Tag Archives: clinical trials

Hispanic Heritage Month: The Changing Face of Health Care

By Israel Rocha, CEO, Doctors Hospital at Renaissance

Israel Rocha_FinalSeptember 15 marks the beginning of Hispanic Heritage Month, a time to pay tribute to the generations of Hispanics who have enriched America’s history. It’s also an important time to consider how this community can be further empowered to make important contributions, particularly in the future of health care.

Research demonstrates that certain diseases disproportionately impact the Hispanic community, including diabetes, liver cancer, cervical cancer and HIV/AIDS. Clinical trials help researchers find better ways to diagnose, prevent and treat these diseases and others. However, Hispanics are significantly underrepresented in clinical trials. Despite representing 16 percent of the U.S. population, Hispanics comprise only 1 percent of clinical trial participants.

Given this historic underrepresentation, there is tremendous opportunity to boost clinical trial participation within diverse patient populations. According to a July 2013 study by Research!America:

  • More than 40 percent of Hispanics greatly admire clinical trial participants.
  • More than 2/3 of Hispanics would be willing to share health information to help researchers find better ways to prevent and treat disease.
  • Nearly half of the Hispanics polled rate a physician’s recommendation to participate in a clinical trial as very important.

Continue reading →

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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 →

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 →

Clinical Research

Letter to the editor by Research!America VP of Communications Suzanne Ffolkes published in The New York Times in response to article, Labs Are Told to Start Including a Neglected Variable: Females” (May 14, 2014)

In addressing gender bias in biomedical and clinical research, it’s also important to close gaps in clinical trial participation among minorities to understand how different segments of the population respond to various treatments. When asked if they or someone in their family had ever participated in a trial, only 17 percent of Hispanics, 15 percent of African-Americans and 11 percent of Asian-Americans said yes in polling commissioned by Research!America, a nonprofit advocacy alliance.

This is primarily rooted in a history of distrust and lack of awareness, but attitudes appear to be evolving as more minorities express a willingness to participate in trials if recommended by a doctor or a health care professional.

Boosting enrollment among women and ethnic groups is critical to achieving better health outcomes for all Americans.

Celebrating Science

Excerpt of a blog post by Dr. Tom Insel, Director of the National Institute of Mental Health.

(From NIMH blog)

(From NIMH blog)

The Research!America awards dinner is like a lot of DC galas, complete with members of Congress, celebrities, and speeches to honor those who have contributed to a cause.  For Research!America, the cause is biomedical research and this year, as in each of the past 25 years, there were honors bestowed on advocates for cancer and rare diseases.  Kathy Giusti, diagnosed with multiple myeloma in 1998, spoke passionately about the lack of research on this blood cancer and her singular fight to create a registry and clinical trials, leading to new treatments that have extended her own life and the lives of many others well beyond all predictions.  The parents of Sam Berns, an icon for the rare disease progeria, spoke of their son’s commitment to find a cure for this disorder in which children age rapidly and die early.  Sam died last month at age 17, but during his brief life, and partly through his efforts working with the world’s foremost genetics labs, the genetic cause was found and new treatments were developed that will almost certainly extend life for others with this rare mutation (see Sam’s inspirational Ted talk ).

For me, what made this event different from previous years was the recognition of advocates for people with mental illness.  The actress Glenn Close was recognized for co-founding BringChange2Mind, a campaign to reduce negative attitudes toward those with mental illness.  In her eloquent remarks accepting the award, Glenn introduced her sister, Jessie Close, and her nephew, Calen Pick, who each battle serious mental illness.  Jessie has struggled with bipolar disorder and Calen with schizophrenia.

When Glenn invited Jessie and Calen to make a few remarks, the evening really became historic.  Together, they described a journey undertaken with Deborah Levy and her colleagues at McLean Hospital and elsewhere over the past 3 years.   The research team found that Calen and Jessie shared a rare genomic copy number variant resulting in extra copies of the gene for glycine decarboxylase.  This gene encodes the enzyme that degrades glycine, a key modulator of the NMDA receptor, which has been implicated in psychosis.  Having extra copies of this gene, it seemed possible that Jessie and Calen would be deficient in glycine, with less activity of the NMDA receptor.

