National Defense Authorization Act for Fiscal Year 2017--Motion to Proceed

Floor Speech

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Mr. ALEXANDER. Mr. President, while the Senator from Connecticut is still here, I want say through the Chair that I am glad I had a chance to hear his remarks. I agree with him that there is a mental health crisis, and I congratulate him for his leadership, especially with the Senator from Louisiana, Mr. Cassidy, in focusing the Senate's attention on dealing with it this year. I think he has a very passionate and practical way of making the argument that while there may not be a consensus on what we do about guns, there is a consensus, I believe, in this body on what we do about mental health or at least an important step in the direction of dealing with the crisis. If we are able to do it, Senator Murphy, Senator Cassidy, and Senator Murray, the ranking Democrat on the HELP committee, will deserve great credit for that happening. I plan to attend for a while the summit tomorrow that Senators Murphy and Cassidy are hosting. It will help to draw attention to the efforts that the Senators made.

Last year the full Senate passed the Mental Health Improvement Act. This year, working with the Senators from Connecticut and Louisiana, and the Senator from Washington, Senator Murray, we have incorporated that into the Mental Health Reform Act. We are very hopeful we can pass that legislation on the Senate floor in June and work with the House to turn it into a law this year.

No doubt we will have more to do on the mental health crisis after that, and we will have more debates on this floor about what the Senator from Connecticut calls the gun crisis. But there is no reason we cannot move ahead with what we already have a consensus on in mental health. I am committed, as I know Senator Murray is, and so are other Members on this side of the aisle. I know that Senator Blunt from Missouri feels passionate about mental health needs. Senator Cornyn is working on helping us resolve this legislation. And Senator McConnell has said that if we can find a consensus among ourselves and reduce the amount of time it takes to put it on the floor, he will interrupt the appropriations process, put it on the floor, and try to get a result this year.

So I am glad I had a chance to hear the Senator. I pledge to continue to work with him to get a result on the Mental Health Reform Act that he has played such a key role in fashioning. 21st Century Cures Legislation

Mr. President, I would like to speak on another issue that the Senator from Connecticut has also played a role in because he is an important Member of the HELP committee in the Senate, and that is what we call the 21st Century Cures legislation. This legislation, in which President Obama is interested and which we have mostly finished in terms of our committee work in the Senate, has already passed the House.

A little over a week ago, the New York Times Magazine published a special health issue on the new frontier in cancer treatment--how doctors and researchers are trying new tips, new drugs, even new ways of thinking about cancer. This month the photographer Brandon Stanton, who documents the stories of ordinary people in his popular photography blog, ``Humans of New York,'' turned his lens on the pediatrics department of Memorial Sloan Kettering Cancer Center in New York City to help raise money for cancer treatment and the research hospital there.

Also this month, two former U.S. Senators, both of them physicians and one a cancer survivor--Dr. Bill Frist and Dr. Tom Coburn--wrote an op-ed in the Wall Street Journal about what the Senate is doing to help bring safe treatments and cures to doctors' offices, patients, and medicine cabinets more quickly.

In the New York Times Magazine issue, one oncologist writes:

[For patients] for whom the usual treatments fail to work, oncologists must use their knowledge, wit and imagination to devise individualized therapies. Increasingly, we are approaching each patient as a unique problem to solve. Toxic, indiscriminate, cell-killing drugs have given way to nimbler, finer-fingered molecules that can activate or deactivate complex pathways in cells, cut off growth factors, accelerate or decelerate the immune response or choke the supply of nutrients or oxygen. More and more, we must come up with ways to use drugs as precision tools to jam cogs and turn off selective switches in particular cancer cells. Trained to follow rules, oncologists are now being asked to reinvent them.

The article continues:

Cancer--and its treatment--once seemed simpler. . . . A breakthrough came in the 2000s, soon after the Human Genome Project, when scientists learned to sequence the genomes of cancer cells.

Gene sequencing allows us to identify the genetic changes that are particular to a given cancer. We can use that information to guide cancer treatment--in effect, matching the treatment to an individual patient's cancer.

In another Times story, the reporter writes:

Today, a better understanding of cancer's workings is transforming treatment, as oncologists learn to attack tumors not according to their place of origin but by the mutations that drive them. The dream is to go much deeper, to give an oncologist a listing of all a tumor's key mutations and their biological significance, making it possible to put aside the rough typology that currently reigns and understand each patient's personal cancer. Every patient, in this future situation, could then be matched to the ideal treatment and, with luck, all responses would be exceptional.

This idea, more broadly, has been called precision medicine: the hope that doctors will be able to come to a far more exact understanding of each patient's disease, informed by genetics, and treat it accordingly.

