FastTrack Summer Issue Just Released

Be sure to check out the just released summer issue of FastTrack, FasterCures' quarterly electronic newsletter. We welcome your comments and suggestions for future issues of FastTrack.

Candidates: Can we talk about your medical research platforms?

by Margaret Anderson, COO, FasterCures

Over the next two and a half months, the two presidential candidates will have endless opportunities to give the American public specifics on their platforms. With several competing priorities vying for their attention, it seems hard to imagine that there will be much airplay for the importance of and challenges for medical research. Why is this?

One reason might be America’s low level of scientific literacy. A 2007 Harris Interactive survey of 1,304 adults found that only 26 percent believe that they themselves have a good understanding of science, and 44 percent couldn’t name a single scientist, living or dead, that they’d consider a role model for our young people. But this does not mean Americans do not care about science. In fact, another Harris poll found that 85 percent of Americans want a presidential debate on science. Maybe Americans are leaving the medical research discussions to “those” people who are in the know.

Another reason could be that medical research doesn’t rise up your priority list until your health is personally affected. We know that we’ll all be patients, some day, but if you are not yet a patient, why worry, right? People also probably don’t realize the continuum of how we get from basic research to clinical research to therapies. But as the baby boomers age, the issue of how close we are to cures continues to take on new and more important meaning.

No matter what the reason, the fact remains that Americans need to hear more than just the specifics of the health care reform platforms that focus mainly on economic issues. They need to hear about a care– to–cure platform, and our nation’s leaders need to answer the question Michael J. Fox posed, “Who is in charge of finding cures?” The list of challenges is long: flat funding for NIH, concerns about retaining the next generation of researchers, questions about the appropriate balance between basic and translational research at the, low levels of funding for FDA, inability to get the Reagan-Udall Foundation off the ground because of political games, need for research to be included in discussions of electronic health records...the list goes on.

We are part of ongoing discussions with many organizations about these issues and have several initiatives to address these problems. We are one of the partners supporting Research!America's voter education initiative Your Candidates. Your Health, which highlights presidential and congressional candidates' positions on health and research.

We welcome your thoughts on how to shift the debate from one focused on health care to one encompassing care and cures.

FasterCures' Ten to Watch Mid-Year Review

by Greg Simon, President, FasterCures

FasterCures started the year with its Ten to Watch in 2008. Before summer's end, we wanted to share some of our insights on the ten things we've been watching (other than the Olympics) and how they are faring.

1. Return on philanthropy. This fall, FasterCures will preview its Philanthropy Advisory Service, which will help philanthropists decide where their contributions will have the greatest Return on Philanthropy – the greatest impact in finding new cures. The Gates and Robert Wood Johnson Foundations are supporting this effort to create an information marketplace to improve the efficiency and productivity of both the philanthropic investor and the nonprofit disease research organizations that depend on such support. Watch this space for updates.

2. The FDA. It hasn’t been a great year for FDA. In the first half of 2008 alone, the agency had to deal with contaminated heparin from China, salmonella-tainted jalapenos from Mexico, and a Supreme Court decision that has made it a shield protecting medical device manufacturers from lawsuits by patients. The silver lining is that all this bad news is focusing attention on the agency’s critical importance and woeful lack of resources. FDA chief Andy von Eschenbach even broke ranks with the Administration and confessed that the agency needs a larger budget than requested to do its job. But it needs more than that, starting with Congressional leadership that supports it constructively rather than attacking and denigrating it. A key step would be to fund the Reagan-Udall Foundation, and realize FDA’s Critical Path initiative.

3. Research: Lost in translation. The call for more translational research is now coming from a wider range of stakeholders, including interesting messengers such as Katie Couric. In a recent interview about the September 5, 2008 Stand Up To Cancer fundraising effort on “Larry King Live,” Couric said that its focus will be supporting research that has practical applications and patient-relevant outcomes. She noted that the funding will be"...focusing on cutting edge cancer research, which will hopefully inform people about how close we are to new therapies and new approaches and how…scientists need additional funding so these can go from the lab to the clinic and hopefully, eventually, save a lot of lives.”

4. Science 2.0. On June 3rd, members of FasterCures’ TRAIN network of disease research foundations spent some time with two innovators in the use of online platforms for scientific collaboration. June Kinoshita, Executive Editor of Alzheimer Research Forum, a pioneering e-community for Alzheimer’s researchers, is currently working on an ambitious project called Semantic Web Applications in Neuromedicine (SWAN), which will create a common semantic framework to allow researchers to more quickly and seamlessly integrate and combine data from diverse sources rather than just exchange documents. Jeff Shrager, Chief Technology Officer of CollabRx, demonstrated its product – a “virtual biotech,” a Web-based collaborative research platform that would enable funding organizations and research teams to manage, track, and prioritize their operations as well as to share data, knowledge, resources, and services. CollabRx is also working with Science Commons on its Health Commons initiative, which envisions a virtual marketplace or ecosystem where participants share data, knowledge, materials and services to accelerate research.

