Category Archives: Clinical Research

A Weekly Advocacy Message from Mary Woolley- Warning: A government shutdown could be dangerous to your health

Dear Research Advocate:

Congress is on the brink of forcing a government shutdown on Tuesday, October 1. The implications of a shutdown are being subsumed by coverage of the political theater taking place. That is an injustice to Americans, who will be affected.  History is illustrative on this point.

During the 1995 and 1996 shutdowns, the NIH turned away new patients at the Clinical Center. Research studies housed at federal institutions ceased for the duration of the shutdown; researchers and leaders of industry, academia as well as in government agencies were unable to plan effectively, wasting time and money; the CDC was forced to stop disease surveillance programs, leaving us unacceptably vulnerable to emerging health threats and even pandemics; NSF could not release grant funds, resulting in a backlog of thousands of proposals, and those were just a few of numerous effects. Compounding the impact this time around is the costly toll that sequestration — on top of a decade of stagnant funding — has already taken in undermining the promise of research and innovation.

A recent New York Times op-ed by Thomas Friedman that was published in other newspapers underscored for me exactly how high the stakes are right now, and a Roll Call op-ed by Morton Kondracke provides additional context.  These two voices are prominent among this week’s sampling from an increasing number of informed individuals who are articulating what all the trends show:  the US is on a path to scientific, and potentially general, decline.  Add to this that the US is already ranked far below where we should and aspire to be in health indicators.  The question is:  why are these twin realities not receiving more attention from our elected officials? Too few Americans are demanding common sense from Washington; please raise your voice louder and longer, and do it now. Then urge everyone in your network to do the same.  Help us deliver this message to your members of Congress — we want #curesnotcuts! Continue reading →

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Highlights of the 2013 National Health Research Forum

Research!America’s National Health Research Forum — held September 12 at the Newseum’s Knight Conference Center in Washington, DC — examined the current and future state of research to improve health. This year’s theme was “Straight Talk about the Future of Medical and Health Research.” Three expert panels delved into different aspects of the research ecosystem.

_DSC5052Reseach Amercia NatHealth Research Forum 9.12.13 BarrettResearch!America’s president and CEO, Mary Woolley, and chair, The Honorable John Edward Porter, opened the program. Porter introduced Bart Peterson, JD, senior vice president of corporate affairs and communications at Lilly who delivered a brief keynote speech.

“We developed an innovation ecosystem, and that ecosystem requires sound public policy. From the private sector perspective, that includes solid intellectual property protection; a fair, rigorous, transparent regulatory system; a market system of health care delivery and pricing that offers choice for patients and health care providers,” Peterson said. “But the public sector has a role far beyond just producing sound public policy … Public funding for research, which is so threatened today, is absolutely critical to the future and we care about that as much from the private sector perspective as anybody else does.”

R!A 2013 Forum

The first panel, focusing on biomedical research and development, was moderated by journalist Eleanor Clift of Newsweek and the Daily Beast and featured John Crowley, president and CEO of Amicus Therapeutics and a patient advocate; William Hait, MD, PhD, global head of R&D at Janssen Pharmaceuticals; Margaret Hamburg, MD, commissioner of the Food and Drug Administration (FDA); and Peterson. The discussion centered on innovation within the pharmaceutical industry and the relationship between companies and regulators. Continue reading →

ACRO’s new video series about the importance of clinical research

Clinical research is key to saving lives, lowering health care costs and reducing waste and inefficiencies in our health care system. To highlight the latest insights from prominent health and research leaders, The Association of Clinical Research Organization has launched a new video series about the importance of clinical research. In the latest installment, John Lewis, Vice President of Public Affairs interviews Research!America president and CEO, Mary Woolley about what’s next for research, the public perception of clinical trials and how we should encourage more minority participation in clinical trials. According to a recent Research!America poll, altruism is a strong motivating factor for clinical trial participation in the general population and more so among several minority groups. To view the series, check out @ACROHealthChannel.

