[Congressional Record Volume 163, Number 177 (Wednesday, November 1, 2017)]
[House]
[Pages H8381-H8383]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ADVOCATING FOR PATIENTS' RIGHT TO TRY
The SPEAKER pro tempore. Under the Speaker's announced policy of
January 3, 2017, the Chair recognizes the gentleman from Arizona (Mr.
Biggs) for 30 minutes.
General Leave
Mr. BIGGS. Mr. Speaker, I ask unanimous consent that all Members have
5 legislative days in which to revise and extend their remarks and
include extraneous material on the topic of this Special Order.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Arizona?
There was no objection.
Mr. BIGGS. Mr. Speaker, I am here this evening, along with my friend
and colleague, Representative Brian Fitzpatrick, as we advocate for the
passage of the Right to Try Act. This bill, which we introduced
together, has dozens of bipartisan cosponsors, including Members here
tonight.
We are both supportive of Senator Ron Johnson's efforts to champion
Right to Try in the Senate. He has been a tireless advocate of Right to
Try for years, and his bill has already passed the Senate with
unanimous consent. If you are watching the Senate very closely, you
will know that nothing comes out of there, and certainly nothing with
unanimous consent; so that tells how strong the sentiment is in favor
of this bill.
Our legislation allows terminally ill patients who have no further
options left--I repeat that, no further options left--the opportunity
to try experimental drugs that could save their own lives.
Yes, there are also provisions in our bill to protect both the
patients, as well as the pharmaceutical companies who want to
participate, but those provisions are secondary to the primary purpose
of this legislation. The primary purpose of the Right to Try Act is to
give brave patients across this country some choice over their own
destinies, when all other avenues are gone.
We want to give hope to these Americans, and we should all share that
same goal of doing everything we can for patients fighting to save
their lives. This policy has significant bipartisan support. The Trump
administration strongly supports Right to Try, and President Trump has
indicated he would likely sign this bill into law.
Time is of the essence, for time is one thing a terminally ill
patient does not have. And the status quo is not the answer. The FDA
and other agency officials claim that their own expanded access program
is working and continues to improve. There may be some truth to that,
but the program is simply not enough; and I know that because I have
talked to dozens and dozens of patients, family members, and advocates
who tell me it is not enough. They come to my office, they call me on
the phone, they write me impassioned letters.
These same advocates have ensured that Right to Try has become law in
38 States. Think about that for a moment. With one more State, you
could actually ratify a Constitutional amendment. And in half of those
38 States, Right to Try laws passed with unanimous support. In my home
State of Arizona, voters approved that initiative by 80 percent of the
popular vote.
At a time when pundits are claiming that our politics are broken, and
Republicans and Democrats can't come together on anything, here is a
cause that Americans of all political stripes can unite in.
Mr. Speaker, I yield to the gentleman from Pennsylvania (Mr.
Fitzpatrick).
Mr. FITZPATRICK. Mr. Speaker, I want to thank my friend and
colleague, Andy Biggs, for him joining all of us in this fight to stand
up for terminally ill patients across this country.
Mr. Speaker, each year, more Americans receive the devastating news
of a terminal diagnosis. Even with the amazing work done in American
medical research and development, for too many families, access to
these potentially lifesaving treatments will come too late or not at
all.
Thousands of terminally ill patients, like my constituent, Matt
Bellina, suffer needlessly while awaiting final approval for drug
therapies and other medical technologies.
In April 2014, at age 30, Matt was diagnosed with ALS, otherwise
known as Lou Gehrig's disease. ALS attacks nerve cells in the brain and
spinal cord, causing those with ALS to lose control of their muscles.
Although this disease stopped Matt's career as a U.S. Navy aviator in
its tracks, he persisted and actively involved himself in the ALS
community as a strong advocate for Right to Try legislation.
While the Food and Drug Administration carries out its three-phase
approval process, which can take years and cost billions of dollars,
many patients simply want the chance to try treatments that have
already been demonstrated to be safe.
A bill that was unanimously passed by the Senate will offer them a
chance to extend their lives. The Right to Try Act, S. 204, would
ensure that terminally ill patients, together with their physicians and
pharmaceutical manufacturers, can administer investigational treatments
where no alternative exists. In fact, this bipartisan idea is already
the law in 37 States.
