[Congressional Record Volume 157, Number 62 (Monday, May 9, 2011)]
[Senate]
[Pages S2800-S2801]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PROFIT OVER HEALTH
Mr. BROWN of Ohio. Mr. President, yesterday across this country, we
celebrated Mother's Day, marking the contribution of mothers across our
country. But 2 months ago, the health of tens of thousands of expectant
mothers and their unborn children was threatened by a drug company
putting profit over public health. Two months ago, there was justified
public outrage that the cost of a drug hormone, progesterone, to
prevent premature births went from approximately $10 a dose--20 doses
are needed through the course of a pregnancy--to $1,500 per dose. The
entire course of the 20-week treatment, therefore, was about $200 three
months ago. Two months ago, it went to $30,000--$200 to $30,000.
This was once an affordable, common treatment to help women facing
high-risk labor. I visited Toledo Children's Hospital, MetroHealth in
Cleveland, and St. Elizabeth's Health Center in Youngstown to hear
directly from patients and physicians and hospital executives about how
the outrageous price increase affects them. Patients explained what it
was like to overcome a previous miscarriage and rely on this
progesterone to carry to full term today. Physicians and public health
advocates explained the risk to women and children's health if the
therapy were no longer affordable and accessible. Hospital
administrators and State Medicaid directors worried what such an
exorbitant increase would mean to already-stretched budgets.
Meanwhile, several colleagues and I began to ask questions about how
and why the increase happened in the first place. We are concerned
about how companies, private companies, abuse the FDA approval process
or manipulate existing rules to shortchange consumers while those
companies reap massive windfall profits. That is especially so because,
in addition to affixing such a high cost to the drug, this company, KV
Pharmaceuticals from St. Louis, sent a letter threatening a cease and
desist order to compounding pharmacies--those pharmacies that actually
make their own progesterone, in this case--a cease and desist order to
prevent these pharmacies from producing it, further solidifying KV
Pharmaceutical's monopolization in the marketplace. All the while,
pregnant women are left without the critical medicine their doctors
prescribe for them, and either taxpayers foot the bill, insurance
companies foot the bill, driving the price up, or women simply do
without, increasing the number of miscarriages, increasing the number
of low-birth-weight babies, increasing the cost to taxpayers, and
increasing the heartache in mother after mother and father after
father.
Fortunately, in an unusual response--unusual in the sense that this
case was so dramatically outrageous and unbelievably greedy on the part
of KV Pharmaceutical executives--the FDA did something it doesn't
normally do: It asserted its authority and made clear it would not
enforce the cease and desist order. What was KV's response after the
public outrage, after the refusal to enforce the cease and desist
order, therefore allowing the pharmacies to keep producing the
progesterone? It reduced the price from $1,500 a dose--remember, it was
$10 per dose as recently as 3 months ago. They take a shot every week
for 20 weeks during the pregnancy. It was $10 a dose, and they raised
it to $1,500. But do you know what they did after the FDA and a small
number of Democratic Senator's pushed them, embarrassed them in public?
They brought the price down to $690 a dose. It went from $10 when
compounding pharmacies were doing it, to $1,500 when they thought they
could get away with it, to $690--as if they thought they were doing
America's women a favor. That means instead of it being $30,000 for the
whole cost of the pharmaceutical, the 20 doses, it would be about
$15,000. What a bargain. On top of that, they did what companies whose
hands are caught in the cookie jar always do: They hired high-powered
Washington, DC, lobbyists to fight for their rights, this exclusivity
for this drug, trying to prohibit the critical work of compounding
pharmacists.
I agree with drug companies; generally they need to recoup their
investment. I want America's drug companies to do the boldest, most
innovative, most progressive research in the world, and I want them to
make a profit doing it so they can afford to do it and keep doing it.
They should reflect the amount of R&D to bring drugs to market, the
cost of their manufacture, the cost of their distribution, but in the
case of this progesterone, the case of this pharmacy compound,
taxpayers--in this case, through the National Institutes of Health--
funded the initial research and continue to fund critical research on
premature births. KV Pharmaceutical didn't do the research; they bought
the exclusive rights to a monopoly by reimbursing another company--
contracting with them--I believe that actually conducted the clinical
trials and incurring the costs needed for FDA approval.
[[Page S2801]]
Something is very wrong when a company with limited R&D investments
can grossly overprice a drug that in its absence virtually guarantees
an increase in premature births.
