Life Love & Health (.pdf version)

NARRATOR: Life Love & Health.

CHRISTOPHER SPRINGMANN: I’m Christopher Springmann, and you’re watching Life Love & Health, Special Edition, recorded in the studios of public television WHYY in Philadelphia. Today’s show explores Altzheimer’s disease, often a world of shadows and darkness. But our program today, will bring some light to the reality that millions of Americans find themselves living in both as Alzheimer’s sufferers and their care giving families.

A new survey by the MetLife foundation finds that Alzheimer’s disease is the second most feared disease for Americans just behind cancer. A fact that our next guest knows personally and professionally. She is Dr. Winnifred S. Hayes, Ph.D President, CEO, and Founder of Hayes, Inc., created in response to a growing need in the health care industry for evidence-based assessments of health technologies.

Dr. Hayes, thank you so much for joining us today on Life Love & Health, Special Edition. Now before we get deeply into today’s show, which is about Altzheimer’s screening, diagnosis, treatment and the societal, emotional, and economic impact this condition has on people, providers, and payers. Please tell me about Hayes, Inc. and want unmet need occurred that persuaded you to start this company.

DR. WINNIFRED S. HAYES, PH.D: Haye’s Inc. founded in 1989 was involved in working with health insurers and manage-care companies. And one of the struggles that I observed back then was that as new medical technologies entered the marketplace, health insurers had great difficulty deciding, is this a proven therapy? Will it really make a difference for patients? And the process they used was largely based on opinion. It was pretty clear to me that if we tapped into what the scientific evidence had to say about these medical technologies, we could improve that process. And that process I’m talking about was decisions involving coverage and reimbursement.

CHRISTOPHER SPRINGMANN: Who are your clients categorically?

DR. WINNIFRED S. HAYES, PH.D: We support several stakeholder groups. Obviously, one of the first were manage-care companies and insurance companies. Second, we support government agencies both federal and state. And more recently, we work with hospitals and health systems. And we provide a little bit of support as well for patients or consumers and employers.

CHRISTOPHER SPRINGMANN: You and your staff have done an enormous amount of work to provide valuable information to these stakeholders, providers, and payers regarding Alzheimer’s. How will they actually utilize this information in their decision making process?

DR. WINNIFRED S. HAYES, PH.D: In a variety of ways. For example, let’s take an insurance carrier. There are various ways to diagnose Alzheimer’s disease. There are various ways to treat symptoms. Unfortunately, as you know Chris, there’s no cure for Alzheimer’s, and there’s no prevention. But as they look at these medical technologies, they need to make decisions about whether they work and they’re effective for their intended purpose. And it will directly inform an ensurer’s coverage and reimbursement policy. The information that we provide them, it helps to ensure that those decisions are based on evidence not just somebody’s opinion.

CHRISTOPHER SPRINGMANN: Why is it important for consumers to know what you know and, frankly, what their providers know too?

DR. WINNIFRED S. HAYES, PH.D: Because the course of Alzheimer’s disease is over several years. And the burden to the patient and his or her family is significant. It’s important as these people make choices that they understand what the evidence says about what is effective or not effective, and what the role of a drug or a diagnostic test is in helping them manage the care of the patient with Alzheimer’s disease. They need it in order to ask questions and participate in shared decision making with their physicians. And their physician, the health care facilities within which these patients are treated, they need that same kind of evidence to really focus resources on those things that make the most difference for Alzheimer’s patients.

CHRISTOPHER SPRINGMANN: Many of our listeners may not be familiar with Hayes, Inc. Let’s discuss issues about objectivity and integrity, and how you resist the influence of certain groups and organizations in your decision making process. Especially people with financial interests that could be adversely affected by your recommendations.

DR. WINNIFRED S. HAYES, PH.D: Another great question. First of all, we are a privately held corporation. We have no relationships with any other entity. No fiscal relationships or other kind of partnerships that would create a conflict of interest. Our processes are transparent. They’re based on sound scientific methods, and I think it’s important to know also that we do not do commission work for manufactures, pharmaceutical companies, or bio tech companies. We’re very much independent. And that’s reflected in the work we do.

