Beating Heart Disease Should
Be Top Priority for Americans

Fred Hassan, Chairman and Chief Executive Officer
Schering-Plough Corporation

All of us share in an important mission. Cardiovascular disease is an enormous threat, an insidious threat around the world. It destroys lives. It destroys quality of life.

We all have a noble mission. We are joined in a mission to save lives and to improve lives for patients today and for patients of the future.

I would like to talk with you about four things that I believe are important to all of us. First, I'd like to make a few comments on the historic advances in cardiovascular health. The advances are quite remarkable. Second, let me address what I see as some of the biggest challenges ahead. Third, let me share with you my perspective on the big opportunities that also lie ahead. Fourth and finally, I'd like to conclude with some remarks directed to the incoming class of Congressional legislators in the U.S., who will take office in January.

First, some reflections on what has been achieved in cardiovascular health. This past summer, I read an important article in The New York Times by Gina Kolata. Gina is one of the better writers I know of on health issues. Her story reported on research done on health records of Union Army soldiers. It compared the health of those Civil War soldiers with the health of Americans today.

What was found was fascinating. The research showed that in the Civil War era, most soldiers were small and sickly by their 20s. Things got rapidly worse. Those that were still alive in their 40s were often chronically ill. For example, according to the Civil War veteran health records, heart disease hit 10 to 20 years earlier than today. Nearly 80% of that male population suffered from heart disease by age 60.

Today, less than 50% of males suffer from heart disease by age 60. This is just one statistic among many that is proof of remarkable progress. So a lot has been achieved. But as we know, the challenges we continue to face are enormous.

Despite the progress, many challenges in cardiovascular care are growing. Just one example: metabolic syndrome today affects one in four Americans, and it is growing. The dramatic increase in obesity in the U.S. is a serious health challenge. The Centers for Disease Control (CDC) operates what is termed the CDC Behavioral Risk Factor Surveillance System. It tracks the prevalence of obesity, among other risk factors.

Back in 1991, every state in the Union showed obesity prevalence rates of below 20%, according to this CDC measure. By 2005, the situation had changed starkly for the worse. In 2005, the same CDC assessment found that all but four states had obesity prevalence rates of 20% or more, and 17 states had prevalence rates of 25% or more. Obesity is spreading around the world to Europe; to Asia and the Far East; and to Latin America. We see a lot of other worrying statistics. For example, on adherence to treatment plans. According to one study, it took only one month after leaving the hospital for one out of eight heart attack patients to stop taking the lifesaving drugs prescribed for them. The patients who stopped taking three proven drugs (aspirin, beta-blockers and LDL-lowering treatments) were three times more likely to die during the next year than the patients who stayed on their medications.

We also have challenges when it comes to patient communications and education. There is a lot of room for improvement even in a sophisticated country like the U.S.

But of all the challenges we face, perhaps the biggest one is this: The tendency for health delivery systems to focus on short-term cost containment vs. quality of health delivery for the long term. This is familiar to many of you from other countries as taking the form of government control of health care, health priorities and health budgets.

In the U.S., this is now the challenge facing managed care. Managed care in the U.S. must certainly focus on containing cost, but it must also focus on improving quality of care.

The better managed care plans are genuinely focused on long-term health benefits for the patients. Better managed care gives patients access to education, to preventive care and to quality and choice. Better managed care works with physicians, not against them. Better managed care recognizes the unique and special role of the physician as the "learned intermediary" with the patient.

Being a physician is a special calling. As medical practitioners, all of you entered this calling because you saw your role as a true champion for the patient. That is what the Hippocratic oath is all about. Your role as a physician requires the freedom to exercise medical judgment for the good of the patient. Your role also requires adequate time with the patient for the good of the patient.

So one of our biggest challenges in this field of cardiovascular care and across all of health care is how to advance and encourage better managed care while discouraging and reducing low-quality managed care. Those are some of the big challenges we have in front of us.

