[Congressional Record (Bound Edition), Volume 162 (2016), Part 11]
[Senate]
[Pages 14746-14749]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        21ST CENTURY CURES BILL

  Ms. WARREN. Mr. President, I am glad to be here with my colleagues

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today to have a chance to talk about the 21st Century Cures bill. On 
Monday I came to the Senate floor to speak against a deal that was 
emerging in the House of Representatives around this bill.
  When Congress first started working on this proposal 2 years ago, the 
idea was for Democrats and Republicans to work together to improve 
medical innovation and access to lifesaving cures. For over 2 years a 
lot of people worked really hard on that effort. We had a chance to 
bring down the cost of skyrocketing drugs. We had a chance to support 
medical research so we could start to cure diseases such as Alzheimer's 
and diabetes. We had a chance to help coal miners whose health care is 
on the ropes and who are running out of time. Unfortunately, the Cures 
bill introduced in the House last week didn't do any of those things. 
Instead, it was a typical Washington deal--a deal that ignored what 
voters want, and held a bunch of commonsense, bipartisan health 
proposals hostage unless Congress also agreed to pass a giant giveaway 
to drug companies.
  So how did this happen? Lobbyists. Kaiser Health News estimated that 
the new Cures bill has generated more lobbying than almost all of the 
11,000 bills that have been proposed during this Congress. At one 
point, there were about three lobbyists for every single Member of 
Congress. Every one of those lobbyists wanted favors. Wow. Did they get 
some doozies here: a provision to make it easier for drug companies to 
commit off-label marketing fraud--taking pills that are approved for 
one use and using them for a whole lot of other purposes--without any 
evidence that it is either safe or effective, a provision making it 
easier for drug companies to hide gifts they give to doctors who 
prescribe certain drugs, a giveaway to a major super PAC donor who 
stands to benefit financially through pushing regenerative therapies 
through FDA, even if they don't meet the FDA's gold standard for safety 
and effectiveness.
  This bill is not about doing what the American people want. This bill 
is about doing what drug companies and donors want. On Monday, I made 
it clear that I oppose this. Since then, two things have happened. 
First, since Monday, the public has gotten wind of this deal and they 
don't like it. In the last 24 hours, more than 100,000 people have 
signed petitions calling on Congress to just reject the deal. Second, 
since Monday, we have seen the bill changed a little.
  Last night, after they got some heat, the House took out the 
provision letting drug companies hide kickbacks to donors. Good. I 
guess they were having a hard time explaining to anybody why it made 
any sense to help drug companies cover up bribery. The lobbyists are 
disappointed about that, but they are still pushing for the bill 
because even though the kickbacks are out, letting drug companies get 
away with fraud is still in.
  Giveaways are bad in this bill, but that is not the only thing that 
is a problem with this bill. What is not in the bill also hurts. 
Seventy years ago, Congress promised to provide for the health and 
welfare of American coal miners and their families. Now 120,000 coal 
miners, their widows, and their families will see massive cuts to their 
health benefits and retirement pensions. Why? Because the bipartisan 
mine workers protection act was left out of this bill. Without it, 
12,500 coal miners will lose their health insurance on December 31 of 
this year. Another 10,000 will lose their coverage next year and on and 
on into the future.
  According to exit polls, 70 percent of voters say they think the 
American economy and the lawmakers who oversee it are owned--owned by 
big companies and special interests. Bills like the 21st Century Cures 
Act are the reason why. There is so much we could do with this bill.
  This Congress could step up for thousands of American coal miners. 
For their entire lives, these coal miners have sacrificed everything 
for their families, for their communities, and for this country. They 
have literally sacrificed their health. They are running out of time. 
We could help.
  This Congress could step up to help millions of people who are 
struggling with exploding drug prices. We could help bring down the 
cost of drugs. This Congress could step up to help the millions of 
families who have been touched by Alzheimer's, diabetes, cancer, and 
other deadly disease.
  We could help by providing more funding for the research that would 
generate real cures. This Congress could step up to deal with drug 
companies that think they are above the law, giant corporations that 
think they can break the rules and then get Congress to do special 
favors for them. We can just say: No, that is not what we are in 
business to do. The American people are not clamoring for the Cures 
bill, at least not this version.
  Tens of thousands of people have asked us not to pass it. Even the 
conservative group Heritage Action for America has come out strongly 
against this deal. I don't agree with all of their objections, but they 
explain, ``In Washington terms, backroom negotiators have turned the 
Cures bill into a Christmas tree loaded with handouts for special 
interests, all at the expense of the taxpayer.''
