the Medical Center Hour. This is a weekly forum
under the auspices of the Center for Biomedical
Ethics and Humanities. I’m Jim Childress, pinch hitting
for the regular moderator, Marcia Childress. It’s a commonplace,
widely noted in the media as well as in medical and
public health and context and literature, that
we face a crisis– an opioid epidemic. At least two million people
in the United States who are addicted to prescription
opioids, and about 600,000 more have an opioid use
disorder involving heroin. And average of
Americans die each day from overdoses
involving an opioid. This epidemic has many
causes, but few if any clear solutions– certainly no simple solutions. So what can we do? We’re pleased to have
two very distinguished speakers help us today better
understand this epidemic, and identify ways
to move forward in the short run
and the long run. Our first speaker is
Professor Richard Bonnie, who is Harrison Foundation
Professor Medicine and Law, professor of Psychiatry and
Neurobehavioral Sciences, Director of the Institute
of Law, Psychiatry, and Public Policy,
School of Law, UVA. And he was the
chair of the study– a consensus study for the
Institute of Medicine– formerly Institute of Medicine,
now the National Academy of Medicine under the
National Academies– of pain management
and opiod epidemic analyzing societal and
individual benefits and risk of prescription opioid use. Our second speaker will
be Dr. Leslie Blackhall, who is Associate Professor of
Medicine and Medical Education and Section Head, Palliative
Medicine Division of General, Geriatric, Palliative, and
Hospital Medicine, Department of Medicine UVA. And there are fuller bios
for both of these speakers on the handout. Each will speak for
about 20 minutes, thus allowing plenty
of time for interaction with you for your questions
and comments and concerns. Professor Bonnie. RICHARD J. BONNIE: As you
heard– thank you Jim. As you heard, my
assignment is to talk about the National Academies
report, consensus study. Quite a deep dive for me. This is– the charge
included pain management, and I learned a lot about pain
that I didn’t know before, and it’s connection to
the opioid epidemic. And here the report– 400 pages long. But I think it’s a pretty
good job, actually. So I’m going to try to give
you an overview of the report, I think in terms of the
connection between what I’m doing and Leslie– I am giving you the big
picture policy perspective. We’re actually talking more
about the national policy in what I’m saying here– FDA commissioned the report. And she’s obviously
going to talk about the challenges in the
clinical clinical setting. Hopefully there will
be some intersections that we can explore later. So Jim gave you some of
the essential figures here in terms of the
background, but it is worth making my emphasizing the point
that this crisis that we’re facing lies at the intersection
of two public health challenges– helping the tens of
millions of people who suffer from chronic pain
while containing what we know to be the rising death toll
of harms to individuals, their families, and
communities that are associated with addiction to
opioids or otherwise to misuse and diversion
of those products. As Jim indicated, as of 2015–
we’re still waiting, actually, for more recent data, we’re
all using the 2015 figures, and they’re undoubtedly
higher than this– two million Americans
aged 12 or older had opiod use disorder
involving prescription opioids and another 600,000 had a opioid
use disorder involving heroin. Drug overdose as I think we
hear a drumbeat in the media about this, this is probably
something you’ve heard before, is now the leading cause
of unintentional injury death in the United States,
and most of these deaths involve opioids– somewhere over 30,000 in 2015,
and somewhere over 50,000 for all drug overdoses. What is, I think,
particularly noteworthy is that during the
period from 1999 to 2011, the annual number of overdose
deaths from prescription opioids tripled, and it leveled
off in subsequent years. However, during the
period from 2011 to 2015, overdose deaths from
illicit opioids, including heroin and
synthetic opioids– such as fentanyl–
nearly tripled in that four year period. And this was driven,
in large part, by the growing number of
people whose use of opioids began with prescription
opioids, and then they gravitated to the
illegal market. And that is, among other
things, the most troubling part is this epidemic. Because you can’t look at
the problem of prescription opioid abuse or
misuse or an addiction without recognizing
the intersection with the illicit market. And this is the slide that kind
of demonstrates the increasing and then leveling off, as I
said tripling from 1999 to 2015, or overdose deaths related
to prescription opioids. And then you see a very
flat curve with regard to heroin overdoses,
then quadrupling in a very short period of time. The elevator speech version of
this is pretty simple to put, and I want to make
sure that I say it before I try to give
you a little bit more of the detailed report. I think the magnitude
of this problem is even greater than the
daily headlines suggest. When you look, obviously beneath
these measurable overdose deaths and diagnosed
disorders and begin to look you know more at the
geospatial features of this, you can dive into the
people who are suffering from these problems
and the impact on their families
and communities, is really astounding and
alarming what is happening. And it is going to get
worse before it gets better. I mean, I think that that’s– I didn’t know that when we
first started studying this. But certainly I think
everybody on that committee believes that, that this is– we haven’t reached the
leveling of off this, even despite the attention
that’s being given to it and the steps that
are being taken– it’s going to get worse
before it gets better. And it’s going to take many
years for this to unwind, given the number of people that
have opioid use disorder now. And as you know, it’s a
chronic relapsing disorder, and there are going
to be more cases. So the story here, as far as
our committee was concerned, is that we need an all hands
on deck approach to this. We have to have coordination
across all of the stakeholder groups– professional
groups as well as the state and
local governments and the federal
government, and all the different federal agencies. There’s obviously
a tremendous amount of siloing and so on here. Nobody is really in
charge at all of this, and some greater
coordinated effort is going to have
to be undertaken. And it’s going to
have to be sustained. We are not good at
