The link between PROP (Physicians for responsible Opioid Prescribing) and the CDC and their advisory committee on opiate prescribing

http://www.thesoberworld.com/march15_issue.pdf

INTERVIEW WITH DR ANDREW KOLODNY
By Patricia Rosen

I recently had the pleasure of interviewing Dr. Andrew Kolodny who
is the Chief Medical Officer of Phoenix House, which has locations
throughout the United States, and President of Physicians for
Responsible Opioid Prescribing.
Patricia- Thank you so much for this interview. When I read about
a doctor who felt the same way that I and so many other people
throughout the country feel about the way pain pills are being
prescribed, I had to reach out to you.
Dr. Kolodny- It’s my pleasure.
Patricia- Before we speak about PROP and how you became involved
in that tell our readers a little about yourself.
Dr. Kolodny- I graduated Temple University School of Medicine,
completed my residency in Psychiatry at Mount Sinai and pursued my
interest in Public Health with a public psychiatry fellowship at Columbia
University and a Congressional Health Policy fellowship in the
United States Senate. Once that was completed I worked as Medical
Director for Special Projects in the Office of the Executive Deputy
Commissioner for the New York City Department of Health and Mental
Hygiene.
Patricia- What did you do for them?
Dr. Kolodny- My first assignment was to reduce drug overdose deaths
in New York City. This was in the beginning of the 2000’s. When you
talked about a drug overdose death, it was mostly in New York City’s
highest need, lower income minority communities that had been
hit with addiction epidemics in the past. They happened mostly in
neighborhoods like East Harlem, the South Bronx and Central Brooklyn.
Most of the overdoses were from heroin, and many of these people
were struggling with this since their addiction in the 70”s. There were
also overdoses from crack cocaine although this era was winding down.
Overdose deaths in middle class white neighborhoods were very rare.
Patricia- Was it just New York City that was affected by this?
Dr. Kolodny- Well, because I was working with the health department
on drug overdoses I was plugged into a national data base on drug
overdose deaths. As I was looking at some of the data that was
coming in from different parts of the country, I couldn’t believe what I
was looking at, especially in New England and Appalachia. I thought
they had the decimal point wrong. This is when I first realized there
was a serious problem not just in New York City but other parts of the
country as well.
Patricia- What did you do to try to reduce these deaths?
Dr. Kolodny- One of the things we did in New York City and we were
one of the first in the country to do it and do it legally, was we started
giving out Naloxone through a syringe exchange program to people
addicted to heroin so they would get training and know how to respond
to an overdose. We didn’t do this directly. We funded a project with
the harm reduction coalition. The idea was that clients of the syringe
exchange program would be taught how to rescue their peers when
they witnessed an overdose.
Patricia- So you were really ahead of your time because I know now,
15 years later they are trying to get the Naloxone Access Law passed
in many states. What is your opinion for some states not wanting to
pass that law which would enable police, EMT’s, parents, people
with drug dependency and all other emergency first responders to be
trained and equipped with Naloxone?
Dr. Kolodny- I don’t think there is much of an argument against it. I
think early on you heard that they thought it would encourage risky
use or that somehow the government was condoning drug use. At this
point I don’t think its opposition, I think its more inertia, getting states to
change their rules. It would be helpful if the federal government could do
something like that. I think we were ahead of our time because the health
commissioner at that time was Dr.Thomas Frieden who is now the director

