[Congressional Record (Bound Edition), Volume 162 (2016), Part 2]
[Senate]
[Pages 1525-1527]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      PRESCRIPTION DRUG ADDICTION

  Mr. MANCHIN. Mr. President, first, I say to my colleague from Ohio--
Senator Portman, who is a dear friend--that we all have it; you are 
right, it is nonpartisan. This has no home. This has affected every 
American family one way or another. There is not a person I know in my 
State or in the good State of Ohio that doesn't have a family member--
immediate family, extended family--or close friend who hasn't been 
affected by legal prescription drug abuse. We are looking at a whole 
cultural change that needs to go on, and I am on the floor to share 
letters with you.
  Senator Portman, I am sure you are getting the same letters. I would 
encourage all our colleagues to read just one letter a week from a 
family whose lives have been changed. They have lost a husband, they 
have lost their childhood, or they have lost a dear family member. It 
has destroyed their family life as they knew it. They can't get a job--
a first-time felony offense, and they are out of the workforce now.
  If you talk to law enforcement, there is not a law enforcement agency 
in America today that will not tell you that 80 percent of their crimes 
are drug related. Theft, arson, robbery--whatever it may be, it is 
around drug abuse.
  So I come to the floor to continue to share the story of millions of 
Americans--most importantly, of some of my very dear West Virginia 
family members--who have had this.
  I applaud the good Senator from Ohio. All of us are working. This 
will go through a normal process, I hope. It will be an open amendment 
process, and we are all going to make a piece of legislation and maybe 
for the first time start changing the culture in America, starting 
right here in Washington, DC, with the Food and Drug Administration. I 
will talk about that too.
  West Virginia has been hit the hardest per capita. Just this past 
year, 600 West Virginians have died--in a State with less than 2 
million people. The American people are drowning under the weight of 
prescription opioid abuse. Nationally, more than 51 people die every 
day--in my State, Oklahoma, Ohio, all across this great Nation.
  The FDA must get serious about the dangers--we have been speaking 
about this--of prescription drugs, and this will not be accomplished 
without a significant change in the culture. It starts with them.
  Although the FDA announced that the agency will be taking steps in 
the right direction to address these problems, it is not enough and 
more needs to be done. Let me explain why. The FDA's No. 1 priority 
must be public health and well-being--nothing else. Yet time and again 
the FDA has stood in the way of efforts to address the opioid abuse 
epidemic and improve public health.
  The FDA plays a critical role in the epidemic as the agency 
overseeing the approval. Let me make sure we understand. This starts 
with a prescription. A legally licensed company makes medicine for pain 
reduction, if you will, pain suppressant, an opiate, and then they 
bring that to the FDA, and the FDA goes through a process of evaluating 
it to see if it should go on the market. They go through an 
evaluation--or their committee, basically an oversight committee--and 
then they say this is a product that should be on the market or should 
not. Many times the FDA has gone against the advice of their own 
advisory committee.
  These are things we have to protect the American public from. Why?
  So last week they decided to slightly improve the agency's response 
to the opioid epidemic. I am pleased at this small step, but let me 
tell you about this small step. They said that now they are going to be 
serious about the dangers of prescription drugs, and they said they are 
going to finally start listening--mind you, listening--to the advice of 
their advisory committee. Oh, that is wonderful; they are going to 
listen to them now. That means they haven't really been listening to 
them up until now, but they are going to start now.
  What they don't tell you is they are not going to be required to take 
the recommendation of their experts. A perfect example is Zohydro. It 
took us 3 years to get all opiates--Vicodin and Lortab, which are the 
most prescribed pain relievers and pain pills in the country--3 years 
to get the FDA to change that from a schedule III to a schedule II, 
even after I went personally, when I was first in the Senate 5 years 
ago, to the advisory committee and they voted overwhelmingly that, yes, 
this should be a schedule II. Within the bureaucracy, the FDA took 3 
years. The day they did that and made that piece of legislation or that 
rule saying that now it will be schedule II, we saw the immediate 
effect. It took 1.1 billion--billion with a ``b''--pills off the 
market. Twenty-two percent of the amount of opioids on the market were 
reduced immediately within the first year. Within a week of their 
finally