that in this society. We’re not good at
prevention generally. But we– sustaining an effort– I mean, we’re getting
public attention now. Obviously you see it actually
had a little bit of an impact on the health care debate that
was going on in the Congress, because of the attention
that was being drawn to this. People are paying
attention to this now. Declaration of
national emergency is the buzzword for the moment. But we have to sustain this
attention for many years. It took all of this
time for this to happen, and it’s going to take
a very long time for it to unwind, too. And I think that,
in a way, is maybe the most important
message of the report. We did recommend an action plan. I want to just summarize
key parts of this. Later on, if I run
out of time, you’ll at least to get the
big picture here. So there are basically
six points here. We need a culture change
in provider education and in public understanding. A lot of attention, of
course, to the prescribers, and some of the
concerns that people have had about whether there’s
been adequate education of the various prescribers. But it’s not only
provider education. I think that what hasn’t
been focused on yet is public understanding
about the role of opioids and effecting
public expectations about whether opioids are the
right answer and the risks that are associated with them
and with the benefits of alternatives
to opiods might be for whatever their problem is. You can imagine– I mean have
you seen any media effort or media campaign that
really is focused on this? You see a lot of
ads for the drugs, but is there really any
sustained public education campaign that will reflect the
demand and the expectations that people have regarding
treatment of pain– and it’s partly that we don’t
talk about pain very much, except “take a drug for it.” Secondly, we need an
investment in increasing– clearly we need a huge
investment in increasing access to treatment for
opioid use disorder and particularly to remove
the impediments that now exist both financial and
otherwise to the use of medications to treat
opioid addiction. And this is a huge challenge. It’s going to be
expensive to do this. We need Medicaid expansion
in order to be able to do it. We need a lot of effort
to focused on this. And again, it’s just hard
to emphasize that enough. Obviously we want to
continue to increase access to lifesaving medications to
reverse the effects of overdose and the various steps that are
being taken around the country to increase access to
naloxone and to otherwise assist to prevent overdose. We need to intensify FDA efforts
to incorporate public health considerations into
opioid regulation in a systematic fashion, and to
provide aggressive monitoring and oversight of what
happens once the drugs are on the market. The FDA did request this report. They knew that they
needed to sort of broaden their regulatory
vision in order to be able to take these
considerations that go beyond the risks and
benefits of the drug to that particular patient, and
those that effect what happens to the market once the
drugs are on the market, taking into account diversion
to the risk of diversion, taking into account the
connections as I’ve already indicated between the licit
market and the illegal market, and all the dynamic
aspects of this epidemic. It’s unprecedented. Everything that’s going now– we’ve had a problem of– in a later slide
talk about– we’ve had a history of trying to
think about the regulation of opioid drugs since
the 19th century. And a lot of troubles in
relation to opioid addiction over these years. This, of course,
what is happening now is totally unprecedented. We have an endemic problem
that’s lasted a long time. You have episodic changes, but
nothing has happened like this. And so FDA needs
to think about how to regulate these drugs in a way
that takes all of those factors into account and to monitor
the effects in the market. I mean, even the issue
about abuse deterrent properties of certain drugs,
new formulations of them– they can backfire, actually,
if, you don’t recognize how they might used once
they’re in the marketplace, and you might make
situation even worse by people trying
to beat the drug– the deterrent
features of the drug. We need to increase–
to strengthen the data and surveillance at all levels. One of the problems here is this
part of the– one of the many reasons or the factors
that went into this, we didn’t have decent
surveillance systems with regard to these– the connections between
prescribing and illicit market, but we had some. There were monitoring
data, people were monitoring
people in the jails to get an understanding of
what the prevalence of drug use and particularly
opioid and opioid addiction was in
that population. There were seizures
that were undertaken and assessments of pricing
through other data systems that were used in
law enforcement. And during recession,
these things got cut out– these data systems. So just at the time that this
epidemic was really increasing, we were missing the
data systems that would have provided some advance
notice of what was going on. There’s a lot about
pain and the treatment and the prevalence of pain– the data are not really adequate
on that either, and certainly not at the intersection of pain
treatment and opioid addiction. So strengthening
data and surveillance is absolutely essential. We need obviously as well
to invest in research on understanding the
neurobiology of pain, and its relationship to
addiction, and on ultimately, the holy grail here,
the development of non-addictive
alternatives to opioids. We have to reverse what has been
a longstanding under-investment in pain research and in
research on pain management. The committee included
equal numbers, essentially, of people– anesthesiologists
and others– who concentrate in pain and pain
management and pain research, and then people from
the public health world with special knowledge
of policy development and opioid addiction. It was a huge committee,
and it was really excellent, the membership. It was just a very
impressive group of people. That’s why U say I learned
so much from having done it. So what I had in mind is
maybe some additional items of summarizing the report and
then a couple of reflections just from my own perspective
on the challenges that I think that this posed. I presented, I think, sounds
like a fairly coherent report, and maybe persuasive to you. But there are a lot of
puzzles that are involved in thinking about this topic. The task was to summarize
the state of the science, and particularly with
regard to pain management since the IOM did a report