A Weekly Advocacy Message from Mary Woolley: Is a do-nothing Congress a public health threat?

Dear Research Advocate:

Last week, I wrote about the international trade deficit our country faces. This week, I’d like to focus on the budget deficit. From 2003 to 2011, Medicare and Medicaid spending grew 74% while our economy only grew 35%. With that kind of differential, no government can balance its budget. We need research to address disabling and costly illnesses, but that won’t be enough in and of itself to bridge the gap. We also need tax and entitlement reform that preserves needed services, squeezes out waste and inefficiency (by the way, that’s why we must also fight to protect health economics research, health services research and other research that optimizes health care financing and delivery) and promotes pro-innovation tax changes that are designed to sustain a prosperous nation.

One vocal advocate for a long-term view of the steps our nation must take to secure human and economic progress, including committing to ample and stable public support for medical research, is The Honorable John Porter, Research!America chair and former U.S. representative. He recently penned an op-ed published on CNN.com and elsewhere titled “A do-nothing Congress isn’t healthy.” Mr. Porter makes it clear that we must “view research through the prism of future generations” to properly set a legislative course towards prosperity and good health, and we must not delay. Continue reading →

Sequestration Forces Scientist To Euthanize His Genetically Modified Rabbits

Excerpt of an article published in The Huffington Post with first-hand accounts of how sequestration is impacting scientific research.

When The Huffington Post published an in-depth look at how budget cuts were affecting scientific research, we encouraged readers to offer reactions and share personal experiences.

Responses varied. There were some in the political world, primarily conservatives, who believed the issue was overblown. Funding for the National Institutes of Health, they noted, remained robust at $29 billion. And while the agency’s budget has decreased because of sequestration, it is still dramatically higher than it was under Bill Clinton, even when adjusted for inflation.

Reactions from academics and advocates were decidedly different. If anything, they thought the piece undersold the problem. Michael Lubell, Director of Public Affairs at the America Physical Society, one of the world’s largest organizations of physicists, noted that the NIH budget “stagnated and in purchasing power declined significantly” in the past few years. And it isn’t just the NIH feeling the pinch, he added. The Department of Energy, National Science Foundation, and other government agencies are all slashing support for grants.

The most illustrative feedback, however, came from scientists, researchers and students from throughout the country who offered their own personal experiences with funding cuts, ranging from being forced to move their families to other countries to find work, to euthanizing the bunnies on which they’d been conducting experiments. Continue reading →

The sequester’s a public health hazard

Excerpt of an op-ed by columnist George F. Will, published in The Washington Post.

“The capacity to blunder slightly is the real marvel of DNA. Without this special attribute, we would still be anaerobic bacteria and there would be no music.”

— Lewis Thomasgeorge_will

The pedigree of human beings, Thomas wrote, probably traces to a single cell fertilized by a lightning bolt as the Earth was cooling. Fortunately, genetic “mistakes” — mutations — eventually made us. But they also have made illnesses. Almost all diseases arise from some combination of environmental exposures and genetic blunders in the working of DNA. Breast cancer is a family of genetic mutations.

The great secret of doctors, wrote Thomas — who was a physician, philosopher and head of Memorial Sloan-Kettering Cancer Center — “is that most things get better by themselves; most things, in fact, are better in the morning.” But many things require intelligent interventions — cures. So, to see the federal government at its best, and sequester-driven spending cuts at their worst, visit the 322 acres where 25,000 people work for the National Institutes of Health.

This 60th anniversary of the Clinical Center, the NIH’s beating heart, is inspiriting and depressing: Public health is being enhanced — rapidly, yet unnecessarily slowly — by NIH-supported research here, and in hundreds of institutions across the country, into new drugs, devices and treatments. Yet much research proposed by extraordinarily talented physicians and scientists cannot proceed because the required funding is prevented by the intentional irrationality by which the sequester is administered. Continue reading →

Millennials Move On

By Tyler Wiechman

Wiechman currently works in the cardiovascular specialty of a privately owned pharmaceutical company working with specialists and hospitals in the Central Pennsylvania Region.  He withdrew from a PhD in biomedical sciences from the Penn State University Hershey College of Medicine and received his BS in Psychology from the University of Delaware in 2011. He has worked for three different labs focusing on Neurological/Psychological health and behavior. 

