A Weekly Advocacy Message from Mary Woolley: No recess for advocates!

Dear Research Advocate:

As I write, most members of Congress are on the way home for August recess. As anticipated, no further action has been taken on the appropriations front – or much else, for that matter. In terms of issues we care about: no movement on tax reform, which means no much-needed enhancement of the research and development tax credit; no repeal of the medical device tax; and no final passage of Fiscal Year 2015 appropriations bills.  In upcoming letters I will talk in more detail about Capitol Hill-focused advocacy strategies through the election and beyond.

In the absence of legislative action, some attention – in a bipartisan manner – is being given to research for health. In previous letters, I’ve talked about an effort spearheaded by House Energy and Commerce Chairman Fred Upton (R-MI-06) and Ranking Member Diana Degette (D-CO-01) called the 21st Century Cures Initiative that will remain active over the recess. Public input is being sought as central to this initiative. The truly engaged and whip-smart congressional staff coordinating this initiative have indicated that they would welcome your thoughts at any time. They are particularly interested in the National Institutes of Health, the Food and Drug Administration and public-private partnerships. If you believe the key to faster medical progress is increased funding, tell them. If you feel that bottlenecks in the clinical trials process are the priority concern, tell them. This is not only an opportunity to seed positive change; it is an opportunity to elevate the priority of medical progress going forward. When you think about it, the volume of comments is nearly as important as their content. Issues with an army behind them get attention. To submit comments, e-mail cures@mail.house.gov. Continue reading →

Support NIH

Ask Your Senators to Support the Accelerating Biomedical Research Act

Funding to the National Institutes of Health (NIH) has remained flat in recent years, and uncertainty is growing over the ability of universities and other research institutions to conduct the noncommercial medical research underlying new preventative measures, diagnostic tools, treatments, and cures. In response to significant concerns about the erosion of NIH’s purchasing power, Senator Tom Harkin (D-IA) has introduced legislation, the Advancing Biomedical Research Act, that empowers Congress to provide up to 10% increases in NIH funding for FY 2015 and FY 2016, and up to 5% increases through 2021. These increases are more than justified by the scientific opportunity unleashed when the human genome was sequenced. And that’s just one of the developments that has set the stage for accelerated medical progress. We need to conquer Alzheimer’s Disease, cancer, Parkinson’s Disease, and other deadly and disabling health threats…and we can. Show Congress that you support Senator Harkin’s efforts to fuel medical progress. Urge the senators who represent you to support the Accelerating Biomedical Research Act now!

Take action.

A Weekly Advocacy Message from Mary Woolley: A long letter with timely news

Dear Research Advocate:

Today, Senator Tom Harkin (D-IA) — one of the most effective and dedicated champions of medical and health research ever to serve in public office — introduced major new legislation, the Accelerate Biomedical Research Act.  This visionary legislation would increase the budget caps in order to boost National Institutes of Health (NIH) funding to $46.2 billion by FY 2021, a strategy for restoring NIH purchasing power without cutting into funding for other national priorities. You can view my statement on the legislation here and our thank you letter to the Senator here.  It would be terrific if you would write a letter of support for the legislation and send a message encouraging your Senator to sign on.

There’s more good news to share! The Senate Labor-H bill and accompanying report language were released today.  We are grateful to Appropriations Committee Chairwoman Barbara Mikulski (D-MD) and Labor-H Subcommittee Chairman Harkin for helping to conceive of, and agreeing to include, report language to fund a Blue Ribbon Commission on science literacy and public appreciation of science. We’re pleased to have played a role in making this happen but every science advocate deserves credit when federal leaders take a step like this.