Think of the greed involved here. They paid some number of millions
of dollars to do a clinical trial, which was a good thing. They then
brought the price from $10 to $1,500--times 20, again, with the number
of doses people need in their treatment. With an initial investment of
less than $200 million, the first year they would have reaped over $3
billion in revenue. Those are the kinds of numbers they were operating
on, as if that is fair.
When a company used taxpayer-funded research to produce a drug so
important that it reduces infant mortality and birth defects, that
company should also take on the responsibility for pricing it in a
reasonable manner. But prices should never be inflated, particularly on
a public health drug where this company did not do the basic
foundational research; all it did was pay for clinical trials that did
not prove much more than we already knew. A company should never be
allowed to inflate prices of a public health drug to reap these kinds
of massive profits, nor should the FDA approval process ever be
manipulated to achieve that same end, which it was.
While balancing the benefits of corporate profit--and I understand
the balance, and I want the companies to continue to invest and move
ahead--while it can be challenging balancing corporate earnings and
societal benefits, we can't lose sight of our responsibility to make
innovative medicines available and accessible to as many people as
possible.
I would like to close with a story about why all this matters. Not
too long ago--last month, I guess it was, early April--I was in Port
Columbus International Airport about to fly to Washington when Karen
Turano, whom I never met before, walked up to me to share her story.
She has since e-mailed after our discussion where she talked about this
drug, and she sent me this letter:
I met you at the Columbus airport with my husband Thad and
our 17-month-old son Ryker. Again, I just wanted to say thank
you for the work you are doing to make the progesterone shots
affordable again.
Our first son, Tyler, was born August 18, 2008 and passed
away the next day, August 19, 2008. I prematurely went into
labor at 24 weeks and had an emergency C-section. Tyler was
born at 9:59, weighing 1 pound 10 ounces.
Thad went to be with [my son] since I was recovering from
surgery. He called me early the next morning and told me the
worst news a new mother could hear: There was nothing more
that could be done and that Tyler would pass away. My mother-
in-law took me to see and hold Tyler for the first and last
time in his precious life. It was devastating.
Thad and I have since worked with public health advocates
to raise awareness on ways to prevent premature births--while
following doctor's orders to wait 6 months before we tried
again.
After I became pregnant with Ryker, I was monitored closely
and started the progesterone shots at 16 weeks which
continued through 36 weeks.
She had these shots through 20 consecutive treatments, once a week
for 20 weeks.
I am convinced that these shots allowed me to carry the
pregnancy to term.
Interrupting the letter for a moment, understand that when a doctor
sees someone like Karen who has had a pregnancy like she had where a
baby was born that prematurely, that doctor understands that a
progesterone like this progesterone we are talking about can make a
huge difference in her carrying her baby to full term.
Ryker was born at 38 weeks on October 30, 2009, my
Halloween baby. My husband is a Columbus firefighter and I am
an attorney practicing in workers' compensation. We look
forward to more children in the near future, but the cost of
this shot concerns us greatly. We have experienced the
horrible pain of losing a child. No mother or father should
have to go through this pain.
She writes, signed:
Sincerely, Karen, Thad, Ryker and Tyler Turano.
Today is Karen's birthday, coincidentally. She celebrates with her
son Ryker and husband Thad and other family and friends--and she does
with Tyler in her memory. I thank Karen for sharing her story and the
patients in Toledo, Cleveland, Youngstown, and across our Nation and
State who have spoken about this, who deserve the affordable and
accessible treatment they need. I am optimistic we can continue to find
ways to ensure that the majority of women in this country will still
have access to affordable versions of this critical lifesaving
injection. It should not take public outrage, it should not take
congressional action, it should not take the FDA altering a policy it
normally doesn't alter for a company to do the right thing.
Mr. President, as you know, with the unemployment in your State and
the unemployment in my State and the problems we have as a nation on so
many levels, this is particularly outrageous because this progesterone
is a public health pharmacy compound that has worked and meant many
more women will have safe births with growing, healthy children,
contrasted with, if they do not have the opportunity to get this
progesterone at a reasonable rate, at a reasonable price, we know what
happens then. But rest assured, we will keep up the outrage, and we
will continue to move through Congress, if that is what it takes, to
get progesterone at an affordable price to America's women.
It is an outrage what KV Pharmaceuticals did. I applaud the FDA for
changing its policy to make it more accessible.
I ask KV Pharmaceuticals to again come to the table. Instead of
lobbying Congress to get their way and make a huge amount of money on a
relatively small investment, I ask them to come to the table and work
with us so we can make this very important pharmacy compound accessible
to all American women whose doctors prescribe it to them.
I yield the floor.
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