  Boy, got that one right. This kind of backroom dealing that helps 
those with money and connections and leaves scraps for everyone else is 
why people hate Washington. It is the reason I will oppose this bill.
  The PRESIDING OFFICER (Mr. Sasse). The Senator from Illinois.
  Mr. DURBIN. Mr. President, I thank the Senator from Massachusetts for 
calling us together on the floor to discuss this important bill, the 
21st Century Cures Act. It is a bill I followed closely because I 
started off introducing the American Cures Act.
  My goal in medical research was inspired by Dr. Francis Collins at 
the NIH. He just told me point blank: If you want to increase the 
output of medical research, find cures for diseases and help innocent 
people, increase the spending at the NIH by 5 percent real growth a 
year for 10 years, and I will light up the scoreboard.
  That is what I set out to do. That is what the American Cures Act set 
out to do, including the Centers for Disease Control and the Department 
of Defense medical research. As is usually the case in Congress, it is 
no surprise when someone sees an idea and thinks they can do it a 
little differently and a little better so, in the House of 
Representatives, Congressman Fred Upton and Congresswoman Diana DeGette 
introduced the 21st Century Cures Act.
  Theirs was a different approach. I guess it reflected a difference in 
philosophy. What we see today is what has happened to an originally 
good idea as it worked its way through the House of Representatives 
over a long period of time. The simple concept of increasing medical 
research spending at NIH by 5 percent a year has now become a very 
complicated formula.
  Frankly, it is one I have very mixed feelings over. I look at it and 
think: It would have been so simple for us to make a national 
commitment on a bipartisan basis to increase NIH funding by 5 percent a 
year and to do it over 10 years. I know we would see the difference.
  Just to put things in perspective so we understand them, there are 
certain diseases now which are costing us dearly: Alzheimer's. We know 
about that, don't we. There is hardly a family in America who does not 
have someone in their family or a friend who has been stricken by 
Alzheimer's. Think of this for a moment. An American is diagnosed with 
the Alzheimer's disease once every 67 seconds--once every 67 seconds.
  Twenty percent--twenty percent of all the money we spend on Medicare 
in America is spent for Alzheimer's and dementia--one out of five 
dollars--but you add to that, one out of three dollars in Medicare is 
spent on diabetes, so between diabetes and Alzheimer's, over half of 
our Medicare budget is going to those patients.
  When we talk about the need to develop new drugs to intervene and, 
with God's blessing, to cure some of these diseases, we are talking 
about not only alleviating human suffering, we are talking about the 
very real cost of government and health care--the very real cost that 
we bear as individuals, as

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families, as businesses, as a government, and as taxpayers.
  In this bill are some positive things, this 21st Century Cures bill. 
I do want to highlight them because they are worthy; the fact that we 
are now going to commit ourselves to deal with issues such as opioids. 
The opioid-heroin epidemic in America is real, and we are not investing 
in what we need to treat it and deal with it. We need to have substance 
abuse treatment--much, much more than we have today.
  One out of six or eight people who are currently addicted are 
receiving treatment. We need to do dramatically better. This bill puts 
money into that. It also includes language, including some parts I 
offered as an amendment, that will deal with mental illness. Mental 
illness and substance abuse treatment are basically on the same track 
in terms of helping people. This bill addresses that. I am glad it 
does. I think that is very positive.
  What is disappointing about this bill--there are several things. 
First, the money we are spending in this bill largely comes from one 
source, prevention--health care prevention funding in the Affordable 
Care Act. How important is that? Do you know how that money is being 
spent? We have something called the 317 vaccination program. What it 
says is, if you come from one of the poorest families in America, we 
will pay for our children to be vaccinated so they don't have to worry 
about the diseases that can change the life or even take the life of an 
infant.
  The 317 vaccine program, half of the money comes from the prevention 
funds we are raiding for medical research. Does that make sense; that 
we are going to take money away from prevention and vaccination to 
invest in new drugs to treat diseases? We can prevent these diseases in 
the first place with adequate vaccinations.
  It is a warped sense of justice in America that we would eliminate 
the health care prevention funds to pay for health care research funds. 
It is a zero sum as far as I am concerned. It is not just a matter of 
vaccinations. When you look at other things: 43 percent of the money 
that is spent on diabetes in America--prevention of diabetes in 
America--is through the prevention fund in the Affordable Care Act.