Now, let me talk about our opportunities, because I am overall very optimistic that we can achieve positive transformations in cardiovascular care around the world today and for future generations.

Those transformational changes can be accomplished in three critical ways: First, through enhanced prevention; second, through improved intervention; and third, through advancing innovation.

Let me begin with enhanced prevention. Important improvements in cardiovascular health are achievable through disease prevention in all the factors that we know about such as diet, exercise, avoidance of smoking, smoking cessation and simple prophylactic treatments; for example, aspirin to help lessen heart attack risk.

There are two critical factors in prevention of cardiovascular disease: first, patient health literacy and second, disease prevention behavior based especially on health literacy. There are many potential drivers of health literacy and disease prevention: schools, health professionals, employers, government agencies and many others.

In the U.S., one of the important drivers of health literacy and prevention behavior can, and should be, managed care organizations. There are counterparts outside the U.S., whether government programs or other health management programs.

I come back to that concept of "better" managed care. The better managed care plans will put a huge focus on health literacy and disease prevention behavior. They are the most patient-friendly, cost-containing dimension of health care for the long term.

So managed care in the U.S. and other health managers, such as sick funds in other countries, should be encouraged and provided with incentives to build health literacy and disease prevention behavior.

How do we do that? I believe we can achieve great progress across the health care spectrum by aggressively implementing the practice of health metrics scorecards.

I presented this approach recently at the annual meeting of the international association of our industry, the International Federation of Pharmaceutical Manufacturers Associations, or IFPMA, on the occasion of my election as its president.

As I said at that meeting, it is peculiar that consumers today can easily compare the benchmarked fuel efficiencies of automobiles that they are considering for purchase and the annual running costs of refrigerators, yet they cannot easily compare the quality of health delivery.

We can take a major step in breaking down this barrier by publishing simple, transparent, comparable scorecards on important health metrics. In this way, individual enrollees and others, such as employers who pay for their care, can see for themselves how the managed care organization is performing on the key metrics of good health for the long term. This is so enrollees will go to the plans that give the best value, the plans that deliver high performance on the key metrics for long-term good health.

To start with, I suggest that health managers should be scored on just a few critical metrics that are "markers" for health literacy and prevention. These metrics would be related to the percentage of patients covered by a health manager that reach medically endorsed goals on three counts:

1. Reduction in obesity;
2. Smoking avoidance and smoking cessation or reduction; and
3. Increasing exercise.

With this kind of scorecard approach, I believe we would begin to see not only a significant acceleration in health literacy and disease prevention, but also a cost-reduction trend vs. the escalating health-care cost facing all societies.

Now, let me turn to a few comments on enhancing intervention. Here is just one set of statistics that show us how much we can achieve through enhanced intervention: Of the more than 90 million people in the U.S. who could benefit from cholesterol management, only half are diagnosed. Of those people, only half are being treated. And of those being treated, about half are not at goal. In other words, only around 12% of people in the U.S. who are candidates for treatment are getting effective treatment. The goals are getting even lower.

This is only one example of the importance of appropriate interventions in cardiovascular care. There are many, many other examples of underdiagnosis and undertreatment.

In the area of cardiovascular health, I would propose just two metrics to improve intervention. Again, they are based on the percentage of patients enrolled in a managed care plan that are getting to medically endorsed goals: first, metrics on control of high-blood pressure, and second, control of high LDL cholesterol.

With transparent scorecards on these two cardiovascular metrics combined with patient literacy on the importance of these metrics to long-term health, I believe we would accomplish a major upgrade in cardiovascular health.

By the way, beyond the cardiovascular arena that I am addressing with you today, we should also score health providers on other metrics. Other scorecards should include metrics on vaccinations and immunizations; controlling blood sugar levels; and on controlling asthma. Those are some proposals for enhancing intervention.

Now, let me turn to the third dimension of improving cardiovascular care that I mentioned: Innovation. We can see ahead of us enormous opportunities for innovation in many dimensions: new diagnostics; new devices; new delivery systems; and of course, new medicines.

