The national newsletter BioCentury in moving into the video space with a new policy talk show called “BioCentury This Week.” The first program will air this Sunday and will feature a roundtable interview with National Health Council Executive Vice President/COO Marc Boutin and Timothy Coetzee, president of the MS Society’s Fast Forward (learn more about Fast Forward at http://msforward.org/). The focus of the interview is balancing the risk vs. the benefit of new drugs as part of the FDA approval process.

The show will air every Sunday from 8:30 to 9:00 a.m. Eastern time on WUSA, Channel 9, Washington, DC. For those outside the DC market, the program will also be available later that day on the new BioCentury This Week website — http://www.biocenturytv.com/. I hope you will watch it and let us know what you think about this important issue.

The National Health Council’s exciting new web database HealthResearchFunding.Org is nearing completion! The database, which was created with input from the National Institutes of Health (NIH) Office of Extramural Programs, will make information on worthwhile but unfunded research proposals available to NHC members and other potential funding sources of health research. The goal is to capitalize on this unique opportunity for collaboration to foster support for new research that will provide hope to patients and their families for new and better treatments.

Chief scientific/medical officers and researchers from NHC member patient advocacy organizations and representatives from NIH concluded beta-testing on the website in July. The site is now open to all NHC member patient advocacy organizations.

-Read more of this article in the September Issue of Council Currents…

The National Health Council (NHC) released the following statement in support of today’s White House announcement of new federal regulations to strengthen patients’ rights to appeal health insurance denials. The following statement is from Myrl Weinberg, President of the NHC:

People with chronic conditions make up the largest segment of users of health care in this country. They require care and treatment that will allow them to live the healthiest, most productive lives possible. It is essential that they be able to obtain and retain coverage and care that meet their individual health care needs.

A survey released in April by United Healthcare, and Volunteer Match, found that nearly 70 percent of people who have volunteered in the past year reported that volunteering has made them feel physically healthier.

Incorporating service into your life and making a difference in your community is one of the greatest benefits people receive from volunteering.  The intangible benefits such as pride and achievement are meaningful reasons to serve and give your time.

Throughout the non-profit community there is evidence of this type of selfless giving deserving recognition – The National Health Council is able to utilize volunteer representatives from over 100 NHC member organizations from all areas of the health care community advocating for a health care system that Puts Patients First!

We can all take part in volunteering whether it is through our workplace, our children’s schools, or a neighborhood network – volunteering is an activity that improves our community and ourselves. 

Learn more about how the National Health Council takes part in volunteering involving more than just our members but the entire patient community.

The following question and answer interview with NHC President Myrl Weinberg appeared as a special feature in the Wall Street Journal on clinical trials.

Q. What is the largest barrier to increasing patient participation?

A. Individuals simply aren’t asked. Many organizations have done outstanding work to educate people about the importance of participating in clinical trials. We need greater support from both the public and private sectors to encourage participation.

Q. How can we best ensure the safety and cost effectiveness of developing medical products?

A. The National Health Council represents the more than 133 million Americans with chronic diseases and disabilities. People place great hope that science can produce break-through treatments. Unfortunately, new discoveries are judged by old regulatory science. These new drugs that address unmet needs today become the lower-cost generic medicines of tomorrow.

Q. What is the biggest misconception about clinical research?

A. Clinical research is not just about the sick. We need more people—including people in good health—to participate in clinical trials. The core objective is the greater public good of expanding knowledge, not just finding new treatments or cures.

Click here to view the entire feature.

Many said that it would never happen.  But on Tuesday, March 23, President Obama signed into law legislation that truly Puts Patients First in health care.

People living with chronic conditions and their family caregivers may not appreciate the nuts and bolts of passing legislation. They do, however, understand the gravity of their own personal situation. The everyday realities for the people the NHC represents continue to be filled with health challenges and financial uncertainty as they struggle to maintain their health, independence, and well-being.

