JIM CHILDRESS: Welcome to 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]