In terms of FY15 funding, you may recall that the Senate Labor-H subcommittee proposed NIH be funded at $30.5 billion, a $605.7 million increase, or about a 2% bump over FY14 levels.  The proposed measure also funds CDC at nearly $6 billion, a 3.3% increase from FY14 and funds AHRQ at $373.3 million, a mere .6% increase from FY14.  With the appropriations momentum stalled, rumors are floating around the Hill that the House will soon consider a Continuing Resolution or CR (extending current spending levels) through the election and potentially into December.  Continue reading →

Statement by Research!America President and CEO Mary Woolley on the Accelerate Biomedical Research Act

Research!America applauds Senator Tom Harkin for taking bold, decisive action to heal fissures in our nation’s research pipeline with legislation that will strengthen the National Institutes of Health (NIH) budget over the next six years. The Accelerate Biomedical Research Act will establish a pathway for sustained growth in the NIH budget. That budget has remained virtually stagnant over the last decade, jeopardizing promising research to combat disease and deflating the aspirations of early career scientists. NIH-funded research fuels the development of lifesaving therapies and treatments, and creates opportunities for public-private partnerships to better understand Alzheimer’s, cancer, heart disease and other major health threats here and abroad.

Senator Harkin and other congressional leaders recognize the potential of innovative research, but it is Senator Harkin who is taking the lead at a time when too many elected officials appear to have taken their eyes off the ball with our global leadership in science and technology at risk. China and other countries are aggressively increasing their research and development investments, luring scientists to their shores and challenging our dominance in medical research and innovation. According to polling commissioned by Research!America, a majority of Americans are skeptical that the U.S. will maintain its pre-eminence in science by the year 2020, and many policy experts agree. We urge Congress to support the Accelerate Biomedical Research Act to improve the health of Americans and ensure our global competitiveness.

Medical Research: It’s about you and me

collage fact sheetResearch!America’s newest fact sheet series highlights the personal stories of medical research and the importance of increasing the NIH budget in FY15. We hope you will share these fact sheets with your representatives or congressional candidates, or take it with you on Hill or in-district visits. No one who reads these stories can doubt the significance of medical progress. A stronger investment in research is needed now more than ever!

Here are their stories:

What new discoveries are we delaying and missing when we slow the pace of medical and health research?

We’ve made progress. But the funding to sustain it is eroding.

A Weekly Advocacy Message from Mary Woolley: Will research have every opportunity to conquer Alzheimer’s?

Dear Research Advocate:

We are finally seeing action to address the surfeit of regulations placed on the research community. Accountability is essential, but it isn’t a function of how thick the red tape is! The Research and Development Efficiency Act, HR 5056, passed the House this week and is pending before the Senate Committee on Commerce, Science and Transportation.

This is but one example of the direct effect that your legislators can have on medical research. Do you know what your candidates will do to advance medical progress if elected on November 4th? Our Ask Your Candidates! national voter education initiative highlights the views of candidates. We are counting on you to help us reach more candidates. Click www.askyourcandidates.org to see if your candidates have responded—if so, say thank you (Why say thank you?  Because potential champions need to know there is an army of supporters standing behind them!)—if not, ask them to weigh in.

Why should voters and candidates care about medical progress? I can answer that in one word: Alzheimer’s. This disabling and breathtakingly expensive illness is in the news this week as scientists announce new research findings at the Alzheimer’s International Conference in Copenhagen.  A major randomized prevention trial showed that a behavioral intervention featuring changes in diet and exercise produced significant cognitive improvement in Alzheimer’s patients. Continue reading →

New Opportunities in the Changing Landscape of Prevention

Excerpt of article by Derek Yach, MBChB, MPH, The Vitality Institute, The Vitality Group, LLC, New York, New York and Chris Calitz, MPP, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland published in The Journal of the American Medical Association (JAMA).

The focus of medical research has historically been on curative medicine, yielding better drugs, medical devices, and clinical procedures. Prevention science—the systematic application of scientific methods to the causes and prevention of diseases in populations—has yet to receive the necessary investment and support required to reduce the growing burden of largely preventable noncommunicable diseases (NCDs).

