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Program - By Health Track:

Monday, April 23, 2007

  10:15 AM - 11:30 AM

Patients Helping Doctors: Raising Clinical Trials Awareness

Speakers:
Courtney Hudson , CEO and Founder, EmergingMed
Howard Soule , Executive Vice President, Discovery and Translation, Prostate Cancer Foundation; Senior Fellow, Milken Institute
John Walsh , Co-Founder, CEO and President, Alpha-1 Foundation

Moderator:
Margaret Anderson , Chief Operating Officer, FasterCures / The Center for Accelerating Medical Solutions

Representing varying organizations, the three panelists and moderator all supported a common mission: to engage patients in clinical trials in efforts to advance treatment and prognosis associated with cancer and other chronic diseases.

This is no simple task. While there are several reasons to explain the lack of participation in clinical trials, there is little clarity as to why only modest progress has been made to increase the level of patient participation. Margaret Anderson of FasterCures opened the conversation by speaking of the difficult challenge to recruit and retain patients for trials and cited the startling statistic that only 4 percent of adults diagnosed with cancer enter a clinical trial. The subsequent conversation focused on why clinical trials are a necessity for the advancement of medicine, the factors keeping patients from participating in trials and potential solutions to this industry-wide problem.

"Medicine stands still without trials," warned Howard Soule of the Prostrate Cancer Foundation.

Defining a trial as something that "may not help you but may help others down the road," Anderson related the need for trials to her own experience. Her father participated in leukemia trials after receiving a three- to six-month life expectancy. That participation gave his disease meaning, even though he passed away at the six-month mark. "What is not to be forgotten," she noted, "is the need to go back and recognize people who give because we are all going to benefit, some times at the expense of the participant." In this instance, she was referring to her mother, who supported and enabled her father's participation in the studies.

Despite the apparent benefits of clinical trials, several factors remain impediments to patient participation. A reoccurring theme was the communication gap between physicians and patients. As Anderson stated, "if physicians don′t talk to patients about trials, then the opportunity is missed," The system needs to be patient-driven, she said, which means it must be kept simple and inherently trustworthy. Further, according to Courtney Hudson of EmergingMed, "patients already think they're getting the best medicine available, and they can't imagine that there are doctors who don't talk to each other. Most patients diagnosed with cancer have no idea how many doctors and specialists can add to their knowledge base and situation.

EmergingMed, a 7-year old organization has a solution: the company has created a system in which every patient entering partner sites is screened and entered into a database for future assessment of appropriate trials. The goal is to address the lack of accuracy in government databases, in which 50 percent of the information has been proved incorrect. EmergingMed's philosophy is that if you don't start early, it's too late, because most people exhaust all other options and only then consider clinical trials. As clinical trials are based on standard of care, it can be a two-year delay between the observation of results from a trial and FDA drug or treatment approval. Hudson stated that "getting in early, keeping workload off doctors and nurses are key to success in this."

Communication and reliability of the clinical trial process are also big issues. Although prostrate cancer is considered treatable and curable, 24,000 males exhaust all the primary therapies and run out of other alternatives annually. It is exactly this group that needs to participate in trials. The problem is often that complicated medical and economic issues interfere with trials prior to patients having knowledge of the design or expected benefits of the trial.

In response, a clinical trial consortium or "one-stop-shopping scenario for clinical trials" in the prostrate cancer space has been established, whereby no trial occurs without clearing a coordination center at Sloan-Kettering. The group streamlines the protocols, tools and contracts, and will reject proposed trials that do not meet stringent criteria. According to Soule, 27 of 35 ideas have been approved and turned into protocols. Further, 100 percent of the initial sites are leading at least one of these trials. Soule attributed the success to a very scientific approach that "makes sure very early on that the trial is well conceived and creates a sustainable model that will speed the development of drugs."

A third barrier to patient participation is that placebo-controlled trials were viewed to be a difficult sell for individuals. The panelists agreed that the trial can become a more palatable option for the patient if given the option to cross into the active part of the trial, once the drug is proven to be effective.

Overall, the impediments associated with clinical trials are abundant, and the panelists conceded that it will take a revamp of the health-care system to implement change. Common technology, systems and templates, which do not currently exist, are needed to create efficiency and trust in the clinical trial process. Soule called the lack of an integrated system "as much of a sociology problem as a technology problem." The medical research field is very personalized but lacks basic computer literacy skills, he noted. Health-care workers need to develop technical skills in order to establish electronic health records necessary to improve the clinical trial process.

Further, trials are slow to accrue because they are often poorly designed. The development process is broken -- government bureaucracy is horrendous, taking two years to get a trial started. In addition to being cumbersome, the system is not currently economical and most trials don′t break even on cost. Navigating around both the economic and logistical issues is a major deterrent for corporations. In response, many drug companies are running trials in Asia, where the process is both cheaper and more streamlined.

In summary, the problem of limited patient participation in clinical trials is far from resolved. To solve the problem, increased patient/doctor communication, technological advancements across the industry, and improved cost and efficiency are essential.

And John Walsh of Alpha-1 Foundation stated that "there is a need to put the National Institute of Health′s feet to the fire to engage patients with diseases in the clinical process -- they currently are not focused on engaging the patient, who is ultimately necessary to do clinical research."

  2:00 PM - 3:15 PM

Good Health Is Good Business: Board Room Edition

Speaker:
Martin Olson , Senior Vice President, Research, Development and Informatics, Matria Healthcare

The increased burden of health costs has created a need for integration across a range of services, as well as at the individual level, noted Ron Loeppke, M.D., who opened the panel with a discussion of the converging trends in health care that are affecting employers. The health of the work force, he said, is linked to the health of the business. As a result, there has been a recent upsurge in interest around integrating population health and productivity enhancement. Further, the emphasis has been beyond typical care management and into prevention and wellness.

