The 21st Century Cures Act will help bring our health care innovation infrastructure up to speed with advances in science and medicine. The legislation removes barriers that exist in the drug development process and invests in research to bring new cures and treatments to patients faster.
“Over the past 20 years, research at NIH has been making slow progress against cancer, increasing survival rates by about 1% per year,” Greg Satell writes in Forbes. “Yet now, through a new initiative called 21st Century Cures Act, we have a chance to accelerate that progress, perhaps drastically, and finally cure cancer as well as other chronic diseases such as Alzheimer’s and diabetes.”
August 27, 2015
Here's How We Can Win The Race To Cure Cancer
The National Institutes of Health (NIH), which traces its roots as far back as 1887, has long been the primary driver for medical research in not only the United States, but the world. Work at NIH has led to a host of important cures, from life saving vaccines and miracle drugs to the use of fluoride to fight tooth decay.
Over the past 20 years, research at NIH has been making slow progress against cancer, increasing survival rates by about 1% per year. Yet now, through a new initiative called 21st Century Cures Act, we have a chance to accelerate that progress, perhaps drastically, and finally cure cancer as well as other chronic diseases such as Alzheimer’s and diabetes.
Ron DePinho, President of MD Anderson told me, “We have a confluence of major discoveries and technologies that have occurred across a wide range of fronts, which allow us to understand life and disease at a basic level and use those insights to influence its processes. We are now able to make a decisive assault on the cancer problem, if we have the resources.”…
To Win The Future, You Have To Invest In It
As medical science advances, the nature of its challenge evolves. Over the last century, we’ve largely conquered infectious disease and doubled life expectancy, but now must deal with a new set of problems. As people age, the chronic diseases, such as cancer, Alzheimer’s and diabetes are becoming endemic, creating a healthcare—as well as a fiscal—crisis.
Funding medical research would seem to be a no brainer. For a relatively small investment in finding new cures, we can eliminate terrible suffering and greatly decrease the nation’s medical bill. Yet in their zeal to appear fiscally responsible, politicians often seek to defund the NIH and the research it supports, which results in greater costs down the road....
Now, another such decision point is at hand. The 21st Century Cures Act, which aims to restore funds to the NIH for life saving research recently passed the House by a large majority. It now goes to the Senate where it will be submitted to debate and must compete with other priorities. …
So today we are at another crossroads, similar to the ones we faced with AIDS, Ebola and other scientific initiatives. By restoring funding for medical research, we can win the race to cure cancer and other terrible diseases at a fraction of the cost that we will incur if we do not act. The right path forward would seem to be clear.
Read the entire piece online HERE.
WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) issued the following statement regarding the Department of Energy Inspector General report that found, “Solyndra may have provided the Department of Energy with false and misleading information during the application process for a $535 million loan guarantee.” The Energy and Commerce Committee conducted an 18-month investigation into the failed loan guarantee.
“Solyndra was a rotten deal from the get-go. Despite the many red flags, the administration promoted Solyndra, and taxpayers paid the price. The administration was careless with precious dollars, the program was rife with problems, and it was our effective oversight that forced DOE to do its due diligence on subsequent applications,” said Upton.
Read the committee’s 2012 report on Solyndra here.
More Than a Funding Boost, Experts in Washington and North Carolina Outline the Good Within H.R. 6, the 21st Century Cures Act
Last month the House of Representatives voted overwhelmingly in support of H.R. 6, the 21st Century Cures Act. The legislation, 352 pages long, includes a number of provisions to help accelerate the development of new cures and treatments, support scientists, and unleash a new generation of research. H.R. 6 also provides a needed, temporary boost of funding for the National Institutes of Health and the Food and Drug Administration to help carry out these policies.
Peter Pitts, a former associate commissioner of the Food and Drug Administration, writes in Roll Call, “More than just a measure to provide needed funding, though, the 21st Century Cures Act would create a more streamlined drug approval system by revolutionizing procedures for clinical trials. The new rules would make bringing a medication to market less expensive, less time consuming, and more predictable. The result will be that medications will cost less and patients will have access to them sooner.”
Pitts continues, “There’s no doubt that the 21st Century Cures Act would vastly improve the biopharmaceutical drug development process. In addition to funding more basic research and streamlining approvals, the bill would open up opportunities for further improvements as researchers realize the potential from sharing big data.”