The NHC worked closely with many Members of Congress to ensure that the interests of the patient and family caregiver community were addressed in the final bill, and passage of the legislation will dramatically improve the lives of people with chronic conditions. Improvements include making insurance available to those who cannot currently afford it, eliminating discriminatory insurance practices such as exclusions for people with pre-existing conditions and annual and lifetime benefits caps, and improving access to long-term care. Families with children who are ill will have greater security knowing their child cannot be denied insurance coverage due to a pre-existing condition and that older children can remain on a parent’s insurance policy until the age of 26.

Recognizing the need to reform a broken system, Congress and the President took a bold step in enacting meaningful legislation that will benefit the patient community. We look forward to continuing to serve as a partner and resource in the effort to Put Patients First in health care through implementation of this legislation.

People living with chronic conditions benefit from many medical advances developed over the past 20 years. Many diseases that were once fatal diagnoses are now managed utilizing various drug therapies. However, far too often, treatments may work well for some people, while providing marginal benefits or causing significant harm to others.

One example is antidepressants. According to a study at the Tel Aviv University (TAU) Sackler School of Medicine, the most popular antidepressants only work for approximately 60% of the patients with depression. For the other 40% of the patients, it takes a trial-and-error approach to find the right treatment strategy. As David Gurwitz, PhD, at TAU stated, patients need a “best-fit, personalized regimen.” For people with autoimmune diseases, it is even more difficult to create the right treatment plan.

Today, billions of dollars are spent annually on research, development, and clinical trials to create new healthcare products. How can we improve on this process so that patients can reap the full return on investment?

Molecular diagnostics can be an important element in the development of personalized medicine by determining the course of a disease and evaluating the patient’s response to a given therapy based on the individual’s genetic makeup. Such processes are already being tested as a prognostic indicator of congestive heart failure to better identify patients in need of more intensive forms of therapy. Molecular diagnostics have also been applied in the detection and treatment of other disease categories.

The National Health Council (NHC) has engaged in conversations with various patient advocacy groups and other stakeholders to examine new methods to more accurately identify the benefits of therapies at the point of care, taking into consideration a patient’s individual genetic makeup.

Creating and utilizing molecular diagnostic tests could allow us to better target treatments to those who will benefit and reduce costs by more accurately determining safety and efficacy of related medicines. Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the US Food and Drug Administration, has pointed out that targeting therapies to the likely-to-benefit patient groups—or to exclude those individuals with a low probability of a positive response—is a powerful method of increasing value in healthcare delivery. Such advances in science also hold promise for better health outcomes for patients with chronic diseases.

PricewaterhouseCooper states in a 2009 report on diagnostics that there is “a growing imperative, both clinical and budgetary, to accompany therapies with diagnostic tools of increasing sensitivity and specificity to better enable the identification of those patients in the relevant disease subtype and most likely to benefit from the therapy.” The company predicts that the marketing model foreseen for most specialist therapies in 2020 will include a companion diagnostic as a key component.

However, should we wait 10 years while the needs of patients are left unmet? We need a system that ensures that advances in science are more quickly married to the needs of individual patients. The NHC is proposing a public–private approach that would remove the barriers that impede progress in the development and use of molecular diagnostics.

Currently, there is ambiguity in the evidentiary standards for molecular diagnostic tests and the regulatory approval pathway. This lack of certainty discourages investment in the development of the new therapies utilizing such tests. What we need is better communication between government and industry and a goal-oriented approach to revising the regulatory process.

What we also need to do is a better job of explaining to the public that molecular diagnostic tests could ensure that individuals with different but related conditions receive targeted drug therapies that work for their specific disease subtype.

How we go about clarifying and creating a process to support greater use of molecular diagnostic testing is currently under debate. As Dr Woodcock has pointed out, “Given the huge stakes involved in reimbursement decisions and the variety of methodological approaches that could be used to compare interventions, an epistemological ‘food fight’ over evidentiary standards is likely in this emerging field.”