Employers' whole-health productivity costs average three dollars in productivity loss for every dollar spent on medical pharmacy costs. In response to this statistic, a Harvard/HPQ survey was conducted to evaluate what is driving employer health-care costs when presenteeism and absenteeism are combined. The survey also looked at the relationship between workplace productivity and health risks, as 61 percent of respondents believe that there is a strong link between the health of the work force and the bottom line of the company.

Health risks are segmented into two categories: lifestyle and disease management. While historically most of the emphasis has been placed on mitigating disease management risks, improvement in lifestyle has proved to be an area in which increased attention needs to be placed. Annually, more than 900,000 deaths are premature and attributable to such unhealthy lifestyle choices as tobacco, poor diet and lack of exercise. According to Loeppke, "prevention is an investment that ought to be leveraged -- it's not a cost that needs to be justified." The total population enhancement approach that he presented addressed just this, the need to look beyond the 15 percent of people with complex health-care problems, and work with the other 85 percent, as well. The approach focuses on wellness and lifestyle programs, in addition to disease management.

Closing the quality gaps in health-care services is the first step in lower productivity costs. The panelists agreed that integration is key because poor quality in health care ultimately drives higher costs to both employers and employees. Over one-third of employer money spent on health care is a result of medical mistakes, preventable drug interactions, misprescribed medication and unnecessary surgery. One reason for the low quality of service is that patients are not evaluating physicians. On average, Americans receive evidence-based care only half the time. For diabetes patients, this number is 45 percent and, as Loeppke referenced, this creates a "big opportunity to improve the quality, and therefore the impact, on cost in this country."

Two case studies were presented to demonstrate the productivity gains associate with building a culture of health and developing lifestyle enhancement initiatives within companies. In a CDC Cornell study, researchers observed a company with 58,000 employees had lost 27.43 days of productivity per full-time employee per year. The company implemented initiatives, such as such as cash incentives to take a health-care assessment and participate in health enhancement and education programs in order to build a culture of health. The results were impressive: the health status of employees improved by 9 percent from 2005 to 2006, as evaluated by a health-care assessment. This was largely due to improvement in nutrition, physical activity, stress management and metabolic syndrome. The economic benefit to the company was also apparent; the population segments involved in the company′s health programs saw a 30 percent reduction in medical and pharmacy costs compared to those not in programs. In total, the benefit to EBITDA was $2.5 billion in annual savings.

A second case study presented by Martin Olson of Matria Healthcare indicated savings of $14 million per member per month (PMPM) through implementation of similar initiatives. The study applied a seven-segment analysis and looked at the company population based on employees with no risk, unknown risk and total risk. Total risk was then broken into lifestyle risk and disease management risk (DM). Initiatives targeted at reducing lifestyle risks have high costs initially, but the savings in DM risk were more than $6 million. For employees with DM risks, emergency room visits decreased by 15 percent and hospitalizations decreased by 22 percent. Olson indicated that the company can then drill down into the data to understand the result in dollars and increased productivity.

In summary, it is necessary to incur the upfront costs to improve lifestyle, with the economic benefit to be realized in the future. People classified as "no risk" today are not spending a lot of dollars but are spending considerable money later on, which is why it is necessary for companies to invest in lifestyle and prevention programs. Olson noted that "an ounce of prevention is going to be worth a pound of cure, but it's not today -- it is going to take time to develop."

  3:25 PM - 4:40 PM

Global Health

Speakers:
Seth Berkley , President and CEO, International AIDS Vaccine Initiative
William Frist , Former Majority Leader, U.S. Senate
Helene Gayle , President and CEO, CARE USA
Leslie Mancuso , President and CEO, JHPIEGO

Moderator:
Bachi Karkaria , Consulting Editor and Columnist, The Times of India

Moderator Bachi Karkaria, a consulting editor for The Times of India started the session with the statement that "health is everyone′s individual concern, but health with a capital H seems to be no one's concern."

To address this statement, the diverse panel, representing various policy, vaccine and international health organizations, discussed key issues facing global health today.

The challenge of health system capacity building was a major focus of discussion. Leslie Mancuso, president and CEO of JHPIEGO, stated that there is a clear problem in the lack of human capacity development in developing countries, specifically in their ability to take care of and plan for future public health issues. These include the issues of proper education, research and public health deployment in addressing global health issues.

A clear example of the lack of capacity building both in the United States and abroad is present in nursing schools. U.S. nursing schools are not given enough incentives to train nurses locally, she claimed, and instead poach nurses from other countries, thus taking these skilled workers from countries that also need them. Helene Gayle, president and CEO of CARE USA, pointed out that each country needs to build its own system by working with nurses to give them the proper incentives and resources to stay in their home countries. Mancuso added that countries should retain the health-care talent they have and realize that the nurses don't leave for salary reasons alone. For example, some nurses feel that infection control is important; each developing country must look at its own nurses and their issues, and adapt accordingly.

On the issue of whether single organizations can build the appropriate human capacity or whether a global body would be needed to do so, Seth Berkley, president and CEO of International AIDS Vaccine Initiative, argued that the challenge really is thinking that a global body will solve such problems without having solutions that connect to local needs. He emphasizes that both leadership and health-care models much be local to be effective. Gayle added that a global body, such as the WHO, should support efforts of country-led leadership, but not pose the solutions itself.

With the need of capacity building, moderator Karkaria asked what kinds of innovations both financial and technological, have helped to improve global health. Berkeley discussed the importance of developing new connections between public-private practices and stressed that the innovations should focus on speed and efficiency, and not politics. Getting the appropriate people engaged in the issues, he said, would depend on innovation financing mechanisms.

Sen. William Frist, the only physician in the U.S. Senate, gave an example of a technology innovation that has changed the way HIV is dealt with. In the past, HIV test results took too long to obtain and patients who feared the stigma of the disease would leave before the physicians could discuss their results and treatment options. These days, with rapid and nanotechnology, physicians are able to gain a "teachable moment" and provide results in a short period of time. The new technologies, he said, "revolutionize the capacity issue," as patients, even in developing countries, can get their health results easily.