Human and Economic Burdens of Disease

Recent assessments of the burden of risk and disease found that morbidity and chronic disability account for nearly half of the US health burden.Despite the largest per capita health expenditure of all industrialized nations, the United States has fallen behind peer countries in terms of improvements in population health. Americans reach age 50 with a less favorable cardiovascular risk profile, lung disease is more prevalent and associated with higher mortality, and the death rate from heart disease is the second highest among peer countries. Leading NCD risk factors are unhealthy diets, tobacco smoking, high body mass index, high blood pressure, high fasting plasma glucose levels, physical inactivity, and alcohol use.Many of these risks are amenable to preventive interventions based on behavior change, yet comprehensive action by development sectors across the economy to disseminate evidence-based interventions targeting these modifiable risks is inadequate. Furthermore, knowledge about effective prevention interventions for mental illness and musculoskeletal diseases is limited even as their contribution to chronic disability increases.

Noncommunicable diseases have been cited as major contributors to rising health care costs, which the Congressional Budget Office (CBO) projects will be the primary driver of national debt over the next 4 decades. The greatest increase in health care spending between 2000 and 2011 was attributable to drugs, medical devices, and hospital care, with the cost of treating NCDs estimated to exceed 80% of annual health care expenditure, whereas 3% was spent on public health and disease prevention programs.The National Institutes of Health estimates that 20% of its $30 billion annual budget is allocated to prevention; however, less than 10% is spent on human behavioral interventions that target the major modifiable risk factors.More investment in prevention science could lead to greater health gains at lower cost.

Read the full article here.

Research!America’s response to the Yach and Calitz article in JAMA:

The commentary by Derek Yach and Chris Calitz should be required reading for every federal policy maker.  Preventing disease is the best case scenario, not only for patients, but for taxpayers and the economy.  That’s because reducing the incidence of disease is more than a one-time cost-saving strategy; it actually bends the cost curve and helps individuals lead long, productive lives.  Yet the Prevention and Public Health Fund, which allocates grants to states to reduce the prevalence of NCDs,  has been a perennial target of lawmakers who seek every opportunity to defund it and prevention science as a whole continues to be a low national priority. That’s where advocates come in.  Prevention science is not going to flourish until Washington comprehends the return on investment.  Fighting for prevention science is not just right, it is essential.

Invest in NIH research

Excerpt of an op-ed by Society for Neuroscience Early Career Science Policy Fellow Matthew J. Robson, PhD, published in The Tennessean.

robson0705The United States has historically been a consistent, international force of innovation and advancement in biomedical research. Such research is not possible without federal funding of the National Institutes of Health (NIH), an agency within the Department of Health and Human Services.

Although the NIH supports basic biomedical research aimed at a greater understanding of the causes of disease and the improved health of all Americans, relatively few understand the scope of the accomplishments of this agency.

Research that depends upon NIH funding has contributed to improved treatments for many ailments, including asthma; brought advances in imaging technologies, including MRI; nearly eliminated transmission of HIV between mother and child; and more than halved the incidence of mortality from heart disease and stroke, two of the leading causes of death in America. Additionally, NIH funding was crucial in supporting the Human Genome Project, a project that has transformed the way that basic and clinical biomedical research is conducted. These advances in medicine have saved countless lives across the globe. These medical breakthroughs stem from our country’s persistent and sustained investment in basic biomedical research through NIH funding that is allocated by Congress.

Adequate levels of funding for the NIH are crucial for not only future medical advancements, but also the economic health of the United States. Currently, biomedical research results in over $2 of economic activity for every $1 of taxpayer investment. Biomedical research funding is clearly not a “bridge to nowhere,” as it makes up less than 1 percent of the entire federal budget and represents a true investment with real quantifiable returns. NIH-funded research is responsible for nearly half a million high-quality jobs within the United States, jobs that result in economic prosperity in regions where this research activity occurs, including Tennessee. In Tennessee alone, it is estimated that NIH funding is responsible for employing nearly 11,000 people.

Read the full op-ed here.