The Duke Chronicle explains how the funding boost in 21st Century Cures will help young scientists begin their careers in research. “The 21st Century Cures Act aims to boost funds for basic science research, spur innovation and invest in the next generations of scientists. The ‘Innovation Fund’ sets aside $1.75 billion for the NIH each year for the next five years and $110 million annually for the FDA. The partly restored flow of funding will allow larger grants to be awarded to more researchers—especially younger investigators.”
The Chronicle continues, “The bill also hopes to incentivize the development of drugs for rare diseases, remove barriers that block sharing of health data for research, modernize clinical trials and direct funding toward several critical areas of research—including Alzheimer’s disease, precision medicine, the president’s BRAIN initiative and antibiotic resistance.”
Steven Patierno, the deputy director of the Duke Cancer Institute, “compared the government setting specific targets for biomedical research to NASA announcing efforts to get to the moon or sending a spacecraft to Pluto.”
Energy and Commerce Committee Chairman Fred Upton (R-MI) started the 21st Century Cures process nearly two years ago, bringing a conversation to Washington that had been occurring among patients and researchers around the country. After more than a year of listening to these experts and bringing them together to one table, the effort garnered overwhelming bipartisan support in the House of Representatives. The Chronicle notes that the, “bipartisan support exhibited by the House of Representatives reflects politicians’ increasing awareness of the importance of research and health.”
Leading Researcher: “We are on the verge”
H.R. 6, the 21st Century Cures Act, makes vital investments in the next generation of cures and treatments. The nonpartisan legislation recognizes that it is these investments that will help accelerate the pace of new cures and treatments, ultimately saving lives. George Weiner, the director of the University of Iowa cancer center expressed optimism when speaking with The Iowa Gazette. Weiner said, “We are on the verge … And the more funding we have, the faster progress is going to happen.” H.R. 6 includes nearly $9 billion in fully-paid for investments to the National Institutes of Health that will help unleash a new generation of cures and treatments. Learn more about 21st Century Cures online here.
August 20, 2015
University of Iowa Cancer Researchers Push for Funding Bill
Today former president Jimmy Carter revealed in an announcement that metastatic melanoma has spread to his brain. The treatment for that cancer, in part, includes infusions of one of the newest drugs available for that type of cancer.
Research trials — like those occurring daily in the University of Iowa’s Holden Comprehensive Cancer Center — are responsible for the expanding array of new therapies and treatments like the one Carter is using, said George Weiner, director of the UI cancer center.
“We are doing quite a few research trials on melanoma,” Weiner said.
The UI cancer center is not directly involved in Carter’s therapy, but Weiner said the university does have about 200 researchers from six colleges and 26 departments conducting cancer-related research annually.
The researchers are focused on figuring out how the various types of cancers function and attempting to personalize therapy to each individual patient, according to Weiner.
“It’s so important,” he said. “We just don’t want to lose that momentum.”
Maintaining intensive research of this type requires federal support, Weiner told U.S. Rep. Dave Loebsack during his visit to the UI cancer center. Loebsack has been pushing for passage of the 21st Century Cures Act that aims to accelerate “the discovery, development, and delivery of life saving and life improving therapies,” in part, by increasing funding to the National Institutes of Health by nearly $8.75 billion over five years.
The legislation has made it out of the House and is on the Senate floor, and UI officials said passage of the bill could free up billions in federal support for research projects — like those driving advancements in cancer therapy.
“We are on the verge,” Weiner said. “And the more funding we have, the faster progress is going to happen.” …
Read the complete piece online HERE.
#Cures2015 has “potential to propel the U.S. healthcare system into the modern era”
The 21st Century Cures Act encourages collaboration, fosters interoperability of health information technology, and supports innovation in the medical world to accelerate the discovery and development of life-saving cures and treatments. Throughout the process health care organizations, patients, advocates, researchers, and innovators shared their ideas and support for the landmark legislation.