on this subject in 2011, characterize the epidemiology
of the opioid epidemic, and then make recommendations
for the FDA and others. And I’ve summarize
all that for you. With regard to pain management. Maybe by this time,
everybody in this room maybe is aware of
these findings, but they’re important. They underlie so many
of the recently issued clinical guidelines
by CDC and elsewhere. But it can’t be said too many
times that opioid analgesics are widely accepted as
effective for acute pain as well as pain related to
cancer and at the end of life. But data demonstrating
the benefits of long term opioid therapy for chronic
non-cancer pain are lacking. Some data suggest
that it, in fact, makes it worse for some people. And we have very little
that is measured in terms of functional outcomes. We have subjective pain reports. So the data are lacking. I mean, we didn’t say
there aren’t any– I mean we did say
there aren’t any. It’s not that you have proof
of lack of effectiveness. But there is some
evidence of that too. Long term use of
opioids is associated with increased risk,
obviously, of opioid use disorder, overdose, and other
adverse outcomes as well. And so the risk benefit for any
individual patient obviously is a– is not close, unless
nothing else has worked for really severe pain. There are many
non-opioid alternatives for the management
of chronic pain, ranging from non-steroidal
anti-inflammatory drugs, anti-convulsants,
antidepressants, and analgesic
creams and patches. Non-pharmacologic therapies–
cognitive behavioral therapy, mindfulness meditation,
physical therapy, and exercise. Interventional– injections,
nerve stimulators, and medication pumps. There are alternatives. While he’s non-opioid
alternative has its own
indications and risks, these treatments can,
in some patients, be more effective and
at least as effective as opioids for
reducing pain and often carry a lower risk, obviously,
of the adverse outcomes when they are used
appropriately. And when I mention
the importance of pain education for the
population at large, not only for prescribers,
this is important. Compared effectiveness
and long term outcome data are sparse for most
of these alternative therapies as they are of
course with regard to the opioids themselves. Despite recent
scientific advances, identification of individuals
at risk of opioid– at higher risk, particularly
vulnerable, susceptible to, opioid use disorder, requires
much better characterization of the neurobiological
interaction between chronic
pain and opioid use, and despite the prevalence
of pain and opioid use disorder and the related
call to society and repeated calls to action for
more research on this, as I’ve indicated
earlier, research on pain remains poorly resourced. I think this is another thing
that was eye-opening to me. I kind of expected that a lot
of the science in the work would really focus
on the connection between, at the very basic
mechanistic level and then all the way into the clinical and
social level, between opioid– vulnerability to opioid
addiction, and addiction on the one hand and pain
management on the other, and I was just really surprised
at how little there was. And this is a key
recommendation in the report– there should be a whole
other research initiative on this area, and then
in an appropriate time there ought to be another
study on that issue. I think I will skip the
various recommendations, because I’ve kind of
summarized them already. Say a word about the FDA. So this is a
schematic presentation of the FDA’s drug
approval process, as you all presumably
are familiar with. And what we basically
said is that at every step along the way,
from the pre-clinical studies into the initial
clinical trials, into the new drug application
stage approval and then post-approval and the monitoring
afterwards– at every stage of this process, things
have to be done differently with regard to opioids. We’ve kind of– one of
our committee members characterized this as
opioid exceptionalism. There are just special reasons
that you have to do things differently in this connection. And so we make recommendations
about collecting all this relevant data
that is not, as I said, it’s usually beyond the
agency’s regulatory vision. They’re going to have to
undertake different ways of trying to get a hold of it. They’re going to also
have to have a more quantitative approach to
decision making of rating risks and benefits, once you widen the
regulatory vision in this way, that kind of a qualitative
judgment about risk and benefits isn’t
going to do it. We need population
level data, and with all the dynamic effects
in the marketplace that can be affected by putting
these drugs on the market. So there’s a real
challenge here for them to have a different
regulatory approach, and they have to do it every
point along the way they have to be aggressive about it. So the report basically just
walks through– pre-approval, testing, in terms of
getting kinds of data that you don’t normally
get at that stage, post-approval monitoring and
then specific recommendations all the way down the line. So Jim, do I have
until 25 after? JIM CHILDRESS: Yes, go
ahead and finish that part. RICHARD J. BONNIE:
All right, so I wanted to say some things here
about the complexities of doing this. I’ve sort of given you
a picture of the report. I think, as I said, I
think we did a good job. But there are puzzles here. I mean, I’ve given you
the elevator speech. I’m convinced that we need to
do the things that I’ve said. But some of these issues
are actually quite hard. So there are ethical
complexities here. The charge, to
the committee, was to give FDA
recommendations about how it can balance the needs
of patients in pain and the needs of society
that are associated with opioid disorder
and overdose. And conducting that
balance is difficult. I’ve already indicated–
at a policy level, you could kind of imagine
having quality adjusted life years and other
measures in terms of trying to have an overall
mathematical approach to this, and think about what
the benefits of putting the drug on the market in terms
of providing treatment for pain for people who otherwise can’t
get the relief that they need, and then took that
up and then turned up what the consequences of
diversion from the market and opioid use
disorder that develops notwithstanding efforts to
prevent it and so on, and try to figure out– so what is the–
where is the sweet spot here with regard to regulation? And that would apply not only
to the FDA’s approval decisions, but there are decisions,
of course, as we know, that are being made at