A Weekly Advocacy Message from Mary Woolley: American values at stake

Dear Research Advocate:

My colleagues at Research!America have shared the role as author of our weekly letter during my recent sabbatical. My thanks to them for providing timely and actionable information to our wide network. As I am “re-entering” the Washington space, I have been struck by (1) the significantly worse condition of the roads — potholes everywhere, and now even sinkholes in DC! I’ve been in several global capitals this spring, including in less-developed countries, and DC doesn’t look good in comparison. Via recent domestic travels, I can attest to the poor condition of our roads nationwide, taking a toll on vehicles and our economy, while eroding public confidence in government. Public goods — like infrastructure, education and science — that we have long nurtured through steady investment cannot continue to be resource-starved without dire consequences. No wonder the American public is angry at Washington! (2) I have come back just in time to witness the appropriations process grind to a halt. The clock is ticking down toward August recess, and appropriators have a new excuse for failure to take action, i.e., the migrant children emergency. There will always be national emergencies. By definition they are unpredictable, and some are more complex than others; it nonetheless cannot be acceptable for Congress to grind to a halt when one occurs. Continue reading →

Ask Your Candidates! Unveils Ad Campaign

One of the fundamental goals of the Ask Your Candidates! (AYC!) initiative is to ensure that medical progress takes its rightful place among the priorities candidates discuss as they vie for a seat in Congress. To further this and the central, voter education agenda of AYC!, we’ve launched an ad campaign on POLITICO.com.

These ads, which will run through July 27th, have three different frames, each of which poses a question on the topic of medical progress: 1) What will candidates for Congress do to help kids who need cures? 2) What will candidates for Congress do to help the 30 million Americans with a rare disease? 3) What will candidates for Congress do to help families grow old together?

These questions are examples and far from exhaustive. Why do you care about medical progress? Click here to let your candidates know and see if they care, too.

Check out the ads at http://www.politico.com/p/pages/2014-elections and other POLITICO web pages.

AYC politico

A Weekly Advocacy Message from Research!America: Will appropriators do the right thing for research?

Dear Research Advocate:

Research!America board member and co-chair of One Mind, Patrick Kennedy, and the head of neuroscience research at Janssen Research & Development, Husseini Manji, shared their perspectives on the state of neurological and mental health research and treatment in a USA Today op-ed. As Kennedy and Manji remind us, a quarter of our population experience mental illness, but nearly 60% of those individuals do not receive any treatment. Federal funding for medical and health research is crucial to improving diagnosis and treatment, and developing cures for patients who suffer from mental illness, Parkinson’s, Alzheimer’s and a whole range of other diseases.

But time is ticking away on the appropriations process as the August recess approaches. With each passing day, the possibility of regular order diminishes and the likelihood of a continuing resolution (CR) increases. Yet all is not lost. Advocates must continue to push for increased funding for research and health agencies in FY15 (it would take the form of an “anomaly,” which is basically an exception to status quo). There has been talk, albeit muted, that some members may refuse to pass a CR and instead opt for a government shutdown, a scenario most Americans agree is harmful to federally funded programs, including medical research, according to our polling.

We learned first-hand the negative impact a government shutdown can have on research and clinical trials. Patients like Steve — featured in our sixth fact sheet installment — and others with Parkinson’s disease cannot afford delays in clinical trials. Please continue to share this fact sheet series with your networks and Members of Congress. They are generating buzz in congressional offices and getting the attention they deserve. Continue reading →

Member Spotlight: The University of Maryland School of Dentistry

By Mark A. Reynolds, DDS, PhD, MA, dean of the University of Maryland School of Dentistry

Mark ReynoldsThe University of Maryland School of Dentistry (UMSOD) is the world’s first dental school, founded in 1840 in Baltimore, Maryland. The school has a distinguished history of graduating exceptional dentists and dental hygienists who advance the oral and overall health of patients in Maryland and around the world.