CHRISTOPHER SPRINGMANN: And the decisions that are made by these stakeholders, who are your customers, are frankly very difficult decisions to make. Because often people’s welfare relates to risk benefit, cost benefit, and effectiveness. And it’s all wrapped up in something called measurable benefit. And this has a great deal to do with the way you approach questions like Alzheimer’s in terms of evidence-based medicine. Because people make decisions based on facts, and it must be difficult for you to step aside from the emotional engagement that families, very understandably, have about these decisions that are made about their loved ones. How do you reconcile all these issues?

DR. WINNIFRED S. HAYES, PH.D: I guess our approach is we understand the importance of scientific evidence in helping us, helping society, helping our stakeholders determine what works and what doesn’t work and how safe something is or how safe something isn’t. And how an intervention or procedure, or whatever it is, how that might compare with an alternative approach.

As the number of people in this country age, and therefore the number of people with Alzheimer’s or other forms of dementia increase, we want to be very careful that we’re using our resources wisely. And that the therapies that we’re suggesting and the other kinds of interventions really provide some benefit.

Evidence helps us make that determination. It’s something that’s critical. It’s critical to the future of these patients. And it’s also critical in terms of making sure that the resources they need will be available.

CHRISTOPHER SPRINGMANN: Let’s discuss what you have discovered, what you have found in terms of the efficacy and safety of treatments and therapies. Efficacy, basically, does it work? And safety of course speaks for itself. What have you discovered that you feel may be included in your work on Alzheimer’s?

DR. WINNIFRED S. HAYES, PH.D: For example, we’ve looked at various drugs that are used to treat the symptoms of Alzheimer’s. And again let me reinforce, they don’t cure. These drugs are not able to cure Alzheimer’s.

CHRISTOPHER SPRINGMANN: What do they do? And for how long?

DR. WINNIFRED S. HAYES, PH.D: What they do is treat some of the symptoms like memory loss, sometimes confusion, agitation. And they’re effectiveness is modest. It’s not dramatic. That effectiveness is sustained for maybe months, not years. Patients need to understand that you might be buying a little bit of time. their families need to understand as well. And you might be improving some of the symptoms for a period of time. But it’s not going to be sustained over the course of the disease.

CHRISTOPHER SPRINGMANN: In fact, your thoughts are reinforced in a document that I have from the Alzheimer’s Association called “Alzheimer’s Myths,” Myth Number Eight: there are treatments available to stop the progression of Alzheimer’s disease. As you said, at this time, and I’m quoting, “There is no treatment to cure, delay, or stop the progression. Although there are FDA approved drugs that temporarily slow worsening of symptoms for about six to 12 months.” That is probably not what people would like to hear. But it’s certainly a very, very serious fact isn’t it?

DR. WINNIFRED S. HAYES, PH.D: It’s very serious. Most of the care of Alzheimer’s patients, especially in the early stages, is provided by families. In fact, there’s an estimate that we spend well over two hundred billion dollars a year, or we would spend it, on uncompensated care. So let me clarify. Family members might be spending billions of hours a year caring for their loved one. And if we were to pay them, the value placed on that would be about two hundred twenty billion dollars a year.

CHRISTOPHER SPRINGMANN: In fact, the federal government is seeking to address these issues. Kathleen Sebelius, the Secretary of Health and Human Services, announced that the new budget will support older adults and their caregivers with 60 million dollars, an increase of 21 million over fiscal year 2010 to help seniors in their community live without abuse, to essentially remain in their homes. And that’s a significant increase, I believe, of about a 100 million dollars for caregiver services. As you mentioned, counseling, training, and respite care to enable families to better care for their relatives in the community. There are many reasons for this. I believe, in my opinion, it’s not only the right thing to do, but it has a very positive economic value to it.

DR. WINNIFRED S. HAYES, PH.D: I concur entirely.

CHRISTOPHER SPRINGMANN: The subject is Alzheimer’s. And our guest today is Dr. Winnifred S. Hayes Ph.D, President, CEO, and Founder of Hayes, Inc. at hayesinc.com. First of all, let’s talk about the economics.