Mancuso added that similar technology advances have improved cervical cancer treatments in developing countries. The next step, she said, is to scale up these technologies for the populations that need it the most. "Ideally we don′t want to treat," added Berkeley, "we want to prevent."

To put into perspective why global health is important from a business aspect, Sen. Frist illustrated what would happen if the United States had an avian flu (H5NI) pandemic. A three-month pandemic would cut the U.S. economy by $675 billion, which is a 5 percent reduction in GDP.

The panelists concluded with the agreement that all leaders need to look ahead and have a truly long-term vision for the future. Berkeley stated that the challenge is to get a whole health system in place that will be sustainable over time. This system would need to make system-wide changes by working with local leaders to address local issues. Only then will global health head toward an integrated system.

Tuesday, April 24, 2007

  9:25 AM - 10:40 AM

Your Health Care: Getting Through the Maze

Speakers:
Marc Hoffing , Medical Director, Desert Medical Group and Oasis IPA
Glenn Melnick , Professor and Blue Cross of California Chair in Health Care Finance, University of Southern California; Senior Economist, RAND
Robert O'Keefe , CEO, Coastal Communities Physician Network
Gordon Yenokida , Chief Operations Officer, Regal Medical Group

Moderator:
Richard Merkin , CEO and Founder, Heritage Provider Network; FasterCures Board Member

Moderator Richard Merkin of Heritage Provider Network opened this panel with two challenges to his panelists: first, to open the "black box" that health care represents to most Americans and make it transparent. And second, to address ways to lower health-care costs.

Glenn Melnick, a professor at the University of Southern California, noted that in the past year, the nation has seen a 9 percent increase in premiums. Standard health insurance is based on the idea of fee-for-service reimbursement, which means it rewards physicians who perform more tests, prescribe more treatments. In fact, he asserted, many practices are revenue-motivated, and this is a factor in the rise in health-care costs. For example, hospital committees may insist on keeping patients in ICUs -- patients who have no hope for recovery. Such decisions can cost up to $5 million or $6 million per case.

"Lowering costs and improving quality of care may be a nationwide solution" to the problem from the economic perspective, said Melnick.

Marc Hoffing with Desert Medical Group and Oasis IPA explained that organization has come up with various ways to reduce health-care costs. One way is determining high-risk patients and assigning so-called case managers to them and their families. "We have built a system to respond to patients' needs," he said.

"In health care geography is destiny," added Hoffing. For instance, California patients usually spend only a few days in ICUs, while those in Florida may spend several weeks, even for similar conditions. An average hospital stay bill charges may run up to $10,000 or $11,000 per day. One way to reduce these expenses, he explained, is to perform necessary procedures when a patient is admitted to the hospital or, if admitted on Friday, to provide necessary care over the weekend.

Gordon Yenokida with Regal Medical Group agreed that there is a problem with fee-for-service principle. "When doctors are compensated based on the number of the procedures, and not their necessity," he said, "there takes place an over-utilization." Physicians need to start asking themselves if the tests they order are truly necessary.

Robert O'Keefe with Coastal Communities Physician Network provided information on the various programs his organization has implemented. For example, the program Choices helps develop reasonable expectations for patients and their families, including end-of-life options. He agreed that weekend procedures may be beneficial for hospitals. In fact, he stated, "28 percent of health-care costs can be saved by performing procedures on the weekends." O'Keefe also suggested that more can be done in outpatient settings and that hospitals could be used only as ICUs. All participants agreed that health-care system has to consider a variety of issues. As Merkin noted, health care "has to be integrated and led by physicians who can lead and can maintain their organizations with fiscal integrity." Switching from a fee-for-service reimbursement principle, they said, would help change the health-care system and provide higher quality of services and lowered costs.

  9:25 am - 10:40 am

Economic Burden of Chronic Disease: Avoidable Costs and Forgone Economic Growth
By invitation only

Moderator:
Ross DeVol , Executive Director, Economic Research, Milken Institute

In this session, the Milken Institute will preview preliminary results from a major research project. Each year, millions of Americans die or become disabled from chronic diseases, which takes an enormous toll on families and other loved ones. But less talked about is the toll these diseases take on business, government and the economy. This study will show how much chronic diseases cost our economy and how much could be gained if we improved people's health. The total economic burden of chronic disease includes not only the direct medical costs, but the forfeited growth in GDP and income. First-of-its kind elements of this research are estimates of longer-term reductions in economic growth due to morbidity/mortality and lower intergenerational investment in human and physical capital. We project, for the U.S. and all 50 states, how altering prevention (behavioral and other risk factors), early detection (screening and diagnosis) and innovations in treatment can reduce health-care system costs over time and improve economic growth.

This session is by "invitation only" and is limited to invited guests. If you are interested in attending, please send an e-mail request to jmeehan@milkeninstitute.org.

  9:25 AM - 10:40 AM

Financial Innovations Forum for Accelerating Medical Solutions

Speakers:
Mary Beth Borgwing , Senior Vice President, NY Life Sciences Practice Leader, Willis Group Holdings
James Heywood , CEO and d'Arbeloff Founding Director, ALS Therapy Development Foundation
Fredric Pashkow , Chief Medical Officer, Executive Vice President, Cardax Pharmaceuticals
Neil Sandler , Managing Director, Symphony Capital LLC
John Walsh , Co-Founder, CEO and President, Alpha-1 Foundation

Moderator:
Glenn Yago , Director, Capital Studies, Milken Institute

Health care is the single largest industry in the United States, with an estimated $1.9 trillion in expenditures. Spending for health-related issues is expected to grow in excess of 7 percent each year. In spite of suchheavy spending, a great deal of unmet need exists in the health field today. There are many more diseases than cures, with only about 10,000 of 30,000 diseases having treatments. In addition, millions of Americans remain uninsured or underinsured. On a positive note, health care's dramatic growth is fueling the increase in life sciences funding research and the number of public companies within the sector.