  That figure tells us that if we can invest on getting people to 
change their lifestyles, sometimes very slightly, or to take certain 
drugs, they can avoid the onset of diabetes. So we are cutting the 
prevention funds for diabetes in order to pay for more research for 
cures for diabetes. Does that make sense?
  Let me ask you about this: tobacco. A lot of my career in Congress 
has been focused on tobacco, the No. 1 avoidable cause of death in 
America today. Tobacco cessation programs pay off many times over. They 
are paid for by the prevention funds we are now raiding for medical 
research. We are taking away the funds to prevent tobacco addiction, 
and we are going to put more investment in trying to find cures for 
lung disease. There is something wrong with this thinking--completely 
wrong with this thinking.
  At the outset, I would say going to the prevention programs to pay 
for research programs is not clear thinking on the part of the people 
that are putting this together. We are told: Well, you better do it 
because the Republicans will take control of the White House and 
Congress next year and they are going to wipe out all of the prevention 
funds. They want to do away with the Affordable Care Act. We will pay a 
heavy price for that. We are starting to make that payment today.
  The second thing I want to say is, I am totally underwhelmed by the 
amount of money in this bill. When you take a look at the amount of 
money that is being spent here, it has dramatically changed as we have 
debated this bill. Originally, this was a $9.3 billion program for 
medical research, pretty hefty. Over a 5-year-period of time, this 
would have had a dramatic impact in a short period of time.
  Well, that changed. It is about half of that now. It is spread over 
10 years. So the amount of money actually going to the National 
Institutes of Health any given year is interesting--$400 million, $500 
million--but it does not match what was originally promised in the 21st 
Century Cures Act. Of course, the question is, if this money is put in 
out of prevention funding, will it be additive? Will it be more?
  Let me close by saying this. I know there are many who have strong 
feelings about this bill. I think it is a step in the right direction, 
but as Senator Warren has told us, it is at a hefty cost when it comes 
to some of the favors included in this bill for people who have friends 
in high places when it comes to the Congress.
  Here is what I can tell you with certainty. We have been able, for 2 
successive years in the appropriations process, to do something 
important and historic. Let me tip a hat to my colleague from Missouri, 
Senator Roy Blunt, a Republican, who took up this cause in the 
Appropriations Committee and provided 5-percent real growth in spending 
for the National Institutes of Health last year and would do it again 
this year if the Republican leadership would allow us to bring his 
appropriations bill to the floor.
  We know we can make substantial new investments in NIH medical 
research. We have a bipartisan will to achieve it. We have the 
Appropriations Committee ready to act. Instead, what I am afraid of is 
this bill, which is a modest investment in medical research, will be 
the end of the conversation for many Members of Congress.
  When the time comes months from now, whether this passes or not--it 
probably will pass--but when the time comes months from now for us to 
debate medical research, many will say: Oh, we already checked that 
box. We have already done that with the 21st Century Cures bill.
  This bill is a pale imitation of the original bill. It is only a 
fraction of the funding which the Appropriations Committee has already 
put in to enhance medical research at the NIH. It overpromises and 
underdelivers. Some of the aspects of it--the troubling aspects--are 
off-label drugs and special favors for the contributors when it comes 
to medical treatment are out of place here.
  If we did not learn any lesson in this last election about draining 
the swamp, well, shame on us because the American people told us do it 
differently--do it openly. Bring in transparency and honesty in this 
effort. When it comes to medical research, we should expect nothing 
less.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Oregon.
  Mr. MERKLEY. Mr. President, I am delighted to join my colleagues from 
Massachusetts and Illinois to express strong objections to the 21st 
Century Cures Act, a bill that is being considered in the House today 
and will be considered in the Senate.
  This bill proceeds to make effective $6.3 billion in cuts to programs 
while laying out a vision of what might possibly be spent in the future 
to assist in medical research. This is very much an imbalance. Real 
cuts--and as I will point out, those cuts hit things that matter with a 
promise of some of future possible action. We have seen these promises 
made and broken time and time and time again in this Chamber. If you 
are going to make a real commitment, then why isn't the real commitment 
in this bill?
  I ask my colleagues from across the aisle: Why isn't the real 
commitment to these programs in this bill? Why isn't the spending in 
this bill? Why isn't the spending on precision medicine that is 
promised to be considered in the future in this bill? Why isn't the 
funding for the Cancer Moonshot promised to be considered at some point 
in the future actually in this bill? Why isn't the program to help 
address an understanding of and pursue cures for Alzheimer's, which is 
actually just a promise to be considered in the future--why isn't that 
actually in this bill? Why isn't the work promised to be considered in 
the future for adult stem cell research, which could have application 
to multiple cures and multiple diseases, actually in this bill?