DR. WINNIFRED S. HAYES, PH.D: The economics are very interesting. Last year, 2010, it’s estimated that we spent about a 172 billion dollars on the care of Alzheimer’s patients. This year, the estimate is it will climb by 11 billion or 183 billion. By 2050, it’s estimated that for Medicare patients that number is going to be 600% higher. So a sixfold increase by 2050. It’s a staggering number. And of course, part of the reason is baby boomers are aging. We’re now entering our 65th year, and that cohort, that group of people that we call baby boomers– and I’m one of the baby boomers of course.

CHRISTOPHER SPRINGMANN: Congratulations.

DR. WINNIFRED S. HAYES, PH.D: Great, whatever that’s worth. But that group of people will be increasingly subject to the ravages of Alzheimer’s. We estimate that it’s about– I’m trying to remember– I believe it’s about 14% of people age 71 and older have Alzheimer’s. And of that number, there are more women than men. But that’s largely attributed to women living longer than men. It’s a significant number.

CHRISTOPHER SPRINGMANN: These statistics are probably quite well-known to your various stakeholders. And I’m sure they are of great concern. How do these various stakeholders, payers, and providers intend to approach this issue? Because you are dealing with a chronic, debilitating condition and enormous engagement from members of the family very, very often. I believe the typical caregiver in the United States is a woman in her probably late 40′s who probably has children of her own, classic sandwich generation. What are providers going to do? What can they do, now that we’ve essentially, not eliminated, but addressed the limited effectiveness of pharmaceuticals?

DR. WINNIFRED S. HAYES, PH.D: I think one of the things that has occurred, and is continuing to expand, is life-care communities and other kinds of facilities for those who are aging. We have a whole continuum now, if you think about it. We have expanding home care services that allow people to stay in their home much longer. We have assisted living. We have skilled nursing. We have units that are designed specifically for dementia patients. I mentioned before, we have a development in the insurance industry called long-term care insurance, which is something more and more people are looking at as something that’s viable. And I think more and more, it’s important that families be encouraged to discuss what adult parents, if you will, would wish for themselves as they age and especially if they develop dementia. And have those discussions with their adult children and plan ahead.

CHRISTOPHER SPRINGMANN: Let me ask you a complicated question. And after I ask the question, please tell me if I’ve asked you a fair question. What responsibility do payers and providers have to deal with people with Alzheimer’s? Because there is so much family engagement involved. It’s been said that when an individual has Alzheimer’s, the whole family, to a great extent, develops their own form of Alzheimer’s. Because so much care is necessary. In terms of– let me give you the bottom line question– in terms of the people who pay the bills, what are their responsibilities?

DR. WINNIFRED S. HAYES, PH.D: It’s an interesting situation that you’ve described here. Because health insurance–

CHRISTOPHER SPRINGMANN: Well, first of all, is my question relevant? Is it valid? Or am I asking the right question?

DR. WINNIFRED S. HAYES, PH.D: I think you’re asking an important question. And maybe I can say it a different way. And that is, what is society’s responsibility for the care of people with Alzheimer’s and other forms of dementia? And what role does health insurance play? What role does Medicare play? And what responsibility must be assumed by the family? And is there any other government involvement that comes to bear?

CHRISTOPHER SPRINGMANN: Let’s first take the perspective of the people who quote, unquote, pay the bills. Not necessarily the family. Because of course they’re quite engaged financially, emotionally, and socially. Let’s talk about the bill payers.

DR. WINNIFRED S. HAYES, PH.D: Bill payers first and foremost is the estate of the involved individual and their family. At that point in time, when a family can no longer care for someone in the home, and they need to be institutionalized, in a skilled nursing facility, or memory impairment unit, the expectation is that the family will pay for that unless they have some kind of long-term care insurance, or they’ve made some kind of arrangement in a continuous care community. Or that’s part of what they’ve bought. But other than that, that family is responsible for that individual’s care. Except when there is a defined medical condition.

But Medicare will not cover, on a prolonged basis, nursing home care. That’s something that the individual has to pay. Now when the individual and their resources, their estate, is essentially depleted, then Medicaid can kick in. Medicaid would pick up the cost of nursing home care after an individual’s resources are depleted.

CHRISTOPHER SPRINGMANN: Dr. Hayes, why do families need to understand and perhaps appreciate the basis for your work in terms of evidence-based medicine? How can they benefit from that to enhance their understanding of what is going on?