[[Page 1526]]

agreeing to go from a schedule III to a schedule II, which controlled 
the prescriptions, they came out and approved Zohydro against the 
wishes of their advisory committee, 11 to 2. Now you tell me why that 
product came to market.
  So I have legislation that says: Listen, when you are not going to 
take their advice and you don't recommend or you don't basically agree 
with your advisory committee, you have to come to the people's 
representatives--that is us--and tell us why you think this addictive 
drug needs to be on the market.
  I believe we have to do things and take important steps. What we have 
basically turned a blind eye to is unbelievable.
  Let me explain what I think goes on and what goes on. This is of such 
an epidemic proportion that we are afraid to talk about it. If you have 
a child in your family who is addicted, if your mother or father or 
maybe you or your wife is addicted, you are afraid to talk about it. It 
is kind of a shame, so we kind of try to take care of it. Guess what. 
We can't even find treatment centers to help people. And then you can't 
afford it if you can find it--most people in America--and most of the 
times you can't.
  So there are two things that have to be done. First, and I am as 
guilty as anybody here--the last 20 years I thought: Boy, if you are 
going to use these drugs and abuse them, that is a crime. I am going to 
put you in jail. You are going to pay the fine for that, a penalty.
  Well, guess what. It hasn't worked. They go in addicted and come out 
addicted. All we did by convicting them and putting them in jail is 
give them a felony. Now they can't get a job. Now they are out of the 
workforce. Next, they come out more addicted than when they went in.
  As Americans, we must say: Listen, this is an illness, and an illness 
must be treated. You can't just throw them in the jail and say out of 
sight, out of mind; it will take care of itself. So once we change 
that--and we have enough courage here politically to do that--then we 
will start moving in a cultural change that will basically be able to 
take on this epidemic.
  We are fighting on that. I continue to go into all of this, but I 
have always come here and I have said: Listen, all of you in the State 
of West Virginia, please get on my Web site, manchin.senate.gov. It is 
very simple. And all of us have our Senate Web sites. Share with me 
your life-altering letter. Tell me what happened.
  We have been getting them by the hundreds. They are coming from all 
over my State, and they are in every State. I am sure Oklahomans will 
send the Presiding Officer theirs too.
  I am going to read two stories. This brings to light everything we 
are talking about and why we must be successful in fighting this 
horrific epidemic.
  This is Kylie's story:

       In 1994 my dad broke his shoulder.

  We all have accidents in our families.

       He had to have surgery. He was on prescription narcotics 
     from 1994-1996--

  Now you tell me why he was allowed to be on them and why the doctor 
kept prescribing them for 2 years. That is the biggest problem--

     he became addicted in those 2 years. After the doctor would 
     no longer prescribe--

  Finally, maybe the doctor came to his senses--

     him pain medication, he'd illegally purchase them off of the 
     street. His life literally revolved around his pain 
     medication. His pain medication money came before our bills.
       There were a few times we could not have Christmas or 
     Easter because he used all of our money to purchase these 
     drugs. I have 2 sisters. Eventually, he started buying more 
     potent drugs when he couldn't find anyone to buy prescription 
     pain pills off of. Heroin, Cocaine, you name it, he'd buy it. 
     My mother eventually filed for a divorce and that made him so 
     much worse. He started using more and more.

  He used more because of depression on top of that addiction.

       On February 23, 2007, I stayed home from school, I was a 
     junior in High school in Clarksburg. I woke up at 10am, went 
     to check on my dad who had been having drug withdrawals, I 
     found him dead. He'd found drugs and overdosed while I was 
     asleep, leaving me there to find him. It's something I carry 
     with me everyday. I don't have many memories of my father 
     interacting with us kids as a father should. I only have the 
     bad memories of him going above and beyond for drugs. Even 
     back then, if the prescription drug problem wouldn't have 
     been so bad, I feel like he'd still be here today.
       I remember exactly how he was laying when I found him. I 
     remember everything. It's my first thought in the mornings 
     and my last thought at night. It changed my life, taught me a 
     lot of life lessons but it also left me with a lot of 
     heartache.