Read the full post here.

A Weekly Advocacy Message from Mary Woolley: We’re all in this together

Dear Research Advocate:

Fostering research and innovation has long been a multi-pronged effort — government, industry, academia, patients and patient organizations, foundations, and individual philanthropists — all working to advance research. The current interest shown by private philanthropists in advancing science is an echo of a phenomenon witnessed a century ago — and a sign of the opportunity available in some way to all of us to accelerate medical progress and maintain our nation’s competitive edge. As reported in a recent front page New York Times article, private donors are stepping up in a big way at a time when scientific opportunity has never been greater. But it is worth noting that even as philanthropic spending is surging, and while it has historically been an important, often energizing component of U.S. leadership in science, the most robust philanthropic support imaginable would still not be sufficient — nor is it intended to — replace federal support.

In tracking medical R&D spending across all sectors over time, Research!America’s annual investment reports not only support the NYT finding that philanthropic spending is growing, but place that spending in perspective. For example, in 2011, NIH spending dwarfed medical- and health-related philanthropic research spending by nearly $29 billion. That does not mean philanthropic giving isn’t important; rather, it demonstrates that the magnitude of funding needed to drive medical progress is too large to rely on individual or foundation giving. Public and industry dollars are quite simply indispensable to the research pipeline. We call on every sector, every individual (including you billionaires out there!) to step up and increase support. We urge you to fund basic as well as translational research, to identify new approaches and new partnerships, to show us all how to take risks and demand accountability, and to work with and for the overall research enterprise. And — perhaps most important of all — commit to giving confidence to young scientists that their work is valued and will be sustained.

There’s no question about it: We all play a role in achieving better health and quality of life, very much including those who volunteer to participate in clinical trials. We are proud to spread the word about a new campaign initiated by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum (NMQF). The “I’m In” campaign aims to increase diversity in clinical trials and give patients the opportunity to connect with trials in their communities. Research!America polling shows that while Americans are interested in clinical trials, levels of participation are low, especially among African-American, Asian and Hispanic populations. Advancing medical progress means participating! Our newly released America Speaks, Volume 14 poll data summary booklet includes relevant information on public attitudes about clinical trials.

One time-sensitive way you can exercise your responsibility for advancing medical progress is by asking your representatives in Washington to join the chorus of legislators who support strong, continued funding for research. Members of the House and Senate have the opportunity to share their priorities with the appropriations committees until April 4. Send a note to your representatives urging them to submit appropriations requests that support robust medical research funding in FY15.

Finally, I encourage you to review our just-released 2013 Annual Report, which thanks all our members and supporters — you! — for working with us to inform and engage policy makers, media and the public.

Sincerely,

Mary Woolley

What would it take to achieve a cancer-free world?

Excerpt of an article by Research!America VP of Communications Suzanne Ffolkes and Communications Specialist Anna Briseno, published in Elsevier Connect.

A panel hosted by Research!America and the Pancreatic Cancer Action Network discusses challenges and opportunities for advancing cancer research

RA_PANCAN_PanelistsJulie Fleshman’s journey to improve outcomes for pancreatic cancer patients was inspired by her father, who died four months after receiving the diagnosis. That was in 1999. Since then, she’s been advocating for research to support early diagnosis and better treatments.

“That passion drives me every day – anger mixed with hope and optimism of the future,” she said.

Fleshman, President and CEO of the Pancreatic Cancer Action Network (PanCAN), made her remarks on a panel at the New York Academy of Sciences February 27.

Thought leaders from industry, academia, health economics and patient advocacy discussed challenges and opportunities for advancing cancer research and the prospects for a future where cancers are rendered manageable or even eradicated. They examined various aspects of cancer research and patient advocacy from a regulatory, policy and clinical standpoint. They spoke of the challenges posed by regulatory barriers and the role of advocates in fostering medical innovation. And they said there was critical need for collaboration among all stakeholders – including representatives from pharma, medicine, academia, the government and patient organizations – to accelerate medical progress.

The event – called A World Free from Cancer: A Road Paved with Medical Innovation – was hosted by Research!America and PANCAN.

