumatology.
Our rheumatologists are amazing at treating
the auto-immunity associated with rheumatic
diseases as we’ve gotten better and better
drugs to do that, but they’re terrible at
treating pain that it’s not nociceptive in
origin, that is neuropathic or central in
And you see the same thing in a lot of these
special populations, in oncology practices
that are still using way too many opioids.
And so, one of the challenges in these special
populations, because most of the providers
have not been trained in contemporary pain
management, is that is where a lot of the
over-prescribing of opioids is occurring for
We just need to be mindful of that as we move
forward, that some of the education programs
are going to have to be particularly targeted
to those groups of providers.
Because they take care of fairly large numbers
of individuals, but they really know very
little about pain management.
VANILA M. SINGH: Thank you for that.
I do want to emphasize that we have brought
up education, both for the provider level
and patient level, but along with that goes
time and resource in order to bring into the
more novel strategies that are there.
We know that the over-prescription or the
prescription of opioids is driven by many
One is correct clinical indications.
The other is an ease, a lower co-payment and
ease of actually filling those, versus other
non-opioid pharmacology options.
We’ve heard about pregabalin and gabapentin
and other meds being more expensive, unless
you’re in the Dr. Rutherford model, where
she’s dispensing those medicines.
But also getting coverage for those blocks–
and nerve blocks have been around for half
a century or maybe even longer– however,
again, now it’s into the norm, more mainstream,
because of ultrasound and those advances.
So there’s a lot that goes into this.
It’s education, but it’s the ability to implement
So you know how to do it, but then you need
the time and ability to evaluate your patient
and then figure out when and how you can get
it done with authorization.
And then we’ll move to Dr. Gallagher.
ROLLIN GALLAGHER: Thanks.
Yeah, I’d like to address, related to the
topic of special population, some of the things
that Cindy mentioned.
Data, we don’t have big data in pain.
It’s a huge deficit, and it’s one of the key
outcomes I hope with this strategy, this pain
management task force.
It’s been identified for years.
Some of us have been working on it for 20
years trying to get a uniform outcomes measures
project going across the field.
We’ve failed, basically, because of the cost,
technology issues in the beginning, but now
we do have the technology, and there are some
programs that are being tested out in the
VA and DOD.
There’s the promise system in Stanford.
Sean Mackey and his group have developed a
database that’s based on the NIH promise system.
So we have some ways of actually having clinics,
both primary care and paying clinics across
the country, collaborate in developing a single
database just like they did in cancer, which
separated out cancer into multiple cancers
and multiple types of certain types of cancers.
It allowed us to really do analyses that focused
on specific diseases in the cancer population,
and then come up with a cure.
So that’s really critical here, and so, for
example, all the clinics that do sickle cell
disease, really, could have a single database
for that population, similarly for migraines,
low back pain, et cetera.
So that’s a huge gap for us, and I hope we
can solve that and make that one of our key
I’d also like to address the issue of pain
in depression, depression being a special
population of pain patients.
We did a study at Columbia back in the ’90s,
where we looked at predictors of depression
after onset of pain.
It was a family study, so we actually looked
at the genetics and family transmission of
risk in this population of chronic facial
And we found two things that aren’t surprising.
One, those patients with no risks in terms
of family history or personal history of depression.
Took about six months before their rate of
depression started going up.
And this is what Cindy said, like Dr. Pizzo.
After a long time of not getting better–
and one of the risk factors, actually, for
increasing the rate of depression was how
many different providers you’d seen that didn’t
cure your pain.
But anyway, so the risk went up after six
months even if you had no risk factors, no
family factors– or family risk factors for
depression or personal history.
Now, if you had one of those risk factors,
depression came on very quickly after the
onset of chronic pain.
So it was very important to identify it right
off the bat, but long-term, it was important
to identify or to keep looking for it in a
chronic pain patient.
So I wanted to make those points.
VANILA M. SINGH: Thank you, Dr. Gallagher.
MICHAEL LYNCH: Thank you very much.
So as it relates specifically to special populations,
I think you could argue that almost any sort
of group within the diagnosis of chronic pain
is its own kind of special population, where
I work in an emergency department, in particular,
we’re managing acute exacerbations of chronic
I think where one of the places where we struggle
is trying to quantify that and work within
a long-term pain strategy, but also manage
the acute pain that we know can occur.
And so I think some of the strategies that
have been helpful for us are, one, working
with the outpatient physicians and creating–
there’s one thing to have a care plan, but
also to have a clearly identified, even brief,
sort of this is my current plan of care and
what I think about exacerbations and so forth
that take into account what a PCP or specialist
knows about a patient that I can’t.
And I don’t have time to review every outpatient
progress note that are usually useless for
all the reasons we discussed with the EMR.
And the other part of it, I think, is that–
and a lot of people here will know this far
better than I– over time, particularly when
you’re talking about a population who has
grown up either through early childhood or
adolescence with a syndrome that has become
chronically painful that often requires a
number of treatments, including opioids, the
ability to cope with stresses and pain and
different things in life that aren’t necessarily
the acute physical cause of pain kind of funnel
back to, and often end up in, the emergency
And often, the treatment ends up being whatever
the care plan, acute opioid.
It isn’t necessarily the correct treatment
for what is actually occurring at that time.
So the pain seems to be being treated, but
maybe the cause of the pain isn’t being addressed.
And I think that there’s only so much that
people can do as far as getting patients into
offices and so forth.
And one of the other strategies we’ve started
to employ with different populations who are
high utilizers of health care system because
of pain related complaints is having folks,
community, paramedics, and so forth, go out
to the individuals to assess their home situation
so that the things that maybe adding stress
that may be interpreted as pain or contributing
to pain can be addressed outside of the health
care system, at a lower cost, and with reduction
So I think strategies like that will be important,
and certainly, within each of these populations,
I think that concurrent with that has to be
a consideration of a harm reduction strategies,
including naloxone distribution.
We just know folks who are on high doses of
opioids, even if they are tolerant, are at
a higher relative risk of unintentional opioid-related
So I think that that kind of co-occurring
prevention and tertiary prevention, maybe,
the prevention of death related to it is also
very important, something that can be done
at any point along the way, and needs to be
considered, I think, more and more frequently,
and is, fortunately.
VANILA M. SINGH: Well, great points brought
up in all of that.
I hear you with the notes, and I think that’s
something that has come up.
Again, I think that really gets into continuity
of care and understanding.
What’s happened before when we have these
templates that really don’t register, it hinders
our ability to understand what was the last
plan of care and then what is going forward
so that we can actually get to the bottom,
the root cause of what we’re seeing is triggering
the pain, the flares that we hear about.
Our very own best patients, even when they’re
on the best regimens and they’re functional,
there are triggers that cause a flare in their
condition, whether it’s physical, mechanical,
or it’s emotional, or related to other co-morbidities,
and I think that’s a great place.
Also, for the emergency Docs in our group
here to consider the warm hand-offs that we’re
That can be something that we bring up next
We’re going to take a break right now.
We are behind a little bit, but I think we’re
going to be fine in terms of making it up.
We’re going to return back at, let’s see,
at 11:10– 11:05?
10 minute break, sorry.
But we will come back to discuss education,
and that’s what we’re going to get into next,
and that has been brought up.
So I think rather than us reiterating what
we already know, we’ve all discussed, perhaps
the education, we can get a little bit into
the nitty gritty so that we make some progress
towards our report.