  Well, I will tell you what is in this bill. What is in this bill is a 
provision that loosens the rules governing how companies market their 
drugs and the

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anti-fraud laws that go along with them--headache pills being 
advertised on television as a cure for the common cold and hair loss, 
perhaps. This is just what Big Pharma wants: freedom, freedom to 
mislead consumers about what drugs actually have been proven to do.
  I will tell you what else is in this bill. It allows people to sell 
untested treatments and drugs without final FDA approval that has 
demonstrated the treatments are safe. Two big factors deregulating 
responsible provisions for Big Pharma are in this bill. But all of 
those rainbows, all those stars promised--those are for future 
consideration, to dress up special interest provisions for Big Pharma.
  I will tell you what else is in this bill. There are special interest 
provisions for Big Tobacco, taking away $3.5 billion in prevention 
funds from the public health fund, $3.5 billion real dollars in 
prevention. The tobacco companies hate prevention programs because they 
make their money from addicts. Their goal in life is to get people 
addicted. This prevention fund is to prevent people from getting 
addicted. As you ponder all the diseases that stem from the use of 
tobacco--cancer of the lungs, cancer of the esophagus, heart disease in 
one form or another, all kinds of forms of decimation due to the daily 
inhaling of these toxins--that is what the tobacco industry thrives on, 
and they thrive on it from addiction.
  Here we have a fund designed to help people avoid the addiction that 
takes away from their quality of life, often for decades of their time 
on our beautiful, blue-green planet, and, instead, encourages a process 
through which people will not only suffer personally but have massive 
medical bills, driving up the cost of health care in America for 
everyone, driving up the cost of insurance for everyone in America.
  Since its launch in 2012, the Tips campaign has helped more than 
400,000 smokers quit for good. According to the Centers for Disease 
Control and Prevention, it saved 50,000 lives. At a cost of less than 
$400 for each year of life saved, in public health circles it is 
considered a best buy, dollars well spent that improve the quality of 
thousands of people's lives and reduce costs in the health care system. 
That is a win-win.
  But what is in this bill? An assault on that win-win to help the 
tobacco companies get more addicts.
  The chronic diseases and unhealthy behaviors the prevention fund is 
intended to address impose tremendous costs. Tobacco use alone costs 
about $170 billion a year. Last year in health care expenses, more than 
60 percent of it was paid by taxpayers through Medicare and Medicaid, 
so we all feel the impact of this.
  What else gets cut? Oh, Medicare funding gets cut. If you are for 
taking apart the preeminent health care system so that our seniors can 
retire without the stress of worrying about access to health care, then 
vote for this bill. This is an assault on Medicare--big favors for Big 
Pharma, big favors for Big Tobacco, and an assault on Medicare. It 
doesn't trim some Medicare programs that maybe are not as effective as 
others and help the others be stronger, more effective. No, it just 
takes away from Medicare.
  Those are the things that are in this act, but what is not in this 
act? The mine workers protection act championed by my colleague from 
West Virginia, Senator Manchin. The mine workers protection act isn't 
in here, but the provisions expire for thousands of mine workers in the 
near future. There are 12,500 coal miners who will lose their health 
insurance on December 31. Another 10,000 will lose their health 
coverage next year and on into the future if we don't restore this 
program. If this bill is about health care, why isn't the coal miners' 
provision in here? I think it should be, but it is not.
  What else isn't in here? Senator Wyden's provision to help children 
who are foster children gain access to programs to help them address 
mental health and addiction. That was in here yesterday. That would 
have been a positive talking point for this bill yesterday, but it was 
stripped out last night. This bill isn't ready, not just for prime 
time; it is not ready for consideration at all.
  If we are going to cut real programs to fund other real programs such 
as the Moonshot and Alzheimer's research, strengthening NIH, then get 
it into this bill. Don't just put in the real cuts and then say there 
is some promise and an invitation to chase a rainbow down the road. Put 
it in the bill.
  The things that are in here are powerful, deregulatory giveaways to 
Big Pharma and Big Tobacco, making the lives of our citizens worse, not 
better. That is why we should kill this bill.
  Thank you.
  Mr. President, 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. KAINE. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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