the state and local level all over the country
about– and some of them arbitrary restrictions–
on access to opioids, and people, of course, are
worried about the consequences. So people complain,
and their doctors are worried about the
consequences of that. Well how, and given
what I’ve already said is fairly weak data on
a lot of these things, how do you actually conduct
that policy balance? And one of the– the issue is that the ethics of
public health regulation, which requires this
aggregated approach that I’ve just described– our intention with the
ethics at the bedside and the needs particular
patients had the dependence– their relationship with
physicians whose duty is to try to help
the patient as best as possible, given the things
that have worked or not worked. And how do you crank that– the importance of the physician
patient relationship– and the needs of their
particular patient into this kind of mathematical
approach that I just described? And it was a constant
source of tension between some of the
clinically oriented people in the committee as well
as the more mathematically oriented policy people. And we need to do both. And you need to make room
for appropriate discretion. And that’s why I say, the
committee certainly said, even though we’re
trying to push the FDA toward this regulatory
approach that I’ve described, we have to make
sure that you leave room for appropriate [INAUDIBLE]
and responsible exercises of clinical discretion given the
particular needs that patients have and avoid
arbitrary restrictions under those circumstances. So that was one struggle
we had in the report. Another set of issues that
I’ll just mention here, and you can have that in your
mind, is how did this happen? And there are multiple
vectors that are at work here and intersecting
narratives, that I think you can kind of see
almost on a daily basis in the newspapers. There’s kind of the one side
is the supply and the increased of life of opioids
from the manufacturers and then into the marketplace,
and the increased prescribing and the promotion of
the drugs, and so supply is the vector
through the industry, and we had a whole
system failure in trying to prevent bad
things from happening. That’s one story. We also have this incredibly
important inequality in social determinants
story, relating to the number of
people in despair and their vulnerability. And obviously that plays
a huge role in this. And you can see they’re not
inconsistent narratives. But they are
different narratives in terms of trying to
understand why this happened and how we can deal
with it in the future. And I’ve already mentioned and
I’ll just allude to it again, that we have this history. And we have a history of
failure in drug policy. We had an opportunity,
frankly, in the early 1970s, when the Controlled
Substances Act was passed, to actually
take a public health approach to addiction. And we did for a
while in the 70s, and then it disappeared in
the wake of the drug war, and things got worse, and
all the preventive mechanisms that I’ve already described
and the opportunities to actually prevent
things from happening by having more
aggressive oversight, regulation, data collection,
just fell by the wayside. So that’s another part
of the story here, is basically a failure
of governance as well. LESLIE J. BLACKHALL:
Can you guys here me? All right. I’m going to tell a slightly
different story about this, as someone who was, I think,
involved in some of the reasons why we have this problem
we currently have. And I’m putting up this
pendulum for reasons that’ll become clear. So I’m going to start
back a long time ago, when I was in medical
school and residency and starting my practice,
and at that point, starting to do a lot of
work with cancer patients through work in hospice
and palliative care. And in the early 80s and 90s,
we identified a different sort of crisis, which was crisis
of untreated cancer pain. So in general, there
was a lot more attention being paid at that moment
to end of life care– Elizabeth Kubler-Ross
had put a book out– there was a lot of legal
and ethical controversy over whether it was OK to
take people off life support, and how to have
discussions, and that’s when we started having living
wills and advanced directives. And as part of that overall
discussion, a lot of people, a lot of us, started talking
about uncontrolled cancer pain. I don’t know if some
of you are old enough to remember Jack Kevorkian,
who was a guy who believed in euthanasia and had
a little euthanasia machine, he used to euthanize people. And there would be discussions
on NPR about, should people be able to kill themselves
at the end of life rather than suffer
unbearable pain. And I’d be sort of yelling at– I’m this sort of
person anyway, but I’d be yelling at the radio, like,
why don’t we control the pain, as a beginning, anyway of that. And that’s a long story. So here are just a few
the research papers that were very influential
during that time. The support stages which
was a major bioethics study, showing that half of
the seriously ill– seriously ill meaning people
who are likely to die within the next year– adults had pain and a fair
number of them had severe pain. Charles Cleeland did a series
of really excellent studies on cancer pain
showing that about 70% of people with advanced
cancer have severe pain. Some studies have shown people
with metastatic diseases up to 90%, and
almost half of those have inadequate pain control. And the last study
was a study of the– ECOD is the Eastern
Co-operative Oncologist Groups, so these are a major
oncology organization– 86% of then felt that their
patients’ cancer related pain was poorly treated. Half of them felt
that their own pain management of their own
patients were poorly treated. I guess the other 30 percent
felt that everybody else sucked and they were OK. And 31 percent of
them said that they would wait until the patient
was terminally ill, like very close to the end
of life before they would prescribe a narcotic. So at this point I
was in California doing hospice and
palliative medicine and I would see
people in their home with hospice who
had never received an opiate stronger
than hydrocodone, which is a very weak opiate. More than half the oncologists
in California at that time do not even have a DEA license
to prescribe strong narcotics because they were afraid
of getting arrested. They actually– if you wrote
a narcotics prescription, it was a triplicate. One you had to keep– some people are
shaking their heads that remember this– hi John. And one copy you
kept, one copy went to the drugstore,