A Federal Right to Try law would prevent the government from blocking
access to potentially lifesaving medications. It would require patients
to first try all other available treatments and be unable to
participate in clinical trials.
I want to note that these provisions only apply to terminally ill
patients. It does not undo the FDA approval process but provides a
potential lifeline for those who cannot wait. Moreover, it requires a
physician to certify that other options are either exhausted or
unavailable.
This bill requires that a product meet a demonstrated level of safety
by attaining FDA phase I approval. We have worked with the drug
companies to ensure adverse outcomes are not used against the ongoing
application for approval. Additionally, patients, doctors, and
manufacturers do not assume any additional liability under this act.
For those patients caught in between the traditional drug approval
delays, a clinical trial process for which they do not qualify, and
limited time, the Right to Try simply establishes the freedom for
patients and their doctors to try therapies where the benefits far
outweigh the risks. It gives them the option of trying to save their
life.
Mr. Speaker, whether it is a father like Matt courageously battling
ALS, or a brave child living with Duchenne muscular dystrophy, they
deserve the right to try.
{time} 2100
Mr. BIGGS. Mr. Speaker, I thank Mr. Fitzpatrick; I appreciate all
that he has done and continues to do in this cause, this important
cause. He is a great leader in this, and I am grateful for all of his
effort here.
At this point, Mr. Speaker, I am pleased to yield to the gentleman
from Florida (Mr. Gaetz).
Mr. GAETZ. Mr. Speaker, I thank the gentleman for yielding. I thank
him for
[[Page H8382]]
his leadership on this issue on behalf of the terminally ill. I would
also like to thank Senator Johnson for marshaling together the
resources of the Senate to bring this legislation to a head.
I ran for public office because I was tired of the government playing
too large a role in the decisions people make in their private lives,
in their homes, and in their businesses. We live in a world today where
the government wants to tell you where you have got to send your kids
to school, what kind of healthcare plan you have got to buy, what
regulations you have to comply with, and how much money they are going
to take out of your paycheck each and every month.
I certainly don't think the government ought to play a role in
deciding how someone deals with treatment at the end of life. That is
why I am a proud cosponsor of the Right to Try Act with Representative
Biggs, Representative Fitzpatrick, and so many others. My frustration
lies with any regime, regulatory or otherwise, that would impair a
patient's decision to use any medication to be able to alleviate their
symptoms or improve their quality of life in their final days.
It is absolutely ludicrous to me that, in today's world, we don't
allow terminally ill people in every corner of this great country to be
able to use medical cannabis to alleviate their pain and suffering,
particularly at the end of life.
It is so frustrating to me that the Federal Government has lied to
this country for a generation about medical cannabis, saying that it
has no medical value. Well, I can tell you, Mr. Speaker, that is
absolutely not true. I have met with patients in my district who have
received terminal diagnoses, who have been told by their doctors not to
buy green bananas, and yet those folks courageously move forward trying
to be a part of their own treatment and to be a part of their own
clinical plan moving forward.
Too often, doctors, whether it is at the VA or in private practice,
aren't able to counsel their patients and give them advice and comfort
that there is a substance in medical cannabis which has proven in some
circumstances to have medical value.
Stage IV of terminal cancer includes symptoms like loss of appetite,
which can be helped by cannabis, chronic pain, shortness of breath,
difficulty breathing, chemotherapy-induced nausea. All of these things
can be helped by medical cannabis.
Those who are in stage III of AIDS have sleeplessness and weight loss
that can be helped by medical cannabis.
Cannabis has shown great promise in the treatment of Alzheimer's,
Crohn's Disease, multiple sclerosis, and epilepsy, where there are
refractory seizures, at times, 30 or 40 seizures a day.
Mr. Speaker, in this great country, we will have people who will
receive terminal diagnoses each and every day. I say let's get the
government out of their way. Let's let the decisions that impact the
healthcare of patients be made by those patients and their family
members and their doctors, not a bunch of politicians and bureaucrats
in Washington.