Researchers at the School of Dentistry are dedicated to discovering and developing new treatments for diseases. Our scientists are leaders in the fields of oncology, pain and neuroscience, and microbial pathogenesis. UMSOD recognizes that training dental scientists is essential to improve the health of future generations. By offering unique mentorship opportunities and dual-degree programs, such as the combined DDS/PhD, the School of Dentistry provides an environment that encourages students to pursue research endeavors. Continue reading →

A Weekly Advocacy Message from Research!America: The innovation imperative: It’s about Max

Dear Research Advocate:

This week, the research advocacy community suffered a tremendous loss. John Rehm, husband of Diane Rehm, passed away Monday. Diane, the host of The Diane Rehm Show on NPR, was honored by Research!America last year for her advocacy with the Isadore Rosenfeld Award for Impact on Public Opinion. Her late husband was a friend and longtime supporter of the Parkinson’s disease community. Our thoughts are with the Rehm family during this difficult time.

As you pursue your advocacy efforts, we hope the newest fact sheet in our series about the human impact of research will prove useful. Max Hasenauer was diagnosed at 22-months-old with X-linked Agammaglobulinemia (XLA). He is alive today because of research that enables him to receive infusions of antibodies every three weeks. While this technique has been life-saving, more research is desperately needed to address the profound challenges Max continues to face. Thank you for helping to ensure that Congressional Offices are seeing these fact sheets. We continue to receive positive feedback from the Hill thanks to your efforts to share the fact sheets broadly. Continue reading →

Patient Engagement in Drug Development: Myth or Reality?

HR-researcher_1Is the patient voice adequately represented in the drug development process? The situation has improved but the patient community is not yet recognized as a co-equal in drug development or regulatory review according to Marc Boutin, executive vice president and chief operating officer at the National Health Council, a panelist at a BIO International Convention session on Wednesday. “We scare you,” declares Boutin who says there is an adversarial connection between patients, regulators and industry but the relationship has evolved over the last decade. Patient advocates have developed strategies to amplify their voice and demand access, providing the data and evidence to help transform healthcare delivery.

A section in the 2012 FDA Safety and Innovation Act fosters participation of patient representatives in appropriate FDA meetings with medical product sponsors and investigators, and a new transparent framework to communicate FDA benefit-risk approval decisions to the public. From the patient perspective, “benefit-risk decisions are value judgments, they are not science,” says Boutin. He acknowledges that FDASIA meetings are a critical step but sophisticated patient engagement is still lacking. In-depth interviews, focus groups, crowd sourcing and other strategies should be part of the equation, he adds. Getting the patient perspective in benefit-risk could change the discussion dramatically and improve healthcare delivery, Boutin says. Ensure that clinical trials are designed appropriately for people with chronic conditions, for example, to understand the benefit-risk for a subset of the population. Continue reading →

Global Consortium Protects Drug Supply Chain

RX360logo_noTextMaximizing the return on investment in quality innovation was the topic of a BIO International Convention Super Session on Tuesday which explored challenges and opportunities for pharmaceutical companies in improving efficiencies and ensuring patient safety. Panelist Martin VanTrieste, Senior Vice President, Quality, Amgen described a global initiative formed by industry and regulators to share knowledge and best practices that will help secure the pharmaceutical supply chain and quality of materials. Rx-360, a consortium of pharmaceutical companies, suppliers and regulatory agencies, is tasked with developing voluntary standards for the quality and authenticity of supplies and suppliers, and developing audit standards, training and certification programs. The goal is to prevent counterfeited, adulterated and contaminated materials from entering the supply chain, and jeopardizing patient safety. One tragic example was the introduction of contaminated heparin, a blood thinner, linked to 80 deaths in U.S. patients and allergic reactions in 2008. VanTrieste said the consortium “has been highly effective in bringing industry leaders in the quality and supply chain security space together to come up with common solutions” in addressing the very difficult problems associated with globalization. “By working together we get to the answer faster and it’s more efficient.” Continue reading →

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