TylerWAspiring medical scientists face increasing pressure as they aim to eradicate a disease state, find a new genetic marker for cancer or any number of neurological diseases, or create the next clinically sound pharmaceutical product.  First, they have to excel in their bachelor’s level biological and laboratory sciences.  This commitment alone costs tens of thousands of dollars of tuition and other bills and an overwhelming amount of time, but during these intense four years they are also expected to volunteer hundreds of hours to their local hospital and gain independent research experience.  If that’s not enough, they spend the remainder of their precious time studying for the GRE and/or MCAT depending on the degree program they plan on pursuing.  Finally (and with a huge sigh of relief), the acceptance letter is opened and you pack your bags, move to a new apartment and begin the long and arduous road that is graduate level research.

So after putting forth this much work and making so many sacrifices (and of course getting ready to multiply those sacrifices and efforts tenfold) why does a young scientist leave clinical research?  This is especially troubling when many of these pupils have personal stakes in their research due to the loss of a family or friend or a problematic condition in their genetics.  First, it’s important to look at the numbers.  The troubling truth is that, on average, there is a fifty percent attrition rate from PhD programs around the country with an even higher rate (55-59%) in the life sciences. This number is unacceptable and alarming—and I’m a member of that group.  I speak from personal experience when I say that withdrawing from my PhD was one of the hardest decisions I’ve ever had to make—thankfully my work in the pharmaceutical industry and a close relationship with my former mentors still allows me to be active in the healthcare community, but many are not as lucky and abandon their passion completely. Continue reading →

New Poll Shows Minority Populations Support Clinical Trials to Improve Health of Others but Participation Remains Low Among African-Americans, Hispanics and Asians

Low Percentage Hear About Clinical Trials from Health Care Providers

 ALEXANDRIA, Va.—July  31, 2013—Altruism is a strong motivating factor for clinical trial participation in the general population and even more so among several minority groups. A significant percentage of African-Americans (61%), Hispanics (57%) and Asians (50%) say it’s very important to participate as a volunteer in a clinical trial to improve the health of others, compared to 47% of non-Hispanic whites, according to a new national public opinion poll commissioned by Research!America.

These findings are tempered by the reality that participation remains disturbingly low among all groups. When asked if they or someone in their family has ever participated in a clinical trial, only 17% of Hispanics, 15% of African-Americans, 15% of non-Hispanic whites and 11% of Asians said yes.

Only about a quarter of African-Americans, Hispanics and Asians say they have heard about clinical trials from their doctor or other health care provider. The percentage is even lower among non-Hispanic whites (19%). On the positive side, a strong majority — 75% of Hispanics, 72% of African-Americans, 71% of non-Hispanic whites and 65% of Asians — say they would likely participate in a clinical trial if recommended by a doctor.

“The poll reveals a willingness among minorities to participate in clinical trials to improve quality of health care, but enrollment remains stubbornly low,” said Mary Woolley, president and CEO of Research!America. “We must continue to strive toward reaching all segments of the population to boost the level of participation in order to further medical progress.”