As people fall ill, it is my position that this Right to Try Act can
help them, and certainly the inclusion of medical cannabis into this
legislation would make it a great deal more useful and a great deal
better for those in pain.
I thank the gentleman from Arizona for yielding.
Mr. BIGGS. Mr. Speaker, I thank the gentleman from Florida for his
impassioned speech, his position, his comments regarding the bill, and
his desire to see it altered, but I do appreciate his support of the
bill.
Mr. Speaker, I am certainly grateful to have this opportunity to
yield to the gentleman from Pennsylvania (Mr. Smucker).
Mr. SMUCKER. Mr. Speaker, I would like to thank my colleague from
Arizona (Mr. Biggs) for hosting tonight's Special Order. I also thank
Mr. Fitzpatrick, as well, for his leadership in this bill. I am really
glad to be part of this effort.
We could stand here tonight and talk about the FDA's process for
approving drugs. We could talk about the countless patients across the
country who struggle to get accepted into a clinical trial for a drug
that could save their life. We could even stand up here tonight and
share with you one of the uplifting stories of a patient who received a
lifesaving drug because of a State's right-to-try law. But we have
heard this, and we know all of this.
We know the FDA's approval process takes years. We know there are too
few spots in clinical trials for patients in dire need of help. We know
that right-to-try laws give families hope and can save lives. What I
would like to talk about tonight is the moral imperative we face on
this right-to-try legislation.
America is home to the world's greatest doctors and medical experts.
It is home to the world's greatest medical schools and hospitals. We
have cured diseases that were once a death sentence. We have directed
our national resources to fight epidemics that have saved lives here at
home and overseas. We don't give up.
What we do here in this Chamber, Mr. Speaker, speaks volumes. What we
do here shows the Nation and the world where our priorities are.
Is our priority the bureaucracy of this city that too often misses
opportunities simply because of its inability to act, or is our
priority the patients and families whom we represent to consult with a
doctor and decide for themselves how they choose to fight against
illnesses for which we continue to search for a cure?
For me, the choice is clear, Mr. Speaker. I choose my constituents. I
choose life, and I urge every single Member of this body to do the
same. We cannot afford the cost of inaction.
Mr. BIGGS. Mr. Speaker, I thank Mr. Smucker; I appreciate his
comments and his willingness to participate this evening.
Mr. Speaker, I am pleased to yield to the gentleman from Arizona (Mr.
Gosar).
Mr. GOSAR. Mr. Speaker, I thank my friend from Arizona for yielding.
What a great issue. As a conservative, I am an outspoken defender of
one's right to life. But being pro-life doesn't mean that I am just
antiabortion. It also means that I support the right to try, because
life at all stages is worth fighting for.
Every year, over 1 million Americans die from terminal illnesses,
many of whom pass away while waiting for the FDA to approve a drug that
could dramatically change their prognosis, while others die in the
hopeless cycle of trying and trying again to gain acceptance into a
medical trial.
Think about that: we are losing millions of Americans at the hands of
government red tape.
Now, as a healthcare provider for 25 years, I know firsthand how
important innovation is to the medical community. The Right to Try Act,
if made into law, will give hope to the child with leukemia whose
doctors have exhausted all other treatment options. It opens previously
locked doors by allowing healthcare providers to try experimental drugs
as a last-ditch effort for survival.
The experiments that the Right to Try Act will allow for have the
potential to lead to many more birthdays, more piano recitals, and more
camping trips, and offer hope for our future, hope for years to come.
But don't take my word for it. Emily Whitehead was merely 5 years old
when she was diagnosed with acute lymphoblastic leukemia, and her
doctors quickly realized that she was among a small percentage of
patients whose disease was seemingly untouchable by chemotherapy. The
Whiteheads were at the end of their rope. The little girl's body was
resisting chemotherapy, and the window for many more birthdays, more
piano recitals, and more camping trips was wearing thin. Their only
option was to join a clinical trial that experimented with T-cell
therapy, where Emily could be the first pediatric patient to undergo
this treatment.
And do you know what? It worked. Three years later, a groundbreaking
study was conducted where 63 patients received T-cell therapy for 1
year, and 52 of them became cancer free, an absolutely unheard-of
statistic with this deadly strain of leukemia.