Fleshman began the discussion by talking about the rise of the patient advocate who plays “an extremely important role in helping to change outcomes and … raise the awareness in the public, which drives public and private dollars and moves Congress to action.”

Laurie MacCaskill, a seven-year pancreatic cancer survivor, agreed. “Luck shouldn’t play a role in why I’m alive,” she said.

Dr. Amy Abernethy suggested that society should work toward better matching treatments and patients so resources aren’t wasted. She highlighted the need for extensive risk and benefit analysis to maximize opportunities for improved healthcare delivery.

MacCaskill agreed, noting it’s important for cancer patients to know what treatment options are available that best suit their needs. She said stakeholders need to work together to develop solutions that increase access.

Read the full article here.

A Weekly Advocacy Message from Mary Woolley: Finally, tax policy is on the agenda

Dear Research Advocate:

What will determine the speed and scope of medical progress in the years to come? There is more to it than the essential ingredients of money and brainpower.

Sound tax policy is essential if we are to propel medical progress.

Yesterday, Rep. Dave Camp (R-MI-04), chairman of the House Ways and Means Committee, introduced a comprehensive tax reform bill. While the prospects for passage during this election year are — to put a positive spin on it — uncertain, Congressman Camp laid down the gauntlet for much-needed tax and entitlement reform, and he also proposed making the R&D tax credit permanent. Uncertainty surrounding future access to the R&D tax credit has reduced its power to drive private sector R&D investment. While the Camp bill does not contain the ideal package of changes needed to optimize the usefulness of the credit, and in fact contains some potential setbacks, his decision to support making the R&D tax credit permanent sets the stage for finally achieving this long-standing goal.

Scientists, physicians and patients must all work to increase clinical trial participation.

In a recent Washington Post op-ed, a personal hero of mine, former Surgeon General and CDC Director David Satcher, MD, discusses the importance of African-Americans contributing to medical progress by participating in clinical research. Using Alzheimer’s disease as a lens, he argues that adequate research funding is not the only imperative; individuals must be willing to volunteer for clinical trials. Participation is especially valuable for racial and ethnic groups who have much to gain as health disparities persist, but who understandably remember mistreatment in trials in the past. Polling commissioned by Research!America has affirmed this lack of trust but also, importantly, has revealed that African-Americans in particular say they want to help others by participating in trials. We also learned from our polls that most Americans, across all demographics, look to their physicians to be the touchpoint for learning about clinical trial participation.

Improved scientist engagement with the public and policy makers is essential.

Medical research stands a better chance of becoming a higher national priority if people can connect meaningfully to scientists. As Alan Alda said at the annual AAAS meeting last week, and in an interview with Claudia Dreifus in The New York Times, “How are scientists going to get money from policy makers if our leaders and legislators can’t understand what they do?” He and his colleagues at the Alan Alda Center for Communicating Science at Stony Brook use of the some of the same approaches we do to help the science community connect with non-scientists in ways that can truly move mountains. Alda adds a passion for science with dramatic talent for a skill set we can all learn from.

Media attention — old school and new school — is key.

Both traditional and social media play a role in the fate of U.S. medical progress because of their ability to call public and policy maker attention to possibilities and stumbling blocks. Research!America and the Pancreatic Cancer Action Network hosted a media luncheon today to discuss the challenges involved in turning cancer, in all its insidious forms, into a manageable chronic condition. It was reinforced to us that journalists’ questions are good markers of questions the public in general are raising; it’s important for scientists and advocates to listen and respond. Sometimes we fall into the pattern of just repeating our own messages louder and louder, but we should instead step back and listen to the sometimes-challenging questions being raised by media as they seek to inform the public. All of us who care about the future of research for health should seek out opportunities to engage with journalists. Contact us for suggestions on how to get started!

Sincerely,

Mary Woolley

More African Americans need to participate in clinical trials

Excerpt of an op-ed by David Satcher, MD, PhD, honorary chairman of the African American Network Against Alzheimer’s, former U.S. surgeon general and Research!America’s 2007 Raymond and Beverly Sackler Award for Sustained National Leadership award winner, published in The Washington Post.