Although many variables are thought to affect medical solutions, this session was devoted to financial innovations driving medical solutions. Panelist James Heywood of the ALS Therapy Development Foundation explained how his brother's diagnosis with ALS shaped how he views the intersection between the financial and medical worlds. "I shifted the equation from a supply-side problem to demand-side problem," he said, from projects to process. This process involves determining what makes a drug, idea or company valuable. Consequently, his idea of accelerating medical solutions centered on an innovation designed to validate which idea is worthwhile.

Also inspired by a personal story, John Walsh of the Alpha-1 Foundation described how he and his brother were affected by the disease. Ironically, it was not the physical manifestations of the disease that were worrisome, but the fact that there was only one therapy, which was also in short supply. As a result, everyone receiving the therapy was under-treated. So he decided to invest in the infrastructure to hasten medical solutions. This investment, he added, has produced many successes: two new products licensed; three therapies in clinical trials; six therapies in clinical development pipeline; three innovative therapeutic pathways identified; and $28 million invested in research.

Much of the debate included discussion on pharmaceutical advancements, particularly drug discovery and development in the United States, where for the past 20 years there has been a commitment to combinatorial chemistry and high "throughput screening" (HTS). Panelist Fredric Pashkow of Cardax Pharmaceuticals supported the idea of focused drug design to move medical solutions forward through financial ideas. Unlike traditional HTS, focused drug design involves using fewer compounds and reducing preclinical development costs, which eliminated three years or more from the normal drug discovery trajectory.

In a discussion of ethics, panelist Pashkow underscored the importance of transparency and being connected to the best investigators in the field. "You must have trust, an inherently decent compound and a program that translates," he said. Also building on the notion of trust, panelist Neil Sandler of Symphony Capital LLC maintained that transactional trust is imperative to enhancing new discoveries. Mary Beth Borgwing of Willis Group Holdings spoke of the need to insure the risk of humans in clinical trials.

Pashkow suggested collaborating with foundations on drug discovery initiatives. An audience member similarly maintained that nonprofits are in the best position to deliver treatments in an unbiased manner. Regardless of which area each panelist worked, they all acknowledged the need for a system that is ethical and effective and produces returns for investors.

  10:50 AM - 12:05 PM

The Globalization of Medical Discoveries

Speakers:
Seth Berkley , President and CEO, International AIDS Vaccine Initiative
G. Stephen Burrill , CEO, Burrill & Co.
Carol Cruickshank , Vice President, A.T. Kearney
Andrew von Eschenbach , Commissioner, U.S. Food and Drug Administration

Moderator:
Greg Simon , President, FasterCures / The Center for Accelerating Medical Solutions

The world is enjoying an unprecedented era of medical research, accompanied by great hopes and concerns in the globalization of medical discoveries. Globalization opens the problems of the world to great scientists and allows new ways of looking at old problems that will lead to breakthroughs, said Seth Berkley of the International AIDS Vaccine Initiative. The worry, he added, is in making sure that the full range of diseases get researched, not just the diseases the West already focuses on.

Carol Cruickshank of A.T. Kearney pointed out that globalization presents "opportunities to accelerate, to move drugs to market more quickly and bring more to patients faster." The challenge, she said, will be to ensure that the benefits of globalization are spread ethically, and that quality is ensured across the board. G. Stephen Burrill of Burrill & Co. added that one of the challenges in globalization is harmonization from a regulatory and patent standpoint.

The health-care industry is now able to use a global perspective to view differences in persons with disease. According to Andrew von Eschenbach of the U.S. Food and Drug Administration, we are more aware than ever of the molecular processes and needs of individuals. "The personalization of treatments will move us into a world of 'predictiveness' and ultimately in a world of 'preventiveness,' where we will treat the well, not only the sick." He sees challenge is in the need for a higher degree of global interoperability and knowledge sharing among nations.

In a discussion of overseas clinical trials, Cruickshank noted that 48 percent of the trials conducted by the top 12 pharmaceuticals have been located outside the United States. Offshore clinical trial activity has increased by 20 percent in the last year alone. For the most part, these trials are moving to emerging markets; the top countries making ground are China, India and Russia, all attractive to pharma because of the large potential patient pools, developed infrastructures, low costs, available expertise and good regulatory environments.

Eschenbach noted that there are no inherent barriers to the FDA using data generated from offshore trials so long as the entire research continuum -- such as using the appropriate patient pool and collecting reliable raw data -- is acceptable. The FDA judges all trials on a case-by-case and study-by-study basis. And while the agency lacks the resources to check every country's infrastructure, it has sufficient strategic alliances to ensure that proper procedures are being followed. He also pointed out that when using overseas populations for studies, the obligation exists to care for them.

The panel also stressed the importance of globalizing innovation in medical discoveries. Burrill stated that the increased use of generic medications to temper rising health-care costs is a large disincentive for innovation. On average, a new drug costs $1.2 billion to $1.8 billion to bring to market, he said, and only one-third of drugs that make it to the market recover their initial investments. An additional disincentive, said Berkley, is the regulatory uncertainty in the industry. He supports rationalizing a differential pricing strategy for drug sales and concentrating less on blockbuster drugs. Essentially, by charging the most to those who can pay the most and charging the least to the disadvantaged, drug companies could increase their overall profitability while improving access.

The panelist agreed that there will never be an "international FDA" that globalizes medical discoveries, but that we can globalize the processes each country follows. In some views, the FDA process may be superior to other countries' regulatory bodies, but it depends on the type of disease and drug.

  10:50 AM - 12:05 PM

The Science and the Economics of Follow-on Biologics
By invitation only

This session is by "invitation only" and is limited to invited guests. If you are interested in attending, please send an e-mail request to jmeehan@milkeninstitute.org.