I am here today to insert these important stories from the New York Times Magazine, the ``Humans of New York'' blog, and Drs. Frist and Coburn's Wall Street Journal op-ed into the Record and to remind everyone that this year the Senate HELP Committee has passed 19 bipartisan bills that will help drive medical innovation. I am working today with Senator Patty Murray of Washington, the senior Democrat on the committee, on an agreement that will give the National Institutes of Health a surge of funding for the President's Precision Medicine Initiative, which will map 1 million genomes and give researchers a giant boost in their efforts to tailor treatments to a patient's individual genome. It will also provide funding for the Cancer MoonShot, which the Vice President is heading, to try to set us on a faster course to a cure.

To raise money for cancer researchers at Sloan Kettering, Bradley Stanton used photos on his ``Humans of New York'' blog, Facebook, and Instagram accounts. He writes: ``The study of rare cancers involves small and relentless teams of researchers. Lifesaving breakthroughs are made on very tight budgets. So your donations will make a difference. They may save a life.''

The fundraiser wrapped up this past weekend. More than 103,000 people donated more than $3.8 million to help fight pediatric cancer. More than $1 million was donated in the last day of the campaign in honor of a young boy named Max to help research and cure DIPG, the brain tumor that ended his short life.

Stanton shared photos and stories of Sloan Kettering patients and their parents, as well as the doctors and researchers working to treat and cure them--many stories hopeful, all difficult to read. As Stanton put it: ``These are war stories.''

In one post, a researcher at the pediatric center says:

In the movies, scientists are portrayed as having a ``eureka moment''--that singular moment in time when their faces change and they find an answer. . . . [I]t's hard to say what a ``eureka moment'' would look like in my research. Maybe it's when I'm finally able to look patients and parents in the eye and say with confidence that we have what's needed to cure them.

In another, a doctor at the center says:

It's been twelve hours a day, six days a week, for the last thirty years. My goal during all these years was to help all I could help. I've given 200%. I've given transplants to over 1200 kids. I've published as many papers as I could. . . . But now I'm almost finished. It's time for the young people out there to finish the job. They're going to be smarter than us. They'll know more. They're going to unzip the DNA and find the typo. They're going to invent targeted therapies so we don't have to use all this radiation.

How do we make good on these dollars? How do we ensure that these remarkable new discoveries of targeted therapies are able to reach the patients that need to be reached?

We must give the Food and Drug Administration the tools and the authority it needs to review these innovations and ensure that they are safe and effective, that they get to the patients who need them in a timely way. That is exactly the goal of our Senate Cures Initiative that I am committed to seeing through to a result.

Dr. Francis Collins, Director of the National Institutes of Health-- he calls it the National Institutes of Hope--a Federal agency that this year funds $32 billion in biomedical research, offered what he called ``bold predictions'' in a Senate hearing last month about major advances to expect if there is sustained commitment to such research.

Listen to what he said. One prediction is that science will find ways to identify Alzheimer's before symptoms appear, as well as how to slow or even prevent the disease. Today, Alzheimer's causes untold family grief. It cost $236 billion a year. Left unchecked, the cost in 2050 would be more than our Nation spends on national defense.

Dr. Collins' other predictions are equally breathtaking. Using pluripotent stem cells, doctors could use a patient's own cells to rebuild his or her heart. This personalized rebuilt heart, Dr. Collins said, would make transplant waiting lists and anti-rejection drugs obsolete.

I had a phone call from Doug Oliver in Nashville, 54 years old, a medical technician. Vanderbilt Eye Institute pronounced him legally blind. They said: No treatment, no cure, but check the Internet. Last August, he went to Florida for a clinical trial. The doctors took cells from his hip bone using an FDA-cleared device, put them through a centrifuge, and injected them into both eyes. Within 2 days, he was beginning to see. He now has his driver's license back. He is ready to go back to work.

He is sending us emails about our legislation urging us to pass it and give more Americans a chance to have the kinds of treatments he had that have restored his sight.

Continuing with Dr. Collins' predictions for the next 10 years, he expects the development of an artificial pancreas to help diabetes patients by tracking blood glucose levels and by creating precise doses of insulin.

He said that a Zika vaccine should be widely available by 2018 and a universal flu vaccine--flu killed 30,000 people last year--and an HIV/ AIDS vaccine available within a decade.

Dr. Collins said that to relieve suffering and deal with the epidemic of opioid addiction that led to 28,000 overdose deaths in America in 2014, there will be new nonaddictive medicines to manage pain.

Our Senate HELP Committee has approved 50 bipartisan strategies designed to make predictions like these of Dr. Collins come true. These include faster approval of breakthrough medical devices, such as the highly successful breakthrough path for medicines enacted in 2012, and making the problem-plagued electronic health records system interoperable and less burdensome for doctors and more available to patients. We would make it easier for the National Institutes of Health and the Food and Drug Administration to hire the experts needed to supervise research and evaluate safety and effectiveness. We approved measures to target rare diseases and runaway superbugs that resist antibiotics.