Lack of trust is a major reason that individuals don’t participate in clinical trials, according to more than half of African-Americans (61%), Hispanics (52%), Asians (51%) and non-Hispanic whites (54%). In fact, 40% of African-Americans believe people are enrolled in clinical trials without being told, compared to 36% of Hispanics, 35% of Asians and 27% of non-Hispanic whites who are of this opinion. When asked how important the competence and reputation of people of the institution conducting the research would be in the decision to participate as a volunteer in a clinical trial, 73% of African-Americans, 66% of Hispanics and 66% of Asians said very important, compared to 72% of non-Hispanic whites, reinforcing the importance of trust among all groups.  Continue reading →

Member Spotlight: The TMJ Association

TMJ AssociationThe TMJ Association, Ltd. (TMJA), a Research!America member, was founded in 1989 in Milwaukee, WI by two TMJ patients. The organization’s mission is to improve the quality of health care and lives of everyone affected by Temporomandibular Disorders (TMD), commonly called TMJ. TMD are a complex and poorly understood set of conditions characterized by pain in the jaw joint and surrounding tissues with limitation in jaw movements. TMD pain may range from mild discomfort to severe and intractable accompanied by jaw dysfunction necessitating a feeding tube for sustenance. For many sufferers, their ability to chew, swallow, make facial expressions, and even breathe is limited. It is estimated that over 35 million Americans suffer from TMD; the majority are women in their childbearing years.

With no scientific guidance and no research into treatment strategies, health care providers are incapable of making evidence-based treatment decisions for TMD patients. The result has been more than 50 unproven treatments — including drugs and surgery — recommended to TMD patients. When treatment goes awry, pain and dysfunction worsen. So the need for research remains paramount. The only entity currently funding TMD research in America is the National Institutes of Health (NIH). Continue reading →

A Weekly Advocacy Message from Mary Woolley: “Ordinary Americans” at risk

Dear Research Advocate:

Yesterday, I joined Diane Rehm and other guests on her nationally syndicated radio program to discuss how sequestration impacts “ordinary Americans.” I was struck by how deep and distressing the damage is, in so many sectors, including but not limited to our own. Yet somehow the pain is not acute enough to force action.

What strikes me is how low our collective expectations have sunk when it comes to reinvigorating U.S. economic growth and prosperity. Our nation can do better; why don’t we maintain high expectations and hold our elected officials accountable for setting the policy stage to accomplish them? Policy makers should protect discretionary spending, make hard tax and entitlement reform decisions, and commit to policies that foster economic growth and societal (including health) progress. Part of that equation is ample, stable federal funding for medical research and policies that spur private sector medical innovation.

A glimmer of hope for policies creating such an environment can be seen in the Senate agricultural appropriations bill, which provides the FDA an increase of $96 million above FY13 and full access to collected user fees, previously subject to sequestration. The House also provides a modest increase for FDA. But don’t jump for joy; these increases still leave FDA worse off than FY12 and grossly underfunded. That we think of this as an increase is another example of lowered expectations. Meanwhile, the Senate 302(b) allocation levels for FY14 appropriations were adopted today. As expected, the Labor/H budget is significantly higher than the House’s. The Senate and House numbers are so far apart that reconciliation seems unlikely; the odds are still on flat funding minus sequestration. This is a low-expectation, low-outcome scenario, to be sure, and we should all fight against it. If we don’t, “ordinary Americans” will continue to suffer. Continue reading →

Invest in America’s health

By Olivera J. Finn and Robert E. Schoen

An excerpt of an op-ed by Olivera J. Finn, PhD a distinguished professor and chair of immunology at the University of Pittsburgh School of Medicine and Robert E. Schoen, MD, MPH professor of medicine and epidemiology at Pitt’s School of Medicine and Graduate School of Public Health published in the Pittsburgh Post-Gazette.

Olivera J. Finn

Olivera J. Finn, PhD

Robert E. Schoen, MD, MPH

Robert E. Schoen, MD, MPH

Every day, physicians and scientists see the hope and promise that medical research brings to patients and families. For nearly 70 years, research funded by the National Institutes of Health has increased understanding of the causes of disease, contributed to longer life expectancy and improved the health and well-being of all Americans. With such a proud record of economic and social benefit, it is shocking that the House Appropriations Committee has proposed a drastic cut of nearly 20 percent to NIH funding in 2014. This outrageous proposal must be stopped.