  2:10 PM - 3:25 PM

An Ounce of Prevention Really Is Worth a Pound of Cure: The Economic Burden of Chronic Disease

Speakers:
Valerie Fleishman , Chief Operating Officer, New England Healthcare Institute
Wayne Gattinella , President and CEO, WebMD
Jay Gellert , President and CEO, Health Net Inc.
Hala Moddelmog , President and CEO, Susan G. Komen for the Cure

Moderator:
Ross DeVol , Executive Director, Economic Research, Milken Institute

Chronic diseases in the United States have an enormous impact on health. This year alone, approximately 5 million Americans will be diagnosed with cancer, heart disease, stroke or diabetes; and 1.5 million will die from one of these conditions.

All these diseases are highly preventable. The fact that they share some of the same risk factors makes a strong argument that coordinated prevention programs have the potential to make great strides in controlling these diseases.

Chronic diseases cause an economic burden as well. Approximately $277.5 billion will be spent on just seven chronic diseases in 2007 in the United States. It's safe to assume that allocating resources toward prevention would be a cost-effective alternative to medical treatments.

When asked to discuss recent trends in chronic disease among insured individuals, Jay Gellert of Health Net Inc. discussed prenatal outcomes, smoking and obesity in California. Although more than 45 percent of births are from Medicaid-eligible mothers, he said, California rates 43rd in the nation for preterm labor/low-birth-weight children, and is in the top 10 for first trimester prenatal care. California also ranks 50th in the nation in smoking.

Tragically, the war on obesity has not been so successful. Comparing the obesity and smoking campaigns, Gellert noted several differences: ads for poor food choices are not as effective as anti-smoking ads; the differential tax for smoking is nonexistent for foods leading to obesity; there was no single massive campaign targeting obesity; campaigns do not address issues like increased access to processed foods for poor populations; and obesity prevention is largely geared toward adults rather than young people.

As a result, Gellert said, California is in the bottom 10 nationally for diabetes prevention. "We have a long way to go in talking about prevention," he concluded.

Much of the debate surrounding prevention has focused on personal responsibility versus societal responsibility. Hala Moddelmog of Susan G. Komen for the Cure stated that "60 to 70 percent of all chronic diseases are preventable through behavioral changes." So why haven't we made further progress? "We get what we pay for and pay attention to," replied Valerie Fleishman of the New England Healthcare Institute. Ironically, less than 5 percent of spending in this country has been allocated for healthy behavior, while health-care spending has increased annually.

The 2008 presidential candidates have focused on universal health care, but the panelists suggested that a broader approach to health care is imperative. Interestingly enough, Fleishman said, residents in Massachusetts were not necessarily any healthier since the state implemented health-care reform. Other determinants must be considered. A conversation on poverty, racism, lack of transportation and unequal access to care must be included in discussions about prevention, as these factors affect behavioral changes in certain populations.

As a possible solution to disease prevention, Wayne Gattinella of WebMD suggested that better information leads to better health. Since 80 percent of U.S. households have Internet access and eight out 10 use the Internet for health information, he suggested using computer-based approaches to aid in preventive health initiatives. He also recommended the adoption of electronic medical records to reduce errors, increase efficiency and increase quality of life.

Gellert mentioned incentives to encourage people to adopt healthier behaviors but cautioned that "incentives in the absence of tools don't work. Tools with community involvement work." Data was presented that showed financial incentives beginning at $100 will interest people in changing their behavior.

The session concluded with moderator Ross DeVol of the Milken Institute asking the panelists to note one aspect of the health-care system they would change. Responses included: using the Internet for health as commonly as it's used for music or checking stocks; increasing the intensity of the war on obesity; changing patent laws so that prevention drugs can be tested; and encouraging scientists and researchers to share data.

  3:35 PM - 4:50 PM

Building a Food and Drug Administration for the 21st Century

Speakers:
David Gratzer , Senior Fellow, Center for Medical Progress, Manhattan Institute
David Meltzer , Associate Professor, Department of Medicine; Associated Faculty Member, Harris School and the Department of Economics, University of Chicago
Beth Seidenberg , Partner, Kleiner Perkins Caufield & Byers
Andrew von Eschenbach , Commissioner, U.S. Food and Drug Administration

Moderator:
Greg Simon , President, FasterCures / The Center for Accelerating Medical Solutions

The Food and Drug Administration, responsible for regulating food, dietary supplements, cosmetics, drugs, and medical devices, makes decisions that touch our lives on a daily basis and with everyday products. But in recent years, the role of FDA in drug approval has become a point of contention as both consumers and the business community question the speed of drug approval and the perceived safety of new drugs.

After the Vioxx scandal, the Institute of Medicine submitted a report, "The Future of Drug Safety," and offered recommendations for restructuring the FDA in order to meet demands of the 21st century. This panel examined whether the FDA can undergo changes in time to meet these growing demands.

Greg Simon of FasterCures reminded the audience that the challenge of drug approvals has changed, from protecting the public from "drugs that have no benefit at all" protecting us from "drugs that cause harm to some and benefit others." The key tension in this process, as David Meltzer of the Institute of Medicine, explained, is that "you can make mistakes approving drugs that kill people, as well as not approving drugs that save people."

According to David Gratzer from Manhattan Institute, "all political incentives on the part of FDA are to be too cautious." As a result, the agency has become too "safety-conscious" and averse to change. Gratzer compared FDA's outdated and ineffective drug approval process with the tenure process in academia, saying it "places too much emphasis on lengthy clinical trials," with no formal monitoring of after the drug approval process.

Andrew von Eschenbach, the current FDA commissioner, agreed that the FDA′s operation is "woefully inadequate" for the new century. To address the lack of formal monitoring after the drug approval, more feedback is needed from physicians prescribing the drug and observing patients in the field, he said. By some estimates, fewer than 1 percent of doctors report side effects back to the FDA. Von Eschenbach also said that the FDA often does not have adequate informational resources to make good decisions. These shortcomings range from the fact that many processes within the FDA are still not digitized to a lack of tools for more precise testing and tracking of factors that trigger side effects.