the pharmacist, and another went to the DEA. So people just refused to do it. So I go home– I do home visits on patients. And I would get their
pain under control literally in a couple of
days, and the family members would ask me, why did we have
to wait until the last two weeks of his life to
get pain control when he’s had years of
living with this cancer and being miserable. And that was the crisis
we were responding to. I was part of this– the
Cancer Pain Initiatives. There was a state by state
and the national organization to try to improve the
treatment of cancer pain. Here was something the World
Health Organization came out. This was the cancer pain–
they called it the cancer pain ladder, but it looks like
a staircase to me me, but nevermind. So it emphasized– you
start with non-opiates but often go up to my mild
to moderate opiates, that would be like hydrocodone or
something, and then stronger opiates. And there was actually a
study done during that. And there were many
studied looking at the effectiveness of opiates
for cancer related pain, and as Professor
Bonnie said, this is the one indication
in which it’s been shown to be effective. And 70% of patients
in this study using the guidelines–
the WHO guidelines, had good control of
their cancer pain. And 16% had sat– so 86%
had either good control or adequate control,
using this guideline. And so this seemed like
what we needed to do. Betty Ferrell, who was a
nurse PhD at the City of Hope in Duarte, California,
taught a generation of us how to do good cancer pain
control at yearly or twice a year conferences about
that, because there was very little
teaching, and she was the person that headed the
AHCPR guidelines for cancer pain. And part of that
was they did some– looked at studies, some of which
were done by Charles Cleeland, on why is it that
people with cancer can’t get good pain
control, and they were patient related barriers. But the two biggest ones
from the physicians’ side were concerns that they were
going to be arrested or have their license yanked
for prescribing opiates for their cancer patients,
and their patients were going to become addicted. So here is a very famous, very
short letter to the editor that everybody, including
me, cited as a reason why you didn’t have to worry
that your patients was going to become addicted to opiates. And I kid you not, this thing
was cited a million times. Here’s the little thing. It says 264 articles cited. And so they looked at 11,000
of almost 12,000 patients, who got opiates in the hospital,
and found that like four of them had an addiction problem. Of course, they
only looked at them when they were in
the hospital, so I’m not sure how you would have
known the addiction problem, but. So this seemed
like things were– so then what happened– so the AHCPR guidelines
actually suggested, the panel recommends that laws
and regulatory policies aimed at diversion control not
hamper appropriate use of opiate analgesics
for cancer pain. So if you want to know
where the problem came, why people started
prescribing all these opiates, then I will just
say it’s my fault. The fault of my profession
in a certain way. And I would also say. I was there. This is why I have
that pendulum. To see people curled in
the fetal position of pain and nobody would give an opiate
stronger than hydrocodone, even though they had cancer
throughout their whole body. So the JCAHO– Joint
Commission on the Accrediation of Hospitals, partly as a
result of all this pushing, had pain the fifth
vital sign, and then there was this push to
change the regulations, and it was in 2002 where
they proposed changes for the regulation of
opioids for cancer. And here we see the
bleedover into non-cancer, since somehow we had proved– which we really hadn’t, it
was that one little thing– that opiates were the answer
to cancer pain, people who have the worst
pain m they must be good for every
other kind of pain. And so there was
a bleedover there. Around same time also we had
another thing happening, which was the growth of hospices. In 1992, 14% of people
who died had hospice, and by 2007, almost 40% did. And hospice is a
place where people– you have nurses
there who are making sure your pain is
well-controlled, so increasingly people are
getting the pain control they needed, but they’re
having a lot of opiates sitting around their home. They’re not in a hospital
getting the opiates, they’re having 240
oxycodone pills in a bottle at their home. So I would say that
these trends that increase the treatment
of mainly cancer related pain, along with– sort of hooked up with–
the marketing of OxyContin– so OxyContin– the executives
marketing this thing sort of took people’s concern about
cancer related pain and all of a sudden everybody
needed OxyContin. And all sudden, the
prescriptions for opioids skyrocketed. And that seemed OK for a while. You can see up till
about the late 90s, things look fairly
stable, and then bam! So this is a famous
article in the New England Journal of Medicine. And I think you went
through this more, I don’t think we
need to repeat this. So here we are. This is my concern. Here’s the CDC guidelines. The CDC came out with
guidelines for the prescription of opiates for cancer pain. And almost every state has
had new laws and regulations about this. But almost all of them say
except cancer, hospice, and palliative care. So is that right? I mean, so in a way,
that should be all right. We’ve proved that cancer pain
is well treated by opiates. We know what it was like when
people wouldn’t use them. I mean, this is what
I do for a living. I work at the cancer
center, mostly. I see patients in
the hospital as well, but these days my
clinical practice is mostly seeing people
with severe cancer related pain in the Cancer Center. And so maybe we should
just be pulling them back from everyone else. So weirdly enough, I’m
going to argue against that, since I spent the first
half of my career arguing on the other side. What I don’t feel
it is for it to go– we need to come to some
other way of doing this. So where do people who abuse
prescription opiates get them? Well, here’s the thing– they are not stealing them
from a pharmacy or a doctor’s office, because doctors
don’t have them lying around their office. They shouldn’t, anyway. Mostly, 34 percent of them are
getting from a single doctor. They’re not Doctor shopping. They’re getting them from
one doctor, usually for pain. And another 54% are getting them
from a friend or family member. They’re either stealing
them, they’re given them, or they’re buying them. So essentially if
you look at it, people are getting
prescribed opiates for pain and their friends