The Patient Safety Movement Foundation recently emphasized the importance of interoperability in 21st Century Cures:
“We work with healthcare organizations, medical technology companies, patient advocates, and policymakers to identify the leading causes of preventable death in hospitals and develop solutions that can be rapidly implemented to address those issues. We believe that interoperable health technologies will be central in eliminating these preventable deaths… PSMF strongly supported the interoperability provisions in 21st Century Cures Act (Title III, Subtitle A), which have significant potential to propel the US healthcare system into the modern era. … It is not often that such simple changes to the law can have such a significant impact on the quality of care delivered to an at risk population while generating billions of dollars in savings.”
Read the full letter online HERE.
How Social Media Helps Raise Awareness, Boost Funding for Rare Diseases
The 21st Century Cures Act is a product of nonpartisan conversations that took place all across the country. From the start, the committee engaged in the 21st Century Cures dialogue on social media, creating dedicated Facebook and Twitter pages and inviting the public to share their ideas using #Path2Cures. CQ Roll Call described the effort as “a novel initiative that brings issue advocates directly into the deliberations process.” With those ideas, and those gathered from roundtables and meetings across the country, the legislation was born. Ultimately, the House of Representatives approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 in July. Social media has helped raise awareness and encourage action for some very important initiatives:
#ALS #IceBucketChallenge:This time last year, the ALS #IceBucketChallenge campaign went viral. Individuals, organizations, and celebrities across the country and even the world, spread the word about the disease to encourage donations to the ALS foundation for further research. According to CBS News, “researchers from Johns Hopkins are saying they've made a breakthrough in ALS research and that money raised from the ice bucket challenge helped them get there.”
#SmashSMA:Michigan Governor Rick Snyder proclaimed August as Spinal Muscular Atrophy Awareness Month. Snyder also participated in the #SmashSMA social media challenge. The campaign aims to raise awareness for the leading genetic killer of infants and young children. Chairman Fred Upton’s good friends Brooke and Brielle are bravely battling SMA and have taken to Twitter and Facebook to continue the momentum and encourage more research. Celebrities are also starting to get involved in this important effort. “Late night host Jimmy Kimmel took to YouTube to help ‘smash’ SMA asking people to smash something as well, and make a donation at curesma.org,” MLive reports. “Kimmel then wants you to challenge someone else to smash SMA.”
#Path2Cures, #Cures2015, and #CuresIn4Words:The 21st Century Cures Act aims to increase research collaboration, invest in 21st century science and next generation investigators, and provide new incentives for the development of drugs for rare diseases like SMA. Individuals and organizations from coast-to-coast continue to share what the 21st Century Cures Act means to them, their families, and loved ones using #Cures2015 and #CuresIn4Words. Utilizing 21st century social media will help bring 21st Century Cures to light.
After over a year of conversations and collaboration across the country, the House approved H.R. 6, the 21st Century Cures Act, last month. H.R. 6 was created with the help of thousands of peoples’ input to get better, faster cures and treatments to patients who need them most. Throughout the process, members held roundtables in their home states to gather ideas on how to accelerate the pace of cures.
As members are, once again, back home this month, here’s a look back at the Cures conversations this time last year:
August 4, 2014: Summit, New Jersey
Rep. Leonard Lance (R-NJ) joined two-dozen leaders from the patient advocate community, medical innovators and academia in a roundtable discussion to advance biomedical innovation in the 21st century. Learn more here.
August 7, 2014: Indianapolis, Indiana
Rep. Susan Brooks (R-IN) met with the Indiana Health Industry Forum, BioCrossroads, Hoosiers for Health, and the Indiana Medical Device Manufactures Council at Roche Diagnostics to discuss the 21st Century Cures initiative. More here.
August 19, 2014: Lutz, Florida
Rep. Gus Bilirakis (R-FL) held two roundtable discussions with Florida patients and innovators last August to discuss how to better incorporate the patient perspective into health care and how to spur innovation and incentivize investment. Learn more here and here.
August 25, 2014: Boston, Massachusetts
Health Subcommittee Vice Chairman Michael C. Burgess, M.D. (R-TX) participated in a roundtable hosted by the Manhattan Institute in Boston, Massachusetts on “Building a 21st Century Health Care System: Aligning Policy, Accelerating Cures, Delivering Hope.” See what the participants had to say about the event here.
August 27, 2014: Columbus, Ohio
Reps. Bob Latta (R-OH) and Bill Johnson (R-OH) hosted a roundtable at the Nationwide Children’s Hospital. Leading health care stakeholders and researchers from Ohio’s medical schools joined the members to discuss how to keep America at the forefront of health innovation. Learn more from Latta and Johnson and read their joint op-ed on Cures here.