In my own company's work, we see enormous potential ahead. For example, we are working on an important new treatment coming out of our own labs for thrombosis. As you know, current therapy is a combination of aspirin and Plavix. It is not ideal. You may have heard about our very exciting thrombin receptor antagonist compound. We need to see where the science takes us, but we are hoping that this can be in your hands to treat your patients sometime in 2010 or 2011.

Other companies in the pharmaceutical and biotech arena have exciting advances in their pipelines as well, including the exciting new realm of therapies that are targeted and tailored to the individual patient.

However, we face some very big challenges in continuing to power the innovation engine of what I like to call the biopharma industries: Biopharma, because these two worlds of biotech and pharma increasingly converge.

Let me single out today the challenge of product flow. It is clear that the innovation engine that worked so powerfully for several decades is now barely keeping up with products going generic. All across our industry, we see important projects failing, very often at a late stage. The costs of these failures can run to the hundreds of millions of dollars. Even for successful compounds, the cost of clinical trials is going through the roof. This makes it tougher and tougher to fund other new projects, and of course, it increases the cost of treatment.

We have to find ways to make biopharmaceutical innovation more efficient. We need to keep working with regulators and academia on important improvements. For example, we urgently need to see advances in regulatory science that keep pace with the advances in medical science, such as modernizing clinical trial designs, more efficient execution of trials and more efficient subsequent reviews of data packages. Biomarkers and adaptive clinical designs are important examples of the kinds of needed advances in regulatory science that can help make these improvements happen.

We must crack the code on innovation productivity. The entire world of biomedical science must work hard on this because biopharmaceuticals hold such enormous promise for patient benefit not just in cardiovascular care, but across the spectrum of care.

As one example, a steadily rising proportion of our population will be over the age of 80 at which the odds of contracting Alzheimer's disease rise to one in two! One in two! As compassionate societies, we do not want to see this population consigned to cities of nursing homes, and from an economic perspective, we cannot afford it!

Our best hope for a better answer lies with biopharmaceutical innovation. The research under way today in biopharma does hold out hope for remission, or eventually, even cure, of Alzheimer's. But we must build an environment that keeps that innovation happening.

That leads me to my final comment this afternoon. It is a message to our newly elected political leaders here in the U.S. House of Representatives and Senate.

I say to our newly elected law makers: Congratulations on your election. Today, you are already beginning to plan your agendas. As you begin your work, please know that one of your biggest challenges, and biggest responsibilities, is health care. As a nation, and as a society, we are counting on you to play for the long term. Our children and their children are counting on you.

Remember, biomedical research in the U.S. is not only vitally important to the health of our citizens, it is vital to the success of our economy. Other countries understand the high technology power of biomedical innovation. Other countries, such as Japan, are already implementing long-range plans to improve their competitiveness in biomedical research. Countries such as China and India are not far behind.

We are already losing our auto industry and our computer industry to Asia. But America is still pre-eminent in biomedical science. Other countries envy us. My urgent message to the newly elected lawmakers in Washington is this: Don't let this one get away from us.

To sustain our biomedical strength, let me propose one specific priority to the newly elected lawmakers in Washington. I urge you to give the FDA the resources it needs and the independence it needs to do its job well. Benchmark the FDA against other regulators, such as Europe's EMEA, and see where we can improve the innovation, speed and efficiency of the FDA process. And above all, I call on our U.S. lawmakers to be vigilant in keeping the FDA nonpolitical. If we politicize the FDA, we will be damaging not only its authority, but also its science. And if we do that to the FDA, we will be damaging a precious innovation engine of our country.

Finally, I urge our new class of lawmakers to keep just one guiding principle in mind as they address these many important health issues: Do what is right for the patient. If we do what is right for the patient long term, we will see that many, many tough policy questions will be answered in the right way.

Together, we have great opportunities to keep advancing care for the patients. Together, we have great obligations to keep advancing care. We look forward to working with you and collaborating with you on this great mission that we share.