Research is a dynamic process. New, life-improving advances are constantly within reach — but only with uninterrupted effort, commitment and funding. NIH Director Francis Collins says these cuts would be a “profound and devastating” blow at a time of unprecedented scientific opportunity. Continue reading →

A Weekly Advocacy Message from Mary Woolley: What’s wrong with this picture?

Dear Research Advocate:

According to our new national public opinion poll on clinical trials and related topics, most Americans are willing to share their personal health data to advance research, and 72% would be willing to participate in a clinical trial if recommended by their doctor. This complements what we know from other polling, i.e. that Americans want research to proceed at a pace of scientific opportunity. Yet we continue to lose ground in the gridlocked political environment, which, by its inaction, is dashing the hopes of patients and families anxious for new therapies and cures. What’s wrong with this picture?

It isn’t as though research hasn’t yielded both societal and economic benefits! United for Medical Research (UMR) and Battelle Technology Partnership Practice have released a report on the economic and transformative impact of the Human Genome Project, timed as we celebrate the 10th anniversary of its completion. This visionary project has resulted in wildly successful public-private partnerships, more than 4.3 million job-years of supported employment, and nearly $1 trillion in total economic impact since 1988.

The goals of the BRAIN Initiative have been compared to those of the Human Genome Project. Breakthroughs are so desperately needed to overcome Alzheimer’s and a plethora of other serious illnesses. In a recent Bloomberg View article, columnist Al Hunt points out the folly of starving research while we are faced with such major health challenges. Continue reading →

New National Public Opinion Poll Shows Majority of Americans Would Participate in Clinical Trials if Recommended by Their Doctor

Only Small Percentage say Health Care Professionals Have Ever Talked to Them about Medical Research

ALEXANDRIA, Va.-June 12, 2013 – More than two-thirds (72%) of Americans say it’s likely they would participate in a clinical trial if recommended by their doctor, but only 22% say a doctor or other health care professional has ever talked to them about medical research, according to a new national public opinion poll commissioned by Research!America. A wide majority (80%) say they have heard of a clinical trial – more than half (53%) through the Internet and only 24% from a doctor or other health care provider.

Only 16% of those polled say they or someone in their family have ever participated in clinical trials. Respondents believe individuals don’t participate because of a lack of awareness (53%), a lack of trust (53%), concerns that it’s too risky (51%), adverse health outcomes (44%), little or no monetary compensation (35%), privacy concerns (27%), and worries that it takes too much time (27%).

The findings point to the important role of health care providers in talking to their patients about clinical trials. “It is critical for providers and health systems in the U.S. to recognize the importance of generating knowledge about which treatments are best through participation in clinical trials,” said Robert Califf, MD, vice chancellor of clinical and translational research at Duke University Medical Center and board chair of the Clinical Research Forum, a co-sponsor of the poll. “Advances in common diseases like Alzheimer’s and diabetes, as well as rare diseases, depend on physicians and other members of the health care team offering their patients a chance to participate in clinical trials.” Continue reading →

May 29 is World MS Day

Multiple sclerosis, or MS, is a neurological disorder that is a leading cause of disability in young adults. May 29 is World MS Day; started in 2009, it is a global campaign to raise awareness of MS which affects more than 2 million people world-wide and an estimated 400,000 Americans. There is no cure for MS and current therapies have only limited benefits to slow disease progression. Learn more about MS on Research!America’s fact sheet.


Continue reading →

UK plans to use presidency of the G8 to develop international agenda to address dementia

The United Kingdom recently announced a plan that will capitalize on its role as President of the G8 to promote an international cooperation to stop dementia.

This announcement sparks the beginning of increased international collaboration among world governments, industry and non-governmental organizations. Representatives of these diverse entities will gather at an upcoming dementia summit in London, scheduled for September. The global impact of dementia and Alzheimer’s is undeniable—over 35.6 million people worldwide battle with dementia. With the aging global population, this figure is predicted to exceed 110 million people by 2050. Continue reading →