  And unanswered questions--as I told you, the rescheduling took 2 
years. Basically, you could get Vicodin and Lortab that were schedule 
III at this time, and all you had to do was keep calling in. You never 
had to see the doctor after the first visit. They can give them to you 
90 days at a time or even longer. They were like M&M's. So when we went 
from schedule III to schedule II, that knocked it down. It took at 
least a billion that we know of off the market, and we are hoping maybe 
even more. So that is what happened.
  This is Helen's story:

       My husband and I were married for over 21 years. We had two 
     daughters together and I expected to grow old with him and 
     enjoy our grandchildren. He worked in a factory for over 18 
     years. Part of his job was moving 55 gallon drums of 
     different types of fluids. He worked full time. Sometimes 6 
     days a week.
       He sprained his back and was prescribed pain medicine. The 
     doctor he was going to gave him the maximum amount--

  At that time it would have been more than 90 days probably, and he 
didn't have to go back because it felt so good--

     allowed by law for about six years.
       As time went on, he needed a higher dose for it to be 
     effective. Taking more caused him to run out before the next 
     refill. He started going through withdrawals. Instead of 
     going to the emergency room to get help, he took his life. 
     Now I have no husband, my children have no father and my 
     grandchildren do not have a grandpap.
       The stigma surrounding all of this is what kept him from 
     getting the help he needed to get off those pills.

  We have said it is a silent killer. They were afraid to talk about 
it. They couldn't go to anybody, didn't know where to turn, and didn't 
have any types of treatment centers that would bring him off of that.

       The Friday before he ended his life, I spoke with a doctor 
     and told him he needed to get off those pills and get dried 
     out. He didn't want to be admitted and they let him go.

  They knew he was desperately hooked.

       Why do pharmaceutical companies market drugs that cause 
     normal people to give up on their families and life? Why do 
     doctors allow their patients to take something so long and 
     build up such a tolerance for it? I will never find the 
     answers to these questions and it is too late for him now.
       It sickens me to read of others going through this and 
     there just doesn't seem to be an end to it.

  This is why I am standing here. I face it every day. I go home. There 
is not a person who doesn't come up to me knowing that basically their 
lives have been changed and knowing now that they can speak to 
somebody. I am making it a point to give them the comfort of speaking 
to me. I protect their identity. I try to get them help.
  There has to be a way. As my good friend from Ohio and the Presiding 
Officer, my good friend from Oklahoma--this is not partisan. This 
should not be bogged down because of who gets credit, who doesn't get 
credit, or whose fault it is. We are all to blame, and we all can share 
in changing the culture of drugs in America--legal drugs.
  Most drug addicts today--people who are addicted--will tell you if 
they are on heroin or illicit, harder drugs, they started with legal 
drugs that were in their prescription cabinet, in the medicine cabinet 
that their mom had or that they had. This is what has to change. This 
is why--Dr. Robert Califf is being recommended by the President; he is 
a good man with a stellar resume, a stellar performance, very 
honorable. But the culture that he comes from is basically from a 
research institution and a research university that has been funded by 
the pharmaceutical industry. That is just the way they say it is done. 
So they are funding the clinical research, and then we are expecting 
Mr. Califf to come into this industry, into the FDA, and make the 
wholesale changes.
  I need--and I think we all need--for America to find somebody who has 
gone through a life-changing event and who has all of the experience 
and all of

[[Page 1527]]

the education to be able to go into that agency and say: Listen, we are 
not going to give you a prescription just as a frontline in the first 
line of defense because I know the chances of it changing your life are 
greater than my helping you and giving you relief.
  Until we have that and until that permeates clear down through, it 
will not change. Tell me how the CDC--the Centers for Disease Control 
within the agency of DHHS--is able to start responsibly recommending 
guideline changes for how we are going to prescribe and how doctors 
should be trained before they prescribe these life-altering drugs. 
Then, within the FDA they are fighting against it, and they are within 
the same agency of the HHS. So it is deep-rooted, and it has to be 
culturally changed from the top. It doesn't change from the bottom 
within.
  So if this good man would withdraw his name and let us move on, I 
would be tickled to death, because he is a good person and he can be 
very helpful in his knowledge. But I don't think he can drive the 
change that needs to be done for us to save the families and children 
and moms and dads across America.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. ALEXANDER. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. ALEXANDER. Mr. President, I ask unanimous consent to speak as in 
morning business, and will the Presiding Officer advise me when 20 
minutes has expired.
  The PRESIDING OFFICER. The Senator will be so notified.

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