5. Crowd-sourcing innovation. FasterCures is seeking to benefit from the “wisdom of the crowd” by posting an “ideation challenge” on InnoCentive’s Web site this fall, as one of the company’s first “Public Policy and Citizens in Action” challenges seeking solutions to important issues facing society. The New York Times reported in July how this approach is “catching on…as would-be innovators can sign up online to compete for prizes for feats as diverse as landing on the Moon and inventing artificial meat....” Keep an eye out for more details – maybe you’ll have some ideas to offer and potentially win the prize!

6. Prize philanthropy. Top-down prizes are getting a lot of attention this year, not only by the press but by politicians. A panel appointed by the National Research Council recommended that the National Science Foundation offer prizes of $200,000 to $2 million in various areas of science to encourage innovation. Two weeks ago, The Wall Street Journal challenged political and business leaders to outline how they’d spend $10 billion in four years to address global problems. Newt Gingrich proposed the development and diffusion of new technologies by using large, tax-free prizes, arguing that prizes would be a useful experiment in large-scale breakthroughs.

7. Biomarkers Consortium. The Biomarkers Consortium public-private partnership has taken the interesting step of identifying “High Impact Biomarkers Opportunities.” Rather than be, essentially, investigator-driven and wait for participants (industry, academia, foundations) to walk in the door with good ideas, the Foundation for the NIH has chosen to develop this more strategic and prescriptive path, laying out projects that it believes “will have the greatest and most proximal impact on future diagnosis and treatment of patients and drug development.” We will continue to watch with interest to see if this effort proves to be an effective way of addressing the “first-mover disadvantage” in biomarker research and validation – i.e., the first mover spends all money and its competitors get the advantage of the biomarker.

8. Comparative effectiveness. The healthcare reform drumbeat is getting louder -- and much of the call for change is focused on the need for more cost effective and efficient approaches to our nation’s healthcare woes. Despite the buzz around comparative effectiveness, it’s important to note that both presidential nominees recognize that this issue is more complex than it may appear. In response to a question on the issue posed by the “Your Candidates - Your Health” program (of which FasterCures is a sponsor), Sen. McCain said we need “to ensure that [this] does not stifle the spirit of innovation,” and Sen. Obama cautions that the “decision on which treatment to use should be made by patients and doctors, not government or insurance companies.”

9. Electronic health records (EHRs). As the federal government muddles through its continuing effort to figure out what its role in the development of the “healthcare information superhighway” should be, there are at least small signs that it might be waking up to the importance of factoring research uses of EHRs into their plans. FasterCures recently joined a panel of research leaders that called on the group charged with creating the successor to the American Health Information Community to expand its scope and mesh data standards for medical research with its work on standards for e-health records. The group said it would consider how best to do that. Meanwhile, the FDA has launched its Sentinel initiative to better monitor medical product safety, a massive effort that will involve using existing electronic health records for post-marketing surveillance of approved drugs.

10. Clinical trials: Something’s gotta give. The discovery enterprise is calling for revolutionary change in how we conduct clinical trials. The NIH is studying how to accelerate and improve the conduct of clinical trials at its own Clinical Center, which could provide useful information and models to other trial sponsors. The Pioneer Portfolio of the Robert Wood Johnson Foundation (which supports FasterCures’ Philanthropy Advisory Service project) has made its largest grant to build ARCHeS, a Web-based interface and delivery system that will allow far more health and policy decision-makers to use the Archimedes simulation model – a sophisticated database that some believe could be used to radically streamline the design and simulation of clinical trials. This is definitely an area worthy of focused attention by the next President.

August Days

by Greg Simon, President, FasterCures

This August my days are focused on preparing to send my first born to college. Seven years ago this week, I was focused on a very different journey -- my father’s passage from this life at the age of 91 after a short struggle with small cell lung cancer. He died on August 27, 2001, a date notable because it spared him in his last days the trauma of seeing the calling card of 21st Century terrorism on September 11 that year.

I have thought often of my father’s death in the context of my work at FasterCures. He was a model of “compressed morbidity” – living long and dying quickly, rather than fading out over many years. He changed his behavior after a small heart attack in his fifties, brought on no doubt by smoking which he promptly quit. He walked home from his grocery store on Main Street every day for lunch and a nap. He ate healthy food, didn’t drink, and – in addition to the walking commute to the store – exercised by shadow boxing in front of the bathroom mirror every morning.

Despite his personal good habits, he became a victim of the healthcare system of small town America. When he complained about “tingling” in his legs, his doctor gave him Valium to which he promptly became addicted to the point of needing sleeping pills at night since he was medicated all day. When my sister and I discovered this we intervened to switch him to Motrin gradually until finally he didn’t need the Valium. A few months later on another doctor’s visit, the same doctor put him back on Valium.