Think about that: 52 lives were saved; 52 families were given another
birthday, another piano recital, and another camping trip. What a waste
it would have been had they not had the right to try.
Mr. BIGGS. Mr. Speaker, I thank all of my colleagues who have joined
us tonight to champion the cause and inquire how much time I have
remaining.
[[Page H8383]]
The SPEAKER pro tempore. The gentleman from Arizona has 15 minutes
remaining.
Mr. BIGGS. Mr. Speaker, in closing, I want to mention how I came to
really be converted to the cause of right to try.
I served in the Arizona State Legislature with Laura Knaperek, who
was also serving in the legislature when I first met her. By 2014, she
was no longer serving in the State legislature. She was an advocate.
That year, Laura was in the fight of her life against ovarian cancer,
and her mission was to see right-to-try legislation passed into law.
In the end, her efforts for this cause succeeded beyond everyone's
wildest expectations when 80 percent of the electorate in Arizona voted
to enact right to try. But, unfortunately, Laura is not with us because
she lost her brave battle with cancer last year. Her legacy as a
tireless patient advocate lives on.
I will continue to carry on the fight not just for Laura Knaperek,
but for all those patients across this country who are battling against
the odds every day.
I am joined by those who are here tonight, those who have cosponsored
this bill, and many other advocacy groups, such as the Goldwater
Institute in Arizona that continues to fight for this.
I fight for Bertrand Might. Bertrand is a very special little boy. He
was the first person ever to be diagnosed with a rare, fatal genetic
disorder called NGLY1 that has left this 7-year-old paralyzed. Because
the disease was only identified by scientists in 2012 and only a few
people worldwide have been diagnosed with it, there is no cure and no
treatment available. Because the disorder is so rare, a drug may never
be developed to treat it.
But scientists have found that Bertrand responds to certain
investigational therapies. So Bertrand's family will have to rely on
trying those new investigational medications as long as they have
access to them. That is why we need this right-to-try legislation.
I fight for Jordan McLinn. Seven-year-old Jordan says he wants to
grow up to be a firefighter so he can save lives. He has Duchenne
muscular dystrophy, which could leave him paralyzed within 5 years and
shortens his life expectancy to only 20 years. There is a drug now
being used in clinical trials that is helping young people like Jordan,
but it could take another 7 years for that drug to be available on the
market. His parents cannot afford to wait for the FDA to give that drug
its final approval. He could be in a wheelchair by then. This
investigational drug could add years to Jordan's life, which would give
him the chance to save others.
We have already heard, when Representative Fitzpatrick discussed Matt
Bellina, his needs and his advocacy. We fight for him, and we fight for
Mikaela Knapp.
At 24, Mikaela was diagnosed with a deadly form of kidney cancer that
had already migrated into her bones before she even knew she was sick.
She went through every known treatment in a matter of months and
nothing worked. Her high school sweetheart, Keith, heard about a drug
under development that was successfully treating people with this same
cancer, but Mikaela was not allowed to enroll in the clinical trial.
Mikaela and Keith launched a social media campaign to try to get access
to the drug, but it wasn't enough. The FDA didn't help.
Mikaela died on April 24, 2014. Five months later, on September 4,
the FDA gave final approval to the drug that might have saved her.
I fight for Diego Morris. When he was 10 years old, Diego woke up
with a sore leg that his mom thought was just another sports injury,
but the pain didn't go away. They knew something was wrong, but they
never expected osteosarcoma, a rare form of bone cancer.
After exhausting all treatments available, Diego's doctors
recommended he try mifamurtide, which wasn't available in the United
States but was being safely used and had been given the Prix Galien
Award, the gold medal for pharmaceutical development in England. The
Morris family wasted no time and made the move abroad to try to save
Diego's life. The treatments worked. Now Diego is back home in Phoenix
and back to playing his favorite sports.
We fight unitedly for the countless other patients who deserve a
right to try. We must act without further delay. Again, I thank those
who have been here to testify tonight.
Mr. Speaker, I yield back the balance of my time.
____________________