of the CDC. Dr. Frieden was interested
in drug overdose deaths even though
they were common at that time with the
poor and non-white who didn’t vote. The
rest of the country wasn’t interested in
overdose deaths until it hit main stream
white America. As a public Health
Commissioner he cared about drug
overdose deaths before it was a hot topic
and that’s why we were ahead of our time.
Patricia- What other things did you do
to try to prevent overdose deaths?
Dr. Kolodny- Another thing which
we worked on which I feel to this day is still even more important
than access to Naloxone is to expand treatment to those addicted
to opioids. I think that the first line of treatment to those addicted to
heroin or painkillers is Buprenorphine or Suboxone. We worked very
hard to get doctors in New York City trained and able to prescribe
Buprenorphine.
Patricia- Isn’t that something for the short term?I mean do you feel
people should be on Suboxone for a long time? Sometimes you
hear of people on it for a year or 2 years. Don’t you feel it should be
something really used short term and then just tapered off of it?
Dr. Kolodny- Why would you say that?
Patricia- Because then aren’t you substituting one drug for another? I
hear of people abusing Suboxone as well.
Dr. Kolodny- Yes, but how long someone is on it has nothing to
do with the abuse of it. There is some diversion. Sometimes it’s
not prescribed responsibly. Sometimes a doctor won’t check the
urine to make sure the patient is taking it. Some doctors don’t give
more than the prescription as if somehow the prescription alone will
magically cure addiction . Many people need more than Suboxone
unless they are very stable. You do see some people trading it for
other drugs and it ends up on the black market. I don’t think you
have abuse in the sense that people are getting high from it. If your
opioid addicted and taking Suboxone regularly it’s not possible to feel
high from Buprenorphine. Some people do need it long term. Once
patients come off of it, it’s much harder for them to do well. Once
they come off their chances of relapse are greater. For some patients
the right decision for them is just to stay on it. Nobody wants to be
on a medicine long term. Think of people on medicine for high blood
pressure or diabetes. I mean if some diabetics could lose weight or eat
properly they might not need their insulin or pills. That is the better way
to go, but we would never say “ oh, you are just getting your insulin or
pills for 6 months or 8 months and then you’re on your own” People
should take these medicines for as long as they need it.
Patricia- How did you get into the addiction treatment field?
Dr. Kolodny- I got into addiction treatment through the Buprenorphine
work I did with New York City. I realized that you can save someone
from an overdose but if you want to reduce the amount of deaths you
really have to expand the treatment available. We were very interested
in Buprenorphine and Suboxone because of the French experience. In
the mid 90’s Buprenorphine became available in France to treat heroin
addiction. They didn’t have Suboxone which is Buprenorphine mixed
with Naloxone. They only had pure Buprenorphine which frequently
ended up on the black market. People were even injecting it. But
despite all of this, the drug overdose death rate declined 80% in 6
years. We were very excited about that in New York and worked very
hard to expand access to Buprenorphine. One of my jobs working for
New York City was to get doctors to use it. A lot of doctors who worked
with those struggling with heroin addiction started seeing young white
males from Staten Island, Long Island and middle aged pain patients
addicted to painkillers. It started to become clear to us that we were in

