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