The few times in his later years he was admitted to the hospital for minor operations, he was given Demerol which causes you to go psychotic if you are on Valium. But, of course, in those days of paper records (these days too, I should point out), the hospital didn’t know or negligently failed to notice or care that he was on Valium. They found out when orderlies had to chase him down the hall, trailing his feeding tubes, to get him back to bed. I once had to block him from trying to walk through a wall in his hospital room to what he thought was his dining room at home.

His cancer diagnosis brought a completely different set of challenges. First, it was amazing he was diagnosed at all. There were no oncologists in Blytheville, Arkansas then. Two doctors came over from Memphis twice a week on Tuesdays and Thursdays. As I testified at Sen. Kennedy’s hearing on cancer several months ago (before his own diagnosis), in Blytheville, you could only get cancer on Tuesday or Thursday. But with the diagnosis came the Scylla and Charybdis – chemo or radiation, since that was what the two doctors offered.

How was a patient 91 years old living in a small town supposed to make that decision? Fortunately my father knew people who knew people – that would be me. I called Al Rabson at the National Cancer Institute who was well-known in Washington for offering helpful advice on such matters. He reviewed my father’s records and X-Rays, reviewed the two doctors and their training and gave me the news. My father would die from this cancer but he did not need to be in pain, so skip the chemo, focus on radiation to keep the lungs clear enough to avoid pneumonia and enjoy the last months as much as possible.

Of course, giving effective pain medications to someone who has been addicted to Valium for years is not easy. We went through “pain patches,” Oxycontin and finally morphine. After six months, my father slipped into a coma which gave him release from the pain. After a few days, the hospice nurse – a most miraculous find in my small home town – told us “Your father is going to die in the next thirty minutes.” And as my mother and sister and I sat there, we experienced that ineffable but palpable difference when the quick becomes the dead.

I have often thought how different his death would have been if he and my mother had been on their own. How confused they would have been in dealing with the cancer; how painful the end could have become. I have thought too how strong he must have been to survive the bad medical care he received all his life in the Arkansas Delta and to still live to be 91.

It is simply not acceptable or tolerable that we still are killing people with medication errors in hospitals (both by giving them the wrong drug or by giving the “right” drug to the wrong person). It is inexcusable that the best cancer care is still available primarily only to people who know people – no matter how many people those people, including me, try to help.

My father didn’t live to see me launch FasterCures with Mike Milken five years ago. But his life and the circumstances of his leaving it launched me on this path and live with me every day. Through our work I hope we can improve the lives of people who don’t know people, of people who live in places where you can get cancer only on Tuesdays, and of people whose desires to live a full life and avoid a long, painful decline into death depends on the kindness of strangers.

Electronic Health Records: Linking the Care and Cure Communities

by Cecilia Arradaza, Communications Director, FasterCures

"When you go visit your doctor, only three people know what happens during
that visit: you, your doctor, and your insurance agent. None of these people are
responsible for finding a cure for your disease…and none of them are necessarily
connected to the people working to find a cure for your disease… How do we
integrate the care community with the cure community?" -- Greg Simon,
FasterCures President, in remarks to the American Health Information Community, 7/29/2008

Greg joined an expert panel of medical research leaders and advocates recently to call on the American Health Information Community (AHIC) to ensure that the nationwide health information system being built can improve patient care and enable medical research.

In the ongoing discussion surrounding the creation of a national health information technology (IT) system, medical research lurks in the shadows of privacy and interoperability. At the AHIC meeting at the end of July, the medical research community made a resounding call for AHIC or its successor organization to put in place a supplemental process to ensure that the nation’s health IT system is built to improve both healthcare delivery and medical research – and to do so quickly. See coverage of the AHIC meeting.

Ensuring utmost privacy protections and efficient interoperability capabilities are critical to the success and sustainability of a health IT system. As we build the system’s infrastructure, it is just as critical to consider how best to utilize patient data to improve healthcare delivery, enable medical research, and accelerate cures.

There will be new opportunities for health information exchange to support clinical research activities as electronic health record (EHR) adoption increases and a national standardized system evolves. Incorporating medical research into a national health IT system is inevitable. As AHIC transitions into its next entity, it has an important choice to make: to implement a health IT system that protects privacy and ensures operability now, only to rebuild that system to better support medical research OR; to implement a comprehensive, interoperable health IT system with the highest privacy standards and a strong research capacity already in place.

FasterCures believes accelerating cures must be a goal of the emerging Nationwide Health Information Network in addition to improving patient care. While the focus of most efforts to do so has been on improving care by limiting costs and medical errors, the real savings, in terms of both reducing healthcare costs and, more importantly, in eliminating human suffering, will come from curing disease and from limiting its damage.

Related Blogs: Health IT's Real Savings
More information on FasterCures recommendations for using EHRs to bridge patient care and research