DR. WINNIFRED S. HAYES, PH.D: Evidences is hope. Research is hope. Research is the future. It may not feel this way to families who are grappling with Alzheimer’s. But there have been advances. We have a better understanding of what’s occurring in the brain as Alzheimer’s progresses. We have some beginning ideas of factors that might contribute to the occurrence of the disease. And as we gain more and more knowledge about the causes of Alzheimer’s, it sets the stage for possibilities for therapy. Therapy that will be developed and tested through formal research.

All research is not concerned, however, with a drug or a specific treatment. It’s also concerned with programmatic approaches that are helpful to managing people with Alzheimer’s. By programmatic, I’m talking about some of the things we know are helpful, like providing or rearranging the Alzheimer’s patient’s environment. So there are visual cues. So there are other reminders that make them comfortable and help provide them with the cue they need to remember something or to think about something.

For payers, they need to understand what value a treatment or diagnostic tests brings to the management of Alzheimer’s patients. They need to know that it will work. That it’s effective. That it’s safe. And they need to understand what tangible value, from a clinical sense, it brings to these people. That’s important because they are the organizations that determine what’s covered and reimbursed. And for patients and their families, they need to understand because it is critical to their planning and to creating an environment where their loved one is most comfortable and most productive for as long as possible. And it’s also important so they are aware of what the future might hold and what might be gained through developments that are currently under way because of research activities.

CHRISTOPHER SPRINGMANN: I guess the bottom line, Dr. Hayes, is how do you maintain your independence. Because there are lots of people, lots of folks, who have special interests, emotional interests, financial stakes in all this. How do you remain objective?

DR. WINNIFRED S. HAYES, PH.D: We begin by making sure that we have no financial stake in the results of a study or report that we’re producing. We have, as a company, we have no affiliations with any other organization. That’s an important component. As individuals working for that company, we have no affiliations with any of the manufactures or pharmaceuticals that produce the products and services that we’re evaluating.

We follow well-understood and well-documented methods, research methods, in terms of how we do our work. And those things help to ensure that there’s a firewall. We do not solicit the opinion or the input of those organizations that stand to gain financially from the sale of a service or a product. And I think that’s pretty critical. And it’s something we look for in the work we’re doing as we look at the studies that are published in peer reviewed sources.

We take a close look at who’s the funding organization? And we get a little concerned when all funds come from a manufacture and none come from neutral sources like the federal government.

CHRISTOPHER SPRINGMANN: And historically and traditionally, companies, pharmaceutical companies, medical device companies, have supported patient advocacy organizations. In fact, they are very often the main funding. And I think the reason they do this is for all the right reasons but also perhaps enlightened self interest. Dr. Hayes, do you bring in input from patient advocacy groups, patient support groups as a component of your findings and, in this case, for the Alzheimer’s findings? If not, why not?

DR. WINNIFRED S. HAYES, PH.D: We pay attention to and we will report on what different stakeholder groups might have to say about the use of a medical technology for a particular application. And for Alzheimer’s, it’s not different. That input reflects that stakeholder’s perspective and their consensus or opinion. It’s important to understand what’s important to patients. And research should reflect that orientation.

However, because an advocacy group is lobbying or is promoting the use of a particular therapeutic approach doesn’t necessarily mean that the evidence really supports it. Advocacy groups may not be in the best position to evaluate impartially that evidence.

CHRISTOPHER SPRINGMANN: It sounds to me like you’re not being truly inclusionary, Dr. Hayes.

DR. WINNIFRED S. HAYES, PH.D: We are inclusionary in the sense that we want to understand and communicate what a position is. But ultimately, our evidence evaluation is a function of what the scientific evidence tells us. It’s not a function of what a physician group thinks, or a patient-oriented group, or an insurance company group. It’s really a very independent and objective process, where we’re looking at the goodness of the scientific studies and what those scientific studies yielded in the way of conclusions.

CHRISTOPHER SPRINGMANN: Dr. Hayes, thank you so much for joining us today on Life Love & Health, Special Edition.

DR. WINNIFRED S. HAYES, PH.D: Thank you. I enjoyed being here.

Life Love & Health