or family members are stealing them, buying
them, or being given them. That’s how they get there. There’s a little bit
of everything else. But that’s by the majority
where they get them. So the doctors who
prescribe these pain medications– who are they? Well, we looked at UVA for a
project that I was working on. And so who’s prescribing? Where are all these strong
opiates coming from? Well, if you look
at opiates that are prescribed for
more than two weeks, and are stronger than tramadol,
which is the weakest opiate, it’s barely an opiate, and it’s
not usually a drug of abuse, almost half of
them are prescribed in the Cancer Center. And if you look at the
really strong ones, not like somebody gets enough
oxycodone to take one a day for a month, but
the ones who get 20 milligrams every four
hours of oxycodone, that’s the Cancer Center. And rightfully so. But I would argue
that if you want to keep all these opiates
from flooding onto the street, you have to deal with what’s
happening to the Cancer Center, because that’s where
they’re coming from. Even though I was
on all these cancer pain initiatives arguing just
the opposite in a certain way. So I could say that
when we started realizing what was happening,
Dr. Barkley and I– he’s another palliative
care doctor– started the American
Academy of Hospice and Palliative Medicine Special
Interest Group on Substance Abuse and Diversion. And we started
projects around this. We did a lot of research on– just by survey–
research looking at how many oncologists,
palliative care clinicians, and hospices actually have
any formal regulations or rules or policies about
how they prescribe opiates. Do they actually
screen people for risk? Do they ever do
urine drug screens? And do they ever check the
prescription monitoring program, the answer is
very few of them do. At least at the time–
these are in 2013, 2014, I suspect it would
be a little more. So because it’s the cancer
patients who need them, and we were taught that– and
we can see how much they need them– we’re not doing due diligence. But I am telling you, here’s
the two sides of this. First of all, pain
and severe pain, is the most common set of
patients with advanced cancer. And cancer-related
pain, like we said, It’s the only real,
aside from acute pain from surgery or
breaking your leg, whatever, is the only indication
that has ever been shown for opiates to really help. On the other hand, if you want
to get hold of all the opiates that are flowing
into the market, that’s the cancer patients. And just because
you have cancer, doesn’t mean you don’t also
have a substance abuse disorder. On the contrary, I see a lot
of patients with head and neck cancer. One of the most painful
cancers and the treatment– don’t chew tobacco,
guys, because if you have had neck cancer, that’s
seven weeks of radiation to some very tender
parts of your body. And it’s incre– but they have
a very high risk of substance abuse. You get that disease by
not just chewing tobacco but by drinking
very heavily, which is associated, both of
those things associated, with other substances disorders. And they have a high risk
of depression, anxiety. So they both need it, and
they have a very high risk. So here it is– opiates are
effective and often necessary, but patients– I mean, if somewhere
around 10%– I mean, I’ve heard a lot of– you could probably
tell more that I do. I’ve seen some things that
10% of people in– of adults in the country have some form
of a substance abuse disorder. And if you look at
just unemployed people it’s closer to 18%. If 18% of that has– it
means everybody in this room probably has a friend
or a family member who has that problem. People are shaking their head. If you don’t think they do,
I bet there’s someone there. You just don’t know it. My aunt used to drink
a lot of orange. But I don’t think it
was just orange juice. Because I found
those little bottles. And finally, but also, people– so it’s not just
the patients, it’s the family members
who are often having to take care dying cancer
patients as they decline and bear to the
end of their life, and they need someone to
give them their medication. This is a problem. So we started a
project, and we actually have written some policies
for the– model policies for Virginia hospices. And that looks at doing
those things that you’re supposed to do for
non-cancer pain, but doing them in cancer
patients with a slightly different risk
benefit ratio in how do you decide how to use them. So everybody should
get risk assessment. We use a very short thing
called the opioid risk too, because it asks about
family history as well as patient history and because
those patients are in– grandson is driving grandma
to get her cancer treatment, and he just got out of jail
for selling something, heroin or something. Urine PMP is the prescription
monitoring program, the UDSDR drugs. So that’s fine. We can do this. And we do do this on everybody. But what happens when
your patient shows up something abnormal. What are you going
to do about it? So I’m going to give you,
quickly, this is the end, I’m just going to
give you a case to let you a flavor
of what it’s like. So this is a 38-year-old
guy, referred to us because of severe pain. He Was 38 years old, and he had
prostate cancer, metastatic– literally every vertebrae. He was in severe pain. Also, he had a very
longstanding and recent use of a wide variety of illicit
substances, including cocaine, and he already had one
urine drug screening positive for cocaine,
and additionally, he was living with his cousin, who
was an active substance abuser. So here you go. So he was–
definitely this guy is curled on the table
in the fetal position. He needed opiates, number one. And he was very high risk. Like, as high risk
as you can possibly be for misusing his opiates,
combining his opiates with something else that
would cause him to be unsafe, or selling his
opiates by cocaine. This is a bad situation. So in this case,
what we do is we call it putting someone
on a short leash. We agreed– the providers of the
clinic agreed he needed them. We gave him a one week supply. We called social
work and asked them– because we are lucky enough in
the Cancer Center to have those resources, which
most places don’t. We have social workers who
can do counseling and stuff like that. And a urine drug
screened at each visit. And he had a lot of
depression, anxiety, and we treated those things. So once he got the pain
control, he actually improved. He was able to walk into my
clinic, which he hadn’t been. He was feeling better. On the other hand,
his urine drug screen came back with a variety of