Beth Seidenberg of KPCB weighed in from the venture capital side, noting that several companies she is working with have the technology to address personalized predictions for drug interactions based on molecular technology and biomarkers. She believes that a "personalized medicine" approach based on these tools is possible and would be much more effective than the current way of "treating diseases of the populations." However, she cautioned that the FDA needs personnel with technical skills in "basic science, information technology and bioengineering" in order to be "thought partners" with venture capital.

Von Eschenbach noted that to realize this vision, a "profound change" needs to take place not just at his agency, but across the medical field, from drug discovery to doctor's office. Standardization and digitization of data available to the FDA and physicians is the top priority in making this process efficient and safe. Though this may sound simple to accomplish, he warned that there are a host of complexities, not the least of which is privacy of medical information. In addition, Simon noted, this overhaul will require funding. He asked the panelists whether they think the FDA needs a boost to its annual budget of $1 billion. The panelists were divided on whether the increase in funding was necessary, with Gratzer and Seidenberg believing that restructuring can be done in place and von Eschenbach and Meltzer less optimistic.

Simon threw out a proposal for a new drug approval process proposal for reaction. Since every drug hurts someone but may benefit many others, he suggested, we can introduce drugs to the market for a trial of several years, during which time we limit direct-to-consumer advertising and off-label sales, and use proceeds to create a fund for people shown to be harmed by the drug. Meanwhile, we will have access to a higher population than during any clinical trial and can collect data on the real side effects of the drug.

Grazer and Meltzer agreed that this plan would achieve desired results and was worth considering, but von Eschenbach expressed caution, stating that he believed a more radical change is possible that will provide both speed and safety of the drug without limiting information available to consumers.

  3:35 PM - 4:50 PM

Stem Cell Wars

Speakers:
Pete Coffey , Professor of Cellular Therapy and Visual Sciences, Institute of Ophthalmology, University College London
Eve Herold , Director of Public Policy Research and Education, Genetics Policy Institute
Robert Klein , Chairman, Independent Citizens Oversight Committee, California Institute for Regenerative Medicine

Moderator:
Roger Ashby , CEO, StemCell Ventures

The use of stem cells in medical research has become one of the most divisive political issues of our time. This year, for example, the State of California will fund embryonic stem cell (ESC) research at a level more than five times higher than that of the federal government. This funding discrepancy is indicative of a struggle over the highly charged issues involved -- President Bush has twice vetoed bills supporting ESC research and restricted ESC to 21 specific stem cell lines of such deficient quality that "some scientists thing that they′ll never be suitable for clinical use." So said author Eve Herold of the Genetics Policy Institute. In an unabashed pro-ESC session, she, Pete Coffee of University College London and Robert Klein of the California Institute for Regenerative Medicine discussed the political controversy, life-saving potential and the way forward for stem cell research.

Herold provided an overview of the stem cell controversy, explaining the political environment and relating scientific issues to the ethical issues involved. She pointed out several alternative views of the ethical status of embryos and how they related to different policy stances on the issue -- specifically, that those who view embryos as full-fledged human beings tend to fall under the umbrella of Catholics and evangelical protestants opposed to abortion.

However, she pointed out, there is a significant distinction "between an embryo outside the body and a pregnancy under way." She relayed a lesser-known fact that embryos used at the stage of stem cell research have only 30 percent to 40 percent chance of leading to a successful pregnancy, even under the best conditions. Furthermore, she argued, such an embryo has no differentiated nerve cells, and thus there is no way the embryo could experience either consciousness or pain. Rather, she advanced a more nuanced view that embryos outside the womb occupy "a special moral space," a concept that is important in determining how to balance the potentially tremendous life-saving gains from ESC against concerns over the destruction of human life.

While significant controversy over the ethics of stem cell research bubbles at the federal level, some U.S. states and other nations are moving on. Referring to the session title, Coffey pointed out that "in the UK, there is no war. The government is very proactive in promoting and continuing stem cell research." Citing the UK's establishment of a stem cell bank and funding of 78 research projects over the past three years, he described how his research in vision restoration could benefit greatly from human embryonic stem cell research.

Robert Klein, however, needed no convincing. He heads the newly founded California Institute for Regenerative Medicine, which emerged from the passage of Proposition 71 in 2004. CIRM has the task of responsibly allocating the $3 billion in research funds secured by the proposition. Klein says California's leadership role in stem cell research is so large that other nations are dealing directly with the state because they cannot deal with the current administration. California was invited to the International Stem Cell Forum, in which all other participants were nation-states. When it comes to stem cell research, he said, "California is serving as a surrogate (and) replacement for our country."

Overall, the panelists recognized the need for expanding embryonic stem cell research and the hope of new cures it would provide. States advancing their own research agendas, and advocates working to clear away common myths about stem cell research, were both important. In the end, stable funding is the key for this emerging science, and it is important for states and philanthropists around the world to advance the cause without waiting for the federal government and profit-seeking corporations. As moderator Roger Ashby put it: "The drug companies are hiding in the wings, allowing science to progress by donations and by charitable people." Once it has advanced sufficiently, they will step in, and all parties will eventually play an important role. After all, he added, "this is a race against disease. This not a race against states or against nations."

Wednesday, April 25, 2007

  7:55 AM - 9:10 AM

Nutrition: Staying Healthy, Getting Healthy

Speakers:
T. Colin Campbell , Jacob Gould Schurman Professor, College of Human Ecology, Cornell University
David Heber , Professor, Medicine and Public Health; Founding Director, Center for Human Nutrition
Lewis Kuller , Professor of Public Health, Department of Epidemiology, University of Pittsburgh

Moderator:
Caldwell Esselstyn Jr. , Preventive Medical Consultant, Department of General Surgery, Cleveland Clinic

The panelists spoke about the various health issues that have plagued America for the past 50 years or so, and how studies have shown that these issues are directly linked to the American diet. They highlighted research that has proved how plant-based nutrition can reduce many of the major diseases; in fact, much of the discussed research was undertaken by the panelists themselves.