August 29, 2014: Lancaster, Pennsylvania
Health Subcommittee Chairman Joe Pitts (R-PA) hosted a panel of national and local health leaders for a roundtable discussion on the bipartisan 21st Century Cures initiative. Health Subcommittee Vice Chairman Michael C. Burgess, M.D. (R-TX), full committee Chairman Fred Upton (R-MI), and then Health Subcommittee Ranking Member Frank Pallone, Jr., (D-NJ) also participated in the event. Learn more here and view more photos here.
The 21st Century Cures Act is the product of more than a year of listening to and working with patients and experts across the country. Members have been discussing Cures with their local communities throughout the process to gather ideas to improve and modernize our health care system.
“We agreed that we as a nation must do better. And a new bill moving through Congress—the 21st Century Cures Act—will give hope to disease sufferers and their families,” writes Rep. Greg Walden (R-OR) in an op-ed featured on his website. “With this initiative, we are on the cusp of something really big and bold.”
August 18, 2015
21st Century Cures Act will give hope to disease sufferers and their families
By Rep. Greg Walden (R-OR)
All of us have known someone affected by deadly diseases. In my own family, I’ve had loved ones suffer from ovarian and brain cancer, rheumatoid arthritis, stroke, and more. At roundtables in Bend and Medford this month, I met with patients and families impacted by ALS, Parkinson’s, Alzheimer’s, lupus, and diabetes—diseases for which we have no known cure. According to Dr. Francis Collins, director of the National Institutes of Health, there are 10,000 known diseases in the world (7,000 of which are considered rare) but treatments for only 500 of them.
We agreed that we as a nation must do better. And a new bill moving through Congress—the 21st Century Cures Act—will give hope to disease sufferers and their families.
In our increasingly connected world where innovation happens at lightning speed, health research is moving quickly. But government regulations for approval of new drugs and devices are not keeping pace with the science for some of these breakthrough cures. The time and cost associated with delivering a new treatment to patients – from research and discovery through clinical trials to approval –are at all-time highs. It takes upwards of 15 years to bring a new drug to the market, and the cost of developing new drugs has doubled since the early 1980s.
We can do better. With all of today’s advancements in science and technology, it’s clear there’s a lag between ideas, innovation, and actually developing cures that save lives. Our bill would boost medical research and streamline the approval process for new treatments to help accelerate the discovery, development, and delivery of cures. And it is fully paid for with fiscally responsible, meaningful reforms to other sources of spending.
We’ve seen this pioneering work take place in Oregon, which is why I made sure we collected input from some of Oregon’s finest minds, like Dr. Brian Druker, Director of the Knight Cancer Center at the Oregon Health and Science University (OHSU), a true pioneer in cancer research. His work on medicines like Gleevec have turned a previously lethal cancer into a manageable disease and made their way through the FDA approval process in record time. We can continue to make progress like this nationwide.
One part of this is increased support for embracing technology to provide higher quality care to patients through the use of electronic health records, medical apps, and telehealth. The 21st Century Cures Act will help provide regulatory certainty for those who develop potentially life-saving health apps and medical devices using technology. It also seeks to improve the use of telehealth, which is especially important in rural areas.
As one researcher said during development of this bill: 200 years ago, we had the microscope. 100 years ago, we had the stethoscope. Now the next big breakthrough opportunity in medicine is the so-called “datascope,” the idea that researchers can remove all personally identifying information of a patient and plug in to database of medical information. This allows them to match genetic predispositions and biological changes to specific diseases such as cancer, and then use that data to find new cures and treatments.
At a hearing I chaired last year, a representative from Amazon testified about the potential cloud computing holds for health research. Scientists at one health care company discovered a large molecule that’s involved in the development of a particular type of cancer. To figure out how to combat it, the scientists needed to virtually screen 10 million compounds against it. Doing this in-house would have cost the company $40 million. Instead, Amazon built them a system in their cloud that allowed them to perform the equivalent of 39 years of science in less than nine hours—at a cost of $4,200.