things it shouldn’t have, including cocaine, some alcohol,
and different stuff like that. This is not a good thing. So called him– so this
happened over a couple weeks. And he continued
to have problems. So we put together a
further safety plan. The social worker
helped him move out into his ex-wife’s house who
was willing to take care of him despite everything. We referred him to his local
community service board, which he never went to, because he
was getting a lot of radiation, he didn’t have time. And it was so unsafe
what he was doing that he came up with this plan. He had to come– and now this
man lived two hours away. He had to come to our
clinic three times a week, and each time he got
one Fentanyl patch, which we would place on him. And the reason for this is he
couldn’t– there wasn’t enough to really sell effectively
or cause himself the overdose himself. So literally they had to drive
four hours three days a week each time to get
one Fentanyl patch. Within a couple
weeks of that, he stopped having
cocaine in his urine, and we were able to eventually– I don’t want to go
into the whole thing– but over a period of time, his
aberrant use decreased and he went through treatment,
and eventually he– he had metastatic disease, and
within about a year after that, he was on hospice, and at
that time on a whole higher dose of medication. And we maintain our
relationship with him, and he was able to
die and be fairly comfortable during
that whole process. So I’m going to stop, I think. I will just say this is a case– it was actually– they
interviewed me about it in the Washington Post, of a
lady who had dementia and end stage breast cancer, and she
was nonverbal from her dementia, she was always
crying out in pain. Always crying out
in pain, the hospice would call to keep going
up in her medications until her daughter
showed up in the ED– overdosed on her mother’s meds. When her mother came
in, the reason mother was crying out in pain
was because she wasn’t getting any of her medications. So it’s not always the patient. So there’s two questions
people ask me about this. The first is, why do
you worry about this? I mean, people are
dying, who cares if they’re abusing their drugs? So I feel like this is like
in the 1950s, most of you are too young– you’d
have these movies where there was like the happy drunk. You know what I mean? The town drunk. And he was always sort
of a comical character. I think we now know
that people who are actively using substances– they’re not happy people. They’re miserable. They’re suffering, and their
families are suffering. And the community’s
also at risk. So that’s why, even
if the patient’s close to the end of life,
we have to worry about that. And the other question is,
why don’t you just fire them, meeting not prescribe for them? I mean, it’s a
risk to my license to be prescribing pain
medications for someone who has ongoing abnormal
urine drug screens. I mean, if they have no
opiate in there urine, I don’t prescribe for
them, because that means they don’t take it. But if they’re struggling
with their terminal cancer and are not able to
keep quite to the– and are still having problems
with substance misuse– I don’t think that those
people need to die in pain. There are times when I
can’t prescribe them, when the situation is
too risky unless they go to like a skilled
facility of some kind where someone else
can give them to them. But I don’t think
that it’s right that people should die
in the type of pain I used to see people die in. So that’s why. And I’m just saying,
the last thing, just from a clinician’s
point of view, I mean, treatment options for
patients with substance abuse, they are almost non-existent. I have a patient with
severe cocaine disorder, he had to go to rehabilitation
for his clonazepam, which he was not abusing,
just to get into rehab, because there’s
no rehab available for people with his Medicaid
in the state of Virginia. He went– ended up going
somewhere in North Carolina. I mean– you know– sorry, I can rant about this. But if you have a lot
of money, you can do it. But there are no– there’s
one half day suboxone clinic per week at the
University of Virginia. There is no methadone
maintenance. And that’s wrong. And also, all these great
non-pharmacological therapies– RICHARD J. BONNIE:
They’re not co-pay. LESLIE J. BLACKHALL:
You can’t get those. I mean, you can get them
at the Cancer Center because we have
social workers who actually do that with people. But they would have
to– some of them, if they live six hours away,
which some of our patients do, they drive for their
chemo, so they’d have to come there a
couple of hours a week. They’re not– that’s not
available for people, and frankly some of the
non-opioid medications are too expensive. Oxycodone is cheap,
cognitive-behavioral therapy is expensive. And nobody makes
money off of it. Sorry, am I getting
cynical here yet? And I think we all need to
be trained a little better. You know we have a
bunch of patients, like 20% of our population,
who we’re sometimes seeing every week,
every two weeks, this is a lot of work for us. But I think this is
what I’m saying– I don’t think we
want the pendulum to go the whole other way. But we can’t just
exempt cancer and not have because they
have cancer we’re just not going to even look at it. So that’s all I’m saying. I think we have a little
bit of time for questions. So thank you. JIM CHILDRESS:
Thank you very much, Richard and Leslie, for
a wonderful presentation. We do have time for some
questions and comments. So we’ll– John and I have
mikes, we’ll come to you. Raise your hand, identify
yourself, and then give us a question for the figure. DANNY BECKER: I’m Danny Becker,
and I prescribe opioids. Question– did any of
the pharma executives go to prison for hiding evidence
of the addictive properties of OxyContin? I know that Purdue got fined
about half a billion dollars, which is about 5% of their
total profits for OxyContin, but what about jail time? RICHARD J. BONNIE: That sounded
like a rhetorical question, [INAUDIBLE]. LESLIE J. BLACKHALL:
Did anybody go to jail for the entire
collapse of the banking– subprime mortgage? RICHARD J. BONNIE: [INAUDIBLE]. I will say, as far as the
entire committee was concerned, our job was to look
forward, and that’s why I put the well
how did this happen– slide it in. That wasn’t our job to basically
try to ferret this out. But you raise a
legitimate question. I just saw The Big Short. If you saw that movie,
it’s pretty good. DR. Williamson: Dr. Williamson,
retired for some years. What about the advertising? I watch an occasional
program and there’s always some form of Haldol or