If we can get the appropriate stakeholders from the public and private sectors working together, we can come up with workable menu of action steps that will greatly benefit the patient community.

OUR PARENTS told us life isn’t fair. People with chronic diseases and disabilities know this more intimately than most people.

A woman with rheumatoid arthritis had a successful career in public relations and advertising and now relies on Social Security disability payments. A husband copes as best he can to care for his twin sons and a wife diagnosed with Alzheimer’s before she turned 50. A young man about to enter college worries about his course load and his treatment schedule for Crohn’s disease, a condition for which there is no cure.

The more than 133 million people with chronic conditions in America can teach us all lessons about life’s inequities. They can also teach us about being pragmatic. For them, health-care reform is not just about expanding access to cures. Health-care reform is about changing our overall delivery system so that it meets a patient’s broad and complex agenda to live longer and feel better.

The Agency for Healthcare Research and Quality says that 20 percent of the population incurs 80 percent of total health-care expenses. We also know that this segment is made up of people with chronic conditions. Developing a delivery system that addresses the needs of people with high-cost, chronic diseases and those who are at greatest risk for hospitalization will have a major impact on managing the health-care budget.

Better outcomes while curbing costs could be achieved through better care coordination for patients with chronic conditions. Care coordination focuses on the individual patient’s unique situation and ensures that medical knowledge and health care information are appropriately used to let the patient make educated decisions regarding his or her treatment.

While not necessary for everyone, care-coordination delivery models can apply a laser approach at improving the delivery of health care to people with complex chronic conditions — people whose health-care needs dramatically impact our total health costs. Help them, and you help the entire health-care delivery system.

An effective care-coordination model incorporates three equally important elements: health and medical research; recognition of the patient’s unique personal circumstances (including the individual’s genetic, ethnic, religious and socioeconomic status at the point of care); and appropriate incentives for both the provider and the patient.

A three-legged stool, all three elements are needed to support the delivery model. Ignore one and the stool collapses.

This model reimburses a health team to assess a patient’s unique health history and lifestyle and to coordinate the care. The team would work with the patient to develop an individualized care plan (ICP) that is based on quality research and the person’s life situation. In exchange for an ICP, the patient would have explicit responsibilities: be a willing and engaged participant in the treatment plan and reap the benefits of lower out-of-pocket costs, or go back to the current uncoordinated system and pay his or her out-of-pocket costs.

Too often the health-care reform debate is unbalanced — focusing on program cost and ignoring individual patient expense, or touting the advantages of research but missing the human element and “real world” application of medical advances. New delivery models that are founded on principles of evidence-based medicine, respectful of the individual patient’s unique situation at the point of care, and committed to reducing out-of-pocket expenses while reimbursing for care coordination are already proving to be the most cost-effective health-reform strategies available.

The National Health Council has undertaken a study of about a dozen health-plan initiatives in different states and different community sizes. Preliminary results reported by the programs have been encouraging. Take, for example, the Geisinger Health System, in Pennsylvania. It implemented new programs in 2005 to improve patient care, including the use of electronic health records and a personal health navigator to better manage chronic diseases. In 2007, it reported that among the participants there was a 12 percent decrease in acute-care hospital admissions and an 11.7 percent decrease in hospital readmissions. Care sites that offered the program reported an 8 percent lower differential in medical costs, compared to care sites that did not participate in the program.

Patient-focused delivery models aren’t a panacea, and patients with chronic diseases and disabilities understand that. That said, creating new plan initiatives is crucial for achieving the health-care reform patients seek.

If we can create a system that provides for and appropriately addresses the unique needs of the 20 percent of the population who are driving the health-care dollars spent in America, we’re 80 percent of the way toward a health-care solution for all.

This piece by Myrl Weinberg, president, National Health Council, ran in the Providence Journal on July 27, 2009.