the midst of a new epidemic.
Patricia- Tell me a little bit about PROP and why and when you started it.
Dr. Kolodny- I realized we had a painkiller problem and knew we had
an opioid epidemic in the United States but didn’t know the cause very
well. There was a very important article published in 2006 that said
that overdose deaths were increasing in parallel with increases in the
prescribing of painkillers. It became very clear to me from this research
that the epidemic of overdose deaths and addiction was being caused
by doctors prescribing too much. I began to learn more about the use
of opioids especially for chronic pain and became very concerned that
doctors were aggressively prescribing these medications for conditions
that you would be more likely to hurt the patient then to help them by
putting them on opioids long term. Many doctors in different specialties
were also coming to the same conclusion that the medical community
was part of the problem. Many of our colleagues bought into this
campaign- a campaign funded by the pharmaceutical companies to
prescribe aggressively. The argument for aggressive prescribing was
very compelling. They told them things like patients were suffering
needlessly, that the compassionate way to prescribe is aggressively,
that with any complaint of pain, opioids should be the drug of choice
and they weren’t addictive. These were the messages. Many of our
colleagues bought into this. When we first started speaking out, some
of our colleagues thought we were going to punish those suffering with
pain because of bad behavior by drug abusers. That’s how we were
seen. We would say” no, no, no that’s not what’s going on!”
Patricia- Well, here in Florida we had pain clinics on just about every
corner. It was terrible. There were doctors writing prescriptions for 120
80mg pills at a time along with other pills! It was awful.
Dr. Kolodny- hmmm
Patricia- It was really a problem.
Dr. Kolodny- Yes, well we felt the prescribing was too aggressive
but we couldn’t get our colleagues that interested in what we were
saying. Initially they thought our views were too anti-opioid. Since 2010
the evidence is much clearer, and our view that opioids shouldn’t be
used LONG-TERM for MOST PATIENTS WITH CHRONIC pain is
much more an accepted position. Older less competent doctors are
still prescribing them but the younger doctors are hearing what we
are saying. The American Academy of Neurology recently issued a
statement that we should NOT be using long term opioids for lower
back pain or headaches. The federal government put out a new review
of evidence basically saying that there is no evidence that it’s effective
but LOTS of evidence that it’s dangerous.
Patricia- It’s evident by all the overdoses and people that can’t get
their pills that are turning to heroin.
Dr. Kolodny- It’s not just the young people getting addicted through
recreational use; the pain patients are being harmed.
Patricia- Yes and people in their 70’s and 80’s!
Dr. Kolodny- The rate for overdose is highest for people 45-54 who
get it prescribed by doctors.
Patricia- I didn’t know that.
Dr. Kolodny- yes, so the drug companies were saying and the pain
organizations that take money from the drug companies, they were
trying to tell the government that we have 2 problems in America. We
have drug abuse and chronic pain as a problem. They wanted policy
makers to think that these drugs were good for chronic pain and all the
harm was limited to the drug abusers. What they were really saying
to the policy makers was don’t punish the pain patients for the bad
behavior of the drug user. What PROP is saying is we don’t have these
2 distinct groups, so called drug abusers that are harmed and millions
of pain patients that are helped. There is tremendous overlap and what
we really have is an epidemic of addiction to these medicines. People
are getting addicted through medical use and recreational use but we
have to stop creating new cases of addiction and treat the people that
are already addicted if we ever hope to bring it under control.
Patricia- I would like to know when our tolerance for pain became so
low. Years ago if you broke your wrist or leg you were told you would
feel better in a day or two , take two aspirin and call your doctor in the
morning . Today they are ready to give you dilaudid or morphine for
that!
Dr. Kolodny- That was part of the campaign by the pharmaceutical
companies to make pain the 5th vital sign. Hospitals ask patients in
surveys after their hospital visit if the hospital did everything to address
their pain. So now we have hospital administrators telling doctors to
prescribe more aggressively.
Patricia- I saw it first hand with my mother which is another story but
I brought her in for nausea and they kept asking her level of pain and
giving her painkillers.
Dr. Kolodny- That’s what they do. They keep asking your pain level.
That was an aspect of a brilliant pharmaceutical campaign that paid off
very well for those companies.
Patricia- It sure did. Purma Pharma who manufactures OxyContin
made billions of dollars. What’s your opinion of the new drugs like
Zohydro and Hysingla?
Dr. Kolodny- I am very concerned that the FDA keeps approving
these drugs. The fact that some are harder to crush or snort doesn’t
make it any better or less addictive. When people become addicted,
they become addicted by swallowing the pills. I am very concerned
because when a company brings a new drug on the market, it costs
them millions and the only way to recoup their investment is to
convince doctors to prescribe it.
Patricia- That’s so true and then we will have another addictive drug
on the market.
Dr. Kolodny- What concerns me is when we are in an epidemic of
addiction and overdose deaths caused by too much prescribing of
opioid pills, the last things we need is a new opioid being released and
a marketing campaign to convince doctors to prescribe them. The FDA
keeps approving these drugs and they allow the drug companies to
promote them for conditions where their use is not safe or effective.
The CDC is trying to convince doctors not to use opioid medicine for
chronic pain, yet the FDA keeps approving new opioids and allows the
drug companies to promote them for chronic pain which I believe is a
violation of federal law. The law is called the Food, Drug and Cosmetic
Act. That law states that drug companies can only promote products
for conditions where using the product is proven safe and effective.
Since we know that long term use of opioids for most patients with
chronic pain is not safe or effective, the FDA should not be allowing
drug companies to promote that practice.
Patricia- My understanding is that the panel voted 11-2 NOT to
approve Zohydro yet it was approved anyway. Since they started The
Prescription Drug User Fee Act the FDA is getting a lot of money from the
pharmaceutical companies and unfortunately approving all these drugs.
Dr. Kolodny- Your right- the PDUFA has transformed the FDA
which was regulating pharmaceutical companies to one that now
seems more concerned with providing good customer service to
pharmaceutical companies.
Patricia- Exactly, but who is protecting us?
Dr. Kolodny- Correct. Another example, last week the FDA
approved Vyvance for binge eating disorders even though we had
an amphetamine epidemic caused by marketing amphetamines for
weight loss. That practice became prohibited but just last week the
FDA approved a new amphetamine to be marketed for so called binge
eating disorder.
INTERVIEW WITH DR ANDREW KOLODNY
By Patricia Rosen Continued from page 6
Cont

Patricia- What is the answer to stop this, is it up to the people to rally
together? How do we protect ourselves?
Dr. Kolodny- I haven’t heard the current administration mention
this epidemic at all and the FDA is their agency. They also haven’t
put in the appropriate resources for this problem. It was similar to
the aids epidemic. Ronald Reagan was criticized for not mentioning
it and ultimately did only after 20,000 people died. Why didn’t he
want to mention it? Because it involved a public health problem that
involved gay men and people with addiction. I really think this health
crisis should be handled by the Department of Health and Human
Services. You have the CDC, FDA and SAMSHA all in that agency
and they should take the lead in this. I am surprised that the current
administration is allowing the FDA to approve these drugs.
Patricia- I can see if you’re on your deathbed and they give you a drug
like that or if you have broken every bone in your body but other than
that I see no need for a drug that strong.
Dr. Kolodny- If the FDA had limited their marketing of extended
release opioids to end of life care we might not have an opioid crisis
today, but the FDA is letting drug makers promote their products for
common chronic problems.
Patricia- I want to thank you for this interview. It’s nice to know there
is a group of doctors out there trying to educate the medical field and
bring awareness to this terrible epidemic.
Dr. Kolodny- I want to thank you for all you do with The Sober World.
It’s magazines like The Sober World that help educate and keep
people informed about the latest issues in the addiction and behavioral
health field.

Filed under: General Problems