Yes, we can harness technology to fight deadly diseases – including rare diseases which, in total affect 1 in 10 Americans. But we need to make sure that the federal government doesn’t needlessly stand in the way. Streamlining the innovation pipeline at all levels ensures patients will have access to the best treatments as quickly and safely as possible.
The 21st Century Cures Act passed the U.S. House on an overwhelmingly bipartisan basis in July. I hope that the U.S. Senate will quickly take action on it. With this initiative, we are on the cusp of something really big and bold
Read the entire op-ed online HERE.
WASHINGTON, DC – Energy and Power Subcommittee Chairman Ed Whitfield (R-KY) issued the following statement in response to the EPA’s proposed regulations relating to cutting methane emissions associated with oil and natural gas production.
“Once again, EPA continues its heavy-handed regulatory overreach that threatens affordable energy and jobs. Domestic energy production is on the rise, while at the same time, EPA’s own data shows that methane emissions are down significantly. The oil and gas industry has taken many welcome steps to deploy technologies to reduce methane emissions, but the EPA seems intent on handcuffing the industry,” said Whitfield. “The best way to achieve emissions reductions is through innovation and we should be celebrating continued success rather than punishing it.”Read More
21st Century Cures Will Provide Hope for Patients Across the Country
By Rep. Fred Upton (R-MI)
Max joined me and my #Cures2015 partner Rep. Diana DeGette of Colorado after the historic House vote to thank us.
When six-year-old Max Schill was born, his mother, Lisa, noticed that her son’s eyes seemed spaced a little wider than normal, and that his ears also appeared to be set lower than average. Max was quickly taken to the neonatal intensive care unit where doctors discovered that he had low oxygen levels, pulmonary valve stenosis, atrial septal defects, failure to thrive, reflux, qualitative platelet defect, chiari malformation of the brain, and a tethered spinal cord.
But he was a fighter. And after a year and a half, Max was diagnosed with a Rasopathy called Noonan Syndrome, a rare genetic condition that prevents normal development in various parts of the body.
Of the 30 million rare disease patients in America, it is estimated that 50 percent are children, which means our nation’s youth are bearing the burden of incurable diseases.
There are 10,000 known diseases in the world, of which 7,000 are rare, and only 500 have effective treatments or cures.
The cost of developing a new drug has doubled since the early 1980s. While medical innovation has boomed, the process for approving new treatments, cures, and devices has remained stagnant, unintentionally slowing those products’ ability to help ailing patients.
The health, societal, and economic impacts of these diseases are undeniable and show an absolute need to modernize the process. This is why the House of Representatives passed H.R. 6, the 21st Century Cures Act, on July 10, by an overwhelming bipartisan vote of 344–77.
If you haven’t heard by now, the 21st Century Cures Act is a bill that, when it becomes law, will provide nearly $9 billion in funding for the National Institutes of Health and more than $500 million to the Food and Drug Administration in order to support researchers, doctors, and patients in combating disease in America. This investment in science and technology will also help streamline the process of clinical trials so that patients like Max, who are in dire need of treatments, can regain hope and aspire to a full and healthy life.
Illness and disease impact far more than just a patient’s body — these types of diseases have significant impacts on the patient’s mind, their caregiver’s health, and the country’s economy.
A study published in 2013 by clinical trial research firm Shire found that 75 percent of patients suffering from a rare disease also suffer from depression and 65 percent of those patients feel isolated due to their ailment. Similarly, three out of every four caregivers who provide support for those patients suffer from depression symptoms.
The same study also found that it takes an average of seven years for an accurate diagnosis of a rare disease after an average of three misdiagnoses.
In addition to the human toll, disease saps productivity from on our economy. Alzheimer’s alone costs government, families, and businesses a total of $300 billion a year while chronic diseases such as cancer, heart disease, and pulmonary conditions cost the U.S. economy more than $1 trillion annually.
These statistics will only continue to grow without action.
The 21st Century Cures Act is the reform we need. It encourages a patient perspective in new drug research and will speed up the process for new treatments to reach the market, which currently takes upwards of 15 years.
More than 700 patient and medical organizations have signaled support for the 21st Century Cures Act because they know this bill will have a profound impact on millions of patients, doctors, and our entire country.
Best of all, for patients like Max, #Cures2015 provides hope. This nonpartisan effort is Congress at its best.
Read the post online HERE.
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