aspirin or this or that, and then this
[INAUDIBLE] and he says, hey, I’ve got
opioid-induced constipation. And he’s fit as a fiddle. How do we sell that? We should stop as a profession. We should stop the
availability of advertising for drugs and medication. Period. LESLIE J. BLACKHALL: [INAUDIBLE] RICHARD J. BONNIE: Well, so
short answer to this is– the Supreme Court has
interpreted the First Amendment to cover commercial speech. 30 years ago you
didn’t have these ads, and now we have them. We did recommend to
the FDA that they use the maximum amount of
constitutional authority and push the edges on their
constitutional authority to be much more aggressive
in regulating direct consumer advertising, as well
as advertising that’s directed at physicians, too. So their promotional
activities goes back to what Danny
was saying before. I mean, they obviously
played a role in this, and continue to
play a role in it. And the FDA– we’re
just asking them to be more aggressive about it. But from a regulator
standpoint, if you’ve got so many things to do, do
you want to sort of concentrate your efforts on something
that you’re going to get thrown out in court? DR. WINSLOW: Pass a law. RICHARD J. BONNIE:
Well, the Constitution is in the way of a law,
that’s what I’m saying. ERIC HEWLITT: Hi, my
name is Eric Hewlitt, I’m a retired faculty member
of the Department of Medicine, and I don’t prescribe opioids. How does the prescription–
or monitoring plan– program work? Who does the monitoring? Does the program do
that and inform people, or do you have to do
it yourself actively? How’s it work? LESLIE J. BLACKHALL:
So all pharmacies have to report to the
prescription monitoring program any time they fill an opioid
prescription for how many and who wrote it,
where it was filled. So all I have to
do, and it’s going to get even easier with the new
computer system we’re putting together, all I have to do– well actually
somebody my office– before all my patients
come in, does it, and I can look at
everything they’ve gotten in the past year– when they got it, what it was,
and who wrote the prescription. I mean, this helps in general,
like somebody comes in, a new consult, what do
you take for your pain? The little white one. Like, I don’t know what that is. So then I can look it up. But yeah– so
that’s how it works. We don’t have to do it– the
pharmacists have to do it. ERIC HEWLITT: This is within
the state of Virginia? LESLIE J. BLACKHALL: Yes, it’s
a Virginia PMP, but I can click and say I want to
look at West Virginia. A lot of them around here
have, like, reciprocal things, so I can look at West
Virginia, Tennessee, and I think Maryland. So usually people are not– I think for a
while the VA didn’t have to report– but I think–
didn’t they get rid of that? Yeah, so for a while, the VA
was except for some reason, because I don’t know why. Because– I don’t know. But now they have to report. RICHARD J. BONNIE: The
details on these programs differ widely across the states. And the data so
far are not robust. And so different
people have access to the information
in different space, so we recommended
obviously that that needs to be studied carefully,
and that the things that seem to work and get
the balance right should be developed elsewhere. LESLIE J. BLACKHALL: But
if you saw that slide I had of where are people
getting the drugs, it mostly isn’t that
they’re doctor shopping. They’re mostly getting it from– they’re stealing
it from grandma. And my patients have
their feeling members steal their medications. RICHARD J. BONNIE:
By the way, I mean, on what Leslie said
earlier, I mean, when she first mentioned
to me this percentage, I think she said 48%– LESLIE J. BLACKHALL: 45%. RICHARD J. BONNIE: 45%– of all the drugs
stronger than tramadol on an outpatient basis,
you know or described in the Cancer Center– I was completely flabbergasted. We just, as she suggested,
we just sort of carved out cancer pain and said
that’s a separate problem, and most of our
problem was presumably not attributable to
diversion from patients who were receiving
pain for cancer– or receiving treatment
for their cancer pain. So this is just astounding,
actually, this figure, and we paid no attention
to it whatsoever. LESLIE J. BLACKHALL: So
here’s a story from one of the hospice nurses told me. She went to the house
of a patient who just died to pronounce the patient. And she was helping
the family dispose of the pain– the medications,
including the narcotics, which included methadone, which we
use a lot for strong pain. And the granddaughter
looked at her and said, you can’t throw that away. That’s my inheritance. Hi, my name’s Catherine, I’m
an undergraduate biomedical engineer. So in terms of
training and guidelines for physicians that are
prescribing opioids, is there anything more in depth
than that ladder staircase you showed, or is
it just judgement based on patient files, what
the patient’s telling you? LESLIE J. BLACKHALL: Did– I don’t even think
the undergraduate– the medical students get,
like, almost zero training. Wouldn’t you say, Danny? Very little. DANNY BECKER: Very little. It comes up a lot at the
general medicine clinic, and we give that–
two hours of that to the interns during
the first couple months. And its– most of what we learn,
we learn on the front lines. And it’s unavoidable. So I think there is a skill set,
and it’s pretty comprehensive. But there’s a lack of resources. So we end up with
pain that we really can’t manage very effectively. RICHARD J. BONNIE: This was
the central recommendation in the report. Again, this is one of the
pain specialists were just– I could not believe how little
undergraduate medical education was devoted to this. LESLIE J. BLACKHALL:
Even the people who–? RICHARD J. BONNIE: And
we have to do something. I mean, that, I think, is
a central recommendation. And I do think the name of
the Academy of Medicine, the Surgeon General, the
public health leadership of this country, really
needs to focus on this. If there’s anything
else, if there’s anything that happens as
a result of this work, if this were accomplished, I
think we would make progress. DANNY BECKER: The
state of Virginia has required that all licensed
physicians get two hours of CME on opioid use. Two hours. RICHARD J. BONNIE: Wow. JIM CHILDRESS: Unfortunately,
given all the important issues raised by our
wonderful panelists, and the questions you
have, we unfortunately have to bring this to a close. I think they may be able to
stay around for a few minutes, if you want to
follow up with them. I thank– join me in
thanking them very much for a wonderful program. [APPLAUSE]