Professor T. Colin Campbell of Cornell University has done a great deal of experimental research on lab animals and observed the effects of intake of animal-based protein on tumor development. His studies indicate that by adjusting animal-based protein intake, we can turn the development of tumors on and off. In fact, his research has so far indicated that incidence rates of various cancers increase with the consumption of animal-based foods. Campbell went as far to assert that proper nutrition can prevent, suspend and/or cure other major diseases, such as heart disease, multiple sclerosis, kidney stones, cataracts and osteoporosis, just to name a few, along with promoting superior physical fitness.

So how do researchers and scientists define a proper diet? The chief components are a diet based on plants and whole grains. Out off 144 studies on this subject, all have statistically shown the positive health effects and disease prevention power of proper nutrition.

As humans, we are well adapted to fighting starvation and infections. However, the same does not hold true when we run into overnutrition and fighting infections. To help cope with this, experts agree that humans need a balance in their diet to silence abnormal genes. This balance comes from a healthy dose of Omega 3 and Omega 6 fatty foods that have been shown to act as anti-oxidants. Professor David Heber of the Center for Human Nutrition noted, "What is important to understand is that proper nutrition is not about eating less, but rather about eating better." This means we should incorporate more colorful fruits and vegetables. In fact, experts argue that the more colorful your plate, the better off you will be. As such, a recent topic in this area of research by many scientists has been the positive health effects of pomegranate fruits. Pomegranates are believed to be the "apple in the garden of Eden" and have been shown to have four times the antioxidant potency of green tea.

The FDA's original 1970s-era food pyramid is no longer the correct model to follow; a new pyramid was defined in 1997 to encourage more fruits, vegetables, whole grains and spices at the base of the pyramid. By doing so, Lewis Kuller from the University of Pittsburgh pointed out that proper diet is the only way to reduce health-care costs.

Unfortunately, many dietary improvements are coming too late. Most men and women over age 65 develop some form of coronary heart disease, the result of an over-consumption of saturated fats and too low consumption of foods with omega 3 and omega 6 persist. Excessive caloric intake and decreased energy expenditures continue to lead people toward obesity, which in turn increases chances of diabetes, various cancers, stroke and kidney disability. These trends may continue to evolve as developing countries continue to urbanize and adopt the same fast food model as the United States.

The panel agreed that understanding how many of these diseases come about and educating the public is the first step toward prevention. The food industry and advertisers must collaborate in increasing health awareness and proper nutrition in order to promote a healthy lifestyle and longevity. Sadly, many individuals believe that even with a proper diet they are doomed due to genetic predispositions. But Campbell noted that "if you are consuming the right kind of diet, you can control the mischievous genes in your body." As such, consumer education and consumer demand could drive food processors to sell healthier foods and advertisers to promote more nutritional diets. The recent successes of the water bottle companies and organic producers are clear examples that consumer education and demand will drive the industry to make healthy foods available on shelf spaces.

  9:20 AM - 10:35 am

Personalized Medicine

Speakers:
David Agus , Director, Spielberg Family Center for Applied Proteomics; Research Director, Louis Warschaw Prostate Cancer Center, Cedars-Sinai Medical Center
Ryan Phelan , Founder and CEO, DNA Direct Inc.
Randy Scott , Co-Founder, Chairman and CEO, Genomic Health Inc.

Moderator:
Greg Simon , President, FasterCures / The Center for Accelerating Medical Solutions

It's all about YOU: genomes, biomarkers, bio-specimens and genetic markers. These words are constantly emerging in stories related to our health and medical research. What do they mean? Why should we care? This panel, featuring leading experts in the field of personalized medicine, will tackle these questions, describe the vast potential of this new area to improve diagnosis and treatment of disease -- by providing individualized treatment based on a person's specific makeup -- and address the potential barriers to moving forward in this new area of research.

  10:45 am - 12:00 pm

Public/Private Partnerships: Innovation in Medical Research

Speakers:
Russell Bromley , Chief Operating Officer, Myelin Repair Foundation
Kathy Giusti , President and CEO, Multiple Myeloma Research Foundation
James Greenwood , President and CEO, Biotechnology Industry Organization
James Heywood , CEO and d'Arbeloff Founding Director, ALS Therapy Development Foundation

Moderator:
Deborah Brooks , President and Co-Founder, Michael J. Fox Foundation for Parkinson's Research

Drug development is not just for the big pharmaceutical companies any more. Some of the most innovative work in drug development is being done where you least expect it - nonprofit disease research groups. Often spending as much as a small biotech startup, these organizations are creating innovative research collaborations with industry, new methods of sharing data and using a business-model approach to accelerate new breakthroughs in disease research. This panel will profile some of the organizations leading this trend and highlight the benefits of these new industry/non-profit collaborations.

  2:10 PM - 3:25 PM

Addressing America's Health-Care Coverage Challenges

Speakers:
Steven Burd , Chairman, President and CEO, Safeway Inc.
Thomas Donohue , President and CEO, U.S. Chamber of Commerce
Billy Tauzin , President and CEO, Pharmaceutical Research and Manufacturers of America

Moderator:
Earl Rousseau , President, Health Enhancement, Matria Healthcare

Business often talks about the 80-20 rule, but currently health-care costs are following the 74-26 rule. As Steven Burd, Chairman of Safeway Inc, explained, "Seventy-four percent of the entire health-care spending is spent on four chronic diseases." And with the general exception of cancer, cardiovascular disease, diabetes and overweight/obese complications are directly related to patient behavior. Specifically, these patients are not taking care of the disease in the early stages, and late treatment results in 50 percent to 70 percent of the overall health-care costs.

Although these statistics are staggering, Burd stressed that businesses can correct the health behaviors of their employees by offering economic incentives to lower rising health-care costs.