DavidSatcher1Every February our society measures its progress in the march toward equality as part of Black History Month. But seldom do we discuss inequality in health, an injustice that continues to plague African Americans.

A whole host of health disparities remains unaddressed, including Alz­heimer’s — a disease that African Americans are two to three times more likely to develop than non-Hispanic whites. This disparity is rooted as much in our cultural heritage as in our genes.

For years, studies have found that African Americans have a profound mistrust of doctors and scientists. Consequently, we participate in clinical trials at far lower rates than other ethnic groups, which helps to perpetuate the sort of disparities seen with diseases such as Alzheimer’s. This fear of clinical trials dates to a dark chapter in our shared history: the Tuskegee syphilis experiments.

The Tuskegee study was an infamous clinical experiment in which researchers and the U.S. Public Health Service led African American men with syphilis to believe that they were receiving free medical care while, unbeknown to them, they were being left untreated so scientists could study the effects of prolonged syphilis. After the Associated Press exposed the truth, sparking a public outcry, the U.S. government ended the study in 1972, 40 years after it began.

The 1974 National Research Act set new guidelines for the use of humans in clinical studies. In 1997, the Clinton administration worked with higher education institutions to usher in new training requirements and ethical standards for physicians, researchers and medical students as part of an official apology President Bill Clinton issued on behalf of the nation to the victims of the experiments. While these standards go a long way toward helping to prevent future such experiments, much damage was already done among African Americans.

Read the full op-ed here.

A Weekly Advocacy Message from Mary Woolley: Does Congress care if Nobel laureates of the future are put at risk?

Dear Research Advocate:

Like most Americans, we are alarmed by the ongoing government shutdown. Since the shutdown began, I have been in Georgia, Massachusetts and Ohio, speaking to business and academic leaders, state and local elected officials, philanthropic leaders, and working scientists. Everyone is outraged! Clearly, biomedical and health research — already compromised via sequestration — is not the only priority placed at risk by the impasse, but it is a critical one. From limiting access to clinical trials to undermining the ability to protect our food supply or investigate disease outbreaks, Americans are put at unnecessary risk when government employees are furloughed. We sent letters at the end of last week to Members of Congress and the president, urging action. We received responses from offices on both sides of the aisle: Many spoke passionately of their support for medical research; some hewed the party line; others lamented the budget impasse.

We are doing everything we can to keep the spotlight on the damage done to medical and health research when the government is shut down. When the public and its policy makers look back on the 2013 shutdown, we want them to remember which government functions most tellingly exemplified the cost — fiscal and societal — our nation incurs when the ability to function is derailed. Continue reading →

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 →

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: Dispelling a Few Myths

Dear Research Advocate:

Myth #1: Congress doesn’t pay attention during the August recess. Not true! Many town hall meetings are planned. Since the debt ceiling and appropriations negotiations are coming up in September, the August recess is actually a very important time for advocacy. Use this month to drive the point home that medical research should not be subjected to budget cuts by attending a town hall meeting, meeting with district staff and participating in our social media campaign, #curesnotcuts. Click here for sample messages, or draw from a recent op-ed penned by The Honorable John Edward Porter, Research!America chair. The op-ed ran in several McClatchy-Tribune newspapers across the country last weekend. In it, he highlights the dangers that indiscriminate budget cuts pose to our medical and health research ecosystem.

Myth #2: It makes no difference when scientists speak out. On the contrary, one of the most effective strategies for promoting and protecting research is public engagement by scientists. It may seem like a waste of time or an unjustifiable obligation, but if scientists don’t speak up about their work, the funding that allows that work may evaporate. In a recent entry on his website, David Eagleman, a PhD researcher who recently received an award from the Society for Neuroscience, makes the case that the benefits (such as inspiring critical thinkers, stemming the flow of bad information, informing public policy and more) clearly outweigh the cost of time to engage in outreach and advocacy. For those ready to engage, some important points and valuable tips on how to communicate clearly and effectively were highlighted in yesterday’s Nature blog. Research!America Board member and AAAS CEO Alan Leshner is among the experts quoted. 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 →

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 →