By Israel Rocha, CEO, Doctors Hospital at Renaissance
September 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.
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 →
Excerpt of a blog post by Dr. Tom Insel, Director of the National Institute of Mental Health.
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.
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 →