As Drs. Frist and Coburn--the former Senators--wrote in their Wall Street Journal op-ed that this 21st century cures legislation ``touches every American'' and that ``[m]illions of patients and the medical community are counting on Congress.''

The House has already passed by a vote of 344 to 77 companion legislation called 21st century cures, including a surge of funding for the National Institutes of Health. The President has his Precision Medicine Initiative. The Vice President started his Moonshot to cure cancer. The Senate HELP Committee has passed 19 bipartisan bills, as I said, either unanimously or by a wide margin.

There is no excuse whatsoever for us not to get a result this year. It would be extraordinarily disappointing to millions of Americans if we did not. If the Senate finishes its work and passes these bipartisan biomedical innovation bills, as well as a surge of funding for the National Institutes of Health, and takes advantage of these advancements in science, we can help more patients live longer and healthier lives and help more researchers who want to look the parent of a small child in the eye and say: We found a cure.

I notice that the Senator from Pennsylvania has come to the floor. I am ready to yield my time, but before I do--and I see the Senator from Missouri as well--before I do, I want to say of both of them, the Senator from Pennsylvania has been a critical component of the 21st century cures committee work in the Senate. Several of the 19 bills that our committee approved were sponsored by him. I thank him for his work. The Senator from Missouri--I spoke a little earlier about the mental health focus and consensus that we are developing and how we hope to get a result this year on mental health in the Senate, as well as 21st century cures. The Senator from Missouri has been key in both of them. Last year, working with Senator Murray, he was the principal architect of a boost of $2 billion in funding to the National Institutes of Health. This year, he is pushing hard for advances in mental health. So with this kind of bipartisan cooperation, we ought to be able to get a result in June or early July, and I am pledged to try to do that.

senators, we've seen firsthand how medical innovation benefits patients. Those on our operating tables and in our practices--and we ourselves when we've needed medical care--have benefited from breakthroughs in science and newly approved treatments that translate into better health and longer lives.

Yet, tragically, millions of Americans are still suffering and dying from untreatable diseases or the lack of better treatment options. Now is the time to pass legislation that we know will safely speed treatments to patients in need. Lives are at stake.

Before the Senate is a powerful medical-innovation package of 19 bills--a companion to the House-approved 21st Century Cures Act--that will streamline the nation's regulatory process for the discovery, development and delivery of safe and effective drugs and devices, bringing the process into the new century.

Today, researchers and developers spend as much as $2 billion to bring a new drug or therapy to market and the regulatory process can take more than 10 years. That's too long and too expensive for the five million Americans suffering from Alzheimer's; the 1.6 million who will be diagnosed with cancer this year; the 60,000 Americans with Parkinson's; and the nearly 800,000 people who die from heart disease each year.

This legislation, crafted by the Senate's Health, Education, Labor and Pensions Committee, touches every American. Each of us has personal health battles or knows family members and friends who are fighting against devastating diseases. Passing this package will help ensure that patients' perspectives are integrated into the drug- development and approval process and speed up the development of new antibiotics and treatments for those who need them most. It will also give a big boost to President Obama's cancer ``moonshot'' and his Precision Medicine Initiative, which will map one million genomes and help researchers develop treatments for diseases more quickly.

The U.S. has invested more than $30 billion in electronic health records over the past six years. Yet the majority of systems still are not able to routinely exchange patient information. This legislation will improve interoperability and electronic-information sharing across health-care systems, playing a fundamental role in improving the cost, quality and outcome of care. It encourages the adoption of a common set of standards to improve information sharing. It also allows patients easier access to their own health records and makes those records more accessible to a patient's entire health team so they can collaborate on treatment decisions.

The legislation will also improve the Food and Drug Administration's ability to hire and retain top scientific talent, which is vital to accelerating safe and effective treatments and cures. Additional provisions in the bills will improve the timeliness and effectiveness of processes for developing important combination products, such as a heart stent that releases medication into the body.

Alzheimer's is already the most expensive disease in America, and the number of people diagnosed with this debilitating neurological condition is expected to nearly triple to 13.8 million by 2050. This legislation will help advance our understanding of neurological diseases and give researchers access to more data so they can discover new therapies and cures--giving families hope for the future.

Collectively, these 19 bills are expected to deliver new, safe and effective treatments. Any political impediments to this should be overcome immediately. We believe, along with patients, providers, innovators and policy makers, that the nation's current process for developing and delivering drugs and devices to cure life-threatening diseases must change.

Millions of patients and the medical community are counting on Congress to help make that change. After 10 committee hearings and more than a year's work crafting bipartisan legislation, it's time for a Senate vote.

American lives depend on it.

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