Billy Tauzin of Pharmaceutical Research and Manufacturers of America (PhRMA) stated that "medicines are a huge potential part of the solution" and should be offered at the onset of illness so that society as whole does not have to pay for mistakes later.

Panelists noted that "behavior matters for auto insurance, home insurance, and life insurance, but not for health insurance." This needs to change, they agreed, while conceding that employees should not be penalized for genetic diseases. Companies that have initiated wellness programs and rewarded employees for good health have realized as much as a 25 percent reduction in health-care costs, they noted, and have also increased employee productivity. Unions, they suggested, should have the same interest as management in finding creative ways to drive down health-care costs.

On a broader scale, the issue of health insurance is both a cost and coverage problem. Approximately 46 million Americans remain uninsured, and insurance premiums keep rising. To address America's health-care coverage challenges, the panel proposed five core principles for reform: (1)the health-care system needs to be market-based: (2) it should provide universal coverage with individual responsibility; (3) it should provide financial assistance for low income individuals and families: (4) it should promote healthier behaviors and incentives; and (5) it should apply equal tax treatment.

Thomas Donohue of the U.S. Chamber of Commerce explained that health-care reform is the "single most emotional political issue in the country." There is no easy answer to fixing the problems, he said, "but business, government, labor and the intellectual community can rally together and get it done." Moderator Earl Rousseau of Health Enhancement asked panelists what they thought the role of government should be. Tauzin stated that government should auto-enroll people who are eligible for coverage, understand why some people choose to not buy insurance, and adjust or reallocate the federal subsidies for employer coverage to truly subsidize those in the system who cannot afford insurance.

Burd stressed the importance of the need to create believers in Congress by proving the potential of a market-driven health coverage system that would lower costs and increase quality. Government can provide the basic information to kick start consumer demand for cost and quality information, he said. Like a market-driven strategy, cost and quality information should be transparent to the consumer. This would translate to individuals being able to access provider information and choose the lowest cost and highest-quality of available treatment. Physicians would have to remain competitive. The value transparency alone could result in a 20 percent reduction in health-care costs, he said.

The upcoming presidential election may be a positive step in the debate over health-care reform, panelists agreed, noting that while none of the current candidates has a well-articulated reform plan, perhaps business will be able to influence them to develop proposals.

  3:35 PM - 4:50 PM

The Internet and Your Health

Speakers:
David Agus , Director, Spielberg Family Center for Applied Proteomics; Research Director, Louis Warschaw Prostate Cancer Center, Cedars-Sinai Medical Center
Adam Bosworth , Vice President, Google
Wayne Gattinella , President and CEO, WebMD
Glen Tullman , Chairman and CEO, Allscripts Healthcare Solutions Inc.

Moderator:
Steve Downs , Deputy Director, Health Group, Robert Wood Johnson Foundation

All panelists agreed that the Internet is already playing an important role in the lives of patients, as well as physicians, and that its importance will only grow with the time. "Today, eight out of every 10 online users search the Internet for health information," said Wayne Gattinella of WebMD. "This is an exciting time for both physicians and patients. Everyone would be in a better shape if (more)health-care-related information were available online."

Gattinella noted that a million registered doctors are coming to WebMD each month. It is common for large physician groups to turn to the Internet as the source of information, he added. Smaller physician groups have not yet used the web to such an extent.

Adam Bosworth of Google said that Internet users are searching for health-related web sites for various reasons. They may seek information for use as a diagnostic tool concerning their own symptoms; to learn about specific institutions, doctors and caregivers; to search out the latest research and health news; or to locate other people or support groups coping with same disease, particularly in connection with the chronic and recurring diseases.

At the same time, the panelists agreed, while both patients and physicians are turning to Internet, it is important to distinguish what they are trying to achieve. Some doctors feel threatened by their patients' Internet searches of symptoms. The chief problem, of course, is that sourcing may not be accurate or even legitimate. "Doctors have little time to see a patient," said David Agus of Cedars-Sinai Medical Center, "and here comes a patient with lot of printouts from the web. The question is, how useful is the information?"

What is more helpful is when doctors themselves direct their patients to reputable health sites for information. "Seventy percent of doctors actually do refer their patients to web sites," explained Agus. It wasn't so long ago that physicians downplayed the use of online information altogether; nowadays, they're needed as guides through an overabundance of information, some of which is not helpful.

Another challenge lies in electronic health records (EHRs) and patient privacy. With the use of HER, about 7,000 lives can be saved annually, lives otherwise put in risk because of handwriting errors or other simple human mistakes. For instance, said Glen Tullman of Allscripts Healthcare Solutions, 93 percent of all prescriptions are written outside the hospital. But if information on patients were kept easily accessible and available, medication errors and other safety issues would decrease. EHRs can be part of databases so that all the information on a patient is available with a single click. There are privacy concerns, but at the same time, there is a need to share this information, said Gattinella, adding that health information needs to be portable, uninterrupted and transparent. And the Internet can allow all this to happen.

The Internet has also provided employers with better outreach to large groups of people. Corporate awareness of the benefits of employee health are paying off, said Gattinella, and some companies even include their efforts on behalf of employee wellness in their missions statements.

In the conclusion, all speakers agreed that health and the Internet will grow more interconnected. Medical school graduates now have interactive medical educational backgrounds. But online information is simply a means to an end, and physicians and patients need to share their information. And while the Internet is changing how patient-physician relationships develop, it is still just a tool to help people stay healthy, said Steve Downs of Robert Wood Johnson Foundation. And Bosworth noted, "The problem is that a lot of patients are walking with much more information, but still so many of them may have a disease and may be not diagnosed."

It's good that patients come to the doctors with already researched information," said Tullman. In 10 years at most, he added, we will look back at doctors who didn't use Internet today and think their hesitation was absurd. "It′s impossible to keep all that information in your head, so it is normal to rely on the Internet as a source of information that is easily accessed," he said.

The Internet, he concluded, should be used in addition to a physician. "If it's used as a substitute to a doctor, we will fail."


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